Memoranda

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...

The Office of Science and Technology Policy (OSTP) published on April 4, 2022, a request for information (RFI) from interested parties on federal programs and activities in support of sustainable chemistry. 87 Fed. Reg. 19539. OSTP notes that “[t]he term “sustainable chemistry” does not have a consensus definition and most uses of the term indicate that it is synonymous with “green chemistry.”” OSTP requests information on the preferred definition for sustainable chemistry. OSTP...

The U.S. Department of Transportation’s (DOT) Pipeline and Hazardous Materials Safety Administration (PHMSA) announced on March 22, 2022, 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. 87 Fed. Reg. 16308. PHMSA states that by creating a FAQ repository, it seeks to eliminate the need for recurring...

On March 16, 2022, the House Science, Space, and Technology Subcommittee on Energy held a hearing on “Bioenergy Research and Development for the Fuels and Chemicals of Tomorrow.” According to the hearing charter, the purpose of the hearing was to examine the status of bioenergy research, development, and demonstration (RD&D) activities carried out by the U.S. Department of Energy (DOE). The hearing also considered advancements in bioenergy research and the potential role of this...

On March 16, 2022, the U.S. Environmental Protection Agency (EPA) announced two actions intended to safeguard communities from products containing per- and polyfluoroalkyl substances (PFAS). First, as part of EPA’s efforts to identify, understand, and address PFAS contamination leaching from fluorinated containers, EPA states that it is notifying companies of their obligation to comply with existing requirements under the Toxic Substances Control Act (TSCA) to ensure unintentional...

As reported in our February 25, 2022, blog item, the U.S. Environmental Protection Agency (EPA) announced on February 25, 2022, the proposed Toxic Substances Control Act (TSCA) New Chemicals Collaborative Research Program. 87 Fed. Reg. 10784. On March 10, 2022, EPA posted the draft document entitled “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA.” The Office of Chemical Safety and Pollution Prevention (OCSPP) proposes to...

On March 7, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of the final scope of the risk evaluation to be conducted for octamethylcyclotetra-siloxane (D4), a chemical substance for which EPA received a manufacturer request for risk evaluation under the Toxic Substances Control Act (TSCA). 87 Fed. Reg. 12696. The scope document includes the conditions of use (COU), hazards, exposures, and the potentially exposed or susceptible subpopulations (PESS)...

The U.S. Environmental Protection Agency (EPA) announced on March 4, 2022, that EPA Administrator Michael S. Regan signed a final rule on March 3, 2022, that will amend the regulations applicable to phenol, isopropylated phosphate (3:1) (PIP (3:1)) promulgated under the Toxic Substances Control Act (TSCA). EPA states that it is extending the compliance date applicable to the prohibition on processing and distribution in commerce of certain PIP (3:1)-containing articles, and the PIP (3:1) used...

On February 23, 2022, the U.S. Environmental Protection Agency (EPA) held a webinar on requirements under the Toxic Substances Control Act (TSCA) and the premanufacture notice (PMN) process for biofuels. 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. According to EPA, it has received...

Contrary to popular opinion, the U.S. Environmental Protection Agency’s (EPA) enforcement activity under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) has been trending upward over the last couple of years. As noted in our earlier advisory memorandum on enforcement activity under the Toxic Substances Control Act (TSCA), although most parties subject to TSCA inspections receive a “boilerplate” letter, FIFRA enforcement actions tend to be more heterogeneous....

Environment and Climate Change Canada (ECCC) announced on February 9, 2022, that the government introduced in the Senate the Strengthening Environmental Protection for a Healthier Canada Act (Bill S-5), intended to modernize the Canadian Environmental Protection Act, 1999 (CEPA) and make related amendments to the Food and Drugs Act (FDA). The bill was initially introduced in the 43rd Parliament in April 2021 as Bill C-28, but it was not considered due to the federal election...

On January 20, 2022, the European Commission (EC) launched a public consultation seeking comment on a proposed revision of the Registration, Evaluation, Authorisation and Restriction of Chemicals (REACH) regulation (No. 1907/2006). The consultation is the most extensive to date; it covers many elements of the legislation and, once changes are implemented, will have a significant impact on industry for the future. The consultation topics include: The consultation is a product of the EC’s...

The U.S. Food and Drug Administration (FDA) issued a proposed rule on January 26, 2022, to amend procedures for determining when a food contact substance notification (FCN) is no longer effective. 87 Fed. Reg. 3949. FDA states that the proposed rule would allow industry and FDA more flexibility in responding to new information on the safety and use of food contact substances. The amendments aim to create administration mechanisms to improve the program’s overall efficiency. Comments...

On January 21, 2022, the U.S. Environmental Protection Agency (EPA) announced the availability of and solicited public comments on the “Draft TSCA Screening Level Approach for Assessing Ambient Air and Water Exposures to Fenceline Communities Version 1.0” (screening level methodology). 87 Fed. Reg. 3294. EPA will use the screening level methodology to evaluate potential chemical exposures and associated potential risks to fenceline communities in its Toxic Substances Control Act (TSCA)...

On December 6, 2021, the United Kingdom’s (UK) Secretary of State for Environment, Food and Rural Affairs, George Eustice, sent a letter to the Chemical Industries Association (CIA). The letter confirms that the government is exploring a new model for transitional UK REACH registrations — the registrations under UK REACH of substances that were registered in the European Union (EU) in accordance with the EU’s Registration, Evaluation, Authorization and Restriction of...

Click here for a PDF brochure of the memorandum. Bergeson & Campbell, P.C. (B&C®) and its consulting affiliate The Acta Group (Acta®) and consortia management affiliate B&C® Consortia Management, L.L.C. (BCCM) are pleased to offer you our Forecast 2022. The extraordinary diversity and complexity of global industrial, agricultural, and biocidal chemical initiatives in which our clients engage are reflected in the detailed summary that follows, prepared by the legal,...

The U.S. Environmental Protection Agency (EPA) announced on December 29, 2021, the availability of the Draft Scope of the Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos (Draft Scope). 86 Fed. Reg. 74088. In the Part 2 risk evaluation, EPA will evaluate the conditions of use of asbestos (including other types of asbestos fibers in addition to chrysotile) that EPA had excluded from Part 1 as legacy uses and...

On December 29, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of a draft revision to the risk determination for the cyclic aliphatic bromide cluster (HBCD) risk evaluation issued under the Toxic Substances Control Act (TSCA). 86 Fed. Reg. 74082. EPA is reconsidering two key aspects of the risk determinations for HBCD. First, EPA proposes that the appropriate approach to these determinations under TSCA and implementing regulations is to make an unreasonable...

On December 20, 2021, the U.S. Environmental Protection Agency (EPA) released the Draft Systematic Review Protocol Supporting TSCA Risk Evaluations for Chemical Substances (Draft Protocol) for public comment. 86 Fed. Reg. 71891. According to EPA’s press release, the Draft Protocol will strengthen EPA’s approach to reviewing and selecting the scientific studies that are used to inform Toxic Substances Control Act (TSCA) chemical risk evaluations and ensure that EPA has the...

On December 13, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice proposing modifications to the revisions it first proposed on January 8, 2021, to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). More information regarding the January 8, 2021, proposal is available on our blog. OEHHA is requesting comments on its Notice and the modifications to the proposed...

On December 2, 2021, the U.S. Environmental Protection Agency (EPA) published an updated New Approach Methods (NAM) Work Plan (Updated Work Plan). EPA created the work plan to prioritize its efforts and resources toward activities that aim to reduce the use of vertebrate animal testing while continuing to protect human health and the environment. EPA describes its updated roadmap and identifies steps intended to reduce the use of vertebrate animals for toxicity testing and related research...

On December 7, 2021, the House Science, Space, and Technology Subcommittees on Environment and on Research and Technology held a joint hearing entitled “Forever Chemicals: Research and Development for Addressing the PFAS Problem.” Four witnesses spoke before the subcommittees on their respective knowledge of the current state of per- and polyfluoroalkyl substances (PFAS) and where each felt future actions should be focused: Dr. Elsie Sunderland, Gordon McKay Professor of...

The U.S. Environmental Protection Agency (EPA) announced on November 23, 2021, legally mandated changes to the fee requirements under the Toxic Substances Control Act (TSCA). This is not the fee adjustment we have been awaiting. It is a routine increase that TSCA directs EPA every three years to adjust the fees. The adjustment will go into effect on January 1, 2022, and will apply to all TSCA fees. The fee adjustment will not be retroactive and will not...

On November 23, 2021, Senator Cory Booker (D-NJ) announced his intention to reintroduce the Protect America’s Children from Toxic Pesticides Act of 2021, that would amend the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) “to [protect fully] the safety of children and the environment, to remove dangerous pesticides from use, and for other purposes.” Similar legislation was introduced in the House (H.R. 7940) and Senate (S. 4406) in 2020, but the bills did not...

On November 8, 2021, the Infrastructure Investment and Jobs Act (H.R. 3684) was presented to President Joseph Biden (D) for signature. The House passed the bill on November 5, 2021, by a vote of 228 to 206, and the Senate passed the bill on August 10, 2021, by a vote of 69 to 30. The bill contains many important provisions. We highlight below some of the provisions in the 1,039-page bill that we believe our clients and...

The House Energy and Commerce Subcommittee on Environment and Climate Change held a hearing on October 27, 2021, on “TSCA and Public Health: Fulfilling the Promise of the Lautenberg Act.” The October 25, 2021, briefing memorandum notes that the Frank R. Lautenberg Chemical Safety for the 21st Century Act (the Lautenberg Act) comprehensively amended the Toxic Substances Control Act (TSCA), “including key reforms to increase [the U.S. Environmental Protection Agency’s (EPA)]...