All Things Chemical

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved

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.

©2022 Bergeson & Campbell, P.C. All Rights Reserved