TSCA at Seven: As Reasonably Foreseen, ELI and B&C Conclude Another Riveting Conference

On June 29, 2023, 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 — Seven Years Later.” This virtual conference marked the seventh Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and where TSCA stands today. Speakers covered a variety of topics, including risk evaluation, risk management, new chemical review, and per- and polyfluoroalkyl substances (PFAS). The fact that there were more than 800 program registrants demonstrates the continuing, if not growing, interest in the U.S. Environmental Protection Agency’s (EPA) challenging implementation of TSCA. A recording of the conference is available online. ELI members who are logged in to the ELI website can view a recording of the conference and the conference materials on the ELI website.

Madison Calhoun, Senior Manager, Educational Programs, ELI, welcomed attendees. Lynn L. Bergeson, Managing Partner, B&C, and Robert M. Sussman, Principal, Sussman & Associates, offered their reflections on the current state of TSCA implementation. Bergeson stated that her own view has not changed since years ago. The bottom line, then and now, is that public health is better served by the Lautenberg Act’s implementation, but there is room for improvement. Reasonably foreseen conditions of use (COU) have impeded innovation, while some risk management proposals seek to ban chemicals even though the risk from use can be managed. Sussman expressed frustration with the lack of progress, particularly since EPA is focusing on well-studied chemicals with well-documented negative effects. According to Sussman, it should be a given that EPA will protect workers against unreasonable risks and will accept that releases to air, soil, and water pose risk to fenceline communities and workers and cannot be ignored just because they are addressed under other laws.

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, introduced the keynote speaker, Michal Ilana Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). Freedhoff stated that last year, she spoke about money and how OCSPP did not have enough of it. Although the problem has not really been fixed, thanks to a modest increase in its budget and hard work, it has come a long way. EPA will change its onboarding process so that it will have five to six chemicals under review each year instead of 20 at a time. OCSPP is spending its time on the riskiest uses, and the upcoming draft supplement will provide an example. OCSPP has built on the fenceline process, looking at aggregate risks for communities exposed to 1-dioxane through water contamination. Freedhoff noted that EPA is addressing PFAS in a variety of ways, including its new framework for addressing new PFAS and new uses of PFAS, its TSCA Section 8(a) reporting and recordkeeping rule that will be issued in final “soon,” its proposed rule that would make PFAS categorically ineligible for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), and its proposed significant new use rules (SNUR) for PFAS designated as inactive on the TSCA Inventory.

Eve C. Gartner, Director, Crosscutting Toxics Strategies, Earthjustice, moderated Panel 1: Risk Evaluation. The panelists included David B. Fischer, Counsel, Keller & Heckman LLP; Rashmi Joglekar, Ph.D., Associate Director, Science & Policy, Program on Reproductive Health and the Environment (PRHE), University of California, San Francisco; Jeffery Morris, Ph.D., Director, Existing Chemicals Risk Assessment Division, Office of Pollution Prevention and Toxics (OPPT), EPA; and Jennifer Sass, Ph.D., Senior Scientist, Natural Resources Defense Council (NRDC). The panel discussed various aspects of EPA’s risk evaluation of chemical substances, including EPA’s potential use of European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) data, EPA’s use of new approach methodologies (NAM), the effectiveness of a “whole chemical approach” to risk determinations, and the incorporation of cumulative risk assessment (CRA) approaches.

Jim Jones, President, J. Jones Environmental, moderated Panel 2: Risk Management. The panelists included Jonathan Kalmuss-Katz, Supervising Senior Attorney, Earthjustice; W. Caffey Norman, Senior Partner, Squire Patton Boggs; Brian Symmes, Acting Director, Existing Chemicals Risk Management Division, OCSPP, EPA; and Meredith Williams, Director, California Department of Toxic Substances Control (CDTSC). The panel discussed EPA’s authority under the Lautenberg Act to manage chemical risks and options for deploying its authority. Panelists addressed how EPA manages workplace risks, enforcement mechanisms for risk management restrictions, whether EPA’s risk management rulemakings are adequately addressing environmental justice (EJ) concerns, and potential legal challenges to final risk management rules.

Bergeson moderated a special lunch discussion with former assistant administrators (AA) for OCSPP, previously the Office of Prevention, Pesticides, and Toxic Substances, including James V. Aidala, Senior Government Affairs Consultant, B&C; Alexandra Dapolito Dunn, Partner, Baker Botts LLP; Goldman; Jones; and Steve Owens, Chairperson, U.S. Chemical Safety Hazard Investigation Board. The former AAs discussed the challenges faced in implementing new legislation and whether an AA handbook is necessary to pass on institutional knowledge.

Dunn moderated Panel 3: New Chemical Review. The panelists included Shari Barash, Acting Director, New Chemicals Division, EPA; Maria Doa, Ph.D., Senior Director, Chemicals Policy, Environmental Defense Fund (EDF); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Daniel Rosenberg, Director, Federal Toxics Policy, People & Communities Program, NRDC. The TSCA new chemical program was significantly revised by the 2016 amendments, and what the law requires has been vigorously debated. The panel discussed opportunities for transparency, processes to guide new chemical review, new approaches to assess chemical risks, protection of workers, Section 5(e) orders, and recent trends with EPA’s review of new chemical substances.

Sussman moderated Panel 4: PFAS. The panelists included Emily Donovan, Co-Founder, Clean Cape Fear; Ben Grumbles, Executive Director, Environmental Council of the States (ECOS); Matt Klasen, PFAS Council Manager, EPA; Pamela Miller, Executive Director, Alaska Community Action on Toxics; Steve Risotto, Senior Director, Chemical Products & Technology, American Chemistry Council (ACC); and Barash. The panel discussed the unique role of TSCA, as compared to other EPA programs, in addressing the issue of PFAS. The panel addressed subjects such as laws EPA is implementing to address PFAS, EPA’s working definition of PFAS, EPA’s TSCA PFAS testing strategy, and the upcoming PFAS reporting rule under TSCA.

Jordan Diamond, President, ELI, provided concluding remarks.

Commentary

By any metric, the conference was hugely successful. It attracted a record number of registrants from all over the world. Online participation was robust, and the chat box and question and answer (Q&A) box filled with useful commentary from meeting registrants. Interest in EPA’s implementation of TSCA continues to be high, indeed growing. With the Biden Administration’s approach to Lautenberg Act implementation, stakeholders must remain engaged and focused, whatever their positions, to enable EPA to make good decisions rooted in the facts and advocate as appropriate. Only through continued dialogue, engagement, and collaboration will diverse chemical stakeholders achieve the goals Congress set in enacting the Lautenberg Act. ELI’s facilitation of this important annual conference is an essential element in our collective success in this regard.