This week, I welcomed back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. Karin and I discuss an old but evolving concept in FDA circles called GRAS -- Generally Recognized as Safe. As listeners may know, “food additives” require pre-market approval by FDA. Substances “generally recognized” as safe under the conditions of a substance’s intended use are excluded from the definition of “food additive,” are not subject to mandatory pre-market review by FDA, and may be added to human and animal food. How companies make GRAS determinations, FDA’s role in the process, and whether the GRAS concept should be modernized are a few of the hot topics Karin and I explore. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2024 Bergeson & Campbell, P.C.  All Rights Reserved

This week, listeners are in for a real treat as I sit down with Dr. Meibao Zhuang, Senior Scientist/Regulatory Consultant with B&C and our consulting affiliate, The Acta Group, to discuss double-stranded ribonucleic acid interference, better known as ds RNAi. Ds RNAi is a technology that allows scientists to silence (or interfere with) a particular gene. In the agricultural sector, this genetic modification can be used to great advantage to control pests of all sorts with extreme precision. Meibao will discuss EPA’s proposed registration of the first sprayable RNAi biopesticide and the exciting implications of this technology. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, I had the distinct pleasure of visiting with Rachel James, an attorney with the Southern Environmental Law Center (SELC). Rachel’s background and specialized training make her uniquely well suited to address some of the very interesting issues in which she engages at SELC on behalf of a diverse set of community groups. The Biden-Harris Administration has made environmental justice and accounting for susceptible subpopulations core components of its approach to environmental protection. My conversation with Rachel provides greater insights into how this is working in practice. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, I welcomed back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. Karin and I discuss Revision 10 of the Globally Harmonized System of Classification and Labeling of Chemicals, commonly referred to as GHS. Release of any new GHS revision is a big deal, and Revision 10 is no exception. Karin highlights key elements of the revision, including changes to “weight of evidence,” the classification of ozone-depleting chemicals, precautionary statements, and much more. No one reports on GHS better than Karin, and this episode covers Revision 10 as only Karin can. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, B&C, along with the Environmental Law Institute and the George Washington  University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions to enable our podcast audience to listen to the sessions in this venue. Our topic in this podcast is the Toxic Substances Control Act’s (TSCA) application to per- and polyfluoroalkyl substances (PFAS) and how the U.S. Environmental Protection Agency’s (EPA) implementation of Lautenberg has influenced EPA’s regulatory actions. Our experts address a range of subjects, including EPA’s evolving definition of PFAS under TSCA, EPA’s TSCA PFAS testing strategy, the PFAS reporting rule under TSCA Section 8(a)(7), and much, much more. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, B&C, along with the Environmental Law Institute and the George Washington  University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions to enable our podcast audience to listen to the sessions in this venue. Our topic in this podcast is the U.S. Environmental Protection Agency’s (EPA) new chemicals review process under Lautenberg. As many listeners know, the Toxic Substances Control Act (TSCA) New Chemicals Program was significantly revised by the 2016 TSCA amendments, and what the law requires has been vigorously debated and remains unclear. This panel discusses opportunities for transparency, processes to guide new chemicals review, new approaches to assess chemical risks, protection of workers, Section 5(e) orders, recent trends with EPA’s review of new chemical substances, and much, much more. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored an all-day virtual conference, TSCA Reform -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content inspired us to re-broadcast the discussion to our podcast audience. This panel discusses the U.S. Environmental Protection Agency’s (EPA) authority under Toxic Substances Control Act (TSCA) Section 6 to manage chemical risks that EPA has determined to be unreasonable and options at EPA’s disposal for deploying its authority. Panelists address how EPA manages workplace risks, enforcement mechanisms for risk management restrictions, whether EPA’s risk management rulemakings are adequately addressing environmental justice concerns, potential legal challenges to final risk management rules, and much, much  more. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

On June 29, 2023, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform -- Seven Years Later. The conference was hugely successful and over 700 people registered for it. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions to enable our podcast audience to listen to the sessions in this venue. The topic of this podcast is the panel discussion on the U.S. Environmental Protection Agency’s (EPA) risk evaluation process under Lautenberg. The panel discussed various aspects of EPA’s risk evaluation of chemical substances under Toxic Substances Control Act (TSCA) Section 6. The panel experts touch upon crucially important issues, including EPA’s potential use of European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) data, EPA’s use of new approach methodologies (NAM), the effectiveness of a “whole chemical approach” to risk determinations, the incorporation of cumulative risk assessment (CRA) approaches, and  much, much more. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the distinct pleasure of visiting with Mark Washko, Head of Federal Government Affairs at BASF Corporation. I have worked with Mark and admire his extraordinary communication skills, particularly his ability to advocate on complex science policy and chemical issues clearly and in a way that is relatable. We in the chemical community are constantly challenged on so many levels in this regard -- how to speak clearly, and to speak in a way that wins friends and influences those many who do not share our perspective, and how to remain respectful when addressing issues we care deeply about. Mark is top notch in these areas, and our conversation offers some lessons in effective government advocacy. We discuss Mark’s winning style, his approach to Members and staff on Capitol Hill, what prepared him best for his role, and his advice to those thinking about embarking on a career in government affairs. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved

This week, we are re-releasing my conversation with Dr. Richard E. Engler, Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, originally recorded in April. We discussed then a lawsuit challenging the U.S. Environmental Protection Agency’s (EPA) issuance of a Consent Order under Section 5(e) of the Toxic Substances Control Act (TSCA). As listeners may know, judicial challenges to TSCA Section 5(e) orders are rare, and this one is even more unusual because the petitioner is a non-governmental organization (NGO) and the challenge was filed well beyond the statutory period for judicial challenge. We discuss TSCA Section 5(e) orders, the process for challenging them, and some of the underlying issues at play here, including the concept of “chemical categories” under TSCA Section 5, concerns with EPA’s new chemicals review process, and EPA’s assessment and communication of risk in the new chemicals it reviews under Section 5. The topic is as lively now as it was earlier this year. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW. ©2023 Bergeson & Campbell, P.C.  All Rights Reserved