Category: Risk Assessment Issues

July 25, 2025

EPA’s Office of Research and Development — Villain or Victim?

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...
June 12, 2025

Chemical and Material Risk Management Program TSCA Market Analysis — A Conversation with Patricia Underwood, Ph.D., DABT, MBA and Richard E. Engler, Ph.D.

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...
June 5, 2025

President Signs EO to Restore Gold Standard for Science, Calls for Reevaluation of Biden Administration’s Scientific Integrity Policies

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...
March 14, 2025

EPA Will Review 2024 Rule Amending the TSCA Risk Evaluation Framework Rule

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...
February 7, 2025

Lynn L. Bergeson, Kelly N. Garson, and Lara A. Hall, “Testing, Testing,” Environmental Forum, March/April 2025.

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...
January 28, 2025

EPA Releases Draft Scope Document for Vinyl Chloride TSCA Risk Evaluation

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 23, 2025

Register Now for “What’s New with New Approach Methodologies: A Webinar Featuring EPA CCTE’s Katie Paul Friedman, Ph.D., and PETA Toxicology Specialist Adam Bettmann, MS, DABT®”

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...
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...
January 6, 2025

2025 Forecast for U.S. Federal and International Chemical Regulatory Policy

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...
September 26, 2024

EPA Releases Draft Risk Evaluation for DINP for Public Comment

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...
August 14, 2024

Ensuring Data Quality and Compliance to Support Global Antimicrobial Registrations, September 25, 2024, 12:00 p.m. – 1:00 p.m. (EDT), via webinar

Lara A. Hall, Senior Regulatory Scientist/Quality Assurance Specialist, B&C, and Michelle C. Mims, Regulatory Scientist/Quality Assurance Specialist, B&C, are pleased to present "Ensuring Data Quality and Compliance to Support Global Antimicrobial Registrations" during the Household & Commercial Products Association's (HCPA) Antimicrobial Regulatory Frameworks Across the Globe Webinar Series. This session will explore the overarching quality and compliance requirements of data...
August 14, 2024

Registration Opens for August 28, 2024, Webinar on Use of NAMs

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...
August 1, 2024

Sponsor’s Role in Regulatory Testing — A Conversation with Lara Hall

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...
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...
June 5, 2024

NIOSH Science Blog Item Reviews NIOSH Risk Assessment of Engineered Nanomaterials

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...
August 2, 2023

EPA Extends Comment Period on Proposed Updates to TSCA New Chemicals Regulations; Comments Due August

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”...
July 3, 2023

EPA Proposes SNURs for Flame Retardants in Support of Risk Evaluations

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...
June 28, 2023

Registration Now Open for “Preparing a PFAS Game Plan in the U.S., the UK, and the EU” Webinar

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,...