Memoranda

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...

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 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...

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 to...

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: Revision of the registration requirements,...

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 are...

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 Chemicals...

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...

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...

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...