All Knowledge & Insights By Date

The U.S. Food and Drug Administration (FDA) announced on July 14, 2025, that it is extending the public comment period on its proposed method for ranking chemicals in the food supply by 30 days, to August 18, 2025. As reported in our July 8, 2025, blog item, FDA proposes to use Multi-Criteria Decision Analysis (MCDA) to determine a score for each chemical based on evaluating the information about a chemical against a pre-determined set of criteria. FDA notes that this method is similar in...

Register Now For “Regulation Without Borders: The EUDR and the New Era of Global Due Diligence,” August 5, 2025, 10:00 a.m. – 11:15 a.m. (EDT): Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®); EPPA; and Preferred by Nature (PBN) are pleased to present “Regulation Without Borders: The EUDR and the New Era of Global Due Diligence,” a complimentary webinar providing a detailed exploration of the European Union Deforestation Regulation (EUDR) and how it applies to...

The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking chemicals in the food supply. According to the document, the systematic post-market assessment of food chemicals consists of the following steps: signal detection, triage, prioritization, scoping, scientific assessment (safety, risk, and/or hazard), risk management review, and risk management action. FDA states that it will publish a full description of the process later in 2025...

Register Now For “TSCA Reform – Nine Years Later” Virtual Conference, 8:30 a.m. – 4:30 p.m. (EDT), June 25, 2025: Complimentary registration is now open for this dynamic virtual conference providing updates and insights regarding the current state of Toxic Substances Control Act (TSCA) implementation, ongoing and emerging issues, and related developments. As with our previous TSCA anniversary events, a stellar faculty of speakers from government, non-governmental organizations, industry,...

On May 15, 2025, the U.S. Food and Drug Administration (FDA) announced the launch of “a stronger, more systematic review process for food chemicals already on the market -- especially those that concern consumers most.” Over the coming months, FDA will roll out the following key actions: A modernized, evidence-based prioritization scheme for reviewing existing chemicals. According to FDA, it will soon release a draft for public comment; A final, systematic post-market review process shaped...

Register Now For “PFAS Updates: What’s Happening in the U.S. and EU,” May 13, 2024, 11:00 a.m. – 12:00 p.m. (EDT), Via Webinar: Register now to join Bergeson & Campbell, P.C. (B&C®) affiliate The Acta Group (Acta®) and EPPA for “PFAS Updates: What’s Happening in the U.S. and EU,” a complimentary webinar offering expert updates on per- and polyfluoroalkyl substances (PFAS) regulatory developments. During this webinar, Meglena Mihova, Managing Partner, EPPA, and Richard E....

ABA And B&C Announce Release Of Chemical Product Law and Supply Chain Stewardship Book: Chemical Product Law and Supply Chain Stewardship, edited by Lynn L. Bergeson and published by the American Bar Association (ABA), provides a road map to navigate efficiently the transformational changes in chemical product law, identifies the practical business and product stewardship implications of the new normal in product regulation, and explains the urgent need for supply chain awareness so that the...

2025 Forecast For U.S. Federal And International Chemical Regulatory Policy: On January 6, 2025, Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) published the “Forecast for U.S. Federal and International Chemical Regulatory Policy 2025.” This carefully curated document represents our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New...

Bergeson & Campbell, P.C. (B&C®), its global consulting affiliate The Acta Group (Acta®), and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to share with you our 2025 Forecast. For all the reasons you might imagine, our seasoned team was especially challenged this year in speculating on what to expect in 2025 regarding global industrial, agricultural, and biocidal chemical regulatory and policy initiatives. Given the European Parliamentary...

Mark Hartman, the highly respected Deputy Director for Programs in the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), will become Director of the U.S. Food and Drug Administration’s (FDA) Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI) in its newly formed Human Foods Program (HFP). According to FDA’s website, OFCSDSI “uses a risk-based approach to food chemical safety and dietary supplement policy and...

TSCA/FIFRA/TRI EPA Proposes To Add 16 PFAS And 15 PFAS Categories To The TRI List Of Chemicals: The U.S. Environmental Protection Agency (EPA) proposed on October 8, 2024, to add 16 individual per- and polyfluoroalkyl substances (PFAS) and 15 PFAS categories representing more than 100 individual PFAS to the Toxics Release Inventory (TRI) list of toxic chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA) to...

Download transcript. 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...

TSCA/FIFRA/TRI White House OSTP Releases PFAS Federal R&D Strategic Plan:The White House Office of Science and Technology Policy (OSTP) announced on September 3, 2024, the release of its Per- and Polyfluoroalkyl Substances (PFAS) Federal Research and Development Strategic Plan (Strategic Plan). Prepared by the Joint Subcommittee on Environment, Innovation, and Public Health PFAS Strategy Team (PFAS ST) of the National Science and Technology Council, the Strategic Plan provides a federal...

TSCA/FIFRA/TRI EPA Updates Safer Choice And DfE Standard: The U.S. Environmental Protection Agency (EPA) announced on August 8, 2024, the availability of the final updated Safer Choice and Design for the Environment (DfE) Standard (the Standard). 89 Fed. Reg. 64915. According to EPA, the update includes a name change to the title of the Standard, a revision to the packaging criteria, a new certification for cleaning service providers, a new provision allowing for preterm partnership termination...

On September 10, 2024, the House Energy and Commerce Subcommittee on Health will hold a legislative hearing on “Evaluating FDA Human Foods and Tobacco Programs.” According to the Committee’s September 3, 2024, hearing announcement, the hearing will give members a chance to hear from the head of the Human Foods Program, as well as the head of the Tobacco Center, to learn how the U.S. Food and Drug Administration (FDA) is “helping adult smokers quit, keeping illegal products away from...

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in U.S. Food and Drug Administration (FDA) submissions. PCRM notes that traditionally, submissions have included data from animal studies, but industry has started submitting NAMs. According to PCRM, the use of NAMs in FDA submissions is expected to grow, as many toxicologists seek to use human-based...

As reported in our August 7, 2024, blog item, the U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of an enhanced systematic process for its post-market assessment of chemicals in food. 89 Fed. Reg. 65633. FDA has posted a Discussion Paper Development of an Enhanced Systematic Process for the FDA’s Post-Market Assessment of Chemicals in Food (Discussion Paper). The Discussion Paper “broadly...

TSCA/FIFRA/TRI EPA Releases Draft Risk Evaluation For 1,1-Dichloroethane And Draft Hazard Assessment Of 1,2-Dichloroethane For Public Comment And Peer Review: On July 2, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of the draft risk evaluation for 1,1-dichloroethane (1,1-DCE) and the draft human health hazard assessment supporting the draft risk evaluation for 1,2-dichloroethane (1,2-DCE, also known as ethylene dichloride) prepared under the Toxic Substances Control...

The U.S. Food and Drug Administration (FDA) announced on August 1, 2024, that it will hold a public meeting on September 25, 2024, on the development of an enhanced systematic process for its post-market assessment of chemicals in food. FDA states that this includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants. According to FDA, this is intended to guide its post-market assessment work going forward and...

The U.S. Food and Drug Administration (FDA), the primary federal agency committed to safe exposure to chemicals in the food supply, has recently stepped up efforts to ensure food safety, especially in the post-market assessment area. Stakeholders in commercial chemical operations and product lines involving chemicals used for or found in the food supply should be prepared for increased inspections and enforcement in this area. Chemicals in Food The Federal Food, Drug, and Cosmetic Act (FFDCA)...

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TSCA/FIFRA/TRI                                                                                                                           EPA Announces New Resource Portal And Reporting Tool Improvements Before CDR Reporting Begins On June 1, 2024: On May 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the creation of CDR GuideME, a new resource portal, and...

Please note that the date of this webinar has moved forward one day, from Wednesday, June 12, 2024, to Thursday, June 13, 2024, 11:00 a.m. – 12:00 p.m. (EDT). Register now to join Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) for “Sponsor’s Role in Regulatory Testing — Complying with GLP Standards,” a complimentary webinar covering the roles and responsibilities of Study Sponsors, as defined by Good Laboratory Practices (GLP) regulations and related...

Please note that the date of this webinar has moved forward one day, from Wednesday, June 12, 2024, to Thursday, June 13, 2024, 11:00 a.m. – 12:00 p.m. (EDT). Register now to join Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) for “Sponsor’s Role in Regulatory Testing — Complying with GLP Standards,” a complimentary webinar covering the roles and responsibilities of Study Sponsors, as defined by Good Laboratory Practices (GLP) regulations and related advisory...

TSCA/FIFRA/TRI                                                                                                                           EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk To Human Health: On April 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested...

TSCA/FIFRA/TRI EPA Seeks Comment On Proposed Settlement Agreement To Conclude A TSCA Rulemaking Regulating Lead Wheel Weights, Publishes ANPRM Regarding Lead Wheel Weights: On March 13, 2024, the U.S. Environmental Protection Agency (EPA) published notice of a proposed settlement agreement to address a petition for writ of mandamus filed by the Ecology Center, the Center for Environmental Health, United Parents Against Lead & Other Environmental Hazards, and the Sierra Club in the United...

The U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM). FDA states that “[a]sbestos was not detected in any of the 50 samples tested in 2023.” FDA states that it selected and purchased cosmetic products, and then it blinded and transferred the samples to...

The U.S. Food and Drug Administration (FDA) issued a Constituent Update on March 4, 2024, that updates its “List of Select Chemicals in the Food Supply Under FDA Review.” FDA states that the intent of this update is “…to provide more insight on the status of the FDA’s post-market assessments of chemicals in the food supply.” The information posted today includes many chemicals that FDA has been actively engaged in reviewing for the past several years. The Update also explains the...

The U.S. Food and Drug Administration (FDA) has posted a February 2024 guidance entitled “Foods Derived from Plants Produced Using Genome Editing: Guidance for Industry.” According to FDA, one purpose of the guidance is to clarify how its 1992 policy statement “Statement of Policy: Foods Derived from New Plant Varieties” (NPV policy) (57 Fed. Reg. 22984) applies to foods derived from NPVs produced using genome editing. The NPV policy provides scientific and regulatory guidance on foods...

Download transcript. 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...

On September 15, 2023, the U.S. Food and Drug Administration (FDA) announced that it is seeking comment on its newly developed draft electronic submission portal (Cosmetics Direct) and paper forms (Forms FDA 5066 and 5067). The submission portal and paper forms are part of FDA’s implementation of the new registration and listing requirements mandated by the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). FDA has provided screenshots of the draft electronic system, draft Form FDA...

As reported in our May 10, 2023, blog item, the National Nanotechnology Initiative (NNI) is holding two public webinars providing an overview of the key activities of U.S. government agencies in tackling the challenge of plastic waste in the environment. According to NNI, the breakdown of bulk plastics to micro- and nanoscale particles in the environment “has further challenged efforts to understand the potential human and environmental impacts of plastics over their full life cycles,”...

The National Nanotechnology Initiative (NNI) will hold two public webinars providing an overview of the key activities of U.S. government agencies in tackling the challenge of plastic waste in the environment. NNI states that the plastic waste issue includes more than just solid waste accumulation. According to NNI, the breakdown of bulk plastics to micro- and nanoscale particles in the environment “has further challenged efforts to understand the potential human and environmental impacts of...

The U.S. Food and Drug Administration (FDA) announced on May 3, 2023, that it has filed a color additive petition (CAP 3C0325), submitted by the Environmental Defense Fund (EDF), the Center for Environmental Health (CEH), the Center for Food Safety (CFS), the Center for Science in the Public Interest (CSPI), and the Environmental Working Group (EWG). 88 Fed. Reg. 27818. The petition proposes that FDA repeal the color additive regulation for titanium dioxide in 21 C.F.R. Section 73.575,...

By Lynn L. Bergeson and Carla N. Hutton   On April 25, 2023, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it published a new five-year strategic plan. According to APHIS, it incorporates input it received from stakeholders on the strategic framework, a summarized version of the plan that it published in June 2022. The plan includes six strategic goals that focus on working to: Protect agriculture from plant and animal...

The U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPRM) on April 13, 2023, seeking information to assist in the consideration of potential development of future regulations pertaining to per- and polyfluoroalkyl substances (PFAS) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 88 Fed. Reg. 22399. EPA states that it seeks input and data regarding potential future hazardous substance designation under...

In a somewhat unexpected move, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. MoCRA significantly strengthens the U.S. Food and Drug Administration’s (FDA) authority over cosmetic products. Key provisions are summarized in this article.

On February 22, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) announced that it will co-host a virtual public meeting with the U.S. Food and Drug Administration’s (FDA) Center of Veterinary Medicine (CVM) on March 22, 2023. As stated in our February 17, 2023, blog, EPA and FDA are considering how best to update their respective oversight responsibilities for specific products in an efficient and...

On January 27, 2023, plaintiffs in the Southern District of New York announced their displeasure with the inconvenient fact that Tom’s Wicked Fresh! mouthwash contains measurable concentrations of PFAS. They channeled their displeasure by bringing a class action suit against Colgate-Palmolive Company and Tom’s of Maine, Inc. for fraud and unjust enrichment based on several state consumer protection laws, the federal Magnuson-Moss Warranty Act, and common law tort. Plaintiffs assert...

On February 15, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Chemical Safety and Pollution Prevention (OCSPP) and the U.S. Food and Drug Administration’s (FDA) Center for Veterinary Medicine (CVM) announced plans to seek public input on the best approaches for updating their respective oversight responsibilities for specific products. EPA states the goal is to determine responsibilities in an efficient and transparent manner and in alignment with each agency’s...

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Applications (NURA) program is offering a free three-session training series on replacing the traditional two-year bioassay with a more effective, human-relevant carcinogenicity assessment. In “Tomorrow’s Data Today: Sunsetting the 2-year Carcinogenicity Assay,” toxicologists, risk assessors, and scientists will hear directly from other experts on the current progress among working...

In a move that some may not have seen coming, Congress enacted the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on December 29, 2022, as part of the Omnibus Appropriations Act. The MoCRA significantly strengthens the U.S. Food and Drug Administration (FDA) authority over cosmetic products. Key impacts are summarized below. Background On April 16, 2021, the Performance Enhancement Reform Act was introduced to the House of Representatives by Representative Gerald E. Connolly (D-VA)....

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2023, our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year. We have worked hard to offer our best-informed judgment on the trends...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order creating a National Biotechnology and Biomanufacturing Initiative (NBBI) to accelerate biotechnology innovation and grow America’s bioeconomy across multiple sectors in industries such as health, agriculture, and energy. On December 20, 2022, the White House Office of Science and Technology Policy (OSTP) published two...

October 26, 202212:00 p.m. - 1:00 p.m. (EDT) The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to outbreaks to...

By Lynn L. Bergeson and Carla N. Hutton   As reported in our September 13, 2022, blog item, on September 12, 2022, President Joseph Biden signed an Executive Order (EO) creating a National Biotechnology and Biomanufacturing Initiative “that will ensure we can make in the United States all that we invent in the United States.” The White House hosted a Summit on Biotechnology and Biomanufacturing on September 14, 2022. According to the White House fact sheet on the summit, federal...

Download transcript. 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...

October 26, 202212:00 p.m. - 1:00 p.m. (EDT)Register Now  The U.S. Food and Drug Administration (FDA) reports that 48 million people in the United States (1 in 6) get sick, 128,000 are hospitalized, and 3,000 die each year from foodborne diseases. In 2011, President Obama signed into law the Food Safety Modernization Act (FSMA) in part to address this significant public health issue. FSMA is a comprehensive law intended to shift the focus of foodborne illness management from responding to...

The U.S. Food and Drug Administration (FDA) will hold the “FDA NanoDay Symposium 2022” on October 11, 2022. The symposium will address the following topics: An overview and discussion of the recent “Guidance for Industry: Drug Products, Including Biological Products, that Contain Nanomaterials.” More information on the guidance is available in our April 24, 2022, blog item; A contextualized discussion of the development of the COVID mRNA lipid nanoparticle vaccine products; A...

On September 7, 2022, the Environmental Defense Fund (EDF) held a webinar to introduce a cumulative risk assessment (CRA) framework that takes into account multiple exposures to chemical and non-chemical stressors. Sarah Vogel, Senior Vice President for Health at EDF, moderated the webinar. According to Vogel, for decades, environmental justice leaders have documented disproportionate chemical exposures to disadvantaged communities. These chemical and social stressors (e.g., racism and...