Memoranda

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...

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...

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 impact...

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 friends may find interesting. Pesticides Under the...

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)]...

The U.S. Environmental Protection Agency (EPA) announced on October 21, 2021, that it is proposing to extend further the compliance dates related to articles containing phenol, isopropylated phosphate (3:1) (PIP (3:1)) to ensure supply chains for key consumer and commercial goods are not disrupted. As reported in our September 3, 2021, memorandum that addresses a September 17, 2021, final rule, EPA provided a short-term extension of certain compliance dates for PIP (3:1)...

On October 20, 2021, the Senate Committee on Environment and Public Works held a hearing on “Evaluating the Federal Response to the Persistence and Impacts of PFAS Chemicals on our Environment.” The sole witness called before the Committee was the U.S. Environmental Protection Agency (EPA) Assistant Administrator for the Office of Water, Radhika Fox. The focus of the hearing was to address the recently released EPA Strategic Roadmap for per- and polyfluoroalkyl substances (PFAS)....

On October 18, 2021, the Biden Administration announced a multi-agency plan to address per- and polyfluoroalkyl substances (PFAS) contamination nationwide. According to the White House, agencies, including the U.S. Environmental Protection Agency (EPA), the Department of Defense (DOD), the Food and Drug Administration (FDA), the U.S. Department of Agriculture (USDA), the Department of Homeland Security (DHS), and the Department of Health and Human Services (DHHS), will take actions to...

On September 14, 2021, the United Nations (UN) published an electronic version of the ninth revised edition (Rev 9) of the Globally Harmonized System of Classification and Labeling of Chemicals (GHS) available for free for consultation purposes. The amendments to the eighth revision of the GHS (Rev 8) include extensive revision of Chapter 2.1 (explosives) to address explosion hazard determination better when explosives are not in transit; the revision of decision logic; the revision of...

The United Kingdom (UK) Department for Environment, Food & Rural Affairs (DEFRA) has published a UK REACH: Grandfathered Registrations Notified Substances List. According to an item in the Health and Safety Executive’s (HSE) October 1, 2021, UK REACH eBulletin, the list contains the names and Chemical Abstracts Service (CAS)/European Community (EC) numbers for substances taken from notifications made under UK REACH Article 127B(4)(a). Article 127B(4)(a) required...

The Occupational Safety and Health Administration (OSHA) concluded last week a three-day informal public hearing on its February 16, 2021, notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS). The NPRM was open for comment until May 19, 2021. OSHA stated that it would schedule an informal public hearing on the NPRM if a request was made during the comment period. A request was made, and OSHA scheduled the public hearing for September 21-23,...

On September 15, 2021, the Senate Committee on Environment and Public Works held a hearing on several U.S. Environmental Protection Agency (EPA) nominees, including Amanda Howe, nominated for Assistant Administrator for Mission Support, and David Uhlmann, nominated for Assistant Administrator for Enforcement and Compliance Assurance. Amanda Howe has a long history of public service, including such roles as the Chief Operating Officer for the now-Vice President, Kamala Harris, for...

The U.S. Environmental Protection Agency (EPA) announced on September 3, 2021, that it intends to initiate a new rulemaking and anticipates proposing new rules for five persistent, bioaccumulative, and toxic (PBT) chemicals that are the subject of final risk management rules under the Toxic Substances Control Act (TSCA). Additionally, and importantly, EPA is extending the compliance dates for the prohibitions on processing and distribution and the associated recordkeeping requirements of one of...

On August 31, 2021, the U.S. Environmental Protection Agency (EPA) announced the availability of the final scope documents for the manufacturer-requested risk evaluations (MRRE) of di-isodecyl phthalate (DIDP) and diisononyl phthalate (DINP). 86 Fed. Reg. 48695; 86 Fed. Reg. 48693. The scope documents include the conditions of use, hazards, exposures, and the potentially exposed or susceptible subpopulations that EPA plans to consider in conducting the risk...

The European Commission (EC) is holding a targeted consultation on potential revisions to the Annexes to Regulation (EC) No 1907/2006 on the Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) to introduce information requirements to improve the identification of substances with endocrine disrupting potential. The EC has developed two different options that would amend the Annexes to include new standard tests providing information on endocrine disrupting...

On July 26, 2021, Representative Jan Schakowsky (D-IL), Chair of the House Energy and Commerce Subcommittee on Consumer Protection and Commerce, introduced the Food Chemical Reassessment Act of 2021 (H.R. 4694), which would require the U.S. Food and Drug Administration (FDA) to study and reassess chemicals used in food. Representative Rosa DeLauro (D-CT) joined Schakowsky in introducing the legislation. According to Schakowsky’s July 26, 2021, press release, “thousands” of...

In a July 30, 2021, filing in the U.S. Court of Appeals for the Ninth Circuit, the U.S. Environmental Protection Agency (EPA) states that it cannot “meaningfully commence” risk management rulemaking for 1,4-dioxane until it nears completion of its reconsideration of the final risk evaluation. EPA released the final risk evaluation for 1,4-dioxane on January 8, 2021, in the final weeks of the Trump Administration. On June 30, 2021, the Biden-Harris EPA announced several policy...

The U.S. Environmental Protection Agency (EPA) convened a public webinar on July 27, 2021, to engage with stakeholders on the development of a proposed rule under the Toxic Substances Control Act (TSCA) to implement a tiered data collection strategy intended to inform EPA’s prioritization, risk evaluation, and risk management activities for chemical substances or mixtures. According to the July 14, 2021, Federal Register notice announcing the webinar, EPA currently...

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 incorporate new...

On June 30, 2021, 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 - Five Years Later.” This virtual conference marked the fifth 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 topics,...

The U.S. Environmental Protection Agency (EPA) published a final rule on June 29, 2021, that requires manufacturers (including importers) of 50 specified chemical substances to report certain lists and copies of unpublished health and safety studies to EPA. 86 Fed. Reg. 34147. EPA is issuing the final rule pursuant to Section 8(d) of the Toxic Substances Control Act (TSCA) and the TSCA Health and Safety Data Reporting rule codified at 40 C.F.R. Part 716. The chemical substances subject to...

The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS). The actions include proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States, withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS, and publishing a final rule that incorporates three...

On May 13, 2021, the Getting Ready for Baby Campaign, a collaboration of over 100 non-governmental organizations (NGO), released a report entitled Peeling Back the Green Façade: Calling out “Greenwashing” in the Crib Mattress Market as Lessons on Brand Manipulation of Health and Environmental Claims. Using the research for the report, Clean and Healthy New York (CHNY) filed a complaint with the Federal Trade Commission (FTC) on May 13, 2021, requesting that FTC investigate and...

On March 1, 2021, the White House Office of Management and Budget (OMB) received for review under Executive Order 12866 (Regulatory Planning and Review) from the U.S. Environmental Protection Agency (EPA) a proposed rule entitled “Reporting and Recordkeeping for Perfluoroalkyl or Polyfluoroalkyl Substances Under Section 8(a)(7) of the Toxic Substances Control Act (TSCA)” (Proposed Rule). This action is required under Section 7351 of the National Defense...

On May 12, 2021, the Senate Committee on Environment and Public Works held a hearing on several Department of the Interior and U.S. Environmental Protection Agency (EPA) nominees, including Michal Freedhoff, Ph.D., to be Assistant Administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP). In her opening statement, Dr. Freedhoff stated that during her time working for the legislative branch, she believes that she “earned a reputation for being fair,...

The U.S. Environmental Protection Agency (EPA) announced on April 29, 2021, that it will be “taking important steps under the Toxics Release Inventory (TRI) to advance Environmental Justice, improve transparency, and increase access to environmental information.” EPA plans to expand the scope of TRI reporting requirements to include additional chemicals and facilities, including facilities that are not currently reporting on ethylene oxide (EtO) releases, and provide new...

On February 16, 2021, the Occupational Safety and Health Administration (OSHA) published a notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS). On April, 12, 2021, OSHA published a Federal Register notice to extend the comment period of the NPRM to amend the HCS by one month. The HCS is the federal-level regulation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous...

On March 16, 2021, Earthworks, Global Witness, and Greenpeace USA jointly filed a Federal Trade Commission (FTC) complaint against Chevron for “unlawfully deceptive advertisements which overstate investment in renewable energy and its commitment to reducing fossil fuel pollution.”  According to Earthworks’ March 16, 2021, press release, the complaint claims that Chevron “is consistently misrepresenting its image to appear climate-friendly and racial justice-oriented, while its...

On April, 12, 2021, the Occupational Safety and Health Administration (OSHA) published a Federal Register notice to extend the comment period of the notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS) by one month. The HCS is the federal-level regulation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces....

On February 8, 2021, the U.S. Environmental Protection Agency (EPA) received a petition seeking a rule reversing EPA’s 1991 Bevill regulatory determination excluding phosphogypsum and process wastewater from phosphoric acid production (process wastewater) from hazardous waste regulation under Subtitle C of the Resource Conservation and Recovery Act (RCRA). The petition also urges EPA to promulgate regulations under RCRA Subtitle C governing the safe treatment, storage, and disposal...

On March 10, 2021, the House Energy and Commerce Subcommittee on Oversight and Investigations held a hearing on “The Path Forward: Restoring the Vital Mission of EPA.” According to the March 7, 2021, memorandum from Representative Frank Pallone, Jr. (D-NJ), Chair of the Committee, to the Subcommittee, the U.S. Environmental Protection Agency’s (EPA) current responsibilities include reviewing national air pollution standards and overseeing or carrying out cleanups at most of the...

The United Kingdom (UK) Health and Safety Executive (HSE) published an HSE Biocides eBulletin on March 8, 2021, announcing upcoming deadlines for businesses under the Great Britain (GB) Biocidal Products Regulation (GB BPR). As of January 1, 2021, HSE no longer has access to the European Union’s (EU) information technology (IT) systems to access applications (including the data dossiers) previously submitted under those systems. Businesses must therefore resubmit...

On March 5, 2021, the U.S. Environmental Protection Agency (EPA) announced that “[i‌]n support of the Biden-Harris Administration’s commitment to making evidence-based decisions to protect human health, U.S. Environmental Protection Agency (EPA) is taking an important step by proposing the cancellation of the registration of pentachlorophenol.” Pentachlorophenol, a well-recognized wood preservative in use for decades, is registered under the Federal Insecticide, Fungicide, and...

The European Chemicals Agency (ECHA) has begun a public consultation on a derogation to the exclusion criteria for creosote for product type 8 (PT 8; wood preservatives). Under the European Union (EU) Biocidal Products Regulation (BPR), active substances that meet the exclusion criteria can be approved or renewed only if they meet one or more of the following derogation criteria: exposure is negligible; the active substance is essential to prevent a serious danger to human or animal...

The United Kingdom (UK) Health and Safety Executive (HSE) published a REACH eBulletin on February 26, 2021, announcing upcoming deadlines for businesses for UK REACH. As reported in our February 9, 2021, memorandum, “Following Brexit, UK Establishes New Chemical Regulatory Regimes,” the UK brought the European Union (EU) Registration, Evaluation, Authorization and Restriction of Chemicals (REACH) regulation into law on January 1, 2021, as UK REACH. According to HSE,...

On January 26, 2021, several public health advocacy organizations and scientists (Petitioners) filed a notice of intent (NOI) to sue the U.S. Environmental Protection Agency (EPA) to compel it “to perform its non-discretionary duty to address the use and disposal of ‘legacy’ asbestos” in its risk evaluation for asbestos under Section 6(b) of the Toxic Substances Control Act (TSCA). As reported in our January 4, 2021, memorandum, “EPA Publishes Final Risk Evaluation for...

On February 16, 2021, the Occupational Safety and Health Administration (OSHA) published a notice of proposed rulemaking (NPRM) to amend the Hazard Communication Standard (HCS). The HCS is the federal-level regulation that sets forth the classification, labeling, Safety Data Sheet (SDS), and training requirements for hazardous chemicals intended to be used, handled, or stored in workplaces. The current HCS is based on the third revised edition (Rev 3) of the United Nations (UN)...

The United Kingdom (UK) completed its withdrawal from the European Union (EU) on December 31, 2020, and, as of January 1, 2021, is a “third country” from the EU perspective.  Companies worldwide must be aware of the significant implications for compliance under the following newly established independent chemical regulatory regimes:  the Great Britain (England, Scotland, and Wales) (GB) Biocidal Products Regulation (GB BPR); the GB Classification, Labeling, and Packaging Regulation...

The U.S. Environmental Protection Agency (EPA) announced on January 15, 2021, that it has issued test orders under Section 4 of the Toxic Substances Control Act (TSCA) to obtain additional data on nine of the next 20 chemicals undergoing risk evaluation. EPA states that after reviewing the available data on these chemicals, it needs additional data and is using its TSCA test order authority to require companies to develop and submit information on environmental hazard and inhalation...

The U.S. Environmental Protection Agency (EPA) announced on January 14, 2021, the release of the final risk evaluation for C.I. Pigment Violet 29 (PV29) under the Toxic Substances Control Act (TSCA), meeting a “major chemical safety milestone.” In the risk evaluation, EPA reviewed 14 conditions of use for PV29, including as an intermediate for other perylene pigments, as well as a component of paints, coatings, industrial carpeting, and plastic and rubber products used...

On January 8, 2021, the California Office of Environmental Health Hazard Assessment (OEHHA) proposed significant revisions to its Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings. When OEHHA’s revisions to the warning requirements were issued in 2016 (and in full effect as of August 30, 2018), OEHHA included a short-form warning option as an acceptable alternative to the revised requirements for consumer product exposure...

The U.S. Environmental Protection Agency (EPA) announced on January 12, 2021, that it signed a memorandum of understanding (MOU) with the Occupational Safety and Health Administration (OSHA) “that advances collaboration and communication on EPA’s review of new chemicals under the Toxic Substances Control Act (TSCA).” The goal of the MOU is to improve the combined efforts of the agencies to protect workers who may be exposed to a new chemical substance by providing guidelines for...

On December 28, 2020, the House overrode President Trump’s veto and passed the National Defense Authorization Act for Fiscal Year 2021 (H.R. 6395) by a vote of 322 to 87, and the Senate passed the bill on January 1, 2021, by a vote of 81 to 13. Subtitle E of Title II of the Act (Subtitle E) includes the text of the bipartisan Sustainable Chemistry Research and Development Act of 2019. Subtitle E will establish an interagency working group led by the Office of Science and Technology...

On December 19, 2020, the Department of Health in Canada published in the Canada Gazette, Part I a notice of its intent to amend the Hazardous Products Regulations (HPR). The HPR is the federal level legislation that sets forth the classification, labeling, and Safety Data Sheet (SDS) requirements for hazardous products intended to be used, handled, or stored in workplaces in Canada. The HPR is based on the fifth revised edition (Rev 5) of the United Nations (UN) Globally...

On January 8, 2021, the U.S. Environmental Protection Agency (EPA) released the final risk evaluation for 1,4-dioxane. 86 Fed. Reg. 1495. The final risk evaluation identifies unreasonable risk to workers for 13 out of 24 conditions of use. EPA states that it found no unreasonable risk to the general population and the environment. EPA notes that it also published a supplemental analysis to the draft risk evaluation that evaluated eight additional conditions of use for 1,4-dioxane...

On January 6, 2021, the U.S. Environmental Protection Agency (EPA) issued a final rule on “Strengthening Transparency in Pivotal Science Underlying Significant Regulatory Actions and Influential Scientific Information.” 86 Fed. Reg. 469. EPA’s January 5, 2021, press release states the final rule establishes that when promulgating significant regulatory actions or developing influential scientific information, EPA will give greater consideration to studies where the...

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 2021. In this document, rich with detail and helpful content, the legal, scientific, and regulatory professionals of B&C, Acta, and BCCM distill key trends in U.S. and global chemical law and policy, and provide our best...

The U.S. Environmental Protection Agency (EPA) released on December 30, 2020, the final risk evaluation for asbestos, part 1: chrysotile asbestos. Of the six use categories evaluated (chlor-alkali diaphragms, sheet gaskets, other gaskets, oilfield brake blocks, aftermarket automotive brakes/linings, and other vehicle friction products), EPA states that it found that there is unreasonable risk to workers, occupational non-users (ONU), consumers, and/or bystanders within each of the six...

On December 21, 2020, the U.S. Environmental Protection Agency (EPA) released a proposed rule that would amend the 2018 Toxic Substances Control Act (TSCA) fees rule. According to EPA, the proposed rule “reflects real-world situations, narrows the broad scope of current requirements, significantly reduces the burden on American businesses, and increases the flexibility for surrounding TSCA fees requirements.” Under TSCA, EPA collects fees from chemical manufacturers and...