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Spring 2024 Updates from the Pesticides and Chemicals Committee

James Aidala, Karin F Baron, Ales Bartl, Nancy Beck, Lynn L. Bergeson, Janet Kathleen Bond, Samuel B Boxerman, Erin Lynn Brooks, Lisa Burchi, Samuel Austin Butler, Ryan Joseph Sylvester Carra, Barbara Christianson, Nessa Horewitch Coppinger, Lawrence E Culleen, Robert T Denney, Riley Desper, Mark N Duvall, Richard Engler, Nicholas J Hanel, Carla N Hutton, Merrit M Jones, Bryan E Keyt, John R Kindschuh, Garrett Kral, K Russell Lamotte, Thomas Simmons Lee, Matthew Zane Leopold, Martha E Marrapese, Brandon Wade Neuschafer, Paul Nyffeler, Hannah Posen, Judah Prero, Rose Quam-Wickham, Tyler Scandalios, Yuvaraj Sivalingam, Kathryn Coniglio Skaggs, Todd Stedeford, Andrew Ross Stewart, Javaneh Tarter, Matthew D Thurlow, Gregory Wall, Sara Beth Watson, David Weber, Theodore Jason Weiss, and Graham Campbell Zorn

Summary

  • The U.S. Environmental Protection Agency’s (EPA) Office of Pollution Prevention and Toxics (OPPT) has been especially busy this quarter, issuing a record number of Lautenberg implementation measures. The long arm of the Congressional Review Act may have quickened the pace.
  • EPA issued a ban on uses of chrysotile asbestos, demonstrating EPA’s resolve to utilize the full measure of its Toxic Substances Control Act (TSCA) section 6 authority.
  • EPA’s regulation of per- and polyfluoroalkyl substances (PFAS) shows no signs of slowing down. The agency issued additional reporting requirements, the courts are more engaged, and the states remain hyper-focused on PFAS. The U.S. Food and Drug Administration (FDA) is also active in this space.
  • Pesticide initiatives are also underway at the Office of Pesticide Programs (OPP) and state level.
Spring 2024 Updates from the Pesticides and Chemicals Committee
lutavia via Getty Images

TSCA Articles

EPA Overhauls Rules for Evaluating Existing Chemical Risks: Three Key Takeaways for Downstream Users

Published May 6, 2024, by Martha E. Marrapese and Sara Beth Watson

Only six months after proposing to amend the procedures for risk evaluations under the Toxic Substances Control Act (TSCA), the final rule was published in the Federal Register on May 3, 2024. A flurry of activity will soon follow on many reviews that were put on hold while the U.S. Environmental Protection Agency (EPA) made fundamental shifts in direction on how these evaluations will be conducted in the years to come. There is plenty to digest in this rule, and Wiley will host a webinar on May 16 to discuss the changes in a comprehensive and thorough way. For a full list of the chemicals under scrutiny, click here.

EPA Issues Asbestos Part 2 Draft Risk Evaluation, Preliminarily Determines That Asbestos Poses Unreasonable Risk to Human Health

Published April 29, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Carla N. Hutton

On April 16, 2024, EPA announced the availability of and requested public comment on a draft document titled “Draft Risk Evaluation for Asbestos Part 2: Supplemental Evaluation Including Legacy Uses and Associated Disposals of Asbestos.89 Fed. Reg. 26878. EPA is evaluating legacy uses and associated disposals of asbestos, including chrysotile asbestos, five additional fiber types, asbestos-containing talc, and Libby asbestos. EPA states that it has used the best available science to determine preliminarily that asbestos poses unreasonable risk to human health. EPA will hold a webinar on May 13, 2024, to provide an overview of its risk evaluation. To receive the webcast meeting link and audio teleconference information before the meeting, registration had to be completed by 12:00 p.m. (EDT) on April 25, 2024. Requests for special accommodations are due by 5:00 p.m. (EDT) on May 6, 2024. Comments are due June 17, 2024. EPA has entered into a consent decree to complete the final risk evaluation by December 1, 2024.

EPA Publishes ANPRM Regarding Lead Wheel Weights

Published April 9, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA published on April 3, 2024, an advance notice of proposed rulemaking (ANPRM) regarding lead for wheel-balancing weights (lead wheel weights). 89 Fed. Reg. 22972. EPA requests comments and information to assist in the potential development of regulations for the manufacture (including importing), processing (including recycling), and distribution in commerce of lead for lead wheel weights under TSCA. To inform this consideration, EPA states that it is requesting comment and information from all stakeholders on the use and exposure to lead from the manufacture (including importing), processing (including recycling), distribution in commerce, use, and disposal of lead wheel weights, as well as information on their substitutes, to help determine if there is unreasonable risk to human health and the environment associated with this use. EPA notes that the ANPRM is relevant to a petition for a writ of mandamus filed in August 2023 by the Ecology Center, Center for Environmental Health, United Parents Against Lead & Other Environmental Hazards, and Sierra Club in the U.S. Court of Appeals for the Ninth Circuit requesting the court to direct EPA to conduct a rulemaking regulating lead wheel weights under TSCA. As reported in our March 21, 2024, blog item, on March 13, 2024, EPA published notice of a proposed settlement agreement that would resolve all claims in the case by establishing deadlines for EPA to take final action.

FDA Reports That No Asbestos Was Detected in Its 2023 Testing of Talc-Containing Cosmetic Products

Published April 9, 2024, by Lynn L. Bergeson, Karin F. Baron, MSPH, and Carla N. Hutton

The U.S. Food and Drug Administration (FDA) announced on April 5, 2024, the results of its 2023 sampling assignment, testing talc-containing cosmetic products for the presence of asbestos. The testing was conducted using Polarized Light Microscopy (PLM) and Transmission Electron Microscopy (TEM). FDA states that “[a]sbestos was not detected in any of the 50 samples tested in 2023.”

EPA Proposes to Require Submission of Health and Safety Studies for 16 Chemicals Being Considered for TSCA Risk Evaluation

Published April 5, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Carla N. Hutton

EPA published on March 26, 2024, a proposed rule requiring manufacturers (including importers) of 16 chemical substances to submit copies and lists of certain unpublished health and safety studies to EPA. 89 Fed. Reg. 20918. EPA identified 15 of the chemical substances as potential candidates for prioritization through a screening process based on a combination of hazard, exposure (including uses), and persistence and bioaccumulation characteristics. EPA also included the N-(1,3-Dimethylbutyl)-N′-phenyl-p-phenylenediamine (6PPD) transformation product 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) due to a response to a recent citizen’s petition filed under section 21 of TSCA on 6PPD and 6PPD-quinone. According to the proposed rule, health and safety studies sought by this action will help inform EPA’s responsibilities pursuant to TSCA, including prioritization, risk evaluation, and risk management. Comments are due May 28, 2024.

GAO Will Review EPA’s Practices for Managing and Assessing the Performance of Its New Chemicals Review Program

Published April 3, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA provided notice of disclosure on April 2, 2024, to all potentially affected businesses under TSCA that submitted information to EPA pursuant to TSCA section 5 that it will disclose information to the U.S. Government Accountability Office (GAO). 89 Fed. Reg. 22713. According to the notice, GAO is initiating a review of EPA’s practices for managing and assessing the performance of EPA’s New Chemicals Review program under TSCA section 5. To do so, GAO has requested access to records, data, and documents submitted to EPA pursuant to TSCA, the Pollution Prevention Act (PPA), and other applicable statutes administered by EPA’s Office of Pollution Prevention and Toxics (OPPT) from October 1, 2021, through the date of the notice. EPA states that the requested information may include submissions that have been claimed as, or have been determined to be, confidential business information (CBI). EPA notes that “GAO has not indicated which or how many TSCA section 5 submissions they may need to access, but their planned review of this information will likely require the viewing and analysis of some features of unredacted submissions that have been claimed as CBI” and that GAO staff may view CBI material in TSCA section 5 submissions incidental to their review and examination of the New Chemicals Review program. EPA also intends to disclose any information related to data systems that house new chemicals review information to assess the reliability of system data. At the conclusion of its GAO review, GAO will destroy, delete, or return to EPA all CBI-claimed documents, if applicable. More information on GAO’s February 2023 report entitled “EPA Chemical Reviews: Workforce Planning Gaps Contributed to Missed Deadlines” is available in our February 24, 2023, memorandum.

EPA Bans Ongoing Uses of Chrysotile Asbestos

Published March 28, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Carla N. Hutton

On March 28, 2024, EPA issued a final rule under TSCA to address to the extent necessary the unreasonable risk of injury to health presented by chrysotile asbestos based on the risks posed by certain conditions of use (COU). 89 Fed. Reg. 21970. According to the final rule, the injuries to human health include mesothelioma and lung, ovarian, and laryngeal cancers resulting from chronic inhalation exposure to chrysotile asbestos. The final rule prohibits the manufacture (including import), processing, distribution in commerce, and commercial use of chrysotile asbestos for chrysotile asbestos diaphragms in the chlor-alkali industry; chrysotile asbestos-containing sheet gaskets in chemical production; chrysotile asbestos-containing brake blocks in the oil industry; aftermarket automotive chrysotile asbestos-containing brakes/linings; other chrysotile asbestos-containing vehicle friction products; and other chrysotile asbestos-containing gaskets. It also prohibits the manufacture (including import), processing, and distribution in commerce for consumer use of aftermarket automotive chrysotile asbestos-containing brakes/linings; and other chrysotile asbestos-containing gaskets. The final rule specifies the compliance dates for these prohibitions. The final rule also includes disposal and recordkeeping requirements for these COUs. The final rule will be effective May 28, 2024.

What’s New? Fifth Circuit Invalidates EPA Orders on Significant “New” Uses

Published March 25, 2024, by Ryan J. Carra, Mark N. Duvall, and Robert T. Denney

A small business that fluorinates plastic containers and fuel tanks secured a victory on March 21 under TSCA. The U.S. Court of Appeals for the Fifth Circuit invalidated two unilateral orders EPA had issued directing that company to stop fluorinating—and, in effect, to shut down and go bankrupt. The case is Inhance Technologies, L.L.C. v. USEPA, No. 23-60620.

EPA Issues Draft Risk Evaluation for Formaldehyde, Preliminarily Finds That Formaldehyde Poses Unreasonable Risk to Human Health

Published March 21, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Carla N. Hutton

EPA announced on March 15, 2024, the availability of and solicited public comment on the 2024 draft risk evaluation for formaldehyde prepared under TSCA. 89 Fed. Reg. 18933. EPA states that it “preliminarily finds that formaldehyde poses unreasonable risk to human health. The risk evaluation notes that these risks may not apply to everyone, everywhere and describes some of the sources of uncertainties in EPA’s findings.” EPA will submit the draft risk evaluation to the Science Advisory Committee on Chemicals (SACC) for peer review. EPA also announced that there will be two virtual public meetings of SACC. Written comments on the draft risk evaluation must be submitted by May 14, 2024.

EPA Seeks Comment on Proposed Settlement Agreement to Conclude a TSCA Rulemaking Regulating Lead Wheel Weights

Published March 21, 2024, by Lynn L. Bergeson and Carla N. Hutton

On March 13, 2024, EPA published notice of a proposed settlement agreement to address a petition for writ of mandamus filed by the Ecology Center, the Center for Environmental Health, United Parents Against Lead & Other Environmental Hazards, and the Sierra Club in the United States Court of Appeals for the Ninth Circuit (Ecology Center v. EPA, No. 23-70158 (9th Cir.)). 89 Fed. Reg. 18408. The petitioners filed a petition for writ of mandamus on August 22, 2023, requesting that the Ninth Circuit direct EPA to “conclude a rulemaking under [TSCA] regulating lead wheel weights within six months.” EPA states that the mandamus petition alleges that EPA’s 14-year delay violated the Administrative Procedures Act’s (APA) requirement that a federal agency “conclude a matter presented to it . . . within a reasonable time,” and that the court has the authority to “compel agency action unlawfully withheld or unreasonably delayed.” The proposed settlement agreement would resolve all claims in the case by establishing deadlines for EPA to take final action.

U.S. Environmental Protection Agency Releases Draft Risk Evaluation Under the Toxic Substances Control Act for Formaldehyde

Published March 21, 2024, by Samuel B. Boxerman, Hannah Posen, and Riley Desper

On March 15, 2024, EPA published its draft risk evaluation under TSCA for formaldehyde. This proposal is one of a series of risk evaluations EPA is conducting as required by the 2016 amendments to TSCA. The draft risk evaluation—posted as 14 separate documents—preliminarily finds that all industrial and many commercial uses of the chemical pose an “unreasonable risk” resulting from certain activities using formaldehyde and formaldehyde-containing products. The evaluation’s executive summary states that most of the 62 activities that were considered are believed to contribute to unreasonable risk due to noncancer effects associated with inhalation or dermal contact with formaldehyde, while only one activity could pose an unreasonable risk due to nasopharyngeal cancer.

Earth Day Fee Increases: EPA Significantly Increases TSCA Fees to Add Resources for TSCA Implementation

Published March 12, 2024, by Nancy B. Beck, Ph.D., DABT, Matthew Z. Leopold, Paul T. Nyffeler, Ph.D., Javaneh S. Tarter, and Gregory R. Wall

On February 21, 2024, EPA released its final rule adjusting the fees it collects under TSCA. EPA is required under TSCA section 26 to review and, if necessary, adjust the fees every three years to ensure that funds are sufficient to defray part of the costs of administering TSCA. While EPA has significantly increased TSCA fees for manufacturers, importers, and processors of chemicals, it has also finalized new, key exemptions from fee requirements. These new fees will be effective on April 22, 2024.

EPA Announces Settlement with Haifa North America to Resolve Alleged TSCA Reporting Violations

Published March 12, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on March 6, 2024, a settlement requiring Haifa North America, Inc. (Haifa) to pay a civil penalty of $664,267 “for violations of chemical data reporting regulations under the Toxic Substances Control Act (TSCA).” EPA states that it alleged that Haifa failed to submit a data report required under TSCA for 32 chemical substances that Haifa had imported between 2016 and 2019. According to EPA, Haifa imports “various chemicals for businesses that formulate specialty fertilizers and plant nutrition solutions for agricultural applications.”

EPA Seeks Nominations for Ad Hoc Reviewers to Assist SACC with Peer Reviewing DIDP and DINP

Published March 11, 2024, by Lynn L. Bergeson and Carla N. Hutton

On February 29, 2024, EPA requested public nominations of scientific and technical experts for service as ad hoc reviewers assisting SACC with the peer review of the agency’s evaluation of the risks from di-isodecyl phthalate (DIDP) and di-isononyl phthalate (DINP) being conducted to inform risk management decisions under TSCA. 89 Fed. Reg. 14836. EPA states that it is planning to convene a virtual public meeting of SACC in summer 2024 to review the draft risk evaluations. According to EPA, at that time, EPA will solicit comments from SACC on the novel approaches used, the unique exposure analyses and other calculations, and selection of key hazard endpoints. Nominations are due April 1, 2024.

EPA Accepting Comments on Candidates for Peer Review of Formaldehyde

Published March 4, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on February 28, 2024, that it is seeking public comment on the candidates under consideration for selection as ad hoc peer reviewers to assist SACC with its peer review of the agency’s evaluation of the risks from formaldehyde being conducted to inform risk management decisions under TSCA. 89 Fed. Reg. 14648. The SACC peer review will take place during a four-day public meeting in May 2024. EPA states in its February 29, 2024, press release that it is specifically seeking SACC’s feedback on EPA’s data analyses and methodologies relevant to human health and ecological hazard. According to EPA, these include (but are not limited to) the value that will be used to evaluate dermal exposures, chronic inhalation exposures, and exposure analyses that have not been previously peer-reviewed. Biographies for all candidates are available via docket EPA-HQ-OPPT-2023-0613. Comments on the candidates are due March 14, 2024.

EPA Announces Pollution Prevention in Action: New Webinar Series with OCSPP

Published March 1, 2024, by Lynn L. Bergeson and Carla N. Hutton

On March 1, 2024, EPA’s Office of Chemical Safety and Pollution Prevention (OCSPP) announced a new webinar series, “Pollution Prevention in Action.” On the second Wednesday of the month, Jennie Romer, EPA deputy assistant administrator for Pollution Prevention, will host webinars featuring businesses, Pollution Prevention grantees, and other experts about innovations and successes in implementing source reduction strategies to advance sustainability across sectors. The webinar series will run through August 2024.

EDF Releases Chemical Exposure Action Map

Published February 27, 2024, by Lynn L. Bergeson and Carla N. Hutton

The Environmental Defense Fund (EDF) published a blog item on February 22, 2024, announcing its Chemical Exposure Action Map, a tool “designed to spur the Environmental Protection Agency (EPA) to transform the assessment of risks posed by toxic chemicals in our communities.” EDF states that the map focuses on multiple high-priority chemicals, highlighting the potential for cumulative risks. EDF notes that when conducting risk assessments under TSCA, EPA typically considers the exposures and risks of one chemical at a time. The Chemical Exposure Action Map “emphasizes the need for a more holistic evaluation that mirrors the real-world scenarios of communities facing exposures from multiple chemicals and various sources.” According to EDF, the map focuses on three major health categories—cancer, harm to pregnant women and infants (developmental harm), and asthma—“revealing how communities are cumulatively exposed to chemicals that contribute to these health risks.”

EPA Finalizes Significantly Higher TSCA User Fees

Published February 27, 2024, by Sara Beth Watson and Martha E. Marrapese

EPA has issued its final rule that significantly raises user fees under TSCA. There are large fee increases in key areas such as new chemical submissions and existing chemical reviews. These fees go into effect on April 22, 2024.

EPA Announces Latest Update to the TSCA Inventory

Published February 22, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on February 20, 2024, that it has released the latest TSCA Inventory. According to EPA, “[t]his biannual update to the public TSCA Inventory is part of EPA’s regular posting of non-confidential TSCA Inventory data.” EPA plans the next regular update of the Inventory for summer 2024.

Get Ready for Higher TSCA Fees

Published February 21, 2024, by Ryan J. Carra, Mark N. Duvall, and Nicholas J. Hanel

EPA has substantially raised its fees for most actions under TSCA. In a final rule published on February 21, 2024, 89 Fed. Reg. 12961, EPA increased all the fees in 40 C.F.R. Part 700, Subpart C. The new fees take effect on April 22, 2024, and will apply through fiscal year 2026. EPA originally proposed a fee increase for fiscal years 2022–2024 in January 2021, which EPA then supplemented in a 2022 proposed rule. EPA has now finalized its 2022 rule with some changes. The final rule reduces some of the fees from the 2022 proposed rule while still more than doubling almost every TSCA fee when compared to the previous fees. Overall, EPA has reduced its estimated TSCA program costs by 19 percent from the 2022 proposed rule due to “efficiencies gained through implementation experience.”

EPA Extends Submission Deadline for Polymer Exemption Reports and Accompanying Claims

Published February 16, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA published a final rule on February 16, 2024, amending TSCA regulations for polymers manufactured under the terms of the polymer exemption by extending the submission deadline for reporting. 89 Fed. Reg. 12248. EPA notes that the regulations require that manufacturers (includes importers) of polymers manufactured under the terms of the exemption submit a report of manufacture or import by January 31 of the year subsequent to initial manufacture. EPA states that on June 7, 2023, it amended the exemption reporting requirement to require that the exemption report and accompanying confidentiality claims be submitted electronically. Because EPA experienced technical difficulties with the launch of the new electronic reporting tool, EPA is extending the reporting period for 2024 from January 31, 2024, to March 31, 2024, to allow manufacturers additional time to submit their reports and accompanying claims to EPA using the electronic reporting tool. The final rule was effective February 16, 2024. More information on EPA’s June 7, 2023, final rule with new and amended requirements concerning the assertion and treatment of CBI claims for information reported to or otherwise obtained by EPA under TSCA is available in our June 12, 2023, memorandum.

EPA Announces Experts for Letter Peer Review of TCEP Draft Risk Evaluation

Published February 15, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on February 14, 2024, the list of 10 scientific experts selected to review the 2023 draft risk evaluation for tris(2-chloroethyl) phosphate (TCEP) under TSCA. Biographies of these experts are available in docket EPA-HQ-OPPT-2023-0265. EPA states that it will hold a virtual public meeting on March 5, 2024, to review the documents and draft charge questions being posed to the reviewers and address any questions from reviewers and the public regarding the scope and clarity of the questions. EPA notes that the meeting “also gives the public the opportunity to ask questions about the documents with the letter peer reviewers present.” Registration is open until March 1, 2024, to attend the meeting. EPA expects the letter peer review to begin on March 13, 2024. EPA will use feedback received from public comments and the letter peer review to inform the final risk evaluation. More information on EPA’s draft risk evaluation is available in our December 21, 2023, memorandum.

FIFRA Articles

EPA Announces End Dates for Sales, Distribution, and Use of Existing Stocks on Over-the-Top Uses of Dicamba

Published April 15, 2024, by James V. Aidala, Lisa R. Burchi, and Barbara A. Christianson

On April 3, 2024, EPA issued a Federal Register notice providing notice of its issuance of an existing stocks order and announcing the end dates for sales, distribution, and use of existing stocks on over-the-top (OTT) uses of dicamba subject to the Order. 89 Fed. Reg. 23010. This announcement follows the February 14, 2024, Existing Stocks Order for Dicamba Products Previously Registered for Over-the-Top Use on Dicamba-Tolerant Cotton and Soybean (existing stocks order) and the revised existing stocks order issued on March 12, 2024, which were in response to the February 6, 2024, ruling by the U.S. District Court of Arizona vacating the 2020 registrations for OTT dicamba products.

Mark Your Calendar: FIFRA Annual Production Reports Must Be Filed with EPA by March 1, 2024

Published February 16, 2024, by Nancy B. Beck, Ph.D., DABT, Garrett Kral, Matthew Z. Leopold, Javaneh S. Tarter, and Gregory R. Wall

By March 1, 2024, all establishments that produce pesticides, devices, or active ingredients for pesticides must file their annual production reports for the 2023 reporting year pursuant to section 7 of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). 7 U.S.C. § 136e(c)(1). Last year, EPA’s Office of Enforcement and Compliance Assurance (OECA) reminded stakeholders that the agency is poised to act against companies that violate FIFRA and noted that non-compliance with the requirements related to producing pesticides and devices by EPA-registered establishments is increasing.

States Initiatives

Washington State Petitions EPA to Ban Inadvertently Generated PCBs—Targeted to Pigments, Inks, and Dyes

Published April 9, 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 (PCB) 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. On April 9, 2024, EPA published a notice denying the petition by Ecology under section 21 of TSCA for EPA to initiate a rulemaking under TSCA section 6 to phase out inadvertently generated PCBs. EPA stated in its response that Ecology “failed to point with any specificity to deficiencies in the Agency’s 1984 final rule and determination of no unreasonable risk under TSCA.” Ecology, therefore, according to EPA, failed to show that it is “necessary” to initiate this rulemaking as required under section 21. Ecology has 60 days to commence a civil action in a U.S. district court to compel EPA to initiate the requested rulemaking.

EPA Denies Petition to Eliminate Current Allowances for PCBs in Consumer Products

Published April 8, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA is scheduled to publish a notice on April 9, 2024, announcing its denial of the Washington Department of Ecology’s (WDOE) petition under section 21 of TSCA seeking a rulemaking to eliminate the current allowances for PCBs in consumer products. EPA states that it “shares the petitioner’s concerns regarding risks to human health and the environment posed by PCBs, and the Agency continues to work towards better understanding and reducing exposures to PCBs.” EPA notes that WDOE failed to point with any specificity to deficiencies in the agency’s 1984 final rule and determination of no unreasonable risk under TSCA, however. As a result, according to EPA, “the petitioner has not provided adequate justification—based on the rulemaking process and record for the 1984 final rule and information provided or otherwise available to the Agency—to support reassessing the limits on allowable inadvertent PCBs in consumer products.” EPA “finds that the petition is insufficiently specific, and that the petitioner did not meet their burden under TSCA of establishing that it is necessary to amend the 1984 final rule.”

PFAS Articles

EPA Releases Updated Interim Guidance on Destroying and Disposing of Certain PFAS and PFAS-Containing Materials, Will Hold 180-Day Comment Period

Published May 7, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Carla N. Hutton

EPA announced on April 9, 2024, the release of an updated “Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances.” According to EPA, the updated guidance “reflects the latest, best available science to provide information that managers of [per- and polyfluoroalkyl substance (PFAS)] wastes can use to evaluate the most appropriate destruction, disposal, or storage method among those currently available.” EPA notes that the guidance recommends that decision-makers “prioritize the use of technologies with the lowest potential for environmental release, to better protect people and communities from PFAS exposures.” EPA announced the availability of the guidance on April 16, 2024, beginning a 180-day comment period. 89 Fed. Reg. 26879. Comments are due October 15, 2024. The updated interim guidance does not establish requirements for destruction or disposal of PFAS materials.

Maine Significantly Amends Its PFAS Consumer Products Law

Published May 3, 2024, by Thomas S. Lee, Bryan E. Keyt, Erin L. Brooks, and John R. Kindschuh

In 2021, Maine passed the most sweeping law related to the regulation of PFAS in consumer products at that time. Subsequently, the law was amended in 2023, and on April 16, 2024, Governor Mills signed L.D. 1537, entitled “An Act to Amend the Laws Relating to the Prevention of Perfluoroalkyl and Polyfluoroalkyl Substances Pollution,” which further modifies the scope and requirements of the law. Interestingly, the amended version of the law is now more similar to Minnesota’s HF 2310, which is the only other enacted state law that will eventually prohibit the presence of intentionally added PFAS in almost all consumer products. The Maine Department of Environmental Protection (MDEP) also published a helpful resource entitled “PFAS in Products,” which, in part, presents information regarding this law.

EPA Issues Fourth TSCA Test Order for PFAS

Published April 22, 2024, by Lynn L. Bergeson, Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Carla N. Hutton

EPA announced on March 25, 2024, that it has issued the fourth TSCA test order requiring testing on PFAS under its National PFAS Testing Strategy. According to EPA, the action requires the 3M Company and Wacker Chemical Corporation to conduct and submit testing on the physical-chemical properties of 2-(N-Methylperfluoro-1-octanesulfonamido)ethanol (NMeFOSE) (Chemical Abstracts Service Registry Number® (CAS RN®) 24448-09-7), including testing on the health effects following inhalation of this chemical. According to EPA, NMeFOSE “has been used widely in products, including clothing and carpet treatments as well as furniture coatings (paint and varnish).” EPA states that NMeFOSE has been found in the air and in biosolids, a byproduct of the water treatment processes often used on agricultural fields as fertilizer. EPA notes that studies have demonstrated that NMeFOSE can accumulate in indoor dust and air, as well as in outdoor environmental media.

Maine Narrows Reporting Requirements, Amends Phase-Out Timeline for Products Containing PFAS

Published April 19, 2024, by Ryan J. Carra, Nessa Horewitch Coppinger, Graham C. Zorn, and Nicholas J. Hanel

On April 16, 2024, Maine enacted significant new amendments to the state statute restricting the sale of products containing intentionally added PFAS. Maine’s PFAS law remains one of the most restrictive nationwide, and the new amendment accelerates a sales ban for certain product categories. However, Maine also delayed and significantly narrowed reporting requirements for PFAS product manufacturers, delayed a general ban on the sale of products containing PFAS from 2030 to 2032, and identified categories of products exempted from that ban.

GAO Examines DOD Efforts to Address PFAS Contamination at Joint Base Pearl Harbor-Hickam

Published April 18, 2024, by Lynn L. Bergeson and Carla N. Hutton

GAO published a report on April 15, 2024, entitled “Persistent Chemicals: Navy Efforts to Address PFAS at Joint Base Pearl Harbor-Hickam.” GAO states that it was asked to examine the Department of Defense’s (DOD) efforts to address PFAS contamination at Joint Base Pearl Harbor-Hickam. The report describes DOD’s response to a November 2022 aqueous film-forming foam (AFFF) release at the installation; DOD processes for ongoing monitoring and long-term cleanup of PFAS at Joint Base Pearl Harbor-Hickam; and DOD’s and EPA’s policies addressing PFAS in the environment.

GSA Publishes RFI Regarding PFAS in Products

Published April 17, 2024, by Lynn L. Bergeson and Carla N. Hutton

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

NGOs Petition EPA to Remove PFAS Immediately from Fluorinated Plastic Containers

Published April 15, 2024, by Lynn L. Bergeson and Carla N. Hutton

Public Employees for Environmental Responsibility (PEER) announced on April 11, 2024, that a coalition of public health groups filed a petition under section 21 of TSCA seeking to stop immediately the manufacture and distribution of “hundreds of millions of plastic containers with dangerous levels of PFAS that leach from these containers into household products and the environment.” The petition “demands that EPA take action to implement its previous determination that the treatment of these containers with fluorine constitutes an unreasonable risk to human health and the environment.” Petitioners ask EPA to use its TSCA section 6 authority to prohibit immediately the production of three toxic long-chain PFAS—perfluorooctanoic acid (PFOA), perfluorononanoic acid (PFNA), and perfluorodecanoic acid (PFDA)–during this fluorination process.

Biden-Harris Administration Announces Action to Cut PFAS from U.S. Government Custodial Contracts

Published April 12, 2024, by Lynn L. Bergeson and Carla N. Hutton

EPA announced on April 8, 2024, that it is directing government contractors to purchase cleaning products for federal buildings that are free of PFAS. This change is the result of a collaboration between EPA and GSA to implement President Biden’s Federal Sustainability Plan, which directs federal agencies to prioritize the purchase of sustainable products and services, including products without added PFAS. The change is reflected in GSA’s custodial specification. Contractors will be required to use products certified to ecolabels such as EPA’s Safer Choice that meet strict criteria for human health and the environment by using effective, safer chemical alternatives, as well as certain Green Seal® certifications.

Fifth Circuit Limits EPA’s Attempts to Regulate PFAS Under Toxic Substances Control Act in Inhance Technologies v. EPA

Published March 28, 2024, by Samuel B. Boxerman, Andrew R. Stewart, Rose Quam-Wickham, and Riley Desper

On March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated two EPA orders under section 5 of TSCA, holding that EPA had exceeded its statutory authority when it issued the orders in an attempt to regulate the manufacture of PFAS by petitioner Inhance Technologies, LLC (Inhance). The Fifth Circuit’s decision comes after EPA’s OECA announced its National Enforcement and Compliance Initiatives for Fiscal Years 2024–2027, which involve increased emphasis on addressing PFAS exposure and contamination through enforcement actions and potential additional regulations.

Minnesota Publishes New Information Concerning PFAS in Products

Published March 28, 2024, by Lynn L. Bergeson and Carla N. Hutton

The Minnesota Pollution Control Agency (MPCA) announced on March 26, 2024, that it has published new information concerning PFAS in products. This information includes recommendations on how to dispose of products that may contain PFAS when they reach the end of their useful life and details on the types of products that will be subject to PFAS prohibitions in January 2025.

PFAS in Children’s Products: State-by-State Regulations

Published March 27, 2024, by Thomas S. Lee, Bryan E. Keyt, Merrit M. Jones, and John R. Kindschuh

PFAS in Children’s Products is a major focus for state legislators across the country, prompting some of the most stringent PFAS restrictions in consumer products. Thus far, eight states have enacted legislation concerning PFAS substances in Children’s or Juvenile Products (Children’s Products). Seven additional states have proposed Children’s Products laws, and many of these are expected to continue to move through the legislative process in future months.

Appellate Court Vacates EPA’s TSCA Section 5 Orders Prohibiting Inhance from Manufacturing or Processing PFAS during Its Fluorination Process

Published March 25, 2024, by Lynn L. Bergeson and Carla N. Hutton

On March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated EPA’s December 2023 orders prohibiting Inhance Technologies, L.L.C. (Inhance) from manufacturing or processing PFAS during its fluorination process. The court notes that in March 2022, EPA “charged for the first time” that Inhance’s fluorination process was subject to the significant new use rule (SNUR) regarding long-chain perfluoroalkyl carboxylate chemical substances. The court states that “[b]ecause the EPA exceeded its statutory authority in doing so, we vacate the orders.”

FDA Announces That Manufacturers Are No Longer Selling Food Packaging Grease-Proofing Agents That Contain PFAS

Published March 13, 2024, by Lawrence E. Culleen, Brandon W. Neuschafer, Judah Prero, and Tyler M. Scandalios

FDA recently announced that substances containing certain PFAS for use as grease-proofing agents on paper food packaging are no longer being sold in the United States by their manufacturers. This new development is primarily the result of the fulfillment of voluntary market phaseout commitments made by the manufacturers of specific short-chain 6:2 fluorotelomer alcohol (6:2 FTOH) PFAS substances for use as grease-proofing agents on paper food packaging. And although FDA had not raised concerns with other types of FDA-authorized short-chain PFAS substances, FDA also recently received confirmation that the manufacturers of the remaining FDA-authorized grease-proofing short-chain PFAS substances had also voluntarily ceased to sell such substances for food contact use in the United States. Of note, food contact substances containing long-chain PFAS have not been sold in the United States since around 2016, because of similar voluntary market phaseout commitments by manufacturers, as well as FDA’s revocation of certain regulations that had authorized long-chain PFAS in food packaging.

EPA Releases New Methodology to Detect Low Levels of PFAS in HDPE Containers

Published March 7, 2024, by Lynn L. Bergeson, Richard E. Engler, Ph.D., Todd J. Stedeford, Ph.D., DABT, ERT, ATS, and Carla N. Hutton

On February 15, 2024, EPA announced the release of a new methodology for detecting 32 PFAS in high-density polyethylene (HDPE) containers. According to EPA, the method can accurately identify PFAS contamination at levels as low as 0.002 parts per billion (ppb) (or 2 parts per trillion (ppt)). EPA states that in releasing this method to the public, it “is enabling the industries that utilize HDPE containers, including container manufacturers, to test the containers before use, preventing PFAS contamination of pesticides and other products stored in HDPE plastic containers.” EPA notes that the method also has wide applicability for other industries, as it can be modified to test for PFAS in additional solid samples, such as fabric, packaging paper, and more.

PFAS in Food Packaging: State-by-State Regulations

Published March 6, 2024, by Thomas S. Lee, Bryan E. Keyt, and Merrit M. Jones

In the absence of comprehensive federal regulation of PFAS in food packaging, states are dishing out their own laws. Thus far, 12 states have enacted laws addressing PFAS substances in food containers and packaging materials (Food Packaging), and there are 14 proposed bills that are currently pending in numerous states. These laws are intended to address concerns that storing food in food packaging that contains PFAS compounds may result in increased ingestion of those PFAS substances. Related to food packaging, a growing number of states are enacting or proposing general bills involving recyclability of food or beverage packaging, but this client alert does not specifically address those requirements as these measures do not exclusively involve PFAS substances.

Will California Soon Join Maine and Minnesota in Banning All PFAS Containing Products?

Published March 6, 2024, by Yuvaraj Sivalingam, Brandon W. Neuschafer, Lawrence E. Culleen, and Judah Prero

This year, the California state legislature will consider expansive new legislation, Senate Bill (SB) 903, that would prohibit the sale or distribution of products containing intentionally added PFAS, beginning in 2030. If enacted, California will join the states of Maine and Minnesota, which are already implementing similar laws.

The California Legislature Will Consider Sweeping New PFAS Legislation This Year

Published March 4, 2024, by Yuvaraj Sivalingam, Brandon W. Neuschafer, Lawrence E. Culleen, and Judah Prero

In recent years, the California legislature has considered several bills seeking to regulate or prohibit intentionally added PFAS in specific product categories, such as cosmetics, textile articles, and juvenile products. This year, the state legislature will consider a significantly more expansive proposal, Senate Bill (SB) 903. The legislation, introduced by state senator Nancy Skinner (D-Berkeley), seeks to prohibit the sale or distribution of all products containing intentionally added PFAS regardless of category, beginning in 2030. If enacted, California will join the states of Maine and Minnesota, which are already implementing similar laws.

Comments Regarding the Intentional Use of PFAS in Products and CUUs Due March 1, 2024, in Maine and Minnesota

Published February 26, 2024, by Lynn L. Bergeson and Carla N. Hutton

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 currently unavoidable use (CUU) by MDEP. MDEP is currently 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. Proposals are due March 1, 2024, and should be submitted to [email protected]. More information is available in our January 9, 2024, blog item.

EPA Adopts PFAS Reporting Requirements Applicable to Article Importers and Chemical Manufacturers

Published February 26, 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.

Reducing the Risk of PFAS False Advertising Class Actions

Published February 26, 2024, by J. Kathleen Bond, Kathryn C. Skaggs, and Samuel A. Butler

With new cases filed as recently as last month, a wave of class actions continues to pummel products that allegedly contain PFAS. Typically, plaintiffs may either find third-party test results or commission their own testing that suggests the presence of PFAS in a product. Subsequently, plaintiffs may challenge advertising for the product, alleging that it misleads consumers by conveying an absence of PFAS. But where simply revising advertising claims will not necessarily prevent a filing, what are companies to do?

California’s Approach to PFAS Regulation Creates Compliance Challenges

Published February 21, 2024, by Matthew D. Thurlow and Theodore Weiss

In the past 10 years, several U.S. states have been at the forefront of environmental regulation of PFAS, including Maine, New Hampshire, Vermont, and New Jersey. But in the past few years, California has emerged with some of the strictest consumer product regulations of PFAS in the country. Some of the state legislature’s most ambitious measures, including a universal PFAS reporting law (AB 2247), never made it out of Sacramento. But other PFAS regulations, including labeling requirements on cookware and a ban on PFAS in food packaging, have already gone into effect. Still others, including new rules limiting PFAS in apparel, may have a significant impact on the textile and clothing industries starting next year.

PFAS Update: 2024 Look-Ahead

Published February 20, 2024, by Thomas S. Lee, Bryan E. Keyt, Erin L. Brooks, and John R. Kindschuh

As discussed in more detail in BCLP’s 2023 federal recap client alert, PFAS were a major focus for EPA in 2023, and 2024 will likely mark even more significant activity in the federal regulation of these compounds. While we expect a variety of actions at the federal level, this alert highlights five developments that we anticipate in 2024 will have substantial economic impacts across a wide range of industries.

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