Memoranda

On August 3, 2023, the Joint Subcommittee on Environment, Innovation, and Public Health Sustainable Chemistry Strategy Team (Sustainable Chemistry ST) of the National Science and Technology Council (NSTC) published a report entitled Sustainable Chemistry Report: Framing the Federal Landscape. As reported in our January 19, 2021, memorandum, the fiscal year (FY) 2021 National Defense Authorization Act (NDAA) included the text of the bipartisan Sustainable Chemistry Research and...

The U.S. Environmental Protection Agency (EPA) announced on August 15, 2023, that it issued the third Toxic Substances Control Act (TSCA) test order requiring testing on per- and polyfluoroalkyl substances (PFAS) under EPA’s National PFAS Testing Strategy. EPA has ordered the Chemours Company FC LLC, E. I. du Pont de Nemours and Company, and 3M Company to conduct and submit testing on 2,3,3,3-Tetrafluoro-2-(heptafluoropropoxy)propanoyl fluoride (HFPO-DAF), “a substance used as...

On July 27, 2023, the United Nations (UN) published an electronic version of the tenth revision (Rev 10) of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) available for free for consultation purposes. The amendments to the ninth revision of the GHS (Rev 9) include the classification procedure for desensitized explosives (Chapter 2.17); the use of non-animal testing methods for classification of health hazards, in particular: skin corrosion/irritation...

Health Canada has begun a consultation on a proposal to introduce new requirements for consumer chemical products under the Canada Consumer Product Safety Act (CCPSA). Health Canada states that many substances found in consumer chemical products, like household cleaning products, have been linked to human health hazards of concern (HHHOC) such as carcinogens, mutagens, and reproductive toxicants. The proposed new requirements include the introduction of classification criteria for...

The U.S. Food and Drug Administration (FDA) issued draft guidance for industry on the registration and listing of cosmetic products under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA) on August 7, 2023. The draft guidance provides details on the submissions process, including the information required and who is responsible for the submission. FDA is accepting comments until September 7, 2023. In addition, FDA seeks applications from interested parties to...

On August 2, 2023, the U.S. Environmental Protection Agency’s (EPA) Office of Inspector General (OIG) released a report entitled The EPA Lacks Complete Guidance for the New Chemicals Program to Ensure Consistency and Transparency in Decisions. According to OIG, EPA’s New Chemicals Division (NCD) “lacks assurance that the new chemicals review process operates as intended and achieves its objective to protect human health and the environment.” OIG made four recommendations, including...

Canada published a notice in the Canada Gazette on June 24, 2023, announcing that it is collecting information on 850 substances for the purpose of prioritization, risk assessment, and risk management. Canada is gathering information from Canadian manufacturers, importers, and users on the commercial status, facility information (for example, releases), and uses of these substances in Canada, pursuant to Section 71 of the Canadian Environmental Protection Act (CEPA)....

On July 10, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of the draft supplement to the risk evaluation for 1,4-dioxane for public comment and peer review. 88 Fed. Reg. 43562. EPA states in its July 7, 2023, press release that the draft supplement to the 2020 risk evaluation considers air and water exposure pathways that were excluded from the earlier risk evaluation and exposure to 1,4-dioxane generated as a byproduct. The draft...

On July 25, 2023, the U.S. Environmental Protection Agency announced an opportunity for public input on the potential expansion of the Safer Choice and Design for the Environment (DfE) programs’ certification to new product categories. EPA notes in its July 27, 2023, Federal Register notice that Safer Choice “helps consumers, businesses, and purchasers find products that perform and contain ingredients that are safer for human health and the environment.” 88 Fed....

On July 17, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will propose to ban uses of carbon tetrachloride (CTC) that have been phased out and establish a workplace chemical protection program (WCPP) for uses not prohibited to address the unreasonable risk to human health. EPA states in the prepublication version of the proposed rule that it determined that CTC presents an unreasonable risk of injury to health due to cancer from chronic inhalation and...

On July 3, 2023, the Brazil Association of Technical Standards (ABNT) adopted the amendment to the standard for classifying and labeling chemicals according to NBR 14725. The “new” NBR 14725:2023 merges the four-part standard into one, and adopts the 7th revised edition of the United Nations (UN) Globally Harmonized System of Classification and Labeling of Chemicals (GHS). These revisions enter into force on July 4, 2025. The following four parts consolidated into NBR 1475:2023...

The U.S. Environmental Protection Agency (EPA) announced on June 29, 2023, a new framework (the Framework) for addressing new per- and polyfluoroalkyl substances (PFAS) and new uses of existing PFAS. The Framework outlines EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, EPA will undertake an extensive evaluation to ensure they pose no harm to human health and the environment....

On July 5, 2023, the Pipeline and Hazardous Materials Safety Administration (PHMSA) published an advance notice of proposed rulemaking (ANPRM) to solicit stakeholder feedback on initiatives PHMSA is considering that may modernize the Hazardous Materials Regulations (HMR) and improve efficiencies while maintaining or improving a current high level of safety. 88 Fed. Reg. 43016. To engage fully with stakeholders, the ANPRM solicits comments and input on questions related to 46 distinct topics...

On July 6, 2023, the U.S. Environmental Protection Agency (EPA) announced a final rule under Section 8(a) of the Toxic Substances Control Act (TSCA) that will require reporting and recordkeeping requirements for asbestos. The pre-publication version of the final rule states that EPA will require certain persons who manufactured (including imported) or processed asbestos and asbestos-containing articles, including as an impurity, in the four years prior to the date of...

The U.S. Environmental Protection Agency (EPA) announced on June 16, 2023, a 60-day public comment period on the draft Guidelines for Cumulative Risk Assessment Planning and Problem Formulation (draft CRA Guidelines). 88 Fed. Reg. 39424. According to EPA, the draft CRA Guidelines describe steps for the planning and problem formulation of CRAs and offer guidelines for when CRAs could be appropriate. Planning defines both the process for conducting the risk assessment and its...

On June 29, 2023, Bergeson & Campbell, P.C. (B&C®), the Environmental Law Institute (ELI), and the George Washington University Milken Institute School of Public Health presented “TSCA Reform — Seven Years Later.” This virtual conference marked the seventh Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and...

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...

Bill S-5, Strengthening Environmental Protection for a Healthier Canada Act (the Act), received Royal Assent on June 13, 2023. According to Environment and Climate Change Canada’s (ECCC) Backgrounder, the Act modernizes the Canadian Environmental Protection Act, 1999 (CEPA) and represents the first set of comprehensive amendments to CEPA since it was enacted over 20 years ago. It also makes related amendments to the Food and Drugs Act. The Act was initially introduced in the...

On June 20, 2023, the U.S. Environmental Protection Agency (EPA) proposed significant new use rules (SNUR) under the Toxic Substances Control Act (TSCA) for 18 chemicals that were the subject of premanufacture notices (PMN) and are also subject to an order issued by EPA pursuant to TSCA. 88 Fed. Reg. 39804. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these chemical substances for an activity...

The U.S. Environmental Protection Agency (EPA) proposed on June 16, 2023, to ban most uses of perchloroethylene (PCE). 88 Fed. Reg. 39652. According to EPA’s June 8, 2023, press release, the proposed rule “would protect people from these risks by banning all consumer uses while allowing for many industrial/commercial uses to continue only where strict workplace controls could be implemented, including uses related to national security, aviation and other critical infrastructure,...

The U.S. Environmental Protection Agency (EPA) published on June 7, 2023, a final rule with new and amended requirements concerning the assertion and treatment of confidential business information (CBI) claims for information reported to or otherwise obtained by EPA under the Toxic Substances Control Act (TSCA). 88 Fed. Reg. 37155. The final rule notes that amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and treatment of confidentiality...

On May 30, 2023, the U.S. Environmental Protection Agency (EPA) announced it has taken additional steps in addressing concerns that per- and polyfluoroalkyl substances (PFAS) have been found in pesticide products. As part of its ongoing efforts, EPA has completed its verification analysis of a study published in September 2022 in the Journal of Hazardous Materials entitled “Targeted analysis and Total Oxidizable Precursor assay of several insecticides for PFAS.” This...

On May 31, 2023, the U.S. Environmental Protection Agency (EPA) issued a final rule that exempts a class of plant-incorporated protectants (PIP) created using genetic engineering from registration requirements under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and from the food or feed residue tolerance requirements under the Federal Food, Drug, and Cosmetic Act (FFDCA). 88 Fed. Reg. 34756. EPA states that the final rule includes exemptions as described in its October...

On May 20, 2023, Canada published a Canada Gazette notice announcing the availability of its Draft State of Per- and Polyfluoroalkyl Substances (PFAS) Report (Draft Report). Canada proposes to conclude that the class of PFAS meets one or more criteria set out in Section 64 of the Canadian Environmental Protection Act, 1999 (CEPA). According to the notice, the Minister of the Environment and the Minister of Health (the ministers) propose to recommend that the class of...

The U.S. Environmental Protection Agency (EPA) announced on May 16, 2023, that it will propose amendments to the new chemicals procedural regulations under the Toxic Substances Control Act (TSCA). According to the pre-publication version of the proposed rule, 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...

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 global legal and scientific developments and take steps now to minimize legal, regulatory, and commercial risk. Bergeson & Campbell, P.C. (B&C®) and its global consulting affiliate The Acta Group (Acta®) have prepared...

The United Kingdom’s (UK) Health and Safety Executive (HSE) issued a call for evidence on April 26, 2023, to gather information and evidence that will support HSE and the UK Health and Security Agency (UKHSA) with the preparation of a regulatory management options analysis (RMOA) that examines exposure of the general public to formaldehyde from formaldehyde releasers in articles. HSE states that it is “interested in all aspects of the manufacture, import and use of articles that...

Each year about this time, companies are focused on the deadline to submit Toxics Release Inventory (TRI) data to the U.S. Environmental Protection Agency (EPA). This year is no different as the July 1, 2023, deadline is rapidly approaching. By this date, entities subject to the reporting requirement must submit data for activities that occurred during 2022. Companies are required to report if they meet chemical activity thresholds and: EPA’s TRI Threshold Screening Tool can...

On May 3, 2023, the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies held a hearing on “A Review of the President’s Fiscal Year 2024 Budget Request for the Environmental Protection Agency.” On May 10, 2023, the House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials held a hearing on “The Fiscal Year 2024 Environmental Protection Agency Budget.” For each Subcommittee, Michael S. Regan, Administrator of the U.S....

On April 7, 2023, the Office of Management and Budget (OMB) requested comments on proposed Circular A-4, “Regulatory Analysis.” 88 Fed. Reg. 20915. According to OMB, since 2003, OMB Circular A-4, Regulatory Analysis, has provided guidance to federal agencies on the development of regulatory analysis as required under Section 6(a)(3)(C) of Executive Order (EO) 12866 (Regulatory Planning and Review), the Regulatory Right-to-Know Act, and a variety of related authorities. OMB...

On May 10, 2023, the Northeast Waste Management Officials’ Association, Inc. (NEWMOA) held a webinar to provide an overview and discuss the provisions of its PFAS Draft Model Legislation (draft model) that is intended to reduce the use of per- and polyfluoroalkyl substances (PFAS) in consumer products. Viewers had the opportunity to ask questions and provide comments regarding the draft. NEWMOA invites the submission of public comments until June 29, 2023,...

On April 20, 2023, the European Commission (EC) announced the implementation dates for the introduction of new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labelling, and Packaging of Substances and Mixtures (CLP). The new hazard classes and criteria rules will be phased in over several years. New substances must comply by May 1, 2025, and new mixtures by May 1, 2026. Substances placed on the market before May 1, 2025,...

On April 24, 2023, the U.S. Environmental Protection Agency (EPA) held a virtual public preparatory meeting for the Science Advisory Committee on Chemicals (SACC) members, ad hoc reviewers, and the public to comment on and ask questions regarding the scope and clarity of the draft charge questions to be used for the May 8-11, 2023, review of two draft documents related to cumulative risk assessment (CRA) under the Toxic Substances Control Act (TSCA). As reported in our...

On May 2, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of the Draft National Strategy to Prevent Plastic Pollution (Draft Strategy) for public comment. 88 Fed. Reg. 27502. EPA states in its April 21, 2023, press release that the Draft Strategy includes “ambitious actions to eliminate the release of plastic and other waste from land-based sources into the environment by 2040.” EPA released the Draft Strategy alongside a new White...

On April 20, 2023, the U.S. Environmental Protection Agency (EPA) announced the release of a proposed rule under Section 6(a) of the Toxic Substances Control Act (TSCA) that would prohibit most uses of methylene chloride. EPA states that its unreasonable risk determination for methylene chloride was driven by risks associated with workers, occupational non-users (ONU), consumers, and those in close proximity to a consumer use. EPA identified risks for adverse human health effects,...

On April 14, 2023, the Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) published a request for feedback on its recycled plastics policy. 88 Fed. Reg. 23140. PHMSA states that it published the notice to solicit information pertaining to how the potential use of recycled plastic resins in the manufacturing of specification packagings may affect hazardous materials transportation safety; ensure transparency of its current policy pertaining...

The U.S. Environmental Protection Agency (EPA) published an advance notice of proposed rulemaking (ANPRM) on April 13, 2023, seeking information to assist in the consideration of potential development of future regulations pertaining to per- and polyfluoroalkyl substances (PFAS) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). 88 Fed. Reg. 22399. EPA states that it seeks input and data regarding potential future hazardous substance designation under...

On April 5, 2023, the European Chemicals Agency (ECHA) convened an online information session as part of the consultation period regarding the proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The speakers during the information session explained how the REACH restriction process works, provided details regarding the restriction proposal, and described how...

On March 30, 2023, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program (NCP) held the second of a two-part webinar series on EPA’s new standardized process to assess risk and apply mitigation measures, as appropriate, for mixed metal oxides (MMO), including new and modified cathode active materials (CAM). Under the Toxic Substances Control Act (TSCA), EPA reviews new chemical substances before they enter the marketplace to ensure they do not present unreasonable risk to...

On March 29, 2023, the Internal Revenue Service (IRS) published a notice of proposed rulemaking (NPRM) relating to the Superfund excise taxes imposed on certain chemicals and certain imported substances, effective July 1, 2022. 88 Fed. Reg. 18446. There are two separate Superfund chemical excise taxes: a tax on the sale or use of “taxable chemicals” and a tax on the sale or use of imported “taxable substances.” The NPRM contains proposed regulations under Sections 4661,...

On March 28, 2023, the House Appropriations Subcommittee for Interior, Environment, and Related Agencies held a hearing on the fiscal year (FY) 2024 budget request for the U.S. Environmental Protection Agency (EPA). EPA Administrator Michael Regan was the Committee’s only witness. As reported in our March 14, 2023, blog item, according to EPA’s March 9, 2023, press release, President Biden’s budget requests over $12 billion in discretionary budget authority for EPA in...

The Senate Committee on Environment and Public Works held a hearing on March 22, 2023, on the U.S. Environmental Protection Agency’s (EPA) fiscal year (FY) 2024 budget proposal. EPA Administrator Michael Regan was the Committee’s only witness. In his written testimony, Regan notes that EPA has “significant responsibilities” under amendments to the Toxic Substances Control Act (TSCA) to ensure the safety of chemicals in or entering commerce and to address...

On March 17, 2023, the U.S. Environmental Protection Agency (EPA) released additional data related to the proposed risk management rule for chrysotile asbestos for public comment. 88 Fed. Reg. 16389. According to EPA’s March 16, 2023, press release, these data concern chrysotile asbestos diaphragms used in the chlor-alkali industry and chrysotile asbestos-containing sheet gaskets used in chemical production. EPA states that it may use the data in the development of the final rule,...

On March 14, 2023, the U.S. Environmental Protection Agency (EPA) held the first of two public listening sessions to receive individual input related to concerns about potential liability under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). According to EPA’s March 2, 2023, press release, EPA will review and consider the input received in drafting a “CERCLA per- and polyfluoroalkyl substances (PFAS) enforcement discretion and settlement policy to the...

On March 14, 2023, the U.S. Environmental Protection Agency (EPA) announced that it will propose the first-ever national drinking water standard for six per- and polyfluoroalkyl substances (PFAS) in the latest action under EPA’s PFAS Strategic Roadmap. The proposed National Primary Drinking Water Regulation (NPDWR) would regulate perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS) as individual contaminants and will regulate four other PFAS —...

On February 28, 2023, the U.S. Environmental Protection Agency (EPA) New Chemicals Program held the third and final webinar in its series on EPA’s process for assessing the potential risks of new chemicals under Section 5 of the Toxic Substances Control Act (TSCA) and the types of data EPA considers in this assessment. The webinar covered commonly missed information in Section 5 submissions and how EPA evaluates environmental release information for operations that occur at...

On February 27, 2023, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comment on two draft documents that are being submitted to the Science Advisory Committee on Chemicals (SACC) for peer review: “Draft Proposed Principles of Cumulative Risk Assessment under the Toxic Substances Control Act” (draft proposed principles) and “Draft Proposed Approach for Cumulative Risk Assessment of High-Priority Phthalates and a Manufacturer-Requested...

The U.S. Government Accountability Office (GAO) released a report on February 23, 2023, entitled “EPA Chemical Reviews: Workforce Planning Gaps Contributed to Missed Deadlines.” GAO evaluated the extent to which the U.S. Environmental Protection Agency (EPA) met selected Toxic Substances Control Act (TSCA) deadlines for reviewing existing and new chemicals since June 2016, and to which EPA engaged in workforce planning for implementing its chemical review responsibilities. GAO identified...

On February 14, 2023, the Maine Department of Environmental Protection (MDEP) announced a much anticipated proposed rule intended to provide additional guidance on the notification requirements and sales prohibitions for products and product components containing intentionally added per- and polyfluoroalkyl substances (PFAS). MDEP will hold a public hearing on April 20, 2023. Comments are due May 19, 2023, by 5:00 p.m. (EDT). Background Maine enacted “An Act To...

On February 7, 2023, the European Chemicals Agency (ECHA) announced the availability of a much anticipated detailed proposal to restrict more than 10,000 per- and polyfluoroalkyl substances (PFAS) under the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation. The national authorities of Denmark, Germany, the Netherlands, Norway, and Sweden (dossier submitters) submitted the proposal after finding risks in the manufacture, placement on the...