This week I had the pleasure of speaking with U.S. Food and Drug Administration (FDA) Deputy Commissioner for Human Foods, Jim Jones, about all the amazing initiatives Jim is overseeing as the first FDA Deputy Commissioner for Human Foods. Many of us in the chemical community know Jim and his extraordinary career at the U.S. Environmental Protection Agency (EPA) leading both the EPA pesticides and toxics program offices, culminating his EPA career as Assistant Administrator for Toxics in the Obama Administration. Jim’s keen understanding of the administrative, chemical prioritization, risk evaluation, and risk management processes makes him uniquely well suited to lead the Human Foods office at FDA and implement successfully the new Human Foods organizational structure and achieve the office’s ambitious goals. We discuss the Human Foods’ priorities and new organizational structure, the recently released proposed systematic post-market review process on which FDA seeks comments, how Jim intends to tackle the many challenges FDA faces with regard to food chemicals, contaminants, and food additives, and much more.

Evaluating FDA Human Foods and Tobacco Programs, Before the Subcommittee on Health Committee on Energy and Commerce, 118th Cong. (2024) (statement of Jim Jones, Deputy Commissioner for Human Foods - Food and Drug Administration).

FDA, Discussion Paper: Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food, (Aug. 2024).

FDA, Development of an Enhanced Systematic Process for the Food and Drug Administration's Post-Market Assessment of Chemicals in Food; Public Meeting; Request for Comments,” 89 Fed. Reg. 65633, (Aug. 12, 2024).

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of speaking with Linda Reinstein, President and Cofounder of the Asbestos Disease Awareness Organization (ADAO), about her many years of asbestos disease awareness advocacy. Having lost her husband, Alan, to mesothelioma two decades ago, Linda set out to educate others about the diseases associated with asbestos exposure. Her story is one of grit, perseverance, and devotion.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

On June 26, 2024, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform — Eight Years Later. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions. B&C and ELI are pleased to co-sponsor this episode of All Things Chemical® to enable our podcast audience to listen to these sessions.

Lynn L. Bergeson moderated Panel 4: Shaping the Agenda: Section 21 Citizens’ Petitions and Other Mechanisms Influencing Priority Setting. The panelists included Ryan J. Carra, Ph.D., Principal, Beveridge & Diamond, P.C.; Michael Connett, Partner, Siri & Glimstad LLP; Thomas Groeneveld, Senior Advisor, Existing Chemicals Risk Management Division, EPA; and Robert M. Sussman, Principal, Sussman & Associates. Citizens’ petitions under TSCA Section 21 are increasingly playing a prominent and evolving role in influencing EPA’s policy and regulatory priorities. Other mechanisms are also being used to revisit EPA’s priorities. The panel discussed the utility of these mechanisms, how they are impacting EPA’s regulatory agenda, and other opportunities for citizen engagement. The panel commented on the implications of EPA’s decision to grant a TSCA Section 21 petition to address only a single condition of use (COU) of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD). More information on the petition to address 6PPD in tires is available in our November 3, 2023, blog item.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

On June 26, 2024, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform — Eight Years Later. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions. B&C and ELI are pleased to co-sponsor this episode of All Things Chemical® to enable our podcast audience to listen to these sessions.

Samantha Liskow, Lead Counsel, Health Program, EDF, moderated Panel 3: New Chemical Review. The panelists included Shari Barash, Director, NCD, OPPT, EPA; Kyla Bennett, Ph.D., Director, Public Employees for Environmental Responsibility (PEER); Kerry Coy, Product Regulation Specialist, BASF Corporation; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Daniel Rosenberg, Senior Attorney, Environmental Health, Natural Resources Defense Council (NRDC). The panelists discussed the latest updates to EPA’s new chemical review process, whether challenges are being addressed and how, whether review times are being diminished, scientific integrity, and best available science.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

On June 26, 2024, B&C, along with the Environmental Law Institute and the George Washington University Milken Institute of Public Health, sponsored the all-day virtual conference, TSCA Reform — Eight Years Later. The quality of the discussion, the caliber of the participants, and the timeliness of the content motivated us to repurpose the substantive sessions. B&C and ELI are pleased to co-sponsor this episode of All Things Chemical® to enable our podcast audience to listen to these sessions.

Maria J. Doa, Ph.D., Senior Director, Chemicals Policy, Environmental Defense Fund (EDF), moderated Panel 2: Risk Evaluation and the Supporting Role Sections 4 and 8 Play. The panelists included David B. Fischer, Counsel, Keller and Heckman LLP; Jeffery T. Morris, Ph.D., Director, Existing Chemicals Risk Assessment Division, Office of Pollution Prevention and Toxics (OPPT), EPA; Katherine O’Brien, Senior Attorney, Toxic Exposure and Health Program, Earthjustice; Judah Prero, Counsel, Arnold & Porter; and Tracey Woodruff, Ph.D., Professor and Director, University of California, San Francisco, Program on Reproductive Health and the Environment. The panel considered EPA’s revised chemical prioritization and risk evaluation processes; the role and extent of peer review; and the utility and timing of Section 4 test rules. More information on EPA’s final 2024 rule amending the risk evaluation framework rule is available in our May 14, 2024, memorandum.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

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.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of speaking with Michael Connett, Partner with Siri & Glimstad, LLP to discuss his epic litigation representing Food & Water Watch, a non-profit consumer organization that sued EPA over the fluoridation of drinking water. This issue has a long and complicated administrative and litigation history, and Michael and his firm are actively engaged in a groundbreaking federal litigation based on a judicial appeal of a denied Toxic Substances Control Act (TSCA) Section 21 citizen petition. Michael concluded a bench trial earlier this year in federal district court in the Northern District of California. The case is fascinating and much watched. We discuss the case, why TSCA citizen petitions in general are filed, Michael’s thoughts on how to prepare petitions to maximize their success (as most are denied), and other means of citizen engagement under TSCA. Resources:

TSCA Section 21 Petition Trends Pre- and Post-Lautenberg

TSCA Reform – Eight Years Later

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

This week I had the pleasure of speaking with W. Scott Thurlow with Thurlow Law & Public Affairs, headquartered Ottawa, Ontario, about Canada’s most recent updated draft report on the state of per- and polyfluoroalkyl substances (PFAS). The updated draft report defines PFAS to exclude fluoropolymers, an issue in which Scott and his firm are deeply engaged. We discuss the draft report, Canada’s approach to the regulation of PFAS, and Scott’s practice as a Canadian lawyer and public affairs specialist.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

This week, I welcomed to the studio Lara Hall, Senior Regulatory Scientist/Quality Assurance Specialist at B&C and our consulting affiliate, The Acta Group, to discuss the critical importance of understanding the role of the study sponsor. As our listeners know, chemical data -- testing results, chemical studies, exposure information, environmental fate and monitoring data, to name a few -- are the new currency in the chemical community. These data are incredibly valuable, often proprietary, and increasingly used both to support chemical applications and to rebut allegations of adverse consequences resulting from chemical exposure. How these data are developed, who serves as study sponsor, how the sponsor interacts with the study monitor, laboratory, and others are significant issues and subject to Good Laboratory Practice (GLP) standards. Lara and I discuss GLP and the rights, duties, and obligations of all the actors involved in chemical testing and offer some tips and insights in managing this increasingly complicated space.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved

This week, I welcomed back to the studio Karin F. Baron, Director of Hazard Communication and International Registration Strategy at B&C and our consulting affiliate, The Acta Group. And none too soon. Just when you were giving up hope in tackling the monster final Hazard Communication Standard rule issued on May 20, you realized Karin and I are devoting an entire podcast to the final rule!

As many of you know, Karin is second to none when it comes to hazard communication, GHS, and related domestic and international hazard standards and communicating hazards to global stakeholders. There is no one better suited to discuss the final rule, what in the rule makes us happy, what remains a concern, and how best to read and digest the more than 300 pages of new hazard communication provisions.

ALL MATERIALS IN THIS PODCAST ARE PROVIDED SOLELY FOR INFORMATIONAL  AND ENTERTAINMENT PURPOSES. THE MATERIALS ARE NOT INTENDED TO CONSTITUTE LEGAL ADVICE OR THE PROVISION OF LEGAL SERVICES. ALL LEGAL QUESTIONS SHOULD BE ANSWERED DIRECTLY BY A LICENSED ATTORNEY PRACTICING IN THE APPLICABLE AREA OF LAW.

©2024 Bergeson & Campbell, P.C.  All Rights Reserved