August 22, 2024

FDA Posts Discussion Paper on Development of an Enhanced Systematic Process for Its Post-Market Assessment of Chemicals in Food; Comments Due December 6, 2024

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)....
August 22, 2024

Lynn L. Bergeson Quoted in Bloomberg Law Article “Health Agency Finalizes Fluoride Dose Harmful to Babies’ IQ”

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 of Bergeson &...
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...
August 20, 2024

EPA Proposes SNUR for Graphene Nanoplatelets (Generic)

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...
August 20, 2024

NSF Biomaterials Program Publishes RFI

The National Science Foundation’s (NSF) Biomaterials Program published a request for information (RFI) on August 20, 2024. NSF requests input from stakeholders on opportunities, challenges, emerging areas, and frontiers in biomaterials research. 89 Fed. Reg. 67498. According to NSF, the RFI will help inform future program directions, new initiatives, and potential funding opportunities. The Biomaterials Program supports fundamental materials research related to biological materials;...
August 20, 2024

Canada Begins 60-Day Comment Period on Computational Tool for Chemical Screening and Prioritization

As part of its implementation of the modernized Canadian Environmental Protection Act, 1999 (CEPA), on August 17, 2024, Health Canada published a Canada Gazette notice announcing the availability of its Science Approach Document — Chemical Screening and Prioritization: Health Canada’s Automated Workflow for Prioritization (HAWPr). The science approach document (SciAD) describes the scientific approach that Canada applied to more than 25,000 chemicals on the Domestic Substances List...
August 16, 2024

IRS Announces Correction to Petition to Add Nylon 6 to List of Chemical Substances Subject to Superfund Excise Tax

The Internal Revenue Service (IRS) announced on August 14, 2024, a correction to the stoichiometric material consumption equation in the notice of filing for the nylon 6 petition that was published in the February 22, 2024, Federal Register. 89 Fed. Reg. 66175. According to the notice, after the comment period for the original notice closed, an error was discovered in the stoichiometric material consumption equation for nylon 6, and the petitioner subsequently provided a corrected...
August 15, 2024

Recent Federal Developments for August 2024

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...
August 15, 2024

Canada Proposes Exclusion of Fluoropolymers from PFAS — A Conversation with W. Scott Thurlow

This week I had the pleasure of speaking with W. Scott Thurlow with Thurlow Law & Public Affairs, headquartered Ottawa, Ontario, about Canada’s most recent updated draft report on the state of per- and polyfluoroalkyl substances (PFAS). The updated draft report defines PFAS to exclude fluoropolymers, an issue in which Scott and his firm are deeply engaged. We discuss the draft report, Canada’s approach to the regulation of PFAS, and Scott’s practice as a Canadian...
August 15, 2024

OIRA Report Highlights Examples of Agencies Seeking to Strengthen Public Participation and Community Engagement in the Regulatory Process

The Office of Management and Budget’s (OMB) Office of Information and Regulatory Affairs (OIRA) published a blog item on August 14, 2024, announcing the availability of a report highlighting examples of agencies seeking to strengthen public participation and community engagement in the regulatory process. According to OIRA, while agencies have adopted a range of approaches depending on the type of action under consideration and the stakeholders they are seeking to engage, there are four...