On May 27, 2025, President Trump signed an Executive Order (EO) on “Restoring Gold Standard Science.” 90 Fed. Reg. 22601. The EO states that the Trump Administration “is committed to restoring a gold standard for science to ensure that federally funded research is transparent, rigorous, and impactful, and that Federal decisions are informed by the most credible, reliable, and impartial scientific evidence available.” The EO restores the scientific integrity policies of the first Trump...
Category: Research and Testing
The 41st SQA Annual Meeting will cover "hot topics" in GCP, GLP, GMP, pharmacovigilance, scientific archiving, computer validation, veterinary medicine, and other QA disciplines. Lara A. Hall, MS, RQAP-GLP, Senior Regulatory Scientist and Quality Assurance Specialist, B&C, and Michelle C. Mims, MS, RQAP-GLP, Regulatory Scientist and Quality Assurance Specialist, B&C, will present "A Sponsor’s Role in Regulatory Testing under EPA GLP" on April 8, 2025.
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...
October 30, 2024
Registration Open for NURA Webinar Series on Addressing Systemic Toxicity with NAMs
The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program has announced two upcoming webinars in the DyNAMic Discussions series. This webinar series invites speakers to share candid perspectives on how they have overcome barriers to apply NAMs in their fields and discuss how these examples can be used to promote the use of NAMs in other situations. November 14, 2024, at 10:00 a.m. (EST): Next steps toward the...
August 21, 2024
EPA Authors Describe Categorization Approach to PFAS to Identify Potential Candidates for Testing and Human Health Assessments
On August 18, 2024, Computational Toxicology published an article entitled “Development of chemical categories for per- and polyfluoroalkyl substances (PFAS) and the proof-of-concept approach to the identification of potential candidates for tiered toxicological testing and human health assessment.” Co-authored by members of the U.S. Environmental Protection Agency’s (EPA) Center for Computational Toxicology & Exposure (CCTE) and Office of Chemical Safety and Pollution Prevention...
The U.S. Environmental Protection Agency (EPA) announced on August 7, 2024, that it will hold a webinar on August 28, 2024, on the use of new approach methodologies (NAM). The webinar, “The CATMoS Model for Acute Oral Toxicity and Evaluation of its Potential Use in a Regulatory Context for Pesticide Hazard and Risk Assessment,” is the fifth in a series held in collaboration with PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California...
On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane (1,1,2-TCA) issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA). The court states that “EPA’s...
The National Nanotechnology Coordination Office (NNCO), on behalf of the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the Committee on Technology, National Science and Technology Council (NSTC), requested comments on June 13, 2024, on the “National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy: 2024 Update” (2024 Update). 89 Fed. Reg. 50390. NNCO states that federal agencies participating in NSET’s Nanotechnology Environmental and...
The European Union (EU) Observatory for Nanomaterials (EUON) invites proposals for upcoming studies aimed at addressing knowledge gaps for nanomaterials within the EU market, such as: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment; Specific issues surrounding the uses, associated risks, and benefits of nanomaterials; or Information about markets of nanomaterials. EUON notes that studies are based on desk research and surveys and should...
The U.S. Environmental Protection Agency (EPA) announced on March 25, 2024, that it has issued the fourth Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under its National PFAS Testing Strategy. According to EPA, the action requires the 3M Company (3M) and Wacker Chemical Corporation (Wacker) to conduct and submit testing on the physical-chemical properties of 2-(N-Methylperfluoro-1-octanesulfonamido)ethanol (NMeFOSE) (Chemical...