Wrap-Up of Federal and State Chemical Regulatory Developments, May 2024

By Bergeson & Campbell, P.C.

May 17, 2024

TSCA/FIFRA/TRI

EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk To Human Health:On April 16, 2024, the U.S. Environmental Protection Agency (EPA) announced the availability of and requested public comment on a draft document titled “Draft Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos.” 89 Fed. Reg. 26878. EPA is evaluating legacy uses and associated disposals of asbestos, including chrysotile asbestos, five additional fiber types, asbestos-containing talc, and Libby asbestos. EPA states that it has used the best available science to determine preliminarily that asbestos poses unreasonable risk to human health. EPA held a webinar on May 13, 2024, to provide an overview of its risk evaluation. Comments are due June 17, 2024. EPA has entered into a consent decree to complete the final risk evaluation by December 1, 2024. Please read the full memorandum for more information on this draft risk evaluation.

EPA Amends Procedural Framework Rule For Conducting TSCA Risk Evaluations: EPA released a final rule on April 23, 2024, that amends the procedural framework rule for conducting risk evaluations under the Toxic Substances Control Act (TSCA). According to the final rule, published in the Federal Register on May 3, 2024, EPA reconsidered the procedural framework rule for conducting such risk evaluations and is revising certain aspects of that framework to align better with the statutory text and applicable court decisions, to reflect its experience implementing the risk evaluation program following enactment of the 2016 TSCA amendments, and to allow for consideration of future scientific advances in the risk evaluation process without the need to amend further the Agency’s procedural rule. 89 Fed. Reg. 37028. The final rule will take effect July 2, 2024. For more information on the final rule and our insightful commentary, please read the full memorandum.

EPA Accepting Comment On Proposed Consent Decrees To Settle Lawsuits Challenging Time To Complete TSCA Risk Evaluations:On April 26, 2024, EPA requested comment on proposed consent decrees that would address lawsuits filed by the Community In-Power and Development Association Inc. (CIDA), Learning Disabilities Association of America, Louisiana Environmental Action Network, Sierra Club, and Texas Environmental Justice Advocacy Services (CIDA Plaintiffs) in the U.S. District Court for the District of Columbia on September 18, 2023, CIDAv.EPA, Case No. 1:23-cv-02715 (the CIDA action), and by the American Chemistry Council (ACC) in the same court on December 19, 2023, ACC v. EPA, Case No. 1:23-cv-03726 (the ACC action). 89 Fed. Reg. 32424. The CIDA Plaintiffs and ACC filed cases pursuant to TSCA, alleging that EPA failed to perform non-discretionary duties under TSCA to complete timely several risk evaluations. The cases were consolidated on January 17, 2024. EPA is providing notice of the proposed consent decrees, which would resolve all claims in both cases by establishing deadlines for EPA to take action on the subject risk evaluations. Comments are due May 28, 2024. More information is available in our May 10, 2024, memorandum.

EPA Bans Most Uses Of Methylene Chloride, Requires Stronger Worker Safety Requirements For Remaining Industrial Uses: EPA issued on May 8, 2024, a final rule to address the unreasonable risk of injury to health presented by methylene chloride under its conditions of use (COU). 89 Fed. Reg. 39254. EPA notes in the final rule that TSCA “requires that EPA address by rule any unreasonable risk of injury to health or the environment identified in a TSCA risk evaluation and apply requirements to the extent necessary so that the chemical no longer presents unreasonable risk.” According to EPA, the final rule will prevent serious illness and death associated with uncontrolled exposures to methylene chloride by preventing consumer access to methylene chloride, restricting the industrial and commercial use of methylene chloride while also allowing for a reasonable transition period where an industrial and commercial use of methylene chloride is being prohibited; provide a time-limited exemption for a critical or essential use of methylene chloride for which no technically and economically feasible safer alternative is available; and protect workers from the unreasonable risk of methylene chloride while on the job. The final rule will be effective July 8, 2024. More information will be available in a forthcoming memorandum.

EPA Holds Webinar On “Reducing PFAS In Products: Progress And Challenges”: On May 8, 2024, EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) held a webinar on “Reducing PFAS in Products: Progress and Challenges.” The webinar was the third in EPA’s series on “Pollution Prevention in Action.” Jennie Romer, EPA Deputy Assistant Administrator for Pollution Prevention, hosts webinars featuring businesses, Pollution Prevention grantees, and other experts about innovations and successes in implementing source reduction strategies to advance sustainability across sectors. EPA will post a recording of the May 8, 2024, webinar on its website. Recordings of previous webinars are already available. More information on the webinar will be in a forthcoming memorandum.

Registration Open For May 23, 2024, NURA Program Webinar On “Validation, Qualification, And Regulatory Acceptance Of New Approach Methodologies: An ICCVAM Report”: The Physicians Committee for Responsible Medicine (PCRM) New Approach Methodologies (NAM) Use for Regulatory Application (NURA) program will hold a webinar on May 23, 2024, on “Validation, Qualification, and Regulatory Acceptance of New Approach Methodologies: An ICCVAM Report.” National Toxicology Program (NTP) Interagency Center for the Evaluation of Alternative Toxicological Methods (NICEATM) Director Dr. Nicole Kleinstreuer will present on the 2024 Interagency Coordinating Committee on the Validation of Alternative Methods (ICCVAM) Report. More information is available in our May 7, 2024, blog item.

EPA Will Host Webinar On Advancing Eye Irritation Assessment With Non-Animal Methods For Industrial Chemicals And Agrochemicals: EPA announced on May 8, 2024, that, in collaboration with the PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (DPR), on Wednesday, May 29, 2024, it will hold a webinar on the use of NAMs. The webinar, “Advancing Eye Irritation Assessment with Non-Animal Methods for Industrial Chemicals and Agrochemicals: Progress at the US EPA,” is the fourth webinar in a series hosted in collaboration with PSCI, IIVS, and DPR on the use of NAMs. The presenters for the webinar are Lindsay O’Dell, EPA’s Office of Pesticide Programs (OPP), and Renee Beardslee, Ph.D., EPA’s Office of Pollution Prevention and Toxics (OPPT). More information is available in our May 10, 2024, blog item.

EPA Announces Virtual Pesticide Program Dialogue Committee Meeting: On May 8, 2024, EPA announced that it will hold a virtual public meeting of the Pesticide Program Dialogue Committee (PPDC) on June 5 and June 6, 2024, from 11:00 a.m. to 5:00 p.m. (EDT). The meeting is open to the public, but registration to attend is required. Register to attend the meeting by May 29, 2024. To provide comments during the meeting, request special accommodations, or receive more information, please contact Jeffrey Chang by May 22, 2024. According to EPA, topics for the meeting will include:

An overview of OPP’s priorities and accomplishments for Fiscal Year (FY) 2024, including Pesticide Registration Improvement Act of 2022 (PRIA 5) and Endangered Species Act (ESA) implementation. Additional priorities include modernizing information technology infrastructure and developing a framework to improve how EPA evaluates antimicrobial resistance;

Updates from PPDC sub-workgroups, including the Pesticide Label Reform Workgroup, Emerging Pathogens Implementation Workgroup, and Pesticide Resistance Management Workgroup #2;

A discussion about the formation of a workgroup to address pesticide-related issues impacting the farmworker community. Potential charge questions will also be presented for discussion; and

A presentation on EPA’s effort to increase public awareness of Integrated Pest Management and other risk reduction best practices.

The agenda and additional information can be found here.

EPA Will Hold June 4, 2024, Webinar On Final Methylene Chloride Risk Management Rule: EPA will hold a webinar on June 4, 2024, on its final methylene chloride risk management rule. According to EPA, the webinar will provide an overview of EPA’s final regulatory action and implementation timeframes, as well as answer key questions submitted in advance by registered webinar attendees. To submit a question for EPA to consider for the webinar, registration must be completed by May 28, 2024. When registering, select “Yes” on the registration form when asked “Would you like to send your question to EPA?” and enter the question in the box provided. Questions may also be e-mailed to EPARulemaking@icf.com. Stakeholders may register to attend and listen only at any time up to June 3, 2024.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Denies Petition To Remove Stationary Combustion Turbines Source Category From List Of Categories Of Major Sources Of HAPs: On April 16, 2024, EPA announced its decision to deny a petition requesting the removal of the Stationary Combustion Turbines source category from the list of categories of major sources of hazardous air pollutants (HAP) subject to regulation under the Clean Air Act (CAA). 89 Fed. Reg. 26835. EPA states that it is denying the petition based on its determination that the petition is incomplete and because it found that the submitted information is inadequate to determine that no source in the category emits HAP in quantities that may cause a lifetime risk of cancer greater than one-in-one million to the individual in the population who is most exposed to emissions of such pollutants from the source. EPA is denying the petition with prejudice and will deny any future petition to delist as a matter of law unless such future petition is accompanied by substantial new information or analysis. Petitions for judicial review of this action must be filed by June 17, 2024.

EPA Updates CWA Methods For Analysis Of Effluent: EPA published a final rule on April 16, 2024, updating the test procedures required to be used by industries and municipalities when analyzing the chemical, physical, and biological properties of wastewater and other samples for reporting under the EPA’s National Pollutant Discharge Elimination System (NPDES) permit program. 89 Fed. Reg. 27288. EPA notes that the Clean Water Act (CWA) requires it to promulgate these test procedures for analysis of pollutants. EPA states that it anticipates that these changes will provide increased flexibility for the regulated community in meeting monitoring requirements while improving data quality. In addition, this update to the CWA methods will incorporate technological advances in analytical technology and make a series of minor changes and corrections to existing approved methods. According to the final rule, as such, EPA expects that these changes will not result in any negative economic impacts. The final rule will be effective June 17, 2024. The incorporation by reference (IBR) of certain material listed in this rule is approved by the Director of the Federal Register as of June 17, 2024.

EPA Issues Final Multi-Pollutant Emissions Standards For MYs 2027 And later Light-Duty And Medium-Duty Vehicles: On April 18, 2024, EPA established new, more protective emissions standards for criteria pollutants and greenhouse gases (GHG) for light-duty vehicles and Class 2b and 3 (medium-duty) vehicles that will phase-in over model years (MY) 2027 through 2032. 89 Fed. Reg. 27842. The final rule revises the GHG program in several areas, including off-cycle and air conditioning credits, the treatment of upstream emissions associated with zero-emission vehicles and plug-in hybrid electric vehicles in compliance calculations, medium-duty vehicle incentive multipliers, and vehicle certification and compliance. EPA also established new standards to control refueling emissions from incomplete medium-duty vehicles and battery durability and warranty requirements for light-duty and medium-duty electric and plug-in hybrid electric vehicles. The final rule makes minor amendments to update program requirements related to aftermarket fuel conversions, importing vehicles and engines, evaporative emission test procedures, and test fuel specifications for measuring fuel economy. The final rule will be effective June 17, 2024. The IBR of certain publications listed in this regulation is approved by the Director of the Federal Register beginning June 17, 2024. The IBR of certain other publications listed in this regulation is approved by the Director of the Federal Register as of March 27, 2023.

EPA Issues GHG Emissions Standards For Heavy-Duty Vehicles-Phase 3: EPA promulgated on April 22, 2024, new GHG emissions standards for MY 2032 and later heavy-duty highway vehicles that phase in starting as early as MY 2027 for certain vehicle categories. 89 Fed. Reg. 29440. According to EPA, the phase in revises certain MY 2027 GHG standards that were established previously under EPA’s GHG Emissions and Fuel Efficiency Standards for Medium- and Heavy-Duty Engines and Vehicles — Phase 2 rule (HD GHG Phase 2). The final rule also updates discrete elements of the Averaging Banking and Trading program, including providing additional flexibilities for manufacturers to support the implementation of the Phase 3 program balanced by limiting the availability of certain advanced technology credits initially established under the HD GHG Phase 2 rule. EPA also added warranty requirements for batteries and other components of zero-emission vehicles and requires customer-facing battery state-of-health monitors for plug-in hybrid and battery electric vehicles. The final rule includes clarifying and editorial amendments to certain highway heavy-duty vehicle provisions and certain test procedures for heavy-duty engines. The final rule will be effective June 21, 2024. The IBR of certain material listed in this rule is approved by the Director of the Federal Register beginning June 21, 2024. The IBR of certain other material listed in this rule was previously approved by the Director of the Federal Register as of March 27, 2023.

EPA Announces 45th Update Of The Federal Agency Hazardous Waste Compliance Docket: Since 1988, EPA has maintained a Federal Agency Hazardous Waste Compliance Docket (Docket) under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). CERCLA requires EPA to establish a Docket that contains certain information reported to EPA by federal facilities that manage hazardous waste or from which a reportable quantity of hazardous substances has been released. EPA published a notice on April 22, 2024, identifying the federal facilities not previously listed on the Docket and identifying federal facilities reported to EPA since the last update on October 26, 2023. 89 Fed. Reg. 29325. In addition to the list of additions to the Docket, the notice includes a section with revisions of the previous Docket list and a section of federal facilities that are to be deleted from the Docket. The list is current as of March 28, 2024.

EPA Designates PFOA And PFOS As CERCLA Hazardous Substances, Releases CERCLA Enforcement Discretion Policy: On April 19, 2024, EPA announced a final rule that will designate perfluorooctanoic acid (PFOA), perfluorooctanesulfonic acid (PFOS), and their salts and structural isomers as hazardous substances under CERCLA. EPA states that under the rule, entities are required to report immediately releases of PFOA and PFOS that meet or exceed the reportable quantity (RQ) of one pound within a 24-hour period to the National Response Center (NRC), state, Tribal, and local emergency responders. According to EPA, “[t]he designation of PFOA and PFOS as hazardous substances under CERCLA enables the agency to use one of its strongest enforcement tools to compel polluters to pay for or conduct investigations and cleanup, rather than taxpayers.” EPA issued a separate PFAS Enforcement Discretion and Settlement Policy Under CERCLA “that makes clear that EPA will focus enforcement on parties who significantly contributed to the release of [per- and polyfluoroalkyl substances (PFAS)] … into the environment, including parties that have manufactured PFAS or used PFAS in the manufacturing process, federal facilities, and other industrial parties.” The final rule will be effective July 8, 2024. 89 Fed. Reg. 39124.

PHMSA Publishes Notice Of Public Meetings In 2024 For International Standards On The Transport Of Dangerous Goods: The Pipeline and Hazardous Materials Safety Administration (PHMSA) announced on April 24, 2024, that its Office of Hazardous Materials Safety will host three public meetings during 2024 in advance of certain international meetings. 89 Fed. Reg. 31250. The first meeting will be held in preparation of the 64th session of the United Nations Sub-Committee of Experts on the Transport of Dangerous Goods (UNSCOE TDG) scheduled for June 24-July 3, 2024, in Geneva, Switzerland. The second meeting will be held in preparation of the International Civil Aviation Organization’s (ICAO) Dangerous Goods Panel (DGP) Working Group 24 (WG/24) tentatively scheduled for October 2024 in Montreal, Canada. The third meeting will be held in preparation of the 65th session of the UNSCOE TDG scheduled for November 25-December 3, 2024, in Geneva, Switzerland. For each of these meetings, PHMSA states that it will solicit public input on current proposals. Each public meeting will take place approximately two weeks preceding the international meeting at the U.S. Department of Transportation (DOT) Headquarters in Washington, D.C. A remote participation option will also be available. PHMSA will post specific information for each meeting when available on its website under “Upcoming Events.”

EPA Amends GHG Reporting Rule: EPA published a final rule on April 25, 2024, amending specific provisions in the GHG Reporting Rule to improve data quality and consistency. 89 Fed. Reg. 31802. The final rule updates the General Provisions to reflect revised global warming potentials; expands reporting to additional sectors; improves the calculation, recordkeeping, and reporting requirements by updating existing methodologies; improves data verifications; and provides for collection of additional data to inform better and be relevant to a wide variety of CAA provisions that EPA carries out. The final rule adds GHG monitoring and reporting for five source categories, including coke calcining; ceramics manufacturing; calcium carbide production; caprolactam, glyoxal, and glyoxylic acid production; and facilities conducting geologic sequestration of carbon dioxide with enhanced oil recovery. The revisions also include changes intended to improve implementation of the rule, such as updates to applicability estimation methodologies, simplifying calculation and monitoring methodologies, streamlining recordkeeping and reporting, and other minor technical corrections or clarifications. The final rule also establishes and amends confidentiality determinations for the reporting of certain data elements to be added or substantially revised in these amendments. The rule will be effective January 1, 2025. The IBR of certain material listed in this final rule is approved by the Director of the Federal Register beginning January 1, 2025. The IBR of certain other material listed in the rule was approved by the Director of the Federal Register as of January 1, 2018.

EPA Denies Petition To Classify Discarded PVC As RCRA Hazardous Waste: EPA announced on April 26, 2024, that it denied a petition filed by the Center for Biological Diversity (CBD) requesting that discarded polyvinyl chloride (PVC) be listed as a hazardous waste under the Resource Conservation and Recovery Act (RCRA). 89 Fed. Reg. 32416. EPA notes that the petition does not specifically request that EPA list discarded PVC as a hazardous waste pursuant to 40 C.F.R. Section 261.11(a)(1). EPA states that “it does provide some information that could be construed as relevant to a request for such a listing,” however. EPA notes that the petition specifically requests that EPA conduct a hazardous waste listing pursuant to 40 C.F.R. Section 261.11(a)(3). Accordingly, EPA has considered information to be relevant to the petition if it is relevant to either Section 261.11(a)(1) or (a)(3). On January 12, 2023, EPA proposed to deny the petition based on the lack of information provided by CBD. After considering public comment on the tentative denial, EPA “concludes that the Petition, even as supplemented by the information received through the public comment period, still provides insufficient information to justify a listing of discarded PVC as a hazardous waste at this time under either 261.11(a)(1) or 261.11(a)(3).”

EPA Issues First-Ever Drinking Water Standards For PFAS:EPA issued on April 26, 2024, the final National Primary Drinking Water Regulation (NPDWR) for six PFAS. 89 Fed. Reg. 32532. The NPDWR establishes Maximum Contaminant Levels (MCL) for six PFAS in drinking water: PFOA, PFOS, perfluorohexane sulfonic acid (PFHxS), perfluorononanoic acid (PFNA), and hexafluoropropylene oxide dimer acid (HFPO-DA) as contaminants with individual MCLs, and PFAS mixtures containing at least two or more of PFHxS, PFNA, HFPO-DA, and perfluorobutane sulfonic acid (PFBS) using a Hazard Index MCL to account for the combined and co-occurring levels of these PFAS in drinking water. EPA also issued final health-based, non-enforceable Maximum Contaminant Level Goals (MCLG) for these PFAS. The final rule will take effect June 25, 2024. For more information about the final rule, please read the full memorandum.

House Subcommittee Holds Hearing On EPA’s RMP Rule: The House Energy and Commerce Subcommittee on the Environment, Manufacturing, and Critical Materials held a hearing on May 7, 2024, on “EPA’s RMP Rule: Failures to Protect the American People and American Manufacturing.” The May 3, 2024, hearing memorandum states that EPA’s March 11, 2024, final rule amending the Risk Management Program (RMP) “include[s] several changes to the accident prevention program requirements for natural hazards, power loss, and [safer technologies and alternative analysis (STAA)], as well as enhancements to the emergency response requirements, expansion of public availability of chemical hazard information, third-party audit and recordkeeping requirements, and mandatory employee rights and participation.” The Subcommittee heard from the following witnesses:

The Honorable Gentner Drummond, Attorney General, State of Oklahoma;

Jatin Shah, Senior Principal Consultant, BakerRisk;

Richard Erstad, Vice President and General Counsel, Hawkins, Inc., on behalf of the Alliance of Chemical Distributors (ACD); and

James “Jim” Savage, Legislative Representative, United Steel, Paper and Forestry, Rubber, Manufacturing, Energy, Allied Industrial and Service Workers International Union.

EPA’s final rule took effect May 10, 2024. More information on the final rule is available in our March 5, 2024, memorandum.

EPA Amends NESHAP For EGUs Source Category: EPA published a final rule on May 7, 2024, amending the national emission standards for hazardous air pollutants (NESHAP) for the Coal- and Oil-Fired Electric Utility Steam Generating Units (EGU) source category. 89 Fed. Reg. 38508. EPA notes that the amendments are the result of its review of the 2020 Residual Risk and Technology Review (RTR). The changes, proposed under the technology review in April 2023, include amending the filterable particulate matter (fPM) surrogate emission standard for non-mercury metal HAPs for existing coal-fired EGUs, the fPM emission standard compliance demonstration requirements, and the mercury (Hg) emission standard for lignite-fired EGUs. Additionally, EPA is revising the definition of “startup.” The final rule will be effective July 8, 2024. The IBR of certain material listed in the rule was approved by the Director of the Federal Register as of April 16, 2012.

EPA Final Rule Addresses GHG Emissions From Fossil Fuel-Fired EGUs: EPA issued a final rule on May 9, 2024, under CAA Section 111 addressing GHG emissions from fossil fuel-fired EGUs. 89 Fed. Reg. 39798. First, EPA repealed the Affordable Clean Energy (ACE) Rule. Second, EPA issued final emission guidelines for GHG emissions from existing fossil fuel-fired steam generating EGUs, including both coal-fired and oil/gas-fired steam generating EGUs. Third, EPA revised the New Source Performance Standards (NSPS) for GHG emissions from new and reconstructed fossil fuel-fired stationary combustion turbine EGUs. Fourth, EPA revised the NSPS for GHG emissions from fossil fuel-fired steam generating units that undertake a large modification, based upon the eight-year review required by the CAA. EPA notes that it is not issuing final emission guidelines for GHG emissions from existing fossil fuel-fired stationary combustion turbines at this time; instead, EPA states that it intends to take further action on the proposed emission guidelines at a later date. The final rule will be effective July 8, 2024. The IBR of certain publications listed in the rule is approved by the Director of the Federal Register as of July 8, 2024. The IBR of certain other materials listed in the rule was approved by the Director of the Federal Register as of October 23, 2015.

EPA Amends NESHAP For Primary Copper Smelting Major And Area Source Categories: On May 13, 2024, EPA issued in final the RTR conducted for the Primary Copper Smelting major source category NESHAP. 89 Fed. Reg. 41648. EPA also issued in final the technology review for the Primary Copper Smelting area source NESHAP. The final amendments for the major source NESHAP include particulate matter (PM) emission standards as a surrogate for metal HAPs other than mercury (primarily lead and arsenic) for anode refining point sources, process fugitive emissions from roofline vents, Hoboken converter process fugitive capture systems where they combine with anode refining point sources, and new converters. The final rule also includes final emission standards for previously unregulated HAP, including mercury, benzene, toluene, hydrogen chloride (HCl), chlorine, polycyclic aromatic hydrocarbons (PAH), and dioxins and furans (D/F). In addition, EPA states that it is taking final action in the major source NESHAP to establish work practice standards for bypass stacks and to add a new emissions limit for lead and emissions control design standards to minimize process fugitive emissions at facilities with flash furnaces and Peirce-Smith converters. Final amendments for both the major source NESHAP and the area source NESHAP include removing exemptions and associated provisions for periods of startup, shutdown, and malfunction (SSM), specifying that the emission standards apply at all times, and requiring electronic reporting of performance test results and notification of compliance reports. The final rule was effective May 13, 2024, except for amendatory instruction 3, which is effective July 15, 2024. The IBR of certain publications listed in the rule is approved by the Director of the Federal Register as of May 13, 2024.

EPA Amends GHG Reporting Rule Requirements For Petroleum And Natural Gas Systems: EPA published a final rule on May 14, 2024, that amends requirements that apply to the petroleum and natural gas systems source category of the GHG Reporting Rule to ensure that reporting is based on empirical data, accurately reflects total methane emissions and waste emissions from applicable facilities, and allows owners and operators of applicable facilities to submit empirical emissions data that appropriately demonstrate the extent to which a charge is owed under the Waste Emissions Charge. 89 Fed. Reg. 42062. EPA also amended certain requirements that apply to the general provisions, general stationary fuel combustion, and petroleum and natural gas systems source categories of the GHG Reporting Rule to improve calculation, monitoring, and reporting of GHG data for petroleum and natural gas systems facilities. EPA states that this action also establishes and amends confidentiality determinations for the reporting of certain data elements to be added or substantially revised in these amendments. The rule will be effective January 1, 2025, except for Section 98.233 (amendatory instruction 12), Section 98.236 (amendatory instruction 16), and Section 98.238 (amendatory instruction 19), which will be effective July 15, 2024. The IBR of certain material listed in the final rule is approved by the Director of the Federal Register as of January 1, 2025.

FDA

FDA Releases Update On PFAS: On April 18, 2024, the U.S. Food and Drug Administration (FDA) released an April 2024 update on PFAS that highlights recent testing results and additional activities in which FDA is engaged to understand PFAS in the U.S. food supply. Of 95 samples tested, PFAS was detected in eight samples (two beef and six seafood samples). FDA concluded that the levels measured are “not likely to be a health concern for young children or the general population.” Additional information is available at the link here.

FDA Opens Comment Period For Color Additive Certification Fee Rule: On April 26, 2024, FDA reopened the comment period for the proposed rule “Color Additive Certification; Increase in Fees for Certification Services,” originally published on November 2, 2022. 89 Fed. Reg. 32384. FDA notes that it is reopening the comment period to add supporting information to the administrative record and to adjust the record to reflect the same cost and benefits figures that were published in the preliminary regulatory impact analysis. Electronic and written comments must be submitted by May 28, 2024.

FDA Publishes Final Rule For Pre-Harvest Agricultural Water: On May 6, 2024, FDA published a Food Safety Modernization Act (FSMA) final rule that replaces the previous pre-harvest water microbial quality criteria and testing requirements for certain produce with requirements for systems-based, pre-harvest agricultural water assessments for hazard identification and risk management decision-making purposes. 89 Fed. Reg. 37448. The updated requirements reflect recent science, findings from investigations of several produce-related outbreaks, and comments from interested parties. A summary of the final rule is available here. The final rule is effective July 5, 2024. FDA is holding a webinar on May 20, 2024, to provide an overview of the final rule and answer questions. Details on the webinar are available at the link here.

NANOTECHNOLOGY

EUON Welcomes New Study Proposals: The European Union (EU) Observatory for Nanomaterials (EUON) invited proposals for upcoming studies aimed at addressing knowledge gaps for nanomaterials within the EU market. Proposals were due April 30, 2024. More information is available in our April 23, 2024, blog item.

NIOSH Continues To Enroll Companies In NTRC Carbon Nanotube Registry: The National Institute for Occupational Safety and Health (NIOSH) posted a NIOSH Science Blog item on May 2, 2024, entitled “The Nanotechnology Research Center Carbon Nanotube Registry.” The NIOSH Nanotechnology Research Center (NTRC) maintains a Carbon Nanotube Registry, a roster of U.S. workers employed in various carbon nanotube industries. Companies that are interested in participating, have questions, or would like more information can contact NIOSH at nano@cdc.gov. More information is available in our May 2, 2024, blog item.

BIOBASED/RENEWABLE PRODUCTS/SUSTAINABILITY

B&C^® Biobased And Sustainable Chemicals Blog: For access to a summary of key legislative, regulatory, and business developments in biobased chemicals, biofuels, and industrial biotechnology, go to https://www.lawbc.com/brand/bioblog/.

LEGISLATIVE

Water Systems PFAS Liability Protection Act Introduced In The House: Representatives John Curtis (R-UT) and Marie Gluesenkamp-Perez (D-WA) introduced the Water Systems PFAS Liability Protection Act (H.R. 7944) on April 11, 2024. Curtis’ press release states that the bill would ensure that water utilities can continue to focus their efforts on maintaining water quality. According to the press release, EPA’s enforcement discretion policy is insufficient to ensure that drinking water and clean water ratepayers will be permanently protected from CERCLA legal defense costs and cleanup liability for PFAS.

Bicameral Legislation Would Ban Non-Essential PFAS Uses Within Ten Years: On April 18, 2024, Representative Betty McCollum (D-MN) announced that she and Senator Dick Durbin (D-IL) introduced the Forever Chemical Regulation and Accountability Act (H.R. 8074, S. 4187), “bicameral legislation to address the excessive use of [PFAS] across the nation’s supply chain, which has led to the harmful compounds contaminating water sources, as well as surrounding environments and communities.” According to McCollum’s press release, the bill would:

Initiate a National Academies of Sciences, Engineering, and Medicine (NASEM) study to review the persistence, bioaccumulation, and human health risks of PFAS. NASEM would also identify current PFAS uses and provide guidance on classification of essential or non-essential uses that will be used by EPA to require those designated “non-essential” be phased out;

Require all PFAS manufacturers and users to file reports with EPA to disclose certain information relating to PFAS and require manufacturers and users to submit a phaseout schedule of their products to be completed within ten years;

Direct EPA to facilitate phasing out non-essential PFAS production, consumption, and possession and to prohibit manufacturers and commercial users from releasing any PFAS into the environment within ten years;

Establish deadlines for manufacturers to remove PFAS from certain consumer goods such as rugs, furniture, and child products;

Reinforce that, to the maximum extent possible, PFAS should be eliminated from products or replaced by substitutes that reduce risk to human health and the environment. The bill also would direct federal agencies to maximize resources to achieve this goal;

Establish regional PFAS rapid response hubs to advance PFAS replacement and remediation;

Require EPA to collect fees to administer the reporting and petition processes;

Prevent large corporations from exploiting bankruptcy procedures to avoid persistent, bioaccumulative, and toxic chemicals (PBT), including PFAS, claims, ensuring that individuals who have been harmed by such chemicals can have their day in court; and

Update CERCLA to toll state statutes of limitations and statutes of repose for newly designated hazardous substances, such as PFAS, until the later of the date on which it was designated as a hazardous substance or when the plaintiff knew or reasonably should have known their injury was caused by the substance.

Bipartisan, Bicameral Clean Water Standards For PFAS Act Reintroduced In Congress: Representative Chris Pappas (D-NH) announced on April 18, 2024, that he and Senator Kirsten Gillibrand (D-NY), along with Representatives Brian Fitzpatrick (R-PA) and Dan Kildee (D-MI) re-introduced the bipartisan, bicameral Clean Water Standards for PFAS Act (H.R. 8076, S. 4161). According to Pappas, the legislation requires EPA to develop water criteria for PFAS under the CWA and provides EPA “with an ambitious yet achievable roadmap” to establish effluent limitations guidelines (ELG) and standards for eight priority industry categories for all measurable PFAS or classes of PFAS within three years. The bill also includes significant federal support to assist communities in upgrading their municipal water infrastructure to safeguard public health and protect ratepayers.

MISCELLANEOUS

EPA Releases Updated Interim Guidance On Destroying And Disposing Of Certain PFAS And PFAS-Containing Materials, Will Hold 180-Day Comment Period:EPA announced on April 9, 2024, the release of an updated “Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances.” According to EPA, the updated guidance “reflects the latest, best available science to provide information that managers of [per- and polyfluoroalkyl substances (PFAS)] wastes can use to evaluate the most appropriate destruction, disposal, or storage method among those currently available.” On April 16, 2024, EPA published a notice of availability of the interim guidance in the Federal Register, beginning a 180-day comment period. 89 Fed. Reg. 26879. Comments are due October 15, 2024. The updated interim guidance does not establish requirements for destruction or disposal of PFAS materials. For more information on the guidance, please read the full memorandum.

GAO Examines DOD Efforts To Address PFAS Contamination At Joint Base Pearl Harbor-Hickam: The U.S. Government Accountability Office (GAO) published a report on April 15, 2024, entitled “Persistent Chemicals: Navy Efforts to Address PFAS at Joint Base Pearl Harbor-Hickam.” The report describes the Department of Defense’s (DOD) response to a November 2022 aqueous film-forming foam (AFFF) release at the installation; DOD processes for ongoing monitoring and long-term cleanup of PFAS at Joint Base Pearl Harbor-Hickam; and DOD’s and EPA’s policies addressing PFAS in the environment. More information is available in our April 18, 2024, blog item.

OECA Issues Strategic Civil-Criminal Enforcement Policy: EPA’s Office of Enforcement and Compliance Assurance (OECA) has posted an April 17, 2024, memorandum regarding “Strategic Civil-Criminal Enforcement Policy” from David M. Uhlmann, OECA Assistant Administrator. The Strategic Civil-Criminal Enforcement Policy sets forth requirements to ensure that EPA’s enforcement program maintains and strengthens the strategic partnership between civil and criminal enforcement. According to the Policy, to promote collaborative strategic planning and ensure that EPA exercises its enforcement discretion fairly and consistently, the Policy requires:

Increased collaboration between the civil and criminal enforcement programs on the development and implementation of EPA’s national and regional priorities, including the National Enforcement and Compliance Initiatives (NECI) and regional strategic plans;

Enhanced case screening to promote fairness and consistency and robust discussion of what enforcement option should be used to address violations, including whether parallel proceedings should be initiated, and continued coordination throughout each enforcement action to ensure those initial case choices protect public health and the environment;

Improved case management through enhanced tracking of case screening that promotes information sharing about violations and ensures ready access to compliance histories and case developments, while maintaining enforcement confidentiality; and

Updated training programs to ensure effective partnership between civil and criminal enforcement offices that include the requirements of this Policy, factors to consider in deciding whether to pursue criminal, civil, or administrative enforcement, and best practices for managing information sharing and parallel proceedings to prevent case delays.

More information is available in our April 26, 2024, blog item.

GSA Publishes RFI Regarding PFAS In Products: According to an April 16, 2024, request for information (RFI), as part of its ongoing commitment to advancing sustainable acquisition, the General Services Administration (GSA) is exploring opportunities to reduce or eliminate potential PFAS “with the intent to reduce exposure from products offered to the Government through GSA’s contract solutions.” 89 Fed. Reg. 26887. GSA states that it is publishing the RFI to obtain comments “to help us understand potential areas for focus, and to identify potential unintended negative impacts.” According to the RFI, at this time, GSA has not determined whether it should work toward a notice of proposed rulemaking to address this topic. Comments are due June 17, 2024. More information is available in our April 17, 2024, blog item.

California DPR Announces Detailed Information On Proposed Registration Fee Increase And Information On Webinar Scheduled For April 23, 2024:On April 23, 2024, the California DPR held a webinar to discuss and receive feedback from registrants and other stakeholders on DPR’s intent to increase registration fees to a level that, according to DPR, supports the current and future business needs of the pesticide registration program. Comments on the proposed fee increases are due on or before May 17, 2024. Comments may be sent to regfees@cdpr.ca.gov, or by U.S. mail to Department of Pesticide Regulation, Pesticide Registration Branch, 1001 I Street, P.O. Box 4015, Sacramento, CA 95812-4015. Comments submitted by U.S. mail must be postmarked no later than May 17, 2024. For more information on the fee increases, please consult our April 19, 2024, blog item.

CPSC Announces Availability Of Final Supplemental Guidance For Its Chronic Hazard Guidelines: The Consumer Product Safety Commission (CPSC) announced on April 23, 2024, the availability of final supplemental guidance for its Chronic Hazard Guidelines. 89 Fed. Reg. 30326. The supplemental guidance contains two guidance documents, one for the use of benchmark dose methodology in risk assessment and the other for the analysis of uncertainty and variability in risk assessment. CPSC intends the Guidelines to assist firms in identifying products that present chronic hazards and to meet their labeling obligations under the Federal Hazardous Substances Act and the Labeling of Hazardous Art Materials Act.

EPA Announces Environmental Justice Clearinghouse: EPA announced on April 23, 2024, the Environmental Justice Clearinghouse, “a first-of-its-kind online collection of resources related to environmental justice.” According to EPA, the preliminary resources listed on the Environmental Justice Clearinghouse were submitted by agencies from across the federal government, including funding opportunities, screening and mapping tools, and technical assistance. The Environmental Justice Clearinghouse features searchable categories to simplify results for the public to ensure a more efficient and accessible process for accessing information related to environmental justice. EPA states that its Office of Environmental Justice and External Civil Rights will continue to add information on a rolling basis and welcomes input and any submissions from the public for review and potential inclusion.

EPA Announces Opportunity For Stakeholder Engagement In The ENERGY STAR Products Program Plans: EPA announced on April 24, 2024, an opportunity for public input on ENERGY STAR product specification development activities. 89 Fed. Reg. 31201. According to EPA, since its creation in 1992, the ENERGY STAR program has grown to designate highly efficient products in more than 75 categories, all of which are independently certified. EPA states that it relies on broad stakeholder engagement to develop and maintain its ENERGY STAR product specifications and grow and evolve the products portfolio. Through its products work, EPA also looks for innovative ways to accelerate market movement to greater efficiency. EPA has posted the ENERGY STAR products specification 2024 annual workplan to allow interested parties to determine how they wish to engage with EPA to track progress and share feedback. Stakeholders who are not ENERGY STAR partners and wish to stay informed about these specification development activities can e-mail join@energystar.gov to be added to the mailing list. The general public may also track specific opportunities for public input on the products public notices web page.

House And Senate Hold Hearings On EPA’s FY 2025 Budget Request: On April 30, 2024, the House Appropriations Subcommittee for Interior, Environment, and Related Agencies held a hearing on the FY 2025 budget request for EPA. The Senate Appropriations Subcommittee for the Interior, Environment, and Related Agencies held a separate hearing on EPA’s FY 2025 budget request on May 1, 2024, and the Senate Committee on Environment and Public Works held its own hearing on May 8, 2024. On May 15, 2024, the House Energy and Commerce Subcommittee on Environment, Manufacturing, and Critical Materials held a hearing. EPA Administrator Michael S. Regan testified before both of the House Subcommittees, the Senate Subcommittee, and the Senate Committee (written testimony is hyperlinked). More information will be available in a forthcoming memorandum.

ATSDR Opens Docket For Draft Toxicological Profiles For Acrolein, n-Hexane, And Naphthalene, 1-Methylnaphthalene, And 2-Methylnaphthalene: On May 3, 2024, the Agency for Toxic Substances and Disease Registry (ATSDR) announced the opening of a docket to obtain comments on drafts of three updated toxicological profiles: acrolein, n-hexane, and naphthalene, 1-methylnaphthalene, and 2-methylnaphthalene. 89 Fed. Reg. 36820. ATSDR states that it prepared the drafts based on current understanding of the health effects and availability of new studies and other information since their initial release. ATSDR considers key studies for these substances during the profile development process, using a systematic review approach. ATSDR seeks public comments and additional information or reports on studies about the health effects of these substances for review and potential inclusion in the profiles. ATSDR will evaluate the quality and relevance of such data or studies for possible inclusion in the profile. According to the online docket, comments are due August 1, 2024.

EPA, FDA, And USDA Issue Joint Regulatory Plan For Biotechnology: On May 8, 2024, EPA, FDA, and the U.S. Department of Agriculture (USDA) released a plan to update, streamline, and clarify their regulations and oversight mechanisms for products of biotechnology. The Coordinated Framework for the Regulation of Biotechnology: Plan for Regulatory Reform under the Coordinated Framework for the Regulation of Biotechnology (the Plan) provides a roadmap for actions the agencies will take, individually and collaboratively, to improve regulatory clarity, streamline regulatory oversight, reduce regulatory redundancies and gaps, and increase regulatory coordination for specific product categories and across the Coordinated Framework. The Plan identifies regulations and guidance documents that can be updated, streamlined, or clarified and identifies potential new guidance or regulations, where needed. These actions will focus on the following areas of biotechnology product regulation: modified plants; modified animals; modified microorganisms; human drugs, biologics, and medical devices; and cross-cutting issues. More information will be available in a forthcoming memorandum.

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