U.S. Chemical Regulation – What to Expect and How to ... Webinar - US Chemical...Perc Consumer...

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Copyright © 2018 | www.khlaw.com Keller and Heckman LLP 1 U.S. Chemical Regulation – What to Expect and How to Prepare in 2018 March 15, 2018 Eric Gotting Keller and Heckman LLP Washington, DC Office +1 202.434.4269 [email protected] James Votaw Keller and Heckman LLP Washington, DC Office +1 202.434.4227 [email protected] Greg Clark Keller and Heckman LLP Washington, DC Office +1 202.434.4302 [email protected] Environmental Practice Group

Transcript of U.S. Chemical Regulation – What to Expect and How to ... Webinar - US Chemical...Perc Consumer...

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U.S. Chemical Regulation –What to Expect and How to Prepare in 2018

March 15, 2018

Eric GottingKeller and Heckman LLP

Washington, DC Office+1 202.434.4269

[email protected]

James VotawKeller and Heckman LLP

Washington, DC Office+1 202.434.4227

[email protected]

Greg ClarkKeller and Heckman LLP

Washington, DC Office+1 202.434.4302

[email protected]

Environmental Practice Group

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Eric Gotting

[email protected] • 202.434.4269

Eric Gotting is a partner at Keller and Heckman and focuses his practice on litigation and administrative law matters. He counsels and defends clients in environmental law, food and tobacco regulations, toxic torts, product liability, administrative procedure, and corporate law, as well as internal investigations and enforcement actions. Mr. Gotting counseled chemical companies during the TSCA reform efforts on preemption issues and works with clients on TSCA matters related to enforcement and product liability issues.

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Overview

Context: 2016 Amendments to TSCA

Risk evaluation of existing chemicals

Changes to EPA’s new chemical review program

TSCA Inventory reset reporting - implications for the value chain

TSCA fees proposed rule

Changes in treatment of Confidential Business Information

Nanoscale materials reporting obligations

Update on key chemical litigation

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James G. Votaw

James Votaw is an environmental law partner at Keller and Heckman focusing on regulation of new and existing conventional and nanoscale chemicals under the Toxic Substances Control Act (TSCA) and pesticides and pesticidal devices under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Among other things, James obtains pre-market approvals, negotiates testing orders, and defends enforcement actions under these statutes.

[email protected] • 202.434.4227

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Context - 2016 TSCA Reform

Toxic Substances Control Act (1976)

June 2016: Frank R. Lautenberg Chemical Safety for the 21st Century Act

Structural changes:

• Testing (§4): More practicable for EPA to compel

• TSCA Inventory (§8): Partial “Reset”

• New Chemicals (§5): Reduced EPA’s discretion in review

• Existing Chemicals (§6): Mandate to evaluate risks

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Risk Evaluation of Existing Chemicals

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Existing Chemicals: 3-Step Risk Evaluation Process

Prioritization screening to designate “high priority” and “low priority” substances for risk evaluation• Deadlines to push EPA work forward• 2017 “Prioritization Rule” to implement

Risk evaluation of “high-priority” substances• “Presents an unreasonable risk”?• Evaluated under “conditions of use” determined by EPA • Deadlines to push EPA work forward• 2017 “Risk Evaluation Rule” to implement

Risk management • §6(a) rules control identified risks to extent necessary• Deadlines to push EPA work forward

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Key Existing Chemicals Deadlines

December 2019: Complete Prioritization of 40 Substances • Designate 20 High-Priority and 20 Low-Priority

Chemicals

• 9-12 month process

• Prioritization candidates must be selected in 2018

December 2019: Complete Risk Evaluations for 1st 10• Using “systematic review” procedures

• “Scopes” issued in 2017 (particular uses to be evaluated)

• “Problem formulation statements” for 1st 10 to be issued in 2018

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First 10 Chemicals Slated to Undergo New TSCA “Risk Evaluation”

Chemical Identified Uses Hazard Information from 2014

Work Plan

1,4-Dioxane Consumer products. Possible human carcinogen

1-Bromopropane Consumer products. Possible human carcinogen

Asbestos

Chlor-alkali production, consumer products,

coatings and compounds, plastics, roofing

products, and other applications. imported

friction products, gaskets, packing materials

and building materials.

Known human carcinogen;

Acute and chronic toxicity from

inhalation exposures

Carbon Tetrachloride Commercial /industrial products. Probable human carcinogen

Cyclic Aliphatic Bromide

Cluster (HBCD)

Flame retardant in extruded polystyrene foam,

textiles, and electrical and electronic

appliances.

Acute aquatic toxicity

Methylene Chloride (MC) Consumer products. Probable human carcinogen

N-methylpyrrolidone (NMP) Consumer products. Reproductive toxicity

Pigment Violet 29 Consumer products. Aquatic toxicity

TCE Consumer products. Probable human carcinogen

Perc Consumer products and dry cleaning. Probable human carcinogen

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The “Prioritization” Process Signed June 22, 2017 (40 CFR Part 702)

Four-step process:1.Pre-Prioritization – Non-regulatory; EPA chooses which

substances to put into the formal prioritization process

2.“Initiation” – EPA collects and analyzes information on uses, hazards and exposures; 90-day comment period

3.“Proposed Designation” – EPA’s tentative designation as High- or Low-Priority; 90-day comment period

4.“Final Designation”

• High-Priority: go on to risk evaluation

• Low-Priority: No further action for time being

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Prioritization Timeline1st Comment

Period 2d Comment

Period

JAN 2019

FEB MAR APR MAY JUN JUL AUG SEP OCT NOVDEC 2019

Initiate Prioritization

40 substances

Propose 40 High/Low

priority designations

Designate 20 High-

Priority substances

2018

: P

re-P

rior

itiz

atio

n

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High- vs. Low-Priority

High Priority –• Substance MAY present an unreasonable risk of

injury to health or the environment because of apotential hazard and a potential route of exposure under the conditions of use

Low Priority – prove the negative

• EPA concludes that substance does not meet the standard for “High-Priority”

• EPA finding must be supported by substantial evidence

Without sufficient evidence, substances will default to High-Priority

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Prioritization Timeline

1st Comment Period

2d Comment Period

JAN 2019

FEB MAR APR MAY JUN JUL AUG SEP OCT NOVDEC 2019

Initiate Prioritization

40 substances

Propose 40 High/Low

priority designations

Designate 20 High-

Priority substances

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Does Prioritization Affect You?

1. Pigment Violet 29

2. Asbestos & Asbestos-like Fibers

3. 1-Bromopropane

4. Carbon tetrachloride

5. Decabromodiphenyl ethers (DecaBDE)

6. 1,4-Dioxane

7. Hexabromocyclododecane (HBCD)

8. Methylene chloride

9. N-Methyl-2-pyrrolidone (NMP)

10. Pentachlorothio-phenol

11. Tetrachloroethylene (PERC)

12. Trichloroethylene (TCE)

13. Tris(2-chloroethyl) phosphate (TCEP)

14. 2,4,6-Tris(-tert-butyl)phenol

15. Acetaldehyde

16. Acrylonitrile

17. tert-Amyl methyl ether

18. Antimony & Antimony Compounds

19. Arsenic & Arsenic Compounds

20. Barium Carbonate

21. Benzenamine

22. Benzene

23. Bisphenol A (BPA)

24. 1,3-Butadiene

25. Pigment Yellow 83

26. Butanamide, 2-[(4-methoxy-2-nitrophenyl) azo]-N-(2-methoxyphenyl)-3-oxo- (Pigment Yellow 65)

27. Butyl benzyl phthalate (BBP) 1,2-Benzene-dicarboxylic acid, 1-butyl 2(phenylmethyl) ester

28. 4-sec-Butyl-2,6-di-tert-butylphenol

29. Cadmium & Cadmium Compounds

30. Chromium & Chromium Compounds

31. Cobalt & Cobalt Compounds

32. Creosotes

33. Cyanide Compounds (Limited to dissociable compounds)

34. Dibutyl phthalate (DBP) (1,2-Benzene-dicarboxylic acid, 1,2-dibutyl ester)

35. o-Dichlorobenzene

36. p-Dichlorobenzene

37. 3,3'-Dichlorobenzidine

38. 3,3'-Dichlorobenzidine dihydrochloride

39. 1,1-Dichloroethane

40. 1,2-Dichloroethane

41. trans-1,2-Dichloroethylene

42. 1,2-Dichloropropane

43. Dicyclohexyl phthalate

44. Di-ethylhexyl phthalate (DEHP) (1,2-Benzene-dicarboxylic acid, 1,2-bis(2-ethylhexyl) ester )

45. Di-isobutyl phthalate (DIBP) (1,2-Benzene-dicarboxylic acid, 1,2-bis-(2methylpropyl) ester)

46. Di-isodecyl phthalate (DIDP) (1,2-Benzene-dicarboxylic acid, 1,2-diisodecyl ester)

47. Di-isononyl phthalate (DINP) (1,2-Benzene-dicarboxylic acid, 1,2-diisononyl ester)

48. 1,2-Dimethoxyethane (Monoglyme)

49. 2-Dimethylaminoethanol

50. Di-n-octyl phthalate (DnOP) (1,2-Benzene-dicarboxylic acid, 1,2-dioctyl ester)

51. Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,5,5-tetramethyl-2-naphthalenyl)-

52. Ethanone, 1-(1,2,3,4,5,6,7,8-octahydro-2,3,8,8-tetramethyl-2-naphthalenyl)-

53. Ethanone, 1-(1,2,3,4,6,7,8,8a-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl)-

54. Ethanone, 1-(1,2,3,5,6,7,8,8a-octahydro- 2,3,8,8-tetramethyl-2-naphthalenyl)-

55. Ethylbenzene

56. Ethylene dibromide

57. bis(2-Ethylhexyl) adipate

58. 2-Ethylhexyl 2,3,4,5-tetrabromobenzoate (TBB)

59. bis(2-Ethylhexyl) -3,4,5,6-tetrabromophthalate (TBPH)

60. Formaldehyde

61. 2,5-Furandione

62. Hexachlorobutadiene

63. 1-Hexadecanol

64. 1,3,4,6,7,8-Hexahydro-4,6,6,7,8,8-hexamethylcyclopenta [g]-2-

benzopyran (HHCB)

65. 2-Hydroxy-4-(octyloxy) benzophenone

66. Lead & Lead Compounds

67. Long-chain chlorinated paraffins (C18-20)

68. Medium-chain chlorinated paraffins (C14-17)

69. 4,4'-Methylene bis(2-chloroaniline)

70. 4,4'-(1-Methylethylidene)bis[2,6-dibromophenol] (TBBPA)

71. Molybdenum and Molybdenum Compounds

72. Naphthalene

73. 2-Naphthalenecarboxylic acid, 4-[(4-chloro-5-methyl-2-sulfophenyl) azo]-3-hydroxy-, calcium salt (1:1) (Pigment Red 52)

74. Nickel & Nickel Compounds

75. N-Nitroso- diphenylamine

76. Nonylphenol and Nonylphenol Ethoxylates (NP/NPEs)

77. Octamethylcyclotetra-siloxane (D4)

78. 4-tert-Octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol)

79. p,p'-Oxybis(benzenesulfonyl hydrazide)

80. Phenol, isopropylated, phosphate (3:1) (iPTPP)

81. Phosphoric acid, triphenyl ester (TPP)

82. Phthalic anhydride

83. Styrene

84. Tribromomethane (Bromoform)

85. 1,1,2-Trichloroethane

86. Triglycidyl isocyanurate

87. Vinyl chloride

88. m-Xylene

89. o-Xylen

90. p-Xylene

EPA’s 2014 TSCA Work Plan Chemicals

https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-work-plan-chemical-assessments-2014-update

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Implications for the Value Chain

• Lifecycle data may be critical to avoid adverse regulatory decisions

• No time to develop data after prioritization starts

• Initial prioritization and risk evaluation proceedings will set procedural precedents

• EPA plans to collect use, hazard and exposure data

• Risk of discovering past violations (§8(e)) or creating new violations (CBI cert, incomplete data) or contractual breaches (use of REACH data)

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What you should be doing now

Know all the substances important to your business

Know when they will be in play

Organize value chain to prepare and provide EPA with timely hazard and exposure data

Understand “systematic review” and prepare to identify substantive and process issues in systematic review risk evaluation

Shape the precedents - Participate in EPA’s work on first 10 risk evaluation chemicals and pre-prioritization for first 40 substances

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Changes to EPA’s New Chemical Review Program

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TSCA: Changes to “New Chemicals” Program

Prior “New Chemical” Review:• Can’t manufacture/import “new” chemicals until reviewed for risk

by EPA

• Company submits pre-manufacture notice (PMN)

• EPA had 90-days to regulate (or not)

2016 Statutory Changes:• EPA required to assess risks of “foreseeable” potential uses not

contemplated by PMN submitter

• EPA must issue affirmative, written risk determinations

• No deadline for EPA decisions (90-day limit functionally eliminated)

• Arguable loss of regulatory flexibility; obligation to issue “orders”

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Lautenberg Act Changes (§5)

“A” risk determination

Presents...

Must act under §5(f): Shall -

• Issue proposed §6(a) rule, or

• Issue a proposed 5(f) order; or

• Apply for an injunction

“C” risk determination

Not likely to present…

• Submitter may start manufacture

• Does not have to wait full 90 days• Determination subject to judicial

review

“B” risk determination

• Insufficient info, and or• May present…

Must act as required by §5(e): May

• Shall issue §5(e) order … to the extent necessary to protect against unreasonable risk; or if no order

• Must apply for an injunction

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Implications Very significant delays in bringing “new chemicals” to

market

• PBT chemicals no longer eligible for Low Volume Exemptions (LVE)

• EPA time-limiting some LVE approvals

• Unpredictable timelines: Reviews > six months; backlog?

• Requests for pre-market testing to assess risks of unintended uses

Many more subject to specific risk management rules

• 5(e) control order (personal to submitter);

• Significant New Use Rules (SNURs) (applicable to everybody)

Increased cost to introduce and use “new chemicals”

• Time, transaction, testing

• Ongoing order/rule compliance and management (e.g., export notice)

• Stigma of “regulated chemical” may chill customer interest

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EPA ResponseStaffing up to address backlog

Providing guidance to get “better” PMNs from industry

Looking at informal procedural changes to increase review speed (pre-notice consultation)

Experimenting with formal procedural changes

• “Two-step” Method: Order followed by SNUR

• Considering “one-step” SNUR-only process

• Not likely faster

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What Can/Should You Do?

• Anticipate extended review periods in business planning

• Consider useful PMN exemptions (temporary or permanent) Test Marketing, Low Volume, Export only

• Prepare better PMNs Perform a conservative risk assessment using EPA tools to

determine critical data gaps before submitting a PMN

Pre-notice consultations

Anticipate and answer use, hazard and exposure questions with data (voluntary)

• Advocacy to streamline review process

• Consider the implications of the new TSCA fee rule

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Gregory A. Clark

Greg Clark practices in the area of environmental law, advising clients on compliance with TSCA and the Lautenberg Act amendments to TSCA, the Clean Air Act, FIFRA, and other health, safety, and environmental laws and regulations in U.S. and foreign jurisdictions. Mr. Clark has a background in biotechnology and experience in emergency preparedness and analytical method validation.

[email protected] • 202.434.4302

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TSCA Inventory Reset Reporting

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TSCA Inventory “Reset”

Statutory requirement to “reset” TSCA Inventory

• §§8(b)(4)–(5)

EPA required to issue rule within one year of Lautenberg Chemical Safety Act (LCSA)

EPA must require manufacturers and importers to report

• Reporting period set by statute (180 days)

EPA “may” require processor reporting

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Retrospective Reporting

40 C.F.R. Part 710 Subpart B

Companies must report via CDX all non-exempt substances that they manufactured or imported for non-exempt purpose during the 10-year “lookback period”

• Lookback period: June 21, 2006 to June 21, 2016

Reporting by processors is voluntary

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Exemptions From Reset

Non-“chemical substances”

• e.g., food additives, pesticides

R&D / test marketing substances

Substances in processed/imported “articles”

720.30(g) and (h) exempt substances

• Byproducts, impurities, non-isolated intermediates, end-use, etc.

Export-only substances (unless EPA §12(a)(2) finding made)

“Interim active substances”

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“Interim Active” Substances

Reported for TSCA §8(a) CDR (by anyone) as being produced in 2010, 2011, 2012, 2013, 2014, or 2015

• i.e., reported for 2012 or 2016 CDR

Deemed “active” - do not need to report interim active substances for the Inventory reset

• But reporting required to maintain chemical identity as CBI

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Retrospective Reporting Timeline

Aug. 11, 2017 –Reporting Begins

Feb. 7, 2018 –Manufacturer/Importer

Reporting Ends

Oct. 5, 2018 –Processor

Reporting Ends

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Forward-Looking Reporting

Based on “retrospective” reports, EPA will subdivide Inventory into separate lists of “active”, “inactive” substances

“Inactive” substances prohibited from being manufactured, imported, or processed unless EPA notified (“forward-looking reporting”)

• EPA cannot delist inactive substances or require a PMN to change to active

• Submit Form B no earlier than 90 days before manufacture, import, or processing

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Processor Reporting

Retrospective reporting is voluntary October 5, 2018 deadline Why report?

• “Once and done”: no prospective reporting• Covers downstream processors (customers)

How-to• Identify “processed” vs. “used” substances

– Mixtures• Review interim active list• Eliminate exempt substances• Register for CDX and submit Form A

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Options for Missed Deadlines

Manufacturer/importer reporting due Feb. 7, 2018

Per substance penalties EPA “Audit Policy”

• Disclose and correct• Gravity-based penalties waived if nine

conditions met Statute of limitations for TSCA section 8: 5 years

• Does not resolve for downstream customers• If inactive, still need to report before

manufacture, import, or processing

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TSCA Fees Proposed Rule

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TSCA Fees Proposed Rule

Published Feb. 26, 2018; 60 days to comment

Significant increases in fees

• PMNs: $2,500 $16,000

• Exemption notices: $0 $4,700

Small businesses: increased fees, expanded definition

New fees

• Risk evaluations: $1.35M - $2.6M

• Test rule: $29,500 per substance

EPA expects consortia to form to pay fees

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TSCA Confidential Business Information Updates

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Confidential Business Information

EPA working on several actions relating to CBI

“Unique identifiers” rulemaking

Expanded CBI access

• LCSA permits EPA to disclose TSCA CBI to state and local governments, certain professionals, and emergency responders

• Three guidance documents released

No update (yet) to CBI regulations

EDF lawsuit on Inventory reset includes CBI issues

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Nanomaterials Reporting Under TSCA

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First EPA rule directed at Nanomaterials as a “class”• Aimed at NM already in commerce (existing chemicals)

• NM manufacturers, importers and processors

• Requires submission of pseudo-PMN:

Manufacture, processing and use information

Health data; exposure and environmental release

Not predicated on hazard or risk finding

Data use by EPA:

• Identify materials potentially warranting risk management

• Identify nanoscale materials in commerce

• Inform future “new chemical” (PMN) reviews

2017 – TSCA Reporting Rule for Nanomaterials

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Which Materials Are Subject to Reporting?

Reportable Chemical Substances

“Chemical substance”

Solid at 25°C and atmospheric pressure

Manufactured, imported or processed in a form with particles ≤ 100 nm in any one dimension

• Includes NM dispersed in liquids;

• Possible exemption for NM dispersed in solids / semi solids

• Aggregates / agglomerates >100 nm excluded

– Made to exhibit “Unique and Novel Properties”…

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“Unique and Novel Properties”

1. Size-dependent property

2. Property varies from property of larger form (>100 nm) of the same chemical substance

3. Intent: Property is a reason material was made / processed in the nanoscale size form

• Does not include merely enhanced properties that scale with size: Surface area; size, density; same but more vibrant pigment tones

• May exclude some exotics with no larger size form (e.g., carbon nanotubes)

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Exempt Materials:

Chemicals not on TSCA Inventory • “New chemicals,” LoREX, LVE, exempt polymers

R&D materials

NM solely as part of an article • But, not process of incorporating NM into an article

Unintentional impurities

NM that dissociate completely in water (i.e., salts)

DNA, proteins, other biologicals

Pesticides, food, drugs, cosmetics, tobacco

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What information must be reported?

• Specific chemical identity• Categories of use • Manufacture and processing

volumes• By-products of manufacture and

use• All existing data concerning

environmental and health effects• Physical-chemical properties

• No. of persons exposed in the workplace and extent of exposure

• Environmental release information

• Material characterization• Methods of manufacturing and

processing• Risk management practices

Like a PMN, but more extensive – 175 hours estimated

No obligation to develop new data (test) Due diligence standard: “Known to or reasonably ascertainable”

• All information known, possessed or controlled

• All information that a similarly situated reasonable person would know

• May include contacting vendors and key customers to fill data gaps

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Who Must Report?

• Manufacturers, Importers and Processors of NM that meet the reporting criteria

• One-time report, per company:1. For each reportable substance…

2. And for each “discrete form” of the substance

• Result: Many companies will report the same use of the same material E.g., each new customer of a NM supplier

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Discrete forms of NM substances also reported1. Different shape (morphology, e.g., tubes, rods); or

2. Different chemical coating or surface treatment; or

3A. Change in process intended to change properties (one or more):

3B. And - change in particle size (>± 7x the standard deviation)

3C. And - change in any of the other 4 properties (>± 7x mean SD)

Nanomaterials Subject to Reporting

• Particle size• Zeta potential• Specific surface area

• Dispersion stability; or• Surface reactivity

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When are reports due?

• For current & former (last 3 years) M/I/Ps:

Aug. 14, 2018 (1 year from effective date)

• For all future M/I/Ps (i.e., commencing after 08-14-17):

Report 135 days before commencing M/I/P of the reportable substance; or

Report 30 days “after forming intent” to M/I/P

Source: Working Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce (Aug. 2017)

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When is intent to manufacture formed?

“Formation of intent” starts compliance clock, but not defined in rule

Guidance: “Taking one or more actions necessary to engage in the commercial activity”

Examples:• R&D complete and company begins scale-up of pilot

process toward full scale

• Execution of contracts for delivery of reportable substances (alone or in mixture) to be processed

• Significant modifications made to operations / equipment to accommodate or make the reportable substance

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When are reports due?

Source: Working Guidance on EPA’s Section 8(a) Information Gathering Rule on Nanomaterials in Commerce (Aug. 2017)

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Controversial Forward-Looking Reporting

135-day reporting: Problematic

• Plain rule language requires waiting 135 days after reporting

• Would function like an illegal SNUR if companies were required to wait

• Notwithstanding rule language, preamble / guidance assert waiting 135 days is not required

30-day alternative option may be impracticable

• 30-days from formation of intent is not enough time to report (5+ hrs/day every day for 30 days)

• No reason to provide such short time frames

May need to control “intent formation” date

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NM Reporting Rule Next Steps

New manufacturers and processors of reportable nanoscale materials subject to reporting obligations now• Reduce burden on customers (processors)• Document non-applicability

Past manufacturers / processors’ reports due August 14, 2018• Allow enough lead time • Review historic materials using exclusion criteria “Unique and novel,” size

A number of reporting uncertainties remain • Remaining uncertainties may require experience / case-

by-case resolution• Get guidance

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Key Chemical Litigation Update

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Key Litigation: TSCA Section 21 Background

“Any person” may petition EPA to issue, amend, or repeal certain rules

• Section 4 chemical test rules

• Section 8 rules requiring information reporting

• Section 5(e) orders affecting new chemical substances

• Section 6 rules imposing regulatory controls

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Key Litigation: How Section 21 Works

Petition must “set forth the facts”

EPA has 90 days to deny or grant petition

If granted, EPA initiates proceedings

If denied, EPA publishes reasoning in Federal Register

Petitioner may file action in federal district court if petition is denied or EPA fails to respond

• “preponderance of the evidence”

• “de novo proceedings”

• Under Section 6, proceed straight to imposing regulatory restrictions, thus skipping over risk assessment

NGOs can get costs and attorneys’ fees

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Key Litigation: Fluoridation Case

Food & Water Watch, Inc. v. EPA, Case No. 3:17-cv-02162 (N.D. Cal.)

• Seeks Section 6(a) rule banning fluoridation of drinking water supplies

EPA denied previous Section 21 petition

• Petitioners filed lawsuit asking court to review EPA’s denial

EPA filed a motion to dismiss based on procedural grounds

• Petitioners failed to identify specific fluoridation chemicals/category

• Petitioners failed to address “all” conditions of use for fluoridation chemicals

Court denied EPA’s motion to dismiss

• Petitioners sufficiently identified the chemicals/category

• Section 21 petitions do not need to identify “all” conditions of use

Environmental and consumer non-profits filed amicus brief

• Court cited amicus brief in support of denial

• Industry did not file an amicus brief

Court’s review not limited to administrative record

• “de novo proceedings” means NGOs can introduce additional evidence

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Key Litigation: Takeaways from Fluoridation Case

Will see increase in litigation under Section 21

Difficult for EPA to avoid trial on the merits

NGOs get second bite at the apple under de novo review

Increased uncertainty when judge, not EPA, makes decision

Industry should consider intervening in litigation

Impact of expanding court’s “de novo” review

Industry should consider filing amicus briefs

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Key Litigation: EPA Framework Rules and Guidance

Prioritization and Risk Assessment Rules

• Safer Chem. Healthy Families, et al. v. EPA, No. 17-72260 (9th Cir.)

Inventory Notification Rule

• Envtl. Def. Fund v. EPA, No. 17-1201 (D.C. Cir.)

New Chemicals Decision-Making Framework

• Natural Res. Def. Council v. EPA, No. 18-25 (2d Cir.)

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The Next TSCA 30/30:Wednesday, April 11, 2018

register at: www.khlaw.com/tsca3030

30-minute complimentary webinar each month on a current chemical regulatory topic

Also: Keller and Heckman’s OSHA 30/30 and FIFRA 30/30 series

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