Dichlorvos petition NRDC - December 2012

of 262 /262
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

Embed Size (px)

description

Dichlorvos

Transcript of Dichlorvos petition NRDC - December 2012

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 __________________ PETITIONERS 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 EPAs Use of Studies Intentionally Exposing Humans to Pesticides ....................................................................... 9 III. Congress Passed Section 201 to Restrict EPAs Use of Studies Intentionally Exposing Humans to Pesticides .................................. 12 IV. EPAs Human Testing Rule Permits EPA to Use Ethically Deficient Human Dosing Studies, Contrary to Section 201 and the National Academys Recommendations .......................................................................................... 16 V. EPA Used a Study Testing Dichlorvos on Humans to Assess the Pesticides Safety, in Reliance on Its Unlawful Human Testing Rule ...................................................................................... 18 iii A. EPAs Office of Pesticides Reviewed and Identified Ethical Deficiencies in the Dichlorvos Human Study ...............................21 B. EPAs 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 EPAs 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. EPAs Use of the Dichlorvos Human Study Violated Section 201 .................................................................................................... 37 A. EPAs Application of Its Significantly Deficient Test to Allow It to Use the Dichlorvos Human Study Violated Section 201 ..................................................................................38 B. Section 201 Requires EPAs Rule on Use of Intentional Human Dosing Studies to Be Consistent with the National Academy of Sciences Recommendations ......................................................................................44 III. EPA Unlawfully Denied NRDCs 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 EPAs 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. Dept 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 Commn, 656 F.2d 791 (D.C. Cir. 1981) .......................................................................32 Hunt v. Wash. State Apple Adver. Commn, 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 Commn, 589 F.2d 603 (D.C. Cir. 1978) .......................................................................32 Motor Vehicle Mfrs. Assn 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 Natl Assn of Home Builders v. Defenders of Wildlife, 551 U.S. 644 (2007).......................................................................................39 Natl Corn Growers Assn v. EPA, 613 F.3d 266 (D.C. Cir. 2010) .......................................................................37 NRDC v. EPA, 658 F.3d 200 (2d Cir. 2011) .................................................................. passim OHara v. Natl Union Fire Ins. Co. of Pittsburgh, 642 F.3d 110 (2d Cir. 2011) ..........................................................................48 Pactra Indus. v. Consumer Prod. Safety Commn, 555 F.2d 677 (9th Cir. 1977) .........................................................................61 vii Rainwater v. Alarcon, 268 F. Appx 531 (9th Cir. 2008) ..................................................................50 Ratanasen v. Cal. Dept 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 EPAs denial of NRDCs request under the Food Act, 21 U.S.C. 346a(g)(2)(B), for an evidentiary hearing on disputed factual issues concerning whether the studys 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 pesticides 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. EPAs 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 EPAs 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 investigators 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 Boarda body established pursuant to Section 201 and charged with evaluating human studies conducted by third parties and submitted to EPAto conclude the study had at best limited . . . 4 value for EPAs 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 dichlorvoss 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 NRDCs subsequent administrative objections to EPAs 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 EPAs 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 NRDCs 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 NRDCs request for an evidentiary hearing, under the Food Act, on material factual issues concerning the adequacy of the dichlorvos human studys informed consent procedure and the studys statistical validity. 21 U.S.C. 346a(g)(2)(B).2 This Court should accordingly vacate EPAs 2012 order. The Court should also prevent EPA from relying on the human study or, in the alternative, order EPA to grant NRDCs hearing request. 1 The 2012 order was signed by Steven Bradbury, Director of EPAs 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 NRDCs petition and vacated and remanded the relevant portions of EPAs 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 EPAs 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). EPAs regulatory assessment of a pesticides 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 animalscalled 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 EPAs 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 datas 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 childrens safety factor. 21 U.S.C. 346a(q)(1). II. The National Academy of Sciences Has Proposed Principles to Restrict EPAs 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 FQPAs 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 childrens 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 Acts 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 EPAs 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 EPAs 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 EPAs 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 EPAs 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 Reports 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 EPAs 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 amendments 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 EPAs 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 Academys standard. A-337. EPAs 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 EPAs viewnot the view of the National Academythat 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 EPAs use of third-party human tests. The Senate passed an amendment to EPAs 2006 appropriations bill that, like the House amendment discussed above, would have prohibited EPAs 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 EPAs 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 EPAs draft rule for its insertion of the word significantly to modify the National Academys 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. Congresss final 2006 appropriations bill for EPA includes a provision that bans EPAs 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. EPAs Human Testing Rule Permits EPA to Use Ethically Deficient Human Dosing Studies, Contrary to Section 201 and the National Academys 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 Academys 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 Congresss reference to principles proposed in the 2004 report to refer not to the Academys 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 Rules significantly deficient threshold for rejection of older studies made it inconsistent with Recommendation 5-7 in the National Academys Report, and accordingly violated Congresss 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 Pesticides 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 dichlorvoss 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 subjectssix young, healthy, white maleswere 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 dichlorvoss 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. EPAs Office of Pesticides Reviewed and Identified Ethical Deficiencies in the Dichlorvos Human Study In 2006, EPAs 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 Associations 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 studys 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 (dichlorvoss manufacturer) as the studys 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 studys 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 studys 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 studys 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 EPAs Human Studies Review Board. A-417. B. EPAs 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 EPAs 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 EPAs initial ethics review that the study had several clear deficiencies when measured against the ethical standards prevailing at the time the study was carried outi.e., the Declaration of Helsinki. A-679 to 682 (quote at 681). The Board found that the studys 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 studys 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 studys serious ethical shortcomings, the Board called into question the studys ability to supply EPA with reliable data about dichlorvoss toxicity. The Board identified numerous weaknesses in the study design and execution. A-674 to 675. It also criticized as small the studys 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 EPAs initial ethics review: the study investigators 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 studys 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 studys 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 Rules 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 Boards factual analysis of the dichlorvos human studys 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 EPAs 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 EPAs 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 EPAs 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. NRDCs 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 NRDCs 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 EPAs 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 studys consent procedure and the studys 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 studys ethical deficiencies. A-740 to 741 (incorporating legal argument from NRDCs 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 EPAs 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 NRDCs objections and hearing request in a final order dated July 23, 2008. SPA-021. NRDC petitioned for review of EPAs 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 studys ethical and statistical validity. Id. at 219. Second, EPA failed to provide a rational basis for waiving the childrens safety factor. Id. at 218. The Court reached only this second issue and granted NRDCs petition on that issue, holding that EPA failed to provide a lawful explanation for its departure from the childrens 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 Courts vacatur and remand on the childrens 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 NRDCs request for a hearing on the study. Id. at 219. 29 Following remand, EPA again denied NRDCs objections and hearing request by final order dated September 5, 2012. SPA-001.5 The 2012 order preserves EPAs 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 EPAs 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. Commn, 432 U.S. 333, 343 (1977). NRDC satisfies this test. NRDCs members have standing to challenge EPAs 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 EPAs 2012 order renews its denial of NRDCs 2008 objections and references and incorporates analysis from EPAs 2008 order. See SPA-002 (col. 2) (EPA again denies NRDCs objections as to those portions of the July 23, 2008 order that were vacated.), SPA-004 (col. 1). 30 NRDCs 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 NRDCs 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. NRDCs 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 dichlorvoss 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 EPAs 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 EPAs 2012 order to NRDC members is likely to be redressed by a decision vacating the order and prohibiting EPAs use of the dichlorvos human study. EPA relied on the studys 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). NRDCs standing to challenge EPAs 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 NRDCs 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 studys statistical validity before an administrative law judge. This is a cognizable injury for standing purposes. Midwestern Gas Transmission Co. v. Fed. Energy Regulatory Commn, 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 Commn, 656 F.2d 791, 795 n.9 (D.C. Cir. 1981) (same). It would be redressed by 33 a decision vacating EPAs 2012 order and directing the agency to conduct an evidentiary hearing. NRDCs 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 NRDCs 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 Academys 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 201embodied in EPAs 2006 Human Testing Rulethat 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 EPAs 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 NRDCs request for an evidentiary hearing on disputed factual issues material to EPAs 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 studys 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 studys consent procedure and statistical design. EPA nonetheless arbitrarily denied NRDCs hearing request. This violated the Food Act and EPAs 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 EPAs 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. EPAs 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). EPAs denial of NRDCs 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 NRDCs second argument challenging EPAs 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 Acts drug application provisions), affd as modified Weinberger v. Hynson, Westcott & Dunning, Inc., 412 U.S. 609, 622-23 (1973). This Court must set aside EPAs 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. Assn 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). EPAs 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 Acts food additive provisions, 21 U.S.C. 37 348(f)(1)); see also 21 U.S.C. 346a(g)(2)(B) (Food Acts 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 EPAs 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. EPAs 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 EPAs 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 [agencys] 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 agencys 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 Rules adoption so long as those studies are not significantly deficient relative to then-prevailing ethical standards. 40 C.F.R. 26.1704 (emphasis added). EPAs interpretation of Section 201 to allow it to use the dichlorvos human study contravened both the statutes plain language and its legislative history, which reflects Congresss desire to reign in EPAs use of such studies. A. EPAs Application of Its Significantly Deficient Test to Allow It to Use the Dichlorvos Human Study Violated Section 201 EPAs use of the dichlorvos human study, based on the agencys application of language in its Human Testing Rule, violated Section 201s 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 agencys 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.; Natl Assn of Home Builders v. Defenders of Wildlife, 551 U.S. 644, 661 (2007) (Congresss 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 EPAs use of such older studies where there is clear and convincing evidence that the studys conduct is deficient relative to ethical standards prevailing at the time of the study. Id. Despite Congresss command that any EPA rule for use of intentional human dosing studies be consistent with the Academys 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 Rules adoption unless clear and convincing evidence shows that the studys 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 Academys 40 proposed principle that EPA reject all deficient studies. A-337 (also explaining that EPAs insertion of the qualifier significantly reflects EPAs viewnot the Academysconcerning 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 Boards finding, under the Human Testing Rule, that EPA could use the study), SPA-041 (col. 2) (EPAs 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 EPAs 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 studys sponsor and investigators), A-680 (Board) (consent forms failed to fully meet the standards in the Helsinki Declaration). EPAs 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 studys 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 Boards reasoning, similarly based its decision to approve use of the study on its view that the studys numerous ethical deficiencies did not amount to significantly deficient conduct relative to then-prevailing standards. SPA-030. Had EPAs consideration of the study been guided by the Academys proposed principlewhich forbids use of all studies that are deficient relative to applicable ethical standardsEPA would not have been able to accept the study in light of the ethical faults it identified. EPAs application of the significantly deficient standard, rather than the deficient standard the National Academy proposed in its Report, thus contravened Section 201s requirement that the standard be consistent with the Reports proposed principles. SPA-116. Section 201s legislative history underscores Congresss 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 EPAs 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 EPAs 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 Congresss 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 201s sponsors recognized as unethical and sought to prevent EPA from using: the dichlorvos human study. In sum, both Section 201s 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. EPAs 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. Dept 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 EPAs 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 Academys Recommendations. SPA-116. Section 201s 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 Congresss intent). The legislation that became Section 201 was introduced and passed in response to Members concerns that EPAs 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 Academys own use of the words proposals and principles in its 2004 Report supports this plain construction. The Reports 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 Reports 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 Academys 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 EPAs 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 EPAs expressed intention to go against the recommendation of the [Academy]). 46 statutory construction, Chevron, 467 U.S. at 843 n.9legislative language and historyprovide a clear sense that the phrase principles proposed in Section 201 refers to the Recommendations, Congresss 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 NRDCs 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 studys 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 EPAs implementing regulations. See 21 U.S.C. 346a(g)(2)(B); 40 C.F.R. 178.32(b). EPAs denial of NRDCs 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 EPAs 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 EPAs 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). EPAs 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); OHara v. Natl 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 casethe 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). EPAs 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 EPAs 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. Appx 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 EPAs 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 studys 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 Boards final report, which was cited in EPAs 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-26