Download PDF
January 15, 2025

Recent Federal Developments for January 2025

Bergeson & Campbell, P.C.

2025 Forecast For U.S. Federal And International Chemical Regulatory Policy: On January 6, 2025, Bergeson & Campbell, P.C. (B&C®), The Acta Group (Acta®), and B&C® Consortia Management, L.L.C. (BCCM) published the “Forecast for U.S. Federal and International Chemical Regulatory Policy 2025.” This carefully curated document represents our seasoned team’s collective take on what to expect regarding global industrial, agricultural, and biocidal chemical initiatives in the New Year. Given the European Parliamentary elections this past summer and the right wing shift they brought about, along with the new Trump Administration, change in chemical policy is expected on both sides of the Atlantic.

WEBINAR ON-DEMAND — What to Expect When You Don’t Know What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2025: A recording is now available for our January 14 webinar “What to Expect When You Don’t Know What to Expect in Chemicals Policy and Regulation and on Capitol Hill in 2025.” B&C presenters Lynn L. Bergeson, Managing Partner; James V. Aidala, Senior Government Affairs Consultant; Richard E. Engler, Ph.D., Director of Chemistry; and Mark J. Washko, Senior Government Affairs Advisor, unpacked the likely impacts of the new Administration on the regulated community, provided their seasoned outlook on how similar or different the Trump II Administration might be from the first term, and discussed what companies can do to respond to the opportunities and challenges presented. Watch now.

TSCA/FIFRA/TRI

EPA Issues Final Risk Management Rules For TCE, PCE, And CTC: The U.S. Environmental Protection Agency (EPA) released final risk management rules under the Toxic Substances Control Act (TSCA) for trichloroethylene (TCE) and perchloroethylene (PCE) on December 9, 2024, and for carbon tetrachloride (CTC) on December 11, 2024. EPA states that all uses of TCE will be banned over time, with “the vast majority of identified risks eliminated within one year,” and safer alternatives readily available for the majority of uses. The PCE rule 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. The CTC rule will require “robust worker safety programs” while banning some uses. For more information and commentary on all three rules, please read our full memorandum.

EPA Requires Submission Of Health And Safety Studies For 16 Chemicals Being Considered For Risk Evaluation Under TSCA: On December 13, 2024, EPA published a final Health and Safety Reporting Rule under TSCA to require 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. The rule applies to manufacturers in the North American Industrial Classification System (NAICS) codes for chemical manufacturing (NAICS code 325) and petroleum refineries (NAICS code 324110) that are currently manufacturing (including importing) a listed chemical substance (or will do so during the chemical’s reporting period), or that have manufactured (including imported) or proposed to manufacture (including import) a listed chemical substance within the last ten years. EPA notes that the rule may also affect manufacturers of substances for commercial purposes that coincidentally produce the substance during the manufacture, processing, use, or disposal of another substance or mixture, including byproducts and impurities. According to EPA, “such byproducts and impurities may, or may not, in themselves have commercial value,” but “[t]hey are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.” EPA will use the health and safety studies to inform its actions in carrying out its responsibilities pursuant to TSCA, including prioritization, risk evaluation, and risk management. The rule was effective January 13, 2025. The final rule states that “[g]enerally, the reporting . . . is required by March 13, 2025.” For more information, please read our December 23, 2024, memorandum.

EPA Designates Five Known Or Probable Carcinogens As High-Priority Substances, Begins Prioritization Process For Next Five Chemicals: On December 18, 2024, EPA announced the formal designation of five known or probable carcinogens as High-Priority Substances (HPS) (89 Fed. Reg. 102900) and that it is beginning the process to prioritize the next five chemicals under TSCA (89 Fed. Reg. 102903). The HPSs are acetaldehyde, acrylonitrile, benzenamine, 4,4’-methylene bis(2-chloroaniline) (MBOCA), and vinyl chloride, and the designations were effective December 18, 2024. The chemical substances selected for prioritization are benzene, ethylbenzene, naphthalene, styrene, and 4-tert-octylphenol. Relevant information on these substances is due March 18, 2025. More information will be available in a forthcoming memorandum.

Appellate Court Vacates Requirement That Downstream Entities Reporting By Non-Confidential Accession Number Assert CBI Claims: On December 20, 2024, the U.S. Court of Appeals for the District of Columbia Circuit denied the Environmental Defense Fund’s (EDF) petition and granted the American Chemistry Council (ACC) and American Fuel and Petrochemical Manufacturers’ (AFPM) petition for review of EPA’s final rule updating the requirements concerning the assertion and treatment of confidential business information (CBI) claims under TSCA. EDF v. EPA (No. 23-1166). Regarding the claim made by ACC and AFPM, the court states that the final rule’s assertion and substantiation requirements are unlawful as applied to entities reporting by accession numbers and without knowledge of the underlying chemical identity. According to the court, reporting entities that lack knowledge of specific chemical identities are unable to assert or substantiate CBI claims for such identities. The court notes that these entities are required by the rule to assert and substantiate CBI claims for already protected specific chemical identities, however, otherwise they waive confidentiality for the specific chemical identity. This then causes an upstream entity that properly asserted and substantiated a CBI claim to lose confidentiality protection. More information is available in our January 7, 2025, blog item.

EPA Will Not Proceed With Rulemaking For Lead Wheel Weights: EPA announced on December 23, 2024, that it decided not to proceed with the development of a regulation addressing the manufacture, processing, or distribution in commerce of lead for wheel-balancing weights (lead wheel weights) under TSCA. 89 Fed. Reg. 104486. EPA granted a 2009 TSCA Section 21 petition, which EPA granted, asking EPA to initiate a rulemaking to regulate the manufacturing, processing, or distribution in commerce of lead wheel weights. In 2023, the same parties filed a petition for a writ of mandamus that sought to compel EPA to initiate the rulemaking proceeding requested in the 2009 petition. EPA states that after reviewing the information submitted in response to an advance notice of proposed rulemaking (ANPRM) issued in April 2024 and EPA’s technical analysis thereof, EPA has decided not to proceed with the development of a proposed rule. According to EPA, addressing potential remaining exposures from lead continues to be a high priority, as reflected in EPA’s announcement that “Lead and Lead Compounds” is on its list of candidate chemical substances currently being considered for future prioritization actions under TSCA. The decision was effective December 23, 2024.

NGOs Appeal Dismissal Of Suit Seeking TSCA Section 6 Rule Prohibiting Production Of PFOA During Fluorination Of Plastic Containers: On December 26, 2024, the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) filed notice in the U.S. District Court for the District of Columbia that they are appealing the court’s December 11, 2024, decision dismissing their suit to the U.S. Court of Appeals for the District of Columbia Circuit. As reported in our December 17, 2024, blog item, the court dismissed a suit filed against EPA seeking a rule under TSCA Section 6 to prohibit the production of perfluorooctanoic acid (PFOA) during Inhance Technologies, LLC’s (Inhance) fluorination process. PEER v. Regan (No. 2024-2194). 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 per- and polyfluoroalkyl substances (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 Publishes Preliminary Lists Of Manufacturers (Including Importers) Subject To Fees For Risk Evaluations: On December 31, 2024, EPA announced the availability of and solicited comment on the preliminary lists of manufacturers (including importers) subject to fees for the next five chemicals undergoing risk evaluation under TSCA Section 6(b). 89 Fed. Reg. 107099. The five chemicals that have been designated as HPS for risk evaluation and for which fees will be charged are acetaldehyde (Chemical Abstracts Service Registry Number® (CAS RN®) 75-07-0); acrylonitrile (CAS RN 107-13-1); benzenamine (CAS RN 62-53-3); vinyl chloride (CAS RN 75-01-4); and MBOCA (CAS RN 101-14-4). According to the notice, EPA developed the preliminary lists “using the most up-to-date information available, including information submitted to the Agency (e.g., information submitted under TSCA section 8(a) (including the Chemical Data Reporting (CDR) Rule), TSCA section 8(b), and to the Toxics Release Inventory (TRI)).” EPA states that manufacturers (including importers) are required to self-identify as a manufacturer (or importer) of one or more of the five identified HPSs “irrespective of whether they are included on the preliminary lists” and that they may use this period to do so. Where appropriate, entities may also certify as to “no manufacture,” “cessation” of manufacture, or to meeting an exemption. The public will also have the opportunity to correct errors in the preliminary lists during the comment period. EPA expects to publish the final lists of manufacturers (including importers) subject to fees no later than concurrently with the publication of the final scope documents for risk evaluations of these five HPSs. Manufacturers (including importers) identified on the final lists will be subject to the applicable fees. Comments are due March 3, 2025.

EPA Proposes Plan To Track The Adoption Of Bilingual End-Use Pesticide Labels: On January 2, 2025, EPA released for comment a proposed plan to track the adoption of bilingual labeling of pesticide products. 90 Fed. Reg. 99. The Pesticide Registration Improvement Act of 2022 (PRIA 5) amended the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) to require Spanish language translation of the health and safety sections of end-use pesticide product labels on a rolling schedule that begins in December 2025 and ends in December 2030. PRIA 5 also requires that EPA develop, implement, and make publicly available a plan for tracking the adoption of the bilingual labeling by December 29, 2024. Spanish is the primary language for most American farmworkers. EPA states that this effort advances environmental justice by making health and safety information on pesticide labels more accessible, fostering better understanding and compliance with label instructions. Comments are due on or before February 3, 2025. More information is available in our January 3, 2025, blog.

EPA Releases Final Risk Evaluations For Formaldehyde And DIDP, Finding Each Presents An Unreasonable Risk Of Injury To Human Health: EPA announced the availability of its final risk evaluations for formaldehyde (90 Fed. Reg. 316) and diisodecyl phthalate (DIDP) (90 Fed. Reg. 638) on January 3 and January 6, 2025, respectively. EPA states that the purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the conditions of use (COU). According to EPA, it used the best available science to prepare the final risk evaluations and determined, based on the weight of scientific evidence, that formaldehyde and DIDP present an unreasonable risk of injury to human health. Under TSCA, EPA must initiate risk management actions to address the unreasonable risk. More information will be available in a forthcoming memorandum.

EPA Further Extends Review Period For CBI Claims For The Identity Of Chemicals On The TSCA Inventory: On January 6, 2025, EPA announced the extension of the review period for CBI claims for specific identities of all active chemical substances listed on the confidential portion of the TSCA Inventory submitted to EPA under TSCA. 90 Fed. Reg. 645. As reported in our February 7, 2024, blog item, EPA previously extended the review period by one year, to February 19, 2025. According to EPA, several issues and factors caused delays that prevented EPA from completing its review within the five-year period and are going to prevent completion within the previous one-year extension. EPA was delayed in commencing Review Plan reviews for approximately six months to a year as a result of the decision of the U.S. Court of Appeals for the District of Columbia Circuit in EDF v. EPA, 922 F.3d 446 (D.C. Cir. 2019), which resulted in a need for additional rulemaking activity to add a reporting requirement. According to EPA, the additional reporting requirement “created confusion among some reporting entities, further slowing the review process.” The review period is now extended to February 19, 2026. More information is available in our January 10, 2025, blog item.

EPA Issues SNURs For Certain Chemicals: EPA issued final significant new use rules (SNUR) on January 6, 2025, for certain chemical substances that were the subject of premanufacture notices (PMN). 90 Fed. Reg 567. 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. The SNURs will be effective March 7, 2025.

EPA Adds Nine PFAS To TRI For Reporting Year 2025: EPA announced on January 6, 2025, that it is updating the list of chemicals subject to toxic chemical release reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). 90 Fed. Reg. 573. The PFAS added to the TRI and the triggering events are:

  • Ammonium perfluorodecanoate (PFDA NH4) (CAS RN 3108-42-7) (Final Toxicity Value);
  • Sodium perfluorodecanoate (PFDA-Na) (CAS RN 3830-45-3) (Final Toxicity Value);
  • Perfluoro-3-methoxypropanoic acid (CAS RN 377-73-1) (Final Toxicity Value);
  • 6:2 Fluorotelomer sulfonate acid (CAS RN 27619-97-2) (Final Toxicity Value);
  • 6:2 Fluorotelomer sulfonate anion (CAS RN 425670-75-3) (Final Toxicity Value);
  • 6:2 Fluorotelomer sulfonate potassium salt (CAS RN 59587-38-1) (Final Toxicity Value);
  • 6:2 Fluorotelomer sulfonate ammonium salt (CAS RN 59587-39-2) (Final Toxicity Value);
  • 6:2 Fluorotelomer sulfonate sodium salt (CAS RN 27619-94-9) (Final Toxicity Value); and
  • Acetic acid, [(γ-ω-perfluoro-C8-10-alkyl)thio] derivs., Bu esters (CAS RN 3030471-22-5) (CBI Declassification).

The final rule will be effective February 5, 2025. As of January 1, 2025, facilities that are subject to reporting requirements for these PFAS should begin tracking their activities involving these chemicals as required by EPCRA Section 313. Reporting forms will be due by July 1, 2026.

EPA Requests Comment On Draft Risk Evaluation For DCHP, Releases Draft Cumulative Risk Analysis For Phthalates And Draft Hazard Technical Support Documents For DIBP, DBP, DEHP, And BBP: On January 7, 2025, EPA announced the availability of and requested public comment on a draft risk evaluation under TSCA for dicyclohexyl phthalate (DCHP). 90 Fed. Reg. 1125. EPA states that “[t]he purpose of risk evaluations under TSCA is to determine whether a chemical substance presents an unreasonable risk of injury to health or the environment, without consideration of costs or other non-risk factors, including unreasonable risk to potentially exposed or susceptible subpopulations identified as relevant to the risk evaluation by EPA, under the [COUs].” According to EPA, it used the best available science to prepare the draft risk evaluation and to determine preliminarily that DCHP poses unreasonable risk to human health. Comments are due March 10, 2025. More information will be available in a forthcoming memorandum.

EPA, PSCI, IIVS, And CDPR Will Hold Webinar On January 29, 2025, On Reducing Animal Testing: EPA announced on January 8, 2025, that it will hold a webinar on January 29, 2025, with the PETA Science Consortium International (PSCI), the Institute for In Vitro Sciences (IIVS), and the California Department of Pesticide Regulation (CDPR) on New Approach Methodologies (NAM)-Based Strategies for Systemic Toxicity Assessment. The presenters for the webinar are:

  • Dr. Katie Paul Friedman from EPA’s Office of Research and Development, Center for Computational Toxicology and Exposure. This presentation will focus on the development of NAMs-based toxicity values for chemicals that affect the entire body or multiple organs, and how they compare to the traditional animal-based model. The presentation will include recent work on this topic within the Accelerating the Pace of Chemical Risk Assessment (APCRA) initiative, an international effort to promote collaboration and dialogue on the use of NAMs in regulatory decision making.
  • Elisabet Berggren from the European Commission (EC) Joint Research Centre, Systems Toxicology Unit. This presentation asks, “How would we do chemical safety assessments if we started from scratch?” The presentation will reflect on challenges and possible ways to do chemical risk assessments without any animal testing based on today’s existing knowledge and expertise.

EPA Releases Compliance Guides For PCE Risk Management Rule: EPA announced on January 10, 2025, the release of guides on the use of PCE for dry cleaning and energized electrical cleaning to help users and others comply with its December 2024 risk management rule issued under TSCA. The compliance guides include information about why EPA is regulating PCE; how to determine if a business is affected by the rule; responsibilities of affected entities; detailed information on how to comply with the prohibitions and restrictions; compliance timeframes; and other helpful definitions and notes.

EPA And OSHA Sign MOU For Implementation Of TSCA Section 6: EPA announced on January 13, 2025, that it signed a memorandum of understanding (MOU) with the Occupational Safety and Health Administration (OSHA) formalizing coordination on EPA’s work to assess and manage existing chemicals under TSCA Section 6. According to EPA’s press release, “EPA and OSHA anticipate that better coordination under this MOU will result in improved workplace health and safety protections for workers using existing chemical substances under TSCA and the Occupational Safety and Health (OSH) Act and allow for effective implementation of our national workplace and environmental protection statutes.” More information is available in our January 15, 2025, memorandum.

EPA Proposes Risk Management Rule To Protect Workers From Inhalation Exposure To PV29: On January 14, 2025, EPA issued a proposed rule to address the unreasonable risk of injury to human health presented by C.I. Pigment Violet 29 (PV29) under its COUs as documented in EPA’s January 2021 risk evaluation and September 2022 revised risk determination. 90 Fed. Reg. 3107. The proposed rule states 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 the chemical no longer presents unreasonable risk. To address the identified unreasonable risk, EPA proposes requirements to protect workers during manufacturing and processing, certain industrial and commercial uses of PV29 and disposal, while also allowing for a reasonable transition period prior to enforcement of said requirements. Comments are due February 28, 2025. Under the Paperwork Reduction Act (PRA), comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy on or before February 13, 2025. More information will be available in a forthcoming memorandum.

EPA Releases Compliance Guide For TCE Risk Management Rule: EPA announced on January 14, 2025, that it released a guide to assist the regulated community in complying with the new regulation for TCE under TSCA. The guide provides an overview of the requirements set by the final rule, including important regulatory deadlines. While EPA’s rule will result in a complete prohibition of TCE, EPA notes that the prohibition will take longer to phase in for certain uses, and the rule sets strict workplace protection requirements for those uses in the interim. According to EPA, the guide is intended for persons who own or operate a business that manufactures (including imports), processes, distributes in commerce, uses, or disposes of TCE. This guide may also be of interest to people who may be exposed to TCE in the workplace, as well as consumers, community members, or anyone else that may be affected by exposure to TCE.

EPA Releases Final Risk Evaluation For DINP, Finding Unreasonable Risk Of Injury To Human Health When Workers Are Exposed Under Four COUs: On January 15, 2025, EPA released the final risk evaluation for diisononyl phthalate (DINP) conducted under TSCA. 90 Fed. Reg. 3828. EPA states in its January 14, 2025, press release that it has determined that DINP presents an unreasonable risk of injury to human health because workers could be exposed to high concentrations of DINP in mist when spraying adhesive, sealant, paint, and coating products that contain DINP. According to EPA, DINP can cause developmental toxicity and harm the liver and can cause cancer at higher rates of exposure. EPA notes that DINP can also harm the developing male reproductive system, known as “phthalate syndrome,” and that it is including DINP in its cumulative risk analysis for six phthalates that demonstrate effects consistent with phthalate syndrome. EPA released this draft risk analysis on January 6, 2025. More information will be available in a forthcoming memorandum.

RCRA/CERCLA/CWA/CAA/PHMSA/SDWA

EPA Announces Draft National Recommended Ambient Water Quality Criteria For PFOA, PFOS, And PFBS: EPA announced on December 26, 2024, the availability of draft Clean Water Act (CWA) national recommended ambient water quality criteria (AWQC) for the protection of human health for three PFAS — PFOA, perfluorooctane sulfonic acid (PFOS), and perfluorobutane sulfonic acid (PFBS) — for a 60-day public comment period. 89 Fed. Reg. 105041. EPA states that it developed these draft PFAS national recommended human health criteria (HHC) to reflect the latest scientific information, consistent with current EPA guidance, methods, and longstanding practice. When the PFAS national recommended HHC are issued in final, they will provide information that states and Tribes may consider when adopting water quality standards. The draft HHC, as corrected on January 15, 2025 (90 Fed. Reg. 3827), are:

PFASWater + Organism HHC (nanograms per liter (ng/L))Organism Only HHC (ng/L)
PFOA0.00090.0036
PFOS0.060.07
PFBS400500


Comments are due February 24, 2025.

EPA Proposes Amendments To Polyether Polyols Production Industry NESHAP: On December 27. 2024, EPA proposed amendments to the National Emission Standards for Hazardous Air Pollutants (NESHAP) under the Clean Air Act (CAA) that apply to the Polyether Polyols (PEPO) Production industry. 89 Fed. Reg. 105986. EPA states that it proposes decisions resulting from its technology review of the PEPO NESHAP and decisions based on its reconsideration of certain issues raised in an administrative petition for reconsideration. EPA notes that furthermore, it proposes to strengthen the emission standards for ethylene oxide emissions after considering the results of a risk assessment for the PEPO NESHAP. EPA also proposes to require performance testing once every five years, to add work practice standards for certain activities where alternatives are appropriate, and to add provisions for electronic reporting. According to EPA, it estimates that the proposed amendments to the PEPO NESHAP, excluding the ethylene oxide emission standards, would reduce hazardous air pollutant (HAP) emissions from PEPO sources by approximately 157 tons per year (tpy). EPA expects the proposed ethylene oxide emission standards to reduce ethylene oxide emissions by approximately 14 tpy and estimates that the proposed amendments to the NESHAP will reduce excess emissions of HAP from flares in the PEPO Production source category by an additional 75 tpy. Comments are due February 25, 2025. Under the PRA, comments on the information collection provisions are best assured of consideration if OMB receives comments by January 27, 2025.

EPA Denies Petition For Reconsideration Of The Safer Communities By Chemical Accident Prevention Rule: EPA received a petition for reconsideration of the Safer Communities by Chemical Accident Prevention Rule, published in the Federal Register on March 11, 2024. EPA provided notice on December 30, 2024, that it is denying the petition for reconsideration. 89 Fed. Reg. 106479. The basis for EPA’s action is set out fully in a letter addressed to the petitioner, available in the rulemaking docket. According to EPA, the petition fails to establish that the objections meet the criteria for mandatory reconsideration under CAA Section 307(d)(7)(B), which requires EPA to convene a proceeding for reconsideration of a rule if a party raising an objection to the rule “. . . can demonstrate to the Administrator that it was impracticable to raise such objection within [the public comment period] or if the grounds for such objection arose after the period for public comment (but within the time specified for judicial review) and if such objection is of central relevance to the outcome of the rule.” More information on EPA’s March 2024 rule is available in our March 5, 2024, memorandum.

EPA Determines No Revisions Are Necessary To PCE Dry Cleaning NESHAP: On January 7, 2025, EPA published a final determination that there are no necessary revisions for the PCE Dry Cleaning NESHAP after considering developments in practices, processes, and control technologies. 90 Fed. Reg. 1041. EPA notes that a separate regulatory action under TSCA has established a ten-year phaseout of the use of PCE in dry cleaning. Therefore, EPA is not amending the currently promulgated NESHAP standards under CAA Section 112(d)(6). Further, in response to the voluntary remand of the 2006 risk and technology review (RTR), EPA is likewise concluding that no further evaluation of the NESHAP’s approach to addressing the PCE ban and phaseout for co-residential sources in the 2006 RTR is warranted, considering EPA’s “recent more comprehensive prohibition of the use of PCE in dry cleaning and spot cleaning under TSCA.” The action was effective January 7, 2024.

EPA Releases Draft Risk Assessment Of PFOA And PFOS In Biosolids, Holds Webinar On January 15, 2025: EPA announced on January 15, 2025, a draft risk assessment of the potential human health risks associated with the presence of PFOA and PFOS in biosolids, also known as sewage sludge. 90 Fed. Reg. 3859. According to EPA’s January 14, 2025, press release, the findings show that there may be human health risks associated with exposure to PFOA or PFOS with all three methods of using or disposing of sewage sludge — land application of biosolids, surface disposal in landfills, or incineration. The draft risk assessment focuses on those living on or near impacted sites or those that rely primarily on those sites’ products (e.g., food crops, animal products, drinking water). EPA notes that the draft risk assessment does not model risks for the general public. EPA states that once prepared in final, the assessment will help EPA and its partners understand the public health impact of PFAS in biosolids and inform any potential future actions to help reduce the risk of exposure. EPA held a webinar on January 15, 2025, to provide information on the draft risk assessment. The webinar included an opportunity for questions and answers. EPA will post a recording of the webinar. Comments are due March 17, 2025.

EPA Announces Preliminary Regulatory Determinations For CCL 5: On January 15, 2025, EPA presented the preliminary regulatory determinations and supporting rationale for contaminants listed on its fifth Contaminant Candidate List (CCL 5). 90 Fed. Reg. 3830. Since EPA announced the fourth round of regulatory determinations in March 2021, it has made determinations to regulate PFAS, including individual determinations for three PFAS: perfluorononanoic acid (PFNA), perfluorohexanesulfonic acid (PFHxS), and hexafluoropropylene oxide dimer acid and its ammonium salt (HFPO-DA, also known as GenX or GenX chemicals); and mixtures including two or more of these three PFAS and PFBS. In April 2024, EPA issued a final National Primary Drinking Water Regulation (NPDWR) that includes these four PFAS, as well as PFOA and PFOS. In this Federal Register notice, EPA makes preliminary determinations not to regulate nine additional contaminants from CCL 5: 2-aminotoluene, cylindrospermopsin, ethoprop, microcystins, molybdenum, permethrin, profenofos, tebuconazole, and tribufos. EPA requests public comment on these preliminary determinations and other aspects of this notice. EPA also presents updates on additional contaminants from CCL 5, as well as on some of those that have been considered in previous rounds of regulatory determinations and for which EPA has not yet made a regulatory determination. EPA also presents and requests comment on the process and analyses used for this round of regulatory determinations, the supporting information, and the rationale used to make these preliminary decisions. Comments are due March 17, 2025.

FDA

FDA Opens Portal For Voluntary Qualified Importer Program: On December 10, 2024, the U.S. Food and Drug Administration (FDA) announced that the Voluntary Qualified Importer Program (VQIP) application portal opens on January 1, 2025. The VQIP, a component of the Food Safety Modernization Act (FSMA), is a voluntary fee-based program that provides importers expedited review and importation of human and animal foods into the United States. The portal will remain open until September 1, 2025.

FDA Updates Guidance For Cosmetic Products: On December 12, 2024, FDA announced the availability of a final guidance for industry entitled “Guidance for Industry: Registration and Listing of Cosmetic Product Facilities and Products.” 89 Fed. Reg. 100508. The guidance will assist persons submitting cosmetic product facility registrations and product listing submissions to FDA under the Modernization of Cosmetics Regulation Act of 2022 (MoCRA). According to FDA, this guidance includes three new draft frequently asked questions (FAQ) and answers about cosmetic product facility registrations and product listing submissions, in Appendix B, for comment purposes only. Aside from the three new draft FAQs and answers, this guidance finalizes the draft Appendix B published in an otherwise final guidance on December 19, 2023. This guidance also includes minor changes to the final guidance for clarity. Comments on the portion of this guidance in Appendix B that describes the three new FAQs and answers were due January 13, 2025.

FDA Announces Food Safety Webinar Series: On December 16, 2024, FDA announced a continuation of a webinar series, “Collaborating on Culture in the New Era of Smarter Food Safety.” The first of seven webinars is scheduled for January 29, 2025. Registration details are available here.

FDA Creates Inventory Of Meetings Held For Genome-Edited Plants: On December 16, 2024, FDA released an inventory list of meetings held between FDA and developers of certain new genome-edited plant varieties. This inventory follows FDA guidance released in February 2024, titled “Guidance for Industry: Foods Derived from Plants Produced Using Genome Editing,” that describes steps industry may wish to take voluntarily to “inform FDA of the steps they have taken to ensure the safety of foods from their new genome-edited plant varieties.”

FDA Extends Comment Period For Export Certification: On December 23, 2024, FDA announced an extension to the comment period for an FDA request for information titled “Export Lists for Human Food.” 89 Fed. Reg. 105059. FDA is seeking comments regarding “other countries’ establishment listing, certification, and registration requirements,” “challenges you have experienced with exporting human food products included on the export lists,” and “specific suggestions about how FDA should approach the implementation of fees.” Comments must be submitted on or before February 21, 2025.

FDA Proposes Rule For Testing Asbestos In Cosmetic Products: On December 26, 2024, FDA issued a proposed rule that would require manufacturers of talc-containing cosmetic products to test their products for asbestos using specific testing methods. 89 Fed. Reg. 105490. FDA issued the proposed rule pursuant to MoCRA. FDA is accepting comments until March 27, 2025.

FDA Updates Definition Of “Healthy”: On December 27, 2024, FDA issued a final rule in which FDA “revises the requirements for when the term ‘healthy’ can be used as an implied nutrient content claim in the labeling of human food products to help consumers identify foods that are particularly useful as the foundation of a nutritious diet that is consistent with dietary recommendations.” 89 Fed. Reg. 106064. Major provisions of the rule, effective February 25, 2025, include establishing:

  • Parameters for use of the term “healthy” and derivative terms;
  • A framework based on food groups and nutrients to limit for the “healthy” claim; and
  • That “food group,” for the purposes of the “healthy” claim, refers to vegetables, fruits, dairy, grains, protein foods, and oils defined in 21 C.F.R. §  101.65(d)(2).

The rule’s compliance date is February 25, 2028.

FDA Announces FCNs That Are No Longer Effective For Certain PFAS: On January 6, 2025, FDA announced its determination that Food Contact Notifications (FCN) for 35 PFAS are no longer effective. 90 Fed. Reg. 653.This announcement follows an FDA program from February 2024 entitled “Market Phase-Out of Grease-Proofing Substances Containing PFAS.” The effective date for most of the PFAS is January 6, 2025, but FDA has also specified a “Compliance Date” of June 30, 2025, for four PFAS.

NANOTECHNOLOGY

ECHA Publishes Second Interim Evaluation Of EUON: The European Union (EU) Observatory for Nanomaterials (EUON) announced on December 4, 2024, the availability of the European Chemical Agency’s (ECHA) Second interim evaluation of the European Union Observatory for Nanomaterials (EUON). Prepared by WSP acting as a third-party evaluator, the interim evaluation assesses EUON against six criteria: effectiveness; efficiency (including economy and proportionality); relevance; coherence; EU-added value; and utility.

NNI Releases 2024 NanoEHS Research Strategy Update: On December 18, 2024, the National Nanotechnology Initiative (NNI) announced the availability of the National Nanotechnology Initiative Environmental, Health, and Safety Research Strategy: 2024 Update. Prepared by the Nanotechnology Environmental and Health Implications (NEHI) Working Group within the Nanoscale Science, Engineering, and Technology (NSET) Subcommittee of the National Science and Technology Council, the 2024 update builds on the initial 2011 strategy, laying out a comprehensive, integrated approach that reflects current opportunities to enable responsible nanotechnology innovation.

NNCO Releases NNI Supplement To President Biden’s 2025 Budget: On December 19, 2024, the National Nanotechnology Coordination Office (NNCO) released The National Nanotechnology Initiative Supplement to the President’s 2025 Budget, which also serves as the annual report for NNI. According to the report, President Biden’s fiscal year (FY) 2025 budget requests over $2.2 billion for NNI, with cumulative funding totaling over $45 billion since the inception of NNI in 2001 when Congress approved increased funding for nanotechnology in FY 2021 appropriations. The report states that NNI participating agencies support applied research, experimental development, pre-commercialization, and standards-related efforts that build economic competitiveness, facilitating the adoption of a wide range of nanotechnologies, and helping create good-paying jobs across the country, including in both traditional and emerging industries. More information is available in our January 14, 2025, 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

The 119th Congress — Day 1 — A Tale Of Two Legislative Bodies And The Beginning Of A Busy Year: The opening hours of the 119th Congress provided an interesting look at the two bodies of Congress, the United States House of Representatives (House) and the United States Senate (Senate), and offered a glimpse of what to expect from the leaders of those bodies during the next two years. While Republicans control the House and the Senate, their slim majorities will present challenges in legislating during the 119th Congress. In the House, it will take only a handful of Republican defections to threaten passage of any legislation that does not have Democratic support. In the Senate, Majority Leader Thune (R-SD) promised to retain the filibuster, meaning that any legislation pursued under regular order will require Democratic votes to proceed. More information on the opening hours of the 119th Congress is available in our January 6, 2025, blog item.

Senate Committee Hearing On Nomination Of Lee Zeldin To Be Administrator Of U.S. Environmental Protection Agency Scheduled For January 16, 2025, At 10:00 a.m.: Senator Shelly Moore Capito (R-WV), Chair of the Senate Committee on Environment and Public Works (EPW), has scheduled a hearing on the Nomination of Lee Zeldin to be Administrator of the Environmental Protection Agency for Thursday, January 16, at 10:00 a.m. The hearing will be held in room 406 of the Senate Dirksen Office Building and will be viewable by webcast as well.

It will be interesting to hear what Mr. Zeldin shares about his priorities as EPA Administrator and how the Trump Administration will approach environmental protection. The question-and-answer period will provide insights into priority issues for both Republican and Democratic Senators — and may identify potential areas for bipartisan cooperation during the 119th Congress.

MISCELLANEOUS

EPA Announces Availability Of Draft IRIS Toxicological Review Of Chloroform (Inhalation): EPA announced on December 18, 2024, a 60-day public comment period associated with the release of the draft Integrated Risk Information System (IRIS) Toxicological Review of Chloroform (Inhalation). 89 Fed. Reg. 102892. EPA states that it is releasing the draft IRIS assessment for public comment in advance of a Science Advisory Board (SAB) managed peer review. SAB will convene a public meeting to discuss the draft assessment with the public during Step 4 of the IRIS Process. The external peer reviewers will consider public comments submitted to the EPA docket in response to this notice and any others provided during external peer review. EPA will consider all comments submitted to the docket when revising the document post-peer review. Comments are due February 18, 2025.

Maine Proposes Rule Regarding Products Containing Intentionally Added PFAS: On December 20, 2024, the Maine Department of Environmental Protection (MDEP) published a proposed rule regarding products containing intentionally added PFAS. The rule would establish criteria for currently unavoidable uses (CUU) of intentionally added PFAS in products and implement sales prohibitions and notification requirements for products containing intentionally added PFAS but determined to be a CUU. MDEP will hold a public hearing on January 16, 2025, at 9:00 a.m. (EST). Comments are due January 28, 2025, at 5:00 p.m. (EST). The proposed rule and a fact sheet are available on MDEP’s website. More information is available in our December 31, 2024, memorandum.

EPA Adjusts Civil Monetary Penalty Amounts: On January 8, 2025, EPA issued a final rule adjusting the level of the maximum and minimum statutory civil monetary penalty amounts under the statutes that EPA administers. 90 Fed. Reg. 1375. EPA notes that this action is mandated by the Federal Civil Penalties Inflation Adjustment Act of 1990, as amended through the Federal Civil Penalties Inflation Adjustment Act Improvements Act of 2015. The 2015 Act prescribes a formula for annually adjusting the statutory maximum and minimum amount of civil monetary penalties to reflect inflation, maintain the deterrent effect of statutory civil monetary penalties, and promote compliance with the law. The rule does not establish specific civil monetary penalty amounts EPA may seek in particular cases. EPA calculates those amounts, as appropriate, based on the facts of particular cases and applicable agency penalty policies. EPA’s civil penalty policies, which guide enforcement personnel on how to exercise EPA’s discretion within statutory penalty authorities, take into account a number of fact-specific considerations, e.g., the seriousness of the violation, the violator’s good faith efforts to comply, any economic benefit gained by the violator as a result of its non-compliance, and the violator’s ability to pay. The final rule was effective January 8, 2025.

Cookware Association Files Federal Challenge To Minnesota’s Ban On PFAS In Cookware: The Cookware Sustainability Alliance (CSA) announced on January 9, 2025, that it has filed suit in the U.S. District Court for the District of Minnesota, seeking a preliminary injunction of Minnesota’s ban on the sale of cookware containing intentionally added PFAS. CSA v. Kessler (No. 0:25-cv-00041). According to CSA, the chemical coating on nonstick cookware contains fluoropolymers, which “are fundamentally different compounds from the chemicals that have motivated concerns about PFAS.” CSA claims that Minnesota’s ban violates the U.S. Constitution’s prohibition on individual states regulating interstate commerce and has raised other constitutional challenges to Minnesota’s statute. CSA states that it has offered to work cooperatively with Minnesota “to secure an exemption for fluoropolymer coated nonstick cookware because of their low-risk profile.”

EPA Announces Final IRIS Assessments Of PFHxS And Related Salts, Inorganic Arsenic: EPA announced on January 13, 2025, the availability of two final IRIS assessments:

  • IRIS Toxicological Review of Perfluorohexanesulfonic Acid (PFHxS) and Related Salts: The IRIS assessment reviews the evidence on the potential cancer and noncancer human health effects that may result from exposure to PFHxS. The IRIS assessment of PFHxS will serve as a critical source of toxicity information for EPA, state and local health agencies, other federal agencies, and international health organizations; and
  • IRIS Toxicological Review of Inorganic Arsenic: The new IRIS assessment reviews the evidence on the potential cancer and noncancer human health effects that may result from exposure to inorganic arsenic. The IRIS assessment of inorganic arsenic will serve as a critical source of toxicity information for EPA, state and local health agencies, other federal agencies, and international health organizations.

Rulemaking Petition Seeks Elimination Of Flame Retardant Chemicals From Cars: Consumer Reports, the Green Science Policy Institute (GSPI), and the International Association of Fire Fighters formally filed a petition for rulemaking on January 14, 2025, with the National Highway Traffic Safety Administration (NHTSA) for an updated flammability standard for car interiors and child car seats. According to GSPI’s January 14, 2025, press release, to meet the current standard (FMVSS 302), automotive manufacturers add flame retardant chemicals to seat foam and other interior materials. The press release states that these chemicals are often known or suspected carcinogens, endocrine disruptors, and neurotoxins.

This Update is provided as a complimentary service to our clients and is for informational purposes. This Update may be copied or quoted, provided proper attribution is given. The contents are not intended and cannot be considered as legal advice.