TSCAblog®

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....

The July 13, 2024, Canada Gazette will include a notice announcing the availability of the Updated Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Updated Draft Report) and Revised Risk Management Scope for Per- and Polyfluoroalkyl Substances (PFAS) (Revised Risk Management Scope). The Updated Draft Report defines PFAS as “fluorinated substances that contain at least one fully fluorinated methyl or methylene carbon atom (without any [hydrogen, chlorine, bromine, or iodine...

As part of its efforts to strengthen public engagement in the federal regulatory process, the Office of Information and Regulatory Affairs (OIRA) in the Office of Management and Budget (OMB) announced on July 10, 2024, that it will offer training sessions on effective public participation in the public comment process. 89 Fed. Reg. 56777. OIRA states that notice-and-comment rulemaking generally affords any interested individual or organization the opportunity to provide written input on the...

On July 5, 2024, the U.S. Court of Appeals for the District of Columbia Circuit issued its decision in Vinyl Institute, Inc. v. EPA (No. 22-1089). As reported in our May 31, 2022, blog item, on May 23, 2022, the Vinyl Institute, Inc. (VI) filed suit against the U.S. Environmental Protection Agency (EPA), seeking review of EPA’s March 2022 test order for 1,1,2-trichloroethane (1,1,2-TCA) issued under Section 4(a)(2) of the Toxic Substances Control Act (TSCA)....

The House Committee on Oversight and Accountability will hold a full committee hearing on July 10, 2024, on “Oversight of the U.S. Environmental Protection Agency.” According to the Committee’s July 3, 2024, press release, “[t]he hearing will conduct oversight and gather information from U.S. Environmental Protection Agency (EPA) Administrator Michael Regan on the Biden Administration’s push of excessive environmental regulations and abuse of environmental protection authorities.”...

The U.S. Department of Homeland Security’s (DHS) Cybersecurity and Infrastructure Security Agency (CISA) is hosting the fully virtual 2024 Chemical Security Seminars on July 11 and 18, 2024, from 10:00 a.m. – 3:00 p.m. (EDT). The sessions will cover a range of topics related to the security of dangerous chemicals. The preliminary agenda includes: The seminars are free to attend and open to the public....

As reported in our July 27, 2023, memorandum, in July 2023, the U.S. Environmental Protection Agency (EPA) proposed an expansion of the Safer Choice and Design for the Environment (DfE) programs to include certification of additional product categories. According to EPA’s website, “EPA thanks the many commenters for their input. EPA reviewed the comments and understands several categories are of interest to stakeholders and Safer Choice partners. With the 2024 decrease in EPA’s funding,...

The Minnesota Department of Health (MDH) recently noted that Health Risk Assessment scientists at MDH have published two articles in the Journal of Environmental Exposure Assessment related to per- and polyfluoroalkyl substances (PFAS): MDH notes that the work was supported by the Clean Water Fund, funded by the 2008 Clean Water, Land and Legacy Amendment....

Bergeson & Campbell, P.C.’s (B&C®) June 18, 2024, webinar, “There Is More to TSCA Reporting Than CDR: TSCA Sections 8(a), (c), (d), and (e),” is now available for on-demand viewing. During this one-hour webinar Dave Turk, Supervisor for the Toxics Release Inventory (TRI) Regulatory and Policy Branch, U.S. Environmental Protection Agency (EPA) Office of Pollution Prevention and Toxics (OPPT); Stephanie Griffin, Acting Supervisor of the Data Collection Branch, EPA...

During the June 26, 2024, “TSCA Reform — Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute, (ELI), and the George Washington University Milken Institute School of Public Health, Michal Ilana Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention, U.S. Environmental Protection Agency (EPA) provided the keynote address. During her remarks, Freedhoff announced four new initiatives...

The Minnesota Pollution Control Agency (MPCA) will hold two public webinars in July 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: As reported in our January 12, 2024, blog item, MPCA published a request for comments (RFC) on planned new rules governing CUU determinations for products containing PFAS. According to the RFC, the main purpose of...

The U.S. Environmental Protection Agency (EPA) announced on June 13, 2024, the change in the peer review mechanism from the letter peer review to a Science Advisory Committee on Chemicals (SACC) peer review; the addition of the draft human health hazard assessment for 1,2-dichloroethane for peer review; and the availability of and solicitation of comment on the list of candidates under consideration for selection as ad hoc peer reviewers that will assist SACC with its...

TSCA Reform — Eight Years LaterJune 26, 2024, 8:00 a.m. – 4:30 p.m. (EDT) In person at George Washington University Milken Institute School of Public Health, Washington, D.C.,and virtually via livestream Register now to attend in person or virtually the complimentary “TSCA Reform — Eight Years Later” conference, presented by Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of...

On June 10, 2024, the U.S. Court of Appeals for the Fourth Circuit affirmed the U.S. District Court for the Eastern District of North Carolina’s decision to dismiss a case challenging the U.S. Environmental Protection Agency’s (EPA) response to a petition seeking a test order for 54 per- and polyfluoroalkyl substances (PFAS) for lack of jurisdiction. CEH v. EPA, No. 23-1476. The district court granted EPA’s motion to dismiss, finding that EPA granted the petition...

Register now to join Dave Turk, Supervisor for the Toxics Release Inventory (TRI) Regulatory and Policy Branch, EPA Office of Pollution Prevention and Toxics (OPPT); Stephanie Griffin, Acting Supervisor of the Data Collection Branch, EPA OPPT; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Lynn L. Bergeson, Managing Partner, B&C, for “There Is More to TSCA Reporting Than CDR: TSCA Sections 8(a), (c), (d), and (e).” The U.S. Environmental Protection Agency (EPA) has...

Cherokee Concerned Citizens watchers will be interested to know that on June 6, 2024, the U.S. Environmental Protection Agency (EPA) filed an unopposed motion in the U.S. Court of Appeals for the District of Columbia Circuit to extend the deadlines in Cherokee Concerned Citizens v. EPA, (No. 23-1096). As reported in our April 17, 2023, blog item, Cherokee Concerned Citizens filed suit in April 2023 seeking review of an Order for a New Chemical Substance...

On May 28, 2024, the U.S. Government Accountability Office (GAO) publicly released a report entitled Priority Open Recommendations: Environmental Protection Agency. According to the report, since GAO’s May 2023 letter, the U.S. Environmental Protection Agency (EPA) implemented four of GAO’s 15 open priority recommendations, including three recommendations related to assessing and controlling toxic chemicals: GAO’s report states that in April 2023, it issued its biennial update to its...

Please note that the date of this webinar has moved forward one day, from Wednesday, June 12, 2024, to Thursday, June 13, 2024, 11:00 a.m. – 12:00 p.m. (EDT). Register now to join Bergeson & Campbell, P.C. (B&C®) and The Acta Group (Acta®) for “Sponsor’s Role in Regulatory Testing — Complying with GLP Standards,” a complimentary webinar covering the roles and responsibilities of Study Sponsors, as defined by Good Laboratory Practices (GLP) regulations and related advisory...

The Internal Revenue Service (IRS) published a notice of determination on May 31, 2024, that the list of taxable substances is modified to include polyoxymethylene. 89 Fed. Reg. 47238. As reported in our December 29, 2022, blog item, the IRS announced in December 2022 that it received a petition requesting the addition of polyoxymethylene to the list of taxable substances under Section 4672(a) of the Internal Revenue Code. Celanese Ltd., an exporter of polyoxymethylene, submitted...

The U.S. Environmental Protection Agency (EPA) announced on May 23, 2024, that it has updated the Toxic Substances Control Act (TSCA) Inventory. EPA states that this biannual update to the public TSCA Inventory is part of its regular posting of non-confidential TSCA Inventory data. EPA notes that this update coincides with the 2024 Chemical Data Reporting (CDR) cycle submission period beginning June 1, 2024. According to EPA, “[m]anufacturers (including importers) should refer to the latest...

On April 16, 2024, Governor Janet Mills (D) signed LD 1537, amending An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution. On May 20, 2024, the Maine Department of Environmental Protection (MDEP) updated its “PFAS in Products” web page to reflect the amendments, which include eliminating the general notification requirement that was scheduled to take effect January 1, 2025. The legislation also creates new sales prohibitions for products with intentionally added per- and...

On May 20, 2024, the Public Employees for Environmental Responsibility (PEER) announced that on May 17, 2024, they filed a notice of intent to sue (NOI) the U.S. Environmental Protection Agency (EPA) “to stop the manufacture and distribution of hundreds of millions of plastic containers with dangerous levels of a carcinogenic per-and polyfluoroalkyl substance (PFAS) called perfluorooctanoic acid (PFOA).” Filed with the Center for Environmental Health (CEH), the NOI states that EPA “has...

The U.S. Environmental Protection Agency (EPA) published a final rule on May 17, 2024, to update the list of chemicals subject to Toxics Release Inventory (TRI) reporting to include seven additional per- and polyfluoroalkyl substances (PFAS) for Reporting Year 2024(reporting forms due by July 1, 2025). 89 Fed. Reg. 43331. The Fiscal Year (FY) 2020 National Defense Authorization Act (NDAA) includes a provision that automatically adds PFAS to the TRI list upon EPA’s adoption of...

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 will begin June 1, 2024, and end September 30, 2024. On May 16, 2024, EPA announced the creation of CDR GuideME, a new resource portal, and improvements to the reporting tool to make the reporting process easier. Data that must be reported include information concerning the manufacturing, processing,...

Chemical Watch’s “TSCA Fundamentals” course, taught by Richard E. Engler, Ph.D., Director of Chemistry, Bergeson & Campbell, P.C. (B&C®), will provide in-depth training on the very latest Toxic Substances Control Act (TSCA) regulatory and policy developments, their impact, and how to anticipate their requirements, comply with the law, and remain commercially competitive. Chemical Watch will offer a 15% discount for B&C clients and friends. To redeem this discount, please...

The House Energy and Commerce Subcommittee on the Environment, Manufacturing, and Critical Materials held a hearing on May 7, 2024, on “EPA’s RMP Rule: Failures to Protect the American People and American Manufacturing.” The May 3, 2024, hearing memorandum states that the U.S. Environmental Protection Agency’s (EPA) March 11, 2024, final rule amending the Risk Management Program (RMP) “include[s] several changes to the accident prevention program requirements for natural hazards, power...

On April 18, 2024, Representative Betty McCollum (D-MN) announced that she and Senator Dick Durbin (D-IL) introduced the Forever Chemical Regulation and Accountability Act (H.R. 8074, S. 4187), “bicameral legislation to address the excessive use of per- and polyfluoroalkyl substances (PFAS) across the nation’s supply chain, which has led to the harmful compounds contaminating water sources, as well as surrounding environments and communities.” According to McCollum’s press release, the...