TSCAblog®

Register now to join Bergeson & Campbell, P.C. (B&C®) for “What to Expect When You Don’t Know What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2025,” a complimentary webinar offering our best-informed judgment as to the trends and key developments chemical industry stakeholders can expect in 2025. The return of President-elect Trump for a second term instantly raises important questions: will the Senate defer some of its traditional roles as a...

On December 11, 2024, the U.S. District Court for the District of Columbia dismissed a suit filed against the U.S. Environmental Protection Agency (EPA) seeking a rule under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the production of perfluorooctanoic acid (PFOA) during Inhance Technologies, LLC’s (Inhance) fluorination process. Public Employees for Environmental Responsibility (PEER) v. Regan (No. 2024-2194). As reported in our July 30, 2024, blog item, PEER and the...

Mark Hartman, the highly respected Deputy Director for Programs in the U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT), will become Director of the U.S. Food and Drug Administration’s (FDA) Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI) in its newly formed Human Foods Program (HFP). According to FDA’s website, OFCSDSI “uses a risk-based approach to food chemical safety and dietary supplement policy and...

On November 29, 2024, the U.S. Environment Protection Agency (EPA) issued a supplemental notice of proposed rulemaking (SNPRM) that would update the December 2, 2022, proposed significant new use rules (SNUR) for 17 per- and polyfluoroalkyl substances (PFAS) that were the subject of premanufacture notices (PMN) and are also subject to an Order issued by EPA pursuant to the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 94642. The SNURs would require persons who intend...

On November 22, 2024, the U.S. District Court for the District of Columbia entered two consent decrees establishing deadlines for completing risk evaluations for 20 High-Priority Chemicals and two manufacturer-requested risk evaluations (MRRE). The Community In-Power and Development Association Inc. (CIDA), v. EPA, Case No. 1:23-cv-02715. As reported in our May 10, 2024, memorandum, CIDA, the Learning Disabilities Association of America, Louisiana Environmental Action Network, Sierra Club, and...

On November 29, 2024, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances: More information on the Superfund excise tax on chemicals is available in our April 4, 2023, memorandum, “IRS Proposes Regulations Regarding Superfund Tax on Chemicals,” our July 13, 2022, memorandum, “Superfund Tax on Chemicals: What You Need to Know to Comply,” and our May 19, 2022, memorandum, “Reinstated Superfund...

The Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight of the U.S. Senate Committee on Environment and Public Works will hold a hearing on December 5, 2024, titled “Examining the Public Health Impacts of PFAS Exposures.” The Subcommittee will hear from the following witnesses: As reported in our October 9, 2024, blog item, this hearing, which was originally scheduled for September 26, 2024, was postponed September 25, 2024, when Congress...

The U.S. Environmental Protection Agency (EPA) announced on November 20, 2024, the launch of the Tackling Emerging Contaminants (TEC) initiative, a new, no-cost technical assistance effort focused on reducing exposure to perfluoroalkyl and polyfluoroalkyl substances (PFAS) and other emerging contaminants in small or disadvantaged communities. According to EPA, the objective of the TEC Water Technical Assistance (WaterTA) is to support small or disadvantaged communities assess and address...

On November 20, 2024, the U.S. Environmental Protection Agency (EPA) announced an extension to the comment period for the notice published September 30, 2024, seeking public comment on the manufacture of certain per- and polyfluoroalkyl substances (PFAS), including perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA), during the fluorination of high-density polyethylene (HDPE) and other plastic containers to inform regulations as appropriate under the...

On November 14, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its third annual progress report, “highlighting the significant achievements the agency has made under its PFAS Strategic Roadmap and the Biden-Harris Administration’s whole-of-government strategy to protect communities from the impacts of forever chemicals.” According to EPA’s press release, progress on per- and polyfluoroalkyl substances (PFAS) during the Biden-Harris Administration includes:...

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program has announced two upcoming webinars in the DyNAMic Discussions series. This webinar series invites speakers to share candid perspectives on how they have overcome barriers to apply NAMs in their fields and discuss how these examples can be used to promote the use of NAMs in other situations. All DyNAMic Discussion webinars have been recorded. Materials,...

The U.S. Department of Agriculture’s Agricultural Research Service (ARS) announced on October 16, 2024, several key outcomes from a workshop held to develop a research roadmap leading to short- and long-term science-based solutions to meet the challenges posed by the discovery of per-and polyfluoroalkyl substances (PFAS) in agricultural soils and waters. ARS, its Center of Excellence for Environmental Monitoring and Mitigation, and the University of Maine collaborated during the workshop to...

On September 27, 2024,  the U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) extended its May 2, 2023, Enforcement Statement regarding the Toxic Substances Control Act (TSCA) Section 6(h) Rule prohibiting the processing and distribution in commerce of decabromodiphenyl ether (decaBDE)-containing wire and cable insulation for use in nuclear power generation facilities after January 6, 2023. According to the memorandum, “EPA does not intend to...

The list of pending issues that Congress could consider during the lame duck session in 2024 continues to grow. The list includes “must pass” items, including appropriations to fund the government through the remainder of Fiscal Year (FY) 2025 and the National Defense Authorization Act (NDAA). This blog focuses on issues not getting the congressional attention they deserve. Members of Congress returned to Washington, D.C., from summer recess for a three-week work period in September....

As reported in our September 24, 2024, blog item, the Senate Committee on Environment and Public Works (EPW) was scheduled to hold a hearing on September 26 titled “Examining the Public Health Impacts of [Per- and Polyfluoroalkyl Substances (PFAS)] Exposures.” The hearing was postponed on September 25, 2024, when the Senate adjourned until November after enactment of H.R. 9747, the Continuing Appropriations and Extensions Act, 2025, also known as the Continuing Resolution (CR) to fund...

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-Hexadecanol 2-Ethylhexyl 2,3,4,5-tetrabromobenzoate (TBB) 4-tert-Octylphenol (4-(1,1,3,3-Tetramethylbutyl)-phenol) Benzene bis(2-Ethylhexyl)...

The Minnesota Pollution Control Agency (MPCA) held two public webinars in July 2024 to provide updates and answer questions on Minnesota’s per- and polyfluoroalkyl substances (PFAS) in products law (Amara’s Law), which takes effect in stages between 2025 and 2032. MPCA has posted its presentations, recordings of the webinars, and written responses to questions received during the webinars. The questions and answers (Q&A) note that the written responses “are advisory as of September 12,...

The U.S. Environmental Protection Agency (EPA) announced on September 30, 2024, that it is updating the Safer Chemical Ingredients List (SCIL) “to enhance transparency in safer chemistry, help consumers and organizations find safer chemical alternatives, and increase innovation and growth of safer products.” According to EPA, with this update, there are 957 chemicals on the SCIL. The updates include: EPA recharacterized methyl ethyl ketone (CAS RN 78-93-3) as a specialized industrial...

After the U.S. Environmental Protection Agency (EPA) denied a 2016 petition filed under Section 21 of the Toxic Substances Control Act (TSCA) requesting that EPA consider whether fluoride in drinking water presents an unreasonable risk of injury to human health, a coalition of non-governmental organizations (NGO) promptly filed suit in the U.S. District Court for the Northern District of California. Food & Water Watch v. EPA (No. 3:17-cv-02162-EMC). After a bench trial in 2020, the...

On September 22, 2024, the State of California Department of Justice announced that it filed a lawsuit in the San Francisco County Superior Court against ExxonMobil “for allegedly engaging in a decades-long campaign of deception that caused and exacerbated the global plastics pollution crisis.” California “seeks to compel ExxonMobil, which promotes and produces the largest amount of polymers — essentially the building blocks used to make single-use plastic — that become plastic...

On September 20, 2024, the U.S. Environmental Protection Agency (EPA) filed a motion in the U.S. Court of Appeals for the District of Columbia Circuit for a voluntary remand of the case brought by Cherokee Concerned Citizens or review of an Order for a New Chemical Substance under Section 5 of the Toxic Substances Control Act (TSCA). Cherokee Concerned Citizens v. EPA (No. 23-1096). EPA states that it wishes to withdraw the Order and reconsider...

The Senate Committee on Environment and Public Works will hold a hearing on September 26, 2024, on “Examining the Public Health Impacts of [Per- and Polyfluoroalkyl Substances (PFAS)] Exposures.” The Committee will hear from the following witnesses:...

On September 20, 2024, the U.S. Environmental Protection Agency (EPA) announced that it is extending the submission deadline for 2024 Chemical Data Reporting (CDR) reports from September 30, 2024, to November 22, 2024. The CDR regulations require manufacturers (including importers) of chemicals listed on the Toxic Substances Control Act (TSCA) Inventory to report data on the manufacturing, processing, and use of those chemicals every four years. For the 2024 data submission period, this applies...

Congress has not passed legislation to fund the federal government for fiscal year 2025 (FY 2025) that begins October 1, 2024. The House of Representatives on September 18 tried — and failed — to pass legislation to fund the government into March 2025. The good news, however, is that Congress is expected to fund the federal government before the current funding expires at midnight, September 30. Congress will return to Washington, D.C., after the election...

The U.S. Environmental Protection Agency (EPA) announced on September 18, 2024, the launch of an Outdoor Use Safer Choice label. According to EPA, this new label expands on its existing Safer Choice label and will identify outdoor use products — such as pet care products, fire defense products, and car, boat, or grill cleaners — that meet additional EPA criteria to help protect the environment. EPA states that it examines every ingredient, no matter its...

The U.S. Environmental Protection Agency (EPA) called for nominations on September 18, 2024, of scientific and technical experts that EPA can consider for service as ad hoc peer reviewers to assist the Science Advisory Committee on Chemicals (SACC) with the peer review of the draft risk evaluation for 1,3-butadiene conducted under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 76467. EPA states that it will submit the draft risk evaluation of 1,3-butadiene and associated...

On September 12, 2024, the Organisation for Economic Co-operation and Development (OECD) published a report entitled Synthesis report on understanding Perfluoropolyethers (PFPEs) and their life cycle. OECD states that the report presents a synthesis of publicly available information on PFPEs with the aim of elucidating the identities of PFPEs on the global market and analyzing their life cycle. OECD notes that this includes their production and use, presence of other per- and polyfluoroalkyl...

The Chemical Data Reporting (CDR) rule requires manufacturers (including importers) to report data to the U.S. Environmental Protection Agency (EPA) every four years. The 2024 submission period began June 1, 2024, and will end September 30, 2024. The CDR rule requires all companies to report data electronically using e-CDRweb through EPA’s Central Data Exchange (CDX) system. CDR reporting in CDX is currently malfunctioning, however. EPA has issued two alerts:...

In August 2024, the U.S. Chamber of Commerce released a report entitled Essential Chemistries: Providing Benefits Across the U.S. Economy that “examines the dependence of seven critical U.S. sectors, including aerospace manufacturing, data centers, defense equipment and systems, energy transition, health care, mobility, and semiconductors on essential fluorochemistries,” including per- and polyfluoroalkyl substances (PFAS). Third-party experts in environmental and economic policy engaged by...

On September 3, 2024, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances: Comments and requests for a public hearing are due November 4, 2024. More information on the Superfund excise tax on chemicals is available in our April 4, 2023, memorandum, “IRS Proposes Regulations Regarding Superfund Tax on Chemicals,” our July 13, 2022, memorandum, “Superfund Tax on Chemicals: What You Need...

The U.S. Securities and Exchange Commission (SEC) announced on September 10, 2024, that it charged Keurig Dr Pepper Inc. (Keurig®) with making inaccurate statements regarding the recyclability of its K-Cup® single-use beverage pods. To settle SEC’s charges, Keurig agreed to pay a $1.5 million civil penalty. SEC’s order states: Beginning in or around 2016, Keurig performed tests of its pods at various recycling facilities, in which Keurig tracked the progress of pods throughout the...

On September 10, 2024, the House Energy and Commerce Subcommittee on Health will hold a legislative hearing on “Evaluating FDA Human Foods and Tobacco Programs.” According to the Committee’s September 3, 2024, hearing announcement, the hearing will give members a chance to hear from the head of the Human Foods Program, as well as the head of the Tobacco Center, to learn how the U.S. Food and Drug Administration (FDA) is “helping adult smokers quit,...

The U.S. Environmental Protection Agency is scheduled to publish a direct final rule on September 5, 2024, that will amend the Toxic Substances Control Act (TSCA) regulation with reporting and recordkeeping requirements for perfluoroalkyl and polyfluoroalkyl substances (PFAS) to make a “one-time modification” to change the data submission period from November 12, 2024, through May 8, 2025, to July 11, 2025, through January 11, 2026. For any reporter who is reporting exclusively as an article...

The U.S. Environmental Protection Agency (EPA) will hold a webinar on September 19, 2024, on “A Safer Choice for Cleaning: Increasing Access to Products with Safer Ingredients.” Jennie Romer, EPA Deputy Assistant Administrator for Pollution Prevention, will host a webinar on how EPA’s Safer Choice program helps people find and have access to cleaning and other products made with safer ingredients and how the program works in partnership with a broad range of stakeholders to...

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 reported in our July 29, 2024, blog item, on July 27, 2024, Canada’s Minister of the Environment published a Canada Gazette notice announcing a mandatory survey to obtain information on the manufacture, import, and use of 312 specific per- and polyfluoroalkyl substances (PFAS). On September 11, 2024, at 1:30 p.m. (EDT), Environment and Climate Change Canada (ECCC) will hold an information session in English on the survey. The session will be non-interactive and will...

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a series of webinars on human-based methods in U.S. Food and Drug Administration (FDA) submissions. PCRM notes that traditionally, submissions have included data from animal studies, but industry has started submitting NAMs. According to PCRM, the use of NAMs in FDA submissions is expected to grow, as many toxicologists seek to use human-based...

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)....

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...

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...

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...

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...

Bergeson & Campbell, P.C. (B&C®) is pleased to present the on-demand recording for “Determining PFAS Content in Your Supply Chain and Expanding Data Collection Practice,” a complimentary webinar covering the basics of the U.S. Environmental Protection Agency’s (EPA) reporting rule for per- and polyfluoroalkyl substances (PFAS). With Chemical Data Reporting (CDR) wrapping up this fall, companies still have time to gather the necessary information regarding PFAS to begin reporting...

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. FDA states that this includes ingredients considered generally recognized as safe (GRAS), food additives, color additives, food contact substances, and contaminants. According to FDA, this is intended to guide its post-market assessment work going forward and...

The U.S. Consumer Product Safety Commission (CPSC) announced on July 30, 2024, that it issued a Decision and Order against Amazon.com, Inc. (Amazon). CPSC states that, in a unanimous vote, it “determined that Amazon was a ‘distributor’ of products that are defective or fail to meet federal consumer product safety standards, and therefore bears legal responsibility for their recall.” According to CPSC, more than 400,000 products are subject to the Order, specifically faulty carbon...

On July 25, 2024, the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed suit against the U.S. Environmental Protection Agency (EPA) in the U.S. District Court for the District of Columbia seeking a rule under Section 6 of the Toxic Substances Control Act (TSCA) to prohibit the production of perfluorooctanoic acid (PFOA) during Inhance Technologies, LLC’s (Inhance) fluorination process. As reported in our May 23, 2024, blog item on their...

On July 27, 2024, Canada’s Minister of the Environment published a Canada Gazette notice announcing a mandatory survey to obtain information on the manufacture, import, and use of 312 specific per- and polyfluoroalkyl substances (PFAS). Canada’s “Guidance manual for responding to the: Notice with respect to certain per- and polyfluoroalkyl substances (PFAS)” (Guidance Manual) states that the purpose of the notice is to collect information on certain PFAS substances, either alone, in...

The Senate Committee on Environment and Public Works will hold a hearing on July 31, 2024, on “Understanding the Potential Environmental Impacts of the Chemical 6PPD.” The scheduled witnesses include: As reported in our November 3, 2023, blog item, on November 2, 2023, the U.S. Environmental Protection Agency (EPA) granted a petition filed under Section 21 of the Toxic Substances Control Act (TSCA) to address the use of N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) in tires....

The standard of judicial review for most critical TSCA determinations under section 19 is “substantial evidence in the record taken as a whole”. This is a tough standard, considerably more rigorous than the Administrative Procedure Act (APA) standard under section 706, where agency action will be set aside if it is “arbitrary, capricious, an abuse of discretion, or otherwise not in accordance with law.” The recent Loper...

Register now to join Bergeson & Campbell, P.C. (B&C®) for “Determining PFAS Content in Your Supply Chain and Expanding Data Collection Practice,” a complimentary webinar covering the basics of the U.S. Environmental Protection Agency’s (EPA) reporting rule for per- and polyfluoroalkyl substances (PFAS). With Chemical Data Reporting (CDR) wrapping up this fall, companies still have time to gather the necessary information regarding PFAS to begin reporting as early as this November....