All Things Chemical

This week, I discuss with my colleagues, Carla N. Hutton, Senior Regulatory Analyst for B&C, and Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, the ever-expanding and complicated scope of per- and polyfluoroalkyl substances (PFAS) regulation in the United States. We convened a webinar on this topic in mid-May and attracted a record-breaking 1000+ registrants, suggesting to us that PFAS continues to be a topic of enormous interest. In our discussion, Carla, Rich, and I address the federal Toxic Substances Control Act (TSCA) reporting obligation and the diverse constellation of state-specific reporting and product restrictions that are mushrooming around the country. Keeping up with these restrictions is important and increasingly diverse and thus challenging to track and with which to comply. Our hope is our discussion will focus our listeners on this important, sprawling topic and offer some tips to help manage it. 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 had the pleasure of speaking with Karyn Schmidt, now a principal at Squire Patton Boggs in its Public Policy practice, after spending 25 years at the American Chemistry Council (ACC). For the many members in the chemical community who know Karyn, her deep understanding of chemical law and policy will serve the firm's clients well. We discuss Karyn's transition to private practice, her work at ACC, and Karyn's thoughts on what is in store for chemical stakeholders now and the foreseeable future. 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 had the pleasure of speaking with Melissa Owen, attorney/owner of Ambiente Legal, about the significant regulatory developments regarding chemical registration in Latin America, including Latin American Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) initiatives and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). We discuss Brazil REACH, which requires by law the government to have an implementing regulation issued by May 2025, Colombia REACH, also subject to a fast-approaching May 2025 deadline, and other Latin American REACH and GHS deadlines. We also discuss the August 2025 deadline in Chile for the notification of chemicals included in professional and consumer products, and much more regarding developments in countries south of our border. 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 had the pleasure of speaking with Lioba Oerter, Director of Expert Services, 3E Expert Service Processing Centre (ESPC), and Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group, about the significant changes to product classification, labeling, and packaging (CLP) in the European Union (EU). Lioba and I shared a podium recently and found we also have a shared belief that these forthcoming CLP changes will have a profound commercial impact on product classification, labeling, and packaging globally and that with everything going on in the world these days, this impact may be a bit underappreciated. Karin and I spoke about these matters last year, and I welcomed an opportunity to consider them again with Karin and Lioba in light of the new CLP developments as of December 2024. Karin, Lioba, and I discuss the CLP changes, including those recently made, why they came to be, what they mean for commercial operations, and conclude with some tips on staying ahead of this coming storm. 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 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

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. 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. 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. 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. 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

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). 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 Michael Connett, Partner with Siri & Glimstad, LLP to discuss his epic litigation representing Food & Water Watch, a non-profit consumer organization that sued EPA over the fluoridation of drinking water. This issue has a long and complicated administrative and litigation history, and Michael and his firm are actively engaged in a groundbreaking federal litigation based on a judicial appeal of a denied Toxic Substances Control Act (TSCA) Section 21 citizen petition. Michael concluded a bench trial earlier this year in federal district court in the Northern District of California. The case is fascinating and much watched. We discuss the case, why TSCA citizen petitions in general are filed, Michael's thoughts on how to prepare petitions to maximize their success (as most are denied), and other means of citizen engagement under TSCA. Resources: TSCA Section 21 Petition Trends Pre- and Post-Lautenberg TSCA Reform – Eight Years Later 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 W. Scott Thurlow with Thurlow Law & Public Affairs, headquartered Ottawa, Ontario, about Canada's most recent updated draft report on the state of per- and polyfluoroalkyl substances (PFAS). The updated draft report defines PFAS to exclude fluoropolymers, an issue in which Scott and his firm are deeply engaged. We discuss the draft report, Canada's approach to the regulation of PFAS, and Scott's practice as a Canadian lawyer and public affairs specialist. 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, to discuss the critical importance of understanding the role of the study sponsor. As our listeners know, chemical data -- testing results, chemical studies, exposure information, environmental fate and monitoring data, to name a few -- are the new currency in the chemical community. These data are incredibly valuable, often proprietary, and increasingly used both to support chemical applications and to rebut allegations of adverse consequences resulting from chemical exposure. How these data are developed, who serves as study sponsor, how the sponsor interacts with the study monitor, laboratory, and others are significant issues and subject to Good Laboratory Practice (GLP) standards. Lara and I discuss GLP and the rights, duties, and obligations of all the actors involved in chemical testing and offer some tips and insights in managing this increasingly complicated space. 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 back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. And none too soon. Just when you were giving up hope in tackling the monster final Hazard Communication Standard rule issued on May 20, you realized Karin and I are devoting an entire podcast to the final rule! As many of you know, Karin is second to none when it comes to hazard communication, GHS, and related domestic and international hazard standards and communicating hazards to global stakeholders. There is no one better suited to discuss the final rule, what in the rule makes us happy, what remains a concern, and how best to read and digest the more than 300 pages of new hazard communication provisions. 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 Elissa Reaves, Ph.D., Director, Office of Pollution Prevention and Toxics (OPPT) at the U.S. Environmental Protection Agency (EPA), to discuss Dr. Reaves' recent ascent to this position, her approach to office management, her priorities and goals for OPPT, and some interesting comparisons and contrasts with Dr. Reaves' former stomping ground, EPA's Office of Pesticide Programs (OPP). 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 Joel A. Tickner, Ph.D., Professor, Department of Public Health, University of Massachusetts Lowell, and Executive Director of Change Chemistry, to discuss green chemistry and Joel's important work at Change Chemistry. We all appreciate that chemicals are essential to society. Green chemistry is all about engineering chemicals to diminish their adverse impacts and ensure chemicals, materials, and products are safe, efficacious, and sustainable. We discuss Joel's pioneering work in this field, his leadership of Change Chemistry, implementation of the Sustainable Chemistry Research and Development (R&D) Act of 2019, and EPA's implementation of amendments to the Toxic Substances Control Act (TSCA) addressing new chemical review, and much more. 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 discuss with my colleague, Mark Washko, Senior Government Affairs Advisor for B&C and The Acta Group, our consulting affiliate, the importance of government affairs engagement in the current political environment. Mark recently joined us, having spent 16 years as Head of Federal Government Affairs for BASF Corporation here in Washington, D.C. Mark has significant experience in engaging with Congressional staff and Members to ensure his clients' interests are well served. We discuss a few specific examples of how government affairs engagement has helped, Lautenberg and his work on new chemicals, and how best to prepare for the coming November elections. 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 Nora von Bergen, LL.M., a lawyer with Food Lex AG, to discuss her role as an accomplished food practitioner in Bern, Switzerland. Nora and I are both officers of the International Bar Association Agriculture and Food Law Section, and I have learned more over the past several years about Nora's practice and find it fascinating. We discuss what Nora does at Food Lex and in that context, recent comprehensive amendments to Swiss food law that went into effect recently, and  a few of the challenging legal issues Nora and her colleagues are addressing.  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 discuss with my colleague, Heather Blankinship, Senior Scientist/Regulatory Consultant for B&C and The Acta Group, and Senior Manager for B&C® Consortia Management, L.L.C. (BCCM) to discuss the value of coalition advocacy, and its essentiality in the chemical space, especially now. Heather manages many chemical coalitions and does a masterful job of managing issues and people. When you think about it, engaging commercial competitors to align on advocacy involving critically important regulatory, testing, and science policy issues is daunting. It involves strong communication skills, strong people skills, a keen understanding of the substantive issues, and endless patience. Heather explains how she does what she does, extolls the virtues of consortia advocacy, discusses some of BCCM's successes, and explains why she and BCCM are as busy as they are these days. 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 discuss with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, the U.S. Environmental Protection Agency's (EPA) important and recently issued first final risk management rule for chrysotile asbestos. Those of us in the Toxic Substances Control Act (TSCA) community know asbestos occupies a special place in TSCA's checkered past, and EPA's final rule is an important chapter in that book. Whether you care about asbestos or not, by any independent standard this final rule is a big deal for several reasons. There is no better expert than Rich Engler to discuss with me what this rule does, what it tells us about EPA's approach to risk management under TSCA, why it is relevant to any chemical undergoing review by EPA, why in all probability neither industry nor the non-governmental organization (NGO) community is happy, and why litigation may well be in our future. 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 was excited to sit down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group, to discuss FIFRA hot topics. For those of us who work in the complicated and ever-changing area of agricultural and biocidal products, federal and state regulation of ag products is often hard to understand and to monitor. Jim knows this space better than anyone, having worked on the Hill, led EPA's toxics office, and now serving the private sector. We discuss tip-of-the-spear issues in 2024, including what to expect in pesticides when electing (2024 general elections and ag policy), the Endangered Species Act and the regulation of ag chemicals, Pesticide Registration Improve Act 5 (PRIA 5) issues, new policies relating to “free of” claims, and the regulation of pesticide devices. It's a lot of real estate, but we enjoyed the ride. 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 discuss with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, the super-hot topic of per- and polyfluoroalkyl substances (PFAS) reporting under the Toxic Substances Control Act (TSCA). PFAS, the class of so-called forever chemicals, are the talk of this town, and likely the talk of many jurisdictions given the intense global scrutiny all things PFAS endure. Rich and I focus our broad ranging discussion on federal TSCA reporting under TSCA Section 8(a)(7). We discuss what PFAS are reportable, what information is due and by when, why finished product importers are on the hook for reporting, why there is a 12-year look back, and the all-important topic of how much diligence is due before you conclude information is “not known or reasonably ascertainable.” 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 distinct pleasure of visiting with former Chief Justice of the Delaware Supreme Court, the Honorable Leo E. Strine, Jr., Of Counsel, at Wachtell, Lipton, Rosen & Katz. Judge Strine and I discuss the intense focus on environmental, social, and governance (ESG) standards and the pressures on corporate directors and managers occasioned by the Caremark decision and its progeny, among other developments. These initiatives have particular relevance to businesses many of our clients and listeners manage, as they often involve environmentally sensitive chemical products and manufacturing operations. We discuss Judge Strine's thoughts on implementing ESG programs by building upon existing corporate compliance programs and how best to allocate compliance responsibilities between corporate boards and senior management. Leo E. Strine, Jr., Kirby M. Smith, and Reilly S. Steel, “Caremark and ESG, Perfect Together: A Practical Approach to Implementing an Integrated, Efficient, and Effective Caremark and EESG Strategy,” Iowa Law Review, Volume 106, Issue 4, 2021. https://ilr.law.uiowa.edu/print/volume-106-issue-4/caremark-and-esg-perfect-together-a-practical-approach-to-implementing-an-integrated-efficient-and-effective-caremark-and-eesg-strategy Leo E. Strine, Jr., “Good Corporate Citizenship We Can All Get Behind?: Toward A Principled, Non-Ideological Approach To Making Money The Right Way,” The Business Lawyer, Volume 78, Spring 2023. https://papers.ssrn.com/sol3/papers.cfm?abstract_id=4296287 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 discuss with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, what to expect in 2024 regarding TSCA developments. Rich is a leading voice on all things TSCA, especially new chemicals, and a widely sought after thought leader on the U.S. Environmental Protection Agency's (EPA) implementation of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg), Congress' 2016 amendments to the Toxic Substances Control Act (TSCA). We begin with the most recent Senate hearing on TSCA on January 24 and then discuss Rich's thoughts on key TSCA initiatives the rest of the year. 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 Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group. As many of our listeners know, Jim is a former Assistant Administrator of the Toxics office at the U.S. Environmental Protection Agency (EPA). He has worked on Capitol Hill as a pesticide policy expert and a keen student of all things political. We discuss what to expect in 2024 from the Hill and EPA's Office of Chemical Safety and Pollution Prevention (OCSPP) when it comes to key chemical matters. We cover a lot of territory -- EPA staffing deficits, a deeply divided Congress, and the many challenging legal, scientific, and policy issues that this OCSPP is tasked with solving, or at least managing, in 2024 as it stares down national elections in about 10 months and all the uncertainty that fact invites. 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 back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. Karin and I discuss an old but evolving concept in FDA circles called GRAS -- Generally Recognized as Safe. As listeners may know, “food additives” require pre-market approval by FDA. Substances “generally recognized” as safe under the conditions of a substance's intended use are excluded from the definition of “food additive,” are not subject to mandatory pre-market review by FDA, and may be added to human and animal food. How companies make GRAS determinations, FDA's role in the process, and whether the GRAS concept should be modernized are a few of the hot topics Karin and I explore. 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, listeners are in for a real treat as I sit down with Dr. Meibao Zhuang, Senior Scientist/Regulatory Consultant with B&C and our consulting affiliate, The Acta Group, to discuss double-stranded ribonucleic acid interference, better known as ds RNAi. Ds RNAi is a technology that allows scientists to silence (or interfere with) a particular gene. In the agricultural sector, this genetic modification can be used to great advantage to control pests of all sorts with extreme precision. Meibao will discuss EPA's proposed registration of the first sprayable RNAi biopesticide and the exciting implications of this technology. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, I had the distinct pleasure of visiting with Rachel James, an attorney with the Southern Environmental Law Center (SELC). Rachel's background and specialized training make her uniquely well suited to address some of the very interesting issues in which she engages at SELC on behalf of a diverse set of community groups. The Biden-Harris Administration has made environmental justice and accounting for susceptible subpopulations core components of its approach to environmental protection. My conversation with Rachel provides greater insights into how this is working in practice. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, I welcomed back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. Karin and I discuss Revision 10 of the Globally Harmonized System of Classification and Labeling of Chemicals, commonly referred to as GHS. Release of any new GHS revision is a big deal, and Revision 10 is no exception. Karin highlights key elements of the revision, including changes to “weight of evidence,” the classification of ozone-depleting chemicals, precautionary statements, and much more. No one reports on GHS better than Karin, and this episode covers Revision 10 as only Karin can. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, 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 -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions to enable our podcast audience to listen to the sessions in this venue. Our topic in this podcast is the Toxic Substances Control Act's (TSCA) application to per- and polyfluoroalkyl substances (PFAS) and how the U.S. Environmental Protection Agency's (EPA) implementation of Lautenberg has influenced EPA's regulatory actions. Our experts address a range of subjects, including EPA's evolving definition of PFAS under TSCA, EPA's TSCA PFAS testing strategy, the PFAS reporting rule under TSCA Section 8(a)(7), and much, much more. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, 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 -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions to enable our podcast audience to listen to the sessions in this venue. Our topic in this podcast is the U.S. Environmental Protection Agency's (EPA) new chemicals review process under Lautenberg. As many listeners know, the Toxic Substances Control Act (TSCA) New Chemicals Program was significantly revised by the 2016 TSCA amendments, and what the law requires has been vigorously debated and remains unclear. This panel discusses opportunities for transparency, processes to guide new chemicals review, new approaches to assess chemical risks, protection of workers, Section 5(e) orders, recent trends with EPA's review of new chemical substances, and much, much more. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored an all-day virtual conference, TSCA Reform -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content inspired us to re-broadcast the discussion to our podcast audience. This panel discusses the U.S. Environmental Protection Agency's (EPA) authority under Toxic Substances Control Act (TSCA) Section 6 to manage chemical risks that EPA has determined to be unreasonable and options at EPA's disposal for deploying its authority. Panelists address how EPA manages workplace risks, enforcement mechanisms for risk management restrictions, whether EPA's risk management rulemakings are adequately addressing environmental justice concerns, potential legal challenges to final risk management rules, and much, much  more. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, 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 -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions to enable our podcast audience to listen to the sessions in this venue. The topic of this podcast is the panel discussion on the U.S. Environmental Protection Agency's (EPA) risk evaluation process under Lautenberg. The panel discussed various aspects of EPA's risk evaluation of chemical substances under Toxic Substances Control Act (TSCA) Section 6. The panel experts touch upon crucially important issues, 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, the incorporation of cumulative risk assessment (CRA) approaches, and  much, much more. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the distinct pleasure of visiting with Mark Washko, Head of Federal Government Affairs at BASF Corporation. I have worked with Mark and admire his extraordinary communication skills, particularly his ability to advocate on complex science policy and chemical issues clearly and in a way that is relatable. We in the chemical community are constantly challenged on so many levels in this regard -- how to speak clearly, and to speak in a way that wins friends and influences those many who do not share our perspective, and how to remain respectful when addressing issues we care deeply about. Mark is top notch in these areas, and our conversation offers some lessons in effective government advocacy. We discuss Mark's winning style, his approach to Members and staff on Capitol Hill, what prepared him best for his role, and his advice to those thinking about embarking on a career in government affairs. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, we are re-releasing my conversation with Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, originally recorded in April. We discussed then a lawsuit challenging the U.S. Environmental Protection Agency's (EPA) issuance of a Consent Order under Section 5(e) of the Toxic Substances Control Act (TSCA). As listeners may know, judicial challenges to TSCA Section 5(e) orders are rare, and this one is even more unusual because the petitioner is a non-governmental organization (NGO) and the challenge was filed well beyond the statutory period for judicial challenge. We discuss TSCA Section 5(e) orders, the process for challenging them, and some of the underlying issues at play here, including the concept of “chemical categories” under TSCA Section 5, concerns with EPA's new chemicals review process, and EPA's assessment and communication of risk in the new chemicals it reviews under Section 5. The topic is as lively now as it was earlier this year. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I discuss with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, the importance of engaging early and often with the U.S. Environmental Protection Agency (EPA) in the Toxic Substances Control Act (TSCA) Section 6 risk evaluation process. We discuss conditions of use (COU) of a chemical being evaluated by EPA, the reasons why educating EPA on COUs is critically important to regulated businesses, the relevance of ECELs, existing chemical exposure limits, and the consequences of a Significant New Use Rule (SNUR) for use conditions out of scope of a risk evaluation. We also discuss EPA's evolving thinking regarding ECELs and why EPA's thinking is a hot topic of discussion. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, I was excited to speak with Dr. Catherine M. Croke, Bergeson &Campbell's and our consulting affiliate's, The Acta Group, Director of Product Stewardship and Regulatory Affairs, about product stewardship and its role in achieving competitive advantage. There is a direct relationship between the two if you know how to leverage excellent stewardship to achieve competitive advantage. In my conversation with Catherine, we consider the nature of this relationship. We explore how employee and management engagement in product stewardship is essential, how products can be brought to market faster, how fulfilling customer expectations is part of the equation, and how to measure the business success of implementing an effective product stewardship program.  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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of visiting with Dr. Lesa Rice-Jackson, CPPS, Managing Principal Consultant, Rice Jackson Health Safety & Regulatory Compliance Consulting, to discuss Lesa's expertise in occupational safety and health and product stewardship issues. Dr. Jackson has a distinguished career in private practice as an employee of a large industrial chemical company, and now is President of her own consultancy. Lesa is both a much sought after service provider to B&C and some of its clients and a member of the Board of Directors of the Product Stewardship Society, which I served on for several years before stepping down as President and Chair of the Board a few years ago. Lesa is a seasoned, practical, and extremely efficient professional to whom I could listen all day, given her insights on all things occupational safety and health related. We discuss the pending amendments to the Occupational Safety and Health Administration (OSHA) Hazard Communication Standard (HCS), key issues likely to complicate compliance, and how best to balance occupational safety and health compliance with emerging and more rigorous best practice standards. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, we are re-releasing a podcast I recorded with my colleague, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, much earlier this year on the U.S. Environmental Protection Agency's (EPA) development of new chemical categories to help streamline Toxic Substances Control Act (TSCA) Section 5 new chemical review. Since January, the concept of chemical categories has attracted significant attention. Rich and I discuss in the podcast the new categories for mixed metal oxides (MMO) and cathode active materials (CAM), and another category for biofuels. More recently, EPA has focused on regulating PFAS chemicals as a category and has sought comment on disallowing Low Volume and Low Release and Low Exposure Exemptions under TSCA Section 5. While this is an entirely different way of streamlining the review process, the proposal raises interesting questions that we address in our firm memorandum on this subject posted on our website. The podcast discussion is directly relevant to these more recent developments. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of speaking with Lee Bowers, Vice President -- Environmental, Health & Safety (EHS), RPM International, Inc., and Bergeson & Campbell's own Karin Baron, Director of Hazard Communication and International Registration Strategy, to discuss the consequential changes to the classification, labeling, and packaging of substances and mixtures (CLP) system in the European Union (EU). As some of our listeners may know, in April 2023, the European Commission entered into force significant changes to the CLP regulation. The real-world impacts of these changes are now being felt in a host of commercial transactions. These challenges arise because of the lack of alignment between CLP and the Globally Harmonized System of Classification of Labeling of Chemicals (GHS), which may sound less urgent than it is. Karin and I have been beating this drum for a while now, and Lee Bowers and Karin Baron are here to discuss actual instances and real case studies that listeners may find helpful to know. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of speaking with Retired Rear Admiral Melissa Bert, who served as the Judge Advocate General and Chief Counsel of the U.S. Coast Guard, the first woman to serve in this position. Admiral Bert's accomplishments are too numerous to note here, but her Wikipedia page is sure to impress. We discuss Coast Guard responsibilities, what the Chief Counsel of the Coast Guard does, some of Admiral Bert's more memorable engagements, and the Admiral's founding of the Coast Guard Women's Leadership Initiative and Leadership Diversity Advisory Council. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of speaking with Shanisha Smith, Health, Safety, and Environmental (HSE) Counsel for LyondellBasell, about her role as counsel and the rewards and challenges of advising a major chemical producer on HSE legal and product stewardship issues. In our conversation, we learn about Shanisha's beginnings not far from here on Maryland's Eastern Shore to now living in Houston and counseling LyondellBasell's, one of the world's largest chemical manufacturers, global team of HSE and product stewardship professionals on an incredibly diverse range of legal and product stewardship issues. We discuss Shanisha's impressive personal background, how it prepared her for the demands of her current job, and Shanisha's approach to counseling her client on evolving legal and stewardship topics, many of which are emerging with no clear answer. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of speaking with Dr. Jane Vergnes, Director of Toxicology and Vice President, Scientific Affairs, here at B&C and its consulting affiliate, The Acta Group (Acta®), about the regulation of PFAS under REACH. Many of our listeners know the European Chemicals Agency (ECHA) released on February 7 its long-awaited restriction proposal for the regulation of per- and polyfluoroalkyl substances in the European Union (EU) under the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations. The proposal is a monster -- complex, far-ranging, and very consequential. The six-month consultation period is open until late September, and regulated entities on both sides of the Atlantic are urged to read and comment on the proposal. Jane and I cover lot of territory in our discussion. We discuss the risk options ECHA considered, what it has proposed, some legal vulnerabilities with the approach ECHA has taken that commentators are discussing, and how best to prepare for the final restrictions, whenever they are issued and in whatever form. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, returned to the studio to discuss a recently filed lawsuit challenging the U.S. Environmental Protection Agency's (EPA) issuance of a Consent Order under Section 5(e) of the Toxic Substances Control Act (TSCA). Judicial challenges to TSCA Section 5(e) orders are rare, and this one is even more unusual because the petitioner is a non-governmental organization (NGO) and the challenge was filed well beyond the statutory time period for judicial challenge, according to some. We discuss TSCA Section 5(e) orders, the process for challenging them, and some of the underlying issues at play here, including the concept of “chemical categories” under Section 5, concerns with EPA's new chemical review process, and EPA's assessment and communication of risk in the new chemicals it reviews under Section 5. 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. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved