April 6, 2022

OSTP Publishes RFI Regarding Sustainable Chemistry

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...
March 24, 2022

PHMSA Seeks Comment on Initiative to Convert Historical LOIs into HMR FAQs

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...
March 18, 2022

House Committee Holds Hearing on Bioenergy RD&D for the Fuels and Chemicals of Tomorrow

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...
March 17, 2022

EPA Actions to Address PFAS in Commerce Include TSCA Compliance Notification Letter on PFAS in HDPE Containers

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...
March 14, 2022

EPA Posts Draft Document on “Modernizing the Process and Bringing Innovative Science to Evaluate New Chemicals Under TSCA”

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...
March 8, 2022

EPA Publishes Final Scope of D4 Risk Evaluation, Seeks Comment on Draft Revision to PV29 Risk Determination

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)...
March 7, 2022

EPA Will Extend Compliance Dates for Articles Containing PIP (3:1)

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...
March 1, 2022

EPA Holds Webinar on TSCA Requirements and PMN Process for Biofuels

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...
February 28, 2022

FIFRA Stakeholders: Update to How to Respond to an Enforcement Action or Inquiry

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....
February 22, 2022

Canadian Government Introduces Bill Intended to Modernize CEPA

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...
February 2, 2022

European Union Opens Consultation on Changes to EU REACH

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...
January 27, 2022

FDA Proposes Changes to FCN Program

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...
January 24, 2022

EPA Requests Comment on Draft TSCA Screening Methodology to Evaluate Chemical Exposures and Risks to Fenceline Communities

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)...
January 11, 2022

UK Proposes to Extend UK REACH Registration Deadline and Explore Alternative Information Requirements

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...
January 5, 2022

Forecast for U.S. Federal and International Chemical Regulatory Policy 2022

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,...
December 30, 2021

EPA Publishes Draft Scope of the Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos

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...
December 29, 2021

Draft Revision to Risk Determination for HBCD Retains Finding of Unreasonable Risk of Injury

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...
December 21, 2021

EPA Intends Draft TSCA Systematic Review Protocol to Strengthen Science Used in Chemical Risk Evaluations

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...
December 14, 2021

Proposition 65: OEHHA Modifies Proposed Changes to “Short-Form” Warnings

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...
December 9, 2021

EPA Publishes Updated NAMs Work Plan

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...