Published February 7, 2024, by Lynn L. Bergeson and Carla N. Hutton
EPA announced on January 24, 2024, that it is extending the review period for confidential business information (CBI) claims for specific identity of all active chemical substances listed on the confidential portion of the TSCA Inventory submitted to EPA under TSCA. 89 Fed. Reg. 4605. EPA states that it “has determined that an extension of the statutory review period for the review of CBI claims under TSCA are necessary to allow the Agency to complete the required reviews under TSCA.” According to EPA, the additional time is necessary “given the volume of submissions that require review, information technology issues, and other legal and administrative delays that have affected the review process.” EPA extended the review period to February 19, 2025. As this extended deadline approaches, EPA may further extend the deadline as necessary to complete the reviews.
Published February 5, 2024, by Javaneh S. Tarter, Nancy B. Beck, PhD, DABT, Gregory R. Wall, Matthew Z. Leopold, Paul T. Nyffeler, Ph.D., Julia J. Casciotti, Meredith K. Doswell, and Jaclyn Lee
In December 2023, federal agencies released their “Fall 2023” Regulatory Agendas that provide an outlook for numerous upcoming regulatory actions on chemicals that could have significant implications for the regulated community. Hunton Andrews Kurth LLP’s chemical regulatory team has provided analyses of these upcoming regulatory actions:
Published January 30, 2024, by David B. Fischer, M.P.H. and Elizabeth L. Nugent
On January 24, 2024, Michal Freedhoff, the assistant administrator for the Office of Chemical Safety and Pollution Prevention (OCSPP) at EPA, testified on EPA’s implementation of TSCA before the Senate Environment and Public Works Committee. The purpose of Freedhoff’s testimony was to provide an update on progress made since TSCA was amended in 2016, and to advocate for additional funds to better support the Act’s implementation.
Published January 29, 2024, by Herbert Estreicher, Ph.D., and David B. Fischer, M.P.H.
In December 2023, EPA announced five new chemicals that will be prioritized for risk evaluation as prescribed by section 6 of TSCA as amended in 2016. The chemicals in the spotlight include:
- Vinyl Chloride
- Acetaldehyde
- Acrylonitrile
- Benzenamine
- 4,4’-Methylene bis(2-chloroaniline) (MBOCA)
Public comment on the prioritization of all the above chemicals is due March 18, 2024. The EPA is interested in comments on such things as hazard and exposure potential, persistence and bioaccumulation, instances of storage near sources of drinking water, any significant changes in conditions of use, significant changes in production, and any other information relevant to their risk potential. Keller and Heckman attorneys and scientists anticipate that all five candidates will be designated as “high priority,” at which point EPA will initiate risk evaluation for each of the five.
Published January 29, 2024, by Lynn L. Bergeson, Carla N. Hutton, and Richard E. Engler, Ph.D.
The Senate Environment and Public Works Committee held a hearing on January 24, 2024, on “Oversight of Toxic Substances Control Act (TSCA) Amendments Implementation.” Michal Freedhoff, Ph.D., assistant administrator of EPA’s OCSPP was the committee’s sole witness. Committee chair Tom Carper (D-DE) and ranking member Shelley Moore Capito (R-WV) provided opening statements. On the whole, no new ground was broken, and the takeaway is that everyone—EPA, the Hill, and industry—remains frustrated with TSCA’s implementation, but for very different reasons.
According to Carper, EPA is addressing the backlog of chemicals awaiting review while also reviewing new submissions, and since June 2023, EPA has more than doubled the average amount of new chemicals reviews completed each month. Capito noted that since 2021, the number of cases that have received a determination of “not likely to present risk” has dropped by 75 percent. Capito stated that submitters that have heeded EPA’s advice to come in earlier to find out what data EPA needs have not fared well and that no amount of data provided to EPA appears sufficient to overcome its worst-case assumptions of risk. Last week, before the hearing, Capito shared with Freedhoff a summary of ideas to improve management and accelerate the new chemicals review process.
In her testimony, Freedhoff highlighted changes that EPA has made, including meeting with stakeholders and obtaining their input before announcing the next five chemicals that it expects to evaluate. According to Freedhoff, in FY 2023, EPA completed 70 percent more risk assessments compared to FY 2022. Since June 2023, EPA has more than doubled the average number of completed risk assessments as compared to the year before and cleared out about 50 percent of the older backlog of cases. Freedhoff stated that TSCA is underfunded, as concluded by EPA’s analysis, as well as that of EPA’s Office of Inspector General (OIG) and the U.S. Government Accountability Office (GAO). Full funding would mean 25 new hires to review new chemicals and 75 new people to finish risk evaluations and rules more quickly.
Published January 22, 2024, by Nancy B. Beck, Ph.D., DABT, Javaneh S. Tarter, Gregory R. Wall, Matthew Z. Leopold, Paul T. Nyffeler, Ph.D., and Meredith K. Doswell
In 2022 and 2023, EPA proposed five risk management rules under section 6(a) of TSCA imposing restrictions and bans on chemical uses. This is the first group of risk management rules that EPA has published since Congress amended TSCA in 2016, establishing EPA’s process to address “unreasonable risks” identified for certain uses of existing chemicals. These proposed rules provide a roadmap for EPA’s approach to chemical regulation under section 6(a), establishing the precedent for future regulation.
Companies should anticipate more proposed bans, especially for consumer uses of a chemical, along with significantly lower chemical exposure limits compared to occupational exposure limits. Rigorous workplace requirements, including exposure monitoring, respiratory protection, and additional personal protective equipment (PPE) requirements are also expected. And the absence of industry data on a chemical’s use may lead to more stringent proposed regulation.
Published January 9, 2024, by Lynn L. Bergeson, Carla N. Hutton, Richard E. Engler, Ph.D., and Todd J. Stedeford, Ph.D., DABT, ERT, ATS
EPA released on January 8, 2024, a decision framework for identifying eye irritation or corrosion hazards for new chemicals reviewed under TSCA. 89 Fed. Reg. 1093. EPA states that the “New Chemicals Program Decision Framework for Hazard Identification of Eye Irritation and Corrosion” provides a decision framework for use by the Office of Pollution Prevention and Toxics (OPPT) New Chemicals Division (NCD) to identify eye irritation or corrosion hazards for new chemical substances based on prioritization of reproducible, human-relevant data. EPA notes that the framework supports its mandate under TSCA to promote the development and implementation of New Approach Methodologies (NAM) to reduce, refine, or replace vertebrate animal testing and provide information of equivalent or better scientific quality and relevance for assessing risks of injury to health or the environment.
Published January 5, 2024, by Lynn L. Bergeson and Carla N. Hutton
On December 28, 2023, EPA released comments from the letter peer review for its 2023 white paper presenting EPA’s quantitative approach for the human health risk assessment for part 2 of TSCA risk evaluation for asbestos. EPA notes in its December 28, 2023, press release that under the previous administration, it narrowed the scope of the asbestos risk evaluation by reviewing only ongoing uses and excluding legacy uses and disposals. Because only chrysotile asbestos has ongoing uses, EPA did not consider other fiber types. In 2019, a court ruled that EPA unlawfully excluded “legacy uses” and “associated disposal” from TSCA’s definition of “conditions of use,” however, resulting in the need to supplement EPA’s initial review of asbestos (part 1) with a part 2 risk evaluation focused on legacy uses and associated disposals. Part 2 also includes other types of asbestos fibers in addition to chrysotile (crocidolite, amosite, anthophyllite, tremolite, and actinolite) and asbestos-containing talc.
In August 2023, EPA released a white paper for public comment and letter peer review identifying existing hazard values for asbestos and describing how the Agency proposes to use them in the risk evaluation. EPA also described its systematic review approach to identify and evaluate relevant scientific studies for the quantification of asbestos hazards and to make decisions about which are most relevant for part 2 of the risk evaluation in a fit-for-purpose manner. Consistent with EPA and Office of Management and Budget (OMB) guidance on peer review of scientific and technical work products, EPA requested a letter peer review by independent experts of the quantitative approach to the human health assessment to be used in part 2 of the risk evaluation. EPA states that it submitted the white paper, rather than the full draft risk evaluation, for peer review to focus on key technical aspects of the forthcoming risk evaluation and to make the most efficient use of the experts’ time. According to EPA, the peer review comments will help shape its asbestos part 2 risk evaluation, which the Agency plans to release for public comment in early 2024.
Published January 3, 2024, by Lynn L. Bergeson
Bergeson & Campbell, P.C. (B&C) and its global consulting affiliate The Acta Group (Acta) and consortia management affiliate B&C Consortia Management, L.L.C. (BCCM) are delighted to share with you our Forecast 2024. 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 global state of play, speculating on how things will shake out in 2024 is challenging.
Published January 2, 2024, by Ryan J. Carra, Mark N. Duvall, and Nicholas J. Hanel
In December 2023, EPA announced three significant actions under TSCA:
It published a notice that it is initializing the prioritization process for five chemical substances under section 6(b)(1) of TSCA. This is the first stage in the regulatory process that may lead to EPA restricting or banning the use of these chemicals. Stakeholders have until March 18, 2024, to submit public comments. The five chemicals are:
- Acetaldehyde
- Acrylonitrile
- Benzenamine
- Vinyl chloride
- MBOCA
EPA issued a data call-in for MBOCA under section 8(c) of TSCA. The Agency must receive records of significant adverse effects to human health or the environment related to MBOCA on or before February 26, 2024. In connection with this action, EPA has released new guidance on reporting information under section 8(c).
EPA announced that it expects to issue a proposed rule under TSCA section 8(d) to require manufacturers and importers of certain existing chemicals to send EPA copies of unpublished health and safety studies. The proposed rule is expected to be published in March 2024, followed by the final rule in September 2024.
Published December 28, 2023, by Lynn L. Bergeson and Carla N. Hutton
On December 18, 2023, EPA issued final significant new use rules (SNUR) under TSCA for several chemical substances that were the subject of premanufacture notices (PMN) and are also subject to Orders issued by EPA pursuant to TSCA. 88 Fed. Reg. 87346. The SNURs include four chemical substances identified as:
- Multi-walled carbon nanotubes (MWCNT); closed; 4.4-12.8 nanometer (nm) diameter; bundle length 10.6 to 211.1 micrometer (µm); Grade: Jenotube 6 (PMN P-20-62);
- MWCNTs; closed; 5.1 to 11.6 nm diameter; bundle length 1.9 to 552.0 µm; Grade: Jenotube 8 (PMN P-20-63);
- MWCNTs; closed; 7.9-14.2 nm diameter; bundle length 9.4 to 106.4 µm; Grade: Jenotube 10 (PMN P-20-64); and
- MWCNTs; closed; 17.0 to 34.7 nm diameter; globular shape; Grade: Jenotube 20 (PMN P-20-65).
Published December 27, 2023, by Lynn L. Bergeson, Carla N. Hutton, Richard E. Engler, Ph.D., Todd J. Stedeford, Ph.D., DABT, ERT, ATS
EPA announced on December 18, 2023, that it is beginning the process to prioritize five additional toxic chemicals for risk evaluation under TSCA. 88 Fed. Reg. 87423. The chemicals are acetaldehyde, acrylonitrile, benzenamine, MBOCA, and vinyl chloride. EPA seeks relevant information, including but not limited to, the chemical substance’s hazard and exposure potential; the chemical substance’s persistence and bioaccumulation; potentially exposed or susceptible subpopulations relevant to the prioritization; whether there is any storage of the chemical substance near significant sources of drinking water; the chemical substance’s conditions of use or significant changes in conditions of use, including information regarding trade names; the chemical substance’s production volume or significant changes in production volume; and any other information relevant to the potential risks of the chemical substance that might be relevant to the designation of the chemical substance’s priority for risk evaluation. Comments are due March 18, 2024. EPA has opened a chemical-specific docket for each of the five chemicals. EPA’s December 14, 2023, press release includes the following information regarding the five chemicals:
- Acetaldehyde is primarily used in the manufacturing and processing of adhesives, petrochemicals, and other chemicals, as well as intermediates for products like packaging and construction materials. Exposure to acetaldehyde may result in a range of health effects such as irritation of the respiratory system. It is a probable human carcinogen.
- Acrylonitrile is primarily used in the manufacturing and processing of plastic materials, paints, petrochemicals, and other chemicals. Exposure to acrylonitrile may result in a range of health effects such as irritation of the respiratory system. It is a probable human carcinogen.
- Benzenamine is used in the manufacturing and processing of dyes and pigments, petrochemicals, plastics, resins, and other chemicals. Exposure to benzenamine may result in a range of health effects such as adverse effects on the blood, fetal development, and reproduction. Benzenamine is a probable human carcinogen.
- MBOCA is used in the manufacturing and processing of rubbers, plastics, resins, and other chemicals. It is a probable human carcinogen. There is also extensive data that demonstrate exposure to MBOCA may damage genetic material in cells, potentially leading to other adverse health effects, particularly when exposure occurs to infants and children.
- Vinyl chloride is primarily used in the manufacturing and processing of plastic materials like polyvinyl chloride (PVC), plastic resins, and other chemicals, and many of these materials are used for pipes, insulating materials, and consumer goods. This chemical was also involved in the Norfolk Southern train derailment in East Palestine, Ohio. Exposure to vinyl chloride may result in a range of health effects, such as liver toxicity. It is also a known human carcinogen. In the 1970s, the White House Council on Environmental Quality and EPA officials raised serious concerns about the health impacts of vinyl chloride. These concerns were the impetus for Congress to write a law to ensure chemicals were made and used safely, which led to passage of the “original” TSCA in 1976.
Published December 21, 2023, by Lynn L. Bergeson, Carla N. Hutton, Richard E. Engler, Ph.D., and Todd J. Stedeford, Ph.D., DABT, ERT, ATS
On December 15, 2023, EPA announced the availability of and solicited public comment on its draft risk evaluation for tris(2-chloroethyl) phosphate (TCEP) and related draft charge questions. 88 Fed. Reg. 86894. EPA states on its website that it reviewed the exposures and hazards of TCEP uses and made risk findings on TCEP. EPA considered relevant risk-related factors, including, but not limited to the hazards and exposure, magnitude of risk, exposed population, severity of the hazard, and uncertainties, as part of its unreasonable risk determination. EPA proposes to determine that TCEP, as a whole chemical substance, presents unreasonable risk to human health and the environment.
EPA states in its December 14, 2023, press release that this is the first draft risk evaluation it has released for the 20 high-priority substances prioritized in 2019. EPA notes that it has incorporated improvements to the risk evaluation process announced in 2021 into the risk evaluation, including an assessment of exposure to potentially exposed and susceptible subpopulations such as workers, children, and subsistence fishers.
Published December 12, 2023, by Lynn L. Bergeson and Carla N. Hutton
On December 6, 2023, a group of Republican representatives sent a letter to EPA Administrator Michael S. Regan regarding EPA’s risk evaluation of existing chemicals under TSCA. According to the letter, the representatives are “concerned that the EPA is using TSCA section 6 in a way that both subverts and supplants the statutory responsibilities of the Occupational Safety and Health Administration (OSHA).” The letter notes that, for example, OSHA sets enforceable, permissible exposure limits (PEL) to protect workers against the health effects of exposure to hazardous chemicals. In its risk management rules, EPA “has construed its authority so broadly through the creation of Existing Chemical Exposure Limits (ECELs) that it is—for the first time—claiming the authority to regulate indoor air and is usurping OSHA’s PEL authority on a chemical-by-chemical basis,” however.
FIFRA Articles
Published February 8, 2024, by James V. Aidala and Heather F. Collins, M.S.
On February 1, 2024, EPA released guidance to clarify how it will evaluate “absence of an ingredient” claims for pesticide products regulated under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). EPA states that it is aware that the regulated community seeks clarity on whether and how “absence of an ingredient” claims can be made lawfully on FIFRA-regulated product labels.
Published February 6, 2024, by Alan J. Sachs, Nicholas J. Hanel, and Elizabeth A. Johnson
On February 1, 2024, EPA issued new guidance on “absence of an ingredient” claims for pesticide products. According to EPA, this guidance is intended to clarify the status of “absence of an ingredient” claims on FIFRA-regulated product labels. The guidance reinforces EPA’s decades-old position that “absence of an ingredient” claims are inappropriate when they “could give users the impression that products without a certain ingredient are safe or safer, less risky, better, or more desirable than products containing that ingredient.” But EPA newly acknowledges that “absence of an ingredient” claims may also be used in ways that limit potential confusion to consumers in some circumstances. According to EPA’s new guidelines, a proposed “absence of an ingredient” claim will be approved if EPA determines that the claim is not false or misleading because 1. it is used for purposes other than conveying information about product safety for humans or the environment, and 2. it is supported by data demonstrating that the claim would not be misleading to users or appropriately qualified to limit the potential to mislead users.
Published February 5, 2024, by Alan J. Sachs and Kathryn Szmuszkovicz
EPA officially reinstated all tolerances for chlorpyrifos on February 5, 2024, undoing a prior rule that had halted chlorpyrifos use on all food and feed commodities in early 2022.
At the same time, EPA signaled through a posting on its website that it would take steps to revoke all of these uses except for the following: alfalfa, apple, asparagus, cherry (tart), citrus, cotton, peach, soybean, strawberry, sugar beet, wheat (spring), and wheat (winter). EPA also announced that it plans to “expeditiously” propose new restrictions on the chlorpyrifos uses that are retained.
Published January 31, 2024, by Heather F. Collins, M.S.
The March 1, 2024, deadline for all establishments, foreign and domestic, that produce pesticides, devices, or active ingredients to file their annual production for the 2023 reporting year is fast approaching. Pursuant to FIFRA section 7(c)(1) (7 U.S.C. § 136e(c)(1)), “Any producer operating an establishment registered under [section 7] shall inform the Administrator within 30 days after it is registered of the types and amounts of pesticides and, if applicable, active ingredients used in producing pesticides” and this information “shall be kept current and submitted to the Administrator annually as required.”
Published January 9, 2024, by Heather F. Collins, M.S.
EPA has released the annual pesticide registration maintenance fee materials for FY 2024. The January 16, 2024, deadline for payment of EPA’s annual maintenance fee for pesticide registrations is fast approaching. 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. More information on the annual maintenance fees is available on EPA’s website.
Published December 29, 2023, by Carla N. Hutton and Meibao Zhuang, Ph.D.
EPA announced on December 22, 2023, that it has registered biopesticide products containing the new active ingredient Ledprona for three years, “a timeframe that is consistent with EPA’s approach to other novel biopesticide products.” Ledprona is a new type of pesticide that relies on a natural mechanism, RNA interference (RNAi), used by plants and insects to protect against disease. As reported in our October 12, 2023, blog item, Ledprona is a sprayable double-stranded ribonucleic acid (dsRNA) product targeting the Colorado potato beetle (CPB), a major pest of potato crops grown in the United States. According to EPA, while the CPB is known to develop resistance rapidly to chemical-based insecticides, the sprayable dsRNA product “kills the pest by ‘silencing’ the CPB gene needed to produce the PSMB5 protein, whose role is essential to keeping the CPB alive, without resulting in a genetically modified organism.” EPA notes that this pesticide is “the first sprayable dsRNA pesticide in the world allowed to be used commercially and sprayed on plants.”
Published December 11, 2023, by Tracy Heinzman, Hume M. Ross, and Edith Nagy
On November 24, 2023, EPA announced that it is accepting comments on a petition for rulemaking submitted by the Public Employees for Environmental Responsibility (PEER), the American Bird Conservancy (ABC), and several other groups. The petition asks EPA to amend regulations implementing FIFRA to require submission of efficacy data for neonicotinoid insecticides and other systemic insecticides (both for existing and any pending or future registrations) and to review currently registered products in view of that data. The full petition for rulemaking can be found in the docket at EPA-HQ-OPP-2023-0428.
The requested change would be a paradigm shift in how EPA evaluates a large percentage of the pesticide products it registers and would create significant administrative burdens on EPA. Against the backdrop of EPA’s long-standing procedure for evaluating registration applications, the petition in effect challenges the rationality of EPA’s prior registration decisions for a large number of widely used pesticide products. Neonicotinoid insecticides include clothianidin, thiamethoxam, and imidacloprid. Systemic pesticides are chemicals absorbed by an organism that make the organism toxic to pests; they include fipronil, flupyradifurone, and sulfoxaflor. Petitioners do not define the extent of what active ingredients would be considered “systemic insecticides” for purposes of their proposal, though they do reference a list maintained by a third party. See Xerces Society’s “Systemic Insecticides List.”
States Initiatives
Published February 5, 2024, by Robert P. Frank and Dianne R. Phillips
2024 is off to a busy start for folks following state laws related to per- and polyfluoroalkyl substances (PFAS) in products. Multiple states have passed legislation impacting product manufacturers and retailers. Maine and Minnesota are leading the way, but several other states have enacted laws that go into effect in 2024.
Published January 23, 2024, by Ryan J. Carra, Mark N. Duvall, David C. Weber, and Nicholas J. Hanel
The Washington State Department of Ecology (Ecology) filed a petition on January 4, 2024, under TSCA requesting that EPA reduce allowances for inadvertently generated polychlorinated biphenyls (PCBs) in consumer products. Ecology’s petition asks EPA to initiate a rulemaking to phase-in “an eventual limit of zero” for inadvertently generated PCBs over a 10-year period. Ecology is primarily concerned with inadvertently generated PCBs found in pigments, inks, and dyes.
Published January 19, 2024, by Lynn L. Bergeson and Carla N. Hutton
As reported in our December 5, 2023, memorandum, EPA proposed updates to the Safer Choice Standard on November 14, 2023, that include a name change to the Safer Choice and Design for the Environment (DfE) Standard (Standard), an update to the packaging criteria, the addition of a Safer Choice certification for cleaning service providers, a provision allowing for preterm partnership termination under exceptional circumstances, and the addition of several product and functional use class requirements. 88 Fed. Reg. 78017. On January 16, 2024, California attorney general Rob Bonta announced that, alongside a coalition of 12 attorneys general, he submitted a comment letter that:
- Supports EPA’s proposed revisions to its Safer Choice Standard;
- Recommends that EPA not allow products with plastic primary packaging to use the Safer Choice label or DfE logo;
- Recommends that if EPA does allow products with plastic primary packaging to use the label and logo, EPA should prohibit the use of chemical recycling in meeting the proposed standard’s plastic packaging recycled content requirements; and
- Calls on EPA to exclude any products or packaging that contain any PFAS, “whether intentionally introduced or not.”
Published January 16, 2024, by Lynn L. Bergeson and Carla N. Hutton
On January 4, 2024, the Washington Department of Ecology (WDOE) submitted a petition to EPA under section 21 of TSCA seeking a rulemaking to eliminate the current allowances for PCBs in consumer products. WDOE states that its research found that when PCBs are found in consumer products, “they are byproducts known to be associated with pigments, paints, or inks used in the manufacturing process.” According to WDOE, “[t]hese inadvertent PCBs currently allowed under TSCA directly expose people and contribute to PCB contamination in the environment.” Under TSCA section 21, EPA must either grant or deny the petition within 90 days of receipt of the petition. EPA’s response is due April 3, 2024.
Published January 12, 2024, by Lynn L. Bergeson and Carla N. Hutton
The Minnesota Pollution Control Agency (MPCA) has published a request for comments (RFC) on planned new rules governing currently unavoidable use (CUU) determinations for products containing PFAS. According to the RFC, the main purpose of the rulemaking is to establish criteria and processes through which MPCA will make decisions on what uses of intentionally added PFAS will qualify as CUUs in products sold, offered for sale, or distributed in Minnesota. Any such determinations must be published by rule by MPCA by January 1, 2032. MPCA states that it would appreciate comment on several questions.
Published January 9, 2024, by Lynn L. Bergeson and Carla N. Hutton
In 2021, Maine enacted “An Act To Stop Perfluoroalkyl and Polyfluoroalkyl Substances Pollution.” Under the statute, beginning January 1, 2030, any product containing intentionally added PFAS may not be sold in Maine unless the use of PFAS in the product is specifically designated as a CUU by the Maine Department of Environmental Protection (MDEP). According to MDEP’s website, CUU determinations must be made through major substantive rulemaking, meaning that first the Board of Environmental Protection will adopt the CUUs and then the legislature will review them. To bring CUU proposals to the legislature in 2025, MDEP is accepting requests for proposals from those seeking CUU determinations. Manufacturers may submit proposals individually or collectively. MDEP notes that these determinations will be for uses of PFAS in products within specific industrial sectors and that a separate proposal must be submitted for each individual product category.
Published January 8, 2024, by Ryan J. Carra, Nessa Horewitch Coppinger, K. Russell LaMotte, Graham C. Zorn, and Robert T. Denney
MDEP is soliciting proposals for CUU designations under the state’s statute regulating the use of PFAS in products. Under the law, companies may not sell, offer for sale, or distribute for sale in Maine any product that contains intentionally added PFAS beginning January 1, 2030, unless the use of PFAS in the product has been designated a CUU. MDEP is now accepting proposals from those seeking such CUU determinations, which must be submitted by March 1, 2024. MDEP then plans to initiate a rulemaking process concerning these initial CUU designations. In informal communications with stakeholders, MDEP noted that it anticipates future rounds of CUU determinations prior to 2030; however, the current request for proposals represents an opportunity for the public to inform the process early on.
Published December 12, 2024, by Ryan J. Carra, Nessa Horewitch Coppinger, K. Russell LaMotte, David C. Weber, and Nicholas J. Hanel
Continuing Washington State’s push toward implementing one of the nation’s strictest chemicals laws, the Department of Ecology (Ecology) recently published its Draft Regulatory Determinations Report on certain products containing PFAS. These regulatory determinations, set to be finalized in June 2024, would guide Ecology’s future rulemaking on placing restrictions or reporting requirements on certain PFAS-containing products. These products include apparel and gear, firefighting PPE, cleaning products, automotive washes, waxes (for automobiles, floors, and skis), hard surface sealants, and cookware and kitchen supplies. Stakeholders should note which products might have reporting requirements or restrictions and provide comments to Ecology during the comment period, which expires on January 22, 2024.
The Safer Products for Washington program is a four-phase cycle that repeats every five years. During the first phase, Ecology identifies priority chemicals and classes it will focus on. During the second phase, Ecology identifies priority consumer products that contain the identified priority chemicals or classes. During the third phase, Ecology determines whether it will take regulatory action by requiring reporting or imposing chemical restrictions. Finally, during the fourth phase, Ecology adopts rules to implement the regulatory actions it identified in the previous phase. Each phase offers opportunities for public comment to Ecology.
This regulatory determination is part of “phase three” of Ecology’s “Cycle 1.5” of implementing the Safer Products for Washington program. The governing statute was amended to instruct Ecology to proceed directly to phases three and four for certain priority products containing PFAS.
PFAS Articles
Published February 7, 2024, by Thomas S. Lee, Bryan E. Keyt, Erin L. Brooks, and John R. Kindschuh
As expected, 2023 was an expansive year for the regulation of PFAS at the federal level. EPA took (or at least proposed) significant actions under a range of different regulatory programs and environmental statutes including the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), TSCA, the Safe Drinking Water Act (SDWA), the Clean Water Act (CWA), and the Toxics Release Inventory (TRI) Program. That noted, there were two significant absences from the list of new regulations and actions taken by EPA in 2023 that we discuss below: 1. finalizing the drinking water limitations for six PFAS substances; and 2. formally designating perfluorooctanoic acid (PFOA) and perfluorooctane sulfonate (PFOS) as “Hazardous Substances” under CERCLA.
Published January 30, 2024, by Lynn L. Bergson and Carla N. Hutton
On January 25, 2024, EPA held a webinar on EPA’s TSCA section 8(a)(7) rule on the reporting and recordkeeping requirements for PFAS. During the webinar, EPA provided an overview of the rule’s requirements. EPA also answered questions from webinar participants and stated that it is preparing a frequently asked questions (FAQ) document that it intends to circulate in early summer 2024. EPA will post the slides and recording of the webinar on its website.
Published January 29, 2024, by Ryan J. Carra, Mark N. Duvall, Nessa Horewitch Coppinger, K. Russell LaMotte, and Robert T. Denney
EPA has finalized a one-time reporting rule regarding the manufacture (including import) of PFAS. Despite heavy industry opposition, obligated companies will include importers of articles that contain any amount of PFAS. The rule does not incorporate exemptions typically applied in other TSCA rules (e.g., byproducts, impurities, most research and development (R&D)). The rule also does not incorporate a de minimis volume threshold. For most companies, reports will be due by May 8, 2025. Reports must cover in-scope activities in each calendar year from 2011 through 2022.
Published January 19, 2024, by Thomas S. Lee, Bryan E. Keyt, Emma R. Cormier, and John R. Kindschuh
EPA started the new year by finalizing two rules involving PFAS under TSCA and TRI. The first rule requires industries to consult with EPA before using any of the designated 329 inactive PFAS substances. The second rule adds seven PFAS substances to the list of chemicals that entities must report. The details of the new rules are below, but these actions demonstrate EPA’s continued commitment to regulate PFAS substances under a wide range of environmental laws.
Published January 18, 2024, by Lynn L. Bergeson and Carla N. Hutton
EPA announced on January 9, 2024, the automatic addition of seven PFAS to the list of chemicals covered by the TRI. For TRI Reporting Year 2024 (reporting forms due by July 1, 2025), reporting is required for these seven additional PFAS, bringing the total PFAS subject to TRI reporting to 196. The FY 2020 National Defense Authorization Act (NDAA) includes a provision that automatically adds PFAS to the TRI list upon EPA’s adoption of a final toxicity value. Six PFAS were automatically added for Reporting Year 2024 due to EPA having adopted a final toxicity value during 2023.
Published January 16, 2024, by Dianne R. Phillips, Robert P. Frank, Brian C. Bunger, Anne-Mette Elkjaer Andersen, and Meaghan A. Colligan
2023 was a busy year for folks following legal developments related to PFAS. In December, EPA issued its Second Annual Progress Report. Some of the highlights are described in this article, along with an update on the massive PFAS multidistrict litigation pending in South Carolina.
Published January 16, 2024, by Thomas S. Lee, Bryan E. Keyt, Emma R. Cormier, and John R. Kindschuh
In the absence of an enforceable federal drinking water standard for PFAS—for the time being anyway—many states have regulated PFAS compounds in drinking water. The result is a patchwork of regulations and standards of varying levels, which presents significant operational and compliance challenges to impacted industries. This client alert surveys the maximum contaminant levels (MCLs), as well as guidance and notification levels, for PFAS compounds—typically PFOS and PFOA—in drinking water across the United States.
Published January 12, 2024, by Lynn L. Bergeson, Carla N. Hutton, Richard E. Engler, Ph.D., and Todd J. Stedeford, Ph.D., DABT, ERT, ATS
On January 11, 2024, EPA issued a final SNUR to prevent companies from starting or resuming the manufacture (including import) or processing of 329 PFAS that are designated as inactive on the TSCA Chemical Substance Inventory. 89 Fed. Reg. 1822. The final rule notes that persons subject to the final SNUR are required to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the chemical substance for a significant new use. Once EPA receives a significant new use notification (SNUN), EPA must review and make an affirmative determination on the SNUN and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. EPA states that such a review “will assess whether the new use may present unreasonable risk to health or the environment and ensure that EPA takes appropriate action as required to protect health or the environment.” The SNUR will take effect March 11, 2024.
Published January 11, 2024, by Gregory A. Clark, David B. Fischer, M.P.H., and Elizabeth L. Nugent
On January 11, 2024, EPA finalized a TSCA SNUR to require that companies notify EPA and seek approval before manufacturing, importing, or processing over 300 PFAS listed on the TSCA Inventory but assumed not to be actively manufactured (including import) or processed because the substances are designated on the Inventory as “inactive.” Per- and Poly-Fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory; Significant New Use Rule, 89 Fed. Reg. 1822 (Jan. 11, 2024). The final rule becomes effective 60 days after publication in the Federal Register, on March 11, 2024. A petition for judicial review of the final rule must be filed within 60 days of the rule’s promulgation date, by March 25, 2024. 15 U.S.C. § 2618.
Published January 11, 2024, by Matthew D. Thurlow
The new year will be a busy one for federal and state PFAS regulations. There are a number of new federal rulemakings, including those under CERCLA and the SDWA, slated to be announced over the next few months that may shape PFAS regulation (and litigation) for years, if not decades, to come. Likewise, there are new state regulations slated to go into effect that will significantly impact the manufacture, import, marketing, and sale of a wide variety of products containing PFAS. While there is much that is already known about new PFAS regulations, there are also a number of critical unknown factors that could shape PFAS regulations, including the final language adopted in rulemakings, potential litigation of key rulemakings, and new legislation of PFAS by state legislatures and Congress. Chemical and product manufacturers, importers, and retailers will need to continue to closely monitor legal developments to manage PFAS-related risks.
Published January 3, 2024, by Lynn L. Bergeson and Carla N. Hutton
The Organization for Economic Cooperation and Development (OECD) has published a draft report entitled Draft Report on Per- and Polyfluoroalkyl Substances and Alternatives in Coatings, Paints and Varnishes (CPVs): Hazard Profile. OECD intends the draft report to complement its 2022 report, Per- and Polyfluoroalkyl Substances and Alternatives in Coatings, Paints and Varnishes (CPVs), by compiling information on the hazard profile of the fluoropolymers, short-chain PFAS, and non-fluorinated substances identified in terms of hazard classifications from authorities and industry and available assessments from authorities on persistence, bioaccumulation, and environmental and health hazards. OECD conducted the main search for this report from January to July 2022, and it revised the report based on feedback from stakeholders during January to March 2023.
According to the draft report, the study demonstrates that the hazard profiles of many of the fluoropolymers, short-chain PFAS, and non-fluorinated alternatives used in CPVs are not available. OECD states that “[o]ut of the 45 substances identified in the OECD (2022) report and examined here, only nine substances have been classified by authorities and 30 by industry, while published assessments by authorities were available for just over half of the fluorinated substances and a significantly lower proportion of the non-fluorinated alternatives. No classifications or hazard assessments were identified for 15 substances.”
Published December 20, 2023, by Martha E. Marrapese and Edith Nagy
We took a look at the 2024 NDAA with respect to PFAS, since Congress has a track record of passing substantive provisions to require EPA to regulate PFAS in prior NDAA legislation. Although not as consequential as the 2020 NDAA, thanks to which we now have the TSCA section 8(a)(7) PFAS reporting rule, the 2024 NDAA does contain some PFAS-related amendments:
- Sec. 331. Modification of timing of report on activities of PFAS Task Force. As amended by the 2024 NDAA, reporting requirements related to PFAS substances will be reduced in frequency, from quarterly to annually through 2029.
- Sec. 332. Budget justification document for funding relating to PFAS. As amended by the 2024 NDAA, the DOD will have to include, with the submission of the annual budget request, a separate budget justification document on DOD’s PFAS-related activities.
- Sec. 333. Increase of transfer authority for funding of study and assessment on health implications of PFAS contamination in drinking water by Agency for Toxic Substances and Disease Registry. As amended, the authorization and funding transfer to the Centers for Disease Control and Prevention is extended, but the transfer amounts are limited to not more than $5 million during FY 2024.
- Sec. 334. Prizes for development of technology for thermal destruction of perfluoroalkyl substances or polyfluoroalkyl substances. As amended, the U.S. Secretary of Defense is authorized to carry out a pilot program that uses thermal destruction to dispose of PFAS substances.
- Sec. 335. Treatment of certain materials contaminated with perfluoroalkyl substances or polyfluoroalkyl substances. As amended, the Secretary of Defense may treat covered materials, including soils that have been contaminated with PFAS, through the use of any remediation or disposal technology that is approved by the administrator of the EPA.
- Sec. 336. Government Accountability Office reports on testing and remediation of perfluoroalkyl substances and polyfluoroalkyl substances. As amended, the Comptroller General will submit a report assessing the state of ongoing testing and remediation by the DOD of current or former military installations contaminated with PFAS substances. This report will include assessment of the state of the ongoing testing and remediation by the DOD of current or former military installations contaminated by PFAS substances.
As proposed, in the original House version, the 2024 NDAA would have prohibited the U.S. Department of Defense (DOD) from purchasing select products made with certain PFAS compounds, including some broadly defined as containing only a single fully fluorinated carbon atom coupled with a nonfluorinated carbon atom. A DOD report and Coalition Letter on PFAS in the FY24 NDAA Conference Agreement, dated October 12, 2023, was sent to Congress, advocating a more reasoned approach. It looks like Congress listened.
Published December 19, 2023, by Dianne R. Phillips, Dimitrios J. Karakitsos, and Chiara D. Kalogjera-Sackellares
The 2024 NDAA (H.R. 2670), which authorizes expenditures for DOD (or the Department), passed the House of Representatives on Dec. 14, 2023, and is headed to President Joe Biden for signature. The bill passed the Senate on Dec. 13, 2023, after lengthy negotiations described in a Conference Report of more than 3,000 pages. The annual, bipartisan and bicameral effort includes PFAS provisions in subtitle C, sections 331-336, as it has done in prior years, including the NDAA for FY 2022 (Dec. 27, 2021), which created DOD's PFAS Task Force codified at 10 U.S.C. § 2714 and required testing for PFAS at military installations and off-base drinking water.
Published December 19, 2023, by Thomas S. Lee, Bryan E. Keyt, Emma R. Cormier, and John R. Kindschuh
Numerous states have either enacted or proposed regulations regarding PFAS present in Class B Aqueous Film-Forming Foams (AFFF) used for firefighting, or present in firefighters’ clothing and equipment. These regulations typically involve restrictions in four general areas:
- Discharge or Use Restrictions. These regulations usually limit or prohibit the use of AFFF in training or testing exercises, and may only allow the use of AFFF in active firefighting situations;
- Disposal, Storage, Inventory or “Take-back” Provisions. Some states have enacted state-run programs to purchase and dispose of AFFF, usually purchasing supplies from government agencies;
- Notification or Reporting Requirements. When continued use of AFFF is allowed, some states have required that businesses report specific details regarding their discharge; and
- Limitations on PPE. Some states have limited or prohibited PPE for firefighters that contains PFAS compounds.
Published December 13, 2023, by Thomas S. Lee, Christian Bromley, Justin Jorgensen, and John R. Kindschuh
Marketing campaigns describing products as “green,” “natural,” and “clean” have become increasingly popular as companies seek to attract environmentally conscientious consumers. With a simultaneous increase in public awareness for PFAS, these marketing campaigns may now pose litigation risks when plaintiffs allege the products contain PFAS. If plaintiffs challenge these marketing statements, a Motion to Dismiss the complaint is among the most important considerations for a defendant’s initial response. Bryan Cave Leighton Paisner LLP (BCLP) has reviewed numerous cases filed in 2022 involving false and misleading advertising claims based on the allegation that a product contains PFAS substances. While each case has fact-specific nuances, the consistent issue that has been highlighted in the Motions to Dismiss or an equivalent state court motion is plaintiff’s standing to pursue the claims based on their theory of economic damages.
Based on the rulings that have been issued thus far, courts appear to be more receptive to allow plaintiffs to explore their claims through discovery rather than dismissing the case at the pleading stage if plaintiffs pursue what is known as a “price premium economic injury theory.” Courts are usually less deferential when plaintiffs utilize a “benefit of the bargain theory.”