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Sponsor’s Role in Regulatory Testing — A Conversation with Lara Hall

Release Date: 08/01/2024

First Six Months of the Trump Administration — A Conversation with James V. Aidala

All Things Chemical

This week, I was pleased to welcome back to the studio , Senior Government Affairs Consultant at B&C and its consulting affiliate, The Acta Group (Acta®), to discuss the first six months of the Trump Administration. We have all been trying to take in and process the many Executive Orders, Presidential Directives, and other developments of all sorts coming out of the White House at a head-spinning pace, and assess their impacts on the industrial and agricultural chemical community and federal workforce. Jim is a keen observer of Presidential and executive level administrative action,...

Chemical and Material Risk Management Program TSCA Market Analysis — A Conversation with Patricia Underwood, Ph.D., DABT, MBA and Richard E. Engler, Ph.D.

All Things Chemical

This week, I discuss with , DABT, MBA, Chief Toxicologist, Principal Director – Chemical and Material Risk Management, Office of the Assistant Secretary of Defense, Department of Defense, and my colleague, , Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, the U.S. Department of Defense’s (DOD) recent Request for Information (RFI) on chemicals undergoing U.S. Environmental Protection Agency (EPA) review as part of the Toxic Substances Control Act (TSCA) Section 6 risk evaluation process. DOD has a significant need for certain chemicals but admittedly...

Book Announcement — Chemical Product Law and Supply: A Guide to New TSCA

All Things Chemical

Hello, this is Lynn Bergeson. As many of our listeners may know, we here at Bergeson & Campbell, P.C. recently published a book through the American Bar Association's Section of Environment, Energy, and Resources, titled Chemical Product Law and Supply: A Guide to New TSCA. Recently, my ABA colleague Amy Edwards, a partner at Holland & Knight LLP, and I recorded a podcast to discuss the book—why we wrote it, and why chemical stakeholders of all kinds—especially business professionals, non-TSCA experts, and those involved in due diligence and commercial transactions—should read...

U.S. State PFAS Initiatives — A Conversation with Richard E. Engler, Ph.D. and Carla N. Hutton

All Things Chemical

This week, I discuss with my colleagues, , Senior Regulatory Analyst for B&C, and , Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, the ever-expanding and complicated scope of per- and polyfluoroalkyl substances (PFAS) regulation in the United States. We convened a webinar on this topic in mid-May and attracted a record-breaking 1000+ registrants, suggesting to us that PFAS continues to be a topic of enormous interest. In our discussion, Carla, Rich, and I address the federal Toxic Substances Control Act (TSCA) reporting obligation and the diverse...

Chemical Law and Policy — A Conversation with Karyn Schmidt

All Things Chemical

This week I had the pleasure of speaking with , now a principal at Squire Patton Boggs in its Public Policy practice, after spending 25 years at the American Chemistry Council (ACC). For the many members in the chemical community who know Karyn, her deep understanding of chemical law and policy will serve the firm’s clients well. We discuss Karyn’s transition to private practice, her work at ACC, and Karyn’s thoughts on what is in store for chemical stakeholders now and the foreseeable future. ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL AND ENTERTAINMENT...

REACH and GHS in Latin America — A Conversation with Melissa Owen

All Things Chemical

This week I had the pleasure of speaking with , attorney/owner of Ambiente Legal, about the significant regulatory developments regarding chemical registration in Latin America, including Latin American Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) initiatives and the Globally Harmonized System of Classification and Labeling of Chemicals (GHS). We discuss Brazil REACH, which requires by law the government to have an implementing regulation issued by May 2025, Colombia REACH, also subject to a fast-approaching May 2025 deadline, and other Latin American REACH and...

CLP Changes And What They Mean For Commercial Operations — A Conversation with Karin Baron and Lioba Oerter

All Things Chemical

This week I had the pleasure of speaking with Lioba Oerter, Director of Expert Services, 3E Expert Service Processing Centre (ESPC), and Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group, about the significant changes to product classification, labeling, and packaging (CLP) in the European Union (EU). Lioba and I shared a podium recently and found we also have a shared belief that these forthcoming CLP changes will have a profound commercial impact on product classification, labeling, and packaging...

Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA — A Conversation with Richard E. Engler, Ph.D. and Kelly N. Garson

All Things Chemical

This week, I discuss with my colleagues, , Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, and , Senior Associate for B&C and Acta, our recently released book, titled Chemical Product Law and Supply Chain Stewardship: A Guide to New TSCA, published by the American Bar Association. As listeners know, as a law firm and consulting firm, we do a lot of work under the Toxic Substances Control Act (TSCA) and have gained a significant amount of hands-on practical knowledge about the law, the 2016 Lautenberg Chemical Safety for the 21st Century Act...

TSCA Developments — A Conversation with Richard E. Engler, Ph.D.

All Things Chemical

This week, I discuss Toxic Substances Control Act (TSCA) developments with my colleague, , Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate. The U.S. Environmental Protection Agency’s (EPA) implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act amendments has been a dynamic, evolving, and unpredictable work in progress for almost nine years. Given the new Administration, we are at a most uncertain time because of the lack of clarity regarding what the new leaders at the Office of Chemical Safety and Pollution Prevention...

The New Administration and Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Developments — A Conversation with Jim Aidala

All Things Chemical

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

More Episodes

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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