Regulatory and Litigation Developments
April 22, 2024: The European Commission’s Guidance on Essential Uses May Influence PFAS Legislation in the U.S.
On April 22, 2024, the European Commission issued “Guiding criteria and principles for the essential use concept in EU legislation dealing with chemicals” – guidelines that could influence existing and developing laws in the U.S. The guidelines provide criteria for determining whether use of a harmful substance is an essential use – namely, if (1) that use is necessary for health or safety or is critical for the functioning of society, and (2) there are no acceptable alternatives. The guidelines recognize that the concept of essential use only has legal effect when introduced into specific legislation, and are focused on providing guidance for EU legislation. However, as a number of states – including California, Maine, and Minnesota – are already considering or applying the similar concept of currently unavoidable uses as an exemption to restrictions on products that include PFAS, the European Commission’s guidelines may have influence beyond the EU. The European Commission’s guidelines can be found here.
April 19, 2024: EPA Announces New Rule Designating PFOA and PFOS as Hazardous Substances Under CERCLA, Issues Enforcement Policy Not to Pursue Certain Entities
On April 19, 2024, EPA announced its final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under CERCLA. This designation allows federal, state, and local public agencies, as well as private parties, to take cleanup actions and then seek to recover related costs using CERCLA’s strict liability standard at any site where these two PFAS chemicals are present and need to be remediated, particularly where drinking water supplies are at risk. Although EPA has simultaneously announced an enforcement policy indicating that it will not generally pursue cleanups by certain entities – such as publicly owned water systems, municipal solid waste landfills, airports, and local fire departments, as well as farms where biosolids are applied – we are likely at the brink of a wave of CERCLA litigation filed by EPA, other agencies, and private parties. Businesses that own or operate industrial properties, as well as anyone acquiring such properties, will now need to take this serious litigation risk into account.
EPA’s pre-publication notice of the final rule designating PFOA and PFOS as hazardous substances under CERCLA can be found here, and the final rule will be effective 60 days after being published in the Federal Register. EPA’s enforcement policy related to the designation can be found here.
April 12, 2024: Fifteen California Cities and Water Districts File a Lawsuit on the Heels of EPA’s Announcement of MCLs for PFAS in Drinking Water
Two days after EPA announced Maximum Contaminant Levels (MCLs) for six PFAS in drinking water, fifteen California cities and water districts filed a lawsuit seeking injunctive relief and damages, based in part on the requirements imposed by those new standards. The complaint states that a principal purpose of the lawsuit is to recover the costs of cleaning up PFAS contamination in groundwater allegedly caused by PFAS-containing products manufactured by the eight defendants. The lawsuit, filed in federal district court, alleges contamination by “PFOA, PFOS, PFBS, PFHxS (and other PFAS compounds that may subsequently be regulated)” and asserts claims based on strict products liability, negligence, trespass, nuisance, and other state law theories. The complaint in Orange County Water District, et al. v. AGC Chemicals Americas, Inc., et al. was filed on April 12, 2024, in the Central District of California, and can be found here.
April 10, 2024: EPA Announces Enforceable Contaminant Levels for Six PFAS in Drinking Water
On April 10, 2024, the EPA announced the final National Primary Drinking Water Regulation (NPDWR) establishing legally enforceable Maximum Contaminant Levels (MCLs) and health-based, non-enforceable Maximum Contaminant Level Goals (MCLGs) for six PFAS in drinking water. MCLs and MCLGs have been set for five individual PFAS and certain PFAS mixtures:
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Public water systems have until 2029 to meet these MCLs, or will be required to provide public notification of the violations and to take other actions to reduce PFAS exceeding the MCLs in their drinking water. The Biden-Harris Administration’s announcement can be found here, and more information can be found on EPA’s website here.
April 5, 2024: OEHHA Adopts Public Health Goals for PFOA and PFOS in Drinking Water
On April 5, 2024, the California Office of Environmental Health Hazard Assessment (OEHHA) adopted public health goals (PHGs) for drinking water of 0.007 parts per trillion (ppt) for perfluorooctanoic acid (PFOA) and 1 ppt for perfluorooctane sulfonic acid (PFOS). Although OEHHA recognized that use of PFOA and PFOS has significantly declined, the adoption of these PHGs reflects the agency’s concern that these PFAS persist in the environment and are present in drinking water sources. The PHGs are the culmination of a five-year process that included public participation and external scientific review, and are a determination of the level of PFOA and PFOS in drinking water that does not pose a significant risk to health, when considering lifetime exposure from all uses of tap water. The California State Water Resources Control Board’s Division of Drinking Water (DDW) will use these PHGs to develop mandatory drinking water standards for PFOS and PFOA that water systems will need to achieve. OEHHA’s press release can be found here, and additional information on adoption of these PHGs can be found here.
March 21, 2024: Appeals Court Holds EPA Exceeded Authority Under Section 5 of TSCA, Vacates Orders
On March 21, 2024, the U.S. Court of Appeals for the Fifth Circuit vacated two EPA orders prohibiting Inhance Technologies LLC from manufacturing or processing PFAS during the fluorination of its plastic containers. The two EPA orders were part of efforts EPA has taken since confirming the presence of PFAS in a pesticide that had been stored in containers fluorinated by Inhance. The Court found that EPA had exceeded its authority under Section 5 of the Toxic Substances Control Act (TSCA), which allows EPA to regulate any “significant new use” of a chemical substance. In so doing, the Court rejected EPA’s argument that a “significant new use” is any use previously unknown to EPA – commenting that EPA’s interpretation “defies common sense” – and found that EPA “may not contort the plain language of TSCA’s Section 5 to deem a forty-year-old ongoing manufacturing process a ‘significant new use’ subject to the accelerated regulatory process provided by that part of the statute.” The Court’s opinion can be found here.
February 28, 2024: FDA Confirms Elimination of PFAS in Food Packaging
On February 28, 2024, the FDA announced the complete cessation of sales of PFAS-containing grease-proofing materials for use in food packaging in the U.S. market. According to the FDA, the February 28, 2024 announcement was the culmination of voluntary commitments from manufacturers obtained in 2020 to phase out the use of PFAS chemicals in food packaging paper and paperboard.
February 21, 2024: California State Senator Nancy Skinner Announces Introduction of Bill to Effect a Total Ban on PFAS in Products Sold or Used in California by 2030
On February 21, 2024, State Sen. Nancy Skinner announced the introduction of SB 903 – the “Ending Forever Chemicals Act.” SB 903 follows in the footsteps of similar laws already passed in Maine and Minnesota, and, if passed, will prevent the sale or use in California by the year 2030 of any products that contain PFAS chemicals. As currently drafted, SB 903 does contain a “currently unavoidable use” (CUU) exception, whereby manufacturers would be able to petition the California Department of Toxics Substances Control (DTSC) that PFAS in a specific product is unavoidable because there is no non-PFAS alternative and the PFAS-containing product is necessary for the health, safety, or functioning of society.
February 15, 2024: Environmental Groups File Suit to Obtain Access to TSCA Documents Containing Claimed CBI
On February 15, 2024, two nonprofit environmental groups sued EPA in federal district court, seeking to obtain unredacted versions of documents related to formation of certain long-chain PFAS during fluorination of plastic containers. In Public Employees for Environmental Responsibility et al. v. Environmental Protection Agency (D.D.C. Civ. Action No. 24-00445), PEER and the Center for Environmental Health are seeking to compel production of redacted test data and other information in these documents, which were submitted by a TSCA-regulated private entity as confidential business information (CBI). PEER and CEH claim that EPA must provide unredacted copies, as the redacted material is not subject to CBI protection under TSCA Section 14 and therefore cannot be withheld under FOIA exemption (b)(4). Click here to view the complaint.
February 15, 2024: EPA Releases New Methodology to Detect PFAS in Plastic Containers as Part of Ongoing Efforts to Address PFAS in Pesticides and Other Packaging
On February 15, 2024, EPA released a new methodology that can detect 32 PFAS from the walls of plastic containers. Since learning about potential PFAS contamination in a mosquito pesticide in September 2020, EPA has determined that the PFAS contamination leached into the pesticide from fluorinated high-density polyethylene (HDPE) containers used to store and transport the pesticide, and has taken action against the company that manufactured those containers (Inhance Technologies LLC). As EPA points out on its website, under Section 6(a)(2) of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA), pesticide registrants may need to report within 30 days additional factual information obtained regarding previously unidentified PFAS contaminants and impurities in their pesticides. EPA’s press release can be found here, and more information on EPA’s efforts regarding PFAS in Pesticides and Other Packaging can be found here.
February 13, 2024: ASTM E1527–21 Is Now the Required ASTM Standard for All Appropriate Inquiries in Real Estate Transactions
As of February 13, 2024, ASTM E1527–21 is the required ASTM standard for All Appropriate Inquiries (AAI) in real estate transactions. Conducting AAI is required to establish the innocent landowner defense, as well as the bona fide prospective purchaser and contiguous property owner liability protections, under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). Importantly, diligence activities that have already been conducted for currently pending acquisitions may need to be revised before the acquisition closes, if they rely on the previous ASTM standard (ASTM E1527-13). EPA’s final rule amending the AAI to reference ASTM E1527-21 can be found here.
February 8, 2024: EPA Publishes Two Proposed Rules That Would Have Significant Implications for How PFAS Can Be Addressed Under RCRA
On February 8, 2024, EPA published two proposed rules that would have significant implications for how PFAS can be addressed in Resource Conservation and Recovery Act (RCRA) facility assessments and corrective actions. One of the proposed rules would list the following nine PFAS as hazardous constituents under RCRA: PFOA, PFOS, PFBS, HFPO-DA (also known as GenX), PFNA, PFHxS, PFDA, PFHxA, and PFBA. If finalized, this rule would allow these nine PFAS to be included in RCRA facility assessments and further investigations and cleanup through the RCRA corrective action process. This proposed rule can be found here, and public comments on this proposed rule must be received by April 8, 2024.
The other proposed rule would amend RCRA’s definition of hazardous waste applicable to corrective actions to address releases to include any substance that meets the statutory definition of hazardous waste, rather than only substances listed or identified as hazardous waste in the applicable regulations. Importantly, this proposed rules states that, “[w]hile this proposed rule would not directly address PFAS, it would facilitate the use of RCRA corrective action authority to address emerging contaminants such as PFAS . . . .” This proposed rule can be found here, and public comments on this proposed rule must be received by March 11, 2024.
January 11, 2024: EPA Publishes Significant New Use Rule for 329 PFAS
On January 11, 2024, EPA published a final significant new use rule (SNUR) for 329 PFAs that are designated as inactive on the TSCA Inventory and not subject to an existing SNUR. Entities subject to the final SNUR must provide notice to EPA at least 90 days before manufacturing, importing, or processing these PFAS for a significant new use. EPA’s final rule can be found here and the TSCA Inventory can be found here.
January 9, 2024: Seven New PFAS Added to the Toxics Release Inventory for Reporting Year 2024
On January 9, 2024, EPA issued a press release announcing the addition of seven additional PFAS to the Toxics Release Inventory (TRI) for Reporting Year 2024. These seven PFAS were automatically added to the TRI for Reporting Year 2024 pursuant to Section 7321(c) of the National Defense Authorization Act for Fiscal Year 2020. Reporting forms for Reporting Year 2024 are due by July 1, 2025. A list of the seven additional PFAS is included in EPA’s press release, which can be found here.
November 28, 2023: EPA Seeking Approval for New Information Collection Request Targeting PFAS Discharges by Textile Manufacturers
On November 28, 2023, EPA gave notice that it plans to seek approval for a new information collection request (ICR) that will target PFAS discharges by textile manufacturers. Importantly, the notice states that the ICR is necessary, because very few of the data sources reviewed by EPA include PFAS monitoring data and “[n]one of these data sources define a complete population of textile mills in the United States, nor do they provide detailed information on specific facility operations including any recent phase out of PFAS usage.” EPA’s notice can be found here.
October 11, 2023: EPA Publishes Final PFAS Reporting Rule Pursuant to TSCA Section 8(a)(7)
On October 11, 2023, EPA published a final rule pursuant to TSCA section 8(a)(7) requiring entities that have manufactured or imported PFAS in any year since January 1, 2011, to submit reasonably ascertainable information regarding PFAS uses, production volumes, byproducts, disposal, exposures, and existing information on environmental or health effects. The rule provides a structural definition of PFAS that includes any chemical substance containing at least one of three specified chemical substructures. Although the reporting deadline is May 8, 2025, the reporting requirement may impose a significant burden on some entities, and any confidentiality claims must be asserted at the time of submission. The rule also requires reporting entities to retain documentation of any information reported to EPA for five years. The final rule can be found here.