211123 Coalition Comments PFAS Categories SABBOSC

Published

November 30, 2021

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Dear Dr. Cullen and Dr. Gilman:

The undersigned organizations urge you to consider additional public input regarding underpinning science and associated approaches for developing possible categories to regulate per-and polyfluoroalkyl substances (PFAS). We support EPA’s commitment in the recent PFAS Roadmap to follow the science and are pleased that the agency indicated that it would not regulate PFAS as a class. This aside, the National PFAS Testing Strategy was released in October 2021. These test orders were issued far in advance of the Agency’s PFAS categorization framework that we view as essential to a logical pursuit of test orders to obtain data critical for informing the Agency about PFAS hazards, exposure, and risk. Furthermore, the strategy and test orders were developed and submitted without feedback from the impacted industries and without the scientific assessment and advice of the SAB and BOSC.

To assist with the SAB and BOSC review, the business community provides the following concepts and factors essential for the soundest scientific and technical groupings of PFAS chemistries into categories. These concepts and factors are intended to provide suggestions that will scientifically support a sound framework that regulators can use in evaluating whether and when to group substances for a variety of regulatory purposes. The list identifies questions regulators should address when examining whether and when grouping may be appropriate, even if different answers are reached for different substances or situations. These grouping principles include considerations identified by multiple sources and are consolidated here to provide a broad view of relevant issues when evaluating grouping substances, not just PFAS for regulatory purposes. Source identification appears at the end of the document in Appendix 1.

Our collective organizations ask that SAB and BOSC technical experts recommend that EPA develop potential categories based on a robust analysis of these principles and that EPA conduct this analysis as the Agency considers issuing test orders under TSCA. Through this recommendation, the public can be confident that EPA is following the best available science and not predetermining answers without appropriate evaluation. We also request that you propose to EPA that additional public deliberation and stakeholder engagement are needed, including with the business community, scientific experts, NGOs, and community leaders.

Concepts and factors:

Identification Considerations

  • Can the substances included in a grouping be clearly identified? (17)
  • Is there a validated method to test for the grouped substances or each individual substance within a group in the relevant media? (17)
  • How many substances would be included if all criteria are applied? (17)

Structural Considerations

  • Are the substances structurally similar? (3, 6,11, 13, 14) Do the substances have the same or similar functional groups? (1, 3, 6, 7, 9, 12, 14)
  • Do the substances have similar molecular weight? (3, 6, 10, 13, 14)
  • Is the physical state (solid, liquid, gas) of the substance under relevant conditions the same? (17)
  • Are particles or supermolecular structures relevant? For example: size, shape, density, arrangement of molecules, or 3D-structure. (4, 11)

Toxicological Considerations

  • Is the toxicological endpoint the same for an identified category? (7)
    • Are the substances associated with similar adverse effects (i.e., all category members are hepatoxic and produce identical pathological changes that can be verified with dose-dependency and replication across studies?)
  • Are chemistries similarly bioaccumulative? (17)
    • What parameters will be used to establish common bioaccumulative properties for a specific PFAS category (e.g., clearance rates, target organ tissue distribution similarities, metabolism similarities)?

Exposure Considerations (1,2)

  • Do the grouped substances have similar exposure frequency and duration? (17)
  • Do the grouped substances present cumulative risk? (17)
  • Is the time frame of exposure and potential for adverse effects the same? (17)

Ecological Considerations

  • Are the fate and transport characteristics the same? (15, 17)
    • Is the level of persistence in the environment similar for the grouped substances?17
  • Are the grouped substances responsive to the same remedial techniques?17
  • Are the ecotoxicological effects similar?17

Quality of Evidence Considerations

  • Are there uncertainties or missing data for one or more substances proposed for inclusion in a group? (17)
  • Are there objective measures supporting data quality?
    • Have the data used to support the grouping decision been selected through a recognized assessment methodology to evaluate the quality of the literature? (7)
    • If weight of evidence or other expert judgment methods have been used, was the reasoning available for public review and comment? (7)
    • Has there been an independent scientific peer review of the grouping approach for which the public has an opportunity to comment on the proposed panelists, charge questions, and review materials? (16)
    • Does the independent peer review panel have the opportunity to hear public comments and ask the opinion of independent scientific experts? (16)
  • Have data drawn from different evidence streams (e.g., in vitro, in vivo, mechanistic, animal studies) been integrated using quantitative methods? (7)

Legal and Regulatory Considerations

  • Can the method of grouping be applied consistently for regulatory purposes?
  • Does the grouping include substances with essential/critical uses? (17)

Our coalition is committed to working with regulators, Members of Congress, interested stakeholders, and technical experts to establish standards that protect human health and the environment through a risk-based approach that will accelerate clean-ups in communities across our nation. Scientifically sound groupings will help. We welcome the opportunity to discuss these issues with you during your upcoming public meetings and stand ready to assist you.

If you have any questions, please contact Chuck Chaitovitz, Vice President, Environmental Affairs and Sustainability at the U.S. Chamber of Commerce at cchaitovitz@uschamber.com.

Sincerely,

American Apparel & Footwear Association

American Coatings Association

American Farm Bureau Federation

American Forest & Paper Association

American Fuel and Petrochemical Manufacturers

American Petroleum Institute

National Association of Chemical Distributors

National Association of Printing Ink Manufacturers

National Council of Textile Organizations

National Milk Producers Federation

National Mining Association

Plastics Industry Association

PRINTING United Alliance

U.S. Chamber of Commerce

cc: Radhika Fox, Assistant Administrator, Office of Water

Dr. Michal Freedhoff, Office of Chemical Safety and Pollution Prevention

Deb Szaro, Acting Administrator, Region 1


APPENDIX 1: CITATIONS

1. European Chemicals Agency (ECHA). Grouping of Substances and Read-Across.

https://echa.europa.eu/support/registration/how-to-avoid-unnecessary-testing-onanimals/

grouping-of-substances-and-read-across (ECHA cites REACH Annex XI,

Section 1.5 for identifying conditions for grouping).

2. European Chemicals Agency (ECHA). Work on Groups–Getting to Safer Use of

Chemicals Faster.

https://echa.europa.eu/documents/10162/10543934/work_on_groups_kuster_20211006_e

n.pdf/bfe99239-f814-b1f2-e50b-79c27380aa1a?t=1633513173424

3. European Commission. Technical Assistance Related to the Review of REACH with

Regard to the Registration Requirements on Polymer Final Report (2015).

https://ec.europa.eu/environment/chemicals/reach/pdf/FINAL%20REPORT%20POLYM

ER%20SI671025.pdf

4. Hartmann et. al. Are We Speaking the Same Language? Recommendations for a

Definition and Categorization Framework for Plastic Debris, Environmental Science &

Technology, 2019, 53, 1039–1047. https://pubs.acs.org/doi/10.1021/acs.est.8b05297

5. National Research Council 2014. Review of EPA’s IRIS Process. Washington, D.C.:

The National Academies Press. https://doi.org/10.17226/18764. See Box 8-1, the NRC’s

list of high-priority reforms.

6. OECD (2009). Data Analysis of the Identification of Correlations between Polymer

Characteristics and Potential for Health or Ecotoxicological Concern, OECD Task Force

on New Chemicals Notification and Assessment, Expert Group Meeting on Polymers;

2007 Mar; Tokyo, Japan. Paris (FR). https://www.oecd.org/env/ehs/riskassessment/

42081261.pdf

7. OECD (2017). Guidance on Grouping of Chemicals, Second Edition, Series on Testing &

Assessment. No. 194. https://www.oecd-ilibrary.org/docserver/9789264274679-

en.pdf?expires=1635227239&id=id&accname=guest&checksum=A7791CDC142A12E1

3A6E6AC6820C5427

8. OECD (2018). Considerations for Assessing the Risk of Combined Exposure to Multiple

Chemicals, Series on Testing and Assessment. No. 296, Environment, Health and Safety

Division, Environment Directorate.

9. Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH), Annex

XI, Section 1.5. https://reachonline.eu/REACH/EN/REACH_EN/articleXI.html

6

10. TR 133-1 – The ECETOC Conceptual Framework for Polymer Risk Assessment

(CF4Polymers). https://www.ecetoc.org/wp-content/uploads/2019/06/ECETOC-TR133-

1CF4Polymers.pdf TR 133-2 – The Applicability of Analytical Tools, Test Methods and

Models for Polymer Risk Assessment. https://www.ecetoc.org/wpcontent/

uploads/2020/03/ECETOC-TR133-2.Polymers-Risk-Asessment.pdf TR 133-3 –

A Selection of Case Studies Addressing Different Components of Polymer Grouping and

RA to Put the CF4Polymers into Practice. https://www.ecetoc.org/wpcontent/

uploads/2021/10/ECETOC-TR-133-3-CF4Polymers-Case-Studies.pdf

11. U.S. Environmental Protection Agency. National PFAS Testing Strategy.

https://www.epa.gov/system/files/documents/2021-10/pfas-natl-test-strategy.pdf

12. U.S. Environmental Protection Agency. Office of Pollution Prevention and Toxics,

Chemical Categories. https://www.epa.gov/sites/default/files/2017-

12/documents/presentation_4_and_5_-

categoriessustainable_futures_december_6th_pub.pdf

13. U.S. Environmental Protection Agency, Office of Pollution Prevention and Toxics,

TSCA New Chemicals Program (NCP): Chemical Categories.

https://www.epa.gov/sites/default/files/2014-

10/documents/ncp_chemical_categories_august_2010_version_0.pdf

14. U.S. Environmental Protection Agency, Polymer Exemption Guidance Manual (1997).

https://www.epa.gov/sites/default/files/2015-03/documents/polyguid.pdf

15. U.S. Environmental Protection Agency, Risk Assessment Forum, Framework for

Cumulative Risk Assessment (2003). https://www.epa.gov/sites/default/files/2014-

11/documents/frmwrk_cum_risk_assmnt.pdf

16. U.S. Office of Management and Budget. Final Information Quality Bulletin for Peer

Review, Peer Review Bulletin 70 FR 2671-2672.

17. These principles are based on an overall review of the literature and general scientific

principles that can be found in numerous supporting sources.