All Things Chemical

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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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.

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This week, I sat down with the truly legendary Robert M. Sussman, of Sussman & Associates, to discuss Bob’s extraordinary career engaging in all things Toxic Substances Control Act (TSCA), new and old. Bob was a prominent private-practice attorney and frequent senior official at the U.S. Environmental Protection Agency (EPA) before TSCA was amended in 2016. Since the Frank R. Lautenberg Chemical Safety for the 21st Century Act, Bob has been extraordinarily successful putting his TSCA know-how and finely honed litigation skills to effective use for a wide range of public-interest clients. During our conversation, we discuss Bob’s amazing career, his litigation successes, his views on new TSCA, and his hopes for the future of chemical management.

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.

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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 the newly enacted Modernization of Cosmetics Regulation Act of 2022, better known as MoCRA. The U.S. Food and Drug Administration has been the subject of criticism for years over what some regard as inadequate regulation of cosmetics and the facilities where they are produced. MoCRA is intended to modernize the regulation of cosmetics and imposes sweeping changes on the review and regulation of cosmetics about which our listeners need to know. In our conversation, Karin addresses the most consequential new regulatory provisions MoCRA imposes and explains when they are effective and how they will impact the manufacture and marketing of cosmetic products.

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.

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The train derailment in East Palestine, Ohio, has inspired a lot of conversation involving a wide range of topics, including emergency response measures, rail transport of chemicals, and most pertinent to this conversation, communicating chemical risk information to the public. Several of my colleagues here at Bergeson & Campbell have worked at the U.S. Environmental Protection Agency (EPA) in varying capacities and other federal agencies charged with regulating chemicals and communicating safety and risk information. We thought it would be interesting to have a conversation with these former regulators about the challenges federal and state agencies face in responding to major incidents like the train derailment in East Palestine. So this week, I sat down with Jim Aidala and Dennis Deziel, both Senior Government Affairs Advisors at B&C and its consulting affiliate, The Acta Group, and Dr. Richard Engler, Director of Chemistry at B&C and Acta, to speak about some of these issues, given their unique perspective as former government representatives. Among the issues we discuss is what happens when the call comes in reporting on a major incident, how did each plan for the unexpected, what are the key challenges in communicating risk information about chemicals to the public, and their thoughts on restoring trust in what the government reports during major incidents.

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.

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This week, I sat down with Dr. Tina N. Armstrong, a Vice President with Arcadis U.S., Inc., to discuss the role of product stewardship in business organizations today. To those of us in this space, Tina is a rock star. In addition to her role as a business leader and scientist at Arcadis, Tina is a professor in product stewardship strategy and management at the Indiana University Richard M. Fairbanks School of Public Health, an author of many books and articles on product stewardship, and the 2022 awardee of the prestigious Allan K. Fleeger Distinguished Service Award conferred by the Product Stewardship Society for her many contributions to product stewardship. We discuss what product stewardship is, its origins, it value to companies, particularly those in the chemical and chemical product manufacturing sector, and the essential elements of a stewardship team.

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.

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This week, I had the pleasure of catching up with Dr. Catherine M. Croke, B&C’s and our consulting affiliate’s, The Acta Group, new Director of Product Stewardship and Regulatory Affairs. Catherine joined us recently from Evonik Corporation, where she was Senior Advocacy and Compliance Manager. Catherine’s diverse and truly extraordinary background working for industrial chemical companies in a variety of science, business, and advocacy roles have made Catherine a core part of the B&C and Acta team. We discuss the expanding role and growing importance of product stewards in corporate America today, what is product stewardship, the value this role offers to companies, and where to begin if your company is without a product steward.

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.

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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. During this 100th All Things Chemical podcast, Karin and I discuss the very important recently released amendments to the Canadian Hazardous Products Regulations (HPR). The amendments are intended to align the HPR with the seventh revised edition (Rev 7) of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). No one on planet Earth knows the global state of play of GHS regulation better than Karin. We focus here on what listeners need to know regarding the new HPR provisions, when they must be implemented, and how they will impact the classification and labeling of hazardous products in Canada and beyond.

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.

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This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group. We discuss what to expect in 2023 from Capitol Hill and the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) when it comes to key chemical matters. Jim is, of course, one of the country’s most talented pesticide experts and, as a former Assistant Administrator of what is now OCSPP and a founding member of the Capitol Steps, offers laser-focused insights on chemicals with wit and flair. We cover a lot of territory -- EPA staffing deficits, a divided Congress, and the many daunting legal, science, and policy issues that this OCSPP is tasked with solving, or at least managing.

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.

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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 what to expect in Toxic Substances Control Act (TSCA) regulation in the New Year. While we cannot predict with precision, we know 2023 will be a consequential year for several reasons: the first final risk management rule will be issued, the final per- and polyfluoroalkyl substance (PFAS) reporting rule will be issued, and the final Confidential Business Information rule will be issued -- and this is the first quarter of the year!

In addition to these new and significant final rules, we know the new Republican-led House is expected to schedule oversight hearings on a variety of U.S. Environmental Protection Agency (EPA) topics, including TSCA implementation. Litigation is also likely to darken our collective doorways in 2023, so we discuss what issues are likely to be litigated and who might bring the lawsuits.

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.

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This week, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, returned to the studio to discuss the U.S. Environmental Protection Agency’s (EPA) bold moves in developing new chemical categories to help streamline the review of new chemicals under Toxic Substances Control Act (TSCA) Section 5. While the categorical approach to new chemical review is by no means new, it has stalled out in recent years, and EPA’s renewed work in this area is both timely and essential. Rich and I discuss the new category for mixed metal oxides (MMO) and cathode active materials (CAM) and another category for biofuels. We answer the questions “Why now?,” “How are the categories developed?,” “Where is EPA headed?,” and we discuss why you should care.

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.

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This week, Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group, our consulting affiliate, returned to the studio to discuss the stubbornly vexatious problem of TSCA’s regulation of articles, a fancy name for products or finished goods. Most listeners to the podcast appreciate that this U.S. Environmental Protection Agency (EPA) Administration has specifically applied TSCA regulations to articles far more than in decades past. This policy pivot has caused a significant amount of commercial disruption and business uncertainty. This will not abate in the years ahead. Rich Engler explains why this is the case and suggests some steps regulated entities may wish to consider to comply with current regulations and prepare for the 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.

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This week, I welcomed back to the studio Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. Karin and I discuss the controversial changes proposed by the European Commission to the regulation on classification, labeling, and packaging of substances and mixtures, better known as the CLP regulation. As our listeners know, no one knows this space better than Karin Baron. Karin explains why the proposed changes are likely to inject even greater dis-harmonization in the area of the global harmonization of packaging and labeling at a time when global commerce can least afford 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.

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This week, I sat down with Dr. Claire Skentelbery, Director General, EuropaBio -- The European Association for Bioindustries. Many of you may know Claire from her prior role as Director General of the Nanotechnology Industries Association, where she energized that Brussels-based trade association to new and exciting heights. Claire has brought her considerable scientific, science policy, and trade association management skills to EuropaBio at an exciting time, as biotechnology is widely recognized to be a pivotal component of the European Union’s (EU) commitment to sustainability. We cover a lot of territory in our conversation and discuss evolving perceptions of biotechnology in the EU, how biotechnology is advancing the EU’s commitment to sustainability and circularity, and what’s next for biotech advocacy in the EU.

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.

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This week I sat down with Doug Charnas, a nationally- recognized corporate and tax attorney and partner at McGlinchey, in its Washington, D.C. offices, and our own Dr. Richard Engler, Director of Chemistry at Bergeson & Campbell and at our consulting affiliate, The Acta Group. We discuss the recently reinstated Superfund Tax, which entities the tax applies to, what exactly is a taxable chemical and how to distinguish between taxable chemicals and taxable substances, and why just about everyone is really grumpy about this newly reinstated tax.

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.

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This week, I welcomed back to the studio Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. Karin and I discuss the U.S. Food and Drug Administration’s (FDA) initiative called the New Era of Smarter Food Safety. The goal of this initiative is to diminish the number of foodborne illness, which, surprisingly, has not diminished since the Food Safety Modernization Act was enacted 11 years ago. We discuss FDA’s “blueprint for the future” as the initiative has come to be called, the use of emerging technologies to achieve FDA’s goal, and how FDA is trying to change the culture of food safety in the United States.

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.

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This week I sat down with James Cox, M.S., Senior Scientist with B&C. James is an exceptional biologist with significant experience assessing the risk of industrial chemicals. Before joining B&C, James served in a variety of leadership positions in the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevent and Toxics, one of which was Chair of the Risk Assessment Technical Team, which provided recommendations to inform EPA’s policy positions on New Approach Methodologies or NAMs. James discusses NAMs, their significance in chemical risk assessment under the Toxic Substances Control Act (TSCA), how NAMs will enable diminished reliance on animal testing, and some of the challenges facing chemical stakeholders in moving away from animal testing. Now, here is my conversation with James Cox.

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.

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This week I sat down with Professor Delcianna J. Winders, Professor and Animal Law and Policy Institute Director at the Vermont Law School. Professor Winders is a total rock star in the exploding area of animal law. Prior to joining the Vermont Law School faculty and founding the Animal Law and Policy Institute, Professor Winders was on the faculty of Lewis & Clark Law School. She previously served as Vice President and Deputy General Counsel at the People for the Ethical Treatment of Animals Foundation, was the first Academic Fellow of the Harvard Animal Law & Policy Program, and a visiting scholar at the Elizabeth Haub School of Law at Pace University.

We touch on just a few of the many fascinating issues included under the broad umbrella of animal law, including Professor Winders’ judicial successes involving the Animal Welfare Act, her thoughts on alternatives to animal testing, how the concept of one health intersects with animal law, the role of restorative justice in animal and chemical law, 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.

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This week I sat down with Dr. Richard E. Engler, B&C’s and The Acta Group’s (our consulting affiliate) Director of Chemistry, to discuss the new chemical bias. Our listeners know that Rich Engler has worked for decades reviewing Premanufacture Notifications submitted under the Toxic Substances Control Act (TSCA). PMNs are applications to manufacture or import chemical substances that are not listed on the TSCA Inventory and thus are considered “new.” Much has changed in terms of the new chemical review process since Congress revised TSCA six years ago. As we discuss in our podcast, however, one thing has not changed: the new chemical bias is as potent today as it was before Lautenberg was enacted in 2016. Rich and I discuss the new chemical bias, explain why it continues to confound chemical innovators, and what is being done to eliminate the bias and level the playing field.

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.

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This week, I sat down with Dr. Dianne Barton, Water Quality Coordinator at the Columbia River Inter-Tribal Fish Commission in Portland, Oregon, where she puts her Ph.D. in geochemistry to good use by providing technical expertise related to water quality, environmental toxics, regulatory processes, and the fate and transport of contaminants. Dr. Barton, who is a member of the Bad River Band of Lake Superior Chippewa, Chairs the National Tribal Toxics Council (NTTC), which is a U.S. Environmental Protection Agency (EPA) - tribal partnership group that provides tribes with opportunities to engage more specifically with EPA on toxics issues. In our conversation, Dr. Barton shares her significant expertise on toxics issues and how the NTTC is engaged with EPA on a wide variety of Frank R. Lautenberg Chemical Safety for the 21st Century Act implementation issues, particularly those affecting tribal communities.

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.

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This week, I sat down with David Cragin, Ph.D., DABT®, Quality Assurance and External Affairs Director for a large multinational pharmaceutical company, to discuss his experience living and working in China. For many listeners, working with foreign regulators can be particularly challenging for a variety of reasons, including language barriers, cultural differences, and differing regulatory standards. Dave shares his experience working in China and explains his approach to managing these issues successfully.

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.

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This week, I sat down with Sheryl Lindros Dolan, Senior Regulatory Consultant with B&C and Senior Regulatory Specialist with our consulting affiliate, The Acta Group, and Meibao Zhuang, Ph.D., Senior Scientist/Regulatory Consultant with B&C and Acta, to discuss pesticide tolerances, what are they, how does the U.S. Environmental Protection Agency (EPA) develop them, and how well government and industry stakeholders communicate their utility in ensuring a safe and reliable food supply. We also wander into the complex world of soil amendments and adjuvants, so if you do not know what these are, listen up.

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.

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This week, I sat down with Jake Li, Deputy Assistant Administrator for Pesticide Programs, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA), and my colleague, Jim Aidala, Senior Government Affairs Consultant here at B&C. My guests have much in common -- they both have served (or in Jake’s case is serving) in senior policy positions in this space at EPA, and they both have a keen understanding of the legal, policy, and commercial implications of the Endangered Species Act (ESA). Enacted almost 50 years ago, the ESA is intended to preserve and protect imperiled species. As anyone in this space knows, implementing the ESA and balancing the need for pesticide use has proven to be a challenging issue for decades.

Our conversation today covers what the Administration is doing to balance wildlife protection and responsible pesticide use, what the federal Interagency Working Group is doing in this regard, and consider how the ESA Workplan is helping EPA’s Pesticide Program meet its ESA obligations.

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.

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This week, I sat down with Lisa R. Burchi, Of Counsel, Bergeson & Campbell, P.C., and resident expert on Proposition 65 (Prop 65), among many other chemical laws. Few state laws are more notorious, or controversial, as this 1986 California law that revolutionized the concept of a consumer’s or worker’s “right to know” whether a product or work space might present exposures to chemicals considered carcinogens or reproductive toxins. Fast forward 36 years, and the familiar label warning on products as diverse as industrial chemicals to coffee and other common food items are found literally everywhere, in and out of the state of California.

Lisa bring us up to date on some important new Prop 65 developments, reflects a bit on the law’s successes and misses, and discusses a few important judicial rulings about which our listeners will want 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.

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This week, I welcomed back to the studio Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. Karin is an internationally recognized expert on hazard communication, risk assessment, the regulation of food contact materials, and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Karin’s expertise in hazard communication and GHS was recently recognized as Karin was elected to the Board of Directors of the Society for Chemical Hazard Communication (SCHC), an organization Karin has held leadership positions in for years. Our conversation focuses on the truly seismic changes underway in South and Central America, in the European Union and United Kingdom, and in Asia with regard to adoption of the GHS and the Safety Data Sheet implications of these actions. These initiatives have a profound impact on the movement of goods and materials internationally, and the unwary can find themselves in a world of trouble by not keeping up. Karin’s special talent in this space is directed at helping her clients avoid bad commercial things from happening. 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.

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This week I had the pleasure of sitting down again with one of my favorite people on planet Earth, Kate Sellers, Technical Fellow at ERM, where Kate leads a multidisciplinary team of professionals dedicated to helping companies recognize the business value of product stewardship. Kate is also an adjunct professor at Harvard Extension School and Indiana University’s School of Public Health, where she is an instructor in the Master of Science in Product Stewardship program. Kate and I last spoke on the podcast in December 2020, when we vowed to speak again in about a year.

Over the past year, Kate has seen an uptick in several product sustainability trends, including implementation of the Toxic Substances Control Act (TSCA), life-cycle assessment, circular economy programs, and sustainability initiatives. We discuss all of these trends and more in our 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.

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This week, I sat down with Dr. Steven Bennett, Executive Vice President, Scientific & Regulatory Affairs, Household & Commercial Products Association, here in Washington, D.C. Steve’s membership represents an amazing diversity of products used to clean and disinfect homes and commercial environments. As Executive Vice President of scientific and regulatory affairs, Steve routinely addresses an equally diverse and challenging range of scientific, regulatory, and science policy issues, from consumer exposures, to chemicals used in cleaning products, to the role HCPA members play in addressing COVID-19 and related public health issues.

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.

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This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group. As a former Assistant Administrator in what is now the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention, Jim has a truly unique and exceedingly focused perspective on EPA and Congressional initiatives involving the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Unsurprisingly, the new (or not so new now) Administration has taken positions on key FIFRA issues that are quite different from those of the prior Administration. We cover pollinators, Pesticide Registration Improvement Extension Act of 2018 (PRIA 4) renewal, the Endangered Species Act (ESA), and a host of other FIFRA hot topics, reported as only Jim can describe, given his extraordinary experience and entertaining style.

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.

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This week, I was delighted to visit again with Alexandra Dunn, now a Partner with Baker Botts and immediate past Assistant Administrator of the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP). As Assistant Administrator, Alex was respected and liked by a diversity of industrial and agricultural chemical stakeholders, revered by her immediate staff, and hugely popular as an EPA senior leader. Alex led OCSPP at a pivotal time in EPA’s implementation of revisions to the Toxic Substances Control Act (TSCA) and worked tirelessly to meet the many deadlines imposed under the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg). We discuss Alex’s transition back into the private law sector, get a sense of the issues on which Alex is focusing now that she is back in private practice, and reflect on current EPA policies under TSCA and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to understand what has changed since Alex left EPA.

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.

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This week, I sat down with Dr. Jane Vergnes, Director of Toxicology and Vice President, Scientific Affairs, here at B&C and its consulting affiliate, The Acta Group (Acta®), and Dr. Steven P. Brennan, Senior Manager of REACH at Acta, and resident in our UK office in Manchester, England. In our podcast, we seek to answer the question “How is the UK government doing in implementing UK REACH?” We are just past year one of UK REACH as it came into force at 11:00 p.m. UK time on December 31, 2020. Creating a parallel regulatory framework for the management of industrial chemicals in Great Britain is no small feat, and Jane and Steven bring us up to speed on what has happened over the past year and tell us what to look forward to in 2022. 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.

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This week I had the pleasure of sitting down with Kelly Scanlon, DrPH, CIH, Director of Environmental Policy & Research, Global Government Relations, at IPC. IPC, as many of you know, is an organization accredited by the American National Standards Institute as a standards development organization. It publishes the most widely used acceptability standards for the electronic industry. Dr. Scanlon was brought on at IPC in 2019 to direct environment, health, and safety (EHS) policy and research, a role that has become critically important given certain Toxic Substances Control Act (TSCA) rulemakings that have extended TSCA jurisdiction to certain electronic product manufacturers. These regulatory developments, implemented against a backdrop of supply chain disruption occasioned by COVID-19, have made for a very eventful and likely unexpected first two years on the job. Dr. Scanlon and I discuss IPC’s work on EHS policy, enhanced regulation of articles under TSCA, and other challenges the electronics industry faces.

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.

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This week I had the pleasure of sitting down with Baskut Tuncak, newly named Director, Toxics Use Reduction Institute (TURI), at the University of Massachusetts, Lowell. Baskut is a lawyer and former research chemist with a truly distinguished and fascinating career in a diverse range of public and private sector roles in toxics issues. Baskut most recently served as the United Nations (UN) Special Rapporteur on toxics and human rights. In our conversation, Baskut explains the role of rapporteur to the UN and outlines for us his goals as Director of TURI, one of three agencies implementing the Massachusetts Toxics Use Reduction Act.

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.

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This week I was thrilled to sit down with James V. Aidala, B&C’s Senior Government Affairs Consultant, and Dr. Richard E. Engler, B&C’s and The Acta Group’s (our consulting affiliate) Director of Chemistry, to discuss what to expect in 2022 with regard to industrial and agricultural chemical regulation. As our listeners know, each year we publish a Forecast, a written summary of our best professional judgment as to the trends and key developments we expect in the New Year. Our 2022 Forecast is a monster -- 103 pages of well written, expert analysis on global chemical developments. My conversation, spirited and candid, with Jim Aidala and Rich Engler, focuses on domestic industrial and pesticide policy, trends, and regulatory 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.

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Mathy Stanislaus was recently appointed as Vice Provost and Executive Director of Drexel University’s Environmental Collaboratory, which brings interdisciplinary expertise in environmental sciences, engineering, law, health, business, economics, policy, and humanities to co-design transformative environmental solutions in partnership with community leaders, nonprofits, corporations, and governments. He was formerly the Interim Director and Director of Public Policy and Engagement for the Global Battery Alliance (GBA), a partnership of over 70 businesses, governments, and non-governmental organizations focused on ensuring that battery production supports green energy, safeguards human rights, and promotes health and environmental sustainability. During this episode of All Things Chemical, Lynn L. Bergeson and Mathy Stanislaus cover a broad range of issues, including the mission of GBA, Mathy’s new role, GBA’s fascinating and potentially transformational Battery Passport project, and other interesting topics.

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.

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This week I was delighted to sit down with Katherine Meighan, Associate Vice-President and General Counsel of the International Fund for Agricultural Development (IFAD), a United Nations agency headquartered in Rome, Italy. We spoke with Katie in the summer of 2019, after an International Bar Association (IBA) webinar on sustainable investment in agriculture I helped organize in my role as Vice Chair of the IBA Agricultural Law Section. I was so impressed with Katie’s work, we decided to do a podcast shortly thereafter. Since then, much has changed, and IFAD’s role in eradicating poverty and hunger by investing in the rural poor has intensified greatly over the past two years. As the world now looks past the major climate conference that just wrapped up in Glasgow, there has been discussion about the inherent dilemma/contradiction between greening the planet/decreasing emissions and the need to feed people and support their livelihoods across a diverse range of populations. Katie discusses the delicate balance between food and climate, and the essential the role IFAD plays in addressing this challenge.

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.

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This week I sat down with Dr. Richard E. Engler, B&C’s and The Acta Group’s (our consulting affiliate) Director of Chemistry, and Dr. Todd J. Stedeford, B&C’s Of Counsel, to discuss a range of issues regarding the U.S. Environmental Protection Agency’s (EPA) all important implementation of the Lautenberg amendments to the Toxic Substances Control Act (TSCA). Rich was a 17-year veteran of EPA’s Office of Pollution Prevention and Toxics (OPPT) before joining our team. Todd is a more recent addition to our team, and is a lawyer and a toxicologist who recently completed a 20-year career with EPA where he served most recently as Senior Science Advisor in EPA’s OPPT, and in other EPA leadership positions.

Rich and Todd discuss a range of issues I know our listeners will find interesting and timely. These include EPA new chemical reviews, when is something “reasonably foreseen,” and what is an “unreasonable risk,” among other topics.

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.

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This week I was delighted to sit down with Dr. Michal I. Freedhoff, Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA), arguably the busiest person in Washington, D.C. Dr. Freedhoff is EPA’s top Toxic Substances Control Act (TSCA) official, and she also administers the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). Dr. Freedhoff discusses OCSPP’s priorities, plans for the new year, and focuses on a few key issues, including new chemical review, industrial chemical testing, EPA’s PFAS Action Plan for per- and polyfluoroalkyl substances, and how OCSPP is dealing with a workload that is not matched by existing resources.

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.

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This week I sat down with Kurt M. Landgraf, former Chairman and CEO of DuPont Pharmaceuticals Company and most recently former President of Washington College located in Chestertown, Maryland. I have known Kurt for a number of years now, and I thought a conversation focusing on Kurt’s extraordinarily diverse background would be an interesting mix of pharmaceutical management issues, higher education, and Kurt’s observations on preparing students for careers in environmental disciplines. Kurt’s storied career makes for a fascinating conversation that I think you will enjoy.

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.

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David’s 1999 Paper on e-commerce and the environment

This week I sat down with David Rejeski, Visiting Scholar with the Environmental Law Institute (ELI), to learn more about his engagement in the Project on the Energy and Environmental Implications of the Digital Economy. With support from the Alfred P. Sloan Foundation, ELI, the Yale School of the Environment, and the Center for Law, Energy & the Environment at UC Berkeley, the Project is shedding much-needed light on the true environmental and energy implications of the digital economy, focusing on blockchain technologies, sharing platforms, artificial intelligence, and other technologies. We also look back at David’s pioneering work on the implications of nanotechnology when he was heading up the Project on Emerging Nanotechnologies at the Woodrow Wilson International Center for Scholars.

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.

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All Things Chemical will reach our 3rd anniversary on October 23rd and we want to share this celebration with you. As we look back on the last three years I wanted to bring back an older episode from the summer of 2020, “Implementing Lautenberg — A Conversation with former OPPT Director Jeffery T. Morris, Ph.D.” During this episode I spoke with Jeff Morris about how the Office of Pollution Prevention and Toxics implemented Lautenberg back in 2016, and how TSCA can be implemented in the future to address social inequities and achieve its goals of environmental justice. I hope you enjoy it and take this opportunity to listen to some more episodes from our archives.

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This week I sat down with Dr. Jeff Morris, immediate past Director of EPA’s Office of Pollution Prevention and Toxics (OPPT), the EPA office that regulates the industrial chemical sector. Jeff directed EPA’s implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA) and headed the office most immediately impacted by the significant changes brought about by the Lautenberg amendments.

In our discussion, we talk about how Jeff and his OPPT colleagues managed the daunting task of implementing a new law, and how the Agency has fared since the law’s enactment four years ago. We discuss Jeff’s interest in environmental justice, and how TSCA might be used to address the impact of environmental harms and their disproportionate adverse impact on people of color and the poor.

We also discuss Jeff’s important role in EPA’s Office of Research and Development and its research program on nanomaterials and nanotechnology, and how his background prepared Jeff well for addressing TSCA’s application to emerging chemical technologies.

We conclude by learning more about what Jeff is up to now in his new role as a principal in Jeff Morris Solutions, LLC. I really enjoyed my conversation with Jeff. He and I have known each other for many years, and I have long admired Jeff’s integrity, his commitment to public service, and his epic understanding of chemical policy, science, and regulation.

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.

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This week I sat down with my new colleague, Dennis R. Deziel, B&C’s and our consulting affiliate’s, The Acta Group, Senior Government Affairs Advisor, to discuss Toxic Substances Control Act (TSCA) reform. Dennis served as Director of Federal Government Affairs for the Dow Chemical Company when the TSCA amendments were considered and eventually enacted by Congress in 2016. After leaving Dow, Dennis served as EPA Region 1 Administrator (New England). I thought it would be interesting to speak with Dennis and seek his views on TSCA reform, as it was happening when he was a senior executive for one of the world’s largest chemical companies, and then as a Senate-confirmed political appointee, after TSCA reform was enacted and he was part of the team implementing the new law.

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.

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This week I sat down with Dr. Richard E. Engler, B&C’s and The Acta Group’s (our consulting affiliate) Director of Chemistry, to discuss the U.S. Environmental Protection Agency’s (EPA) continuing struggle to regulate certain persistent, bioaccumulative, and toxic (PBT) chemicals, especially those found in finished products, what EPA refers to as “articles.” The Toxic Substances Control Act (TSCA) has always applied to the products, or articles, that contain chemical substances of interest to EPA under TSCA. While EPA previously used that authority somewhat sparingly, the 2016 Amendments to TSCA have jump-started a new wave of regulations that expressly apply to articles. EPA is required under TSCA to regulate certain PBTs, and EPA issued a final rule earlier this year that inspired chaos in the business community, especially in the electronics sector and its complicated supply chain. Rich and I discuss these PBT rules and help explain what may well be the new normal with regard to the regulation of finished products under TSCA.

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.

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This week, I sat down with Daniel Rosenberg, Director, Federal Toxics Policy, Healthy People & Thriving Communities Program, at the Natural Resources Defense Council (NRDC). Daniel’s distinguished legal career has placed him at the forefront of the evolving law and policy of domestic chemical regulation. Daniel and I discuss new Toxic Substances Control Act (TSCA), the U.S. Environmental Protection Agency’s (EPA) implementation of the 2016 amendments to TSCA under Lautenberg, several recent regulatory initiatives involving persistent, bioaccumulative, and toxic (PBT) chemicals and per- and polyfluoroalkyl substances (PFAS), and much more. An engaging and formidable advocate, Daniel’s views are always forcefully spoken and clearly articulated.

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.

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This week I sat down with Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. Karin works extensively with the European Union’s (EU) Registration, Evaluation, Authorization, and Restriction of Chemicals, better known as REACH, which is the EU counterpart to the U.S. Toxic Substances Control Act (TSCA). We discuss REACH Article 41 “compliance checks,” an innocuous-sounding component of REACH that has the potential to cause considerable business anxiety, delay, and expense if a company’s REACH dossier is found to be deficient as a result of a compliance check. Karin walks us through what these checks are for, what could happen if you are caught up in one, and how best to respond if your dossier becomes ensnared in a compliance check.

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.

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This week I sat down with Carla N. Hutton, Regulatory Analyst at B&C. Carla is also co-editor of the Nano Blog that B&C has prepared for years. Carla is uniquely well suited to discuss a report the National Institute for Occupational Safety and Health (NIOSH) recently issued on developing occupational exposure limits or “bands” for engineered nanomaterials. There are thousands of chemicals in use in the workplace, but far fewer government-issued, authoritative, peer-reviewed occupational exposure limits for workplace chemicals. The recent NIOSH report discusses an approach to evaluate scientific information to derive occupational exposure limits or bands for engineered nanomaterials.

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.

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This week I sat down with Karin F. Baron, Senior Regulatory Consultant at B&C and our consulting affiliate, The Acta Group. We tackle the daunting topic of combustible dust, a common workplace hazard that is more pervasive perhaps than people think. Combustible dust poses an explosion hazard in a wide variety of industries, including food, plastic, wood, and textiles, among many others. Karin helps us understand what combustible dust includes and then walks us through the somewhat complicated governance frameworks that have emerged among the Occupational Safety and Health Administration (OSHA), private standard-setting organizations, and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). The space is crowded and remarkably unclear, especially given the severity of the incidents that have occurred over the years.

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.

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This week I sat down with Dr. Richard E. Engler, B&C’s and The Acta Group’s (our consulting affiliate) Director of Chemistry, to discuss a very new component on the U.S. Environmental Protection Agency’s (EPA) PFAS Action Plan. The plan represents EPA’s “all of agency” approach to address the risks posed by per- and polyfluoroalkyl substances (PFAS) that can accumulate in humans and remain in the body for long periods. PFAS have been widely used in many consumer articles for years, and the action plan represents the totality of EPA’s actions to identify areas of risk and steps to address risks to human health and the environment.

EPA recently proposed a PFAS reporting rule under the Toxic Substances Control Act (TSCA) that would compel the submission of certain information on some 1,000 listed PFAS chemicals. The proposal is controversial because of how it defines this class of chemicals, the standard of knowledge that triggers reporting, and the types of entities subject to the reporting requirements. Rich Engler helps us understand what these issues are and why you should care.

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This week, I sat down with Bruce Jarnot, Ph.D., DABT®, Senior Manager, Product Compliance, at Assent Compliance. Bruce is a board-certified industrial toxicologist with much experience assisting businesses with chemical product compliance. I have known Bruce for years, but over the past several months, Bruce and I have spoken often about the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) and certain new rules that apply to manufacturers of finished goods, called “articles” under TSCA. Several rules issued in final this year or proposed apply to importers of finished goods and other downstream entities. A proposed reporting rule issued in June would apply to small businesses, a cohort historically exempt from TSCA reporting requirements. We discuss these rules and their significant commercial impacts, and we speculate on whether these broad reporting requirements are the new normal under new TSCA.

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.

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This week, I sat down with Meglena Mihova, Managing Partner, EPPA, the Brussels-based premier consultancy on matters involving key business sectors, including chemicals and chemical regulation. Meglena is expert on all matters involving the European Chemicals Agency (ECHA) and the complex relationships between and among ECHA, European Union (EU) member states, the European Commission, and other stakeholders. Meglena chairs the Environment Committee of the American Chamber of Commerce to the EU, which is the leading U.S. business representation body in the EU. We cover a lot of territory, including amendments to the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulations, the EU Green Deal, the chemicals strategy for sustainability under the EU Green Deal, and the regulation of per- and polyfluoroalkyl substances (PFAS) and microplastics.

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.

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This week, I sat down with Heather J. Blankinship, Senior Manager with B&C Consortia Management, a Bergeson & Campbell affiliate, and Richard E. Engler, Ph.D., B&C’s Director of Chemistry, to discuss chemical testing under the Toxic Substances Control Act (TSCA). Since Congress amended TSCA in 2016, EPA has been slowly ratcheting up required chemical testing under TSCA Section 4. Congress gave EPA expanded testing authority under the 2016 Amendments, and EPA is exercising its new authority to compel chemical data production. These test orders authorize EPA to demand the production of new test data by the manufacturers and sometimes processors of the chemical substances at issue. Transactionally, this means competitors in the marketplace band together to generate the data EPA seeks. We discuss the reality of quickly forming these consortia and the business and scientific challenges consortia managers face in complying with these federally enforceable test orders. It is not as easy as you may think!

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.

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This week, I sat down with Brenna Finn, Assistant Attorney General, Colorado Department of Law. I am proud to report that Brenna was a law intern here at the firm years ago, as Brenna began her legal career, and pleased to report that her experience with the firm focused her career, in part, on chemical regulation. Brenna’s substantive skills in Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Toxic Substances Control Act (TSCA) regulation have served her well in private practice and prepared her for her current position with the State of Colorado Attorney General’s office, where Brenna heads up the Agricultural Unit in the Business & Licensing Section of the Colorado Department of Law. Brenna enforces the Department’s pesticide registration and application laws, among other responsibilities. Brenna is also an adjunct law professor at the University of Denver, Sturm College of Law, where she teaches Food and Pesticide Regulation. After briefly summarizing Brenna’s successful career, we discuss Colorado’s regulation of pesticides used on cannabis and the key enforcement issues on which Brenna’s unit focuses. We also review other enforcement priorities in the state, as Colorado grows many crops in addition to cannabis.

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This week, I sat down with Scott J. Burya, Ph.D., a regulatory chemist with B&C and our affiliated consulting firm, The Acta Group. Scott works extensively in the food contact area and other areas involving Federal Food, Drug, and Cosmetic Act (FFDCA) regulatory matters. We discuss how U.S. regulatory professionals working in the all-important food contact space can leverage a European Union (EU) measure applicable to plastic food contact materials and articles. The Plastics Implementing Measure, or PIM, includes, among other features, a list of more than 1,000 chemical substances and specific migration levels. Scott describes the EU measure and its strengths and perceived deficits, and discusses how U.S. regulatory professionals in this space can leverage the PIM and the specific migration limits in other regulatory contexts here in the United States and elsewhere.

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.

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This week, I sat down with Daniella Taveau, a Regulatory and Global Trade Strategist and the founder of Bold Text Strategies. As a former International Trade Negotiator for the U.S. Environmental Protection Agency, Daniella represented the United States in all U.S. Free Trade Agreements and before the World Trade Organization, the United Nations (U.N.) Food and Agriculture Organization, and the Asia-Pacific Economic Cooperation. Daniella also served as an International Policy Analyst with the U.S. Food and Drug Administration.

Given Daniella’s rich background on global trade issues, we discussed the incoming Biden Administration’s approach to trade, what the Biden Trade Plan might include, what chemical and pesticide companies might expect in the months ahead, and what some of the key differences are between the new Administration’s approach to trade and the former Administration’s trade strategy.

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.

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This week I sat down with Karin Baron, Senior Regulatory Consultant to B&C and our affiliated consultancy, The Acta Group, to discuss the European Union’s (EU) Commission Regulation issued last June relating to the completion of safety data sheets (SDS). As listeners know, SDSs are critically important commercial documents that describe the hazards identified with a particular chemical product or mixture as it makes its way in commerce. While this is an EU rule, Karin explains why the new regulation has important consequences for U.S. businesses.

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.

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This week, I sat down with Dr. Jane Vergnes, Director of Toxicology and Vice President, Scientific Affairs, here at B&C and its consulting affiliate, The Acta Group (Acta®), and Dr. Richard Engler, Director of Chemistry, at B&C and Acta. We discussed the provocative question “is everything carcinogenic?” In asking this question, Jane and Rich discuss the marketing and labeling implications of a cancer classification for a chemical substance found as an ingredient in a consumer or industrial product. In today’s “informed consumer” market, product manufacturers are challenged as never before to contextualize the significance of a cancer classification or other hazard characteristic. If Proposition 65 has taught us anything, it is that “over” warning dilutes the significance of important product information and dulls consumer awareness of information that could be communicated more meaningfully.

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.

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This week I sat down with Karin Baron, Senior Regulatory Consultant to B&C and our affiliated consultancy, The Acta Group, to discuss the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). Listeners know GHS is the non-mandatory framework intended to aid in identifying, classifying, and communicating information on the hazards of chemicals or substances for occupational, consumer, and environmental exposures. Despite the “harmonization” part in GHS, there continue to be significant areas of non-harmonization on a global scale that confound stakeholders at all levels. For professionals working in this space, GHS can be rewarding, immensely confusing, and a bit frustrating.

Karin talks a bit about the new Biden Administration and any foreseeable changes in the Occupational Safety and Health Administration’s (OSHA) implementation of the Hazard Communication Standard (HCS) and the recently proposed rule that will amend the HCS, brings us up to date on the current status of GHS Revision 9, and addresses the status of GHS more globally, especially in Canada, as what is going on with our northern neighbors is always significant for U.S. businesses.

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.

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This week, I sat down with Jim Aidala, Senior Government Affairs Consultant, and Dr. Richard Engler, Director of Chemistry, at B&C and its consulting affiliate, The Acta Group. As both of these gentlemen previously worked at the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention, Jim as former Assistant Administrator of that office and Rich as a senior chemist and head of the Green Chemistry Division, each has a keen sense of how EPA prepares for and transitions to a new Administration. After reviewing how a new Administration fills key positions and otherwise prepares to take the reins, we discuss a few topics on everyone’s mind -- what we can expect from a Biden EPA on critical topics like climate change, environmental justice, TSCA implementation, pesticide policy, and more. EPA policies are always front and center in a new Administration, but with climate issues bearing down, the stakes are even more consequential in this transition.

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.

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A change in Administration invites a sense of both excitement and anxiety. Nowhere is this ambivalence more present that in the minds of regulated entities subject to the Toxic Substances Control Act (TSCA). After four years of the Trump Administration’s implementation of the many TSCA amendments occasioned by Lautenberg, regulated entities and other stakeholders have come to understand the U.S. Environmental Protection Agency’s (EPA) interpretation of revised TSCA. Not everyone agrees with these views, but they are known. What is unclear is whether the Biden Administration will continue these interpretations or go back to the drawing board.

This week I sat down with Richard E. Engler, Ph.D., B&C’s Director of Chemistry, to explore exactly this question. We discuss some of the many uncertainties facing businesses as we approach inauguration day. Key new terms like “conditions of use” and “reasonably foreseen” have been defined over the past years, and regulated entities have much riding on their known definitions. Rich walks us through how a new Administration might see things differently and what businesses might expect in the months ahead. Rich also shares his view on how the Trump EPA is doing in meeting its statutory obligations under TSCA, how the Courts are viewing EPA’s implementation efforts, and what to watch out for in the Biden EPA.

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.

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This week I had my final visit with the U.S. Environmental Protection Agency’s (EPA) Assistant Administrator Alexandra Dunn. As many of our listeners know, Alex Dunn heads the Office of Chemical Safety and Pollution Prevention and is responsible for implementing the nation’s industrial and agricultural chemical laws, the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), respectively. Alex has done a superb job since taking office in early 2019, and her steady hand in managing TSCA implementation and a wide range of hot button pesticide issues has been effective and comforting.

Prior to Alex’s current role, she served as the Regional Administrator for EPA Region 1, and before Region 1, Alex served as the executive director and general counsel for the Environmental Council of the States.

We focused our discussion on a look back at Alex’s many achievements since taking office, including implementation of the amendments to TSCA, which Congress enacted in 2016. Alex also addressed some of the most controversial pesticides -- glyphosate, dicamba, and chlorpyrifos, among others -- all the while implementing one of the most consequential pieces of environmental legislation ever passed by Congress.

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.

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This week I sat down with my friend and colleague, Howard Gutman, who served as Ambassador to Belgium in the Obama Administration and is now a consultant for global businesses. Ambassador Gutman addresses a broad range of timely and important topics, including the 2020 elections and what happened exactly, and what CEOs should be thinking about because of the change in Administration, both for U.S.-based and foreign-based businesses. Given Ambassador Gutman’s unique view of global business, we also touch upon the European Union’s precautionary principle and regulatory decision-making, European and American views on big tech, and some of the biggest challenges to global growth.

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.

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This week I was thrilled to sit down with Kate Sellers, Technical Director at ERM, where Kate leads multidisciplinary teams to help clients meet their business goals through product stewardship and sustainability initiatives. Kate is immediate past President of the Product Stewardship Society and one of the country’s most visionary leaders in the area of product stewardship. Kate counsels some of the largest companies in the world on optimizing business practices to producer better, safer products in a sustainable and efficient way. I have known Kate for years, and believe me, when Kate speaks, business leaders listen.

We discuss why now more than ever, businesses need to be sustainable, to shift from a linear to a circular economy, and to understand how to integrate product stewardship principles and practices into their business dealings. We also discuss the impact of the European Union’s chemical strategy for sustainability on U.S. companies, COVID-19’s influence on supply chain systems, the role of Artificial Intelligence in governance, and other fascinating topics. After listening to this podcast, you will know why Kate’s practice is thriving and she is in demand as a speaker and presenter.

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.

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This week I sat down with Dr. Jeff Morris, immediate past Director of EPA’s Office of Pollution Prevention and Toxics (OPPT), the EPA office that regulates industrial chemicals. Jeff is now a principal of Jeff Morris Solutions LLC, a consulting firm helping entities navigate the complexities of industrial chemical regulation. While at EPA, Jeff directed the Agency’s implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA), the U.S. law regulating industrial chemicals, and headed the office most immediately impacted by the significant changes brought about by the Lautenberg amendments.

In our discussion, we look back on Jeff’s leadership of the Office of Pollution Prevention and Toxics and its accomplishments in implementing Lautenberg, which policies the current Administration has implemented that should continue, and how the new Administration should and can do more using TSCA to address social inequities and achieve the goals of environmental justice. Jeff discusses his recent articles on this important topic, as well as the important role international collaboration plays in understanding both the commercial promise and chemical profile of nanomaterials.

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.

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This week, my colleague, Dr. Jane Vergnes, and I sat down with Bjorn Hansen, Executive Director of the European Chemicals Agency (ECHA). As our listeners may know, ECHA is the European Union (EU) regulatory agency charged with managing the scientific, technical, and administrative aspects of chemical management programs in the EU, including the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH), the Classification, Labeling, and Packaging Regulation (CLP), the Biocidal Products Regulation (BPR), the Prior Informed Consent Regulation (PIC), and a definition of substances of very high concern (SVHC). Bjorn leads approximately 600 employees, many of whom are located in Helsinki, where ECHA’s offices are located. In addition to speaking about the imminent end of the transition period between the EU and Great Britain under Brexit, which has been no small endeavor, Bjorn discusses the very recent issuance of the EU Chemicals Strategy for Sustainability Towards a Toxic-Free Environment. Issued on October 14, 2020, this new Strategy includes some 50 initiatives intended to complement the European Green Deal announced last December, under which the EU has committed to no net greenhouse gas emissions by 2050.

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.

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This week, I sat down with Dr. Jane Vergnes, Director of Toxicology here at B&C and Vice President, Scientific Affairs, and Director of Toxicology at B&C’s consulting affiliate, The Acta Group. Jane has lead responsibility for our United Kingdom (UK) and Brussels offices and has been deeply engaged in Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) and the impact of Brexit on our European Union (EU), UK, and U.S. clients.

Given the fast approaching end of the transition period between the UK and EU, I thought it would be timely to parachute in and see what is top of the mind for companies in the chemical space with regard to what to expect in the New Year, and to check in on what else is front and center across the Pond, as it were. Jane and I discuss the transition period, the new UK REACH law, what is actually happening on the ground as we approach the end of the transition period, and a few other hot topics in the EU, including new obligations issued by the Commission recently of which EU REACH registrants must be aware. As Brexit also applies to biocides and plant protection products, we also touch upon biocides and agricultural chemicals and what to expect at the end of the year. Brexit has invited no small amount of uncertainty and anxiety for chemical stakeholders, especially against the backdrop of an already uncertain, pandemic-challenged world. My conversation with Jane provides some comforting clarity and useful thoughts on what to do as the transition period comes to an end.

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.

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This week, I sat down with Lisa Campbell, my Partner here at Bergeson & Campbell (B&C®) and its consulting affiliate, The Acta Group (Acta®), and a well-recognized expert on all things regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). With so much attention focused on registering new products to combat COVID-19, we thought it timely to check in again with the U.S. Environmental Protection Agency (EPA) Office of Pesticide Programs (OPP) and see what it is up to. OPP has been extraordinarily busy since March keeping up with new products to combat the coronavirus and forging new ways of leveraging its resources while maximizing the public health benefits of these new products.

We also discuss the government’s heightened interest in ensuring that marketers of products -- new and existing -- are precluded from placing products on the market that EPA believes are not effective against COVID-19, when they are promoted as effective against the virus. EPA has been quite aggressive in ensuring that products that claim to be effective in fact are effective.

We then update our listeners on a few other OPP developments unrelated to the pandemic, as OPP’s jurisdiction extends far beyond approving new products to address COVID-19.

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.

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This week, I sat down with Jim Aidala, Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group. As a former Assistant Administrator in what is now the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention, Jim has a keen sense of how EPA prepares for and transitions to changes in Administrations. As we prepare for the November elections, we thought it would be good to check-in with Jim and get a sense of how our colleagues at EPA are faring. After reviewing key topics in the pesticide world, Jim walks us through how and when pesticide registrants and others in the commercial value chain can prepare for any forthcoming transition, consequential or otherwise. Jim discusses whether regulated entities can expect policy changes occasioned by a new Administration, regardless of who wins. Jim also addresses the implications of changes in the Supreme Court in light of Justice Ginsburg’s death. Jim’s insights in these areas is spot on and timely.

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This week I sat down with Vincent Caprio, Founder and Executive Director of the NanoBusiness Commercialization Association (NanoBCA). Vince has been on the forefront of nano innovations and optimizing opportunities for businesses to commercialize their nano creations for more than two decades. In founding the NanoBCA, Vince has placed it at the center of nanotechnology commercialization, national policy, law, and business since the beginning of the public’s focus on nanotechnology. NanoBCA has provided a much-needed spotlight on how nanotechnology has been a critical driver for the development of advanced materials, smart technology, innovations in chemistry, and a diverse range of other initiatives that have greatly benefited many economic sectors of the economy. As Chair of the Environment, Health, and Safety (EHS) Committee of the NanoBCA, I have long admired Vince’s vision, organization-building skills, and his seemingly endless list of contacts -- there is no one in Washington, D.C., or elsewhere, whom Vince does not know!

In our conversation, Vince shares a bit about the early days of nanotechnology, how NanoBCA helped frame critical EHS issues in a way that moved the technology forward, his relationship with and deep engagement in the activities of the National Nanotechnology Initiative, his engagement with key Senators and Representatives on nano matters, and what’s next for nanotechnology after the 2020 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.

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This week I sat down with Sheryl Lindros Dolan, Senior Regulatory Consultant at B&C and its consulting affiliate, The Acta Group. Sheryl is on the front line of pesticide registration and engages in a remarkably diverse range of pesticides and pesticide devices. Sheryl is particularly gifted at charting regulatory strategies for new and novel pesticide innovations and other agricultural chemical products like biostimulants, biopesticides, and other chemical products. Sheryl’s training as a scientist and a lawyer is invaluable in guiding clients to obtaining their regulatory approvals swiftly and efficiently.

Our conversation covers a broad range of topics beginning with a check-in with how the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs is faring under our now not-so-new pandemic-focused times. We discuss how EPA is addressing the greatly increased number of pesticide registration applications in response to the COVID-19 virus, the submission of emergency exemption applications under FIFRA Section 18, and how to manage client expectations, especially those harbored by innovators who believe their products will help protect against the virus and thus have a sense of urgency that is challenging to align with even accelerated government approval time lines.

We also discuss EPA’s compliance advisory for pesticide devices making coronavirus claims and EPA’s continuing efforts to prevent the marketing of bogus products that are unregistered and thus illegal. Sheryl’s expertise and broad experience in these areas make for a great 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.

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This week I sat down with Dr. Jeff Morris, immediate past Director of EPA’s Office of Pollution Prevention and Toxics (OPPT), the EPA office that regulates the industrial chemical sector. Jeff directed EPA’s implementation of the 2016 amendments to the Toxic Substances Control Act (TSCA) and headed the office most immediately impacted by the significant changes brought about by the Lautenberg amendments.

In our discussion, we talk about how Jeff and his OPPT colleagues managed the daunting task of implementing a new law, and how the Agency has fared since the law’s enactment four years ago. We discuss Jeff’s interest in environmental justice, and how TSCA might be used to address the impact of environmental harms and their disproportionate adverse impact on people of color and the poor.

We also discuss Jeff’s important role in EPA’s Office of Research and Development and its research program on nanomaterials and nanotechnology, and how his background prepared Jeff well for addressing TSCA’s application to emerging chemical technologies.

We conclude by learning more about what Jeff is up to now in his new role as a principal in Jeff Morris Solutions, LLC. I really enjoyed my conversation with Jeff. He and I have known each other for many years, and I have long admired Jeff’s integrity, his commitment to public service, and his epic understanding of chemical policy, science, and regulation.

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.

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This week I sat down with Richard E. Engler, Ph.D., B&C’s Director of Chemistry, and all-around TSCA savant. Rich is an organic chemist and a 17-year veteran with the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics, where Rich managed the Green Chemistry Program and reviewed some 10,000 new chemical notifications.

Given all that is going on at EPA with implementing the Frank R. Lautenberg Chemical Safety for the 21st Century Act, which extensively amended the Toxic Substances Control Act (TSCA), Rich and I discussed a wide range of ongoing and planned EPA initiatives. These include EPA’s risk evaluations under TSCA Section 6, progress EPA has made in reviewing new chemicals and work that remains to be done, how EPA has responded to staff and resources challenges, key ongoing litigations challenging various aspects of TSCA implementation, and what to look for as we approach the end of the calendar year and the impact of the pending National election. Rich’s insights are always fascinating and enlightening, and our conversation is sparkling and entertaining.

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.

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This week I sat down with Congressman John M. Shimkus, a Member of the United States House of Representatives for the 15th District of Illinois. As listeners of the podcast know well, Congressman Shimkus is a senior Member of the House Energy and Commerce Committee. In this capacity, Congressman Shimkus has become a rock star in the industrial chemical community, given his tireless efforts to modernize the Toxic Substances Control Act (TSCA) , which of course resulted in passage four years ago of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg).

Given Congressman Shimkus’s extensive involvement in and personal commitment to reforming TSCA, our conversation focused on the efforts that have been under way since June 2016 to implement the massive and complicated new law. We address many aspects of Lautenberg’s implementation, not just by the U.S. Environmental Protection Agency (EPA), but also efforts under way by other industrial chemical stakeholders, including industry, non-government organizations (NGOs), states, and the courts. We discuss the many, many rulemakings EPA has issued since 2016 and survey the next leg of EPA’s journey to implement the new law over the next 12 to 24 months, which will be extremely busy. Congressman Shimkus is as passionate today as he was four years ago about chemical safety, as you will hear in this recording.

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.

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This week I sat down with James Aidala, B&C’s Senior Government Affairs Consultant, to catch up on what the U.S. Environmental Protection Agency’s (EPA) Office of Pesticide Programs (OPP) is up to and to get a sense of what we might expect to develop over the remainder of the year. As a former Assistant Administrator of what is now the Office of Chemical Safety and Pollution Prevention, Jim’s thoughts and analyses are always spot on.

We discuss leadership within OPP, which is transitioning. Not surprisingly, who holds the position of Office Director is always of great interest to the agricultural and biocidal chemical communities.

We also touch upon a number of high-profile pesticide science policy debates about substances, some of which have been raging literally for years. These substances include dicamba, glyphosate, and chlorpyrifos. The legal and scientific administrative and judicial reviews under way in the United States and internationally are fascinating, precedent setting, and closely watched.

Our conversation also includes a bit about the commercial agricultural chemical community. Industry consolidation and international trade issues continue to challenge the commercial landscape, and they make keeping up with these issues all the more important.

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

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This week I sat down with EPA Assistant Administrator Alexandra Dunn. As many of our listeners know, Alex Dunn heads the Office of Chemical Safety and Pollution Prevention and is responsible for implementing the nation’s industrial and agricultural chemical laws, the Toxic Substances Control Act (TSCA) and the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), respectively.

Alex has an extensive background in the environmental field and is a leading voice on TSCA and FIFRA. Prior to Alex’s current role, she served as the Regional Administrator for EPA Region 1, and before Region 1, Alex served as the executive director and general counsel for the Environmental Council of States. She has published extensively in the areas of the ethics of community advocacy, environmental justice, urban sustainability, water quality, cooperative federalism, the Clean Water Act, and more.

Given Alex’s high profile role at EPA, we focused our discussion on implementation of the amendments to TSCA, which Congress enacted in 2016. As we record this session, we are at the four-year anniversary of the new law, and we celebrate EPA’s many accomplishments in implementing the Congressionally mandated changes to the law. As pollution prevention is an integral part of EPA’s mission, we also focus on initiatives under way to introduce safer and greener chemicals. Finally, our discussion includes a look ahead to what is on EPA’s agenda for the remainder of the year, which promises to be extraordinarily busy.

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.

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As we are now into June, Toxic Substances Control Act (TSCA) aficionados will be quick to note that “new TSCA” is now almost four years old. Passage in June 2016 of the Frank R. Lautenberg Chemical Safety for the 21st Century Act occasioned EPA’s implementation of a law that has transformed industrial chemical regulation in the United States. This week, to mark Lautenberg’s fourth birthday, I sat down with Dr. Richard E. Engler, B&C’s Director of Chemistry and all-around expert on all things TSCA, to look back on what EPA stakeholders have achieved over the past four years, and to look forward to what to expect the remainder of this year and beyond. We address the progress EPA has made in reviewing new chemical innovations, regulating existing industrial chemicals, what early challenges have been resolved, and a few of the frustrations that linger. As a 17-year veteran of EPA’s Office of Pollution Prevention and Toxics and now an extremely busy and tops in his field private consultant, Rich knows TSCA from both sides, and his insights are always spot on.

Rich is a Ph.D. chemist who focuses here at B&C and our consulting affiliate, The Acta Group (Acta®), on all aspects of TSCA regulation and science policy. In addition to his duties as a top chemist at EPA, Rich also headed EPA’s Green Chemistry Program. Rich has reviewed more than 10,000 chemical notifications under TSCA and now is an indispensable part of our deep TSCA bench here at B&C and Acta.

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.

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This week, as employees around the country are returning to their offices and work stations, I was excited to visit with Larry Sloan, CEO of the American Industrial Hygiene Association (AIHA), located here in the Washington, D.C., area. AIHA may not be a well-known organization to many of our listeners, but that could be about to change. Founded in 1939, AIHA is a non-profit organization serving professionals dedicated to the identification, evaluation, control, and confirmation of environmental stressors in or arising from the workplace. Given AIHA’s extraordinary institutional expertise in workplace stressors, its role and prominence in getting workers back into a safe and healthful work environment in light of the COVID-19 pandemic has rocketed its Back to Work Safely initiative, one of the subjects of our fascinating conversation with Larry, into national prominence.

Larry is a chemical engineer by training, and obtained an MBA from Northwestern’s Kellogg School of Management. Larry is a well-respected professional in Washington, D.C., chemical circles, with a distinguished career in trade association management. Prior to becoming CEO of AIHA in 2016, Larry was CEO of the Society of Chemical Manufacturers and Affiliates (SOCMA), an organization advancing the interests of specialty chemical manufacturers, and before joining SOCMA, Larry was President of the Adhesive and Sealant 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.

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The question posed by this podcast may sound easy, but it is anything but. This podcast explores the fascinating yet commercially vexing jurisdictional divide between and among biostimulants, biopesticides, and fertilizers as each of these agricultural chemical products is vital to the agricultural community. According to a recent U.S. Department of Agriculture report, the plant biostimulant industry alone is expected to be at least a $2.2 billion global market, swelling to $5 billion in 2025.

As big as this market is, there is surprisingly a great deal of confusion in markets globally regarding what exactly is a biostimulant and how it differs from a fertilizer or a pesticide, and importantly how the U.S. Environmental Protection Agency (EPA) goes about regulating the claims made for these products. This podcast focuses on these issues, especially as they relate to how EPA defines and regulates biostimulants, and offers some tips to stakeholders in this commercial space on how to avoid enforcement scrutiny.

My guests today are my colleagues, Lisa Burchi and Sheryl Dolan. Lisa is a resident in California and Of Counsel to B&C. Lisa counsels clients on chemical law and regulation and has significant experience with legal and regulatory matters specifically related to these jurisdictional lines, which most often arise in the context of enforcement actions brought by EPA headquarters and regional offices.

Sheryl Dolan is B&C’s Senior Regulatory Consultant. Sheryl works with a wide variety of chemical innovators to commercialize their products and works closely with the legal team to make this happen. Both Lisa and Sheryl are also employees of B&C’s consulting affiliate, The Acta Group, with offices here in D.C, Manchester, U.K., Brussels, Belgium, and Beijing, China.

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.

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This week, I was thrilled to sit down with Richard Keigwin, Director of the Office of Pesticide Programs (OPP) at the U.S. Environmental Protection Agency (EPA) here in Washington, D.C. As OPP Director, Rick leads the EPA office that reviews and approves pesticide products used to combat the spread of SARS-CoV-2, the virus that causes COVID-19. Historically, OPP has consistently been one of the busiest offices in EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP). The pandemic has invited a virtual flood of interest in the next generation of antimicrobial pesticides to combat the virus’s spread, and Rick and his team have been navigating this flood and keeping their heads above water, as it were, from the safety of their own homes. Rick takes us through what EPA is doing to accelerate the availability of new tools to combat the spread of the virus, how he has been orchestrating this massive effort from his remote office, and how he has been doing so while simultaneously addressing the usual heavy load of routine pesticide business during this pandemic.

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.

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This week, I sat down with Eric Byer, President and CEO of the National Association of Chemical Distributors (NACD). Eric, like many of us these days, is working hard and under extraordinary circumstances ensuring that his member companies are able to continue to distribute much needed chemical products, including sanitizers and other cleaning products, in response to the pandemic. Our conversation focused on these uniquely “in the moment” issues and a broad range of federal, state, and international issues on which NACD is focused, including extending the Chemical Facility Anti-Terrorism Standards (CFATS) program, TSCA implementation initiatives, and the impact of tariffs on imports from China on NACD member companies. Eric is an amazing leader of an essential trade association, and our conversation provides insights into his success as President of NACD.

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.

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This week, I sat down with Lisa Campbell, my business partner of many years and one of the nation’s foremost legal experts on the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA).

Given Lisa’s expertise, we engaged in a very timely discussion about the approval by the U.S. Environmental Protection Agency (EPA) of products under FIFRA to combat COVID-19, the disease caused by the coronavirus. EPA has been deluged with applications to approve new products and/or new uses of existing products to combat the virus. Lisa explains how antimicrobial pesticide products play an important role in public health and safety, the kinds of antimicrobial product categories regulated by EPA (including sanitizers, sterilants, disinfectants, and others), how approved products are deployed to combat the novel pathogen that causes COVID-19, and what EPA is doing to fast-track the approval process to get products out there to protect public health. And as important as the federal EPA is in this regard, Lisa also explains the important role of state agencies in the pesticide product approval area. We round out our discussion on EPA’s efforts, along with other federal law enforcement offices, to stop the proliferation of virus scams, most notably the sale and distribution of antimicrobial products falsely claiming to be effective against the spread of the coronavirus.

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This week, I sat down with my colleague Karin Baron, a senior regulatory consultant here at B&C.

In this conversation, Karin talks about recent European Union enforcement initiatives that have to do with the CLP legislation: Classification, Labeling, and Packaging legislation. Karin begins by telling us about the current state of harmonization along the lines of the GHS model, and how this might be more an aspiration than a reality. Then we talk about the history of the CLP legislation: how it was introduced, how it has changed over the years, and what recent changes are doing to bring it more in line with the GHS.

We also go into a number of different themes that might be of interest to you, including why “mixture classifications” can be so varied across different regions and Karin gives some concrete recommendations and tips for manufacturers, distributors, and exporters that deal with the EU.

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.

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This week, I sat down with my colleague, Dr. Richard Engler, Director of Chemistry here at B&C and The Acta Group (Acta®). We brought everyone up to date on the U.S. Environmental Protection Agency’s (EPA) implementation of the Toxic Substances Control Act (TSCA) fee rule and how it applies to entities obligated to pay a portion of the $1,350,000 per chemical fee for preparing an EPA-initiated risk evaluation, the legal and regulatory significance of the supplemental rulemaking on long-chain perfluoroalkyl carboxylate (LCPFAC) chemicals and the precedent it sets for eliminating the article exemption for imported articles containing these substances, and the significance of the recently updated TSCA Chemical Inventory with regard to the fast-approaching Chemical Data Reporting (CDR) cycle. As always, Rich is a font of information on these topics, and he does a great job of contextualizing this information for busy business people working in the chemical 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.

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This week, I sat down with my colleague, Sheryl Dolan, a Senior Regulatory Consultant here at Bergeson & Campbell and The Acta Group. As Sheryl’s practice focuses primarily on pesticide matters, we addressed a few hot topics captivating our interest. Sheryl briefed us on the Environmental Protection Agency’s (EPA) Office of Pesticide Programs’ (OPP) forthcoming move from Crystal City, Virginia, to D.C. later this year, OPP’s recent deployment of its Emerging Pathogen Policy in light of the Coronavirus gripping the world, OPP’s continuing efforts to help define the jurisdictional divide between Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)-regulated pesticides and non-pesticide plant stimulants, enforcement initiatives in the pesticide area, and the fast approaching March 1 reporting deadline for pesticide establishments.

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.

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This week, I sat down with my colleague, Dr. Richard Engler, Bergeson & Campbell’s Director of Chemistry, to discuss what the fuss is over EPA’s January 27, 2020, issuance of a “preliminary list” of companies responsible for the $1,350,000 per-chemical fee EPA charges to conduct a risk evaluation of a high-priority chemical under TSCA Section 6. The scope of the entities “on the hook” is far broader than expected, and companies with little understanding of TSCA may be presumptively liable for these fees and TSCA enforcement scrutiny for failure to address the situation by March 27, 2020. In our conversation, Rich explains how the fee rule works and discusses the reasons why industry was caught by surprise and unclear about how best to respond to the January notice. Rich and I then explain why it is critically important for impact entities to begin now to think about forming a consortium to share the cost of the fees and related expenses and how B&C Consortia Management can assist.

We also go into a number of different themes that might be of interest to you, including why the fee rule interpretation diverges from historical TSCA “carve-outs” for byproducts, impurities, and articles, and what companies can do to protect their interests.

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.

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This week, I sat down with my colleagues Sheryl Lindros Dolan, Chris Bryant, and Dr. Richard Engler to discuss our fabulous 2020 Forecast, B&C’s and The Acta Group’s (Acta®) richly detailed overview of key trends in U.S. and global chemical law and policy. This 67-page document provides a comprehensive “one-stop” overview of global initiatives for the New Year of which stakeholders in the global chemical market must be aware. My colleagues provide a spirited overview of key developments, speculate on the impact of the U.S. general elections later this year, and muse generally about the shape of things to come with regard to all things chemical. 2020 may well be like no other election year, given all that is in the pipeline, statutorily mandated, and/or percolating at the state level.

Download the 2020 Forecast here.

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This week, I sat down with my colleague Christopher Bryant, a Senior Regulatory Consultant here at Bergeson & Campbell. Chris has over 25 years of experience in environmental, health, and safety compliance, and, in particular, hazardous waste management and regulation under the Resource Conservation and Recovery Act (RCRA).

I asked Chris to the studio to speak with me about RCRA: what it is, how the law has developed, what is covered under it, and how we might expect -- or hope -- it to change for the better. We discussed the history and stated goals of RCRA, and why, in our opinion, it has not lived up to some of its founding principles.

Chris hits upon the subject of plastics and PFAS materials, and explains the evolution of EPA’s thinking about waste over the last few decades, including how RCRA has adapted to a business world that is becoming increasingly more sustainability-oriented. We also talk about how other countries and regions manage hazardous waste regulation and how practices beyond RCRA can be influenced to achieve improved results.

When it comes to hazardous waste and RCRA, Chris is simply the best, and it was great to sit down with him and pick his brain on this important topic. So, here is my discussion with Chris Bryant about all things RCRA.

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This week, I sat down with Jim Jones, Executive Vice President Strategic Alliances & Industry Relations at the HCPA, or Household & Commercial Products Association. Before moving into the private sector, as many of our listeners know, Jim served a long and very distinguished career with the U.S. Environmental Protection Agency in Washington, D.C. Jim began his career in the toxics office, specifically in pesticides, and eventually served as Assistant Administrator of the Office of Chemical Safety and Pollution Prevention in the Obama Administration.

We talk about Jim’s extraordinary background and how it prepared him for the task of helping to modernize the Toxic Substances Control Act in passing the Lautenberg Act amending TSCA in 2016. Jim takes us back to the summer of 2016 and paints a picture of what it felt like to watch with anticipation as the political proceedings surrounding the amendment unfolded.

In addition to talking about TSCA’s recent history and EPA’s implementation of it, Jim shares career advice, tips for other industry groups, and first-hand experiences about the difference between the private and public sectors of this industry.

Jim has a wealth of knowledge and experience, and I am excited to share my conversation with him with you. So, here is my discussion with Jim Jones about his experiences leading up to passage of the Lautenberg Act…

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This week, I moderated a spirited discussion with two members of the B&C team: Sheryl Dolan, a senior regulatory consultant who specializes in agricultural and biocidal chemical product registration and defense, and Dr. Richard Engler, our Director of Chemistry and a 17-year-veteran of EPA. Both Sheryl and Rich are expert in marshaling new product chemical technologies through the gauntlet of federal, state, and international chemical product approval.

Throughout our discussion, Sheryl and Rich walk us through what it takes to bring a new technology to EPA (or any other regulatory authority) and to help the regulators understand the benefits and safety of the new technology, especially when dealing with older regulatory frameworks that are sometimes ill-suited to anticipate the challenges posed by cutting edge technologies. We talk about the regulatory challenges that the developer of a new product is likely to face, and how our team recommends preparing for these often make or break challenges. We also get into a bit of the history of TSCA and FIFRA, the impact that public opinion and transparency can have on the regulation process, and how regulatory systems are informed of and respond to technological change.

There is a lot to unpack in this discussion for anyone with an interest in the regulatory process, whether you are planning on bringing an innovative product to market or enhancing a new aspect of an existing product. It was great having Sheryl and Rich in the studio to walk me through some of this, and I am excited to share it with you. So, here is my discussion with Sheryl Dolan and Dr. Rich Engler about new technologies and their regulatory processes…

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.

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This week, I sat down with 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.

Dr. Goldman is widely regarded as one of the most influential public health physicians of our time and served as Assistant Administrator for Toxic Substances in the U.S. Environmental Protection Agency from 1993 through 1998 under President Bill Clinton. During her tenure, Dr. Goldman and her team are credited with implementing the 1996 amendments to our nation’s pesticide law, the Federal Insecticide, Fungicide, and Rodenticide Act or FIFRA, known as the Food Quality Protection Act. This ground-breaking law modernized the legal framework for regulating pesticide residues on raw agricultural commodities and processed foods.

In our conversation about our industrial chemical law, Toxic Substances Control Act or TSCA, especially under her watch as Toxics Assistant Administrator in the ‘90s, we delve into Dean Goldman’s background as a pediatrician and how that came to influence her decisions in office. We talk about new TSCA’s roots as the “Kids Safe Chemicals Act,” as well as about how Dr. Goldman and others built upon Senator Lautenberg’s interest in TSCA reform legislation, the parallels with implementing new TSCA, and Dr. Goldman’s experience implementing what was then considered the “new FIFRA.” We also talk about some of the truly fascinating research that Dean Goldman has pursued at the Milken Institute School of Public Health at George Washington University, including the publication of the 2018 study evaluating the fatality account in Puerto Rico due to Hurricane Maria.

It was great speaking with Dean Goldman about her work, past and present, and to get some insight into the historical development of TSCA from someone who was involved in its shaping. So, here is my discussion with Dr. Lynn Goldman, Michael and Lori Milken Dean at the Milken Institute School of Public Health at George Washington University….

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This week, we have B&C’s and The Acta Group’s Senior Regulatory Consultant, Karin Baron, back in the studio to discuss K-REACH, its recent amendment, and potential harmonization of chemical regulations in the region. K-REACH is the South Korean government’s industrial chemical substance registration program signed into law in 2013, and effective in 2015.

Karin is uniquely well-suited to provide practice tips and information on why our listeners should be aware of what is going on with this South Korea chemical regulatory program. As a well-recognized expert in international hazard classification programs like the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) and domestic OSHA Hazard Communication, as well as a veteran of European Union (EU) REACH chemical hazard and risk assessment issues, Karin draws upon her extensive experiential database to paint a picture of what stakeholders exporting chemicals to South Korea need to be aware of and navigate around to be commercially successful. Like so many new global chemical programs, K-REACH is similar to EU REACH, but maddeningly different to cause serious commercial disruption for the unprepared.

In our conversation, Karin lays out the case for why everyone in the regulatory space might do well to pay close attention to K-REACH, not just those with business interests in South Korea. Karin breaks down how K-REACH works, how it was developed, and how it differs from the EU REACH framework. We discuss the fast-paced development and implementation of recent amendments to the legislation as well as the concept of “REACH-creep,” and what it might mean for the future of the ASIA-PACIFIC region.

Finally, for those with specific interests in South Korea, listen up, because Karin has some valuable information to share before moving forward and meeting important deadlines.

As always, it was great having Karin in the studio to discuss K-REACH. Whether or not you currently have a business in South Korea, you are sure to get something useful out of this podcast. So, here is my discussion with Karin Baron, Senior Regulatory Consultant here at B&C and Acta, about K-REACH.

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.

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This week, I sat down with Scott Fulton, President of the Environmental Law Institute, on the occasion of ELI’s 50th anniversary. 

Scott is ELI’s 5th President. As a former ELI Board member myself and a practicing lawyer in the environmental space, I have known Scott for years given his many high profile roles as a former EPA General Counsel, Assistant Chief of the Environmental Enforcement Section at the U.S. Department of Justice, among other prominent positions.

In our conversation, Scott explains the various lines of work in which the ELI is currently engaged, how the Institute has evolved over its 50-year history, and how it maintains its status as a well respected, internationally recognized, non-partisan organization. We talk about the impact of the current federal Administration on the legal infrastructure, ELI’s judicial training efforts around the world, the concept of “soft law,” as well as about the role that new technologies will play in in the future of environmental monitoring and law.

It was great speaking with Scott about his work at ELI, and to celebrate an organization that has been an important part of the environmental law landscape for the past fifty years. So, here’s my discussion with Scott Fulton, President of the Environmental Law Institute.

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This week, I sat down with Dr. Lisa E. Friedersdorf, the Director of the National Nanotechnology Coordination Office (or NNCO) to discuss all things nano.

For anyone in the nano space, Lisa is a rock star and well known to all. To those less familiar, Lisa joined NNCO several years ago, having served as the Associate Director of the Materials Research Center at Lehigh University and Director of the Industry Liaison Program. Lisa was also Director of the Virginia Nanotechnology Initiative. While with the University of Virginia, Lisa served as managing director of the nano STAR Institute and led the development of pan university initiatives as a program manager in the Office of the Vice President for Research.

As you can see, Lisa’s past positions have been squarely at the intersection of science, industry, and academia, and her experience has served her well for her current position. Lisa earned her Ph.D. and MSE in Materials Science and Engineering from the Johns Hopkins University and BS in Mechanical Engineering from the University of Central Florida.

In our conversation, Lisa breaks down the central goals and challenges of the National Nano Initiative, a governmental program designed to facilitate research and development in nanotechnology, educate people about nanotechnology, and ensure the responsible development of nano by understanding nano’s potential environmental, safety, and health implications. Lisa explains how her work at the NNCO helps direct and ensure that the many, many billions of dollars of funding available for nanotechnology applications and implications are allocated in ways that are efficient and invite the greatest return on investment and coordinated with other international nano initiatives. We also talk about some of the wonderfully surprising and unique applications for nanotechnology existing currently in our daily lives, as well as potential future applications of the technology for the field of agricultural and chemical production.

It was fantastic to speak with Lisa about her work and the field of nanotechnology, something about which we here at B&C are incredibly passionate and excited. So, here is my discussion with Dr. Lisa Friedersdorf, Director of the National Nanotechnology Coordination Office…

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Last October, at the Annual Meeting of the International Bar Association in Rome, I was fortunate enough to be introduced to Katherine Meighan, the General Counsel of IFAD, the International Fund for Agricultural Development. Katherine gave an eye-opening presentation at the IBA conference on IFAD’s efforts to address the issue of food security and world hunger, and I knew I had to have her on the podcast to share her message and to dig deeper into her work as General Counsel and IFAD’s incredible work in general.

Katherine’s unique background has served her well in preparing for the role of IFAD General Counsel. Before joining IFAD, Katherine was Assistant General Counsel and Manager at the International Finance Corporation, where Katherine led the legal work globally for Financial Institutions, Treasury, and restructuring/litigation. During her 17 years at IFC, Katherine was based in Buenos Aires, Istanbul, and Washington, D.C. Previously, Katherine worked at a global law firm in Washington, D.C. and Paris focusing on international transactions and capital markets work for financial institutions. Katherine has a law degree from the University of Virginia and an undergraduate degree from William & Mary, where she is a member of the Advisory Board of the International Center.

In our conversation, Katherine tells us more about IFAD, the entities with which it works, and how it operates. Katherine explains why the organization focuses on supporting agricultural development of the “rural poor” and the “missing middle.” I had Katherine walk me through the Sustainable Development Goals set-out by the United Nations and how IFAD has developed innovative funding mechanisms to leverage private funds and create partnerships to make progress on increasing food security worldwide.

We also touched upon the important social issues affecting global agriculture, including climate change and mass migration, as well as the tremendous gap between the number of women worldwide who are involved in food production and the number of women who actually own and manage land.

As you will hear, Katherine is passionate about her work, and I really enjoyed getting to learn more about her and IFAD’s inspiring and important mission to eradicate hunger for the world’s most underserved rural poor. Bergeson & Campbell’s interest in food security is rooted in our deep engagement in the law and science of precision agriculture and fertilizers, and we are really excited to share with you IFAD’s important work on food security. So, here is my discussion with Katherine Meighan, General Counsel of the International Fund for Agricultural Development.

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This week, I sat down with a highly-regarded member of the environmental NGO community, Eric Schaeffer, who currently serves as the Executive Director of the Environmental Integrity Project, which he co-founded in 2002. Previously, Eric worked for more than a decade at EPA, including a five-year stint as the Director of EPA’s Office of Civil Enforcement, which, as you will hear in our conversation, was a very formative time for his thinking.

At a time when some news outlets and EPA detractors are reporting environmental enforcement numbers to be at historic lows, Eric and I had a great discussion about the possible reasons for this, as well as the other goals and methods that his organization employs to encourage compliance and help protect the environment.

Throughout our conversation, we also managed to touch on EPA’s evolving enforcement strategy, how ideally to address non-compliant companies, voluntary disclosures by businesses that discover indiscretions, remote pollution monitoring techniques, and even the much-discussed idea of cooperative federalism.

Eric has a well-deserved reputation for being tough but fair and honest. His candid assessment of what is working well for EPA enforcement and industry compliance professionals and what needs improvement may surprise you. What comes through in a very big way is Eric’s approach to analyzing and addressing issues, one that, not surprisingly, is based on the integrity of the enforcement process and a respect for the environment.

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I am so pleased to present a very special guest this week, the Assistant Administrator for EPA's Office of Chemical Safety and Pollution Prevention (OCSPP): Alexandra Dunn. Alex’s professional training could not be more perfect. Alex is a lawyer and has practiced in both the private and non-profit sectors. Alex has taught environmental law at several law schools and, while Dean of Environmental Law Programs at the Elisabeth Haub School of Law at Pace University, focused on environmental justice, a subject on which Alex has written and lectured extensively.

When Alex’s appointment was unanimously confirmed by the Senate at the beginning of this year, many of us were excited and confident that Alex would lead OCSPP with her characteristic integrity, resolve, and warmth. Alex’s leadership over the past five months has well supported our confidence. Alex has shown a commitment to making the work of the OCSPP more transparent, and her team has continued EPA’s streak of hitting every one of the deadlines imposed by the 2016 Toxic Substances Control Act (TSCA) amendments.

As Assistant Administrator Dunn has spent just over five months in office, we sat down and talked about what it’s been like to take over OCSPP at this crucial time when post-Lautenberg TSCA is just coming into its maturity. We discussed the challenges OCSPP is currently facing, and how Alex and her team have kept morale up while managing to meet all of the many deadlines imposed on OCSPP thus far. We touched on the role of litigation in EPA’s work, plans for TSCA at 3, the significance of certain Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) registration decisions, and how to channel the many voices of such a broad range of stakeholders as those the EPA must address. And finally, we talked about what to expect and what is to come for the remainder of this year.

This was a fantastic opportunity to gain insight into what has been going on inside the OCSPP over the last few months, and what to expect from it in the next few months. I really think you’re going to enjoy this one, so, here’s my conversation with Assistant Administrator Alexandra Dunn.

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We have a repeat guest this week: fan favorite, Dr. Richard Engler, Bergeson & Campbell’s Director of Chemistry and Toxic Substances Control Act (TSCA) guru-in-residence. I sat down with Rich to find out more about so-called “New Chemicals” and the challenges faced by not only new chemical manufacturers, but also by the U.S. Environmental Protection Agency (EPA) in trying to fulfill its duties as a regulatory gatekeeper.

As a seasoned veteran of EPA himself, where he worked for 17 years in the Office of Pollution Prevention and Toxics’ (OPPT) Green Chemistry Program, Rich understands the pressures placed on both manufacturers and regulators, and uses this dual knowledge to inform his (and our) understanding of the timelines and processes involved in new chemical registration.

If you wish to learn a bit more about the inner-workings and pressures of EPA, are looking for tips on improving your innovative chemical’s registration process, or are just curious about what a “new chemical” even is anyway -- then this is an episode for you. So, here’s my conversation with Dr. Richard Engler on Innovation and New Chemicals under TSCA.

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This week, I invited my friend and business colleague, the former U.S. Ambassador to Belgium, Howard Gutman, into the studio to talk about what every CEO needs to know about the world right now.

I know I say this a lot, but it’s really true this time around: We covered a lot of ground in this conversation. Howard provides his perspective on what to pay attention to with regard to Brexit, energy policy, climate change, trade, the globalized economy, and the 2020 presidential election. Ambassador Gutman also provides advice on how to manage business perception, create opportunities from regulatory changes, and even shares some helpful thoughts on how to fill board seats to be more innovative.

Howard’s resume is, well, extraordinary. He is a Harvard educated lawyer, who clerked for the U.S. Court of Appeals for the Fifth Circuit. He worked for Cravath Swaine, left its employment to clerk for Supreme Court Justice Potter Stewart, then worked for the celebrated Washington D.C. powerhouse litigation firm, Williams & Connolly, which is where Howard and I became friends, as he counselled Bergeson & Campbell. Howard went on to become Special Assistant to FBI Director Bill Webster, and then rejoined Williams & Connolly.

Throughout his legal career, politics was always part of Howard’s DNA. Howard has worked with Al Gore, Bill Clinton, and Barack Obama, who named Howard U.S. Ambassador to Belgium in 2009, a post he served until 2013. Howard is also an actor -- he is a card carrying member of the Screen Actors Guild and has appeared in the HBO series K Street, Tim Robbins’ Film Noise, and the 2009 film Fame. Howard’s consulting firm, The Gutman Group, focuses on a broad array of cross-border investment, market access, venture capital, and international relations issues.

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This week, I sat down with my colleague Jim Aidala, a Senior Government Affairs Consultant here at the firm, to discuss 2019 and the state of industrial and agricultural chemical regulation: what is to come, what to expect, and how we can prepare for it.

We begin, of course, by looking at 2018, chiefly, the appointment and confirmation of Alexandra Dunn, the new EPA Assistant Administrator in the Office of Chemical Safety and Pollution Prevention, the office tasked with administering TSCA and FIFRA.

Jim fills us in on EPA’s current and projected workload and what can be expected regarding Pesticide Registration Improvement Act (PRIA) deadlines. We also touch on the updated TSCA chemical Inventory, issues arising under the Endangered Species Act, and what it means to be identified as a high- or low-priority chemical under EPA’s newly implemented chemical prioritization process.

As a former Assistant Administrator of the Toxics office, Jim’s observations are always spot on and honed by his significant experience as a former Capitol Hill staffer and as a senior government affairs consultant in private practice tackling some of the most challenging science policy issues of our time.

There is a lot packed into this episode, so if you or your organization needs to know what is coming with regard to TSCA or general chemical regulation in 2019, listen up!

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This week, we offer something a little different. My colleague Christopher Bryant, a senior regulatory consultant here at the firm, invited Daniella Taveau and Daniel Pearson into our studio to sit down and talk about trade issues.

As you will hear, their conversation ranged far and wide, hitting upon all aspects of the trade discussion which might be relevant to anyone working in the chemical manufacturing space.

Listeners will hear about developing a historical context in which to understand the U.S.’ shifting trade policies; analysis and speculation about current and possible future trade policies as well as their philosophical underpinnings (or lack thereof); and specific discussion about practical current issues such as re-negotiating NAFTA, the effects of the trade war with China, the automobile industry, and what stakeholders should be doing in this moment of protectionist policies.

Chris’ extensive dealings in trade matters pertinent to the chemical community makes him the perfect person to moderate this spirited discussion. There are few areas of chemical regulatory and trade practice that Chis has not explored, and his mastery of this space shines through and guides this session.

Daniella Taveau is a Regulatory and Global Trade Strategist and founder of Bold Text Strategies. Daniella an internationally-recognized expert in developing global business and regulatory strategies encompassing areas such as international trade, finance, agriculture, food safety, and industrial chemicals. She has extensive experience working with senior political officials and multinational corporations in six continents.

Daniel Pearson is principal at Pearson International Trade Services, LLC, a trade policy consultancy. His focus includes speaking and writing on behalf of trade liberalization, business consulting, and consulting on trade remedy proceedings.

If your or your business’ interests have anything to do with trade, then this episode is for you. Without further delay, here’s Chris’ conversation with Daniella and Daniel about all things trade related.

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This week, I sat down with my colleague Sheryl Dolan, a senior regulatory consultant here at Bergeson & Campbell, to discuss all things pesticides: past, present, and future.

In our discussion, Sheryl provides the historical and legal/regulatory background necessary to understand the current state of pesticide regulation, which the U.S. Environmental Protection Agency (EPA) manages under the Federal Insecticide, Fungicide, and Rodenticide Act, or FIFRA, as we like to call it.

Among other interesting topics, Sheryl sheds light on the legal and regulatory differences between conventional and non-conventional pesticides, highlights exciting technological developments in biopesticides, and explains the nuances of the regulatory hurdles facing businesses seeking registration of new products.

Leaning on our experience bringing many of these newer products to market, we discuss some of the pitfalls and stumbling blocks that many companies face when first approaching FIFRA and EPA’s Office of Pesticide Programs. Sheryl offers a peak behind the curtain as to how our firm advises clients to prepare for this challenging but also rewarding process.

I was excited to speak with Sheryl about this topic because Sheryl has deep experience in registering new innovations and knowing how to work with EPA scientists and regulators in defining new technologies in a way that even an aging regulatory infrastructure can accommodate. Sheryl is also excellent at shepherding businesses new to this commercial space through this complex regulatory gauntlet. Sheryl is an extremely accomplished expert and a joy to work with here at B&C.

Whether you are an innovator of a new chemical product looking for tips, or a grizzled regulatory veteran looking to bone up on the historical evolution of pesticide regulation law, you are sure to get something out of this conversation. So, without further delay, here is my conversation with Sheryl Dolan about pesticides and navigating new technologies under FIFRA.

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Recently, the European Commission kicked-off a process to evaluate and likely revise the current EU Food Contact Materials (FCM) legislation. Now, this is a big deal for any stakeholders in this space—domestic or European -- considering that the current legislation has been in in-place for many years and the proliferation of national standards has greatly complicated an already complex area. That is why I was excited when Renato Addis, of the Brussels-based regulatory consulting firm EPPA and this week’s guest, told me that he had been invited to participate in this kick-off meeting.

Renato talked to me about what he learned during this important meeting and all the reasons why 2019 will be a critical year for anyone following this space. We had an interesting and wide-ranging discussion that covered a whole lot of ground: we discussed the term “fit for purpose”, the EU’s regulation of single-use plastics, the timeline of important opportunities for stakeholders to engage in the process of shaping this new legislation, and even the potential impact of Brexit.

Renato and his firm, EPPA, are long-time friends and collaborators with B&C and our consulting affiliate, The Acta Group, which conveniently has an office in Brussels co-located with EPPA. Renato is a partner with EPPA. His prior’s. experience of working with the EC’s External Affairs Directorate, representing the Commission before the European Parliament, the Economic and Social Committee, and the Committee on the Regions make him ideally suited to discuss the law, politics, and logistics of the FCM initiative.

There is sure to be a lot of interest in this legislative review, and Renato does a fantastic job of helping us here in the U.S. begin to wrap our minds around 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.

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This week, I took part in a roundtable discussion about biobased products with my colleagues Kathleen Roberts and Dr. Rich Engler. Over the last several years, there has been a significant trend towards the use of renewable, biobased chemicals. Although these chemicals often have similar, if not identical, functionalities as the non-renewable, fossil-based chemical that they are intended to replace, there are a number of regulatory challenges in bringing these to market. In this conversation, we discuss what these commercial challenges are, why the EPA has, in most cases, “pre market approval authority” over the commercialization of these chemicals, and get down into the science of what exactly constitutes a “biobased” chemical anyway.

I am excited to have Rich and Kathleen on this episode. Rich managed EPA’s Green Chemistry program when he was at EPA and has considerable experience with EPA’s review of biobased chemical substances from a TSCA perspective. Kathleen is Vice President of B&C Consortia Management and manages the Biobased and Renewable Products Advocacy Group (BRAG), which has as one of its primary goals aligning regulatory frameworks for biobased and more traditional fossil-based chemical substances.

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This week, I sat down with Karin Baron, a senior regulatory consultant here at Bergeson & Campbell and all around expert on chemical product labeling to discuss recent developments pertinent to the United States Hazard Communication Standard (HCS). These regulatory developments have been proposed to bring the HCS more in line with GHS, the Global Hazard Communication Standard. Karin unpacks this complex but really important area of the law and focuses on the aspirational and important goals of harmonization, in a way that focuses on the realities of a world that actually ensures dis-harmonization.

Karin has more than 15 years’ experience developing, implementing, and managing complex chemical regulatory compliance matters for some of the world’s largest industrial and specialty chemical companies. One of Karin’s many talents is the ability to communicate clearly and make sense out of the complex morass of global product hazard warning and labeling requirements.

Our conversation touches upon the intricacies of this issue, including product labeling processes, managing Safety Data Sheets, the implications of harmonization on competition and anti-trust, as well as the interactions with TSCA and REACH.

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Recently, we published a 3 part article with Bloomberg News entitled: New Chemicals Under New TSCA—Stalled Commercialization. This week, I sat down with Charles Auer, a Senior Regulatory and Policy advisor here at the firm, and Dr. Richard Engler, our Director of Chemistry, two of my co-authors on this article to talk about it.

Our thesis is simple: EPA’s interpretation of our brand new industrial chemical law, the Frank R. Lautenberg Chemical Safety for the 21st Century Act, signed into law in June 2016, needs to change. We believe that Congress never intended fundamentally to overhaul the new chemical review process and to require that EPA regulate north of 80% of all new chemicals. Ironically, that is exactly what the new law is being interpreted to do, in contrast to old law that regulated, appropriately, about 10-15% of new chemicals. Our article explains the new law, contrasts it with the old law, and critically reviews the numbers—the new chemical statistics from EPA’s database, to prove our point. We then offer some suggestions to fix the problem.

Charlie Auer and Rich Engler are the perfect guests. Charlie ran the Office of Pollution Prevention and Toxics for years before he joined our staff and knows more about EPA’s workings in this area than anyone. Rich review about 10,000 new chemical notifications during his 17 years at EPA before joining our staff and has been working closely with clients and EPA to address these issues.

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This week, I sat down with Dr. Richard Engler, our Director of Chemistry, to discuss Confidential Business Information (CBI). CBI is both a term of art under the Toxic Substances Control Act (TSCA) and can be understood broadly to be anything from trade secrets to you know, the secret sauce of a chemical formulation that makes a product profitable. In our conversation, we focused on how this concept of CBI functions under TSCA and how businesses need to handle CBI during the EPA’s chemical review process.

Rich is the perfect person to discuss the concept of CBI. Rich is 17-year veteran of the U.S. Environmental Protection Agency (EPA). He has participated in thousands of Toxic Substances Control Act (TSCA) substance reviews at EPA, and knows the ins-and-outs of how CBI should be handled.

Our conversation touches upon some of the most important legal and business considerations when dealing with CBI and the EPA: how the EPA exactly defines CBI, where problems can arise, and how to avoid these through careful preparation and planning.

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This week, I sat down with Michael Wenk, one of our senior regulatory consultants, to discuss his new book Chemical Regulation in the Middle East. Michael’s book focuses on eight countries in the Middle East that have a combination of well developed and emerging chemical regulatory schemes. His book provides a comprehensive examination of the main chemical management laws in force for each particular country, and summarizes general trends and issues facing the region as a whole.

Michael has managed global regulatory affairs and product stewardship divisions at Fortune 500 chemical and chemical product companies for over 20 years. Michael’s book reflects his expertise in this area of chemical practice, which compliments Michael’s internationally-recognized expertise in chemical regulation in Central and South America.

If you are interested in Michael's book, you can find links to both an executive summary as well as purchasing instructions from our website.

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This week, I got to have a roundtable discussion with several of my colleagues about a Strategic Research Plan released by the EPA earlier this summer, outlining their approach to reduce and replace “vertebrate” testing. What we’re really talking about, of course, is animal testing. In keeping with the commitment outlined in 2016’s Toxic Substances Control Act (TSCA), the EPA proposes several so-called New Approach Methodologies, or NAMs, which they hope will be able to replace and reduce animal testing.

Weighing in on this hot topic are several of my colleagues: Dr. Rich Engler, our director of Chemistry, Dr. Jane Vergnes, our senior Toxicologist, and Dr. Oscar Hernandez, our senior regulator chemist.

If you want to learn more, check out our regulatory blog on www.lawbc.com where we have an entire section devoted to keeping up with TSCA. All Things Chemical is produced by Bergeson & Campbell and Jackson Bierfeldt with Bierfeldt Audio.

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Hi, this is Lynn Bergeson of Bergeson & Campbell in Washington, D.C. I'm here to announce that we have launched a podcast. It's called All Things Chemical. And whether you are a lawyer in the chemical space, a scientist or a manager, or a CEO of a Fortune 50 chemical company, you will want to listen up. Starting November 1st we will be releasing a podcast every other week. We're going to be dealing with a whole host of really interesting issues including animal testing and alternatives to it, chemical regulation in the Middle East, the ever quirky and complicated area of confidential business information. These are just a couple of the topics that we consider. And we do this because we have an amazing array of professionals here: lawyers, chemists, toxicologists. The issues that we pursue in our day to day business are ever so interesting and we wish to share our knowledge, our insights, and our enthusiasm for these issues with you. Join us on All Things Chemical.

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