Bergeson & Campbell, P.C. extends its best wishes to our clients and many friends. We wish you and your family a safe and healthy New Year. As we have for many years, the firm has made a contribution to the House of Ruth, a shelter for battered women and their children, in lieu of gifts to our clients, and on our clients’ behalf.

Register Now For “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2025,” January 14, 2024, 11:00 a.m. – 12:00 p.m. (EST), Via Webinar: Registration is now open for Bergeson & Campbell, P.C.’s (B&C^®) “What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2025” webinar. Lynn L. Bergeson, Managing Partner, B&C; James V. Aidala, Senior Government Affairs Consultant, B&C; Richard E. Engler, Ph.D., Director of Chemistry, B&C; and Mark J. Washko, Senior Government Affairs Advisor, B&C, will engage in a lively, timely, and focused discussion on the new Administration and expected impacts on the regulated community in 2025.

B&C Launches “Public Policy and Regulation Blog^™”: B&C is pleased to announce the launch of the Public Policy and Regulation Blog to provide insights on policy developments affecting the manufacturing, use, and regulation of industrial and agricultural chemicals and the products they make possible. B&C’s legal and government affairs professionals possess the requisite skill set needed to offer expert commentary on the complex intersection of science, law, and public policy. This blog goes beyond updates on news and legislation, drawing on B&C’s unique blend of expertise to share seasoned perspectives on legislative developments, focusing on what they mean to the chemical and chemical products community.

B&C And Acta To Publish Forecast 2025: Start 2025 with the information you need — B&C and The Acta Group (Acta^®) will publish our Forecast for U.S. Federal and International Chemical Regulatory Policy 2025 the first week of January 2025. In the Forecast, our legal, scientific, and regulatory professionals distill key trends in U.S. and global chemical law and provide their best-informed judgment of key developments likely in the coming year.

TSCA/FIFRA/TRI

EPA Releases Final Supplement To The Risk Evaluation And Revised Unreasonable Risk Determination For 1,4-Dioxane: On November 13, 2024, the U.S. Environmental Protection Agency (EPA) announced the release of its final supplement to the risk evaluation and revised unreasonable risk determination for 1,4-dioxane under the Toxic Substances Control Act (TSCA). 89 Fed. Reg. 89993. EPA states in the Federal Register notice that it “used the best available science to prepare this final supplement to the risk evaluation and has determined that 1,4-dioxane poses unreasonable risk to human health.” EPA notes that under TSCA, it now must initiate risk management actions to address the unreasonable risk. More information is available in our December 10, 2024, memorandum.

EPA Issues ANPRM Under TSCA Section 6 On 6PPD And 6PPD-Quinone: On August 1, 2023, Earthjustice filed a petition under TSCA Section 21 asking EPA to establish regulations prohibiting the manufacturing, processing, use, and distribution of the chemical N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) for and in tires. Earthjustice filed the petition on behalf of the Yurok Tribe, the Port Gamble S’Klallam Tribe, and the Puyallup Tribe of Indians, and EPA granted the petition in November 2023. On November 19, 2024, EPA published an advance notice of proposed rulemaking (ANPRM) to solicit and collect information from the public on the potential risks associated with 6PPD and its transformation product, 6PPD-quinone. 89 Fed. Reg. 91299. EPA also seeks information about potential alternatives and regulatory options to help inform its consideration of potential future regulatory actions under TSCA. Comments are due January 21, 2025. More information is available in our November 19, 2024, memorandum.

EPA Issues Final Rule Revising PBT Rules For decaBDE And PIP (3:1): On November 19, 2024, EPA issued a final rule revising the regulations for decabromodiphenyl ether (decaBDE) and phenol, isopropylated phosphate (3:1) (PIP (3:1)), two of the five persistent, bioaccumulative, and toxic (PBT) chemicals addressed in final rules issued under TSCA in January 2021. 89 Fed. Reg. 91486. According to the final rule, after receiving additional comments, EPA “has determined that revisions to the decaBDE and PIP (3:1) regulations are necessary to address implementation issues and to further reduce the potential for exposures to decaBDE and PIP (3:1) for humans and the environment to the extent practicable.” EPA notes that it is not revising the chemical-specific provisions for the other three PBT chemical substances addressed in 40 C.F.R. Part 751, Subpart E (2,4,6-tris(tert-butyl)phenol (2,4,6-TTBP), hexachlorobutadiene (HCBD), and pentachlorothiophenol (PCTP)). The final rule will take effect January 21, 2025. More information is available in our November 13, 2024, memorandum.

EPA Extends Deadline For Public Comment On Manufacture Of Certain PFAS During Fluorination Of HDPE And Other Plastic Containers: On November 20, 2024, EPA announced an extension to the comment period for the notice published September 30, 2024, seeking public comment on the manufacture of certain per- and polyfluoroalkyl substances (PFAS), including perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA), during the fluorination of high-density polyethylene (HDPE) and other plastic containers to inform regulations as appropriate under TSCA. 89 Fed. Reg. 91739. That notice established a public comment period that was scheduled to end November 29, 2024. According to EPA, it received a request to extend the comment period “from an interested stakeholder who requested additional time to collect information relating to EPA’s notice and develop thoughtful responses to the issues raised in EPA’s notice.” EPA states that it “believes it is appropriate to extend the comment period in order to give stakeholders including the requester additional time to identify and gather information related to the issues identified in EPA’s notice and to prepare comprehensive comments.” Comments are now due December 30, 2024. More information on EPA’s request for information is available in our October 9, 2024, memorandum.

EPA Announces Release Of Draft Guidance To Support Registration Of Pre-saturated Disinfecting Wipes: On November 20, 2024, EPA announced the release of its draft guidance for public comment to support registration and evaluation of efficacy claims for pre-saturated antimicrobial towelettes on hard non-porous surfaces such as stainless steel, metal, glass, hard plastic, or sealed wood, commonly seen in the market as “disinfecting wipes,” using a recently approved standard test method. The draft guidance is available at EPA-HQ-OPP-2024-0414-0004. Comments are due on or before January 21, 2025. More information is available in our December 4, 2024, blog.

District Court Approves Consent Decrees Establishing Deadlines For Completing TSCA Risk Evaluations: On November 22, 2024, the U.S. District Court for the District of Columbia entered two consent decrees establishing deadlines for completing risk evaluations for 20 High-Priority Chemicals and two manufacturer-requested risk evaluations (MRRE). The Community In-Power and Development Association Inc. (CIDA), v. EPA, Case No. 1:23-cv-02715. As reported in our May 10, 2024, memorandum, CIDA, the Learning Disabilities Association of America, Louisiana Environmental Action Network, Sierra Club, and Texas Environmental Justice Advocacy Services (CIDA Plaintiffs) filed suit in the U.S. District Court for the District of Columbia on September 18, 2023, and the American Chemistry Council (ACC) filed suit in the same court on December 19, 2023. The CIDA Plaintiffs and ACC claim that EPA failed to perform non-discretionary duties under TSCA to complete timely several risk evaluations. The cases were consolidated on January 17, 2024. Under the consent decree with the CIDA Plaintiffs, EPA will complete its risk evaluations for the High-Priority Chemicals in accordance with the following schedule:

• EPA shall transmit to the Office of the Federal Register notices of availability of draft risk evaluations for at least six of the High-Priority Chemicals, including a draft risk evaluation for 1,3-butadiene, by no later than December 31, 2024. EPA issued its draft risk evaluation on December 2, 2024, and more information will be available in a forthcoming memorandum;
• EPA shall transmit to the Office of the Federal Register notices of availability of final risk evaluations for three of the High-Priority Chemicals, identified as tris(2-chloroethyl) phosphate (TCEP), formaldehyde, and 1,1-dichloroethane, by no later than December 31, 2024;
• EPA shall transmit to the Office of the Federal Register a notice of availability of draft risk evaluation for at least one of the remaining High-Priority Chemicals by no later than March 31, 2025;
• EPA shall transmit to the Office of the Federal Register notices of availability of final risk evaluations for seven of the remaining High-Priority Chemicals, one of which shall be 1,3-butadiene, by no later than December 31, 2025; and
• EPA shall transmit to the Office of Federal Register notices of availability of final risk evaluations for the remaining ten High-Priority Chemicals by no later than December 31, 2026.

Under the consent decree with ACC, EPA will complete its risk evaluations for the MRRE chemicals in accordance with the following schedule:

• EPA shall transmit a notice of availability of final risk evaluation for di-isodecyl phthalate (DIDP) to the Office of the Federal Register by no later than December 31, 2024; and
• EPA shall transmit a notice of availability of final risk evaluation for di-isononyl phthalate (DINP) to the Office of the Federal Register by no later than January 15, 2025.

EPA Announces The Availability Of Thousands Of Records On EPA’s Review Of Studies On Pesticides: On November 22, 2024, EPA announced the availability of more than 4,500 Data Evaluation Records (DER) in ChemView, a public portal that houses data and review of toxic chemicals. EPA defines a DER as the documented EPA review of studies submitted during the request to register a pesticide or during the registration review process. The studies for which EPA may prepare a DER include product chemistry, toxicology, ecological effects, human exposure, spray drift, environmental fate, and residue chemistry. Importantly, EPA states that DERs do not contain confidential business information (CBI). For more information, please read our November 26, 2024, blog.

EPA’s Final Asbestos Part 2 Risk Evaluation Concludes That Asbestos Poses Unreasonable Risk To Human Health: On November 27, 2024, EPA released the final Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos (Asbestos Part 2) conducted under TSCA. 89 Fed. Reg. 95777. EPA evaluated legacy uses and associated disposals of asbestos, including chrysotile asbestos, five additional fiber types, conditions of use (COU) for asbestos-containing talc that are subject to TSCA, and Libby asbestos. EPA states in the Federal Register notice that it used the best available science to prepare this final supplemental risk evaluation and determined, based on the weight of scientific evidence, that asbestos poses unreasonable risk to human health. EPA notes that under TSCA, it now must initiate risk management actions to address the unreasonable risk. More information will be available in a forthcoming memorandum.

EPA Proposes To Update Proposed SNURs For 17 PFAS, Designating Manufacture (Including Import) As A Significant New Use: On November 29, 2024, EPA issued a supplemental notice of proposed rulemaking (SNPRM) that would update the December 2, 2022, proposed significant new use rules (SNUR) for 17 PFAS that were the subject of premanufacture notices (PMN) and are also subject to an Order issued by EPA pursuant to TSCA. 89 Fed. Reg. 94642. The SNURs would require persons who intend to manufacture (defined by statute to include import) or process any of these 17 PFAS to notify EPA at least 90 days before commencing that activity. EPA notes that the manufacture or processing may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination. Comments are due December 30, 2024. More information is available in our December 6, 2024, blog item.

EPA Proposes Batches Of SNURs For Certain Chemicals: On November 29, 2024, EPA proposed SNURs for certain chemical substances that were the subject of PMNs. 89 Fed. Reg. 94635. EPA notes that the chemical substances received “not likely to present an unreasonable risk” determinations pursuant to TSCA. On December 2, 2024, EPA proposed SNURs for certain chemical substances that were the subject of PMNs and are also subject to an Order issued by EPA pursuant to TSCA. 89 Fed. Reg. 95688. Both batches of SNURs would require persons to notify EPA at least 90 days before commencing the manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. The required notification initiates EPA’s evaluation of the conditions of that use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification; made an appropriate determination regarding that notification; and taken such actions as required by that determination. Comments are due December 30, 2024, and January 2, 2025, respectively.

EPA Announces Proposed Rule To Revoke Most Food Uses Of The Insecticide Chlorpyrifos: On December 2, 2024, EPA announced a proposed rule to revoke all tolerances for chlorpyrifos except for those tolerances associated with the 11 food and feed crops that remain registered. 89 Fed. Reg. 99184. EPA is taking this action in response to a decision by the U.S. Court of Appeals for the Eighth Circuit. Comments on the proposed rule are due on or before February 10, 2025. Comments can be submitted to docket ID EPA-HQ-OPP-2024-0431 at www.regulations.gov. More information is available in our December 11, 2024, blog.

EPA Releases Proposed Guidance For Antimicrobial Pesticides That Require Endangered Species Act Reviews: On December 2, 2024, EPA released, and is seeking public comment on, its proposed guidance for antimicrobial pesticide registrants intended to improve the efficiency of Endangered Species Act (ESA) considerations for new active ingredients, new uses, and registration review actions for antimicrobial pesticides. Comments are due on or before January 1, 2025. More information is available in our December 6, 2024, blog.

EPA Preliminarily Determines That 1,3-Butadiene Presents An Unreasonable Risk Of Injury To Human Health For Workers And The General Population: On December 3, 2024, EPA announced the availability of the draft risk evaluation for 1,3-butadiene. 89 Fed. Reg. 95779. EPA preliminarily determined that 1,3-butadiene presents an unreasonable risk of injury to human health for workers and the general population (including fenceline communities) from inhalation exposure. EPA prepared the draft risk evaluation under TSCA and will submit it to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA also announced that there will be two virtual public meetings of the SACC: on February 4, 2025, a preparatory meeting for the SACC to consider the scope and clarity of the draft charge questions for the peer review; and on February 25 through 28, 2025, the peer review meeting for SACC to consider the draft documents and public comments. Comments on the draft risk evaluation are due February 3, 2025. More information will be available in a forthcoming memorandum.

EPA Seeks Ad Hoc Reviewers For BBP, DBP, DEHP, DIBP, And DCHP Technical Support Documents: EPA announced on December 3, 2024, that it is seeking public nominations of scientific and technical experts that EPA can consider for service as ad hoc reviewers assisting SACC with the peer review of the technical support documents for benzyl butyl phthalate (BBP), dibutyl phthalate (DBP), di(2-ethylhexyl) phthalate (DEHP), diisobutyl phthalate (DIBP), and dicyclohexyl phthalate (DCHP) and the cross-phthalate technical support documents for human health benchmark dose (BMD) analysis, cancer analysis, and cumulative risk analysis. 89 Fed. Reg. 95782. EPA plans to convene a virtual public meeting of SACC in spring 2025 to review the technical support documents. Nominations are due January 2, 2025.

EPA Amends New Chemicals Regulations To Improve Efficiency, Remove LVE And LoREX Exemptions For PFAS And Certain PBTs: On December 4, 2024, EPA released a final rule amending the new chemicals procedural regulations under TSCA. EPA states in the pre-publication version of the final rule that the amendments align the regulatory text with the amendments to TSCA’s new chemicals review provisions contained in the 2016 Frank R. Lautenberg Chemical Safety for the 21st Century Act (Lautenberg Act) and “will improve the efficiency of EPA’s review processes, and update the regulations based on existing policies and experience implementing the New Chemicals Program.” EPA notes that the final rule includes amendments that will increase the quality of information initially submitted in new chemicals notices and improve its processes for timely, effective completion of individual risk assessments and the new chemicals review process overall. EPA is also amending the regulations for low volume exemptions (LVE) and low release and exposure exemptions (LoREX), which will require EPA approval of an exemption notice prior to commencement of manufacture, make PFAS categorically ineligible for these exemptions, and provide that certain PBT chemical substances are ineligible for these exemptions. The final rule will take effect 30 days after publication in the Federal Register. More information will be available in a forthcoming memorandum.

EPA Announces The Issuance Of First Voucher To Incentivize The Development Of Novel Mosquito Control Products: On December 6, 2024, EPA announced that it has issued its first voucher under its Vector Expedited Review Voucher (VERV) Program as a result of a recent approval by EPA of a new active ingredient, Wolbachia pipientis wAlbB strain. The VERV Program, which is required by the Pesticide Registration Improvement Act of 2022 (PRIA 5) and announced in December 2023, was developed in response to ongoing challenges with mosquito control due to developing resistance to currently registered pesticides. VERV gives companies incentives to develop novel or unique mosquito control products to help prevent the spread of mosquito-borne diseases like malaria, dengue, and Zika. More information is available in our December 13, 2024, blog.

Final Risk Management Rules Will Ban All Uses Of TCE And All Consumer And Many Commercial Uses Of PCE: On December 9, 2024, EPA announced the release of final risk management rules for trichloroethylene (TCE) and perchloroethylene (PCE). According to EPA, “all uses of TCE will be banned over time (with the vast majority of identified risks eliminated within one year), and safer alternatives are readily available for the majority of uses.” The final rule for PCE will ban manufacture, processing, and distribution in commerce of PCE for all consumer uses and many commercial uses, while allowing some workplace uses to continue only where robust workplace controls can be implemented. EPA notes that the chemicals can often serve as alternatives for each other. For several uses of TCE that will be totally prohibited, there is an analogous use of PCE that can continue safely in perpetuity under workplace controls. EPA states that some examples of uses that will be prohibited under the TCE rule but will continue under the PCE rule include: industrial and commercial use as an energized electrical cleaner, in laboratory use for asphalt testing and recovery, use to make refrigerants and other chemicals, and for vapor degreasing. More information will be available in a forthcoming memorandum.

EPA Announces Schedule For TSCA Risk Evaluations Of Phthalates: EPA announced on December 10, 2024, its schedule for releasing TSCA draft risk evaluations and supporting documents for five phthalate chemicals: BBP, DBP, DEHP, DIBP, and DCHP. EPA states that it will also release a draft cross-phthalate technical support document for human health BMD analysis, cancer analysis, and cumulative risk analysis for BBP, DBP, DEHP, DIBP, DCHP, and DINP. Separately, EPA will “soon” release final risk evaluations for DIDP and DINP.

EPA Releases Final Risk Management Rule For Carbon Tetrachloride, Will Establish Workplace Safety Requirements For Most COUs: On December 11, 2024, EPA released a final risk management rule that will ban some uses of carbon tetrachloride that have already ceased and establish robust workplace protections, including a Workplace Chemical Protection Program (WCPP) and prescriptive controls, for uses not prohibited to address the unreasonable risk to human health. EPA states that some uses prohibited by the proposed rule will be allowed to continue under the final rule, because public comments and supporting information demonstrated both that the uses were ongoing and that the workplace protections could be implemented. Uses of carbon tetrachloride allowed to continue under the WCPP (which includes inhalation exposure limits and dermal protections) include:

• Incorporation into formulation, mixture or reaction products in agricultural products manufacturing, vinyl chloride manufacturing (originally proposed for prohibition), and other basic organic and inorganic chemical manufacturing;
• Repackaging for use as a laboratory chemical;
• Use as a processing aid to manufacture agricultural products;
• Use as a processing aid to manufacture vinyl chloride (originally proposed for prohibition);
• Use in the elimination of nitrogen trichloride in the production of chlorine and caustic soda and the recovery of chlorine in tail gas from the production of chlorine;
• Import, recycling, disposal, and domestic manufacture of carbon tetrachloride; and
• Processing as a reactant in the production of hydrochlorofluorocarbons (HCFC), hydrofluorocarbons (HFC), hydrofluoroolefins (HFO), and PCE.

More information will be available in a forthcoming memorandum.

District Court Dismisses Suit Seeking TSCA Section 6 Rule Prohibiting Production Of PFOA During Fluorination Of Plastic Containers: On December 11, 2024, the U.S. District Court for the District of Columbia dismissed a suit filed against EPA seeking a rule under TSCA Section 6 to prohibit the production of PFOA during Inhance Technologies, LLC’s (Inhance) fluorination process. Public Employees for Environmental Responsibility (PEER) v. Regan (No. 2024-2194). As reported in our July 30, 2024, blog item, PEER and the Center for Environmental Health (CEH) filed suit on July 25, 2024. As noted in the court’s decision dismissing the case, before PEER and CEH filed suit, on July 10, 2024, EPA granted their April 11, 2024, TSCA Section 21 petition seeking a TSCA Section 6 rule prohibiting the manufacture, processing, use, distribution in commerce, and disposal of three PFAS formed during the fluorination of plastic containers. The court states that it agrees with EPA that it has fulfilled any nondiscretionary duties under TSCA, and it granted EPA’s motion to dismiss. Inhance had moved to intervene in the suit, and the court denied the motion as moot. More information on the petition is available in our July 16, 2024, memorandum.

EPA Issues SNURs For Certain Chemicals: EPA issued SNURs on December 12, 2024, for certain chemical substances that were the subject of PMNs and are also subject to an Order issued by EPA pursuant to TSCA. 89 Fed. Reg. 100361. The SNURs require persons to notify EPA at least 90 days before commencing the manufacture (defined by statute to include import) or processing of any of these chemical substances for an activity that is designated as a significant new use in the SNUR. The required notification initiates EPA’s evaluation of the conditions of that use for that chemical substance. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification; made an appropriate determination regarding that notification; and taken such actions as required by that determination. This rule is effective February 10, 2025.

EPA Requires Submission Of Health And Safety Studies For 16 Chemicals Being Considered For TSCA Risk Evaluation: EPA published on December 13, 2024, a final rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed. Reg. 100756. EPA identified 15 of the chemical substances as potential candidates for prioritization through a screening process based on a combination of hazard, exposure (including uses), and persistence and bioaccumulation characteristics. EPA also included the 6PPD transformation product 6PPD-quinone due to a response to a recent citizen’s petition filed under TSCA Section 21 on 6PPD and 6PPD-quinone. According to the final rule, health and safety studies sought by this action will inform EPA actions in carrying out its responsibilities pursuant to TSCA, including prioritization, risk evaluation, and risk management. The final rule will be effective January 13, 2025. More information will be available in a forthcoming memorandum.

EPA Announces 2025 Annual Pesticide Maintenance Fee Forms Available To Download From EPA Website — Deadline For Paying Is January 15, 2025: EPA has released the annual pesticide registration maintenance fee materials for fiscal year (FY) 2025. The deadline for payment of EPA’s annual maintenance fee for pesticide registration is January 15, 2025. Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) Section 4(i)(1)(A) requires everyone who holds an active or suspended pesticide registration granted under FIFRA Sections 3 and 24(c) (special local needs) to pay an annual maintenance fee to keep the registration in effect. The maintenance fee requirement does not apply to supplemental distributor registrations, which are identified by a three-element registration number.

Registrants should receive an e-mail from EPA notifying them of the FY 2025 maintenance fee materials. EPA will not send maintenance fee information by mail. The instructions, maintenance fee filing form, fee tables, and product listings grouped by company number are available to download on EPA’s website. After payment, the completed forms and supporting documents must be e-mailed to maintfee@epa.gov. The entire process remains electronic in 2025; thus, a paper copy of the maintenance fee materials should not be mailed to EPA.

The fee for 2025 is $4,875 for each registration, the same amount as for FY 2024, up to the maximum fees that can be assessed to a single registrant. Each registrant of a pesticide must pay the annual fee and e-mail the response to EPA by Wednesday, January 15, 2025. Registrations for which the fee is not paid will be canceled, by order and without a hearing. As in years past, payment must be made electronically online at www.pay.gov.

For certain qualified small businesses, the first product registration maintenance fee may be reduced by 25 percent if the applicant meets the following criteria:

1. 1. The applicant has 500 or fewer employees globally;

    

2. 2. During the three-year period prior to the most recent maintenance fee billing cycle, the applicant has average annual gross revenue from all sources that does not exceed $10 million; and

    

3. 3. The applicant holds a total of five or fewer registrations subject to the maintenance fee.

There also are maintenance fee waivers for products that meet the criteria in two specific categories: minor agricultural use products and public health pesticides. The procedure for requesting a fee waiver for individual products is described in the instructions provided by EPA.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA’s Tackling Emerging Contaminants Initiative Will Reduce Exposure To PFAS And Other Emerging Contaminants In Water: EPA announced on November 20, 2024, the launch of the Tackling Emerging Contaminants (TEC) initiative, a new, no-cost technical assistance effort focused on reducing exposure to PFAS and other emerging contaminants in small or disadvantaged communities. According to EPA, the objective of the TEC Water Technical Assistance (WaterTA) is to support small or disadvantaged communities assess and address emerging contaminants and PFAS in drinking water, help connect more communities to historic federal funding through the Bipartisan Infrastructure Law (BIL), and help communities comply with the PFAS National Primary Drinking Water Regulation (NPDWR). More information is available in our November 21, 2024, blog item.

EPA Issues Memoranda On PFAS NPDWR: EPA issued two memoranda on November 21, 2024, that provide drinking water primacy agencies, laboratories, and water systems with clarifying information related to the monitoring and reporting requirements under the PFAS NPDWR. According to EPA, the memoranda are similar and include information on the initial monitoring requirements and how previously collected data, such as data from the fifth Unregulated Contaminant Monitoring Rule (UCMR 5), can be used to satisfy some or all of these requirements and inform PFAS compliance monitoring frequency determinations. EPA states that additionally, the memoranda provide information related to laboratory analytical requirements and recommendations for reporting of PFAS drinking water sample results.

EPA Amends Guideline On Air Quality Models: EPA promulgated revisions to the Guideline on Air Quality Models (Guideline) on November 29, 2024. 89 Fed. Reg. 95034. EPA notes that the Guideline has been incorporated into its regulations, satisfying a requirement under the Clean Air Act (CAA) for EPA to specify, with reasonable particularity, models to be used in the Prevention of Significant Deterioration (PSD) program. The Guideline provides EPA-preferred models and other recommended techniques, as well as guidance for their use in predicting ambient concentrations of air pollutants. EPA is revising the Guideline, including enhancements to the formulation and application of the EPA’s near-field dispersion modeling system, AERMOD, and updates to the recommendations for the development of appropriate background concentration for cumulative impact analyses. The rule will be effective January 28, 2025.

EPA Amends NESHAP For Rubber Tire Manufacturing: On November 29, 2024, EPA issued a final rule amending the National Emission Standards for Hazardous Air Pollutants (NESHAP) for Rubber Tire Manufacturing. 89 Fed. Reg. 94886. To ensure that all emissions of hazardous air pollutants (HAP) from sources in the source category are regulated, EPA states that it is promulgating emissions standards for the rubber processing subcategory of the rubber tire manufacturing industry, which is the only unregulated subcategory within the Rubber Tire Manufacturing source category. The final rule was effective November 29, 2024. The incorporation by reference (IBR) of certain publications listed in the rule is approved by the Director of the Federal Register as of November 29, 2024.

EPA Releases TracMyAir Web Application For Researchers: EPA announced on December 9, 2024, the availability of TracMyAir, a web application that predicts near real-time individual air pollution exposure and dose for fine particulate matter and ozone. The web app is a research tool for scientists conducting epidemiologic and field studies of air pollution. TracMyAir runs two models: EPA’s Exposure Model for Individuals (EMI) and Microenvironment Tracker (MicroTrac). Researchers can export all input and output data to a file to use for subsequent analysis (EPA notes that no user-provided information is stored and will be deleted after closing the app).

EPA Makes Technical Corrections To The Hazardous Waste Generator Improvements Rule, The Hazardous Waste Pharmaceuticals Rule, And The Definition Of Solid Waste Rule: EPA issued a final rule on December 11, 2024, making five amendments that were included in its August 9, 2023, direct final rule that made technical corrections to the 2016 Hazardous Waste Generator Improvements Rule, the 2019 Hazardous Waste Pharmaceuticals Rule, and the 2018 Vacatur of the Definition of Solid Waste Rule. 89 Fed. Reg. 99727. The provisions in the final rule relate to the 2016 Hazardous Waste Generator Improvements Rule and the 2019 Hazardous Waste Pharmaceuticals Rule. According to EPA, these technical corrections will correct or clarify the regulations for generators and handlers of hazardous waste. EPA is also responding in the preamble to the adverse comments on the items that are included in this action. The three provisions not included in the final rule will not go into effect with this action, and EPA states that it is not responding to the adverse comments on these three provisions. The final rule is effective on February 10, 2025.

EPA Issues Final Rule Amending Restrictions On Use Of HFCs In Variable Refrigerant Flow Air Conditioning Subsector: On December 12, 2024, EPA amended a provision of the 2023 Technology Transitions regulations promulgated under the American Innovation and Manufacturing (AIM) Act. 89 Fed. Reg. 100381. The final rule provides until January 1, 2027, for the installation of certain new variable refrigerant flow air conditioning and heat pump systems that use components manufactured in the United States or imported into the United States prior to January 1, 2026. This action also provides until January 1, 2028, for the installation of certain new variable refrigerant flow air conditioning and heat pump systems if a building permit that approves the use of an HFC or blend containing an HFC in such a system was issued prior to October 5, 2023, provided that the system uses components manufactured in the United States or imported into the United States prior to January 1, 2026. According to EPA, this action will mitigate the potential for stranded inventory of variable refrigerant flow systems. The final rule will be effective January 13, 2025.

FDA

OPPT Deputy Director Mark Hartman Will Become Director Of FDA’s Office Of Food Chemical Safety, Dietary Supplements, And Innovation: Mark Hartman, the highly respected Deputy Director for Programs in EPA’s Office of Pollution Prevention and Toxics (OPPT), will become Director of the U.S. Food and Drug Administration’s (FDA) Office of Food Chemical Safety, Dietary Supplements, and Innovation (OFCSDSI) in its newly formed Human Foods Program (HFP). According to FDA’s website, OFCSDSI “uses a risk-based approach to food chemical safety and dietary supplement policy and coordinates on regulatory and scientific issues for foods made through innovative technologies.” Hartman will begin his position at FDA on December 29, 2024. In his new role, Hartman intends to build an even stronger working relationship between EPA and FDA given the agencies’ common interests in sound scientific risk assessment and regulatory management.

FDA Updates Guidance For FSMA Program: On November 14, 2024, FDA released updates to guidance for the Food Safety Modernization Act (FSMA) Voluntary Qualified Importer Program (VQIP) that are “intended to streamline processes, enhance flexibility, and elevate the overall efficiency of the program.” Key updates include a revised inspection approach. FDA notes that the new approach may reduce user fees. Participants will now have the option to add new foreign suppliers and foods to their existing program throughout the FY. Additional details are available on FDA’s website.

FDA Requests Information For PFAS In Seafood: On November 20, 2024, FDA filed a request for data and information concerning: PFAS concentrations in seafood; PFAS concentrations in the environment; PFAS concentrations in processing water; and mitigation strategies for PFAS in seafood. 89 Fed. Reg. 91765. FDA notes that “[i]t is important to know whether samples were found to contain detectable PFAS. Information about samples where no PFAS was detected is just as important as samples where PFAS was detected. This information helps identify where PFAS was observed and lets us know that it was undetected, as opposed to simply not sampled.” FDA’s request for information includes numerous questions subordinate to the four general questions listed above (e.g., seafood type and source, processing, storage, and container types, testing details). Electronic or written comments must be submitted by February 18, 2025.

FDA Extends Comment Period For Post-Market Assessment Process: On November 21, 2024, FDA announced an extension to the comment period to allow interested persons additional time to submit comments about approaches to systematic post-market assessment of chemicals in food. 89 Fed. Reg. 92130. Electronic or written comments must now be submitted by January 21, 2025. Additional information is available from a public meeting hosted by FDA on September 25, 2024, titled “Development of an Enhanced Systematic Process for the Food and Drug Administration’s Post-Market Assessment of Chemicals in Food.”

FDA Hosts Webinar For Allergen Labeling: On November 19, 2024, FDA announced that it will host an “educational webinar for regulatory partners and industry, including retail food stores and food service establishments, on Wednesday, December 18, 2024, at 2 p.m. ET to provide an overview of food labeling and food allergen labeling requirements and compliance.” The webinar will include an overview of labeling requirements and compliance, as well as a question and answer session. Registration details are available online.

NANOTECHNOLOGY

EPA Issues Final SNURs For Multi-Walled Carbon Nanotubes (Generic) (P-21-216 And P-21-217): On December 12, 2024, EPA issued several final SNURs for certain chemical substances that were the subject of PMNs and are also subject to an Order issued by EPA pursuant to TSCA. 89 Fed. Reg. 100361. Two of the SNURs are for substances identified generically as multi-walled carbon nanotubes (PMN P-21-216 and PMN P-21-217). The SNURs require persons who intend to manufacture (including import) or process any of these chemical substances for an activity that is designated as a significant new use to notify EPA at least 90 days before commencing that activity. In addition, the manufacture or processing for the significant new use may not commence until EPA has conducted a review of the required notification, made an appropriate determination regarding that notification, and taken such actions as required by that determination. The SNURs will be effective February 10, 2025. More information is available in our December 16, 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/.

PUBLIC POLICY AND REGULATION

How DOGE Can Help EPA: Proposing A Fourth Reform — Improving Agency Efficiency: President-elect Trump’s proposed (and aspirational) Department of Government Efficiency (DOGE) is the latest incarnation of a new Administration’s attempt to leave its mark on the federal government. In the November 20, 2024, Wall Street Journal, Elon Musk and Vivek Ramaswamy published an Op-ed about the DOGE effort they will lead and the three kinds of reform DOGE will pursue: regulatory recissions, administrative reductions, and cost savings. We propose that DOGE add a fourth, equally important focus, to improve the efficiency and productivity of federal agencies, especially EPA.

With nearly everything in commerce, from autos to electronics, touched by chemistry, improving the process by which EPA evaluates industrial chemicals would be significant. EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) is charged with conducting safety reviews of existing products and is the gatekeeper for new products. If DOGE can identify ways to improve the operation and efficiency of OCSPP (e.g., by ensuring appropriate resources and updated technology), this could lead to economic gains, greater investment, innovation, and sustainability, and yes, more jobs in the United States. More information is available in our November 22, 2024, blog item.

Senate Subcommittee Holds Hearing On Public Health Impacts Of PFAS Exposures: On December 5, 2024, the Senate Environment and Public Works (EPW) Subcommittee on Chemical Safety, Waste Management, Environmental Justice, and Regulatory Oversight held a hearing on “Examining the Public Health Impacts of PFAS Exposures.” The Subcommittee heard from the following witnesses (written testimony is not available at this time):

• Laurel Schaider, Ph.D., Senior Scientist, Environmental Chemistry and Engineering, Silent Spring Institute;
• Sue Fenton, Ph.D., Director of the Center for Human Health and the Environment, Professor of Biological Sciences, North Carolina State University; and
• Michael D. Larrañaga, Ph.D., P.E., President and Managing Principal, R.E.M. Risk Consultants, on behalf of the American Industrial Hygiene Association (AIHA).

A transcript of the hearing is available online. More information is available in our December 11, 2024, memorandum.

Final Election Results; Slim Majorities Will Test Republican Unity In The 119th Congress: While Election Day was November 5, 2024, the final results of the races for Congress were announced on Tuesday, December 3, 2024. Representative-elect Adam Gray (D-CA) narrowly defeated Representative John Duarte (R-CA), resulting in one of the smallest margins in history (220-215) to begin the 119th Congress on January 3, 2025.

That narrow margin will shrink by three seats in several steps beginning January 3, 2025. Former-Representative Matt Gaetz (R-FL) resigned from the 118th Congress and stated that he would not serve in the 119th Congress, despite being re-elected. On Inauguration Day, January 20, 2025, Representative Michael Waltz (R-FL) will be President Trump’s National Security Advisor, vacating his current seat in Congress. President-elect Trump nominated Representative Elise Stefanik (R-NY) to serve as Ambassador to the United Nations, and she is expected to resign her seat when confirmed. The Ambassador to the United Nations must be confirmed by the Senate, so the date of her resignation is to be determined. More information is available in our December  6, 2024, blog item.

LEGISLATIVE

Bipartisan Legislation Would Establish Pentagon Position For Coordinator For PFAS-Impacted Defense Engagement: On November 19, 2024, Representatives Brian Fitzpatrick (R-PA) and Dan Kildee (D-MI) introduced legislation (H.R. 10166) that would establish a new position at the Pentagon — Coordinator for PFAS-Impacted Defense Engagement — “to improve transparency, drive remediation, and give a voice to communities suffering from this toxic legacy.” According to Fitzpatrick’s November 19, 2024, press release, under the legislation, the PFAS coordinator would be responsible for:

• Engaging directly with affected communities to address concerns, ensure accountability, and provide updates on remediation efforts;
• Streamlining communication between local stakeholders, advocacy organizations, and federal agencies; and
• Driving progress on cleanup efforts with transparency and urgency.

Senator Markey Reintroduces Legislation To Amend TSCA And Provide Grants To Remediate Toxics In Schools: On November 20, 2024, Senator Ed Markey (D-MA) and Representative Jennifer McClellan (D-VA) introduced the Get Toxic Substances Out of Schools Act of 2024. The bill amends TSCA Section 28 and authorizes grants for $52 billion over ten years to monitor, assess, and remediate hazardous substances in schools and childcare centers. The bill amends TSCA Title V (TSCA Sections 501-504) by expanding the list of environmental hazards to include polychlorinated biphenyls (PCB) and PFAS, and by authorizing $100 million over ten years for the Healthy High-Performance Schools program. Finally, the bill authorizes one billion dollars over ten years to assess, monitor, and improve indoor air quality in schools and childcare centers. More information is available in our November 25, 2024, blog item.

MISCELLANEOUS

Appellate Court Concludes CEQ Has No Authority To Issue Binding NEPA Regulations: On November 12, 2024, a split panel of the U.S. Court of Appeals for the District of Columbia Circuit granted a petition for review of a decision by the Federal Aviation Administration (FAA) and the National Park Service (NPS) not to prepare an environmental analysis under the National Environmental Policy Act (NEPA). Marin Audubon Society v. FAA, No. 23-1067. The National Parks Air Tour Management Act of 2000 requires FAA and NPS to develop plans regulating tour flights over national parks. FAA and NPS issued an Air Tour Management Plan governing tourist flights over four national parks near San Francisco, California, but the agencies determined that an environmental analysis under NEPA was unnecessary because their plan, compared to what existed, would cause no or minimal additional environmental impact. According to the court, as the parties argue the case, it centers on whether the agencies complied with regulations of the White House Council on Environmental Quality (CEQ), an entity within the Executive Office of the President. The court did not address those arguments. Instead, the court concluded that “[t]he CEQ regulations, which purport to govern how all federal agencies must comply with the National Environmental Policy Act, are ultra vires.” Since CEQ’s rulemaking authority is due to an Executive Order, rather than legislation, CEQ has no authority to issue binding NEPA regulations. The court agreed with petitioners’ argument that it was arbitrary and capricious for FAA and NPS to treat interim operating authority as the status quo for their NEPA analysis, vacated FAA’s order, and remanded the case to FAA. According to a partial dissent, the court should not have addressed the issue of CEQ’s statutory authority.

MPCA Requests Comments On Planned PFAS In Products Reporting And Fee Rule: On November 18, 2024, the Minnesota Pollution Control Agency (MPCA) requested comments on planned rules governing reporting and fees paid by manufacturers upon submission of required information about products containing PFAS. MPCA notes that “[a]t this stage, we do not have a draft rule; we want your feedback to inform us about the ideas described under the Subject of Rules section.” Instead, the purpose of the current request for comments (RFC) is to seek feedback on MPCA’s intent to combine two rules from its September 25, 2023, RFC, which proposed separate rules regarding reporting and fees. MPCA will consider comments submitted earlier along with responses to the second RFC, and those comments are available on MPCA’s website. Comments on the current RFC are due 4:30 p.m. (CST) on December 19, 2024. More information is available in our November 20, 2024, memorandum.

EPA Begins Public Consultation On Interim Framework For Advancing Consideration Of Cumulative Impacts: On November 21, 2024, EPA released a draft Interim Framework for Advancing Consideration of Cumulative Impacts (Interim Framework). 89 Fed. Reg. 92125. According to EPA, the Interim Framework provides a shared reference point for EPA programs and regions as they determine when and how to analyze and consider cumulative impacts. EPA states that Agency programs will incorporate the Interim Framework “into their processes and programs, as appropriate, feasible, and consistent with applicable law, in ways that reflect programmatic and context-specific needs.” EPA will consider public input for potential incorporation into the Interim Framework. EPA notes that public input will also inform its expanding knowledge, along with results from scientific research and program evaluation. Comments on the Interim Framework are due February 19, 2025. More information is available in our December 12, 2024, memorandum.

EPA Releases National Strategy To Prevent Plastic Pollution: On November 21, 2024, EPA announced the release of the National Strategy to Prevent Plastic Pollution: Part Three of a Series on Building a Circular Economy for All. According to EPA, together with EPA’s “National Recycling Strategy” and the “National Strategy for Reducing Food Loss and Waste and Recycling Organics,” the “National Strategy to Prevent Plastic Pollution” presents opportunities for voluntary and regulatory actions by businesses, academia, industry, non-governmental organizations (NGO), federal, Tribal, state, local, and territorial governments, and consumers. EPA states that “[t]ogether, these U.S. entities could eliminate the release of plastic waste from land and sea-based sources into the environment by 2040.” More information is available in our November 22, 2024, memorandum.

Petitions Filed To Add Several Chemicals To List Of Taxable Substances; Comments Due January 28, 2025: On November 29, 2024, the Internal Revenue Service (IRS) announced that petitions have been filed to add the following chemicals to the list of taxable substances:

• Di-isobutyl ketone (89 Fed. Reg. 94879): ALTIVIA Ketones & Additives, LLC, an exporter of di-isobutyl ketone, filed the petition. According to the petition, di-isobutyl ketone is an organic compound that is used in solvents; paints and coatings; automobile refinishing; and pharmaceuticals. Di-isobutyl ketone is made from propylene, and taxable chemicals constitute 87.51 percent by weight of the materials used to produce this substance.
• Di-isobutyl carbinol (89 Fed. Reg. 94878): ALTIVIA Ketones & Additives, LLC, an exporter of di-isobutyl carbinol, filed the petition. According to the petition, di-isobutyl carbinol is a nine carbon branched alcohol that is used in high purity hydrogen peroxide and electronics cleaning. Di-isobutyl carbinol is made from propylene, and taxable chemicals constitute 87.51 percent by weight of the materials used to produce this substance.
• Methyl isobutyl carbinol (89 Fed. Reg. 94877): ALTIVIA Ketones & Additives LLC, an exporter of methyl isobutyl carbinol, filed the petition. According to the petition, methyl isobutyl carbinol is an organic chemical compound that is used as a lube oil additive, as a frother in mining applications, and in fracking fluids. Methyl isobutyl carbinol is made from propylene, and taxable chemicals constitute 82.36 percent by weight of the materials used to produce this substance.

EPA Announces FY 2024 Enforcement And Compliance Assurance Results: EPA announced on December 5, 2024, its FY 2024 Enforcement and Compliance Assurance Annual Results, highlighting its efforts to hold polluters accountable and protect communities from harm. EPA notes that the FY 2024-2027 National Enforcement and Compliance Initiatives (NECI), which are designed to address the most significant pollution threats seen nationwide, include the first ever national initiatives on climate change, PFAS, and contamination from coal ash facilities. EPA continued three initiatives from the prior NECI cycle that began during the last administration focused on air toxics, safe drinking water, and preventing chemical accidents. Additional highlights include:

• 2.7 million metric tons of carbon dioxide equivalent emissions were reduced, treated, or eliminated;
• 227 million pounds of pollution eliminated in communities overburdened by pollution, the highest total ever;
• $1.7 billion in penalties, the highest level since FY 2017;
• 1,851 civil cases concluded — the highest number since FY 2017;
• 121 criminal defendants charged, the highest since FY 2019;
• 8,500+ inspections, nearly ten percent increase from FY 2023;
• 53 percent of inspections in areas overburdened by pollution; and
• 82 percent of completed Superfund enforcement settlement agreements at sites in overburdened communities.

Proposition 65: OEHHA Adopts Changes To “Short-Form” Warning Option: On December 6, 2024, the California Office of Environmental Health Hazard Assessment (OEHHA) issued a notice stating that the Office of Administrative Law (OAL) approved changes to the Proposition 65 (Prop 65) Article 6 “clear and reasonable warnings” regulations for “short-form” warnings (Notice). The changes adopted are to the proposed regulations that OEHHA issued on October 27, 2023. The history of these amendments, dating back to January 2021, are set forth in our memoranda available here and here. The effective date for the regulations is January 1, 2025, with a three-year implementation period. More information is available in our December 13, 2024, memorandum.

CSB Urges Chemical Facilities To Prepare For Extreme Cold Weather: On December 9, 2024, the U.S. Chemical Safety Board (CSB) “re-emphasiz[ed] to chemical facilities the importance of being prepared for extreme cold outdoor weather, which includes identifying and implementing best safety practices for cold weather operations to avoid serious chemical accidents this winter.” CSB notes that it “has shared key winterization safety lessons, including a safety digest entitled ‘Preparing Equipment and Instrumentation for Cold Weather Operations,’ that particularly stress the need for dead-legs to be surveyed and, ideally, removed or permanently and effectively isolated from hazardous process streams.” CSB states that companies should identify and winterize equipment susceptible to ice or hydrate formation in cold weather; establish formal, written winterization programs; and identify and control winterization hazards through process hazard analyses, management of change (MOC) evaluations, pre-startup safety reviews, and operating procedures.