All Things Chemical

This week, I discuss with my colleagues, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, and Kelly N. Garson, Senior Associate for B&C and Acta, our recently released book, titled Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA, published by the American Bar Association.

As listeners know, as a law firm and consulting firm, we do a lot of work under the Toxic Substances Control Act (TSCA) and have gained a significant amount of hands-on practical knowledge about the law, the 2016 Lautenberg Chemical Safety for the 21st Century Act amendments to it, and the transformative impact these amendments have had on business transactions. We set out a year or so ago to write a book that explains TSCA through a business transactions lens. Of course, we explain the law, but we really write as business counselors to enable the regulated community -- importers, chemical producers, finished product manufacturers, distributors, and chemical users -- to be TSCA aware. The law has become, whether you like it or not, an important factor in virtually every business decision. My conversation today with Kelly and Rich focuses on several of their chapters in the book, and they explain how they approached writing a book about a law from the perspective of the business community.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2025 Bergeson & Campbell, P.C. All Rights Reserved

This week, I discuss Toxic Substances Control Act (TSCA) developments with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate. The U.S. Environmental Protection Agency's (EPA) implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments has been a dynamic, evolving, and unpredictable work in progress for almost nine years. Given the new Administration, we are at a most uncertain time because of the lack of clarity regarding what the new leaders at the Office of Chemical Safety and Pollution Prevention (OCSPP) will do to address new chemical review concerns, risk evaluation under TSCA Section 6, and risk management actions resulting from those evaluations. As listeners know, all final risk management rules are being challenged and the disposition of those cases is the subject of considerable speculation. So also is OCSPP's consideration of not yet final risk evaluations and how the new Administration intends to interpret TSCA Section 6 in general. There are growing calls for legislative action to remedy some of Lautenberg's deficits, particularly in the area of new chemicals, another important variable that is destabilizing the status quo. Rich and I discuss these topics and many others.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2025 Bergeson & Campbell, P.C. All Rights Reserved

This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group (Acta®), to discuss the early days of the new Administration, what changes we can expect at the U.S. Environmental Protection Agency (EPA) generally, and key issues the Office of Pesticide Programs (OPP) can be expected to tackle. Jim's unique perspective as a former Assistant Administrator of what is now called the Office of Chemical Safety and Pollution Prevention (OCSPP) and keen understanding of the pesticide world always make for a wonderful and insightful conversation.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2025 Bergeson & Campbell, P.C. All Rights Reserved

This week I discuss with my colleague, Mark Washko, Senior Government Affairs Advisor for B&C and The Acta Group, our consulting affiliate, the new 119th Congress and what might be key legislative actions our listeners should look for. The new Congress reflects many new members, new staffs, and a new Republican majority in both chambers. What can we expect? Will Congressional Review Act measures un-do key Biden initiatives? What might we expect in terms of a budget reconciliation package? These issues and a whole lot more are the subject of my conversation with Mark.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2025 Bergeson & Campbell, P.C. All Rights Reserved

Recognizing it has much to do and little time to complete its tasks, the Office of Pollution Prevention and Toxics (OPPT) has been issuing final rules at a fast and furious rate since the election last month. This week, I discuss OPPT's to-do list with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate. In addition to multiple final Section 6 risk management rules, the U.S. Environmental Protection Agency (EPA) has also issued final revisions to its new chemicals review process and a Section 8(d) rule. We conclude with Rich's thoughts on OPPT in 2025.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C. All Rights Reserved

This week, I sat down with our two government affairs experts, Jim Aidala and Mark Washko, to get their take on the very eventful past two weeks and seek their thoughts on what 2025 might look like legislatively and at the U.S. Environmental Protection Agency (EPA) administratively. With the Republican trifecta and some surprising Cabinet and EPA-designate picks, we have much to discuss. We cover the election results, the transition period between now and Inauguration Day, and then speculate on the remainder of 2025, a year that promises to be like no other.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C. All Rights Reserved

This week, I welcomed to the studio Lara Hall, Senior Regulatory Scientist/Quality Assurance Specialist at B&C and our consulting affiliate, The Acta Group (Acta®), to discuss a few of the many critical issues associated with chemical testing. Chemical testing is undertaken for lots of reasons: government mandate; product stewardship; and product defense and support, to name a few. What is under-appreciated is the importance of the standards that apply under Good Laboratory Practices (GLP), the expertise needed to address novel testing approaches that deviate from GLP, how to manage requests from regulators that may not align with GLP requirements, and many other scenarios that require the expertise of highly trained and experienced testing experts. In our conversation, Lara shares with our listeners just a few of her many testing experiences that have made Lara the consummate testing expert that she is.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C. All Rights Reserved

This week I had the pleasure of speaking with U.S. Food and Drug Administration (FDA) Deputy Commissioner for Human Foods, Jim Jones, about all the amazing initiatives Jim is overseeing as the first FDA Deputy Commissioner for Human Foods. Many of us in the chemical community know Jim and his extraordinary career at the U.S. Environmental Protection Agency (EPA) leading both the EPA pesticides and toxics program offices, culminating his EPA career as Assistant Administrator for Toxics in the Obama Administration. Jim's keen understanding of the administrative, chemical prioritization, risk evaluation, and risk management processes makes him uniquely well suited to lead the Human Foods office at FDA and implement successfully the new Human Foods organizational structure and achieve the office's ambitious goals. We discuss the Human Foods' priorities and new organizational structure, the recently released proposed systematic post-market review process on which FDA seeks comments, how Jim intends to tackle the many challenges FDA faces with regard to food chemicals, contaminants, and food additives, and much more.

Evaluating FDA Human Foods and Tobacco Programs, Before the Subcommittee on Health Committee on Energy and Commerce, 118th Cong. (2024) (statement of Jim Jones, Deputy Commissioner for Human Foods - Food and Drug Administration).

FDA, Discussion Paper: Development of an Enhanced Systematic Process for the FDA's Post-Market Assessment of Chemicals in Food, (Aug. 2024).

FDA, Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments," 89 Fed. Reg. 65633, (Aug. 12, 2024).

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C. All Rights Reserved

This week I had the pleasure of speaking with Linda Reinstein, President and Cofounder of the Asbestos Disease Awareness Organization (ADAO), about her many years of asbestos disease awareness advocacy. Having lost her husband, Alan, to mesothelioma two decades ago, Linda set out to educate others about the diseases associated with asbestos exposure. Her story is one of grit, perseverance, and devotion.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C. All Rights Reserved

On June 26, 2024, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform — Eight Years Later. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions. B&C and ELI are pleased to co-sponsor this episode of All Things Chemical® to enable our podcast audience to listen to these sessions.

Lynn L. 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.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C. All Rights Reserved