REGULATORY MEMORANDUM

ELI Concludes Another Successful Annual TSCA Conference

On June 30, 2021, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform - Five Years Later.” This virtual conference marked the fifth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers covered a variety of topics, including the systems of risk evaluation and risk management, environmental justice, regulating per- and polyfluoroalkyl substances (PFAS), new chemicals, and more. The over 600 program registrants demonstrate the continuing interest in the U.S. Environmental Protection Agency’s (EPA) challenging implementation of TSCA.

Lynn R. Goldman, M.D., M.S., M.P.H., Michael and Lori Milken Dean, Milken Institute School of Public Health, Professor of Environmental and Occupational Health, George Washington University, welcomed attendees and provided an overview of the conference.

Michal Ilana Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention, led the morning keynote discussion. Dr. Freedhoff provided a preview of how EPA will move forward with the risk evaluations of the first ten chemicals evaluated under amended TSCA. As reported later in EPA’s press release, EPA has made the following policy changes regarding risk evaluations:

  • Whole Chemical Approach: In the final risk evaluations for the first ten chemicals, EPA made separate unreasonable risk determinations for each condition of use for each chemical. EPA will withdraw the previously issued orders for those conditions of use for which no unreasonable risk was found, issue revised unreasonable risk determinations for these chemicals as a “whole substance,” and seek public comment. Freedhoff noted that this policy shift will not require EPA to change the analyses underlying the risk evaluations. Whether everyone agrees with that conclusion is debatable.
     
  • Use of Personal Protective Equipment (PPE): Unlike the previous Administration, which generally assumed in the final risk evaluations that PPE was always provided to and used by workers, the Biden-Harris EPA is revisiting this assumption. EPA will consider PPE use and other ways that employers limit employee exposure during the risk management phase. According to Freedhoff, removing this assumption does not require new analysis. This shift could change some of the conclusions about risk for some conditions of use for six of the first ten chemicals for which “no unreasonable risk” findings were made, however. According to EPA’s press release, this shift could impact conclusions about risk for some conditions of use for methylene chloride, 1-bromopropane (1-BP), cyclic aliphatic bromide cluster (HBCD), N-Methylpyrrolidone (NMP), perchloroethylene, and 1,4-dioxane.
     
  • Expanding Consideration of Exposure Pathways and Fenceline Community Exposure Screening Level Approach: The previous Administration chose not to consider air, water, and soil contamination because these exposures are already regulated under other environmental laws such as the Clean Air Act (CAA), Safe Drinking Water Act (SDWA), and Clean Water Act (CWA). EPA intends to reopen the 1,4-dioxane risk evaluation to consider exposures through drinking water, ambient air, and occupational exposures where 1,4-dioxane is generated as a byproduct and that were not considered. There will be a public comment period on any proposed revisions to the risk evaluation.

For six chemicals, methylene chloride, trichloroethylene, carbon tetrachloride, perchloroethylene, NMP, and 1-BP, EPA will identify risks posed by the chemicals to fenceline communities. EPA will sample air and water, work with its air and water offices, and use a screening level approach going forward. If EPA determines that there is no unreasonable risk to fenceline communities, it will move forward to the risk management stage. If EPA finds that there may be an unreasonable risk that cannot be addressed without supplementing the risk evaluation or through the risk management approaches being considered, EPA will conduct a more comprehensive exposure assessment of fenceline communities and supplement the risk evaluation for that chemical with the new information.

The TSCA Scientific Advisory Committee on Chemicals (SACC) will peer review the screening level approach, and EPA will update the methodology based on SACC and public comments.

  • Chemicals Moving to Risk Management: EPA has reviewed the risk evaluations issued for HBCD, C.I. Pigment Violet 29 (PV29), and asbestos (part 1: chrysotile asbestos) and believes the risk evaluations are likely sufficient to inform the risk management approaches being considered. Moving forward, EPA intends to reissue the risk determinations that amend the approach to PPE and include a whole chemical risk determination for these three chemicals. EPA is also “working expeditiously” on risk management and believes the proposed rules for these three chemicals will likely be the first of the ten to be ready for release.
     

Robert M. Sussman, Principal, Sussman & Associates, moderated Panel 1: Risk Evaluation under TSCA. Panelists included Ryan Carra, Ph.D., Principal, Beveridge & Diamond, P.C.; Penny Fenner-Crisp, Ph.D., Environmental Protection Network; Suzanne Hartigan, Ph.D., Senior Director, American Chemistry Council (ACC); and Jon Kalmuss-Katz, Supervising Staff Attorney, Earthjustice. Panelists discussed whether EPA met its statutory objectives in the first ten risk evaluations. Fenner-Crisp stated that EPA failed to use its expanded authority such as requiring chemical testing under TSCA Section 4. According to Hartigan, EPA’s goal should be to have final risk evaluations that have sufficient detail for risk management decisions to be made. Carra stated that there were some stakeholder comments submitted on the final risk evaluations, and EPA should consider these comments as it reviews the final risk evaluations. Kalmuss-Katz noted that with respect to what EPA has proposed to consider on remand in cases challenging the final risk evaluations, what EPA has proposed to consider is limited and does not address all the issues raised in the lawsuits. The panelists discussed whether EPA should use a whole chemical approach to conditions of use or a use-by-use approach, as well as the decision to exclude environmental exposures addressed under other environmental statutes and programs.

Jeffery T. Morris, Ph.D., Jeff Morris Solutions, LLC, moderated Panel 2: Risk Management under TSCA. The panelists included Eve C. Gartner, Managing Attorney, Toxic Exposure & Health Program, Earthjustice; Randy S. Rabinowitz, Executive Director, OSH Law Project LLC; Sara Beth Watson, Of Counsel, Steptoe & Johnson LLP; and Kimberly Wise White, Ph.D., Vice President, Regulatory and Technical Affairs, ACC. Gartner stated that knowing what chemicals are on the Work Plan is an important factor that stakeholders need to take into account. Manufacturers and processors should understand now where in the supply chain those chemicals are used. Watson suggested that EPA needs to ensure that it appropriately understands the consequences of rules like the final persistent, bioaccumulative, and toxic (PBT) rules, but manufacturers need to understand what is in their supply chain. According to Wise White, referrals to other agencies to manage risks will be critically important. EPA does not have to rely just on itself, but can also rely on the expertise of other agencies and other program offices and coordinating that thinking will be crucial. Rabinowitz described the importance of coordination, stating that EPA can learn a lot about occupational risk management from the Occupational Safety and Health Administration (OSHA) and the National Institute for Occupational Safety and Health (NIOSH). According to Rabinowitz, EPA may still mischaracterize OSHA regulations and think that OSHA has the ability to enforce compliance with warnings on safety data sheets (SDS).

Lynn L. Bergeson moderated Panel 3: TSCA and Environmental Justice. Panelists included Dianne Barton, Council Chair, National Tribal Toxics Council; Marianne Engelman-Lado, Deputy General Counsel, Environmental Initiatives, EPA Office of General Counsel; Timothy W. Hardy, Partner, Breazeale, Sachse & Wilson, L.L.P.; and Adrienne Hollis, Ph.D., Senior Climate Justice and Health Scientist, Union of Concerned Scientists. Hollis commented on the importance of science and scientific integrity being back in EPA’s work. Engelman-Lado described the type of outreach that EPA should do to ensure that it has both relevant data about exposures and data from the populations that are most affected. Barton stated that TSCA should not be a gap-filling statute but rather the primary statute for controlling chemicals. For TSCA to be effective, EPA needs to seek out and identify the most exposed populations and evaluate their exposure pathways. According to Hardy, EPA did not meet its responsibility in identifying vulnerable populations and susceptible subpopulations by failing to consider factors such as life stage, genetics, disease status, or nutrition. EPA needs to consider what happens at fencelines, to drinking water and surface water sources, and during disposal. Hardy suggested that industry include stakeholders who typically cannot afford to be at the table. Industry should work with local communities and with government to provide assistance grants to ensure that communities are at the table.

Bonnie Englebardt Lautenberg provided the luncheon keynote. She described the work involved in passing the Frank R. Lautenberg Chemical Safety for the 21st Century Act in 2016. She is currently working on a book on Frank Lautenberg’s life, and her next project will be a documentary on Lautenberg and TSCA.

Lawrence E. Culleen, Partner, Arnold & Porter Kaye Scholer LLP, moderated Panel 4: New Chemical Review. Panelists included Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P.; Richard A. Denison, Ph.D., Lead Senior Scientist, Environmental Defense Fund (EDF); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Daniel Rosenberg, Director, Federal Toxics Policy, Healthy People & Thriving Communities Program, Natural Resources Defense Council (NRDC). The panelists discussed issues such as how EPA should consider reasonably foreseeable conditions during its review of new chemicals, the differences between a consent order and a significant new use rule (SNUR), and the issues involved in EPA providing timely information to the public on new chemical submissions.

Sussman moderated Panel 5: TSCA and PFAS. Panelists included Dennis R. Deziel, B&C and former Administrator for EPA Region I; Liz Hitchcock, Director, Safer Chemicals Healthy Families; Robert J. Simon, Vice President, Chemical Products and Technology and Chlorine Chemistry, ACC; and Betsy Southerland, Issue Team, TSCA, Environmental Protection Network. The panelists discussed PFAS and whether and how TSCA can be used to mitigate its risks. For EPA to proceed with a TSCA rulemaking, it needs to have data concerning the risks posed to human health and the environment. Simon suggested that using subcategories for PFAS would recognize the differences among all PFAS and allow EPA to focus on prioritizing, evaluating, and managing the risks posed by the subclasses of PFAS. Southerland stated that EPA should use its TSCA Section 4 and Section 8 authority to obtain analytical standards already developed by industry or require industry to develop them. According to Southerland, EPA’s recent reporting rule should be expanded to include processors and EPA should make non-confidential business information available as quickly as possible.

Bergeson moderated Panel 6: TSCA Litigation Update. The panelists included Martha E. Marrapese, Partner, Wiley Rein LLP, and Gavin McCabe, Special Assistant Attorney General, New York State Office of Attorney General. Bergeson noted that many of the questions prepared before the webinar were potentially no longer relevant in light of EPA’s announced path forward for TSCA chemical risk evaluations. Marrapese stated that Freedhoff’s announcement is an attempt by EPA to “get its arms around” the TSCA Section 6 litigation. McCabe discussed EPA’s motions in several risk evaluation cases to remand the final risk evaluations without vacatur. Marrapese suggested that TSCA Section 21 and citizen petitions could be the new “gap filler.” EPA may not handle discretionary requests well, but once ordered by a court to address an issue, EPA adjusts its priorities.

John Pendergrass, Vice President, Programs & Publications, ELI, provided concluding remarks.

Commentary

The conference was hugely successful in several respects. As noted, over 600 people registered for the program. This reflects the intense interest in EPA’s implementation of TSCA. While Lautenberg was enacted five years ago, it is plainly the gift that keeps on giving with respect to challenging legal, regulatory, and political issues.

It also reflects a fact that commercial entities in the industrial chemical community have been slow to acknowledge -- EPA’s implementation of TSCA is directly and specifically implicating non-traditional members of the commercial value chain. One need only review the TSCA Section 6(h) PBT rulemaking as it relates to PIP (3:1) to get a whiff of the inconvenient fact that finished product importers are the newest stakeholder group to be acquainted with TSCA’s broad jurisdictional reach. The recently proposed TSCA reporting rule for PFAS substances promises to be a redux of both PIP (3:1) and the Fees Rule.

Finally, the conference demonstrates that reasonable people can disagree and that TSCA implementation continues to be exceedingly challenging. While there were many people “in the room” when Lautenberg was drafted, there appears to be no consensus as to what went on and why. Stakeholders across the board need to continue to engage with EPA and each other to move the program forward.

 
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