Regulatory and Litigation Developments
June 3, 2025: EPA Continues Reassessment of its 2024 Designation of PFOA and PFOS as CERCLA Hazardous Substances
The EPA is continuing to reevaluate whether to change its position regarding the Biden administration’s 2024 listing of PFOA and PFOS as hazardous substances under CERCLA.
As reported in our March 15 update (available here), on February 24, 2025, the D.C. Circuit Court of Appeals granted EPA’s unopposed request for a stay of pending legal challenges to the former administration’s action. EPA’s rationale for the stay was that new agency leadership needed time to familiarize themselves with the issues and determine how to proceed, including potentially via taking actions that could obviate the need for judicial resolution of the pending challenges. The court granted the motion and ordered the case held in abeyance for 60 days. On April 30, 2025, the Court granted an EPA motion to continue the stay for another 30 days, until May 30, 2025.
On May 30, 2025, EPA filed a new motion (available here) requesting that the stay continue in place, and stating in part that “EPA’s new leadership is currently still in the process of reviewing the issues presented in this case, evaluating the [CERCLA listing] within the broader context of EPA’s comprehensive strategy to address PFOA and PFOS, and developing EPA’s position on how to proceed in this litigation.” The agency noted that it was still possible that it would take further action that would resolve the litigation. On June 2, 2025, the court granted the motion and ordered that the case continue to remain stayed, until July 2, 2025.
Given recent decisions by new EPA leadership to reverse major regulatory actions taken by prior administrations—including its partial reversal of the Biden administration’s regulation setting drinking water standards for certain PFAS compounds—it is likely that the EPA will rescind or formally reopen the CERCLA listings of PFOA and PFOS, and defer any such listings to an unspecified future date.
May 14, 2025: EPA Announces It Will Keep Drinking Water Limits for PFOA and PFOS, But Rescind Limits for Four Other PFAS Compounds
On May 14, 2025, EPA issued a news release (available here) stating that the agency will maintain the Safe Drinking Water Act (SDWA) National Primary Drinking Water Regulations (NPDWRs) promulgated in April 2024—but only with respect to two PFAS compounds: PFOA and PFOS. These NPDWRs originally established legally enforceable Maximum Contaminant Levels (MCLs) and health-based, non-enforceable Maximum Contaminant Level Goals (MCLGs) for six PFAS in drinking water (see 4/10/24 post below). EPA now states it will rescind and reconsider the limits for the other four PFAS included in the April 2024 NPDWRs (PFHxS, PFNA, HFPO-DA (aka GenX), and mixtures of these three plus PFBS). EPA also announced that it would extend the time for drinking water systems to comply with the new PFOA and PFAS limits, from 2029 until 2031, and it reiterated its plan to launch the PFAS OUTreach Initiative (PFAS OUT), a program that will aim to connect EPA with public water utilities that are known to require capital improvements to address PFAS in their systems.
EPA plans to issue a proposed rule summarizing these announcements in Fall 2025 and finalize the rule in Spring 2026. In the meantime, multiple legal challenges to the April 10, 2025 rule remain pending (see 6/10/24 post below), and presumably will be maintained, at least with respect to the MCLs for PFOA and PFOS.
May 12, 2025: EPA Announces Interim Rule Further Delaying TSCA Section 8(a)(7) PFAS Reporting by Nine Months
On May 12, 2025, EPA announced that it will be publishing an interim rule further delaying by nine months the one-time reporting required under TSCA section 8(a)(7) for entities manufacturing or importing PFAS at any time between 2011-2022. The interim rule will amend the final rule EPA published on October 11, 2023, which is addressed in a prior blog post available here, and the eight-month delay published in a final rule on September 5, 2024, which is addressed in a prior blog post available here.
The six-month reporting period is currently scheduled to run from July 11, 2025, through January 11, 2026, but the interim rule would delay the reporting period to run from April 13 to October 13, 2026. The interim rule states that the “change is necessary because EPA requires more time to prepare the reporting application to collect this data.”
Significantly, EPA also appears to be considering a future, separate action that would reopen public comments on certain aspects of the final rule requiring reporting under TSCA section 8(a)(7) in light of Executive Order 14192: Unleashing Prosperity Through Deregulation (90 FR 9065, January 31, 2025). As stated in the interim rule, EPA “is separately considering reopening certain aspects of the rule to public comment,” and “[t]he delayed reporting date ensures that EPA has adequate time to consider the public comments and propose and finalize any modifications to the rule before the submission period begins.”
There will be a thirty-day public comment period on the interim rule following its publication in the Federal Register, which is scheduled to happen on May 13, 2025.
The unpublished, public inspection version of the interim rule can be found here.
April 29, 2025: Comment Period Extended Again for Federal PFOA/PFOS Risk Assessment for Sewage Sludge Applied to Agricultural Land as Fertilizer
Interested parties – including businesses raising crops or animals on agricultural and ranch lands potentially impacted by PFAS in groundwater; entities operating wastewater treatment plants (WWTPs); and related interest groups and associations – should be aware that the public comment period has been further extended—until August 14, 2025—for EPA’s Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS), notice of which was originally published on January 15, 2025 (90 Fed. Reg. 3859). As discussed in our prior post, the original comment period was scheduled to end on March 17, but was extended to April 16. EPA has now extended the comment period by an additional four months, “in response to stakeholder requests for more time.” See 90 Fed. Reg. 16128 (April 17, 2025). The full text of the draft risk assessment and supporting documents, along with related fact sheets and webinar materials, are available on EPA’s website, here.
April 17, 2025: California Legislation Banning Wide Range of PFAS-Containing Products (SB 682) Moves Forward in Senate Committees
The California Senate’s Environmental Quality Committee recently passed, as amended, SB 682, and referred the bill to the Senate Committee on Health for a further hearing. If ultimately enacted as law, SB 682 would result in the phase-out of a vast range of consumer products and many commercial/industrial products containing any amount of “intentionally added PFAS,” starting in 2027. The preamble of SB 682 states that the “intent of this act is to phase out the sale of products with avoidable PFAS use to address the imminent threat of further contamination of the environment in the state.” To effectuate this intent, SB 682 would, over time, ban almost all consumer products and a wide-range of commercial/industrial products that contain “intentionally added PFAS,” which is defined to include both (a) PFAS added to a product that has a functional or technical effect in the product, and (b) PFAS intentionally used or produced during the manufacturing process that has a functional or technical effect on the product or that process. The proposed ban phases are as follows:
- January 1, 2027: prohibits distribution or sale of a “covered product” that contains intentionally added PFAS, unless the prohibition is preempted by federal law or the product is previously used. Covered products are defined as the following product categories: cleaning products, cookware, dental floss, juvenile products, food packaging, and ski wax.
- January 1, 2035: prohibits distribution or sale of any consumer product that contains intentionally added PFAS that is not specified in the 2027 or 2040 bans, unless the Department of Toxic Substances Control (DTSC) has determined that the use of PFAS in the product is a currently unavoidable use, the prohibition is preempted by federal law, or the product is previously used.
- January 1, 2040: prohibits distribution or sale of certain commercial/industrial products that contain intentionally added PFAS, including certain textile products, refrigerants, solvents, propellants, automotive products, lubricants, and other industry-specific products (including for semiconductor manufacturing and petroleum production), unless DTSC has made a determination that the use of PFAS in the product is a currently unavoidable use, the prohibition is preempted by federal law, or the product is previously used.
With respect to the 2035 and 2040 bans, the burden will be on manufacturers and trade associations to petition DTSC for a “currently unavoidable use” determination, which will require the petitioner to demonstrate all of the following: (1) there are “no safer alternatives to PFAS that are reasonably available”; (2) inclusion of PFAS in the product is “necessary for the product to work”; and (3) the use of PFAS in the product is “critical for health, safety, or the functioning of society.”
If SB 682 is enacted as law, it will be the most far-reaching PFAS ban implemented by the California Legislature to date, and it will result in major costs and technical hurdles for affected industries and manufacturers, including with respect to reformulation of products, substantiating petitions for “currently unavoidable use” determinations, and (if neither of those avenues is effective) ceasing distribution and sale of regulated products in California. The current text of SB 682 and related legislative information is available at the California Legislative Information website, here. The Senate Committee on Health hearing on SB 682 will be held at 1:30pm on April 30, 2025. The hearing may be livestreamed at the Committee’s website (link here).
April 2, 2025: Industrial Company Files Action Challenging EPA Disclosure of Confidential Business Information Submitted to EPA During Enforcement Action Proceedings
On April 2, 2025, Inhance Technologies LLC initiated an action in the U.S. District Court for the District of Columbia—Inhance Technologies LLC v. Zeldin, Case No. 1:25-cv-00980-JEB—challenging EPA’s refusal to withhold allegedly “highly confidential test data” from disclosure in response to a Freedom of Information Act (FOIA) request. The FOIA request, submitted by Public Employees for Environmental Responsibility (PEER) and the Center for Environmental Health (CEH), sought information about PFAS in containers fluorinated by Inhance. Inhance alleges that this FOIA request was “part of a broader public-relations and litigation campaign that PEER and CEH have been waging against the company for years.” Complaint, ¶ 29. Inhance alleges that, in particular, PEER and CEH sought disclosure of information that had been submitted to EPA during an investigation and enforcement action by the agency under Section 5 of the Toxic Substances Control Act (TSCA), including information that Inhance had designated as confidential business information not subject to FOIA disclosure, per TSCA and applicable EPA regulations. (Inhance ultimately prevailed in that underlying enforcement action in March 2024, as previously discussed, below).
EPA requested that Inhance substantiate its confidential business information claim as to 262 documents that fell within the scope of the FOIA request. Inhance alleges that it substantiated all such claims, including with respect to 217 documents “reflecting information related to Inhance’s proprietary process—test data investigating the conditions under which PFAS impurities may form during Inhance’s fluorination process,” including “reports and spreadsheets summarizing internal and third-party analytical results prepared in furtherance of Inhance’s research and development program.” Complaint, ¶ 33. On February 28, 2025, EPA issued its final confidentiality determination and notified Inhance that the agency intended to release these 217 documents, in full or in part, because “Inhance had not demonstrated a likelihood that the disclosure would lead to substantial competitive harm.” Complaint, ¶ 37. Inhance alleges that EPA’s decision is a misapplication of FOIA Exemption 4, TSCA, and EPA’s regulations, and constitutes an arbitrary and capricious action in violation of the Administrative Procedure Act (APA). The complaint is available here.
Interested parties – including businesses raising crops or animals on agricultural and ranch lands potentially impacted by PFAS in groundwater; entities operating wastewater treatment plants (WWTPs); and related interest groups and associations – should be aware that the public comment period closes in one month, on April 16, 2025, for EPA’s Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS), notice of which was published on January 15, 2025 (90 Fed. Reg. 3859). The original comment period was scheduled to end on March 17. However, on February 22, EPA extended the comment period to April 16, to “allow interested parties additional time to thoroughly review and analyze” the risk assessment. See 90 Fed. Reg. 10078 (Feb. 22, 2025).
Per EPA, “the draft risk assessment reflects the agency's latest scientific understanding of the potential risks to human health and the environment posed by the presence of PFOA and PFOS in sewage sludge that is land applied as a soil conditioner or fertilizer (on agricultural, forested, and other lands), surface disposed, or incinerated,” focused on those persons living near impacted sites or relying on crops and animal products associated with those sites. 90 Fed. Reg. 10078. If the final risk assessment identifies risks above acceptable thresholds, “the EPA expects to propose a regulation under CWA section 405 to manage PFOA and/or PFOS in sewage sludge to protect public health and the environment,” and it may also “consider developing regulations under other statutory authorities to further reduce PFAS discharged to WWTPs [wastewater treatment plants].” 90 Fed. Reg. 3859, 3864.
The full text of the draft risk assessment and supporting documents, along with related fact sheets and webinar materials, are available on EPA’s website, here.
March 15, 2025: EPA Signals Potential Change of Position Regarding Key 2024 PFAS Rulemakings
In February 2025, newly installed EPA leadership sought and obtained orders from the D.C. Circuit Court of Appeals, staying pending legal challenges to two key rulemaking actions by the former administration: the setting of Maximum Contaminant Levels for six PFAS in drinking water under the Safe Drinking Water Act (SDWA), and the listing of PFOA and PFOS as hazardous substances under CERCLA. These legal challenges were previously discussed in updates below, dated June 10, 2024 (SDWA case) and July 29, 2024 (CERCLA case).
EPA recently filed an unopposed motion in each case, to hold the litigation in abeyance for 60 days (available here (February 7 request in SDWA case) and here (February 11 request in CERCLA case). In the SDWA case, the motion stated that “a new administration took office on January 20, 2025. There is now new leadership at EPA. That new leadership is in the process of familiarizing itself with the issues presented in this case and related litigation.” In the CERCLA case, the motion included a similar but not identical rationale: “With the change in administration on January 20, 2025, there is new EPA leadership. EPA needs time to brief new administration officials about this case and the underlying rule. To provide new leadership with time to familiarize themselves with these issues and determine how to proceed, [abeyance is being requested].” In both cases, EPA argued that abeyance was legally warranted, as “courts have long recognized that agencies may generally review and, if appropriate, revise their past decisions,” and “courts routinely grant stays or abeyance in circumstances like those presented here where a new administration seeks to review prior actions. . . . It is possible that after its review, EPA could take further action that may obviate the need for judicial resolution of some or all of the disputed issues.” The court granted both motions and ordered the cases held in abeyance.
Given these motions, as well as recent decisions by new EPA leadership to reverse major regulatory actions taken by prior administrations, it is highly likely that the two PFAS-related rulemakings at issue will not survive, either via EPA refusing to defend the pending actions, or otherwise agreeing to rescind the regulations.
January 14, 2025: EPA Releases Draft Risk Assessment for PFOA and PFOS in Biosolids
On January 14, 2025, EPA released for public comment its Draft Sewage Sludge Risk Assessment for Perfluorooctanoic Acid (PFOA) and Perfluorooctane Sulfonic Acid (PFOS). This draft risk assessment evaluates potential human health risks associated with PFOA and PFOS in biosolids, also known as sewage sludge, and finds that there may be human health risks associated with exposure to these chemical via all three methods of use or disposal – namely, land application (i.e., use as fertilizer), surface disposal in landfills, and incineration. Importantly, the draft risk assessment is focused on a specific population – those living on or near sites impacted by these chemicals, such as farms or landfills, or those relying primarily on products from those sites, such as crops, animal products, or drinking water – and does not model risks to the general public. EPA’s press release also specifies that its analysis does not suggest that the general food supply is impacted by use of biosolids containing PFOA or PFOS.
This risk assessment is not independently enforceable and, once final, will inform EPA’s future actions to reduce risk from PFOA and PFOS in biosolids. Public comments on the draft risk assessment must be received by March 17, 2025.
EPA’s press release can be found here, and more information on the risk assessment can be found here. EPA’s Federal Register notice can be found here.
January 3, 2025: EPA Announces Automatic Addition of Nine Additional PFAS to Toxics Release Inventory
On January 3, 2025, EPA issued a press release announcing that nine additional PFAS had been added to the Toxics Release Inventory (TRI) for Reporting Year 2025. These nine PFAS were automatically added to the TRI pursuant to Section 7321(c) of the National Defense Authorization Act for Fiscal Year 2020 (NDAA), and a total of 205 PFAS are now subject to TRI reporting for Reporting Year 2025. Reporting forms for Reporting Year 2025 are due by July 1, 2026.
The nine additional PFAS added to the PRI pursuant to the NDAA for Reporting Year 2025 are:
- Ammonium perfluorodecanoate (PFDA NH4) (3108-42-7)
- Sodium perfluorodecanoate (PFDA-Na) (3830-45-3)
- Perfluoro-3-methoxypropanoic acid (377-73-1)
- 6:2 Fluorotelomer sulfonate acid (27619-97-2)
- 6:2 Fluorotelomer sulfonate anion (425670-75-3)
- 6:2 Fluorotelomer sulfonate potassium salt (59587-38-1)
- 6:2 Fluorotelomer sulfonate ammonium salt (59587-39-2)
- 6:2 Fluorotelomer sulfonate sodium salt (27619-94-9)
- Acetic acid, [(γ-ω-perfluoro-C8-10-alkyl)thio] derivs., Bu esters (3030471-22-5)
EPA’s press release can be found here, and additional information on the automatic addition of PFAS to the TRI pursuant to the NDAA can be found here.
December 19, 2024: EPA Announces Draft Human Health Criteria for Three PFAS in Waterbodies
On December 19, 2024, EPA announced draft national recommended human health criteria (HHC) for three PFAS in waterbodies: perfluorooctanoic acid (PFOA), perfluorooctane sulfonic acid (PFOS), and perfluorobutane sulfonic acid (PFBS). As provided in EPA’s announcement the draft HHC are as follows:
PFAS |
Water + Organism HHC (ng/L) |
Organism Only HHC (ng/L) |
PFOA |
0.0009 |
0.00036 |
PFOS |
0.06 |
0.07 |
PFBS |
400 |
500 |
EPA’s recommended HHC were developed pursuant to the Clean Water Act (CWA) and will not be legally binding. However, when final, the HHC may be considered by states and authorized tribes when adopting water-quality criteria required by the CWA to protect designated water uses.
EPA’s HHC are subject to a 60-day comment period, and comments must be received by February 24, 2025.
EPA’s announcement in the Federal Register and guidance on submitting public comments can be found here. More information on this announcement can be found on EPA’s website here.
November 29, 2024: EPA Issues Supplemental Proposed Rule Updating SNURs for 17 PFAS
On November 29, 2024, EPA issued a supplemental proposed rule to update significant new use rules (SNURs) previously proposed for 17 PFAS under Section 5 of the Toxic Substances Control Act (TSCA). A SNUR creates a notification requirement for significant new uses of a chemical, and provides EPA with the opportunity to review and make a risk determination for those significant new uses. EPA previously proposed SNURs for these 17 PFAS on December 2, 2022 (87 Fed. Reg. 74072) that would have required notice to EPA for uses other than those described in applicable premanufacture notices (PMNs) or EPA orders issued pursuant to TSCA as well as for annual production over 2,500 pounds. In response to a public comment on the December 2022 proposal, because these 17 PFAS are not on the TSCA Inventory and no exemptions were granted for their manufacture, the supplemental proposed rule would find that there are no ongoing uses of these PFAS. Accordingly, any use of these 17 PFAS would be a significant new use that would require 90-day notice to EPA and completion of EPA review before manufacture, import, or processing can commence.
Public comments on this supplemental proposed rule are due by December 30, 2024, and the proposed rule and a link for submitting public comments can be found here.
November 14, 2024: Biden-Harris Administration Announces Release of EPA’s Third Annual Progress Report on the PFAS Strategic Roadmap
On November 14, 2024, the Biden-Harris Administration announced the release of EPA’s third annual progress report on EPA’s PFAS Strategic Roadmap, and the report indicates a growing focus on PFAS-related enforcement and compliance. Among other things, the report highlights the designation of PFOA and PFOS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA), and the related enforcement policy that “reinforces the EPA’s laser focus on the significant contributors to the PFAS contamination challenge—and not on entities where equitable factors do not support seeking response actions or costs under CERCLA, such as farms where biosolids are applied to the land, community water systems, or publicly owned treatment works.” The report also highlights EPA’s addition of ”Addressing Exposure to PFAS” as a National Enforcement and Compliance Initiative that will “ensure [EPA] continues to build upon its goals to take enforcement actions to protect public health.”
The Biden-Harris Administration’s announcement can be found here, and EPA’s Third Annual Progress Report can be found here.
October 8, 2024: EPA Proposes Addition of 16 Individual and 15 Categories of PFAS to the TRI
On October 8, 2024, the EPA proposed adding 16 individual and 15 categories of PFAS to the Toxics Release Inventory (TRI) list of chemicals subject to reporting under the Emergency Planning and Community Right-to-Know Act (EPCRA) and the Pollution Prevention Act (PPA). As part of this proposed rule, a number of individually listed PFAS will be reclassified as categories of PFAS, which will automatically include the acid and the associated salts, acyl/sulfonyl halides, and the anhydride. For all PFAS listed under this proposed rule, EPA proposes a reporting threshold of 100 pounds and a designation of chemicals of special concern. EPA estimates that the proposed rule will result in an additional 356 to 1,110 TRI reporting forms being filed annually.
Comments on EPA’s proposed rule are due by December 9, 2024. The proposed rule can be found here and more information on the proposed rule can be found here.
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.
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.
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 54 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 54 PFAS. Four citizen groups (“Petitioners”) had petitioned EPA under TSCA to require testing of 54 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.
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: 15 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, 15 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.