ARTICLE
3 September 2024

The Chemical Compound — August 2024

AP
Arnold & Porter

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This quarterly newsletter provides essential updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business.
United States Energy and Natural Resources

This quarterly newsletter provides essential updates on litigation, regulatory, legislative, and other notable developments involving chemicals of concern to business. Our primary focus continues to be matters affecting chemical substances which are the subject of regulatory activity or scrutiny by various federal and state government agencies and potential litigants. This includes per- and polyfluoroalkyl substances (PFAS), as well as substances identified by the U.S. Environmental Protection Agency (EPA or the Agency) under the 2016 amendments to the Toxic Substances Control Act (TSCA) for prioritization, risk evaluation, and regulation.

Table of Contents

PFAS-Related Developments

  • EPA Issues Final PFAS CERCLA Rule
  • EPA Issues Final National Primary Drinking Water Regulation for Six PFAS
  • EPA Adds Seven PFAS to TRI List
  • EPA Has Released Analysis for 2022 TRI Reporting Data
  • EPA Delays Final Rule Issued To Designate Certain PFAS as Hazardous Constituents Under RCRA
  • Other PFAS-Related Program Delays
  • EPA Receives Petition To Address PFAS Under FIFRA
  • EPA Grants TSCA Section 21 Petition To Address PFAS in Fluorinated Containers
  • EPA Issues Updated PFAS Disposal/Destruction Guidance

Other Federal Regulatory Developments

  • EPA Proposed TSCA Risk Management Rule for n-Methylpyrrolidone
  • Final Amendments to TSCA "Persistent, Bioaccumulative, and Toxic" Rules Undergoing Review at OMB
  • Other TSCA Risk Mitigation Rules
  • TSCA Prioritization Efforts
  • EPA, FDA, and USDA Issue Updates to the Joint Regulatory Plan for Biotechnology
  • EPA Finalizes Amendments to Its TSCA Chemical Risk Evaluation Procedural Rule
  • TSCA Section 8(d) Health and Safety Data Reporting Proposed Rule
  • EPA Released Its Draft Risk Evaluation of Formaldehyde
  • EPA's Final TCE Risk Management Rule at OMB for Review
  • EPA's Final PCE Risk Management Rule at OMB for Review
  • EPA's Proposed Risk Management Rule for 1-Bromopropane
  • TSCA Risk Evaluation Rule Finalized

Other Litigation

  • D.C. Circuit Court Grants Vinyl Institute's Petition for Review, Vacates EPA-Issued TSCA Section 4 Test Order Based on Standard of Review in Vinyl Institute, Inc. v. EPA
  • Court Rules Against EPA in Review of Agency's Orders To Stop Production of PFAS-Containing Lining in HDPE Plastic Containers and Related Actions Dropped
  • Judge Dismisses Industry Challenge to "Biased" Formaldehyde Peer Review
  • Orange County Water District and More Than a Dozen Other California Water Utilities Sue PFAS Manufacturers

Federal Legislation

  • H.R. 8074/S. 4187 Pertaining to Forever Chemical Regulation and Accountability Act
  • H.R. 8076/S. 4173 Pertaining to Clean Water Standards for PFAS Act of 2024

State Regulatory and Legislative Action

  • Maine Substantially Changes Prohibitions on PFAS in Products
  • Minnesota Releases News Concerning PFAS in Products Reporting System
  • Alaska Bans PFAS in Aqueous Fire Fighting Foam
  • New Hampshire Requires PFAS Disclosure for Property Sales
  • New Hampshire Bans PFAS in Certain Products
  • Vermont Bans PFAS in Certain Products
  • Connecticut Bans PFAS in Certain Products
  • Colorado Bans PFAS in Certain Products
  • Maryland Bans PFAS in Playground Surfacing Materials

PFAS-Related Developments

EPA Issues Final PFAS CERCLA Rule

On April 17, 2024, EPA signed the "first-of-its-kind" final rule designating the two most studied PFAS — perfluorooctanoic acid (PFOA) and perfluorooctane sulfonic acid (PFOS), including their salts and structural isomers — as "hazardous substances" under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The rule is precedent setting as it represents the first time EPA has used regulation, through CERCLA Section 102, to add substances to the Superfund law's hazardous substances list.

Litigants, including various trade associations, have lodged challenges to the final rule in pleadings filed in the D.C. Circuit. Those actions have been consolidated by the court, which also recently granted a motion to intervene by various environmental groups.

EPA Issues Final National Primary Drinking Water Regulation for Six PFAS

In April 2024, EPA released its Final PFAS National Primary Drinking Water Regulation (NPDWR) for six PFAS. The finalized rule includes new individual limits for the six PFAS and gives water systems five years to comply with the drinking water contaminant levels.

Under the Safe Drinking Water Act, EPA must issue enforceable drinking water regulations for new contaminants that may present public health issues. Every five years, the EPA publishes a Contaminant Candidate List (CCL) detailing chemicals that may be present in drinking water and cause public health hazards. After receiving information from the CCL, EPA makes a regulatory determination to regulate or not regulate at least five different contaminants from the current CCL and begins the NPDWR development process.

In March 2023, EPA proposed the PFAS NPDWR. The proposed NPDWR provided both enforceable Maximum Contaminant Levels (MCLs) and non-enforceable, health-based Maximum Contaminant Level Goals (MCLGs). The Agency set the MCLG for PFOA and PFOS at zero, with a proposed enforceable MCL at 4.0 parts per trillion (ppt or nanograms/liter). For PFNA, PFHxS, PFBS, and HFPO-DA, the EPA proposed utilizing a Hazard Index (HI) calculation for both the MCL and the MCLG.

In the final rule, EPA extended the proposed compliance deadline for water systems to meet the MCLs from the initial three years out to five years from the date of publication in the Federal Register. The Agency also set individual MCLs and MCLGs for PFHxS, PFNA, and HFPO-DA rather than codifying the original HI measurement. The HI measurement was reworked rather than fully dropped and now encompasses water containing at least two of the target substances (PFHxS, PFNA, HFPO-DA, and PFBS). The Agency deferred setting an individual level for PFBS, but may release an updated rule addressing it in the future. For PFOA and PFOS, EPA set the MCLG, a non-enforceable health-based goal, at zero. EPA set the enforceable MCLs at 4.0 parts per trillion for PFOA and PFOS, individually. For PFNA, PFHxS, and HFPO-DA, EPA set the MCLGs and MCLs at 10 parts per trillion. EPA also set a limit for any mixture of two or more of the following PFAS: PFNA, PFHxS, PFBS, and HFPO-DA (so-called GenX Chemicals). Facilities will need to complete initial monitoring and reporting requirements three years after the publication of the final rule, except for notifications related to violations of the MCLs. Facilities will need to comply with all MCLs within five years of the publication of the final rule.

Trade associations and water utilities are challenging the final rule in filings the D.C. Circuit has recently consolidated. Several environmental groups have been authorized as intervenors on EPA's behalf.

EPA Adds Seven PFAS to TRI List

EPA has added seven PFAS, listed below, to the expanding list of approximately 200 PFAS that are now covered by the Toxics Release Inventory (TRI) reporting requirements. The additions are triggered by the terms of Fiscal Year 2020 National Defense Authorization Act, which provides the framework for the automatic additions of certain PFAS to TRI each year in response to specified EPA activities involving such substances. The Federal Register notice formally promulgating the final rule and its June 17, 2024 effective date was published May 17, 2024. This announcement brings the total number of PFAS subject to TRI reporting to 196. Reporting for the new additions under Section 313 of the Emergency Planning and Community Right-to-Know Act will be due by July 1, 2025. The seven most recently-added PFAS are as follows:

  1. Ammonium perfluorohexanoate, Chemical Abstract Service Registration Number (CASRN) 21615-47-4
  2. Lithium bis[(trifluoromethyl)sulfonyl] azanide, CASRN 90076-65-6
  3. Perfluorohexanoic acid (PFHxA), CASRN 307-24-4
  4. Perfluoropropanoic acid (PFPrA), CASRN 422-64-0
  5. Sodium perfluorohexanoate (NaPFHx), CASRN 2923-26-4
  6. 1,1,1-Trifluoro-N-[(trifluoromethyl)sulfonyl] methanesulfonamide, CASRN 82113-65-3
  7. Betaines, dimethyl(.gamma.-.omega.-perfluoro-.gamma.-hydro-C8- 18-alkyl), CASRN 2816091-53-7

EPA Has Released Analysis for 2022 TRI Reporting Data

Each year, EPA analyzes the most recent TRI data, and compiles various comparative analyses with TRI data for previous years and publishes its findings in the TRI National analysis. Recently, EPA made available its analysis of the 2022 TRI data.

There are specific sections in the report devoted to certain chemistries and other information. For example, the 2022 reporting includes information on 180 PFAS targeted for TRI reporting during prior reporting cycles. Fifty different facilities reported releases of PFAS.

In 2024, the reporting thresholds for the reportable PFAS will be reduced based on the recent amendment to those requirements classifying listed PFAS as chemicals of special concern.

EPA Delays Final Rule Issued To Designate Certain PFAS as Hazardous Constituents Under RCRA

After issuing its proposal in February to add nine PFAS to the Resource Conservation and Recovery Act (RCRA) list of hazardous constituents, the Agency moved the final rule from the active portion of its Regulatory Agenda to the long-term actions portion of the Regulatory Agenda. The nine PFAS EPA proposed to list as hazardous constituents were as follows:

  1. Perfluorooctanoic acid
  2. Perfluorooctanesulfonic acid
  3. Perfluorobutanesulfonic acid
  4. Hexafluoropropylene oxide-dimer acid
  5. Perfluorononanoic acid
  6. Perfluorohexanesulfonic acid
  7. Perfluorodecanoic acid
  8. Perfluorohexanoic acid
  9. Perfluorobutanoic acid

The delay likely reflects EPA's awareness of the ambitiousness of its plans to implement its "PFAS Roadmap" in light of opposition voiced in comments on the proposal.

Other PFAS-Related Program Delays

Reporting on all PFAS that have been domestically manufactured or imported into the U.S. in the period commencing January 1, 2011 through the end of 2022 may also be delayed by resource constraints within EPA. The possibility of delays in the construction and beta testing of EPA's reporting system for its TSCA Section 8(a)(7) rule was foreshadowed in public remarks made during late June by EPA Assistant Administrator, Dr. Michal Freedhoff. The reporting period for which the system is required is expected to open November 12, 2024.

EPA Receives Petition To Address PFAS Under FIFRA

A coalition of environmental and other groups have petitioned EPA to address PFAS in pesticides and their containers under the Federal Insecticide, Fungicide and Rodenticide Act (FIFRA). FIFRA itself does not contain a citizen's petition provision; the petition was submitted pursuant to "the Right to Petition Government Clause contained in the First Amendment of the United States Constitution and the Administrative Procedure Act."

  • The petition calls on EPA to cancel currently registered PFAS ingredients in pesticides, both active and inert; amend its FIFRA regulations to prohibit future registrations of pesticides with ingredients that qualify as PFAS; define PFAS in its regulations as "a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom"; amend FIFRA regulations to prohibit fluorinated high-density polyethylene (HDPE) and polypropylene containers for pesticide storage; and explicitly require reporting of PFAS contamination.
  • The petition states that EPA's failure to take the requested actions in the petition "would severely harm Petitioners' interests" and "would also violate FIFRA's mandates and constitute arbitrary and capricious agency action." It further states that "[i]n view of the severity of the impacts the Petitioners are suffering, EPA must act on the requests in this Petition within 180 days of its filing date." However, there is no explicit legal requirement compelling EPA to respond to the petition.

EPA Grants TSCA Section 21 Petition To Address PFAS in Fluorinated Containers

The EPA has granted a TSCA § 21 Citizens Petition filed by the Center for Environmental Health, Public Employees for Environmental Responsibility, Alaska Community Action on Toxics, Clean Cape Fear, Clean Water Action, Delaware Riverkeeper, and Merrimack Citizens for Clean Water to address PFAS formed during the fluorination of plastic containers, specifically PFOA, PFNA, and PFDA.

  • In September 2020, EPA was made aware of PFAS contamination in a mosquitocide, and the Agency later determined that the PFAS found came from the fluorinated HDPE plastic container used to store the product, which was manufactured by Inhance Technologies LLC (Inhance). In March 2022, EPA issued a Notice of Violation to Inhance for its "manufacture" of the four PFAS formed in the fluorination process in violation of a TSCA Significant New Use Rule. EPA then issued orders under section 5 of TSCA to Inhance to cease the "manufacture" of the PFAS via fluorination. The U.S. Court of Appeals for the Fifth Circuit vacated the orders in March 2024.
  • In response, in April 2024 the above listed nonprofit organizations submitted a petition under TSCA Section 21 requesting that EPA prohibit the manufacturing, processing, use, distribution in commerce, and disposal of PFOA, PFNA, and PFDA formed during the fluorination of plastic containers under TSCA § 6.
  • EPA has stated that it intends to request information, including the number, location, and uses of fluorinated containers in the United States; alternatives to the fluorination process that generates PFOA, PFNA, and PFDA; and measures to address risk from PFOA, PFNA, and PFDA formed during the fluorination of plastic containers. After that has been accomplished, EPA can determine what action, if any, can be taken under TSCA § 6.

Although TSCA Section 8 grants EPA the authority to collect certain information from manufacturers and processors of chemical substances, to date, EPA has not issued a proposed information collection regulation pursuant to the granted petition.

EPA Issues Updated PFAS Disposal/Destruction Guidance

EPA released an updated "Interim Guidance on the Destruction and Disposal of Perfluoroalkyl and Polyfluoroalkyl Substances and Materials Containing Perfluoroalkyl and Polyfluoroalkyl Substances."

  • The updated interim guidance retains the 2020 guidance's focus on three existing technologies: underground injection, landfills, and thermal treatment under certain conditions.
  • On interim storage, EPA says it may be a short-term option for some PFAS materials, such as containerized materials. Class 1 UIC wells are an option for managing PFAS-containing fluid, although the technology may not be available everywhere.
  • On landfill disposal, EPA says it recommends hazardous waste landfilling when landfill disposal is selected and PFAS concentrations in waste are high; it cautions new data "shows landfills release more PFAS ... than previously thought."
  • On thermal treatment, EPA states "[p]ermitted hazardous waste combustors such as commercial incinerators, cement kilns, and lightweight aggregate kilns and granular activated carbon reactivation units with thermal oxidizers may operate under conditions more conducive to destroying PFAS and controlling related products of incomplete combustion."

EPA is accepting comments on the interim guidance for 180 days following publication in the Federal Register.

Other Federal Regulatory Developments

EPA Proposed TSCA Risk Management Rule for n-Methylpyrrolidone

In June 2024, EPA proposed a risk management rule under Section 5 of the TSCA to address the unreasonable risk posed to human health by the chemical solvent n-methylpyrrolidone (NMP). The risk determination eliminates the individual conditions of use component in favor of assessing NMP as a whole chemical substance, and assumes that workers may not be properly protected against NMP exposure by personal protective equipment (PPE). The rule would limit NMP concentrations allowed in consumer and commercial products, establish strict workplace health controls, and prohibit some NMP uses that cannot safely continue where alternative chemicals exist. The commercial use ban would prohibit NMP use in automotive care products, cleaning and degreasing products, metal products, cleaning and furniture care products, antifreeze, de-icing products, and lubricants. EPA also proposes to ban NMP commercial use in fertilizers and agricultural manufacturing products until it has adequate information demonstrating they can be used safely. Comments on the proposal are due July 29, 2024.

Final Amendments to TSCA "Persistent, Bioaccumulative, and Toxic" Rules Undergoing Review at OMB

White House Office of Management and Budget (OMB) has begun its review of EPA's final risk management rules for PIP (3:1) and decabromo diphenylether (decaBDE). EPA paused enforcement of the PIP (3:1) prohibition of articles containing PIP (3:1), and later formally extended the deadlines for phasing out both PIP (3:1) and decaBDE until October 31, 2024.

  • For PIP (3:1), EPA proposed to give companies an additional 10 years from publication of any final rule before enforcing a ban on the chemical "in manufacturing equipment and in the semiconductor industry." It also narrowed several exclusions and imposed phaseouts on some uses that previously would have been allowed to continue indefinitely under the original rule.
  • For decaBDE, EPA has proposed a detention until the end of the service life of wires containing decaBDE coatings when used in nuclear power installations.

Other TSCA Risk Mitigation Rules

On July 18, 2024, EPA sent its final TSCA risk-management rule for trichloroethylene (TCE) to the OMB for review, the last step before EPA issues a final rule. Under the proposed rule issued in October 2023, TCE use in industrial scenarios would be prohibited a year after issuance of the final rule, and "critical or essential" use would be phased out over 10 years.

TSCA Prioritization Efforts

In late July, EPA proposed the designation of five chemicals as "High-Priority Substances" for risk evaluations under TSCA. Finalizing the designations would mean EPA would immediately commence the risk evaluations for the five chemical substances, though the designation as high-priority does not inherently represent a finding of risk. EPA initiated the process of prioritizing the five chemicals in December 2023 and is required to complete risk evaluations within three to three and one-half years. The five chemicals are:

  • Acetaldehyde (CASRN 75-07-0)
  • Acrylonitrile (CASRN 107-13-1)
  • Benzenamine (CASRN 62-53-3)
  • Vinyl Chloride (CASRN 75-01-4)
  • 4,4'-Methylene bis(2-chloroaniline) (MBOCA) (CASRN 101-14-4)

EPA, FDA, and USDA Issue Updates to the Joint Regulatory Plan for Biotechnology

On May 8, 2024, in response to President Biden's Executive Order 14081, "Advancing Biotechnology and Biomanufacturing Innovation for a Sustainable, Safe, and Secure American Bioeconomy," EPA, the U.S. Food and Drug Administration (FDA), and the U.S. Department of Agriculture (USDA) published a plan to update, streamline, and clarify their regulations and oversight mechanisms for biotechnology products.

The plan is intended to ensure public confidence in the biotechnology regulatory system and improve its transparency, predictability, coordination, and efficiency. It also incorporates processes and timelines to implement regulatory reform, such as identifying guidance and regulations to update, streamline, or clarify, and identifying the potential need for new guidance or regulations.

The agencies are taking a joint approach in implementing the following efforts:

  1. Clarify and streamline regulatory oversight for genetically engineered plants, animals, and microorganisms
  2. Update and expand their information sharing through an Memorandum of Understanding to improve and broaden communication and coordination of oversight of modified microbes
  3. Undertake a pilot project focused on modified microbes to explore and consider the feasibility and costs of developing a web-based tool that informs developers about which agency may regulate a given product category

Additional information is available at the Unified Website for Biotechnology Regulation.

EPA Finalizes Amendments to Its TSCA Chemical Risk Evaluation Procedural Rule

On April 23, 2024, EPA finalized amendments to TSCA Section 6 "framework" rule for conducting risk evaluations of high-priority existing chemical substances. The OMB approved EPA's final version of the procedural rule on April 17, 2024. The final rule was filed on April 29, 2024, and the Federal Register publication date was May 3, 2024. The final rule is effective July 2, 2024.

Initially proposed on October 19, 2023, the amended rule overhauls much of the TSCA current "framework" rule issued in 2017 by the Trump administration and significantly furthers implementation of TSCA reforms. The new rule would affect TSCA risk evaluations to determine whether a chemical substance should be designated a "high-priority" for review and whether the identified substance presents an "unreasonable risk" of injury to health and the environment requiring regulation."

The final rule codifies the Agency's decision to assume, for purposes of Risk Evaluations, that workers do not generally reliably use PPE to minimize chemical exposures. The final rule also removes a regulatory definition of the "best available science" that EPA said (if it had been retained) would otherwise limit the Agency's ability to consider "new advances" and data. While expressing EPA's commitment to consider risks resulting from cumulative exposures to certain substances (when available information supports doing so), the final rule does not require EPA to consider this in each Risk Evaluation.

Litigants promptly filed actions challenging EPA's Risk Evaluation procedural rule. A pair of trade associations are among the chemical-industry petitioners in consolidated litigation over the final risk evaluation rule — filed in the D.C. Circuit. A lawsuit also was filed by labor unions challenging the rule.

TSCA Section 8(d) Health and Safety Data Reporting Proposed Rule

On March 26, 2024, EPA issued a proposed rule under TSCA Section 8(d) that would require manufacturers (including importers) of 16 chemical substances listed in this document to submit copies and lists of certain unpublished health and safety studies to the Agency. EPA initiated prioritization of five of the 16 chemicals for risk evaluation back on December 18, 2023.
The rule would add the substances identified to an existing framework regulation which appears at 40 CFR Part 716. Thirteen of the listed substances are from the TSCA Work Plan list from 2014 (which makes them prime candidates for Prioritization and Risk Evaluations.) Five of the listed substances, italicized below, already are undergoing Risk Evaluations. The chemicals that would be subject to the proposed rule are:

  1. 4,4-Methylene bis(2-chloraniline) (CASRN 101-14-4)
  2. 4-tert-octylphenol(4-(1,1,3,3-Tetramethylbutyl)-phenol) (CASRN 140-66-9)
  3. Acetaldehyde (CASRN 75-07-0)
  4. Acrylonitrile (CASRN 107-13-1)
  5. Benzenamine (CASRN 62-53-3)
  6. Benzene (CASRN 71-43-2)
  7. Bisphenol A (CASRN 80-05-7)
  8. Ethylbenzene (CASRN 100-41-4)
  9. Hydrogen fluoride (CASRN 7664-39-3)
  10. N-(1,3-Dimethylbutyl)-N'-phenyl-p-phenylenediamine (6PPD) (CASRN 793-24-8)
  11. 2-anilino-5-[(4-methylpentan-2-yl) amino]cyclohexa-2,5-diene-1,4-dione (6PPD-quinone) (CASRN 2754428-18-5)
  12. Naphthalene (CASRN 91-20-3)
  13. Styrene (CASRN 100-42-5)
  14. Tribomomethane (Bromoform) (CASRN 75-25-2)
  15. Triglycidyl isocyanurate (CASRN 2451-62-9)
  16. Vinyl Chloride (CASRN 75-01-4)

EPA Released Its Draft Risk Evaluation of Formaldehyde

EPA evaluated 62 conditions of use (COUs) for formaldehyde, including manufacturing of formaldehyde, processing and manufacturing of articles and products, composite wood products, plastics used in toys, rubber materials, and various adhesives and sealants. The resulting draft TSCA evaluation of formaldehyde says all of its industrial uses and many commercial formaldehyde applications pose "unreasonable risk" to human health. EPA determined that only four of the COUs do not contribute to the unreasonable risk for formaldehyde: commercial use of formaldehyde in paper, plastic and rubber products, toys, and sporting or playground equipment; and consumer use of water treatment products, machinery, electronics, and lawn and garden products.

EPA calculated a draft occupational exposure value (OEV) of 11 parts per billion (ppb) for formaldehyde. This value is almost 70 times below the existing OSHA permissible exposure limit (750 ppb), almost 30 times below the recently updated European Union occupational limits (300 ppb), just above the level of formaldehyde in exhaled human breath, below the detection limit for all National Institute for Occupational Safety and Health and OSHA-approved formaldehyde analytical methods, and below levels measured in ambient air and U.S. residences.

The OEV, a level above which EPA says there is unreasonable risk, is being set below the average formaldehyde levels seen in a typical home environment. This would mean that more than 50% of the population is currently experiencing an unreasonable risk due to formaldehyde exposure in their homes.

EPA's Final TCE Risk Management Rule at OMB for Review

On July 18, 2024, EPA sent its final TSCA risk-management rule for TCE to the OMB for review, the final step before EPA issues a final rule. Under the proposed rule issued in October 2023, TCE use in industrial scenarios would be prohibited a year after issuance of the final rule, and "critical or essential" use would be phased out over 10 years.

EPA's Final PCE Risk Management Rule at OMB for Review

EPA has sent its final Section 6 rule for perchloroethylene (PCE) to OMB for review. The proposed version of the rule included a ban on PCE in multiple uses with certain exceptions for uses in petrochemical manufacturing, aircraft coatings manufacturing, and aerospace parts and engine manufacturing using PCE vapor degreasing. EPA has been pressing OMB for rapid review of all TSCA-related actions, especially final rules which are overdue.

EPA's Proposed Risk Management Rule for 1-Bromopropane

The proposed risk management rule for 1-Bromopropane appeared in the Federal Register on August 8, 2024. The proposal includes a ban on all consumer uses and four commercial and industrial uses of the substance, and strict workplace controls or perspective controls for certain occupational condition of use. The comment deadline for the proposal is September 23, 2024.

Other Litigation

D.C. Circuit Court Grants Vinyl Institute's Petition for Review, Vacates EPA-Issued TSCA Section 4 Test Order Based on Standard of Review in Vinyl Institute, Inc. v. EPA

In May 2024, Vinyl Institute, Inc. filed suit against EPA in the U.S. Court of Appeals, D.C. Circuit, challenging a test order EPA issued in March 2022 directing seven chemical manufacturers and processors — C-K Tech, Inc., Kem Krest, LLC, Formosa Plastics Corp USA, HAAS Group International, Occidental Chemical Holding Corp, Olin Corp, and Westlake Chemical Corp, all managed by the petitioner — to test the chronic toxicity of 1,1,2-Trichloroethane (1,1,2-TCA) pursuant to TSCA 15 U.S.C. Sections 2601-2629. Petitioner alleged EPA failed to comply with statutory requirements when issuing the order because the Agency relied upon a portion of the record that was not made publicly available prior to the start of litigation, and therefore cannot lawfully be included in the administrative record. On July 5, 2024, the court granted Vinyl Institute's petition for review and held that EPA failed to meet its statutory mandate of providing "substantial evidence in the record taken as a whole" as related to non-public portions of the administrative record EPA relied upon in issuing the order.

Court Rules Against EPA in Review of Agency's Orders To Stop Production of PFAS-Containing Lining in HDPE Plastic Containers and Related Actions Dropped

In 2023, EPA issued two orders barring Inhance Technologies from conducting fluorination work, directing it to shut down its barrier technology facilities until it eliminated PFAS from the process. On March 21, 2024, the United States Court of Appeals for the Fifth Circuit issued a unanimous decision in favor of Inhance finding that EPA lacked statutory authority to issue the orders under the Toxic Substances Control Act directing Inhance to cease its fluorination work. The court's decision vacates EPA's orders and allows Inhance Technologies to continue operations of its 11 U.S.-based barrier technology facilities. To date, EPA has declined to appeal the court's ruling.

In a separate but related TSCA enforcement action, two environmental nonprofit organizations (ENGOs) — the Center for Environmental Health (CEH) and Public Employees for Environmental Responsibility (PEER) — filed a notice of intent letter against EPA on May 17, 2024 for falling short of its duty under TSCA Section 4(f), which requires EPA to regulate chemical uses when there is an "unreasonable risk" to human health or the environment, and also under TSCA Section 7, which requires EPA to seek an immediate halt to uses that meet a statutory definition of "imminent hazard." PEER and CEH argued that Inhance's PFAS containing production process violates the TSCA Significant New Use Rule (SNUR), proposed in 2015. Under TSCA, EPA may regulate a new use under SNUR only if (1) the use is new (i.e., not preexisting or ongoing) and (2) the new use is subject to its SNUR. Though the ENGOs maintain the position that the 5th Circuit holding does not relieve EPA of its obligations under TSCA Section 4(f), they voluntarily dismissed their claims against EPA and are considering other options to hold Enhance accountable for alleged SNUR violations.

Judge Dismisses Industry Challenge To "Biased" Formaldehyde Peer Review

On March 15, 2024, in American Chemistry Council v. National Academy of Sciences, et al., a federal district judge for the District of Columbia, Judge John D. Bates, found in favor of the government, rejecting the plaintiff trade group's lawsuit over what it claimed "was an illegally biased peer review of EPA's draft Integrated Risk Information System (IRIS) formaldehyde assessment."

Judge Bates held that the plaintiff, American Chemistry Council, failed to identify any real harm suffered from EPA's preliminary chemical review. Instead, the court backed separate arguments by the National Academy of Sciences (NAS) and EPA that the trade group lacked either constitutional standing or a statutory cause of action to sue over alleged violations of the Federal Advisory Committee Act in the NAS' formaldehyde peer review.

Orange County Water District and More Than a Dozen Other California Water Utilities Sue PFAS Manufacturers

On April 12, 2024, the Orange County Water District and at least a dozen other California Water Utilities filed suit in Los Angeles federal court against seven PFAS manufacturers alleging they should be held responsible for contamination caused by PFAS "forever chemicals." The utility companies accuse the PFAS manufacturers of negligence and creating a nuisance by contaminating the water, and seek monetary damages to remediate that contamination.

Federal Legislation

H.R. 8074/S. 4187 Pertaining to Forever Chemical Regulation and Accountability Act

On April 18, 2024, Congresswoman Betty McCollum and Senator Dick Durbin introduced the Forever Chemical Regulation and Accountability Act [H.R. 8074/S. 4187] to address excessive PFAS use across the United States. The act would, among other things, initiate a NAS study to review the persistence, bioaccumulation, and human health risks of PFAS and document current uses to provide guidance on designating essential uses to mitigate potential points of exposure and contamination while ensuring access to essential PFAS. Additionally, the act would institute a 10-year timeline for PFAS manufacturers to stop production of non-essential PFAS and prohibit all PFAS releases from their production facilities. Notably, the act would also update CERCLA to toll state statutes of limitations for newly designated hazardous substances such as PFAS.

H.R. 8076/S. 4173 Pertaining to Clean Water Standards for PFAS Act of 2024

On April 18, 2024, Senator Kirsten Gillibrand introduced the Clean Water Standards for PFAS Act of 2024 [H.R. 8076/S. 4173] to establish effluent limitations and standards and water quality criteria for perflouoroalkyl and polyfluoroalkyl substances under the Federal Water Pollution Control Act.

State Regulatory and Legislative Action

Maine Substantially Changes Prohibitions on PFAS in Products

First passed in 2021, the PFAS in Products Law was amended on April 16, 2024 when Governor Janet Mills signed into law the Amendment to Maine PFAS in Products Program LD1537. The amendment eliminates the broad-based reporting requirement and instead requires manufacturers who intentionally incorporate PFAS into their products to report this to the U.S. Department of Environmental Protection (DEP) beginning January 1, 2025. Though the ban on all products containing intentionally added PFAS at one time was eliminated, the amendment incrementally restricts the sale of specific products containing intentionally added PFAS, phasing them out over time according to the following schedule:

  • January 1, 2026: cleaning products, cookware, cosmetics, dental floss, juvenile products, menstruation products, ski wax, upholstered furniture, and most textiles
  • January 1, 2029: artificial turf and outdoor apparel for wet weather (unless the apparel includes a disclosure)
  • January 1, 2032: all other products, except for refrigeration, cooling and heating, ventilation, and air conditioning equipment
  • January 1, 2040: refrigeration, cooling and heating, ventilation, and air conditioning equipment

Where DEP has made the determination that the use of PFAS in a specific product is a "currently unavoidable use" and therefore presently exempt from the otherwise applicable prohibition, the exemption is limited to either five years from the effective date of the DEP rule determination or five years from the effective date of the otherwise applicable prohibition, whichever is longer.

Finally, the amendment prohibits the sale of all intentionally added PFAS containing products beginning in 2030, with limited product exceptions where DEP determines that the use of PFAS in the product is a "currently unavoidable use."

The recent amendments also exclude from the scope of the statute's notification requirements and prohibitions:

  • Firefighting or fire suppressing foam
  • Medical devices, drugs, etc. regulated by the FDA
  • Veterinary products regulated by the FDA, USDA, or EPA
  • Products developed for public health, environmental, or water quality testing
  • Products required to meet standards or requirements of the U.S. Department of Transportation, Federal Aviation Administration, National Aeronautics and Space Administration, U.S. Department of Defense, or U.S. Department of Homeland Security
  • Motor vehicles and motor vehicle equipment
  • Watercraft
  • Semiconductors
  • Non-consumer laboratory equipment or electronics
  • Equipment directly used in the manufacture or development of the above exempted products

Minnesota Releases News Concerning PFAS in Products Reporting System

The Pollution Control Agency of Minnesota (MPCA) has released information during a recent webinar advising that the agency is targeting the fall of 2025 to begin "beta testing" its reporting database for use by manufacturers of PFAS-containing products. A full launch of the reporting system would be completed by the end of 2025, if all goes as planned.

When completed, the reporting system is intended for use when manufacturers submit data in response to the Minnesota law that prohibits the sale of textiles and many household and certain other products containing PFAS beginning next year. The statute requires that PFAS-containing products that are not prohibited sooner, be prohibited from distribution in the state beginning January 1, 2032, unless uses of PFAS in a product has been determined by MPCA to be "currently unavoidable." During the recent MPCA webinar, agency staff reported that the state will likely use a system adapted from an existing model, High Priority Chemicals Data System, which is part of the Interstate Chemicals Clearinghouse. MPCA is collaborating with the Northeast Waste Management Officials Association, which operates the clearinghouse, and with a technical consulting group.

Alaska Bans PFAS in Aqueous Firefighting Foam

Alaska firefighting departments are now prohibited from using fire-suppression foams containing PFAS. The prohibition was passed by the state legislature earlier this year. In addition to mandating that Alaska fire departments switch to non-PFAS foams, the new law creates a system for small rural villages to dispose of the PFAS-containing foams stored there. Under the new law, the villages are to be reimbursed by the Department of Environmental Conservation for that work.

New Hampshire Requires PFAS Disclosure for Property Sales

Governor Chris Sununu has signed a new law to include PFAS, along with radon and arsenic, in the notification provided to prospective property purchasers about common contaminants in well waters located on New Hampshire properties.

The notice will state that PFAS "have been detected at levels that exceed federal and/or state advisories or standards in wells throughout New Hampshire.... Testing of the water by an accredited laboratory can measure PFAS levels and inform a buyer's decision regarding the need to install water treatment systems."

New Hampshire Bans PFAS in Certain Products
The New Hampshire legislature has passed a bill to ban the sale of certain consumer products containing intentionally added PFAS, effective January 1, 2027. The following are prohibited from being sold, offered for sale, or distributed for sale or for promotional purposes if they contain intentionally added PFAS:

  • Carpets or rugs
  • Cosmetics
  • Textile treatments
  • Feminine hygiene products
  • Food packaging and containers
  • Juvenile products
  • Upholstered furniture
  • Textile furnishings

Products made with at least 85% recycled content, products manufactured prior to the ban, and replacement parts for products manufactured prior to the ban are exempt.

In a notable departure from many state bills, the bill uses the definition of PFAS found in the federal TSCA PFAS Reporting Rule.

The bill defines intentionally added PFAS as "PFAS that a manufacturer has intentionally added to a product or product component and that have a functional or technical effect in the product or product component, including PFAs components of intentionally added chemicals and PFAS that are intentional breakdown products of an added chemical that also have a functional or technical effect in the product."

Vermont Bans PFAS in Certain Products

As anticipated, Vermont Governor Phil Scott signed into law a bill that bans the production, sale, or distribution of numerous products that are made with intentionally added PFAS.
The ban on intentionally added PFAS in the following products takes effect on January 1, 2026:

  • Aftermarket stain and water-resistant treatments
  • Artificial turf
  • Cookware
  • Cosmetics
  • Incontinency protection products
  • Juvenile products
  • Menstrual products
  • Rugs and carpet
  • Ski wax
  • Textiles and textile articles
  • Class B firefighting foam
  • Food packaging

Also, as of January 1, 2026, manufacturers of firefighting PPE that contains PFAS must provide written notice to the purchaser of the PFAS content.

  • The bill defines "personal protective equipment" as clothing designed, intended, or marketed to be worn by firefighting personnel in the performance of their duties and designed with the intent for use in fire and rescue activities, and includes jackets, pants, shoes, gloves, helmets, and respiratory equipment.
  • The bill defines PFAS as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.

Connecticut Bans PFAS in Certain Products

The Connecticut state legislature has passed a bill regulating the use of PFAS in certain household products and textiles, and Governor Lamont is expected to sign the bill into law.

  • Starting October 1, 2024, the bill prohibits the sale and use of soil amendments made from sewage residues or wastewater sludge that contain PFAS.
  • Starting January 1, 2026, the bill requires written disclosures about the existence of intentionally added PFAS for all outdoor apparel designed for severe wet conditions and turnout gear used by firefighters and emergency personnel.
  • Starting on July 1, 2026, all "apparel, carpets or rugs, cleaning products, cookware, cosmetics, dental floss, fabric treatments, children's products, menstruation products, ski wax, textile furnishings, and upholstered furniture" with intentionally added PFAS must include a label notifying consumers about the presence of the chemicals. Additionally, manufacturers of such products must provide prior written notice to the U.S. Department of Energy and U.S. Environmental Protection Agency about the use of PFAS.
  • The product ban expands to the regulated categories on January 1, 2028.

Colorado Bans PFAS in Certain Products

The Colorado legislature passed legislation to restrict PFAS in several products. As of January 1, 2026, the sale of cookware, dental floss, menstruation products, and ski wax with intentionally added PFAS will be prohibited. As of January 1, 2028, the sale of the following products with intentionally added PFAS will be prohibited: textile articles, outdoor apparel for severe wet conditions, and food equipment intended primarily for use in commercial settings that comes into direct contact with food. The new law also prohibits the installation of artificial turf containing intentionally added PFAS beginning on January 1, 2026.

Maryland Bans PFAS in Playground Surfacing Materials

Maryland Governor Wes Moore has signed into law a bill that bans the use of playground surfacing materials with intentionally added PFAS starting October 1, 2024.
"Playground surfacing materials" are products, materials, or substances used or installed on the ground surface of a playground that come into direct contact with a person, and "playground" is defined as a public outdoor recreation area for children equipped with one or more play structures.

* Andra Popa contributed to this Newsletter. Ms. Popa is an attorney in the firm's Washington, D.C. office and is admitted to the practice of law.

The content of this article is intended to provide a general guide to the subject matter. Specialist advice should be sought about your specific circumstances.

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