TSCAblog®

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 not be recorded....

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). The Discussion Paper “broadly...

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 (DSL) to...

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 petition....

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: Katrina Lassiter, Program Manager, Hazardous Waste and Toxics Reduction Program, Washington State Department of Ecology (WDOE); Tracey Norberg, Executive Vice President and General Counsel, U.S. Tire Manufacturers Association (USTMA); and David B. Fischer, MPH, Counsel, Keller and Heckman LLP....

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 Bright decision overturning Chevron has invited much...

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 court states that “EPA’s...

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: State of Chemical Security (Kelly Murray, Associate Director, CISA Chemical Security); Transnational Threats Impacting Chemical Security (Robert...

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): “A revised and improved toxicokinetic model to simulate serum concentrations of bioaccumulative PFAS”: According to MDH, the publication “presents an updated method to determine how PFAS accumulates in human bodies from birth through childhood.” “Per-...

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 OPPT; Richard E....

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 in...

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: Progress on rule development, July 18, 2024, 10:00 a.m. - 11:30 a.m. (CDT): Join MPCA staff for a presentation on preliminary rule writing for the PFAS in products reporting, fees, and currently unavoidable use (CUU) rules....

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 peer review of EPA’s...

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 Public Health....

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 and that the court lacks...

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 been using...

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 under Section 5 of the Toxic Substances...

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: In May 2023, EPA’s chemical assessment program provided information to its program...

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 petition....

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 a final toxicity...

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, and...

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...

The U.S. Environmental Protection Agency (EPA) announced on May 8, 2024, that, in collaboration with the PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR), on Wednesday, May 29, 2024, it will hold a webinar on the use of new approach methodologies (NAM).  The webinar, “Advancing Eye Irritation Assessment with Non-Animal Methods for Industrial Chemicals and Agrochemicals: Progress at the US...

The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a webinar on May 23, 2024, on “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies: An ICCVAM Report.” National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) Director Dr. Nicole Kleinstreuer will present on the 2024 Interagency Coordinating Committee on...

The Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing on May 1, 2024, to review President Biden’s fiscal year (FY) 2025 budget request for the U.S. Environmental Protection Agency (EPA). The Subcommittee will hear from EPA Administrator Michael S. Regan. As reported in our March 15, 2024, Monthly Federal Developments Memorandum, according to EPA’s March 11, 2024, statement on President Biden’s FY 2025 budget, the $11 billion proposed for...

The U.S. Environmental Protection Agency (EPA) Office of Enforcement and Compliance Assurance (OECA) has posted an April 17, 2024, memorandum regarding “Strategic Civil-Criminal Enforcement Policy” from David M. Uhlmann, OECA Assistant Administrator. The Strategic Civil-Criminal Enforcement Policy sets forth requirements to ensure that EPA’s enforcement program maintains and strengthens the strategic partnership between civil and criminal enforcement. According to the Policy, to promote...

The House Appropriations Subcommittee on Interior, Environment, and Related Agencies will hold a hearing on April 30, 2024, on the fiscal year (FY) 2025 budget request for the U.S. Environmental Protection Agency (EPA). EPA Administrator Michael S. Regan will testify, and he will be accompanied by EPA Chief Financial Officer Faisal Amin. As reported in our March 15, 2024, Monthly Federal Developments Memorandum, according to EPA’s March 11, 2024, statement on President Biden’s FY 2025...

The U.S. Government Accountability Office (GAO) published a report on April 15, 2024, entitled “Persistent Chemicals: Navy Efforts to Address PFAS at Joint Base Pearl Harbor-Hickam.” GAO states that it was asked to examine the Department of Defense’s (DOD) efforts to address per- and polyfluoroalkyl substance (PFAS) contamination at Joint Base Pearl Harbor-Hickam. The report describes DOD’s response to a November 2022 aqueous film-forming foam (AFFF) release at the installation; DOD...

According to an April 16, 2024, request for information (RFI), as part of its ongoing commitment to advancing sustainable acquisition, the General Services Administration (GSA) is exploring opportunities to reduce or eliminate potential per- and polyfluoroalkyl substances (PFAS) “with the intent to reduce exposure from products offered to the Government through GSA’s contract solutions.” 89 Fed. Reg. 26887. GSA states that it is publishing the RFI to obtain comments “to help us...

The Public Employees for Environmental Responsibility (PEER) announced on April 11, 2024, that a coalition of public health groups filed a petition under Section 21 of the Toxic Substances Control Act (TSCA) seeking to stop immediately the manufacture and distribution of “hundreds of millions of plastic containers with dangerous levels of per- and polyfluoroalkyl substances (PFAS) that leach from these containers into household products and the environment.” The petition “demands that the...

The U.S. Environmental Protection Agency (EPA) announced on April 8, 2024, that it is directing government contractors to purchase cleaning products for federal buildings that are free of per- and polyfluoroalkyl substances (PFAS). This change is the result of a collaboration between EPA and the U.S. General Services Administration (GSA) to implement President Biden’s Federal Sustainability Plan, which directs federal agencies to prioritize the purchase of sustainable products and services,...