12-3671-ag

In the U.S. Court of Appeals for the Second Circuit __________________

Natural Resources Defense Council, Inc.,

Petitioner,

v.

United States Environmental Protection Agency,

Respondent. __________________

On Petition for Review of an Order of the

United States Environmental Protection Agency __________________

PETITIONER’S BRIEF AND SPECIAL APPENDIX

Of Counsel: Nicholas Morales

Natural Resources Defense Council 1152 15th Street, NW, Suite 300

Washington, DC 20005 (202) 289-1060 Selena Kyle Natural Resources Defense Council 111 Sutter Street, Floor 20 San Francisco, CA 94104 (415) 875-6100 Counsel for Petitioner NRDC

i

CORPORATE DISCLOSURE STATEMENT

Pursuant to Fed. R. App. P. 26.1, petitioner Natural Resources Defense

Council states that it has no parent companies, subsidiaries, or affiliates that have

issued shares to the public in the United States or abroad.

ii

TABLE OF CONTENTS

CORPORATE DISCLOSURE STATEMENT .......................................................... i

TABLE OF CONTENTS .......................................................................................... ii

TABLE OF AUTHORITIES ..................................................................................... v

LIST OF ACRONYMS AND ABBREVIATIONS ................................................. xi

JURISDICTIONAL STATEMENT .......................................................................... 1

STATEMENT OF ISSUES ....................................................................................... 1

STATEMENT OF THE CASE .................................................................................. 2

STATEMENT OF FACTS ........................................................................................ 6

I. The Food Act Requires EPA to Assess Pesticides’ Risks to Human Health and to Prevent the Sale of Unsafe Pesticides ......................................................................................................... 6

II. The National Academy of Sciences Has Proposed Principles to Restrict EPA’s Use of Studies Intentionally Exposing Humans to Pesticides ....................................................................... 9

III. Congress Passed Section 201 to Restrict EPA’s Use of Studies Intentionally Exposing Humans to Pesticides .................................. 12

IV. EPA’s Human Testing Rule Permits EPA to Use Ethically Deficient Human Dosing Studies, Contrary to Section 201 and the National Academy’s Recommendations .......................................................................................... 16

V. EPA Used a Study Testing Dichlorvos on Humans to Assess the Pesticide’s Safety, in Reliance on Its Unlawful Human Testing Rule ...................................................................................... 18

iii

A. EPA’s Office of Pesticides Reviewed and Identified Ethical Deficiencies in the Dichlorvos Human Study ...............................21

B. EPA’s Human Studies Review Board Identified Ethical and Statistical Deficiencies in the Dichlorvos Human Study .............................................................................................23

C. EPA Relied on the Dichlorvos Human Study to Authorize Continued Use of Dichlorvos ...................................................25

VI. NRDC Brought Administrative and Legal Challenges to EPA’s Use of the Dichlorvos Human Study and Continued Approval of Dichlorvos ............................................................... 27

STANDING ............................................................................................................. 29

SUMMARY OF ARGUMENT ............................................................................... 33

ARGUMENT ........................................................................................................... 35

I. Standard of Review........................................................................................ 35

II. EPA’s Use of the Dichlorvos Human Study Violated Section 201 .................................................................................................... 37

A. EPA’s Application of Its “Significantly Deficient” Test to Allow It to Use the Dichlorvos Human Study Violated Section 201 ..................................................................................38

B. Section 201 Requires EPA’s Rule on Use of Intentional Human Dosing Studies to Be Consistent with the National Academy of Sciences’ Recommendations ......................................................................................44

III. EPA Unlawfully Denied NRDC’s Request for an Evidentiary Hearing on Material Factual Issues Concerning the Scientific Reliability of the Dichlorvos Human Study and the Existence of Informed Consent ................................. 46

iv

A. The Food Act and EPA’s Implementing Regulations Require EPA to Conduct an Evidentiary Hearing to Resolve Genuine, Material, and Substantial Issues of Fact .............................................................................................................47

B. The Food Act Entitles NRDC to a Hearing to Determine Whether the Dichlorvos Human Study Was Conducted Without the Informed Consent of Its Subjects ......................................................................................................49

C. NRDC Was Entitled to a Hearing to Determine Whether the Dichlorvos Human Study Was Scientifically Unreliable ............................................................................55

CONCLUSION ........................................................................................................ 64

CERTIFICATE OF COMPLIANCE ....................................................................... 65

v

TABLE OF AUTHORITIES

CASES

Adams v. EPA, 38 F.3d 43 (1st Cir. 1994) ..............................................................................37

Alabama-Tombigbee Rivers Coal. v. Dep’t of Interior, 26 F.3d 1103 (11th Cir. 1994) .......................................................................43

Am. Cyanamid Co. v. FDA, 606 F.2d 1307 (D.C. Cir. 1979) .............................................................. 46, 61

Anderson v. Liberty Lobby, Inc., 477 U.S. 242 (1986).......................................................................................48

Baur v. Veneman, 352 F.3d 625 (2d Cir. 2003) ..........................................................................31

Bellevue Hosp. Ctr. v. Leavitt, 443 F.3d 163 (2d Cir. 2006) ..........................................................................62

Chambers v. TRM Copy Ctrs. Corp., 43 F.3d 29 (2d Cir. 1994) ..............................................................................52

Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837 (1984).......................................................................... 37, 44, 46

Citizens for Jazz on WRVR, Inc. v. FCC, 775 F.2d 392 (D.C. Cir. 1985) .......................................................................49

City of Wausau v. United States, 703 F.2d 1042 (7th Cir. 1983) .......................................................................37

Cmty. Nutrition Inst. v. Young, 773 F.2d 1356 (D.C. Cir. 1985) .............................................................. 36, 60

DeNeui v. Wellman, No. Civ. 07-4172, 2009 WL 4847086 (D.S.D. Dec. 9, 2009) ..........................................................................................................50

vi

Friends of the Earth v. Laidlaw Envtl. Servs., 528 U.S. 167 (2000)................................................................................ 29, 31

Gen. Dynamics Land Sys. v. Cline, 540 U.S. 581 (2004).......................................................................................46

Gen. Motors Corp. v. Fed. Energy Regulatory Comm’n, 656 F.2d 791 (D.C. Cir. 1981) .......................................................................32

Hunt v. Wash. State Apple Adver. Comm’n, 432 U.S. 333 (1977)................................................................................ 29, 33

Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215 (4th Cir. 1972) ............................................................ 36, 61, 62

Midwestern Gas Transmission Co. v. Fed. Energy Regulatory Comm’n, 589 F.2d 603 (D.C. Cir. 1978) .......................................................................32

Motor Vehicle Mfrs. Ass’n v. State Farm Mut. Auto. Ins. Co., 463 U.S. 29 (1983).........................................................................................36

N.Y. Pub. Interest Grp. v. Whitman, 321 F.3d 316 (2d Cir. 2003) ..........................................................................31

Nat’l Ass’n of Home Builders v. Defenders of Wildlife, 551 U.S. 644 (2007).......................................................................................39

Nat’l Corn Growers Ass’n v. EPA, 613 F.3d 266 (D.C. Cir. 2010) .......................................................................37

NRDC v. EPA, 658 F.3d 200 (2d Cir. 2011) .................................................................. passim

O’Hara v. Nat’l Union Fire Ins. Co. of Pittsburgh, 642 F.3d 110 (2d Cir. 2011) ..........................................................................48

Pactra Indus. v. Consumer Prod. Safety Comm’n, 555 F.2d 677 (9th Cir. 1977) .........................................................................61

vii

Rainwater v. Alarcon, 268 F. App’x 531 (9th Cir. 2008) ..................................................................50

Ratanasen v. Cal. Dep’t of Health Servs., 11 F.3d 1467 (9th Cir. 1993) .................................................................. 58, 60

United States v. FCC, 652 F.2d 72 (D.C. Cir. 1980) .........................................................................37

Waterkeeper Alliance v. EPA, 399 F.3d 486 (2d Cir. 2005) ................................................................... 35, 37

Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973)................................................................................ 36, 37

STATUTES

Federal Food, Drug, and Cosmetic Act

21 U.S.C. § 342(a)(2)(B) ........................................................................................... 6

21 U.S.C. § 342(a)(4) ................................................................................................. 6

21 U.S.C. § 346a(a)(1) ............................................................................................... 6

21 U.S.C. § 346a(b)(2)(A)(i) ...................................................................................31

21 U.S.C. § 346a(b)(2)(A)(ii) .................................................................................... 6

21 U.S.C. § 346a(b)(2)(C) ......................................................................................... 8

21 U.S.C. § 346a(b)(2)(C)(ii)(II) ............................................................................... 9

21 U.S.C. § 346a(d) .......................................................................................... 27, 47

21 U.S.C. § 346a(g) .................................................................................................27

21 U.S.C. § 346a(g)(2) .............................................................................................27

21 U.S.C. § 346a(g)(2)(A)-(B) ................................................................................47

21 U.S.C. § 346a(g)(2)(B) ............................................................................... passim

21 U.S.C. § 346a(h)(1) ............................................................................................... 1

viii

21 U.S.C. § 346a(q)(1) ............................................................................................... 9

21 U.S.C. § 348(f)(1)) ..............................................................................................37

Federal Insecticide, Fungicide, and Rodencticide Act

7 U.S.C. § 136(bb) .................................................................................................6, 7

7 U.S.C. § 136a(a) ...................................................................................................... 6

7 U.S.C. § 136a(c)(5)(C) ........................................................................................6, 7

Department of the Interior, Environment, and Related Agencies Appropriations Act of 2006,

Pub. L. No. 109-54, § 201, 119 Stat. 499 .............................................. passim

5 U.S.C. § 706(2)(A) ................................................................................................35

47 U.S.C. § 309(d)(2)...............................................................................................49

REGULATIONS

40 C.F.R. § 26.1602(b)(2) ........................................................................................23

40 C.F.R. § 26.1603 .................................................................................................17

40 C.F.R. § 26.1603(b) ............................................................................................23

40 C.F.R. § 26.1701 .......................................................................................... 54, 62

40 C.F.R. § 26.1704 ......................................................................................... passim

40 C.F.R. § 178.32(b) ........................................................................... 46, 48, 49, 54

40 C.F.R. § 178.32(b)(1) ............................................................................. 58, 59, 63

40 C.F.R. § 178.32(b)(2) .................................................................................. passim

40 C.F.R. § 178.32(b)(3) ............................................................................. 54, 62, 63

40 C.F.R. § 179.24 ...................................................................................................62

40 C.F.R. § 179.60 ............................................................................................ 47, 62

ix

40 C.F.R. § 179.70 ...................................................................................................47

40 C.F.R. § 179.85 ............................................................................................ 47, 49

40 C.F.R. § 179.93 ............................................................................................ 47, 49

40 C.F.R. § 179.105(a) .............................................................................................47

60 Fed. Reg. 50,338 (Sept. 28, 1995) ......................................................................19

70 Fed. Reg. 6661 (Feb. 8, 2005) ............................................................................12

71 Fed. Reg. 6138 (Feb. 6, 2006) ........................................................... 9, 10, 16, 17

72 Fed. Reg. 68,662 (Dec. 5, 2007) ................................................................. passim

73 Fed. Reg. 42,683 (July 23, 2008) ................................................................ passim

76 Fed. Reg. 5735 (Feb. 2, 2011) ............................................................................18

77 Fed. Reg. 54,402 (Sept. 5, 2012) ................................................................ passim

LEGISLATIVE HISTORY

151 Cong. Rec. H3671 (May 19, 2005) ............................................................ 13, 45

151 Cong. Rec. H7013-7023 (July 28, 2005) .................................................. passim

151 Cong. Rec. S7551-7561 (June 29, 2005) .................................................. passim

Minority Staff of the Special Investigations Division of the House Committee on Government Reform & Office of Senator Barbara Boxer, Human Pesticide Experiments (2005) .......................................................................... 10, 20, 42

Minority Staff of the Special Investigations Division of the House Committee on Government Reform, Flash Report: New EPA Proposal Encourages Human Pesticide Experiments (2005) .................................................... 15, 42

OTHER AUTHORITIES

EPA Human Studies Review Board, April 4-6, 2006 Meeting Report (June 26, 2006) ............................................................ passim

x

EPA Office of Prevention, Pesticides and Toxic Substances, Initial Ethics Review of DDVP Human Study (Mar. 16, 2006) ............................................................... passim

EPA, Final Agency Review DRAFT, Protections for Test Subjects in Human Research; Proposed Rule (June 20, 2005) ........................................................................................... 13, 14, 40

National Academy of Sciences, Intentional Human Dosing Studies for EPA Regulatory Purposes (2004) ..................................................................................................... passim

COURT RULES

Fed. R. App. P. 26.1 .................................................................................................. ii

Fed. R. Civ. P. 56 .....................................................................................................48

xi

LIST OF ACRONYMS AND ABBREVIATIONS

The Academy The National Academy of Sciences

The Board Human Studies Review Board

DDVP Dichlorvos

EPA U.S. Environmental Protection Agency

FIFRA Federal Insecticide, Fungicide, and Rodenticide Act

Food Act Federal Food, Drug, and Cosmetic Act

FQPA Food Quality Protection Act of 1996

NRDC Natural Resources Defense Council

Section 201 Section 201 of the Department of the Interior, Environment, and Related Agencies Appropriations Act of 2006

1

JURISDICTIONAL STATEMENT

This Court has jurisdiction under the Federal Food, Drug, and Cosmetic Act

(Food Act), which provides that “any person who will be adversely affected” by an

order denying pesticide objections and a request for an evidentiary hearing may

file a petition for review in the appropriate circuit court of appeals. 21 U.S.C.

§ 346a(h)(1). The U.S. Environmental Protection Agency (EPA) issued a final

order on September 5, 2012 (2012 order) denying objections and a hearing request

filed by Petitioner Natural Resources Defense Council (NRDC) concerning the

pesticide dichlorvos. SPA-001; see also infra, Statement of Facts VI.

This petition was timely filed within sixty days of publication of the 2012

order. 21 U.S.C. § 346a(h)(1); SPA-147. This venue is appropriate because NRDC

resides and maintains its principal place of business in New York. 21 U.S.C.

§ 346a(h)(1); SPA-152 (Lopez Decl. ¶ 3). NRDC has standing to bring this

petition, as discussed below. See infra, Standing.

STATEMENT OF ISSUES

1. Did EPA violate Section 201 of the Department of the Interior,

Environment, and Related Agencies Appropriations Act of 2006 (Section 201),

Pub. L. No. 109-54, § 201, 119 Stat. 499, 531, by using a study in which humans

2

were intentionally dosed with dichlorvos that was deficient relative to the ethical

standards prevailing at the time the study was conducted?

2. Was EPA’s denial of NRDC’s request under the Food Act, 21 U.S.C.

§ 346a(g)(2)(B), for an evidentiary hearing on disputed factual issues concerning

whether the study’s participants gave their informed consent to be dosed with

dichlorvos and whether the study was scientifically reliable, arbitrary and

capricious and contrary to law?

STATEMENT OF THE CASE

The pesticide dichlorvos, also known as DDVP, is a potent neurotoxin and a

likely carcinogen. A-486, 536-37, 545. In 1997, the sole United States

manufacturer of dichlorvos funded a study in which six young men swallowed pills

containing dichlorvos each morning for twenty-one days, to measure the

pesticide’s toxic effects on the nervous system. A-414, 418, 673-74, 702. The

manufacturer commissioned the study to gather data that could support the

continued sale of dichlorvos, A-418, 451, following 1996 amendments to the Food

Act that required pesticides to meet a more protective margin of safety. Id.; NRDC

v. EPA, 658 F.3d at 202-03. EPA’s assessment of the health risks affect the

pesticide levels EPA may allow to remain as residues on food crops and to be used

3

in other products, like home insecticides. NRDC v. EPA, 658 F.3d at 203-04; infra,

Statement of Facts I.

In 2005, Congress passed Section 201, which requires EPA to follow

scientific and ethical principles proposed by the National Academy of Sciences in

deciding what human studies it may use in its pesticide regulatory work. SPA-116;

infra, Statement of Facts III. With respect to human studies in existence before

EPA’s adoption of regulations implementing Section 201, the statute bars EPA

from using studies that are “deficient” relative to the ethical standards prevailing at

the time such studies were conducted. Infra, Argument II.A.

EPA has twice reviewed the dichlorvos human study and found

“deficien[cies]” relative to then-prevailing ethical standards. A-413 to 417, 678-82.

The deficiencies identified by EPA include the study investigator’s use of

misleading consent forms that may have led the subjects dosed with dichlorvos to

believe they were ingesting a medical drug, not a pesticide. A-414 to 415, 680-81;

infra, Statement of Facts V.A. EPA also found substantial scientific flaws in the

study, flaws that led its Human Studies Review Board—a body established

pursuant to Section 201 and charged with evaluating human studies conducted by

third parties and submitted to EPA—to conclude the study had at best “limited . . .

4

value” for EPA’s regulatory decisionmaking. A-456, 674-76, 680; infra, Statement

of Facts V.B.

Despite its own findings that the dichlorvos human study was ethically

deficient and scientifically flawed, EPA used and relied on the study to leave in

place regulations that allow widespread use of and human exposure to dichlorvos.

See infra, Statement of Facts V.C; see also NRDC v. EPA, 658 F.3d at 207

(surveying approved uses of dichlorvos).

To protect its members and the public from the health risks posed by

dichlorvos and to prevent EPA from continuing to rely on an unethical and

statistically invalid human study to authorize dichlorvos’s continued use, NRDC in

2006 petitioned EPA under the Food Act to revoke regulatory approvals for

dichlorvos. NRDC v. EPA, 658 F.3d at 205. EPA denied that petition and, in a final

order in 2008 (2008 order), denied NRDC’s subsequent administrative objections

to EPA’s dichlorvos approvals and request for an evidentiary hearing on specific

ethical and scientific flaws in the dichlorvos study. A-695; SPA-021. NRDC

petitioned for review of EPA’s 2008 order in this Court, which in 2011 vacated in

part and remanded to EPA. On September 5, 2012, following remand, EPA issued

5

a second final order in which it once again denied NRDC’s objections and

evidentiary hearing request (2012 order).1 SPA-001.

This petition challenges the 2012 order on two grounds. First, EPA has

violated Section 201 by using an ethically deficient human study. Second, EPA has

arbitrarily denied NRDC’s request for an evidentiary hearing, under the Food Act,

on material factual issues concerning the adequacy of the dichlorvos human

study’s informed consent procedure and the study’s statistical validity. 21 U.S.C.

§ 346a(g)(2)(B).2 This Court should accordingly vacate EPA’s 2012 order. The

Court should also prevent EPA from relying on the human study or, in the

alternative, order EPA to grant NRDC’s hearing request.

1 The 2012 order was signed by Steven Bradbury, Director of EPA’s Office of

Pesticide Programs. SPA-020. 2 NRDC presented this evidentiary hearing issue in its 2008 petition for review

in this Court, but this Court did not reach the issue because it granted NRDC’s petition and vacated and remanded the relevant portions of EPA’s 2008 order on another ground. See infra, Statement of Facts VI; NRDC v. EPA, 658 F.3d at 219.

6

STATEMENT OF FACTS

I. The Food Act Requires EPA to Assess Pesticides’ Risks to Human Health and to Prevent the Sale of Unsafe Pesticides

The Food Act prohibits the sale of food containing pesticide residue unless

EPA has set a “tolerance,” or maximum limit, for the pesticide in or on the food,

and the level of pesticide residue falls below the regulatory limit. 21 U.S.C.

§§ 342(a)(2)(B), 346a(a)(1), (4). EPA may establish or leave in place a tolerance

on a food only if EPA determines it is “safe.” Id. § 346a(b)(2)(A)(ii). A tolerance

is “safe” for purposes of the Act if there is a reasonable certainty that no harm to

humans will result from aggregate exposure to the pesticide, which includes all

non-dietary exposures. Id. § 346a(b)(2)(A)(ii). This standard governs both EPA’s

establishment of tolerances and its denials of administrative petitions to revoke

tolerances under the Food Act. SPA-003 (col. 1).

EPA also regulates pesticides under a second, related statute, the Federal

Insecticide, Fungicide, and Rodenticide Act (FIFRA), which requires EPA to

register pesticides before they can be sold or distributed in the United States. 7

U.S.C. § 136a(a). In determining whether a pesticide may be registered under

FIFRA, EPA must consider whether the pesticide is safe under the Food Act. Id.

§§ 136(bb), 136a(c)(5)(C). FIFRA prevents EPA from registering (or reregistering)

7

a pesticide if this would cause “unreasonable adverse effects on the environment.”

Id. § 136a(c)(5)(C). Those effects include “human dietary risk from residues that

result from a use of a pesticide in or on any food inconsistent with the standard

under [the Food Act].” Id. § 136(bb). EPA’s regulatory assessment of a pesticide’s

risks under the Food Act can therefore affect how the pesticide is used both on

food crops and in other products (such as home insecticides) regulated through

FIFRA.

To assess the risk to humans of aggregate exposure to a pesticide, EPA

generally reviews the results of laboratory animal studies designed to measure the

pesticides’ toxicity to animals. SPA-023 (col. 3) to 024 (col. 1). EPA uses these

animal studies to set a level of exposure to the pesticide that EPA determines has

been shown not to cause harm to animals, called the “no effects” dose. SPA-024

(col. 2). Where the available data from animal studies do not allow EPA to

determine a “no effects” dose, EPA instead estimates that dose by extrapolating

from available information on the lowest dose shown to cause harm in animals––

called the “low effects” dose. SPA-005 to 007, 024 (col. 2), 033 (col. 3); see also

NRDC v. EPA, 658 F.3d at 207-08.

This no (or low) effects dose is the “starting point” for EPA’s assessment of

what health risks the pesticide poses to humans who may be exposed through

8

various pathways, such as ingestion of pesticide residues on food or in drinking

water or inhalation of vapors from insecticide strips used in homes. SPA-024 (cols.

2-3), 029 (col. 2) (both discussing starting point, or “point of departure”); A-489

(discussing exposure scenarios). EPA then typically applies one or more safety

factors intended to account for uncertainties in the experimentally-derived data that

limit the data’s reliability as a means of determining what exposure levels are

“safe” for all humans. NRDC v. EPA, 658 F.3d at 208; SPA-004.

Until 1996, EPA typically applied two basic types of uncertainty factors.

NRDC v. EPA, 658 F.3d at 208; SPA-004 (col. 2). First, to account for the fact that

the laboratory animals on which pesticides are usually tested may be less sensitive

to those pesticides than humans would be, EPA applied an interspecies safety

factor. SPA-004 (col. 2). Second, to account for the fact that individuals may differ

widely in their sensitivity to a particular pesticide, EPA increased the target margin

of exposure by a second, intraspecies safety factor. Id.

In the Food Quality Protection Act of 1996 (FQPA), Congress amended the

Food Act to require EPA to apply an additional safety factor to account for the fact

that children may be significantly more vulnerable to pesticide exposures than

adults. 21 U.S.C. § 346a(b)(2)(C); NRDC v. EPA, 658 F.3d at 202-04. The FQPA

now requires EPA to reduce by tenfold the levels of pesticide exposure it would

9

have deemed safe based on other considerations to help ensure that its final

regulatory approvals are safe for children.3 21 U.S.C. § 346a(b)(2)(C); NRDC v.

EPA, 658 F.3d at 203, 208; A-040. The FQPA also required EPA to reassess its

existing pesticide approvals to ensure that they remain lawful under the Food Act

after accounting for this new, Congressionally mandated children’s safety factor.

21 U.S.C. § 346a(q)(1).

II. The National Academy of Sciences Has Proposed Principles to Restrict EPA’s Use of Studies Intentionally Exposing Humans to Pesticides

The additional margin of safety Congress mandated in the FQPA caused

concern among some pesticide manufacturers that, upon reassessment, certain

long-used pesticides would no longer qualify as safe under the Food Act and

FIFRA and could no longer be sold or distributed in the United States. A-039, 040

(National Academy of Sciences’ account of manufacturers’ concerns that “certain

pesticide uses . . . might otherwise have been precluded under FQPA’s new safety

standards”), 397 (col. 1). In an effort to help ensure continued sales of their

products, some pesticide manufacturers submitted studies that deliberately exposed

humans to pesticides. A-039 to 040, 346 (col. 3) (submission of human toxicity

3 The FQPA allows EPA to use a value different than ten for the children’s

safety factor only where reliable data for a particular pesticide shows a different value will be sufficiently protective. 21 U.S.C. § 346a(b)(2)(C)(ii)(II).

10

studies was “rare” pre-FQPA and “increased” after its passage, with twenty or

more studies submitted since 1996), 397 (col. 1) (“Much third-party research is

conducted by private, for profit organizations in the hope that the results will lead

to financial benefits, often through changes in government regulation.”). These

human dosing studies were submitted in an effort to develop data that might

“justify reducing the interspecies uncertainty factor” EPA typically applies when it

must extrapolate from animal studies, and thereby “permit[] the continuation of

certain pesticide uses” that otherwise would not meet the Food Act’s strict standard

of safety. A-040 to 041; see also A-039, 397 (col. 1), 451; SPA-133 (col. 1). Some

pesticide manufacturers have paid human subjects to eat or drink pesticides, to

enter pesticide vapor “chambers,” and to have pesticides sprayed into their eyes or

rubbed onto their skin. A-305 to 308, 328-31.

When initially faced with the question of whether to use these intentional

human dosing studies in its regulatory work, EPA declared that it did not need the

results of human tests to safely regulate pesticides, and that “[t]he protection of

public health from adverse effects of pesticides can be achieved through reliance

on animal testing and use of the highest ethical standards.” A-743 (quoting EPA’s

July 27, 1998 statement); see also A-041. EPA also sought the guidance of the

National Academy of Sciences, an organization Congress chartered to advise the

11

federal government on scientific matters. A-017 to 019, 022. EPA asked the

Academy to “provide recommendations to [EPA] to help address the scientific and

ethical questions related to . . . research involving deliberate exposure of human

subjects to toxicants when used to identify or quantify toxic endpoints.” A-017.

The Academy responded to EPA’s charge by launching an inquiry to

determine “whether and, if so, under what circumstances EPA should accept and

consider intentional human dosing studies conducted by companies or other

sources outside the agency . . . to gather evidence relating to the risks of a

chemical . . . .” A-038. In 2004, the Academy concluded its investigation and

published a report (“Report”) that sets out seventeen specific principles, which the

Report enumerates as “Recommendations.” A-020 to 021, 043-57. Several of those

principles address EPA’s use of human dosing studies. The Academy concluded

that as a general rule, “EPA should not use data from ethically problematic studies

to inform its regulatory efforts.” A-163. With respect to human studies already in

existence, the Academy proposed a specific standard, labeled “Recommendation 5-

7” in its Report, that reads in relevant part:

EPA should accept scientifically valid studies conducted before its new rules are implemented unless there is clear and convincing evidence that the conduct of those studies was fundamentally unethical (e.g., the studies were intended to seriously harm participants or failed to obtain

12

informed consent) or that the conduct was deficient relative to then-prevailing ethical standards.

A-167 (emphasis added) (footnote omitted). The Report proposed additional

principles to govern which future human studies EPA should deem acceptable for

use in regulatory decisions. A-163 to 166.

III. Congress Passed Section 201 to Restrict EPA’s Use of Studies Intentionally Exposing Humans to Pesticides

Not long after the Academy published its 2004 Report, EPA issued a

“proposed plan” for its consideration of human tests in pesticide regulation in

which it promised to “consider” the Report, but made no commitment to follow the

Report’s Recommendations. A-274 (col. 2). EPA also said it would propose a rule

to govern its use of “newly conducted” human studies and “consider whether to

propose a rule applying to certain previously conducted human studies.” A-274

(cols. 1-2). EPA also advised that until such time as it chose to adopt a rule, it

planned to “generally accept” previously conducted studies it deemed scientifically

valid “unless there is clear evidence that the conduct of those studies was

fundamentally unethical . . . or was significantly deficient relative to the ethical

standards prevailing at the time the study [sic] was conducted.” Id. (emphasis

added).

13

Just months after EPA announced its “proposed plan,” the House of

Representatives passed an amendment to EPA’s appropriations bill for 2006 that

would have placed a moratorium on any EPA use of human dosing studies for

pesticides. SPA-120 to 121. The amendment’s sponsors expressed displeasure that

“EPA has chosen to go against the recommendation of the National Academy of

Sciences.” SPA-121 (cols. 1-2) (statement of Rep. Solis). Concerned that EPA

would continue to accept and use the results of human studies which “fail to meet

minimum international standards,” to the detriment of public health, the sponsors

crafted the amendment to bar EPA’s use of such studies until EPA put “binding

safeguards in place.” Id. (col. 2).

Despite this expression of disapproval, EPA developed a “Final Agency

Review Draft” (or “draft rule”) of a proposed regulation on use of human pesticide

studies that departed from key Recommendations of the National Academy of

Sciences. See A-333 to 340 (draft rule); SPA-141 (col. 2) (statement of Sen.

Clinton). With respect to Recommendation 5-7, in which the Academy proposed

that EPA reject previously conducted studies that were ethically “deficient”

relative to then-prevailing ethical standards, EPA stated that it had “modified” the

Academy’s standard. A-337. EPA’s draft rule proposed that EPA reject such

studies only if it determined they were “significantly deficient” compared to then-

14

prevailing ethical standards. Id. (emphasis added). EPA explained that this “change

reflects EPA’s view”––not the view of the National Academy––“that refusing to

rely on data . . . should be reserved for the most egregious of conduct.” Id.

(emphasis added).

Less than two weeks after EPA developed its draft rule, the Senate took up

the issue of EPA’s use of third-party human tests. The Senate passed an

amendment to EPA’s 2006 appropriations bill that, like the House amendment

discussed above, would have prohibited EPA’s use of all “third-party intentional

dosing human studies for pesticides.” SPA-138 (col. 1), 146. Senators criticized the

standard EPA intended to propose as “in direct contradiction to the key

recommendations made by the National Academy of Sciences.” SPA-141 (col. 2)

(statement of Sen. Clinton). The underlying concern, expressed again and again

during the floor debate, was that the previously conducted studies testing pesticides

on humans should not be used by EPA due to the studies’ many ethical and

scientific faults. See, e.g., id. (statement of Senator Clinton denouncing studies that

“failed to obtain informed consent, inflicted harm on the human subjects, . . . or

failed to conduct long-term monitoring”), SPA-144 (col. 1) (statement of Senator

Obama criticizing EPA’s consideration of data from human studies that were not

15

“scientifically valid,” “failed to take the health complaints of the subjects

seriously,” and “failed to disclose the risk to the subjects”).

During further debate on the conference report for the 2006 appropriations

bill, Members of Congress expressly chided EPA’s draft rule for its insertion of the

word “significantly” to modify the National Academy’s proposal that EPA reject

all older studies that were “deficient” relative to then-prevailing ethical standards.

SPA-133 (col. 1); A-284 to 285 (report submitted into Congressional record). The

House sponsor of the legislation submitted a report into the record that stated that

this change would “permit EPA to continue relying on old unethical studies” in

contravention of the National Academy of Sciences recommendation. A-284 to

285; SPA-133.

Congress’s final 2006 appropriations bill for EPA includes a provision that

bans EPA’s use of outside human studies until EPA adopts a regulation adhering to

the Recommendations made by the National Academy of Sciences. The provision,

entitled Section 201, states in relevant part:

Sec. 201. None of the funds made available by this Act may be used by the Administrator of the Environmental Protection Agency to accept, consider, or rely on third-party intentional dosing human toxicity studies for pesticides, or to conduct intentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject . . . . Such rule

16

shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with the principles proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principles of the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects Review Board.

Department of the Interior, Environment, and Related Agencies Appropriations

Act of 2006, Pub. L. No. 109-54, § 201, 119 Stat. 499, 531 (emphasis added).

IV. EPA’s Human Testing Rule Permits EPA to Use Ethically Deficient Human Dosing Studies, Contrary to Section 201 and the National Academy’s Recommendations

In 2006, EPA issued a final regulation known as the Human Testing Rule.

A-373 (codified at 40 C.F.R. Parts 9 and 26). The Rule, like the draft rule EPA

completed shortly before Congress enacted Section 201, purports to allow EPA to

use human studies conducted before adoption of the Rule unless there is “clear and

convincing evidence” that either the conduct of the study was “fundamentally

unethical” or was “significantly deficient relative to the ethical standards prevailing

at the time the research was conducted.” 40 C.F.R. § 26.1704 (emphasis added).

In its Federal Register notice adopting the Rule, EPA explained that it did not

consider itself bound by Section 201 to adopt standards consistent with the

seventeen principles, called “Recommendations,” that comprise the core of the

National Academy’s 2004 Report. A-400 (cols. 1-2). EPA conceded that Section

17

201 requires it to adopt a rule that is consistent with the “principles proposed in the

2004 report of the National Academy of Sciences.” Id. (col. 1); SPA-116. EPA

asserted, however, that it read Congress’s reference to “principles proposed in the

2004 report” to refer not to the Academy’s seventeen proposed principles, but to

three much vaguer concepts (“beneficence,” “justice,” and “respect for persons”)

identified in a 1979 document called the “Belmont Report” and mentioned by the

Academy in scattered background portions of its 2004 Report. A-087 to 088, 094,

149, 151-53, 400 (cols. 1-2). EPA then explained that it understood the Rule to be

consistent with the concepts of “beneficence,” “justice,” and “respect for persons.”

A-400 (col. 2).

The Rule also established a Human Studies Review Board, consisting of

EPA-appointed members, to review and comment on the scientific and ethical

aspects of human studies submitted to EPA. 40 C.F.R. § 26.1603; SPA-028 (col.

3).

A coalition of public health and farmworker rights organizations, including

NRDC, challenged the Human Testing Rule as contrary to Section 201; their

petitions for review were consolidated in this Court. See NRDC v. EPA, Nos. 06-

0820-ag (L), 06-1895-ag (CON), 06-2149-ag (CON), 06-2360-ag (CON) (lead

petition filed Feb. 23, 2006). Petitioners argued, among other things, that the

18

Rule’s “significantly deficient” threshold for rejection of older studies made it

inconsistent with Recommendation 5-7 in the National Academy’s Report, and

accordingly violated Congress’s mandate to EPA to adopt a rule “consistent with”

the principles proposed in the Report. The parties reached a settlement, pursuant to

which EPA agreed to propose an amendment to the Rule that would remove the

term “significantly” from the standard regulating agency use of previously

conducted human dosing studies. See 76 Fed. Reg. 5735, 5740-41, 5750 (Feb. 2,

2011) (discussing settlement). EPA agreed to take final action adopting the

amended Rule by December 18, 2011. Id. at 5741 (col. 1). Although EPA did

propose the amendment, id. at 5735, the settlement deadline for finalizing the

proposal passed over a year ago, and EPA has never finalized the amendment.

V. EPA Used a Study Testing Dichlorvos on Humans to Assess the Pesticide’s Safety, in Reliance on Its Unlawful Human Testing Rule

Dichlorvos was developed from World War II nerve warfare agents. A-599.

It is now widely used to kill insects. A-486. People may become exposed to

dichlorvos by inhaling vapors from “no-pest” strips sold for home use; by

ingesting dichlorvos residues on food and in drinking water; and by coming into

contact with dichlorvos used in picnic areas, parking lots, and other outdoor

19

spaces, as well as in restaurants, theaters, and other building interiors. A-486, 517,

519, 527, 563-64, 599.

Exposure to dichlorvos can seriously harm humans. EPA has recognized that

dichlorvos interferes with the normal functioning of the nervous system, impairing

the function of a critical enzyme called cholinesterase that facilitates

communication among nerve cells. A-523, 536-37, 599, 601. Other health effects

associated with dichlorvos exposure range from vomiting, diarrhea, sweating, and

muscle twitching to more serious symptoms like seizures, loss of consciousness,

and death. A-549 to 550, 599.

Dichlorvos also has been connected to increased rates of cancer in both

humans and animals. A-599 (use of dichlorvos “no-pest strips” in home linked to

three-fold increased risk of leukemia in children under age fifteen); A-545 (EPA

finding that dichlorvos is “suggestive” of cancer in humans); 60 Fed. Reg. 50,338,

50,338 (Sept. 28, 1995) (EPA conclusion that dichlorvos poses “carcinogenic

risks”). California has classified dichlorvos as a known human carcinogen. A-599.

In 2006, following a reassessment of dichlorvos’s health risks mandated by

the FQPA, see supra, Statement of Facts I, EPA decided to sanction the continued

sale of dichlorvos. SPA-029 (col. 3); A-527. In reaching this decision, EPA relied

on data from an unpublished study, conducted one year after Congress amended

20

the Food Act in 1996 to require more stringent regulation of pesticides, in which

humans were intentionally dosed with dichlorvos (“dichlorvos human study”) to

measure its toxic effects on the tested subjects’ nervous systems. SPA-008 (col. 3),

041 (cols. 2-3).4

The chemical company Amvac, the sole U.S. manufacturer of dichlorvos,

funded the human study to supply data that could support reduction of the tenfold

interspecies safety factor. A-414, 418, 451, 702. The study was conducted overseas

and authored by A.J. Gledhill. A-413; SPA-030 (col. 1). The tested subjects—six

young, healthy, white males—were paid 330 pounds sterling (about $500) each to

swallow pesticide pills each morning for three weeks. A-414, 673-74. Blood

samples were collected from the subjects to measure dichlorvos’s inhibition of

cholinesterase, an enzyme critical to nervous system functioning. A-674.

The dichlorvos human study was one of the human dosing studies that Congress

specifically condemned for its ethical and scientific defects in the debate that led

up to its enactment of Section 201. See SPA-132 (col. 3) to 133 (col. 1), 138 (col.

3); A-310, 316, 319-21, 326-27.

4 This study is entitled Dichlorvos: A Single Blind, Placebo Controlled,

Randomized Study to Investigate the Effects of Multiple Oral Dosing on Erythrocyte Cholinesterase Inhibition in Healthy Male Volunteers (MRID 44248801) (Mar. 24, 1997).

21

A. EPA’s Office of Pesticides Reviewed and Identified Ethical Deficiencies in the Dichlorvos Human Study

In 2006, EPA’s Office of Prevention, Pesticides and Toxic Substances

(Pesticide Office) conducted an initial review of whether the dichlorvos human

study complied with ethical standards prevailing at the time the study was

conducted. A-413. EPA identified the World Medical Association’s Declaration of

Helsinki of 1989 as the source of ethical standards prevailing at the time the

dichlorvos human study was conducted and reviewed the study against those

standards. A-413 to 415.

EPA noted several serious ethical problems with the study, including with its

procedure for obtaining the informed consent of its human subjects. First, EPA

found that the consent form and accompanying materials employed by the study

investigator “may well have misled subjects into thinking they were participating

in a drug trial” rather being dosed with a toxic pesticide. A-415. For example, the

boilerplate consent form referred to dichlorvos as “the drug” and did not identify it

as a pesticide. Id. The form also stated that the study’s purpose was “the

acquisition of medical knowledge” and said its results might be disclosed to

“regulatory authorities for medicines.” Id. The notes accompanying the form

22

incorrectly called dichlorvos a “trial drug[]” and referred repeatedly to “drugs you

will be receiving.” Id.

EPA also found other ethical deficiencies in the consent materials. For

example, the consent form included a statement that the human health risks the

study posed to its test subjects “are very unlikely to occur,” and a suggestion that

an antidote would be available if harm did befall a subject. Id. The form did not

identify Amvac (dichlorvos’s manufacturer) as the study’s sponsor. Id. Despite

these numerous deficiencies, EPA concluded informed consent was obtained

because the notes to the consent form elsewhere described dichlorvos as an

insecticide, and subjects were given a twenty-four-hour waiting period before

being asked to sign the consent forms. A-414 to 415.

In addition to problems with the study’s consent materials, EPA identified a

host of other “apparent” “ethical deficiencies” in the way the study was conducted,

relative to the principles of the Declaration of Helsinki. A-415 to 417 (quotes at

415). Among the more serious transgressions, EPA found that the study’s

investigator failed to follow its own predetermined criteria for withdrawing the test

subjects from further testing when their neurotoxic impairment reached levels of

concern. A-415 to 416. Other “ethical deficiencies” described by EPA included

inadequate medical monitoring of the subjects, who were released from the clinic

23

each day after swallowing the pesticide pill (rather than held for observation). A-

416. EPA also found “deficien[t]” the study’s failure to establish that the

committee charged with reviewing the adequacy of the study procedure was

independent from the pesticide manufacturer and study investigator. Id. According

to EPA, ethical violations in the conduct of the study reflected “little consideration

for the well-being of the subjects.” A-415 to 416. EPA deferred deciding the

“overall significance of the identified deficiencies” in the study until further

analysis by EPA’s Human Studies Review Board. A-417.

B. EPA’s Human Studies Review Board Identified Ethical and Statistical Deficiencies in the Dichlorvos Human Study

The Human Studies Review Board next considered the dichlorvos human

study and issued a report advising EPA of its findings, pursuant to EPA’s Human

Testing Rule. See 40 C.F.R. §§ 26.1602(b)(2), 26.1603(b). To assess whether EPA

could use the study for regulatory decision making, the Board applied the relevant

standard from the Rule. See id. § 26.1704. Specifically, the Board looked for “clear

and convincing evidence” that the conduct of the dichlorvos study was

“significantly deficient relative to the ethical standards prevailing at the time.” A-

671 (emphasis in original); accord A-679; see also 40 C.F.R. § 26.1704.

24

In its report, the Board agreed with the author of EPA’s initial ethics review

that the study had several clear “deficiencies” when measured against the ethical

standards prevailing at the time the study was carried out—i.e., the Declaration of

Helsinki. A-679 to 682 (quote at 681). The Board found that the study’s consent

materials “failed to fully meet the standards” of voluntary informed consent

followed at the time. A-680. The Board also found that medical monitoring of the

human subjects who were fed pesticide pills was “inadequate.” Id. The Board

concluded that the study “failed to fully meet the specific ethical standards

prevalent at the time the research was conducted.” A-665. Nonetheless, the Board

offered its “tepid endorsement” of the study. A-457. The Board did so, it

explained, because the study’s ethical violations “did not reach the threshold of

significantly deficient” under the Human Testing Rule. Id.; see also A-665.

In addition to commenting on the study’s serious ethical shortcomings, the

Board called into question the study’s ability to supply EPA with reliable data

about dichlorvos’s toxicity. The Board identified “numerous weaknesses” in the

study design and execution. A-674 to 675. It also criticized as “small” the study’s

sample size of six young, white, male test subjects, and three control subjects. Id.

The Board also found that “it was not clear whether the study was properly

powered, given that no sample size calculations seem to have been used in order to

25

arrive at the number of volunteers used in the study.” Id. The Board concluded that

the “low number of subjects” studied “greatly limited the study[’s] value” for the

regulatory process. A-455 to 456.

The Board also discussed another problem first identified in EPA’s initial

ethics review: the study investigator’s failure to continue to medically monitor

certain test subjects whose levels of nervous system impairment reached levels of

concern, while exposing them to further doses of the toxin. A-456; see also A-675

to 676. The Board concluded that this conduct was “not scientifically defensible.”

A-456; see also A-675 to 676. Although the Board recognized the study had

“numerous weaknesses” in its design and execution that called into question the

study’s reliability as a source of information about dichlorvos, it allowed EPA to

use the study for its dichlorvos risk assessment. A-674, 676 (also finding the

“scientific limitations of the study design” were too great to justify the study’s use

for a different, cumulative pesticide risk assessment process).

C. EPA Relied on the Dichlorvos Human Study to Authorize Continued Use of Dichlorvos

As part of a reassessment of the health risks of dichlorvos mandated by the

1996 Food Act amendments, EPA applied the Human Testing Rule’s unlawful

“significantly deficient” standard to decide what older human studies it could use.

26

SPA-030 (cols. 1-2), 041 (cols. 2-3). EPA adopted the Human Studies Review

Board’s factual analysis of the dichlorvos human study’s compliance with this

standard. SPA-030 (cols. 1-2), 041 (cols. 2-3). Like the Board, EPA found it could

rely on the study because the study was not “significantly deficient” compared to

ethical standards prevailing at the time the study was done. SPA-030 (cols. 1-2).

EPA then relied on this finding to use the study in evaluating the health risks of

exposure to dichlorvos. SPA-008 (col. 3) to 009 (cols. 1-3), 030 (col. 2).

EPA first used the human study data to derive a low effects dose, or “starting

point,” for its risk assessment. SPA-003 (col. 3), 009 (cols. 2-3); see also supra,

Statement of Facts I (discussing EPA’s general approach to estimating and using

low effects doses). Next, and importantly, EPA decided that because its low effects

dose was based on data from human rather than animal studies, it could eliminate

its presumptive tenfold interspecies safety factor. SPA-009 (col. 2); see also supra,

Statement of Facts I (explaining EPA’s general approach to applying safety

factors). EPA relied on this analysis to approve a set of food tolerances that

allowed continued sale of the pesticide under the Food Act. A-565 to 567, 596-97;

SPA-002 (cols. 1-2), 029 (col. 3), 041 (cols. 2-3); see also NRDC v. EPA, 658 F.3d

at 201.

27

VI. NRDC Brought Administrative and Legal Challenges to EPA’s Use of the Dichlorvos Human Study and Continued Approval of Dichlorvos

To protect against the dangers posed by dichlorvos, NRDC in 2006

petitioned EPA pursuant to the Food Act, 21 U.S.C. § 346a(d). A-598. NRDC’s

petition sought to prohibit any application of the chemical that results in unsafe

levels of human exposure, and requested that EPA revoke all food tolerances for

dichlorvos. Id. EPA denied the petition in 2007, after an eighteen-month delay. A-

695 (col. 1). To justify denying NRDC’s petition and leaving the dichlorvos food

tolerances in place, EPA once again relied on data from the dichlorvos human

study. A-707 (cols. 2-3) to 708 (cols. 1-2).

NRDC challenged EPA’s 2007 petition denial by filing administrative

objections under the Food Act. A-732; 21 U.S.C. § 346a(g) (permitting the filing

of administrative objections). NRDC also requested an evidentiary hearing on

material factual issues concerning the adequacy of the dichlorvos human study’s

consent procedure and the study’s statistical validity. A-732; 21 U.S.C.

§ 346a(g)(2) (authorizing a request for an evidentiary hearing). NRDC objected

that EPA had violated Section 201 by applying the Human Testing Rule to allow it

to use the study in spite of the study’s ethical deficiencies. A-740 to 741

(incorporating legal argument from NRDC’s challenge to Rule that standard

28

supplied by Rule materially deviated from National Academy of Sciences

Recommendation 5-7, contrary to Section 201). NRDC also objected to EPA’s

failure to apply the full tenfold safety factor for the protection of children that

Congress established in its 1996 Food Act amendments. A-736.

EPA denied NRDC’s objections and hearing request in a final order dated

July 23, 2008. SPA-021. NRDC petitioned for review of EPA’s 2008 order in this

Court. NRDC v. EPA, 658 F.3d at 201. NRDC raised two issues in its first petition

for review in this Court. First, EPA was compelled to grant NRDC an evidentiary

hearing on genuine, material, and substantial factual issues concerning the

dichlorvos study’s ethical and statistical validity. Id. at 219. Second, EPA failed to

provide a rational basis for waiving the children’s safety factor. Id. at 218. The

Court reached only this second issue and granted NRDC’s petition on that issue,

holding that EPA failed to provide a lawful explanation for its departure from the

children’s safety factor. Id. Based on this holding, the Court vacated the 2008 order

in part and remanded to EPA for further proceedings. Id. at 218, 220. Because the

Court’s vacatur and remand on the children’s safety issue encompassed those parts

of the 2008 order in which EPA relied upon the dichlorvos human study, the Court

found it unnecessary to resolve whether EPA had also arbitrarily rejected NRDC’s

request for a hearing on the study. Id. at 219.

29

Following remand, EPA again denied NRDC’s objections and hearing

request by final order dated September 5, 2012. SPA-001.5 The 2012 order

preserves EPA’s current regulatory approvals for dichlorvos and allows sales of the

pesticide to continue. See SPA-002 (cols. 1-3).

STANDING

NRDC and its members are harmed by EPA’s 2012 order, and NRDC has

standing to challenge it. To establish standing, NRDC must show that its members

would have standing to sue in their own right, the interests it seeks to protect are

germane to its organizational purposes, and the litigation will not require its

members’ individual participation. Hunt v. Wash. State Apple Adver. Comm’n, 432

U.S. 333, 343 (1977).

NRDC satisfies this test. NRDC’s members have standing to challenge

EPA’s 2012 order because they suffer “injury in fact” that is both fairly traceable

to the challenged order and likely to be redressed by a favorable decision on the

issues presented in this petition for review. Friends of the Earth v. Laidlaw Envtl.

Servs., 528 U.S. 167, 180-81 (2000).

5 EPA’s 2012 order renews its denial of NRDC’s 2008 objections and

references and incorporates analysis from EPA’s 2008 order. See SPA-002 (col. 2) (“EPA again denies NRDC’s objections as to those portions of the July 23, 2008 order that were vacated.”), SPA-004 (col. 1).

30

NRDC’s members are injured by their risk of exposure to dichlorvos, a toxic

chemical that interferes with the nervous system and is linked to cancer. See supra,

Statement of Facts V. In denying NRDC’s objections and hearing request in its

2012 order, EPA left in place tolerances that allow the widespread use of

dichlorvos to kill insects at agricultural sites; in food warehouses and processing

plants; in homes and businesses; and in outdoor areas including picnic grounds,

parking lots, and backyards. A-486, 517, 519, 549, 599; SPA-002.

NRDC’s members are reasonably concerned about the health risks they and

their families face from exposure to dichlorvos in their homes and communities.

SPA-148 to 150 (Britton Decl. ¶¶ 3-6), 154-55 (Raymes Decl. ¶¶ 4-6). Because

dichlorvos may be encountered in a variety of public and private spaces, as well as

in residues in food and water, NRDC members cannot reliably know when they are

being exposed to the pesticide. A-486, 517, 519, 549; SPA-148 to 150 (Britton

Decl. ¶¶ 4-6), 154-55 (Raymes Decl. ¶¶ 4, 6). Even members who are aware of and

concerned about dichlorvos’s health risks, and who have taken steps to try to

reduce dichlorvos exposure in more controlled settings like their homes, are

nevertheless unable to fully protect themselves and their families from exposure.

SPA-148 to 150 (Britton Decl. ¶¶ 4-7), 154-55 (Raymes Decl. ¶¶ 4-6).

31

The risk of health harm posed by dichlorvos is a “credible threat of harm”

sufficient to constitute an injury in fact. Baur v. Veneman, 352 F.3d 625, 633, 637

(2d Cir. 2003) (“threatened harm in the form of an increased risk of future injury

may serve as injury-in-fact”); see also Laidlaw Envtl. Servs., 528 U.S. at 185

(“threat of future injury” is a cognizable harm adequate to confer standing); N.Y.

Pub. Interest Grp. v. Whitman, 321 F.3d 316, 325-26 (2d Cir. 2003) (health risks of

exposure to “potentially excessive” air pollution levels “are sufficient to establish

injury-in-fact”).

NRDC members’ injuries are also fairly traceable to EPA’s unlawful 2012

denial order, which left in place tolerances on dichlorvos that subject members to a

risk of harm by approving unsafe levels of exposure to dichlorvos. See supra,

Statement of Facts V.C & VI.

The risk of harm posed by EPA’s 2012 order to NRDC members is likely to

be redressed by a decision vacating the order and prohibiting EPA’s use of the

dichlorvos human study. EPA relied on the study’s data in its assessment of the

risks of dichlorvos. SPA-162 to 164 (Sass Decl. ¶¶ 11-12); see also supra,

Statement of Facts V.C. In the absence of the study, the Food Act would require

EPA to reevaluate existing approvals for dichlorvos in order to identify a safe level

of exposure to humans. See 21 U.S.C. § 346a(a)(1)(A), (b)(2)(A)(i); SPA-166

32

(Sass Decl. ¶ 18). If EPA relied on the best available data and applied appropriate

safety factors, without the human study, it is likely that some currently approved

uses of dichlorvos would be found unsafe, which would reduce total exposures and

associated health risks. See SPA-164 to 166 (Sass Decl. ¶¶ 13-16, 18); see also

SPA-150 (Britton Decl. ¶¶ 8-9), 155 (Raymes Decl. ¶¶ 7-8).

NRDC’s standing to challenge EPA’s denial of its evidentiary hearing

request is based on the procedural injury the organization has suffered while trying

to protect the underlying health interests of its members. The Food Act grants any

person the right to a public evidentiary hearing to determine material issues of fact

raised by a petition denial. 21 U.S.C. § 346a(g)(2)(B). By arbitrarily denying

NRDC’s hearing request, EPA has deprived NRDC of the opportunity to present

and examine evidence concerning the existence of informed consent for the

dichlorvos human study and the study’s statistical validity before an administrative

law judge. This is a cognizable injury for standing purposes. Midwestern Gas

Transmission Co. v. Fed. Energy Regulatory Comm’n, 589 F.2d 603, 626 (D.C.

Cir. 1978) (party requesting an evidentiary hearing has standing to challenge

agency denial of that request); Gen. Motors Corp. v. Fed. Energy Regulatory

Comm’n, 656 F.2d 791, 795 n.9 (D.C. Cir. 1981) (same). It would be redressed by

33

a decision vacating EPA’s 2012 order and directing the agency to conduct an

evidentiary hearing.

NRDC’s interest in protecting the public from the harms posed by

dichlorvos is germane to its purpose. NRDC is an environmental and public health

organization with approximately 363,000 members nationwide. SPA-153 (Lopez

Decl. ¶ 4). One of NRDC’s organizational priorities is reducing the load of

dangerous chemicals to which we are exposed. Id. (Lopez Decl. ¶ 5). Because

NRDC does not seek any individualized relief for its members, the participation of

individual members is not required. Hunt, 432 U.S. at 343. NRDC has standing to

sue.

SUMMARY OF ARGUMENT

This petition presents two arguments. First, EPA violated Section 201 by

using an ethically deficient human study to authorize continued use of dichlorvos.

In Section 201, Congress prohibited EPA from using studies exposing humans to

pesticides until EPA adopted a final rule regulating its use of such studies.

Congress said that rule “shall be consistent with the principles proposed in the

2004 report of the National Academy of Sciences on intentional human dosing.”

SPA-116. One of the Academy’s proposed principles requires EPA to reject human

34

studies, conducted before adoption of its rule, that clear and convincing evidence

shows were “deficient” relative to ethical standards prevailing at the time. A-167.

EPA conducted two internal ethics reviews of the dichlorvos human dosing

study at issue here. Each review identified numerous ethical deficiencies in the

study. See supra, Statement of Facts V.A & V.B. EPA nonetheless used and relied

on the study to authorize its current regulatory approvals of dichlorvos. It did so by

applying an unlawful reading of Section 201—embodied in EPA’s 2006 Human

Testing Rule—that requires it to reject only studies it finds are “significantly

deficient” relative to then-prevailing ethical standards. 40 C.F.R. § 26.1704

(emphasis added). This violated Section 201. The Court should vacate EPA’s 2012

order and prevent EPA from relying on the dichlorvos human study.

Second, it was arbitrary and capricious and contrary to the Food Act for

EPA to deny NRDC’s request for an evidentiary hearing on disputed factual issues

material to EPA’s use of the dichlorvos human study. The Food Act gives NRDC

the right to a hearing before an independent factfinder on material issues of fact

raised in objections to an EPA pesticide approval. The evidence NRDC submitted

with its objections establishes genuine, material, and substantial issues of fact

regarding both (1) the existence of informed consent for the dichlorvos study and

(2) the study’s statistical reliability. This evidence included peer-reviewed analysis

35

by scientists and medical doctors, as well as EPA internal reviews that identified

defects in the study’s consent procedure and statistical design. EPA nonetheless

arbitrarily denied NRDC’s hearing request. This violated the Food Act and EPA’s

regulations. The Court should vacate the denial and order a hearing.6

ARGUMENT

I. Standard of Review

Judicial review is governed by the standards supplied in the Administrative

Procedure Act, 5 U.S.C. § 706(2)(A). This Court must hold unlawful and set aside

EPA’s 2012 order if it is “arbitrary, capricious, an abuse of discretion, or otherwise

not in accordance with law.” NRDC v. EPA, 658 F.3d at 215.

EPA’s use of the dichlorvos human study is contrary to law if such use

violates the plain language of Section 201. See Waterkeeper Alliance v. EPA, 399

F.3d 486, 497, 504 (2d Cir. 2005).

EPA’s denial of NRDC’s request for an evidentiary hearing is reviewed

under the arbitrary and capricious standard, as well as the contrary to law standard.

Cf. Hynson, Westcott & Dunning, Inc. v. Richardson, 461 F.2d 215, 220 (4th Cir.

6 If this Court grants an order preventing EPA from using the dichlorvos human

study, then the Court need not reach NRDC’s second argument challenging EPA’s arbitrary denial of an evidentiary hearing.

36

1972) (the APA does not “permit[] an arbitrary denial” of a hearing request where

there are genuine and substantial factual issues in dispute) (reviewing denial of

hearing request under Food Act’s drug application provisions), aff’d as modified

Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 622-23 (1973).

This Court must set aside EPA’s decision if it “relied on factors which Congress

has not intended it to consider, entirely failed to consider an important aspect of the

problem, offered an explanation for its decision that runs counter to the evidence

before the agency, or is so implausible that it could not be ascribed to a difference

in view or the product of agency expertise.” Motor Vehicle Mfrs. Ass’n v. State

Farm Mut. Auto. Ins. Co., 463 U.S. 29, 43 (1983). EPA must examine the relevant

data and establish a “rational connection between the facts found and the choice

made.” Id. (internal quotation marks and citation omitted).

EPA’s denial of a hearing request should be overturned if “an examination

of the record discloses that material issues of fact are apparent to any reasonable

examiner.” Cmty. Nutrition Inst. v. Young, 773 F.2d 1356, 1363 (D.C. Cir. 1985)

(discussing hearing request under Food Act’s food additive provisions, 21 U.S.C.

37

§ 348(f)(1)); see also 21 U.S.C. § 346a(g)(2)(B) (Food Act’s provision for

evidentiary hearings on “material issues of fact raised by [pesticide] objections”).7

The inquiry articulated in Chevron U.S.A., Inc. v. NRDC, 467 U.S. 837

(1984) controls EPA’s interpretation of Section 201 and the Food Act. If Congress

“unambiguously expressed” its meaning in the statute, id. at 843, that meaning

controls. See Waterkeeper Alliance, 399 F.3d at 497.

II. EPA’s Use of the Dichlorvos Human Study Violated Section 201 In Section 201, Congress directed EPA to suspend its use of intentional

human dosing studies until it adopted a rule governing use of such studies. Section

201 says that the rule “shall be consistent with the principles proposed in” the

National Academy of Sciences’ 2004 Report. SA-116 (Pub. L. No. 109-54, § 201).

Under those principles, EPA cannot use human studies that predate its adoption of

7 In National Corn Growers Association v. EPA, the D.C. Circuit referred to the

standard of review for EPA’s denial of a hearing request as “necessarily deferential.” 613 F.3d 266, 271 (D.C. Cir. 2010). This Court should not read that standard to be more deferential than arbitrary and capricious review. The sufficiency of an evidentiary proffer is a legal question that courts can readily evaluate; no heightened deference is warranted. See Weinberger, 412 U.S. at 622 (when reviewing an agency order denying an evidentiary hearing, “a court of appeals must determine whether the [agency’s] findings accurately reflect” the record); United States v. FCC, 652 F.2d 72, 92 (D.C. Cir. 1980) (same). See also Adams v. EPA, 38 F.3d 43, 55, 58 (1st Cir. 1994) (same); City of Wausau v. United States, 703 F.2d 1042, 1044 (7th Cir. 1983) (applying arbitrary and capricious standard to review agency’s denial of rehearing request).

38

a human testing rule if clear and convincing evidence shows they are “deficient”

relative to ethical standards prevailing at the time of the study. A-167 (Report).

EPA twice reviewed the dichlorvos human study and found it deficient

relative to the ethical standards prevailing at the time the study was done. EPA

used the study anyway, in reliance on a provision of its Human Testing Rule that

purports to allow EPA to use studies conducted before the Rule’s adoption so long

as those studies are not “significantly deficient” relative to then-prevailing ethical

standards. 40 C.F.R. § 26.1704 (emphasis added). EPA’s interpretation of Section

201 to allow it to use the dichlorvos human study contravened both the statute’s

plain language and its legislative history, which reflects Congress’s desire to reign

in EPA’s use of such studies.

A. EPA’s Application of Its “Significantly Deficient” Test to Allow It to Use the Dichlorvos Human Study Violated Section 201

EPA’s use of the dichlorvos human study, based on the agency’s application

of language in its Human Testing Rule, violated Section 201’s unambiguous terms.

Section 201 prohibits EPA from accepting, considering, or relying upon studies

intentionally dosing humans with pesticides (through a ban on the use of funds for

such purpose) without a rule in place to govern the agency’s consideration of such

studies. See SPA-116. It also imposes specific limitations on the substance of that

39

rule. Of chief importance here, Section 201 mandates that the rule “shall be

consistent with the principles proposed in the 2004 report of the National Academy

of Sciences on intentional human dosing.” Id.; Nat’l Ass’n of Home Builders v.

Defenders of Wildlife, 551 U.S. 644, 661 (2007) (Congress’s use of “shall”

imposes “mandatory” obligations on EPA). One of the principles proposed in the

Report is Recommendation 5-7, which prescribes when it is appropriate for EPA to

use previously conducted dosing studies on humans. A-167. Recommendation 5-7

prohibits EPA’s use of such older studies where there is clear and convincing

evidence that the study’s conduct is “deficient” relative to ethical standards

prevailing at the time of the study. Id.

Despite Congress’s command that any EPA rule for use of intentional

human dosing studies be “consistent with” the Academy’s proposed principles,

SPA-116, EPA materially modified Recommendation 5-7 in its 2006 Human

Testing Rule by inserting the qualifier “significantly” before the word “deficient.”

The Rule accordingly allows EPA to use and rely on a human dosing study

conducted before the Rule’s adoption unless clear and convincing evidence shows

that the study’s conduct was “significantly deficient” relative to then-prevailing

ethical standards. 40 C.F.R. § 26.1704 (emphasis added). EPA concedes that by

adding the word “significantly,” it “modified” and “chang[ed]” the Academy’s

40

proposed principle that EPA reject all “deficient” studies. A-337 (also explaining

that EPA’s insertion of the qualifier “significantly” “reflects EPA’s view”—not the

Academy’s––concerning which ethically problematic studies should be rejected).

EPA relied on its modified “significantly deficient” test for older studies to

determine that it could use the dichlorvos human study to assess the risks of

dichlorvos. SPA-030 (col. 2) (2012 order) (discussing and adopting Human Studies

Review Board’s finding, under the Human Testing Rule, that EPA could use the

study), SPA-041 (col. 2) (EPA’s decision to rely on the study was made pursuant

to the Rule). EPA could not have used the study under the principle proposed in

Recommendation 5-7, as its own documented reviews of that study establish. Both

EPA’s Pesticide Office and Human Studies Review Board found numerous ways

in which the study violated then-prevailing ethical standards set forth in the

Declaration of Helsinki. See generally supra, Statement of Facts V.A & V.B; A-

415 to 416 (Pesticide Office) (“apparent” “ethical deficiencies” relative to Helsinki

standards included inadequate medical monitoring of dosed subjects and failure to

verify whether the committee charged with reviewing study protocols was

independent from the study’s sponsor and investigators), A-680 (Board) (consent

forms “failed to fully meet the standards” in the Helsinki Declaration). EPA’s

Pesticide Office, which authored the initial review, observed that some of these

41

deficiencies “suggest[] little consideration for the well-being of the subjects.” A-

416 (discussing inadequate medical monitoring). The Board expressed similar

concerns, see A-679 to 682 (surveying problems with the study’s medical

monitoring and informed consent protocols), but ultimately concluded that the

study “did not reach the threshold of significantly deficient,” and on that basis

offered its “tepid endorsement.” A-457.

EPA, by adopting the Board’s reasoning, similarly based its decision to

approve use of the study on its view that the study’s numerous ethical deficiencies

did not amount to “significantly deficient” conduct relative to then-prevailing

standards. SPA-030. Had EPA’s consideration of the study been guided by the

Academy’s proposed principle—which forbids use of all studies that are

“deficient” relative to applicable ethical standards—EPA would not have been able

to accept the study in light of the ethical faults it identified.

EPA’s application of the “significantly deficient” standard, rather than the

“deficient” standard the National Academy proposed in its Report, thus

contravened Section 201’s requirement that the standard be “consistent with” the

Report’s proposed principles. SPA-116.

Section 201’s legislative history underscores Congress’s intent to prevent

EPA from using the dichlorvos human study and similar studies that were deficient

42

relative to ethical standards prevailing at the time. During debate on Section 201,

for example, Members repeatedly referenced certain human studies under EPA

review as examples of studies the agency should not use due to their “gross

violation of ethical standards.” SPA-141 (col. 2) (statement of Sen. Clinton).8 The

dichlorvos human study was among the studies Members identified and

condemned for their ethical and scientific flaws.9 Members also expressly

criticized EPA’s proposed “significantly deficient” test on the grounds that it

would “permit EPA to continue relying on old unethical studies.”10

8 See also SPA-138 (col. 1) (statement of Senator Boxer condemning human

dosing studies under review by EPA for violating international ethical standards and Academy recommendations), SPA-141 (col. 2) (statement of Senator Clinton denouncing studies that “failed to obtain informed consent, inflicted harm on the human subjects, . . . or failed to conduct long-term monitoring”), SPA-143 (col. 3) to 144 (col. 1) (statement of Senator Obama criticizing EPA’s consideration of data from studies that were not “scientifically valid,” “failed to take the health complaints of the subjects seriously,” and “failed to disclose the risk to the subjects”).

9 See supra, n.4 (full name of dichlorvos human study); A-326 to 327 (report prepared for Senator Boxer and Representative Waxman that lists dichlorvos human study among studies “[EPA] is reviewing, or expects to review”), A-310 n.89 and accompanying text (same, discussing dichlorvos study), A-316 n.120 and accompanying text (same), A-320 to 321 notes 142, 149, & accompanying text (same); SPA-132 (col. 3) (statement of Representative Solis referencing surveyed studies), SPA-138 (col. 1) (statement of Sen. Boxer) (same).

10 A-284 to 285 (report prepared for Representatives Waxman and Solis and Senator Boxer); SPA-133 (statement of Representative Solis discussing and submitting report into Congressional record).

43

In other words, EPA has not only defied Congress’s mandate in Section 201

by adopting a modified “significantly deficient” test for acceptance of older

studies. EPA has also applied that unlawful test to accept one of the very studies

Section 201’s sponsors recognized as unethical and sought to prevent EPA from

using: the dichlorvos human study.

In sum, both Section 201’s plain language and its legislative history show

that Congress intended for EPA to adopt a rule “consistent with” the principles

proposed by the National Academy. Such a rule would have bound EPA to reject

older studies that clear and convincing evidence shows are ethically “deficient”

relative to then-prevailing standards. EPA has reviewed the dichlorvos human

study and found it deficient. EPA’s use of and reliance on the study in its 2012

order was accordingly contrary to law. The Court should vacate the 2012 order and

direct EPA not to use the study in its pesticide regulatory work. Cf. Alabama-

Tombigbee Rivers Coal. v. Dep’t of Interior, 26 F.3d 1103, 1105, 1107 (11th Cir.

1994) (affirming district court order barring federal agency from using scientific

report that was the “product of a tainted procedure” that violated federal law).

44

B. Section 201 Requires EPA’s Rule on Use of Intentional Human Dosing Studies to Be Consistent with the National Academy of Sciences’ Recommendations

When Congress required EPA to make its human testing rule “consistent

with” “principles proposed in the 2004 report of the National Academy of

Sciences,” Congress was directing EPA to follow the Academy’s

Recommendations. SPA-116. Section 201’s legislative history makes this clear.

See Chevron, 467 U.S. at 842-43 & n.9, 845 (legislative history analyzed at “step

one” to help determine Congress’s intent).

The legislation that became Section 201 was introduced and passed in

response to Members’ concerns that EPA’s draft rule would allow EPA to depart

from the Recommendations enumerated in the 2004 Report, including the

Recommendation that EPA reject ethically “deficient” older studies. See supra,

Statement of Facts III & Argument II.A. During floor debates, Members

emphasized that the legislation would “require” adherence to “the

recommendations of the [National Academy of Sciences].” SPA-132 to 133 (quote

at 133) (statement of Representative Solis, the House co-sponsor), SPA-131 (col.

2) (statement of Rep. Dicks) (conference report “reflects the will of both the House

45

and the Senate to stop such tests until the EPA develops regulations reflecting the

recommendation of the National Academy of Science[s]”).11

The Academy’s own use of the words “proposals” and “principles” in its

2004 Report supports this plain construction. The Report’s executive summary

introduces and explicitly refers to its seventeen Recommendations as “proposals.”

A-043 (“[T]o be specific about the proposals being made, the recommendations

follow.”). The Report also uses the phrase “scientific and ethical principles

described in earlier chapters” interchangeably with the phrase “substantive

recommendations offered in previous chapters.” Compare A-083 (emphasis added)

with A-180 (emphasis added). For the Academy, like Congress, the 2004 Report’s

“Recommendations” were the “scientific and ethical principles” the Academy

proposed in the Report.

Particularly in light of this history, the only plausible reading of Section 201

is that in stating “principles proposed” by the Academy, Congress meant the

Academy’s seventeen “Recommendations.” Because the “traditional tools of

11 See also SPA-141 (cols. 1-2) (statement of Senator Clinton, the Senate co-

sponsor, observing that EPA’s “draft regulations are in direct contradiction to the key recommendations made by the National Academy of Sciences”), SPA-121 (cols. 1-2) (statement of Representative Solis criticizing EPA’s expressed intention to “go against the recommendation of the [Academy]”).

46

statutory construction,” Chevron, 467 U.S. at 843 n.9––legislative language and

history––provide a “clear sense” that the phrase “principles proposed” in Section

201 refers to the Recommendations, Congress’s clear purpose ends the inquiry at

Chevron “step one.” Gen. Dynamics Land Sys. v. Cline, 540 U.S. 581, 600 (2004).

III. EPA Unlawfully Denied NRDC’s Request for an Evidentiary Hearing on Material Factual Issues Concerning the Scientific Reliability of the Dichlorvos Human Study and the Existence of Informed Consent

With its objections, NRDC requested an evidentiary hearing on material

factual issues concerning (1) whether the dichlorvos human study was conducted

without the informed consent of its subjects, and (2) whether the study’s small

sample size made it scientifically unreliable. A-734, 743 to 746. EPA denied the

hearing request. SPA-021. NRDC identified specific and substantial evidence on

each issue that, if proven, would prevent EPA from relying on the dichlorvos

human study. This entitled NRDC to a hearing under the Food Act and EPA’s

implementing regulations. See 21 U.S.C. § 346a(g)(2)(B); 40 C.F.R. § 178.32(b).

EPA’s denial of NRDC’s hearing request was arbitrary and capricious and violated

the Food Act and its implementing regulations. The Court should vacate the denial

and order a hearing. See Am. Cyanamid Co. v. FDA, 606 F.2d 1307, 1324 & n.166

(D.C. Cir. 1979) (agency ordered to conduct evidentiary hearing where requester

presented evidence raising an issue of fact).

47

A. The Food Act and EPA’s Implementing Regulations Require EPA to Conduct an Evidentiary Hearing to Resolve Genuine, Material, and Substantial Issues of Fact

The Food Act permits any person to petition EPA to revoke pesticide

tolerances, and, if EPA denies the petition, to file administrative objections to the

denial and request an evidentiary hearing. 21 U.S.C. § 346a(d), (g)(2)(A)-(B). The

Act says EPA “shall . . . hold a public evidentiary hearing if and to the extent the

Administrator determines that such a public hearing is necessary to receive factual

evidence relevant to material issues of fact raised by the objections.” Id.

§ 346a(g)(2)(B). The Act and EPA’s regulations provide for an administrative law

judge to preside over hearings for the purposes of authorizing discovery and

issuing subpoenas to compel testimony or documents, receiving evidence, and

resolving the disputed factual issues. See id.; 40 C.F.R. §§ 179.60, 179.70, 179.85,

179.93, 179.105(a).

EPA’s regulations provide that EPA must grant a request for an evidentiary

hearing if three conditions are met: (1) “[t]here is a genuine and substantial issue of

fact,” (2) “[t]here is a reasonable possibility that available evidence identified by

the requestor would, if established, resolve one or more of such issues in favor of

the requestor,” and (3) “[r]esolution of the factual issue(s) in the manner sought by

the person requesting the hearing would be adequate to justify the action

48

requested.” Id. § 178.32(b). Once a hearing is granted, separate provisions govern

creation of the evidentiary record and the ultimate factual determination. Compare

40 C.F.R. Part 178, Subpart B (“Procedures for Filing Objections and Requests for

Hearing”) with 40 C.F.R. Part 179 (“Formal Evidentiary Public Hearing”).

As EPA has acknowledged, these regulations establish “summary judgment-

type procedures” that require a hearing to resolve “disputed material factual

issues,” analogous to the procedures in Federal Rule of Civil Procedure 56. SPA-

032 (cols. 1-2). EPA must therefore grant a public evidentiary hearing if a

requester raises any genuine issue of material fact in support of a pesticide

objection. See Fed. R. Civ. P. 56; Anderson v. Liberty Lobby, Inc., 477 U.S. 242,

247-48 (1986). A hearing cannot be denied, much as summary judgment cannot be

granted, where “reasonable minds could differ as to the import of the evidence.”

Anderson, 477 U.S. at 250.

Like a party seeking to avoid summary judgment in district court, a party

requesting an evidentiary hearing need only submit evidence that establishes the

existence of a material factual dispute. See 21 U.S.C. § 346a(g)(2)(B); 40 C.F.R.

§ 178.32(b); O’Hara v. Nat’l Union Fire Ins. Co. of Pittsburgh, 642 F.3d 110, 117

(2d Cir. 2011). The requester need not make a “fully persuasive case” or submit all

of the evidence it would present at the evidentiary hearing. Citizens for Jazz on

49

WRVR, Inc. v. FCC, 775 F.2d 392, 397 (D.C. Cir. 1985) (Scalia, J.) (interpreting

the similar language of 47 U.S.C. § 309(d)(2)). The requester must submit only

“what a reasonable factfinder might view as a persuasive case—the quantum, in

other words, that would induce a trial judge to let a case go to the jury even though

he himself would (if nothing more were known) find against the plaintiff.” Id. at

397 (emphasis in original). EPA’s regulations confirm that, to get a hearing, a

requester need only show a “reasonable possibility” that a materially disputed issue

would be resolved in his favor; he need not conclusively resolve the dispute. 40

C.F.R. § 178.32(b)(2). Once a hearing is granted, the law provides for fuller

development of the facts. 21 U.S.C. § 346a(g)(2)(B); 40 C.F.R. §§ 179.85, 179.93.

B. The Food Act Entitles NRDC to a Hearing to Determine Whether the Dichlorvos Human Study Was Conducted Without the Informed Consent of Its Subjects

With its objections, NRDC asked EPA for a hearing to determine whether

the dichlorvos human study had an adequate process for obtaining informed

consent from human subjects to be exposed to pesticides. A-734, 743-46. Informed

consent is an essential ethical requirement set forth in both EPA’s regulations and

the Declaration of Helsinki, without which EPA cannot consider the study for

regulatory purposes. 40 C.F.R. § 26.1704; A-014 to 015, 264 (col. 4). The

existence of informed consent is a question of fact. See Rainwater v. Alarcon, 268

50

F. App’x 531, 534 (9th Cir. 2008) (unpublished) (plaintiff “presented sufficient

evidence to show that a question of fact exists as to whether he was provided with

information that allowed him to give informed consent” to medical treatment);

DeNeui v. Wellman, No. Civ. 07-4172, 2009 WL 4847086, at *4 (D.S.D. Dec. 9,

2009) (unpublished) (whether a patient gave informed consent to undergo a

medical procedure is “a material question of fact” and therefore “summary

judgment is inappropriate”).

The following evidence identified by NRDC specifically establishes a

material and substantial factual issue as to the existence of informed consent:

1. A memorandum authored by EPA’s Pesticide Office presenting an

initial review of the ethical deficiencies in the dichlorvos human study. A-413.

After identifying multiple problems with the informed consent procedure used,

EPA observed that the consent materials “may well have misled subjects into

thinking they were participating in a drug trial” rather than being dosed with a

harmful pesticide. A-415. As EPA described, the boilerplate consent form named

dichlorvos only in its title and referred to it as “the drug” without identifying it as a

pesticide. Id. The consent form did not tell participants that the study was

sponsored by a pesticide manufacturer. Id. Participants were told that the study’s

purpose was “the acquisition of medical knowledge” and that its results might be

51

disclosed to “regulatory authorities for medicines.” Id. The consent materials

suggested that the risks of harm posed by the study were very unlikely to

materialize. Id. The materials told subjects that an antidote would be available to

counteract any harm. Id. The notes that accompanied the consent form did describe

dichlorvos as an insecticide, but they also “referred repeatedly to ‘drugs you will

be receiving’ or ‘trial drugs.’” Id.

2. The Human Studies Review Board draft and final reports evaluating

the dichlorvos human study. A-458, 663, 734 (incorporating the Board’s final

report, which was cited in EPA’s petition denial, see A-729 (col. 2)), A-743. (The

draft report is substantively identical to the final report in all relevant respects.)

The Board found “[i]t is clear that the written documentation for informed consent

failed to fully meet the standards” of voluntary informed consent applicable at the

time the study was conducted, and concluded that the statements in the consent

forms “are highly undesirable, and should not be used as part of modern-day

practice in writing such consent materials.” A-472 to 473, 680-681, 743.

3. A published, peer-reviewed article by Dr. Alan Lockwood, a

neurologist. A-260 (Alan H. Lockwood, Human Testing of Pesticides: Ethical and

Scientific Considerations, 94 Am. J. Pub. Health 1908 (2004)), 243, 746. After

reviewing the dichlorvos human study and five other human dosing studies, Dr.

52

Lockwood stated that the dichlorvos study subjects were not informed that the

purpose of the study was to gather data for pesticide regulation. A-264 (col. 4). Dr.

Lockwood identified other “[u]nacceptable deficiencies in the consent documents”

for the dichlorvos study and other human dosing studies which “raise serious

doubts as to whether the participant’s [sic] signatures were a reasonable reflection

of informed voluntary consent.” Id. These deficiencies included “failure to identify

the test compound as a pesticide,” “misleading statements about the effects,” and

“a failure to identify the source of funding.” Id.

The evidence identified by NRDC that study subjects did not give their

informed consent creates a genuine, material, and substantial issue of disputed fact.

NRDC’s submissions discuss serious deficiencies in the dichlorvos human study’s

consent process that are both genuine and substantial, and the factual inferences to

be drawn as to the meaning of these defects are contested. See Chambers v. TRM

Copy Ctrs. Corp., 43 F.3d 29, 38 (2d Cir. 1994) (“It is not the province of the

summary judgment court itself to decide what inferences should be drawn.”).

NRDC presented the expert opinion of a medical doctor in a peer-reviewed article

that the informed consent procedure in the dichlorvos human study was

“unacceptable” and failed to obtain the informed consent of the study subjects. A-

260 (col. 1), 264 (col. 4). NRDC is now entitled to present evidence to a neutral

53

factfinder to attempt to establish that the misleading consent materials were

inadequate to obtain the voluntary and informed consent of the test subjects.

NRDC’s submissions also show a “reasonable possibility” that an

administrative law judge would decide the contested issue in NRDC’s favor. 40

C.F.R. § 178.32(b)(2). Although the parties disagree about whether the subjects

gave their informed consent, A-414, 417, there can be no question that evidence

proffered by NRDC specifically identifies major problems with the consent

materials. EPA’s own ethics reviewers faulted the materials for inaccurately

referring to dichlorvos as a “drug” and to the experiment as designed to acquire

“medical knowledge” and influence the regulation of “medicines,” which “may

well have misled subjects” about the nature of the study. A-415. EPA’s internal

reviewers also identified further abuses of the consent process: downplaying the

study’s risks, withholding key information about the availability of an antidote, and

omitting the name of the study sponsor. Id.

Many of the deficiencies EPA identified are also noted in the report of the

Human Studies Review Board and in the scientific article cited by NRDC. See A-

264 (opining the informed consent procedure was “[u]nacceptable”), 472-473, 681.

The Board said the consent materials were “highly undesirable” and “should not be

used as part of modern-day practice.” A-472 to 473, 680-81. NRDC’s evidentiary

54

submissions are more than sufficient to establish a “reasonable possibility” that the

evidence would justify a determination that the study lacked informed consent. 40

C.F.R. § 178.32(b)(2); cf. Anderson, 477 U.S. at 250 (summary judgment is

inappropriate if “reasonable minds could differ as to the import of the evidence”).

Finally, the existence of informed consent is “determinative” of the legality

of EPA’s continued approval of dichlorvos. See 40 C.F.R. § 178.32(b)(3). If the

dichlorvos human study was conducted without the informed consent of its

subjects, EPA cannot use it to set tolerances for dichlorvos. Id. §§ 26.1704,

26.1701 (preventing EPA from relying on studies that “failed to obtain informed

consent” in actions under the Food Act and FIFRA); see also SPA-041 (cols. 2-3).

In a reevaluation of the pesticide’s safety under the Food Act, if EPA relied on

appropriate data from research on animals in lieu of the human study, EPA would

likely have to set more protective limits on dichlorvos. 21 U.S.C. § 346a(a)(1)(A),

(b)(2)(A)(i); see supra, Statement of Facts I & V.C (tenfold interspecies safety

factor added when extrapolating from animal data).

In sum, NRDC’s evidentiary submissions satisfy the Food Act and each

prong of the test supplied in 40 C.F.R. § 178.32(b). NRDC’s evidence shows that

the existence of informed consent in the dichlorvos human study is a disputed fact,

has a reasonable possibility of being resolved in NRDC’s favor, and is material to

55

EPA’s justification for maintaining dichlorvos approvals. The arbitrary and

unlawful denial of NRDC’s request should be vacated and a hearing ordered.

C. NRDC Was Entitled to a Hearing to Determine Whether the Dichlorvos Human Study Was Scientifically Unreliable

In its objections and request for an evidentiary hearing, NRDC presented

evidence that the dichlorvos human study was statistically invalid because six test

subjects do not constitute an adequate sample size from which to draw conclusions

about the general population. A-734, 743-45. Because of the small number of

subjects, NRDC objected that the study’s design could not reliably determine

either (1) the full range of health harms from dichlorvos exposure or (2) the dose at

which such harms would occur. A-734, 743-45.

In support of this factual dispute, NRDC identified the following evidence:

1. The Human Studies Review Board draft and final reports evaluating

the dichlorvos human study. A-458, 663, 734 (incorporating the Board’s final

report, which was cited in EPA’s petition denial, see A-729 (col. 2)), A-743. The

Board noted that “[t]he sample size was small and included only male” subjects,

and concluded “it was not clear whether the study was properly powered, given

that no sample size calculations seem to have been used in order to arrive at the

number of volunteers used.” A-466, 674.

56

2. A memorandum authored by EPA’s Pesticide Office that presented

the results of EPA’s initial review of the ethical deficiencies in the dichlorvos

human study. A-413, 734, 745-46. EPA observed that the study protocol “says

only” that “‘[t]he number of volunteers is based on the desire to gain adequate

information on the influence of dichlorvos on erythrocyte cholinesterase activity,

whilst exposing as few volunteers as possible to the study procedures.’” A-419.

3. A published, peer-reviewed article by Dr. Lockwood reviewing the

dichlorvos human study and five other human pesticide-dosing studies. A-260

(Alan H. Lockwood, Human Testing of Pesticides: Ethical and Scientific

Considerations, 94 Am. J. Pub. Health 1908 (2004)), 746. Dr. Lockwood

concluded that the dichlorvos human study had “low statistical power” and was

“flawed” and “inconclusive.” A-264 (col. 1), 266 (col. 4) to 267 (cols. 1-2)

(discussing the dichlorvos human study, listed at note 7, and other studies).

4. An article published in a scientific journal by Dr. Herbert Needleman,

a medical doctor with the University of Pittsburgh School of Medicine, and Dr.

Jennifer Sass, an NRDC biologist, that found the dichlorvos human study lacked

an adequate sample size to accurately measure harmful health effects. A-247 (col.

3) (Jennifer B. Sass & Herbert L. Needleman, Industry Testing of Toxic Pesticides

on Human Subjects Concluded “No Effect,” Despite the Evidence, 112 Envtl.

57

Health Perspectives A 150 (2004)), A-746. Drs. Needleman and Sass discussed the

dichlorvos human study and several other studies and observed that “[a] study of a

handful of healthy adult subjects is inadequate to determine the expected response

to toxic chemical exposures from population diverse in ethnicity, life-stage, sex,

health status, genetic makeup, metabolism, and nutritional status.” A-247 (col. 3).

The authors stated that such studies “often lack enough subjects to provide

adequate statistical power to detect an effect if it is present.” Id.

5. A letter published in a scientific journal from Drs. Needleman and

Sass responding to comments on the article cited above. A-258 (Jennifer B. Sass &

Herbert L Needleman, Letter, Human Testing: Sass and Needleman Respond to

Industry, 112 Envtl. Health Perspectives A 340 (2004)), 746. Drs. Needleman and

Sass found that in the dichlorvos human study and two others, “sample sizes and

statistical power were too small to find an effect, if one were present.” A-258 (col.

2). In support, the authors stated: “The calculated statistical power to find an effect

was in the range of 0.2. This means that they had a one-in-five chance of detecting

an effect if it were present, practically guaranteeing a finding of no effect.” Id. (col.

3). In other words, the study did not have enough subjects to reliably detect the full

range of exposure levels at which humans may suffer adverse effects.

58

6. A published essay by Dr. Lockwood about human pesticide dosing

studies in which the authors concluded that a human study with “as few as six

subjects” has “too few subjects to be statistically valid.” A-372 (col. 3) (Alan H.

Lockwood, The Ethical Bar Drops to Unacceptable, Envtl. Forum at 48

(Nov./Dec. 2005)), A-746.

7. Written comments Dr. Sass submitted to EPA’s Human Studies

Review Board regarding the minimum sample size required for a human study to

produce a statistically significant result. A-423, 430, 746. Dr. Sass estimated that

“[s]tudies with sample sizes < 50 had about a 3% chance of finding an effect if it

were present.” A-430.

The evidence proffered by NRDC creates a genuine, material, and

substantial issue of fact that required EPA to hold an evidentiary hearing. 40

C.F.R. § 178.32(b)(1). The adequacy of a study’s sample size is a factual question.

Ratanasen v. Cal. Dep’t of Health Servs., 11 F.3d 1467, 1469 (9th Cir. 1993)

(“[W]hether the use of sampling and extrapolation is proper is a question of law,

while whether the sample size, etc., were appropriate is a question of fact.”).

The scientific evidence that NRDC cited and submitted with its hearing

request was far more than necessary to show the existence of a material disputed

fact. EPA’s own Human Studies Review Board found that the dichlorvos human

59

study’s small sample size and lack of calculations on its statistical reliability raises

a substantial question of whether the study was scientifically reliable. A-674.

NRDC supplemented this evidence with published articles and letters three

scientists (two medical doctors and one Ph.D. biologist) who found that the

dichlorvos human study lacked an adequate sample size to identify either the toxic

effects from exposure or the dose at which those harmful effects occur. A-247 (col.

3), 258-59, 264 (col. 1), 266 (col. 4) to 267 (col. 1), 372, 430. Dr. Sass’s written

comments to the Board, for example, elaborate on the conditions that must be

satisfied in any human study in order for it to adequately detect harmful effects,

and explain that a study with fewer than fifty subjects has only a three percent

chance of identifying a harmful effect. A-430. The dichlorvos study had just six

dosed subjects and three controls. A-414, 419.

This proffer more than satisfied NRDC’s burden of identifying a genuine,

material, and substantial issue of fact under the first prong of EPA’s hearing

regulations. See 40 C.F.R. § 178.32(b)(1). Assuming the Court does not conclude

Section 201 bars EPA from using the dichlorvos human study, see supra,

Argument II, the factual question NRDC has raised concerning the study’s

statistical validity would be best resolved in an evidentiary proceeding, through the

submission of testimony on the parties’ competing views concerning the study’s

60

statistical power and reliability. See Cmty. Nutrition Inst., 773 F.2d at 1364 (a

material issue of disputed fact should be susceptible to a “meaningful hearing”);

Ratanasen, 11 F.3d at 1469, 1471-72 (describing hearing conducted to resolve

factual dispute concerning validity of statistical methods); cf. A-674 (Board’s

acknowledgment of need for calculations to resolve whether study’s sample size

was adequate).

Turning to the second prong of the regulations, the evidence NRDC

submitted also demonstrates there is a “reasonable possibility” that the statistical

issue will be decided in NRDC’s favor. 40 C.F.R. § 178.32(b)(2). NRDC’s

objection that a study of only six male test subjects is statistically unreliable is

substantiated by analysis from scientists and doctors. Each of the experts discussed

above concludes that the study lacked an adequate sample size to reliably identify

the range of harms resulting from the study or the amount of the pesticide required

to cause those harms. A-258 to 259, 264 (col. 1), 267-68, 430, 746. These experts’

considered opinions, several of them published and peer-reviewed, provide ample

grounds for a decision in NRDC’s favor. Indeed, the only countervailing evidence

EPA cited in denying NRDC’s hearing request was the report of the Human

Studies Review Board—which itself raised and did not fully dispel questions about

the study’s statistical validity. SPA-021, 030 (cols. 1-2), 044 (cols. 1-3); A-674

61

(Board’s observation that “it was not clear whether the study was properly

powered”).

It is true that the Board, in an analysis EPA adopted, ultimately gave EPA its

“tepid endorsement” of the study data for use in the dichlorvos risk assessment. A-

457. But EPA cannot deny a hearing request simply because it would prefer to

avoid further examination of a factual question it has chosen to call in its favor.

Hynson, 461 F.2d at 220 (“[T]he applicant does not have to satisfy or convince the

[agency] by his evidence . . . as a predicate for securing his right to a hearing. If

that were his burden, a hearing would never be necessary or appropriate.”); Pactra

Indus. v. Consumer Prod. Safety Comm’n, 555 F.2d 677, 684 (9th Cir. 1977) (an

agency cannot refuse a hearing “merely because [it] has concluded that the

scientific evidence is adequate to support its order”). At the very least, the Board’s

analysis shows a “reasonable possibility” that the statistical question NRDC has

raised could be resolved in NRDC’s favor after hearing—which is all EPA’s

hearing regulations require. 40 C.F.R. § 178.32(b)(2); see Am. Cyanamid Co., 606

F.2d at 1318-19 (hearing required where responsible scientific experts differed in

their interpretations of a toxicity study). It is no surprise that EPA does not believe

its own factual conclusions about the dichlorvos human study should be reversed,

but the Food Act reserves that decision for a neutral factfinder. See 21 U.S.C.

62

§ 346a(g)(2)(B); 40 C.F.R. §§ 179.24, 179.60; Hynson, 461 F.2d at 220 (to require

a hearing requester to proffer enough evidence in support of his position to

“convince” the agency would render the hearing right “purely illusory”).

The statistical issue NRDC has raised is also “determinative” of the legality

of EPA’s continued approval of dichlorvos, and thus satisfies the third and final

prong of EPA’s hearing test. 40 C.F.R. § 178.32(b)(3). It is arbitrary and unlawful

for EPA to use statistically invalid data to justify pesticide approvals. See Bellevue

Hosp. Ctr. v. Leavitt, 443 F.3d 163, 179 (2d Cir. 2006) (arbitrary for agency to

continue to rely on a limited set of data that had “proved inadequate” to allow

agency to fulfill certain statutory mandates); 40 C.F.R. § 26.1701 (Human Testing

Rule “applies to EPA’s decisions whether to rely [in actions under the Food Act

and FIFRA] on scientifically valid and relevant data” from intentional human

dosing studies (emphasis added)). Without the study, the Food Act would require

EPA to reevaluate existing approvals for dichlorvos in order to identify a safe level

of exposure to humans. See 21 U.S.C. § 346a(a)(1)(A), (b)(2)(A)(i). The use of

more appropriate animal data would likely lead EPA to set more protective

tolerances for dichlorvos. See supra, Statement of Facts I & V.C (tenfold

interspecies safety factor added when extrapolating from animal data).

63

In sum, the evidence NRDC proffered with its hearing request was more

than sufficient to demonstrate a genuine, material, and substantial dispute of fact

regarding the statistical validity of the dichlorvos human study. 21 U.S.C.

§ 346a(g)(2)(B); 40 C.F.R. § 178.32(b)(1), (3). NRDC also established a

“reasonable possibility” that a neutral factfinder would resolve the dispute in its

favor. 40 C.F.R. § 178.32(b)(2). Because NRDC met its legal burden to

demonstrate entitlement to an evidentiary hearing, EPA’s denial of the hearing

request was arbitrary, capricious, and not in accordance with the Food Act or

EPA’s own regulations. A hearing should be ordered.

64

CONCLUSION

For these reasons, this Court should vacate the 2012 denial order and forbid

EPA from using the dichlorvos human study. In the alternative, the Court should

direct EPA to conduct an evidentiary hearing.

Dated: December 20, 2012 Respectfully submitted,

s/ Nicholas Morales Nicholas Morales Natural Resources Defense Council 1152 15th Street, NW, Suite 300 Washington, D.C. 20005 nmorales@nrdc.org Phone: (202) 717-8234 Fax: (202) 289-1060

Selena Kyle Natural Resources Defense Council 111 Sutter Street, 20th Floor San Francisco, CA 94104 skyle@nrdc.org Phone: (415) 875-6100 Fax: (415) 875-6161

Counsel for Petitioner

65

CERTIFICATE OF COMPLIANCE

This brief complies with the type-volume limitation of Federal Rule of

Appellate Procedure 32(a)(7)(B) because it contains 13,974 words.

This brief complies with the typeface and type style requirements of Federal

Rules of Appellate Procedure 32(a)(5) and 32(a)(6) because it is written in a

proportionally spaced typeface in 14-point font.

s/ Nicholas Morales Nicholas Morales

SPECIAL APPENDIX

i

SPECIAL APPENDIX

Order Denying NRDC’s Objections on Remand, 77 Fed. Reg. 54,402 (Sept. 5, 2012). .......................................................................SPA-001

Order Denying NRDC’s Objections and Requests for Hearing, 73 Fed. Reg. 42,683 (July 23, 2008). .................................................SPA-021

7 U.S.C. § 136. ..............................................................................................SPA-052

7 U.S.C. § 136a. ............................................................................................SPA-064

21 U.S.C. § 342.............................................................................................SPA-085

21 U.S.C. § 346a. ..........................................................................................SPA-089

Department of the Interior, Environment, and Related Agencies Appropriations Act of 2006, Pub. L. No. 109-54 § 201, 119 Stat. 499. ......................................................................................SPA-115

40 C.F.R. § 26.1704. .....................................................................................SPA-117

40 C.F.R. § 178.32. .......................................................................................SPA-118

151 Cong. Rec. H3670-3671 (May 19, 2005). .............................................SPA-120

151 Cong. Rec. H6941-6943 (July 28, 2005). ..............................................SPA-122

151 Cong. Rec. H7013-7023 (July 28, 2005) ...............................................SPA-125

151 Cong. Rec. S7551-7561 (June 29, 2005) ...............................................SPA-136

NRDC, Petition for Review, No. 12-3671-ag (filed Sept. 17, 2012) ...................................................................................................SPA-147

Declaration of Jasanna Britton (Dec. 14, 2012)............................................SPA-148

Declaration of Linda Lopez (Dec. 13, 2012) ................................................SPA-152

Declaration of Joyce Kennedy Raymes (Dec. 11, 2012)..............................SPA-154

Declaration of Jennifer Sass, Ph.D (Dec. 19, 2012) .....................................SPA-157

54402 Federal Register / Vol. 77, No. 172 / Wednesday, September 5, 2012 / Rules and Regulations

§ 86.1105–87 Emission standards for which nonconformance penalties are available. * * * * *

(e) The values of COC50, COC90, and MC50 in paragraphs (a) and (b) of this section are expressed in December 1984 dollars. The values of COC50, COC90, and MC50 in paragraphs (c) and (d) of this section are expressed in December 1989 dollars. The values of COC50, COC90, and MC50 in paragraph (f) of this section are expressed in December 1991 dollars. The values of COC50, COC90, and MC50 in paragraphs (g) and (h) of this section are expressed in December 1994 dollars. The values of COC50, COC90, and MC50 in paragraph (i) of this section are expressed in December 2001 dollars. The values of COC50, COC90, and MC50 in paragraph (j) of this section are expressed in December 2011 dollars. These values shall be adjusted for inflation to dollars as of January of the calendar year preceding the model year in which the NCP is first available by using the change in the overall Consumer Price Index, and rounded to the nearest whole dollar in accordance with ASTM E29–67 (reapproved 1980), Standard Recommended Practice for Indicating Which Places of Figures Are To Be Considered Significant in Specified Limiting Values. This method was approved by the Director of the Federal Register in accordance with 5 U.S.C. 552(a) and 1 CFR part 51. This document is available from ASTM International, 100 Barr Harbor Drive, P.O. Box C700, West Conshohocken, PA 19428–2959, and is also available for inspection as part of Docket A–91–06, located at the U.S. EPA, Air and Radiation Docket and Information Center, 1301 Constitution Ave. NW., Room 3334, EPA West Building, Washington, DC 20004, (202) 202–1744 or at the National Archives and Records Administration (NARA). For information on the availability of this material at NARA, call 202–741–6030, or go to: http://www.archives.gov/ federal-register/cfr/ibr-locations.html. This incorporation by reference was approved by the Director of the Federal Register on January 13, 1992. These materials are incorporated as they exist on the date of the approval and a notice of any change in these materials will be published in the Federal Register. * * * * *

(j) Effective in the 2012 and later model years, NCPs will be available for the following emission standard:

(1) Diesel heavy-duty engine oxides of nitrogen standard of 0.20 grams per brake horsepower-hour in § 86.007– 11(a)(1)(i).

(i) [Reserved].

(ii) For heavy heavy-duty diesel engines:

(A) The following values shall be used to calculate an NCP in accordance with § 86.1113–87(a):

(1) COC50: $3,219. (2) COC90: $3,775. (3) MC50: $10,729 per gram per brake

horsepower-hour NOX. (4) F: 1.173. (5) UL: 0.50 grams per brake

horsepower-hour NOX. (B) The following factor shall be used

to calculate the engineering and development component of the NCP for the standard set forth in § 86.007– 11(a)(1)(i) in accordance with § 86.1113–87(h): 0.005.

(2) Manufacturers may not generate emission credits for any pollutant from engines for which the manufacturer pays an NCP for the NOX standard identified in paragraph (j)(1) of this section.

(3) The penalty shall be adjusted annually as specified in § 86.1113–87 with 2012 as the first year. Note that this means AAF2012 is equal to 1.

■ 5. Section 86.1113–87 is amended by revising paragraph (g)(1) to read as follows:

§ 86.1113–87 Calculation and payment of penalty.

* * * * * (g)(1) Except as provided in paragraph

(g)(2) of this section, the nonconformance penalty or penalties assessed under this subpart must be paid as follows:

(i) By the quarterly due dates, i.e., within 30 days of the end of each calendar quarter (March 31, June 30, September 30 and December 31), or according to such other payment schedule as the Administrator may approve pursuant to a manufacturer’s request, for all nonconforming engines or vehicles produced by a manufacturer in accordance with paragraph (b) of this section and distributed into commerce for that quarter.

(ii) The penalty shall be payable to U.S. Environmental Protection Agency, NCP Fund, Motor Vehicle and Engine Compliance Program, P.O. Box 979032St. Louis, MO 63197–9000. Note on the check and supporting information that this is an NCP payment. * * * * * [FR Doc. 2012–21967 Filed 9–4–12; 8:45 am]

BILLING CODE P

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA–HQ–OPP–2002–0302; FRL–9359–9]

Dichlorvos (DDVP); Order Denying NRDC’s Objections on Remand

AGENCY: Environmental Protection Agency (EPA) ACTION: Final Order.

SUMMARY: In this order, EPA denies an objection to a prior order denying a petition requesting that EPA revoke all pesticide tolerances for dichlorvos under section 408(d) of the Federal Food, Drug, and Cosmetic Act. The objection was filed on February 1, 2008, by the Natural Resources Defense Council (NRDC). The original petition was also filed by NRDC. Previously, in July 2008, EPA denied this same objection but the United States Court of Appeals for the Second Circuit vacated that decision, in part, and remanded the matter to EPA. This order is being issued in response to the court’s remand.

DATES: This order is effective September 5, 2012. ADDRESSES: The docket for this action, identified by docket identification (ID) number EPA–HQ–OPP–2002–0302, is available either electronically through http://www.regulations.gov or in hard copy at the OPP Docket in the Environmental Protection Agency Docket Center (EPA/DC), located in EPA West, Rm. 3334, 1301 Constitution Ave. NW., Washington, DC 20460–0001. The Public Reading Room is open from 8:30 a.m. to 4:30 p.m., Monday through Friday, excluding legal holidays. The telephone number for the Public Reading Room is (202) 566–1744, and the telephone number for the OPP Docket is (703) 305–5805. Please review the visitor instructions and additional information about the docket available at http://www.epa.gov/dockets. FOR FURTHER INFORMATION CONTACT: Melanie Biscoe, Pesticide Re-evaluation Division (7508P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave. NW., Washington, DC 20460–0001; telephone number: (703) 305–7106; email address: biscoe.melanie@epa.gov. SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this action apply to me?

In this document EPA denies an objection by the Natural Resources Defense Council (NRDC) concerning

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EPA’s denial of NRDC’s petition to revoke pesticide tolerances. This action may also be of interest to agricultural producers, food manufacturers, or pesticide manufacturers. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (North American Industrial Classification System (NAICS) code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

B. How can I get electronic access to other related information?

You may access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s e-CFR site at http://ecfr.gpoaccess.gov/cgi/t/ text/text-idx?&c=ecfr&tpl=/ecfrbrowse/ Title40/40tab_02.tpl.

II. Introduction

A. What action is the agency taking?

In this order, EPA is issuing a revised denial of an objection to an earlier EPA order, (72 FR 68662, December 5, 2007), denying a petition to revoke all tolerances established for the pesticide dichlorvos (DDVP) under the Federal Food, Drug, and Cosmetic Act (FFDCA), 21 U.S.C. 346a. Both the objection as well as the petition was filed with EPA by NRDC. (Refs. 1 and 2). EPA had previously denied this objection, (73 FR 42683, July 23, 2008), but that order was vacated, in part, by the United States Court of Appeals for the Second Circuit. (NRDC v. US EPA, 658 F.3d 200 (2d Cir. 2011)).

NRDC’s petition, filed on June 2, 2006, pursuant to FFDCA section 408(d)(1), asserted numerous grounds as to why the dichlorvos tolerances allegedly fail to meet the FFDCA’s safety standard. This petition was filed as EPA was completing its reassessment of the safety of the dichlorvos tolerances pursuant to FFDCA section 408(q). (Ref. 3). In response to the petition, EPA undertook an extensive review of its dichlorvos safety evaluation in the tolerance reassessment decision. Based on this extensive review, EPA

concluded that dichlorvos met the FFDCA safety standard and, therefore, denied the petition. (72 FR 68695). NRDC then filed objections with EPA to the petition denial order and requested a hearing on its objections. The objections narrowed NRDC’s claims to two main assertions—that, in assessing the risk to dichlorvos, EPA unlawfully reduced the statutory tenfold (10X) additional safety factor for the protection of infants and children and EPA unlawfully relied on a human toxicity study (the Gledhill study). After carefully reviewing the objections and hearing requests, EPA determined that NRDC’s hearing requests did not satisfy the regulatory requirements for such requests and that its substantive objections were without merit. (73 FR 42709–42711). NRDC sought review of EPA’s decision in the United States Court of Appeal for the Second Circuit. As noted, the Second Circuit court vacated a portion of EPA’s order finding that ‘‘[b]ecause EPA failed to explain why it did not use a 10X children’s safety factor for dichlorvos risk assessments that relied on the Gledhill study, EPA acted in an arbitrary and capricious manner.’’ (658 F.3d at 218). Specifically, the court vacated ‘‘those portions of EPA’s July 23, 2008 order assessing the risk of dichlorvos based on the Gledhill study * * * ’’ (Id.). The court remanded the matter to EPA. (Id. at 219).

On remand, EPA has carefully examined the court’s opinion and has reconsidered that portion of its prior decision that relied on the Gledhill study in assessing dichlorvos risk. Because the court found this portion of EPA’s order to be arbitrary and capricious due to its absence of an adequate explanation on the additional safety factor for the protection of infants and children, EPA focused on a reexamination of what additional safety factor for the protection of infants and children should be applied for the assessments based on the Gledhill study. EPA concludes, like it did in the July 23, 2008 order, that a threefold (3X) additional safety factor will protect the safety of infants and children. Accordingly, EPA again denies NRDC’s objections as to those portions of the July 23, 2008 order that were vacated. Although EPA reaches the same conclusion on remand on the additional safety factor for the protection of infants and children, EPA has provided a revised, more extensive explanation for its position. Because this revised explanation addresses the court’s reason for finding portions of the July 23, 2008 order to be arbitrary and capricious,

EPA has not otherwise reopened or reconsidered that prior order.

B. What is the agency’s authority for taking this action?

NRDC petitioned to revoke the dichlorvos tolerances pursuant to the petition procedures in FFDCA section 408(d)(1). (21 U.S.C. 346a(d)(1)). Under section 408(d), EPA may respond to such a petition by either issuing a final or proposed rule modifying or revoking the tolerances or issuing an order denying the petition. (21 U.S.C. 346a(d)(4)). Here, EPA responded by issuing an order under section 408(d)(4)(iii) denying the petition. (72 FR 68622, December 5, 2007).

Orders issued under section 408(d)(4)(iii) are subject to a statutorily- created administrative review process. (21 U.S.C. 346a(g)(2)). Any person may file objections to a section 408(d)(4)(iii) order with EPA and request a hearing on those objections. (Id.). EPA is required by section 408(g)(2)(C) to issue a final order resolving the objections to the section 408(d)(4)(iii) order. (21 U.S.C. 346a(g)(2)(C)). NRDC filed objections to EPA’s denial of its dichlorvos petition and EPA issued a section 408(g)(2)(C) order denying NRDC’s objections. (73 FR 42683, July 23, 2008). EPA’s order denying NRDC’s objections was vacated, in part, and remanded to EPA. This revised order on remand is also being issued under section 408(g)(2)(C).

III. Statutory and Regulatory Background

In this Unit, EPA provides background on the relevant statutes and regulations governing the matter on remand as well as a much-abbreviated discussion on pertinent Agency risk assessment policies. A full discussion of EPA’s approach to pesticide risk assessment is included in EPA’s prior order on NRDC’s objections. (73 FR 42685–42688). Because the court’s decision focused on the explanation offered by EPA for its use of safety factors, this Unit includes an expanded discussion on use of safety or uncertainty factors, including the additional safety factor required by the FQPA for the protection of infants and children. Further, because Benchmark Dose Methods analysis is discussed for the first time in this revised order, a short section explaining that concept is included.

A. FFDCA/FIFRA and Applicable Regulations

1. In general. EPA establishes maximum residue limits, or ‘‘tolerances,’’ for pesticide residues in food and feed commodities under

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section 408 of the FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from the requirement of a tolerance, a food containing a pesticide residue is ‘‘adulterated’’ under section 402 of the FFDCA and may not be legally moved in interstate commerce. (21 U.S.C. 331, 342). Monitoring and enforcement of pesticide tolerances are carried out by the U.S. Food and Drug Administration (FDA) and the U.S. Department of Agriculture (USDA). Section 408 was substantially rewritten by the Food Quality Protection Act of 1996 (FQPA), which added the provisions discussed below establishing a detailed safety standard for pesticides, additional protections for infants and children, and the endocrine disrupting substances screening program. (Pub. L. 104–170, 110 Stat. 1489 (1996)).

EPA also regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), (7 U.S.C. 136 et seq). While the FFDCA authorizes the establishment of legal limits for pesticide residues in food, FIFRA requires the approval of pesticides prior to their sale and distribution, (7 U.S.C. 136a(a)), and establishes a registration regime for regulating the use of pesticides. FIFRA regulates pesticide use in conjunction with its registration scheme by requiring EPA review and approval of pesticide labels and specifying that use of a pesticide inconsistent with its label is a violation of Federal law. (7 U.S.C. 136j(a)(2)(G)).

2. Safety standard for pesticide tolerances. A pesticide tolerance may be promulgated or left in effect by EPA only if the tolerance is ‘‘safe.’’ (21 U.S.C. 346a(b)(2)(A)(i)). This standard applies when responding both to petitions to establish and petitions to revoke tolerances. ‘‘Safe’’ is defined by the statute to mean that ‘‘there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ (21 U.S.C. 346a(b)(2)(A)(ii)).

Risks to infants and children are given special consideration. Providing additional protection to infants and children was a particular focus of the FQPA. Section 408(b)(2)(C) requires EPA to make a specific determination regarding the safety of tolerances to infants and children and to consider, among other things, information ‘‘concerning the special susceptibility of infants and children to the pesticide chemical residues * * *.’’ (21 U.S.C. 346a(b)(2)(C)(i)(II) and (ii)(II)). This provision also creates a presumptive additional safety factor for the

protection of infants and children. Specifically, it directs that ‘‘[i]n the case of threshold effects, * * * an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.’’ (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to ‘‘use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.’’ (Id.). For convenience’s sake, the legal requirements regarding the additional safety margin for infants and children in section 408(b)(2)(C) are referred to throughout this Order as the ‘‘FQPA safety factor for the protection of infants and children’’ or simply the ‘‘FQPA safety factor.’’

3. Procedures for establishing, amending, or revoking tolerances. Tolerances are established, amended, or revoked by rulemaking under the unique procedural framework set forth in the FFDCA. Generally, a tolerance rulemaking is initiated by the party seeking to establish, amend, or revoke a tolerance by means of filing a petition with EPA. (See 21 U.S.C. 346a(d)(1)). EPA publishes in the Federal Register a notice of the petition filing and requests public comment. (21 U.S.C. 346a(d)(3)). After reviewing the petition, and any comments received on it, EPA may issue a final rule establishing, amending, or revoking the tolerance, issue a proposed rule to do the same, or deny the petition. (21 U.S.C. 346a(d)(4)).

Once EPA takes final action on the petition by establishing, amending, or revoking the tolerance or denying the petition, any party may file objections with EPA to EPA’s decision on the petition and seek an evidentiary hearing on those objections. (21 U.S.C. 346a(g)(2)). Objections and hearing requests must be filed within 60 days. (Id.). The statute provides that EPA shall ‘‘hold a public evidentiary hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections.’’ (21 U.S.C. 346a(g)(2)(B)). EPA regulations make clear that hearings will only be granted where it is shown that there is ‘‘a genuine and substantial issue of fact,’’ the requestor has identified evidence that ‘‘would, if established, resolve one or more of such issues in favor of the requestor,’’ and the issue is ‘‘determinative’’ with regard to the relief requested. (40 CFR 178.32(b)). Further,

a party may not raise issues in objections unless they were part of the petition and an objecting party must state objections to the EPA decision and not just repeat the allegations in its petition. Corn Growers v. EPA, 613 F.2d 266 (D.C. Cir. 2010), cert. denied, 131 S. Ct. 2931 (2011). EPA’s final order on the objections is subject to judicial review. (21 U.S.C. 346a(h)(1)).

B. EPA Risk Assessment for Tolerances—Policy and Practice

1. The safety determination—risk assessment. To assess risk of a pesticide tolerance, EPA combines information on pesticide toxicity with information regarding the route, magnitude, and duration of exposure to the pesticide. The risk assessment process involves four distinct steps: (1) Identification of the toxicological hazards posed by a pesticide; (2) determination of the ‘‘level of concern’’ with respect to human exposure to the pesticide; (3) estimation of human exposure to the pesticide; and (4) characterization of risk posed to humans by the pesticide based on comparison of human exposure to the level of concern.

Toxicological hazards posed by a pesticide are identified through use of testing in laboratory animals or humans. Generally, EPA will use the lowest ‘‘no observed adverse affect level’’ (NOAEL) or ‘‘lowest observed adverse effect level’’ (LOAEL) from the available studies or a calculated value called a Benchmark Dose as a starting point (called ‘‘the Point of Departure’’) in estimating the ‘‘level of concern’’ for human exposure to the pesticide. Points of Departure and levels of concern will be identified for all exposure routes to the pesticide (oral, dermal, and inhalation) and durations of exposure (acute, short-term, intermediate-term, and chronic). Another critical aspect of the ‘‘level of concern’’ determination involves the use of safety or uncertainty factors to compensate for the limitations of toxicology testing. Safety and uncertainty factors are discussed in detail in Unit III.B.2. below. Having identified a pesticide’s hazards, the Point(s) of Departure, and level(s) of concern, EPA then estimates exposure to the pesticide taking into account the various routes of exposure, how exposures vary over time, and the differences in exposure to different subpopulations. Finally, EPA combines information on hazard, level of concern, and exposure to produce a characterization of the risk posed by the pesticide. Risks are calculated for all of the various routes and durations of exposure scenarios associated with a pesticide. These risk assessment

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scenarios may be calculated separately for different age-based population groups (e.g., non-nursing infants) or applied to all population groups, including infants and children, depending on information on the potential for exposure and data on differential sensitivity. A more comprehensive discussion of this risk assessment process is presented in EPA’s previous order denying objections. (73 FR 42685–42689).

Before turning to a detailed discussion of safety and uncertainty factors, EPA’s risk characterization process is briefly summarized because it is frequently referred to in this order. For pesticides that pose a risk over a certain threshold of exposure, EPA’s characterization of risk is presented in one of two ways: Either using the Reference Dose (RfD) approach or the Margin of Exposure (MOE) approach. Importantly, these different approaches do not render substantively different results. Both approaches use the same data—the Point of Departure, the applicable safety/uncertainty factors, and human exposure to the pesticide; they just express the characterization of risk in a different metric. Under the RfD approach, EPA directly extrapolates a dose from an animal or human study to an overall safe dose for humans. An RfD is calculated by dividing all applicable safety/uncertainty factors into the level of exposure from animal or human studies determined appropriate for assessing risk (i.e., the ‘‘Point of Departure’’). Estimated human exposure to the pesticide is then compared to the RfD to determine if it is excessive. Under the Margin of Exposure (MOE) approach, EPA does not calculate a safe dose in humans but rather focuses on the margin of exposure between a dose from an animal or human study and human exposure to the pesticide. A MOE is calculated by dividing human exposure to the pesticide into the Point of Departure. To determine whether that MOE is considered sufficiently protective of humans, EPA compares it to the product of all applicable safety/ uncertainty factors, referred to as the target MOE. MOEs that are less than the target MOE indicate a risk of concern. At bottom, both approaches extrapolate a safe measure of human exposure from animal or human studies using a mixture of uncertainty/safety factors.

2. Safety and uncertainty factors. i. History. It has long been a standard risk assessment practice to use numerical factors in conjunction with experimental toxicity data in assessing risk to humans from exposure to chemical substances. (Ref. 4). These numerical factors are designed to

provide an additional margin of safety so that risks to the populations covered by an assessment are not understated. The practice was first developed by the Food and Drug Administration (FDA) in the middle part of the last century. (Ref. 5). An influential 1954 paper by two FDA scientists called for a hundredfold margin of safety when extrapolating from long-term animal experiments to calculate safe doses in humans. (Ref. 6). The paper justified this safety factor on the basis of, among other things, potential differences in sensitivity between humans and laboratory animals as well as potential variations in sensitivity within humans. Accordingly, the paper recognized that a smaller factor would be appropriate where adequate human data are available. An explicit recommendation for a factor ‘‘as low as 10’’ was made by the Joint Food and Agricultural Organization/World Health Organization (FAO/WHO) Meeting on Pesticide Residues in 1965 for circumstances where human data was relied upon. (Ref. 7 at 12). Eventually, it became common regulatory practice to treat the hundredfold margin of safety as comprised of two tenfold factors: The first addressing the potential difference in sensitivity between humans and experimental animals (i.e., interspecies sensitivity) and the second addressing variation within the human population (i.e., intraspecies sensitivity). The rationale for these two factors is concisely summarized in a recent publication from the International Programme on Chemical Safety:

The interspecies uncertainty factor can be considered to convert the NOAEL/NOAEC [No observed adverse effect concentration] for animals (derived from a small group of relatively homogeneous test animals) into the NOAEL/NOAEC anticipated for an average representative healthy human. The uncertainty factor for human variability converts the NOAEL/NOAEC for the average human into a NOAEL/NOAEC for susceptible humans. Although adverse effect data in humans can be used directly without the need for an interspecies factor, the paucity of such data means that the vast majority of risk assessments are based on studies in experimental animals.

(Ref. 8 at 15). EPA, as well as other Federal and

international regulatory bodies, also will, where appropriate, apply additional numerical factors to take into account chemical-specific considerations affecting the risk assessment. (Ref. 9) Use of these additional factors is further explained in Unit III.B.2.v., vi, and vii.

ii. Terminology. Different terminology has been used to label numerical factors

used in calculating safe doses of chemical substances. As noted, they were first referred to as ‘‘safety’’ factors. The terminology has evolved over the decades, however, such that what was once generally called a safety factor has come to be generally referred to as an uncertainty factor. (Ref. 10 at A–3). The rationale for the change was that, although the use of such factors does promote safety, there was a concern that the use of the term ‘‘safety’’ implied that these factors provided absolute safety. (Ref. 11). The FQPA reintroduced the term ‘‘safety’’ factors with its reference to a ‘‘margin of safety.’’ 21 U.S.C. 346a(b)(2)(C). Subsequent to the passage of FQPA, EPA’s Office of Pesticide Programs (OPP) has used the terms safety factor and uncertainty factor interchangeably. Both terms have been criticized by the National Academy of Sciences (NAS). The NAS explained that the terms safety and uncertainty imply that factors ‘‘are simply added on for safety or because of a lack of knowledge or confidence in the process.’’ (Ref. 12 at 132). To the contrary, according to the NAS, these factors are scientifically-based and used ‘‘to adjust for differences in individual human sensitivities, for humans’ generally greater sensitivity than test animals’ on a milligram-per-kilogram basis, for the fact that chemicals typically induce harm at lower doses with longer exposures, and so on.’’ (Id.).

iii. Scientific basis for inter- and intraspecies factors. Only limited scientific data, involving differing sensitivity of humans and animals, are cited in the 1954 article in justification of the recommendation for a hundredfold safety factor. Subsequent investigations of both animal and human toxicity data, however, have provided general support for the protectiveness of the tenfold factors for interspecies and intraspecies sensitivity differences if an adequate toxicity database is available. (Refs. 9, 13, 14, and 15). The interspecies factor has been investigated through comparisons of toxicity testing in laboratory animals and humans. (Refs. 15 and 16). The protectiveness of the human intraspecies factor has been assessed through examining sub-population differences both among various human age groups (the young, adults, and elderly) as revealed in pharmaceutical trials and between juvenile and adult laboratory animals identified in toxicity testing. (Ref. 13 at 211 (‘‘For substances other than pharmaceuticals, age-related differences in toxicity have been primarily investigated in rodent studies.’’); Ref. 17 at 462–463

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(describing pharmaceutical trials involving humans and comparative studies in juvenile and adult laboratory animals)). For example, the NAS, in its report ‘‘Pesticides in the Diets of Infants and Children,’’ looked to both human data and animal data in evaluating the potential for increased sensitivity in infants and children to pesticides. (Ref. 18 at 344–345).

iv. Adjustment of inter- and intraspecies factors. In addition to evaluating the protectiveness of the intra- and interspecies uncertainty factors, scientists have also examined both generic biological as well as chemical-specific factors that may affect intra- and interspecies variability with the aim of deriving more accurate uncertainty factor values than the default tenfold values.

One reason humans are considered to be potentially more sensitive to toxic agents than laboratory animals is that otherwise equivalent external doses of such agents for humans and animals on a milligram-per-kilogram of body weight basis may result in a greater internal dose for humans. This is due to species differences in general metabolic processes—commonly referred to as toxicokinetics—and ‘‘is thought to be related to species differences in exchange surfaces and distribution networks that constrain concentration and flux of metabolic reactants.’’ (Ref. 19 at 4–35; see Ref. 15 at 228).

In addition to toxicokinetic effects on internal dose, differences between humans and laboratory animals are also driven by toxicodynamic factors. Toxicodynamics refers to the manner in which the target tissue and body respond to the toxic agent. Thus, interspecies differences are a factor of both differences in the internal dose received by humans and animals and differences in how humans and animals react to the internal dose received. Similarly, sensitivity differences between juveniles and adults, whether humans or animals, are also considered to be tied to toxicokinetic and toxicodynamic factors. Accordingly, both the inter- and intraspecies uncertainty factors are considered to have toxicokinetic and toxicodynamic components. EPA typically has considered both the tenfold (10X) inter- and intraspecies factors to be roughly equally divided on a logarithmic basis (i.e., 100.5 or roughly a 3X factor) between toxicokinetics and toxicodynamics. (Ref. 19 at 4–29; see also Ref. 19 at 4–40 (explaining why two 3X factors [technically, 3.16X] would be equivalent to a 10X factor)). Other organizations have recommended that, while toxicokinetics and

toxicodynamics play an equal role in intra-human variability, toxicokinetics has a greater effect on interspecies differences and thus recommend that the tenfold interspecies factor be divided into a fourfold factor for toxicokinetics and 2.5-fold factor for toxicodynamics. (Ref. 8 at 17; see Ref. 14).

Of the toxicokinetic and toxicodynamic differences between humans and animals and among various human subgroups, the most is known about the toxicokinetic differences between humans and animals. For inhalation exposures, EPA has used toxicokinetic information on humans and animals to create generic dosimetric adjustment factors that replace that portion of the interspecies factor tied to toxicokinetic differences. (Refs. 19 at 4– 29; 20). Where such dosimetric adjustment factor is used, the interspecies factor is reduced to 3X.

EPA guidance entitled ‘‘A Review of the Reference Dose and Reference Concentration Processes’’ (‘‘RfD Guidance’’) also urges that data be developed to support substitution of chemical-specific adjustment factors (sometimes referred to as data-derived factors) for the default 10X uncertainty factors for inter- and intraspecies variability. (Ref. 19 at xviii –xix, 4–47). This guidance recognizes that chemical- specific data from both humans and animals has been relied upon by EPA to adjust the human intraspecies uncertainty factor citing an article by Dourson et al. That article collects instances in which EPA has adjusted uncertainty factors on a chemical- specific basis. (Ref. 9). For example, Dourson et al. point to a 1996 EPA assessment of Aroclor that reduced the human intraspecies factor to 3X given that the Point of Departure came from a sensitive animal population—there, infant rhesus monkeys. In discussing the Dourson et al. article, the RfD Guidance notes that:

In those cases where developmental effects were the most sensitive endpoint (0 RfCs, 6 RfDs), reduction of the intraspecies [uncertainty factor] from 10 to 3 was based on data derived either from human data showing which age groups or time periods were most susceptible (e.g., methyl mercury exposure to the developing fetus) or from an animal study with support from strong human or other data (e.g., Aroclor 1016 in utero exposure in monkeys, strontium- induced rachitic bones in young rats).

(Ref. 19 at 4–43). The RfD Guidance endorsed a view similar to that expressed in an agency-wide paper prepared in development of EPA’s Children’s Safety Factor Policy. That paper also noted that there were

circumstances where data from human studies or from animal studies might support reduction of the human intraspecies uncertainty factor: ‘‘The Toxicology Working Group recommends that reduction of the intraspecies uncertainty factor from a default of 10 be considered only if data are complete and the age group or window of vulnerability during development has been clearly delineated, preferably based on human data or on animal data with supporting human data.’’ (Ref. 21 at 28). On the other hand, the RfD guidance also recognized that a 10X intraspecies factor ‘‘may sometimes be too small because of factors that can influence large differences in susceptibility, such as genetic polymorphisms.’’ (Ref. 19 at 4–44).

In sum, the 10X inter- and intraspecies factors are default values. Although there is substantial scientific support for these default values, chemical-specific human and animal data may be relied upon in reducing, confirming, or increasing these default values.

v. Additional Safety/Uncertainty Factors. In addition to the inter- and intraspecies factors, risk assessors from EPA as well as other Federal and international regulatory agencies also apply ‘‘additional’’ or ‘‘modifying’’ safety/uncertainty factors based on specific circumstances related to the toxicity data, particularly with regard to deficiencies in that data. Like the inter- and intra-species factors, these additional factors help to ensure that risks to populations covered by an assessment are not understated. Additional factors are applied to address: (1) An absence of critical toxicity data; (2) the failure of a study to identify a NOAEL; (3) the necessity of using sub-chronic data to choose a Point of Departure for estimating chronic risk; and (4) results in a study that suggest the inter- or intraspecies factors may not be sufficient (sometimes referred to as a ‘‘modifying factor’’). (Ref. 10 at 9). Generally, a safety factor value of 10X or 3X (which is considered to be one-half of 10X on the logarithmic scale) is used to address these concerns.

The protectiveness of these default values has also been the subject of scientific examination. Studies have been done on the variations in the levels of NOAELs in the databases for various pesticides. They confirm the need for an additional factor when core data are lacking. (Ref. 22). Examination of the completeness of the animal database remains important even when human data are used as the Point of Departure for calculating the RfD. The latest EPA guidance on RfDs emphasizes that in

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these circumstances ‘‘[i]nformation on life stages and organ systems may come from either animal or human studies.’’ (Ref. 19 at 4–45). The guidance notes that ‘‘the lack of a two-generation animal reproduction study might be considered a deficiency even if the reference value is based on human data.’’ (Id.). Similarly, research has been conducted on existing databases to determine the adequacy of uncertainty factors used to address reliance on a LOAEL instead of a NOAEL, or subchronic data to estimate chronic risk. (Refs. 9 and 15).

Selection of particular values for these additional uncertainty values depends on what is known from the full body of information about the chemical, including both data from testing with animals and humans, about the chemical. For example, as EPA’s RfD Guidance advises: ‘‘the size of the database factor to be applied will depend on other information in the database and on how much impact the missing data may have on determining the toxicity of a chemical and, consequently, the POD [Point of Departure].’’ (Ref. 19 at 4–45). With regard to an additional factor for extrapolation of a NOAEL from a LOAEL, Dourson et al. report that ‘‘[a]nalysis of several data bases suggest that a factor of 10 or lower is adequate and that use of data does support a lower factor with certain chemicals.’’ (Ref. 9 at 112). The critical consideration, according to Dourson et al., is the severity of the effect at the LOAEL: ‘‘The data indicate that when faced with a LOAEL and not a NOAEL, the choice of uncertainty factor should generally depend on the severity of the effect at the LOAEL.’’ (Id.). Specifically, Dourson et al. note that ‘‘[l]ess severe effects would not require a large factor, because, presumably, the LOAEL is closer to the unknown NOAEL.’’ (Id.).

vi. FQPA safety factor—integration with traditional uncertainty factors. EPA’s safety/uncertainty factor practice with regard to pesticides was altered to a degree by the Food Quality Protection Act (FQPA). (Ref. 10). That Act established a presumptive additional ‘‘safety’’ factor of 10X to protect infants and children. The additional factor was designed to account for the completeness of the toxicity and exposure databases and the potential for pre- and post-natal toxicity. EPA has interpreted this legislation as both a ‘‘codification and expansion’’ of prior EPA practice with regard to additional safety/uncertainty factors. (Ref. 10 at A– 3—A–5). It codified EPA’s prior practice by requiring the additional presumptive

factor to address toxicity data completeness issues (i.e., absence of a particular study, lack of a NOAEL in a completed study, or absence of chronic data). These traditional additional uncertainty factors became FQPA safety factors for the protection of infants and children. This accords greater protection to infants and children because for FQPA safety factors, unlike pre-FQPA additional factors, there is a presumption, which can only be overcome by reliable data, that they will be applied. At the same time, EPA concluded that Congress had not intended EPA to double-up on safety factors by, for example, applying an additional uncertainty factor due to missing data, and applying an FQPA additional safety factor as well to address the same missing data. (Ref. 10 at A–4). Congress expanded EPA’s prior practice by providing that the additional FQPA safety factor for the protection of infants and children was designed to address not just toxicity data deficiencies but exposure data deficiencies as well and by its emphasis on protecting against potential pre- and post-natal toxicity. In theory, EPA could have, prior to the enactment of the FQPA, used an ‘‘additional’’ or ‘‘modifying’’ factor to address health risks to children not otherwise protected by the interspecies, intraspecies, or data deficiency safety factors, but use of such a factor was not common. The FQPA also modified the status quo by making the additional safety factor for infants and children presumptive in nature.

The narrowly-focused and highly- prescriptive nature of the FQPA safety factor provision has required careful integration with pesticide risk assessment approaches under other statutes and, more generally, with Agency risk assessment practices. As noted above, the FQPA, with regard to the assessment of risks to infants and children, essentially codified EPA’s prior risk assessment practice as to additional uncertainty factors and it expanded the use of additional uncertainty factors into new areas. The FQPA, however, did not speak to use of traditional (non-additional) uncertainty factors (i.e., the inter- and intraspecies factors). Thus, the end result was that some uncertainty factors for FFDCA pesticides remained unaffected by the new statutory requirements (the inter- and intraspecies factors), some uncertainty factors became FQPA safety factors (additional uncertainty factors that addressed toxicity data deficiencies), and some safety factors that either had previously never existed or were at least extremely rare were

created as a statutory phenomenon (a factor to address exposure data base deficiencies and a factor to address potential pre- and post-natal toxicity). This selective inter-weaving of statutory requirements with Agency science policy made FFDCA risk assessments for pesticides unique compared to general Agency risk assessment practice.

Pesticide risk, however, is not regulated under a single statute. Risks to workers or the environment from pesticide use are regulated by EPA under FIFRA, not the FFDCA. Further, EPA may address risks posed by pesticide contamination of the environment under several other statutes, including the Safe Drinking Water Act, 42 U.S.C. 300f et seq., the Resource Conservation and Recovery Act, 42 U.S.C. 6901 et seq., and the Comprehensive Environmental Response, Compensation, and Liability Act, 42 U.S.C. 9601 et seq. Prior to enactment of the FQPA’s specific provisions on pesticide risk assessment, a pesticide risk assessment performed by EPA’s Office of Pesticide Programs under the aegis of FFDCA section 408 could generally be easily translated for use by the Office of Pesticide Programs under FIFRA, or by the other media offices within EPA for use under other statutes. However, once pesticide risk assessment under the FQPA became not simply a matter of good scientific practice but was channeled by explicit statutory requirements, it became incumbent upon the Office of Pesticide Programs to prepare its FFDCA pesticide risk assessments in a manner that clearly delineated what aspects of the assessment were driven solely by science and what aspects primarily by FQPA statutory requirements. Specifically, the Office of Pesticide Programs had to be transparent with regard to whether it was relying on FQPA safety factors based on unique FQPA requirements (exposure database deficiencies and potential pre- and post- natal toxicity) or FQPA safety factors that are essentially a codification of prior general EPA ‘‘additional’’ safety/ uncertainty factor practice.

EPA addressed these transparency issues at length in its 2002 policy statement on the FQPA safety factor. To clarify how the FQPA safety factor provision left a portion of prior safety/ uncertainty practice unchanged, codified another portion, and also expanded the use of safety factors, EPA explained the overlap between the FQPA safety factor and additional safety factors in depth and included the following figure to graphically illustrate the issue:

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With regard to providing transparency on the FQPA safety factor decisions, EPA took two steps. First, it adopted a new term, the ‘‘special’’ FQPA safety factor, for children safety factors that were based solely on the new FQPA requirements. Second, it adopted the approach of calculating two different safe doses for a pesticide: one that excluded any ‘‘special’’ FQPA safety factors and one that included them. The former was referred to, in line with standard EPA policy, as a Reference Dose (RfD), and the latter as a Population Adjusted Dose (PAD). Introducing the new terminology on FQPA safety factors into long- established safety factor practice has proved challenging. EPA staff on occasion drafted documents that (1) claimed no FQPA safety factor was needed but applied an additional uncertainty factor to address the completeness of the toxicity data base or reliance on a LOAEL; or (2) treated the ‘‘special’’ FQPA safety factor as the only type of FQPA safety factor. However, as EPA’s policy made clear, EPA interpreted FFDCA section 408(b)(2)(C)

as codifying prior practice as to additional uncertainty factors such that these factors became FQPA factors. The mislabeling of uncertainty factors did not substantively change risk assessment outcomes but it did raise the confusion level on an already complex topic. Eventually, EPA determined that the term ‘‘special’’ FQPA safety factor caused more problems than it solved and abandoned it. However, EPA has retained the approach of continuing to calculate both a safe dose with, and without, what was once referred to as ‘‘special’’ FQPA safety factors.

vii. FQPA safety factor—decision- making guidance. In 2002, EPA issued detailed policy guidance for Agency risk assessors on decision-making under the FQPA safety factor provision. The purpose of this guidance was concisely set forth by EPA: ‘‘[T]his guidance explains how OPP intends to ‘take intoaccount * * * potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children’’ as directed by FFDCA section 408(b)(2)(C)(i).’ ’’ (Ref. 10 at ii).

Although the guidance is structured around these statutory considerations, EPA also emphasizes throughout that the FQPA safety factor decision is a weight-of-the-evidence decision that must consider all available data. Thus, the policy specifies that ‘‘[b]efore any decisions are made on the appropriate FQPA safety factor applied to ensure the safety of infants and children from the use of a particular pesticide, all of the relevant submitted data for the pesticide should be assembled and reviewed by Agency scientists.’’ (Id. at 8).

This emphasis on the broadness of the inquiry is repeated in the discussion of the statutory consideration related to the completeness of the toxicity database. According to EPA, this consideration should not be narrowly focused on EPA’s existing database requirements. Rather, ‘‘the ‘completeness’ inquiry should be a broad one that takes into account all data deficiencies.’’ (Ref. 10 at 23). At the same time, the guidance stresses that ‘‘a determination of the possible need for and size of the database uncertainty factor will necessarily involve an assessment that

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considers the overall weight-of-evidence to evaluate the significance of the data deficiency.’’ (Id. at 26).

With regard to potential pre- and post- natal toxicity, the policy emphasizes that evaluation of this consideration cannot be divorced from the existing process for choosing levels of concern (i.e., RfDs, PADs, and target MOEs). Thus, EPA instructs risk assessors to evaluate the concern with data showing pre- and post-natal toxicity by considering, among other things, ‘‘the degree to which protection for infants and children is provided by the standard approach for deriving RfDs through the application of traditional uncertainty factors.’’ (Id. at 29). The guidance stresses that ‘‘[i]n particular, the risk assessor should consider the protection accorded infants and children by the intraspecies uncertainty factor.’’ (Id.). EPA notes that the scientific literature as well as the National Academy of Sciences has concluded that the intraspecies factor is generally adequate to protect infants and children; however, the policy points out that certain chemicals may display greater than 10X age-related variability. For this reason, EPA reiterates that ‘‘[t]he adequacy of the standard intraspecies factor to address the potential for greater sensitivity or susceptibility of children should be considered in the context of evidence on potential pre- and post-natal toxicity as discussed below.’’ (Id.; see also Id. at 51–52). The policy paper went on to provide numerous examples of weight- of-the-evidence considerations relevant to evaluation of human and animal data on pre- and post-natal toxicity. (Id. at 30–33).

The discussion on the completeness of the exposure database focuses on whether the various approaches EPA uses to assess exposure are likely to understate it. Risk assessors are to evaluate whether their assessments ‘‘have addressed all significant exposure routes’’ and whether ‘‘there may be uncertainty about whether OPP’s approach to estimating exposure for a particular use pattern, pathway, or aggregate exposure is sufficiently health protective.’’ (Id. at 48).

3. Benchmark dose approach. As indicated above, EPA has traditionally used a NOAEL or LOAEL as a Point of Departure in estimating an exposure level of concern for a pesticide or other substance. Increasingly, however, EPA uses a more sophisticated modeling tool known as the Benchmark Dose approach as an alternative to using NOAELs or LOAELs for Point of Departure selection. (Refs. 23). A benchmark dose, or BMD, is a point estimate along a

dose-response curve that corresponds to a specific response level. For example, a BMD10 represents a 10% change from the background level (the background level is typically derived from the control group). In addition to a BMD, a confidence limit may also be calculated. Confidence limits express the uncertainty in a BMD that may be due to sampling and/or experimental error. The lower confidence limit on the BMD is termed the benchmark dose limit (BMDL). Use of a BMD or BMDL for deriving the Point of Departure allows more precise estimates of the Point of Departure, resulting in tighter confidence intervals. Use of the BMDL also helps ensure with high confidence (e.g., 95% confidence) that the selected percentage of change from background is not exceeded. Numerous scientific peer review panels over the last decade have supported the Agency’s application of the BMD approach as a scientifically supportable method for deriving Point of Departures in human health risk assessment, and as an improvement over the historically applied approach of using NOAELs or LOAELs. (Refs. 24, 25, and 26). The NOAEL/LOAEL approach can look at the dose response at only the few doses used in a study, and is therefore limited by the characteristics of the study design, such as dose selection, dose spacing, and sample size. (Ref. 23 at 3– 5). With the BMD approach, all the dose response data are used to derive a dose response curve. For all of these reasons, BMD analysis is preferred by EPA to the NOAEL/LOAEL approach of selecting a Point of Departure from studies when the available data are amenable to BMD modeling consistent with the biological processes relevant to the study in question.

IV. Dichlorvos Dichlorvos is a chlorinated

organophosphate pesticide that inhibits plasma, red blood cell (RBC), and brain cholinesterase in a variety of species. (Ref. 3 at 122–123). Cholinesterase inhibition is a disruption of the normal process in the body by which the nervous system chemically communicates with muscles and glands. Although cholinesterase inhibition in the nervous system is not itself regarded as a direct adverse effect, it is ‘‘generally accepted as a key component of the mechanism of toxicity leading to adverse cholinergic effects.’’ (Ref. 27 at 25; see 73 FR 42688–42689). Inhibition of blood cholinesterase ‘‘is not an adverse effect, but may indicate a potential for adverse effects on the nervous system’’ and thus serves as a ‘‘surrogate’’ for cholinesterase inhibition

in the nervous system (Ref. 27 at 28). Subchronic and chronic oral dichlorvos exposures to rats and dogs as well as chronic inhalation dichlorvos exposure to rats resulted in significant decreases in plasma, RBC, and/or brain cholinesterase activity. Repeated, oral subchronic dichlorvos exposures in male humans were associated with statistically and biologically significant decreases in RBC cholinesterase inhibition. These cholinesterase effects occurred at dose levels below levels at which any other adverse effect was seen. Generally, there was no evidence of increased sensitivity to young animals following exposure to dichlorvos. No evidence of increased sensitivity to young animals was seen following in utero dichlorvos exposure to rat and rabbit fetuses as well as pre/ post natal dichlorvos exposure to rats in developmental, reproduction, and comparative cholinesterase studies. The only evidence of sensitivity in the young was seen in one parameter, auditory startle amplitude, in a developmental neurotoxicity study; however, the effects in the rat pups in that study were at levels well above levels that result in RBC cholinesterase inhibition.

Because inhibition of cholinesterase activity was identified as the most sensitive effect, it was selected as the toxicity endpoint for assessment of risks for all acute and chronic dietary exposures, as well as short-, intermediate-, and long-term (chronic) dermal, inhalation, and incidental oral residential exposures. For each risk assessment scenario, EPA selected a Point of Departure based on either an animal or human study taking into account the duration of the study and the route of exposure used in the study. (Ref. 3 at 130–135). These Points of Departure were used in calculating RfD/ PADs and acceptable MOEs. Due to the lack of sensitivity differences between adults and juveniles, the resulting RfD/ PADs and acceptable MOEs were designated as applicable to all population subgroups, including infants and children. Animal studies were used in choosing levels of concern for evaluating risk from acute and chronic dietary exposure; acute dermal exposure; and acute and chronic inhalation exposure. A human study (the Gledhill study) was used in evaluating risk from short-term incidental oral exposure; short-, intermediate-, and long-term dermal exposure; and short- and intermediate- term inhalation exposure. All of the studies from which a Point of Departure was selected were conducted in adults

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(adult humans or adult animals). (See Table 1).

Safety factor determinations used in determining the level of concern for each risk assessment scenario differed based on whether EPA relied on one of several different animal studies or a human study for the Point of Departure for that scenario. For levels of concerns derived from a Point of Departure from an animal study, EPA generally applied a 100X safety factor (10X for interspecies variability and 10X for intraspecies variability). Based on a weight-of-the-evidence evaluation, EPA removed the 10X FQPA safety factor for risk assessments based on an animal study. (See Table 1). EPA’s weight-of- the-evidence evaluation concluded that (1) the toxicity database was complete; (2) most of the data indicated no

increased sensitivity in the young and the only evidence of increased sensitivity occurred at levels well above the Points of Departure used for establishing the levels of concern; and (3) its estimate of human exposure to dichlorvos was not understated.

For levels of concerns derived from a Point of Departure from the human study, EPA applied a 10X safety factor for intraspecies variability and a 3X FQPA safety factor. (72 FR 68694– 68695). No interspecies factor was applied because EPA was not extrapolating a level of concern in humans from a dose in an animal study. The weight-of-the-evidence balance for the FQPA safety factor was slightly different for risk assessments relying on the Gledhill human study for the Point of Departure. In addition to all of the

considerations pertaining to the assessments with an animal-derived Point of Departure, the Gledhill-based risk assessments introduced another factor to consider—namely, that the Gledhill study raised a data completeness issue due to the fact that it only identified a LOAEL. This latter factor convinced EPA to retain a portion of the FQPA safety factor when relying on the human study for the Point of Departure. EPA concluded, however, that reliable data supported reduction of the 10X factor to 3X because the effect seen at the LOAEL in that study was so marginal (16 percent RBC cholinesterase inhibition) that a lower dose would have been unlikely to detect any adverse effect. (72 FR 68694–68695; see Table 1).

TABLE 1—SUMMARY OF RISK ASSESSMENT SCENARIOS, POPULATION GROUPS, AND UNCERTAINTY/SAFETY FACTORS FOR DICHLORVOS

Scenario Study from which point of departure taken

Age and species of study subjects

Population groups covered by risk assessment Uncertainty/safety factors

Acute Dietary ................ Rat acute oral cholin-esterase study.

Adult rats ..................... All population groups, in-cluding infants and chil-dren.

Interspecies—10X; Intraspecies— 10X; FQPA—1X.

Chronic Dietary ............ 1-year dog study .......... Adult dogs .................... All population groups, in-cluding infants and chil-dren.

Interspecies—10X; Intraspecies— 10X; FQPA—1X.

Short-term Incidental Oral.

Human 21-day oral study.

Adult humans ............... All population groups, in-cluding infants and chil-dren.

Interspecies—1X; Intraspecies— 10X; FQPA—3X.

Acute Dermal and Acute Incidental Oral.

Rat acute oral cholin-esterase study.

Adult rats ..................... All population groups, in-cluding infants and chil-dren.

Interspecies—10X; Intraspecies— 10X; FQPA—1X.

Short-, Intermediate- and Long-term Der-mal.

Human 21-day oral study.

Adult humans ............... All population groups, in-cluding infants and chil-dren.

Interspecies—1X; Intraspecies— 10X; FQPA—3X.

Acute Inhalation ........... Rat acute oral cholin-esterase study.

Adult rats ..................... All population groups, in-cluding infants and chil-dren.

Interspecies—10X; Intraspecies— 10X; FQPA—1X.

Short- and Inter-mediate-term Inhala-tion.

Human 21-day oral study.

Adult humans ............... All population groups, in-cluding infants and chil-dren.

Interspecies—1X; Intraspecies— 10X; FQPA—3X.

Long-term Inhalation .... 2-year rat inhalation study.

Adult rats ..................... All population groups, in-cluding infants and chil-dren.

Interspecies—10X; Intraspecies— 3X; FQPA—1X.

V. NRDC’s Petition to Revoke Dichlorvos Tolerances and the Administrative Proceedings on the Petition

A. NRDC’s Petition and EPA’s Denial of the Petition

On June 2, 2006, the NRDC filed a petition with EPA which, among other things, requested that EPA conclude the dichlorvos tolerance reassessment process by August 3, 2006, with a finding that the dichlorvos tolerances do not meet the FFDCA safety standard and issue a final rule by August 3, 2006, revoking all dichlorvos tolerances. NRDC’s petition contained dozens of

claims as to why dichlorvos’ FFDCA tolerances should be revoked. After carefully considering all of NRDC’s claims, the public comment received on the petition, and a revised risk assessment EPA conducted in response to the petition, EPA issued an order pursuant to FFDCA section 408(d)(4)(iii) denying the request to revoke dichlorvos’ FFDCA tolerances. (72 FR 68662, December 5, 2007).

B. NRDC’s Objections and EPA’s Denial of the Objections

On February 1, 2008, NRDC filed, pursuant to FFDCA section 408(g)(2), objections to EPA’s denial of its

tolerance revocation petition and requested a hearing on those objections. NRDC’s objections and requests for hearing included two main claims: (1) That EPA has unlawfully failed to retain the full 10X safety factor for the protection of infants and children; and (2) that it was unlawful for EPA to rely on a toxicity study for dichlorvos (the Gledhill study) that was conducted with humans. Because NRDC did not seek judicial review on EPA’s substantive conclusions on the latter issue but only challenged EPA’s denial of a hearing on the issue, and because the Second Circuit court on review did not reach the hearing issue, the Gledhill study is

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further discussed only to the extent it bears on the FQPA safety factor decision.

NRDC cited several grounds for its assertion that EPA unlawfully lowered the 10X children’s safety factor. However, only two of its arguments were later raised in NRDC’s judicial challenge to EPA’s decision. First, NRDC claimed that EPA lacked adequate data on dichlorvos’ potential effects on the endocrine system because EPA had not received data on endocrine effects through the Endocrine Disruptor Screening Program. Second, NRDC argued that EPA’s choice of a 3X additional safety factor was based on generic data and ‘‘not [ ] on any data specific to DDVP.’’ (Ref. 1 at 5).

EPA denied both of NRDC’s reasons for its objection to the choice of a 3X FQPA factor. EPA rejected NRDC’s endocrine data argument on both legal and factual grounds. EPA concluded that the statute gave it broad discretion to determine what data are needed in making a determination on the FQPA safety factor and that nothing in section 408(p), creating the Endocrine Disruptor Screening Program, overrode that broad discretion. As a factual matter, EPA found that it had adequate data on endocrine effects from the existing dichlorvos database. (73 FR 42697– 42698).

EPA also rejected NRDC’s claim that it relied on wholly generic data, rather than dichlorvos-specific data, in choosing a 3X FQPA factor. NRDC’s argument here was that EPA chose 3X because EPA considers 3X to be a half- value of a 10X factor rather than on data pertaining to dichlorvos. In response, EPA noted that its petition denial order had comprehensively restated its basis for its FQPA safety factor decision, and that restatement focused in great detail on the toxicology data for dichlorvos, particularly, the data on the sensitivity of the young. (73 FR 42695). EPA further pointed out that although the statutory considerations underlying the FQPA safety factor generally supported removal of the 10X additional factor, the reason EPA chose to retain a 3X FQPA safety factor for some assessments was directly tied to a deficiency in a dichlorvos study (the Gledhill study) that is critical to those assessments. (Id.). Thus, there was no basis for NRDC’s claim that EPA had not relied on dichlorvos-specific data in making its FQPA safety factor decision.

VI. Judicial Review of EPA’s Denial Order

A. NRDC’s Petition for Judicial Review and the Matters Presented on Review

NRDC petitioned the Second Circuit court for review of EPA’s denial of certain of its objections and hearing requests. As to its hearing requests, NRDC argued that EPA improperly denied its request for a hearing on statistical and informed consent issues presented by the Gledhill study. As to its objections, NRDC asserted (1) that, as a legal matter, EPA was required to retain the 10X FQPA factor if it did not have data from the Endocrine Disruptor Screening Program; and (2) that EPA’s choice of a 3X FQPA factor was arbitrary and capricious because EPA had relied upon ‘‘generic assertions that unlawfully fail to take into account any dichlorvos-specific information for infants and children.’’ (Ref. 28 at 37). NRDC supported the latter argument in the following fashion. First, it argued that EPA chose 3X solely because it was half of 10X. Second, NRDC asserted that EPA’s consideration of the Gledhill study did not constitute ‘‘dichlorvos- specific information for infants and children’’ because the Gledhill study was conducted with adults. Third, NRDC dismissed EPA’s reliance on dichlorvos developmental studies in animals on the ground that a prior case had held that EPA had not, in that particular case, offered an adequate explanation of how the data on developing animals supported the FQPA factor chosen.

In response, EPA explained that NRDC’s focus on EPA’s discussion of why 3X is considered half of 10X ignored the central part of EPA’s analysis: An assessment of whether the dichlorvos data showed 3X would be safe. EPA responded to the claim of a failure to consider ‘‘dichlorvos-specific information for infants and children’’ by noting that the Gledhill study had not been considered in isolation in the decision on the FQPA safety factor but in the context of ‘‘the animal data showing no difference in adult-young sensitivity’’ because it was ‘‘that very data that shows why the Gledhill study is appropriate for the entire population * * *’’ (Ref. 29 at 63). Further, EPA noted that NRDC’s argument that EPA reliance on animal sensitivity data does not justify a choice of 3X contradicted the core of NRDC’s claim—that EPA had not considered ‘‘dichlorvos-specific information for infants and children.’’ (Id. at 62).

B. The Second Circuit Court’s Decision on Review

On review, the Second Circuit court addressed three issues: (1) Was EPA legally compelled to retain the 10X FQPA safety factor in the absence of obtaining data from the Endocrine Disruptor Screening Program; (2) did EPA adequately explain its decision on the FQPA safety factor; and (3) was NRDC entitled to an evidentiary hearing with regard to its claims regarding the alleged statistical and informed consent deficiencies in the Gledhill study.

1. Endocrine data. The court held that EPA was not statutorily required to retain the 10X FQPA factor in circumstances where it has not obtained the data required under the Endocrine Disruptor Screening Program. (658 F.3d at 219). The court found ‘‘no indication in the statute or legislative history that Congress * * * intended the children’s safety factor to be mandatory in assessing the risks of all pesticides until EPA completed the estrogen disruptor screening program * * *’’ (Id.). According to the court, ‘‘Congress allowed EPA to determine, based on all available data, whether there was ‘reliable data’ supporting a reduced or waived children’s safety factor * * *’’ (Id.).

2. FQPA safety factor. Contrary to the narrow FQPA safety factor issue presented to EPA in NRDC’s objections—did EPA’s decision on the FQPA safety factor rely on ‘‘a generic assertion [instead of being] based on any data specific to DDVP’’?—the court framed the issue on the FQPA factor more broadly: ‘‘NRDC now seeks review of that EPA order, arguing in part that EPA failed to explain why, when assessing the safety of dichlorvos for certain exposure scenarios, EPA did not apply an additional tenfold children’s safety factor, to account for potential pre- and post-natal toxicity and completeness of data with respect to exposure and toxicity to infants and children.’’ (Id. at 201).

The court found that, for risk assessments relying on the Gledhill study in deriving the Point of Departure, EPA had provided essentially no explanation with regard to the FQPA safety factor. The court noted that EPA had retained an additional 3X safety factor for these risk assessments but the court concluded that it was EPA’s express position that this factor was not based on any evaluation of the risks to infants and children but rather was intended to address the lack of NOAEL in the Gledhill study only. According to the court, ‘‘[i]n EPA’s IRED and two published orders, EPA consistently

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reiterated this position and declined to claim that the 3X factor was based on any evaluation of the risk to infants and children.’’ (Id. at 216). Further, the court concluded that, unlike the risk assessments that were not based on the Gledhill study, EPA did not rely on the developmental animal studies showing no differential sensitivity between adult and juvenile animals. According to the court, ‘‘EPA explicitly stated that it did not rely on any animal studies.’’ (Id. at 217). The court thought this abnegation of reliance of animal studies was confirmed by EPA’s decision not to apply an interspecies factor to the Gledhill-based assessments. (Id.). Although the court noted that EPA called the 3X factor a FQPA factor, the court found that label to be insufficient absent an explanation ‘‘[i]n []either its IRED []or its two orders [of] how the 3X factor was designed ‘to take into account potential pre- and post-natal toxicity and completeness of the data with respect to infants and children.’ ’’ (Id.). The court held that EPA’s reasoning concerning the marginal effects seen at the LOAEL in the Gledhill study did not constitute a sufficient explanation because EPA did not relate that reasoning ‘‘to ‘potential pre- and post- natal toxicity and completeness of the data with respect to infants and children.’ ’’ (Id.). Finally, the court questioned EPA’s analysis that the effects at the LOAEL were marginal suggesting that EPA had not done a proper statistical analysis. (Id. at 218).

Accordingly, the court concluded that, as to risk assessments that used the Gledhill study to derive the Point of Departure, EPA’s order was arbitrary and capricious due to EPA’s failure to provide an adequate explanation with regard to its decision on the FQPA safety factor. (Id.). Given this conclusion, the court vacated the aspect of EPA’s order pertaining to risk assessments based on the Gledhill study and remanded the matter to EPA. (Id. at 220).

3. Evidentiary hearing. With regard to NRDC’s request for an evidentiary hearing on issues it raised concerning the Gledhill study, the court determined that it did not need to resolve this question given its disposition of the FQPA safety factor issue. As the court pointed out, ‘‘EPA may decide, on remand, not to rely on the Gledhill study or to rely on the study in a different manner or for different reasons.’’ (Id. at 219).

VII. FQPA Safety Factor Determination for Gledhill-based Assessments

A. Introduction FFDCA section 408(b)(2)(C) expressly

requires EPA to apply a default additional 10X safety factor for the protection of infants and children unless EPA determines, based on reliable data, that a different factor would be safe. Under the terms of the statute, this additional safety factor is imposed ‘‘to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.’’ (21 U.S.C. 346a(b)(2)(C)). To implement these statutory commands, EPA has released detailed guidance that advises EPA risk assessors in making decisions on the FQPA safety factor to focus on potential pre- and post-natal toxicity and the completeness of the toxicity and exposure databases. In the dichlorvos IRED and the two orders responding to NRDC’S dichlorvos petition, EPA devoted several pages to explaining how its decision to apply a 3X FQPA safety factor complied with the statutory directives on the FQPA safety factor and was consistent with its policy guidance document. (See Ref. 3 at 128–132; 72 FR 68694–68695; 73 FR 42695–42696). From start to finish this discussion centered on the issues of completeness of the toxicity and exposure databases for dichlorvos and the potential increased sensitivity of infants and children to dichlorvos from pre- and post-natal toxicity.

Nevertheless, in vacating, in part, EPA’s dichlorvos order, the Second Circuit court held that there was a complete absence of an explanation from EPA as to how EPA’s choice of a safety factor protected infants and children. As the court repeatedly stated, ‘‘EPA did not explain why a children’s safety factor less than 10X would ‘take into account potential pre- and post- natal toxicity and completeness of the data with respect to infants and children.’ ’’ (658 F.3d at 217). In fact, the court rejected EPA’s claim to have applied any FQPA safety factor at all. According to the court, the additional safety factor applied by EPA could not be considered a FQPA safety factor given what the court viewed as EPA’s denial that the additional safety factor had anything to do with infants and children. (Id. at 211, 216).

Following a close review of EPA’s prior explanations and the court’s opinion, EPA now recognizes that the discussion of the FQPA safety factor in its dichlorvos IRED and orders was less than transparent. EPA’s explanation for its position on the FQPA safety factor

used, at times, a form of short-hand that hid rather than elucidated its reasoning. In particular, EPA’s short-hand appears to have led the court to the following two misunderstandings: (1) That EPA’s use of a 3X safety factor to address the lack of a NOAEL in the Gledhill study had nothing to do with the safety of infants and children; and (2) that EPA did not consider the animal developmental data in making a determination on the FQPA safety factor for assessments relying on the Gledhill study. Clarification of EPA’s position on these two issues is critical to an understanding of EPA’s FQPA safety factor decision. Accordingly, on remand, EPA has first addressed how the Gledhill-based assessments relate to protection of infants and children and how EPA used animal developmental data in these assessments. Only then does EPA offer its explanation as to how, in light of the court’s opinion, its choice of a FQPA safety factor for the Gledhill-based risk assessment is protective of the safety of infants and children, as required by FFDCA section 408(b)(2)(C).

B. Clarifications 1. Applying a FQPA safety factor to

address the lack of a NOAEL in the Gledhill Study. Numerous times in the IRED as well as its dichlorvos orders, EPA stated that an additional 3X safety factor was applied in risk assessments using the LOAEL in the Gledhill study as the Point of Departure due to a ‘‘lack of a NOAEL’’ in the study. (Ref. 3 at 133; 658 F.3d at 217 (collecting cites)). EPA explained that the safety factor was used to project a NOAEL for the study. The court interpreted these statements as meaning the 3X factor had nothing to do with the protection to infants and children. According to the court, ‘‘EPA explained that the 3X factor [used in conjunction with the Gledhill study] was not based on any risk to children or infants, but accounted for EPA’s ‘failure to identify a NOAEL in the [Gledhill] study.’ ’’ (Id. at 214). Certainly, the narrow issue addressed by the use of the 3X factor was the lack of a NOAEL in the Gledhill study. However, extrapolating a NOAEL through use of a safety factor is not an end in itself. Rather, the safety factor was used to ensure that dichlorvos risk assessments relying on the LOAEL in the Gledhill study adequately protect the population groups covered by those assessments. Importantly, the population groups covered by the Gledhill-based assessments include infants and children. Thus, the 3X factor to account for the lack of a NOAEL in the Gledhill study was critical to

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protecting infants and children. However, EPA’s orders and IRED failed to make this linkage between the 3X factor and the safety of infants and children clear. That linkage is fleshed out in detail below.

As discussed in Unit III.B.2.v., prior to the passage of FQPA, EPA had applied an additional uncertainty factor to address a data deficiency such as when adverse effects were seen in the lowest dose of a toxicological study (i.e., when the study did not provide a NOAEL). Such a factor is used to essentially extrapolate a NOAEL for the study. Without an additional safety factor, there is uncertainty as to whether reliance on the LOAEL as a Point of Departure in calculating a RfD/PAD or MOE is adequately protective of the populations covered by the risk assessment scenario relying on that RfD/ PAD or MOE.

EPA has interpreted the FQPA as codifying this LOAEL-to-NOAEL uncertainty factor as a FQPA safety factor when the factor is used in a portion of a risk assessment (i.e., in a particular exposure scenario) that assesses, at least in part, the risk to infants and children. (Ref. 10 at 11–16, A–3—A–4). The logic here is straightforward. A study that fails to produce a NOAEL is considered to be a data deficiency that affects the completeness of the toxicity database. The statute specifically references completeness of the toxicity database as a reason for requiring an additional safety factor for the protection of infants and children. Thus, when the LOAEL from a study that lacks a NOAEL is chosen for the Point of Departure for a risk assessment applying to infants, children, or women of child-bearing age (for the purpose of protecting fetuses), the safety factor used to address this data deficiency is a FQPA safety factor for the protection of infants and children. This is the case whether or not the Point of Departure is used for infants, children, or women of child- bearing age only or for both adults and all other population groups, including infants and children. Many risk assessments for particular exposure scenarios use the same Point of Departure for both adults and infants and children because frequently the relevant toxicity data show a lack of differential sensitivity between adults and the young. However, use in a risk assessment of the same Point of Departure for both adults and the young does not make the FQPA safety factor provision inapposite. EPA’s position is that any assessment of risk for a particular exposure scenario that includes, at least in part, an assessment

of risks to infants and children triggers the FQPA safety factor provision. Nothing in section 408(b)(2)(C) limits the safety factor provision only to situations where infants or children are more sensitive than adults. For similar reasons, it is also irrelevant to application of the FQPA safety factor provision whether the Point of Departure is from a study involving juveniles or adults. Points of Departure for assessing risks to infants and children are based on the studies showing the most sensitive effects, whether the studies are conducted in adults or juveniles. (See Ref. 17 at 452 (‘‘[C]hronic and subchronic tests in [adult animals] have value in assessing potential risks to children by, for example, identifying target sites for toxicity and providing dose-response information that may be useful for human safety assessment, irrespective of life stage.’’). The critical factor for the FQPA safety factor provision is whether the study is being used for a Point of Departure for assessing risk to infants and children.

With this background, the connection between the use of a 3X safety factor to address the Gledhill study LOAEL and the protection of the infants and children can now be explicated. Because the Gledhill study produced cholinesterase effects at the lowest level in the subchronic studies in the dichlorvos database and the database showed no age-related sensitivity, (see discussion in Unit VII.C.), EPA chose the Gledhill LOAEL as the Point of Departure for assessing risks for short- and intermediate-term exposure scenarios to all population groups, including infants and children. In other words, the Gledhill LOAEL was selected as the Point of Departure for all population groups for these exposure scenarios because the dichlorvos database demonstrated that the Gledhill study not only provided the best measure of cholinesterase inhibition for protecting adults but that it was the best measure for protecting infants and children. Nonetheless, EPA also recognized that the data deficiency in the Gledhill study—the failure of the Gledhill study to identify a NOAEL— raises uncertainty as to what that study indicates regarding the threshold below which exposure to dichlorvos will not result in cholinesterase inhibition. To address this uncertainty and thus protect the safety of all population groups covered by the risk assessments, including infants and children, EPA chose to apply an additional safety factor of 3X. This choice of a safety factor was made under the rubric of the

FQPA safety factor provision because the uncertainty raised by reliance on a LOAEL both (1) affected the assessment of the risk to infants and children; and (2) was driven by a data deficiency affecting the completeness of the toxicity database. (73 FR 42695; 72 FR 68694–68695; Ref. 3 at 133, 134). Thus, the additional 3X safety factor used in assessments relying on the Gledhill study was not simply to address the lack of a NOAEL in that study but rather to ensure the protection of infants and children (among others) given that a LOAEL was used as the Point of Departure for assessing risk to infants and children for several exposure scenarios. Regrettably, the connection between a safety factor used to address the lack of a NOAEL in a study in adults and the protection of infants and children was not transparent in EPA’s IRED or its denial of NRDC’s petition and objections. That linkage should now be clear.

2. Reliance on animal developmental data. EPA’s FQPA safety factor policy emphasizes the importance of considering the ‘‘weight-of-evidence analyses for the completeness of the toxicity database, the degree of concern for pre- and postnatal toxicity, and results of the exposure assessments’’ in making a safety factor determination. (Ref. 10 at 50). In particular, the policy stresses ‘‘taking into account all pertinent information in evaluating potential pre- and postnatal toxicity.’’ (Id. at 29). The policy recognizes that human data on pre- and postnatal toxicity is ‘‘difficult to obtain’’ and for that reason discusses, in detail, how animal developmental data should be considered in evaluating the potential for pre- and post-natal toxicity in humans. (Id. at 28–31). Although EPA did discuss the animal data on juvenile sensitivity in its FQPA safety factor determination, (72 FR 68694–68695), the court concluded that EPA had not considered that data in making a determination on the FQPA safety factor for assessments relying on the Gledhill study for the Point of Departure.

To support this conclusion, the court opined that EPA’s orders specifically referenced the animal developmental studies in conjunction with the safety factor determination for the non- Gledhill-based assessments but had not done so as to the Gledhill-based assessments. The court is correct that EPA did not clearly explain that its discussion of the animal developmental data related both to the assessments based on a Point of Departure from animal data as well as the assessments relying on the Gledhill study for the Point of Departure. EPA’s discussion of

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1 The one human study that was not used for selection of a Point of Departure was conducted with the pesticide oxamyl. The oxamyl human study was submitted for the purpose of justifying a reduction of the 10X interspecies factor despite use of an animal study for the Point of Departure. The Human Studies Review Board concluded that the ‘‘intentional human dosing study of oxamyl was sufficiently robust to be used for reducing the 10x inter-species (i.e. animal to human) uncertainty factor in the cumulative risk assessment for the N- methyl carbamates.’’ (Ref. 36 at 28). Thus, it is not even a given that a full interspecies factor will be applied when an animal study is relied upon to extrapolate a dose in humans.

the Gledhill study, and the data deficiency therein, followed the analysis of the animal developmental data but did not directly reference that data or the statutory considerations bearing on the FQPA safety factor decision. (Id.). To avoid this error in its revised safety factor finding below, EPA has included a discussion of the data deficiency in the Gledhill study under the topic of ‘‘completeness of the data with respect to * * * toxicity’’ and also explicitly discussed how the statutory consideration pertaining to the potential for pre- or post-natal toxicity, and the animal data bearing on this issue, was considered in the context of the Gledhill-based assessments.

The court also concluded that ‘‘EPA explicitly stated that it did not rely on any animal studies’’ in connection with the Gledhill-based assessments, (658 F.3d at 217), citing to language in the IRED that specified that where the Point of Departure was chosen from the Gledhill study ‘‘there was no need to account for interspecies extrapolation * * * [s]ince the study was conducted in human subjects.’’ (Ref. 3 at 133, 134). According to the court, ‘‘[w]hen EPA did rely on the animal studies * * * [it] properly applied a safety factor of ‘10X for interspecies differences.’ ’’ (658 F.23d at 217). The court appears to have drawn the conclusion that the interspecies factor should be applied whenever EPA considers animal studies in any aspect of the risk assessment. Thus, the court reasoned that because EPA did not apply an interspecies factor for the Gledhill-based assessments, it could not have considered the animal developmental data in the FQPA safety factor determination for dichlorvos.

The court has misapprehended the reason EPA uses an interspecies factor in risk assessments. The factor is not automatically applied whenever animal data are considered in any aspect of a risk assessment. Rather, as explained in Unit III.B.2., the interspecies factor is used when extrapolating from a dose in an animal study (generally a NOAEL or LOAEL) on a milligram-per-kilogram of body weight basis to a dose in humans. (See Ref. 10 at 10 (an interspecies factor is used ‘‘if animal data have been used as the basis for deriving the hazard values’’). The interspecies factor is designed to account for possible toxicokinetic and toxicodynamic differences in humans and laboratory animals that may result in differences in internal dose and organ sensitivity between humans and animals. Thus, in the dichlorvos animal assessments in which EPA relied on animal data for the Point of Departure, EPA did apply an interspecies factor. For those

assessments, EPA was either extrapolating a RfD for humans from animal data or comparing the margin between human exposure and the dose in animals that was judged to be a NOAEL. No interspecies factor was necessary in assessments based on the LOAEL from the Gledhill study because EPA was not extrapolating from a NOAEL or LOAEL in laboratory animals to humans or comparing human exposure to a dose from an animal study. Rather, EPA had data in humans—the Gledhill study—and was relying on that data for the Point of Departure. There was no need to account for the toxicokinetic and toxicodynamics differences between humans and animals when deriving a safe dose for humans from a study conducted with humans.

EPA, however, did rely on the animal developmental data in the FQPA safety factor determination for the Gledhill- based assessments. But that reliance was for a purpose distinct and separate from use of the data for extrapolating a dose from animals to humans. In accordance with Agency FQPA safety factor policy, EPA considered the dichlorvos animal developmental data with regard to the important information it provides on whether the 10X intraspecies factor for dichlorvos is protective of infants and children. (Ref. 10 at 29). A primary focus of the animal developmental data (the rat and rabbit developmental studies, the rat reproduction study, the rat developmental neurotoxicity study, and comparative cholinesterase studies) is on the relative sensitivity of adult and juvenile animals. Because EPA would rarely have data on the relative sensitivity among different age groups of humans to a pesticide, these animal data help inform, as EPA policy makes clear, whether the 10X intraspecies factor is sufficiently protective of infants and children. (Id.).

Considering animal developmental data in evaluating the intraspecies factor is a standard part of EPA’s risk assessment process. As discussed in Unit III.B.2 and above, animal developmental data are central both to establishing the justification for the 10X default value for the intraspecies factor and for evaluating the protectiveness of this default value for specific chemicals. Although broad-based surveys of data on adult/juvenile sensitivity in both humans and animals generally support the use of a 10X default value for the intraspecies factor, there is wide recognition that the possibility of heightened sensitivity in infants and children warrants obtaining particularized data on juvenile/adult animal sensitivity for individual

chemical risk assessments. When these data are available, they may indicate that there is no heightened concern warranting an additional safety factor or that an additional factor is necessary above and beyond the default 10X value for the intraspecies factor. In a few cases, EPA has even relied, at least in part, on animal data as supporting a reduction in the default 10X intraspecies factor.

Yet, despite the centrality of animal data to the justification for and selection of the intraspecies factor, EPA is not aware of any instance where an interspecies factor has been applied solely for reliance on animal data on adult-juvenile sensitivity to evaluate the protectiveness of the human intraspecies factor. For example, EPA’s long-established and consistent practice is not to apply an interspecies factor when relying on a human study for the Point of Departure even though a decision on the intraspecies factor is still an essential part of such assessments. Dourson et al. collected a summary of all EPA’s RfDs on EPA’s Integrated Risk Information System (IRIS) as of May 2000 that used human data for the Point of Departure. (Ref. 17). All 24 such assessments identified used an interspecies factor of 1X (i.e., no factor). EPA has identified 9 additional such risk assessments on IRIS post- dating May 2000, and each one of those also does not apply an interspecies factor. (Ref. 30). Even more on point are EPA pesticide risk assessments relying on human data. Since the promulgation of the 2006 Human Research Rule, EPA has accepted 10 human studies for use in pesticide risk assessments other than the Gledhill study. (Id.). A Point of Departure was selected from 9 of those 10 studies.1 Yet, in none of those assessments did EPA apply an interspecies factor in conjunction with a Point of Departure from a human study even though the assessments do not focus on the human data exclusively. Animal developmental data play a critical part in these assessments, particularly where a FQPA safety factor analysis is required.

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The FQPA safety factor analysis in the tolerance reassessment document for the pesticide ethephon provides a good example of this. With ethephon, ‘‘[t]he conventional UF of 10X for interspecies extrapolation was not applied because the endpoint selected for the risk assessment was from a human study.’’ (Ref. 31 at 6). At the same time, EPA noted that:

The Agency concluded that no FQPA Safety Factor is necessary to protect the safety of infants and children in assessing ethephon exposure and risks because the toxicology database for ethephon contains acceptable guideline developmental and reproductive studies as well as acute and subchronic neurotoxicity studies. [Guideline studies are conducted in animals. (40 CFR 158.500)]. The Agency also concluded that there is no quantitative or qualitative evidence of increased susceptibility following in utero or postnatal exposure in any of the developmental or reproductive studies. The RfDs and toxicity endpoints established are protective of pre/postnatal toxicity following acute and chronic exposures.

(Id.). A variation on the approach in ethephon is the safety/uncertainty factors chosen in assessing the risk of the pesticide methomyl. (Ref. 32 at 5). For the methomyl risk assessments that relied on a human study for the Point of Departure, the Agency applied a 10X intraspecies, a 1X interspecies factor (no extrapolation from a dose in animals to humans), and a 2X (data-derived) FQPA safety factor. The 2X FQPA factor was chosen because, unlike dichlorvos, the adult/juvenile comparative cholinesterase data in rats showed that juveniles were approximately twice as sensitive to methomyl as adults. Thus, a 2X FQPA safety factor was applied to ensure that the 10X intraspecies factor was sufficiently protective. However, just as with dichlorvos and ethephon, no interspecies factor (1X) was used because the Point of Departure was derived from a human, not animal, study. A final example illustrating that consideration of animal data in conjunction with choice of a Point of Departure from a human study does not result in use of a 10X interspecies factor is the assessment of the pesticide chloropicrin. With chloropicrin, EPA relied upon a human study for the Point of Departure and thus no interspecies factor (1X) was applied. However, EPA’s consideration of the data from humans and animals also led EPA to conclude that no intraspecies factor (1X) was needed either. (Ref. 33). No interspecies factor was applied as a result of consideration of animal data in evaluating the need for an intraspecies factor.

Use of a 10X interspecies factor for reliance on animal developmental data to evaluate the protectiveness of the intraspecies factor would also lead to illogical results. For example, animal developmental data are now considered so critical to evaluating pre- and post- natal toxicity that the FQPA imposes a presumptive 10X safety factor in their absence. Yet, once the data are submitted, it does not make sense to replace the 10X safety factor that addressed their absence with a safety factor of equivalent value to address their mere use for evaluation of pre- and post-natal toxicity. Leaving aside what the animal developmental data show, there cannot be equal need for safety factors both in the absence and presence of adequate animal developmental data.

In sum, it would not only be unprecedented, but inconsistent with well-established safety factor practice, to suggest that the mere consideration of animal data in evaluating the protectiveness of the intraspecies factor triggers application of an interspecies factor. Importantly, under the FFDCA section 408, EPA is only authorized to consider ‘‘safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safety of food additives are generally recognized as appropriate for the use of animal experimentation data.’’ 21 U.S.C. 346a(b)(2)(D)(ix).

Unfortunately, EPA’s short-hand description of its FQPA determination misled the court regarding EPA’s consideration of the animal developmental data. Further, EPA’s brief explanation for why it did not apply an interspecies factor did not clarify the situation. This, in turn, resulted in confusion regarding the role of the interspecies factor. EPA’s revised FQPA safety factor explanation attempts to avoid such pitfalls.

C. Revised FQPA Safety Factor Decision 1. Introduction and background. The

Second Circuit court has vacated that portion of EPA’s order on NRDC’s objections ‘‘assessing the risk of dichlorvos based on the Gledhill study * * * .’’ (658 F.3d at 220). The court found that EPA had ‘‘failed to explain why it did not use a 10X children’s safety factor’’ for those assessments. (Id.).

In the IRED, EPA relied on the Gledhill human study for selection of the Point of Departure for assessing dermal (short-, intermediate-, and long- term), incidental oral (short-term), and inhalation (short- and intermediate- term) risk for all population subgroups, including infants and children. Agency- wide guidance on Reference Dose

selection emphasizes that human data provides the best source for assessing human risk: ‘‘Adequate human data are the most relevant for assessing risks to humans. When sufficient human data are available to describe the exposure- response relationship for an adverse outcome(s) that is judged to be the most sensitive effect(s), reference values should be based on human data.’’ (Ref. 19 at 4–12; see Ref. 10 at 33 (‘‘human data are the most relevant data for assessing health risks’’)). EPA chose the Gledhill study, in particular, for determination of the Point of Departure because it evaluated cholinesterase inhibition, the most sensitive effect for dichlorvos as shown by animals studies, and because the Gledhill study has ‘‘the lowest LOAEL established for RBC cholinesterase inhibition in a repeated oral exposure to dichlorvos.’’ (Ref. 3 at 133). Specifically, it was the lowest LOAEL considering both the human and animal studies and cholinesterase effects in adults and juveniles. EPA’s determination that the Gledhill study ‘‘is sufficiently robust for developing a Point of Departure for estimating dermal, incidental oral, and inhalation risk from exposure to DDVP,’’ was concurred in by the Human Studies Review Board, an independent expert panel of scientists. (72 FR 68675).

The level of concern for the risk assessments relying on the Gledhill study for the Point of Departure was expressed in terms of a target MOE of 30. That value was based on an intraspecies uncertainty factor of 10X and a FQPA safety factor of 3X. Although EPA concluded that neither the data on pre- or postnatal toxicity or on exposure to dichlorvos showed a need for a FQPA safety factor, EPA found that the data deficiency with regard to the Gledhill study—namely, its lack of a NOAEL—justified the retention of a 3X FQPA safety factor.

2. FQPA safety factor decision. In making a FQPA safety factor determination, EPA follows a weight-of- the-evidence approach that focuses on the three considerations explicitly noted in FFDCA section 408(b)(2)(C): the completeness of the toxicity database; the potential for pre- and post-natal toxicity; and the completeness of the exposure database. (Ref. 10 at iv). Each of those considerations is discussed below.

i. Completeness of the toxicity database. In ruling on NRDC’s petition, EPA concluded that it had a complete toxicity database under the pesticide data requirements in 40 CFR part 158. This included all required data specifically pertaining to effects on the young—developmental studies in two

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2 Statistical significance is a term used to describe observed data that differ from the overall distribution of values by a level that is unlikely to be due to random error. Statistical significance is

examined in terms of the probability of the observed differences occurring. By convention, observed values that have a 5 or 1 percent chance of occurring are treated as statistically significant,

with 1 percent being the more rigorous standard. (Ref. 43).

species (rat and rabbit); a two-generation reproduction study in rats; and a developmental neurotoxicity study in rats. EPA also had comparative cholinesterase inhibition data in adult and juvenile rats. EPA did not have data submitted pursuant to the Endocrine Disruptor Screening Program, but for the reasons explained in its order denying NRDC’s petition, EPA has concluded that it has adequate data on dichlorvos’ endocrine effects for the purposes of its FQPA safety factor decision. (73 FR 42697–42698).

In addition to these standard animal toxicity studies, the dichlorvos registrant had submitted one toxicity study in humans, the Gledhill study, that EPA had determined was in compliance with its Human Research

Rule. (40 CFR part 26). As discussed below, there is a data deficiency issue with this study that is pertinent to the completeness of the toxicity database consideration. Although this study was conducted in adults, it is highly relevant to the protection of infants and children because EPA has, for the reasons explained in Units VII.B.1. and VII.C.1, selected the Gledhill study for identifying a Point of Departure for as to several risk assessment scenarios for all population groups, including infants and children. Thus, how EPA addresses the data deficiency in the Gledhill study will directly affect how it assesses risks to infants and children.

The Gledhill study was a repeat dose study measuring RBC cholinesterase inhibition in control and dichlorvos-

treated human subjects. Only a single dose level (7 mg) was used in the study. Cholinesterase inhibition in the treated subjects reached a level of 16 percent by day 18 of treatment (i.e., cholinesterase activity levels declined to 84 percent of the pre-dose mean by day 18). As shown in Table 2 below (reprinted from EPA’s Data Evaluation Record of the Gledhill study and the Gledhill study report), the statistical analysis of the results of the Gledhill study shows a high level of statistical significance (at the 1 percent level) 2 for cholinesterase activity levels both between controls and treated subjects and between pre- and post- dosing cholinesterase levels for treated subjects for most days post-dosing.

TABLE 2—RESULTS OF THE GLEDHILL STUDY

Timepoint

Placebo (n = 3) Dosed (n = 6)

Mean SD % pre-dose mean Mean SD % pre-dose mean

Pre-dose ........... 18483 .52 1346 .91 100 17738.33 1713.50 100 Day 1 ................ 17930 .00 1404 .24 97 17628.33 1914.45 99 Day 2 ................ 18180 .00 1564 .7 98 16816.67* 1546.63 95 Day 4 ................ 18740 .00 1771 .13 101 16933.33** 1597.33 95 Day 7 ................ 18530 .00 1888 .36 100 16181.67** †† 1759.48 91 Day 9 ................ 18460 1007 .03 100 16708.33 2504.97 94 Day 11 .............. 19210 .00 1035 .95 104 16036.67** †† 1654.38 90 Day 14 .............. 18490 .00 1642 .35 100 15333.33** †† 1250.34 86 Day 16 .............. 17706 .67 2470 .15 96 15191.67** †† 1062.59 86 Day 18 .............. 18260 .00 2298 .87 99 14855.00** †† 1198.51 84

* Statistically significant difference from pre-dose at the 5% level (paired t-test). ** Statistically significant difference from pre-dose at the 1% level (paired t-test). †† Statistically significant difference between placebo and dose groups at the 1% level (t-test, based on repeated measures of analysis of

covariance).

(Refs. 34 and 35). EPA found these statistical results to

be sufficiently ‘‘robust’’ to support use of the Gledhill study as the Point of Departure. This judgment was concurred on by the Human Studies Review Board. (Ref. 36). The Board relied upon the following aspects of the study: The repeated dose approach which allowed examination of the sustained nature of RBC cholinesterase inhibition; robust analysis of RBC cholinesterase inhibition both in terms of identifying pre-treatment levels and consistency of response within and between subjects; and the observation of a low, but statistically significant RBC cholinesterase inhibition response. (Id. at 39). The HSRB concluded that ‘‘[a]lthough a study using a single dose level is not ideal for establishing a LOAEL, there was general consensus

that RBC cholinesterase is a well- characterized endpoint for compounds that inhibit acetylcholinesterase activity and therefore, because the decreased activity in RBC cholinesterase activity observed in this study was at or near the limit of what could be distinguished from baseline values, it was unlikely that a lower dose would produce a measurable effect in RBC cholinesterase activity.’’ (Id. at 41).

There is one significant deficiency with the Gledhill study, however. Because the study used a single dose level, and that dose was found to cause an adverse effect on RBC cholinesterase activity, the study does not identify a NOAEL. As discussed earlier, this type of deficiency is incorporated and addressed as part of the FQPA safety factor because it relates to the first consideration noted in FFDCA section

408(b)(2)(C)—completeness of the toxicity database. (See Unit III.B.2.vi.).

In deciding what level of safety factor is necessary to address this data deficiency, EPA is guided by EPA science policy on use of uncertainty factors, the scientific literature on safety factors, and EPA prior practice with regard to FQPA safety factor decisions. EPA’s RfD policy recommends a default value of 10X for an uncertainty factor addressing the lack of a NOAEL but makes clear that ‘‘[t]he size of the LOAEL-to-NOAEL uncertainty factor may be altered, depending on the magnitude and nature of the response at the LOAEL.’’ (Ref. 19 at 4–44). Further, as discussed in Unit III.B.2.v, Dourson et al. concluded that ‘‘[t]he data indicate that when faced with a LOAEL and not a NOAEL, the choice of uncertainty factor should generally depend on the

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severity of the effect at the LOAEL.’’ (Ref. 9). In specific FQPA safety factor decisions, the magnitude of the response has frequently been an important consideration supporting use of a 3X FQPA safety factor to address reliance on a LOAEL for the Point of Departure. (See, e.g., 75 FR 22245, 22249, April 28, 2010 (selecting a 3X FQPA safety factor for lack of a NOAEL where ‘‘[t]he neurotoxic effects in this study showed a good dose response which resulted in minimal effects on motor activity and locomotor activity at the LOAEL.’’); 74 FR 67090, 67094, December 18, 2009 (selecting a 3X FQPA safety factor for lack of a NOAEL where ‘‘[t]he gastric lesions (most sensitive effect) are due to the direct irritant properties of endothall (i.e., portal effects) and not as a result of frank systemic toxicity; the severity of the lesions were minimal to mild; and there was no apparent dose-response for this effect.’’); 74 FR 53172, 53177, October 16, 2009 (‘‘The concern is low for the use of a LOAEL to extrapolate a NOAEL, given the relatively insignificant nature of the effect (transient diarrhea seen in the rat); the fact that diarrhea was only seen in studies involving gavage dosing in the rat but not in repeat dosing through dietary administration in rats, mice, rabbits, and dogs; the very high dose level needed to reach the acute oral lethal dose (LD)50 (>5,000 milligrams/ kilogram (mg/kg)), and the overall low toxicity of azoxystrobin.’’); 74 FR 26536, 26541, June 3, 2009 (selecting a 3X FQPA safety factor for lack of a NOAEL where ‘‘[t]he response was marginal at the LOAEL.’’); 72 FR 41224, 41228, July 27, 2007 (‘‘The uncertainty factor of 3X for use of the LOAEL instead of the NOAEL is considered appropriate because an increased incidence and severity of epithelial hyperplasia, hyperkeratosis and ulceration of the non-glandular region of the stomach in females were seen in few animals and were minimal in severity and observed in one sex only.’’); 72 FR 33901, 33905, June 20, 2007 (‘‘The 3X factor is considered to be protective because the incidence of the effects at the lowest dose tested was only marginally higher than the historical controls.’’); 71 FR 71052, 71056, December 8, 2006 (‘‘A 3x safety factor (as opposed to a 10x) for the lack of a NOAEL in this critical study is adequate because the magnitude of the response was low (low incidences without dose response) and the effect of concern was seen in an unusual strain (Chinchilla) of rabbits and not in the New Zealand strain

commonly used in developmental toxicity studies.’’)).

EPA’s policy on cholinesterase inhibition provides important guidance on characterizing the magnitude of a RBC cholinesterase finding. The policy explains that cholinesterase activity data is treated ‘‘like most continuous endpoints (i.e., graded measures of response such as changes in organ weight, hormone levels or enzyme activity),’’ in that ‘‘no fixed generic percentage of change from the baseline is considered to separate adverse from non-adverse effects.’’ (Ref. 27 at 14). Given the continuous nature of the inhibition response, ‘‘OPP has used statistical significance, rather than a fixed percentage of response from baseline, as the primary, but not exclusive, determinant of toxicological and biological significance in selecting Points of Departure.’’ (Id.) Nonetheless, the policy advises that, in examining what level of cholinesterase inhibition will be judged an adverse effect, the level of inhibition must be critically evaluated ‘‘in the context of both statistical and biological significance.’’ (Id. at 37) (emphasis in original). Although the policy notes that ‘‘[n]o fixed percentage of change (e.g., 20% for cholinesterase enzyme inhibition) is predetermined to separate adverse from non-adverse effects,’’ (Id.), it explains that ‘‘OPP’s experience with the review of toxicity studies with cholinesterase- inhibiting substances shows that differences between pre- and post- exposure of 20% or more in enzyme levels is nearly always statistically significant and would generally be viewed as biologically significant.’’ (Id. at 37–38). The policy recommends that ‘‘[t]he biological significance of statistically-significant changes of less than 20% would have to be judged on a case-by-case basis, noting, in particular the pattern of changes in the enzyme levels and the presence or absence of accompanying clinical signs and/or symptoms.’’ (Id. at 38). The policy notes that similar or higher levels of cholinesterase inhibition are used ‘‘in monitoring workers for occupational exposures (even in the absence of signs, symptoms, or other behavioral effects).’’ (Id. at 31). For example, the policy points out that the California Department of Health Services requires that workers exposed to toxic chemicals such as organophosphate pesticides be removed from the workplace if ‘‘red blood cell cholinesterase levels show 30% or greater inhibition,’’ and that the World Health Organization ‘‘has guidelines with the same RBC action levels (i.e., 30% or greater inhibition).’’

(Id.). In conducting Benchmark Dose analyses for dichlorvos, as well as other organophosphate pesticides, EPA generally has used a 10 percent inhibition level as indicating an adverse effect for both RBC and brain compartments given that both of these compartments were used for developing Points of Departure. (Ref. 37 at I.B p.17). A close examination of the cholinesterase inhibition data for dichlorvos, however, has shown that, while both brain and RBC compartments have similar levels of inhibition for acute or very short-term exposures, for longer-term exposures brain cholinesterase inhibition is much less sensitive than RBC inhibition and thus 20 percent RBC inhibition would be adequately protective. (72 FR 68691; Ref. 38). RBC cholinesterase inhibition is not itself an adverse effect; rather, it is used as a surrogate for effects on the nervous system.

In the Gledhill study, the average level of RBC cholinesterase inhibition of the final day of treatment was 16 percent. Although the level of RBC cholinesterase inhibition was relatively low and not accompanied by clinical signs, EPA concluded, contrary to the study’s author, that the 7 mg dose did produce an adverse effect. In reaching this conclusion, EPA relied on the uniform nature of the results in the subjects that showed a clear pattern of increasing response over time and a high level of statistical significance in the differences in cholinesterase inhibition both between treated and control subjects and between pre- treatment and post-treatment of individual subjects. Nonetheless, consistent with its cholinesterase policy and its conclusions in regard to other dichlorvos cholinesterase data, EPA found the magnitude of the change in cholinesterase levels to be marginal. The Human Studies Review Board agreed both with EPA’s determination on adversity and the marginality of the response. As to the marginality of the response, the Board specifically noted that ‘‘because the decreased activity in RBC cholinesterase activity observed in this study was at or near the limit of what could be distinguished from baseline values, it was unlikely that a lower dose would produce a measurable effect in RBC cholinesterase activity.’’ (Ref. 36 at 41). Under EPA’s cholinesterase policy, the level of cholinesterase inhibition in the Gledhill study falls at the low end of the scale of what might be considered an adverse effect and the policy recommends a case-by-case inquiry into the adversity determination for inhibition at this

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3 The court stated that EPA had found the Gledhill study to ‘‘have had sufficient statistical power to detect a cholinesterase inhibition greater than 0, [but] EPA did not explain whether the 9- person study (six dosed subjects, 3 placebo subjects) had sufficient power to determine with any level of precision the magnitude of the cholinesterase inhibition.’’ (Ref. at 218) (emphasis added). To clarify, EPA did not do a ‘‘statistical power’’ calculation because statistical power is a way of determining the probability of whether a study would detect an effect of a given size if such an effect is there to find. The concern is that a study may indicate that there is no effect when, in fact, the study missed the effect because it had a low probability of finding it (i.e., the study gives a false negative). Because the Gledhill study identified the positive effect it was looking for (cholinesterase inhibition), EPA dismissed NRDC’s arguments regarding statistical power as irrelevant. (73 FR 42704–42706). What EPA’s statistical analysis of the Gledhill study did show was that there was a statistically significant difference (at the level of 1 percent) in cholinesterase inhibition between control and treated subjects and between pre- and post-dosing for treated subjects on most days of treatment. That is, the differences in cholinesterase inhibition between controlled and treated subjects and between pre- and post-dosing of treated subjects were very unlikely to have been due to chance.

level. Accordingly, EPA determined previously, and reaffirms in this order, that a full 10X safety factor is not needed to address the lack of a NOAEL in the Gledhill study. When a full order of magnitude of additional protection (i.e. 101) is unnecessary, EPA will generally use a half of that value (i.e, 10.5 or approximately 3X) if that value is protective. Here, EPA determined, and in this order reaffirms, that the marginal nature of the cholinesterase response shows that a 3X factor is safe.

In reaching its determination, EPA placed, and continues to place, great weight on the view of the Human Studies Review Board. This Board was created by EPA in response to a congressional mandate. (71 FR 6138 (February 6, 2006)). It is comprised of non-EPA scientists, overwhelmingly from academia, who are specialists in the field of bioethics, biostatistics, human health risk assessment, and human toxicology. (73 FR 42690). The members of the Board at the time the Gledhill study was considered are listed in Appendix 1 to EPA’s prior denial order. (73 FR 42713). The Board is charged with reviewing both the ethics and scientific merit of intentional exposure human studies. Its proceedings are conducted in public and it accepted three rounds of public comment on review of the Gledhill study: (1) Written comment submitted prior to its open meeting on dichlorvos; (2) oral comments at the open meeting; and (3) oral comments at a telephone conference on its proposed decision. (73 FR 42692). No comments were submitted prior to the Board’s review suggesting that the cholinesterase response was greater than a marginal response and no meaningful comments were submitted to the Board or EPA, following release of the proposed and final Board opinions, contesting the conclusions of this independent and expert scientific panel on this point. The Board’s conclusion with regard to the marginality of the cholinesterase inhibition effects in the Gledhill study are strongly supportive of EPA’s choice of a 3X factor to address the lack of a NOAEL in the Gledhill study. After all, the Board concluded that ‘‘it was unlikely that a lower dose would produce a measurable effect in RBC cholinesterase activity.’’ (Ref. 36 at 41). Use of a 3X factor is protective because it represents a choice of not simply of any lower dose (decreasing the dose by 10 percent fits this criterion) but of a significantly lower dose than that in the Gledhill study for estimating risk (by applying a 3X factor EPA was

essentially dividing the dose by a factor of 3).

The court suggested in its opinion that EPA had not conducted an adequate statistical analysis to determine the accuracy of the 16 percent cholinesterase inhibition figure and thus had no basis for making a conclusion ‘‘with any level of precision [as to] the magnitude of the cholinesterase inhibition.’’ 3 658 F.3d at 218. Although EPA scientists and the scientists on the Human Studies Review Board, including the three biostatisticians, found the statistical analysis sufficient to support their conclusion on the marginality of the cholinesterase effect, EPA agrees that a precision analysis, i.e., the calculation of confidence intervals, conveys valuable information on the plausible range in which, within a certain degree of probability, the true value lies. Accordingly, EPA has calculated the confidence intervals for the mean cholinesterase inhibition levels. (Ref. 39). For the days 14, 16, and 18 which had average cholinesterase inhibition levels of 14 percent, 14 percent, and 16 percent, respectively, this calculation shows a 95 percent confidence that average inhibition is between 9- and 18 percent, 9- and 19 percent, and 8- and 24 percent, respectively. Because these ranges of RBC cholinesterase inhibition consistently fall at the low end of what might be found to be a statistically and biologically significant effect on RBC cholinesterase activity, EPA reaffirms its conclusion that the RBC cholinesterase inhibition seen in the Gledhill study was marginal.

Finally, the determination to retain a FQPA safety of 3X for assessments for which the Point of Departure was selected from the Gledhill study is also supported by two BMD analyses on the dose levels causing cholinesterase inhibition in animals performed in conjunction with the IRED. As explained earlier, BMD analysis is preferred by EPA to the NOAEL/LOAEL approach of selecting a Point of Departure from studies because all of the data from a study can be used in deriving a dose response curve. (Ref. 23). In the absence of the Gledhill study, these analyses would substitute for the LOAEL in the Gledhill study for selection of the Point of Departure for short- and intermediate-term risk assessments because they define the most sensitive effect for these exposure durations. The first of these analyses is a BMD analysis of comparative cholinesterase studies conducted in adult and juvenile rats. (This BMD analysis is discussed in more detail immediately below in the section on ‘‘pre- and post-natal toxicity.’’) The lowest BMDL from that analysis (focusing on pooled historical controls) is 0.38 mg/kg/day. (Ref. 42). The second BMD analysis is an analysis of the cholinesterase inhibition results of the subchronic toxicity rat study. (Ref. 40). There, the BMDL was calculated as 0.4 mg/kg/day. The only other potential animal study for use in selecting a Point of Departure for short- and intermediate- term exposures, the subchronic neurotoxicity study, had a significantly higher LOAEL (7.5 mg/kg/day) and produced percentage inhibition levels consistent with, or lower than, the other animal cholinesterase studies. (Ref. 41). A 100X safety factor to address interspecies extrapolation and interspecies variability would be used with these BMDLs if they were chosen as Points of Departure. No additional FQPA factor would be needed for the same reasons that a FQPA factor was not applied to the other assessments relying on animal data. (72 FR 68694–68695). Reliance on the BMD analyses for the Point of Departure with a 100X safety factor produces a level of concern that is comparable to using the Gledhill study for the Point of Departure with a 30X safety factor. This is most easily seen if alternative RfD/PADs are calculated using the BMD analyses from the comparative cholinesterase studies and the subchronic study and from the LOAEL in the Gledhill study. With Gledhill study, the LOAEL of 0.1 mg/kg/ day would be divided by 30 (10X for intraspecies and 3X for FQPA) yielding a RfD/PAD of 0.0033 mg/kg/day. With

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the BMD analyses, the BMDL of 0.38 mg/kg/day or 0.4 mg/kg/day would be divided by 100 (10x for interspecies and 10X for intraspecies) for a RfD/PAD of 0.0038 mg/kg/day or 0.004 mg/kg/day, respectively. The similarity of these results, whether extrapolating from the animal or human data, provides extra confidence in EPA’s FQPA safety factor decision. Additionally, EPA notes that reliance of the Gledhill study produces a marginally lower and thus more protective level of concern.

Thus, the completeness of the toxicity database consideration indicates that an additional safety factor of no greater than 3X is needed to protect the safety of all populations, including infants and children, due to a data deficiency in the Gledhill study. This decision is consistent with EPA policies on RfD selection, the FQPA safety factor, and cholinesterase inhibition, and with the scientific literature on safety/ uncertainty factors. It is also consistent with long-established practice in making FQPA safety factor decisions in circumstances where a LOAEL-to- NOAEL extrapolation is necessary. Finally, EPA’s scientific conclusions underlying this determination have been concurred in by the Human Studies Review Board, an independent panel of scientific experts in the field of toxicology and bio-statistics.

ii. Pre- and post-natal toxicity. There was no evidence for increased susceptibility of rat and rabbit offspring to prenatal or postnatal exposure to dichlorvos. In both rat and rabbit developmental studies, no developmental effects were observed. In the rat reproduction study, the parental/ systemic NOAEL/LOAEL was 2.3/8.3 mg/kg/day, which was identical to the reproductive/offspring NOAEL/LOAEL. The developmental neurotoxicity study showed evidence of sensitivity in one parameter, auditory startle amplitude. However, there are no residual concerns for sensitivity from this parameter because the effects in pups were seen at a dose well above the Points of Departure upon which EPA is regulating and a clear NOAEL for the effect (again, well above the Points of Departure) was identified.

In addition, EPA evaluated the relative sensitivity of adult and juvenile animals to cholinesterase inhibition from dichlorvos exposure using a Benchmark Dose (BMD) analysis. For dichlorvos, EPA did a BMD analysis of the rodent toxicity studies for adult and juvenile cholinesterase inhibition (in both brain and RBC) in acute and repeated dose scenarios. (Refs. 3 at 129; 42). EPA analyzed for a BMD showing a 10 percent inhibition of

cholinesterase. EPA found similar results for BMDs and BMDLs for cholinesterase inhibition in both the acute and repeated dose scenarios for compartments (brain or RBC), sex, and age. In other words, this analysis indicated that there was no significant sensitivity difference with regard to cholinesterase inhibition between adults and juveniles.

These data showing a lack of sensitivity of juvenile animals relative to adults indicate a low level of concern that the intraspecies factor applied to the Point of Departure from the Gledhill study will fail to protect infants and children. Therefore, the potential pre- and post-natal toxicity consideration, by itself, indicates that risks to infants and children can be safely assessed absent an additional safety factor.

iii. Completeness of the exposure database. EPA has extensive data for estimating human exposure levels to dichlorvos. Although NRDC objected to portions of EPA’s dietary exposure assessment, after a careful re-analysis of that assessment EPA concluded that its dichlorvos exposure estimate from food, if anything, overstates dichlorvos exposure given the many conservatisms retained in the food exposure assessment and dichlorvos’ documented volatility and rapid degradation. (73 FR 42699; 72 FR 68686). Further, EPA concluded that drinking water exposure to dichlorvos was also likely to have over-estimated exposure because of conservative assumptions. (72 FR 68679–68680). A similar conclusion was reached as to residential exposure to dichlorvos after EPA revised this assessment taking into account concerns raised by NRDC. (72 FR 68691). Thus, the completeness of the exposure base consideration, by itself, also does not indicate a need for an additional safety factor to protect infants and children.

3. Conclusion. The FQPA safety factor provision requires EPA to presumptively retain an additional 10X safety factor for the protection of infants and children. EPA may apply a different factor only if reliable data show that factor to be safe. Under EPA policy, EPA considers whether the additional FQPA safety factor is warranted taking into account the other safety factors being applied.

For the Gledhill-based risk assessments, EPA has applied a 10X intraspecies safety/uncertainty factor to account for the potential for variable sensitivity among humans. EPA has not applied an interspecies factor in these risk assessments because the Point of Departure is drawn from a study in humans, not laboratory animals. (See Unit VII.B.2). Thus, the precise question

under the FQPA safety factor provision for dichlorvos is whether EPA should retain the presumptive additional 10X factor for the protection of infants and children or whether there are reliable data showing that a different additional factor will, in conjunction with the 10X intraspecies factor, protect the safety of infants and children. As the above discussion of the all-important FQPA safety factor considerations indicates, there are (1) reliable data from animal studies on adult/juvenile sensitivity showing that the standard 10X intraspecies factor will be protective of potential pre- and post-natal toxicity to infants and children; (2) reliable data on human exposure to dichlorvos demonstrating that an additional safety factor is not needed to protect infants and children due to exposure concerns; and (3) reliable data with regard to the one toxicity data deficiency identified to show that a 3X additional factor will be protective of all human populations, including infants and children, as to the only toxicity data completeness issue. Therefore, EPA reaffirms its selection of a 3X FQPA safety factor for Gledhill- based assessments.

D. Conclusion For all of the reasons set forth above,

EPA denies NRDC’s objection to the use of a 3X FQPA safety factor for assessments relying on the Gledhill study for a Point of Departure. Based on the revised explanation provided in this order, EPA concludes, like it did in the July 23, 2008 order, that a 3X additional safety factor will protect the safety of infants and children. Because this revised explanation addresses the court’s reason for finding portions of the July 23, 2008 order to be arbitrary and capricious, EPA has not otherwise reopened or reconsidered that prior order.

VIII. Statutory and Executive Order Reviews

This action denies an objection to a denial of a petition to revoke tolerances, is in the form of an order and not a rule. (21 U.S.C. 346a(g)(2)(C)). Under the Administrative Procedure Act (APA), orders are expressly excluded from the definition of a rule. (5 U.S.C. 551(4)). Accordingly, the regulatory assessment requirements imposed on a rulemaking do not apply to this action, as explained further in the following discussion.

A. Executive Order 12866 and Executive Order 13563

Because this order is not a ‘‘regulatory action’’ as that term is defined in Executive Order 12866 entitled ‘‘Regulatory Planning and Review’’ (58

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FR 51735, October 4, 1993), this action is not subject to review by the Office of Management and Budget (OMB) under Executive Orders 12866 and 13563 entitled ‘‘Improving Regulation and Regulatory Review’’ (76 FR 3821, January 21, 2011).

B. Paperwork Reduction Act This action does not contain any

information collections subject to OMB approval under the Paperwork Reduction Act (PRA), 44 U.S.C. 3501 et seq.

C. Regulatory Flexibility Act Since this order is not a rule under

the APA (5 U.S.C. 551(4)), and does not require the issuance of a proposed rule, the requirements of the Regulatory Flexibility Act (RFA) (5 U.S.C. 601 et seq.) do not apply.

D. Unfunded Mandates Reform Act; and Executive Orders 13132 and 13175

This order denies an objection to a denial of a petition to revoke tolerances; it does not alter the relationships or distribution of power and responsibilities established by Congress in the preemption provisions of section 408(n)(4) of FFDCA. As such, the Agency has determined that this action will not have a substantial direct effect on States or tribal governments, on the relationship between the national government and the States or tribal governments, or on the distribution of power and responsibilities among the various levels of government or between the Federal Government and Indian tribes. Thus, the Agency has determined that Executive Order 13132 entitled ‘‘Federalism’’ (64 FR 43255, August 10, 1999) and Executive Order 13175 entitled ‘‘Consultation and Coordination with Indian Tribal Governments’’ (65 FR 67249, November 9, 2000) do not apply to this order. In addition, this order does not impose any enforceable duty or contain any unfunded mandate as described under Title II of the Unfunded Mandates Reform Act (UMRA) (2 U.S.C. 1531–1538).

E. Executive Orders 13045, 13211 and 12898

As indicated previously, this action is not a ‘‘regulatory action’’ as defined by Executive Order 12866. As a result, this action is not subject to Executive Order 13045, entitled ‘‘Protection of Children from Environmental Health Risks and Safety Risks’’, (62 FR 19885, April 23, 1997) and Executive Order 13211 entitled ‘‘Actions Concerning Regulations That Significantly Affect Energy Supply, Distribution, or Use’’, (66 FR 28355, May 22, 2001). In

addition, this order also does not require any special considerations under Executive Order 12898 entitled ‘‘Federal Actions to Address Environmental Justice in Minority Populations and Low-Income Populations’’ (59 FR 7629, February 16, 1994).

F. National Technology Transfer and Advancement Act

This action does not involve any technical standards that would require Agency consideration of voluntary consensus standards pursuant to section 12(d) of the National Technology Transfer and Advancement Act (NTTAA), (15 U.S.C. 272 note).

IX. Congressional Review Act

The Congressional Review Act, 5 U.S.C. 801 et seq. does not apply because this action is not a rule as that term is defined in 5 U.S.C. 804(3).

X. References

1. Natural Resources Defense Council. (February 1, 2008). Objection to the Order Denying NRDC’s Petition to Revoke All Tolerances for Dichlorvos (DDVP), and Request for Public Evidentiary Hearing.

2. Natural Resources Defense Council. (June 2, 2006). Petition of Natural Resources Defense Council To Conclude Special Review, Reregistration and Tolerance Reassessment Processes and To Revoke All Tolerances and Cancel All Registrations for the Pesticide DDVP.

3. Office of Prevention, Pesticides and Toxic Substances, EPA. (June 2006). Interim Reregistration Eligibility Decision for Dichlorvos (DDVP). Available from: http://www.epa.gov/oppsrrd1/reregistration/REDs/ddvp_ired.pdf.

4. Lu, F. and Sielken, R. (1991). Assessment of safety/risk of chemicals: inception and evolution of the ADI and dose- response modeling procedures. Toxicology Letters 59, 5–40.

5. Schueplein, R. (2002). Pesticides and Infant Risk: Is There a Need for an Additional Margin of Safety. Regulatory and Toxicological Pharmacology. 31, 267–279.

6. Lehman, A. and Fitzhugh, O. (1954). Hundredfold margin of safety. Quarterly Bulletin of the Association of Food and Drug Officials of the United States. 33–35.

7. Food and Agriculture Organization. (1965). Evaluation of the toxicity of pesticide residues in food. Joint report of the FAO working party on pesticide residues and the WHO Expert Committee on Pesticide Residues FAO Meeting Report PL/1965/10/1, WHO/Food Add./27.65, Rome. Stoner, H. (1964). The Concept of acceptable Daily Intakes of Pesticides for Man. Food and Cosmetics Toxicology. 2, 457–466.

8. International Programme on Chemical Safety. (2005). Chemical-specific adjustment Factors for Interspecies Differences and Human Variability: Guidance Document for use of DATA in Dose/Concentration- Response Assessment. Available from: http://

whqlibdoc.who.int/publications/2005/ v9241546786_eng.pdf.

9. Dourson, M., Felter, S., and Robinson, D. (1996). Evolution of Science-Based Uncertainty Factors in Noncancer Risk Assessment. Regulatory Toxicology and Pharmacology. 24, 108–120.

10. Office of Pesticide Programs, U.S. EPA, Office of Pesticide Programs’ Policy on the Determination of the Appropriate FQPA Safety Factor(s) for Use in the Tolerance Setting Process (February 28, 2002). Available from: http://www.epa.gov/oppfead1/trac/science/determ.pdf.

11. Barnes, D. and Dourson, M. (1988). Reference Dose (RfD): Description and Use in Health Risk Assessments. Regulatory Toxicology and Pharmacology. 8, 471–486.

12. National Research Council. (2009). Science and Decisions: Advancing Risk Assessment. (The National Academies Press).

13. Burin, G. and Saunders, D. (1999). Addressing Human Variability in Risk Assessment—The Robustness of the Intraspecies Uncertainty Factor. Regulatory Toxicology and Pharmacology. 30, 209–216.

14. Renwick, A. and Lazarus, N. (1998). Human Variability and Noncancer Risk Assessment—An analysis of the Default Uncertainty Factor. Regulatory Toxicology and Pharmacology. 27, 3–20.

15. Dourson, M. and Stara, J. (1983). Regulatory History and Experimental Support of Uncertainty (Safety) Factors. Regulatory Toxicology and Pharmacology. 3, 224–238.

16. Renwick, A.G. (1991). Safety factors and establishment of acceptable daily intake. Food Additives & Contaminants. 8, 135–150.

17. Dourson, M., Charnley, G., and Scheuplein, R. (2002). Differential Sensitivity of children and Adults to Chemical Toxicity. Regulatory Toxicology and Pharmacology. 35, 448–467.

18. National Research Council. (1993). Pesticides in the Diets of Infants and Children. (National Academy Press).

19. EPA. (2002). A review of the Reference Dose and Reference Concentration Processes. EPA/630/P–02/002F.

20. U.S. EPA. (1994) Methods for derivation of inhalation reference concentrations and application of inhalation dosimetry. EPA/600/8–90/066F.

21. U.S. EPA. (1999) Toxicology Data Requirements For Assessing Risks Of Pesticide Exposure To Children’s Health: Report of the Toxicology Working Group of the 10X Task Force [April 28, 1999 draft]. Available from: http://www.epa.gov/scipoly/sap/meetings/1999/may/10xtx428.pdf.

22. Dourson, M., Knauf, L., and Swartout, J. (1992). On Reference Dose (RfD) and its underlying toxicity data base. Toxicology and Industrial Health 8(3), 171–189.

23. U.S. EPA. (2012). Benchmark Dose Technical Guidance Document. EPA/100/R– 12/001.

24. FIFRA Science Advisory Panel. (March 19, 2002). Methods Used to Conduct a Preliminary Cumulative Risk Assessment for Organophosphate Pesticides. Final Report from the FIFRA Scientific Advisory Panel Meeting of February 5–7, 2002 Available from: http://www.epa.gov/scipoly/sap/meetings/2002/february/final.pdf.

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25. FIFRA Science Advisory Panel. (April 15, 2005). Final report on N-Methyl Carbamate Cumulative Risk Assessment: Pilot Cumulative Analysis. Final Report from the FIFRA Scientific Advisory Panel Meeting of February 2005. Available from: http://www.epa.gov/scipoly/sap/meetings/2005/february/minutes.pdf.

26. FIFRA Science Advisory Panel. (October 13, 2005). Final report on Preliminary N-Methyl Carbamate Cumulative Risk Assessment. Final Report from the FIFRA Scientific Advisory Panel Meeting of July 29–30, 2005. Available from: http://www.epa.gov/scipoly/sap/meetings/2005/august/minutes.pdf.

27. Office of Pesticide Programs, U.S. EPA. (2000). The Use of Data on Cholinesterase Inhibition for Risk Assessments of Organophosphorous and Carbamate Pesticides. Available from: http://www.epa.gov/oppfead1/trac/science/cholin.pdf.

28. Natural Resources Defense Council. (July 30, 2010). Petitioner’s Brief, NRDC v. U.S. EPA, No. 08–3771–ag (2d Cir.).

29. U.S. EPA, Respondent’s Brief. (November 18, 2010). NRDC v. U.S. EPA, No. 08–3771–ag (2d Cir.).

30. Office of Chemical Safety and Pollution Prevention, U.S. EPA. (August 8, 2012). Memorandum from Ray Kent to Melanie Biscoe, ‘‘Lists of chemicals for which human studies were either: Approved by the Human Studies Review Board, or the basis for RfDs or RfCs in IRIS.’’

31. Office of Prevention, Pesticides and Toxic Substances, U.S. EPA. (June 15, 2006). Report of the Food Quality Protection Act (FQPA) Tolerance Reassessment and Risk Management Decision (TRED) for Ethephon. Available from: http://www.epa.gov/oppsrrd1/REDs/ethephon_tred.pdf. Regulatory Toxicology and Pharmacology.

32. Office of Prevention, Pesticides and Toxic Substances. (June 19, 2007). U.S. EPA, Memorandum from Feleica Fort to Tom Myers, ‘‘Methomyl. Acute, Probabilistic Aggregate Dietary (Food and Drinking Water) Exposure and Risk Assessments for the Reregistration Eligibility Decision.’’

33. Office of Prevention, Pesticides and Toxic Substances, U.S. EPA. (June 25, 2008). Memorandum from Elissa Reaves and Anna Lowit to Karen Santora, ‘‘Mode of Action, Eye Irritation, and the Intra-Species Factor: Comparison of Chloropicrin and MITC.’’

34. Office of Pesticide Programs, U.S. EPA. (March 24, 1998). ‘‘Data Evaluation Report: Dichlorvos: A Single Blind, Placebo Controlled, Randomized Study to Investigate the Effects of Multiple Oral Dosing on Erythrocyte Cholinesterase Inhibition in Healthy Male Volunteers.’’

35. Gledhill, A.J. (1997). Dichlorvos: A Single Blind, Placebo controlled, Randomised Study to Investigate the Effects of Multiple Oral Dosing on Erythrocyte Cholinesterase Inhibition in Healthy Male Volunteers.

36. EPA Human Studies Review Board. (May 15, 2006). Minutes of the United States Environmental Protection Agency (EPA) Human Studies Review Board (HSRB) April 4–6, 2006 Public Meeting.

37. Office of Pesticide Programs, U.S. EPA. (June 2002). Revised Cumulative Risk

Assessment of the Organophosphorus Pesticides. Available from: http://www.epa.gov/pesticides/cumulative/rra-op/.

38. Office of Prevention, Pesticides and Toxic Substances, U. S. EPA. (November 16, 2007). Memorandum from Ray Kent to Robert McNally, Dichlorvos (PC 084001). Additional characterization of inhalation risk posed by use of dichlorvos-containing resin strips. DP332823.

39. Office of Chemical Safety and Pollution Prevention, U.S. EPA. (August 9, 2010). Memorandum from Bayasid Sarkar to Ray Kent, Precision analysis of Gledhill study for litigation of DDVP.

40. Kent, R., Office of Pesticide Programs, U.S. EPA. (April 5, 2006). Dichlorvos: WOE Comparison of Human and Animal Studies for Single Chemical Assessment and OP Cumulative Assessment.

41. Office of Pesticide Programs, U.S. EPA. (June 20, 1994). Memorandum from Brigid Lowery to Jocelyn E. Steward, Dichlorvos (DDVP). Review of Subchronic Neurotoxicity Study in Sprague-Dawley Rats.

42. Office of Prevention, Pesticides and Toxic Substances, U.S. EPA. (June 9, 2006). Memorandum from Anna Lowit to Ray Kent, Benchmark Dose analysis of cholinesterase inhibition in neonatal and adult rats (MRID no. 46688914) following exposure to DDVP.

43. National Research Council, Reference Manual on Scientific Evidence 249–252 (3rd ed. 2011).

List of Subjects in 40 CFR Part 180 Environmental protection,

Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: August 29, 2012. Steven Bradbury, Director, Office of Pesticide Programs. [FR Doc. 2012–21844 Filed 9–4–12; 8:45 am]

BILLING CODE 6560–50–P

FEDERAL COMMUNICATIONS COMMISSION

47 CFR Part 101

[WT Docket No. 10–153; RM–11602; FCC 12–87]

Facilitating the Use of Microwave for Wireless Backhaul and Other Uses and Providing Additional Flexibility To Broadcast Auxiliary Service and Operational Fixed Microwave Licensees

AGENCY: Federal Communications Commission. ACTION: Final rule.

SUMMARY: In this document, the Commission takes further steps to remove regulatory barriers and lowering costs for the wireless microwave backhaul facilities that are an important component of many mobile wireless

networks. The steps we take will remove regulatory barriers that today limit the use of spectrum for wireless backhaul and other point-to-point and point-to-multipoint communications. This will also facilitate better use of Fixed Service (FS) spectrum and provide additional flexibility to enable FS licensees to reduce operational costs and facilitate the use of wireless backhaul in rural areas. By enabling more flexible and cost-effective microwave services, the Commission can help foster deployment of broadband infrastructure across America. In addition, a number of parties sought reconsideration of the Backhaul Report and Order, and we address those requests and deny reconsideration, for the most part. DATES: Effective October 5, 2012.

The effective date for the Rural Microwave Flexibility Policy, which contains new or modified information collection requirements has not been approved by the Office of Management and Budget (OMB). The Commission will publish a document in the Federal Register announcing the effective date of that policy. ADDRESSES: Federal Communications Commission, 445 12th Street SW., Washington, DC 20554. A copy of any comments on the Paperwork Reduction Act information collection requirements contained herein should be submitted to Judith B. Herman, Federal Communications Commission, Room 1– B441, 445 12th Street SW., Washington, DC 20554 or via the Internet at Judith B. Herman@fcc.gov. FOR FURTHER INFORMATION CONTACT: John Schauble, Wireless Telecommunications Bureau, Broadband Division, at 202– 418–0797 or by email to John.Schauble@fcc.gov. For additional information concerning Paperwork Reduction Act information collection requirements contained in this document, contact Judith B. Herman at (202) 418–0214, or via the Internet at PRA@fcc.gov. SUPPLEMENTARY INFORMATION: This is a summary of the Commission’s document, FCC 12–87, adopted and released on August 3, 2012. The full text of this document is available for inspection and copying during normal business hours in the FCC Reference Information Center, Room CY–A257, 445 12th Street SW., Washington, DC 20554. The complete text of the Backhaul Second Report and Order, Order on Reconsideration, and Memorandum Opinion and Order (Backhaul 2nd R&O, OOR, and MO&O) and related Commission documents may be purchased from the

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[FR Doc. E8–16833 Filed 7–22–08; 8:45 am] BILLING CODE 6560–50–P

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA–HQ–OPP–2002–0302; FRL–8372–5]

Dichlorvos (DDVP); Order Denying NRDC’s Objections and Requests for Hearing

AGENCY: Environmental Protection Agency (EPA). ACTION: Final Order.

SUMMARY: In this order, EPA denies objections to, and requests for hearing on, a prior order denying a petition requesting that EPA revoke all pesticide tolerances for dichlorvos under section 408(d) of the Federal Food, Drug, and Cosmetic Act. The objections and hearing requests were filed on February 1, 2008, by the Natural Resources Defense Council (‘‘NRDC’’). The Original petition was also filed by NRDC.

DATES: This order is effective July 23, 2008.

ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2002–0302. To access the electronic docket, go to http:// www.regulations.gov, and search for the docket number. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the OPP Regulatory Public Docket in Rm. S- 4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The Docket Facility is open from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305- 5805. FOR FURTHER INFORMATION CONTACT: Susan Bartow, Special Review and Reregistration Division (7508P), Office of Pesticide Programs, Environmental

Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460-0001; telephone number: 703-603-0065; e-mail address: bartow.susan@epa.gov. SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

In this document EPA denies objections and hearing requests by the Natural Resources Defense Council (‘‘NRDC’’) concerning EPA’s denial of NRDC’s petition to revoke pesticide tolerances. This action may also be of interest to agricultural producers, food manufacturers, or pesticide manufacturers. Potentially affected entities may include, but are not limited to those engaged in the following activities:

• Crop production (North American Industrial Classification System (‘‘NAICS’’) code 111), e.g., agricultural workers; greenhouse, nursery, and floriculture workers; farmers.

• Animal production (NAICS code 112), e.g., cattle ranchers and farmers, dairy cattle farmers, livestock farmers.

• Food manufacturing (NAICS code 311), e.g., agricultural workers; farmers; greenhouse, nursery, and floriculture workers; ranchers; pesticide applicators.

• Pesticide manufacturing (NAICS code 32532), e.g., agricultural workers; commercial applicators; farmers; greenhouse, nursery, and floriculture workers; residential users.

This listing is not intended to be exhaustive, but rather to provide a guide for readers regarding entities likely to be affected by this action. Other types of entities not listed in this unit could also be affected. The NAICS codes have been provided to assist you and others in determining whether this action might apply to certain entities. If you have any questions regarding the applicability of this action to a particular entity, consult the person listed under FOR FURTHER INFORMATION CONTACT.

B. How Can I Access Electronic Copies of this Document?

In addition to accessing an electronic copy of this Federal Register document through the electronic docket at http:// www.regulations.gov, you may access this Federal Register document electronically through the EPA Internet under the ‘‘Federal Register’’ listings at http://www.epa.gov/fedrgstr. You may also access a frequently updated electronic version of EPA’s tolerance regulations at 40 CFR part 180 through the Government Printing Office’s pilot e-CFR site at http://www.gpoaccess.gov/ ecfr.

C. Acronyms

The following is a list of acronyms used in this order: CSFII - Continuing Survey of Food Intakes by

Individuals CNS - Central Nervous System DDVP - dichlorvos EDSTAC - Endocrine Disruptor Screening

and Testing Advisory Committee EPA - Environmental Protection Agency FACA - Federal Advisory Committee Act FDA - Food and Drug Administration FIFRA - Federal Insecticide, Fungicide, and

Rodenticide Act FFDCA - Federal Food, Drug, and Cosmetic

Act FQPA - Food Quality Protection Act of 1996 HSRB - Human Studies Review Board IRED - Interim Reregistration Eligibility

Decision LOAEL - Lowest Observed Adverse Effect

Level MOE - Margin of Exposure MRID - Master Record Identification NOAEL - No Observed Adverse Effect Level NRDC - Natural Resources Defense Council OECD - Organisation for Economic Co-

operation and Development PAD - Population Adjusted Dose ppm - parts per million RBC - red blood cell RED - Reregistration Eligibility Decision RfD - Reference Dose SDWA - Safe Drinking Water Act SOP - Standard Operating Procedure USDA - United Stated Department of

Agriculture

II. Introduction

A. What Action Is the Agency Taking?

In this order, EPA denies objections, and requests for a hearing on those objections, to an earlier EPA order, (72 FR 68662 (December 5, 2007)), denying a petition to revoke all tolerances established for the pesticide dichlorvos (‘‘DDVP’’) under the Federal Food, Drug, and Cosmetic Act (‘‘FFDCA’’), 21 U.S.C. 346a. (Refs. 1 and 2). Both the objections and hearing requests, as well as the petition, were filed with EPA by NRDC.

NRDC’s petition, filed on June 2, 2006, pursuant to FFDCA section 408(d)(1), asserted numerous grounds as to why the DDVP tolerances allegedly fail to meet the FFDCA’s safety standard. This petition was filed as EPA was completing its reassessment of the safety of the DDVP tolerances pursuant to FFDCA section 408(q). (Ref. 3). In response to the petition, EPA undertook an extensive review of its DDVP safety evaluation in the tolerance reassessment decision. Based on certain concerns raised by NRDC, EPA determined it was necessary to incorporate updated data on numerous points and to adopt revised and more conservative assumptions, in its DDVP risk assessments. This led to complete revisions of both EPA’s assessments of

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dietary and residential risks from exposure to DDVP. (72 FR at 68678, 68687-68691). Nonetheless, EPA concluded that its revised risk assessments demonstrated that DDVP met the FFDCA safety standard and, therefore, denied the petition. (Id. at 68695). EPA’s denial was issued in the form of an order under FFDCA section 408(d)(4)(iii). (21 U.S.C. 346a(d)(4)(iii)).

NRDC then filed objections with EPA to the petition denial order and requested a hearing on its objections. These objections and hearing requests were filed pursuant to the procedures in the FFDCA section 408(g)(2). (21 U.S.C. 346a(g)(2)). The objections narrowed NRDC’s claims to two main topics - that, in assessing the risk to DDVP, EPA unlawfully reduced the statutory safety factor for the protection of infants and children and EPA unlawfully relied on a human toxicity study. As to these claims, NRDC largely repeats the arguments as presented in its petition without addressing EPA’s substantial revisions to the DDVP risk assessment and proffers little to no evidence in support of its requests for a hearing. After carefully reviewing the objections and hearing requests, EPA has determined that NRDC’s hearing requests do not satisfy the regulatory requirements for such requests and that its substantive objections are without merit. Therefore, EPA, in this final order, denies NRDC’s objections and its requests for a hearing on those objections.

B. What Is the Agency’s Authority for Taking This Action?

NRDC petitioned to revoke the DDVP tolerances pursuant to the petition procedures in FFDCA section 408(d)(1). (21 U.S.C. 346a(d)(1)). Under section 408(d), EPA may respond to such a petition by either issuing a final or proposed rule modifying or revoking the tolerances or issuing an order denying the petition. (21 U.S.C. 346a(d)(4)). Here, EPA responded by issuing an order under section 408(d)(4)(iii) denying the petition. (72 FR 68622 (December 5, 2007)).

Orders issued under section 408(d)(4)(iii) are subject to a statutorily- created administrative review process. (21 U.S.C. 346a(g)(2)). Any person may file objections to a section 408(d)(4)(iii) order with EPA and request a hearing on those objections. (Id.). EPA is required by section 408(g)(2)(C) to issue a final order resolving the objections to the section 408(d)(4)(iii) order. (21 U.S.C. 346a(g)(2)(C)).

III. Statutory and Regulatory Background

In this Unit, EPA provides background on the relevant statutes and regulations governing NRDC’s objections and requests for hearing as well as on pertinent Agency policies and practices. As noted, NRDC’s objections and requests for hearing raise two main claims: (1) that EPA has unlawfully failed to retain the full tenfold safety factor for the protection of infants and children; and (2) that it was unlawful for EPA to rely on a toxicity study for DDVP that was conducted with humans. The children’s safety factor claim is based on assertions regarding DDVP’s potential endocrine effects and the adequacy of EPA’s data and risk assessments pertaining to exposure to DDVP in food as a result of the use of DDVP (and similar pesticides) in agriculture or food storage and through use of DDVP in residential settings. The human studies claim involves a challenge to the EPA regulation governing reliance on human studies as well as to EPA’s application of that rule to a particular human study. The human study in question measured cholinesterase inhibition in humans resulting from administration of DDVP. Background information on each of these topics is included in this Unit.

Unit III.A. summarizes the requirements and procedures in section 408 of the FFDCA and applicable regulations pertaining to pesticide tolerances, including the procedures for petitioning for revocation of tolerances and challenging the denial of such petitions and the substantive standards for evaluating the safety of pesticide tolerances. This unit also discusses the closely-related statute under which EPA regulates the sale, distribution, and use of pesticides, the Federal Insecticide, Fungicide, and Rodenticide Act (‘‘FIFRA’’), (7 U.S.C. 136 et seq.).

Unit III.B. provides an overview of EPA’s risk assessment process. It contains an explanation of how EPA identifies the hazards posed by pesticides, how EPA determines the level of exposure to pesticides that pose a concern (‘‘level of concern’’), how EPA measures human exposure to pesticides, and how hazard, level of concern conclusions, and human exposure estimates are combined to evaluate risk. Further, this unit presents background information on two Agency policies with particular relevance to this action, EPA’s policy with regard to the statutory safety factor for the protection of infants and children and its policy with regard to cholinesterase inhibition.

Unit III.C. summarizes EPA’s program for implementing the statutory requirement to screen pesticides for potential endocrine effects. Unit III.D. describes the EPA regulation on use of human studies.

A. FFDCA/FIFRA and Applicable Regulations

1. In general. EPA establishes maximum residue limits, or ‘‘tolerances,’’ for pesticide residues in food under section 408 of the FFDCA. (21 U.S.C. 346a). Without such a tolerance or an exemption from the requirement of a tolerance, a food containing a pesticide residue is ‘‘adulterated’’ under section 402 of the FFDCA and may not be legally moved in interstate commerce. (21 U.S.C. 331, 342). Monitoring and enforcement of pesticide tolerances are carried out by the U.S. Food and Drug Administration (‘‘FDA’’) and the U.S. Department of Agriculture (‘‘USDA’’). Section 408 was substantially rewritten by the Food Quality Protection Act of 1996 (‘‘FQPA’’), which added the provisions discussed below establishing a detailed safety standard for pesticides, additional protections for infants and children, and the estrogenic substances screening program. (Public Law 104-170, 110 Stat. 1489 (1996)).

EPA also regulates pesticides under the Federal Insecticide, Fungicide, and Rodenticide Act (‘‘FIFRA’’), (7 U.S.C. 136 et seq). While the FFDCA authorizes the establishment of legal limits for pesticide residues in food, FIFRA requires the approval of pesticides prior to their sale and distribution, (7 U.S.C. 136a(a)), and establishes a registration regime for regulating the use of pesticides. FIFRA regulates pesticide use in conjunction with its registration scheme by requiring EPA review and approval of pesticide labels and specifying that use of a pesticide inconsistent with its label is a violation of federal law. (7 U.S.C. 136j(a)(2)(G)). In the FQPA, Congress integrated action under the two statutes by requiring that the safety standard under the FFDCA be used as a criterion in FIFRA registration actions as to pesticide uses which result in dietary risk from residues in or on food, (7 U.S.C. 136(bb)), and directing that EPA coordinate, to the extent practicable, revocations of tolerances with pesticide cancellations under FIFRA. (21 U.S.C. 346a(l)(1)).

2. Safety standard for pesticide tolerances. A pesticide tolerance may only be promulgated by EPA if the tolerance is ‘‘safe.’’ (21 U.S.C. 346a(b)(2)(A)(i)). ‘‘Safe’’ is defined by the statute to mean that ‘‘there is a reasonable certainty that no harm will

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result from aggregate exposure to the pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there is reliable information.’’ (21 U.S.C. 346a(b)(2)(A)(ii)). Section 408(b)(2)(D) directs EPA, in making a safety determination, to:

consider, among other relevant factors- ...

(v) available information concerning the cumulative effects of such residues and other substances that have a common mechanism of toxicity;

(vi) available information concerning the aggregate exposure levels of consumers (and major identifiable subgroups of consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under the tolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non- occupational sources;

(viii) such information as the Administrator may require on whether the pesticide chemical may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects. ...

(21 U.S.C. 346a(b)(2)(D)(v), (vi) and (viii)).

EPA must also consider, in evaluating the safety of tolerances, ‘‘safety factors which . . . are generally recognized as appropriate for the use of animal experimentation data.’’ (21 U.S.C. 346a(b)(2)(D)(ix).

Risks to infants and children are given special consideration. Specifically, section 408(b)(2)(C) states that EPA:

shall assess the risk of the pesticide chemical based on— ...

(II) available information concerning the special susceptibility of infants and children to the pesticide chemical residues, including neurological differences between infants and children and adults, and effects of in utero exposure to pesticide chemicals; and

(III) available information concerning the cumulative effects on infants and children of such residues and other substances that have a common mechanism of toxicity. ...

(21 U.S.C. 346a(b)(2)(C)(i)(II) and (III)). This provision also creates a

presumptive additional safety factor for the protection of infants and children. Specifically, it directs that ‘‘[i]n the case of threshold effects, ... an additional tenfold margin of safety for the pesticide chemical residue and other sources of exposure shall be applied for infants and children to take into account potential pre- and post-natal toxicity and completeness of the data with respect to exposure and toxicity to infants and children.’’ (21 U.S.C. 346a(b)(2)(C)). EPA is permitted to ‘‘use a different margin of safety for the pesticide chemical residue only if, on the basis of reliable data, such margin

will be safe for infants and children.’’ (Id.). The additional safety margin for infants and children is referred to throughout this order as the ‘‘children’s safety factor.’’

3. Procedures for establishing, amending, or revoking tolerances. Tolerances are established, amended, or revoked by rulemaking under the unique procedural framework set forth in the FFDCA. Generally, a tolerance rulemaking is initiated by the party seeking to establish, amend, or revoke a tolerance by means of filing a petition with EPA. (See 21 U.S.C. 346a(d)(1)). EPA publishes in the Federal Register a notice of the petition filing and requests public comment. (21 U.S.C. 346a(d)(3)). After reviewing the petition, and any comments received on it, EPA may issue a final rule establishing, amending, or revoking the tolerance, issue a proposed rule to do the same, or deny the petition. (21 U.S.C. 346a(d)(4)).

Once EPA takes final action on the petition by either establishing, amending, or revoking the tolerance or denying the petition, any person may file objections with EPA and seek an evidentiary hearing on those objections. (21 U.S.C. 346a(g)(2)). Objections and hearing requests must be filed within 60 days. (Id.). The statute provides that EPA shall ‘‘hold a public evidentiary hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections.’’ (21 U.S.C. 346a(g)(2)(B). EPA regulations make clear that hearings will only be granted where it is shown that there is ‘‘a genuine and substantial issue of fact,’’ the requestor has identified evidence ‘‘which, if established, resolve one or more of such issues in favor of the requestor,’’ and the issue is ‘‘determinative’’ with regard to the relief requested. (40 CFR 178.32(b)). EPA’s final order on the objections is subject to judicial review. (21 U.S.C. 346a(h)(1)).

4. Tolerance reassessment and FIFRA reregistration. The FQPA required that EPA reassess the safety of all pesticide tolerances existing at the time of its enactment. (21 U.S.C. 346a(q)). EPA was given 10 years to reassess the approximately 10,000 tolerances in existence in 1996. In this reassessment, EPA was required to review existing pesticide tolerances under the new ‘‘reasonable certainty that no harm will result’’ standard set forth in section 408(b)(2)(A)(i). (21 U.S.C. 346a(b)(2)(A)(i)). This reassessment was substantially completed by the August 3, 2006 deadline. Tolerance reassessment was generally handled in

conjunction with a similar program involving reregistration of pesticides under FIFRA. (7 U.S.C. 136a-1). Reassessment and reregistration decisions were generally combined in a document labeled a Reregistration Eligibility Decision (‘‘RED’’).

5. Estrogenic substances screening program. The FQPA also imposed requirements regarding creation of an estrogenic substances screening program. Section 408(p) gives EPA 2 years from enactment of the FQPA to ‘‘develop a screening program ... to determine whether [pesticide chemicals and certain other substances] may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or such other endocrine effect as the Administrator may designate.’’ (21 U.S.C. 346a(p)(1)). This screening program must use ‘‘appropriate validated test systems and scientifically relevant information.’’ (Id.). Once the program is developed, EPA is required to take public comment and seek independent scientific review of it. Following the period for public comment and scientific review, and not later than 3 years following enactment of the FQPA, EPA is directed to ‘‘implement the program.’’ (21 U.S.C. 346a(p)(2)).

The scope of the estrogenic screening program was expanded by an amendment to the Safe Drinking Water Act (‘‘SDWA’’) passed contemporaneously with the FQPA. That amendment gave EPA the authority to provide for the testing, under the FQPA estrogenic screening program, ‘‘of any other substance that may be found in sources of drinking water if the Administrator determines that a substantial population may be exposed to such substance.’’ (42 U.S.C. 300j-17).

B. EPA Risk Assessment for Tolerances—Policy and Practice

1. The safety determination - risk assessment. To assess risk of a pesticide tolerance, EPA combines information on pesticide toxicity with information regarding the route, magnitude, and duration of exposure to the pesticide. The risk assessment process involves four distinct steps: (1) Identification of the toxicological hazards posed by a pesticide; (2) determination of the ‘‘level of concern’’ with respect to human exposure to the pesticide; (3) estimation of human exposure to the pesticide; and (4) characterization of risk posed to humans by the pesticide based on comparison of human exposure to the level of concern.

a. Hazard identification. In evaluating toxicity or hazard, EPA reviews toxicity studies, primarily in laboratory animals,

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to identify any adverse effects on the test subjects. Animal studies typically involve investigating a broad range of endpoints including gross and microscopic effects on organs and tissues, functional effects on bodily organs and systems, effects on blood parameters (such as red blood cell count, hemoglobin concentration, hematocrit, and a measure of clotting potential), effects on the concentrations of normal blood chemicals (including glucose, total cholesterol, urea nitrogen, creatinine, total protein, total bilirubin, albumin, hormones, and enzymes such as alkaline phosphatase, alanine aminotransfersase and cholinesterases), and behavioral or other gross effects identified through clinical observation and measurement. EPA examines whether adverse effects are caused by either short-term (e.g., ‘‘acute’’) or longer-term (e.g., ‘‘chronic’’) pesticide exposure and the effects of pre-natal and post-natal exposure in animals.

EPA also considers whether the adverse effect has a threshold - a level below which exposure has no appreciable chance of causing the adverse effect. For non-threshold effects, EPA assumes that any exposure to the substance increases the risk that the adverse effect may occur. At present, EPA only considers one adverse effect, the chronic effect of cancer, to potentially be a non-threshold effect. (Ref. 4 at 8-9). Not all carcinogens, however, pose a risk at any exposure level (i.e., ‘‘a non-threshold effect or risk’’). Advances in the understanding of the mode of action of carcinogenesis have increasingly led EPA to conclude that some pesticides that cause carcinogenic effects in animal studies only cause such effects above a certain threshold of exposure. EPA has traditionally considered non-cancer adverse effects on the endocrine system to be threshold effects; that determination is being reexamined in conjunction with the endocrine disruptor screening program.

b. Level of concern/dose-response analysis. Once a pesticide’s potential hazards are identified, EPA determines a toxicological level of concern for evaluating the risk posed by human exposure to the pesticide. In this step of the risk assessment process, EPA essentially evaluates the levels of exposure to the pesticide at which effects might occur. An important aspect of this determination is assessing the relationship between exposure (dose) and response (often referred to as the dose-response analysis). EPA follows differing approaches to identifying a level of concern for threshold and non- threshold hazards.

i. Threshold effects. In examining the dose-response relationship for a pesticide’s threshold effects, EPA evaluates an array of toxicity studies on the pesticide. In each of these studies, EPA attempts to identify the lowest observed adverse effect level (‘‘LOAEL’’) and the next lower dose at which there are no observed adverse affect levels (‘‘NOAEL’’). Generally, EPA will use the lowest NOAEL from the available studies as a starting point (called ‘‘the Point of Departure’’) in estimating the level of concern for humans. (Ref. 4 at 9 (The Point of Departure ‘‘is simply the toxic dose that serves as the ‘starting point’ in extrapolating a risk to the human population.’’)). At times, however, EPA will use a LOAEL from a study as the Point of Departure when no NOAEL is identified in that study and the LOAEL is close to, or lower than, other relevant NOAELs. The Point of Departure is in turn used in choosing a level of concern. EPA will make separate determinations as to the Points of Departure, and correspondingly levels of concern, for both short and long exposure periods as well as for the different routes of exposure (oral, dermal, and inhalation).

In estimating and describing the level of concern, the Point of Departure is at times used differently depending on whether the risk assessment addresses dietary or non-dietary exposures. For dietary risks, EPA uses the Point of Departure to calculate an acceptable level of exposure or reference dose (‘‘RfD’’). The RfD is calculated by dividing the Point of Departure by all applicable safety or uncertainty factors. Typically, EPA uses a baseline safety/ uncertainty factor equal to 100. That value includes a factor of ten (‘‘10X’’) where EPA is using data from laboratory animals to reflect potentially greater sensitivity in humans than animals and a factor of 10X to account for potential variations in sensitivity among members of the human population as well as other unknowns. Additional safety factors may be added to address data deficiencies or concerns raised by the existing data. Under the FQPA, an additional safety factor of 10X is presumptively applied to protect infants and children, unless reliable data support selection of a different factor. This FQPA additional safety factor largely replaces pre-FQPA EPA practice regarding additional safety factors. (Ref. 5 at 4-11).

In implementing FFDCA section 408, EPA’s Office of Pesticide Programs, also calculates a variant of the RfD referred to as a Population Adjusted Dose (‘‘PAD’’). A PAD is the RfD divided by any portion of the FQPA safety factor

that does not correspond to one of the traditional additional safety factors used in general Agency risk assessments. (Ref. 5 at 13-16). The reason for calculating PADs is so that other parts of the Agency, which are not governed by FFDCA section 408, can, when evaluating the same or similar substances, easily identify which aspects of a pesticide risk assessment are a function of the particular statutory commands in FFDCA section 408. Today, RfDs and PADs are generally calculated for both acute and chronic dietary risks although traditionally a RfD or PAD was only calculated for chronic dietary risks. Throughout this document general references to EPA’s calculated safe dose are denoted as a RfD/PAD.

For non-dietary, and combined dietary and non-dietary, risk assessments of threshold effects, the toxicological level of concern is not expressed as a RfD/PAD but rather in terms of an acceptable (or ‘‘target’’) margin of exposure (‘‘MOE’’) between human exposure and the Point of Departure. The ‘‘margin’’ of interest is the ratio between human exposure and the Point of Departure which is calculated by dividing human exposure into the Point of Departure. An acceptable MOE is generally considered to be a margin at least as high as the product of all applicable safety factors for a pesticide. For example, if a pesticide needs a 10X factor to account for inter-species differences, 10X factor for intra-species differences, and 10X factor for the FQPA children’s safety provision, the safe or target MOE would be a MOE of at least 1,000. What that means is that for the pesticide to meet the safety standard, human exposure to the pesticide would have to be at least 1,000 times smaller than the Point of Departure. Like RfD/PADs, specific target MOEs are selected for exposures of different durations. For non-dietary exposures, EPA typically examines short-term, intermediate-term, and long- term exposures. Additionally, target MOEs may be selected based on both the duration of exposure and the various routes of non-dietary exposure - dermal, inhalation, and oral.

ii. Non-threshold effects. For risk assessments for non-threshold effects, EPA does not use the RfD/PAD or MOE approach to choose a level of concern if quantification of the risk is deemed appropriate. Rather, EPA calculates the slope of the dose-response curve for the non-threshold effects from relevant studies using a linear, low-dose extrapolation model that assumes that any amount of exposure will lead to some degree of risk. This dose-response

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analysis will be used in the risk characterization stage to estimate the risk to humans of the non-threshold effect. Linear, low-dose extrapolation is typically used as the default approach for estimating the risk to carcinogens, unless there are mode of action data indicating a threshold response (or nonlinearity).

c. Estimating human exposure. Risk is a function of both hazard and exposure. Thus, equally important to the risk assessment process as determining the hazards posed by a pesticide and the toxicological level of concern for those hazards is estimating human exposure. Under FFDCA section 408, EPA is concerned not only with exposure to pesticide residues in food but also exposure resulting from pesticide contamination of drinking water supplies and from use of pesticides in the home or other non-occupational settings. (See 21 U.S.C. 346a(b)(2)(D)(vi)).

i. Exposure from food. There are two critical variables in estimating exposure in food: (1) The types and amount of food that is consumed; and (2) the residue level in that food. Consumption is estimated by EPA based on scientific surveys of individuals’ food consumption in the United States conducted by the USDA. (Ref. 4 at 12). Information on residue values comes from a range of sources including crop field trials, data on pesticide reduction (or concentration) due to processing, cooking, and other practices, information on the extent of usage of the pesticide, and monitoring of the food supply. (Id. at 17).

In assessing exposure from pesticide residues in food, EPA, for efficiency’s sake, follows a tiered approach in which it, in the first instance, assesses exposure using the worst case assumptions that 100 percent of the crop in question is treated with the pesticide and 100 percent of the food from that crop contains pesticide residues at the tolerance level. (Id. at 11). When such an assessment shows no risks of concern, a more complex risk assessment is unnecessary. By avoiding a more complex risk assessment, EPA’s resources are conserved and regulated parties are spared the cost of any additional studies that may be needed. If, however, a first tier assessment suggests there could be a risk of concern, EPA then attempts to refine its exposure assumptions to yield a more realistic picture of residue values through use of data on the percent of the crop actually treated with the pesticide and data on the level of residues that may be present on the treated crop. These latter data are used to estimate

what has been traditionally referred to by EPA as ‘‘anticipated residues.’’

Use of percent crop treated data and anticipated residue information is appropriate because EPA’s worst-case assumptions of 100 percent treatment and residues at tolerance value significantly overstate residue values. There are several reasons this is true. First, all growers of a particular crop would rarely choose to apply the same pesticide to that crop; generally, the proportion of the crop treated with a particular pesticide is significantly below 100 percent. (70 FR 46706, 46731 (August 10, 2005)). Second, the tolerance value represents a high end or worst case value. Tolerance values are chosen only after EPA has evaluated data from experimental crop field trials in which the pesticide has been used in a manner, consistent with the draft FIFRA label, that is likely to produce the highest residue in the crop in question (e.g., maximum application rate, maximum number of applications, minimum pre-harvest interval between last pesticide application and harvest). (Refs. 4 and 6). These crop field trials are generally conducted in several fields at several geographical locations. (Id. at 5, 7 and Tables 1 and 5). Several samples are then gathered from each field and analyzed. (Id. at 53). Generally, the results from such field trials show that the residue levels for a given pesticide use will vary from as low as non-detectable to measurable values in the parts per million (‘‘ppm’’) range with the majority of the values falling at the lower part of the range. (70 FR at 46731). EPA uses a statistical procedure to analyze the field trial results and identify the upper bound of expected residue values. This upper bound value is used as the tolerance value. (Ref. 7). There may be some commodities from a treated crop that approach the tolerance value where the maximum label rates are followed, but most generally fall significantly below the tolerance value. If less than the maximum legal rate is applied, residues will be even lower. Third, residue values in the field do not take into account the lowering of residue values that frequently occurs as a result of degradation over time and through food processing and cooking.

EPA uses several techniques to refine residue value estimates. (Ref. 4 at 17- 28). First, where appropriate, EPA will take into account all the residue values reported in the crop field trials, either through use of an average or individually. Second, EPA will consider data showing what portion of the crop is not treated with the pesticide. Third, data can be produced showing pesticide

degradation and decline over time, and the effect of commercial and consumer food handling and processing practices. Finally, EPA can consult monitoring data gathered by the FDA, the USDA, or pesticide registrants, on pesticide levels in food at points in the food distribution chain distant from the farm, including retail food establishments.

Another critical component of the exposure assessment is how data on consumption patterns are combined with data on pesticide residue levels in food. Traditionally, EPA has calculated exposure by simply multiplying average consumption by average residue values for estimating chronic risks and high- end consumption by maximum residue values for estimating acute risks. Using average residues is a realistic approach for chronic risk assessment due to the fact that variations in residue levels and consumption amounts average out over time. Using average values is inappropriate for acute risk assessments, however, because in assessing acute exposure situations it matters how much of each treated food a given consumer eats and what the residue levels are in the particular foods consumed. Yet, using maximum residue values for acute risk assessment tends to greatly overstate exposure because it is unlikely that a person would consume at a single meal multiple food components bearing high-end residues. To take into account the variations in short-term consumption patterns and food residue values for acute risk assessments, EPA has more recently begun using probabilistic modeling techniques for estimating exposure when more simplistic models appear to show risks of concerns.

All of these refinements to the exposure assessment process, from use of food monitoring data through probabilistic modeling, can have dramatic effects on the level of exposure predicted, reducing worst case estimates by 1 or 2 orders of magnitude or more. (Ref. 8 at 16-17; 70 FR 46706, 46732 (August 10, 2005).

ii. Exposure from water. EPA may use either or both field monitoring data and mathematical water exposure models to generate pesticide exposure estimates in drinking water. Monitoring and modeling are both important tools for estimating pesticide concentrations in water and can provide different types of information. Monitoring data can provide estimates of pesticide concentrations in water that are representative of specific agricultural or residential pesticide practices and under environmental conditions associated with a sampling design. Although monitoring data can provide a

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direct measure of the concentration of a pesticide in water, it does not always provide a reliable estimate of exposure because sampling may not occur in areas with the highest pesticide use, and/or the sampling may not occur when the pesticides are being used.

In estimating pesticide exposure levels in drinking water, EPA most frequently uses mathematical water exposure models. EPA’s models are based on extensive monitoring data and detailed information on soil properties, crop characteristics, and weather patterns. (69 FR 30042, 30058-30065 (May 26, 2004)). These models calculate estimated environmental concentrations of pesticides using laboratory data that describe how fast the pesticide breaks down to other chemicals and how it moves in the environment. These concentrations can be estimated continuously over long periods of time, and for places that are of most interest for any particular pesticide. Modeling is a useful tool for characterizing vulnerable sites, and can be used to estimate peak concentrations from infrequent, large storms.

iii. Residential exposures. Generally, in assessing residential exposure to pesticides EPA relies on its Residential Standard Operating Procedures (‘‘SOPs’’). (Ref. 9). The SOPs establish models for estimating application and post-application exposures in a residential setting where pesticide- specific monitoring data are not available. SOPs have been developed for many common exposure scenarios including pesticide treatment of lawns, garden plants, trees, swimming pools, pets, and indoor surfaces including crack and crevice treatments. The SOPs are based on existing monitoring and survey data including information on activity patterns, particularly for children. Where available, EPA relies on pesticide-specific data in estimating residential exposures.

d. Risk characterization. The final step in the risk assessment is risk characterization. In this step, EPA combines information from the first three steps (hazard identification, level of concern/dose-response analysis, and human exposure assessment) to quantitatively estimate the risks posed by a pesticide. Separate characterizations of risk are conducted for different durations of exposure. Additionally, separate and, where appropriate, aggregate characterizations or risk are conducted for the different routes of exposure (dietary and non- dietary).

For threshold risks, EPA estimates risk in one of two ways. Where EPA has calculated a RfD/PAD, risk is estimated

by expressing human exposure as a percentage of the RfD/PAD. Exposures lower than 100 percent of the RfD/PAD are generally not of concern. Alternatively, EPA may express risk by comparing the MOE between estimated human exposure and the Point of Departure with the acceptable or target MOE. As described above, the acceptable or target MOE is the product of all applicable safety factors. To calculate the actual MOE for a pesticide, estimated human exposure to the pesticide is divided into the Point of Departure. In contrast to the RfD/PAD approach, the higher the MOE, the safer the pesticide. Accordingly, if the target MOE for a pesticide is 100, MOEs equal to or exceeding 100 would generally not be of concern.

As a conceptual matter, the RfD/PAD and MOE approaches are fundamentally equivalent. For a given risk and given exposure of a pesticide, if exposure to a pesticide were found to be acceptable under an RfD/PAD analysis it would also pass under the MOE approach, and vice-versa. However, for any specific pesticide, risk assessments for different exposure durations or routes may yield different results. This is a function not of the choice of the RfD/PAD or MOE approach but of the fact that the levels of concern and the levels of exposure may differ depending on the duration and route of exposure.

For non-threshold risks (generally, cancer risks), EPA uses the slope of the dose-response curve for a pesticide in conjunction with an estimation of human exposure to that pesticide to estimate the probability of occurrence of additional adverse effects. For non- threshold cancer risks, EPA generally considers cancer risk to be negligible if the probability of increased cancer cases falls within the range of 1 in 1 million. Risks exceeding values within that range would raise a risk concern.

2. EPA policy on the children’s safety factor. As the above brief summary of EPA’s risk assessment practice indicates, the use of safety factors plays a critical role in the process. This is true for traditional 10X safety factors to account for potential differences between animals and humans when relying on studies in animals (inter- species safety factor) and potential differences among humans (intra- species safety factor) as well as the FQPA’s additional 10X children’s safety factor.

In applying the children’s safety factor provision, EPA has interpreted it as imposing a presumption in favor of applying an additional 10X safety factor. (Ref. 5 at 4, 11). Thus, EPA generally refers to the additional 10X factor as a

presumptive or default 10X factor. EPA has also made clear, however, that this presumption or default in favor of the additional 10X is only a presumption. The presumption can be overcome if reliable data demonstrate that a different factor is safe for children. (Id.). In determining whether a different factor is safe for children, EPA focuses on the three factors listed in section 408(b)(2)(C) - the completeness of the toxicity database, the completeness of the exposure database, and potential pre- and post-natal toxicity. In examining these factors, EPA strives to make sure that its choice of a safety factor, based on a weight-of-the- evidence evaluation, does not understate the risk to children. (Id. at 24-25, 35).

3. EPA policy on cholinesterase inhibition as a regulatory endpoint. Cholinesterase inhibition is a disruption of the normal process in the body by which the nervous system chemically communicates with muscles and glands. Communication between nerve cells and a target cell (i.e., another nerve cell, a muscle fiber, or a gland) is facilitated by the chemical, acetylcholine. When a nerve cell is stimulated it releases acetylcholine into the synapse (or space) between the nerve cell and the target cell. The released acetylcholine binds to receptors in the target cell, stimulating the target cell in turn. As EPA has explained, ‘‘the end result of the stimulation of cholinergic pathway(s) includes, for example, the contraction of smooth (e.g., in the gastrointestinal tract) or skeletal muscle, changes in heart rate or glandular secretion (e.g., sweat glands) or communication between nerve cells in the brain or in the autonomic ganglia of the peripheral nervous system.’’ (Ref. 10 at 10).

Acetylcholinesterase is an enzyme that breaks down acetylcholine and terminates its stimulating action in the synapse between nerve cells and target cells. When acetylcholinesterase is inhibited, acetylcholine builds up prolonging the stimulation of the target cell. This excessive stimulation potentially results in a broad range of adverse effects on many bodily functions including muscle cramping or paralysis, excessive glandular secretions, or effects on learning, memory, or other behavioral parameters. Depending on the degree of inhibition these effects can be serious, even fatal.

EPA’s cholinesterase inhibition policy statement explains EPA’s approach to evaluating the risks posed by cholinesterase-inhibiting pesticides such as DDVP. (Ref. 10). The policy focuses on three types of effects associated with cholinesterase-

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inhibiting pesticides that may be assessed in animal and human toxicological studies: (1) Physiological and behavioral/functional effects; (2) cholinesterase inhibition in the central and peripheral nervous system; and (3) cholinesterase inhibition in red blood cells and blood plasma. The policy discusses how such data should be integrated in deriving an acceptable dose (RfD/PAD) for a cholinesterase- inhibiting pesticide.

Clinical signs or symptoms of cholinesterase inhibition in humans, the policy concludes, provide the most direct evidence of the adverse consequences of exposure to cholinesterase-inhibiting pesticides. Nonetheless, as the policy notes, due to strict ethical limitations, studies in humans are ‘‘quite limited.’’ (Id. at 19). Although animal studies can also provide direct evidence of cholinesterase inhibition effects, animal studies cannot easily measure cognitive effects of cholinesterase inhibition such as effects on perception, learning, and memory. For these reasons, the policy recommends that ‘‘functional data obtained from human and animal studies should not be relied on solely, to the exclusion of other kinds of pertinent information, when weighing the evidence for selection of the critical effect(s) that will be used as the basis of the RfD or RfC.’’ (Id. at 20).

After clinical signs or symptoms, cholinesterase inhibition in the nervous system provides the next most important endpoint for evaluating cholinesterase-inhibiting pesticides. Although cholinesterase inhibition in the nervous system is not itself regarded as a direct adverse effect, it is ‘‘generally accepted as a key component of the mechanism of toxicity leading to adverse cholinergic effects.’’ (Id. at 25). As such, the policy states that it should be treated as ‘‘direct evidence of potential adverse effects’’ and ‘‘data showing this response provide valuable information in assessing potential hazards posed by anticholinesterase pesticides.’’ (Id.). Unfortunately, useful data measuring cholinesterase inhibition in the central and peripheral nervous systems has only been relatively rarely captured by standard toxicology testing, particularly as to peripheral nervous system effects. For central nervous system effects, however, more recent neurotoxicity studies ‘‘have sought to characterize the time course of inhibition in ... [the] brain, including brain regions, after acute and 90–day exposures.’’ (Id. at 27).

Cholinesterase inhibition in the blood is one step further removed from the direct harmful consequences of

cholinesterase-inhibiting pesticides. According to the policy, inhibition of blood cholinesterases ‘‘is not an adverse effect, but may indicate a potential for adverse effects on the nervous system.’’ (Id. at 28). The policy states that ‘‘[a]s a matter of science policy, blood cholinesterase data are considered appropriate surrogate measures of potential effects on peripheral nervous system acetylcholinesterase activity in animals, for central nervous system (‘‘CNS’’) acetylcholinesterase activity in animals when CNS data are lacking and for both peripheral and central nervous system acetylcholinesterase in humans.’’ (Id. at 29). The policy notes that ‘‘there is often a direct relationship between a greater magnitude of exposure [to a cholinesterase-inhibiting pesticide] and an increase in incidence and severity of clinical signs and symptoms as well as blood cholinesterase inhibition.’’ (Id. at 30). Thus, the policy regards blood cholinesterase data as ‘‘appropriate endpoints for derivation of reference doses or concentrations when considered in a weight-of-the-evidence analysis of the entire database ....’’ (Id. at 29). Between cholinesterase inhibition measured in red blood cell (‘‘RBC’’) or blood plasma, the policy states a preference for reliance on RBC acetylcholinesterase measurements because plasma is composed of a mixture of acetylcholinesterase and butyrylcholinesterase, and inhibition of the latter is less clearly tied to inhibition of acetylcholinesterase in the nervous system. (Id. at 29, 32).

If a measure of cholinesterase inhibition (e.g., RBC cholinesterase) is being considered as a potential adverse effect or surrogate for an adverse effect, the policy advises that the level of inhibition must be critically evaluated ‘‘in the context of both statistical and biological significance.’’ (Id. at 37) (emphasis in Original). The policy notes that ‘‘[n]o fixed percentage of change (e.g., 20% for cholinesterase enzyme inhibition) is predetermined to separate adverse from non-adverse effects.’’ (Id.). Rather, the policy explains that ‘‘OPP’s experience with the review of toxicity studies with cholinesterase-inhibiting substances shows that differences between pre- and post-exposure of 20% or more in enzyme levels is nearly always statistically significant and would generally be viewed as biologically significant.’’ (Id. at 37-38). The policy recommends that ‘‘[t]he biological significance of statistically- significant changes of less than 20% would have to be judged on a case-by- case basis, noting, in particular the

pattern of changes in the enzyme levels and the presence or absence of accompanying clinical signs and/or symptoms.’’ (Id. at 38). The policy notes that similar or higher levels of cholinesterase inhibition are used ‘‘in monitoring workers for occupational exposures (even in the absence of signs, symptoms, or other behavioral effects).’’ (Id. at 31). For example, the policy points out that the California Department of Health Services requires that workers exposed to toxic chemicals such as organophosphate pesticides be removed from the workplace if ‘‘red blood cell cholinesterase levels show 30% or greater inhibition,’’ and that the World Health Organization ‘‘has guidelines with the same RBC action levels (i.e., 30% or greater inhibition).’’ (Id.).

C. Endocrine Disruptor Screening Program

The 1996 FQPA and SWDA amendments directed EPA to develop and implement an endocrine screening program. To aid in the design of this program called for in the FQPA and SDWA amendments, EPA created the Endocrine Disruptor Screening and Testing Advisory Committee (‘‘EDSTAC’’), which was comprised of members representing the commercial chemical and pesticides industries, federal and state agencies, worker protection and labor organizations, environmental and public health groups, and research scientists. (63 FR 71542, 71544, Dec. 28, 1998). The EDSTAC presented a comprehensive report in August 1998 addressing both the scope and elements of the endocrine screening program. (Ref. 11). The EDSTAC’s recommendations were largely adopted by EPA.

As recommended by EDSTAC, EPA expanded the scope of the program from focusing only on estrogenic effects to include other effects on the endocrine system (i.e., androgenic and thyroid effects). (63 FR at 71545). Further, EPA, again on the EDSTAC’s recommendation, chose to include both human and ecological effects in the program. (Id.). Finally, based on EDSTAC’s recommendation, EPA established the universe of chemicals to be screened to include not just pesticides but also a wide range of other chemical substances. (Id.). As to the program elements, EPA adopted EDSTAC’s recommended two-tier approach with the first tier involving screening ‘‘to identify substances that have the potential to interact with the endocrine system’’ and the second tier involving testing ‘‘to determine whether the substance causes adverse effects,

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identify the adverse effects caused by the substance, and establish a quantitative relationship between the dose and the adverse effect.’’ (Id.). Tier 1 screening is limited to evaluating whether a substance is ‘‘capable of interacting with’’ the endocrine system, and is ‘‘not sufficient to determine whether a chemical substance may have an effect in humans that is similar to an effect produced by naturally occurring hormones.’’ (Id. at 71550). Based on the results of Tier 1 screening, EPA will decide whether Tier 2 testing is needed. Importantly, ‘‘[t]he outcome of Tier 2 is designed to be conclusive in relation to the outcome of Tier 1 and any other prior information. Thus, a negative outcome in Tier 2 will supersede a positive outcome in Tier 1.’’ (Id. at 71554-71555).

The EDSTAC provided detailed recommendations for Tier 1 screening and Tier 2 testing. The panel of the EDSTAC that devised these recommendations was comprised of distinguished scientists from academia, government, industry, and the environmental community. (Ref. 11 at Appendix B). As suggested by the EDSTAC, EPA has proposed a battery of short-term in vitro and in vivo assays for the Tier 1 screening exercise. (63 FR at 71550-71551). Validation of all but one of these assays is complete. As to Tier 2 testing, EPA, on the recommendation of the EDSTAC, has proposed using five longer-term reproduction studies that, with one exception, ‘‘are routinely performed for pesticides with widespread outdoor exposures that are expected to affect reproduction.’’ (Id. at 71555). EPA is examining, pursuant to the suggestion of the EDSTAC, modifications to these studies to enhance their ability to detect endocrine effects.

EPA has published a draft list of the first group of chemicals that will be tested under the Agency’s endocrine disruptor screening program. (72 FR 33486 (June 18, 2007)). The draft list was produced based solely on the exposure potential of the chemicals and EPA has emphasized that ‘‘[n]othing in the approach for generating the initial list provides a basis to infer that by simply being on this list these chemicals are suspected to interfere with the endocrine systems of humans or other species, and it would be inappropriate to do so.’’ (Id.)

D. EPA’s Human Research Rule EPA decisions regarding the ethics of

human studies are governed by the Protection for Subjects in Human Research final rule (‘‘Human Research rule’’), which significantly strengthened

and expanded protections for subjects of human research. (71 FR 6138 (February 6, 2006)). The framework of the Human Research rule rests on the basic principle that EPA will not, in its actions, rely on data derived from unethical research. The rule divides studies involving intentional dosing of human subjects into two groups: ‘‘new’’ studies - those initiated after April 7, 2006 (the effective date of the rule) - and ‘‘old’’ studies - those initiated before April 7, 2006. The Human Research Rule forbids EPA from relying on data from any ‘‘new’’ study, unless EPA has adequate information to determine that the research was conducted in substantial compliance with the ethical requirements contained therein. (40 CFR. 26.1705). These ethical rules are derived primarily from the ‘‘Common Rule,’’ (40 CFR part 26), a rule setting ethical parameters for studies conducted or supported by the federal government. In addition to requiring informed consent and protection of the safety of the subjects, among other things, the rule specifies that ‘‘[r]isks to subjects [must be] reasonable in relation to . . . the importance of the knowledge that may reasonably be expected to result [from the study].’’ (40 CFR 26.1111(a)(2)). In other words, a study would be judged unethical if it did not have scientific value outweighing any risks to the test subjects.

As to ‘‘old’’ studies, the Human Research Rule forbids EPA from relying on such data if there is clear and convincing evidence that the conduct of the research was fundamentally unethical or significantly deficient with respect to the ethical standards prevailing at the time the research was conducted. (40 CFR 26.1704). EPA has indicated that in evaluating ‘‘the ethical standards prevailing at the time the research was conducted’’ it will consider the Nuremburg Code, various editions of the Declaration of Helsinki, the Belmont Report, and the Common Rule, as among the standards that may be applicable to any particular study. (71 FR at 6161). Further, reflecting the concern that scientifically invalid data are ‘‘always unethical,’’ (71 FR at 6160), the rule limits the human research that can be relied upon by EPA to ‘‘scientifically valid and relevant data.’’ (40 CFR 26.1701).

Whether the data are ‘‘new’’ or ‘‘old,’’ the Human Research rule forbids EPA from relying on data from any study involving intentional exposure of pregnant women, fetuses, or children subject to a very limited exception. (40 CFR 26.1703, 1706).

To aid EPA in making scientific and ethical determinations under the

Human Research rule, the rule established an independent Human Studies Review Board (‘‘HSRB’’) to review both proposals for new research (‘‘new’’ studies) and reports of completed human research (‘‘old’’ studies) on which EPA proposes to rely. (40 CFR 26.1603). The rule directs that HSRB shall be comprised of non-EPA employees ‘‘who have expertise in fields appropriate for the scientific and ethical review of human research, including research ethics, biostatistics, and human toxicology.’’ (40 CFR 26.1603(a)). If EPA decides to rely on the results from ‘‘old’’ research conducted to identify or measure a toxic effect, EPA must submit the results of its assessment to the HSRB for evaluation of the ethical and scientific merit of the research. (40 CFR 26.1602(b)(2)).

EPA has established the HSRB as a federal advisory committee under the Federal Advisory Committee Act (‘‘FACA’’) to take advantage of ‘‘the benefits of the transparency and opportunities for public participation’’ that accompany a FACA committee. (71 FR at 6156). The HSRB, as appointed by EPA, contains approximately 16 distinguished experts in the fields of bioethics, biostatistics, human health risk assessment and human toxicology, primarily from academia. (Ref. 12).

NRDC and other parties have challenged the legality of the Human Research rule. (NRDC v. U.S. EPA, No. 06-0820-ag (2d Cir.)). A decision on this challenge is presently pending before the United States Court of Appeals for the Second Circuit.

IV. Regulatory History of DDVP

A. In General

1. DDVP use. Dichlorvos (2, 2- dichlorovinyl dimethyl phosphate), also known as DDVP, is an insecticide used in controlling flies, mosquitoes, gnats, cockroaches, fleas, and other insect pests. (Ref. 3). DDVP is registered for use on agricultural sites; commercial, institutional, and industrial sites; and for domestic use in and around homes. Agricultural and other commercial uses include in greenhouses; mushroom houses; storage areas for bulk, packaged and bagged raw and processed agricultural commodities; food manufacturing/processing plants; animal premises; and non-food areas of food-handling establishments. It is also registered for treatment of cattle, poultry and swine. DDVP is not registered for direct use on any field grown commodities. Currently, there are 27 tolerances listed in 40 CFR 180.235 for DDVP on agricultural (food and feed) crops and animal commodities. DDVP is

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applied with aerosols, fogging equipment, and spray equipment, and through use of impregnated materials such as resin strips which result in slow release of the pesticide. The current registrant for the technical active ingredient, DDVP, is Amvac Chemical Corporation (‘‘Amvac’’).

2. DDVP risks. The following information on the assessment of the risks posed by DDVP is drawn from EPA’s decision on the reassessment of DDVP tolerances and its response to NRDC’s petition.

DDVP is a chlorinated organophosphate pesticide which inhibits plasma, RBC, and brain cholinesterase in a variety of species. (Ref. 3 at 122-123). Subchronic and chronic oral DDVP exposures to rats and dogs as well as chronic inhalation DDVP exposure to rats resulted in significant decreases in plasma, RBC and/or brain cholinesterase activity. However, DDVP does not cause delayed neurotoxicity in the hen. Repeated, oral subchronic DDVP exposures in male humans were associated with statistically and biologically significant decreases in RBC cholinesterase inhibition. There was no evidence of increased susceptibility to young animals following in utero DDVP exposure to rat and rabbit fetuses as well as pre/post natal DDVP exposure to rats in developmental, reproduction, and comparative cholinesterase studies. Evidence of sensitivity in the young was seen in one parameter, auditory startle amplitude, in a developmental neurotoxicity study; however, the effects in the rat pups here was at levels well above levels which result in RBC cholinesterase inhibition. Cancer studies with DDVP provide suggestive evidence of DDVP’s potential human carcinogenicity; however, following the advice of numerous independent scientific panels, EPA has determined that DDVP poses a negligible cancer risk to humans due to the lack of relevance to humans of the tumors identified in the DDVP cancer studies. (72 FR at 68671-68673).

Inhibition of cholinesterase activity was the toxicity endpoint selected to assess hazards for all acute and chronic dietary exposures, as well as short-, intermediate-, and long-term (chronic) dermal, inhalation, and incidental oral residential exposures. Doses selected for the Point of Departure in determining the level of concern - i.e., RfD/PADs and acceptable MOEs - were based on both human and animal studies. (Ref. 3 at 130-135). Animal studies were used in choosing levels of concern for evaluating risk from acute and chronic dietary exposure; acute dermal exposure; and acute and chronic

inhalation exposure. A human study was used evaluating risk from short- term incidental oral exposure; short-, intermediate-, and long-term dermal exposure; and short- and intermediate- term inhalation exposure.

Safety factor determinations used in selecting the level of concern differed based on whether EPA relied on one of several different animal studies or a human study. For levels of concerns derived from a Point of Departure from an animal study, EPA generally applied a 100X safety factor (10X for inter- species variability and 10X for intra- human variability). EPA removed the 10X children’s safety factor for risk assessments based on an animal study. For levels of concerns derived from a Point of Departure from the human study, EPA applied a 10X safety factor for intra-human variability and a 3X children’s safety factor. (Id.).

EPA based its decision to remove the children’s safety factor when relying on animal data on its conclusions that (1) the toxicity database was complete; (2) most of the data indicated no sensitivity in the young and the only evidence of sensitivity occurred at levels well above the Points of Departure used for establishing the levels of concern; and (3) its estimate of human exposure to DDVP was not understated. EPA retained a portion of the children’s safety factor when relying on the human study because that study did not determine a NOAEL. EPA concluded, however, that reliable data supported reduction of the 10X factor because the effect seen at the LOAEL in that study was so marginal that a lower dose would have been unlikely to detect any adverse effect. (72 FR 68694-68695).

EPA has estimated exposure to DDVP taking into account the potential for DDVP residues in food, drinking water, and in the home as the result of the use of DDVP pest strips. DDVP exposure may result not only from use of DDVP but use of two closely-related pesticides, naled and trichlorfon, which metabolize or degrade to DDVP in food, water, or the environment. In assessing the risks of DDVP, EPA has taken into account exposure to DDVP resulting from use of all three of these pesticides. (Ref. 3 at 147-149). Additionally, DDVP, naled, and trichlorfon are within a family of pesticides known as the organophosphates. EPA has classified the organophosphate pesticides and their common cholinesterase-inhibiting degradates as having a common mechanism of toxicity. Thus, in addition to assessing the risks posed by exposure to organophosphate pesticides individually, EPA has assessed the potential cumulative effects from

concurrent exposure to organophosphate pesticides. (Ref. 13).

As discussed in Unit IV.B.1. below, taking all of the above information into account, EPA concluded that the tolerances for DDVP were safe.

B. FFDCA Tolerance Reassessment and FIFRA Pesticide Reregistration

1. In general. As required by the FQPA of 1996, EPA reassessed the safety of the DDVP tolerances under the new safety standard established in the FQPA. EPA released for comment a preliminary risk assessment for DDVP in October, 2000. (65 FR 60430 (October 11, 2000)). Subsequently, after consideration of public comment, EPA, on June 30, 2006, issued an Interim Reregistration Eligibility Document (‘‘IRED’’) for DDVP. In that document, EPA determined that aggregate exposure to DDVP as a result of use of DDVP, naled, and trichlorfon, complied with the FQPA safety standard. (Ref. 3 ). Separately, on July 31, 2006, EPA determined that cumulative ffects from exposure to all organophosphate residues were safe. (Ref. 14). In combination, these findings satisfied EPA’s obligation to review the DDVP tolerances under the new safety standard.

As a result of the FIFRA reregistration and FFDCA tolerance reassessment process there were numerous changes made to DDVP’s registration that affect non-occupational exposure to DDVP. Specifically, on May 9, 2006, EPA received from Amvac, the only registrant of DDVP as a product for manufacturing end-use DDVP products, an irrevocable request to cancel certain uses and include additional pest strip label restrictions on the DDVP active ingredient product labels. Pursuant to section 6(f) of FIFRA, on June 30, 2006, the Agency published a notice in the Federal Register that it had received the request and sought comment on EPA’s intention to grant the request and cancel the specified uses. (71 FR 37570 (June 30, 2006)). On October 20, 2006, EPA issued the final cancellation order. (71 FR 61968 (October 20, 2006)).

The added restrictions on the use of the pest strip products were approved on October 11, 2006, and provided, among other things, that large pest strips could no longer be used in homes except for garages, attics, crawl spaces, and sheds that are occupied for less than 4 hours per day. The only pest strips permitted for use in occupied areas inside the home were significantly smaller strips for use in closets, wardrobes, or cupboards. Additionally, in early March, 2007, Amvac requested the voluntary cancellation of all its pet

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collar and bait registrations and deletion of those uses from its technical label. Pursuant to section 6(f) of FIFRA, Amvac’s requests to cancel the pet collar and bait registrations as well as deleting such uses from the technical label were published in the Federal Register on March 23, 2007. (72 FR 13786 (March 23, 2007)). On June 27, 2007, EPA issued the final cancellation notice for the pet collar and bait registrations. (72 FR 35235 (June 27, 2007)).

Cancellation of uses and label restrictions imposed on Amvac’s registration apply to all formulated DDVP end-use products because it is unlawful to use a pesticide in a manner inconsistent with its label. (7 U.S.C. 136(ee)). This bar on use inconsistent with the label applies to the formulation of end-use pesticide products from manufacturing use products. Accordingly, because Amvac holds the only registration for a DDVP manufacturing use product, the removal of uses and the addition of restrictions with respect to Amvac’s manufacturing use product label has the effect of imposing those use cancellations and label restrictions on all DDVP end-use products.

2. Review of human study. Completion of the DDVP IRED was delayed, in part, by questions regarding whether it was appropriate for EPA to rely on several human toxicity studies conducted with DDVP which were submitted by Amvac. The study receiving principal attention was a study involving repeated dosing over several days conducted in 1997 by A.J. Gledhill. (Refs. 3 at 133; and 15). That study is identified by the Master Record Identification (‘‘MRID’’) number of 44248801. Amvac also cited approximately a dozen other human studies, several of which were also conducted by Gledhill. (Ref. 16).

Following promulgation of the Human Research rule, EPA evaluated whether the human data submitted by Amvac complied with the rule, and, pursuant to the rule’s requirements, presented these data and its recommendations to the Human Studies Review Board (‘‘HSRB’’) for review. On March 9, 2006, the HSRB published a notice in the Federal Register announcing that a public meeting would be held to consider the DDVP studies as well as human studies for several other pesticides. (71 FR 12194 (March 9, 2006)). The meeting was scheduled for April 4-6, 2006. The notice alerted the public of the opportunity to file both written comments with the HSRB and to make oral comments at the April meeting. The members of the HSRB at

the time of this meeting are listed in Appendix 1.

NRDC filed written comments with the HSRB concerning DDVP, (Ref. 17), and also presented oral testimony at the public meeting. (Ref. 18). NRDC’s comments and oral remarks specifically focused on whether the Gledhill study had sufficient statistical power ‘‘to detect an effect when it may occur’’ and the fact that the Gledhill study only used healthy, male test subjects. (Ref. 7 at 13). Other subjects discussed at the meeting included the relative strengths and weaknesses of the Gledhill study such as its repeat dosing regime, the failure to test blood plasma cholinesterase, the failure to monitor subjects after testing, and the study’s consent form. (Id.; Ref. 18 at 18, 20-23). On May 23, 2006, the HSRB published a notice in the Federal Register alerting the public that it had released a draft report (dated May 16, 2006) and would be holding a public teleconference meeting on June 6, 2006 to discuss its draft report. (71 FR 29624 (May 23, 2006)). The notice included instructions on how members of the public could participate in the teleconference and explained the procedure for providing oral and written comments. (Ref. 19). NRDC did not file comments on the draft report. (Ref. 20).

On June 26, 2006, the HSRB issued its finding that reliance on the Gledhill human study was appropriate given that the study had scientific value and there was no clear and convincing evidence that the study was fundamentally unethical. (Ref. 21). The HSRB concluded that the other DDVP human studies should not be used in the DDVP risk assessment. These findings were unchanged from its May 16, 2006 draft report.

EPA agreed with the findings of the HSRB and relied upon the HSRB’s reasoning in using the Gledhill study in its DDVP risk assessment. (72 FR at 68675).

V. NRDC Petition Regarding DDVP On June 2, 2006, the NRDC filed a

petition with EPA which, among other things, requested that EPA: (1) Conclude the DDVP Special Review by August 3, 2006, with a finding that DDVP causes unreasonable adverse effects on the environment; (2) conclude the DDVP FIFRA reregistration process by August 3, 2006, with a finding that DDVP is not eligible for reregistration; (3) submit draft notices of intent to cancel all DDVP registrations to the FIFRA Scientific Advisory Panel and USDA by August 3, 2006, and issue those notices 60 days thereafter; (4) conclude the DDVP tolerance reassessment process by

August 3, 2006, with a finding that the DDVP tolerances do not meet the FFDCA safety standard; and (5) issue a final rule by August 3, 2006, revoking all DDVP tolerances. (Ref. 2). Shortly after the petition was filed, on June 30, 2006, EPA released the IRED for DDVP which addressed DDVP’s eligibility for reregistration under FIFRA and assessed, in part, whether DDVP’s tolerances met the new safety standard enacted by the FQPA. NRDC submitted comments on the IRED and some of these comments bore on issues in its petition. (Ref. 3).

NRDC’s petition contained dozens of claims as to why DDVP’s registration under FIFRA should be canceled and its FFDCA tolerances revoked. These issues are not presented in detail here because many raised solely FIFRA concerns and NRDC has not pursued most of its tolerance-related claims in its objections and hearing requests.

EPA published notice of the petition for comment on October 11, 2006. (71 FR 59784 (October 11, 2006)). EPA received roughly 1,500 brief comments in support of the petition. These comments added no new information pertaining to whether the tolerances were in compliance with the FFDCA. Detailed comments in opposition to the petition were submitted by Amvac. (Ref. 22).

EPA responded to the petition in three separate documents: (1) It issued an order closing out the DDVP Special Review; (72 FR 72709 (December 21, 2007)); (2) it issued an order denying the request to cancel DDVP’s FIFRA registration (72 FR 68581(December 5, 2007)); and (3) it issued an order pursuant to FFDCA section 408(d)(4)(iii) denying the request to revoke DDVP’s FFDCA tolerances (78 FR 68662 (December 5, 2007). Today’s final order only concerns the objections filed to the section 408(d)(4)(iii) order denying the request to revoke tolerances.

VI. EPA Response to the Petition to Revoke DDVP Tolerances

EPA issued a section 408(d)(4)(iii) order responding to the petition’s request to revoke DDVP tolerances on December 5, 2007 (hereinafter referred to as EPA’s ‘‘petition response’’ or ‘‘petition denial order’’). (72 FR 68662 (December 5, 2005). That order denied the petition finding that none of the grounds asserted by NRDC demonstrated that the DDVP tolerances should be revoked. Nonetheless, EPA did conclude that NRDC raised several pertinent concerns with EPA’s assessment of the risks posed by DDVP.

To respond to NRDC’s concerns, EPA completely revamped both its dietary

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and residential risk assessments. In its new risk assessments, EPA included updated information on residue levels of DDVP in food, the amount of usage of DDVP and related pesticides in agriculture, and food consumption patterns of infants and children. EPA also adopted modified and more conservative assumptions regarding exposure patterns to DDVP in residential settings and exposure to DDVP from naled’s use to control mosquitoes. Because, however, EPA concluded that the revised risk assessments still showed that the DDVP tolerances are safe, EPA denied NRDC’s petition.

EPA’s specific responses to the claims in the petition that are relevant to NRDC’s objections are summarized in the portion of this order responding to the objections and hearing requests.

VII. NRDC’s Objections and Requests for Hearing

On February 1, 2008, NRDC filed, pursuant to FFDCA section 408(g)(2), objections to EPA’s denial of its tolerance revocation petition and requested a hearing on those objections. As indicated above, NRDC’s objections and requests for hearing raise two main claims: (1) that EPA has unlawfully failed to retain the full 10X safety factor for the protection of infants and children; and (2) that it was unlawful for EPA to rely on a toxicity study for DDVP that was conducted with humans.

NRDC cites three grounds for its assertion that EPA unlawfully lowered the 10X children’s safety factor: (1) that EPA lacked adequate data on DDVP’s potential effects on the endocrine system; (2) that EPA lacked adequate data on several matters related to assessing dietary exposure to DDVP residues in food; and (3) that EPA has inadequate data on exposure to DDVP from its use in residential pest strips. As to the DDVP human study, NRDC claimed that EPA’s regulation concerning use of human studies is unlawful and that the study is scientifically flawed and ethically compromised. In analyzing NRDC’s claims, EPA has broken NRDC’s two main claims down into 19 separate sub- issues. Each sub-issue is described in detail and responded to separately in Unit VIII.

In support of its request for hearing, NRDC proffered the following documents as evidence that a hearing would be appropriate:

(1) the Interim Reregistration Eligibility Determination for DDVP; (2) the entire record for the IRED and the documents referenced and cited therein; (3) NRDC’s comments on the IRED; (4) EPA’s petition denial and the

references cited in that denial; (5) NRDC’s petition and all references cited in the petition; and (6) the arguments, citations, and attachments contained in these objections.

(Ref. 1 at 3) (citations and references to attachments omitted).

VIII. Response to Objections and Requests for Hearing

A. Overview

EPA denies each of NRDC’s objections as well as its hearing requests. NRDC’s hearing requests fail to meet the statutory and regulatory requirements for holding a hearing. NRDC has failed to proffer evidence on its hearing requests which would, if established, resolve one or more issues in its favor. Rather, NRDC relies on mere allegations and general denials and contentions. Further, many of NRDC’s claims do not present genuine and substantial issues of fact and/or are immaterial to the relief requested. On the merits, NRDC’s objections are denied for substantially the same reasons given in EPA’s petition denial order. NRDC’s objections largely restate the claims in its petition. Significantly, NRDC does not acknowledge or respond to the substantial revisions to the DDVP dietary and residential risk assessments made in response to the NRDC petition. Similarly, NRDC does not acknowledge or respond to EPA’s detailed summary of why it adopted the conclusion by the independent HSRB that the Gledhill human study complied with EPA’s Human Research rule.

The remainder of this Unit is organized in the following manner. Unit VIII.B. describes in greater detail the requirements pertaining to when it is appropriate to grant a hearing request. Unit VIII.C. examines the evidence proffered by NRDC in support of its hearing requests. Units VIII.D. and E. provide EPA’s response to the NRDC’s objections and hearing requests. Unit VIII.D. addresses NRDC’s claims regarding the children’s safety factor and subunit E addresses NRDC’s arguments concerning reliance on the Gledhill human study. EPA’s conclusions on the hearing requests and objections are summarized in Units VIII.F. and G., respectively.

EPA has adopted a 4-part format in Units VIII.D. and E. for explaining its ruling on each of the 19 sub-issues EPA identified in the objections. First, NRDC’s claim and any arguments or evidence tendered to support that claim are described. Second, background information on the claim is provided including whether and how the claim was presented in NRDC’s petition and, if it was presented, EPA’s reasons for

denying the claim in its earlier petition denial order. Third, EPA explains its reasons for denying a hearing on that claim. Finally, EPA explains its reasons for denying the claim on the merits.

B. The Standard for Granting an Evidentiary Hearing

EPA has established regulations governing objections to tolerance rulemakings and tolerance petition denials and requests for hearings on those objections. (40 CFR Part 178; 55 FR 50291 (December 5, 1990)). Those regulations prescribe both the form and content of hearing requests and the standard under which EPA is to evaluate requests for an evidentiary hearing.

As to the form and content of a hearing request, the regulations specify that a hearing request must include: (1) a statement of the factual issues on which a hearing is requested and the requestor’s contentions on those issues; (2) a copy of any report, article, or other written document ‘‘upon which the objector relies to justify an evidentiary hearing;’’ and (3) a summary of any other evidence relied upon to justify a hearing. (40 CFR 178.27).

The standard for granting a hearing request is set forth in section 178.32. That section provides that a hearing will be granted if EPA determines that the ‘‘material submitted’’ shows all of the following: (1) There is a genuine and substantial issue of fact for resolution at a hearing. An evidentiary hearing will not be granted on issues of policy or law. (2) There is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one or more of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary. An evidentiary hearing will not be granted on the basis of mere allegations, denials, or general descriptions of positions and contentions, nor if the Administrator concludes that the data and information submitted, even if accurate, would be insufficient to justify the factual determination urged. (3) Resolution of the factual issue(s) in the manner sought by the person requesting the hearing would be adequate to justify the action requested. An evidentiary hearing will not be granted on factual issues that are not determinative with respect to the action requested. For example, a hearing will not be granted if the Administrator concludes that the action would be the same even if the factual issue were resolved in the manner sought.

(40 CFR 178.32(b)). This provision essentially imposes

four requirements upon a hearing requestor. First, the requestor must show it is raising a question of fact, not

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one of law or policy. Hearings are for resolving factual issues not for debating law or policy questions. Second, the requestor must demonstrate that there is a genuine dispute as to the issue of fact. If the facts are undisputed or the record is clear that no genuine dispute exists, there is no need for a hearing. Third, the requestor must show that the disputed factual question is material - i.e., that it is outcome determinative with regard to the relief requested in the objections. Finally, the requestor must make a sufficient evidentiary proffer to demonstrate that there is a reasonable possibility that the issue could be resolved in favor of the requestor. Hearings are for the purpose of providing objectors with an opportunity to present evidence supporting their objections; as the regulation states, hearings will not be granted on the basis of ‘‘mere allegations, denials, or general descriptions of positions or contentions.’’ (40 CFR 178.32(b)(2)).

EPA’s hearing request requirements are based heavily on FDA regulations establishing similar requirements for hearing requests filed under other provisions of the FFDCA. (53 FR 41126, 41129 (October 19, 1988)). FDA pioneered the use of summary judgment-type procedures to limit hearings to disputed material factual issues and thereby conserve agency resources. FDA’s use of such procedures was upheld by the Supreme Court in 1972, (Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609 (1973)), and, in 1975, FDA promulgated generic regulations establishing the standard for evaluating hearing requests. (40 FR 22950 (May 27, 1975)). It is these regulations upon which EPA relied in promulgating its hearing regulations in 1990.

Unlike EPA, FDA has had numerous occasions to apply its regulations on hearing requests. FDA’s summary of the thrust of its regulations, which has been repeatedly published in the Federal Register in orders ruling on hearing requests over the last 24 years, is instructive on the proper interpretation of the regulatory requirements. That summary states:

A party seeking a hearing is required to meet a ‘threshold burden of tendering evidence suggesting the need for a hearing.’ [] An allegation that a hearing is necessary to ‘sharpen the issues’ or ‘fully develop the facts’ does not meet this test. If a hearing request fails to identify any evidence that would be the subject of a hearing, there is no point in holding one.

A hearing request must not only contain evidence, but that evidence should raise a material issue of fact concerning which a meaningful hearing might be held. [] FDA need not grant a hearing in each case where

an objection submits additional information or posits a novel interpretation of existing information. [] Stated another way, a hearing is justified only if the objections are made in good faith and if they ‘‘draw in question in a material way the underpinnings of the regulation at issue.’’ Finally, courts have uniformly recognized that a hearing need not be held to resolve questions of law or policy.

(49 FR 6672, 6673 (February 22, 1984); 72 FR 39557, 39558 (July 19, 2007) (citations omitted)). EPA has been guided by FDA’s application of its regulations in this proceeding.

Congress confirmed EPA’s authority to use summary judgment-type procedures with hearing requests when it amended FFDCA section 408 in 1996. Although the statute had been silent on this issue previously, the FQPA added language specifying that when a hearing is requested, EPA ‘‘shall . . . hold a public evidentiary hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections.’’ (21 U.S.C. 346a(g)(2)(B)). This language grants EPA broad discretion to determine whether a hearing is ‘‘necessary to receive factual evidence’’ to objections.

C. Evidentiary Proffer by NRDC

As noted above, the purpose for holding hearings is ‘‘to receive factual evidence.’’ (U.S.C. 346a(g)(2)(B); 53 FR 41126, 41129 (‘‘Hearings are for the purpose of gathering evidence on disputed factual issues . . . .’’)). A requestor must identify evidence relied upon to justify a hearing and either submit copies of that evidence or summarize it. (40 CFR 178.27). After reviewing the proffer, EPA must find that there is a reasonable possibility that the proffered evidence, if established, would resolve one or more genuinely- disputed, material factual issues in a requestor’s favor. (40 CFR 178.32(b)). Because a substantial portion of NRDC’s evidentiary proffer is deficient on its face, EPA finds it most efficient to preliminarily review the proffer before turning to the individual issues raised by NRDC.

As previously mentioned, NRDC proffered the following items as evidence supporting its requests for hearing:

(1) the Interim Reregistration Eligibility Determination for DDVP; (2) the entire record for the IRED and the documents referenced and cited therein; (3) NRDC’s comments on the IRED; (4) EPA’s petition denial and the references cited in that denial; (5) NRDC’s petition and all references cited in the petition; and (6) the arguments, citations, and attachments contained in these objections.

(Ref. 1 at 3). These items can be divided into two groups: (1) items produced or assembled by EPA (the IRED; the IRED record; and EPA’s petition denial); and (2) items produced by NRDC (NRDC’s comments on the IRED; NRDC’s petition; and NRDC’s objections).

The items in the first group - the EPA documents - clearly do not constitute a proper proffer. Essentially, this is a non- specific identification of every document and piece of data EPA has considered and relied upon in the multi-year process of conducting the FIFRA reregistration and FFDCA tolerance reassessment for DDVP and in responding to NRDC’s DDVP petition. This could easily encompass hundreds, if not thousands of documents, and tens of thousands of pages of analysis and data. EPA’s petition response alone cited 82 documents and those documents generally were EPA analytical papers and not the underlying data. EPA concludes that NRDC’s citation to the thousands of pages in the IRED, the IRED record, and the petition denial is so vague a proffer as to not constitute a proffer at all. It would be as if a lawyer, in responding to a court’s request for case law authority for a principle he or she was defending, cited the court to West’s Federal Reporter, 3rd Series. While somewhere in those hundreds of volumes a case may exist that supports the asserted principle, the lawyer cannot be said to have identified it by a vague wave at a substantial portion of the law library. Further, given that the purpose of a hearing is to gather or receive evidence, proffering evidence already considered and relied upon by EPA would not seem to be grounds for holding a hearing. Finally, as a matter of law, EPA does not understand how it can be argued that a proffer consisting of a general reference to a record of decision which EPA has found supported one result could constitute evidence that if established, would justify the opposite conclusion. At bottom, the proffer of the items in the first group fails to ‘‘identify’’ evidence which would, if established, resolve an issue in NRDC’s favor.

NRDC’s second group of documents consists of NRDC’s comments on the IRED; NRDC’s petition; and NRDC’s objections. In analyzing this proffer, EPA has focused on NRDC’s objections because the objections appear to contain, almost word-for-word, the arguments and claims put forward in its petition and IRED comments with regard to the children’s safety factor and reliance on human studies. The objections reference 16 documents. For the reasons explained below, 10 of these documents can be rejected on their face

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as not justifying a hearing. Four of the documents, however, potentially include factual evidence supporting a hearing and are analyzed more thoroughly in connection with the specific issue in the hearing request to which they are tied. The other two documents that are referenced are NRDC’s DDVP petition and NRDC’s comments on the DDVP IRED. As described above, these documents do not add anything beyond what is in the objections.

1. Documents that clearly do not proffer evidence of a genuinely- disputed, material issue of fact. (10 items)

• Five Newspaper Stories. NRDC cites to an Associated Press story from 2002 and four Los Angeles Times stories from 2007. These news stories contain basic background information about DDVP; general contentions from Amvac, NRDC, and EPA regarding the safety of DDVP; and no more than a cursory, passing reference to any of the issues raised in the petition. There can be no serious contention that these articles present evidence justifying a hearing.

• NRDC comments to HSRB. NRDC references the comments it submitted to the HSRB with regard to the HSRB’s review of the human studies conducted with DDVP. The comments - three pages of bulleted talking points and one graph - are a summary of the slightly more detailed arguments contained in NRDC’s objections. This document adds no justification for a hearing not otherwise included in NRDC’s objections.

2. Legal Briefs in NRDC v. EPA, No. 06-0820-ag (2d Cir.). NRDC cites to its opening and reply briefs in NRDC v. EPA, the case adjudicating NRDC’s challenge to EPA’s Human Research rule. These briefs contain legal arguments regarding the lawfulness of the Human Research rule. They contain no factual evidence justifying NRDC’s DDVP hearing requests.

• Three Law Review Articles. NRDC references: (1) a short article by a NRDC attorney summarizing his legal objections to EPA’s Human Research rule; (2) an article concerning EPA’s implementation of the FQPA; and (3) an article focusing on how tort law might be used to supplement the FQPA to protect children. None of these articles mention DDVP and no serious contention can be made that they provide factual evidence justifying a hearing.

3. Documents which may present evidence of a genuinely-disputed, material issue of fact. (4 items)

• Lockwood Articles. NRDC cites two articles by Dr. Alan Lockwood which discuss science and ethical issues with

regard to several human intentional dosing studies involving pesticides. Several of the human studies addressed were DDVP studies, one of which is the Gledhill human study that is the focus of this proceeding. Whether the information presented in these articles supports NRDC’s hearing requests is examined in Unit VIII.E.3.a.

• Sass Letters. NRDC cites two letters published in the journal Environmental Health Perspectives co-authored by Dr. Jennifer Sass of NRDC. These letters discuss science and ethical issues with regard to two human studies, including the DDVP human study in question in this proceeding. Whether the information presented in these letters supports NRDC’s hearing requests is examined in Unit VIII.E.3.a.

D. Response to Specific Issues Raised in Objections and Hearing Requests - Children’s Safety Factor

1. Failure to support children’s safety factor decision with DDVP-specific data— a. Objection/hearing request sub- issue. NRDC asserts that EPA, in choosing a 3X children’s safety factor for DDVP, did not rely on reliable data showing that such a factor was safe for infants and children because EPA’s choice of 3X ‘‘is not based on any data specific to DDVP.’’ (Ref. 1 at 5). NRDC’s argument is that EPA erred by not deriving a precise safety factor for DDVP but instead used a value that EPA considered to be half of the 10X safety factor. NRDC claims that ‘‘EPA could not have determined that ‘such margin’ [i.e., 3X] will be safe, when the replacement safety factor is simply a generic stand-in for EPA’s conclusion that ‘something less than 10X’ is enough.’’ (Id.). According to NRDC, EPA should have explained ‘‘what reliable data supports a 3X safety factor in particular, as opposed to 4X or some other number, for DDVP specifically.’’ (Id.).

b. Background. Similar assertions were made in NRDC’s petition and its IRED comments. For example, the petition claimed that ‘‘[t]he Agency did not explain why it chose 3X as opposed to 4X or any other factor,’’ (Ref. 2 at 14), and the IRED comments asserted that there was a ‘‘complete lack of explanation’’ for EPA’s safety factor decisions. (Ref. 23 at 5). Both documents also alleged there were inadequacies in the toxicity and exposure databases. (Refs. 2 at 15, and 38-41; and 23 at 8-9).

In response to these claims by NRDC, EPA, in the petition response, comprehensively restated its reasoning for its decisions on the children’s safety factor for DDVP in the IRED. (72 FR at

68694-68695). EPA noted that it had a complete toxicity database for DDVP and it carefully reviewed the evidence regarding the sensitivity of the young to DDVP and explained why an additional safety factor was not needed to protect infants and children. Further, EPA detailed why it had concluded that its exposure assessments would not understate human exposure to DDVP.

For some DDVP risk assessments EPA chose to remove the children’s safety factor entirely, and for others EPA reduced the safety factor to 3X. EPA explained that it retained a 3X children’s safety for certain assessments because the toxicity study which was relied upon in conducting those risk assessments had not identified a ‘‘no adverse effect level’’ (‘‘NOAEL’’) in its subjects but rather only a ‘‘lowest adverse effect level’’ (‘‘LOAEL’’). Despite the failure to identify a NOAEL in the study, EPA concluded that ‘‘a 3X factor’’ would be more than adequate to identify a NOAEL based upon the slight adverse effect (marginal RBC cholinesterase inhibition in a human study) observed at the LOAEL.’’ (72 FR at 68695). EPA noted that an independent science review board had confirmed that lower doses were unlikely to produce a measurable effect. Finally, EPA explained why it chose 3X instead of 4X or some other value. (Id.). The petition response noted that ‘‘where the data does not warrant a full 10X, EPA generally does not attempt to mathematically derive a precise replacement safety factor because regulatory agencies’ traditional use of 10X safety factors (upon which the FQPA safety factor was modeled) was based on rough estimates rather than detailed calculations. Instead, where a 10X factor would clearly overstate the uncertainty, EPA simply applies a factor valued at half of 10X.’’ (Id.). EPA explained that it considers 3X to be half of 10X assuming a lognormal distribution of effects. (Id.).

c. Denial of hearing request. In analyzing whether a hearing would be appropriate on this sub-issue, it is helpful to break the sub-issue down into three separate, but related, questions: (1) Whether EPA, in selecting a children’s safety factor lower than 10X, is required to justify with precision why it chose one factor over another; (2) whether EPA offered a justification for the children’s safety factor it chose; and (3) whether EPA relied upon DDVP specific information in choosing a safety factor or instead relied upon ‘‘generic assertions.’’ When broken down in this way, it is clear that none of these questions meets the standard for a hearing.

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The first question is a pure question of law - does FFDCA section 408(c) require EPA to offer a reasoned explanation for its choice of a children’s safety factor, including an explanation as to why a different factor is not needed. A question of fact, not of law, is required to justify a hearing. (40 CFR 178.32(b)(1)).The second and third questions fail to present a matter of genuinely-disputed facts because it is plain on the record that EPA did offer a reasoned justification for its decision and, in that justification, relied upon DDVP-specific facts. EPA’s petition response to NRDC’s 10X arguments laid out in careful detail information regarding the extent of the toxicity and exposure database on DDVP and the data bearing on DDVP’s effects on young animals. (72 FR at 68694-68695 (discussing the completeness of the DDVP toxicity database, DDVP studies bearing on pre- and post-natal toxicity, and the basis for DDVP exposure estimates)). Further, NRDC proffers no evidence - because there is none to proffer - suggesting that EPA did not consider DDVP-specific information in making its children’s safety factor decision. Therefore, this question does not meet the standard for a hearing both because there are no genuinely-disputed facts and NRDC has proffered no evidence which, if established, could resolve this issue in its favor. 57 FR 6667, 6672 (February 27, 1992) (‘‘A hearing must be based on reliable evidence, not on mere allegations or on information that is inaccurate and contradicted by the record.’’)

d. Denial of objection. EPA agrees with NRDC that general principles of administrative law require it to provide a reasoned explanation for its decision on selection of a children’s safety factor. (Baltimore Gas & Electric Co. v. NRDC, 462 U.S. 87, 103 (1983)). EPA disagrees with NRDC, however, to the extent it is suggesting that as part of this reasoned explanation for its selection of a children’s safety factor, EPA must show why it did not choose some other mathematical value. Rather, the statute imposes upon EPA, if it decides to vary from the presumptive 10X children’s safety factor, the burden to show that any ‘‘different’’ safety factor is safe. Once EPA has made that showing, its obligation to offer a reasoned explanation is complete. Because EPA offered a reasoned explanation as to why the children’s safety factors it chose protect the safety of infants and children, (72 FR 68694-68695), EPA denies NRDC’s objection on this point.

As to the substance of EPA’s explanation of why it chose a 3X safety factor for certain DDVP risk

assessments, NRDC claims that EPA erred because its choice of 3X is based on ‘‘a generic assertion not [] on any data specific to DDVP.’’ (Ref. 1 at 5). NRDC is wrong. The generic assertion NRDC mentions is EPA’s explanation of why 3X is half of 10X. EPA’s choice of 3X, however, is not based on its conclusion that 3X is half of 10X but on the data in the DDVP human study at issue. As noted above, the petition response explained in detail that a full 10X safety factor was not needed to address the uncertainty raised by the failure of the DDVP human study to identify a NOAEL. The effects seen in that study at the LOAEL were only marginally adverse at best, and therefore, EPA concluded that applying the full 10X safety factor (i.e., dividing the LOAEL by another factor of 10X in addition to the 10X factor for intra- human variability) was more than was needed to address the lack of a NOAEL. The HSRB confirmed as much when it wrote: ‘‘because the decreased activity in RBC cholinesterase activity observed in this study was at or near the limit of what could be distinguished from baseline values, it was unlikely that a lower dose would produce a measurable effect in RBC cholinesterase activity.’’ (Ref. 21 at 41).

EPA chose a safety factor of 3X for DDVP based on its conclusion that not only was 10X overprotective but that 3X would be protective given the results seen in the relevant DDVP study. (72 FR at 68695). As EPA concluded in the petition denial order: ‘‘a 3X safety factor would be more than adequate to identify a NOAEL based upon the slight adverse effect (marginal RBC cholinesterase inhibition in a human study) observed at the LOAEL.’’ (Id.). Generally, EPA uses a 3X safety factor as the default value when reducing a 10X safety factor. (Refs. 5 at 9-10, 26; and 24 at 4-40 - 4- 41; ). A safety factor of 3X is deemed to be approximately half the value of a safety factor of an order of magnitude (10X). As EPA explained in the petition denial order:

In choosing a safety factor in circumstances where the data does not warrant a full 10X, EPA generally does not attempt to mathematically derive a precise replacement safety factor because regulatory agencies’ traditional use of 10X safety factors (upon which the FQPA safety factor was modeled) was based on rough estimates rather than detailed calculations. Instead, where a 10X factor would clearly overstate the uncertainty, EPA simply applies a factor valued at half of 10X. In determining half of a 10X factor, EPA assumes that the distribution of effects within the range of a safety factor is distributed lognormally (which is generally the case for biological effects), and reduction of a lognormal

distribution by half is equal to half a log (10-5) or approximately 3X. A lognormal distribution is a distribution which if plotted based on the logarithm of each of its values would yield a bell-shaped (normal) distribution but if plotted according to actual values would be skewed having a clumping of values along the vertical axis of the plot.

(72 FR at 68695) (citations omitted). NRDC does not challenge EPA’s

reasoning regarding whether the choice of 3X is justified based on the results of a DDVP-specific study and thus, the merits of EPA’s DDVP-specific reasoning is not here at issue. Rather, NRDC denies that EPA engaged in DDVP-specific reasoning in choosing 3X. Because NRDC’s argument is contradicted on the face of the petition response, it is denied.

2. Endocrine effects. As described below, NRDC claims that EPA cannot remove the children’s safety factor because it has not completed the endocrine screening program for DDVP under section 408(p) and because EPA has inadequate endocrine data for DDVP. Although NRDC did argue in its petition that EPA cannot make a safety finding without completing the endocrine screening program, it did not assert claims regarding endocrine data and the children’s safety factor. EPA has previously ruled that a petitioner may not raise new issues in filing objections to EPA’s denial of its Original petition. (72 FR 39318, 39324 (July 18, 2007) (‘‘The FFDCA’s tolerance revocation procedures are not some sort of ‘game,’ whereby a party may petition to revoke a tolerance on one ground, and then, after the petition is denied, file objections to the denial based on an entirely new ground not relied upon by EPA in denying the petition.’’)). Accordingly, NRDC’s objections and hearing requests as to the children’s safety factor and endocrine data are denied.

Even if these claims were properly presented in these objections, for the reasons set forth below they neither entitle NRDC to a hearing nor justify the relief sought.

a. Endocrine disruptor screening program—i. Objection/hearing request sub-issue. NRDC argues that EPA must retain the 10X children’s safety factor because EPA has not fulfilled its obligations under FFDCA section 408(p) to screen pesticides, including DDVP, for endocrine disruption potential. (Ref. 1 at 5). Essentially, NRDC argues that EPA must retain the children’s safety factor for any pesticide until testing under the endocrine screening program is completed for that pesticide.

ii. Background. In its petition, NRDC claimed that failure to conduct the

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endocrine screening program for DDVP under section 408(p) made it impossible for EPA to conclude that the DDVP tolerances are safe. (Ref. 2 at 49). EPA responded to this argument by citing its denial of a petition to revoke various pesticide tolerances in which the claim was made that EPA could not remove the children’s safety factor if endocrine screening under section 408(p) had not been conducted. (72 FR at 68676). There, EPA concluded that the statute did not impose a mandatory bar upon removal of the children’s safety factor until completion of the endocrine screening program. (71 FR 43906, 43920 (August 2, 2006)). EPA also found in responding to the prior petition that it had sufficient data on endocrine screening for the pesticide in question to make a safety finding. (71 FR at 43920-43921). After analyzing the endocrine data for DDVP, EPA concluded that it had sufficient data to make a safety finding as to DDVP. (72 FR at 68676 - 68677).

iii. Denial of hearing request. The question of whether completion of the endocrine screening program under FFDCA section 408(p) is a mandatory prerequisite to removal of the children’s safety factor is a legal issue. A question of fact, not of law, is required to justify a hearing. (40 CFR 178.32(b)(1)).

iv. Denial of objection. In response to a prior pesticide tolerance revocation petition, and objections filed as to EPA’s denial of that petition, EPA has already rejected the legal claim presented in this objection. (71 FR at 43920; 72 FR 39318, 39327-39328 (July 18, 2007). After analyzing the statutory language, structure, and legislative history, EPA concluded that section 408(p) does not override the ‘‘clear and unmistakable language[] [in section 408(b)(2)(C)] grant[ing] EPA discretion to make a fact- based determination of whether a safety factor different than the 10X default value is safe for children.’’ (71 FR at 43920). EPA summarized its reasoning as follows: under section 408(b)(2)(C) EPA clearly has the discretion to determine, in any given case, whether it has reliable data to choose a factor different than the 10X default value. Not only is there no statutory language supporting the [petitioners’] argument in favor of automatic retention of the 10X until completion of the endocrine screening program but the legislative history is in no way supportive of construing the enactment of the program as intended to have such a dramatic impact. Further, since the enactment of the FQPA, EPA’s contemporaneous and consistent approach to the endocrine screening program has been to treat that information-gathering exercise as not imposing some type of statutorily- prescribed, automatic injunction barring

removal of the children’s safety factor until completion of information-gathering under the program.

(Id.). EPA also catalogued the extensive data requirements already in place for pesticides that produced information on a pesticide’s potential endocrine effects. (71 FR at 43920-43921). EPA concluded that ‘‘in many instances the totality of the information gleaned from current data required for pesticides used on food will make it possible to develop a meaningful weight-of-the-evidence determination on the potential of the pesticide to adversely affect the endocrine system.’’ (Id.).

NRDC has done nothing more than state in a conclusory fashion that completion of endocrine screening under section 408(p) is necessary to a decision to remove the children’s safety factor. Accordingly, EPA denies this objection for the reasons stated in its previous two orders addressing this claim. (71 FR at 43920 - 43921; 72 FR at 39327-39328).

b. DDVP endocrine data—i. Objection/hearing request sub-issue. In its objections, NRDC argues that EPA has inadequate data on endocrine effects to remove the children’s safety factor. As support for this argument NRDC asserts: (1) that the studies relied upon by EPA ‘‘were not designed to detect endocrine disruption . . . ;’’ and (2) that the two-generation rat reproduction study does not meet EPA’s 1998 guideline for such studies and, given that the reproduction study did show endocrine effects, a ‘‘[p]roper histopathology in the two generation rat reproduction study could have revealed adverse effects at lower levels than’’ the levels at which cholinesterase inhibition was seen in DDVP studies. (Ref. 1 at 6).

ii. Background. As noted above, NRDC’s petition argued that EPA could not make a safety finding for DDVP in the absence of data collected under the section 408(p) screening program. EPA responded to this claim by examining the data on DDVP bearing on its potential endocrine effects. EPA concluded that it could make a safety finding for DDVP in absence of further endocrine data given that: ‘‘(1) data bearing on potential endocrine effects from a two-generation reproduction study as well as other chronic data in which effects on reproductive organs were examined; (2) EPA well understands DDVP’s most sensitive mechanism of toxicity (cholinesterase inhibition); and (3) the potential endocrine-related effects seen for DDVP appeared in the presence of significant cholinesterase inhibition and at levels nearly two orders of magnitude above

the most sensitive cholinesterase effects. . . .’’ (72 FR at 68677).

iii. Denial of hearing request. A hearing on this sub-issue is not appropriate because NRDC’s request is based on mere allegations, general contentions, and speculation. NRDC claims that the studies EPA relied upon were not ‘‘designed’’ to investigate endocrine effects; however, NRDC proffers no evidence to support such an allegation. Further, such a claim has little, if any, materiality, given that the important question is not whether the studies were ‘‘designed’’ to measure endocrine effects but whether they actually measure such effects. Notably, NRDC does not, and cannot upon this record, make the latter contention. (See 72 FR at 68676 (discussing the numerous endocrine-related endpoints assessed in the DDVP database)). Further, NRDC’s claim that if the DDVP two-generation rat reproduction study had been conducted pursuant to the 1998 guidelines it might have shown endocrine effects at lower doses than the doses at which DDVP’s cholinesterase effects were seen is nothing more than speculation. In applying its hearing regulations, FDA has routinely denied hearings on speculation about what redoing a study might show. For example, in a proceeding establishing a food additive regulation for acesulfame potassium, FDA denied a hearing to an objector who challenged FDA’s rejection of a study for only containing partial histopathological data. (57 FR 6667 (February 27, 1992)). The objector had argued that full histopathological data might have altered FDA’s conclusion. FDA found such an argument unconvincing: ‘‘Because complete histopathological examination of tissues from all animals in the first rat study was not done and cannot be done now, any prediction of the results of such an examination is simply speculation. Speculation regarding data that do not exist cannot serve as the basis for a hearing.’’ (Id. at 6671). For all of the above reasons, the hearing request on this sub-issue is denied.

iv. Denial of objection. EPA denies NRDC’s objection that EPA does not have adequate endocrine data on DDVP to remove the children’s safety factor. First, NRDC is wrong to imply that existing, required toxicity studies do not provide valuable information on potential endocrine effects. EPA discussed this issue in detail in an earlier order involving similar claims concerning a different pesticide. There, EPA pointed out that:

The primary proposed Tier 2 study [for the Endocrine Disruptor Screening Program]

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relevant to endocrine effects on humans is the 2-generation reproductive toxicity study in rats. This is one of the core studies required for all food-use pesticides since 1984. In this reproduction study, potential hormonal effects can be detected through behavioral changes, ability to become pregnant, duration of gestation, signs of difficult or prolonged parturition, apparent sex ratio (as ascertained by anogenital distances) of the offspring, feminization or masculinization of offspring, number of pups, stillbirths, gross pathology and histopathology of the vagina, uterus, ovaries, testis, epididymis, seminal vesicles, prostate, and any other identified target organs. In fact, EPA, in 1998, in discussing this study’s use in Tier 2, identified 39 endpoints examined in this study relevant to estrogenic, androgenic, or thyroid effects. At that time, EPA noted that it was evaluating whether to add another 10 endocrine-related endpoints to the study protocol to enhance the utility of the study to detect endocrine effects. Despite the ongoing evaluation of additional endpoints, EPA has concluded that the existing 2-generation mammalian assay is valid for the identification and characterization of reproductive and developmental effects, including those due to endocrine disruption, based on the long history of its use, the endorsement of the 1998 test guideline by the FIFRA Scientific Advisory Panel, and acceptance by member countries of the Organizations for Economic Cooperation and Development (OECD).

(71 FR 43906, 43921 (August 2, 2006) (citations omitted)). That order also catalogued the numerous endocrine- related endpoints in other chronic toxicities routinely-required for pesticides used on agricultural commodities. (Id.).

Specifically as to DDVP, in its response to NRDC’s petition, EPA detailed four long-term DDVP toxicity studies, submitted under EPA data requirements that provided data on numerous effects that are relevant to potential endocrine disruption. EPA wrote:

EPA has adequate data on DDVP’s potential endocrine effects to evaluate DDVP’s safety. In the 1989 NTP cancer studies with rats and mice, male and female reproductive organs (prostate, testes, epididymis, ovaries, uterus) were examined and no changes attributable to DDVP were found. The 52–week dog study with DDVP also was without effect in the reproductive organs (testes, prostate, epididymides, cervix, ovaries, uterus, vagina). EPA also has a 1992 two-generation rat reproduction study with DDVP (via drinking water) that is similar to the most recent guidelines (1998) for conduct of such a study with respect to endocrine- related endpoints. Although that study did not include certain evaluations that the 1998 guidelines recommended related to endocrine-related effects (age of vaginal opening and preputial separation), it did incorporate other aspects of the 1998 guidelines such as an examination of esterous cycling in females and sperm

number, motility, and morphology in males. The study did identify an adverse effect on esterous cycling in females but only at the high dose (8.3 mg/kg/day). All doses in the study showed significant cholinesterase inhibition. Further, the NOAEL and LOAEL from the esterous cycling endpoint in the reproduction study are nearly two orders of magnitude higher than the NOAEL and LOAEL used as a Point of Departure in setting the chronic RfD/PAD for DDVP.

(72 FR at 68676 (citations omitted). Further, the petition response additionally discussed a DDVP study from the scientific literature examining endocrine-related effects. (Id.).

NRDC’s speculation - that further testing of DDVP might reveal endocrine effects at levels below those at which cholinesterase inhibition has been measured - does not convince EPA that there is not a reliable basis for removing the children’s safety factor as regards endocrine effects. As EPA indicated in its denial of the NRDC petition, it has several studies addressing numerous endpoints bearing on DDVP’s potential endocrine effects, DDVP’s cholinesterase inhibition effects are well-defined by existing data, and the only endocrine effect seen in the DDVP data occurred in the presence of significant cholinesterase inhibition and at a level two orders of magnitude (i.e., 100X) greater than the level at which the most sensitive cholinesterase effects were seen. As a pesticide, DDVP is subject to testing under the endocrine disruptor screening program; however, EPA expects that that data will confirm its conclusion regarding DDVP’s potential endocrine effects. NRDC’s objection on this point is denied.

3. Dietary exposure—a. Objection/ hearing request sub-issue. NRDC claims that there are numerous uncertainties in EPA’s estimate of dietary exposure to DDVP from food and that these uncertainties preclude EPA from departing from the 10X children’s safety factor. (Ref. 1 at 6). Specifically, NRDC cites to a list of uncertainties noted by EPA in a preliminary risk assessment for DDVP released in 2000. Those uncertainties involve the number of infants surveyed for the food consumption database; foods consumed from farm stands; use of data on residue decline from cooking studies; reliance on the residue sampling from the FDA Total Diet Study; and lack of monitoring data, and extensive use of data translation, for fumigated commodities. With the exception of the infant consumption issue, NRDC makes no claim other than to allege that ‘‘[e]ach of these shortcomings poses a serious risk of understating the risks posed by DDVP contamination of food.’’ (Id.). As to the

infant consumption data, NRDC offers various challenges to the size and representativeness of the group of infants sampled in conjunction to the 2000 preliminary risk assessment. NRDC acknowledges that EPA, in its response to the NRDC petition, states that it used updated infant consumption data but NRDC objects that ‘‘EPA does not assert that these data represent a statistically adequate or representative sample.’’ (Id.). Finally, NRDC implies that EPA thinks the data are not reliable by citing an EPA statement regarding the reliability of monitoring data.

b. Background. NRDC made almost identical claims in its petition to revoke DDVP tolerances. EPA responded with a detailed examination of each of the factors cited by NRDC as well as several additional factors. (72 FR at 68684- 68686). Where EPA identified weaknesses in the exposure database it either incorporated new, updated data in its risk assessment (for example, replacing data from the FDA Total Diet Study with data from USDA’s Pesticide Data Program) or explained how that weakness had been addressed by conservative assumptions. (72 FR at 68684). This led to an entirely revised dietary exposure and risk assessment for DDVP. As to this revised assessment, EPA concluded that ‘‘its assessment of exposure to DDVP from food will not under-estimate but rather over-estimate, and in all likelihood substantially over- estimate, DDVP exposure.’’ (72 FR at 68686). EPA also noted that the largest ‘‘driver’’ or contributor to dietary exposure of DDVP was DDVP in drinking water and not DDVP in food. (Id.). Specifically, as to food consumption data for infants, EPA stated that it had incorporated the most recent consumption data for infants that is used in all EPA pesticide risk assessments currently in its revised risk assessment for DDVP. This most recent data was collected at the direction of Congress in the FQPA. (Public Law 104- 170, sec. 301; 110 Stat. 1489, 1511).

c. Denial of hearing request. NRDC’s objection and request for a hearing on this sub-issue suffers from several infirmities. First, NRDC has objected to an outdated document, EPA’s preliminary risk assessment for DDVP. With the exception of the issue concerning food consumption data for infants, NRDC has made no effort to object to EPA’s current assessment of the reliability of various factors cited by NRDC in EPA’s petition response issued under FFDCA section 408(d)(4)(iii). When an objector does not challenge EPA conclusions in the section 408(d)(4)(iii) order but rather challenges some prior conclusion that was

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superseded by the section 408(d)(4)(iii) order, the objector has not raised a live controversy as to an issue material to the section 408(d)(4)(iii) order. (See 53 FR 53176, 53191 (December 30, 1988) (where FDA responds to a comment in the final rule, repetition of the comment in objections does not present a live controversy unless the objector proffers some evidence calling FDA’s conclusion into question)). In fact, in these circumstances, it is questionable whether EPA has jurisdiction to consider the objection and hearing request because objections may only be filed as to a section 408(d)(4)(iii) order or other statutorily-specified action. (21 U.S.C. 346a(g)(2)(A)).

Second, NRDC has made no proffer of evidence supporting its claim that each of the factors cited from EPA’s preliminary risk assessment ‘‘poses a serious risk of understating the risks posed by DDVP contamination of food.’’ (Ref. 1 at 6). NRDC’s entire argument concerning the effect these factors (other than the infant food consumption data issue) would have on the DDVP exposure assessment is a single conclusory sentence. A hearing will not be granted on ‘‘mere allegations’’ or ‘‘general contentions.’’ (40 CFR 178.32(b)(2)). Although NRDC discusses the infant food consumption data issue at greater length, this discussion provides no support for granting a hearing. NRDC’s discussion is limited to: (1) a presentation of a short analysis of the adequacy of the superseded consumption data as opposed to the data upon which EPA relied in denying NRDC’s objection; and (2) a claim that EPA has not made a finding that the more recent infant food consumption data ‘‘represent a statistically adequate or representative sample.’’ (Ref. 1 at 6- 7). However, the superseded data is irrelevant to the present proceeding and the allegation about an absent finding is framed as a procedural/legal challenge, not an identification of evidence supporting factual contentions. (See 53 FR 53176, 53199 (December 30, 1998) (‘‘Rather than presenting evidence, [the objector] asserts that FDA did not adequately justify its conclusions. Such an assertion will not justify a hearing.’’).

Third, ignoring for a moment the other serious flaws identified above, a hearing is inappropriate on this issue because NRDC has not shown a disputed factual issue. Rather, NRDC is essentially arguing about the correct conclusion that should be drawn from the factual findings made by EPA in its preliminary risk assessment. (47 FR 55471, 55474 (December 10, 1982) (‘‘[Objectors] assertion about this evidence is, at best, an argument that a

different inference (i.e., that the pieces are not ‘reasonably uniform’ and ‘cube shaped’) should be drawn from established fact (the dimensions of the pieces) than the agency has drawn. No hearing is required in such circumstances.’’).

Finally, this entire issue suffers a materiality problem because dietary exposure to DDVP in food is so small relative to other DDVP exposures. As EPA noted in its petition denial, the ‘‘latest dietary assessment shows that, by a large margin, the biggest driver in the DDVP dietary risk assessment are DDVP residues in water not food.’’ (72 FR at 68686). Moreover, in evaluating aggregate exposure to DDVP from all sources EPA found that dietary exposure from food and water was ‘‘insignificant’’ compared to exposures from pest strips. NRDC has made no showing that its concerns regarding dietary exposure to DDVP in food are material to the overall exposure assessment. (See 53 FR 53176, 53202 (December 30, 1998) (The objector claims that radiation causes nutrient loss but ‘‘to justify a hearing on this point, it is not enough for [the objector] to simply assert that some nutrient loss can occur. [The objector] must present evidence that suggests that nutrient losses in food irradiated at doses permitted by the regulation are sufficiently large and would so affect the diet that such food would be nutritionally unwholesome or unsafe.’’).

For all of the above reasons, NRDC’s hearing request on the adequacy of the DDVP dietary exposure assessment are denied.

d. Denial of objections. EPA questions whether NRDC’s repetition of EPA’s statements from a preliminary risk assessment constitute an objection to a superseding risk assessment in a section 408(d) petition denial. In any event, EPA has already explained in great detail in its petition denial why the factors cited in its preliminary risk assessment do not raise a concern that EPA in its latest assessment has understated DDVP dietary exposure. To the contrary, EPA concluded that its dietary assessment will ‘‘over-estimate, and in all likelihood substantially over- estimate, DDVP exposure.’’ (72 FR at 68686). Accordingly, NRDC’s objections, to the extent they merely repeat the claims in the petition, are denied for the same reasons stated in the petition denial. (72 FR at 68684-68686).

EPA also denies NRDC’s apparent objection that the updated infant food consumption data is unreliable and thus EPA may not depart from the 10X children’s safety factor. The only two grounds NRDC cited for this objection

were: (1) EPA’s alleged failure to confirm that these data are ‘‘statistically adequate or [a] representative sample;’’ and (2) a reference EPA made to monitoring data. NRDC’s arguments here are without merit.

EPA has traditionally relied upon large scale surveys of food consumption conducted by the USDA in assessing dietary exposure and risk from pesticides. USDA generally conducts these surveys roughly every 10 years. EPA currently relies primarily on the Continuing Survey of Food Intakes by Individuals (‘‘CSFII’’) which was conducted in 1994-96. Prior surveys were performed by USDA in 1977-78 and 1989-91. The 1994-96 CSFII was supplemented in 1998 to expand the number of data points for infants and children. As EPA has explained: ‘‘These surveys were designed to monitor food use and food consumption patterns in the U.S. population. The data were collected as a multistage, stratified, probability sample that was representative of the U.S. population. [] The most recent survey (CSFII 1994- 1996/1998) was designed to obtain a sample that would provide equal precision over all sex-age domains. The data are used by a number of federal and state agencies to improve understanding of factors that affect food intake and the nutritional status of the U.S. population. [EPA’s Office of Pesticide Programs] considers the CSFII data adequate to model the daily variability in the U.S. diet.’’ (Ref. 5 at 39).

The 1998 supplemental survey was collected in response to the mandate in the FQPA specifying that USDA, in consultation with EPA, was to ‘‘coordinate the development and implementation of survey procedures to ensure that adequate data on food consumption patterns of infants and children are collected.’’ (Public Law 104-170, sec. 301; 110 Stat. 1489, 1511). Congress specified that ‘‘[t]o the extent practicable, [these] procedures [] shall include the collection of data on food consumption patterns of a statistically valid sample of infants and children.’’ (Id.). Working together, EPA and USDA adopted a survey plan designed to be statistically reliable and representative. (Refs. 25 and 26). The 1998 survey involved sampling of 5,559 infants and children. When combined with the 4,253 infants and children from the 1994-96 survey, the total sample size for infants and children in the two surveys is near 10,000. EPA and USDA concluded that that ‘‘the sample sizes for each sex-age group [from the combined surveys] provide a sufficient level of precision to ensure statistical reliability of the estimates’’ except as to

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certain low consumption items for individual age groups (e.g., infant consumption of lettuce). (Ref. 25 at 1). Comparison of the 1994-96 and 1998 surveys indicated few statistical differences in nutrient consumption for the different age groups with the exception of 3-5 year olds. Even so, ‘‘[t]he differences seen, although statistically significant, were relatively small and likely to be of little practical or biological significance.’’ (Ref. 26 at 2- 3).

Because EPA, in conjunction with USDA, has taken care to insure that its surveys of food consumption constitute a statistically valid and representative sample of infants and children, NRDC’s unsupported objection suggesting that this data is somehow inadequate is rejected.

NRDC’s reference to an EPA statement about monitoring data does not in any way undermine this conclusion. EPA began a section of the petition denial which discusses, among other things, monitoring data of residues in food, infant food consumption data, and fumigant monitoring data, with the broad statement that ‘‘[i]n general, EPA disagrees that the monitoring data are unreliable.’’ (72 FR at 68684). While NRDC highlights the qualifying language ‘‘in general,’’ it ignores the critical following sentence that provides: ‘‘To the contrary, EPA believes that the monitoring data provide for an appropriately conservative risk assessment.’’ (Id.). The first sentence was qualified by the phrase ‘‘[i]n general,’’ because in two instances the EPA’s residue monitoring data were less than optimal; however, as noted in the second sentence, EPA concluded that the risk assessment was appropriately conservative because either the data in question were insignificant or other factors compensated for any uncertainty in the data. The first instance involved residue monitoring data for one minor commodity (berries not including strawberries) out of dozens of commodities where EPA relied on FDA enforcement monitoring data rather than its preferred source, data from USDA’s Pesticide Data Program. EPA prefers using the USDA data because it is collected using a sampling plan designed to capture a representative sample of food in the United States, whereas sampling for FDA enforcement data is targeted at food where violations are more likely to occur. Such targeted enforcement data generally overstates, in comparison to a more representative sample, both the frequency of finding pesticide residues in commodities and the level of the residues detected. In the

second instance, fumigant monitoring data was not available for all bagged and packaged commodities so EPA translated data across commodities. Although noting that this translation introduced some uncertainty, EPA concluded that ‘‘this uncertainty was more than offset by other factors,’’ including a testing procedure that utilized maximum application rates and sampling within six hours of treatment and the assumption that all bagged and packaged commodities would be treated. Finally, the mention of ‘‘monitoring data’’ is a reference to studies that ‘‘monitor’’ residues in food not surveys of people’s food consumption patterns. The latter topic was inadvertently included in a section of the order devoted to ‘‘[f]ood monitoring data.’’ (72 FR at 68683). Thus, the sentence cited by NRDC does not even refer to food consumption survey data.

4. Pest strip exposure. NRDC claims that EPA’s assessment of exposure to DDVP from residential pest strips ‘‘is based on unsupported assumptions and inadequate data.’’ (Ref. 1 at 8). Accordingly, NRDC concludes the EPA lacks reliable data on DDVP exposure from pest strips and cannot reduce or remove the 10X children’s safety factor. EPA has identified seven separate allegations made by NRDC and they are analyzed individually below.

a. Representativeness of Collins and DeVries study—i. Objection/hearing request sub-issue. NRDC argues that the Collins and DeVries study which EPA used to estimate DDVP exposure from pest strips had an inadequate sample size (15 houses). According to NRDC, 15 houses is not adequate to represent the diversity of housing in the United States given the variations in housing design and ventilation characteristics. (Ref. 1 at 7). Additionally, NRDC claims that, because the study was conducted in a single geographic area and for a period no longer than 91 days, it does not account for the varying weather conditions which can have differential effects on the movement and degradation of airborne residues.

ii. Background. NRDC made the identical claim in its petition. EPA’s response in its petition denial order was two-fold. First, EPA pointed out that the Collins and DeVries study was not the only study considered by EPA in assessing DDVP exposure from pest strips. EPA reviewed several other studies involving over 100 homes in the United States and Europe. The results in the Collins and DeVries study were consistent with the results in the other studies and, thus, EPA concluded that it was reasonable to use the data from the

Collins and DeVries study in assessing DDVP risk. (72 FR at 68692). Second, in response to this claim (as well as several of NRDC’s other claims), EPA substantially revised the DDVP exposure and risk assessment. (72 FR at 68687-68691). Additional conservative assumptions were adopted and these conservative assumptions further offset any theoretical unrepresentativeness of the Collins and DeVries study. These assumptions were that exposed individuals spent 24 hours per day in a treated home, that a person spent all of the 24 hours per day in a room in the house with a pest strip, and that inclusion of a pest strip in a closet resulted in the same exposure as hanging the strip in the room itself. Further, EPA no longer averaged the exposure results from the houses in the study but evaluated each house individually.

iii. Denial of hearing request. NRDC’s request for hearing on this issue is flawed for two reasons. First, as in its petition, NRDC proffers no evidence to support its claim that the Collins and DeVries study is inadequate due to the diversity of housing stock and geographic conditions in the United States. NRDC merely asserts that to be the case. However, hearings will not be granted on the basis of mere allegations or general contentions. (40 CFR 178.32(b)(2); see also 68 FR 46403, 46406-46407 (8/5/2003) (FDA denied a hearing involving a challenge to FDA’s reliance on consumption pattern data because the objector ‘‘did not present any specific information to dispute P & G’s consumption pattern data; instead, [objector] simply asserted that other consumption patterns were likely.’’); accord Community Nutrition Institute v. Novitch, 773 F.2d 1356, 1363 (D.C. Cir. 1985) (‘‘Mere differences in the weight or credence given to particular scientific studies . . . are insufficient [to show a material issue of fact for a hearing].’’)).

Second, NRDC’s hearing request is inadequate because NRDC does not object to the basis EPA asserted in its petition denial for concluding that the Collins and DeVries study does provide a sufficient basis for estimating residential exposure. Specifically, NRDC does not challenge EPA’s conclusion that the Collins and DeVries study is consistent with several other pest strip studies and proffer evidence in support of that challenge. Neither does NRDC challenge and proffer evidence regarding EPA’s conservative use of the Collins and DeVries study in assessing exposure. Rather, NRDC just repeats its assertions regarding the unrepresentativeness of the Collins and DeVries study from its petition. This

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failure to challenge the basis of EPA’s petition denial affects the materiality of the objection and hearing request. Even if NRDC could demonstrate in a hearing that the ventilation design of a house, for example, can affect the rate at which airborne contaminants are dissipated, that evidence would not contradict the fact that the Collins and DeVries study is consistent with DDVP pest strip studies in over 100 other homes in varying locations.

Prior FDA decisions under its regulations are instructive here. Objections and hearing requests were filed in response to a food additive regulation covering the irradiation of poultry. (62 FR 64102 (December 3, 1997). The objector argued that the addition of an anti-oxidant (ethoxyquin) to irradiated chicken prior to the chicken’s use in animal feeding studies compromised the studies because the ethoxyquin would have decreased the level of lipid peroxides in the chicken to levels found in chicken that had not been irradiated. The FDA noted, however, that it had considered the question of ethoxyquin’s effect on lipid peroxide levels in the final rule and determined that while ethoxyquin can retard the normal oxidation of chicken fat to peroxides, ethoxyquin cannot reverse oxidation that has already occurred. FDA denied the hearing request reasoning that because the objector did ‘‘not dispute FDA’s explanation in the final rule as to why addition of ethoxyquin did not compromise the CIVO studies, and provided no information that would have altered the agency’s conclusion on this issue . . . there is no factual issue that can be resolved by available and specifically identified reliable evidence.’’ (62 FR at 64105; see also 53 FR 53176, 53191 (December 30, 1988) (FDA denied a hearing request noting that given FDA’s prior conclusion that the studies relied upon by the objector were unreliable, the ‘‘burden shifted to [the objector] to maintain the viability of its objection by proffering some information that called into question the agency’s conclusion on this matter.’’)). Similarly, here, NRDC has not challenged the basis EPA asserted for rejecting NRDC’s challenge to EPA’s reliance on the Collins and DeVries study and NRDC has not proffered any information calling into question EPA’s conclusion.

iv. Denial of objection. Because NRDC offers no basis for its objection to EPA’s denial of the challenge in its petition to EPA’s reliance on the Collins and DeVries study—other than the claims made in its petition, itself—EPA denies the objections for the reasons in the

petition denial order (i.e., the consistency of the Collins and DeVries study with other DDVP pest strip studies and the conservativeness of the DDVP pest strip exposure assessment).

b. Sampling location in the Collins and DeVries study—i. Objection/hearing request sub-issue. NRDC argues that the Collins and DeVries study is flawed because air concentration levels of DDVP were sampled in only one location in the house. According to NRDC, this sampling regime was inadequate because it ‘‘provides no information about the movement of residues from room-to-room and therefore exposure in other rooms in the homes.’’ (Ref. 1 at 7).

ii. Background. NRDC repeats this claim verbatim from its petition. The petition denial order rejected this challenge to the Collins and DeVries study and the manner of EPA’s use of the study in its exposure assessment noting that ‘‘the sample location in each instance was in a room with a pest strip, pest strips were used in other rooms of the house, and EPA assumed, for its calculation of the MOE, that the air concentration for all areas of a house is the same as at the sampled location.’’ (72 FR at 68692).

iii. Denial of hearing request. This objection and hearing request does not involve a genuine and substantial issue of disputed fact. There is no dispute concerning how or where sampling was done in the Collins and DeVries study or how EPA used that data in estimating DDVP exposure from pest strips. NRDC’s objection attacks EPA’s conclusion that it is reasonable to assess residential DDVP exposure from pest strips using air concentrations of DDVP from rooms which contained a pest strip. A challenge to an EPA inference drawn from undisputed facts does not qualify as a disputed factual question. (47 FR 55471, 55474 (December 10, 1982) (‘‘[Objectors] assertion about this evidence is, at best, an argument that a different inference (i.e., that the pieces are not ‘reasonably uniform’ and ‘cube shaped’) should be drawn from established fact (the dimensions of the pieces) than the agency has drawn. No hearing is required in such circumstances.’’)). Moreover, NRDC does not explain why knowledge of the amount of room-to-room DDVP movement is relevant given that EPA based its exposure assumption on the level of DDVP found in a room with a pest strip, much less proffer any evidence to suggest why this issue is material and should be resolved in its favor. For all of these reasons, NRDC’s hearing request on this issue is denied.

iv. Denial of objection. This objection is denied for the same reason stated in the petition denial order: knowledge of the amount of room-to-room movement of DDVP is irrelevant if EPA bases its exposure assessment on a room that contains a pest strip. In both its petition and its objections, NRDC cites the following statement from EPA’s preliminary risk assessment as supporting its conclusion regarding the inadequacy of use of a single air monitor in the Collins and DeVries study: ‘‘A more accurate exposure would be possible if air measurements were available from different rooms in the house.’’ (Ref. 1 at 7). NRDC, however, misunderstands the thrust of this sentence. EPA was simply pointing out that monitoring in rooms without pest strips would have provided a more accurate and realistic - i.e., lower - estimate of exposure than using values from a room containing a pest strip. The sentences immediately following the language quoted by NRDC make this clear. EPA stated: ‘‘Limited data suggest that the level of Dichlorvos in the air declines with distance from the resin pest strip. There are data from the Dichlorvos Flea Collar Study that show Dichlorvos levels are lower some distance away from the pet flea collar.’’ (Ref. 27 at 53).

c. Averaging DDVP concentrations over 120 days—i. Objection/hearing request sub-issue. NRDC objects to EPA’s assessment of exposure to pest strips challenging EPA’s alleged use of a 120–day average of DDVP concentration levels. NRDC argues that ‘‘[r]ather than using averages, the Agency should have presented the range of risks displayed over time, peak measurements, and the daily monitoring data so that trends over time could be determined.’’ (Ref. 1 at 7).

ii. Background. NRDC repeats this claim verbatim from its petition. In its petition denial order, EPA agreed with NRDC and revised its residential exposure assessment to examine exposure and risk based on the first day of exposure after hanging the pest strip, the first 2 weeks of exposure, and exposure over a 91 day period. (72 FR at 68687).

iii. Denial of hearing A hearing can only be based on a genuine issue of disputed fact. Where a party’s factual allegations are contradicted by the record, there is no genuine dispute. (57 FR 6667, 6672 (February 27, 1992) (‘‘A hearing must be based on reliable evidence, not on mere allegations or on information that is inaccurate and contradicted by the record.’’).

iv. Denial of objection. NRDC’s objection is directed at a prior,

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superseded risk assessment, not the risk assessment relied upon in the petition denial order. Thus, this objection is not material to this proceeding and is denied. (See Unit VIII.D.3.c.).

d. Replacement cycle for pest strips— i. Objection/hearing request sub-issue. NRDC objects to EPA’s assumption that pest strips are replaced no more frequently than 120 days even though the pest strip label does not prohibit more frequent replacement. (Ref.1 at 8). NRDC argues that EPA has no data to substantiate this assumption and claims that homeowners may decide ‘‘to replace strips sooner ‘for good measure.’’’ (Id.). Recognizing that EPA decreased its assumption concerning the replacement cycle to 91 days in the revised risk assessment in the petition denial order, NRDC asserts that this value is equally arbitrary.

ii. Background. The challenge to the 120–day replacement assumption was included in NRDC’s petition. EPA responded to NRDC’s argument in the petition denial order by decreasing its assumption as on the replacement cycle of pest strips to 91 days. (72 FR at 68692).

iii. Denial of hearing. This sub-issue does not meet the standard for a hearing. NRDC disputes the reasonableness of EPA’s choice of a replacement cycle for pest strips in the absence of a restriction on the pesticide label or data documenting consumer usage. NRDC proffers no evidence challenging EPA’s use of a 91–day replacement cycle. Rather, NRDC asserts a legal argument that in the absence of specific data on consumer usage, EPA may not make an assumption about consumer practices. Hearings are not appropriate on legal questions. (40 CFR 178.32(b)(1)). Similarly, NRDC’s speculation about how often homeowners may replace pest strips does not constitute an evidentiary proffer justifying a hearing. (See 57 FR 33244, 33248 (July 27, 1992) (NRDC claimed that the removal of premix batch analysis would lead to misformulation of selenium in feeds. A hearing was denied because NRDC ‘‘provided no factual information to support its claim . . . . [A] hearing will not be granted on the basis of mere allegations.’’)).

iv. Denial of objection. In its preliminary risk assessment and in the IRED, EPA assumed that pest strips would be replaced no more frequently than 120 days because the pest strip label specifies: ‘‘Drafts, weather, and other conditions may affect the performance, but treatment usually last for 4 months. Record the date of installation and replace with a new,

fresh, full-strength strip at the end of 4 months or when effectiveness diminishes.’’ (Ref. 28). Given that the manufacturer was essentially designating 120 days as the likely effective period and that consumers might leave the pest strips up for either longer or shorter periods, EPA assumed that 120 days was a reasonable estimate of the average replacement cycle for pest strips. EPA generally uses average values for chronic exposure scenarios because over time high and low values tend to average out. (Ref. 5 at 42). Nonetheless, in recognition of NRDC’s contention that homeowners might replace strips more frequently, EPA amended its pest strip exposure to assume a 91–day replacement cycle (the length of the Collins and DeVries study) rather than extrapolate the data from the Collins and DeVries study over 120 days as was done previously. EPA believes 91 days is a reasonable estimate of the replacement cycle especially given the label language and the numerous conservative assumptions in the risk assessment such as, for example, the assumption of 24 hours per day exposure in a room containing a pest strip. Accordingly, NRDC’s objection on this sub-issue is denied.

e. Number of pest strips—i. Objection/ hearing request sub-issue. NRDC claims that EPA’s assessment of DDVP exposure from pest strips is not based on adequate data because EPA does not have any data on how many strips people use in their homes. EPA assessed residential DDVP exposure based on the Collins and DeVries study which used 3-4 strips per house in each of the studied houses. NRDC argues that some homeowners may use more than 3-4 strips because there is no limitation on the label as to the number of strips per house.

ii. Background. NRDC repeats this claim verbatim from its petition. EPA rejected NRDC’s concern in the petition denial order reasoning that its assessment was based on data on the air concentration of DDVP in a room containing a pest strip. (72 FR at 68692). EPA also noted that the only strips allowed in occupied areas of the home under the current registration are for closets, wardrobes, or cupboards and given that they treat a relatively small space, compared to the bigger strips used in the Collins and DeVries study, they are unlikely to result in significant DDVP air concentrations in rooms other than in the room containing the treated area. (Id.).

iii. Denial of hearing. NRDC has not alleged and proffered evidence on a genuine and substantial issue of disputed fact. NRDC speculates that use

of pest strips in every, or almost every, room in a house may lead to higher residues in a room containing a pest strip than a room containing a pest strip in a house which has a pest strip in 3- 4 rooms. Based on this speculation, NRDC claims that EPA’s exposure assessment is inadequate because EPA has not documented how many strips people use in their houses. A hearing will not be granted on the basis of mere allegations or speculation about what other studies might show. (See 57 FR 33244, 33248 (July 27, 1992) (NRDC claimed that the removal of premix batch analysis would lead to misformulation of selenimum in feeds. A hearing was denied because NRDC ‘‘provided no factual information to support its claim . . . . [A] hearing will not be granted on the basis of mere allegations.’’)).

iv. Denial of objection. For several reasons, NRDC’s speculation that a house containing strips in nearly every room might lead to greater DDVP exposures than estimated by EPA must be rejected. First, EPA based its DDVP pest strip exposure assessment on a study (Collins and DeVries) which measured DDVP concentrations in a room containing a pest strip. Second, the Collins and DeVries study did not involve a house with a single strip but used pest strips in 3-4 rooms of the studied houses. Third, the results of the Collins and DeVries study were consistent with the results of several other pest strip studies. Fourth, although corrected for the smaller size of current pest strips compared to the pest strips used in the Collins and DeVries study, EPA did not adjust its assessment for the fact that current strips may not be used for general space treatment but must be put in closets, wardrobes, or cupboards. Taking into account these factors, EPA’s assessment of exposure from DDVP pest strips was reasonable and based upon adequate, reliable data to reduce or remove the children’s safety factor.

f. Exposure time per day—i. Objection/hearing request sub-issue. NRDC objects that it was unreasonable for EPA to assume that the high end exposure period in the home is 16 hours and that a low end exposure period is 2 hours. NRDC argues that some groups of people may spend significantly greater amounts of time in their homes. NRDC asserts that EPA does not adequately justify these assumptions in its petition denial order.

ii. Background. NRDC repeats this claim verbatim from its petition. In response to NRDC’s petition, EPA substantially revised its pest strip exposure assessment. As to exposure

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periods, EPA completely dropped its prior approach and assessed exposure assuming a person spent 24 hours per day in their home in a room containing a pest strip. (72 FR at 68687).

iii. Denial of hearing. A hearing can only be based on a genuine issue of disputed fact. Where a party’s factual allegations are contradicted by the record, there is no genuine dispute. (57 FR 6667, 6672 (February 27, 1992) (‘‘A hearing must be based on reliable evidence, not on mere allegations or on information that is inaccurate and contradicted by the record.’’).

iv. Denial of objection. NRDC’s objection is directed at a prior, superseded risk assessment, not the risk assessment relied upon in the petition denial order. Thus, this objection is not material to this proceeding and is denied. (See Unit VIII.D.3.c.).

g. Movement of DDVP from unoccupied areas of the home to occupied areas—i. Objection/hearing request sub-issue. NRDC claims that EPA does not have a sufficient basis for its conclusion that pest strips used in unoccupied places in a house (garages, attics, crawl spaces, sheds) will not migrate to occupied portions of the house. Thus, NRDC argues EPA does not have reliable data to reduce or remove the children’s safety factor.

ii. Background. NRDC made the same argument in its petition. Additionally, in the petition, NRDC cited a study with another pesticide which NRDC claimed showed that pesticides could migrate into the house. EPA disagreed with NRDC’s assertion, pointing out that migration was unlikely unless the unoccupied portion was connected to the air exchange system for the house. EPA also explained in detail why the study cited by NRDC was not relevant to DDVP. NRDC did not renew its arguments based on this study.

iii. Denial of hearing. NRDC has not alleged and proffered evidence on a genuine and substantial issue of disputed fact. NRDC speculates that use of pest strips in unoccupied areas of a house may lead to migration of DDVP residues to occupied portions of the house. Based on this speculation, NRDC claims that EPA’s exposure assessment is inadequate because EPA has not documented that such migration does not occur. A hearing will not be granted on the basis of mere allegations or speculation about what other studies might show. (See 57 FR 33244, 33248 (July 27, 1992) (NRDC claimed that the removal of premix batch analysis would lead to misformulation of selenium in feeds. A hearing was denied because NRDC ‘‘provided no factual information to support its claim . . . . [A] hearing will

not be granted on the basis of mere allegations.’’)).

iv. Denial of objection. NRDC’s objection is denied. Given EPA’s knowledge of the chemical properties of DDVP, it was reasonable to assume that DDVP would not migrate from unoccupied portions of the home to occupied portions absent some type of air exchange connection between the two areas. DDVP is a highly volatile chemical that quickly degrades once released to the environment. EPA reasonably concluded that the low concentration of airborne DDVP produced from a DDVP pest strip would not penetrate the walls of a home in meaningful amounts.

E. Response to Specific Issues Raised in Objections and Hearing Requests - Reliance on Human Study

1. Background. In making its FFDCA tolerance reassessment decision and FIFRA reregistration decision for DDVP, EPA relied upon one human toxicity study in deriving an acceptable level of exposure for several exposure scenarios. The study in question was conducted in 1997 by A.J. Gledhill. In this study, six male volunteers were administered 7 mg of DDVP in corn oil (equivalent to approximately 0.1 mg/kg/day) via capsule daily for 21 days. Three control subjects received corn oil as a placebo. Baseline values for RBC cholinesterase activity for each study participant were determined based upon repeated measurements prior to the administration of DDVP. After dosing started, RBC cholinesterase activity was monitored on days 2, 4, 7, 9, 11, 14, 16, and 18, and then on day 25 or 28 post- dosing. Although no toxicity attributable to administration of DDVP was reported by the test subjects, mean RBC cholinesterase activity was statistically significantly reduced in treated subjects on days 7, 11, 14, 16, and 18. These values were 8, 10, 14, 14, and 16 percent below the pre-dose mean. (Refs. 15 and 16).

EPA’s decision to rely on the Gledhill study was made pursuant to its Human Research rule. As explained in Unit III.D, that rule establishes different ethical standards for the review of completed human studies depending on whether they were initiated before or after the effective date of the rule on April 7, 2006. For an intentional human exposure study such as the Gledhill study, that was initiated prior to April 7, 2006, EPA is barred, subject to a very limited exception, from relying on it if there is clear and convincing evidence that the conduct of the research was fundamentally unethical or significantly deficient with respect to the ethical

standards prevailing at the time the research was conducted. (40 CFR 26.1704, 1706). Further, the rule limits the human research that can be relied upon by EPA to ‘‘scientifically valid and relevant data.’’ (40 CFR 26.1701). Finally, because the Gledhill study was conducted with the purpose of identifying or measuring a toxic effect, EPA is required by the rule to submit its determination regarding these issues to an independent expert advisory body known as the Human Studies Review Board (‘‘HSRB’’) for review. These procedures were followed with regard to the Gledhill study.

Previously, NRDC has challenged the lawfulness of the Human Research rule. Following promulgation of the Human Research Rule, NRDC filed a petition for judicial review of the rule in the United States Court of Appeals for the Second Circuit. (NRDC v. U.S. EPA, No. 06- 0820-ag (2d Cir.)). That case has been briefed and argued and is awaiting decision.

NRDC also previously challenged the scientific merit and ethics of the Gledhill study in comments to EPA and to the HSRB. Specifically as to the HSRB, NRDC filed written comments prior to the HSRB’s review of EPA’s determination regarding the appropriateness of relying on the Gledhill study and also presented oral testimony at the public hearing the HSRB held with regard to that study. Subsequently, the HSRB, after taking into account the comments of NRDC and others, advised EPA that reliance on the Gledhill study was consistent with the Human Research rule. EPA relied heavily on the analysis of the HSRB in denying NRDC’s petition to revoke DDVP tolerances. (72 FR at 68675).

In its petition to revoke DDVP tolerances, NRDC repeated its arguments made to the HSRB as to why the Gledhill study does not comply with the Human Research rule. As support, NRDC cited to a draft HSRB report on the Gledhill study, released shortly before NRDC filed its petition, which noted scientific and ethical deficiencies in the study. (Ref. 2 at 26). NRDC did not acknowledge, however, that despite identifying deficiencies in the Gledhill study, the HSRB, in its draft report, stated its agreement with EPA’s determination that it would be acceptable to rely on the Gledhill study.

In its objections, NRDC once again makes the same arguments on the Gledhill study it made to the HSRB and in its petition to EPA (including the misleading reference to a portion of the draft report of the HSRB). Similar to the approach taken in the petition, NRDC does not even acknowledge the

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recommendations made by the HSRB in its draft and final decisions despite EPA’s explicit reliance on the HSRB’s reasoning in EPA’s petition denial order.

NRDC’s objections also include a challenge to the legality of the Human Research rule paralleling the case pending in the Second Circuit.

2. Challenge to the human research rule—a. Objection/hearing request sub- issue. NRDC argues that ‘‘to the extent [its] facial challenge to the [Human Research] rule is not proper,’’ it is renewing its arguments regarding the legality of the rule in its objections. (Ref. 1 at 9-10). The objections incorporate by reference NRDC’s legal briefs filed in the Second Circuit and its comments filed on the Human Research rule as support for this objection. In its legal briefs, NRDC argues that EPA’s rule is inconsistent with a congressional funding moratorium in an Appropriations Act. (Ref. 29). That Act prohibited EPA from ‘‘accept[ing], consider[ing] or rely[ing] on third-party intentional dosing human toxicity studies for pesticides . . . until [EPA] issues a final rulemaking on this subject.’’ (Public Law 109-54, sec. 201, 119 Stat. 499, 531 (August 2, 2005)). According to NRDC, EPA did not comply with this legislation’s requirement that the EPA human testing rule bar testing on pregnant women, infants and children and be consistent with the principles in a 2004 National Academy of Sciences Report and the Nuremburg Code on human experimentation. (Ref. 29 at 23). NRDC did not specifically lay out the arguments in its legal briefs in its objections other than to include a summary of some of the principles of the Nuremberg Code. (Ref. 1 at 11-12). Similar arguments are made in NRDC’s comments on EPA’s proposed Human Research rule. (Ref. 30).

b. Background. Arguments concerning the legality of the Human Research Rule were not contained in the petition.

c. Denial of hearing request. In this sub-issue, NRDC presents, by reference, various arguments that the Human Research rule is not consistent with congressional legislation bearing on the rule. These arguments raise questions regarding the proper interpretation of statutory language and hearings are not appropriate on such issues. (40 CFR 178.32(b)(1)).

d. Denial of objection. To the extent this matter is not resolved by the Second Circuit and NRDC has standing to challenge a rule whose ‘‘primary concern’’ is the ‘‘[p]rotection of the health and safety of human test subjects,’’ (Ref. 1 at 15), EPA denies

NRDC’s objections to the legality of the Human Research rule. EPA believes the Human Research rule is fully consistent with the Appropriations Act and EPA has fully explained the basis for this conclusion in the rulemaking record (EPA–HQ–OPP–2003–0132) and its legal brief filed in the Second Circuit proceeding. (Ref. 31).

3. Challenge to reliance on the Gledhill Study—a. Statistical power - too few subjects to detect an effect—i. Objection/hearing request sub-issue. NRDC objects that the number of test subjects in the Gledhill study was low and thus there are statistical issues with extrapolating from the results of the Gledhill study to the general human population. (Ref. 1 at 13). In part, NRDC frames this argument as the Gledhill study lacks ‘‘statistical power’’ and NRDC references four published letters or articles in support of this claim. (Ref. 1 at 15). Further, NRDC claims that the statistical power issue is particularly important for studies such as the Gledhill study which measure cholinesterase inhibition because of the variability among individuals of cholinesterase inhibition over time. According to NRDC, the ‘‘range of variability both between and for the individual test subjects means that even greater than the customary number of test subjects would be required to permit adequate statistical power to detect effects caused by the test substance above background variations.’’ (Ref. 1 at 13). As evidence of this cholinesterase inhibition variability in humans, NRDC cites to another human study by Gledhill (MRID # 4428802 rather than MRID # 44248801).

NRDC’s objection here appears to be confusing two separate issues: (1) did the Gledhill study have sufficient statistical power to detect an effect caused by DDVP; and (2) does the Gledhill study contain sufficient data to reliably estimate a safe dose for humans. The first issue is addressed in this Unit and the second in Unit VIII.E.3.b.

ii. Background. NRDC’s objection repeats assertions made in its petition to revoke DDVP tolerances and its comments on the DDVP IRED. (Ref. 2 at 26-27; Ref. 23 at 14-17). EPA rejected NRDC’s claims about statistical power, explaining that ‘‘[a]lthough as a general matter more subjects would provide greater ‘statistical power,’ in this case the use of 6 to 9 subjects with the appropriate statistical methodology is acceptable to EPA because a positive response was seen.’’ (72 FR at 68675). EPA also noted that the variability within the cholinesterase inhibition of the tested subjects ‘‘is not large,

particularly since the percentage inhibition in all instances was at the marginal end of the range.’’ (Id.).

iii. Denial of hearing. A hearing is not required on NRDC’s statistical power claim because the concept of statistical power is simply not applicable to the conclusions EPA drew with regard to the Gledhill study and thus this issue is not material to NRDC’s requested relief. Further, the evidence proffered by NRDC would not, if established, resolve this issue in NRDC’s favor.

To understand EPA’s ruling here, some basic definitional information on the concept of ‘‘statistical power’’ and how it applies in the context of toxicity studies may be helpful. Toxicity testing is designed to test the veracity of the hypothesis that there will be no differences in health outcomes between treated and untreated (control) subjects. Statisticians refer to this hypothesis as the ‘‘null hypothesis.’’ The ‘‘alternative hypothesis’’ is that there will be a difference between treated and control subjects. In general terms, statistical power measures the probability that a toxicological study will find a treatment-related adverse health outcome when there is a treatment- related adverse effect to be found. (Ref. 32 at 125 and n.144). In the language of a statistician, statistical power measures the ‘‘probability of rejecting the null hypothesis when the alternative hypothesis is right.’’ (Id.). A study with a statistical power value of near one (1) would have a very high chance of (properly) rejecting the null hypothesis if the alternative hypothesis is true, whereas a power value close to zero (0) would indicate that there is little chance that the study will identify any true adverse health outcomes occurring as a result of treatment.

Statistical power can also be used to calculate the probability that the study will falsely find that there is no difference in the health outcomes between treated and control subjects, that is, whether the study will falsely affirm the null hypothesis. The probability of such a false negative, is determined by subtracting the statistical power of a study from one (1). (Id.). Thus, the chance that a study will result in a false negative is directly related to the chance that the study will identify any effects present. For example, if a study has low statistical power, there will be a low probability that the study will find an effect if there is one and a high probability that the study will falsely affirm that there is no effect. Statistical power, therefore, is a important tool in designing studies to ensure that effects from treatment are not missed and may play a role in

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evaluating completed studies that confirm the null hypothesis to determine the probability that the null hypothesis was not falsely affirmed (i.e., a false negative).

If analysis of a toxicological study shows that there are treatment-related effects (i.e., the null hypothesis of no treatment-related effect is rejected), then the question of the statistical power of the study becomes largely irrelevant. Put another way, if a study shows a positive outcome, the probability that the study might have produced a false negative becomes a moot point. Importantly, with the Gledhill study, the null hypothesis of no treatment- related effect was rejected: that is, the HSRB and EPA concluded that there was a significant difference in cholinesterase inhibition both between controls and DDVP-treated subjects and between the inhibition levels pre- and post-treatment of the DDVP-treated subjects.

With that background, the scientific papers cited by NRDC can be more easily followed. First, NRDC cites a one- page letter to the Environmental Health Perspectives journal which was co- authored by Jennifer Sass, a NRDC senior scientist, and a subsequent letter, again co-authored by Sass, that responded to various letters expressing a different viewpoint. (Ref. 1 at 15, and Refs. 33 and 34). The topic of both Sass letters is nicely captured by the title attached to the first letter: ‘‘Industry Testing of Toxic Pesticide on Human Subjects Concluded ‘No Effect,’ Despite the Evidence.’’ (Ref. 33 ).

The first letter discusses the DDVP Gledhill study and a second human study involving a different pesticide. With regard to the DDVP Gledhill study, Sass criticizes Amvac’s analysis of that study. Amvac had concluded that the Gledhill study demonstrated a NOAEL arguing that the cholinesterase inhibition effects seen at the single dose in that study were not biologically significant. Sass counters that ‘‘the only biological end point measured in the study was cholinesterase inhibition, and this was significantly inhibited.’’ (Ref. 33 at A150). As to statistical power, Sass claims that studies involving only a few human subjects ‘‘often lack enough subjects to provide adequate statistical power to detect an effect if it is present.’’ (Id.).

The second letter repeats this latter assertion and claims that the statistical power of human studies then available have such low statistical power that they ‘‘practically guarantee[d] a finding of no effect.’’ (Ref. 34 at A340). Sass then returns to the Gledhill study and notes with approval EPA’s conclusion

that that study demonstrated a LOAEL: ‘‘the U.S. Environmental Protection Agency (EPA) rejected AMVAC’s interpretation of the results, instead concluding that ‘the reduction in RBC cholinesterase activity was considered by the Hazard ID [identification] Committee to be biologically significant, and the dose tested was considered to be a lowest observed effect level (LOEL).’’’ (Id.). EPA’s reversal of the Amvac conclusion is cited by the letter as illustrative of bias by chemical manufacturers in the design and interpretation of studies.

For at least two reasons, these letters neither demonstrate the materiality of NRDC’s statistical power claims nor constitute a sufficient evidentiary proffer. First, although they do contain allegations about low statistical power of human studies with low numbers of subjects, they only address the question of whether such studies can detect an effect even if an effect is present (i.e., are they likely to falsely affirm the null hypothesis that there are no treatment- related adverse effects). In the DDVP Gledhill study, however, EPA and the HSRB concluded that the study did identify an adverse effect. Accordingly, the letters have little relevance to EPA’s ultimate finding with regard to the Gledhill study. Second, these letters do not challenge EPA’s analysis of the Gledhill study - rather, they ratify it. Thus, the letters do not proffer evidence, which would, if established, resolve a material issue in NRDC’s favor. (See 57 FR 33244, 33246 (July 7, 1992) (Studies cited by NRDC do not provide a basis for the hearing because they ‘‘support the [FDA] conclusion in question.’’)).

NRDC also cites two articles by Alan Lockwood. One is an article in the American Journal of Public Health discussing ethical and scientific considerations with regard to six human toxicology studies, including the Gledhill study at issue in this proceeding. (Refs. 1 at 15; and 35). The second is a one-page summary of the earlier article that was published in The Environmental Forum. (Ref. 36). The first article contains the following paragraph discussing statistical power:

A power analysis to define the proper size of study group(s) is an essential part of the design. If too many participants are enrolled, the excess will be subjected to unnecessary risk. If too few are enrolled, the investigator risks erroneous acceptance of the null hypothesis. Underpowered studies are inconclusive, and all participants in an underpowered study will have been exposed to risk unnecessarily. All of these studies were underpowered.

(Ref. 35 at 1912). There is little to no explanation provided in the article for

the ‘‘underpowered’’ conclusion other than the notation that the six studies involved young healthy adults. There is little, if any, discussion of the Gledhill DDVP study at issue in this proceeding. The summary article adds nothing new to the longer article.

Like the Sass letters, therefore, the Lockwood articles do not constitute a proffer of evidence that if established would resolve a material issue in favor of NRDC. Not only do they not proffer any evidence, they focus on an issue not involved here - do human studies, such as the Gledhill study, have sufficient statistical power to avoid ‘‘erroneous acceptance of the null hypothesis.’’ Both EPA and the HSRB rejected the null hypothesis as to the Gledhill study (i.e., an adverse effect on the treated subjects was identified). Additionally, these articles do not advance specific evidence, or even arguments, concerning the Gledhill study itself. (See 53 FR 53176, 53179-53180 (December 30, 1998) (a general assertion in a letter to Science magazine is not basis for a hearing); 68 FR 46403, 46405- 46406 (August 5, 2003) (a hearing was denied because the cited studies only contained equivocal statements supporting the objector’s position)).

NRDC also cites the variable level of cholinesterase inhibition within individuals as supporting its statistical power argument. NRDC references a different DDVP human study by Gledhill (MRID # 44248802) to show variability in cholinesterase inhibition. This argument and these data also do not justify a hearing.

Initially, it must be noted that EPA cannot consider this other Gledhill study because both EPA and the HSRB concluded it was without scientific merit and therefore does not qualify for EPA consideration under the Human Research rule. (Ref. 21 at 42-43). Whether or not the aspect of the study cited by NRDC is implicated by this conclusion has not been evaluated; nonetheless, EPA does not disagree with NRDC’s assertion that individual humans have variable levels of cholinesterase inhibition and thus this is not a disputed issue of fact. Neither does EPA dispute that variability of cholinesterase inhibition should be taken into account in considering statistical power and in analyzing the results of a human study.

However, as discussed above, statistical power is no longer a relevant concept once EPA has concluded that a toxicity study shows that the pesticide has an adverse effect on treated subjects. Statistical power is a tool used to evaluate the possibility of accepting false negatives. Moreover, the variability

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of cholinesterase inhibition in subjects is also a factor relating to a concern with false negatives. Normal variation in the responses of individual test subjects may mask treatment-related effects leading to a false conclusion that there were no treatment-related effects. Finally, NRDC’s claims on variability amount to no more than a mere allegation that the existence of variable rates of cholinesterase inhibition indicate a flaw in the Gledhill study and EPA’s reliance on it. Without an evidentiary proffer, however, a hearing is not appropriate.

iv. Denial of objection. NRDC has misconstrued the concept of statistical power. It has little relevance in circumstances where a positive effect is found in a toxicological study. NRDC’s objection that EPA should not have relied upon the Gledhill study because it lacked statistical power is denied.

b. Too few test subjects to establish a NOAEL—i. Objection/hearing request. NRDC objects to reliance on the Gledhill study claiming that because it only involved six treated test subjects it cannot ‘‘support the establishment of a reliable NOAEL or dose response curve . . . .’’ (Ref. 1 at 13).

ii. Background. NRDC’s claim was contained in both its petition and its comments on the IRED. (Refs. 1 at 26; and 23 at 15). In its petition denial order, EPA responded to these claims by concurring with the HSRB’s conclusion that the Gledhill study was ‘‘sufficiently robust for developing a Point of Departure for estimating dermal, incidental oral, and inhalation risk from exposure to DDVP in a single chemical assessment.’’ (72 FR at 68675 (quoting HSRB Report)). The HSRB found the study to be ‘‘robust’’ based on the following attributes: ‘‘the repeated dose approach which allowed examination of the sustained nature of RBC cholinesterase inhibition; robust analysis of RBC cholinesterase inhibition both in terms of identifying pre-treatment levels and consistency of response within and between subjects; and the observation of a low, but statistically significant RBC cholinesterase inhibition response.’’ (Id.; Ref. 21 at 39-41).

iii. Denial of hearing. NRDC has not met the requirements for a hearing on this sub-issue. First, NRDC has proffered no evidence that the six treated subjects in the Gledhill subject were too few for EPA to use data from that study as a Point of Departure. Rather, NRDC does no more than state ‘‘[w]e are aware of no statistical test’’ which would support EPA’s use of the Gledhill data. (Ref. 1 at 13). As EPA’s regulations make clear, a mere ‘‘denial’’ of an EPA position is

not sufficient to satisfy the standard for granting a hearing. (40 CFR 178.32(b)(2)). Second, NRDC does not confront the reasoning of the HSRB, which was adopted by EPA, for why the data from the Gledhill study are sufficiently robust to justify their use as a Point of Departure. This failure to challenge the basis of EPA’s petition denial affects the materiality of the objection and hearing request. Even if NRDC could demonstrate in a hearing that generally more test subjects are needed to derive a Point of Departure for a RfD/PAD, that evidence would not address the specific factors in the Gledhill study that EPA and the HSRB found convincing on this question. (See Unit VIII.D.4.a.iii).

iv. Denial of objections. EPA does not agree with NRDC’s undocumented assertion that the Gledhill study does not provide an appropriate Point of Departure for assessing DDVP risk. EPA, and the HSRB, found that there were several features of the study and the statistical analysis of the study that made it ‘‘sufficiently robust for developing a Point of Departure . . . .’’ (72 FR at 68675). Important factors cited by the HSRB, and adopted by EPA, included: (1) the study design which involved repeated dosing and repeated measurement of cholinesterase effects in individuals; (2) extensive pre-dosing measurement of the test subjects’ cholinesterase inhibition levels which showed consistency both within and between individual test subjects; and (3) the clear study results which showed a statistically significant effect on cholinesterase inhibition was found (both between controls and treated subjects and between the tested subjects’ pre- and post-dosing levels) that was at or near the lowest level that could be distinguished from baseline values. (72 FR at 68675). Further, as EPA noted in its petition denial order, a similar number of test subjects (four per sex) are recommended for a toxicology study in non-rodents (usually the dog) routinely required for pesticide risk assessment. (72 FR at 68675).

In response to EPA’s and the HSRB’s conclusions as to the Gledhill study, NRDC does little more than repeat its allegation that the Gledhill study was underpowered. NRDC does respond to EPA’s reference to the chronic dog study, alleging without providing any basis that that study is underpowered, and claiming that ‘‘EPA rarely relies upon that study.’’ (Ref. 1 at 13). NRDC is incorrect. The chronic dog study was added to EPA’s testing requirement regulations in 1984 and was included in the revised regulations re-promulgated just last year, although the length of the

study was shortened from 1 year to 13 weeks. (72 FR 60934, 60940-60941 (October 26, 2007); 49 FR 42881 (October 24, 1984)). As a standard study required in evaluating pesticides used on food, the chronic dog study would have been considered and relied upon in virtually every one of the roughly 10,000 FFDCA tolerance reassessments conducted in the 10 years following enactment of the FQPA. (Ref. 37). If, by ‘‘rarely relied upon,’’ NRDC means the results from chronic dog are rarely used as a Point of Departure, NRDC is still incorrect. For example, a cursory review of rules establishing new tolerances in 2005 showed at least eight instances in which the Point of Departure for assessment of a pesticide’s risk was based on the chronic dog study. (70 FR 77363, 77366 (December 30, 2005) (hexythiazox); 70 FR 74688, 74690 (December 16, 2005) (bifenazate); 70 FR 55740, 55743 (September 23, 2005) (fenpropathrin); 70 FR 55752, 55757 (September 23, 2005) (amicarbazone); 70 FR 55761, 55764 (September 23, 2005) (pyridaben); 70 FR 54640, 54644 (September 16, 2005) (fluoxastrobin); 70 FR 53944, 53946 (September 13, 2005); 70 FR 51615, 51617 (August 31, 2005) (halosulfuron-methyl). A retrospective analysis performed by EPA in 2005 also showed that 116 out of 304 chronic RfDs for pesticides was based on the chronic dog study. (Ref. 38). Finally, another example somewhat closer to home would be DDVP, where the NOAEL from the chronic dog study is used as the Point of Departure in assessing chronic dietary risk. (Ref. 3 at 132).

Further, EPA’s recommendation for four test subjects per sex per dose in the sub-chronic and chronic non-rodent (dog) study is widely followed. The FDA has a similar recommendation for conducting non-rodent studies of sub- chronic and chronic duration as does the Organisation for Economic Co- operation and Development (‘‘OECD’’), Canada which has accepted the OECD guideline on the sub-chronic and chronic non-rodent (dog) study, and the European Commission’s Joint Research Centre of the European Union. (Refs. 39, 40, 41, 42, and 43).

c. Adult males only—i. Objection/ hearing request sub-issue. NRDC objects to the Gledhill study because it included as test subjects only adult males. (Ref. 1 at 14). NRDC claims that adult males are ‘‘biologically unrepresentative’’ of the human population.

ii. Background. NRDC’s objection is drawn verbatim from its comments on the DDVP IRED. EPA responded to this argument by pointing out that ‘‘no sex differences were observed in the

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comparative cholinesterase studies.’’ (72 FR at 68675). EPA also found no age- related differences in cholinesterase inhibition. (72 FR at 68694).

iii. Denial of hearing. A hearing is denied on this sub-issue because there is no disputed factual matter for resolution at a hearing. There is no dispute concerning the subjects in the Gledhill study - they were adult males. Thus, the only question is whether a human study using only adult males meets the regulatory requirement of ‘‘scientifically valid and relevant data.’’ (40 CFR 26.1701). Because NRDC has proffered no evidence regarding the representativeness of adult males to the general population, this question requires the application of a legal standard to undisputed facts. Hearings are not appropriate on questions of law or policy. (40 CFR 178.32(b)(1)). FDA has repeatedly confirmed that the application of a legal standard to undisputed facts is a question of law for which a hearing is not required. (See, e.g., 68 FR 46403, 46406 n.18, 46408, 46409 (August 5, 2003) (whether facts in the record show there is a reasonable certainty of no harm is a question of law; whether a particular effect is a ‘‘harm’’ is a question of law)).

NRDC’s hearing request is also flawed because NRDC does not object to the basis EPA asserted in its petition denial for concluding that the Gledhill study provided scientifically valid data despite its use of only adult male subjects. As noted above, EPA thought representativeness concerns were addressed by the fact that animal studies with DDVP showed no differences in sensitivities between males and females and adults and the young. NRDC, however, has not challenged and proffered evidence to rebut this conclusion nor has NRDC challenged or proffered evidence to rebut EPA’s analysis of the underlying data. Rather, NRDC just repeats its assertions regarding the unrepresentativeness of adult males generally. This failure to challenge the basis of EPA’s petition denial affects the materiality of the objection and hearing request. Even if NRDC offers evidence to show sex- and age-related sensitivities in the population to some toxicants, such evidence would not rebut the DDVP-specific data on sensitivity. (53 FR 53176, 53191 (December 30, 1988) (FDA denied a hearing request noting that given FDA’s prior conclusion that the studies relied upon by the objector were unreliable, the ‘‘burden shifted to [the objector] to maintain the viability of its objection by proffering some information that called into question the agency’s conclusion on this matter.’’)).

iv. Denial of objection. EPA concludes that it was reasonable to use the Gledhill study despite that fact that it only examined adult males given that the animal toxicology data on DDVP’s cholinesterase effects consistently showed no differences between males and females and adults and the young. Multiple studies involving adult animals yielded consistent cholinesterase inhibition results in males and females. (Ref. 3 at 124-126). Similarly, Benchmark Dose Method analysis of the developmental neurotoxicity data ‘‘did not demonstrate any substantial numerical differences in [Benchmark Dose Method Level] values for either RBC or brain cholinesterase between young and adult animals.’’ (72 FR at 68694).

d. Plasma—i. Objection/hearing request. NRDC objects that the Gledhill study is unreliable because it measured only RBC cholinesterase inhibition and not plasma cholinesterase inhibition. NRDC claims that measuring plasma cholinesterase might have reduced the variability measured in RBC cholinesterase.

ii. Background. In its petition, NRDC argued that plasma cholinesterase should have been measured because it might be a more sensitive indicator of DDVP’s cholinesterase effects. EPA responded to the petition by noting that RBC cholinesterase is the Agency’s preferred cholinesterase inhibition endpoint as compared to plasma cholinesterase. (72 FR at 68676). EPA explained that ‘‘[s]ince the red blood cell contains only acetylcholinesterase, the potential for exerting effects on neural or neuroeffector acetylcholinesterase may be better reflected by changes in red blood cell acetylcholinesterase than by changes in plasma cholinesterases which contain both butyrylcholinesterase and acetylcholinesterase in varying ratios depending upon the species.’’ (Id.). EPA concluded that information on a less preferred endpoint ‘‘adds little meaningful information.’’ (Id.).

iii. Denial of hearing. NRDC proffers no evidence in support of its allegation that collection of plasma cholinesterase inhibition data would be useful in limiting the variability seen in the RBC cholinesterase inhibition data. Hearings will not be granted on mere allegations. (40 CFR 178.32(b)(2)). Further, given EPA’s conclusion that the variability in RBC cholinesterase inhibition in the test subjects was accounted for by pre- and post-treatment measurement, this issue is not material to resolution of NRDC’s claim. Finally, to the extent NRDC is advocating reliance on plasma cholinesterase inhibition data over RBC

cholinesterase inhibition data that is a policy issue and hearings will not be held as to policy issues. (40 CFR 178.32(b)(1)).

iv. Denial of objection. EPA’s well- established policy when evaluating blood cholinesterase inhibition is to use RBC cholinesterase data in preference to plasma cholinesterase. (Ref. 10 at 32). EPA’s reasoning here is straightforward. Blood cholinesterase data is used as an indicator of possible effects on acetylcholinesterase in the peripheral nervous system. RBC cholinesterase is composed entirely of acetylcholinesterase, whereas plasma cholinesterase is a mixture of acetylcholinesterase and butyrylcholinesterase, a compound somewhat similar to acetylcholinesterase in structure that nonetheless is ‘‘different in important ways which often result in it having binding affinities to anticholinesterase agents as well as other characteristics that are quite different from those of acetylcholinesterase.’’ (Id. at 32). The ratio of acetylcholinesterase to butyrylcholinesterase in plasma differs by species; in humans, plasma ‘‘is overwhelmingly butyrylcholinesterase with a ratio of butyrylcholinesterase to acetyl cholinesterase of 1,000:1.’’ (Id.)

It is preferable to have both RBC and plasma cholinesterase data from a study because effects in the RBC may be non- existent, equivocal, or fail to establish a clear-dose response pattern. In those circumstances, plasma cholinesterase inhibition data may serve as a Point of Departure or may aid in the interpretation of the RBC data, particularly when extrapolating animal data to humans. In the Gledhill study, however, the robust RBC cholinesterase sampling approach in humans (multiple pre- and post-dosing samples and sampling after repeat dosing) as well as the clear pattern on RBC cholinesterase inhibition means the absence of plasma cholinesterase inhibition data is of little to no consequence.

In its objections NRDC claims that plasma cholinesterase inhibition data ‘‘might have reduced somewhat’’ the variability in the RBC cholinesterase data. EPA disagrees both because plasma cholinesterase in humans is overwhelmingly composed of butyrylcholinesterase not acetylcholinesterase, and because the robust sampling plan in the Gledhill study well-characterized the RBC cholinesterase variability. For all of these reasons, NRDC’s objection on this issue are denied.

e. Controls over environment—i. Objection/hearing request sub-issue. NRDC argues that because there were

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not controls over the Gledhill test subjects’ exposure to environmental factors which might affect cholinesterase inhibition (e.g., ingestion of pharmaceuticals), the results of Gledhill study might be caused environmental factors and are thus invalid.

ii. Background. This claim is contained in NRDC’s petition and was not specifically addressed by EPA in the petition denial order other than through its acceptance of the HSRB’s analysis.

iii. Denial of hearing request. The control measures used in the Gledhill study are set forth in the study report and are not in dispute. The only question is whether these control measures make the Gledhill study scientifically invalid and thus not in compliance with EPA regulations. Legal questions such as this are not appropriate for a hearing. (40 CFR 178.32(b)(1); see, e.g., 68 FR 46403, 46406 n.18, 46408, 46409 (August 5, 2003) (whether facts in the record show there is a reasonable certainty of no harm is a question of law and thus is not a hearing issue; whether a particular effect is a ‘‘harm’’ is a question of law not of fact and a hearing will not be held on issues of law)). Additionally, NRDC proffers no evidence regarding the effect of the study’s control measures other than speculation about how environmental factors might have affected the study. A hearing will not be granted on the basis of mere allegations or speculation. (40 CFR 178.32(b)(2); (57 FR 6667, 6671 (February 27, 1992)). Finally, NRDC’s argument here is immaterial to its claim. As EPA explains below in denying this objection, the lack of control measures would only be an issue if NRDC is arguing that EPA has wrongfully concluded that the Gledhill study has not shown a measurable effect in the treated subjects.

iv. Denial of objection. NRDC’s objection here might warrant some consideration if the study results had shown no pattern and EPA had concluded that the study established a NOAEL for DDVP. In those circumstances, it could be argued that any effects from DDVP exposure may have been masked by other factors. However, the study results here showed a clear and consistent pattern of marginal effects on RBC cholinesterase inhibition in connection with DDVP dosing. Given these results and the fact that the test subjects were pre-screened for environmental factors that might affect study results (e.g., regular use of pharmaceuticals; excessive alcohol consumption; exposure to organophosphurus compounds), NRDC’s speculation that environmental

factors might have affected the study results is without merit.

f. Consent—i. Objection/hearing request sub-issue. NRDC asserts that informed consent was not obtained from the Gledhill test subjects because the consent form for the experiment identified DDVP as a ‘‘drug.’’ (Ref. 1 at 14). NRDC claims that EPA has ignored this issue. NRDC cites an EPA memorandum dated March 16, 2006, examining the ethics of the Gledhill study and asserts that it ‘‘fails to mention [the informed consent] issue when it concludes that the study was not fundamentally unethical.’’ (Id. at 15). NRDC argues that describing DDVP as a drug ‘‘constitute[s] ‘fundamentally unethical’ actions by any reasonable understanding of that term.’’ (Id.).

ii. Background. This objection comes verbatim from NRDC’s comments on the DDVP IRED. EPA responded to this issue in its denial of NRDC’s petition by adopting the HSRB’s conclusion that informed consent was obtained. EPA explained that ‘‘[t]he HSRB reasoned that references to DDVP as a drug did not vitiate informed consent because ‘the consent materials clearly advised subjects that this was a study involving consuming an insecticide.’’’ (72 FR at 68675).

iii. Denial of hearing. It is not clear from NRDC’s objections whether NRDC is challenging EPA’s conclusion on the ethics of consent issue based on (1) an alleged failure of EPA to address this question; or (2) the legal proposition that identification of a pesticide as a drug ‘‘constitute[s] ‘fundamentally unethical’ actions by any reasonable understanding of that term.’’ In either case, a hearing is not appropriate on NRDC’s objection.

First, NRDC’s allegation that EPA did not address the consent issue does not present a genuinely-disputed issue of fact. It is plain on the face of EPA’s petition denial order, that EPA adopted the reasoning of the HSRB on why references on the consent form to DDVP as a drug do not constitute clear and convincing evidence that the Gledhill study is fundamentally unethical. (72 FR at 68675). After summarizing the decision of the HSRB on the consent issue (see quoted language in Unit VIII.E.3.f.ii. above), EPA stated: ‘‘EPA adopts the HSRB’s reasoning and finds it persuasive in rejecting NRDC’s arguments concerning why the Gledhill study should not be relied upon.’’ (Id.). NRDC’s argument that EPA offered no explanation is based on a memorandum that predates and is superseded by EPA’s denial of NRDC’s petition. The March 16, 2006 memorandum was finalized more than 20 months before

issuance of the DDVP petition denial order and the order contains EPA’s rationale on the consent issue. As noted earlier in Unit VIII.D.3.c., when an objector to a section 408(d)(4)(iii) order challenges an EPA conclusion that has been superseded by the section 408(d)(4)(iii) order, the objector has not raised a live controversy as to a material issue. (See 53 FR 53176, 53191 (December 30, 1988) (where FDA responds to a comment in the final rule, repetition of the comment in objections does not present a live controversy unless the objector proffers some evidence calling FDA’s conclusion into question)). Moreover, objections, and hearing requests on objections, may only be filed as to a section 408(d)(4)(iii) order or other statutorily-specified action. (21 U.S.C. 346a(g)(2)(A)).

Second, the informed consent question as to the Gledhill study is a legal/policy issue not a factual one. There are no disputed facts regarding the consent form. The consent form used in the Gledhill study is set forth in the study report and NRDC has not proffered any other evidence bearing on consent. Accordingly, the only question is the legal/policy one of whether use of the Gledhill study consent form is ‘‘clear and convincing evidence’’ that the Gledhill study was ‘‘fundamentally unethical’’ and thus not in compliance with EPA regulations. (40 CFR 26.1704). In fact, NRDC has framed the consent issue as a legal question, arguing that the undisputed reference to DDVP as a drug in the consent form for the Gledhill study ‘‘constitute[s] [a] ‘fundamentally unethical’ action[] by any reasonable understanding of that [regulatory] term.’’ (Ref. 1 at 15). Further, to support this legal argument, NRDC turns to other legal authorities arguing that ‘‘[t]he requirement for obtaining informed consent is at the core of the [40 CFR] Part 26 regulations and FIFRA section 12(a)(2)(P),’’ and ‘‘[v]iolation of these regulations, laws and international standards in the design and conduct of human studies is fundamentally unethical.’’ (Id.). Hearings are not appropriate on questions of law or policy. (40 CFR 178.32(b)(1)).

Finally, a hearing is not appropriate on this sub-issue because NRDC’s objection does not respond to EPA’s conclusion, based on the HSRB’s reasoning, as to why there was not a problem with consent in the Gledhill study. As such, NRDC’s objection on this point is nothing more than a general denial of EPA’s conclusion and a hearing cannot be justified on this basis. (40 CFR 178.32(b)(2)).

iv. Denial of objection. NRDC has offered no response to EPA’s petition

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denial order which incorporated the HSRB’s reasoning as to why the references to DDVP as a drug did not constitute clear and convincing evidence that the Gledhill study was fundamentally unethical. Specifically, NRDC does not address the HSRB’s conclusion, adopted by EPA, that the test subjects’ consent was informed because ‘‘the consent materials clearly advised subjects that this was a study involving consuming an insecticide.’’ (Ref. 21 at 46). Thus, EPA denies the objection.

g. Protection of health of the test subjects—i. Objection/hearing request sub-issue. NRDC differs with EPA’s conclusion that there was not clear and convincing evidence that the Gledhill study was rendered fundamentally unethical by the failure of the test conductors to retest the subjects until their cholinesterase inhibition levels returned to baseline levels. (Ref. 1 at 14- 15). According to NRDC, EPA acknowledged, in a March 16, 2006, memorandum, that the failure to retest was inconsistent with the standards in the Declaration of Helskinki by showing a lack of concern for the safety of the test subjects. (Id.). NRDC claims that EPA has offered no explanation for why it concluded that the Gledhill study was not fundamentally unethical despite this inconsistency with the Declaration of Helsinki. (Id. at 15).

ii. Background. This objection is adopted verbatim from the comments that NRDC filed on the IRED. (Ref. 23 at 16-17). In responding to this claim, EPA adopted the reasoning of the HSRB that ‘‘[d]eficiencies in monitoring of subjects were found not to provide clear and convincing evidence that the study was ethically deficient by subjecting the test subjects to the threat of serious harm because prior studies by this researcher involving higher doses had only invoked minimal responses.’’ (72 FR at 68675).

iii. Denial of hearing. As with the consent issue, it is not clear from NRDC’s objections whether NRDC is challenging EPA’s conclusion on the ethics of not retesting based on (1) an alleged failure of EPA to offer an explanation for its conclusion; or (2) the legal proposition that a study that is inconsistent with the Declaration of Helsinki is necessarily ‘‘fundamentally unethical’’ under the Human Research rule. In either case, a hearing is not appropriate on NRDC’s objections.

If NRDC is challenging EPA’s alleged lack of an explanation, then NRDC has failed to identify a genuinely-disputed issue of fact. As with the consent issue, EPA, in its petition denial order, summarized and then adopted the

reasoning of the HSRB on why the failure to retest does not constitute clear and convincing evidence that the Gledhill study is fundamentally unethical. (72 FR at 68675) (see quoted language in Unit VIII.E.3.g.ii. above). NRDC’s argument that EPA offered no explanation is based on a memorandum that predates and is superseded by EPA’s denial of NRDC’s petition. For the reasons set forth in Unit VIII.D.3.c and Unit VIII.E.3.f.iii., an objection and hearing request as to a section 408(d)(4)(iii) order based on a memorandum superseded by the section 408(d)(4)(iii) order does not constitute a live controversy on an issue material to the section 408(d)(4)(iii) order and, arguably, not even a valid objection under section 408(g)(2)(A). (21 U.S.C. 346a(g)(2)(A); see 53 FR 53176, 53191 (December 30, 1988) (where FDA responds to a comment in the final rule, repetition of the comment in objections does not present a live controversy unless the objector proffers some evidence calling FDA’s conclusion into question)).

If NRDC is challenging the substance of EPA’s conclusion on the ethics of the Gledhill study, this objection also does not warrant a hearing because NRDC is making no more than a legal or policy argument. There is no dispute with regard to what post-testing was performed as to the Gledhill subjects. NRDC admits as much. (Ref. 1 at 15 (‘‘There is nothing in the [EPA] memo that suggests that there is any uncertainty or controversy about what the various study documents said or what was done in the study in relation to this ethical ‘inconsistency’ with the Helsinki Declaration. . . . Notwithstanding the clear facts of the case [regarding retesting] . . . .’’). The only question is whether the failure to test subjects until cholinesterase inhibition levels returned to baseline is ‘‘clear and convincing evidence’’ that the Gledhill study was ‘‘fundamentally unethical.’’ (40 CFR 26.1704). Like the consent issue, NRDC, itself, has framed the issue as involving a legal question as to which there is only one answer. According to NRDC, ‘‘these failings [as to retesting subjects and consent] both constitute ‘fundamentally unethical’ actions by any reasonable understanding of that term.’’ (Ref. 1 at 15). Further, NRDC argues categorically that ‘‘[v]iolation of . . . international standards in the design and conduct of human studies is fundamentally unethical.’’ (Id.). This is a legal/policy determination regarding application of an EPA regulatory standard and the standards of the Declaration of Helsinki

to undisputed facts. Certainly, NRDC has proffered no genuine factual issue to be resolved at a hearing. Hearings are not appropriate on questions of law or policy. (40 CFR 178.32(b)(1)).

Finally, a hearing is not appropriate on this sub-issue because NRDC’s objection does not respond to EPA’s conclusion, based on the HSRB’s reasoning, as to why the failures in monitoring of subjects following the conclusion of dosing did not amount to clear and convincing evidence that the study was fundamentally unethical. As such, NRDC’s objection on this point is nothing more than a general denial of EPA’s conclusion and a hearing cannot be justified on this basis. (40 CFR 178.32(b)(2)).

iv. Denial of objection. NRDC has offered no response to EPA’s petition denial order which incorporated the HSRB’s reasoning as to why the failure to retest subjects did not constitute clear and convincing evidence that the Gledhill study was fundamentally unethical. Specifically, NRDC does not address the HSRB’s conclusion, adopted by EPA, that the lack of retesting was not fundamentally unethical because ‘‘prior studies by this researcher involving higher doses had only invoked minimal responses.’’ (72 FR at 68675). Thus, NRDC’s objection on this point is denied.

F. Summary of Reasons for Denial of NRDC’s Hearing Requests

EPA denies NRDC’s request for a hearing on whether reliable data support EPA’s reduction of the children’s safety factor and on whether EPA properly relied on the Gledhill human study. EPA’s close examination of each of the 19 sub-issues involved in these two hearing requests demonstrates that none of the issues satisfies the standard for granting a hearing in 40 CFR 178.32. Most fail for multiple reasons.

Several sub-issues do not present an issue of genuinely-disputed fact. Instead, NRDC raises issues presenting purely legal or policy questions or questions involving the application of legal standards to undisputed facts. For example, with regard to its children’s safety factor objection, NRDC makes the legal argument that failure to complete the mandatory endocrine screening program compels EPA to retain the children’s safety factor for DDVP and all other pesticides. (See Unit VIII.D.2.a.). In other cases, NRDC’s description of a factual dispute is clearly contradicted by the record. An example here is NRDC’s assertion that EPA failed to consider acute residential exposure even though EPA, in response to

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NRDC’s petition, amended its risk assessment to include examination of exposure for 1–day and 14–day periods. (See Unit VIII.D.4.c.)

Many of NRDC’s sub-issues lack materiality. In some instances that is due to NRDC’s misunderstanding of a scientific concept - as when NRDC raises questions about the statistical power of the Gledhill study or seeks to invalidate the Gledhill study based on a alleged inadequacy to control for environmental factors. Both of these concepts have little relevance given the positive results found in that study. (See Units VIII.E.3.a. and VIII.E.3.e.). In other instances, the sub-issues presented by NRDC lack materiality either because (1) NRDC objects to aspects of EPA’s risk assessments that were changed in response to the petition; (2) NRDC fails to address the reasons given by EPA for denying NRDC’s petition; or (3) NRDC objects to prior conclusions of EPA that were superseded by the petition denial order. (See Units VIII.D.3., VIII.E.3.b., and VIII.E.3.g.)

Most importantly, as to all of the sub- issues, NRDC fails to identify and proffer evidence which, if established, would resolve one or more questions in NRDC’s favor. As EPA’s analysis shows, NRDC essentially proffered no evidence in support of its hearing requests and objections and instead relies upon legal and policy arguments and unsupported or speculative factual assertions. NRDC’s attempted evidentiary proffers are either: (1) so broad as to be meaningless (e.g., the complete EPA docket for DDVP); (2) too general to define a factual issue as to DDVP (e.g., newspaper and law review articles); (3) supportive of scientifically irrelevant claims (e.g., Sass and Lockwood articles); or (4) mere allegations or general denials (e.g., NRDC’s claim that dietary risk assessment ‘‘poses a serious risk of understating risks posed by DDVP;’’ NRDC’s speculation about how many DDVP pest strips a homeowner may use). (See Units VIII.C., VIII.D.3., and VIII.D.4.e.).

NRDC’s failure to offer evidence in support of its contentions is a consistent pattern in this proceeding. NRDC offered no greater support for its arguments in its petition, in its comments on the IRED, or, for that matter, in its written or oral comments to the HSRB. In these circumstances, EPA questions whether granting a hearing would have been appropriate even if NRDC had, at this last stage of the administrative process, suddenly produced factual evidence in support of its claims. Presumably, Congress created a multi-stage administrative process for resolution of tolerance petitions to give

EPA the opportunity in the first stage of the proceeding to resolve factual issues, where possible, through a notice-and- comment process, prior to requiring EPA to hold a full evidentiary hearing - which can involve a substantial investment of resources by all parties taking part. While EPA has not held any pesticide tolerance hearings under the FFDCA, its experience with pesticide hearings under FIFRA in the 1970s indicates the process can be quite lengthy. (See were e.g., Environmental Defense Fund v. EPA, 548 F.2d 998, 1002 (D.C. Cir. 1976) (4 months were needed for testimony in an expedited FIFRA suspension proceeding); Environmental Defense Fund, Inc. v. EPA, 510 F.2d 1292, 1297 (D.C. Cir. 1975) (13 months of testimony in a FIFRA cancellation proceeding); Environmental Defense Fund v. Ruckelshaus, 489 F.2d 1247, 1251 n. 24 (D.C. Cir. 1973) (‘‘During seven months of hearings [in the DDT cancellation proceeding], 125 witnesses appeared to testify and 365 exhibits were placed in evidence. The transcript of the hearings was over 9,000 pages long.’’); Ref. 44 at 246 (referring to FIFRA cancellation proceedings in the 1970s as the ‘‘‘100– years’ pesticide wars’’). Given that in the ensuing 30 years the pesticide risk assessment process has become exponentially more complex, FFDCA pesticide hearings have the potential for being even more resource intensive. Accordingly, if a party were to withhold evidence from the first stage of a tolerance petition proceeding and only produce it as part of a request for a hearing on an objection, EPA might very likely determine that such an untimely submission of supporting evidence constituted an amendment to the Original petition requiring a return to the first stage of the administrative process (if, consideration of information that was previously available is appropriate at all).

Finally, EPA notes that it is denying NRDC’s hearing requests under 40 CFR 178.32 and does not here rely on the even broader discretionary authority to deny hearing requests in FFDCA section 408(g)(2)(B). As recounted previously, 40 CFR 178.32 predates the explicit addition to the statute by the FQPA of the grant of authority to EPA to deny hearings. That language provides that EPA shall ‘‘hold a public evidentiary hearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidence relevant to material issues of fact raised by the objections.’’ (21 U.S.C. 346a(g)(2)(B)). EPA does not interpret this language as requiring it to

hold a hearing in any instance where factual evidence relevant to a material issue of fact is proffered (essentially the standard set forth in 40 CFR 178.32); rather, EPA construes the statutory language as requiring it to hold a hearing only where it determines a hearing is necessary to receive such proffered evidence. In other words, a party wishing to obtain a hearing must not only satisfy the requirements of 40 CFR 178.32, it must also show that an evidentiary hearing is necessary to presentation of proffered evidence to the Agency. Because, however, NRDC has not satisfied the standard set forth in 40 CFR 178.32, EPA does not need to address whether a hearing is necessary to receive NRDC’s ‘‘evidentiary’’ proffer.

G. Summary of Reasons for Denial of NRDC’s Objections

EPA denies NRDC’s objections to EPA’s petition denial that EPA lacked sufficient data to reduce the children’s safety factor for DDVP, and EPA unlawfully relied on the Gledhill intentional human dosing study in assessing the risk of DDVP exposure.

1. Children’s safety factor objection. In support of its children’s safety factor objection, NRDC claims that EPA has inadequate data on endocrine effects, dietary exposure to DDVP residues in food, and exposure from residential pest strips. On endocrine effects, NRDC argues that EPA lacks adequate data, as a legal matter, because it has not completed the section 408(p) endocrine screening program, and, as a factual matter, because DDVP has not been tested under the most recent two- generation rat reproduction study. EPA has previously rejected NRDC’s legal argument as not consistent with the statutory language, structure, or history, and NRDC has offered no arguments as to why EPA’s previous conclusion was incorrect. On the factual question of whether EPA has adequate endocrine data on DDVP, EPA concluded in the petition denial that, given the existing data bearing on DDVP’s potential to cause endocrine effects and large difference in sensitivity between DDVP’s cholinesterase inhibition effects and potential endocrine effects, EPA had sufficient reliable data on DDVP’s potential endocrine effects to vary from the default children’s safety factor. In its objections, NRDC offers nothing other than speculation about what another two-generation rat reproduction study might show. NRDC’s speculation does not convince EPA that its analysis was incorrect.

As to dietary exposure to DDVP residues in food, NRDC argues that EPA’s dietary exposure assessment has

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many shortcomings that may lead to underestimation of dietary exposure to DDVP. In support of this claim, NRDC relies on statements EPA made in 2000 in a preliminary risk assessment of DDVP. NRDC places particular emphasis on its claim that EPA’s database on food consumption by infants is inadequate. These allegations by NRDC lack merit because NRDC has ignored the many revisions to the DDVP risk assessment since the 2000 preliminary risk assessment. First, EPA completely revised the dietary exposure and risk assessment in response to NRDC’s petition. One of the specific reasons for revising the risk assessment was so that EPA’s latest information on infant food consumption could be incorporated. Second, also in response to NRDC’s petition, EPA comprehensively analyzed its dietary exposure assessment to evaluate whether that assessment potentially underestimated dietary exposure to DDVP. EPA concluded that ‘‘its assessment of exposure to DDVP from food will not under-estimate but rather over-estimate, and in all likelihood substantially over-estimate, DDVP exposure.’’ (72 FR at 68686). NRDC neither acknowledges nor challenges the revised dietary exposure assessment or EPA’s detailed analysis of whether that assessment under- or over-estimates DDVP exposure. Finally, EPA questions the materiality of NRDC’s argument with regard to DDVP exposure from food given that DDVP exposure from this source is trivial compared with other sources. For all of these reasons, EPA rejects NRDC’s arguments on the alleged inadequacy of EPA’s assessment of human dietary exposure to DDVP in food.

With regard to DDVP exposure from residential pest strips, NRDC claims that the data relied upon by EPA (the Collins and DeVries study) was inadequate and EPA’s risk assessment based on that study was based on inadequately- supported assumptions. These arguments, however, are without merit because not only does NRDC offer nothing other than general, undocumented contentions in support but once again NRDC has ignored clear evidence and analysis in the record that contradict its allegations. First, NRDC ignores the other DDVP pest strip exposure studies relied upon by EPA to support the findings in the Collins and DeVries study. EPA concluded that these studies confirmed that the findings in Collins and DeVries were representative of DDVP concentration levels from pest strips that could be expected in houses in other locations.

Second, NRDC ignores EPA’s complete revision to the DDVP residential exposure assessment that was conducted in response to its petition. That revision modified numerous assumptions in the assessment to ensure that the data from the Collins and DeVries study were analyzed in a conservative fashion. NRDC does not acknowledge the new assessment much less offer a rebuttal to EPA’s revised analysis. Most surprisingly, NRDC repeats challenges to several assumptions (only examining DDVP exposure as averaged over a 120–day period; considering 16 hours per day a maximum exposure in a home) that were explicitly modified (adding consideration of 1–day and 14–day exposure periods; assuming 24 hours exposure per day) in the revised risk assessment in response to NRDC’s petition. Accordingly, EPA disagrees with NRDC’s allegations concerning the inadequacy of the data and assumptions underlying its residential pest strip risk assessment.

2. Human study objection. NRDC challenged EPA’s reliance on the Gledhill human study arguing that EPA’s Human Research rule is unlawful and the study was both scientifically flawed and unethically conducted.

NRDC relies on its legal briefs filed in a separate challenge to the Human Research rule and its comments on that rule in support of its legal attack on the rule. Similarly, to the extent NRDC has standing to challenge a rule whose ‘‘primary concern’’ is the ‘‘[p]rotection of the health and safety of human test subjects,’’ (Ref. 1 at 15), EPA relies on its legal brief in the 2nd Circuit proceeding and the administrative record for the rule, in denying NRDC’s challenge to Human Research Rule.

As to the Gledhill study, itself, NRDC makes various claims regarding its scientific validity and ethicality. NRDC has previously presented these claims in writing and orally to EPA’s HSRB. The HSRB is an independent scientific panel, consisting of experts in bioethics, biostatistics, human health risk assessment, and human toxicology, created specifically for the purpose of advising EPA on whether human studies have scientific value and conform to ethical standards. Although NRDC’s concerns as to the Gledhill study were presented to the HSRB, the HSRB concluded that the Gledhill study complied with the Human Research rule and could be considered by EPA in assessing the risk of DDVP. EPA relied heavily on the advice by the HSRB in denying NRDC’s petition. Remarkably, NRDC, in its objections, proceeds as if the HSRB review never occurred. NRDC

neither acknowledges the existence of the HSRB report nor attempts to refute its reasoning. In Unit VIII.E. above, EPA repeats the findings of the HSRB and EPA’s reasons for accepting the HSRB’s conclusions with regard to the specific contentions of NRDC. Based on both the findings of the HSRB and EPA in its petition denial, as described above, as well as NRDC’s failure to meaningfully dispute those findings, EPA rejects NRDC’s challenge to EPA’s reliance on the Gledhill study.

H. Conclusion

For all of the reasons set forth above, EPA denies NRDC’s objections and its requests for a hearing on those objections.

IX. References 1. Natural Resources Defense Council,

‘‘Objection to the Order Denying NRDC’s Petition to Revoke All Tolerances for Dichlorvos (DDVP), and Request for Public Evidentiary Hearing’’ (February 1, 2008).

2. Natural Resources Defense Council, Petition of Natural Resources Defense Council To Conclude Special Review, Reregistration and Tolerance Reassessment Processes and To Revoke All Tolerances and Cancel All Registrations for the Pesticide DDVP (June 2, 2006).

3. Office of Prevention, Pesticides and Toxic Substances, EPA, ‘‘Interim Reregistration Eligibility Decision for Dichlorvos (DDVP)’’ (June 2006).

4. U.S. EPA, ‘‘A User’s Guide to Available EPA Information on Assessing Exposure to Pesticides in Food’’ (June 21, 2000).

5. Office of Pesticide Programs, US EPA, ‘‘Office of Pesticide Programs’ Policy on the Determination of the Appropriate FQPA Safety Factor(s) For Use in the Tolerance Setting Process’’ (February 28, 2002).

6. U.S. EPA, ‘‘Residue Chemistry Test Guidelines: OPPTS 860.1500 Crop Field Trials’’ (August 1996).

7. Office of Pesticide Programs, U.S. EPA and Pest Regulatory Management Agency, ‘‘Health Canada, NAFTA Guidance Document for Guidance for Setting Pesticide Tolerances Based on Field Trial Data’’ (September 28, 2005).

8. Office of Pesticide Programs, U.S. EPA, ‘‘Choosing a Percentile of Acute Dietary Exposure as a Threshold of Regulatory Concern’’ March 16, 2000).

9. Office of Pesticide Programs, U.S. EPA,‘‘Standard Operating Procedures (SOPs) for Residential Exposure Assessments’’ (Draft December 19, 1997).

10. Office of Pesticide Programs, U.S. EPA, ‘‘The Use of Data on

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Cholinesterase Inhibition for Risk Assessments of Organophosphorous and Carbamate Pesticides’’ (August 18, 2000).

11. U.S. EPA, ‘‘Endocrine Disruptor Screening and Testing Advisory Committee Final Report’’ (August 1998).

12. U.S. EPA, U.S. EPA Charter: Human Studies Review Board (2008) (available at http://www.epa.gov/osa/ hsrb/files/dated-hsrb-renewal-charter- effect-030408.pdf).

13. Office of Pesticide Programs, U.S. EPA, ‘‘Organophosphorus Cumulative Risk Assessment – 2006 Update’’ (August 2006).

14. Office of Prevention, Pesticides and Toxic Substances, EPA, Memorandum from Debra Edwards to Jim Jones, ‘‘Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides’’ (July 31, 2006).

15. Office of Pesticide Programs, U.S. EPA, ‘‘Data Evaluation Report: Dichlorvos: A Single Blind, Placebo Controlled, Randomized Study to Investigate the Effects of Multiple Oral Dosing on Erythrocyte Cholinesterase Inhibition in Healthy Male Volunteers’’ (March 24, 1998).

16. Office of Prevention, Pesticides and Toxic Substances, EPA, Memorandum from Ray Kent/William Dykstra to Tina Levine, ‘‘Human Studies Review Board: Final Weight of Evidence Comparison of Human and Animal Toxicology Studies and Endpoints for DDVP Human Health Risk Assessment and Discussion of Interspecies Extrapolation in the Organophosphate Cumulative Risk Assessment’’ (March 20, 2006).

17. Sass, J., Natural Resources Defense Council, ‘‘NRDC comments for the HSRB meeting April 4-6, 2006’’ (undated).

18. EPA Human Studies Review Board, Minutes of the United States Environmental Protection Agency (EPA) Human Studies Review Board (HSRB) April 4-6, 2006 Public Meeting Docket Number: EPA–HQ–ORD–2006–0187 (May 15, 2006).

19. EPA Human Studies Review Board, Letter from Celia Fisher to George Gray, April 4-6, 2006 Meeting EPA Human Studies Review Board Report — Proposed Final Draft V. 1 (May 16, 2006).

20. EPA Human Studies Review Board, Minutes of the United States

Environmental Protection Agency (EPA) Human Studies Review Board (HSRB) June 8, 2006 Public Teleconference Docket Number: EPA–HQ–ORD–2006– 0187 (June 19, 2006).

21. EPA Human Studies Review Board, Letter from Celia Fisher to George Gray, April 4-6, 2006 Meeting EPA Human Studies Review Board Report (June 26, 2006).

22. Amvac Chemical Corporation, Comments of Amvac Chemical Corporation in Reponse to EPA’s Notice of a Petition to Revoke Tolerances Established for Dichlorvos (November 13, 2006).

23. Natural Resources Defense Council, Letter submitting comments Re: Dichlorvos Interim Reregistration Eligibility Decision, 71 FR 37568 (June 30, 2006) (August 28, 2006).

24. Reference Dose/Reference Concentration (RfD/RfC) Technical Panel, Risk Assessment Forum, U.S. EPA, ‘‘A Review of the Reference Dose and Reference Concentration Processes’’ (December 2002).

25. USDA, ‘‘Food and Nutrient Intakes by Children 1994-96, 1998, Table Set 17’’ (December 1999).

26. USDA, ‘‘Documentation: Supplemental Children’s Survey (CSFII 1998) to the 1994-96 Continuing Survey of Food Intakes by Individuals’’ (2000).

27. Office of Prevention, Pesticides and Toxic Substances, EPA, Memorandum from Susan V. Hummel to Kimberly Lowe/Robert McNally, ‘‘Revised Preliminary HED Risk Assessment for Dichlorvos’’ (August 9, 2000).

28. U.S. EPA, Letter from George T. LaRocca, Product Manager (13), Insecticide Branch, Registration Division, to Jon C. Wood, ‘‘Amvac Chemical Corp., Dichlorvos (DDVP) Label Amendments’’ (October 11, 2006).

29. Petitioners’ Brief, NRDC v. EPA, (2nd Cir. 06-0820-ag) (October 4, 2006).

30. Natural Resources Defense Council, ‘‘Protections for Subjects in Human Research; Proposed Rule, 70 FR 53838’’ (Sept. 12, 2005) (December 12, 2005).

31. Respondent’s Brief, NRDC v. EPA, (2nd Cir. 06-0820-ag) (November 16, 2006).

32. Federal Judicial Center, ‘‘Reference Manual on Scientific Evidence’’ (2d ed. 2000).

33. Sass, J.B., Needleman, H.L., ‘‘Industry Testing of Toxic Pesticides on Human Subjects Concluded No Effect, Despite the Evidence,’’ Environmental Health Perspectives. 2004 Mar; 112(3) A150-151.

34. Sass, J.B., Needleman, H.L., ‘‘Human Testing: Sass and Needleman Respond to Industry,’’ Environmental

Health Perspectives. 2004 Ma; 112(6) A340-341.

35. Lockwood, A.H., ‘‘Human Testing of Pesticides: Ethical and Scientific Considerations,’’ American Journal of Public Health 2004 Nov; 94(11) 1908- 1916.

36. Lockwood, A.H., ‘‘The Ethical Bar Drops to Unacceptable,’’ Environmental Forum. 2005 Nov/Dec; 48.

37. U.S. EPA, Tolerance Reassessment (March 6, 2008) (published at http:// www.epa.gov/pesticides/tolerance/ reassessment.htm).

38. Baetcke, K.P., Phang, W., and Dellarco, V., Health Effects Division, Office of Pesticide Programs, U.S. EPA, ‘‘A Comparison of the Results of Studies on Pesticides from 12- or 24-Month Dog Studies with Dog Studies of Shorter Duration’’ (April 7, 2005).

39. U.S. Food and Drug Administration, ‘‘Toxicological Principles for the Safety Assessment of Food Ingredients: Redbook 2000,’’ secs. IV.C.4b and IV.C.5. (November 2003).

40. OECD, ‘‘OECD Guideline For The Testing Of Chemicals: Repeated Dose 90–day Oral Toxicity Study in Non- Rodents — 409’’ (September 1998).

41. OECD, ‘‘OECD Guideline For The Testing Of Chemicals: Chronic Toxicity Studies — 452’’ (May 1981).

42. OECD Test Guideline No. 452, ‘‘Chronic Toxicity Studies’’ dated May 12, 1981; (CPR 52(a)(iii), 52(b)(ii), 52(c)(ii), 59(a)(iii), 59(b)(ii), 59(c)(ii) and 63) (Can).

43. Council Directive No. 2001/59/EC, O.J. L 225 (2001) (Annex V of Dir 67/ 548/EEC on the Classification, Packaging and Labeling of Dangerous Substances (http://ecb.jrc.it/testing- methods/annex5)).

44. William Rodgers, Environmental Law: Pesticides and Toxic Substances (1988).

X. Regulatory Assessment Requirements

As indicated previously, this action announces the Agency’s final order regarding objections filed under section 408 of FFDCA. As such, this action is an adjudication and not a rule. The regulatory assessment requirements imposed on rulemaking do not, therefore, apply to this action.

XI. Submission to Congress and the Comptroller General

The Congressional Review Act, (5 U.S.C. 801 et seq.), as added by the Small Business Regulatory Enforcement Fairness Act of 1996, does not apply because this action is not a rule for purposes of 5 U.S.C. 804(3).

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Appendix 1—United States Environmental Protection Agency Human Studies Review Board

Chair

Celia B. Fisher, Ph.D. Marie Ward Doty Professor of Psychology, Director, Center for Ethics Education, Fordham University, Department of Psychology, Bronx, NY

Vice Chair

William S. Brimijoin, Ph.D., Chair and Professor, Molecular Pharmacology and Experimental Therapeutics, Mayo Foundation, Rochester, MN

Members

David C. Bellinger, Ph.D., Professor of Neurology, Harvard Medical School Professor in the Department of Environmental Health, Harvard School of Public Health Children’s Hospital, Boston, MA

Alicia Carriquiry, Ph.D., Professor, Department of Statistics, Iowa State University Snedecor Hall, Ames, IA

Gary L. Chadwick, PharmD, MPH, CIP, Associate Provost, Director, Office for Human Subjects Protection, University of Rochester, Rochester, NY

Janice Chambers, Ph.D., D.A.B.T., William L. Giles Distinguished Professor, Director, Center for Environmental Health Sciences, College of Veterinary Medicine, Mississippi State University, Wise Center, Mississippi State, MS

Richard Fenske, Ph.D., MPH, Professor, Department of Environmental and Occupational Health Sciences, University of Washington, Seattle, WA

Susan S. Fish, PharmD, MPH, Professor, Biostatistics and Epidemiology, Boston University School of Public Health, Co- Director, MA in Clinical Investigation Boston University School of Medicine, Boston, MA

Suzanne C. Fitzpatrick, Ph.D., DABT, Senior Science Policy Analyst, Office of the Commissioner, Office of Science and Health Coordination, U.S. Food and Drug Administration, Rockville, MD

Kannan Krishnan, Ph.D., Professor, Departement de sante environnementale et sante au travail, Faculte de medicine, Universite de Montreal, Montreal, Canada

KyungMann Kim, Ph.D., CCRP, Professor and Associate Chair, Department of Biostatistics and Medical Informatics, School of Medicine and Public Health, University of Wisconsin-Madison, Madison, WI

Michael D. Lebowitz, Ph.D., FCCP, Professor of Public Health and Medicine. University of Arizona, Tucson, AZ

Lois D. Lehman-Mckeeman, Ph.D., Distinguished Research Fellow, Discovery Toxicology, Bristol-Myers Squibb Company, Princeton, NJ

Jerry A. Menikoff, M.D., Associate Professor of Law, Ethics and Medicine, Director of the Institute for Bioethics, Law and Public Policy, University of Kansas Medical Center, Kansas City, KS

Robert Nelson, M.D., Ph.D., Associate Professor of Anesthesiology and Critical Care, Department of Anesthesiology and Critical Care, University of Pennsylvania School of Medicine, The Children’s Hospital of Philadelphia, Philadelphia, PA

Sean M. Philpott, Ph.D., Research Scientist, David Axelrod Institute, Wadsworth Center for Laboratories and Research, New York State Department of Health, Albany, NY

List of Subjects in 40 CFR Part 180

Environmental protection, Administrative practice and procedure, Agricultural commodities, Pesticides and pests, Reporting and recordkeeping requirements.

Dated: July 11, 2008. Debra Edwards, Director, Office of Pesticide Programs. [FR Doc. E8–16617 Filed 7–22–08; 8:45 am] BILLING CODE 6560–50–S

ENVIRONMENTAL PROTECTION AGENCY

40 CFR Part 180

[EPA–HQ–OPP–2008–0302; FRL–8369–5]

Fludioxonil; Pesticide Tolerance for Emergency Exemption

AGENCY: Environmental Protection Agency (EPA). ACTION: Final rule.

SUMMARY: This regulation establishes a time-limited tolerance for residues of fludioxonil in or on carambola (starfruit). This action is in response to EPA’s granting of an emergency exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) authorizing use of the pesticide on carambola. This regulation establishes a maximum permissible level for residues of fludioxonil in starfruit. The time-limited tolerance expires and is revoked on December 31, 2010. DATES: This regulation is effective July 23, 2008. Objections and requests for hearings must be received on or before September 22, 2008, and must be filed in accordance with the instructions provided in 40 CFR part 178 (see also

Unit I.C. of the SUPPLEMENTARY INFORMATION.

ADDRESSES: EPA has established a docket for this action under docket identification (ID) number EPA–HQ– OPP–2008–0302. To access the electronic docket, go to http:// www.regulations.gov, select ‘‘Advanced Search,’’ then ‘‘Docket Search.’’ Insert the docket ID number where indicated and select the ‘‘Submit’’ button. Follow the instructions on the regulations.gov website to view the docket index or access available documents. All documents in the docket are listed in the docket index available in regulations.gov. Although listed in the index, some information is not publicly available, e.g., Confidential Business Information (CBI) or other information whose disclosure is restricted by statute. Certain other material, such as copyrighted material, is not placed on the Internet and will be publicly available only in hard copy form. Publicly available docket materials are available either in the electronic docket at http://www.regulations.gov, or, if only available in hard copy, at the Office of Pesticide Programs (OPP) Regulatory Public Docket in Rm. S–4400, One Potomac Yard (South Bldg.), 2777 S. Crystal Dr., Arlington, VA. The hours of operation of this Docket Facility are from 8:30 a.m. to 4 p.m., Monday through Friday, excluding legal holidays. The Docket Facility telephone number is (703) 305–5805. FOR FURTHER INFORMATION CONTACT: Andrea Conrath, Registration Division (7505P), Office of Pesticide Programs, Environmental Protection Agency, 1200 Pennsylvania Ave., NW., Washington, DC 20460–0001; telephone number: (703) 308–9356; e-mail address: conrath.andrea@epa.gov.

SUPPLEMENTARY INFORMATION:

I. General Information

A. Does this Action Apply to Me?

You may be potentially affected by this action if you are an agricultural producer, food manufacturer, or pesticide manufacturer. Potentially affected entities may include, but are not limited to:

• Crop production (NAICS code 111). • Animal production (NAICS code

112). • Food manufacturing (NAICS code

311). • Pesticide manufacturing (NAICS

code 32532). This listing is not intended to be

exhaustive, but rather provides a guide for readers regarding entities likely to be affected by this action. Other types of

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§ 136. Definitions, 7 USCA § 136

© 2012 Thomson Reuters. No claim to original U.S. Government Works. 1

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For purposes of this subchapter--

(a) Active ingredient

The term “active ingredient” means--

(1) in the case of a pesticide other than a plant regulator, defoliant, desiccant, or nitrogen stabilizer, an ingredient which willprevent, destroy, repel, or mitigate any pest;

(2) in the case of a plant regulator, an ingredient which, through physiological action, will accelerate or retard the rate ofgrowth or rate of maturation or otherwise alter the behavior of ornamental or crop plants or the product thereof;

(3) in the case of a defoliant, an ingredient which will cause the leaves or foliage to drop from a plant;

(4) in the case of a desiccant, an ingredient which will artificially accelerate the drying of plant tissue; and

(5) in the case of a nitrogen stabilizer, an ingredient which will prevent or hinder the process of nitrification, denitrification,ammonia volatilization, or urease production through action affecting soil bacteria.

(b) Administrator

The term “Administrator” means the Administrator of the Environmental Protection Agency.

(c) Adulterated

The term “adulterated” applies to any pesticide if--

(1) its strength or purity falls below the professed standard of quality as expressed on its labeling under which it is sold;

�������

§ 136. Definitions, 7 USCA § 136

© 2012 Thomson Reuters. No claim to original U.S. Government Works. 2

(2) any substance has been substituted wholly or in part for the pesticide; or

(3) any valuable constituent of the pesticide has been wholly or in part abstracted.

(d) Animal

The term “animal” means all vertebrate and invertebrate species, including but not limited to man and other mammals, birds,fish, and shellfish.

(e) Certified applicator, etc.

(1) Certified applicator

The term “certified applicator” means any individual who is certified under section 136i of this title as authorized to useor supervise the use of any pesticide which is classified for restricted use. Any applicator who holds or applies registeredpesticides, or uses dilutions of registered pesticides consistent with subsection (ee) of this section, only to provide a service ofcontrolling pests without delivering any unapplied pesticide to any person so served is not deemed to be a seller or distributorof pesticides under this subchapter.

(2) Private applicator

The term “private applicator” means a certified applicator who uses or supervises the use of any pesticide which is classifiedfor restricted use for purposes of producing any agricultural commodity on property owned or rented by the applicator orthe applicator's employer or (if applied without compensation other than trading of personal services between producers ofagricultural commodities) on the property of another person.

(3) Commercial applicator

The term “commercial applicator” means an applicator (whether or not the applicator is a private applicator with respect tosome uses) who uses or supervises the use of any pesticide which is classified for restricted use for any purpose or on anyproperty other than as provided by paragraph (2).

(4) Under the direct supervision of a certified applicator

Unless otherwise prescribed by its labeling, a pesticide shall be considered to be applied under the direct supervision of acertified applicator if it is applied by a competent person acting under the instructions and control of a certified applicatorwho is available if and when needed, even though such certified applicator is not physically present at the time and placethe pesticide is applied.

(f) Defoliant

The term “defoliant” means any substance or mixture of substances intended for causing the leaves or foliage to drop from aplant, with or without causing abscission.

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(g) Desiccant

The term “desiccant” means any substance or mixture of substances intended for artificially accelerating the drying of planttissue.

(h) Device

The term “device” means any instrument or contrivance (other than a firearm) which is intended for trapping, destroying,repelling, or mitigating any pest or any other form of plant or animal life (other than man and other than bacteria, virus, or othermicroorganism on or in living man or other living animals); but not including equipment used for the application of pesticideswhen sold separately therefrom.

(i) District court

The term “district court” means a United States district court, the District Court of Guam, the District Court of the VirginIslands, and the highest court of American Samoa.

(j) Environment

The term “environment” includes water, air, land, and all plants and man and other animals living therein, and theinterrelationships which exist among these.

(k) Fungus

The term “fungus” means any non-chlorophyll-bearing thallophyte (that is, any non-chlorophyll-bearing plant of a lower orderthan mosses and liverworts), as for example, rust, smut, mildew, mold, yeast, and bacteria, except those on or in living man orother animals and those on or in processed food, beverages, or pharmaceuticals.

(l) Imminent hazard

The term “imminent hazard” means a situation which exists when the continued use of a pesticide during the time requiredfor cancellation proceeding would be likely to result in unreasonable adverse effects on the environment or will involveunreasonable hazard to the survival of a species declared endangered or threatened by the Secretary pursuant to the EndangeredSpecies Act of 1973 [16 U.S.C.A. § 1531 et seq.].

(m) Inert ingredient

The term “inert ingredient” means an ingredient which is not active.

(n) Ingredient statement

The term “ingredient statement” means a statement which contains--

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(1) the name and percentage of each active ingredient, and the total percentage of all inert ingredients, in the pesticide; and

(2) if the pesticide contains arsenic in any form, a statement of the percentages of total and water soluble arsenic, calculatedas elementary arsenic.

(o) Insect

The term “insect” means any of the numerous small invertebrate animals generally having the body more or less obviouslysegmented, for the most part belonging to the class insecta, comprising six-legged, usually winged forms, as for example,beetles, bugs, bees, flies, and to other allied classes of arthropods whose members are wingless and usually have more than sixlegs, as for example, spiders, mites, ticks, centipedes, and wood lice.

(p) Label and labeling

(1) Label

The term “label” means the written, printed, or graphic matter on, or attached to, the pesticide or device or any of its containersor wrappers.

(2) Labeling

The term “labeling” means all labels and all other written, printed, or graphic matter--

(A) accompanying the pesticide or device at any time; or

(B) to which reference is made on the label or in literature accompanying the pesticide or device, except to current officialpublications of the Environmental Protection Agency, the United States Departments of Agriculture and Interior, theDepartment of Health and Human Services, State experiment stations, State agricultural colleges, and other similar Federalor State institutions or agencies authorized by law to conduct research in the field of pesticides.

(q) Misbranded

(1) A pesticide is misbranded if--

(A) its labeling bears any statement, design, or graphic representation relative thereto or to its ingredients which is falseor misleading in any particular;

(B) it is contained in a package or other container or wrapping which does not conform to the standards established by theAdministrator pursuant to section 136w(c)(3) of this title;

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(C) it is an imitation of, or is offered for sale under the name of, another pesticide;

(D) its label does not bear the registration number assigned under section 136e of this title to each establishment in whichit was produced;

(E) any word, statement, or other information required by or under authority of this subchapter to appear on the label orlabeling is not prominently placed thereon with such conspicuousness (as compared with other words, statements, designs,or graphic matter in the labeling) and in such terms as to render it likely to be read and understood by the ordinary individualunder customary conditions of purchase and use;

(F) the labeling accompanying it does not contain directions for use which are necessary for effecting the purpose forwhich the product is intended and if complied with, together with any requirements imposed under section 136a(d) of thistitle, are adequate to protect health and the environment;

(G) the label does not contain a warning or caution statement which may be necessary and if complied with, together withany requirements imposed under section 136a(d) of this title, is adequate to protect health and the environment; or

(H) in the case of a pesticide not registered in accordance with section 136a of this title and intended for export, thelabel does not contain, in words prominently placed thereon with such conspicuousness (as compared with other words,statements, designs, or graphic matter in the labeling) as to render it likely to be noted by the ordinary individual undercustomary conditions of purchase and use, the following: “Not Registered for Use in the United States of America”.

(2) A pesticide is misbranded if--

(A) the label does not bear an ingredient statement on that part of the immediate container (and on the outside container orwrapper of the retail package, if there be one, through which the ingredient statement on the immediate container cannotbe clearly read) which is presented or displayed under customary conditions of purchase, except that a pesticide is notmisbranded under this subparagraph if--

(i) the size or form of the immediate container, or the outside container or wrapper of the retail package, makes itimpracticable to place the ingredient statement on the part which is presented or displayed under customary conditionsof purchase; and

(ii) the ingredient statement appears prominently on another part of the immediate container, or outside container orwrapper, permitted by the Administrator;

(B) the labeling does not contain a statement of the use classification under which the product is registered;

(C) there is not affixed to its container, and to the outside container or wrapper of the retail package, if there be one, throughwhich the required information on the immediate container cannot be clearly read, a label bearing--

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(i) the name and address of the producer, registrant, or person for whom produced;

(ii) the name, brand, or trademark under which the pesticide is sold;

(iii) the net weight or measure of the content, except that the Administrator may permit reasonable variations; and

(iv) when required by regulation of the Administrator to effectuate the purposes of this subchapter, the registrationnumber assigned to the pesticide under this subchapter, and the use classification; and

(D) the pesticide contains any substance or substances in quantities highly toxic to man, unless the label shall bear, inaddition to any other matter required by this subchapter--

(i) the skull and crossbones;

(ii) the word “poison” prominently in red on a background of distinctly contrasting color; and

(iii) a statement of a practical treatment (first aid or otherwise) in case of poisoning by the pesticide.

(r) Nematode

The term “nematode” means invertebrate animals of the phylum nemathelminthes and class nematoda, that is, unsegmentedround worms with elongated, fusiform, or saclike bodies covered with cuticle, and inhabiting soil, water, plants, or plant parts;may also be called nemas or eelworms.

(s) Person

The term “person” means any individual, partnership, association, corporation, or any organized group of persons whetherincorporated or not.

(t) Pest

The term “pest” means (1) any insect, rodent, nematode, fungus, weed, or (2) any other form of terrestrial or aquatic plant oranimal life or virus, bacteria, or other micro-organism (except viruses, bacteria, or other micro-organisms on or in living manor other living animals) which the Administrator declares to be a pest under section 136w(c)(1) of this title.

(u) Pesticide

The term “pesticide” means (1) any substance or mixture of substances intended for preventing, destroying, repelling, ormitigating any pest, (2) any substance or mixture of substances intended for use as a plant regulator, defoliant, or desiccant,and (3) any nitrogen stabilizer, except that the term “pesticide” shall not include any article that is a “new animal drug” withinthe meaning of section 321(w) of Title 21, that has been determined by the Secretary of Health and Human Services not to be

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a new animal drug by a regulation establishing conditions of use for the article, or that is an animal feed within the meaningof section 321(x) of Title 21 bearing or containing a new animal drug. The term “pesticide” does not include liquid chemicalsterilant products (including any sterilant or subordinate disinfectant claims on such products) for use on a critical or semi-critical device, as defined in section 321 of Title 21. For purposes of the preceding sentence, the term “critical device” includesany device which is introduced directly into the human body, either into or in contact with the bloodstream or normally sterileareas of the body and the term “semi-critical device” includes any device which contacts intact mucous membranes but whichdoes not ordinarily penetrate the blood barrier or otherwise enter normally sterile areas of the body.

(v) Plant regulator

The term “plant regulator” means any substance or mixture of substances intended, through physiological action, for acceleratingor retarding the rate of growth or rate of maturation, or for otherwise altering the behavior of plants or the produce thereof, butshall not include substances to the extent that they are intended as plant nutrients, trace elements, nutritional chemicals, plantinoculants, and soil amendments. Also, the term “plant regulator” shall not be required to include any of such of those nutrientmixtures or soil amendments as are commonly known as vitamin-hormone horticultural products, intended for improvement,maintenance, survival, health, and propagation of plants, and as are not for pest destruction and are nontoxic, nonpoisonousin the undiluted packaged concentration.

(w) Producer and produce

The term “producer” means the person who manufactures, prepares, compounds, propagates, or processes any pesticide ordevice or active ingredient used in producing a pesticide. The term “produce” means to manufacture, prepare, compound,propagate, or process any pesticide or device or active ingredient used in producing a pesticide. The dilution by individualsof formulated pesticides for their own use and according to the directions on registered labels shall not of itself result in suchindividuals being included in the definition of “producer” for the purposes of this subchapter.

(x) Protect health and the environment

The terms “protect health and the environment” and “protection of health and the environment” mean protection against anyunreasonable adverse effects on the environment.

(y) Registrant

The term “registrant” means a person who has registered any pesticide pursuant to the provisions of this subchapter.

(z) Registration

The term “registration” includes reregistration.

(aa) State

The term “State” means a State, the District of Columbia, the Commonwealth of Puerto Rico, the Virgin Islands, Guam, theTrust Territory of the Pacific Islands, and American Samoa.

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(bb) Unreasonable adverse effects on the environment

The term “unreasonable adverse effects on the environment” means (1) any unreasonable risk to man or the environment, takinginto account the economic, social, and environmental costs and benefits of the use of any pesticide, or (2) a human dietary riskfrom residues that result from a use of a pesticide in or on any food inconsistent with the standard under section 346a of Title21. The Administrator shall consider the risks and benefits of public health pesticides separate from the risks and benefits ofother pesticides. In weighing any regulatory action concerning a public health pesticide under this subchapter, the Administratorshall weigh any risks of the pesticide against the health risks such as the diseases transmitted by the vector to be controlledby the pesticide.

(cc) Weed

The term “weed” means any plant which grows where not wanted.

(dd) Establishment

The term “establishment” means any place where a pesticide or device or active ingredient used in producing a pesticide isproduced, or held, for distribution or sale.

(ee) To use any registered pesticide in a manner inconsistent with its labeling

The term “to use any registered pesticide in a manner inconsistent with its labeling” means to use any registered pesticide in amanner not permitted by the labeling, except that the term shall not include (1) applying a pesticide at any dosage, concentration,or frequency less than that specified on the labeling unless the labeling specifically prohibits deviation from the specified dosage,concentration, or frequency, (2) applying a pesticide against any target pest not specified on the labeling if the application isto the crop, animal, or site specified on the labeling, unless the Administrator has required that the labeling specifically statethat the pesticide may be used only for the pests specified on the labeling after the Administrator has determined that the useof the pesticide against other pests would cause an unreasonable adverse effect on the environment, (3) employing any methodof application not prohibited by the labeling unless the labeling specifically states that the product may be applied only by themethods specified on the labeling, (4) mixing a pesticide or pesticides with a fertilizer when such mixture is not prohibitedby the labeling, (5) any use of a pesticide in conformance with section 136c, 136p, or 136v of this title, or (6) any use of apesticide in a manner that the Administrator determines to be consistent with the purposes of this subchapter. After March 31,1979, the term shall not include the use of a pesticide for agricultural or forestry purposes at a dilution less than label dosageunless before or after that date the Administrator issues a regulation or advisory opinion consistent with the study providedfor in section 27(b) of the Federal Pesticide Act of 1978, which regulation or advisory opinion specifically requires the useof definite amounts of dilution.

(ff) Outstanding data requirement

(1) In general

The term “outstanding data requirement” means a requirement for any study, information, or data that is necessary to makea determination under section 136a(c)(5) of this title and which study, information, or data--

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(A) has not been submitted to the Administrator; or

(B) if submitted to the Administrator, the Administrator has determined must be resubmitted because it is not valid,complete, or adequate to make a determination under section 136a(c)(5) of this title and the regulations and guidelinesissued under such section.

(2) Factors

In making a determination under paragraph (1)(B) respecting a study, the Administrator shall examine, at a minimum, relevantprotocols, documentation of the conduct and analysis of the study, and the results of the study to determine whether the studyand the results of the study fulfill the data requirement for which the study was submitted to the Administrator.

(gg) To distribute or sell

The term “to distribute or sell” means to distribute, sell, offer for sale, hold for distribution, hold for sale, hold for shipment,ship, deliver for shipment, release for shipment, or receive and (having so received) deliver or offer to deliver. The term doesnot include the holding or application of registered pesticides or use dilutions thereof by any applicator who provides a serviceof controlling pests without delivering any unapplied pesticide to any person so served.

(hh) Nitrogen stabilizer

The term “nitrogen stabilizer” means any substance or mixture of substances intended for preventing or hindering the processof nitrification, denitrification, ammonia volatilization, or urease production through action upon soil bacteria. Such term shallnot include--

(1) dicyandiamide;

(2) ammonium thiosulfate; or

(3) any substance or mixture of substances. 1 --

(A) that was not registered pursuant to section 136a of this title prior to January 1, 1992; and

(B) that was in commercial agronomic use prior to January 1, 1992, with respect to which after January 1, 1992, thedistributor or seller of the substance or mixture has made no specific claim of prevention or hindering of the process of

nitrification, denitrification, ammonia volatilization 2 urease production regardless of the actual use or purpose for, orfuture use or purpose for, the substance or mixture.

Statements made in materials required to be submitted to any State legislative or regulatory authority, or required by suchauthority to be included in the labeling or other literature accompanying any such substance or mixture shall not be deemed aspecific claim within the meaning of this subsection.

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(jj) 3 Maintenance applicator

The term “maintenance applicator” means any individual who, in the principal course of such individual's employment, uses, orsupervises the use of, a pesticide not classified for restricted use (other than a ready to use consumer products pesticide); for thepurpose of providing structural pest control or lawn pest control including janitors, general maintenance personnel, sanitationpersonnel, and grounds maintenance personnel. The term “maintenance applicator” does not include private applicators asdefined in subsection (e)(2) of this section; individuals who use antimicrobial pesticides, sanitizers or disinfectants; individualsemployed by Federal, State, and local governments or any political subdivisions thereof, or individuals who use pesticides notclassified for restricted use in or around their homes, boats, sod farms, nurseries, greenhouses, or other noncommercial property.

(kk) Service technician

The term “service technician” means any individual who uses or supervises the use of pesticides (other than a ready to useconsumer products pesticide) for the purpose of providing structural pest control or lawn pest control on the property of anotherfor a fee. The term “service technician” does not include individuals who use antimicrobial pesticides, sanitizers or disinfectants;or who otherwise apply ready to use consumer products pesticides.

(ll) Minor use

The term “minor use” means the use of a pesticide on an animal, on a commercial agricultural crop or site, or for the protectionof public health where--

(1) the total United States acreage for the crop is less than 300,000 acres, as determined by the Secretary of Agriculture; or

(2) the Administrator, in consultation with the Secretary of Agriculture, determines that, based on information provided byan applicant for registration or a registrant, the use does not provide sufficient economic incentive to support the initialregistration or continuing registration of a pesticide for such use and--

(A) there are insufficient efficacious alternative registered pesticides available for the use;

(B) the alternatives to the pesticide use pose greater risks to the environment or human health;

(C) the minor use pesticide plays or will play a significant part in managing pest resistance; or

(D) the minor use pesticide plays or will play a significant part in an integrated pest management program.

The status as a minor use under this subsection shall continue as long as the Administrator has not determined that, based onexisting data, such use may cause an unreasonable adverse effect on the environment and the use otherwise qualifies for suchstatus.

(mm) Antimicrobial pesticide

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(1) In general

The term “antimicrobial pesticide” means a pesticide that--

(A) is intended to--

(i) disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms; or

(ii) protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances fromcontamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime; and

(B) in the intended use is exempt from, or otherwise not subject to, a tolerance under section 346a of Title 21 or a foodadditive regulation under section 348 of Title 21.

(2) Excluded products

The term “antimicrobial pesticide” does not include--

(A) a wood preservative or antifouling paint product for which a claim of pesticidal activity other than or in addition toan activity described in paragraph (1) is made;

(B) an agricultural fungicide product; or

(C) an aquatic herbicide product.

(3) Included products

The term “antimicrobial pesticide” does include any other chemical sterilant product (other than liquid chemical sterilantproducts exempt under subsection (u) of this section), any other disinfectant product, any other industrial microbiocideproduct, and any other preservative product that is not excluded by paragraph (2).

(nn) Public health pesticide

The term “public health pesticide” means any minor use pesticide product registered for use and used predominantly in publichealth programs for vector control or for other recognized health protection uses, including the prevention or mitigation ofviruses, bacteria, or other microorganisms (other than viruses, bacteria, or other microorganisms on or in living man or otherliving animal) that pose a threat to public health.

(oo) Vector

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The term “vector” means any organism capable of transmitting the causative agent of human disease or capable of producinghuman discomfort or injury, including mosquitoes, flies, fleas, cockroaches, or other insects and ticks, mites, or rats.

Credits(June 25, 1947, c. 125, § 2, as added Oct. 21, 1972, Pub.L. 92-516, § 2, 86 Stat. 975; amended Dec. 28, 1973, Pub.L. 93-205, §13(f), 87 Stat. 903; Nov. 28, 1975, Pub.L. 94-140, § 9, 89 Stat. 754; Sept. 30, 1978, Pub.L. 95-396, § 1, 92 Stat. 819; Oct. 25,1988, Pub.L. 100-532, Title I, § 101, Title VI, § 601(a), Title VIII, § 801(a), 102 Stat. 2655, 2677, 2679; Dec. 13, 1991, Pub.L.102-237, Title X, § 1006(a)(1), (2), (b)(3)(A), (B), 105 Stat. 1894, 1895; Aug. 3, 1996, Pub.L. 104-170, Title I, §§ 105(a), 120,Title II, §§ 210(a), 221, 230, Title III, § 304, 110 Stat. 1490, 1492, 1493, 1502, 1508, 1512.)

Notes of Decisions (9)

Footnotes1 So in original. Probably should not have a period.

2 So in original. Probably should be followed by “, or”.

3 So in original. No subsec. (ii) has been enacted.

7 U.S.C.A. § 136, 7 USCA § 136Current through P.L. 112-197 approved 11-27-12

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(a) Requirement of registration

Except as provided by this subchapter, no person in any State may distribute or sell to any person any pesticide that is notregistered under this subchapter. To the extent necessary to prevent unreasonable adverse effects on the environment, theAdministrator may by regulation limit the distribution, sale, or use in any State of any pesticide that is not registered under thissubchapter and that is not the subject of an experimental use permit under section 136c of this title or an emergency exemptionunder section 136p of this title.

(b) Exemptions

A pesticide which is not registered with the Administrator may be transferred if--

(1) the transfer is from one registered establishment to another registered establishment operated by the same producersolely for packaging at the second establishment or for use as a constituent part of another pesticide produced at the secondestablishment; or

(2) the transfer is pursuant to and in accordance with the requirements of an experimental use permit.

(c) Procedure for registration

(1) Statement required

Each applicant for registration of a pesticide shall file with the Administrator a statement which includes--

(A) the name and address of the applicant and of any other person whose name will appear on the labeling;

(B) the name of the pesticide;

(C) a complete copy of the labeling of the pesticide, a statement of all claims to be made for it, and any directions for its use;

(D) the complete formula of the pesticide;

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(E) a request that the pesticide be classified for general use or for restricted use, or for both; and

(F) except as otherwise provided in paragraph (2)(D), if requested by the Administrator, a full description of the tests madeand the results thereof upon which the claims are based, or alternatively a citation to data that appear in the public literatureor that previously had been submitted to the Administrator and that the Administrator may consider in accordance withthe following provisions:

(i) With respect to pesticides containing active ingredients that are initially registered under this subchapter afterSeptember 30, 1978, data submitted to support the application for the original registration of the pesticide, or anapplication for an amendment adding any new use to the registration and that pertains solely to such new use, shallnot, without the written permission of the original data submitter, be considered by the Administrator to support anapplication by another person during a period of ten years following the date the Administrator first registers thepesticide, except that such permission shall not be required in the case of defensive data.

(ii) The period of exclusive data use provided under clause (i) shall be extended 1 additional year for each 3 minor usesregistered after August 3, 1996, and within 7 years of the commencement of the exclusive use period, up to a total of 3additional years for all minor uses registered by the Administrator if the Administrator, in consultation with the Secretaryof Agriculture, determines that, based on information provided by an applicant for registration or a registrant, that--

(I) there are insufficient efficacious alternative registered pesticides available for the use;

(II) the alternatives to the minor use pesticide pose greater risks to the environment or human health;

(III) the minor use pesticide plays or will play a significant part in managing pest resistance; or

(IV) the minor use pesticide plays or will play a significant part in an integrated pest management program.

The registration of a pesticide for a minor use on a crop grouping established by the Administrator shall beconsidered for purposes of this clause 1 minor use for each representative crop for which data are provided inthe crop grouping. Any additional exclusive use period under this clause shall be modified as appropriate orterminated if the registrant voluntarily cancels the product or deletes from the registration the minor uses whichformed the basis for the extension of the additional exclusive use period or if the Administrator determines thatthe registrant is not actually marketing the product for such minor uses.

(iii) Except as otherwise provided in clause (i), with respect to data submitted after December 31, 1969, by an applicantor registrant to support an application for registration, experimental use permit, or amendment adding a new use to anexisting registration, to support or maintain in effect an existing registration, or for reregistration, the Administrator may,without the permission of the original data submitter, consider any such item of data in support of an application by anyother person (hereinafter in this subparagraph referred to as the “applicant”) within the fifteen-year period following thedate the data were originally submitted only if the applicant has made an offer to compensate the original data submitterand submitted such offer to the Administrator accompanied by evidence of delivery to the original data submitter ofthe offer. The terms and amount of compensation may be fixed by agreement between the original data submitter and

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the applicant, or, failing such agreement, binding arbitration under this subparagraph. If, at the end of ninety daysafter the date of delivery to the original data submitter of the offer to compensate, the original data submitter and theapplicant have neither agreed on the amount and terms of compensation nor on a procedure for reaching an agreementon the amount and terms of compensation, either person may initiate binding arbitration proceedings by requestingthe Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained bysuch Service. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to sucharbitration proceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no officialor court of the United States shall have power or jurisdiction to review any such findings and determination, except forfraud, misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is averified complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or othermisconduct. The parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator.If the Administrator determines that an original data submitter has failed to participate in a procedure for reaching anagreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of anagreement or arbitration decision concerning compensation under this subparagraph, the original data submitter shallforfeit the right to compensation for the use of the data in support of the application. Notwithstanding any other provisionof this subchapter, if the Administrator determines that an applicant has failed to participate in a procedure for reachingan agreement or in an arbitration proceeding as required by this subparagraph, or failed to comply with the terms of anagreement or arbitration decision concerning compensation under this subparagraph, the Administrator shall deny theapplication or cancel the registration of the pesticide in support of which the data were used without further hearing.Before the Administrator takes action under either of the preceding two sentences, the Administrator shall furnish tothe affected person, by certified mail, notice of intent to take action and allow fifteen days from the date of deliveryof the notice for the affected person to respond. If a registration is denied or canceled under this subparagraph, theAdministrator may make such order as the Administrator deems appropriate concerning the continued sale and use ofexisting stocks of such pesticide. Registration action by the Administrator shall not be delayed pending the fixing ofcompensation.

(iv) After expiration of any period of exclusive use and any period for which compensation is required for the use of anitem of data under clauses (i), (ii), and (iii), the Administrator may consider such item of data in support of an applicationby any other applicant without the permission of the original data submitter and without an offer having been receivedto compensate the original data submitter for the use of such item of data.

(v) The period of exclusive use provided under clause (ii) shall not take effect until 1 year after August 3, 1996,except where an applicant or registrant is applying for the registration of a pesticide containing an active ingredientnot previously registered.

(vi) With respect to data submitted after August 3, 1996, by an applicant or registrant to support an amendment adding anew use to an existing registration that does not retain any period of exclusive use, if such data relates solely to a minoruse of a pesticide, such data shall not, without the written permission of the original data submitter, be considered bythe Administrator to support an application for a minor use by another person during the period of 10 years followingthe date of submission of such data. The applicant or registrant at the time the new minor use is requested shall notifythe Administrator that to the best of their knowledge the exclusive use period for the pesticide has expired and that thedata pertaining solely to the minor use of a pesticide is eligible for the provisions of this paragraph. If the minor useregistration which is supported by data submitted pursuant to this subsection is voluntarily canceled or if such data aresubsequently used to support a nonminor use, the data shall no longer be subject to the exclusive use provisions of thisclause but shall instead be considered by the Administrator in accordance with the provisions of clause (i), as appropriate.

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(G) If the applicant is requesting that the registration or amendment to the registration of a pesticide be expedited, anexplanation of the basis for the request must be submitted, in accordance with paragraph (10) of this subsection.

(2) Data in support of registration

(A) In general

The Administrator shall publish guidelines specifying the kinds of information which will be required to support theregistration of a pesticide and shall revise such guidelines from time to time. If thereafter the Administrator requires anyadditional kind of information under subparagraph (B) of this paragraph, the Administrator shall permit sufficient time forapplicants to obtain such additional information. The Administrator, in establishing standards for data requirements for theregistration of pesticides with respect to minor uses, shall make such standards commensurate with the anticipated extentof use, pattern of use, the public health and agricultural need for such minor use, and the level and degree of potentialbeneficial or adverse effects on man and the environment. The Administrator shall not require a person to submit, in relationto a registration or reregistration of a pesticide for minor agricultural use under this subchapter, any field residue datafrom a geographic area where the pesticide will not be registered for such use. In the development of these standards, theAdministrator shall consider the economic factors of potential national volume of use, extent of distribution, and the impactof the cost of meeting the requirements on the incentives for any potential registrant to undertake the development of therequired data. Except as provided by section 136h of this title, within 30 days after the Administrator registers a pesticideunder this subchapter the Administrator shall make available to the public the data called for in the registration statementtogether with such other scientific information as the Administrator deems relevant to the Administrator's decision.

(B) Additional data

(i) If the Administrator determines that additional data are required to maintain in effect an existing registration of apesticide, the Administrator shall notify all existing registrants of the pesticide to which the determination relates andprovide a list of such registrants to any interested person.

(ii) Each registrant of such pesticide shall provide evidence within ninety days after receipt of notification that it is takingappropriate steps to secure the additional data that are required. Two or more registrants may agree to develop jointly,or to share in the cost of developing, such data if they agree and advise the Administrator of their intent within ninetydays after notification. Any registrant who agrees to share in the cost of producing the data shall be entitled to examineand rely upon such data in support of maintenance of such registration. The Administrator shall issue a notice of intentto suspend the registration of a pesticide in accordance with the procedures prescribed by clause (iv) if a registrant failsto comply with this clause.

(iii) If, at the end of sixty days after advising the Administrator of their agreement to develop jointly, or share in the costof developing, data, the registrants have not further agreed on the terms of the data development arrangement or on aprocedure for reaching such agreement, any of such registrants may initiate binding arbitration proceedings by requestingthe Federal Mediation and Conciliation Service to appoint an arbitrator from the roster of arbitrators maintained by suchService. The procedure and rules of the Service shall be applicable to the selection of such arbitrator and to such arbitrationproceedings, and the findings and determination of the arbitrator shall be final and conclusive, and no official or courtof the United States shall have power or jurisdiction to review any such findings and determination, except for fraud,misrepresentation, or other misconduct by one of the parties to the arbitration or the arbitrator where there is a verified

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complaint with supporting affidavits attesting to specific instances of such fraud, misrepresentation, or other misconduct.All parties to the arbitration shall share equally in the payment of the fee and expenses of the arbitrator. The Administratorshall issue a notice of intent to suspend the registration of a pesticide in accordance with the procedures prescribed byclause (iv) if a registrant fails to comply with this clause.

(iv) Notwithstanding any other provision of this subchapter, if the Administrator determines that a registrant, withinthe time required by the Administrator, has failed to take appropriate steps to secure the data required under thissubparagraph, to participate in a procedure for reaching agreement concerning a joint data development arrangementunder this subparagraph or in an arbitration proceeding as required by this subparagraph, or to comply with the termsof an agreement or arbitration decision concerning a joint data development arrangement under this subparagraph, theAdministrator may issue a notice of intent to suspend such registrant's registration of the pesticide for which additionaldata is required. The Administrator may include in the notice of intent to suspend such provisions as the Administratordeems appropriate concerning the continued sale and use of existing stocks of such pesticide. Any suspension proposedunder this subparagraph shall become final and effective at the end of thirty days from receipt by the registrant of thenotice of intent to suspend, unless during that time a request for hearing is made by a person adversely affected by thenotice or the registrant has satisfied the Administrator that the registrant has complied fully with the requirements thatserved as a basis for the notice of intent to suspend. If a hearing is requested, a hearing shall be conducted under section136d(d) of this title. The only matters for resolution at that hearing shall be whether the registrant has failed to take theaction that served as the basis for the notice of intent to suspend the registration of the pesticide for which additional datais required, and whether the Administrator's determination with respect to the disposition of existing stocks is consistentwith this subchapter. If a hearing is held, a decision after completion of such hearing shall be final. Notwithstanding anyother provision of this subchapter, a hearing shall be held and a determination made within seventy-five days after receiptof a request for such hearing. Any registration suspended under this subparagraph shall be reinstated by the Administratorif the Administrator determines that the registrant has complied fully with the requirements that served as a basis for thesuspension of the registration.

(v) Any data submitted under this subparagraph shall be subject to the provisions of paragraph (1)(D). Whenever such dataare submitted jointly by two or more registrants, an agent shall be agreed on at the time of the joint submission to handleany subsequent data compensation matters for the joint submitters of such data.

(vi) Upon the request of a registrant the Administrator shall, in the case of a minor use, extend the deadline for theproduction of residue chemistry data under this subparagraph for data required solely to support that minor use until thefinal deadline for submission of data under section 136a-1 of this title for the other uses of the pesticide established asof August 3, 1996, if--

(I) the data to support other uses of the pesticide on a food are being provided;

(II) the registrant, in submitting a request for such an extension, provides a schedule, including interim dates to measureprogress, to assure that the data production will be completed before the expiration of the extension period;

(III) the Administrator has determined that such extension will not significantly delay the Administrator's schedule forissuing a reregistration eligibility determination required under section 136a-1 of this title; and

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(IV) the Administrator has determined that based on existing data, such extension would not significantly increase therisk of any unreasonable adverse effect on the environment. If the Administrator grants an extension under this clause, theAdministrator shall monitor the development of the data and shall ensure that the registrant is meeting the schedule forthe production of the data. If the Administrator determines that the registrant is not meeting or has not met the schedulefor the production of such data, the Administrator may proceed in accordance with clause (iv) regarding the continuedregistration of the affected products with the minor use and shall inform the public of such action. Notwithstandingthe provisions of this clause, the Administrator may take action to modify or revoke the extension under this clauseif the Administrator determines that the extension for the minor use may cause an unreasonable adverse effect on theenvironment. In such circumstance, the Administrator shall provide, in writing to the registrant, a notice revoking theextension of time for submission of data. Such data shall instead be due in accordance with the date established by theAdministrator for the submission of the data.

(vii) If the registrant does not commit to support a specific minor use of the pesticide, but is supporting and providing datain a timely and adequate fashion to support uses of the pesticide on a food, or if all uses of the pesticide are nonfood usesand the registrant does not commit to support a specific minor use of the pesticide but is supporting and providing datain a timely and adequate fashion to support other nonfood uses of the pesticide, the Administrator, at the written requestof the registrant, shall not take any action pursuant to this clause in regard to such unsupported minor use until the finaldeadline established as of August 3, 1996, for the submission of data under section 136a-1 of this title for the supporteduses identified pursuant to this clause unless the Administrator determines that the absence of the data is significant enoughto cause human health or environmental concerns. On the basis of such determination, the Administrator may refuse therequest for extension by the registrant. Upon receipt of the request from the registrant, the Administrator shall publish inthe Federal Register a notice of the receipt of the request and the effective date upon which the uses not being supportedwill be voluntarily deleted from the registration pursuant to section 136d(f)(1) of this title. If the Administrator grants anextension under this clause, the Administrator shall monitor the development of the data for the uses being supported andshall ensure that the registrant is meeting the schedule for the production of such data. If the Administrator determines thatthe registrant is not meeting or has not met the schedule for the production of such data, the Administrator may proceedin accordance with clause (iv) of this subparagraph regarding the continued registration of the affected products withthe minor and other uses and shall inform the public of such action in accordance with section 136d(f)(2) of this title.Notwithstanding the provisions of this clause, the Administrator may deny, modify, or revoke the temporary extensionunder this subparagraph if the Administrator determines that the continuation of the minor use may cause an unreasonableadverse effect on the environment. In the event of modification or revocation, the Administrator shall provide, in writing,to the registrant a notice revoking the temporary extension and establish a new effective date by which the minor use shallbe deleted from the registration.

(viii)(I) If data required to support registration of a pesticide under subparagraph (A) is requested by a Federal orState regulatory authority, the Administrator shall, to the extent practicable, coordinate data requirements, test protocols,timetables, and standards of review and reduce burdens and redundancy caused to the registrant by multiple requirementson the registrant.

(II) The Administrator may enter into a cooperative agreement with a State to carry out subclause (I).

(III) Not later than 1 year after August 3, 1996, the Administrator shall develop a process to identify and assist in alleviatingfuture disparities between Federal and State data requirements.

(C) Simplified procedures

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Within nine months after September 30, 1978, the Administrator shall, by regulation, prescribe simplified procedures forthe registration of pesticides, which shall include the provisions of subparagraph (D) of this paragraph.

(D) Exemption

No applicant for registration of a pesticide who proposes to purchase a registered pesticide from another producer in orderto formulate such purchased pesticide into the pesticide that is the subject of the application shall be required to--

(i) submit or cite data pertaining to such purchased product; or

(ii) offer to pay reasonable compensation otherwise required by paragraph (1)(D) of this subsection for the use of anysuch data.

(E) Minor use waiver

In handling the registration of a pesticide for a minor use, the Administrator may waive otherwise applicable datarequirements if the Administrator determines that the absence of such data will not prevent the Administrator fromdetermining--

(i) the incremental risk presented by the minor use of the pesticide; and

(ii) that such risk, if any, would not be an unreasonable adverse effect on the environment.

(3) Application

(A) In general

The Administrator shall review the data after receipt of the application and shall, as expeditiously as possible, either registerthe pesticide in accordance with paragraph (5), or notify the applicant of the Administrator's determination that it does notcomply with the provisions of the subchapter in accordance with paragraph (6).

(B) Identical or substantially similar

(i) The Administrator shall, as expeditiously as possible, review and act on any application received by the Administratorthat--

(I) proposes the initial or amended registration of an end-use pesticide that, if registered as proposed, would be identicalor substantially similar in composition and labeling to a currently-registered pesticide identified in the application, orthat would differ in composition and labeling from such currently-registered pesticide only in ways that would notsignificantly increase the risk of unreasonable adverse effects on the environment; or

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(II) proposes an amendment to the registration of a registered pesticide that does not require scientific review of data.

(ii) In expediting the review of an application for an action described in clause (i), the Administrator shall--

(I) review the application in accordance with section 136w-8(f)(4)(B) of this title and, if the application is found to beincomplete, reject the application;

(II) not later than the applicable decision review time established pursuant to section 136w-8(f)(4)(B) of this title, or,if no review time is established, not later than 90 days after receiving a complete application, notify the registrant if theapplication has been granted or denied; and

(III) if the application is denied, notify the registrant in writing of the specific reasons for the denial of the application.

(C) Minor use registration

(i) The Administrator shall, as expeditiously as possible, review and act on any complete application--

(I) that proposes the initial registration of a new pesticide active ingredient if the active ingredient is proposed to beregistered solely for minor uses, or proposes a registration amendment solely for minor uses to an existing registration; or

(II) for a registration or a registration amendment that proposes significant minor uses.

(ii) For the purposes of clause (i)--

(I) the term “as expeditiously as possible” means that the Administrator shall, to the greatest extent practicable, completea review and evaluation of all data, submitted with a complete application, within 12 months after the submission ofthe complete application, and the failure of the Administrator to complete such a review and evaluation under clause(i) shall not be subject to judicial review; and

(II) the term “significant minor uses” means 3 or more minor uses proposed for every nonminor use, a minor use thatwould, in the judgment of the Administrator, serve as a replacement for any use which has been canceled in the 5years preceding the receipt of the application, or a minor use that in the opinion of the Administrator would avoid thereissuance of an emergency exemption under section 136p of this title for that minor use.

(D) Adequate time for submission of minor use data

If a registrant makes a request for a minor use waiver, regarding data required by the Administrator, pursuant to paragraph(2)(E), and if the Administrator denies in whole or in part such data waiver request, the registrant shall have a full-timeperiod for providing such data. For purposes of this subparagraph, the term “full-time period” means the time period

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originally established by the Administrator for submission of such data, beginning with the date of receipt by the registrantof the Administrator's notice of denial.

(4) Notice of application

The Administrator shall publish in the Federal Register, promptly after receipt of the statement and other data requiredpursuant to paragraphs (1) and (2), a notice of each application for registration of any pesticide if it contains any new activeingredient or if it would entail a changed use pattern. The notice shall provide for a period of 30 days in which any Federalagency or any other interested person may comment.

(5) Approval of registration

The Administrator shall register a pesticide if the Administrator determines that, when considered with any restrictionsimposed under subsection (d) of this section--

(A) its composition is such as to warrant the proposed claims for it;

(B) its labeling and other material required to be submitted comply with the requirements of this subchapter;

(C) it will perform its intended function without unreasonable adverse effects on the environment; and

(D) when used in accordance with widespread and commonly recognized practice it will not generally cause unreasonableadverse effects on the environment.

The Administrator shall not make any lack of essentiality a criterion for denying registration of any pesticide. Where twopesticides meet the requirements of this paragraph, one should not be registered in preference to the other. In consideringan application for the registration of a pesticide, the Administrator may waive data requirements pertaining to efficacy,in which event the Administrator may register the pesticide without determining that the pesticide's composition is suchas to warrant proposed claims of efficacy. If a pesticide is found to be efficacious by any State under section 136v(c) ofthis title, a presumption is established that the Administrator shall waive data requirements pertaining to efficacy for useof the pesticide in such State.

(6) Denial of registration

If the Administrator determines that the requirements of paragraph (5) for registration are not satisfied, the Administratorshall notify the applicant for registration of the Administrator's determination and of the Administrator's reasons (includingthe factual basis) therefor, and that, unless the applicant corrects the conditions and notifies the Administrator thereof duringthe 30-day period beginning with the day after the date on which the applicant receives the notice, the Administrator mayrefuse to register the pesticide. Whenever the Administrator refuses to register a pesticide, the Administrator shall notifythe applicant of the Administrator's decision and of the Administrator's reasons (including the factual basis) therefor. TheAdministrator shall promptly publish in the Federal Register notice of such denial of registration and the reasons therefor.Upon such notification, the applicant for registration or other interested person with the concurrence of the applicant shallhave the same remedies as provided for in section 136d of this title.

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(7) Registration under special circumstances

Notwithstanding the provisions of paragraph (5)--

(A) The Administrator may conditionally register or amend the registration of a pesticide if the Administrator determinesthat (i) the pesticide and proposed use are identical or substantially similar to any currently registered pesticide anduse thereof, or differ only in ways that would not significantly increase the risk of unreasonable adverse effects onthe environment, and (ii) approving the registration or amendment in the manner proposed by the applicant would notsignificantly increase the risk of any unreasonable adverse effect on the environment. An applicant seeking conditionalregistration or amended registration under this subparagraph shall submit such data as would be required to obtainregistration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item of data because it hasnot yet been generated, the Administrator may register or amend the registration of the pesticide under such conditionsas will require the submission of such data not later than the time such data are required to be submitted with respect tosimilar pesticides already registered under this subchapter.

(B) The Administrator may conditionally amend the registration of a pesticide to permit additional uses of such pesticidenotwithstanding that data concerning the pesticide may be insufficient to support an unconditional amendment, if theAdministrator determines that (i) the applicant has submitted satisfactory data pertaining to the proposed additional use,and (ii) amending the registration in the manner proposed by the applicant would not significantly increase the risk ofany unreasonable adverse effect on the environment. Notwithstanding the foregoing provisions of this subparagraph, noregistration of a pesticide may be amended to permit an additional use of such pesticide if the Administrator has issueda notice stating that such pesticide, or any ingredient thereof, meets or exceeds risk criteria associated in whole or in partwith human dietary exposure enumerated in regulations issued under this subchapter, and during the pendency of any risk-benefit evaluation initiated by such notice, if (I) the additional use of such pesticide involves a major food or feed crop,or (II) the additional use of such pesticide involves a minor food or feed crop and the Administrator determines, with theconcurrence of the Secretary of Agriculture, there is available an effective alternative pesticide that does not meet or exceedsuch risk criteria. An applicant seeking amended registration under this subparagraph shall submit such data as would berequired to obtain registration of a similar pesticide under paragraph (5). If the applicant is unable to submit an item ofdata (other than data pertaining to the proposed additional use) because it has not yet been generated, the Administratormay amend the registration under such conditions as will require the submission of such data not later than the time suchdata are required to be submitted with respect to similar pesticides already registered under this subchapter.

(C) The Administrator may conditionally register a pesticide containing an active ingredient not contained in any currentlyregistered pesticide for a period reasonably sufficient for the generation and submission of required data (which are lackingbecause a period reasonably sufficient for generation of the data has not elapsed since the Administrator first imposed thedata requirement) on the condition that by the end of such period the Administrator receives such data and the data do notmeet or exceed risk criteria enumerated in regulations issued under this subchapter, and on such other conditions as theAdministrator may prescribe. A conditional registration under this subparagraph shall be granted only if the Administratordetermines that use of the pesticide during such period will not cause any unreasonable adverse effect on the environment,and that use of the pesticide is in the public interest.

(8) Interim administrative review

Notwithstanding any other provision of this subchapter, the Administrator may not initiate a public interim administrativereview process to develop a risk-benefit evaluation of the ingredients of a pesticide or any of its uses prior to initiating aformal action to cancel, suspend, or deny registration of such pesticide, required under this subchapter, unless such interim

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administrative process is based on a validated test or other significant evidence raising prudent concerns of unreasonableadverse risk to man or to the environment. Notice of the definition of the terms “validated test” and “other significantevidence” as used herein shall be published by the Administrator in the Federal Register.

(9) Labeling

(A) Additional statements

Subject to subparagraphs (B) and (C), it shall not be a violation of this subchapter for a registrant to modify the labelingof an antimicrobial pesticide product to include relevant information on product efficacy, product composition, containercomposition or design, or other characteristics that do not relate to any pesticidal claim or pesticidal activity.

(B) Requirements

Proposed labeling information under subparagraph (A) shall not be false or misleading, shall not conflict with or detractfrom any statement required by law or the Administrator as a condition of registration, and shall be substantiated on therequest of the Administrator.

(C) Notification and disapproval

(i) Notification

A registration may be modified under subparagraph (A) if--

(I) the registrant notifies the Administrator in writing not later than 60 days prior to distribution or sale of a productbearing the modified labeling; and

(II) the Administrator does not disapprove of the modification under clause (ii).

(ii) Disapproval

Not later than 30 days after receipt of a notification under clause (i), the Administrator may disapprove the modificationby sending the registrant notification in writing stating that the proposed language is not acceptable and stating thereasons why the Administrator finds the proposed modification unacceptable.

(iii) Restriction on sale

A registrant may not sell or distribute a product bearing a disapproved modification.

(iv) Objection

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A registrant may file an objection in writing to a disapproval under clause (ii) not later than 30 days after receipt ofnotification of the disapproval.

(v) Final action

A decision by the Administrator following receipt and consideration of an objection filed under clause (iv) shall beconsidered a final agency action.

(D) Use dilution

The label or labeling required under this subchapter for an antimicrobial pesticide that is or may be diluted for use mayhave a different statement of caution or protective measures for use of the recommended diluted solution of the pesticidethan for use of a concentrate of the pesticide if the Administrator determines that--

(i) adequate data have been submitted to support the statement proposed for the diluted solution uses; and

(ii) the label or labeling provides adequate protection for exposure to the diluted solution of the pesticide.

(10) Expedited registration of pesticides

(A) Not later than 1 year after August 3, 1996, the Administrator shall, utilizing public comment, develop procedures andguidelines, and expedite the review of an application for registration of a pesticide or an amendment to a registration thatsatisfies such guidelines.

(B) Any application for registration or an amendment, including biological and conventional pesticides, will be consideredfor expedited review under this paragraph. An application for registration or an amendment shall qualify for expedited reviewif use of the pesticide proposed by the application may reasonably be expected to accomplish 1 or more of the following:

(i) Reduce the risks of pesticides to human health.

(ii) Reduce the risks of pesticides to nontarget organisms.

(iii) Reduce the potential for contamination of groundwater, surface water, or other valued environmental resources.

(iv) Broaden the adoption of integrated pest management strategies, or make such strategies more available or moreeffective.

(C) The Administrator, not later than 30 days after receipt of an application for expedited review, shall notify the applicantwhether the application is complete. If it is found to be incomplete, the Administrator may either reject the request forexpedited review or ask the applicant for additional information to satisfy the guidelines developed under subparagraph (A).

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(d) Classification of pesticides

(1) Classification for general use, restricted use, or both

(A) As a part of the registration of a pesticide the Administrator shall classify it as being for general use or for restricteduse. If the Administrator determines that some of the uses for which the pesticide is registered should be for general useand that other uses for which it is registered should be for restricted use, the Administrator shall classify it for both generaluse and restricted use. Pesticide uses may be classified by regulation on the initial classification, and registered pesticidesmay be classified prior to reregistration. If some of the uses of the pesticide are classified for general use, and other usesare classified for restricted use, the directions relating to its general uses shall be clearly separated and distinguished fromthose directions relating to its restricted uses. The Administrator may require that its packaging and labeling for restricteduses shall be clearly distinguishable from its packaging and labeling for general uses.

(B) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings andcautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread andcommonly recognized practice, will not generally cause unreasonable adverse effects on the environment, the Administratorwill classify the pesticide, or the particular use or uses of the pesticide to which the determination applies, for general use.

(C) If the Administrator determines that the pesticide, when applied in accordance with its directions for use, warnings andcautions and for the uses for which it is registered, or for one or more of such uses, or in accordance with a widespread andcommonly recognized practice, may generally cause, without additional regulatory restrictions, unreasonable adverse effectson the environment, including injury to the applicator, the Administrator shall classify the pesticide, or the particular use oruses to which the determination applies, for restricted use:

(i) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because of adetermination that the acute dermal or inhalation toxicity of the pesticide presents a hazard to the applicator or otherpersons, the pesticide shall be applied for any use to which the restricted classification applies only by or under the directsupervision of a certified applicator.

(ii) If the Administrator classifies a pesticide, or one or more uses of such pesticide, for restricted use because ofa determination that its use without additional regulatory restriction may cause unreasonable adverse effects on theenvironment, the pesticide shall be applied for any use to which the determination applies only by or under the directsupervision of a certified applicator, or subject to such other restrictions as the Administrator may provide by regulation.Any such regulation shall be reviewable in the appropriate court of appeals upon petition of a person adversely affectedfiled within 60 days of the publication of the regulation in final form.

(2) Change in classification

If the Administrator determines that a change in the classification of any use of a pesticide from general use to restricted useis necessary to prevent unreasonable adverse effects on the environment, the Administrator shall notify the registrant of suchpesticide of such determination at least forty-five days before making the change and shall publish the proposed change inthe Federal Register. The registrant, or other interested person with the concurrence of the registrant, may seek relief fromsuch determination under section 136d(b) of this title.

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(3) Change in classification from restricted use to general use

The registrant of any pesticide with one or more uses classified for restricted use may petition the Administrator to change anysuch classification from restricted to general use. Such petition shall set out the basis for the registrant's position that restricteduse classification is unnecessary because classification of the pesticide for general use would not cause unreasonable adverseeffects on the environment. The Administrator, within sixty days after receiving such petition, shall notify the registrantwhether the petition has been granted or denied. Any denial shall contain an explanation therefor and any such denial shallbe subject to judicial review under section 136n of this title.

(e) Products with same formulation and claims

Products which have the same formulation, are manufactured by the same person, the labeling of which contains the sameclaims, and the labels of which bear a designation identifying the product as the same pesticide may be registered as a singlepesticide; and additional names and labels shall be added to the registration by supplemental statements.

(f) Miscellaneous

(1) Effect of change of labeling or formulation

If the labeling or formulation for a pesticide is changed, the registration shall be amended to reflect such change if theAdministrator determines that the change will not violate any provision of this subchapter.

(2) Registration not a defense

In no event shall registration of an article be construed as a defense for the commission of any offense under this subchapter.As long as no cancellation proceedings are in effect registration of a pesticide shall be prima facie evidence that the pesticide,its labeling and packaging comply with the registration provisions of the subchapter.

(3) Authority to consult other Federal agencies

In connection with consideration of any registration or application for registration under this section, the Administrator mayconsult with any other Federal agency.

(4) Mixtures of nitrogen stabilizers and fertilizer products

Any mixture or other combination of--

(A) 1 or more nitrogen stabilizers registered under this subchapter; and

(B) 1 or more fertilizer products,

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shall not be subject to the provisions of this section or sections 136a-1, 136c, 136e, 136m, and 136o(a)(2) of this title ifthe mixture or other combination is accompanied by the labeling required under this subchapter for the nitrogen stabilizercontained in the mixture or other combination, the mixture or combination is mixed or combined in accordance with suchlabeling, and the mixture or combination does not contain any active ingredient other than the nitrogen stabilizer.

(g) Registration review

(1) General rule

(A) Periodic review

(i) In general

The registrations of pesticides are to be periodically reviewed.

(ii) Regulations

In accordance with this subparagraph, the Administrator shall by regulation establish a procedure for accomplishingthe periodic review of registrations.

(iii) Initial registration review

The Administrator shall complete the registration review of each pesticide or pesticide case, which may be composedof 1 or more active ingredients and the products associated with the active ingredients, not later than the later of--

(I) October 1, 2022; or

(II) the date that is 15 years after the date on which the first pesticide containing a new active ingredient is registered.

(iv) Subsequent registration review

Not later than 15 years after the date on which the initial registration review is completed under clause (iii) and each 15years thereafter, the Administrator shall complete a subsequent registration review for each pesticide or pesticide case.

(v) Cancellation

No registration shall be canceled as a result of the registration review process unless the Administrator follows theprocedures and substantive requirements of section 136d of this title.

(B) Docketing

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(i) In general

Subject to clause (ii), after meeting with 1 or more individuals that are not government employees to discuss mattersrelating to a registration review, the Administrator shall place in the docket minutes of the meeting, a list of attendees,and any documents exchanged at the meeting, not later than the earlier of--

(I) the date that is 45 days after the meeting; or

(II) the date of issuance of the registration review decision.

(ii) Protected information

The Administrator shall identify, but not include in the docket, any confidential business information the disclosure ofwhich is prohibited by section 136h of this title.

(C) Limitation

Nothing in this subsection shall prohibit the Administrator from undertaking any other review of a pesticide pursuant tothis subchapter.

(2) Data

(A) Submission required

The Administrator shall use the authority in subsection (c)(2)(B) of this section to require the submission of data whensuch data are necessary for a registration review.

(B) Data submission, compensation, and exemption

For purposes of this subsection, the provisions of subsections (c)(1), (c)(2)(B), and (c)(2)(D) of this section shall be utilizedfor and be applicable to any data required for registration review.

(h) Registration requirements for antimicrobial pesticides

(1) Evaluation of process

To the maximum extent practicable consistent with the degrees of risk presented by an antimicrobial pesticide and the type ofreview appropriate to evaluate the risks, the Administrator shall identify and evaluate reforms to the antimicrobial registrationprocess that would reduce review periods existing as of August 3, 1996, for antimicrobial pesticide product registrationapplications and applications for amended registration of antimicrobial pesticide products, including--

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(A) new antimicrobial active ingredients;

(B) new antimicrobial end-use products;

(C) substantially similar or identical antimicrobial pesticides; and

(D) amendments to antimicrobial pesticide registrations.

(2) Review time period reduction goal

Each reform identified under paragraph (1) shall be designed to achieve the goal of reducing the review period followingsubmission of a complete application, consistent with the degree of risk, to a period of not more than--

(A) 540 days for a new antimicrobial active ingredient pesticide registration;

(B) 270 days for a new antimicrobial use of a registered active ingredient;

(C) 120 days for any other new antimicrobial product;

(D) 90 days for a substantially similar or identical antimicrobial product;

(E) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and

(F) 120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is nototherwise described in this paragraph.

(3) Implementation

(A) Proposed rulemaking

(i) Issuance

Not later than 270 days after August 3, 1996, the Administrator shall publish in the Federal Register proposed regulationsto accelerate and improve the review of antimicrobial pesticide products designed to implement, to the extent practicable,the goals set forth in paragraph (2).

(ii) Requirements

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Proposed regulations issued under clause (i) shall--

(I) define the various classes of antimicrobial use patterns, including household, industrial, and institutionaldisinfectants and sanitizing pesticides, preservatives, water treatment, and pulp and paper mill additives, and othersuch products intended to disinfect, sanitize, reduce, or mitigate growth or development of microbiological organisms,or protect inanimate objects, industrial processes or systems, surfaces, water, or other chemical substances fromcontamination, fouling, or deterioration caused by bacteria, viruses, fungi, protozoa, algae, or slime;

(II) differentiate the types of review undertaken for antimicrobial pesticides;

(III) conform the degree and type of review to the risks and benefits presented by antimicrobial pesticides and thefunction of review under this subchapter, considering the use patterns of the product, toxicity, expected exposure,and product type;

(IV) ensure that the registration process is sufficient to maintain antimicrobial pesticide efficacy and that antimicrobialpesticide products continue to meet product performance standards and effectiveness levels for each type of labelclaim made; and

(V) implement effective and reliable deadlines for process management.

(iii) Comments

In developing the proposed regulations, the Administrator shall solicit the views from registrants and other affectedparties to maximize the effectiveness of the rule development process.

(B) Final regulations

(i) Issuance

The Administrator shall issue final regulations not later than 240 days after the close of the comment period for theproposed regulations.

(ii) Failure to meet goal

If a goal described in paragraph (2) is not met by the final regulations, the Administrator shall identify the goal, explainwhy the goal was not attained, describe the element of the regulations included instead, and identify future steps toattain the goal.

(iii) Requirements

In issuing final regulations, the Administrator shall--

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§ 136a. Registration of pesticides, 7 USCA § 136a

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(I) consider the establishment of a certification process for regulatory actions involving risks that can be responsiblymanaged, consistent with the degree of risk, in the most cost-efficient manner;

(II) consider the establishment of a certification process by approved laboratories as an adjunct to the review process;

(III) use all appropriate and cost-effective review mechanisms, including--

(aa) expanded use of notification and non-notification procedures;

(bb) revised procedures for application review; and

(cc) allocation of appropriate resources to ensure streamlined management of antimicrobial pesticide registrations;and

(IV) clarify criteria for determination of the completeness of an application.

(C) Expedited review

This subsection does not affect the requirements or extend the deadlines or review periods contained in subsection (c)(3) of this section.

(D) Alternative review periods

If the final regulations to carry out this paragraph are not effective 630 days after August 3, 1996, until the final regulationsbecome effective, the review period, beginning on the date of receipt by the Agency of a complete application, shall be--

(i) 2 years for a new antimicrobial active ingredient pesticide registration;

(ii) 1 year for a new antimicrobial use of a registered active ingredient;

(iii) 180 days for any other new antimicrobial product;

(iv) 90 days for a substantially similar or identical antimicrobial product;

(v) 90 days for an amendment to an antimicrobial registration that does not require scientific review of data; and

(vi) 120 days for an amendment to an antimicrobial registration that requires scientific review of data and that is nototherwise described in this subparagraph.

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§ 136a. Registration of pesticides, 7 USCA § 136a

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(E) Wood preservatives

An application for the registration, or for an amendment to the registration, of a wood preservative product for which aclaim of pesticidal activity listed in section 136(mm) of this title is made (regardless of any other pesticidal claim that ismade with respect to the product) shall be reviewed by the Administrator within the same period as that established underthis paragraph for an antimicrobial pesticide product application, consistent with the degree of risk posed by the use of thewood preservative product, if the application requires the applicant to satisfy the same data requirements as are requiredto support an application for a wood preservative product that is an antimicrobial pesticide.

(F) Notification

(i) In general

Subject to clause (iii), the Administrator shall notify an applicant whether an application has been granted or denied notlater than the final day of the appropriate review period under this paragraph, unless the applicant and the Administratoragree to a later date.

(ii) Final decision

If the Administrator fails to notify an applicant within the period of time required under clause (i), the failure shall beconsidered an agency action unlawfully withheld or unreasonably delayed for purposes of judicial review under chapter7 of Title 5.

(iii) Exemption

This subparagraph does not apply to an application for an antimicrobial pesticide that is filed under subsection (c)(3)(B) of this section prior to 90 days after August 3, 1996.

(iv) Limitation

Notwithstanding clause (ii), the failure of the Administrator to notify an applicant for an amendment to a registrationfor an antimicrobial pesticide shall not be judicially reviewable in a Federal or State court if the amendment requiresscientific review of data within--

(I) the time period specified in subparagraph (D)(vi), in the absence of a final regulation under subparagraph (B); or

(II) the time period specified in paragraph (2)(F), if adopted in a final regulation under subparagraph (B).

(4) Annual report

(A) Submission

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§ 136a. Registration of pesticides, 7 USCA § 136a

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Beginning on August 3, 1996, and ending on the date that the goals under paragraph (2) are achieved, the Administratorshall, not later than March 1 of each year, prepare and submit an annual report to the Committee on Agriculture of theHouse of Representatives and the Committee on Agriculture, Nutrition, and Forestry of the Senate.

(B) Requirements

A report submitted under subparagraph (A) shall include a description of--

(i) measures taken to reduce the backlog of pending registration applications;

(ii) progress toward achieving reforms under this subsection; and

(iii) recommendations to improve the activities of the Agency pertaining to antimicrobial registrations.

Credits(June 25, 1947, c. 125, § 3, as added Oct. 21, 1972, Pub.L. 92-516, § 2, 86 Stat. 979; amended Nov. 28, 1975, Pub.L. 94-140,§ 12, 89 Stat. 755; Sept. 30, 1978, Pub.L. 95-396, §§ 2(a), 3-8, 92 Stat. 820, 824-827; Oct. 25, 1988, Pub.L. 100-532, Title I,§§ 102(b), 103, Title VI, § 601(b)(1), Title VIII, § 801(b), 102 Stat. 2667, 2677, 2680; Nov. 28, 1990, Pub.L. 101-624, TitleXIV, § 1492, 104 Stat. 3628; Dec. 13, 1991, Pub.L. 102-237, Title X, § 1006(a)(3), (b)(1), (2), (c), 105 Stat. 1894 to 1896;Aug. 3, 1996, Pub.L. 104-170, Title I, §§ 105(b), 106(b), Title II, §§ 210(b), (c)(1), (d), (e), (f)(2), 222 to 224, 231, 250, 110Stat. 1491, 1494 to 1497, 1499, 1503, 1504, 1508, 1510; Jan. 23, 2004, Pub.L. 108-199, Div. G, Title V, § 501(b), 118 Stat.419; Oct. 9, 2007, Pub.L. 110-94, §§ 2, 3, 121 Stat. 1000.)

Notes of Decisions (90)

7 U.S.C.A. § 136a, 7 USCA § 136aCurrent through P.L. 112-197 approved 11-27-12

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§ 342. Adulterated food, 21 USCA § 342

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A food shall be deemed to be adulterated--

(a) Poisonous, insanitary, etc., ingredients

(1) If it bears or contains any poisonous or deleterious substance which may render it injurious to health; but in case thesubstance is not an added substance such food shall not be considered adulterated under this clause if the quantity of such

substance in such food does not ordinarily render it injurious to health. 1 (2)(A) if it bears or contains any added poisonous oradded deleterious substance (other than a substance that is a pesticide chemical residue in or on a raw agricultural commodityor processed food, a food additive, a color additive, or a new animal drug) that is unsafe within the meaning of section 346of this title; or (B) if it bears or contains a pesticide chemical residue that is unsafe within the meaning of section 346a(a)of this title; or (C) if it is or if it bears or contains (i) any food additive that is unsafe within the meaning of section 348 ofthis title; or (ii) a new animal drug (or conversion product thereof) that is unsafe within the meaning of section 360b of thistitle; or (3) if it consists in whole or in part of any filthy, putrid, or decomposed substance, or if it is otherwise unfit for food;or (4) if it has been prepared, packed, or held under insanitary conditions whereby it may have become contaminated withfilth, or whereby it may have been rendered injurious to health; or (5) if it is, in whole or in part, the product of a diseasedanimal or of an animal which has died otherwise than by slaughter; or (6) if its container is composed, in whole or in part, ofany poisonous or deleterious substance which may render the contents injurious to health; or (7) if it has been intentionallysubjected to radiation, unless the use of the radiation was in conformity with a regulation or exemption in effect pursuantto section 348 of this title.

(b) Absence, substitution, or addition of constituents

(1) If any valuable constituent has been in whole or in part omitted or abstracted therefrom; or (2) if any substance has beensubstituted wholly or in part therefor; or (3) if damage or inferiority has been concealed in any manner; or (4) if any substancehas been added thereto or mixed or packed therewith so as to increase its bulk or weight, or reduce its quality or strength,or make it appear better or of greater value than it is.

(c) Color additives

If it is, or it bears or contains, a color additive which is unsafe within the meaning of section 379e(a) of this title.

(d) Confectionery containing alcohol or nonnutritive substance

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§ 342. Adulterated food, 21 USCA § 342

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If it is confectionery, and--

(1) has partially or completely imbedded therein any nonnutritive object, except that this subparagraph shall not applyin the case of any nonnutritive object if, in the judgment of the Secretary as provided by regulations, such object is ofpractical functional value to the confectionery product and would not render the product injurious or hazardous to health;

(2) bears or contains any alcohol other than alcohol not in excess of one-half of 1 per centum by volume derived solelyfrom the use of flavoring extracts, except that this clause shall not apply to confectionery which is introduced or deliveredfor introduction into, or received or held for sale in, interstate commerce if the sale of such confectionery is permittedunder the laws of the State in which such confectionery is intended to be offered for sale; or

(3) bears or contains any nonnutritive substance, except that this subparagraph shall not apply to a safe nonnutritivesubstance which is in or on confectionery by reason of its use for some practical functional purpose in the manufacture,packaging, or storage of such confectionery if the use of the substance does not promote deception of the consumer orotherwise result in adulteration or misbranding in violation of any provision of this chapter, except that the Secretary may,for the purpose of avoiding or resolving uncertainty as to the application of this subparagraph, issue regulations allowingor prohibiting the use of particular nonnutritive substances.

(e) Oleomargarine containing filthy, putrid, etc., matter

If it is oleomargarine or margarine or butter and any of the raw material used therein consisted in whole or in part of anyfilthy, putrid, or decomposed substance, or such oleomargarine or margarine or butter is otherwise unfit for food.

(f) Dietary supplement or ingredient: safety

(1) If it is a dietary supplement or contains a dietary ingredient that--

(A) presents a significant or unreasonable risk of illness or injury under--

(i) conditions of use recommended or suggested in labeling, or

(ii) if no conditions of use are suggested or recommended in the labeling, under ordinary conditions of use;

(B) is a new dietary ingredient for which there is inadequate information to provide reasonable assurance that suchingredient does not present a significant or unreasonable risk of illness or injury;

(C) the Secretary declares to pose an imminent hazard to public health or safety, except that the authority to makesuch declaration shall not be delegated and the Secretary shall promptly after such a declaration initiate a proceeding inaccordance with sections 554 and 556 of Title 5 to affirm or withdraw the declaration; or

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§ 342. Adulterated food, 21 USCA § 342

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(D) is or contains a dietary ingredient that renders it adulterated under paragraph (a)(1) under the conditions of userecommended or suggested in the labeling of such dietary supplement.

In any proceeding under this subparagraph, the United States shall bear the burden of proof on each element to show thata dietary supplement is adulterated. The court shall decide any issue under this paragraph on a de novo basis.

(2) Before the Secretary may report to a United States attorney a violation of paragraph 2 (1)(A) for a civil proceeding, theperson against whom such proceeding would be initiated shall be given appropriate notice and the opportunity to presentviews, orally and in writing, at least 10 days before such notice, with regard to such proceeding.

(g) Dietary supplement: manufacturing practices

(1) If it is a dietary supplement and it has been prepared, packed, or held under conditions that do not meet current goodmanufacturing practice regulations, including regulations requiring, when necessary, expiration date labeling, issued by theSecretary under subparagraph (2).

(2) The Secretary may by regulation prescribe good manufacturing practices for dietary supplements. Such regulations shallbe modeled after current good manufacturing practice regulations for food and may not impose standards for which thereis no current and generally available analytical methodology. No standard of current good manufacturing practice may beimposed unless such standard is included in a regulation promulgated after notice and opportunity for comment in accordancewith chapter 5 of Title 5.

(h) If it is an article of food imported or offered for import into the United States and the article of food has previously beenrefused admission under section 381(a) of this title, unless the person reoffering the article affirmatively establishes, at theexpense of the owner or consignee of the article, that the article complies with the applicable requirements of this chapter, asdetermined by the Secretary.

(i) If it is transported or offered for transport by a shipper, carrier by motor vehicle or rail vehicle, receiver, or any other personengaged in the transportation of food under conditions that are not in compliance with regulations promulgated under section350e of this title.

Credits(June 25, 1938, c. 675, § 402, 52 Stat. 1046; 1940 Reorg. Plan No. IV, § 12, eff. June 30, 1940, 5 F.R. 2422, 54 Stat. 1237; Mar.16, 1950, c. 61, § 3(d), 64 Stat. 21; 1953 Reorg. Plan No. 1, § 5, eff. Apr. 11, 1953, 18 F.R. 2053, 67 Stat. 631; July 22, 1954, c.559, § 2, 68 Stat. 511; July 9, 1956, c. 530, 70 Stat. 512; Sept. 6, 1958, Pub.L. 85-929, § 3(a), (b), 72 Stat. 1784; Mar. 17, 1959,Pub.L. 86-2, 73 Stat. 3; July 12, 1960, Pub.L. 86-618, Title I, §§ 102(a)(1), (2), 105(c), 74 Stat. 397, 398, 404; June 29, 1966,Pub.L. 89-477, 80 Stat. 231; July 13, 1968, Pub.L. 90-399, § 104, 82 Stat. 352; Feb. 27, 1986, Pub.L. 99-252, § 10, 100 Stat.35; Oct. 29, 1992, Pub.L. 102-571, Title I, § 107(4), 106 Stat. 4499; Aug. 13, 1993, Pub.L. 103-80, § 3(i), 107 Stat. 776; Oct.25, 1994, Pub.L. 103-417, §§ 4, 9, 108 Stat. 4328, 4332; Aug. 3, 1996, Pub.L. 104-170, Title IV, § 404, 110 Stat. 1514; June12, 2002, Pub.L. 107-188, Title III, § 309, 116 Stat. 673; Aug. 10, 2005, Pub.L. 109-59, Title VII, § 7202(a), 119 Stat. 1911.)

Notes of Decisions (291)

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§ 342. Adulterated food, 21 USCA § 342

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Footnotes1 So in original. Probably should be “; or”.

2 So in original. Probably should be “subparagraph”.

21 U.S.C.A. § 342, 21 USCA § 342Current through P.L. 112-197 approved 11-27-12

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§ 346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA § 346a

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(a) Requirement for tolerance or exemption

(1) General rule

Except as provided in paragraph (2) or (3), any pesticide chemical residue in or on a food shall be deemed unsafe for thepurpose of section 342(a)(2)(B) of this title unless--

(A) a tolerance for such pesticide chemical residue in or on such food is in effect under this section and the quantity ofthe residue is within the limits of the tolerance; or

(B) an exemption from the requirement of a tolerance is in effect under this section for the pesticide chemical residue.

For the purposes of this section, the term “food”, when used as a noun without modification, shall mean a raw agriculturalcommodity or processed food.

(2) Processed food

Notwithstanding paragraph (1)--

(A) if a tolerance is in effect under this section for a pesticide chemical residue in or on a raw agricultural commodity, apesticide chemical residue that is present in or on a processed food because the food is made from that raw agriculturalcommodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title despite the lack of atolerance for the pesticide chemical residue in or on the processed food if the pesticide chemical has been used in or on theraw agricultural commodity in conformity with a tolerance under this section, such residue in or on the raw agriculturalcommodity has been removed to the extent possible in good manufacturing practice, and the concentration of the pesticidechemical residue in the processed food is not greater than the tolerance prescribed for the pesticide chemical residue inthe raw agricultural commodity; or

(B) if an exemption for the requirement for a tolerance is in effect under this section for a pesticide chemical residue inor on a raw agricultural commodity, a pesticide chemical residue that is present in or on a processed food because thefood is made from that raw agricultural commodity shall not be considered unsafe within the meaning of section 342(a)(2)(B) of this title.

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(3) Residues of degradation products

If a pesticide chemical residue is present in or on a food because it is a metabolite or other degradation product of a precursorsubstance that itself is a pesticide chemical or pesticide chemical residue, such a residue shall not be considered to be unsafewithin the meaning of section 342(a)(2)(B) of this title despite the lack of a tolerance or exemption from the need for atolerance for such residue in or on such food if--

(A) the Administrator has not determined that the degradation product is likely to pose any potential health risk fromdietary exposure that is of a different type than, or of a greater significance than, any risk posed by dietary exposure tothe precursor substance;

(B) either--

(i) a tolerance is in effect under this section for residues of the precursor substance in or on the food, and thecombined level of residues of the degradation product and the precursor substance in or on the food is at or below thestoichiometrically equivalent level that would be permitted by the tolerance if the residue consisted only of the precursorsubstance rather than the degradation product; or

(ii) an exemption from the need for a tolerance is in effect under this section for residues of the precursor substancein or on the food; and

(C) the tolerance or exemption for residues of the precursor substance does not state that it applies only to particular namedsubstances and does not state that it does not apply to residues of the degradation product.

(4) Effect of tolerance or exemption

While a tolerance or exemption from the requirement for a tolerance is in effect under this section for a pesticide chemicalresidue with respect to any food, the food shall not by reason of bearing or containing any amount of such a residue beconsidered to be adulterated within the meaning of section 342(a)(1) of this title.

(b) Authority and standard for tolerance

(1) Authority

The Administrator may issue regulations establishing, modifying, or revoking a tolerance for a pesticide chemical residuein or on a food--

(A) in response to a petition filed under subsection (d) of this section; or

(B) on the Administrator's own initiative under subsection (e) of this section.

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As used in this section, the term “modify” shall not mean expanding the tolerance to cover additional foods.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or leave in effect a tolerance for a pesticide chemical residue in or on a food onlyif the Administrator determines that the tolerance is safe. The Administrator shall modify or revoke a tolerance if theAdministrator determines it is not safe.

(ii) Determination of safety

As used in this section, the term “safe”, with respect to a tolerance for a pesticide chemical residue, means that theAdministrator has determined that there is a reasonable certainty that no harm will result from aggregate exposure tothe pesticide chemical residue, including all anticipated dietary exposures and all other exposures for which there isreliable information.

(iii) Rule of construction

With respect to a tolerance, a pesticide chemical residue meeting the standard under clause (i) is not an eligible pesticidechemical residue for purposes of subparagraph (B).

(B) Tolerances for eligible pesticide chemical residues

(i) Definition

As used in this subparagraph, the term “eligible pesticide chemical residue” means a pesticide chemical residue as towhich--

(I) the Administrator is not able to identify a level of exposure to the residue at which the residue will not cause orcontribute to a known or anticipated harm to human health (referred to in this section as a “nonthreshold effect”);

(II) the lifetime risk of experiencing the nonthreshold effect is appropriately assessed by quantitative risk assessment;and

(III) with regard to any known or anticipated harm to human health for which the Administrator is able to identifya level at which the residue will not cause such harm (referred to in this section as a “threshold effect”), theAdministrator determines that the level of aggregate exposure is safe.

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(ii) Determination of tolerance

Notwithstanding subparagraph (A)(i), a tolerance for an eligible pesticide chemical residue may be left in effect ormodified under this subparagraph if--

(I) at least one of the conditions described in clause (iii) is met; and

(II) both of the conditions described in clause (iv) are met.

(iii) Conditions regarding use

For purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticidechemical residue are the following:

(I) Use of the pesticide chemical that produces the residue protects consumers from adverse effects on health thatwould pose a greater risk than the dietary risk from the residue.

(II) Use of the pesticide chemical that produces the residue is necessary to avoid a significant disruption in domesticproduction of an adequate, wholesome, and economical food supply.

(iv) Conditions regarding risk

For purposes of clause (ii), the conditions described in this clause with respect to a tolerance for an eligible pesticidechemical residue are the following:

(I) The yearly risk associated with the nonthreshold effect from aggregate exposure to the residue does not exceed10 times the yearly risk that would be allowed under subparagraph (A) for such effect.

(II) The tolerance is limited so as to ensure that the risk over a lifetime associated with the nonthreshold effect fromaggregate exposure to the residue is not greater than twice the lifetime risk that would be allowed under subparagraph(A) for such effect.

(v) Review

Five years after the date on which the Administrator makes a determination to leave in effect or modify a toleranceunder this subparagraph, and thereafter as the Administrator deems appropriate, the Administrator shall determine, afternotice and opportunity for comment, whether it has been demonstrated to the Administrator that a condition describedin clause (iii)(I) or clause (iii)(II) continues to exist with respect to the tolerance and that the yearly and lifetime risksfrom aggregate exposure to such residue continue to comply with the limits specified in clause (iv). If the Administratordetermines by such date that such demonstration has not been made, the Administrator shall, not later than 180 daysafter the date of such determination, issue a regulation under subsection (e)(1) of this section to modify or revoke thetolerance.

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(vi) Infants and children

Any tolerance under this subparagraph shall meet the requirements of subparagraph (C).

(C) Exposure of infants and children

In establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, theAdministrator--

(i) shall assess the risk of the pesticide chemical residue based on--

(I) available information about consumption patterns among infants and children that are likely to result indisproportionately high consumption of foods containing or bearing such residue among infants and children incomparison to the general population;

(II) available information concerning the special susceptibility of infants and children to the pesticide chemicalresidues, including neurological differences between infants and children and adults, and effects of in utero exposureto pesticide chemicals; and

(III) available information concerning the cumulative effects on infants and children of such residues and othersubstances that have a common mechanism of toxicity; and

(ii) shall--

(I) ensure that there is a reasonable certainty that no harm will result to infants and children from aggregate exposureto the pesticide chemical residue; and

(II) publish a specific determination regarding the safety of the pesticide chemical residue for infants and children.

The Secretary of Health and Human Services and the Secretary of Agriculture, in consultation with the Administrator,shall conduct surveys to document dietary exposure to pesticides among infants and children. In the case of thresholdeffects, for purposes of clause (ii)(I) an additional tenfold margin of safety for the pesticide chemical residue andother sources of exposure shall be applied for infants and children to take into account potential pre- and post-nataltoxicity and completeness of the data with respect to exposure and toxicity to infants and children. Notwithstandingsuch requirement for an additional margin of safety, the Administrator may use a different margin of safety for thepesticide chemical residue only if, on the basis of reliable data, such margin will be safe for infants and children.

(D) Factors

In establishing, modifying, leaving in effect, or revoking a tolerance or exemption for a pesticide chemical residue, theAdministrator shall consider, among other relevant factors--

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§ 346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA § 346a

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(i) the validity, completeness, and reliability of the available data from studies of the pesticide chemical and pesticidechemical residue;

(ii) the nature of any toxic effect shown to be caused by the pesticide chemical or pesticide chemical residue in suchstudies;

(iii) available information concerning the relationship of the results of such studies to human risk;

(iv) available information concerning the dietary consumption patterns of consumers (and major identifiable subgroupsof consumers);

(v) available information concerning the cumulative effects of such residues and other substances that have a commonmechanism of toxicity;

(vi) available information concerning the aggregate exposure levels of consumers (and major identifiable subgroupsof consumers) to the pesticide chemical residue and to other related substances, including dietary exposure under thetolerance and all other tolerances in effect for the pesticide chemical residue, and exposure from other non-occupationalsources;

(vii) available information concerning the variability of the sensitivities of major identifiable subgroups of consumers;

(viii) such information as the Administrator may require on whether the pesticide chemical may have an effect in humansthat is similar to an effect produced by a naturally occurring estrogen or other endocrine effects; and

(ix) safety factors which in the opinion of experts qualified by scientific training and experience to evaluate the safetyof food additives are generally recognized as appropriate for the use of animal experimentation data.

(E) Data and information regarding anticipated and actual residue levels

(i) Authority

In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administratormay consider available data and information on the anticipated residue levels of the pesticide chemical in or on foodand the actual residue levels of the pesticide chemical that have been measured in food, including residue data collectedby the Food and Drug Administration.

(ii) Requirement

If the Administrator relies on anticipated or actual residue levels in establishing, modifying, or leaving in effect atolerance, the Administrator shall pursuant to subsection (f)(1) of this section require that data be provided five years

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after the date on which the tolerance is established, modified, or left in effect, and thereafter as the Administrator deemsappropriate, demonstrating that such residue levels are not above the levels so relied on. If such data are not so provided,or if the data do not demonstrate that the residue levels are not above the levels so relied on, the Administrator shall, notlater than 180 days after the date on which the data were required to be provided, issue a regulation under subsection (e)(1) of this section, or an order under subsection (f)(2) of this section, as appropriate, to modify or revoke the tolerance.

(F) Percent of food actually treated

In establishing, modifying, leaving in effect, or revoking a tolerance for a pesticide chemical residue, the Administratormay, when assessing chronic dietary risk, consider available data and information on the percent of food actually treatedwith the pesticide chemical (including aggregate pesticide use data collected by the Department of Agriculture) only ifthe Administrator--

(i) finds that the data are reliable and provide a valid basis to show what percentage of the food derived from such cropis likely to contain such pesticide chemical residue;

(ii) finds that the exposure estimate does not understate exposure for any significant subpopulation group;

(iii) finds that, if data are available on pesticide use and consumption of food in a particular area, the population in sucharea is not dietarily exposed to residues above those estimated by the Administrator; and

(iv) provides for the periodic reevaluation of the estimate of anticipated dietary exposure.

(3) Detection methods

(A) General rule

A tolerance for a pesticide chemical residue in or on a food shall not be established or modified by the Administratorunless the Administrator determines, after consultation with the Secretary, that there is a practical method for detectingand measuring the levels of the pesticide chemical residue in or on the food.

(B) Detection limit

A tolerance for a pesticide chemical residue in or on a food shall not be established at or modified to a level lower than thelimit of detection of the method for detecting and measuring the pesticide chemical residue specified by the Administratorunder subparagraph (A).

(4) International standards

In establishing a tolerance for a pesticide chemical residue in or on a food, the Administrator shall determine whether amaximum residue level for the pesticide chemical has been established by the Codex Alimentarius Commission. If a Codexmaximum residue level has been established for the pesticide chemical and the Administrator does not propose to adopt

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the Codex level, the Administrator shall publish for public comment a notice explaining the reasons for departing from theCodex level.

(c) Authority and standard for exemptions

(1) Authority

The Administrator may issue a regulation establishing, modifying, or revoking an exemption from the requirement for atolerance for a pesticide chemical residue in or on food--

(A) in response to a petition filed under subsection (d) of this section; or

(B) on the Administrator's initiative under subsection (e) of this section.

(2) Standard

(A) General rule

(i) Standard

The Administrator may establish or leave in effect an exemption from the requirement for a tolerance for a pesticidechemical residue in or on food only if the Administrator determines that the exemption is safe. The Administrator shallmodify or revoke an exemption if the Administrator determines it is not safe.

(ii) Determination of safety

The term “safe”, with respect to an exemption for a pesticide chemical residue, means that the Administrator hasdetermined that there is a reasonable certainty that no harm will result from aggregate exposure to the pesticide chemicalresidue, including all anticipated dietary exposures and all other exposures for which there is reliable information.

(B) Factors

In making a determination under this paragraph, the Administrator shall take into account, among other relevantconsiderations, the considerations set forth in subparagraphs (C) and (D) of subsection (b)(2) of this section.

(3) Limitation

An exemption from the requirement for a tolerance for a pesticide chemical residue in or on food shall not be established ormodified by the Administrator unless the Administrator determines, after consultation with the Secretary--

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(A) that there is a practical method for detecting and measuring the levels of such pesticide chemical residue in or onfood; or

(B) that there is no need for such a method, and states the reasons for such determination in issuing the regulationestablishing or modifying the exemption.

(d) Petition for tolerance or exemption

(1) Petitions and petitioners

Any person may file with the Administrator a petition proposing the issuance of a regulation--

(A) establishing, modifying, or revoking a tolerance for a pesticide chemical residue in or on a food; or

(B) establishing, modifying, or revoking an exemption from the requirement of a tolerance for such a residue.

(2) Petition contents

(A) Establishment

A petition under paragraph (1) to establish a tolerance or exemption for a pesticide chemical residue shall be supported bysuch data and information as are specified in regulations issued by the Administrator, including--

(i)(I) an informative summary of the petition and of the data, information, and arguments submitted or cited in supportof the petition; and

(II) a statement that the petitioner agrees that such summary or any information it contains may be published as a partof the notice of filing of the petition to be published under this subsection and as part of a proposed or final regulationissued under this section;

(ii) the name, chemical identity, and composition of the pesticide chemical residue and of the pesticide chemical thatproduces the residue;

(iii) data showing the recommended amount, frequency, method, and time of application of that pesticide chemical;

(iv) full reports of tests and investigations made with respect to the safety of the pesticide chemical, including fullinformation as to the methods and controls used in conducting those tests and investigations;

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(v) full reports of tests and investigations made with respect to the nature and amount of the pesticide chemical residuethat is likely to remain in or on the food, including a description of the analytical methods used;

(vi) a practical method for detecting and measuring the levels of the pesticide chemical residue in or on the food, or forexemptions, a statement why such a method is not needed;

(vii) a proposed tolerance for the pesticide chemical residue, if a tolerance is proposed;

(viii) if the petition relates to a tolerance for a processed food, reports of investigations conducted using the processingmethod(s) used to produce that food;

(ix) such information as the Administrator may require to make the determination under subsection (b)(2)(C) of thissection;

(x) such information as the Administrator may require on whether the pesticide chemical may have an effect in humansthat is similar to an effect produced by a naturally occurring estrogen or other endocrine effects;

(xi) information regarding exposure to the pesticide chemical residue due to any tolerance or exemption already grantedfor such residue;

(xii) practical methods for removing any amount of the residue that would exceed any proposed tolerance; and

(xiii) such other data and information as the Administrator requires by regulation to support the petition.

If information or data required by this subparagraph is available to the Administrator, the person submitting thepetition may cite the availability of the information or data in lieu of submitting it. The Administrator may require apetition to be accompanied by samples of the pesticide chemical with respect to which the petition is filed.

(B) Modification or revocation

The Administrator may by regulation establish the requirements for information and data to support a petition to modifyor revoke a tolerance or to modify or revoke an exemption from the requirement for a tolerance.

(3) Notice

A notice of the filing of a petition that the Administrator determines has met the requirements of paragraph (2) shall bepublished by the Administrator within 30 days after such determination. The notice shall announce the availability of adescription of the analytical methods available to the Administrator for the detection and measurement of the pesticidechemical residue with respect to which the petition is filed or shall set forth the petitioner's statement of why such a methodis not needed. The notice shall include the summary required by paragraph (2)(A)(i)(I).

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(4) Actions by the Administrator

(A) In general

The Administrator shall, after giving due consideration to a petition filed under paragraph (1) and any other informationavailable to the Administrator--

(i) issue a final regulation (which may vary from that sought by the petition) establishing, modifying, or revoking atolerance for the pesticide chemical residue or an exemption of the pesticide chemical residue from the requirement of atolerance (which final regulation shall be issued without further notice and without further period for public comment);

(ii) issue a proposed regulation under subsection (e) of this section, and thereafter issue a final regulation under suchsubsection; or

(iii) issue an order denying the petition.

(B) Priorities

The Administrator shall give priority to petitions for the establishment or modification of a tolerance or exemption fora pesticide chemical residue that appears to pose a significantly lower risk to human health from dietary exposure thanpesticide chemical residues that have tolerances in effect for the same or similar uses.

(C) Expedited review of certain petitions

(i) Date certain for review

If a person files a complete petition with the Administrator proposing the issuance of a regulation establishing a toleranceor exemption for a pesticide chemical residue that presents a lower risk to human health than a pesticide chemical residuefor which a tolerance has been left in effect or modified under subsection (b)(2)(B) of this section, the Administratorshall complete action on such petition under this paragraph within 1 year.

(ii) Required determinations

If the Administrator issues a final regulation establishing a tolerance or exemption for a safer pesticide chemical residueunder clause (i), the Administrator shall, not later than 180 days after the date on which the regulation is issued, determinewhether a condition described in subclause (I) or (II) of subsection (b)(2)(B)(iii) of this section continues to exist withrespect to a tolerance that has been left in effect or modified under subsection (b)(2)(B) of this section. If such conditiondoes not continue to exist, the Administrator shall, not later than 180 days after the date on which the determinationunder the preceding sentence is made, issue a regulation under subsection (e)(1) of this section to modify or revokethe tolerance.

(e) Action on Administrator's own initiative

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(1) General rule

The Administrator may issue a regulation--

(A) establishing, modifying, suspending under subsection (l)(3) of this section, or revoking a tolerance for a pesticidechemical or a pesticide chemical residue;

(B) establishing, modifying, suspending under subsection (l)(3) of this section, or revoking an exemption of a pesticidechemical residue from the requirement of a tolerance; or

(C) establishing general procedures and requirements to implement this section.

(2) Notice

Before issuing a final regulation under paragraph (1), the Administrator shall issue a notice of proposed rulemaking andprovide a period of not less than 60 days for public comment on the proposed regulation, except that a shorter period forcomment may be provided if the Administrator for good cause finds that it would be in the public interest to do so and statesthe reasons for the finding in the notice of proposed rulemaking.

(f) Special data requirements

(1) Requiring submission of additional data

If the Administrator determines that additional data or information are reasonably required to support the continuation of atolerance or exemption that is in effect under this section for a pesticide chemical residue on a food, the Administrator shall--

(A) issue a notice requiring the person holding the pesticide registrations associated with such tolerance or exemptionto submit the data or information under section 3(c)(2)(B) of the Federal Insecticide, Fungicide, and Rodenticide Act [7U.S.C.A. § 136a(c)(2)(B)];

(B) issue a rule requiring that testing be conducted on a substance or mixture under section 4 of the Toxic SubstancesControl Act [15 U.S.C.A. § 2603]; or

(C) publish in the Federal Register, after first providing notice and an opportunity for comment of not less than 60 days'duration, an order--

(i) requiring the submission to the Administrator by one or more interested persons of a notice identifying the personor persons who will submit the required data and information;

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(ii) describing the type of data and information required to be submitted to the Administrator and stating why the dataand information could not be obtained under the authority of section 3(c)(2)(B) of the Federal Insecticide, Fungicide, andRodenticide Act [7 U.S.C.A. § 136a(c)(2)(B)] or section 4 of the Toxic Substances Control Act [15 U.S.C.A. § 2603];

(iii) describing the reports of the Administrator required to be prepared during and after the collection of the data andinformation;

(iv) requiring the submission to the Administrator of the data, information, and reports referred to in clauses (ii) and(iii); and

(v) establishing dates by which the submissions described in clauses (i) and (iv) must be made.

The Administrator may under subparagraph (C) revise any such order to correct an error. The Administrator mayunder this paragraph require data or information pertaining to whether the pesticide chemical may have an effect inhumans that is similar to an effect produced by a naturally occurring estrogen or other endocrine effects.

(2) Noncompliance

If a submission required by a notice issued in accordance with paragraph (1)(A), a rule issued under paragraph (1)(B), oran order issued under paragraph (1)(C) is not made by the time specified in such notice, rule, or order, the Administratormay by order published in the Federal Register modify or revoke the tolerance or exemption in question. In any review ofsuch an order under subsection (g)(2) of this section, the only material issue shall be whether a submission required underparagraph (1) was not made by the time specified.

(g) Effective date, objections, hearings, and administrative review

(1) Effective date

A regulation or order issued under subsection (d)(4), (e)(1), or (f)(2) of this section shall take effect upon publication unlessthe regulation or order specifies otherwise. The Administrator may stay the effectiveness of the regulation or order if, afterissuance of such regulation or order, objections are filed with respect to such regulation or order pursuant to paragraph (2).

(2) Further proceedings

(A) Objections

Within 60 days after a regulation or order is issued under subsection (d)(4), (e)(1)(A), (e)(1)(B), (f)(2), (n)(3), or (n)(5)(C)of this section, any person may file objections thereto with the Administrator, specifying with particularity the provisionsof the regulation or order deemed objectionable and stating reasonable grounds therefor. If the regulation or order wasissued in response to a petition under subsection (d)(1) of this section, a copy of each objection filed by a person otherthan the petitioner shall be served by the Administrator on the petitioner.

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(B) Hearing

An objection may include a request for a public evidentiary hearing upon the objection. The Administrator shall, upon theinitiative of the Administrator or upon the request of an interested person and after due notice, hold a public evidentiaryhearing if and to the extent the Administrator determines that such a public hearing is necessary to receive factual evidencerelevant to material issues of fact raised by the objections. The presiding officer in such a hearing may authorize a party toobtain discovery from other persons and may upon a showing of good cause made by a party issue a subpoena to compeltestimony or production of documents from any person. The presiding officer shall be governed by the Federal Rules ofCivil Procedure in making any order for the protection of the witness or the content of documents produced and shallorder the payment of reasonable fees and expenses as a condition to requiring testimony of the witness. On contest, sucha subpoena may be enforced by a Federal district court.

(C) Final decision

As soon as practicable after receiving the arguments of the parties, the Administrator shall issue an order stating the actiontaken upon each such objection and setting forth any revision to the regulation or prior order that the Administrator hasfound to be warranted. If a hearing was held under subparagraph (B), such order and any revision to the regulation or priororder shall, with respect to questions of fact at issue in the hearing, be based only on substantial evidence of record atsuch hearing, and shall set forth in detail the findings of facts and the conclusions of law or policy upon which the orderor regulation is based.

(h) Judicial review

(1) Petition

In a case of actual controversy as to the validity of any regulation issued under subsection (e)(1)(C) of this section, or anyorder issued under subsection (f)(1)(C) or (g)(2)(C) of this section, or any regulation that is the subject of such an order, anyperson who will be adversely affected by such order or regulation may obtain judicial review by filing in the United StatesCourt of Appeals for the circuit wherein that person resides or has its principal place of business, or in the United StatesCourt of Appeals for the District of Columbia Circuit, within 60 days after publication of such order or regulation, a petitionpraying that the order or regulation be set aside in whole or in part.

(2) Record and jurisdiction

A copy of the petition under paragraph (1) shall be forthwith transmitted by the clerk of the court to the Administrator, or anyofficer designated by the Administrator for that purpose, and thereupon the Administrator shall file in the court the record ofthe proceedings on which the Administrator based the order or regulation, as provided in section 2112 of Title 28. Upon thefiling of such a petition, the court shall have exclusive jurisdiction to affirm or set aside the order or regulation complained ofin whole or in part. As to orders issued following a public evidentiary hearing, the findings of the Administrator with respectto questions of fact shall be sustained only if supported by substantial evidence when considered on the record as a whole.

(3) Additional evidence

If a party applies to the court for leave to adduce additional evidence and shows to the satisfaction of the court that theadditional evidence is material and that there were reasonable grounds for the failure to adduce the evidence in the proceeding

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before the Administrator, the court may order that the additional evidence (and evidence in rebuttal thereof) shall be takenbefore the Administrator in the manner and upon the terms and conditions the court deems proper. The Administrator maymodify prior findings as to the facts by reason of the additional evidence so taken and may modify the order or regulationaccordingly. The Administrator shall file with the court any such modified finding, order, or regulation.

(4) Final judgment; Supreme Court review

The judgment of the court affirming or setting aside, in whole or in part, any regulation or any order and any regulationwhich is the subject of such an order shall be final, subject to review by the Supreme Court of the United States as providedin section 1254 of Title 28. The commencement of proceedings under this subsection shall not, unless specifically orderedby the court to the contrary, operate as a stay of a regulation or order.

(5) Application

Any issue as to which review is or was obtainable under this subsection shall not be the subject of judicial review underany other provision of law.

(i) Confidentiality and use of data

(1) General rule

Data and information that are or have been submitted to the Administrator under this section or section 348 of this title insupport of a tolerance or an exemption from a tolerance shall be entitled to confidential treatment for reasons of businessconfidentiality and to exclusive use and data compensation to the same extent provided by sections 3 and 10 of the FederalInsecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. §§ 136a and 136h].

(2) Exceptions

(A) In general

Data and information that are entitled to confidential treatment under paragraph (1) may be disclosed, under such securityrequirements as the Administrator may provide by regulation, to--

(i) employees of the United States authorized by the Administrator to examine such data and information in the carryingout of their official duties under this chapter or other Federal statutes intended to protect the public health; or

(ii) contractors with the United States authorized by the Administrator to examine such data and information in thecarrying out of contracts under this chapter or such statutes.

(B) Congress

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This subsection does not authorize the withholding of data or information from either House of Congress or from, tothe extent of matter within its jurisdiction, any committee or subcommittee of such committee or any joint committee ofCongress or any subcommittee of such joint committee.

(3) Summaries

Notwithstanding any provision of this subsection or other law, the Administrator may publish the informative summaryrequired by subsection (d)(2)(A)(i) of this section and may, in issuing a proposed or final regulation or order under thissection, publish an informative summary of the data relating to the regulation or order.

(j) Status of previously issued regulations

(1) Regulations under section 346

Regulations affecting pesticide chemical residues in or on raw agricultural commodities promulgated, in accordance withsection 371(e) of this title, under the authority of section 346(a) of this title upon the basis of public hearings instituted beforeJanuary 1, 1953, shall be deemed to be regulations issued under this section and shall be subject to modification or revocationunder subsections (d) and (e) of this section, and shall be subject to review under subsection (q) of this section.

(2) Regulations under section 348

Regulations that established tolerances for substances that are pesticide chemical residues in or on processed food, or thatotherwise stated the conditions under which such pesticide chemicals could be safely used, and that were issued under section348 of this title on or before August 3, 1996, shall be deemed to be regulations issued under this section and shall be subjectto modification or revocation under subsection (d) or (e) of this section, and shall be subject to review under subsection (q)of this section.

(3) Regulations under section 346a

Regulations that established tolerances or exemptions under this section that were issued on or before August 3, 1996, shallremain in effect unless modified or revoked under subsection (d) or (e) of this section, and shall be subject to review undersubsection (q) of this section.

(4) Certain substances

With respect to a substance that is not included in the definition of the term “pesticide chemical” under section 321(q)(1) ofthis title but was so included on the day before October 30, 1998, the following applies as of October 30, 1998:

(A) Notwithstanding paragraph (2), any regulation applying to the use of the substance that was in effect on the daybefore October 30, 1998, and was on such day deemed in such paragraph to have been issued under this section, shall beconsidered to have been issued under section 348 of this title.

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(B) Notwithstanding paragraph (3), any regulation applying to the use of the substance that was in effect on such day andwas issued under this section (including any such regulation issued before August 3, 1996) is deemed to have been issuedunder section 348 of this title.

(k) Transitional provision

If, on the day before August 3, 1996, a substance that is a pesticide chemical was, with respect to a particular pesticidal use ofthe substance and any resulting pesticide chemical residue in or on a particular food--

(1) regarded by the Administrator or the Secretary as generally recognized as safe for use within the meaning of the provisionsof subsection (a) of this section or section 321(s) of this title as then in effect; or

(2) regarded by the Secretary as a substance described by section 321(s)(4) of this title;

such a pesticide chemical residue shall be regarded as exempt from the requirement for a tolerance, as of August 3, 1996.The Administrator shall by regulation indicate which substances are described by this subsection. Any exemption under thissubsection may be modified or revoked as if it had been issued under subsection (c) of this section.

(l) Harmonization with action under other laws

(1) Coordination with FIFRA

To the extent practicable and consistent with the review deadlines in subsection (q) of this section, in issuing a final ruleunder this subsection that suspends or revokes a tolerance or exemption for a pesticide chemical residue in or on food, theAdministrator shall coordinate such action with any related necessary action under the Federal Insecticide, Fungicide, andRodenticide Act.

(2) Revocation of tolerance or exemption following cancellation of associated registrations

If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. § 136 et seq.], cancelsthe registration of each pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, orrequires that the registration of each such pesticide be modified to prohibit its use in connection with the production, storage,or transportation of such food, due in whole or in part to dietary risks to humans posed by residues of that pesticide chemicalon that food, the Administrator shall revoke any tolerance or exemption that allows the presence of the pesticide chemical, orany pesticide chemical residue that results from its use, in or on that food. Subsection (e) of this section shall apply to actionstaken under this paragraph. A revocation under this paragraph shall become effective not later than 180 days after--

(A) the date by which each such cancellation of a registration has become effective; or

(B) the date on which the use of the canceled pesticide becomes unlawful under the terms of the cancellation, whicheveris later.

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(3) Suspension of tolerance or exemption following suspension of associated registrations

(A) Suspension

If the Administrator, acting under the Federal Insecticide, Fungicide, and Rodenticide Act, suspends the use of eachregistered pesticide that contains a particular pesticide chemical and that is labeled for use on a particular food, due inwhole or in part to dietary risks to humans posed by residues of that pesticide chemical on that food, the Administratorshall suspend any tolerance or exemption that allows the presence of the pesticide chemical, or any pesticide chemicalresidue that results from its use, in or on that food. Subsection (e) of this section shall apply to actions taken under thisparagraph. A suspension under this paragraph shall become effective not later than 60 days after the date by which eachsuch suspension of use has become effective.

(B) Effect of suspension

The suspension of a tolerance or exemption under subparagraph (A) shall be effective as long as the use of each associatedregistration of a pesticide is suspended under the Federal Insecticide, Fungicide, and Rodenticide Act. While a suspensionof a tolerance or exemption is effective the tolerance or exemption shall not be considered to be in effect. If the suspensionof use of the pesticide under that Act is terminated, leaving the registration of the pesticide for such use in effect underthat Act, the Administrator shall rescind any associated suspension of tolerance or exemption.

(4) Tolerances for unavoidable residues

In connection with action taken under paragraph (2) or (3), or with respect to pesticides whose registrations were suspendedor canceled prior to August 3, 1996, under the Federal Insecticide, Fungicide, and Rodenticide Act, if the Administratordetermines that a residue of the canceled or suspended pesticide chemical will unavoidably persist in the environmentand thereby be present in or on a food, the Administrator may establish a tolerance for the pesticide chemical residue. Inestablishing such a tolerance, the Administrator shall take into account both the factors set forth in subsection (b)(2) of thissection and the unavoidability of the residue. Subsection (e) of this section shall apply to the establishment of such tolerance.The Administrator shall review any such tolerance periodically and modify it as necessary so that it allows no greater levelof the pesticide chemical residue than is unavoidable.

(5) Pesticide residues resulting from lawful application of pesticide

Notwithstanding any other provision of this chapter, if a tolerance or exemption for a pesticide chemical residue in or on a foodhas been revoked, suspended, or modified under this section, an article of that food shall not be deemed unsafe solely becauseof the presence of such pesticide chemical residue in or on such food if it is shown to the satisfaction of the Secretary that--

(A) the residue is present as the result of an application or use of a pesticide at a time and in a manner that was lawfulunder the Federal Insecticide, Fungicide, and Rodenticide Act; and

(B) the residue does not exceed a level that was authorized at the time of that application or use to be present on the foodunder a tolerance, exemption, food additive regulation, or other sanction then in effect under this chapter;

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unless, in the case of any tolerance or exemption revoked, suspended, or modified under this subsection or subsection (d)or (e) of this section, the Administrator has issued a determination that consumption of the legally treated food during theperiod of its likely availability in commerce will pose an unreasonable dietary risk.

(6) Tolerance for use of pesticides under an emergency exemption

If the Administrator grants an exemption under section 18 of the Federal Insecticide, Fungicide, and Rodenticide Act (7U.S.C. 136p) for a pesticide chemical, the Administrator shall establish a tolerance or exemption from the requirement fora tolerance for the pesticide chemical residue. Such a tolerance or exemption from a tolerance shall have an expiration date.The Administrator may establish such a tolerance or exemption without providing notice or a period for comment on thetolerance or exemption. The Administrator shall promulgate regulations within 365 days after August 3, 1996, governingthe establishment of tolerances and exemptions under this paragraph. Such regulations shall be consistent with the safetystandard under subsections (b)(2) and (c)(2) of this section and with section 18 of the Federal Insecticide, Fungicide, andRodenticide Act.

(m) Fees

(1) Amount

The Administrator shall by regulation require the payment of such fees as will in the aggregate, in the judgment of theAdministrator, be sufficient over a reasonable term to provide, equip, and maintain an adequate service for the performanceof the Administrator's functions under this section. Under the regulations, the performance of the Administrator's servicesor other functions under this section, including--

(A) the acceptance for filing of a petition submitted under subsection (d) of this section;

(B) establishing, modifying, leaving in effect, or revoking a tolerance or establishing, modifying, leaving in effect, orrevoking an exemption from the requirement for a tolerance under this section;

(C) the acceptance for filing of objections under subsection (g) of this section; or

(D) the certification and filing in court of a transcript of the proceedings and the record under subsection (h) of this section;

may be conditioned upon the payment of such fees. The regulations may further provide for waiver or refund of fees inwhole or in part when in the judgment of the Administrator such a waiver or refund is equitable and not contrary to thepurposes of this subsection.

(2) Deposit

All fees collected under paragraph (1) shall be deposited in the Reregistration and Expedited Processing Fund created bysection 4(k) of the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. § 136a-1(k)]. Such fees shall be availableto the Administrator, without fiscal year limitation, for the performance of the Administrator's services or functions asspecified in paragraph (1).

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(3) Prohibition

During the period beginning on the effective date of the Pesticide Registration Improvement Renewal Act and ending onSeptember 30, 2017, the Administrator shall not collect any tolerance fees under paragraph (1).

(n) National uniformity of tolerances

(1) “Qualifying pesticide chemical residue” defined

For purposes of this subsection, the term “qualifying pesticide chemical residue” means a pesticide chemical residue resultingfrom the use, in production, processing, or storage of a food, of a pesticide chemical that is an active ingredient and that--

(A) was first approved for such use in a registration of a pesticide issued under section 3(c)(5) of the Federal Insecticide,Fungicide, and Rodenticide Act [7 U.S.C.A. § 1365(c)(5)] on or after April 25, 1985, on the basis of data determined by theAdministrator to meet all applicable requirements for data prescribed by regulations in effect under that Act [7 U.S.C.A.§ 136 et seq.] on April 25, 1985; or

(B) was approved for such use in a reregistration eligibility determination issued under section 4(g) of that Act [7 U.S.C.A.§ 136a-1(g)] on or after August 3, 1996.

(2) Qualifying Federal determination

For purposes of this subsection, the term “qualifying Federal determination” means a tolerance or exemption from therequirement for a tolerance for a qualifying pesticide chemical residue that--

(A) is issued under this section after August 3, 1996, and determined by the Administrator to meet the standard undersubsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption) of this section; or

(B)(i) pursuant to subsection (j) of this section is remaining in effect or is deemed to have been issued under this section,or is regarded under subsection (k) of this section as exempt from the requirement for a tolerance; and

(ii) is determined by the Administrator to meet the standard under subsection (b)(2)(A) (in the case of a tolerance) or (c)(2) (in the case of an exemption) of this section.

(3) Limitation

The Administrator may make the determination described in paragraph (2)(B)(ii) only by issuing a rule in accordance withthe procedure set forth in subsection (d) or (e) of this section and only if the Administrator issues a proposed rule and allowsa period of not less than 30 days for comment on the proposed rule. Any such rule shall be reviewable in accordance withsubsections (g) and (h) of this section.

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(4) State authority

Except as provided in paragraphs (5), (6), and (8) no State or political subdivision may establish or enforce any regulatorylimit on a qualifying pesticide chemical residue in or on any food if a qualifying Federal determination applies to the presenceof such pesticide chemical residue in or on such food, unless such State regulatory limit is identical to such qualifyingFederal determination. A State or political subdivision shall be deemed to establish or enforce a regulatory limit on a pesticidechemical residue in or on a food if it purports to prohibit or penalize the production, processing, shipping, or other handlingof a food because it contains a pesticide residue (in excess of a prescribed limit).

(5) Petition procedure

(A) In general

Any State may petition the Administrator for authorization to establish in such State a regulatory limit on a qualifyingpesticide chemical residue in or on any food that is not identical to the qualifying Federal determination applicable to suchqualifying pesticide chemical residue.

(B) Petition requirements

Any petition under subparagraph (A) shall--

(i) satisfy any requirements prescribed, by rule, by the Administrator; and

(ii) be supported by scientific data about the pesticide chemical residue that is the subject of the petition or aboutchemically related pesticide chemical residues, data on the consumption within such State of food bearing the pesticidechemical residue, and data on exposure of humans within such State to the pesticide chemical residue.

(C) Authorization

The Administrator may, by order, grant the authorization described in subparagraph (A) if the Administrator determinesthat the proposed State regulatory limit--

(i) is justified by compelling local conditions; and

(ii) would not cause any food to be a violation of Federal law.

(D) Treatment

In lieu of any action authorized under subparagraph (C), the Administrator may treat a petition under this paragraph asa petition under subsection (d) of this section to modify or revoke a tolerance or an exemption. If the Administratordetermines to treat a petition under this paragraph as a petition under subsection (d) of this section, the Administrator shallthereafter act on the petition pursuant to subsection (d) of this section.

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§ 346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA § 346a

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(E) Review

Any order of the Administrator granting or denying the authorization described in subparagraph (A) shall be subject toreview in the manner described in subsections (g) and (h) of this section.

(6) Urgent petition procedure

Any State petition to the Administrator pursuant to paragraph (5) that demonstrates that consumption of a food containingsuch pesticide residue level during the period of the food's likely availability in the State will pose a significant public healththreat from acute exposure shall be considered an urgent petition. If an order by the Administrator to grant or deny therequested authorization in an urgent petition is not made within 30 days of receipt of the petition, the petitioning State mayestablish and enforce a temporary regulatory limit on a qualifying pesticide chemical residue in or on the food. The temporaryregulatory limit shall be validated or terminated by the Administrator's final order on the petition.

(7) Residues from lawful application

No State or political subdivision may enforce any regulatory limit on the level of a pesticide chemical residue that may appearin or on any food if, at the time of the application of the pesticide that resulted in such residue, the sale of such food with suchresidue level was lawful under this section and under the law of such State, unless the State demonstrates that consumptionof the food containing such pesticide residue level during the period of the food's likely availability in the State will pose anunreasonable dietary risk to the health of persons within such State.

(8) Savings

Nothing in this chapter preempts the authority of any State or political subdivision to require that a food containing a pesticidechemical residue bear or be the subject of a warning or other statement relating to the presence of the pesticide chemicalresidue in or on such food.

(o) Consumer right to know

Not later than 2 years after August 3, 1996, and annually thereafter, the Administrator shall, in consultation with the Secretary ofAgriculture and the Secretary of Health and Human Services, publish in a format understandable to a lay person, and distributeto large retail grocers for public display (in a manner determined by the grocer), the following information, at a minimum:

(1) A discussion of the risks and benefits of pesticide chemical residues in or on food purchased by consumers.

(2) A listing of actions taken under subparagraph (B) of subsection (b)(2) of this section that may result in pesticide chemicalresidues in or on food that present a yearly or lifetime risk above the risk allowed under subparagraph (A) of such subsection,and the food on which the pesticide chemicals producing the residues are used.

(3) Recommendations to consumers for reducing dietary exposure to pesticide chemical residues in a manner consistent withmaintaining a healthy diet, including a list of food that may reasonably substitute for food listed under paragraph (2).

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§ 346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA § 346a

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Nothing in this subsection shall prevent retail grocers from providing additional information.

(p) Estrogenic substances screening program

(1) Development

Not later than 2 years after August 3, 1996, the Administrator shall in consultation with the Secretary of Health and HumanServices develop a screening program, using appropriate validated test systems and other scientifically relevant information,to determine whether certain substances may have an effect in humans that is similar to an effect produced by a naturallyoccurring estrogen, or such other endocrine effect as the Administrator may designate.

(2) Implementation

Not later than 3 years after August 3, 1996, after obtaining public comment and review of the screening program describedin paragraph (1) by the scientific advisory panel established under section 25(d) of the Federal Insecticide, Fungicide,and Rodenticide Act [7 U.S.C.A. § 136w(d)] or the science advisory board established by section 4365 of Title 42, theAdministrator shall implement the program.

(3) Substances

In carrying out the screening program described in paragraph (1), the Administrator--

(A) shall provide for the testing of all pesticide chemicals; and

(B) may provide for the testing of any other substance that may have an effect that is cumulative to an effect of a pesticidechemical if the Administrator determines that a substantial population may be exposed to such substance.

(4) Exemption

Notwithstanding paragraph (3), the Administrator may, by order, exempt from the requirements of this section a biologicsubstance or other substance if the Administrator determines that the substance is anticipated not to produce any effect inhumans similar to an effect produced by a naturally occurring estrogen.

(5) Collection of information

(A) In general

The Administrator shall issue an order to a registrant of a substance for which testing is required under this subsection, orto a person who manufactures or imports a substance for which testing is required under this subsection, to conduct testingin accordance with the screening program described in paragraph (1), and submit information obtained from the testingto the Administrator, within a reasonable time period that the Administrator determines is sufficient for the generationof the information.

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§ 346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA § 346a

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(B) Procedures

To the extent practicable the Administrator shall minimize duplicative testing of the same substance for the same endocrineeffect, develop, as appropriate, procedures for fair and equitable sharing of test costs, and develop, as necessary, proceduresfor handling of confidential business information.

(C) Failure of registrants to submit information

(i) Suspension

If a registrant of a substance referred to in paragraph (3)(A) fails to comply with an order under subparagraph (A) ofthis paragraph, the Administrator shall issue a notice of intent to suspend the sale or distribution of the substance by theregistrant. Any suspension proposed under this paragraph shall become final at the end of the 30-day period beginningon the date that the registrant receives the notice of intent to suspend, unless during that period a person adverselyaffected by the notice requests a hearing or the Administrator determines that the registrant has complied fully withthis paragraph.

(ii) Hearing

If a person requests a hearing under clause (i), the hearing shall be conducted in accordance with section 554 of Title5. The only matter for resolution at the hearing shall be whether the registrant has failed to comply with an order undersubparagraph (A) of this paragraph. A decision by the Administrator after completion of a hearing shall be consideredto be a final agency action.

(iii) Termination of suspensions

The Administrator shall terminate a suspension under this subparagraph issued with respect to a registrant if theAdministrator determines that the registrant has complied fully with this paragraph.

(D) Noncompliance by other persons

Any person (other than a registrant) who fails to comply with an order under subparagraph (A) shall be liable for the samepenalties and sanctions as are provided under section 16 of the Toxic Substances Control Act [15 U.S.C.A. § 2615] inthe case of a violation referred to in that section. Such penalties and sanctions shall be assessed and imposed in the samemanner as provided in such section 16.

(6) Agency action

In the case of any substance that is found, as a result of testing and evaluation under this section, to have an endocrine effect onhumans, the Administrator shall, as appropriate, take action under such statutory authority as is available to the Administrator,including consideration under other sections of this chapter, as is necessary to ensure the protection of public health.

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§ 346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA § 346a

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(7) Report to Congress

Not later than 4 years after August 3, 1996, the Administrator shall prepare and submit to Congress a report containing--

(A) the findings of the Administrator resulting from the screening program described in paragraph (1);

(B) recommendations for further testing needed to evaluate the impact on human health of the substances tested underthe screening program; and

(C) recommendations for any further actions (including any action described in paragraph (6)) that the Administratordetermines are appropriate based on the findings.

(q) Schedule for review

(1) In general

The Administrator shall review tolerances and exemptions for pesticide chemical residues in effect on the day before August3, 1996, as expeditiously as practicable, assuring that--

(A) 33 percent of such tolerances and exemptions are reviewed within 3 years of August 3, 1996;

(B) 66 percent of such tolerances and exemptions are reviewed within 6 years of August 3, 1996; and

(C) 100 percent of such tolerances and exemptions are reviewed within 10 years of August 3, 1996.

In conducting a review of a tolerance or exemption, the Administrator shall determine whether the tolerance or exemption

meets the requirements of subsections 1 (b)(2) or (c)(2) of this section and shall, by the deadline for the review of thetolerance or exemption, issue a regulation under subsection (d)(4) or (e)(1) of this section to modify or revoke the toleranceor exemption if the tolerance or exemption does not meet such requirements.

(2) Priorities

In determining priorities for reviewing tolerances and exemptions under paragraph (1), the Administrator shall give priorityto the review of the tolerances or exemptions that appear to pose the greatest risk to public health.

(3) Publication of schedule

Not later than 12 months after August 3, 1996, the Administrator shall publish a schedule for review of tolerances andexemptions established prior to August 3, 1996. The determination of priorities for the review of tolerances and exemptionspursuant to this subsection is not a rulemaking and shall not be subject to judicial review, except that failure to take finalaction pursuant to the schedule established by this paragraph shall be subject to judicial review.

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§ 346a. Tolerances and exemptions for pesticide chemical residues, 21 USCA § 346a

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(r) Temporary tolerance or exemption

The Administrator may, upon the request of any person who has obtained an experimental permit for a pesticide chemical underthe Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. § 136 et seq.] or upon the Administrator's own initiative,establish a temporary tolerance or exemption for the pesticide chemical residue for the uses covered by the permit. Subsections(b)(2), (c)(2), (d), and (e) of this section shall apply to actions taken under this subsection.

(s) Savings clause

Nothing in this section shall be construed to amend or modify the provisions of the Toxic Substances Control Act [15 U.S.C.A.§ 2601 et seq.] or the Federal Insecticide, Fungicide, and Rodenticide Act [7 U.S.C.A. § 136 et seq.].

Credits(June 25, 1938, c. 675, § 408, as added July 22, 1954, c. 559, § 3, 68 Stat. 511; amended Aug. 28, 1958, Pub.L. 85-791, § 20, 72Stat. 947; Oct. 30, 1970, Pub.L. 91-515, Title VI, § 601(d)(1), 84 Stat. 1311; 1970 Reorg. Plan No. 3, § 2(a)(4), (8)(ii), eff. Dec.2, 1970, 35 F.R. 15623, 84 Stat. 2086; Nov. 18, 1971, Pub.L. 92-157, Title III, § 303(a), 85 Stat. 464; Oct. 21, 1972, Pub.L.92-516, § 3(3), 86 Stat. 998; Nov. 8, 1984, Pub.L. 98-620, Title IV, § 402(25)(A), 98 Stat. 3359; June 16, 1992, Pub.L. 102-300,§ 6(b)(1), 106 Stat. 240; Oct. 29, 1992, Pub.L. 102-571, Title I, § 107(7), 106 Stat. 4499; Aug. 13, 1993, Pub.L. 103-80, § 3(k),107 Stat. 776; Aug. 3, 1996, Pub.L. 104-170, Title IV, § 405, 110 Stat. 1514; Oct. 30, 1998, Pub.L. 105-324, § 2(b), 112 Stat.3036; Oct. 9, 2007, Pub.L. 110-94, § 4(d)(2), 121 Stat. 1002; Pub.L. 112-177, § 2(a)(3), Sept. 28, 2012, 126 Stat. 1329.)

Notes of Decisions (30)

Footnotes1 So in original. Probably should be “subsection”.

21 U.S.C.A. § 346a, 21 USCA § 346aCurrent through P.L. 112-197 approved 11-27-12

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DEPARTMENT OF THE INTERIOR, ENVIRONMENT, AND..., PL 109–54, August 2,...

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UNITED STATES PUBLIC LAWS109th Congress - First Session

Convening January 7, 2005

Additions and Deletions are not identified in this database.Vetoed provisions within tabular material are not displayed

PL 109–54 (HR 2361)August 2, 2005

DEPARTMENT OF THE INTERIOR, ENVIRONMENT, AND RELATED AGENCIES APPROPRIATIONS ACT, 2006

An Act Making appropriations for the Department of the Interior, environment, and related agencies for the fiscal year endingSeptember 30,2006, and for other purposes.

Be it enacted by the Senate and House of Representatives of the United States of America in Congress assembled, That thefollowing sums are appropriated, out of any money in the Treasury not otherwise appropriated, for the Department of theInterior, environment, and related agencies for the fiscal year ending September 30, 2006, and for other purposes, namely:

TITLE I—DEPARTMENT OF THE INTERIORBureau of Land Management

MANAGEMENT OF LANDS AND RESOURCESFor necessary expenses for protection, use, improvement, development, disposal, cadastral surveying, classification,

acquisition of easements and other interests in lands, and performance of other functions, including maintenance of facilities,as authorized by law, in the management of lands and their resources under the jurisdiction of the Bureau of Land Management,including the general administration of the Bureau, and assessment of mineral potential of public lands pursuant to PublicLaw 96–487 (16 U.S.C. 3150(a)), $860,791,000, to remain available until expended, of which $1,250,000 is for high priorityprojects, to be carried out by the Youth Conservation Corps; and of which $3,000,000 shall be available in fiscal year 2006subject to a match by at least an equal amount by the National Fish and Wildlife Foundation for cost-shared projects supportingconservation of Bureau lands; and such funds shall be advanced to the Foundation as a lump sum grant without regard to whenexpenses are incurred.In addition, $32,696,000 is for Mining Law Administration program operations, including the cost of administering the mining

claim fee program; to remain available until expended, to be reduced by amounts collected by the Bureau and credited to thisappropriation from annual mining claim fees so as to result in a final appropriation estimated at not more than $860,791,000,and $2,000,000, to remain available until expended, from communication site rental fees established by the Bureau for the costof administering communication site activities.

WILDLAND FIRE MANAGEMENT(INCLUDING TRANSFER OF FUNDS)

For necessary expenses for fire preparedness, suppression operations, fire science and research, emergency rehabilitation,hazardous fuels reduction, and rural fire assistance by the Department of the Interior, $766,564,000, to remain available untilexpended, of which not to exceed $7,849,000 shall be for the renovation or construction of fire facilities: Provided, That suchfunds are also available for repayment of advances to other appropriation accounts from which funds were previously transferredfor such purposes: Provided further, That persons hired pursuant to 43 U.S.C. 1469 may be furnished subsistence and lodgingwithout cost from funds available from this appropriation: Provided further, That notwithstanding 42 U.S.C. 1856d, sumsreceived by a bureau or office of the Department of the Interior for fire protection rendered pursuant to 42 U.S.C. 1856 etseq., protection of United States property, may be credited to the appropriation from which funds were expended to providethat protection, and are available without fiscal year limitation: Provided further, That using the amounts designated underthis title of this Act, the Secretary of the Interior may enter into procurement contracts, grants, or cooperative agreements,

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DEPARTMENT OF THE INTERIOR, ENVIRONMENT, AND..., PL 109–54, August 2,...

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Beginning in fiscal year 2006 and thereafter, and notwithstanding section 306 of the Toxic Substances Control Act, the Federalshare of the cost of radon program activities implemented with Federal assistance under section 306 shall not exceed 60 percentin the third and subsequent grant years.

General Provisions, Environmental Protection AgencySEC. 201. None of the funds made available by this Act may be used by the Administrator of the Environmental Protection

Agency to accept, consider or rely on third-party intentional dosing human toxicity studies for pesticides, or to conductintentional dosing human toxicity studies for pesticides until the Administrator issues a final rulemaking on this subject. TheAdministrator shall allow for a period of not less than 90 days for public comment on the Agency's proposed rule before issuinga final rule. Such rule shall not permit the use of pregnant women, infants or children as subjects; shall be consistent with theprinciples proposed in the 2004 report of the National Academy of Sciences on intentional human dosing and the principlesof the Nuremberg Code with respect to human experimentation; and shall establish an independent Human Subjects ReviewBoard. The final rule shall be issued no later than 180–days after enactment of this Act.SEC. 202. None of the funds made available by this Act may be used in contravention of, or to delay the implementation

of, Executive Order No. 12898 of February 11, 1994 (59 Fed. Reg. 7629; relating to Federal actions to address environmentaljustice in minority populations and low-income populations).SEC. 203. None of the funds made available in this Act may be used to finalize, issue, implement, or enforce the proposed

policy of the Environmental Protection Agency entitled “National Pollutant Discharge Elimination System (NPDES) PermitRequirements for Municipal Wastewater Treatment During Wet Weather Conditions”, dated November 3, 2003 (68 Fed. Reg.63042).SEC. 204. None of the funds made available in this Act may be used in contravention of 15 U.S.C. 2682(c)(3) or to delay

the implementation of that section.SEC. 205. None of the funds provided in this Act or any other Act may be used by the Environmental Protection Agency

(EPA) to publish proposed or final regulations pursuant to the requirements of section 428(b) of division G of Public Law 108–199 until the Administrator of the Environmental Protection Agency, in coordination with other appropriate Federal agencies,has completed and published a technical study to look at safety issues, including the risk of fire and burn to consumers inuse, associated with compliance with the regulations. Not later than 6 months after the date of enactment of this Act, theAdministrator shall complete and publish the technical study.

TITLE III—RELATED AGENCIESDEPARTMENT OF AGRICULTURE

Forest ServiceFOREST AND RANGELAND RESEARCH

For necessary expenses of forest and rangeland research as authorized by law, $283,094,000, to remain available untilexpended: Provided, That of the funds provided, $60,267,000 is for the forest inventory and analysis program.

STATE AND PRIVATE FORESTRYFor necessary expenses of cooperating with and providing technical and financial assistance to States, territories, possessions,

and others, and for forest health management, including treatments of pests, pathogens, and invasive or noxious plantsand for restoring and rehabilitating forests damaged by pests or invasive plants, cooperative forestry, and education andland conservation activities and conducting an international program as authorized, $283,577,000, to remain available untilexpended, as authorized by law of which $57,380,000 is to be derived from the Land and Water Conservation Fund: Provided,That none of the funds provided under this heading for the acquisition of lands or interests in lands shall be available untilthe Forest Service notifies the House Committee on Appropriations and the Senate Committee on Appropriations, in writing,of specific contractual and grant details including the non-Federal cost share: Provided further, That of the funds providedherein, $1,000,000 shall be provided to Custer County, Idaho, for economic development in accordance with the CentralIdaho Economic Development and Recreation Act, subject to authorization: Provided further, That notwithstanding any otherprovision of law, of the funds provided under this heading, an advance lump sum payment of $1,000,000 shall be made availableto Madison County, North Carolina, for a forest recreation center, and a similar $500,000 payment shall be made available toFolkmoot USA in Haywood County, North Carolina, for Appalachian folk programs including forest crafts.

NATIONAL FOREST SYSTEM(INCLUDING TRANSFERS OF FUNDS)

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§ 26.1704 Prohibition of reliance on unethical human research..., 40 C.F.R. § 26.1704

© 2012 Thomson Reuters. No claim to original U.S. Government Works. 1

�������� ���� ��������������� ����� �� ������� ������������������� ��������� ����� ���������������"���� �#������������ ���������!"��� ����� �� ��#�������$�����������"���� �#�������%�����������&�&��� ������������'�������� ������ �������������� ��#���������������������� ���������"���� �#

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Except as provided in § 26.1706, in actions within the scope of § 26.1701, EPA shall not rely on data from any research initiatedbefore April 7, 2006, if there is clear and convincing evidence that the conduct of the research was fundamentally unethical(e.g., the research was intended to seriously harm participants or failed to obtain informed consent), or was significantlydeficient relative to the ethical standards prevailing at the time the research was conducted. This prohibition is in addition tothe prohibition in § 26.1703.

Credits[71 FR 36175, June 23, 2006]

SOURCE: 56 FR 28012, 28022, June 18, 1991; 71 FR 6168, 6176, Feb. 6, 2006; 71 FR 6168, Feb. 6, 2006, unless otherwisenoted.

AUTHORITY: 5 U.S.C. 301; 7 U.S.C. 136w(a)(1); 21 U.S.C. 346a(e)(1)(C); section 201 of Public Law No. 109–54; and 42U.S.C. 300v–1(b).

Current through December 6, 2012; 77 FR 72762

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§ 178.32 Rulings on requests for hearing., 40 C.F.R. § 178.32

© 2012 Thomson Reuters. No claim to original U.S. Government Works. 1

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(a) In the case of each request for an evidentiary hearing that was not denied under § 178.30(a) or (b), the Administrator willdetermine whether such a hearing on one or more of the objections is justified, and will publish in the Federal Register thedetermination in an order issued under § 178.37 or a Notice of Hearing issued under § 179.20 of this chapter. If some requestsfor a hearing are denied and others pertaining to the same order or regulation are granted, the denial order and the hearingnotice may be combined into a single document and shall be issued at the same time unless the Administrator for good causedetermines otherwise.

(b) A request for an evidentiary hearing will be granted if the Administrator determines that the material submitted shows thefollowing:

(1) There is a genuine and substantial issue of fact for resolution at a hearing. An evidentiary hearing will not be grantedon issues of policy or law.

(2) There is a reasonable possibility that available evidence identified by the requestor would, if established, resolve one ormore of such issues in favor of the requestor, taking into account uncontested claims or facts to the contrary. An evidentiaryhearing will not be granted on the basis of mere allegations, denials, or general descriptions of positions and contentions,nor if the Administrator concludes that the data and information submitted, even if accurate, would be insufficient to justifythe factual determination urged.

(3) Resolution of the factual issue(s) in the manner sought by the person requesting the hearing would be adequate tojustify the action requested. An evidentiary hearing will not be granted on factual issues that are not determinative withrespect to the action requested. For example, a hearing will not be granted if the Administrator concludes that the actionwould be the same even if the factual issue were resolved in the manner sought.

(c) Where appropriate, the Administrator will make rulings on any issues raised by an objection which are necessary forresolution prior to determining whether a request for an evidentiary hearing should be granted.

SOURCE: 55 FR 50291, Dec. 5, 1990; 70 FR 33359, June 8, 2005, unless otherwise noted.

AUTHORITY: 21 U.S.C. 346a, 371(a); Reorg. Plan No. 3 of 1970.

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§ 178.32 Rulings on requests for hearing., 40 C.F.R. § 178.32

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Current through December 6, 2012; 77 FR 72762

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CONGRESSIONAL RECORD — HOUSEH3670 May 19, 2005 small quantities of custom glass and ceramic ware for special occasions. Some of Nancy’s work can even be found in the House gift shop and some is sold in the EPA’s gift shop. When they print mugs or glasses for cus-tomers, they sometimes use lead-bear-ing colors on the outside surface. These colors are expensive, so they use a min-imum amount of paint, just that which is needed to color the surfaces and they try to reduce waste. And the finishing process ensures that none of the lead leaches out. So their products are safe for anyone who uses them.

But because of the EPA’s Toxics Re-lease Inventory lead rule, Nancy’s busi-ness is forced to compile daily records on how much color is used for the mugs because the color contains a very small amount of lead. Each year her small business has to report to the EPA how much lead has been used. It costs her about $7,000 annually and across the Nation about $70 million every year. And what do the Americans get for the millions that are spent? Cleaner air? No. Less lead being used? No. Less ex-posure to lead by children? No. The an-swer is none of these. But all the Amer-ican people get from these thousands of reports are estimates on how much lead is being consumed, but our air is not any cleaner.

Mr. Chairman, with the hopes of working during the conference com-mittee report, I intend to withdraw this amendment because I know it is subject to a point of order. I hope that we can work together with the gen-tleman from North Carolina (Chairman Taylor) in the conference report to try to remove some of these unnecessary regulations.

So, in conclusion, we must not move forward with our government to imple-ment regulatory burdens like this on the American public because it drives jobs overseas, it increases the trade deficit, it reduces the Federal revenue, and it moves us toward a third-rate economy.

Mr. Chairman, I ask unanimous con-sent to withdraw the amendment.

The Acting CHAIRMAN. Is there ob-jection to the request of the gentleman from Kansas?

There was no objection.

AMENDMENT NO. 9 OFFERED BY MR. POMBO

Mr. POMBO. Mr. Chairman, I offer an amendment.

The Acting CHAIRMAN. The Clerk will designate the amendment.

The text of the amendment is as fol-lows:

Amendment No. 9 offered by Mr. POMBO: At the end of the bill (before the short

title) add the following new section:

SEC. ll. The funds appropriated in this

Act under the following headings are avail-

able only to the extent provided for in au-

thorizing legislation enacted before the date

of the enactment of this Act or on or after

such date:

(1) ‘‘Bureau of Land Management—Range

Improvements’’.

(2) ‘‘United States Fish and Wildlife Serv-

ice—Resource Management’’.

(3) ‘‘United States Fish and Wildlife Serv-

ice—Cooperative Endangered Species Con-

servation Fund’’.

(4) ‘‘United States Fish and Wildlife Serv-

ice—Neotropical Migratory Bird Conserva-

tion’’.

(5) ‘‘United States Fish and Wildlife Serv-

ice—Multinational Species Conservation

Fund’’.

(6) ‘‘National Park Service—Historic Pres-

ervation Fund’’.

(7) ‘‘United States Geological Survey—Sur-

veys, Investigations, and Research’’.

(8) ‘‘Bureau of Indian Affairs—Indian Land

and Water Claim Settlements and Miscella-

neous Payments to Indians’’.

(9) ‘‘Indian Health Service—Indian Health

Services’’.

(10) ‘‘Indian Health Service—Indian Health

Facilities’’.

(11) ‘‘Executive Office of the President—

Council on Environmental Quality and Office

of Environmental Quality’’.

Mr. DICKS. Mr. Chairman, I reserve a

point of order against the amendment. The Acting CHAIRMAN. Pursuant to

the order of the House of today, the

gentleman from California (Mr. POMBO)

and a Member opposed each will con-

trol 5 minutes. The Chair recognizes the gentleman

from California (Mr. POMBO). Mr. POMBO. Mr. Chairman, I yield

myself such time as I may consume. Appropriations without authoriza-

tions or that exceed authorized levels

violate House rule XXI, clause 2. This

amendment enforces this rule by not

allowing moneys to be spent for 10

specified programs within the Com-

mittee on Resources’ sole jurisdiction

which are not authorized to be funded

in fiscal year 2006 until the Committee

on Resources authorizes them. The

money remains in the bill but cannot

be obligated by the agencies until the

authorizing committee authorizes

them to do so. Because the Interior appropriations

bill often combines both authorized

and unauthorized programs in a single

number, such as funding for survey ac-

tivities of the U.S. Geological Survey,

the amendment assures that these pro-

grams which are authorized by fiscal

year 2006, their funding cannot con-

tinue. For those programs which are au-

thorized but the amount appropriated

exceeds the authorized level, such as in

the case for the Council on Environ-

mental Quality, then the amendment

restricts the funding to the authorized

level. The purpose of this amendment is to

give us the ability to go back and au-

thorize a number of these programs

that have not been authorized for years

and in some cases in excess of a dozen

years. One of the major problems that

we have is the Committee on Appro-

priations gets in the position of having

to continue to appropriate money on

these unauthorized programs because

they are important programs. But in

this case what we are talking about is

$5.3 billion that is being appropriated.

So this is a fiscal issue. I believe that the taxpayer demands

that we do our job in authorizing these

programs and make sure that the pub-

lic is getting their money’s worth out

of these different programs. Currently,

I do not believe that is the case. And it gives us the ability to go back and au-thorize those programs.

I believe this is something that is ex-tremely important. The gentleman from North Carolina (Mr. TAYLOR) and the gentleman from Washington (Mr. DICKS) have worked with us on a num-ber of different things that are in this bill over the past year. But when it comes to some of these major programs that we have not been able to get an authorization on, I believe the time is now for us to move forward and begin to fence off those moneys until we can get an authorization done.

Mr. Chairman, I reserve the balance of my time.

POINT OF ORDER

Mr. DICKS. Mr. Chairman, I raise a point of order against the amendment. I do it with great respect for the chair-man, but I just worry about what the consequences of his amendment would be to this bill.

Therefore, Mr. Chairman, I raise a point of order against the amendment because it proposes to change existing law and constitutes legislation in an appropriation bill and therefore vio-lates clause 2 of rule XXI.

The rule states in pertinent part: ‘‘An amendment to a general appro-priation bill shall not be in order if changing existing law.’’

The Acting CHAIRMAN (Mr. HASTINGS of Washington). Does any Member wish to be heard on the point of order?

Mr. POMBO. Mr. Chairman, I realize that the gentleman is correct when he talks about authorizing an appropria-tions bill and the effect that my amendment would have. But I would urge the Chair to rule the amendment in order because what I am trying to do is strip out and put fencing around ap-propriations for unauthorized pro-grams. It seems kind of ironic that my amendment that goes after unauthor-ized programs would be ruled out of order for the very reason that I have been going after those programs.

I urge the chairman to rule the amendment in order.

The Acting CHAIRMAN. If no other Member wishes to be heard, the Chair is prepared to rule.

The Chair finds that this amendment requires new duties. The amendment therefore constitutes legislation in vio-lation of clause 2 of rule XXI.

The point of order is sustained, and the amendment is not in order.

b 1900

AMENDMENT OFFERED BY MS. SOLIS

Ms. SOLIS. Mr. Chairman, I offer an amendment.

The Acting CHAIRMAN (Mr. HASTINGS of Washington). The Clerk will designate the amendment.

The text of the amendment is as fol-lows:

Amendment offered by Ms. SOLIS: Add at the end of the bill (preceding the

short title) the following: SEC. 4ll. None of the funds made avail-

able in this Act may be used by the Adminis-

trator of the Environmental Protection

Agency—

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CONGRESSIONAL RECORD — HOUSE H3671 May 19, 2005 (1) to accept, consider, or rely on third-

party intentional dosing human studies for

pesticides; or

(2) to conduct intentional dosing human

studies for pesticides.

The Acting CHAIRMAN. Pursuant to

the order of the House today, the gen-

tlewoman from California (Ms. SOLIS)

and a Member opposed each will con-

trol 5 minutes. The Chair recognizes the gentle-

woman from California (Ms. SOLIS). Ms. SOLIS. Mr. Chairman, I yield

myself such time as I may consume. This amendment would ensure that

the Environmental Protection Agency

could not use funds in this legislation

to accept, consider, or rely on studies

from outside parties that intentionally

expose human beings to pesticides. It

would also ensure that the EPA could

not spend any funds conducting its own

studies which intentionally expose hu-

mans to pesticides. According to EPA Administrator

Stephen Johnson back in 2001, EPA

‘‘believes that we have a more than

sufficient database, through use of ani-

mal studies, to make licensing deci-

sions that meet the standard, to pro-

tect the health of the public, without

using human studies.’’ Mr. TAYLOR of North Carolina. Mr.

Chairman, will the gentlewoman yield? Ms. SOLIS. I yield to the gentleman

from North Carolina. Mr. TAYLOR of North Carolina. Mr.

Chairman, if we withdraw any objec-

tion to this amendment, is the gentle-

woman envisioning a rollcall vote or

just a simple voice vote? Ms. SOLIS. Mr. Chairman, no rollcall

vote. Mr. TAYLOR of North Carolina. Mr.

Chairman, I withdraw any objection to

this amendment. Ms. SOLIS. Mr. Chairman, I yield

myself such time as I may consume,

and I thank the gentleman from North

Carolina. Mr. Chairman, I will submit the re-

mainder of my statement for the

RECORD, and I would ask that Members

of the House approve this amendment.

It is long overdue. I am very grateful

to accept support from the other side

of the aisle. Despite this statement, the EPA can

devise and conduct studies where hu-

mans—children and adults—are ex-

posed to pesticides. Current practices also allow the EPA

to accept studies from the pesticide in-

dustry and other outside sources so

these studies can be used to help de-

velop regulations or approve pesticides. Right now, the United States Envi-

ronmental Protection Agency—the

agency in charge of protecting public

health from environmental toxins—is

encouraging industry to use human

beings as guinea pigs. What may be the greatest offense

yet, is that the EPA is conducting and

engaging in these studies with no bind-

ing safeguards to make sure these tests

protect public health. The EPA has chosen to go against

the recommendation of the National

Academy of Sciences and against the

wishes of its own Science Advisory

Board and Science Advisory panel. Not only are there no binding safe-

guards for EPA conducted studies, but

many of the outside studies which the

EPA accepts fail to meet minimum

international standards established in

the Nuremberg Code and in the Hel-

sinki Declaration of the World Medical

Association. This behavior is deplorable, uneth-

ical, and wrong. Our amendment is critical because,

in the absence of binding standards at

EPA, the pesticides industry has in-

creased its use of human testing stud-

ies and putting more humans at risk

for what are frequently statistically in-

valid studies. The trend of using humans—both

children and adults—as guinea pigs is a

trend that needs to stop. The EPA needs to have binding safe-

guards in place, and we need to have

information about how a better under-

standing of how dangerous and toxic

these pesticides are for our children. Without these safeguards the EPA

should not be conducting tests which

dangerously expose humans to pes-

ticides nor should it be developing pol-

icy based on third party studies which

fail to meet even basic internationally

accepted standards. My colleagues, the Solis-Bishop

amendment is supported by environ-

mental and diverse religious organiza-

tions and among more than 80,000 oth-

ers who have written to me saying they

oppose the CHEERS study and support

a moratorium on this type of testing. I urge you to support our amendment

and prevent the unregulated and un-

ethical testing of pesticides on hu-

mans. Mr. Chairman, I yield 2 minutes to

the gentleman from New York (Mr.

BISHOP), the cosponsor of this amend-

ment. Mr. BISHOP of New York. Mr. Chair-

man, I want to thank the gentlewoman

from California for her leadership on

this issue and for yielding me this

time, and I want to thank the chair-

man for accepting our amendment. I have a statement that I will submit

for the RECORD. Mr. Chairman, I thank the gentle-

woman from California (Ms. SOLIS), for

yielding and introducing this amend-

ment, which I’m proud to cosponsor. Mr. Chairman, how do you make a

bad idea worse? If you’re EPA, offer

families $970 to videotape their chil-

dren reacting to bug sprays, carpet

cleaners, and other household pes-

ticides. Then, invite the American Chemistry

Council as a partner in this study,

knowing that in exchange for $2 mil-

lion paid toward the study, it wants

looser regulations for the pesticide in-

dustry, which in turn wants to use hu-

mans instead of animals so it can jus-

tify relaxed exposure limits. EPA’s study is as poorly conceived as

its acronym: CHEERS—which stands

for the Children’s Health Environ-

mental Exposure Research Study. It’s a

trifecta of unethical, immoral, and un-

scientific research. It violates the post World War II

‘‘Nuremburg Code,’’ which outlawed

medical testing, including pesticide

testing on people. It advances private rather than med-

ical interests, putting industry ahead

of public health. And despite EPA’s own Science Advi-

sory Board and Scientific Advisory

Panels recommendening strict safe-

guards for human testing, EPA failed

to adopt them. Mr. Chairman, we all want to under-

stand how common chemicals like

those found under the kitchen sink can

hurt children, the elderly and the most

vulnerable to poisoning. But the way

to collect that information should not

involve hurting the very people we

want to protect. The government should not be asking

families to turn their babies into lab

rats. We should be protecting children,

not exposing them to pesticides. Although we passed this amendment

by unanimous consent two years ago,

EPA resurrected the study when the

fiscal year expired in October. We need to pass the Solis-Bishop

amendment to ensure EPA’s research

is based on sound science with the

highest ethical standards. Our amendment is supported by a

broad coalition of environmental advo-

cates, including the Alliance for

Human Research Protection in my

home state of New York. I strongly encourage my colleagues

to support this amendment, again

thank the gentlewoman from Cali-

fornia for her excellent work. Ms. SOLIS. Mr. Chairman, I yield

back the balance of my time. The Acting CHAIRMAN. The ques-

tion is on the amendment offered by

the gentlewoman from California (Ms.

SOLIS). The amendment was agreed to.

AMENDMENT NO. 3 OFFERED BY MR. GARRETT OF

NEW JERSEY

Mr. GARRETT of New Jersey. Mr.

Chairman, I offer an amendment. The Acting CHAIRMAN. The Clerk

will designate the amendment. The text of the amendment is as fol-

lows:

Amendment No. 3 offered by Mr. GARRETT

of New Jersey: At the end of the bill (before the short

title), insert the following: SEC. ll. None of the funds made available

in this Act may be used to send or otherwise

pay for the attendance of more than 50 Fed-

eral employees at any single conference oc-

curring outside the United States.

The Acting CHAIRMAN. Pursuant to

the order of the House today, the gen-

tleman from New Jersey (Mr. GARRETT)

and a Member opposed each will con-

trol 5 minutes. The CHAIR recognizes the gentleman

from New Jersey (Mr. GARRETT). Mr. GARRETT of New Jersey. Mr.

Chairman, I yield myself such time as

I may consume.

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CONGRESSIONAL RECORD — HOUSE H6941 July 28, 2005 RECOGNIZING STEVE SAULS

(Ms. ROS-LEHTINEN asked and was

given permission to address the House

for 1 minute and to revise and extend

her remarks.)

Ms. ROS-LEHTINEN. Mr. Speaker, I

rise today to recognize Steve Sauls, an

extraordinary advocate for the stu-

dents and the school of Florida Inter-

national University in my hometown of

Miami.

As an experienced member of the ad-

ministration and leadership at the uni-

versity, Steve has worked incredibly

hard to promote the needs and the in-

terests necessary to make FIU the fine

institution that it is today.

Steve is retiring from his current po-

sition as vice president of government

affairs for the university after 14 won-

derful and productive years and has ac-

cepted a job as vice president of cor-

porate relations in a private sector

firm. I know that Steve will be im-

mensely missed at the university, my

alma mater, and will leave a void that

will be difficult to fill. I have no doubt

that Steve will continue to lead and

excel in his new position, and I wish

him all the best and FIU all the best in

the years to come.

f

b 1015

SOCIAL SECURITY CELEBRATES

ITS 70TH ANNIVERSARY

(Mr. PALLONE asked and was given

permission to address the House for 1

minute.)

Mr. PALLONE. Mr. Speaker, on Au-

gust 14, we will be celebrating the 70th

anniversary of Social Security, and

that is 70 years of a guaranteed, prom-

ised benefit to all Americans of a cer-

tain age.

I have to say, I was interested to note

that I looked on the Social Security

Administration Web site, and I did not

see any mention of the 70th anniver-

sary. I think the reason is clear. This

President, who basically is trying to

dismantle Social Security, does not

want the Social Security Administra-

tion to celebrate this landmark

achievement.

Now, the President and House Repub-

licans want Americans to forget how

important Social Security has been for

seniors and for the disabled for the last

70 years. It is a guaranteed benefit the

Republicans want to turn into a risky

privatization plan.

I know that the President continues

to be on the road pushing his risky pri-

vatization plan. Most recently he was

there with his mom, Mrs. Bush. And we

are hearing that when we come back

after the August break, we are going to

see the Republican leadership in the

House once again move forward with

their privatization plan that is going

to only aggravate Social Security’s in-

solvency.

Remember: 70 years of a guaranteed

benefit.

WAIVING POINTS OF ORDER

AGAINST CONFERENCE REPORT

ON H.R. 2361, DEPARTMENT OF

THE INTERIOR, ENVIRONMENT,

AND RELATED AGENCIES APPRO-

PRIATIONS ACT, 2006

Mr. BISHOP of Utah. Mr. Speaker, by direction of the Committee on Rules, I call up House Resolution 392 and ask for its immediate consideration.

The Clerk read the resolution, as fol-lows:

H. RES. 392

Resolved, That upon adoption of this reso-

lution it shall be in order to consider the

conference report to accompany the bill

(H.R. 2361) making appropriations for the De-

partment of the Interior, environment, and

related agencies for the fiscal year ending

September 30, 2006, and for other purposes.

All points of order against the conference re-

port and against its consideration are

waived. The conference report shall be con-

sidered as read.

The SPEAKER pro tempore (Mr. SIMPSON). The gentleman from Utah (Mr. BISHOP) is recognized for 1 hour.

Mr. BISHOP of Utah. Mr. Speaker, for the purpose of debate only, I yield the customary 30 minutes to the gen-tleman from Florida (Mr. HASTINGS), pending which I yield myself such time

as I may consume. During consider-

ation of this resolution, all time yield-

ed is for the purpose of debate only. This resolution waives all points of

order against the conference report and

against its consideration. Mr. Speaker, we now have before us

the first appropriations conference re-

port. The gentleman from North Caro-

lina (Chairman TAYLOR) and those who

have been working with him on the

House side, as well as on the Senate

side, should be applauded for taking

this appropriation process and concept

of prioritization and presenting the

product that we have before us. The In-

terior conferees have produced a con-

ference report which is fiscally respon-

sible and does live within strict budget

discipline. It recommends for the fiscal

year 2006 budget $26.2 billion, which is

actually below last year’s enacted level

of $27 billion. Even though the total number is

lower, it still takes into account sig-

nificant and important and high-pri-

ority items, such as wildland fire-

fighting, $2.7 billion; a $61 million in-

crease for our National Parks; a $31

million increase in our National Forest

System; and $106 million increase for

the Indian Health Service. Indian pro-

grams have been represented at a

record $5.6 billion, which means the

funding will provide for schools and

hospitals, construction, education,

human service needs, as well as law en-

forcement there. With those increases there, it has to

be significant, and there have to be off-

setting balances somewhere else, and

that is where the process of

prioritization takes place. Once again,

whether you like the total and the way

it has been done, at least this com-

mittee has indeed done that process of

prioritization.

I commend the Subcommittee chair-man (Mr. TAYLOR); the chairman of the full Committee on Appropriations, the gentleman from California (Mr. LEWIS); the ranking members who were in-volved in this, as well as all the con-ferees, for shepherding this measure, this funding measure through the con-ference process in a timely and orderly fashion in the midst of a very lean budget climate.

Mr. Speaker, the conference report is obviously not perfect; none of these ever are. We are not totally happy with all of the aspects of it. I, for example, still have a concern over our process that we are doing with Payment in Lieu of Taxes, or the PILT program. This House was wise enough to fund that program at $242 million; the con-ference funds it at $6 million less, at $236 million. That still is $30 million above what the Senate tried to accom-plish. This program, for example, is the basic funding for rural communities; it is rent that is due on the land that is government owned. If the Federal Gov-ernment is going to own the land, they need to be able to fully support that.

Hope springs eternal, and we in the West will continue to work on this pro-gram in the future with the gentleman from North Carolina (Chairman TAY-LOR), the gentleman from California (Chairman LEWIS), and others to make sure that these programs are ade-quately addressed in the future as well.

In closing, and notwithstanding these concerns, Mr. Speaker, the overall con-ference agreement is a good, bipartisan product. It has been done in a timely manner. It is the first one before us. It deserves our support.

Mr. Speaker, I reserve the balance of my time.

Mr. HASTINGS of Florida. Mr. Speaker, I thank the gentleman from Utah (Mr. BISHOP) for yielding me this time, and I yield myself such time as I may consume.

As my colleague from the majority mentioned, the rule is typical to that for all conference reports, and I will not oppose it.

Mr. Speaker, I rise today not in oppo-sition to the Interior and Environ-mental Appropriations conference re-port, but, rather, in disappointment that we have not done enough. Indeed, we live in trying times with enormous fiscal constraints, many of which we have brought upon ourselves. As the chairman and ranking Democrat of the Subcommittee on Interior, Environ-ment, and Related Agencies will prob-ably note today, they did the best that

they could with what they were given.

Indeed, they did, Mr. Speaker. I commend the gentleman from

North Carolina (Chairman TAYLOR) and

the gentleman from Washington (Mr.

DICKS) for their hard and, perhaps most

important, their bipartisan work on

this legislation. I do believe that they

did the best with what the majority

gave them. The Interior conference report in-

cludes $84 million for Everglades res-

toration in my district and throughout

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CONGRESSIONAL RECORD — HOUSEH6942 July 28, 2005 south Florida. It increases funding for

the National Endowment of the Arts

and Humanities, as well as operations

at our national parks and Indian

health care. The underlying report also includes a

provision that I offered during floor

consideration prohibiting funds in the

bill from being used to work in con-

travention of a 1994 executive order re-

quiring that Federal agencies take the

necessary steps to achieve health and

environmental equity across all com-

munity lines. The inclusion of this provision in the

conference report sends a clear mes-

sage to the Environmental Protection

Agency that it must change the way it

goes about doing business. On behalf of

every community in the country which

will benefit from this provision, I

thank the gentleman from North Caro-

lina (Chairman TAYLOR) and the gen-

tleman from Washington (Mr. DICKS)

for their commitment to working with

me on this issue of critical importance. The conference report also includes a

provision championed by my good

friend, the gentlewoman from Cali-

fornia (Ms. SOLIS), that stops EPA from

intentionally exposing pregnant

women and children to pesticides and

requires the agency to establish stand-

ards which will come down on the side

of public health. While I am pleased that the afore-

mentioned is included in the con-

ference report, I am greatly concerned

about the report’s major cuts in clean

drinking water and conservation pro-

grams. These programs are essential to

protecting our environment and the

health of our citizens. It is offensive

that this Congress has found the money

for tax cuts for the best-off of us in our

society, but not enough for these crit-

ical programs. Finally, this legislation includes $1.5

billion in emergency funding for vet-

erans health care. Frankly, this money

should have been appropriated before

the July 4 recess. Instead, the majority

played politics with the Senate, and

our veterans were told no. More than 1 year ago, Democrats

came to this floor with the former Re-

publican chairman of the Committee

on Veterans’ Affairs, the gentleman

from New Jersey (Mr. SMITH), arguing

that the majority was shortchanging

veterans health care by more than $1

billion. What did the majority do about

our concerns? Absolutely nothing.

Democrats got stonewalled, the gen-

tleman from New Jersey (Mr. SMITH)

lost his job, and America’s veterans got

shafted. This spring, Mr. Speaker, our Demo-

cratic prophesy came true. The Bush

administration finally admitted that it

had pushed a budget which short-

changed veterans health care by some

$1 billion. Democrats countered that $1

billion still was not enough, and the

administration waffled. Eventually and

embarrassingly, the Bush administra-

tion finally admitted that the actual

shortfall was closer to $1.5 billion, the

amount appropriated in this conference

report. How is it that this body can willingly

authorize sending our troops into

harm’s way, yet refuse to provide them

with the health care benefits they were

promised? I am pleased that the other

body has the backbone to fix what is

wrong, but I am not pleased by the ef-

forts of the administration and House

Republicans to cover up these short-

falls. Shame on all of us for letting this

happen. Mr. Speaker, individuals on their

own are not going to conduct major en-

vironmental restoration, force power

companies to reduce toxic emissions

from their smokestacks, or clean up

our Nation’s drinking water. But col-

lectively, collectively, we can all make

this happen. Enforcement is not free, and neither

is environmental restoration. Is there

anybody in this body who is unwilling

to pay just a little more to ensure that

every American has clean air to breath

and safe drinking water? If given the

chance, who would not be willing to

pool his or her resources with others in

their neighborhood to collectively en-

sure that everyone has safe drinking

water, or that no child would be forced

to grow up playing in backyards pol-

luted by dangerous levels of mercury

and other toxins? I will most likely support the under-

lying conference report, but I say to

my colleagues, we had an opportunity

to do more in this conference report.

Our willingness to do so, however, was

the missing ingredient. Mr. Speaker, I reserve the balance of

my time. Mr. BISHOP. Mr. Speaker, I yield 2

minutes to the gentleman from Arkan-

sas (Mr. BOOZMAN). Mr. BOOZMAN. Mr. Speaker, I thank

the gentleman for yielding me this

time, and I appreciate all of the hard

work in crafting the Interior bill, the

conference report; and I very much

support it. I really rise today, though, to talk

about something a little bit different.

Mr. Speaker, in a few hours, U.S. Army

Sergeant Arthur Raymond McGill will

be laid to rest. A third district native,

Sergeant McGill gave his life serving

his country in Iraq when his convoy

detonated an improvised device. I rise

today to mourn this tragic loss and

honor his courageous life. Sergeant McGill grew up in the

northwest Arkansas communities of

Gentry, Decatur, and Gravette. At the

age of 17, he joined the National Guard

and later enlisted in the Army. He was

on his second tour of duty in Iraq when

he was killed. Sergeant McGill valued family more

than anything else and wanted to set a

positive example for his daughter,

Kaylee, who his aunt said was the love

of his life. Though his life was cut

short, Sergeant McGill did set a won-

derful example for Kaylee and us all

through his selfless and noble service

to his country.

Mr. Speaker, at the age of 26, Ser-geant Arthur Raymond McGill made the ultimate sacrifice for his country. He is a true American hero, and I cer-tainly ask my colleagues to remember his family, remember his friends in their thoughts and prayers during these very difficult times.

Mr. HASTINGS of Florida. Mr. Speaker, I am very pleased to yield 3 minutes to the distinguished gen-tleman from Massachusetts (Mr. MCGOVERN), my good friend that I serve with on the Committee on Rules.

Mr. MCGOVERN. Mr. Speaker, I thank my colleague, the gentleman from Florida, for yielding me this time.

Mr. Speaker, when this House first considered the Department of Interior appropriations bill, I came to the floor to express my deep outrage that this legislation nearly eliminated funding for the Land and Water Conservation Fund.

I join with my colleagues, the gen-tleman from New York (Mr. KING) and the gentleman from New Jersey (Mr. HOLT), in urging that the House and the Senate conferees restore some level of funding for this vital program. I am pleased that 119 Members shared our concerns about this funding cut and signed on to our bipartisan letter. Mr. Speaker, I will insert the letter for the RECORD at the conclusion of my re-marks.

The Land and Water Conservation

Fund has been an enormous help to our

local communities and the families

who live in them. The Stateside grant

program has helped to preserve open

space, slow urban sprawl, and give our

children safe places to play.

b 1030

It is a true partnership with Federal

grants requiring a full match from

States and local communities. In all,

the stateside program has helped com-

munities by funding 40,000 projects na-

tionally. Success stories can be found

in every State and in 98 percent of U.S.

counties. The Land and Water Conservation

Fund is especially near and dear to my

heart, having led the fight on the floor

of the House back in 1999 to restore $30

million for the stateside grant program

in the fiscal year 2000 Interior appro-

priations bill after it had been zeroed

out in 1995. In my district, the Land and Water

Conservation Fund State assistance

grants have provided much-needed

funds to restore the historic Worcester

Common in Worcester, Massachusetts,

and renovate the Briggs Pool in Attle-

boro, Massachusetts. We have literally

preserved dozens of acres of open space

that otherwise would have been sold off

for development that would not have

been conducive to these communities.

It has also helped to complete con-

struction this coming fall with the

Princeton playing fields in Princeton,

Massachusetts. The Land and Water Conservation

Fund is based upon a simple concept. It

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CONGRESSIONAL RECORD — HOUSE H6943 July 28, 2005 takes revenues from offshore oil and

gas drilling and invests them in our

Nation’s public land, letting States

take the lead. For 40 years this pro-

gram has a proven track record and

benefited from strong bipartisan sup-

port. It was the same bipartisan support

that proved successful here today.

Clearly the level of funding provided in

this bill is far from what is required. In

fact, the level of funding is at the same

level it was when we resuscitated the

program back in 1999. So I am dis-

appointed with that. However, any

amount appropriated to this program,

no matter how small or large, serves a

valuable purpose. I commend my colleagues for their

hard work. I thank those who helped

reinsert funding for the Land and

Water Conservation Fund back into

this bill. I hope that we can come to

some sort of consensus that next year

we will restore funding to a level that

is adequate, and to a level that we all

promised our constituents. Mr. Speaker, I will insert for the

RECORD the letter I referred to earlier.

CONGRESS OF THE UNITED STATES,

Washington, DC, July 22, 2005. DEAR CONFEREE: We are writing to request

that, as you move toward conference with

the Senate on the FY 2006 Interior Appro-

priations Bill, you support the funding levels

that were included for the Land and Water

Conservation Fund (LWCF) in the Senate

passed version of the bill. Since its creation in 1964, the Land and

Water Conservation Fund (LWCF) has been a

critical source of funding for the National

Park Service, Fish and Wildlife Service, Bu-

reau of Land Management, and Forest Serv-

ice. This funding is used to support the ac-

quisition and maintenance of our national

wildlife refuges, parks, forests, and public

domain lands. In addition, the LWCF also funds a match-

ing grant program to assist states and local-

ities in acquiring recreational lands and de-

veloping facilities. An integral part of the

LWCF, the state-side matching grant pro-

gram has provided state and local parks and

recreation directors with the desperately

needed funding to help preserve open space

and develop recreational facilities. Over the

years, these matching grants have been used

successfully to fund more than 37,000 state

and local park and recreation projects, ena-

bling millions of Americans to hike through

magnificent scenery and view historic sites,

bike along seaside and river trails, and pic-

nic and play ball at local parks. The Senate-passed FY 2006 Interior Appro-

priations Bill provides $192 million for

LWCF, which includes $30 million for the

state-side grant program and $162 million for

the federal program. This funding is abso-

lutely essential for the proper stewardship of

our nation’s magnificent natural heritage,

and therefore, we strongly urge you to main-

tain the funding levels for LWCF state-side

and federal grant programs provided for in

the Senate bill. Thank you for your consider-

ation of this request.

Sincerely,

Jim McGovern, Rush Holt, Peter T. King,

Jim Marshall, Robert E. Andrews, Mi-

chael H. Michaud, Michael M. Honda,

Howard L. Berman, Rahm Emanuel,

Barbara Lee, Donald M. Payne, Dennis

J. Kucinich, Joseph Crowley, Richard

E. Neal, Henry Cuellar, Rob Simmons,

Rosa L. DeLauro, Shelley Berkley,

Allyson Y. Schwartz, Melvin L. Watt,

John Spratt, Jim Oberstar, John

Lewis, Nick Rahall, Scott Garrett, Dan

Lipinski, Mike Doyle, Betty McCollum,

Harold Ford, John T. Salazar, Jim

Langevin, Leonard L. Boswell, Elijah

E. Cummings, Lloyd Doggett, Gene

Green, Nancy L. Johnson, John

Shimkus, Jo Bonner, Spencer Bachus,

Mike McIntyre, Julia Carson, Vito

Fossella, Adam Smith, Doris O. Mat-

sui, Solomon P. Ortiz, Brian Higgins,

Silvestre Reyes, Tammy Baldwin, Mike

Thompson, Charles F. Bass, Tim

Holden, Jay Inslee, Frank Pallone, Jr.,

Martin Meehan, Juanita Millender-

McDonald Ike Skelton, Grace F.

Napolitano, Sander Levin, Jerrold Nad-

ler, Bernard Sanders, Chris Van Hollen,

John B. Larson, George Miller, Tom

Lantos, Gary L. Ackerman, Jim

Matheson, Sherwood Boehlert, Ed Case,

Raul M. Grijalva, Dale E. Kildee, Jim

McDermott, Earl Blumenauer, Jim

Saxton, Dennis Cardoza, Carolyn

McCarthy, Michael R. McNulty, Ellen

O. Tauscher, Timothy H. Bishop,

Edolphus Towns, Peter DeFazio, An-

thony D. Weiner, John D. Dingell,

Sherrod Brown, Wm. Lacy Clay, Wil-

liam Delahunt, Louise Slaughter, Bar-

ney Frank, Robert Menendez, Eliot L.

Engel, Bobby Scott, Ben Cardin, Tom

Udall, Janice Schakowsky, Bart Gor-

don, Lynn Woolsey, Stephen F. Lynch,

Donna M. Christensen, Thomas Allen,

Thaddeus G. McCotter, Lois Capps,

Emanuel Cleaver, Mike Ferguson, Bart

Stupak, David Price, Lane Evans,

Carolyn B. Maloney, Jeb Bradley,

Steve Israel, Pete Stark, Bob

Etheridge, Mark Udall, Sue W. Kelly,

Jerry F. Costello, Luis V. Gutierrez,

Christopher Shays, Mike Ross, Charles

A. Gonzalez, Neil Abercrombie, Anna

Eshoo.

Mr. HASTINGS of Florida. Mr. Speaker, I yield back the balance of my time.

Mr. BISHOP of Utah. Mr. Speaker, I

yield myself such time as I may con-

sume. Mr. Speaker, I appreciate all of the

discussion that has gone through on

this particular bill. We have had it on

several different occasions. There are a

lot of good things that are in this par-

ticular bill. The gentleman from Florida (Mr.

HASTINGS) has mentioned the one por-

tion of the $1.5 billion to solve the hole

in the veterans funding area, that once

the issue was validated could have been

an easy chance for people to grand-

stand. But I am very proud of this en-

tire Congress in a bipartisan way, who

gave instructions in a bipartisanship

way, which came as close to a unani-

mous vote as I have seen here on the

floor. Mr. Speaker, it is an appropriate step

to do, to now take this and then review

the process so that we can continue to

go on. We have much to do in this par-

ticular area, but in each year that I

have been here in this Congress, I have

been very proud that we have tried to

move forward in different areas and

make progress to fully fund and fully

maintain our commitments. The same thing has gone on with all

of the other programs in this par-

ticular budget and this particular con-

ference report. This committee has

once again done a great job in trying to

come up with the principle that all ap-

propriators ought to be doing a

prioritizing program. They have

prioritized the programs. Mr. Speaker,

overall, we can be very positive of that. Mr. DICKS. Mr. Speaker, I rise in support of

this rule to allow for the consideration of the conference report on the fiscal year 06 Interior and Environment Appropriations bill. And I in-tend to intend to vote for the conference bill.

Although I am critical of several aspects of this bill—including the low overall spending level—without a doubt this process has been fair and open. Because of the low allocation, there are some problem areas.

But the overall conference report is well worth supporting. With the addition of $1.5 bil-lion in spending for Veterans health care at-tached to this bill, I believe that this con-ference report will get widespread support in both the House and the Senate.

The conference agreement contains another year of healthy increases in National Park Service operations funding. I do wish that the Clean Water Act State Revolving Fund was higher. I also wish that the Conference Report had retained the extra $10 million in NEA funding that the full House approved in a floor amendment last May. It is important to point out that this agreement contains successful compromises on the issue of pesticide testing on humans and on federal funding for the Martin Luther King, Jr. Memorial to be built on the National Mall.

Again I want to reiterate my strong support for this rule and the conference report on the fiscal year 06 Interior and Environment Appro-priations bill. And I want to thank Chairman TAYLOR and his staff for including the minority throughout this process.

Mr. BISHOP of Utah. Mr. Speaker, I

yield back the balance of my time, and

I urge the Members to support the rule

that provides for consideration of this

conference report to the accompanying

H.R. 2361, and I move the previous

question on the conference report. The previous question was ordered. The SPEAKER pro tempore (Mr.

SIMPSON). The question is on the con-

ference report. The question was taken; and the

Speaker pro tempore announced that

the ayes appeared to have it. Mr. HENSARLING. Mr. Speaker, on

that I demand the yeas and nays. The yeas and nays were ordered. The SPEAKER pro tempore. Pursu-

ant to clause 8 of rule XX further pro-

ceedings on this question will be post-

poned.

f

WAIVING POINTS OF ORDER

AGAINST CONFERENCE REPORT

ON H.R. 6, ENERGY POLICY ACT

OF 2005

Mr. HASTINGS of Washington. Mr.

Speaker, by direction of the Com-

mittee on Rules, I call up House Reso-

lution 394 and ask for its immediate

consideration. The Clerk read the resolution, as fol-

lows:

H. RES. 394

Resolved, That upon adoption of this reso-

lution it shall be in order to consider the

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CONGRESSIONAL RECORD — HOUSE H7013 July 28, 2005 Kucinich

Langevin

Lantos

Larsen (WA)

Larson (CT)

Lee

Levin

Lewis (GA)

Lipinski

Lofgren, Zoe

Lowey

Lynch

Maloney

Markey

Marshall

Matsui

McCarthy

McCollum (MN)

McDermott

McGovern

McIntyre

McKinney

McNulty

Meehan

Meek (FL)

Meeks (NY)

Melancon

Menendez

Michaud

Millender-

McDonald

Miller (NC)

Miller, George

Mollohan

Moore (KS)

Moore (WI)

Moran (VA)

Nadler

Napolitano

Neal (MA)

Oberstar

Obey

Olver

Ortiz

Owens

Pallone

Pascrell

Pastor

Payne

Pelosi

Price (NC)

Rahall

Rangel

Reyes

Ross

Rothman

Roybal-Allard

Ruppersberger

Rush

Ryan (OH)

Sabo

Salazar

Sanchez, Linda

T.

Sanchez, Loretta

Sanders

Schiff

Schwartz (PA)

Scott (VA)

Serrano

Sherman

Skelton

Slaughter

Smith (WA)

Snyder

Solis

Spratt

Stark

Strickland

Stupak

Tanner

Tauscher

Terry

Thompson (CA)

Thompson (MS)

Tierney

Towns

Udall (CO)

Udall (NM)

Van Hollen

Velazquez

Visclosky

Wasserman

Schultz

Waters

Watson

Watt

Waxman

Weiner

Wexler

Woolsey

Wynn

ANSWERED ‘‘PRESENT’’—2

Burton (IN) Sensenbrenner

NOT VOTING—7

Andrews

Burgess

Carson

Johnson, Sam

Paul

Schakowsky

Wu

ANNOUNCEMENT BY THE SPEAKER PRO TEMPORE

The SPEAKER pro tempore (during

the vote). Members are advised there

are 2 minutes remaining in this vote.

b 1640

So the bill was passed.

The result of the vote was announced

as above recorded.

A motion to reconsider was laid on

the table.

f

FURTHER MESSAGE FROM THE

SENATE

A further message from the Senate

by Ms. Curtis, one of its clerks, an-

nounced that the Senate has passed

without amendment a bill of the House

of the following title:

H.R. 3423. An act to amend the Federal

Food, Drug, and Cosmetic Act with respect

to medical device user fees.

f

GENERAL LEAVE

Mr. TAYLOR of North Carolina. Mr.

Speaker, I ask unanimous consent that

all Members may have 5 legislative

days within which to revise and extend

their remarks and that I may include

tabular and extraneous material on the

conference report to accompany H.R.

2361.

The SPEAKER pro tempore. Is there

objection to the request of the gen-

tleman from North Carolina?

There was no objection.

f

CONFERENCE REPORT ON H.R. 2361,

DEPARTMENT OF THE INTERIOR,

ENVIRONMENT, AND RELATED

AGENCIES APPROPRIATIONS

ACT, 2006

Mr. TAYLOR of North Carolina. Mr.

Speaker, pursuant to House Resolution

392, I call up the conference report on

the bill (H.R. 2361) making appropria-

tions for the Department of the Inte-

rior, environment, and related agencies

for the fiscal year ending September 30,

2006, and for other purposes.

The Clerk read the title of the bill.

The SPEAKER pro tempore. Pursu-

ant to House Resolution 392, the con-

ference report is considered as having

been read.

(For conference report and state-

ment, see proceedings of the House of

July 26, 2005 at page H6562.)

The SPEAKER pro tempore. The gen-

tleman from North Carolina (Mr. TAY-

LOR) and the gentleman from Wash-

ington (Mr. DICKS) each will control 30

minutes.

The Chair recognizes the gentleman

from North Carolina (Mr. TAYLOR).

b 1645

Mr. TAYLOR of North Carolina. Mr.

Speaker, I yield myself such time as I

may consume.

Mr. Speaker, today we bring before

the House the conference agreement on

H.R. 2361, the Interior, Environment,

and Related Agencies Appropriations

Act for fiscal year 2006. I would like to

thank all of the members of the Sub-

committee for their support and guid-

ance this year. I want to extend special

thanks to the subcommittee vice chair-

man, the gentleman from Idaho (Mr.

SIMPSON), and the gentleman from

Washington (Mr. DICKS), the ranking

member and my good friend, for their

assistance in shaping the bill. We are

under last year, and we are under the

allocation.

The conference report balances many

competitive and diverse needs. It pro-

vides funding for programs in the De-

partment of the Interior, the Environ-

mental Protection Agency, the Forest

Service, the Indian Health Agency, the

Smithsonian Institution, and several

other environmental and cultural agen-

cies and commissions.

With the ongoing war on terrorism

and a sizable Federal debt, the Amer-

ican taxpayer demands fiscal prudence,

yet entrusts us to continue the con-

servation and care of our Nation’s nat-

ural resources, the protection of the

environment, and critical programs for

native Americans and other programs.

The needs far outweigh the funds avail-

able, but I believe this bill addresses

the most critical needs.

The conference report is the product

of a balanced, bipartisan, bicameral ef-

fort that resolves over 2,000 differences

between the House and the Senate

bills. Moreover, it addresses many of

the key issues raised on the House

floor in May and stays true to the fun-

damental issues that helped the bill

pass overwhelmingly in the House.

Here are a few of the highlights:

Payments in Lieu of Taxes are $9

million over the enacted level. The arts

and humanities are $5 million each

over the enacted level. Funding for op-

erations of the national parks has in-

creased by $61 million. Restrictions re-

main in the bill for pesticide testing on

human subjects. Funding for the Clean

Water State Revolving Act is $900 mil-

lion, which is $50 million above the

House level and $170 million above the

budget request.

The Forest Health Program, which is

critical to reducing this Nation’s risk

of catastrophic wildfires, is restored to

the enacted level.

Finally, I am proud to say that this

conference agreement contains $1.5 bil-

lion in critically needed funds for vet-

erans medical care.

Mr. Speaker, I believe the priorities

of the American people are reflected in

the conference agreement, and I urge

all of my colleagues to support it.

I would like to thank staff on both

sides of the aisle because, without their

hard work, we would not be able to

bring this bill forward at this time.

At this time, I will include a table

detailing the various accounts in the

bill for insertion in the RECORD.

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CONGRESSIONAL RECORD — HOUSE H7019 July 28, 2005 Mr. Speaker, I reserve the balance of

my time. Mr. DICKS. Mr. Speaker, I yield my-

self such time as I may consume. I support this conference report on

the fiscal year 2006 Interior and Envi-

ronment Appropriations bill, and I will

vote for it, in just a few minutes, I

hope. With the addition of $1.5 billion

in spending for veterans health care at-

tached to this bill, I believe that this

conference report will get widespread

support in both the House and the Sen-

ate. After we made a decision to add this

$1.5 billion, I contacted back in the

State of Washington the veterans hos-

pital in Seattle and the one at Amer-

ican Lake to find out what the backlog

was, and I was shocked to find out that

there is a backlog of some 2,000 vet-

erans who are waiting to get an initial

appointment at those hospitals. So this

money clearly is needed, and I am

pleased that the other body selected

the Interior appropriations to add this

$1.5 billion to and that we were able to

present it here today to the House. There are several areas of this bill

that I believe are underfunded; how-

ever, I believe these funding decisions

were the result of an inadequate alloca-

tion. Although the majority cannot es-

cape responsibility for this allocation,

I believe that we here in the minority

have been treated fairly during the

process of developing the 2006 Interior

appropriations. First of all, I want to thank the

chairman, the gentleman from North

Carolina (Mr. TAYLOR), for the decision

to provide the Park Service operating

budget another year of healthy in-

creases. Over the last 2 years, we have

provided more than $100 million in in-

creases for the parks operating budget,

and I am very proud of that accom-

plishment. We really were seeing a de-

cline in some of the parks because they

were not able to cover their fixed costs

on an annual basis and had to lay off

people and were unable to provide the

American people with the services that

they needed. However, I am disappointed with the

overall amount for the Clean Water

Act State Revolving Fund. I had hoped

that the conference report would end

up closer to the Senate mark of $1.1

billion, rather than at $900 million,

which is only $50 million above the

House mark. Over the last 2 years, this

funding has been cut by 33 percent. I am also disappointed that we could

not retain the full $10 million increase

for the National Endowment for the

Arts, which was approved on the House

floor in an overwhelming vote, but I

am gratified that we could agree to

some increase for both the NEA and

the NEH. I am glad to see this conference re-

port contains increases over the House

mark for both land acquisition and the

State grant program. Although these

programs are cut from last year, I

agree with the decision to restore some

of the funding; and I am sympathetic

to the argument that, during a year

with such a low allocation, it is most

important to protect core programs

and make land acquisition a more sec-

ondary goal. I am deeply appreciative of every-

one’s efforts to resolve the issue con-

cerning the use of humans during pes-

ticide testing. I think the conference

report reflects the will of both the

House and Senate to stop such tests

until the EPA develops regulations re-

flecting the recommendation of the Na-

tional Academy of Science and follows

the Nuremburg protocols. In addition,

these regulations will prohibit such

testing on pregnant women, infants,

and children. I also want to praise the compromise

contained in this conference report on

the Martin Luther King, Jr., memorial

to be built on the National Mall. The

conference report contains $10 million

that must be matched by private dona-

tions. This matching requirement will

spur increased private donations and

reflects the thinking of the chairman,

the gentleman from North Carolina

(Mr. TAYLOR), who felt very strongly

that we should try to raise as much

money for the memorial from the pri-

vate sector. Again, I want to say that the chair-

man has been very fair and his staff,

led by Debbie Weatherly, has done an

outstanding job in putting together

this bill. I want to congratulate Mike

Stevens and Pete Modoff of my staff for

the exceptional work they did on this

bill. I think this is, in a very difficult

year, I think this is a bill that deserves

our support. Mr. Speaker, I yield 5 minutes to the

distinguished gentleman from Wis-

consin (Mr. OBEY), the ranking Demo-

crat of the full Committee on Appro-

priations. Mr. OBEY. Mr. Speaker, I thank the

gentleman for yielding me this time. I

would simply like to say that this is a

close call on this bill as far as I am

concerned; but weighing all of the con-

flicting pressures, I come down on the

side of recommending a vote for the

bill, primarily because of what it does

to finally provide sufficient funding for

veterans health care. With respect to that item, I would

simply say to our friends on the major-

ity side of the aisle, welcome aboard.

We tried for the last year and a half to

convince this administration and to

convince the majority that the vet-

erans health accounts were under-

funded. Finally, the administration ad-

mitted that that was true; and, in fact,

the amount being added to this bill

today for veterans health care is ex-

actly the amount that we had been

asking be added to that program for

that purpose for a long period of time. I want to make clear, the shortfall

for veterans’ health care is not the re-

sponsibility of the chairman of this

subcommittee. This problem is sup-

posed to be taken care of by another

subcommittee; but, in fact, after run-

ning away from the problem for

months and months, the majority

party has finally decided that they did

not want to go home in August and

have to face the folks at the Legion

hall or the VFW hall without finally

doing something to fix the problem. So

I am glad that they did.

But even though I am going to vote

for this bill because of what it does for

veterans, I think we need to under-

stand that in a number of other areas,

this bill is far from where it ought to

be if we are to meet the responsibilities

that we have to this country’s future.

Overall, funding for the EPA declines

by $291 million in this bill. The Clean

Water State Revolving Fund has now

been cut by 33 percent over 2 years.

Grants to States for conservation and

recreation are reduced by two-thirds

from fiscal year 2005. Every State suf-

fers a 66 percent cut.

In the year 2001, land acquisition

funds in this bill were $442 million.

Today, they are $124 million. That is

the lowest appropriation for this item

in the past 20 years. Construction fund-

ing for national parks and refuges and

forests has been reduced by about 10

percent from last year. The funding for

Forest Service buildings, roads, and

trails has been cut from $514 million to

$441 million, a reduction of 14 percent.

BIA school construction is funded at

a level $53 million below last year.

Health facilities construction for In-

dian health services is funded at $38

million, a reduction of $50 million. I do

not believe those numbers are numbers

that we would be proud to take home.

So we are stuck with a choice. We

can cast a protest vote against the cuts

in this bill, which many of us have al-

ready done; or we can recognize the

fact that in a time of war we have an

obligation to meet the health care

needs of those who have risked every-

thing for this country; and I think we,

in the end, have no real choice but to

come down in favor of voting for that

increased veterans funding.

But I hope that the general public

will understand that the cuts in this

bill do the Nation no favors. We are

shortchanging our country’s future. We

are not meeting our stewardship re-

sponsibilities, and we will pay a long-

term price for that, I regret to say.

Mr. Speaker, let me say one other

thing. I do want to express my appre-

ciation to the subcommittee chairman

for the fairness with which he has dealt

with this bill. I may not agree with the

priorities that the majority party

budget resolution imposed on the sub-

committee, but I do want to say that I

think the chairman has been most fair

in his dealing with the minority; and

we appreciate that.

Mr. TAYLOR of North Carolina. Mr.

Speaker, I reserve the balance of my

time.

Mr. DICKS. Mr. Speaker, I yield 5

minutes to the distinguished gen-

tleman from South Carolina (Mr.

SPRATT), who is one of the leaders in

this House on budget matters.

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CONGRESSIONAL RECORD — HOUSEH7020 July 28, 2005 Mr. SPRATT. Mr. Speaker, I thank

the gentleman for yielding me this

time. Mr. Speaker, I rise in full support of

the $1.5 billion in veterans health care

funding for 2005, which was added on to

this conference report. I am pleased

that my colleagues on the other side

have finally come around to our posi-

tion on veterans funding and now ac-

knowledge that their budgets have not

funded this priority accurately or ade-

quately. This shortfall has not occurred for

lack of notice or foresight. Over warn-

ings from veterans groups and our own

strenuous objections, the budgets

passed by this House have consistently,

consistently, understated the cost of

veterans health care.

b 1700

This is the Veterans Administration

borrowing from Peter to pay Paul, de-

nying or delaying service until a sup-

plement finally comes through. And

then when the supplement comes

through, it busts the spending caps im-

posed in the budget and adds to the def-

icit. This is no way to budget for veterans

health care, and it is no way to budget

generally. The White House just 2

weeks ago issued a midsession review

of the budget, which we received with

some skepticism. We observed that

their projections of the deficit seemed

better, partly because they omit the

full cost of various policies like vet-

erans health care, the ongoing cost of

operations in Afghanistan and Iraq,

and fixing the alternative minimum

tax, extending other tax credits. In the short run, these omissions

make the deficit look better, sure, but

in the long run the true costs emerge,

and the actual deficits turn out to be

worse than projected. Here, for example, is what happened

to veterans health care in the fiscal

2005 budget cycle. When we brought

forth our budget resolutions on the

Democratic side for 2005, we argued

that the discretionary spending levels

in the Republican resolution were too

tight, not realistic, and would short-

change essential priorities like vet-

erans health care. We were not alone. The chairman of

the Veterans’ Affairs Committee ar-

gued that more funding for veterans

health care was badly needed, but our

concerns went unheeded. Now we have

to face the truth. The funding provided

for veterans health care in the 2005

budget was, in fact, not sufficient. And since an accurate funding level

was not built into the budget, today’s

bill will move discretionary spending

for 2005 over the allocation included in

the Republican budget. This

misestimate, like others, was left out

of the deficit projections that OMB an-

nounced just a couple of weeks ago. For the record, let me point out that

the Democrats put forth a responsible

budget for 2005. Our budget brought us

to balance by the year 2012, yet we

funded veterans health care priorities

and other priorities adequately. Our budget provided $1.3 billion more

for veterans health care in 2005, and

$1.5 billion more over a 5-year period of

time. Unfortunately the same story is

playing out, unfolding again in 2006.

Once again, once again, this year we

warned that the budget provided too

little for veterans health care, and

once again it was to no avail. Our resolution provided $1.5 billion

more for veterans health care in 2006,

$16.4 billion more over 5 years, and a

budget, mind you, that balanced by

2012. Just 3 months later, 3 months

later, we are told that the VA appro-

priations bill for 2006 will have to ex-

ceed its budget allocation to accommo-

date the administration’s amended re-

quest for veterans health care. And, of

course, the deficit estimates for 2006

will have to be revised upward accord-

ingly. Mr. Speaker, I would gladly vote to

raise veterans health care to the level

it should have been to start with, but I

urge that we learn a lesson from this

experience and be forthright in the fu-

ture about the cost of veterans health

care. And in that connection, I would

note that in the outyears, 2007, 2008 and

onward, the official estimates of the

Republican budget still grossly

underfund veterans health care, they

understate the deficit, and they defi-

nitely will have to do this all over

again until the numbers are finally

done right. Mr. DICKS. Mr. Speaker, I yield 2

minutes to the gentlewoman from Cali-

fornia (Ms. SOLIS), who has been a real

leader on the issue of dealing with pes-

ticides and their effect on humans. (Ms. SOLIS asked and was given per-

mission to revise and extend her re-

marks.) Ms. SOLIS. Mr. Speaker, I thank the

gentleman for yielding me time. Mr. Speaker, I rise in support of the

Interior-Environment appropriations

bill. I want to especially thank the

gentleman from California (Mr. LEWIS),

the gentleman from Wisconsin (Mr.

OBEY), the gentleman from North Caro-

lina (Mr. TAYLOR) and the gentleman

from Washington (Mr. DICKS), the

ranking, for their work on this legisla-

tion. I am particularly proud of the steps

that Congress has taken today to re-

quire the application of stringent eth-

ical and scientific safeguards of inten-

tional human dosing studies, and to

stop the testing of pesticides on preg-

nant women and children. And I would

like to thank all of your staff for their

leadership on this issue. Mr. DICKS. Mr. Speaker, will the

gentlewoman yield? Ms. SOLIS. I yield to the gentleman

from Washington. Mr. DICKS. Mr. Speaker, I want to

congratulate the gentlewoman on her

hard work on this. I can remember

when we had the amendment on the

floor. It was adopted here in the House

unanimously. And I think your work

and the work of your colleague from

California in the other body on this

matter, where they also won a vote

there, too, was very impressive. And, you know, this is the first year

our committee has had jurisdiction

over the Environmental Protection

Agency, so we are all learning about

these issues. I want to congratulate

you on your real leadership. And I

think what you did will be something

that will protect children and pregnant

mothers and will bring better stand-

ards at EPA on this issue. I congratu-

late you on this effort. Ms. SOLIS. Mr. Speaker, reclaiming

my time, I would like to also submit

that our staffs have worked very hard,

and the outside organizations that

worked in tandem with us, religious or-

ganizations, the scientific, environ-

mental community, as well as activ-

ists. In fact, the United Farm Workers

also submitted a letter of support. This should never have happened. It

should never have taken place, the

testing of pesticides on humans, and

particularly children. So I know that I stand here before

you in the Congress to say that this is

a good moment for us in this particular

time. Thank you very much. Mr. Speaker, as co-sponsor of this amend-

ment, I rise today to support the application of stringent ethical and scientific safeguards to intentional human dosing studies of toxic chemicals and applaud the inclusion of this language in the Interior-Appropriation bill.

This amendment forbids the EPA from con-sidering any intentional human dosing study unless it meets the minimum ethical and sci-entific safeguards outlined in the February 2004 National Academy of Sciences report and the 1947 Nuremberg Code adopted after World War II. I am submitting copies of the NAS report and the Nuremberg Code into the RECORD.

In particular, this amendment prohibits inten-tional human dosing on pregnant women, in-fants, or children, and requires the creation of a review board to evaluate the ethical and sci-entific propriety of intentional human dosing studies before they can be conducted, consid-ered, or relied on. In 2002, the National Acad-emy of Sciences convened a panel to exam-ine the issue of intentionally dosing human subjects with pesticides and other toxic sub-stances.

The report of the NAS, published in Feb-ruary 2004, recognized that these experiments can be ‘‘troubling’’ and in some cases ‘‘repug-nant.’’ For this reason, the NAS concluded that to be ‘‘ethically justified,’’ a human pes-ticide experiment must pass ‘‘rigorous scrutiny on both scientific and ethical grounds.’’

All of the studies currently pending before EPA are scientifically and ethically suspect and appear to fall far short of the stringent cri-teria for EPA consideration outlined by the NAS and the Nuremberg Code, and required in this amendment. EPA provided Congress with a list of all human intentional dosing tests under consideration by the agency. An exten-sive evaluation of these tests shows that they are rife with ethical and scientific flaws and do not approach the standard for acceptability.

Representative WAXMAN and Senator BOXER evaluated the serious flaws in these studies in

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CONGRESSIONAL RECORD — HOUSE H7021 July 28, 2005 a report released last month entitled Human Pesticide Experiments, which I am submitting into the RECORD.

It is also clear that EPA’s draft regulation re-garding human testing similarly fails to meet the minimum criteria required in this amend-ment. EPA circulated internally a draft rule among the agency’s various offices on June 20, 2005. EPA’s draft rule, slated for proposal next month, would have allowed the system-atic testing of pesticides on humans. The draft rule does not comply with the recommenda-tions of the NAS and the Nuremberg Code, and it contains multiple loopholes that invite abuse.

The EPA draft is inconsistent with the stand-ards we require in this amendment. EPA origi-nally commenced its rulemaking in response to a wave of industry pressure to permit inten-tional dosing of human test subjects with toxic chemicals.

The pesticide industry has mounted a cam-paign to expand testing of pesticides on hu-mans in order to weaken health standards. Because of the stricter requirements imposed by the Food Quality Protection Act of 1996, the pesticide industry has been under growing pressure to reduce the risks that pesticides pose to infants and children. The industry has adopted a strategy to evade these require-ments by testing pesticides on a small number of adult human subjects, and then cite these tests to argue that the chemicals are safe.

EPA’s proposed rule encourages this strat-egy and is contrary to the recommendations of the NAS and the ethical guidelines of the Nur-emberg Code that we require in this amend-ment. I am submitting for the record a June 2005 report titled Flash Report: New EPA Pro-posal Encourages Human Pesticide Experi-ments.

As outlined in more detail in this report, EPA’s proposed rule violates the ethical and scientific safeguards now required by this amendment, by failing to establish a national review panel to prevent abusive experiments, and by failing to provide full protections for children and other vulnerable populations.

Furthermore, the EPA draft rule does not clearly require that pesticide experiments com-ply with even its sub par standards. To the contrary, EPA proposed to accept all experi-ments as long as they ‘‘substantially’’ comply. This provision overtly undercuts the protec-tions in the rule. The vague standard of sub-stantial compliance wrongly sends the signal that EPA will not demand strict adherence to ethical standards in human pesticide experi-ments.

Intentional human toxicity testing has a trou-bling history that includes manipulation and abuse of the most vulnerable members of so-ciety. The amendment that I am supporting today will ensure that EPA may not consider or rely on any intentional human-dosing study that does not meet the minimum ethical and scientific criteria recommended by the NAS and expressed in the Nuremberg Code.

Mr. TAYLOR of North Carolina. Mr.

Speaker, I would yield such time as he

may consume to the gentleman from

California (Mr. LEWIS). Mr. LEWIS of California. Mr. Speak-

er, I will not consume very much time.

I rise to express my deep appreciation

one more time to my colleague and

friend, the gentleman from Wisconsin

(Mr. OBEY), for his cooperating with me

as we have gone through this initial

conference process, but most impor-

tantly to congratulate both my col-

league, the gentleman from Wash-

ington (Mr. DICKS), and my colleague,

the gentleman from North Carolina

(Mr. TAYLOR), for the fabulous job on

this first of a series of conference re-

ports that we expect to send to the

President’s desk. It is very early in the process, but

the Interior bill will be on the Presi-

dent’s desk, and I am very certain he

will find it to be to his liking. So con-

gratulations to each of you for your

work. Mr. DICKS. Mr. Speaker, will the

gentleman yield? Mr. LEWIS of California. I yield to

the gentleman from Washington. Mr. DICKS. Mr. Speaker, I think this

is a very important moment today that

we are passing this conference report

before the August recess. And I want to

congratulate the chairman and ranking

member, who has really worked tire-

lessly to work with the chairman to

get these bills enacted. But I think there is absolutely no ex-

cuse not to try to do this and try to

pass the rest of the bills in September

and show the American people that we

can get the job done before the start of

the fiscal year. And I think every time we have a

new chairman, we do better in this re-

gard. The previous chairman, of course,

had to deal with other problems. But I

think the chairman has made this a big

priority. I think it is important that

we do this, and I want to congratulate

him for his leadership as the new chair-

man of the full committee. Mr. LEWIS of California. Mr. Speak-

er, reclaiming my time, let me further

say that none of this would have been

done as effectively and with the high

quality reflected in the conference re-

port without the great help of our

staff. They have done a tremendous

job. They are breaking records here. It

is because of the cooperation of the en-

tire committee, the Members and the

staff working together. Mr. DINGELL. Mr. Speaker, it is with deep

regret that I rise in opposition to this con-ference report. Let me explain. Mr. Speaker, this is a bad bill. It guts some of our most im-portant environmental programs. It seems that the Republican majority realized what a bad bill it was and in order to win support for it, they put $1.5 billion in much needed funds for veterans’ healthcare.

Now, Mr. Speaker, I am a pragmatist. I real-ize that there is no perfect bill. Sometimes we have to settle for some good and some bad. The bill before us, however, is a close call.

The problem is a simple one. You see, for years my Republican colleagues have been shortchanging our veterans. The number of veterans treated at VA facilities increased from 2.7 million to 4.7 million from 1995 to 2004. The Department expects to treat 5.2 million veterans in 2006. Currently, more than 50,000 veterans are waiting in line for at least 6 months for health services from the VA. Med-ical costs are increasing at nearly double the rate of inflation. Yet, over five years, the Re-

publican budget for primarily veterans’ health programs is funded $13.5 billion below the amount needed to maintain services at current levels.

I am pleased that my Republican colleagues have finally seen the light and realized that we cannot ask our men and women in uniform to make the ultimate sacrifice only to come home and have the promise of quality and timely healthcare broken. However, I am angry as hell that they attached this much needed fund-ing to a particularly appalling bill.

You are probably saying, ‘‘Dingell, how ap-palling could it be when we are finally getting this funding for our veterans?’’

Well, let me tell you. EPA has estimated that there is a $388 bil-

lion shortfall between needed clean water and drinking water investments and the current level of spending. What do my Republican col-leagues do to address that shortfall, Mr. Speaker? They cut the Clean Water State Re-volving Loan Fund by $200 million from the FY 05 enacted level! That is a 33 percent cut over the past two years. Moreover, the bill cuts water and sewer construction grants by more than 30 percent—a reduction of $107 million from last year. This hardly seems like a reasonable response.

Conservation and land acquisition got a $41 million reduction. This is 25 percent below last year’s enacted level. Mr. Speaker, my col-leagues on the other side of the aisle have the dubious honor of providing the lowest appro-priation for land and conservation programs in 20 years.

Funding for construction at our National Parks, Refuges and Forests was cut by ten percent and funding for Forest Service build-ings, roads and trails by 14 percent. Stateside grants for conservation and recreation got an amazing two-thirds cut, from $90 million last year to $30 million.

So, you see the conundrum before us. It is with a heavy heart that I feel that I must

stand against not only a bad bill, but also against the process. It is unconscionable that my friends on the other side of the aisle would link this critically important and much needed funding for our Nation’s heroes to a bad bill.

Mr. ETHERIDGE. Mr. Speaker, I rise in re-luctant support of this conference report.

I am very reluctant to support this bill be-cause it contains provisions I strongly oppose. Specifically, this bill contains harmful cuts to important interior and environmental priorities. It cuts $800 million from last year’s funding level for natural resources and the Environ-mental Protection Agency. Environmental and management and science and technology ac-counts are severely cut in this bill. The bill cuts $107 million for water and sewer con-struction STAG grants, cuts $200 million from SRF clean water funds, and cuts $30 million from stateside grants to states for conserva-tion and recreation.

Mr. Speaker, this Congress has a solemn obligation to protect our Nation’s water, air and land resources for public health and safe-ty. We must practice responsible stewardship of our natural resources and pass on to future generations a physical environment as bounti-ful as the one we have enjoyed. This bill fails this test miserably.

I will vote for this bill because it contains desperately needed funding for veterans health care. Specifically, the conference report on H.R. 2631 contains $1.5 billion in veterans

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CONGRESSIONAL RECORD — HOUSEH7022 July 28, 2005 health care funds to make up for the Adminis-tration’s bogus budget proposals. Democrats in this House have been arguing for months that the Administration is shortchanging VA health care, and we should restore that fund-ing in the proper legislation under regular order. A nation at war must take care of its veterans, and I will vote for this bill to provide this critical funding for veterans health care.

Mr. HOLT. Mr. Speaker, I rise to express my disappointment with the Interior Appropria-tions bill that we are considering today. Al-though I will reluctantly vote for this legislation, I am concerned with the reduction in funding for many important domestic programs.

While I am pleased that this conference bill does not completely eliminate the Land and Water Conservation Fun, (LWCF), as in the House-passed version, I am still disappointed that this program only received $30 million, which is one-third of what it received last year.

The Land and Water Conservation Fund has been instrumental in assisting local and State governments preserve vital open spaces. This program was established in 1965 to address rapid overdevelopment by increas-ing the number of high quality recreation areas and facilities and by increasing the local in-volvement in land preservation. To achieve this goal, the fund was separated into two components, one portion of the fund serves as an account from which the Federal govern-ment draws from to acquire land and the other portion is distributed to states in a matching grant program.

New Jersey has been active in seeking grants from this program and has received funds from the LWCF that were used to pre-serve treasures such as the Pinelands Na-tional Reserve and the Delaware National Scenic River. In addition, LWCF has provided more that $111 million in state and local grants to build softball fields, rehabilitate play-grounds and to expand state parks.

Urban and highly developed regions, such as the region that I represent, will suffer the most from the elimination of the LWCF state grant program. The LWCF matching-grant pro-gram has proven to be a successful way to overcome the high cost of living that makes land acquisition and renewal projects costly in these regions. The steep reduction in funding for this program will leave local leaders with-out the capital necessary to enhance the qual-ity of life in their communities.

This bill also cuts other domestic programs that benefit all Americans and future genera-tions. This legislation only provides $900 mil-lion for the Clean Water State Revolving Fund—a reduction of $200 million from last year. This is vitally important to keeping drink-ing water clean and safe by supporting waste-water treatment, nonpoint source pollution and watershed and estuary management. Addition-ally, this bill cuts Federal land acquisition fund-ing by 25 percent and reduces funding for construction projects in our national parks, ref-uges and forests by 10 percent.

Despite my reservations with cuts to impor-tant Environmental Protection Agency, EPA, and the Department of Interior, DOI, pro-grams, I am pleased that this bill does the right thing and finally provides the VA the funds it needs to continue the delivery of care to our veterans through the end of the current fiscal year. This month, our Nation marked the 75th anniversary of the founding of the Vet-erans’ Administration, the forerunner of today’s

Department of Veterans Affairs. Even as we celebrate the VA’s many achievements, par-ticularly in the field of medical research, we should use this opportunity to ask if we, as a country, are truly putting our money where our mouth is regarding VA funding. Every day, VA doctors, nurses, technicians and other staff across our country work to try to deliver the best possible health care to our veterans. They face one critical and continuing obsta-cle—a VA medical system that is chronically, and needlessly, underfunded.

I hope that the Congress will learn from this experience and pass mandatory funding legis-lation for the VA health care system. It’s long past time for Congress to cease its band-aid approach to funding for veteran’s health care, and I urge my colleagues to honor the request of the leaders of our Nation’s veterans organi-zations to deal once and for all with this shameful and avoidable situation.

Another positive provision in this bill is the modest increase in funding for the National Endowment for the Arts and the National En-dowment for the Humanities. Although the final funding levels fall slightly short of the amount approved by the House in May, the additional money will allow the NEA and NEH to build programs that use the strength of the arts and our Nation’s cultural life to enhance communities in every State and every county around America.

It is clear that increasing funding for the arts and humanities are among the best invest-ments that we as a society can make. They help our children learn. They give the elderly intellectual sustenance. They power economic development in regions that are down and out. They tie our diverse society and country to-gether. I thank the conferees for recognizing the importance of this investment and giving the NEA and NEH the funds they need to ad-vance our Nation’s artistic and cultural life.

Even though I strongly oppose cuts to cer-tain programs in this appropriations bill, I will vote in favor of this legislation. I hope in the future we can provide sufficient funding to these programs that enhance our commu-nities, provide the Nation with clean water, and protect our precious natural wonders.

Mr. GENE GREEN of Texas. Mr. Speaker, I rise today in support of this conference re-port to provide funding for the Department of the Interior and the Environmental Protection Agency for fiscal year 2006. Despite a tight al-location, the Chairman and Ranking Member of the Interior subcommittee performed an ad-mirable task in providing the necessary fund-ing for the continued management of federal lands and the operation of our country’s envi-ronmental programs. I was disappointed to learn, however, that the bill does not provide much needed funding for a project I requested for the City of Houston and the University of Texas, Houston to conduct a risk assessment of air toxics in the Greater Houston area.

The Houston Chronicle recently completed a five-part series titled ‘‘In Harm’s Way’’ that in-vestigated air toxics in the ‘‘fence-line’’ com-munities near industrial facilities in Houston’s East End. In particular, the series noted that the Texas Commission on Environmental Quality found that folks residing in some of these neighborhoods experience higher levels of potentially carcinogenic compounds than other areas.

For many years, residents have had con-cerns and questions about the quality of the

air in Houston’s East End, the potential rela-tionship to local industry, and the potential health effects on their families. The City of Houston, partnering with the University of Texas School of Public Health, is already working to characterize the science and weigh the evidence on health effects. Federal fund-ing would allow us to broaden the scope of these efforts to ensure that we include the full range of risk assessment activities in our effort to improve the air in Houston.

While I remain disappointed that the Appro-priations Committee did not include a line-item appropriation for this project, I am pleased that my colleague from Washington, the Interior Subcommittee Ranking Member, recognized the need for this air toxics assessment and has agreed to work with me to encourage the EPA to include this assessment as part of its fiscal year 2006 operations.

I thank my friend, Mr. DICKS, for his willing-ness to work with me on this effort. The folks in these fence-line communities—my constitu-ents—are often the workers who produce many of the essential energy and petro-chemical products we all use everyday, and they deserve accurate information about their environment.

With that, Mr. Speaker, I encourage my col-leagues to support this bill.

Ms. WOOLSEY. Mr. Speaker, there is an old saying that, ‘‘You can put a dress on a pig, but it’s still a pig.’’ While I am happy that the FY06 Interior Appropriations Conference Re-port includes $1.5 billion to make up for the funding shortfall for the Veterans’ Administra-tion, VA, it does not mask the horrible choices that were made in the rest of this bill. It’s still a pig. This legislation includes cuts to the Clean Water State Revolving Fund, decreases in the number of STAG grants, and completely eliminates many conservation grants.

Ensuring that the VA has the funding it needs is one of my highest priorities, which is why I am so disappointed that this money was included in a bill that undermines our environ-ment. It is sad that veterans’ have been short-changed by President Bush who was all to eager to send troops off to war, but failed to account for the cost of their care after they had dutifully served their country. The under-estimation by the White House of $1.5 billion for this year is only the tip of the iceberg with the shortfall for next year already projected to be $2.6 billion. Unfortunately, the shortsighted-ness of the Republican majority failed to in-clude this spending where it should be, in the Military Quality of Life Appropriations bill.

However, Mr. Speaker, in spite of the short-comings for the environment, I will vote for this bill to support our troops.

Mr. SALAZAR. Mr. Speaker, I rise today to express my strong support for the conference report on H.R. 2361, the Interior Appropria-tions bill. This important piece of legislation provides $1.5 billion to remedy the shortfall in veterans’ health care for this year. Earlier this month, I stood here urging this body to step up to the plate when it comes to veterans. Our veterans must be our number one priority. By passing this measure, we take the first step in fulfilling our obligation to the men and women who have served our country with honor and dignity.

Passage of this bill is a necessity—I will never turn my back to our Nation’s veterans. However, I do want to take this opportunity to discuss my concerns with the larger measure

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CONGRESSIONAL RECORD — HOUSE H7023 July 28, 2005 and its failure to address the land and water conservation and management needs of our nation. The Land and Water Conservation Fund has been a valuable program for my dis-trict. This has been a fund to assist commu-nities in helping preserve open space to pro-tect and conserve unique landscapes. The cut in funding for the Land and Water Conserva-tion Fund is a cut in land conservation for Col-orado.

For those who know, the 3rd Congressional District is comprised of rural communities con-taining millions of acres of public lands. These public lands are managed by the U.S. Forest Service, Bureau of Land Management, Na-tional Park Service, and the Fish and Wildlife Service. These agencies and public lands pro-vide many benefits for the local communities in my district. I am disappointed with the de-crease in funding to these agencies in this year’s Interior Appropriations Conference Re-port. These agencies have to maintain a dif-ficult balance of managing our nation’s public lands with budget constraints. By cutting fund-ing to these agencies it makes it very difficult for them to maintain their current management practices and leaves our nation’s public lands in jeopardy.

With that being said, this report does have some positive aspects. The funding of $5.6 bil-lion for Indian programs is beneficial for school and hospital construction, education grants, human services programs, and law enforce-ment needs. These programs are essential for the Native American reservations within my district.

More often than not, in the West, the Fed-eral Government is not just your neighbor, it is the entire neighborhood. Since most of my district cannot raise taxes, Payment in Lieu of Funding is vital. These counties with public lands within their boundaries need this funding for schools, roads, and other infrastructure needs. This program has never been fully funded, yet my counties are dependent upon this program. I hope to see this program fully funded next year.

I also want to see continued funding for the National Fire Plan and the forest health initia-tives. These programs need to see increased funding due to the continued drought periods in the West and the current pine beetle epi-demic. If the beetle infestations are not ad-dressed, we will continue to see our forests

decimated. These insects will continue to cause fire hazards in our nation’s forests if we do not get them under control.

I urge Congress next year to fully fund these agency budgets. This is critical to the Western States and our existence.

Finally, Mr. Speaker, I would like to thank Representatives OBEY and DICKS for their as-sistance in securing $100,000 for Montrose’s City Hall Renovation Project. The City Hall building of Montrose was built in 1926 and has been well preserved throughout the years. However, as the City and County continues to grow, so too must the building in order to ac-commodate the needs of the people. Pre-serving and expanding the City Hall building in Montrose will allow us to keep a part of history alive for future generations of Colorado. Mr. Speaker once again I urge my colleagues to vote in favor of this legislation. We need to sure up our VA budget so we can continue to provide critical health care services to our na-tion’s veterans. In the future we need to re-store the Land and Water Conservation fund-ing and fully fund our agencies budgets.

Mr. TAYLOR of North Carolina. Mr.

Speaker, I have no further requests for

time, and I yield back the balance of

my time.

Mr. DICKS. Mr. Speaker, I have no

further requests for time, and I yield

back the balance of my time.

The SPEAKER pro tempore (Mr.

WALDEN of Oregon). Without objection

the previous question is ordered on the

conference report.

There was no objection.

The SPEAKER pro tempore. The

question is on the conference report.

Pursuant to clause 10 of rule XX the

yeas and nays are ordered.

Pursuant to clause 8 of rule XX fur-

ther proceedings on this question will

be postponed.

f

GENERAL LEAVE

Mr. LEWIS of California. Mr. Speak-

er, I ask unanimous consent that all

Members may have 5 legislative days

within which to revise and extend their

remarks and that I may include tab-

ular and extraneous material on the

conference report to accompany H.R.

2985.

The SPEAKER pro tempore. Is there

objection to the request of the gen-

tleman from California?

There was no objection.

f

CONFERENCE REPORT ON H.R. 2985,

LEGISLATIVE BRANCH APPRO-

PRIATIONS ACT, 2006

Mr. LEWIS of California. Mr. Speak-

er, I call up the conference report on

the bill (H.R. 2985), making appropria-

tions for the Legislative Branch for the

fiscal year ending September 30, 2006,

and for other purposes.

The Clerk read the title of the bill.

The SPEAKER pro tempore. Pursu-

ant to House Resolution 396, the con-

ference report is considered read.

(For conference report and statement

see proceedings of the House of July 26,

2005 at Page H6628.)

The SPEAKER pro tempore. The gen-

tleman from California (Mr. LEWIS) and

the gentleman from Wisconsin (Mr.

OBEY) each will control 30 minutes.

The Chair recognizes the gentleman

from California (Mr. LEWIS).

Mr. LEWIS of California. Mr. Speak-

er, I yield myself such time as I might

consume. I do not expect that we will

use very much of our time, Mr. Speak-

er.

The conference report I bring forth

today to fund the legislative branch in-

volves those activities providing some

$3 billion, 800 million, an increase of 4.5

percent over the year 2005.

Mr. Speaker, the adjustments upward

almost entirely represent increased ex-

penditures for our police services and

security around the Capitol campus,

and, beyond that, expenses that are di-

rectly related to the development of

the Congressional Visitors Center.

Otherwise the bill is absolutely flat

in terms of spending over 2005–2006. It

is a very, very lean bill. I urge the

Members to support the bill.

Mr. Speaker, I submit the following

for the RECORD:

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CONGRESSIONAL RECORD — SENATE S7551 June 29, 2005 Fulton Street in Brooklyn, New York, shall

be known and designated as the ‘‘Congress-

woman Shirley A. Chisholm Post Office

Building’’.

(b) REFERENCES.—Any reference in a law,

map, regulation, document, paper, or other

record of the United States to the facility re-

ferred to in subsection (a) shall be deemed to

be a reference to the Congresswoman Shirley

A. Chisholm Post Office Building.

f

BOONE PICKENS POST OFFICE

The bill (S. 775) to designate the fa-

cility of the United States Postal Serv-

ice located at 123 W. 7th Street in

Holdenville, Oklahoma, shall be known

and designated as the ‘‘Boone Pickens

Post Office’’ was read the third time

and passed, as follows:

Be it enacted by the Senate and House of Rep-

resentatives of the United States of America in

Congress assembled,

SECTION 1. BOONE PICKENS POST OFFICE. (a) DESIGNATION.—The facility of the

United States Postal Service located at 123

W. 7th Street in Holdenville, Oklahoma,

shall be known and designated as the ‘‘Boone

Pickens Post Office’’.

(b) REFERENCES.—Any reference in a law,

map, regulation, document, paper, or other

record of the United States to the facility re-

ferred to in subsection (a) shall be deemed to

be a reference to the ‘‘Boone Pickens Post

Office’’.

f

BRIAN P. PARRELLO POST OFFICE

BUILDING

The bill (S. 904) to designate the fa-

cility of the United States Postal Serv-

ice located at 1560 Union Valley Road

in West Milford, New Jersey, as the

‘‘Brian P. Parrello Post Office

Building’’was read the third time and

passed, as follows:

Be it enacted by the Senate and House of Rep-

resentatives of the United States of America in

Congress assembled,

SECTION 1. BRIAN P. PARRELLO POST OFFICE BUILDING.

(a) DESIGNATION.—The facility of the

United States Postal Service located at 1560

Union Valley Road in West Milford, New Jer-

sey, shall be known and designated as the

‘‘Brian P. Parrello Post Office Building’’.

(b) REFERENCES.—Any reference in a law,

map, regulation, document, paper, or other

record of the United States to the facility re-

ferred to in subsection (a) shall be deemed to

be a reference to the ‘‘Brian P. Parrello Post

Office Building’’.

f

DALIP SINGH SAUND POST OFFICE

BUILDING

The bill (H.R. 120) to designate the

facility of the United States Postal

Service located at 30777 Rancho Cali-

fornia Road in Temecula, California, as

the ‘‘Dalip Singh Saund Post Office

Building’’ was read the third time and

passed.

f

SERGEANT FIRST CLASS JOHN

MARSHALL POST OFFICE BUILD-

ING

The bill (H.R. 289) to designate the

facility of the United States Postal

Service located at 8200 South Vermont

Avenue in Los Angeles, California, as

the ‘‘Sergeant First Class John Mar-

shall Post Office Building’’ was read

the third time and passed.

f

ARTHUR STACEY MASTRAPA POST

OFFICE BUILDING

The bill (H.R. 324) to designate the

facility of the United States Postal

Service located at 321 Montgomery

Road in Altamonte Springs, Florida, as

the ‘‘Arthur Stacey Mastrapa Post Of-

fice Building’’ was read the third time

and passed.

f

RAY CHARLES POST OFFICE

BUILDING

The bill (H.R. 504) to designate the

facility of the United States Postal

Service located at 4960 West Wash-

ington Boulevard in Los Angeles, Cali-

fornia, as the ‘‘Ray Charles Post Office

Building’’ was read the third time and

passed.

f

LINDA WHITE EPPS POST OFFICE

The bill (H.R. 627) to designate the

facility of the United States Postal

Service located at 40 Putnam Avenue

in Hamden, Connecticut, as the ‘‘Linda

White-Epps Post Office’’ was read the

third time and passed.

f

SERGEANT BYRON W. NORWOOD

POST OFFICE BUILDING

The bill (H.R. 1001) to designate the

facility of the United States Postal

Service located at 301 South

Heatherwilde Boulevard in

Pflugerville, Texas, as the ‘‘Sergeant

Byron W. Norwood Post Office Build-

ing’’ was read the third time and

passed.

f

JUDGE EMILIO VARGAS POST

OFFICE BUILDING

The bill (H.R. 1072) to designate the

facility of the United States Postal

Service located at 151 West End Street

in Goliad, Texas, as the ‘‘Judge Emilio

Vargas Post Office Building’’ was read

the third time and passed.

f

FRANCIS C. GOODPASTER POST

OFFICE BUILDING

The bill (H.R. 1082) to designate the

facility of the United States Postal

Service located at 120 East Illinois Av-

enue in Vinita, Oklahoma, as the

‘‘Francis C. Goodpaster Post Office

Building’’ was read the third time and

passed.

f

MAYOR TONY ARMSTRONG

MEMORIAL POST OFFICE

The bill (H.R. 1236) to designate the

facility of the United States Postal

Service located at 750 4th Street in

Sparks, Nevada, as the ‘‘Mayor Tony

Armstrong Memorial Post Office’’ was

read the third time and passed.

f

CAPTAIN MARK STUBENHOFER

POST OFFICE BUILDING

The bill (H.R. 1460) to designate the

facility of the United States Postal

Service located at 6200 Rolling Road in

Springfield, Virginia, as the ‘‘Captain

Mark Stubenhofer Post Office Build-

ing’’ was read the third time and

passed.

f

ED EILERT POST OFFICE

BUILDING

The bill (H.R. 1524) to designate the

facility of the United States Postal

Service located at 12433 Antioch Road

in Overland Park, Kansas, as the ‘‘Ed

Eilert Post Office Building’’ was read

the third time and passed.

f

HONORABLE JUDGE GEORGE N.

LEIGHTON POST OFFICE BUILDING

The bill (H.R. 1542) to designate the

facility of the United States Postal

Service located at 695 Pleasant Street

in New Bedford, Massachusetts, as the

‘‘Honorable Judge George N. Leighton

Post Office Building’’ was read the

third time and passed.

f

FLOYD LUPTON POST OFFICE

The bill (H.R. 2326) to designate the

facility of the United States Postal

Service located at 614 West Old County

Road in Belhaven, North Carolina, as

the ‘‘Floyd Lupton Post Office’’ was

read the third time and passed.

f

MEASURES PLACED ON CAL-

ENDAR—S. 590, S. 867, S. 892, S.

1206, AND S. 1207

Mr. BURNS. Mr. President, I ask

unanimous consent that the Com-

mittee on Homeland Security and Gov-

ernmental Affairs be discharged from

further consideration of S. 590, S. 867,

S. 892, S. 1206, and S. 1207 en bloc, and

these bills placed on the calendar.

The PRESIDING OFFICER. Without

objection, it is so ordered.

The PRESIDING OFFICER. The Sen-

ator from Montana is recognized.

Mr. BURNS. I ask for the regular

order.

f

CONCLUSION OF MORNING

BUSINESS

The PRESIDING OFFICER. Morning

business is closed.

f

DEPARTMENT OF INTERIOR, ENVI-

RONMENT, AND RELATED AGEN-

CIES APPROPRIATIONS ACT, 2006

The PRESIDING OFFICER. Under

the previous order, the Senate will re-

sume consideration of H.R. 2361, which

the clerk will report.

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CONGRESSIONAL RECORD — SENATES7552 June 29, 2005 The journal clerk read as follows:

A bill (H.R. 2361) making appropriations

for the Department of the Interior, Environ-

ment, and Related Agencies for the fiscal

year ending September 30, 2006, and for other

purposes.

Mr. BURNS. Mr. President, I ask

unanimous consent that we proceed to

the regular order. The PRESIDING OFFICER. Without

objection, it is so ordered.

AMENDMENT NO. 1023

Under the regular order, the Boxer

amendment is now pending. The Sen-

ator from California. Mrs. BOXER. Mr. President, what is

the order? As I understand it, Senator

BURNS will be offering an amendment,

or has an amendment, and there will be

a vote on my amendment and his side

by side. First, mine; is my under-

standing correct? Mr. BURNS. That is correct. Mrs. BOXER. And then his. The PRESIDING OFFICER. The vote

will be on the Burns amendment first,

followed by the Boxer amendment. Mrs. BOXER. The time is equally di-

vided an hour a side to debate both

amendments; is that correct? The PRESIDING OFFICER. That is

correct. Mrs. BOXER. Mr. President, I ask

unanimous consent that any quorum

calls when placed be divided evenly. The PRESIDING OFFICER. Without

objection, it is so ordered. The Chair

notes that the Senator from Montana

has not yet called up his amendment. Mrs. BOXER. I defer to him. I yield

the floor. Mr. BURNS. Mr. President, we do not

have it yet. The PRESIDING OFFICER. The

Chair believes that the amendment is

not at the desk yet. Mr. BURNS. Mr. President, I assure

the Senator from California, I know we

have it somewhere, and I will find it. Mrs. BOXER. That is reassuring. Mr. BURNS. That is reassuring; isn’t

it? Everybody gets to read it—that is

different in the Senate. We have it.

AMENDMENT NO. 1068

Mr. BURNS. Mr. President, I send an

amendment to the desk.

The PRESIDING OFFICER. The

clerk will report the amendment.

The journal clerk read as follows:

The Senator from Montana [Mr. BURNS],

for himself, Mr. CHAMBLISS, and Mr. INHOFE,

proposes an amendment numbered 1068.

Mr. BURNS. Mr. President, I ask

unanimous consent that the reading of

the amendment be dispensed with.

The PRESIDING OFFICER. Without

objection, it is so ordered.

The amendment is as follows:

(Purpose: To direct the Administrator of the

Environmental Protection Agency to con-

duct a review of all third-party intentional

human dosing studies to identify or quan-

tify toxic effects)

On page 200, after line 2, add the following:

SEC. . ( a) The Administrator of the En-

vironmental Protection Agency shall con-

duct a thorough review of all third-party in-

tentional human dosing studies to identify

or quantify toxic effects currently submitted

to the Agency under FIFRA to ensure that

they: (1) address a clearly defined regulatory ob-

jective; (2) address a critical regulatory endpoint

by enhancing the Agency’s scientific data

bases; (3) were designed and being conducted in a

manner that ensured the study was adequate

scientifically to answer the question and en-

sured the safety of volunteers; (4) was designed to produce societal bene-

fits that outweigh any anticipated risks to

participants; (5) adhered to all recognized ethical stand-

ards and procedures in place at the time the

study was conducted; and (6) are consistent with section 12(a)(2)(P) of

the Federal Insecticide, Fungicide, and

Rodenticide Act and all other applicable

laws. (b) The Administrator shall, within 60 days

of the enactment of this Act, report to the

House and Senate Committees on Appropria-

tions; the Senate Committee on Agriculture,

Nutrition and Forestry; and the House Com-

mittee on Agriculture on the results of the

review required under subsection (a) and any

actions taken pursuant to the review. (c) Within 180 days of the enactment of this

Act, the Administrator shall issue a final

rule that addresses applying ethical stand-

ards to third party studies involving inten-

tional human dosing to identify or quantify

toxic effects.

The PRESIDING OFFICER. Who

yields time? Mr. BURNS. Mr. President, I ask

unanimous consent that the amend-

ment be set aside and that the Senator

from California be recognized. The PRESIDING OFFICER. Without

objection, it is so ordered. The Senator

from California.

AMENDMENT NO. 1023

Mrs. BOXER. Mr. President, is it nec-

essary to now call up amendment No.

1023? The PRESIDING OFFICER. That

amendment is currently pending. Mrs. BOXER. Mr. President, I think

we are about to have a very important

debate about a very moral subject

which deals with intentional dosing of

human beings, including children, with

dangerous pesticides. I say this is a

moral issue. As a matter of fact, I be-

lieve I can call my amendment a faith-

based amendment because every major

religious organization in this country

supports my amendment. My amendment passed the House

without a single dissenting vote. It was

by unanimous consent. I am shocked

and stunned that we even have opposi-

tion to this very simple amendment. The amendment that was offered by

my good friend, the Senator from Mon-

tana, in my opinion and in the opinion

of people who know about ethics and

science and pesticide testing, it is ac-

tually a very dangerous amendment. It

is offered as, I call it a CY amendment,

cover yourself amendment. You can

vote for his amendment and then

against mine. If you look at his amend-

ment, it is a step back to what is hap-

pening currently. It is a dangerous

amendment because we will push

through a new regulation that already

has been condemned by, as I say, every

major religious organization in this country.

We will debate this for the next cou-ple of hours, but I wanted to make a statement in reaction to the Presi-dent’s speech last night.

PRESIDENT BUSH’S SPEECH

Mr. President, the President had every opportunity last night to lay out his plan for success in Iraq. I had given a number of interviews where I urged him to do that, and colleagues on both

sides urged him to do that. Instead,

what we got was a defense of the status

quo and absolutely no mention of the

need to be ready when our troops come

back, 13,000 plus, with horrific injuries,

physical and mental—an opportunity

to say our troops will have everything

they need when they come home and

every bit of equipment they need on

the field in Iraq was blown last night.

And then there was no plan of how we

are going to get out of this thing, and

a continuation of the myth that the

war in Iraq had something to do with

9/11, which it did not. I looked back yesterday at the De-

partment of State as they looked at

where al-Qaida was on September 11.

Not one al-Qaida cell was in Iraq on

September 11. There were more al-

Qaida cells in my home State of Cali-

fornia. I am very sorry to see we are on that

status quo and the daily news con-

tinues with the disastrous effects of a

policy that is not geared toward suc-

cess.

AMENDMENT NO. 1023

Mr. President, I am now going to

talk about my amendment. I see the

Senator from Florida is here. At an ap-

propriate moment, I will yield to him.

I want to lay out the general aspects of

my amendment. The amendment that I offer will sim-

ply say we need to take a timeout in

terms of the environmental protections

action on accepting for review and, in

essence, condoning pesticide testing on

human beings. We need a timeout.

Christy Todd Whitman thought we

needed a moratorium. She put one in

place. Carol Browner, under President

Clinton, put a moratorium in place.

But now the moratorium has lapsed

and, shockingly, EPA is considering

and encouraging intentional dosing of

human beings with dangerous pes-

ticides. This is not rhetoric. I am going

to show the charts and show the ex-

periments. What my friend and colleague is of-

fering is a figleaf cover amendment:

Don’t vote for Boxer, it actually does

something; vote for the Burns amend-

ment which—listen to what it does—

speeds up a regulation that is already

going through EPA that is downright

dangerous and involves testing of

human beings, including newborn ba-

bies—very ill newborn babies—preg-

nant women, and fetuses. That is why

every major religious organization in

America has entered on the side of the

Boxer amendment and opposed to the

Burns amendment.

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CONGRESSIONAL RECORD — SENATE S7553 June 29, 2005 I am going to show the actual lan-

guage of the Boxer amendment. It is

exactly the language of the House-

passed amendment:

None of the funds made available in this

Act may be used by the Administrator of the

Environmental Protection Agency to (1) accept, consider, or rely on third-party

intentional dosing human studies for pes-

ticides; or (2) to conduct intentional dosing human

studies for pesticides. It is simply a straightforward timeout so

that we can look at the ethical, moral, and

health issues surrounding the current policy

at the EPA.

As I said, Carol Browner, a Demo-

crat, put that moratorium in place;

Christy Todd Whitman, a Republican,

put that moratorium in place. But now

it has been allowed to lapse. I recently released a staff report with

Congressman WAXMAN that reviewed 22

of the studies that EPA is currently

looking at. I want to tell you what we

found after reviewing these studies. We found that human testing of pes-

ticide moratorium was allowed to lapse

by the EPA; that over 20 human dosing

studies are currently being reviewed by

the EPA; and that the studies—and

this is the most important point, Mr.

President—the studies routinely vio-

late ethical and scientific standards

laid out in the Nuremberg Code, the

Declaration of Helsinki, the ‘‘Common

Rule,’’ and the National Academy of

Sciences recommendations on human

testing. In other words, we have noth-

ing in place that would guide these ex-

periments. I am going to show you one of these

experiments that is being reviewed by

the EPA. So let’s go to the UC San

Diego study. I care a lot about this because this

happened in my State. This is a study on chloropicrin. What

is chloropicrin? It is a fumigant. It is

an active ingredient in tear gas, and it

was a chemical warfare agent in World

War I. I told you about chloropicrin. In the

material safety data sheet which is put

out by the manufacturer, this is what

it says about chloropicrin which was

given to UC San Diego students, and I

will talk about the dose they received. Warning statements and warning

properties, this is what it says:

Danger. May be fatal if inhaled or swal-

lowed. Severe burn follows liquid contact

with eyes or skin. May cause severe res-

piratory tract irritation. Causes eye and

skin irritation. Lachrymator—

This means it is the tear gas prop-

erty—

poison may cause lung damage.

Chloropicrin was categorized as a

category 1, which is the most toxic due

to acute lethality and severe irritation. Let’s look at how the students got

these doses. They were paid $15 an

hour. They were told that this was not

dangerous. They signed liability waiv-

ers. This is all unethical, and nothing

in the Burns amendment will stop any

of this and nothing in the Burns

amendment addresses these issues.

Here we can see the students receiv-

ing this dangerous fumigant through

this hose and breathing it in. This is

right from the study:

Figure 10. Showing subjects sampling from

two cones through yokes that directed flow

from the right cone into the right nostril

and from the left cone into the left nostril.

The subjects needed to decide whether they

felt the chloropicrin on the right or the left.

Do you want your daughter breathing

in this dangerous chemical at doses

that are very large, which I will ex-

plain? This is a picture of a young woman

taking part in an experiment where the

chloropicrin dose was up to 1.2 parts

per million. I want you to remember 1.2

parts per million because this is the

point. The workplace safety standard

for chloropicrin is .1 parts per million.

This experiment dosed these kids with

12 times higher than the average level

allowed in the workplace. Let me repeat that. This experiment

dosed these students with 12 times the

level that is considered safe. And this

is a recent experiment. It ended in De-

cember of 2004. I am going to show you what OSHA

says you should wear when you are ex-

posed to chloropicrin at levels higher

than .1, 12 times lower than these stu-

dents were dosed with. It requires a

full-face plate respirator or powered air

purifying respirator with organic car-

tridge to protect from the chemical,

according to the manufacturer. I have to say, what more of a moral

issue can we be facing than allowing

these students to have chloropicrin

pumped through their nostrils at a rate

12 times higher than the safety level

that OSHA, our Federal Government,

says is safe? What right do we have to

allow that to go on? Yet the Burns

amendment will allow it to go on. The only way to stop it is with the

Boxer amendment, which is the iden-

tical amendment to the House amend-

ment where not even TOM DELAY, who

comes from the pesticide industry, reg-

istered a ‘‘no’’ vote. How can we in the Senate, the most

deliberative body in the land, walk

away from a simple moratorium on

this kind of situation? Let us look at the next chart. This

next chart shows the 20 studies under

review since the moratorium was al-

lowed to lapse. I could not even pro-

nounce all of these properly, but I will

give a few of them. Carbofuran,

ethephon, amitraz, methomyl, oxamyl,

malathion, and chloropicrin was the

top one. It also shows the dates. These are all

studies similar to this one. Actually, in

one study did they not have to swallow

pesticide pills for breakfast? That is a

fact. Because I am a member of the Envi-

ronment and Public Works Committee,

as a result of that membership we de-

manded to see all of these studies.

They were being kept from the public

and we now know these things are

going on.

In some studies subjects were

harmed—for example, experiencing

heart arrhythmias; that is, an uneven

heartbeat, a racing heart, and we now

know it was a result of that chemical

that was being used. Many of the stud-

ies had very misleading consent forms.

Some described the pesticide as a drug.

In some studies adverse outcomes were

dismissed. They said, oh, they went to

the hospital because they did not feel

good, but it had nothing to do with the

dosing of the pesticide. Hard to believe.

Most of the studies had no long-term

monitoring reviews and few were large

enough to be statistically valid. The

deficiencies are significant and wide-

spread and that is why we need this

moratorium on this timeout to allow a

set of standards to be developed that

governs the use of these studies. The

development of sound standards is crit-

ical, if the problems with human pes-

ticide testing are to be addressed.

At this point, I yield 8 minutes to the

Senator from Florida.

The PRESIDING OFFICER. The Sen-

ator from Florida.

Mr. NELSON of Florida. Mr. Presi-

dent, I am delighted to join my col-

league from California. We have fought

these battles before. We fought one of

these battles when unbelievably the

EPA wanted to conduct an experiment.

They called it a study. It was a 2-year

study they were going to perform on

infants in my State in Jacksonville,

FL. This 2-year study was going to ex-

pose those infants to pesticides. It was

going to be done with the inducement

by getting the parents of the infants to

sign a contract of which over a 2-year

period they were going to be paid $970,

were going to be given a T-shirt, were

going to be given other kinds of trin-

kets, and a certificate of appreciation

in return for children over that 2-year

period being exposed to pesticides that

were going to be placed in the home.

Oh, by the way, guess which part of

town this was going to occur in. You

guessed it. It was going to occur in the

lower income and minority sections of

Jacksonville.

Senator BOXER and I got wind of it.

Well, she got wind of it because she was

sitting on the committee having to do

with the confirmation of the head of

EPA and she announced that, in fact,

she was not going to let the EPA nomi-

nee go through. Then she came to me

and pointed out that, in fact, this was

occurring in Florida.

This was one of the brochures, if my

colleagues can believe it, that EPA was

going to send out. As a matter of fact,

they had already sent it out in Jack-

sonville. They had gotten some 30 par-

ents to already sign up for this pro-

gram. It states: You’re a parent. Learn

more about your child’s potential pes-

ticide exposure. Am I eligible to par-

ticipate? Only 60 participants will be

selected. To be selected, you must be a

parent of a child less than 3 months old

or one between the ages of 9 and 12

months old.

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CONGRESSIONAL RECORD — SENATES7554 June 29, 2005 Get this, in order to be eligible, one

has to spray or have pesticides sprayed inside their home routinely.

The ad states: Will I be compensated? Oh, of course. You will receive up to $970 over the 2-year period. Your family will receive an official framed certifi-cate of appreciation, a CHEERS bib for your baby, a T-shirt, a calendar, and a study newsletter. You will be allowed to keep the video camcorder they are going to give to you to record this study over the 2 years. You will be al-lowed to keep the video camcorder at the end of the study provided you have completed all of the study activities.

Can anyone believe this is going on in the United States of America in the year 2005?

Well, we put a stop to it because Sen-ator BOXER put a hold on the nominee. I put a hold on the nominee. I had a

conversation with the nominee and I

told the nominee I had no objection to

the nominee. As a matter of fact, I had

heard awfully good things about the

nominee. But as a Senator from Flor-

ida, I certainly was not going to let

that sort of thing go on in my State

and it should not be going on in any

State. All I wanted the nominee to do

was to cancel that study. What they did not tell the local

Jacksonville Health Department was that of the $9 million the study was going to cost, $2 million of the $9 mil-lion was being supplied by the pesticide industry. Needless to say, the Duval County Health Department did not like it when they found that out.

This is the kind of stuff we have had to go through with regard to human testing and it just should not be. So it is time to put it in this bill. This is un-like pharmaceutical studies on humans that offer the possibility that a human subject may benefit from the experi-ment. The human testing of pesticides offers no therapeutic benefit, and under this proposed rule EPA would be al-lowed to test on humans, children, pregnant women, newborns, and in-fants.

This senior Senator from Florida has had a bellyful of this kind of stuff to come in on the citizens of the State of Florida, and I want it stopped. Any ex-posure of an infant child or a pregnant woman to a toxin basically should be prohibited, even in doses that are not expected to do any harm.

With the experience I have had in Jacksonville, it was simply irrespon-sible for the EPA, whose very mission is to protect human health and the en-vironment, to have proposed such a study. The last time I checked, I thought EPA stood for Environmental Protection Agency. Well, then it needs to fulfill its challenge. It needs to ful-fill the goal of its name.

The happy ending to the story in Jacksonville was that we stopped it be-cause the nominee for the head of the EPA cancelled the study. Senator BOXER and I lifted our hold and we send our great wishes to the new adminis-trator of the EPA for a successful ad-ministration.

We need to help the administrator of

EPA have a successful administration

and we can do this with the Boxer-Nel-

son amendment. I yield the floor. Mrs. BOXER. Would the Senator

please yield back his extra time to me? Mr. NELSON of Florida. I certainly

will. Mrs. BOXER. I thank the Senator

from Florida. He is a protector of chil-

dren, families, and the vulnerable of

his State. His help on that CHEERS

program and getting that stopped was

an enormous contribution. Many times

we do big things around here that deal

with huge issues and we do not know

the impact of our work for a long time.

When one works for clean air, clean

water, it takes a while. I say to my friend from Florida, this

is something he can be proud of be-

cause we together, as a team, with the

help of some of our colleagues on the

Environment and Public Works Com-

mittee, were able to use the leverage

each Senator has to force a cancella-

tion of a program that was inten-

tionally dosing little children with pes-

ticides, paying off their parents who

tended to be poor, giving the parents a

video camera, and subjecting these

children to dangerous chemicals. So I

think we have to be proud that we

saved some kids from this. I want to say why my amendment is

so crucial and why the Burns amend-

ment is so bad if one cares about pro-

tecting children and families. The

amendment I have offered with my col-

league from Florida—and, by the way,

I ask unanimous consent that the fol-

lowing Senators be added as cosponsors

to this amendment: Senators SNOWE,

COLLINS, NELSON of Florida, CLINTON,

SCHUMER, OBAMA, JEFFORDS, KERRY,

LAUTENBERG, REID, and LEVIN. The PRESIDING OFFICER. Without

objection, it is so ordered. Mrs. BOXER. I think my colleagues

can see this is a bipartisan amendment.

We want to protect our children. This

has nothing to do with politics. We

want to protect our families. Here is what is happening. The Burns

substitute, which he is going to try to

tell everyone is better than the mora-

torium, essentially encourages the

EPA to continue with their rule-

making. It says, go on, hurry, finish it

up, and it does nothing to stop any of

the testing that is going on right now.

So it is a step back. It is a dangerous

step back. Now, why do I say that? I will tell my

colleagues about the EPA rule that is

coming at us if we do not stop this.

This is straight from the EPA. We are

fortunate enough to have this informa-

tion today.

The Agency has decided not to include any

proposed requirements relating to a Human

Studies Review Board as suggested in the

National Academy of Sciences recommenda-

tion 6–2.

The National Academy of Sciences—

we looked for it so that we have ethical

guidelines. The EPA has rejected the

guidelines of the National Academy of

Sciences and the Burns amendment

says, oh, go right ahead, EPA, finish

your regulations, and the Burns

amendment makes no reference to the

NAS. This is more from the EPA:

The promulgation of rules prescribing such

details [establishment of the Human Studies

Review Board] would unnecessarily confine

EPA’s discretion . . .

So, in other words, they are admit-

ting they are turning away the guide-

lines of the National Academy of

Sciences because they do not want to

be confined in doing what they do. What do they want to do? When you

find that out you will be rather

shocked. Are you ready for this? I say

to my friend from Montana, if this

doesn’t shake his confidence in his

amendment, nothing will. This is a

bombshell that I am about to tell you. The EPA is considering continuing a

limited number of scientific studies in-

volving pregnant women—meaning

they will be dosed with pesticides,

fetuses—meaning fetuses will be dosed

with pesticides, neonates of uncertain

viability—and just for those of you who

do not know, neonates are newborn ba-

bies—of uncertain viability—meaning

they are ill; sick babies will be in these

experiments, or nonviable neonates—

meaning newborns who may not make

it. They are going to dose them as well. If we can’t take a stand to protect

the sickest of the newborn babies, then

we don’t deserve to be here. If we are

going to stand with the pesticide com-

panies against ill, very ill newborn ba-

bies, what are we doing here? We don’t

belong here. Let’s see what some of the religious

groups are saying. For those people

who want to have faith-based legisla-

tion, you are on the faith-based legisla-

tion when you support the Boxer-

Snowe-Nelson-Clinton-Collins, et

cetera amendment. This is the state-

ment of the Leadership of Diverse

Faith Groups on human testing. It is

signed by the National Council of

Churches and the Coalition on the En-

vironment and Jewish Life.

Our faiths teach us to protect the vulner-

able among us and to do so we need a mora-

torium on the use of human testing data in

the registration of pesticides, not another

study or report.

The Burns alternative is another

study. But worse than that, the Burns

amendment encourages and orders the

EPA to get their regulations in place,

regulations that, as I told you, allow

testing on newborn babies and fetuses

and pregnant women and desperately

ill newborns. Why are we having a de-

bate? Why aren’t we all supporting a

moratorium, a timeout, just as

Christie Todd Whitman did, just as

Carol Browner did? This is a bipartisan

effort. Unfortunately, we have to choose. In-

stead of walking down this aisle to-

gether and saying we will not allow

testing on pregnant women—can you

imagine testing pesticides on des-

perately ill newborn babies and testing

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CONGRESSIONAL RECORD — SENATE S7555 June 29, 2005 pesticides on fetuses? I just can’t imag-

ine that that is what we are going to do

today by voting on the Burns amend-

ment and telling EPA to hurry up with

their regulations instead of taking a

timeout. Let’s look at some of the churches

that are involved in supporting the

Boxer amendment. Let’s take a look at

the list of these churches and these re-

ligious organizations. I will just read

some of them: The African Methodist

Episcopal Church; the Alliance of Bap-

tists; Archdiocese of America; the Dio-

cese of the Armenian Church; Christian

Church (Disciple of Christ); the Church

of the Brethren; the Coptic Church; the

Evangelical Lutheran Church; Friends

United Meeting; Greek Orthodox Arch-

diocese of America; International

Council of Community Churches; Ko-

rean Presbyterian Church; Moravian

Church in America, Northern Province

and Southern Province; National Bap-

tist Convention of America; National

Baptist Convention, USA; Orthodox

Church in America; Polish National

Catholic Church of America; Progres-

sive National Baptist Convention; Syr-

ian Orthodox Church of Antioch;

Ukrainian Orthodox Church of the

United States of America; United

Church of Christ; The United Meth-

odist Church. It goes on. The reason I am reading this is this

is very unusual to see a faith-based

amendment that deals with morality,

to have so many of our religious lead-

ers supporting us and opposing the

Burns amendment. Why do we even

have a debate? Certain things are right

and certain things are wrong. Yes, it is

an issue of social justice. Who is going

to step up to the plate and offer up

their newborn baby? Let’s take a look at that again, the

statement about testing on newborns. I

think Senator DURBIN is interested in

this and said he wanted to ask a ques-

tion about it. The fact is, all of the re-

ligious organizations have stepped up

to the plate, in part, because of this.

This is EPA’s own words.

EPA thinks it likely that it will continue

a limited number of scientific studies involv-

ing pregnant women, fetuses, neonates

[meaning newborns] of uncertain viability,

or non-viable neonates [in other words, des-

perately ill babies] in the future.

It is hard to imagine how anyone in

the Senate could vote for an alter-

native which encourages the EPA to

hurry up and produce their regulation,

when we can all come together as ev-

eryone did in the House of Representa-

tives and say: Time out, EPA. This is a

moral issue. Mr. DURBIN. Will the Senator from

California yield for a question? Mrs. BOXER. I will. Mr. DURBIN. I direct the question

through the Chair. Those tuning in to

this debate and starting to listen may

not grasp what is at issue. The way you

described it to us yesterday in the Sen-

ate Democratic caucus luncheon was

that the Environmental Protection

Agency is testing the toxicity, or poi-

sonous nature, of pesticides on human

beings here in the United States. Since

this came to the attention of the House

of Representatives, they have said this

is wrong; we don’t want to endanger

anyone’s life by testing them with pes-

ticides, particularly children, pregnant

women, others—for that matter, any

person. So they decided to suspend, as

I understand it, the authority of the

EPA to go forward with this testing. An argument is being made on the

floor today, by those opposing your

amendment, that we should go ahead

and continue the testing? Is that what

is at issue? Mrs. BOXER. That is the essence.

You can put lipstick on it but essen-

tially the opposition is saying no to

the Boxer amendment, and let’s just

tell the EPA to look at ethical guide-

lines and consider them and hurry up

and issue a regulation. Does it make any reference to the

National Academy of Sciences, which

has very strict regulations? It doesn’t

make any reference to any of the

guidelines that are internationally rec-

ognized. So, in essence, the Burns

amendment is the status quo with a

kicker that we continue these studies

and that, in essence, we say to the

EPA: Hurry up with your regulation. Mr. DURBIN. If the Senator will fur-

ther yield for a question through the

Chair, the photograph she displayed is

the same one she brought before us

yesterday. It depicts two young people,

a man and woman, who are involved in

some testing where they are inhaling

pesticides to determine what the phys-

ical impact would be if they have a cer-

tain amount of pesticide in their sys-

tem. Are you saying the Federal Gov-

ernment is paying for this research,

and is paying these people to come for-

ward and submit to this testing? Mrs. BOXER. This test is being paid

for by the pesticide maker, who wants

to say that they should be allowed to

use more chloropicrin in their pes-

ticide. They have paid the University

of San Diego to do this. The EPA accepted that study. In

other words, they are saying fine, we

are going to look at the results of that

study. It was Ronald Reagan who put a stop

to looking at the tests that came out

of World War II. Because after World

War II, we saw what was going on with

medical studies. Ronald Reagan was

the one who said we are going to stop

this. We are not going to even look at

these studies because they are im-

moral. What we are saying today is, it is im-

moral to take a young woman like

this—and tell her, by the way, she is

not going to be harmed—make her sign

a waiver of liability so she cannot real-

ly recover if she is sick, pay her $15 an

hour because she is a student and prob-

ably needs the money desperately, and

not tell her what this other picture

shows, the man in the mask, that she is

breathing chloropicrin at a rate 12

times the rate that our Federal Gov-ernment, our OSHA says is dangerous.

If you were to have a concentration of this chemical 12 times less than what these kids are getting into their nostrils, into their lungs, you need to wear this type of full-face plate res-pirator or powered air purifying res-pirator with organic cartridge to pro-tect from the chemicals.

Mr. DURBIN. How long has this been going on?

Mrs. BOXER. That is the interesting question. Under Bill Clinton’s adminis-tration, in the late 1990s, Carol Brown-er, the Administrator of EPA, stopped this kind of acceptance of these tests by the EPA.

Christie Todd Whitman agreed with her and stopped all of this and said EPA is not going to look at these. It is immoral. It is wrong.

It is only recently that this morato-rium was allowed to lapse and the cur-rent Administrator—it is Leavitt, I think—started to accept these studies. So it is very recent.

Remember, we had two EPA Admin-istrators who had said no to this. Now, suddenly we are back in the game of utilizing these studies and sending a signal out to the scientific world: Go ahead and do these dosing studies.

Mr. DURBIN. If the Senator will fur-

ther yield for a question? Mrs. BOXER. Yes. Mr. DURBIN. We have people sta-

tioned at the borders between the

United States and Mexico who are test-

ing fruits and vegetables that come

into our country. The Food and Drug

Administration does this. The U.S. De-

partment of Agriculture is involved in

this testing to determine whether

there is pesticide residue on apples and

tomatoes, vegetables and fruits that

come in. And if there is just the slight-

est residue of certain pesticides, we

confiscate the shipment, stop the ship-

ment from coming into the United

States for fear that just the slightest

residue of the pesticide or the fruits

and vegetables may be a danger to pub-

lic health in America. That is why it is so difficult for many

of us who listen to this debate to un-

derstand that at the same time another

agency of our Government, with the

cooperation of a special interest group,

the pesticide industry, is actually test-

ing concentrations of these same pes-

ticides on innocent people in America. I think the Senator has gone on to

say it is not just college students

standing and being paid $15. The test-

ing reaches a level where they are test-

ing on fetuses and on neonates of un-

certain viability? Mrs. BOXER. Yes. Let me take back

my time because the Senator from New

York is on schedule. I want to make

sure she has time to speak. But let me

tell you this. The EPA’s own words are

that, in fact, they will consider testing

on these neonates and the rest. Yes. This is immoral. I would like to

tell you, the U.S. Conference of Catho-

lic Bishops, on their Web site, in 2005,

say this:

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CONGRESSIONAL RECORD — SENATES7556 June 29, 2005 We are very concerned about using humans

for the direct testing of pesticides under any

conditions, particularly when they will not

receive any direct or immediate health ben-

efit but in fact may be harmed.

So we are not here testing pharma-

ceutical products that may help a

baby. We are here looking at harming a

baby, harming a pregnant woman. So the Boxer moratorium vote is

very important. Mr. President, how much time do I

have remaining? The PRESIDING OFFICER (Mr.

GRAHAM). The Senator has 18 minutes. Mrs. BOXER. I will yield 8 minutes

to my colleague from New York, with

an additional 2 minutes should she re-

quire it. Mrs. CLINTON. Mr. President, I rise

in strong, overwhelming support for

the Boxer amendment. I agree with my

friend and colleague from California

that there should not be a single vote

against this amendment. As was done

in the House, this amendment should

pass unanimously, and I hope at the

end of this debate, led by the able Sen-

ator from California, that will be the

conclusion of all of our colleagues, on

both sides of the aisle. This debate is not about whether pes-

ticides can be useful. Pesticide use has

improved crop yields, has helped to

control insect and other pests. We can

all agree on that. I am sympathetic to the farmers that

raised with me the concern they have

about how our current system works

for testing pesticides. The fact is, we

ask our domestic farmers to comply

with detailed pesticide requirements.

We have no similar controls on over-

seas farmers. That is not fair. It does

not keep our food as safe as it should

be. That should be addressed at a later

time. Let’s put that aside. What we are

talking about is pesticide testing. Pes-

ticides are inherently toxic. They have

been linked to a broad range of human

health problems, including cancer,

damage to the central nervous system,

interference with neural development,

and the endocrine system. Children are

particularly vulnerable to the toxic ef-

fects of pesticides. This debate is about ensuring we pro-

tect our children and ourselves from

the adverse effects of pesticides that

could be administered through these

testing programs. We need to ensure

that any studies that Congress sanc-

tions are conducted in a safe and eth-

ical manner.

The reason we are debating this, as

amazing as it is to many who might be

watching, the administration is taking

actions that undermine the protection

we should be able to count on against

misuse of pesticides and pursuing a

path that leads to using testing regi-

mens which are ill thought out, poorly

conceived, and immoral.

At the urging of the pesticide indus-

try, the EPA has reversed a morato-

rium on the consideration of studies in

which humans are intentionally dosed

with pesticides. In addition, the admin-

istration will soon propose a regulation

that will greatly expand the funding

and use of such studies. This amendment, which I am proud

to cosponsor, simply says we need to

stop and take a much closer look at

this issue before we continue down this

dangerous path. At the present time,

the EPA is reviewing more than 20

human pesticide studies. Many of them

violate widely accepted ethical stand-

ards for research involving human sub-

jects. Specifically, there were instances

where those who conducted the studies

failed to obtain informed consent, in-

flicted harm on the human subjects,

dismissed adverse outcomes or failed to

conduct long-term monitoring. That is not just my opinion. That is

the conclusion of the National Acad-

emy of Sciences, in a report issued in

2004, which found that the EPA pes-

ticide studies were in gross violation of

ethical standards set out in the Nurem-

berg Code, the Declaration of Helsinki,

and the common rule that guides med-

ical research in our country. In addition, the NAS concluded that

pesticide manufacturers have sub-

mitted to EPA intentional oral dosing

studies involving humans in order to

justify the reduction or elimination of

safety factors for the regulation of cer-

tain pesticides in food residues. To begin with, it is clear the EPA

should not be using these flawed stud-

ies in any way. That is one part of

what our amendment would do: Pro-

hibit the EPA from using or relying on

third-party human pesticide studies.

The amendment would also prohibit

the EPA from funding such studies. The reason it is so important is in

plain view in yesterday’s news report.

According to them, the EPA is on the

verge of issuing draft regulations that

open the floodgate for new EPA, Gov-

ernment-sponsored studies involving

human pesticide testing. These draft

regulations are in direct contradiction

to the key recommendations made by

the National Academy of Sciences. For

example, as my colleague from Cali-

fornia has pointed out, the draft rule

reportedly legitimizes pesticide testing

on children, pregnant women, and

newborns. It ignores recommendations

for the establishment of an inde-

pendent ethics review board to evalu-

ate proposed studies on a case-by-case

basis. I don’t see how any Member cannot

be concerned about this regulation. We

are going to be monitoring it very

closely. It is clear that in addition to

preventing the EPA from looking at

human studies, we need to prohibit the

EPA from conducting and sanctioning

human studies. I point out that this issue goes much

further than even what we are dis-

cussing in the Senate. It has broad im-

plications for how we protect our chil-

dren. Pesticide manufacturers want to

push for human testing because it may

result in less stringent exposure stand-

ards. That concerns me. The Food

Quality Protection Act of 1996 tight-

ened the regulation of pesticide resi-

dues in food and specifically added

more stringent safety factors to ac-

count for the increased sensitivity of

infants and children. It also includes

safety factors that apply to animal

tests but not to human tests. The EPA is clearly headed in the

wrong direction. We should work dili-

gently to make sure we pass the Boxer

amendment. It is so important to take

a stand on this. We do not need another

study. We know the EPA has studied.

They have looked at the National

Academy of Sciences’ recommenda-

tions. It is clear we need to pass this

immediately to send a signal, joining

with the House which passed such a

prohibition, a moratorium by unani-

mous consent, that this cannot go for-

ward. I urge my colleagues to reject the

second-degree amendment, to pass the

Boxer amendment, and to take a stand

against this kind of reckless, immoral

testing and sanctioning of testing on

children, on infants, and on all human

subjects. I thank my colleague for yielding me

that time. The PRESIDING OFFICER. The Sen-

ator from California. Mrs. BOXER. Mr. President, before

the Senator leaves, I thank the Sen-

ator from New York who has always

been such a credible voice for our chil-

dren and our families and for their

health and well-being. As she said, this should be what the

younger generations calls a ‘‘no

brainer.’’ We need a timeout. We do not

need to have the Burns amendment

passed, which will speed up the EPA

regulation which allows the testing of

pesticides on newborn babies who are

ill. It specifically says ‘‘ill newborn ba-

bies or near-death newborn babies.’’ If

we stand for something, we should

stand with all the religious organiza-

tions in this country that support the

Boxer amendment and oppose the

Burns amendment. I ask unanimous consent to be able

to reserve the balance of my time until

the conclusion of Senator BURNS’s re-

marks and that the quorum call not be

counted against my side. If I could explain to the Senator from

Alaska, I only have about 5 minutes re-

maining, and I want to retain that

time for when Senator BURNS con-

cludes. He knows this. I don’t think he

has a problem with it. The PRESIDING OFFICER. Without

objection, it is so ordered. Mrs. BOXER. I yield the floor, retain

my remaining 9 minutes, and wait for

the conclusion of the debate. Mr. BURNS. Mr. President, we better

open up this morning and characterize

what the Burns-Chambliss-Inhofe

amendment does compared to what is

being advocated by my friend from

California. Our amendment directs the adminis-

trator of EPA to conduct a thorough

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CONGRESSIONAL RECORD — SENATE S7557 June 29, 2005 review of all third-party intentional

human dosage studies based on six

principles listed at the National Acad-

emy of Sciences in their February 2004

report. The National Academy report

found that, in certain cases, the soci-

etal benefits of such studies outweigh

the risks. This amendment also directs the ad-

ministrator to issue a final rule that

addresses applying ethical standards to

third-party studies involving inten-

tional human dosing to identify or

quantify toxic effects within 180 days

of enactment of this act. In other

words, they have an open end now

where they drag their feet as far as of-

fering reports to Congress. By the way, I ask unanimous consent

Senator BROWNBACK of Kansas be added

as a cosponsor. The PRESIDING OFFICER. Without

objection, it is so ordered. Mr. BURNS. Mr. President, we know

we can use very emotional examples to

draw our attention to this issue. My

first thought, I don’t think there is a

chemical engineer or a scientist in this

Senate. I can’t say that for sure, with-

out having a degree in chemical engi-

neering. Nonetheless, we have to rely

on reports. We also have to rely on re-

ports that are peer reviewed from

many different sources. What the Senator from California has

brought to the Senate this morning has

a few flaws. First of all, they are

quoting from a staff draft of a study,

and we do not know what the outcome

will be. We do not know what the final

rule will look like. The administrator

has not even seen it, let alone made

any recommendations to be agreed to.

That is No. 1. Basically, the Senator’s amendment

prohibits the EPA from conducting or

accepting research involving inten-

tional dosing of human subjects. She

referred to the CHEERS study. What is

the CHEERS study? In the CHEERS

study, the agency proposed to monitor

children’s exposure to pesticide in a

specific population. That is what it is

was for. The proposed CHEERS study,

developed by the Office of Research and

Development at EPA, was an observa-

tional and biomonitoring study and not

a dosing study. As a result, her amend-

ment does not impact CHEERS or any

other similar type of study. I want that

in the RECORD. We should be very clear

about that. We are not chemists or chemical en-

gineers. We are not scientists. All of

the warnings and all of the charts we

have seen this morning are a result of

studies, be they EPA, through peer re-

view or third-party studies with peer

review. We would not know this infor-

mation had there not been studies,

third party or by the EPA. Her amend-

ment is very clear. It just says we stop

testing. So I ask my colleagues, on this issue:

How do we know? How can we find out?

Because we need this information. Do

we allow chemists or chemical engi-

neers to do this, with no backup, work-

ing for a private corporation in the

business of selling pesticides, fumi-

gants, herbicides, detergents, car wash-

es, carpets, the padding on our chairs?

Everything we touch or we live with

has a so-called chemical element to it.

Do we just take their word for it, those

who are in the business of selling these

products? Unless there are third-party

studies, with peer review and EPA

studies with the same standards of peer

review, that would be the case. This is not like the testing of pre-

scription drugs. Having no test on

chemicals, no information on chemi-

cals that we use in the production of

food and fiber and shelter in this coun-

try is not a very good idea. It is not a

good idea. As I said, would we know

about the warnings that were used

today had it not been for testing? Senator BOXER’s amendment is so far

reaching that between 60 and 70 chemi-

cals and 1,300 tolerances, or the allow-

able pesticide residue on foods, would

be affected. It would mean taking those

reports, putting them away, and never

referring to them again. That does not

make a lot of sense. Not only is there

the time, money, and effort involved,

but also some of the results we know of

today we would not have known this

morning in order to make this debate. For example, I have a letter from the

American Mosquito Control Associa-

tion, which opposes this amendment of-

fered by my good friend from Cali-

fornia. By the way, they support our

amendment. I am going to offer this

letter in its entirety for the RECORD,

but I want to read one little paragraph

that I think speaks to the essence of

this debate. I quote:

The emergence and spread of West Nile

Virus in the United States has re-emphasized

the need for safe and effective mosquito con-

trol strategies that reduce the risk of acquir-

ing this devastating disease. Personal pro-

tective measures such as repellents figure

prominently in these strategies—as do feder-

ally-registered public health pesticides,

when indicated. This amendment, as written,

will effectively cease future research on al-

ternatives to DEET and curtail sound, eth-

ical studies on the toxicology of public

health pesticides. The AMCA considers the

availability of scientifically sound and ethi-

cally-obtained toxicology data to be essen-

tial in determining levels of risk from both

disease and the means used to control it.

Mr. President, I ask unanimous con-

sent that the entire letter be printed in

the RECORD. There being no objection, the mate-

rial was ordered to be printed in the

RECORD, as follows:

AMERICAN MOSQUITO

CONTROL ASSOCIATION,

North Brunswick, NJ, June 24, 2005. DEAR SENATOR: I am writing on behalf of

the membership of the American Mosquito

Control Association (AMCA) to express our

deep concern over the amendment Senator

Barbara Boxer (D–CA) recently introduced to

the Department of the Interior, Environ-

ment, and Related Agencies Appropriations

Act, 2006. As currently written, the amend-

ment would prohibit research studies having

a profound effect on establishing safety and

toxicity profiles for a number of public

health insect repellents, which are listed as

pesticides, In addition, it would preclude the

use of sound, ethically-derived data in the

registration of several pesticides utilized in

protecting public health. These studies are

critical in evaluating exposure levels and

risk assessment. Without them, extrapo-

lations of risk could be unreliable, placing

the public at undue risk. The sole testing procedure currently ac-

cepted by the U.S. EPA (See: Product Per-

formance Test Guidelines OPPTS § 810.3700.

Insect Repellents for Human Skin and Out-

door Premises, Public Draft. United States

Environmental Protection Agency. EPA 712–

C–99–369, December 1999 requires repellents

be applied to humans to demonstrate effi-

cacy. Furthermore, the National Academy of

Sciences (NAS), in a report entitled, Inten-

tional Human Dosing Studies for EPA Regu-

latory Purposes: Scientific and Ethical

Issues published in February 2004 stated that

such studies ‘‘contribute significant and use-

ful knowledge for regulatory standard set-

ting and other forms of public protection,’’

Indeed, the NAS stated, ‘‘[i]n some cases, in-

tentional dosing of humans may be the only

way to obtain data needed to set regulatory

standards and protect public health’’. The emergence and spread of West Nile

Virus in the United States has re-emphasized

the need for safe and effective mosquito con-

trol strategies that reduce the risk of acquir-

ing this devastating disease. Personal pro-

tective measures such as repellents figure

prominently in these strategies—as do feder-

ally-registered public health pesticides,

when indicated. This amendment, as written,

will effectively cease future research on al-

ternatives to DEET and curtail sound, eth-

ical studies on the toxicology of public

health pesticides. The AMCA considers the

availability of scientifically sound and ethi-

cally-obtained toxicology data to be essen-

tial in determining levels of risk from both

disease and the means used to control it. Furthermore, members of the United

States Armed Forces rely extensively upon

repellents and public health pesticides to re-

duce risk to the various exotic vector-borne

diseases to which they are regularly exposed.

Development of new repellents is urgently

needed to obviate the need for broadcast pes-

ticides to provide protection both here and

abroad. To the extent that repellent use is

curtailed because of acceptability issues,

pesticide applications will have to be in-

creased to afford the same level of protec-

tion. Any reduction of human/mosquito contact

commensurately reduces the risk of disease

transmission. Newer, more acceptable and

effective mosquito repellents would both

protect humans while reducing environ-

mental pesticide load. Research on these

critical control adjuncts requires human

subjects in order to assess their efficacy and

safety. Establishment of safety exposure pa-

rameters to these and other chemicals that

might contact human skin during their ap-

proved application can only be reliably ob-

tained through research fully vetted through

rigorous institutional review boards specifi-

cally organized for those purposes. These are

already in place and are fully compliant with

current laws and regulations. Protection of the health of the American

public and the environment is a core value of

the AMCA. The provisions of this amend-

ment in a very real way conflict with this

important value. Indeed, the amendment

neither promotes public health and safety

nor provides greater protection for your con-

stituents in any foreseeable tangible man-

ner. Therefore, the American Mosquito Con-

trol Association strongly urges you to op-

pose the Boxer Amendment when the Senate

considers the FY06 Interior Appropriations

bill in the near future. Thank you for your

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CONGRESSIONAL RECORD — SENATES7558 June 29, 2005 consideration and attention to this critical

matter.

Sincerely,

JOSEPH M. CONLON,

Technical Advisor, American Mosquito

Control Association.

Mr. BURNS. Studies of this kind on safety must move forward or we will have a public health situation being created by the unintended consequence of not performing those studies.

Now, if I have not convinced you to vote with me yet, I also have an exten-sive list of pesticides that rely on human studies to determine safe expo-sure levels for more than 50 crops grown in our States. In fact, these pes-ticides, cited by Senator BOXER’s and Representative WAXMAN’s June 25 study, have critical uses in 39 States. A few of these States include: Arkansas,

California, Florida, Georgia, Kansas,

Louisiana, Maine, Nebraska, Ohio, and

West Virginia. I say to the Presiding

Officer, I am sorry, they did not men-

tion South Carolina. But these pes-

ticides, for every State listed, are used

in the production of food and fiber for

this country. Now, I realize there are a lot of folks

who do not really understand agri-

culture maybe that much, but you

have to understand the second thing we

do in this country every day—after we

get up—is eat. For the first thing we

do, we have a lot of options. But the

second thing we do is eat. The largest industry probably con-

tributing to the GDP of California is

agriculture. If it is not the largest in-

dustry, I would be surprised. Think

about your brussel sprouts, straw-

berries, apples, dry beans. Look at all

your almond production, beats, pep-

pers, celery, cauliflower, pistachios.

The list goes on and on of these chemi-

cals, these pesticides, these fumigants,

these herbicides, all used in the produc-

tion of food and fiber for this country.

It is pretty amazing. Senator CHAMBLISS and I are offering

a reasonable alternative from the

amendment offered by the Senator

from California. Our amendment is

plum simple. It directs the Adminis-

trator of the EPA to ‘‘conduct a thor-

ough review of all third-party inten-

tional’’—‘‘intentional’’—‘‘human dos-

ing studies’’ based on the National

Academy of Sciences February 2004 re-

port. I think it is found in this book of-

fered as a guideline. I will give you the

headings: ‘‘The Four-Step Process of

Human Health Risk Assessment.’’ Step

one: ‘‘Hazard Identification,’’ ‘‘Dose

Response Assessment,’’ ‘‘Exposure As-

sessment,’’ and ‘‘Risk Characteriza-

tion.’’ That is the guideline. Pretty

simple—a little book. Anyone can

order it. Send me your check and $5 for

handling for mail, and I will get it out

to you. But that is what it says. We are directing the EPA to ‘‘issue a

final rule that addresses applying eth-

ical standards to third-party studies

involving intentional human dosing’’

‘‘within 180 days of the enactment of

this Act.’’

We are putting them on a time line. We want to know. The public has a right to know. Everyone involved wants to know. People who work on al-lergies, many things that are normal in our everyday lives, want to know: Quit dragging your feet. Let’s have it. Let’s get the report because we think it is pretty important.

There are ethical standards estab-lished. They are already in place. Let’s get the final rule. That is what we are telling this Director. That is what we are telling this agency—that we want to know—because as policymakers, we do not want to get caught in this idea of an unintentional consequence.

None of these warnings that we have on the label of our shirt or on our de-tergent when we wash our dishes at night—none of those warnings would be there had there not been extensive work in risk assessment and public health at heart if those tests had not been carried out.

Since that standard is set, what we are saying now is not to proceed just blindly down a path using no guide-lines, but to write the rule that allows policymakers to move forward with adopting the public’s attitude toward this issue.

And we can make a mistake. We usu-ally base all our decisions on history. As to the history of this, we study this without going blindly off a cliff. We usually use history. If we monkey with it, if we take part of it out, and that is not available to us either, or to the EPA, or anybody else who is making a decision as to the reliability or the safety of that particular product, then we have done an injustice to the people who make the decisions. That seems pretty logical to this nonscientist, non-chemist from the State of Montana.

Let’s take the emotion out of it, and let’s look at things as they really are in the world around us. We do not touch anything, folks—we do not leave the garage, we do not even get up in the morning, we do not do anything in this environment around us where there are no chemicals. Some of them are even added by man. But we live in that kind of a world, with our relation-ship even with the Sun, the soil, and the water. We live in a chemically re-active world. The more we know about it, the more we know about our own environment and those steps we have to take in order to protect it.

So what I and my colleagues are pro-posing in this Burns amendment is that we proceed with standards and di-rect the EPA to make their rule final and publish it in the Federal record for all to see—and all to either uphold or criticize. That is all we are doing. It is pretty straightforward. But we cannot just say: Stop, stop the clock. We can-not do that. That is not fair to the American people. It is not fair to the American consumer, and it is not fair to the folks who are involved in pro-ducing food, fiber, and shelter for this country.

If you want more of your food to come from offshore, where there are no

tests, there is no way to regulate, then you just stop the process because that is where it will be coming from, even with our tremendous ability to produce for a society that we think is probably the healthiest in the world.

I reserve the remainder of my time. I yield the floor. Mr. OBAMA. Mr. President, I rise

today to speak in favor of the amend-ment offered by Senator BOXER regard-ing the testing of pesticides on hu-mans. I am pleased to be a cosponsor of this amendment.

Unbeknownst to most of us, the Bush administration has quietly rescinded a ban on the human testing of pesticides even though the EPA is still developing guidelines for such testing. Instead of needlessly exposing people to dan-gerous pesticides, the 1-year morato-rium proposed in this amendment is a reasonable solution until these guide-lines are completed.

Let us be clear. We are not talking about the testing of life-saving medica-tions. By definition, pesticides are de-signed to kill. They are potential car-cinogens and neurotoxins. We need guidelines to ensure that human test-ing of these dangerous chemicals is limited and monitored and that the subjects fully understand the risks they are taking.

Who are the people being exposed to these chemicals? Typically they are young, poor and minorities. Let me give you two examples:

In Florida, an EPA study offered low- income families $970 over 2 years if they let their babies be tested after their homes were sprayed with pes-ticides. One can easily imagine a young mother trying to make ends meet, try-ing to pay the rent and put food on the table, reading that she can collect al-most $1,000 if she allows her child to be tested.

In another study last year, 127 young adults, mostly Asian and Latino col-lege students, agreed to be exposed to a suspected neurotoxicant for $15 an hour. Some were exposed in a chamber for 1 hour for 4 consecutive days, while others had the chemical shot into their eyes and nostrils at amounts 12 times the OSHA recommended levels. This chemical, chloropicrin, has a history: It was used as a chemical warfare

agent in World War I. Yet the consent

form for the 2004 study did not disclose

that fact; it simply said, ‘‘We expect

the discomfort to be short-lived.’’ All across America, there are college

students working long hours so they

can stay in school and get a shot at the

American dream. How tempting it

must be to pick up a handful of cash

for letting a scientist expose you to

some chemical. You are healthy, you

need the cash, and you are probably

not as wise as your parents would like

you to be, so you borrow a chance

against your future health and sign up

for exposure. That is not the kind of

government policy we want to be en-

couraging. All told, the EPA is considering data

from 24 studies that tested pesticides

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CONGRESSIONAL RECORD — SENATE S7559 June 29, 2005 on humans. Many of these studies are

flawed, so the risks these people under-

took did not even contribute to a sci-

entifically valid experiment. Many of

these studies failed to take the health

complaints of the subjects seriously,

many failed to disclose the risk to the

subjects, and many failed to conduct

long-term monitoring of the health ef-

fects of the pesticides. All of these defi-

ciencies should be addressed and pre-

vented from occurring again. Sadly, we do not need to do this

human testing. For years, the EPA has

worked with pesticide manufacturers

and members of the science community

without relying on human testing. For

years, the agency has accomplished its

goals through animal testing. No one doubts that actual human

health data, if properly collected from

a sufficient sample size, would be ad-

vantageous to know. But sensible

guidelines are needed to ensure that

the benefits of any study far outweigh

the potential risks to the study partici-

pants. The commonsense approach is to

temporarily stop this testing, wait for

EPA to issue its guidelines, and safe-

guard the health of the human sub-

jects. I thank the Senator from California

for her commitment to this issue, and

I yield the floor. I reserve the balance of my time and

yield the floor. The PRESIDING OFFICER. Who

yields time? The Senator from Cali-

fornia. Mrs. BOXER. Mr. President, I yield

myself 7 minutes and retain 2 minutes,

if I may. The PRESIDING OFFICER. The Sen-

ator is recognized for 7 minutes. Mrs. BOXER. The Senator from Mon-

tana has, as he usually does, made a

very good presentation for his side. The

only problem is he made a very bad

presentation about the amendment I

had written. In criticizing it, he is

criticizing the Republican-run House of

Representatives which passed this

same amendment without dissent, in-

cluding the one and only Congressman

I know of who was an exterminator,

Tom DeLay. So for all the eloquence

about pesticides, the one person who

was involved in the pesticide over there

did not object. And with all due respect to my col-

league, I don’t have to be lectured

about agriculture. I have been elected

three times from my State. Agri-

culture is an enormous source of pride

to our State. I visited thousands of

acres of farmland. I want the Senator

from Montana to understand some-

thing about my State and my farmers.

Not one of them called and said: Oh,

Senator BOXER, we want to dose babies

and infants and pregnant women and

fetuses with pesticides. Not one. So

let’s set the record straight. Maybe he

heard from some of his farmers. Not

one called me. Why? Because this is all scare tac-

tics. They know we are testing pes-

ticides on animals. They know we are using computer modeling. They know that research moves forward. I am one of the biggest proponents of developing new pesticides.

Then he uses the scare tactics. My God, if we have this moratorium— which, by the way, was put in place by Republican and Democratic adminis-trations in the past—we won’t be able to fight West Nile virus. Baloney. We are already using DEET. We know what to do. There are continuing stud-ies and modeling going on. So let’s get rid of the scare tactics.

I am offering a bipartisan amend-ment today that is the exact amend-ment that passed the House without a dissenting vote. The only people who don’t like it are the pesticide makers. We have a chance to take a stand for the health of our kids or with the pes-ticide makers. That is just clear. We have a chance to take a stand with every major religious organization in this country. I have the list of those. The National Council of Churches, Jew-ish organizations, evangelical Lutherans, the Catholic bishops, all weighed in. My amendment is a faith- based amendment.

Then my colleague says: Let’s not get emotional. Are we supposed to walk in here and lose all of our feel-ings? Are we not supposed to have emo-tion if we lose, for example, a con-stituent in the Iraqi war? If we visit Walter Reed Hospital, as many of us have done, are we supposed to check our emotions at the door when we are elected to the Senate? Let me tell you how I feel when I read about the kind of testing they are going to do which my colleague is endorsing with his amendment because he is saying the EPA should hurry up and bring out their regulation. By the way, he is wrong when he tells you it is a draft. It is a final draft, and we have the proof that this regulation was about to go for comment next week. So let’s set the record straight.

Here is what my colleague supports. He supports an EPA regulation that says there will be a limited number of scientific studies involving pregnant women, fetuses, newborn babies of un-certain viability or nonviable newborns. Imagine, dosing a fetus with pesticides. Dosing a newborn baby. You want me to check my emotions at the door? Sorry. I will not be here and allow a rule to go into effect without doing everything in my power to stop it that is going to dose a dying new-born baby with pesticides because some poor mother is convinced to take $1,000 for it. This is just wrong. Why do you think we have all of these churches op-posing the Burns amendment and sup-porting our amendment: We are ap-palled by the effort to go forward with yet another report—that is the Burns amendment—that does nothing to guarantee the well-being of the chil-dren and other vulnerable groups who are being subjected to pesticides by the chemical industry. We need a morato-rium.

This moratorium was voted for with-out a dissenting vote in the House. Now my colleague calls for a thorough re-view based on the National Academy of Sciences standard.

There is not one mention of the Na-tional Academy of Sciences in his en-tire amendment. Not only is there not one mention there, there is not one mention of the Helsinki Accords. There is not one mention of any protocol that has ever been recognized nationally or internationally in his amendment. It is a general amendment. It is exactly what the EPA wants because they have told us, they don’t want to be hemmed in. They don’t want to have their op-tions limited. They want to be able to dose or accept studies that dose people with chemicals whenever they want to and whoever these people are.

Here is what the EPA says they want: The promulgation of rules pre-

scribing such details would unneces-

sarily confine EPA’s discretion. Won-

derful. My opponent is giving them

that discretion by not referring to any

acceptable scientific guidelines. Then my opponent defends the

CHEERS program. I have never heard

anyone defend the CHEERS program.

The CHEERS program was going to be

done on these babies. Pay their parents

in poor areas, give them a cam camera,

tell them to continue dosing their

homes with pesticides and study the re-

action of the children, when we already

know it is dangerous for kids to be ex-

posed to pesticides. My esteemed

friend—and he is my friend—actually

gets up and defends this program which

no one else in America has done. But it

speaks to the purpose of his amend-

ment which is to move forward with a

rule that would allow all of this. My opponent says I am stopping all

testing. False. The testing will con-

tinue—animal testing, computer mod-

eling. Do you know what Stephen

Johnson of the EPA has said about

human testing? I think it is important

that Members know. He certainly

doesn’t agree with Senator BURNS be-

cause this is his quote:

We believe that we have a more than suffi-

cient database, through use of animal stud-

ies, to make licensing decisions that meet

the standard—to protect the health of the

public—without using human studies.

So my friend is contradicting Ste-

phen Johnson, head of the EPA. The PRESIDING OFFICER. The Sen-

ator has used 7 minutes. Mrs. BOXER. I yield myself 1 more

minute. The PRESIDING OFFICER. The Sen-

ator is recognized. Mrs. BOXER. The fact is the attack

Senator BURNS has made on my amend-

ment is false in every way. It is the

same amendment as his Republican

friends supported over in the House

without a dissenting voice. It is the

same policy that was put in place by

Republicans and Democrats. And then

my friend says: Wouldn’t it be a waste

to throw away studies, even if they did

intentionally dose human beings? Ron-

ald Reagan was faced with that same

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CONGRESSIONAL RECORD — SENATES7560 June 29, 2005 issue. His head of the EPA said there

are certain times when you don’t ac-

cept studies because there is moral

right and there is moral wrong. That is

why the Boxer amendment—supported

by Senators SNOWE and COLLINS, Sen-

ators CLINTON and OBAMA and NELSON

and others—is so important. I ask unanimous consent to add Sen-

ator CORZINE as a cosponsor of my

amendment. The PRESIDING OFFICER. Without

objection, it is so ordered. Mrs. BOXER. To quote President

Reagan’s EPA, they said they would

not accept human dosing type of ex-

periments from World War II because

they were ‘‘morally repugnant.’’ I reserve the remainder of my time. The PRESIDING OFFICER. Who

seeks time? The Senator from Mon-

tana. Mr. BURNS. Mr. President, my

amendment, to answer the National

Academy of Sciences point, the six

quantifying objectives, as mentioned,

come from the book ‘‘Intentional

Human Dosage Studies for the EPA,

Respiratory Purposes, Scientific, and

Ethical Issues.’’ They were taken from

that book. The National Academy is

found in the amendment. Again, we can characterize it any

way we would like. I would just say

that we still base our decisions on his-

tory. This amendment is paramount.

And I understand, nobody likes the

idea of human dosing. If we could get

around it, if there was any sure way we

could get around it, we would. I don’t

like it either. But nonetheless, as we

talk about this, we are holding up test-

ing on the world around us. We cannot

afford to lose any time or information.

We owe that to the American people, to

the consumer. We also owe it to the

people who produce food and fiber. How much time is remaining on the

other side? The PRESIDING OFFICER. The Sen-

ator from California has 52 seconds re-

maining. Mr. BURNS. Mr. President, we have a

vote coming up, and we probably can

get to that in the next 5 or 10 minutes,

if that is OK with the Senator from

California. Mrs. BOXER. Absolutely. Mr. BURNS. If you want to close, I

will make a short statement. Then we

will go to the vote. Mrs. BOXER. Sure. Mr. BURNS. I yield the floor. The PRESIDING OFFICER. The Sen-

ator from California. Mrs. BOXER. Mr. President, this de-

bate is a tough debate because when it

comes to protecting the people of our

country, there are going to be feelings

on either side. This is what it is about.

The quote of James Childress of the

National Academy of Sciences, chair-

man of the panel, who said: A lot of us

were troubled by the dosing studies.

And personally my view is that the

House amendment—that is what my

amendment is—was within the range of

ethically justifiable responses.

The fact is, there is no mention di-

rectly of the National Academy of

Sciences in my colleague’s amendment.

My colleague’s amendment is just a

‘‘cover yourself’’ amendment. I call it a

‘‘CY’’ amendment. People can think they are doing

something, but here is what I need to

tell my colleagues: If they vote for the

Burns amendment, they are taking us

back. They are telling the EPA to

hurry up with their regulations, regu-

lations that we know will test preg-

nant women and babies. Every major

religious organization views this as a

faith-based debate, and the Boxer

amendment is on the right side of that

debate. I hope Members will vote for

the Boxer amendment. I yield the floor. The PRESIDING OFFICER. The Sen-

ator from Montana. Mr. BURNS. Mr. President, I will

recap. Our approach is a commonsense

approach. It just makes sense and logic

that the information we need is only

found in the work that we do on the

safety of pesticides, fungicides, herbi-

cides, all of that. It becomes very im-

portant to the agricultural producers,

but also it is more important to the

safety of our consuming public. It has been a good debate. I yield the

remainder of my time. The PRESIDING OFFICER. The Sen-

ator from California. Mrs. BOXER. Is my friend going to

ask for the yeas and nays on both his

and my amendment, his first and then

mine second? Mr. BURNS. That is correct. The PRESIDING OFFICER. The yeas

and nays have not been ordered. Mrs. BOXER. I ask for the yeas and

nays on the Burns amendment and the

Boxer amendment. The PRESIDING OFFICER. Without

objection, the yeas and nays may be re-

quested on both amendments. Is there a sufficient second? There is a sufficient second. The yeas and nays were ordered. Mr. BURNS. Mr. President, I ask

unanimous consent that there be 2

minutes of debate equally divided prior

to the vote in relation to the Boxer

amendment. Mr. BURNS. The Senator has 1

minute prior to the vote on her amend-

ment. Mrs. BOXER. That is very good. Mr. BURNS. I ask unanimous consent

for that. The PRESIDING OFFICER (Mr.

ISAKSON). Without objection, it is so or-

dered. Mr. BURNS. I thank the Chair. The PRESIDING OFFICER. The

question is on agreeing to the amend-

ment of the Senator from Montana.

The yeas and nays have been ordered. The clerk will call the roll. The assistant legislative clerk called

the roll. Mr. MCCONNELL. The following Sen-

ators were necessarily absent: the Sen-

ator from Utah (Mr. BENNETT) and the

Senator from Indiana (Mr. LUGAR).

Mr. DURBIN. I announce that the

Senator from Connecticut (Mr.

LIEBERMAN) is absent due to death in

family. The PRESIDING OFFICER. Are there

any other Senators in the Chamber de-

siring to vote? The result was announced—yeas 57,

nays 40, as follows:

[Rollcall Vote No. 161 Leg.]

YEAS—57

Alexander

Allard

Allen

Baucus

Bond

Brownback

Bunning

Burns

Burr

Byrd

Chambliss

Coburn

Cochran

Coleman

Conrad

Cornyn

Craig

Crapo

DeMint

DeWine

Dole

Domenici

Dorgan

Ensign

Enzi

Frist

Graham

Grassley

Gregg

Hagel

Hatch

Hutchison

Inhofe

Isakson

Kyl

Landrieu

Lincoln

Lott

Martinez

McCain

McConnell

Murkowski

Nelson (NE)

Pryor

Roberts

Santorum

Sessions

Shelby

Smith

Stevens

Sununu

Talent

Thomas

Thune

Vitter

Voinovich

Warner

NAYS—40

Akaka

Bayh

Biden

Bingaman

Boxer

Cantwell

Carper

Chafee

Clinton

Collins

Corzine

Dayton

Dodd

Durbin

Feingold

Feinstein

Harkin

Inouye

Jeffords

Johnson

Kennedy

Kerry

Kohl

Lautenberg

Leahy

Levin

Mikulski

Murray

Nelson (FL)

Obama

Reed

Reid

Rockefeller

Salazar

Sarbanes

Schumer

Snowe

Specter

Stabenow

Wyden

NOT VOTING—3

Bennett Lieberman Lugar

The amendment (No. 1068) was agreed

to. Mr. BURNS. Mr. President, I move to

reconsider the vote, and move to lay

that motion on the table. The motion to lay on the table was

agreed to.

AMENDMENT NO. 1023

The PRESIDING OFFICER. There

are now 2 minutes of debate equally di-

vided on the Boxer amendment. Mr. BURNS. I yield to the Senator

from California on her amendment.

She has 1 minute. The PRESIDING OFFICER. The Sen-

ator from California. Mrs. BOXER. Mr. President, if I

could have Members’ attention just for

one moment, I hope they will vote for

this. The EPA is about to utilize stud-

ies that will actually intentionally

dose babies with pesticides, pregnant

women with pesticides, newborns with

pesticides, newborns of uncertain via-

bility, meaning they might die, non-

viable newborns. We are talking about

a policy that has won the condemna-

tion of every religious organization in

this country who backed the Boxer

amendment. The Boxer amendment passed with-

out a single dissenting vote in the

House. If Members voted for Burns

they can vote for Boxer. All we are say-

ing is we need a timeout to look at this

immoral policy. That is why we have

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CONGRESSIONAL RECORD — SENATE S7561 June 29, 2005 the Catholic bishops telling us that the

intentional dosing of kids is immoral

and they are very concerned about it.

That is why we have the support of the

National Council of Churches. If my

colleagues ever wanted to vote for a

faith-based amendment, this is the

amendment. Stand on the side of the

innocent, vulnerable kids and vote for

the Boxer amendment. I yield the floor. The PRESIDING OFFICER. The Sen-

ator from Montana. Mr. BURNS. Mr. President, it just

makes sense that we do not suspend

testing at all, as this amendment

would do. It is bad logic to throw aside

almost over 20 reports that give us the

history and the institutional knowl-

edge to complete the work for the safe-

ty of the consumer and also the people

who produce food, fiber, and shelter in

this country. I urge a ‘‘no’’ vote on this

amendment. I yield the floor. The PRESIDING OFFICER. The

question is on agreeing to amendment

No. 1023. The yeas and nays have been

ordered. The clerk will call the roll. The legislative clerk called the roll. Mr. MCCONNELL. The following Sen-

ators were necessarily absent: the Sen-

ator from Utah (Mr. BENNETT), and the

Senator from Indiana (Mr. LUGAR). Mr. DURBIN. I announce that the

Senator from Connecticut (Mr.

LIEBERMAN) is absent due to death in

family. The PRESIDING OFFICER (Mr.

BURR). Are there any other Senators in

the Chamber desiring to vote? The result was announced—yeas 60,

nays 37, as follows:

[Rollcall Vote No. 162 Leg.]

YEAS—60

Akaka

Baucus

Bayh

Biden

Bingaman

Boxer

Byrd

Cantwell

Carper

Chafee

Clinton

Coburn

Collins

Conrad

Corzine

Dayton

DeWine

Dodd

Dorgan

Durbin

Ensign

Feingold

Feinstein

Graham

Harkin

Hutchison

Inouye

Isakson

Jeffords

Johnson

Kennedy

Kerry

Kohl

Landrieu

Lautenberg

Leahy

Levin

Lincoln

McCain

Mikulski

Murkowski

Murray

Nelson (FL)

Nelson (NE)

Obama

Pryor

Reed

Reid

Rockefeller

Salazar

Sarbanes

Schumer

Smith

Snowe

Specter

Stabenow

Talent

Thune

Warner

Wyden

NAYS—37

Alexander

Allard

Allen

Bond

Brownback

Bunning

Burns

Burr

Chambliss

Cochran

Coleman

Cornyn

Craig

Crapo

DeMint

Dole

Domenici

Enzi

Frist

Grassley

Gregg

Hagel

Hatch

Inhofe

Kyl

Lott

Martinez

McConnell

Roberts

Santorum

Sessions

Shelby

Stevens

Sununu

Thomas

Vitter

Voinovich

NOT VOTING—3

Bennett Lieberman Lugar

The amendment (No. 1023) was agreed

to.

Mr. DORGAN. I move to reconsider

the vote. Mr. BURNS. I move to lay that mo-

tion on the table. The motion to lay on the table was

agreed do.

AMENDMENT NO. 1025

Mr. BURNS. Mr. President, by pre-

vious order, we move to the Dorgan

amendment No. 1025. The PRESIDING OFFICER. The Sen-

ator is correct. Mr. DORGAN. Mr. President, I ask

for the regular order to consider

amendment numbered 1025. The PRESIDING OFFICER. The

amendment is pending. Mr. DORGAN. Mr. President, let me

describe the amendment. This amend-

ment is very simple. It does not require

an elaborate explanation. It provides

additional resources, desperately need-

ed resources to particularly the Indian

Health Service. We have had a lot of discussion in the

Senate in the last several years about

the Indian Health Service. We have a

responsibility for the health of Indians

under trust responsibilities to the Fed-

eral Government. The Federal Govern-

ment also has a responsibility for

health care for Federal prisoners. It is

interesting to note that the Federal

Government spends almost twice as

much per person for health care for

Federal prisoners as it does to meet its

trust responsibility per person for

American Indians. If you travel to Indian reservations

in this country, there is a bona fide cri-

sis in health care on reservations and

in other areas as well. Go to a reserva-

tion, and you will find a dentist prac-

ticing out of a trailer house, a small

trailer, for 5,000 people. That is the

dentistry. Go to a reservation and find

half a dozen kids have committed sui-

cide recently. You will discover there

is virtually no mental health treat-

ment available for those kids who end

up taking their lives. There is such a desperate need to sat-

isfy the obligation here for health care

for American Indians. We are so short

of funding, it is unbelievable. This

amendment adds $1 billion to funding

particularly for Indian Health Service

but also to the BIA to provide the

other services that are necessary on

the reservations. I have indicated we have a bona fide

crisis in health care, housing, and edu-

cation on Indian reservations. Let me

tell a story I have told previously

about a young girl named Tamara

Demaris. Tamara was a 3-year-old. I

read about Tamra in a newspaper. I

met with her and her granddad. She

was 3 years old and placed in foster

care by a person who was handling wel-

fare cases and so on. The woman who

was handling the case was handling 150

cases. So this was a case of a 3-year-old

child who was put in a foster care situ-

ation. But the person did not check out

the home to which she was assigning

the 3-year-old child. She was working

on 150 cases. So Tamara Demaris goes

to this home. There is in this home a

drunken brawl and party. The after-

math of that drunken brawl and party

was this 3-year-old girl named Tamara

had a broken nose, a broken arm, and

her hair pulled out at the roots. This is a 3-year-old child. That was

our responsibility. We did not provide

sufficient funds for available resources

to check the foster home in which they

would put this little kid. The result is

this little kid is scarred for life. I helped fix it on that particular res-

ervation so that will not happen now.

But why did it happen? They do not

have the resources. One person handles

150 cases? That is unbelievable. A child

gets injured, badly. It is going on all

across this country on Indian reserva-

tions. Again, I have told my colleagues

about a hearing I held in which a

young woman who had just assumed

the job on an Indian reservation—this

was for child welfare—said on the floor

of her office was a stack of folders with

allegations of child abuse, including

sexual abuse of children. She said they

have not even been investigated. Those

folders sit there without an investiga-

tion because they do not have the re-

sources. She broke down at the hearing and

began to sob, began to cry. She said: I

have to beg and borrow to try to get a

car to take a kid to a clinic or take a

kid to see a psychologist or get mental

health treatment. I don’t have a vehi-

cle, let alone the money to investigate

the cases in the files on the floor. I could go on at great length about

diabetes, about all of the issues faced

on these reservations. My late colleague, Mickey Leland,

with whom I traveled to many areas of

the world, was a great humanitarian.

He died when his plane crashed into a

mountain in Ethiopia. He was a Con-

gressman who worked with me and oth-

ers on hunger issues. Mickey Leland

came to the three affiliated tribes in

North Dakota to hold a hearing. This is what we discovered that day

in the testimony about diabetes. They

do not have double, triple or quadruple

the rate of diabetes of the rest of the

population; theirs was 10, 12 times the

rate of the rest of the population. It is

a devastating situation on Indian res-

ervations. It means people are losing

their legs, losing their good health, los-

ing their lives, sitting through dialysis

in a crowded room. We have so many challenges to meet,

and we are so far from meeting them

with the necessary resources. These are

the first Americans. I am talking about

American Indians. They are the ones

who greeted Christopher Columbus.

These books that say Columbus discov-

ered America—I am sorry, he was

greeted by the American Indians, the

first Americans. Yet we are not meet-

ing our trust responsibility. I suggest now is the time simply to

take the step and say, if we care about

health care, if we care about funding

for these needs on Indian reservations

VerDate Aug 04 2004 07:12 Jun 30, 2005 Jkt 039060 PO 00000 Frm 00019 Fmt 0624 Sfmt 0634 E:\CR\FM\G29JN6.031 S29PT1������

IN THE UNITED STATES COURT OF APPEALSFOR THE SECOND CIRCUIT

____________________________________NATURAL RESOURCES DEFENSE ) COUNCIL, ) Petitioner, ) v. ) Petition for Review ) UNITED STATES ENVIRONMENTAL ) No. ____________PROTECTION AGENCY, ) ) Respondent. ) ____________________________________)

PETITION FOR REVIEW

The Natural Resources Defense Council hereby petitions this Court for

review of the final order of the United States Environmental Protection Agency

titled Dichlorvos (DDVP); Order Denying NRDC’s Objections on Remand,

published at 77 Fed. Reg. 54,402 (Sept. 5, 2012). The challenged final order is

attached at Exhibit A.

Dated: September 17, 2012 Respectfully submitted,

/s/Nicholas MoralesNatural Resources Defense Council1152 15th Street, NW, Suite 300Washington, D.C. 20005nmorales@nrdc.org Phone: (202) 717-8234Fax: (202) 289-1060

Counsel for Petitioner

Case: 12-3671 Document: 1-1 Page: 1 09/17/2012 722399 1

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IN THE UNITED STATES COURT OF APPEALSFOR THE SECOND CIRCUIT

____________________________________NATURAL RESOURCES DEFENSE ) COUNCIL, ) Petitioner, ) v. ) Petition for Review ) UNITED STATES ENVIRONMENTAL ) No. 12-3671-agPROTECTION AGENCY, ) ) Respondent. ) ____________________________________)

DECLARATION OF JENNIFER SASS, PH.D.

I, Jennifer Sass, declare as follows:

1. I am a Senior Scientist for petitioner Natural Resources Defense Council

(NRDC). I have advanced degrees in Anatomy and Cell Biology, with specific

expertise in developmental toxicology, neurotoxicology, and molecular biology. At

NRDC I am responsible for reviewing the science underlying federal regulation of

industrial chemicals and pesticides. I have published over forty articles in peer-

reviewed scientific journals, including many pertaining to pesticide hazards and

regulations. I have provided comments to EPA on dozens of pesticides during the

course of the registration process.

2. I have represented NRDC since 2001 as an active member of the

EPA/USDA Pesticide Program Dialogue Committee (PPDC), a stakeholder

committee that provides feedback to the EPA Office of Pesticide Programs on

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various issues related to pesticide regulation, policy, and program implementation.

I have served on issue-specific PPDC workgroups, providing advice on pesticide

matters. I was also a member of the EPA/USDA Committee to Advise on

Reassessment and Transition (CARAT) from 2001 until the committee disbanded

in 2003. The purpose of CARAT was to provide advice on strategic approaches for

pest management and tolerance reassessment for pesticides as required by the Food

Quality Protection Act.

3. My CV is attached to this declaration as Exhibit A.

4. Dichlorvos, also called DDVP, is an organophosphate pesticide. I have been

reviewing the scientific literature on organophosphate pesticides, including DDVP,

for the past ten years. I have reviewed EPA’s Interim Reregistration Eligibility

Decision (IRED) for Dichlorvos (June 2006), available at

www.epa.gov/oppsrrd1/REDs/ddvp_red.pdf, which outlines EPA’s decision to

reregister DDVP. I have also reviewed the EPA Order titled Dichlorvos (DDVP);

Order Denying NRDC’s Objections on Remand, 77 Fed. Reg. 54,402 (Sept. 5,

2012), and documents referenced in that Order, including Kent, R., Office of

Pesticide Programs, U.S. EPA, Dichlorvos: WOE Comparison of Human and

Animal Studies for Single Chemical Assessment and OP Cumulative Assessment

(April 5, 2006), and Memorandum from Anna Lowit to Ray Kent, Office of

Prevention, Pesticides and Toxic Substances, U.S. EPA, Benchmark Dose analysis

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of cholinesterase inhibition in neonatal and adult rats (MRID no. 46688914)

following exposure to DDVP (June 9, 2006).

5. Organophosphate pesticides are among the most acutely toxic classes of

pesticides still on the market. Organophosphate pesticides were designed as

chemical nerve warfare agents in the 1940s. They interfere with the ability of a

protein enzyme called cholinesterase to degrade the acetylcholine molecule, which

transmits a signal from a nerve cell to a receptor cell. The result of exposure to this

class of pesticides is that the acetylcholine molecule over-stimulates the receptor

cell. Signs of poisoning range from mild symptoms such as increased urination,

salivation, and eye tearing, to gastrointestinal cramps, diarrhea, and nausea, to

more severe symptoms including slowed heart rate, difficulty breathing, dizziness,

muscle weakness, headache, and even convulsions, coma, or death in very severe

poisoning cases. See Agency for Toxic Substances & Disease Registry,

Toxicological Profile for Dichlorvos, available at

http://www.atsdr.cdc.gov/toxprofiles/tp.asp?id=597&tid=111. Poisoning can occur

not only by swallowing the pesticide, but also if it gets on the skin. See National

Institutes of Health, MedlinePlus: Insecticide poisoning, available at

http://www.nlm.nih.gov/medlineplus/ency/article/002832.htm.

6. EPA ranks the acute toxicity of pesticides using a scale of I to IV, with I

being the most acutely toxic and IV being the least toxic. 40 C.F.R. § 156.10(h)(1).

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EPA ranks the acute toxicity of technical (pure) dichlorvos as Category II for oral

and inhalation exposures, Category I for dermal exposures, Category III for eye

irritation, and Category IV (mild or slight) for dermal irritation. IRED at 93.

Because its dermal toxicity is Category I, EPA requires the pesticide label to

include the word “Poison” in red, along with a skull and crossbones. 40 C.F.R.

§ 156.10(h)(1).

7. Chemical exposures during fetal and early childhood development of critical

target organs and systems can cause disruptions that are hard-wired into the

developing system, leading to permanent damage. For example, research on metals

like lead and mercury proves that during brain development, the nervous system is

acutely vulnerable to neurotoxic assault. Exposures to these chemicals during early

life may result in permanent, irreversible brain damage, while exposures to the

same doses during adulthood may have little or no effect. Neurons (cells that

transmit information) do not regenerate, so losses to critical pathways or in critical

areas may never be recovered. The risks from dichlorvos are therefore of particular

concern for prenatal, infant, and childhood exposures.

8. Pre-natal exposure to organophosphate pesticides has been linked to poor

memory, learning deficits, and lower IQ when the children are school-aged, in

three studies conducted by federally-funded university scientists and published in

the prestigious scientific journal Environmental Health Perspectives (EHP). Three

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groups of researchers, conducting three independent studies, looking at the effects

of environmental residential exposure on nearly 800 children from New York and

California, and all found the same thing: maternal exposure to certain pesticides

during pregnancy predicts neurological deficits in children during childhood. The

scientists found that the children with higher exposure to these pesticides had

lower IQ, poorer memory, and diminished perceptual reasoning. The studies are:

a. The Columbia study: Seven-year neurodevelopmental scores and

prenatal exposure to chlorpyrifos, a common agricultural pesticide. Rauh V,

Arunajadai S, Horton M, Perera F, Hoepner L, Barr DB, Whyatt R. Environ

Health Perspect. 2011 Aug;119(8):1196-201.

b. The Mt. Sinai study: Prenatal exposure to organophosphates,

paraoxonase 1, and cognitive development in childhood. Engel SM, Wetmur

J, Chen J, Zhu C, Barr DB, Canfield RL, Wolff MS. Environ Health

Perspect. 2011 Aug;119(8):1182-8.

c. The CHAMACOS study: Prenatal Exposure to Organophosphate

Pesticides and IQ in 7-Year-Old Children. Bouchard MF, Chevrier J, Harley

KG, Kogut K, Vedar M, Calderon N, Trujillo C, Johnson C, Bradman A,

Barr DB, Eskenazi B. Environ Health Perspect. 2011 Aug;119(8):1189-95.

9. EPA expresses residential (non-dietary) risk by calculating a Margin of

Exposure (MOE), which represents how close the actual or projected residential

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exposure is to the Point of Departure (POD), which is often the lowest- or no-

observed-adverse-effect level, LOAEL or NOAEL, derived from animal studies.

The MOE is calculated as the POD divided by the exposure (MOE =

POD/Exposure). To estimate risk, the MOE is compared to the Level of Concern

(LOC). The LOC incorporates uncertainty factors (UFs) to provide a margin of

safety. For example, when 100 is the UF, the LOC is 100. So, an actual MOE

greater than the target MOE, usually 100, is considered likely to be without

appreciable risk, whereas an actual MOE less than the target MOE is unsafe.

10. For dichlorvos, EPA describes its selection of studies to assess the safety of

various exposure scenarios, and identifies the point of departure and uncertainty

factors associated with each exposure scenario, in the Dichlorvos IRED at Table

4.4. See IRED at 138.

11. For short-, intermediate-, and long-term dermal exposures, and short- and

intermediate-term inhalation of vapors, EPA relied upon the human 21-day oral

study conducted by Gledhill (referred to as MRID 44248801) to calculate a POD

and a Level of Concern for risk assessment. IRED at 138. This study was reviewed

by EPA’s Human Studies Review Board (HSRB) in April, 2006. I personally

attended that meeting and took notes. The HSRB identified substantial ethical and

scientific limitations with the study. These limitations included but are not limited

to: failure to properly follow-up the study subjects (the study was carried out for 21

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days, but the data was only collected and analyzed until day 18); the small number

of subjects (only 3 control and 6 treated subjects) and use of only male subjects;

the study likely missed the peak effect of the pesticide poisoning by only collecting

blood samples the day after each treatment; and the study used only a single dose,

which prevents establishing a dose-response relationship between the chemical and

the health effects. See Minutes of the U.S. EPA Human Studies Review Board,

April 4-6, 2006 Public Meeting (Docket No. EPA-HQ-ORD-2006-0187), available

at http://www.epa.gov/hsrb/files/aprilminutes51506wotrack.pdf. These defects

render the study both ethically and scientifically flawed.

12. The human study failed to identify a no-adverse-effect level (a NOAEL).

That is, it only tested a single dose of the pesticide, and that dose caused significant

adverse effects in the test subjects. Because it did not establish a NOAEL, and

because it failed to test a range of doses, a dose-response curve could not be

determined. Therefore, the study cannot provide any insights into whether the

single tested dose level is 10X higher than the true NOAEL, or 1000X higher, or

only 3X higher. Nonetheless, EPA used this study to set the POD and LOC for

residential various exposure scenarios. The study’s single dose of 0.1 mg/kg-day is

a LOAEL, to which EPA applied an uncertainty factor of 10X to account for

variability among individuals and an FQPA adjustment factor of 3X to account for

the failure of the study to establish a no-effect level, for a total of 30X. Because the

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study was conducted on humans, EPA did not use a standard 10X interspecies

factor to adjust for differences when extrapolating from animal studies to human

risk. For residential short-, intermediate-, and long-term dermal exposures, and

short- and intermediate-term inhalation of vapors, EPA’s calculated Level of

Concern is the MOE of 30 from the 21-day human study, and the allowable

exposure limit, called the Reference Dose (RfD), is 0.0033 mg/kg-day

(RfD=NOAEL of 0.1/30 UFs). IRED at 138.

13. Had EPA used the 1-year chronic-feeding dog study (referred to as MRID

41593101) in lieu of the Gledhill human study – which would be more appropriate

by EPA’s own standards – it would lead to more protective values. The dog study

was used by EPA to derive the chronic RfD. See IRED at 138. It should have also

been used by EPA to evaluate the risks from short-, intermediate-, and long-term

exposure scenarios because the chronic timeframe of the 1-year study is more

closely matched to those timeframes. Acute exposures last in the range of hours to

a few days. Short-term exposures last in the range of days to a few weeks.

Intermediate or subchronic exposures are in the range of weeks to months. Long-

term or chronic exposures are a year or longer. Since EPA is evaluating exposure

scenarios lasting from a few days to a year or longer, then the 21-day human study

is far too short to capture intermediate or long-term exposure risks. The dog study

was conducted over a more appropriate time span to capture the risks from lasting

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exposures. Further, using the dog study rather than the human study may add an

appropriate measure of health protection because it captures the possibility that

people may be exposed for longer than realized, rather than shorter.

14. From the dog study EPA derived a POD of 0.05 mg/kg-day (the study

NOAEL), to which it applied uncertainty factors totaling 100X, comprised of 10X

for animal-to-human differences (interspecies), and 10X for differences between

humans (intraspecies). The chronic RfD derived by EPA is 0.0005 mg/kg-day

(RfD=NOAEL of 0.05/100 UFs), and the target MOE derived by EPA is 100.

IRED at 138.

15. The RfD from the chronic dog study (0.0005 mg/kg-day) is 6-fold more

protective than the RfD derived from the Gledhill study (0.0033 mg/kg-day). IRED

at 138.

16. Had EPA used the more appropriate chronic dog study, the target MOEs for

all residential exposure scenarios would be 100, instead of a target MOE of 30

from use of the human study. This means that the residential exposure and risk

estimates for dichlorvos would exceed the acceptable exposure, or target MOE, for

most scenarios, including long-term inhalation exposure to all resin pest strips of

all sizes (MOEs range from 27 to 95). IRED at 165. As a result, all of these

exposures would have been considered unsafe, because the actual level of exposure

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would have exceeded the target level of exposure. The pressurized aerosol toddler

exposure is 100, which would be right at the target MOE. IRED at 160.

17. In its Order denying NRDC’s objections, EPA suggests that, in the absence

of the Gledhill human study, EPA might have derived a POD for short- and

intermediate-term risk assessments from either of two benchmark dose analyses.

77 Fed. Reg. at 54,418-19. EPA describes one of these studies as a comparative

cholinesterase study conducted in adult and juvenile rats, from which EPA derived

a POD of 0.38 mg/kg-day. EPA describes the second study as a cholinesterase

inhibition study of subchronic toxicity in rats, from which EPA derived a POD of

0.4 mg/kg-day. With a standard 100X UF applied to each (10X for inter-species

and 10X for intra-species variability), EPA points out that these would be similar

to the RfD of 0.0038 mg/kg-day derived from the human Gledhill study, because

they all round off to 0.004 mg/kg-day. While this is true, they are all 6-fold less

protective than if EPA had used the more appropriate dog study.

18. EPA would have to reevaluate the safety of dichlorvos if it had not relied on

the flawed human study, and that reevaluation would lead to more protective

values. Without the human study, it is virtually certain that EPA would not have

been able to reach its determination to approve all current uses of dichlorvos.

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EXHIBIT A

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Jennifer Beth Sass

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Jennifer Beth Sass, Ph.D. Natural Resources Defense Council, Senior ScientistGeorge Washington University, Professorial Lecturer

Full-time Employment (January 2001 to present): Senior Scientist, Natural Resources Defense Council 1200 New York Ave, NW, Suite 400 Washington, DC. USA 20005 Tel: 202-289-6868 (main), 202-289-2362 (direct) E-mail: jsass@nrdc.org Academic Affiliation (2008 to present) Professorial lecturer George Washington University School of Public Health and Health Services Department of Environmental and Occupational Health Washington, DC. USA 20052

Short Professional Biography :

I am a Senior Scientist in the Health and Environment program of the NRDC, an environmental non-profit organization. I review U.S. government regulations of industrial chemicals and pesticides, and assess the data underlying the regulatory decisions. I am well versed in the health sciences, with degrees in Anatomy and Cell Biology, and Toxicology, and have published over three dozen articles in peer-reviewed journals. In my work with NRDC I review the science underpinning the regulation of toxic chemicals and emerging contaminants such as nanomaterials, and advocate for health-protective regulations consistent with the environmental statutes. I provide testimony and scientific briefings for the U.S. Congress and regularly participate in stakeholder and expert scientific federal advisory committees.

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Education:

� Post-Doctoral Fellow, 1998-2000. Program in Human Health and the Environment, University of Maryland, Baltimore. Mentor: EK Silbergeld.

� Ph.D. 1998. Dept. of Anatomy and Cell Biology, University of Saskatchewan, Canada. Thesis title: Heat-inducible and Constitutive Expression of the 90kD Heat Shock Protein Gene, Hsp90, During Zebrafish Embryogenesis. Mentor: PH Krone.

� MSc. 1993. Dept. of Anatomy and Cell Biology, University of Saskatchewan, Saskatoon, Canada. Thesis title: Aluminum Pretreatment Impairs the Ability of Astrocytes to Protect Neurons from Glutamate Toxicity. Mentor: BHJ Juurlink.

� B.Sc. Advanced. 1989. Anatomy. University of Saskatchewan, Saskatoon, Canada.

Publications:

1. Sass, J. Putting the public into alternatives assessment. Environmental Health Policy Institute. Physicians for Social Responsibility. Online December 16, 2010. http://www.psr.org/environment-and-health/environmental-health-policy-institute/responses/putting-the-public-into-alternatives-assessment.html

2. Joshi TK, Bailar JC 3rd, Craner J, Davis D, Ehrlich R, Franco G, Frank AL, Huff J, LaDou J, Lanphear B, London L, Melnick RL, O'Neill R, Osaro E, Rosenman KD, Sass J, Smith AH, Soskolne CL, Stephens C, Stuckey R, Takaro TK, Teiteibaum D, Watterson A, Yassi A. Physician expelled from Indian Association of Occupational Health after critique. Int J Occup Environ Health. 2009 Oct-Dec;15(4):419-20.

3. Sass, JB. Supporting the need for rigorous enforceable disclosure policies for scientific journals. Commentary. Addiction 2009 Nov;104(11):1788-9.

4. Sass, JB. Key elements of effective and practical disclosure policies for health science journals. Editorial. Env Health Perspect, 2009 June;117(6):A233.

5. Sass, JB, Musu T, Burns K, Illuminato I. Nanomaterials: Brief review of policy frameworks in the U.S. and Europe and recommendations from an occupational and environmental perspective. European J Oncol, 2009; 13(4):211-218.

6. Sass, JB. Invited book review of Bending Science: How special interests corrupt public health research. T.O. McGarity and W.E. Wagner. Environ Health Perspect. 2008 Nov;116(11):1654-9

7. Sass, JB. Janssen, S. Open letter to Stephen Johnson, Administrator, U.S. Environmental Protection Agency: Ban Endosulfan. Int J Occup Environ Health, 2008, July-Sept; 14(3):236-239.

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8. Huff, James and Jennifer Sass. Atrazine – A likely human carcinogen? Int J Occup Environ Health, 2007, July-Sept;13(3):356-358.

9. Balbus JM, Maynard AD, Colvin VL, Castranova V, Daston GP, Denison RA, Dreher KL, Goering PL, Goldberg AM, Kulinowski KM, Monteiro-Riviere NA, Oberdörster G,Omenn GS, Pinkerton KE, Ramos KS, Rest KM, Sass JB, Silbergeld EK, Wong BA. Meeting report: hazard assessment for nanoparticles--report from an interdisciplinary workshop. Environ Health Perspect. 2007 Nov;115(11):1654-9.

10. Guth JH, Denison RA, Sass J. Require comprehensive safety data for all chemicals. New Solut. 2007;17(3):233-58.

11. Sass JB, Wu M. Budget cuts to the U.S. EPA will reduce government data on pollutants, and increase reliance on industry data. Int J Occup Environ Health. 2007 Apr-Jun;13(2):244-6.

12. Sass JB. Recommendations for improved risk assessment approaches. J Hum Ecol Risk Assessment. 2007.

13. Sass, JB, Colangelo A. European Union bans atrazine, while the United States negotiates continued use. Int J Occup Environ Health, 2006 July;12:260-267.

14. Sass J, Simms P, Negin E. Nanotechnologies: The promise and the perils. Sustainable Development Law & Policy (SDLP) journal, 2006, Apr/May:11-16.

15. Sass, J. No small problem: It’s high time for the United States to get nanotech regulations – and it needs to get them right. Bull Atom Sci, 2006, Mar/April; 62(2): 21-22

16. Sass, J.B. Credibility of Scientists: conflict of interest and bias. Env Health Perspect, 2006 March; 114(3):A147.

17. Needleman HL, Reigart JR, Landrigan P, Sass J, Bearer C, Resnik DB, Portier C. Correspondence: Benefits and Risks of Pesticide Testing on Humans and author response. Environ Health Perspect. 2005 Dec;113(12):a804-5.

18. Sass, JB. Industry efforts to weaken the EPA’s classification of the carcinogenicity of 1,3-butadiene. Int J Occup Environ Health, 2005; 11:378-383.

19. Sass JB, Castleman B, Wallinga D. Vinyl chloride: Sass et al respond. Environ Health Perspect. 2005 Oct;113(10):A654-655.

20. Sass JB, Castleman B, Wallinga D. Vinyl chloride: a case study of data suppression and misrepresentation. Environ Health Perspect. 2005 Jul;113(7):809-12.

21. Sass J, Solomon G. Inappropriate influence by industry on EHP news article. Environ Health Perspect. 2005 Feb;113(2):A87-8.

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22. Sass J. U.S. Department of Defense and White House working together to avoid cleanup and liability for perchlorate pollution. Int J Occup Environ Health. 2004 Jul-Sep;10(3):330-4.

23. Sass JB, Needleman HL. Human testing: Sass and Needleman respond to industry. Environ Health Perspect. 2004 May;112(6):A340-1.

24. Sass JB, Needleman HL. Industry testing of toxic pesticides on human subjects concluded "no effect," despite the evidence. Environ Health Perspect. 2004 Mar;112(3):A150-1; author reply A151-2; discussion. A152-6.

25. Sass JB, Devine JP Jr. The Center for Regulatory Effectiveness invokes the Data Quality Act to reject published studies on atrazine toxicity. Environ Health Perspect. 2004 Jan;112(1):A18; author reply A18-9.

26. Axelson O, Balbus JM, Cohen G, Davis D, Donnay A, Doolittle R, Duran BM, Egilman D, Epstein SS, Goldman L, Grandjean P, Hansen ES, Heltne P, Huff J, Infante P, Jacobson MF, Joshi TK, LaDou J, Landrigan PJ, Lee PR, Lockwood AH, MacGregor G, Melnick R, Messing K, Needleman H, Ozonoff D, Ravanesi B, Richter ED, Sass J, Schubert D, Suzuki D, Teitelbaum D, Temple NJ, Terracini B, Thompson A, Tickner J, Tomatis L, Upton AC, Whyatt RM, Wigmore D, Wilson T, Wing SB, Sharpe VA. Re: Regulatory Toxicology and Pharmacology. Int J Occup Environ Health. 2003 Oct-Dec;9(4):386-9; author reply 389-90.

27. Jacobson MF, Sharpe VA, Angell M, Ashford NA, Blum A, Chary LK, Cho M, Coull BC, Davis D, Doolittle RF, Egilman D, Epstein SS, Greenberg M, Hooper K, Huff J, Joshi TK, Krimsky S, LaDou J, Levenstein C, Miles S, Needleman H, Pellegrino ED, Ravanesi B, Sass J, Schecter A, Schneiderman JS, Schubert D, Soffritti M, Suzuki D, Takaro TK, Temple NJ, Terracini B, Thompson A, Wallinga D, Wing S. Editorial policies on financial disclosure. Nat Neurosci. 2003 Oct;6(10):1001.

28. Sass J. MacLennan et al report on an elevated incidence of prostate cancer among workers in a triazine manufacturing plant. J Occup Environ Med. 2003 Apr;45(4):343-4; author reply 344

29. Sass J. Continued insensitivity to conflicts of interest at IARC. Int J Occup Environ Health, 2003 Jan-Mar; 9(1); 88-9. discussion 89.

30. Sass J. Lead IARC towards compliance with WHO/IARC Declaration of Interests (DOI) policy. Int J Occup Environ Health. 2002 Jul-Sep;8(3):277-8.

31. Axelson O, Castleman B, Epstein S, Franco G, Giannasi F, Grandjean P, Greenberg M, Hooper K, Huff J, Jacobson M, Joshi TK, Kulkarni GK, LaDou J, Mazaheri M, Mekonnen Y, Melnick R, Mirabelli D, Ofrin R, Partanen T, Pott F, Sass J, Soskolne CL, Suplido ML, Terracini B, Tomatis L, Ungvary G, Watterson A, Wesseling C, Yassi A. Re: Implementation of WHO Guidelines on Disclosure of Interest by members of WHO Expert Panels. Int J Occup Environ Health. 2002 Jul-Sep;8(3):271-3.

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32. Sass JB, Greer L. Re: concern that working group members who will be assessing styrene have financial conflicts of interest. Int J Occup Environ Health. 2002 Apr-Jun;8(2):153-5.

33. Choich JA, Sass JB, Silbergeld EK. A novel system applying the 2-deoxyglucose method to fish for characterization of environmental neurotoxins. Toxicology Mechanisms and Methods. 2002; 12: 35-43

34. Gurney S, Sass J. Public trust requires disclosure of potential conflicts of interest. Nature. 2001 Oct 11;413(6856):565.

35. Sass JB, Haselow DT, Silbergeld EK. Methylmercury-induced decrement in neuronal migration may involve cytokine-dependent mechanisms: a novel method to assess neuronal movement in vitro. Toxicol Sci. 2001 Sep;63(1):74-81.

36. Sass JB, Martin CC, Krone PH. Restricted expression of the zebrafish hsp90alpha gene in slow and fast muscle fiber lineages. Int J Dev Biol. 1999;43(8):835-8.

37. Krone PH, Lele Z, Sass JB. Heat shock genes and the heat shock response in zebrafish embryos. Biochem Cell Biol. 1997;75(5):487-97. Review.

38. Sass JB, Krone PH. HSP90alpha gene expression may be a conserved feature of vertebrate somitogenesis. Exp Cell Res. 1997 Jun 15;233(2):391-4.

39. Krone PH, Sass JB, Lele Z. Heat shock protein gene expression during embryonic development of the zebrafish. Cell Mol Life Sci. 1997 Jan;53(1):122-9. Review.

40. Sass JB, Weinberg ES, Krone PH. Specific localization of zebrafish hsp90 alpha mRNA to myoD-expressing cells suggests a role for hsp90 alpha during normal muscle development. Mech Dev. 1996 Feb;54(2):195-204.

41. Krone PH, Sass JB. HSP 90 alpha and HSP 90 beta genes are present in the zebrafish and are differentially regulated in developing embryos. Biochem Biophys Res Commun. 1994 Oct 28;204(2):746-52.

42. Sass JB, Ang LC, Juurlink BH. Aluminum pretreatment impairs the ability of astrocytes to protect neurons from glutamate mediated toxicity. Brain Res. 1993 Sep 10;621(2):207-14.

43. Sass JB, Ang LC, Juurlink BH. A simple, yet versatile, co-culture method for examining neuron-glia interactions. J Neurosci Methods. 1993;47(1-2):115-21.

44. Ang LC, Bhaumick B, Munoz DG, Sass J, Juurlink BH. Effects of astrocytes, insulin and insulin-like growth factor I on the survival of motoneurons in vitro. J Neurol Sci. 1992 Jun;109(2):168-72.

Book Chapters:

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Soffriti M, Sass JB, Castleman B, Gee D. 2012. Vinyl Chloride: a saga of secrecy and a lesson of independent science. Late Lessons from Early Warnings Vol 2: science, precaution, innovation. Chapter 8. Pages 145-168.

Sass JB, D Mergler, EK Silbergeld. 2000. Environmental toxins and neurological disease. In: Diseases of the Nervous System: Clinical Neuroscience and Therapeutic Principles. 3rd edition. Eds. AK Asbury, G McKhann, WI McDonald, PJ Goadsby, JC McArthur. Cambridge Univ Press, NY, NY. Chapter 111.

Reports

� Strengthening Toxic Chemical Risk Assessments to Protect Human Health. An NRDC issue paper by Sarah Janssen, Jennifer Sass, Ted Schettler, Gina Solomon. February 2012.

� The Delay Game: How the industry ducks regulation of the most toxic substances. An NRDC report by Jennifer Sass and Daniel Rosenberg. October, 2011

� Atrazine: Poisoning the Well – Atrazine continues to contaminate surface water and drinking water in the United States. An NRDC Issues Paper by Mae Wu, Mayra Quirindongo, Jennifer Sass, Andrew Wetzler. April 2010

� Asleep at the switch: How EPA is ignoring atrazine contamination in surface and drinking water in the Central United States. An NRDC Issues Paper by Mae Wu, Mayra Quirindongo, Jennifer Sass, Andrew Wetzler. August, 2009

� Effective and practical disclosure policies: NRDC paper on workshop to identify key elements of disclosure policies for health science journals. An NRDC paper by Jennifer Sass. June, 2009. http://www.nrdc.org/health/disclosure/

� Deepest Cuts: Repairing Health Monitoring Programs Slashed Under the Bush Administration. An NRDC Issues Paper by Miriam Rotkin-Ellman, Mayra Quirindongo, Jennifer Sass, Gina Solomon. December 2008. http://www.nrdc.org/health/deepestcuts/

� Nanotechnology’s invisible threat: small science, big consequences. An NRDC Issues Paper by Jennifer Sass. May, 2007. http://www.nrdc.org/health/science/nano/contents.asp

U.S. Congressional Testimony and Briefings

� Briefing before the US Senate Committee on Environment and Public Works on recommendations of the National Academies for improving risk assessments. Washington, DC. February 28, 2011

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� Briefing before the US Senate Committee on Commerce, Science, and Transportation. Green Chemistry: merging business and sustainability. Washington, DC. June 26, 2009

� Testimony before the US House Energy and Commerce Committee, Subcommittee on Oversight and Investigations at hearings entitled, “Science Under Siege: Scientific Integrity at the Environmental Protection Agency”. Washington, DC. September 18, 2008

� Testimony before the US Senate Committee on Environment and Public Works, Subcommittee on Transportation Safety, Infrastructure Security, and Water Quality hearing entitled, “Pharmaceuticals in the Nation’s Water: Assessing Potential Risks and Actions to Address the Issue”. April 15, 2008

� Briefing before the US Senate Committee on Environment and Public Works. Perspectives on Nanotechnology: Business, Government, and Public Health. Washington, DC. May 30, 2007

� Testimony before the US House of Representatives Committee on Science and Technology. Legislative Hearing on the EPA Fiscal Year 2008 Research and Development Budget Proposal. March 14, 2007.

National Academies of Science:

� Invited panelist to address the National Research Council committee to Review of the Federal Strategy to Address Environmental, Health, and Safety Research Needs for Engineered Nanoscale Materials. BEST-K-07-02-A. May, 2008

� Presented testimony to the National Research Council Committee on the Health Risks of Phthalates. BEST-K-07-07-A. December, 2007

� Presented testimony to the National Research Council Committee on Improving Risk Analysis Approaches Used by the U.S. EPA. BEST-K-05-02-A. June, 2007

� Presented testimony to the Institute of Medicine Roundtable on Environmental Health Sciences, Research and Medicine. National Institute of Environmental Health Science Roadmap. June, 2006

� Presented testimony to the National Research Council Committee on Ensuring the Best Science and Technology Presidential and Federal Advisory Committee Appointments. Call for Comments on Science and Technology Presidential and Federal Advisory Committee Appointments. July 21, 2004

� Presented testimony to the National Research Council on scientific and regulatory issues for the Committee on Environmental Decision Making: Principles and Criteria for Models (BEST-K-03-02-A). March, 2004

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� Presented testimony to the National Research Council on scientific issues and environmental concerns, for the “Committee on Coeur d'Alene River Basin” Superfund Site Assessment and Remediation (BEST-K-02-04-A). Additional comments identified concern that numerous members of the committee had close ties to polluters. January, 2004

� Presented testimony to the National Research Council on the scientific issues, for the “Committee to Assess the Health Implications of Perchlorate Ingestion” (BEST-K-03-05-A). Additional comments identified concern that numerous members of the committee had close ties to perchlorate polluters. October, 2003

� Presented testimony to the National Research Council raising concern of industry influence on the provisional committee appointments and charge questions for the NAS advisory panel to address the Toxicologic Risk of Fluoride in Drinking Water (BEST-K-02-05-A). May, 2003

� Presented testimony to the National Academies on the scientific issues, for the “Provisional Committee Appointments for NAS Advisory Panel - Use of Third Party Toxicity Research with Human Research” (STLP-Q-02-02-A). Additional comments identified concern that numerous members of the committee had close ties to pesticide manufacturers. December 3, 2002

Service on U.S. Federal scientific and stakeholder committees:

� Invited panelist. EPA Office of Water. Arsenic Small Systems Working Group. 2012.

� Invited panelist. EPA Office of Water. Drinking Water Strategy – Contaminants as a group process. Stakeholder meeting. September, 2010

� Selected to serve on the Leadership Council of the CDC National Conversation on Public Health and Chemical Exposures. We met throughout 2010 and will continue our work into 2011. The goal is to successfully engage a broad range of groups and individuals representing impacted communities, health professionals, regulatory agencies, and industry to develop an action agenda with clear, achievable recommendations to strengthen government’s efforts to protect health and the environment from chemical hazards.

� Invited participant on a working group of the President’s Council of Advisors on Science and Technology (PCAST), to review the National Nanotechnology Initiative. 2010

� Invited participant on the federal advisory committee to provide Peer Review of the EPA Nanotechnology White Paper. Coordinated by Versar, Inc. (Keith Drewes). 2006

� Member of the National Toxicology Program Nanotechnology Working Group, NTP Board of Scientific Counselors. National Institute of Environmental Health Sciences. 2005.

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� Member of the Public Interest Partners of the National Institute of Environmental Health Sciences (NIEHS PIP). 2005 to 2011.

� Invited member of the National Toxicology Program U.S. Department of Health and Human Services High-Throughput Screening Assays Workshop. December 14-15, 2005. Crystal City, Virginia

� Member of the Interim Ad-Hoc Work Group on Nanoscale Materials, National Pollution Prevention and Toxics Advisory Committee (NPPTAC), U.S. EPA. July-October, 2005

� Invited member of the National Toxicology Program Retreat. Dept of Health and Human Services. To provide input on the Draft paper, Toxicology in the 21st Century: The Role of the National Toxicology Program. Greensboro, NC. August, 2004

� Participant in the Technical Peer Review Workshop on the EPA Risk Assessment Forum Draft Framework for Cumulative Risk Assessment. June, 2002

� Member of the EPA/USDA Pesticide Program Dialogue Committee (PPDC). This Committee provides a forum for a diverse group of stakeholders to provide feedback to the pesticide program on various pesticide regulatory, policy and program implementation issues. Summer 2001 to present

� Member of the EPA/USDA Committee to Advise on Reassessment and Transition (CARAT). The purpose of CARAT to provide advice on strategic approaches for pest management planning, transition, and tolerance reassessment for pesticides as required by the Food Quality Protection Act (FQPA). This committee advises EPA and USDA on ways to ensure smooth implementation of FQPA through use of sound science, consultation with stakeholders, increased transparency, and reasonable transition for agriculture. Summer 2001

� Member of the EPA Expert Peer Review for the Draft Framework for Cumulative Risk Assessment document, US EPA NCEA-F-1098. August 2, 2001. Workshop discussion Arlington, VA. August 2001

Selected Recent Testimony and Comments to the U.S. Environmental Protection Agency:

Pyrethroid Cumulative Risk Assessment. EPA-HQ-OPP-2011-0746. January, 2012.

Chlorpyrifos preliminary human health risk assessment. EPA-HQ-OPP-2008-0850. October, 2011

Pesticides; Policies concerning nanomaterials. EPA–HQ–OPP–2010-0197. August, 2011

Revisions to EPA’s rule on protection of subjects in human research involving pesticides. EPA-HQ-OPP-2010-0785. April, 2011.

Proposal to conditionally register nanosilver pesticide product. September, 2010

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Proposed Rule to increase public availability of the identities of the inert ingredients in pesticide products. EPA-HQ-OPP-2009-0635. April 2010

EPA Policy paper on revised risk assessment methods for agriculture workers, children of workers in agriculture fields, and pesticides with no food uses. EPA-HQ-OPP-2009-0889. April 2010

EPA Draft guidance for pesticide registrants on pesticide drift labeling. EPA-HQ-OPP-2009-0628. March, 2010.

Draft Toxicological Review of Trichloroethylene: In support of the summary information in the Integrated Risk Information System. EPA-HQ-ORD-2009-0791. January, 2010.

FIFRA Scientific Advisory Panel on atrazine. EPA-HQ-OPP-2009-0851. February, 2010.

Fungicides mancozeb, maneb, metiram, and thiram. EPA-HQ-OPP-2009-0431. November, 2009

Atrazine. EPA-HQ-OPP-2009-0759. October, 2009

Perchlorate in drinking water. EPA-HQ-OW-2009-0297. September, 2009

NRDC petition to cancel endosulfan. EPA-HQ-OPP-2002-0262. June, 2009

Selected Recent Testimony and Comments to Regulatory Agencies (other than EPA):

1. Presented testimony and comments at the Maine State Legislature on the health hazards of bisphenol A. March, 2011.

2. Submitted comments in response to the March, 2009 Presidential Memo on Scientific Integrity: Request for Public Comment. May, 2009.

3. Submitted scientific and legal comments to the New Jersey Department of Environmental Protection on a drinking water standard for perchlorate. December, 2007

4. Submitted scientific and legal comments to the FDA on nanoparticles in sunscreens, cosmetics, and personal care products. December 21, 2007. Docket No. 1978N-0038

Selected Recent Invited Speaker:

1. Invited speaker. Collegium Ramazzini Annual Meeting. Vinyl chloride- industrial secrecy, scientific independence, the bioassay, and heroes of health. Carpi, Italy. October 2012

2. Invited panelist at the Society of Environmental Journalists (SEJ). The Economy: Nanotech Update: Economic Boon or Environmental Bane. Lubbock, TX. October, 2012

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3. Invited panelist at the Society of Environmental Journalists (SEJ). The Globe: Women, Water and Health: From Dirty Wells to Endocrine Disruptors. Lubbock, TX. October, 2012

4. Invited speaker at The Kavli Science Journalism Workshop. Nano: the newest technology. Massachusetts Institute of Technology (MIT), June 2012.

5. Invited panelist. Society of Toxicology and EPA Office of Research and Development. Workshop on Contemporary Concepts in Toxicology – Building for Better Decisions. May, 2012.

6. Invited speaker at University of Idaho College of Law, Moscow Idaho. March, 2012

7. Invited speaker and workshop participant, Arizona State University, College of Law. The biggest issues for the smallest stuff: regulation and risk management of nanotechnology. Phoenix, AZ. March, 2011.

8. Invited speaker, DC EcoWomen. Washington, DC March, 2011.

9. Invited speaker, The Appropriate Use of Science in Public Policy. Hosted by the Professionals for the Public Interest (PftPI). Washington, DC October, 2010

10. Invited speaker, graduate class on Science and Policy. Virginia Tech, Blacksburg VA. October, 2010

11. Invited panelist. Nanotechnology: Should we sweat the little things? Society of Environmental Journalists, 20th Annual Conference. Missoula, MT October, 2010.

12. Invited participant. Workshop on Assessing Consistency in Epidemiology Data for Application in Regulatory Risk Assessment. Johns Hopkins School of Public Health (Ron White), Baltimore MD. September, 2010

13. The 10th Transatlantic Consumer Dialogue (TACD) annual meeting. Invited speaker on nanomaterials. Brussels, June, 2009

14. Science, Technology, and Public Policy Program at the Ford School of Public Policy at the University of Michigan. Invited speaker. Title: Nanotoxicology: a review of the science and policy. January, 2009

15. NIEHS AFGE Local 2923 and the NIEHS Diversity Council. Labor Day Keynote Lecturer. Title: Occupational safety, public health, and environmental protection: The historical role of women in making the connection. Research Triangle Park, NC. August, 2008.

16. Region VI Pretreatment Association, U.S. EPA, and State EPA Region VI. Title: Nanomaterials in waste water. Invited presenter. Oklahoma City, OK. August, 2008.

17. Global conference on occupational and environmental cancer prevention. Invited speaker. Title: An international environmental NGO assessment of environmental cancers and their prevention. Scotland. April, 2008.

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18. Resources for the Future, and Wilson Center Project on Emerging Nanotechnologies. Nanotechnology and Nature: Reducing risks and reaping rewards. Washington, DC. June 6, 2007

19. Beyond Pesticides 25th National Pesticide Forum. New Opportunities for Protecting Health and the Environment. Nanotechnologies. Chicago, Il. June 2, 2007

20. American Bar Association Annual Meeting. Section of Environment, Energy, and Resources. Regulation of nanotechnology: size does matter. San Diego, CA. October, 2006

21. Johns Hopkins Bloomberg School of Public Health. Risk Policy, Management, and Communications course. Professor, Ronald White. Baltimore, MA. November/December 2003, 2004, 2005, 2006, 2007, 2008

Provided Peer-Review for Scientific and Professional Journals

Accountability in Research American Journal of Public Health Archives of Environmental & Occupational Health Environmental Health Perspectives European Environmental Agency, Late Lessons from Early Warnings International Journal of Occupational and Environmental Health Journal of Nanoparticle Research Public Health Reports

Selected Recent Professional and Public Service

1. Clean Production Action, Member of the Green Screen Steering Committee. 2012

2. Coming Clean Collaborative. Workgroup leader, Emerging Technologies. 2007, 2008, 2009, 2010, 2011, 2012

3. Center for the Environmental Implications of Nanotechnology (CEINT). Member of the External Advisory Board. 2009, 2010

4. Public Interest Partners, National Institute of Environmental Health Sciences (NIEHS). Liaison with the NIEHS National Advisory Environmental Health Sciences Council (NAEHS). 2007, 2008, 2009, 2010

5. Invited expert on the North American Commission for Environmental Cooperation meeting of experts to guide the further development of its Special Report on Toxic Chemicals and Children’s Health in North America. Montreal, Canada. November, 2004

6. Organizer and session moderator for the annual general conference of the Association for Science in the Public Interest (ASIPI). George Mason University, VA. June, 2003

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7. Reviewer of applicants for the American Association for the Advancement of Science/ National Institutes of Health Science Policy Fellowship Program. March, 2003, 2004

8. Invited participant in the North American Free Trade Agreement (NAFTA) Trilateral Workshop on Risk Assessment and Children’s Environmental Health. Oaxaca, Mexico. February, 2003

9. Invited observer of the International Agency for Research on Cancer (IARC) Monographs on the Evaluation of Carcinogenic Risks to Humans. Preparation of Volume 84: Some drinking-water disinfectants and contaminants, including arsenic. Lyon, France. October, 2002

10. Member of the Roundtable Workshop to discuss Genomics and Environmental Policy, organized by the Woodrow Wilson International Center for Scholars, Washington, DC. Purpose is to discuss the impacts and implications of advances in genomics on environmental protection and policy. May, October, 2002

11. Member of the LifeLine Advisory Committee. This committee advises and reviews the development of the LifeLine model for cumulative risk assessment, developed by Hampshire Research Institute. Coordinators are Paul Price and Christine Chaisson. Summer 2001

12. Co-chair of the organizing committee for the annual general meeting of the Association for Science in the Public Interest, Richmond, VA. May, 2001

Selected Recent Scientific Conference Presentations

1. Sass, JB. 2011. Panelist. Natural Resources Defense Council (NRDC) perspective on transparency, speed and stakeholders involvement in EPAs chemical risk assessment. Society for Risk Analysis Annual Meeting. December, Charleston, SC.

2. Sass JB. 2009. Panelist. The Regulatory Frontier: Addressing products of nanotechnology. Abstract 660. Society of Toxicology Annual Meeting. March, Baltimore, MD.

3. Sass JB. 2008. Panelist. Data gaps and research needs for improving risk analysis of nanoscale materials and nanotechnology. Society of Risk Analysis. September, Washington, DC.

4. Sass JB. 2006. Panelist. Nanotechnology challenges. American Public Health Association Annual Meeting. November, Boston MA

5. Sass JB. 2005. Vinyl Chloride Carcinogenicity and EPA's Chemical Assessment Process. Abstract 121339. American Public Health Association Annual Meeting. December, Philadelphia, PA.

6. Sass JB, Colangelo A. 2005. U.S. Regulation of Atrazine: Taking Care of Business. Collegium Ramazzini Annual Meeting. Living in a Chemical World. September, Bologna, Italy.

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7. Sass J, Colangelo A. 2005. EPA Review of Atrazine Cancer Risks: Taking Care of Business. Meeting of Atrazine and the health of humans and wildlife: state of the science and future research needs. University of Iowa. April, Iowa City, Iowa

8. Sass, JB. 2004. Panelist. Scientific Integrity in Regulation. American Public Health Association Annual Meeting. Session 3214.0. November, Washington, DC

9. Sass, JB. 2003. Panelist. Social Determinants of Health: sound science for sale? (session 4259.0). Presentation title, “Are the regulated industries regulating themselves…where is government?” Abstract 70559. American Public Health Association Annual Meeting, November. San Francisco, CA

10. Sass, JB. 2003. Panelist. Increase Influence of Industry in American and International Assessments of Toxic Chemicals. First International Scientific Conference on Occupational and Environmental Health at the National Institute of Occupational and Environmental Health. November. Hanoi, Viet Nam

Selected Recent Community Service and Activities

� Garrett Park Conservation Action Network. 2008-ongoing � Garrett Park Conservation Trust, Vice-President. 2009-2011 � Wilderness First Responder certified; Wilderness First Aid certified, 2010, 2012 � ACA certified whitewater kayak instructor, American Canoe Association, 2009-ongoing � Solo oar-raft the Grand Canyon, Colorado River, 225 miles. 2009 � Volunteer organizer with the Potomac White Water Festival. 2008-2011 � Runner and fund-raiser for the National AIDS Marathon. Completed the Marine Corps

Marathon, Washington DC. 2005 � Runner and fund-raiser for the National AIDS Marathon. Completed the Baltimore

Marathon, Baltimore MD. 2004

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CERTIFICATE OF SERVICE & CM/ECF FILING

12-3671

I hereby certify that the foregoing Petitioner’s Brief and Special Appendix were served on counsel for Respondent via Electronic Mail generated by the Court’s electronic filing system (CM/ECF) with a Notice of Docket Activity pursuant to Local Appellate Rule 25.1, and a copy via first class mail to:

Kent E. Hanson U.S. Department of Justice P.O. Box 7611, Washington, DC 20044 (206) 220-4198 kent.hanson@usdoj.gov Attorneys for Respondent

An electronic copy was uploaded to the Court’s electronic filing system. Six hard copies of the foregoing Petitioner’s Brief and Special Appendix were sent to the Clerk’s Office by hand delivery to:

Clerk of Court United States Court of Appeals, Second Circuit

United States Courthouse 500 Pearl Street, 3rd floor

New York, New York 10007 (212) 857-8500

on this 20th day of December 2012.

_________________________ Ramiro A. Honeywell

/s/ Ramiro A. Honeywell