Regulatory and Litigation Developments
September 30, 2024: California AB 2515 signed into law, establishing significant penalties for the manufacture and sale of menstrual products containing regulated PFAS
On September 30, 2024, California Governor Gavin Newsom announced that he signed AB 2515 into law. Among other things, AB 2515 prohibits the manufacture, distribution, and sale of menstrual products containing “regulated PFAS.” PFAS are defined as a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom, and “regulated PFAS” are defined as including, starting on January 1, 2025, intentionally added PFAS and, starting on January 1, 2027, PFAS at or above a level of total organic fluorine to be determined by the California Department of Toxic Substances Control (DTSC). By July 1, 2029, manufacturers of menstrual products are required to register with DTSC and to certify that each menstrual product they manufacture is in compliance with AB 2515.
Importantly, a violation of AB 2515 is punishable by a minimum administrative or civil penalty of $10,000, which may be assessed for each violation of AB 2515 and for each day a violation continues.
California AB 2515 can be found here, and Governor Newsom’s announcement can be found here.
September 5, 2024: EPA Publishes Direct Final Rule Delaying TSCA Section 8(a)(7) PFAS Reporting by Eight Months
On September 5, 2024, EPA published a direct final rule delaying by eight months the one-time reporting required under TSCA section 8(a)(7) for entities manufacturing or importing PFAS at any time between 2011-2022. This rule amends the final rule EPA published on October 11, 2023, which is addressed in a prior blog post available here, specifying a six-month submission period from November 12, 2024, through May 8, 2025. Under the September 5 direct final rule, the new six-month submission period would be from July 11, 2025, through January 11, 2026.
The rule explains that the deadline is being extended because, due to a lack of resources to address its increased obligations under TSCA, EPA does not anticipate having a sufficient reporting system in place to handle the “unprecedented” amount of data it anticipates receiving pursuant to this reporting requirement. EPA believes that “[t]his would negatively impact EPA’s ability to collect, organize, and make the collected data available to the public, which is the underlying objective of the regulation as well as the Congressional direction that required its promulgation.”
The rule also corrects an error to require that Organization for the Economic Cooperation and Development’s Harmonised Templates (OHTs) be submitted for “unpublished” study reports, as opposed to “published” study reports. Manufacturers and importers are not required to search open scientific literature for this reporting, and EPA had intended to require submittal of information that is not already available in open scientific literature.
As a direct final rule, this rule will become effective, without further notice, on November 4, 2024. However, if adverse comment is received by October 7, 2024, EPA will withdraw the rule and address all public comments in a subsequent final rule.
EPA’s direct final rule can be found here.
September 3, 2024: Multi-State Petition to EPA Seeks Listing of Four PFAS Compounds as Hazardous Air Pollutants under the Clean Air Act
Three states have lodged a petition with EPA, seeking the listing of four PFAS compounds as hazardous air pollutants (HAPs) under the Clean Air Act (CAA). In the petition, dated August 29, 2024, the North Carolina Department of Environmental Quality, the New Jersey Department of Environmental Protection, and the New Mexico Environment Department propose adding perflurooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), perfluorononanoic acid (PFNA), and hexafluoropropylene oxide dimer acid (HFPO-DA aka “GenX”) to the list of HAPs regulated under Section 112 of the CAA. The states assert that the information provided in the petition demonstrates that these chemicals meet the requirements for Section 112 listing, as (1) they are air pollutants, and (2) “[t]hrough emissions, ambient concentrations, bioaccumulation, or deposition, these PFAS are known to cause or may reasonably be anticipated to cause adverse effects to human health or adverse environmental effects.” The petition can be found here.
August 20, 2024: Petition to EPA Seeks Cancellation and Suspension of Pesticide Registrations and Other Action under FIFRA, Related to PFAS Content
A Legal Rulemaking Petition (citizen petition) has been lodged with EPA, seeking “cancellation and suspension of several existing registrations of pesticide ingredients that are PFAS chemicals and requiring rulemaking regarding PFAS chemical assessment and PFAS in pesticide containers.” The petition was submitted on July 22, 2024 by the Center for Food Safety on behalf of itself, an individual described as a “chemical policy expert,” and eleven environmental and organic farming interest organizations. Petitioners allege that the EPA has violated its duty under FIFRA to ensure no “unreasonable adverse effects on the environment,” by the agency’s continued registering of active pesticide ingredients that qualify as PFAS, maintaining registrations of other PFAS active and inert ingredients, and allowing the use of fluorinated HDPE and polypropylene storage containers that leach PFAS into pesticides. The petition would require that EPA utilize a controversial definition of PFAS that includes any fluorinated organic chemical that contains “at least one fully fluorinated carbon atom.” In addition to seeking the cancellation/suspension of registrations and rulemaking, petitioners seek alternative relief including (1) clarification of FIFRA regulations to explicitly require EPA to consider PFAS chemicals’ impacts on human health and the environment, (2) requiring registrants to submit data on PFAS ingredient persistence in the environment, along with data specific to the environmental fate, bioaccumulation, and toxicity of PFAS chemicals, and (3) creation of a “PFAS in Pesticides” guidance document. The petition can be found here.
July 29, 2024: Pending Legal Challenge to EPA Designation of PFOA and PFOS as CERCLA Hazardous Substances
A legal challenge is pending in the D.C. Circuit Court of Appeals, with respect to EPA’s April 19, 2024 final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under CERCLA (discussed in the April 19 summary, below). A Petition for Review was jointly filed on June 10 by the U.S. Chamber of Commerce, the Associated General Contractors of America (AGC), and the National Waste & Recycling Association (NWRA). In that filing, the AGC describes itself as “the nation’s largest and most diverse trade association in the commercial construction industry, now representing more than 28,000 member companies,” and the NWRA is described as “the trade association representing the private sector recycling and waste industry.” In a Non-Binding Statement of Issues filed on July 12, Petitioners stated six claims against EPA, including failure to provide adequate notice and comment, failure to appropriately consider costs, erroneous interpretation of CERCLA, failure to provide an adequate and reasonable explanation for the rule, arbitrary and capricious agency action, and violation of the U.S. Constitution, including by imposing retroactive liability. Several environmental groups, including the Natural Resources Defense Council (NRDC), have filed a joint motion to intervene in the action. The Petition for Review can be found here, and the Non-Binding Statement of Issues here.
June 10, 2024: Fourth Circuit Affirms that Federal Courts Lack Jurisdiction to Review EPA Grant of Petition Under TSCA to Test Fifty-Four PFAS
On June 10, 2024, in Center for Environmental Health v. Regan (No. 23-1476), the Fourth Circuit Court of Appeals held that federal courts do not have jurisdiction to review EPA’s grant of a petition under the Toxic Substances Control Act (TSCA) to test fifty-four PFAS. Four citizen groups (“Petitioners”) had petitioned EPA under TSCA to require testing of fifty-four PFAS that Petitioners alleged were prevalent in their community. After EPA granted their petition, but declined to adopt the Petitioners’ proposed testing program, Petitioners filed suit in federal court and contended that EPA had, in effect, denied their petition. The Fourth Circuit concluded that, “by promptly commencing a proceeding for determining how to best test PFAS, the EPA gave Petitioners all that they were entitled to receive.” Because TSCA allows federal courts to review the denial of a petition, but not the grant of a petition, the Fourth Circuit affirmed the lower court’s dismissal for lack of jurisdiction.
The Fourth Circuit concluded by pointing out that “[o]ur decision precludes only one potential avenue for relief,” because “Petitioners are free to seek judicial review of any final order the EPA may issue.”
The Fourth Circuit’s decision can be found here.
June 10, 2024: Two Legal Actions Filed, Challenging New EPA Maximum Contaminant Levels (MCLs) for Six PFAS in Drinking Water
Two legal challenges have been filed in the D.C. Circuit Court of Appeals, with respect to EPA’s April 10, 2024 final rule setting legally enforceable Maximum Contaminant Levels (MCLs) for six PFAS in drinking water (discussed in the April 10 summary, below). On June 7, the American Water Works Association (AWWA) and Association of Metropolitan Water Agencies (AMWA) filed a petition for review, stating in part that the “EPA did not rely on the best available science and the most recent occurrence data, and used novel approaches as the basis for certain portions of the rule,” and that the rule will have a significant impact on water affordability, because “EPA has significantly underestimated the costs” of the rule. The AWWA/AMWA petition asserts that the rule is legally defective because it is arbitrary and capricious, in excess of statutory authority, unreasonable, not feasible, and not supported by the best available data and science. On June 10, the National Association of Manufacturers (NAM) and American Chemistry Council (ACC) filed a separate petition for review. The NAM/ACC petition does not recite the substantive bases for the challenge, but asserts that the rule exceeds EPA’s authority under the Safe Drinking Water Act, is arbitrary and capricious, and was not promulgated in accordance with procedures required by law. The AWWA/AMWA petition can be found here, and the NAM/ACC petition can be found here.
May 17, 2024: Notice of Intent to Sue EPA Under TSCA Given Regarding PFOA in Fluorinated Plastic Containers
On May 17, 2024, Public Employees for Environmental Responsibility (PEER) and Center for Environmental Health (CEH) gave notice of intent to sue under section 20(a)(2) of the Toxic Substances Control Act (TSCA). This notice appears to follow in the wake of the March 21 decision by the U.S. Court of Appeals for the Fifth Circuit vacating two EPA orders issued under TSCA section 5 that prohibited Inhance Technologies LLC from manufacturing or processing PFAS during the fluorination of its plastic containers. PEER and CEH assert that EPA has a non-discretionary duty to act under TSCA section 4(f) to address the risk created by PFOA in these containers. Specifically, PEER and CEH assert that EPA has not discharged its duty to initiate action under TSCA sections 5, 6, or 7, and they request that EPA take action as soon as possible to require that Inhance cease all PFOA production during the fluorination of plastic containers.
PEER and CEH’s notice can be found here, and PEER’s press release can be found here. The March 21 decision by the Fifth Circuit can be found here.
May 16, 2024: Federal Legislation Passed to Support Airports’ Transition to PFAS-Free Firefighting Foams
On May 16, 2024, President Biden signed the FAA Reauthorization Act of 2024 (the “Act”), which includes two provisions supporting airports’ transition to PFAS-free firefighting foams. Section 762 of the Act, also known as the Save Our Airports Reporting (SOAR) Act, requires EPA and the Secretary of Defense to report to Congress every six months on the development and implementation of a national plan to transition to fluorine-free firefighting foam. Section 767 of the Act, also known as the Pollution-Free Aviation Sites (PFAS) Act, establishes a $350 million grant program to support this transition.
Representative Salud Carbajal’s press release can be found here, and the FAA Reauthorization Act of 2024 can be found here.
May 8, 2024: “All Appropriate Inquiries” Will Need to Consider PFOA and PFOS for Property Acquisitions Closing on or After July 8, 2024
On May 8, 2024, EPA published in the Federal Register its final rule designating perfluorooctanoic acid (PFOA) and perfluorooctanesulfonic acid (PFOS) as hazardous substances under CERCLA. The designation of these two PFAS will thus be effective on July 8, 2024. For property acquisitions closing on or after July 8, environmental due diligence to meet CERCLA’s “all appropriate inquiries” standard for liability protection, which is typically performed via Environmental Site Assessments, will need to include consideration of PFOA and PFOS.
EPA’s final rule can be found here.
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, and publication of the final rule in the Federal Register 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.