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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...