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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...