Memoranda

On November 23, 2022, the Court of Justice of the European Union (EU) announced a decision of the General Court that annuls the 2019 harmonized classification and labeling of titanium dioxide as a carcinogenic substance by inhalation in certain powder forms. According to the press release, the European Commission (EC) “made a manifest error in its assessment of the reliability and acceptability of the study on which the classification was based and, second, it infringed the criterion...

On November 25, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited comment on an Initial Regulatory Flexibility Analysis (IRFA) and Updated Economic Analysis following the completion of a Small Business Advocacy Review (SBAR) Panel for the Toxic Substances Control Act (TSCA) proposed rule for reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). 87 Fed. Reg. 72439. EPA states that it seeks...

On November 17, 2022, the U.S. Environmental Protection Agency (EPA) held the first 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 human health or the...

On November 16, 2022, the U.S. Environmental Protection Agency (EPA) published a much-anticipated supplemental notice of proposed rulemaking (SNPRM) to modify and supplement its 2021 proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. 87 Fed. Reg. 68647. EPA states that “[w]ith over five years of experience administering the TSCA amendments of 2016, EPA is publishing this document to ensure that the fees charged accurately reflect the level of effort and...

The U.S. Environmental Protection Agency (EPA) announced on November 10, 2022, the availability of the final revision to the risk determination for the methylene chloride risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed .Reg. 67901. EPA states that the revision to the methylene chloride risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science...

The U.S. Environmental Protection Agency (EPA) has provided a report to Congress on its capacity to implement certain provisions of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act). The report provides point-in-time estimates of EPA’s current estimated capacity and resources needed to implement the 2016 Lautenberg Act amendments to the Toxic Substances Control Act (TSCA). TSCA Section 26(m) requires EPA to submit an initial report to Congress within...

On October 29, 2022, Canada published in the Canada Gazette a notice of intent (NOI) announcing that it intends to propose actions under the Canadian Environmental Protection Act, 1999 (CEPA) to require the labeling of certain substances that are listed on the CEPA Schedule 1 List of Toxic Substances in certain products, such as cosmetics, cleaning products, and flame retardants in upholstered furniture. Comments and feedback on the NOI will inform a strategy on...

On October 18, 2022, the U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar 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. Specifically, the webinar covered examples of data (quantitative and qualitative) that are not likely to be accepted for engineering assessment, considerations EPA makes when evaluating data, and...

The U.S. Environmental Protection Agency (EPA) announced on October 5, 2022, a new effort under the Toxic Substances Control Act (TSCA) to implement a streamlined and more efficient process under the New Chemicals Program to assess risk and apply mitigation measures, as appropriate, for new chemicals with applications in batteries, electric vehicles, semiconductors, and renewable energy generation. The new process is for mixed metal oxides (MMO), including new and modified...

On September 20, 2022, the European Commission (EC) began a public consultation on a draft act that would introduce new hazard classes as part of its revision to Regulation (EC) No 1272/2008 on the Classification, Labeling, and Packaging of Substances and Mixtures (CLP). Hazard classes and criteria would be added for endocrine disruptors and substances that are persistent, bioaccumulative, and toxic (PBT), very persistent and very bioaccumulative (vPvB), persistent, mobile, and toxic...

On September 12, 2022, the European Commission (EC) opened a call for evidence on a proposal for a basic regulation for the European Chemicals Agency (ECHA). According to the EC, this initiative aims to strengthen ECHA governance and adapt it to its future role, as well as streamline the working methods of ECHA bodies and make their financing more sustainable. Responses are due October 10, 2022. The EC plans to adopt a regulation in the second quarter of 2023....

On September 7, 2022, the Environmental Defense Fund (EDF) held a webinar to introduce a cumulative risk assessment (CRA) framework that takes into account multiple exposures to chemical and non-chemical stressors. Sarah Vogel, Senior Vice President for Health at EDF, moderated the webinar. According to Vogel, for decades, environmental justice leaders have documented disproportionate chemical exposures to disadvantaged communities. These chemical and social stressors (e.g., racism and...

On September 6, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of the final revision to the risk determination for the Colour Index Pigment Violet 29 (PV29) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 54491. EPA states that the revision to the PV29 risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by...

On August 29, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft revision to the risk determination for the carbon tetrachloride risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 52766. EPA states that the draft revision to the carbon tetrachloride risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way...

The U.S. Environmental Protection Agency (EPA) announced on August 26, 2022, that it will propose to designate perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS), “two of the most widely used per- and polyfluoroalkyl substances (PFAS),” as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The proposal will include the salts and structural isomers of PFOA and PFOS. The rulemaking would require entities...

The U.S. Environmental Protection Agency (EPA) announced on August 19, 2022, that it will propose revisions to the Risk Management Program (RMP) rule to protect further vulnerable communities from chemical accidents, especially those living near facilities with high accident rates. According to EPA, the “Safer Communities by Chemical Accident Prevention” (SCCAP) rule “would strengthen the existing program and includes new safeguards that have not been addressed in prior RMP...

The U.S. Environmental Protection Agency (EPA) announced on August 22, 2022, that as part of its commitment to re-evaluate policies and practices under the Toxic Substances Control Act (TSCA) New Chemicals Program to ensure they adhere to statutory requirements and the Biden Administration’s executive orders and directives, it has updated its policy to discontinue the use of exposure modeling thresholds when assessing the health and environmental risks of new chemicals under TSCA....

The U.S. Environmental Protection Agency (EPA) held a webinar on August 17, 2022, on the “EPA PFAS Strategic Roadmap: Research Tools and Resources.” The webinar provided a brief overview of EPA’s PFAS Strategic Roadmap and ongoing efforts by EPA’s Office of Research and Development (ORD) to address key per- and polyfluoroalkyl substances (PFAS) research needs for environmental decision-making. During the webinar, ORD scientists highlighted two recently released data sources:...

The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) held a webinar on June 27, 2022, on an initiative to convert historical letters of interpretation (LOI) applicable to the Hazardous Materials Regulations (HMR) that have been issued to specific stakeholders into broadly applicable frequently asked questions (FAQ) on its website. A recording of the webinar is available online. During the webinar, Bill Quade, Deputy Associate...

On July 5, 2022, the U.S. Environmental Protection Agency (EPA) issued a final rule amending the regulations governing significant new uses of chemical substances under the Toxic Substances Control Act (TSCA) to align with revisions that were made to the Occupational Safety and Health Administration (OSHA) Hazard Communications Standard (HCS) and changes to the OSHA Respiratory Protection Standard and the National Institute for Occupational Safety and Health (NIOSH) respirator certification...

On August 5, 2022, the Federal Trade Commission (FTC) announced its modified ten-year regulatory review schedule. 87 Fed. Reg. 47947. FTC reviews its rules and industry guides on a ten-year schedule to ensure they remain relevant and not unduly burdensome. FTC publishes its review schedule each year, with adjustments made in response to public input, changes in the marketplace, and resource demands. FTC, in its discretion, may modify or reorder the schedule in the future to...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and...

The U.S. Environmental Protection Agency’s (EPA) New Chemicals Program held a webinar on July 27, 2022, to provide an in-depth look at its analysis of common issues that cause EPA to have to reconduct risk assessments (“rework”) of new chemicals. As reported in our June 27, 2022, memorandum, in June 2022, EPA announced a broad outreach effort to describe and to discuss with stakeholders how EPA evaluates engineering data (i.e., data related to environmental release and...

On July 20, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft revision to the risk determination for the 1-bromopropane (1-BP) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 43265. EPA states that the draft revision to the 1-BP risk determination reflects its announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is...

The U.S. Environmental Protection Agency (EPA) issued a final rule on July 18, 2022, updating the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 87 Fed. Reg. 42651. The final rule updates the regulations to identify five per- and polyfluoroalkyl substances (PFAS) that must be reported pursuant to the National Defense Authorization Act for Fiscal Year 2020 (NDAA)...

The Department for Environment, Food and Rural Affairs (Defra) has begun a public consultation on extending the UK Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) submission deadlines for transitional registrations — the registrations under UK REACH of substances that were registered in the European Union (EU) in accordance with EU REACH on or before December 31, 2020, the end of the Brexit transition period. Defra seeks comment on two options to...

As reported in our May 19, 2022, memorandum, the Superfund excise tax on certain chemical substances was reinstated beginning on July 1, 2022, under the Infrastructure Investment and Jobs Act. The newly reinstated tax has caught many off guard, and most subject to the tax are struggling with computing and reporting the tax. We offer some guidance below and stand ready to assist. Overview There are two separate Superfund chemical excise taxes: a tax on the...

The U.S. Environmental Protection Agency (EPA) recently released draft revisions to the risk determinations for perchloroethylene (PCE) (87 Fed. Reg. 39085), N-methylpyrrolidone (NMP) (87 Fed. Reg. 39511), methylene chloride (87 Fed. Reg. 39824), and trichloroethylene (TCE) (87 Fed. Reg. 40520). Each draft revision to the risk determinations for these chemicals reflects EPA’s announced policy changes to ensure the public is protected from unreasonable risks from chemicals in a way that is...

The U.S. Environmental Protection Agency (EPA) published on June 29, 2022, the final scope of the risk evaluation to be conducted for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos. 87 Fed. Reg. 38746. EPA will evaluate the conditions of use (COU) of asbestos, including other types of asbestos fibers in addition to chrysotile, that EPA had excluded from Part 1 as legacy uses and associated disposals, as well as any COUs of...

On July 2, 2021, the Federal Trade Commission (FTC) announced its modified ten-year regulatory review schedule. 86 Fed. Reg. 35239. FTC reviews its rules and industry guides on a ten-year schedule to ensure they remain relevant and not unduly burdensome. FTC publishes its review schedule each year, with adjustments made in response to public input, changes in the marketplace, and resource demands. FTC, in its discretion, may modify or reorder the schedule in the future to...

On June 29, 2022, 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 — Six Years Later.” This virtual conference marked the sixth Toxic Substances Control Act (TSCA) Annual Conference, reflecting on the accomplishments and challenges since the implementation of the 2016 Lautenberg Amendments and where TSCA stands today. Speakers covered a variety of...

The U.S. Environmental Protection Agency (EPA) announced on June 29, 2022, the availability of the final revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 38747. The revision reflects EPA policy changes intended to ensure the public is protected from unreasonable risks from chemicals in a way that is supported by science and the law. EPA states that it determined...

The U.S. Environmental Protection Agency (EPA) announced on June 24, 2022, that it is “conducting a broad outreach effort to describe and discuss with stakeholders how the Agency evaluates data provided for new chemicals submissions and common issues that cause EPA to have to reconduct risk assessments (‘rework’) for these submissions.” According to EPA, its goal is to reduce rework of initial risk assessments for new chemicals submissions that is caused by submitters...

On June 22, 2022, the sixth anniversary of the enactment of the Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act), the Senate Committee on Environment and Public Works held a hearing on “Toxic Substances Control Act Amendments Implementation.” The Committee’s only witness was Michal Freedhoff, Ph.D., Assistant Administrator, Office of Chemical Safety and Pollution Prevention (OCSPP), U.S. Environmental Protection Agency (EPA). Freedhoff’s written testimony...

The U.S. Environmental Protection Agency’s (EPA) Office of Resource Conservation and Recovery (ORCR) published a request for information (RFI) on June 9, 2022, seeking information on the end-of-life management of batteries, including their generation, collection, recycling, and reuse, as well as the current labeling standards and requirements for batteries regarding their end-of-life. 87 Fed. Reg. 35202. According to the RFI, EPA is developing best practices with respect to the collection...

The U.S. Environmental Protection Agency (EPA) announced on June 6, 2022, that it issued the first in a series of Toxic Substances Control Act (TSCA) test orders to require companies to conduct and submit testing on per- and polyfluoroalkyl substances (PFAS). EPA issued the order as part of its PFAS Strategic Roadmap. When EPA announced the Strategic Roadmap to confront PFAS contamination nationwide, it also released the National PFAS Testing Strategy to help identify...

The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on May 17, 2022, on the fiscal year (FY) 2023 budget for the U.S. Environmental Protection Agency (EPA), and the Senate Appropriations Subcommittee on Interior, Environment, and Related Agencies held a separate hearing on May 18, 2022. EPA Administrator Michael S. Regan was the only witness at each hearing. The hearings included questions about EPA’s implementation of the...

On November 15, 2021, President Biden signed into law the Infrastructure Investment and Jobs Act (IIJA), Public Law 117-58, 135 Stat. 429. Section 80201 of the IIJA reinstates the Superfund excise tax on certain chemical substances under Sections 4661 and 4671 of the Internal Revenue Code (Tax Code), effective July 1, 2022. Section 80201(c)(1) of the IIJA modified the method for determining whether a substance is a taxable substance by lowering the required...

As reported in our May 17, 2022, memorandum, on May 12, 2022, the U.S. Environmental Protection Agency (EPA) proposed 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). 87 Fed. Reg. 29078. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA in 2016 included many new...

On May 12, 2022, the U.S. Environmental Protection Agency (EPA) proposed 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). 87 Fed. Reg. 29078. The Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) amendments to TSCA in 2016 included many new provisions concerning the assertion, EPA review, and...

The European Commission (EC) recently opened a survey focused only on potential reforms to the authorisation and restriction provisions of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (No. 1907/2006), as well as the extension of the Generic Risk management Approach (GRA). The EC is revising REACH to reflect the goals in its ambitious Chemicals Strategy for Sustainability (CSS). The survey supports the EC’s impact assessment for the...

On May 6, 2022, the U.S. Environmental Protection Agency (EPA) proposed reporting and recordkeeping requirements for asbestos under Section 8(a) of the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 27060. EPA proposes to require certain persons that manufactured (including imported) or processed asbestos and asbestos-containing articles (including as an impurity) in the four years prior to the date of publication of the final rule to report electronically certain exposure-related...

On April 29, 2022, the House Appropriations Subcommittee on Interior, Environment, and Related Agencies held a hearing on President Biden’s fiscal year (FY) 2023 budget request for the U.S. Environmental Protection Agency (EPA). In his written testimony, EPA Administrator Michael S. Regan notes that “[c]hemicals and toxic substances are ubiquitous in our everyday lives and are often released into the environment from their manufacture, processing use, or disposal.”...

On April 25, 2022, the European Commission (EC) published a Restrictions Roadmap under the Chemicals Strategy for Sustainability (Restrictions Roadmap) that provides detailed information on all ongoing work on future restrictions under the European Union (EU) chemical legislation. The Restrictions Roadmap prioritizes group restrictions for the most harmful substances to human health and the environment, as set out in the Chemicals Strategy for Sustainability (Strategy)....

On April 20-21, 2022, the U.S. Environmental Protection Agency (EPA) held a virtual public meeting to provide an overview of the Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program and give stakeholders an opportunity to provide input. As reported in our March 14, 2022, memorandum on the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA,” the Office of Chemical Safety and...

The Federal Trade Commission (FTC) announced on April 8, 2022, that it used its Penalty Offense Authority to take action against Kohl’s and Walmart “for falsely marketing dozens of rayon textile products as bamboo.” FTC also charged both companies with making deceptive environmental claims, “touting that the ‘bamboo’ textiles were made using ecofriendly processes, while in reality converting bamboo into rayon requires the use of toxic chemicals and results in hazardous...

The Senate Committee on Environment and Public Works held a hearing on April 6, 2022, on the U.S. Environmental Protection Agency’s (EPA) proposed fiscal year (FY) 2023 budget. The only witness was EPA Administrator Michael S. Regan. In his written testimony, Regan states 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 addressing unreasonable risks to...

On April 5, 2022, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing additional modifications to its proposal to modify its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). OEHHA first proposed to change the short-form warning requirements on January 8, 2021. On December 13, 2021, OEHHA issued a notice proposing modifications to the revisions in its first proposal. More...

The U.S. Environmental Protection (EPA) announced on April 5, 2022, that it will propose to prohibit ongoing uses of chrysotile asbestos, the only known form of asbestos currently imported into the United States. EPA notes that the proposed rule will be “the first-ever risk management rule issued under the new process for evaluating and addressing the safety of existing chemicals under the Toxic Substances Control Act (TSCA) that was enacted in 2016.” EPA will propose to prohibit...

On April 6, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on “New Chemical Risk Management Actions under TSCA.” The slides include an embedded voiceover recording of the webinar. As reported in our January 24, 2022, blog item, in January 2022, EPA announced an effort to streamline the review of new biobased or waste-derived chemicals that could displace current, higher greenhouse gas (GHG)-emitting transportation fuels. EPA states that to support this...