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On July 18, 2025, the U.S. Environmental Protection Agency (EPA) rolled out the “reorganization plan” for its Office of Research and Development (ORD). The stated goal of the plan is to reduce budget expenditures, improve “science,” and have EPA’s research activities better support the work of the media offices, including the Office of Water (OW), Office of Air and Radiation (OAR), and Office of Chemical Safety and Pollution Prevention (OCSPP). The EPA press release refers to the...

Download now. This week, I discuss with Patricia Underwood, Ph.D., DABT, MBA, Chief Toxicologist, Principal Director – Chemical and Material Risk Management, Office of the Assistant Secretary of Defense, Department of Defense, and my colleague, Richard E. Engler, Ph.D., Director of Chemistry for B&C and The Acta Group (Acta®), our consulting affiliate, the U.S. Department of Defense’s (DOD) recent Request for Information (RFI) on chemicals undergoing U.S. Environmental Protection...

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...

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...

A key force propelling reform of the Toxic Substances Control Act through Congress in 2016 was a bipartisan belief, shared by the business and environmental communities alike, that the Environmental Protection Agency needs more information to do its job of protecting the American public from adverse effects caused by chemical exposures. After all, it has been domestic policy under TSCA for almost a half century that “adequate information should be developed . . . and that the development of...

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...

Bergeson & Campbell, P.C. (B&C®) is pleased to present “What’s New with New Approach Methodologies: A Webinar” from 11:00 a.m. - 12:30 p.m. (EST) on February 13, 2025. New Approach Methodologies (NAM) are being increasingly used throughout the field of toxicology due to scientific, logistical, and ethical advantages, as well as legal requirements. The U.S. Environmental Protection Agency (EPA), as directed by the 2016 amendment to the Toxic Substances Control Act (TSCA), is...

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...

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...

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...

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...

Download transcript. This week, I welcomed to the studio Lara Hall, Senior Regulatory Scientist/Quality Assurance Specialist at B&C and our consulting affiliate, The Acta Group, to discuss the critical importance of understanding the role of the study sponsor. As our listeners know, chemical data -- testing results, chemical studies, exposure information, environmental fate and monitoring data, to name a few -- are the new currency in the chemical community. These data are incredibly...

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...

The National Institute for Occupational Safety and Health (NIOSH) continues to celebrate the 20th anniversary of its Nanotechnology Research Center (NTRC). NIOSH highlights NTRC activities in the risk assessment of engineered nanomaterials in a June 3, 2024, NIOSH Science blog item entitled “NIOSH Risk Assessment of Engineered Nanomaterials.” The item notes that NTRC risk assessments were used in developing NIOSH recommended exposure limits (REL) for three different classes of nanomaterials...

By Lynn L. Bergeson and Carla N. Hutton On July 19, 2023, the U.S. Environmental Protection Agency (EPA) extended the comment period on proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 46125. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act”...

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...

10:00 a.m. - 11:00 a.m. (EDT)4:00 p.m. - 5:00 p.m. (CEST)REGISTER NOW Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of these global legal developments and take steps now to minimize legal, regulatory, and commercial risk.In the United States and globally, the number of bans,...

Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act (the Act), received Royal Assent on June 13, 2023. According to Environment and Climate Change Canada’s (ECCC) Backgrounder, the Act modernizes the Canadian Environmental Protection Act, 1999 (CEPA) and represents the first set of comprehensive amendments to CEPA since it was enacted over 20 years ago. It also makes related amendments to the Food and Drugs Act. The Act was initially introduced in the...

The Senate Committee on Environment and Public Works announced on June 22, 2023, that Senators Tom Carper (D-DE), Chair of the Committee, and Shelley Moore Capito (R-WV), Ranking Member of the Committee, have released draft per- and polyfluoroalkyl substances (PFAS) legislation for stakeholder comment. According to the press release, the bipartisan package seeks to improve the mitigation and remediation of PFAS contamination. The Committee seeks stakeholder comments on the...

The U.S. Environmental Protection Agency (EPA) announced on June 15, 2023, that it will issue proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 18 chemicals made from plastic waste-derived feedstocks. According to EPA, the proposed SNURs would require notification to and review by EPA before these fuels could be made using plastic waste-derived feedstocks that contain impurities like per- and polyfluoroalkyl substances (PFAS), heavy metals, dioxins,...

July 11, 202310:00 a.m. - 11:00 a.m. (EDT)4:00 p.m. - 5:00 p.m. (CEST)REGISTER NOW Perfluoroalkyl and polyfluoroalkyl substances (PFAS) are attracting global legal, regulatory, commercial, and litigation attention as no other “emerging contaminant” has. Companies producing, processing, distributing, and/or using these substances must be aware of these global legal developments and take steps now to minimize legal, regulatory, and commercial risk.In the United States and globally, the number...

8:00 a.m. - 5:30 p.m. EDTJune 29, 2023 REGISTER NOW The full program, including session details and confirmed speakers for the 7th annual Toxic Substances Control Act (TSCA) conference, “TSCA Reform -- Seven Years Later,” is detailed below. This timely and essential day-long virtual conference will provide updates on risk evaluation, risk management, new chemical review, per- and polyfluoroalkyl substances (PFAS), and more.Bergeson & Campbell, P.C. (B&C®), the Environmental Law...

8:00 a.m. - 5:30 p.m. EDTJune 29, 2023 REGISTER NOW The full program, including session details and confirmed speakers for the 7th annual Toxic Substances Control Act (TSCA) conference, “TSCA Reform -- Seven Years Later,” is detailed below. This timely and essential day-long virtual conference will provide updates on risk evaluation, risk management, new chemical review, per- and polyfluoroalkyl substances (PFAS), and more.Bergeson & Campbell, P.C. (B&C®), the Environmental Law...

On May 18, 2023, Senator Alex Padilla (D-CA) and Representative Zoe Lofgren (D-CA) introduced the Supercomputing for Safer Chemicals (SUPERSAFE) Act (S. 1685, H.R. 3457). According to Padilla’s May 18, 2023, press release, the legislation would establish a SUPERSAFE Consortium led by the U.S. Environmental Protection Agency (EPA) “to identify chemicals that are safe to use in commerce through science-backed decision making.” The press release states that the bill would direct the use...

On June 8, 2023, the California Department of Pesticide Regulation (DPR) issued Notice 2023-07: Pesticide Registration Program Annual Processing Timelines. Under Notice 2023-07, DPR sets forth its annual report summarizing the past five years of registration and post-registration activities. This includes the number of pesticide product registration and amendment submissions received and processed, and average number of days to complete different types of registration submissions are also...

POSTED IN INTERNATIONAL, LEGAL/REGULATORY ISSUES, OECD The Organization for Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022. Below are highlights on...

The European Commission’s (EC) Scientific Committee on Consumer Safety (SCCS) published on May 16, 2023, the 12th revision of The SCCS Notes of Guidance for the Testing of Cosmetic Ingredients and Their Safety Evaluation. The guidance contains information on the different aspects of testing and safety evaluation of cosmetic substances in Europe. The emphasis of the guidance is on cosmetic ingredients, but it notes that “some guidance is also indirectly given for the safety assessment of...

On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg Act), improve EPA’s efficiency in the review process,...

By Lynn L. Bergeson and Carla N. Hutton   On May 26, 2023, the U.S. Environmental Protection Agency (EPA) proposed amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 34100. According to EPA, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act” (Lautenberg...

The White House Office of Science and Technology Policy (OSTP) has extended the comment period for its April 5, 2023, request for information (RFI) seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 33174. OSTP is soliciting public input from a wide variety of stakeholders, including individuals, industry, academia, research laboratories, nonprofits, and think tanks. OSTP states that it is...

Bergeson & Campbell, P.C.’s (B&C®) May 17, 2023, webinar, “TOP TSCA TOPICS: PFAS, Cumulative Risk, NAMs, Risk Evaluations, CBI, and More,” is now available for on-demand viewing. During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed...

Bergeson & Campbell, P.C.’s (B&C®) May 17, 2023, webinar, “TOP TSCA TOPICS: PFAS, Cumulative Risk, NAMs, Risk Evaluations, CBI, and More,” is now available for on-demand viewing. During this one-hour webinar, Anna B. Lowit, Ph.D., Senior Science Advisor, the U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, discussed...

The U.S. Environmental Protection Agency (EPA) announced on May 16, 2023, that it will propose amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). According to the pre-publication version of the proposed rule, the amendments are “intended to align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the [2016] Frank R. Lautenberg Chemical Safety for the 21st Century Act...

The United Kingdom’s (UK) Health and Safety Executive (HSE) issued a call for evidence on April 26, 2023, to gather information and evidence that will support HSE and the UK Health and Security Agency (UKHSA) with the preparation of a regulatory management options analysis (RMOA) that examines exposure of the general public to formaldehyde from formaldehyde releasers in articles. HSE states that it is “interested in all aspects of the manufacture, import and use of articles that...

On April 7, 2023, the Office of Management and Budget (OMB) requested comments on proposed Circular A-4, “Regulatory Analysis.” 88 Fed. Reg. 20915. According to OMB, since 2003, OMB Circular A-4, Regulatory Analysis, has provided guidance to federal agencies on the development of regulatory analysis as required under Section 6(a)(3)(C) of Executive Order (EO) 12866 (Regulatory Planning and Review), the Regulatory Right-to-Know Act, and a variety of related authorities. OMB...

On April 24, 2023, the U.S. Environmental Protection Agency (EPA) held a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment (CRA) under the Toxic Substances Control Act (TSCA). As reported in our...

The Organization for Economic Cooperation and Development (OECD) has published the latest edition of the Developments in Delegations on the Safety of Manufactured Nanomaterials and Advanced Materials — Tour de Table. The Tour de Table compiles information provided by delegations on the occasion of the 22nd meeting of the OECD Working Party on Manufactured Nanomaterials (WPMN) in June 2022.  The Tour de Table lists U.S. developments on the human health and...

As reported in our March 16, 2023, blog item, on March 14, 2023, the European Union (EU) Observatory for Nanomaterials (EUON) issued a call for study proposals. EUON is looking for studies on: Questions related to the health and safety aspects of nanomaterials, including hazard and risk assessment, exposure to nanomaterials, or worker safety and protection; Specific issues surrounding the uses of nanomaterials; or Information about markets for nanomaterials (e.g., the market for...

May 17, 202311:00 a.m. - 12:00 p.m. EDTREGISTER NOW The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing...

May 17, 202311:00 a.m. - 12:00 p.m. EDTREGISTER NOW The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has advanced groundbreaking science policy initiatives in furtherance of implementation of the Toxic Substances Control Act (TSCA). As EPA advances New Approach Methodologies (NAM), cumulative risk assessment methodologies, and systematic review procedures, chemical stakeholders must understand directionally how these initiatives are influencing...

 The U.S. Environmental Protection Agency (EPA) will hold a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment under the Toxic Substances Control Act (TSCA). As reported in our March 1,...

By Lynn L. Bergeson and Carla N. Hutton   The U.S. Department of Agriculture’s (USDA) Animal and Plant Health Inspection Service (APHIS) announced on April 10, 2023, that it is inviting public comment on a draft Environmental Assessment (EA) and draft Plant Pest Risk Assessment (PPRA). 88 Fed. Reg. 21602. APHIS states that it produced these documents in response to a petition from Pioneer Hi-Bred International, Inc. seeking deregulation of a corn variety developed using genetic...

On April 5, 2023, the European Chemicals Agency (ECHA) convened an online information session as part of the consultation period regarding the proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The speakers during the information session explained how the REACH restriction process works, provided details regarding the restriction proposal, and described how...

The White House Office of Science and Technology Policy (OSTP) published a request for information (RFI) on April 5, 2023, seeking public input in updating the National Nanotechnology Initiative (NNI) Environmental, Health, and Safety (EHS) Research Strategy. 88 Fed. Reg. 20194. OSTP is soliciting public input from a wide variety of stakeholders, including individuals, industry, academia, research laboratories, nonprofits, and think tanks. OSTP states that it is interested in public input...

On March 30, 2023, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program (NCP) held the second of a two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). Under the Toxic Substances Control Act (TSCA), EPA reviews new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to...

The U.S. Environmental Protection Agency (EPA) announced on March 23, 2023, that it is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting the Science Advisory Committee on Chemicals (SACC) with the peer review of the “2023 Draft Supplement to the 1,4-Dioxane Risk Evaluation.” 88 Fed. Reg. 17566. EPA states that it will release the draft supplement for public review and comment in June 2023. EPA also plans to...

The U.S. Environmental Protection Agency (EPA) has posted the justification for its fiscal year (FY) 2024 appropriation estimates for the Committee on Appropriations (Congressional Justification (CJ)). According to the CJ, EPA’s FY 2024 budget includes $470.7 million and 1,677 full-time equivalents (FTE) for Objective 7.1, “Ensure Chemical and Pesticide Safety.” The CJ includes the following target dates for actions under the Toxic Substances Control Act...