REGULATORY MEMORANDUM

TSCA at Six: ELI, B&C, and GWU Conclude Another Fabulous Conference

On June 29, 2022, 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 -- Six Years Later.” This virtual conference marked the sixth 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 interface of science and policy under TSCA, the U.S. Environmental Protection Agency’s (EPA) regulation of new chemicals, risk assessment and risk management, and the regulation of articles under TSCA. The over 700 program registrants demonstrate the continuing, if not growing, interest in EPA’s challenging implementation of TSCA. A recording of the conference is available online.

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 (OCSPP), led the morning keynote discussion. Freedhoff’s comments echoed her statement before the Senate Committee on Environment and Public Works on June 22, 2022, and described how EPA has implemented policy changes that she announced at last year’s conference. These include:

  • Expanding Consideration of Exposure Pathways and Fenceline Community Exposure Screening Level Approach: The previous Administration excluded certain exposures that could be limited under other statutes from its risk evaluations. Freedhoff stated that EPA has developed a screening methodology that it is using on the first ten risk evaluations. If the screening shows that there are no likely added fenceline community risks, EPA will move to the risk management stage. If the screening methodology tells EPA that the previous Administration’s risk evaluation will not support a risk management rule, then EPA will revisit the risk evaluation. More information on EPA’s “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” is available in our January 24, 2022, memorandum.
     
  • Whole Chemical Approach: According to Freedhoff, some have expressed the view that the whole chemical approach is unfair because not all uses may pose a high or moderate risk. Freedhoff stated that there will be no changes to EPA’s underlying analysis and that EPA will not quit working on its risk evaluation once it finds a risky use. Instead, Freedhoff thinks it is a risk communication issue and risk communication is not, according to Freedhoff, as heavy a lift as some fear. An unreasonable risk determination is not the end under TSCA. The ultimate message that EPA wants to send is that the chemical is safe for the conditions of use. More information on EPA’s use of the whole chemical approach is available in our June 30, 2022, memorandum on EPA’s final revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation.
     

Freedhoff stated that EPA has made strides in the New Chemicals Program, such as the biofuels initiative. EPA developed a standardized review process and used the same dedicated team to review 15 biofuel premanufacture notices (PMN). EPA is looking at using it for other sectors. As reported in our June 27, 2022, memorandum, EPA recently announced a broad outreach effort to increase transparency and reduce rework for new chemical submissions.

Freedhoff described the resource challenges that EPA has faced since the enactment of Lautenberg. As Freedhoff testified before the Senate Committee on Environment and Public Works, although Congress expected EPA to collect 25 percent of its TSCA costs in fees, the fees that EPA has collected cover only about 13 percent of EPA’s costs. The previous Administration moved staff from the New Chemicals Program to work on existing chemical risk evaluations, and then the OCSPP reorganization made this move permanent. More information on the Senate Committee’s June 22, 2022, hearing is available in our June 24, 2022, memorandum.

James J. Jones, President, J. Jones Environmental, moderated Panel 1: The Interface of Science and Policy under TSCA. Panelists included Dr. Stanley Barone, Senior Science Policy Advisor, OCSPP; Dr. James S. Bus, Senior Managing Scientist, Exponent; Dr. Vincent James Cogliano, Deputy Director for Scientific Programs, Office of Environmental Health Hazard Assessment, California Environmental Protection Agency; Dr. Jennifer Sass, Senior Scientist, Health and Environment, Natural Resources Defense Council (NRDC); and Dr. Wilma Subra, Environmental Scientist and President, Subra Company. The panel examined key issues at the interface of science and policy under TSCA, including the continuing role of animal studies in supporting risk evaluations, the potential use of New Approach Methodologies (NAM) to inform safety determinations for new and existing chemicals, scientific integrity and the TSCA program, and methodologies for systematic review. The panel discussed whether animal exposure can provide meaningful information in exposure analysis. While it is important not to rely too heavily on NAMs, they do allow users to learn much earlier in the process if every chemical in the class are bad actors or if it is just a couple members of the class. Assessing and regulating chemicals are two different things, but it is clear that many fenceline communities want to know more about cumulative mixture exposures.

Alexandra Dapolito Dunn, Partner, Baker Botts L.L.P., moderated Panel 2: New Chemical Review. The panelists included Dr. Richard E. Engler, Director of Chemistry, B&C; Madison H. Le, Director, New Chemicals Division, OCSPP; Dr. Maria J. Doa, Senior Director, Chemical Policy, Environmental Defense Fund, Inc. (EDF); Patrick MacRoy, Deputy Director, Defend Our Health; and James G. Votaw, Partner, Keller and Heckman LLP. The panelists discussed opportunities for transparency, processes to guide new chemical review, new approaches to assess chemical risks, protection of workers, use of Significant New Use Rules (SNUR), and Section 5(e) orders. The panel discussed the need for EPA to stick to the 90-day review period for new chemicals, and the problems both sides face in terms of a lack of resources and how these delays ultimately hurt all parties involved. The panelists unpacked how they viewed the key regulatory phrase “reasonably foreseen.”

Robert M. Sussman, Principal, Sussman & Associates, moderated Panel 3: Risk Evaluation and Management. The panelists included El'gin Avila, Director, Occupational and Environmental Health and Equity, Bluegreen Alliance; Dr. Dianne Barton, Council Chair, Region 10, Columbia River Inter-Tribal Fish Commission; David B. Fischer, Counsel, Keller and Heckman LLP; Jonathan Kalmuss-Katz, Supervising Senior Attorney, Earthjustice; Dr. Jeffery T. Morris, Director, Existing Chemicals Risk Assessment Branch, Office of Pollution Prevention and Toxics (OPPT), EPA; Swati Rayasam, Program on Reproductive Health and the Environment (PRHE) Science Associate, University of California San Francisco (UCSF); and Brian Symmes, Acting Director, Existing Chemicals Risk Division, OPPT. With the first ten evaluations completed, this panel looked back at the lessons learned and areas for improvement. The panel discussed EPA’s efforts to enhance these evaluations through risk determinations for fenceline communities, revised worker protection assumptions, and the “whole chemical approach.” The panel examined the asbestos risk management proposal and other emerging risk management approaches, evaluated the impact of resource constraints on meeting statutory deadlines, and discussed the role of environmental justice considerations.

Lynn L. Bergeson moderated Panel 4: TSCA Regulation of Articles. The panelists included Lawrence E. Culleen, Partner, Arnold & Porter; Mark A. Hartman, Deputy Director, OPPT; Liz Hitchcock, Director, Safer Chemicals Healthy Families; and Daniel Rosenberg, Director, Federal Toxics Policy, NRDC. TSCA requirements can apply to “articles,” a manufactured good, or finished product. The panel discussed EPA’s push to remove the traditional exemptions for articles and the resulting compliance and implementation challenges. The panelists discussed the potential new reporting obligations for per- and polyfluoroalkyl substances (PFAS) and asbestos requiring reporting on articles, and the application of SNURs and risk management rules to articles. Panelists agreed that the language of the Lautenberg Act indicates Congress’s awareness that EPA would begin regulating articles in a meaningful way.

H. 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 radically different approach to Lautenberg implementation, stakeholders must remain engaged and focused, whatever their position, 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 Lautenberg. ELI’s facilitation of this important annual conference is an essential element in our collective success in this regard.

 
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