TSCA Reform — Eight Years Later: B&C, ELI, and GWU Conclude Best Available Conference

On June 26, 2024, Bergeson & Campbell, P.C. (B&C^®), the Environmental Law Institute (ELI), and the George Washington University (GWU) Milken Institute School of Public Health presented “TSCA Reform — Eight Years Later.” This hybrid conference marked the eighth 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 chemical prioritization and risk evaluation, risk management, new chemical review, Section 21 petitions, and other TSCA provisions available to third parties. The fact that there were almost 1,000 registrants and attendees in person and virtually demonstrates the growing and continuous interest in the U.S. Environmental Protection Agency’s (EPA) challenging implementation of TSCA. A recording of the conference is available online. The conference materials are available on the ELI website.

Madison Calhoun, Senior Manager, Educational Programs, ELI, welcomed attendees. Mark N. Duvall, Principal, Beveridge & Diamond, P.C., moderated the Hot Topics Panel: TSCA Administrative and Judicial Litigation: Much Going On! The panelists included Adam M. Kushner, Partner, Hogan Lovells US LLP; Tosh Sagar, Senior Attorney, Earthjustice; Robert M. Sussman, Principal, Sussman & Associates; and James Votaw, Partner, Keller & Heckman. The panel discussed the implications of Inhance Technologies for EPA’s regulation of significant new uses under TSCA Section 5, the TSCA Section 5(e) consent order being litigated in Cherokee Concerned Citizens, and Vinyl Institute’s challenge to a Section 4 test order. More information on Inhance Technologies is available in our March 25, 2024, memorandum and April 15, 2024, blog item. More information on Cherokee Concerned Citizens is available in our June 7, 2024, blog item.

Michal Ilana Freedhoff, Ph.D., Assistant Administrator of EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP), provided the keynote address. Freedhoff’s remarks, as we have come to expect, offered new developments, especially in the new chemical review area. Freedhoff  acknowledged that EPA may not meet its one-year deadline from final risk evaluation to proposed risk management rule, but stated that EPA is getting close. EPA continues to write the playbook for how to address risks most effectively while lacking sufficient resources. Because of cuts to EPA’s budget over the years and the need to divert funding in the future, Freedhoff also cautioned attendees that EPA’s IT system may not be ready when companies need to begin submitting per- and polyfluoroalkyl substances (PFAS) reporting data.

As reported in our June 26, 2024, blog item, Freedhoff announced four improvements to EPA’s new chemical reviews:

• Engineering checklist: In May 2024, EPA began implementing an internal engineering checklist to review systematically new chemical submissions and identify potential data gaps at the beginning of the review process;

• Worker protections: According to EPA, most TSCA Section 5(e) orders are consent orders that are negotiated between EPA and the notice submitter and use standard “boilerplate” text. In June 2024, EPA updated the boilerplate language to strengthen worker protections and provide further clarity to the text;

• Updated statistics for new chemical review timelines: On June 26, 2024, EPA will begin including completed “rework” risk assessments when reporting monthly statistics on new chemical reviews. EPA has updated its Statistics for the New Chemicals Program under TSCA web page to include a category listing all completed rework risk assessments since the beginning of 2024; and

• Reference Library: On June 26, 2024, EPA launched the New Chemicals Division Reference Library, an index of EPA documents related to the work of the New Chemicals Division (NCD). According to EPA, this resource includes guidance documents, compliance advisories, templates, manuals, and other materials useful to a variety of stakeholders.

Karyn M. Schmidt, Senior Director, Regulatory & Scientific Affairs, American Chemistry Council, moderated Panel 1: Risk Management. The panelists included MaryAnn Hoff, Global Director Advocacy, EHS & Product Stewardship, PPG; Jonathan Kalmuss-Katz, Supervising Senior Attorney, Earthjustice; Eileen Murphy, Ph.D., Director, Existing Chemicals Risk Management Division, EPA; and Meredith Williams, Director, California Department of Toxic Substances Control. The panel discussed how EPA defines the “extent necessary” to control unreasonable risks and under what circumstances EPA will not seek to ban a chemical use, as well as EPA’s final asbestos, methylene chloride, and proposed N-methylpyrrolidone (NMP) risk management rules. More information on the risk management rules is available in our March 28, 2024, memorandum (asbestos), May 17, 2024, memorandum (methylene chloride), and June 21, 2024, memorandum (NMP).

Maria J. Doa, Ph.D., Senior Director, Chemicals Policy, Environmental Defense Fund (EDF), moderated Panel 2: Risk Evaluation and the Supporting Role Sections 4 and 8 Play. The panelists included David B. Fischer, Counsel, Keller and Heckman LLP; Jeffery T. Morris, Ph.D., Director, Existing Chemicals Risk Assessment Division, Office of Pollution Prevention and Toxics (OPPT), EPA; Katherine O’Brien, Senior Attorney, Toxic Exposure and Health Program, Earthjustice; Judah Prero, Counsel, Arnold & Porter; and Tracey Woodruff, Ph.D., Professor and Director, University of California, San Francisco, Program on Reproductive Health and the Environment. The panel considered EPA’s revised chemical prioritization and risk evaluation processes; the role and extent of peer review; and the utility and timing of Section 4 test rules. More information on EPA’s final 2024 rule amending the risk evaluation framework rule is available in our May 14, 2024, memorandum.

Lynn L. Bergeson, Managing Partner, B&C, introduced Lynn R. Goldman, M.D., Michael and Lori Milken Dean, GWU Milken Institute School of Public Health. Goldman donated to GWU’s Special Collections Research Center (SCRC) an enrolled copy of the Lautenberg Act, signed by former President Barack Obama, and her copy of the Food Quality Protection Act of 1996, signed by former President Bill Clinton 20 years prior to the passage of the Lautenberg bill. Robin Delaloye, Associate Dean, Student Success and Scholarly Technology, GWU Libraries and Academic Innovation, accepted the donations on behalf of SCRC.

Samantha Liskow, Lead Counsel, Health Program, EDF, moderated Panel 3: New Chemical Review. The panelists included Shari Barash, Director, NCD, OPPT, EPA; Kyla Bennett, Ph.D., Director, Public Employees for Environmental Responsibility (PEER); Kerry Coy, Product Regulation Specialist, BASF Corporation; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Daniel Rosenberg, Senior Attorney, Environmental Health, Natural Resources Defense Council (NRDC). The panelists discussed the latest updates to EPA’s new chemical review process, whether challenges are being addressed and how, whether review times are being diminished, scientific integrity, and best available science.

Bergeson moderated Panel 4: Shaping the Agenda: Section 21 Citizens’ Petitions and Other Mechanisms Influencing Priority Setting. The panelists included Ryan J. Carra, Ph.D., Principal, Beveridge & Diamond, P.C.; Michael Connett, Partner, Siri & Glimstad LLP; Thomas Groeneveld, Senior Advisor, Existing Chemicals Risk Management Division, EPA; and Robert M. Sussman, Principal, Sussman & Associates. Citizens’ petitions under TSCA Section 21 are increasingly playing a prominent and evolving role in influencing EPA’s policy and regulatory priorities. Other mechanisms are also being used to revisit EPA’s priorities. The panel discussed the utility of these mechanisms, how they are impacting EPA’s regulatory agenda, and other opportunities for citizen engagement. The panel commented on the implications of EPA’s decision to grant a TSCA Section 21 petition to address only a single condition of use (COU) of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD). More information on the petition to address 6PPD in tires is available in our November 3, 2023, blog item.

Jordan Diamond, President, ELI, provided concluding remarks.

For the first time, the conference included pre-recorded videos, shown before each of the panels. The videos provide diverse prospectives of stakeholders from across the United States on how implementation of the Lautenberg Act is going:

• Panel 1 pre-video: Russell N. Hepfer, Vice Chair, Lower Elwha Tribe; Sean Hays, President, SciPinion; and Senator Ed Markey (D-MA);

• Panel 2 pre-video: Mike Schade, Director, Mind the Store, Toxic-Free Future; Pamela Dopart, Ph.D., CIH, Scientist, Industrial Hygienist, Exponent; and former Senator David Vitter (R-LA);

• Panel 3 pre-video: Rebecca Reindel, Director, Occupational Safety and Health, AFL-CIO; John Erickson; Associate General Counsel, BASF Corporation; and Charlotte Brody, Vice President, Occupational and Environmental Health, Blue Green Alliance; and

• Panel 4 pre-video: Pamela Miller, Executive Director, Alaska Community Action on Toxics; Sean Hunt, co-founder and Chief Technology Officer, Solugen; Shanisha Smith, Senior Counsel, LyondellBasell; and Adam Bettman, M.S., DABT, PETA Science Consortium International.

The full 58-minute video was shown to virtual attendees during the lunch break. More interviews are available on the full video version than were shown during the program and include Eve Gartner, Director, Crosscutting Toxics Strategies, Earthjustice; Linda Birnbaum, Ph.D., Professor, University of North Carolina; Wilma Subra, Technical Advisor, Louisiana Environmental Action Network; Jim Aidala, Senior Government Affairs Consultant, B&C; and Wendy Hartley, advocate for safer chemicals and mother of Kevin Hartley, who died from methylene chloride poisoning.

Commentary

By any metric, the conference was hugely successful. The panel discussions were robust and lively. 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, GWU’s, and B&C’s facilitation of this important annual conference is an essential element in our collective success in this regard.