All Knowledge & Insights By Date

On August 27, 2024, the U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced that it recently reviewed the following plants modified using genetic engineering to determine whether they posed an increased plant pest risk relative to non-modified comparators: APHIS states that it found these modified plants were unlikely to pose an increased plant pest risk compared to other cultivated plants. As a result, they are not subject to regulation under...

As reported in our July 29, 2024, blog item, on July 27, 2024, Canada’s Minister of the Environment published a Canada Gazette notice announcing a mandatory survey to obtain information on the manufacture, import, and use of 312 specific per- and polyfluoroalkyl substances (PFAS). On September 11, 2024, at 1:30 p.m. (EDT), Environment and Climate Change Canada (ECCC) will hold an information session in English on the survey. The session will be non-interactive and will...

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...

On August 20, 2024, the California Department of Pesticide Regulation (DPR) announced it will launch its electronic pesticide registration system, the California Pesticide Electronic Submission Tracking (CalPEST), on September 24, 2024. The launch of CalPEST will convert its paper-based pesticide registration process to a streamlined electronic system. According to DPR, it is conducting the final stages of testing and has identified areas for improvement in system functionality and security that...

As part of its quadrennial review of the National Nanotechnology Initiative (NNI), the National Academies of Sciences, Engineering, and Medicine (NASEM) will hold a virtual town hall on September 5, 2024, for stakeholders to share their thoughts on the future of nanotechnology in the United States. The overall objective of NASEM’s review is to identify opportunities and barriers to broadening access to nanotechnology research and development (R&D) infrastructure in the United States. As...

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 under exceptional circumstances, and the addition of...

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)....

On August 21, 2024, comments by Lynn L. Bergeson were featured in Bloomberg Law’s article regarding the publication of the National Toxicology Program’s long-awaited report about fluoride’s hazards. The NTP report is equivocal on the effect, if any, of low fluoride exposures, and saying more research is needed would seem to be unhelpful to Chen in making any dose-response determination in the case over which he is presiding, said Lynn Bergeson, managing partner...

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...

On August 20, 2024, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) ) under the Toxic Substances Control Act (TSCA) for chemical substances, including graphene nanoplatelets (generic), that were the subject of premanufacture notices (PMN) and a Microbial Commercial Activity Notice (MCAN) and are also subject to a TSCA Order. 89 Fed. Reg. 67368. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process...