All Knowledge & Insights By Date

The U.S. Food and Drug Administration (FDA) announced on June 18, 2025, the release of its proposed method for ranking chemicals in the food supply. According to the document, the systematic post-market assessment of food chemicals consists of the following steps: signal detection, triage, prioritization, scoping, scientific assessment (safety, risk, and/or hazard), risk management review, and risk management action. FDA states that it will publish a full description of the process later in 2025...

The U.S. Environmental Protection Agency (EPA) is accepting comment on the next round of chemicals that it may prioritize for risk evaluation under the Toxic Substances Control Act (TSCA). EPA announced the list of 27 chemicals during webinars on September 30 and October 1, 2024. According to the slides from the webinar, the candidate chemicals are: 1-Hexadecanol2-Ethylhexyl 2,3,4,5-tetrabromobenzoate (TBB)4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)-phenol)Benzenebis(2-Ethylhexyl) -...

The U.S. Environmental Protection Agency (EPA) will hold two virtual public meetings, on September 30 and October 1, 2024, to provide information regarding existing chemical pre-prioritization and prioritization activities under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 68894. EPA states in its August 28, 2024, notice that “[t]he purpose of prioritization is to designate a chemical substance as being either high priority for immediate further risk evaluation, or low priority, for...

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 (DSL) to...

On January 31, 2024, the U.S. Environmental Protection Agency (EPA) announced that it will hold a webinar on February 20, 2024, at 1:00 - 4:00 p.m. (EST) on the five chemicals currently undergoing prioritization under the Toxic Substances Control Act (TSCA). EPA states that the webinar is open to all, “but EPA is particularly interested in learning more about how these chemicals are used and how people could potentially be exposed at different points in a chemical’s lifecycle. EPA is also...

On December 17, 2021, Canada published the Chemicals Management Plan implementation table for 2021-2024. Under the Canadian Environmental Protection Act, 1999 (CEPA), Canada plans to take the following actions regarding nanomaterials on the Domestic Substances List (DSL): prioritization of substances in commerce according to responses to the CEPA Section 71 Survey and screening assessment of high-priority nanomaterials on the DSL. The deliverables include: Publish a draft Framework for...

On December 10, 2021, the Biden Administration released its Fall 2021 Unified Agenda of Regulatory and Deregulatory Actions. According to the U.S. Environmental Protection Agency’s (EPA) rule list, the Office of Chemical Safety and Pollution Prevention (OCSPP) is working on the following rulemakings under the Toxic Substances Control Act (TSCA). Rulemakings at the proposed stage include: Tiered Data Reporting to Inform Prioritization, Risk Evaluation, and Risk Management Under TSCA...

The U.S. Environmental Protection Agency (EPA) met with the Environmental Defense Fund (EDF) on August 5, 2021, to clarify concepts from the July 27, 2021, tiered data reporting (TDR) webinar. EPA’s meeting summary states that EDF representatives requested clarification on the following issues discussed during the webinar: Whether EPA intends to scale back the Chemical Data Reporting (CDR) requirements with respect to the amount of information collected per chemical or to the number...

According to a memorandum posted in Docket ID EPA-HQ-OPPT-2021-0436, the U.S. Environmental Protection Agency (EPA) will not extend the comment period stemming from the July 27, 2021, public webinar on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. As reported in our July 29,...

On November 14, 2019, the U.S. Court of Appeals for the Ninth Circuit issued its decision in a case challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  Petitioners argued that provisions in the risk evaluation rule relating to EPA’s evaluation of the risks from a substance’s “conditions of use” violate several of the Toxic Substances Control Act’s (TSCA) requirements. ...

On June 28, 2019, the U.S. Environmental Protection Agency (EPA) filed its response to the non-governmental organizations’ (NGO) supplemental brief in a case challenging EPA’s prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  According to EPA, petitioners “have plausibly alleged standing to challenge only the definitional interpretation of ‘conditions of use’ and the two provisions still subject to EPA’s motion for voluntary...

On May 16, 2019, the U.S. Court of Appeals for the Ninth Circuit heard oral arguments in a case filed by non-governmental organizations (NGO) challenging the U.S. Environmental Protection Agency’s (EPA) prioritization and risk evaluation rules.  Safer Chemicals, Healthy Families v. EPA, No. 17-72260.  During oral arguments, the court asked the Natural Resources Defense Council (NRDC) whether it had standing to be before the court.  NRDC responded that it does, arguing that EPA’s rules...

On March 20, 2019, the U.S. Environmental Protection Agency (EPA) announced it was releasing a list of 40 chemicals to begin the prioritization process required by the amended Toxic Substances Control Act (TSCA).  New TSCA requires EPA to designate 20 chemicals as “high-priority” for subsequent risk evaluation and 20 chemicals as “low-priority,” meaning that risk evaluation is not warranted at this time.  The 20 high priority candidate chemicals include: Seven...

On October 5, 2018, the U.S. Environmental Protection Agency (EPA) issued the general approaches that the Office of Pollution Prevention and Toxics (OPPT) may use to identify potential candidate chemicals for prioritization under TSCA.  83 Fed. Reg. 50366.  EPA notes that it will seek public comment on the approach document and on which chemicals should be identified as potential candidates for the initial 20 high-priority and 20 low-priority chemicals that must be identified...

On September 28, 2018, the U.S. Environmental Protection Agency (EPA) announced it was releasing the approach it will use to identify chemicals that could be included in the next group of risk evaluations under the Toxic Substances Control Act (TSCA) titled “A Working Approach for Identifying Potential Candidate Chemicals for Prioritization” (Working Approach).  EPA states that the information set forth in this document is “intended to describe the general approaches EPA may...

On January 5, 2018, the Natural Resources Defense Council (NRDC) filed a Petition for Review in the U.S. Court of Appeals for the Second Circuit (Second Circuit) of what is characterized as a U.S. Environmental Protection Agency (EPA) “final rule” issued November 7, 2017, entitled “New Chemicals Decision-Making Framework:  Working Approach to Making Determinations under Section 5 of TSCA.”  The Framework Document, as it has come to be called, is the “final rule” at issue...

On December 11, 2017, the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) convened its public meeting on possible approaches for identifying potential candidates for prioritization under the amended Toxic Substances Control Act (TSCA).  Key presenters were Jeffery Morris, Ph.D., Directory of OPPT, as well as several other OPPT staff, Health Canada (HC) and Environmental and Climate Change Canada (ECCC), and Russell S. Thomas with EPA’s...

On December 11, 2017, in the U.S. Court of Appeals for the Fourth Circuit (Fourth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Chemical Risk Evaluation under TSCA (Alliance of Nurses for Healthy Environments v. EPA, Case Nos. 17-1926, 17-2040, and 17-2244 (consolidated)), the Fourth Circuit granted the petitioners’ motions to transfer to the Ninth Circuit.  This was not entirely unexpected, as the U.S. Court of Appeals for...

On November 27, 2017, in the U.S. Court of Appeals for the Ninth Circuit (Ninth Circuit) case on the petition for review of the Toxic Substances Control Act (TSCA) framework rule Procedures for Prioritization of Chemicals for Risk Evaluation (Safer Chemicals, Healthy Families v. EPA, Case Nos. 17-72260, 17-72501, and 17-72968 (consolidated)), the Ninth Circuit issued an order on several pending motions.  It granted the American Chemistry Council’s (ACC) (and other industry groups) motion...

On November 14, 2017, the U.S. Environmental Protection Agency (EPA) released the agenda and meeting materials for its December 11, 2017, Approaches for Identifying Potential Candidates for Prioritization for Existing Chemical Risk Evaluations under the Toxic Substances Control Act (TSCA) meeting.  EPA states that during this meeting, it will describe goals, guiding principles, and possible approaches for identifying potential candidate chemicals for prioritization; and take comment on...