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: Risk Assessment Issues
On March 10, 2025, the U.S. Environmental Protection Agency (EPA) announced its intent to reconsider the May 3, 2024, rule amending the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA) (2024 Risk Evaluation Framework Rule). According to EPA, it will initiate a rulemaking “that will ensure the agency can efficiently and effectively protect human health and the environment and follow the law.” As reported in our February 7, 2025, blog...
On January 16, 2025, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on the draft scope of the risk evaluation to be conducted under the Toxic Substances Control Act (TSCA) for vinyl chloride. 90 Fed. Reg. 4738. EPA notes that under TSCA, the scope documents must include the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS) that EPA expects to consider in conducting its risk...
January 17, 2025
EPA Releases Final Risk Evaluation for DINP, Finding Unreasonable Risk of Injury to Human Health When Workers Are Exposed under Four COUs
On January 14, 2025, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for diisononyl phthalate (DINP) conducted under the Toxic Substances Control Act (TSCA). EPA states that it has determined that DINP presents an unreasonable risk of injury to human health because workers could be exposed to high concentrations of DINP in mist when spraying adhesive, sealant, paint, and coating products that contain DINP. According to EPA, DINP can cause developmental toxicity...
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...
December 23, 2024
EPA Requires Submission of Health and Safety Studies for 16 Chemicals Being Considered for Risk Evaluation under TSCA
On December 13, 2024, the U.S. Environmental Protection Agency (EPA) published a final Health and Safety Reporting Rule under the Toxic Substances Control Act (TSCA) to require manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed. Reg. 100756. The rule applies to manufacturers in the North American Industrial Classification System (NAICS) codes for chemical manufacturing (NAICS code 325) and...
December 10, 2024
EPA Releases Final Supplement to the Risk Evaluation and Revised Unreasonable Risk Determination for 1,4-Dioxane
On November 13, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its final supplement to the risk evaluation and revised unreasonable risk determination for 1,4-dioxane under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 89993. EPA states in the Federal Register notice that it “used the best available science to prepare this final supplement to the risk evaluation and has determined that 1,4-dioxane poses unreasonable risk to human health.” EPA notes that...
The U.S. Environmental Protection Agency (EPA) announced on September 3, 2024, the release of the draft risk evaluation for diisononyl phthalate (DINP) under the Toxic Substances Control Act (TSCA) for public comment. 89 Fed. Reg. 71270. EPA states in its August 30, 2024, press release that it preliminarily determined that two industrial uses and one consumer use “significantly contribute to the unreasonable risk of DINP out of the 45 uses evaluated.” EPA preliminarily determined that DINP...
July 29, 2024
EPA Begins 90-Day Comment Period on Proposed High-Priority Substance Designations for Five Chemicals
The U.S. Environmental Protection Agency (EPA) announced on July 25, 2024, that it is proposing to designate acetaldehyde, acrylonitrile, benzenamine, vinyl chloride, and 4,4-methylene bis(2-chloroaniline) (MBOCA) as high-priority substances (HPS) for risk evaluation under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 60420. EPA is providing a 90-day comment period, during which interested persons may submit comments on the proposed designations of these chemicals as HPSs for risk...
On June 22, 2023, the U.S. Environmental Protection Agency (EPA) published proposed significant new use rules (SNUR) for three flame retardants, tris(2-chloroethyl) phosphate (TCEP), 4,4′-(1-methylethylidene)bis[2,6-dibromophenol], also known as “tetrabromobisphenol A” (TBBPA), and triphenyl phosphate (TPP), which are all undergoing risk evaluations under the Toxic Substances Control Act. 88 Fed. Reg. 40728. EPA states that the proposed significant new uses are manufacture (including...