EPA s Evolving Approach to New Polymers Under TSCA June 14, 2017

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1 EPA s Evolving Approach to New Polymers Under TSCA June 14, 2017 Copyright Keller and Heckman LLP 1

2 Please Don t Forget to Dial-In: Conferencing Number: (800) Access Code: (View the slides via webinar, and the sound via phone) Copyright Keller and Heckman LLP 2

3 Thomas C. Tom Berger Tom Berger has a chemical engineering background and is a partner at Keller and Heckman. His practice focuses on the regulation and approval of new and existing chemicals under the Toxic Substances Control Act (TSCA) and its international counterparts in Australia, Canada, China, the European Union, Japan, Malaysia, New Zealand, the Philippines, South Korea, and Taiwan. Mr. Berger also counsels trade association clients on various matters, including environmental, product disparagement, and defense issues. Mr. Berger has been heavily involved in efforts to "reform" TSCA, EPA's Chemical Data Reporting (CDR) rule, TSCA "Work Plan Chemicals," and "green chemistry" issues. berger@khlaw.com Copyright Keller and Heckman LLP 3

4 Marisa Kreider, PhD DABT Dr. Kreider is a Senior Managing Health Scientist and board-certified toxicologist at Cardno ChemRisk. She serves as the firm s Practice Area Lead for Toxicology, and has experience in designing and managing toxicity testing, conducting exposure and risk assessments, and supporting clients in regulatory compliance and product stewardship/sustainability efforts. She has over 10 years of experience as a consultant in the areas of human health risk assessment. marisa.kreider@cardno.com Copyright Keller and Heckman LLP 4

5 Today s Agenda Statutory changes impacting polymers PMN backlog and review period (RP) issues Issuance of new polymer options letters New polymer concern categories Testing and PPE requirements Copyright Keller and Heckman LLP 5

6 Statutory Changes Impacting Polymers Still must submit PMN (or SNUN) at least 90 days before commencing new substance or activity Under LCSA, EPA must review notice and during RP make affirmative 5(a)(3) (A), (B), or (C) determination for chemical Based on conditions of use circumstances, as determined by the Administrator, under which a chemical substance is intended, known, or reasonably foreseen to be manufactured, processed, distributed in commerce, used, or disposed of No consideration of cost or non-risk factors Must include risk to susceptible populations TSCA polymer exemption remains valid Copyright Keller and Heckman LLP 6

7 Section 5(a)(3) Determinations (A) Determination substance/snu presents unreasonable risk (B) Determination (i) information insufficient to permit reasoned evaluation of substance/snu; or (ii(i)) in absence of sufficient information and evaluation substance may present unreasonable risk; or (ii(ii)) substance is/will be substantial quantities, and enters/may enter environment in substantial quantities or is/may be significant or substantial human exposure (C) Determination substance/snu is not likely to present an unreasonable risk Copyright Keller and Heckman LLP 7

8 Section 5 Actions Required (A) determination ( presents ): must use 5(f) and must issue order or rule (B) determination ( insufficient, may present, or exposure-based): must use 5(e) and must issue order and followup with SNUR (C) determination ( not likely ): may commence non-exempt production even before review period ends Copyright Keller and Heckman LLP 8

9 New General EPA Approach to PMNs Statute does not contemplate non-5(e) SNUR approach Thus EPA proposing to: Work with submitter to determine conditions under which PMN substance not likely to pose unreasonable risk Issue negotiated TSCA section 5(e) order to bind company to those conditions Issue SNUR that would require SNUN for other conditions i.e., (j) SNUR Copyright Keller and Heckman LLP 9

10 PMN Backlog EPA receives ~1,000 PMNs per year At any one time, EPA has ~300 cases under review In June 2016 EPA had 334 cases EPA reset review periods pending as of June 22, 2016 Between June 22, 2016 and June 6, 2017: PMN/MCAN/SNUN reviews completed (397 total) Allowed to commercialize without restrictions - 83 Allowed to commercialize with restrictions (includes insufficient info findings) Not allowed to commercialize pending development of information (includes insufficient info findings) - 3 Banned determination - 0 Cases withdrawn 117 Cases under review as of June 6, EPA plans to eliminate backlog by end of July Copyright Keller and Heckman LLP 10

11 Review Period Length Submitter may voluntarily suspend running of RP if EPA agrees Section 5(c) allows EPA to unilaterally extend period via FR notice for up to 90 days Historically rare Copyright Keller and Heckman LLP 11

12 PMN Options Letters EPA historically issued Options letters near end of RP, providing option to: 1) enter into expedited 5(e) order - testing (normally triggered), PPE, H 2 0 release, etc. 2) submit info to refute EPA s findings 3) withdraw Beginning in mid/late 2016 for most if not all polymers EPA expressed concerns, provided option to: 1) enter into 5(e) order and conduct upfront 90-day study 2) suspend RP until April 30, 2017 and await results of EPA unpublished/published literature search 3) submit full toxicity studies on substance or analog, or other information 4) withdraw Copyright Keller and Heckman LLP 12

13 New EPA Options Letters Beginning May 2017, following completion of literature review EPA began issuing new options letter for polymers ~ two-page boilerplate letter + 45 pages of attachments response requested within 30 days Four categories: 1) general surfactants 2) polycationic substances 3) waterproofing agents 4) polymer lung overload Three options: 1) enter into negotiated 5(e) order 1) different requirements/testing for each category 2) upfront data submission before EPA makes final 5(a)(3) determination 3) withdraw Copyright Keller and Heckman LLP 13

14 What Types of Polymers are Drawing Attention? General Surfactants Polycationic Substances Waterproofing Agents Insoluble Polymers Includes cationic, anionic and non-ionic surfactants Any polymer or substance with multiple functional groups bearing positive charges (e.g. polyamines) Compound applied to solid surface to confer resistance to water, grease or stains (e.g. silanes, alkoxy silane resins, fluoro acrylate resins, other fluorinated agents) Includes a variety of poorly soluble polymers that could result in lung overload (e.g. polyvinyls and polyacrylates) Hazards: Impaired pulmonary function via interference with pulmonary surfactants Hazards: Severe pulmonary toxicity (organizing pneumonia and bronchiolitis obliterans) Hazards: Acute pulmonary toxicity ranging from cough and SOB to pulmonary edema, hemorrhage, respiratory failure and death Hazards: Inflammation, fibrosis, cancer Copyright Keller and Heckman LLP 14

15 Risk Management Framework Options letters spell out risk management options for these categories of chemicals Includes physical chemical property testing, toxicity testing, and PPE requirements Focused on understanding risk based on: Exposure - is it probable? What is it? Hazard - established New Chemical Exposure Limits (NCELs) Copyright Keller and Heckman LLP 15

16 Initial Screening Testing Particle Size Distribution Is it in the Respirable Range? YES- Restriction/other action via likely Consent Order NO- Evaluate other factors Other Factors: -Surfactants and Waterproofing agents- surface tension measurements -Polycationic compounds- Charge density -Insoluble Polymers- Biosolubility Testing Copyright Keller and Heckman LLP 16

17 Occupational Exposure Decision Tree Occupational Exposure Predictions/Data No Data < Maximum Use Concentration (50 x NCEL) Below NCEL Respirator with APF of 1000 Respirator with APF of 50 No respirator Copyright Keller and Heckman LLP 17

18 Toxicity Testing Requirements Step 1: Acute Inhalation Toxicity Test (OECD 403) If LOAEC < 2000 mg/m 3, proceed to step 2 Step 2: 5-day repeated dose study If there is a decrease in point of departure or increase in severity from Step 1, proceed to step 3 28-day inhalation study (OECD 412) Additional tier of testing for insoluble polymers -90-day inhalation study -2-year carcinogenicity study (contingent on 90-day study results) Copyright Keller and Heckman LLP 18

19 The Next TSCA 30/30: July 12, 2017 For more information on past and future TSCA 30/30 programs, please visit and for the most up-to-date TSCA news For those of you interested in Workplace Safety and Health matters, check out our OSHA 30/30 program, Copyright Keller and Heckman LLP 19

THANK YOU Thomas C. Tom Berger berger@khlaw.

20 THANK YOU Thomas C. Tom Berger Marisa Kreider, PhD DABT Copyright Keller TSCA and Heckman 30/30 LLP 20

See Toxic Substances Control Act ( TSCA ) 5(a)(3)(A), 15 U.S.C. 2604(a)(3)(A). 2. See TSCA 5(a)(3)(B)(ii)(I), 15 U.S.C. 2604(a)(3)(B)(ii)(I).

See Toxic Substances Control Act ( TSCA ) 5(a)(3)(A), 15 U.S.C. 2604(a)(3)(A). 2. See TSCA 5(a)(3)(B)(ii)(I), 15 U.S.C. 2604(a)(3)(B)(ii)(I). New Chemicals Decision-Making Framework: Working Approach to Making Determinations under Section 5 of TSCA November 2017 Introduction. This document outlines EPA s approach to making decisions on new chemical