EPA Finalizes TSCA Reporting and Recordkeeping Requirements for PFAS

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EPA has finalized its Toxic Substances Control Act (“TSCA”) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substance (“PFAS”) rule. The rule offers none of the customary TSCA reporting exemptions, such as the di minimus threshold exemption, article exemption, and research and development exemption. Although industry members voiced significant concerns over the proposed rule, the scope of the rule remains expansive. A summary of the final rule is detailed below.

Who does the final rule apply to?

40 CFR § 705.10 identifies the entities that are covered under the rule. The rule, which Congress mandated through the FY2020 National Defense Authorization Act, applies to all entities that have manufactured and/or imported a PFAS for commercial purposes, including those present in a mixture and in an article since January 1, 2011. Those who have only processed, distributed in commerce, used, and/or disposed of PFAS are not subject to this rule.

Which PFAS must be reported under the final rule?

EPA has identified PFAS subject to the rule by a structural definition rather than a list of substance identities (40 CFR § 705.5). However, EPA will provide a public list of substances that meet this definition on its CompTox Chemical Dashboard. The definition of PFAS using a structural definition is as follows:

  • R-(CF2)-CF(R’)R’’, where both the CF2 and CF moieties are saturated carbons;
  • R-CF2OCF2-R’, where R and R’ can either be F, O, or saturated carbons; and
  • CF3C(CF3)R’R’’, where R’ and R’’ can either be F or saturated carbons.

This differs from the proposed rule, which defined PFAS as “a substance that includes the following structure: R-(CF2)–C(F)(R′)R″, in which both the CF2 and CF moieties are saturated carbons and none of the R groups (R, R′ or R″) can be hydrogen.”

Reporting threshold

There is no reporting threshold or de minimis level for PFAS reporting. The traditional TSCA reporting exemptions, such as byproducts and impurities, and low volume exemptions, are not being upheld under this rule and require reporting.

Reporting standard

40 CFR § 705.15 states that the reporting standard that applies to this rule is information “known or reasonably ascertainable” by the manufacturer. This means “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know” (See 40 CFR 704.3). Under this standard, the manufacturer must evaluate not only their current level of knowledge regarding substances that are manufactured or imported, including those in articles, but also any additional information that a reasonable person, similarly situated, would be expected to know, possess, or control.

To obtain the necessary information for reporting, EPA expects the manufacturer/importer to conduct a reasonable inquiry into their own organization and potentially make inquiries outside the organization. According to the Agency, this may require “phone calls or email inquiries to upstream suppliers or downstream users or employers or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing of the PFAS.”

If data is unknown or not reasonably ascertainable, the submitter should, if possible, submit reasonable estimates. If manufacturers or importers need additional information for reporting, but suppliers are unwilling to provide that information, they can send a request for information through EPA’s reporting tool.

What information must be reported?

The scope of information required is vast. Data elements are detailed at 40 CFR §705.15 and include:

  • Chemical-specific information for all PFAS manufactured each year since January 1, 2011, including PFAS incorporated in mixtures.
  • Categories of use, including information on the sector, industrial processing, commercial and consumer use, and product categories.
  • Concentrations of each PFAS used in consumer and commercial products.
  • Manufactured amounts.
  • Byproduct identification.
  • Environmental and health effects data – which must be submitted according to OECD Harmonized Templates for Reporting Chemical Test Summaries.
  • Worker exposure data.
  • Disposal data.

Reporting on PFAS in Articles

Articles importers are subject to the reporting rule. The fact that there is no de minimis concentration threshold makes the scope of this mandate expansive. Because the known and reasonably ascertainable standard applies to this rule, importers must go beyond simply reviewing the SDSs for the imported articles. To demonstrate compliance with the rule, importers will need to survey their suppliers about the presence of PFAS in all of the articles they have imported since January 1, 2011. However, the rule does not mandate any product testing for article importers.

The rule does exempt some data elements from reporting for PFAS imported in articles, such as byproduct identification, worker exposure data, and disposal data.

R&D exemptions to the reporting requirements

Manufacturers and importers of R&D PFAS substances are subject to the reporting rule.  The reporting requirements are reduced where volumes are below 10 kilograms annually.

Electronic reporting

All information must be submitted electronically through CDX (see 40 CFR § 705.35). A new tool, the Chemical Information Submission System (“CISS”), will be added to the CDX module “Submission for Chemical Safety and Pesticide Program” (“CSPP”). Reporting will be submitted through the CISS, which the Agency is currently developing, and will be live prior to the opening of the reporting period.

CBI claims

PFAS manufacturers reporting under this rule may claim CBI consistent with TSCA section 14, but they must make the CBI claim with their submission for this rule. CBI claims submitted for other reporting requirements will not be considered. See 40 CFR § 705.30 for details.

Reporting timeline

Manufacturers and importers will have one year from the effective date of this rule, November 13, 2023, to collect the data necessary for reporting and an additional six months to submit their reports; reports will be due May 13, 2023. Small manufacturers (as defined in 40 CFR 704.3) will have an additional six months to report, making their reporting deadline November 13, 2024.

Recordkeeping requirements

Manufacturers and importers subject to this rule must maintain records of all documents and information reported to EPA for five years, beginning on the last day of the information submission period.

GAO Releases Report on PFAS-Related Recommendations

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In September 2023, the Government Accountability Office (GAO) released a three-page report detailing the recommendations it has previously made to government agencies for the purposes of “detecting, limiting exposure to, and treating PFAS contamination.”

GAO describes the following recommendations it made to EPA, FDA, and Department of Defense (DOD), respectively:

  • In September 2022, GAO recommended that EPA conduct an analysis of the demographic characteristics of communities that have PFAS in their drinking water. EPA agreed and is currently implementing the recommendation.
  • In November 2022, GAO recommended that FDA request legal authority from Congress to compel companies to provide information about certain substances on the market that come into contact with food (such as packaging) that may contain PFAS. FDA is considering the recommendation.
  • In April 2023, GAO recommended that DOD: (1) develop a strategy to help the Department comply with Congress’s directive to stop procuring certain products containing PFAS and (2) update its sustainable product guidance to reflect new PFAS policies. DOD agreed and is currently implementing the recommendation. GAO also recommended that Congress clarify its direction to DOD.

In addition to these recommendations, GAO stated that it is currently monitoring public water systems’ implementation of PFAS treatment methods. GAO also highlighted its July 2022 report on the technologies that could be used to address PFAS-related risks, which recommended that policymakers promote research, expand method development, and support full-scale PFAS treatment.

EPA Settles with Slack Chemical Company Following Alleged EPCRA Violations

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On October 11, 2023, EPA announced a settlement with Slack Chemical Company, Inc. (“Slack”) following alleged violations of the Emergency Planning and Community Right-to-Know Act (EPCRA) at two of the New York corporation’s facilities. The settlement includes a civil penalty of $231,300.

Under Section 313 of EPCRA, owners or operators of certain facilities are required to annually submit a Toxic Chemical Release Inventory Reporting Form R (“TRI Form R”) report for each chemical listed under 40 CFR 372.65 that was manufactured, processed or otherwise used in quantities exceeding a certain threshold. TRI Form R reports require information about on-site releases of the chemical into the environment, transfers of the chemical in waste to off-site locations, on-site waste treatment methods, and source reduction and recycling activities. Alternatively, owners or operators can opt to submit a simpler Toxic Chemical Release Inventory Reporting Form A (“TRI Form A”)  report when the quantity of the chemical manufactured, processed, or otherwise used is one million pounds or less, the total quantity released, disposed, and treated at the facility is 500 pounds or less, and the chemical is not considered to be of special concern. TRI Form R/Form A reports are due no later than July 1 for the preceding calendar year.

EPA alleges that Slack, which describes itself as a “chemical warehousing, repackaging and distribution company,” failed to submit timely TRI Form R/Form A reports at its Carthage and Saratoga Springs facilities for calendar years 2019 and 2021. More specifically, EPA alleges that Slack:

  • Submitted TRI Forms R or A for the chemical’s ammonia, methanol, nitric acid, and toluene at its Carthage facility and a TRI Form R for methanol at its Saratoga Springs facility on May 10, 2021, for calendar year 2019, approximately 10 months late; and
  • Submitted TRI Forms R or A for the same chemicals at the facilities on November 21, 2022, for the calendar year 2021, approximately 4.5 months late.

In a news release, EPA stated that Slack has “voluntarily instituted a corporate compliance plan to prevent recurrence of EPCRA reporting violations,” which includes a written procedure listing the steps needed to identify TRI chemicals and their quantities.

Case Update: Motion to Dismiss Granted in PFAS Lawsuit Against L’Oreal

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In March 2022, a class action lawsuit was filed against L’Oreal U.S.A., Inc. for alleged violations of state consumer protection laws related to the failure to disclose PFAS in their waterproof mascara products. The complaint alleged that L’Oreal violated numerous consumer protection laws, including New York General Business Laws 349 and 350, against fraudulent and misleading advertising by failing to disclose that its waterproof mascara products contain PFAS. (Verdant Law published a detailed blog post on the litigation, which can be found here.)

In a recent ruling on September 30, 2023, the U.S. District Court for the Southern District of New York granted L’Oreal’s motion to dismiss the case. The court concluded that the plaintiffs failed to demonstrate standing, as they didn’t sufficiently prove that the specific mascaras they purchased contained PFAS.

The plaintiffs based their claims on a 2021 University of Notre Dame study that found high fluorine levels in various cosmetic products, including waterproof mascaras, commonly advertised as long-lasting or wear-resistant. Plaintiffs did not allege or provide any evidence that the Notre Dame study had included a review of any L’Oreal products.

The plaintiffs also conducted their own study, alleging that the L’Oreal mascaras tested had PFAS levels above the EPA’s lifetime Health Advisory Level (the health advisory level is the amount of PFAS that is most certain not to cause harmful human effects if consumed over a lifetime). Nonetheless, the court found these allegations lacking in specific details, such has how many samples were tested and if all samples tested were positive for PFAS. Nor, according to the court, did the study link the findings to the actual products purchased by the plaintiffs. The court dismissed the case without prejudice and with leave to amend.

California Governor Vetoes Three Bills Restricting PFAS in Consumer Products

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On October 8, 2023, California Governor Gavin Newsom announced that he had vetoed three bills passed by California’s state legislature designed to restrict PFAS in certain consumer products. The three bills vetoed by Newsom are as follows:

  • AB 727, which would have banned the manufacture and sale of cleaning products containing intentionally added PFAS or PFAS at or above a certain concentration beginning in 2026. The concentration threshold would have decreased over time to 10 ppm in 2028.  The bill also would have banned the manufacture and sale of floor sealers and floor finishers containing intentionally added PFAS or PFAS at or above 10 ppm beginning in 2028.
  • AB 246, which would have banned the manufacture and sale of menstrual products containing intentionally added PFAS or PFAS at or above 10 ppm beginning in 2025.
  • AB 1423, which would have banned the manufacture, sale, or purchase of artificial turf containing intentionally added PFAS or PFAS at or above 20 ppm beginning in 2026.

In his veto messages for each of the three bills, Newsom provided an identical rationale for his decision.  Newsom wrote that he “strongly support[s] the author’s intent and [has] signed similar legislation in the past” but is concerned that the bill does not identify a regulatory agency to determine or enforce compliance with the proposed statute. According to Newsom, similar legislation that has been enacted without regulatory oversight has been challenging to implement due to inconsistent interpretations and confusion among manufacturers on how to comply. Newsom concluded each message by stating that he is directing the Department of Toxic Substances Control to work with the bill’s author and the legislature to consider other approaches to PFAS regulation.

EPA Releases Proposed Rule on Regulatory Requirements for New HAP Additions

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Last month, EPA published a proposed rule that would amend the National Emission Standards for Hazardous Air Pollutants (NESHAP) to facilitate the addition of pollutants to the list of Hazardous Air Pollutants (HAP) under the Clean Air Act (CAA).  The proposed rule seeks to address applicability and compliance issues that EPA identified following the Agency’s 2022 decision to add 1-bromopropane (“1-BP”) to the list of HAP, which was the first addition to the HAP list since its inception in 1990.  Comments on the proposed rule are due on November 13, 2023.

The proposed rule makes the following clarifications:

  • EPA proposes language clarifying that a new HAP would not be regulated under NESHAP promulgated before the effective date of the listing.
  • EPA states that beginning on the effective date of the listing, a new HAP must be included in calculating a facility’s actual emissions, potential emissions, and whether a facility is considered an area source or a major source under CAA. Any facility that becomes a major source under CAA section 112 solely due to the addition of a new HAP, known as a major source due to listing (“MSDL”) facility, will need to evaluate whether any major source NESHAP applies to its operations.  EPA proposes that each MSDL facility be considered an “existing source” under CAA section 112, a designation that typically results in less stringent NESHAP emissions standards.  EPA also proposes that MSDL facilities would not be subject to the original NESHAP compliance schedules, which in many cases would require instantaneous compliance, and instead proposes that these facilities be subject to new deadlines based on the nature of the NESHAP emissions limitations or requirements.
  • When a facility triggers one or more major source NESHAP, it is required to submit an initial notification under each newly applicable NESHAP. EPA proposes that MSDL facilities include a statement that the facility is a major source due to HAP listing in their notification.

The proposed rule does not include any changes to the CAA Title V program.  MSDL facilities that do not elect to reduce their emissions to non-major levels would be required to apply for a Title V operating permit.  Though the proposed rule focuses on the immediate compliance obligations following the addition of a new HAP, EPA states that “future actions within NESHAP will address rule-specific issues,” such as identifying emissions sources and promulgating standards for new HAP.

1-BP was added to the Toxics Release Inventory list of reportable chemicals in 2015.  According to EPA’s website, the Agency “is now in the process of writing a proposed rule to take action to regulate 1-BP” following EPA’s 2022 determination that the chemical poses an unreasonable risk to human health.

EPA Proposes Revisions to the Air Emissions Reporting Requirements

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On August 9, 2023, EPA released a lengthy proposed rule revising the Air Emissions Reporting Requirements (AERR), which requires state, local, and some tribal agencies (“States”) to collect and report data on air pollutant emissions to EPA.

Perhaps most importantly, the proposed rule would require the reporting of point source emissions of Hazardous Air Pollutants (HAP), as enumerated in Clean Air Act section 112(b) and amended in 40 CFR 63 Subpart C.  EPA is proposing to expand the definition of “point source” accordingly to include certain emitters of HAP pollutants.  Owners/operators of point sources would be required to report HAP data directly to EPA unless a State chooses to report these emissions on behalf of owners/operators of point sources within the State.

In addition to the reporting of HAP, EPA proposes that:

  • Owners/operators of point sources report performance test results and performance evaluations that meet certain criteria;
  • States report data on “small generating units” that operate at point sources and meet specific criteria, and
  • Point source reporting should be done for the same sources every year, eliminating the current triennial approach that requires more facilities to be reported every third year by making the triennial year thresholds permanent, among a myriad of other changes.

The comment period for the proposed rule was extended until November 17, 2023.  Though the proposed changes have varying implementation dates, most importantly, most facilities would be required to begin submitting HAP data for the 2026 inventory year.

EPA Releases Draft Supplement for 1,4-Dioxane

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In July 2023, EPA announced the release of a draft supplement to the Risk Evaluation for 1,4-dioxane for public comment and peer review.  1,4-dioxane is solvent used to manufacture other chemicals such as adhesives and sealants.  It is also used as a processing aid and laboratory chemical. In addition, some manufacturing processes, such as the process used for making commercial and consumer dish soaps, result in the chemical being present as a byproduct.

The draft supplement focuses on air and water exposure pathways that were not included in the 2020 Risk Evaluation.  The 2020 Risk Evaluation focused on health risks to workers, consumers, and the general public, but not from drinking water, the air, or exposure where 1,4-dioxane is present as a byproduct.  The omission was identified by the Scientific Advisory Committee on Chemicals (SACC) as an oversight.  The SACC informed EPA that failure to assess the risks posed to the general population from exposure to the chemical may present a risk to human health – with an emphasis on drinking water as an exposure pathway.

The draft supplement identified cancer risk estimates higher than 1 in 10,000 for 1,4-dioxane present as a byproduct and higher than 1 in 1 million for general population exposure scenarios associated with 1,4-dioxane in drinking water sourced downstream of release sites and in air within 1 km of releasing facilities.

The draft supplement did note that the risk estimates include inherent uncertainties and the overall confidence in specific risk estimates fluctuates.  However, the document also stated that the information is beneficial in helping the Agency make a determination on whether the chemical poses an unreasonable risk to people with occupational exposure, through sources of drinking water, and breathing air near release sites.

EPA Settles with Kyocera After Self-Disclosure of TSCA Violations

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On September 5, 2023, EPA signed a consent agreement with Kyocera International, Inc. (“Kyocera”) over three alleged violations of the Toxic Substances Control Act (TSCA). Kyocera’s civil penalty was reduced to $105,937 because of EPA’s audit policy, which rewards companies that “voluntarily discover, promptly disclose and expeditiously correct” violations with reduced fines.

The alleged violations, which pertain to six unnamed chemicals (Chemicals A, B, C, D, E, and F), are as follows:

  1. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without first filing a premanufacture notice (PMN) or an exemption to PMN requirements, in violation of TSCA section 5(a)(1);
  2. Failure to comply with recordkeeping requirements for Chemical D and E’s polymer exemptions to PMN requirements, in violation of TSCA section 5(a)(1); and
  3. Importation of Chemical A at least 12 times, Chemical B at least 21 times, and Chemical C at least 18 times without submission of proper certifications prior to the importation, and importation of Chemical F three times without providing a positive TSCA certification statement for each import, in violation of TSCA section 13(a)(1)(B).

The electronics manufacturer corrected the alleged violations by ceasing importation of Chemicals A, B, C, and D, submitting low-volume exemptions to PMN requirements for Chemicals B and C (which were granted by the Agency), and complying with the polymer exemption requirements for Chemical D. Under the terms of the settlement, EPA gave Kyocera permission to release its self-imposed quarantined stocks of Chemicals B, C, and D.

Kyocera self-disclosed the violations on June 23, 2021, with supplemental information provided in March 2023. The company disclosure and subsequent corrective action satisfied all of EPA’s audit policy conditions except the requirement that the violations be uncovered by “systematic discovery” and was therefore eligible for a 75% reduction in the gravity-based portion of the civil penalty.

The consent decree comes after a June 30, 2022, EPA Inspector General report which found that eDisclosure, EPA’s violation self-disclosure system, “does not have adequate internal controls in place to ensure that the EPA’s screening process is effective and that significant concerns . . . are identified and addressed.” EPA agreed with all four of the report’s recommendations and proposed corrective actions, including the development of national guidance and eDisclosure-specific training for EPA staff who monitor eDisclosure submissions.

CPSC Publishes Request for Information Regarding PFAS in Consumer Products

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On September 20, 2023, the Consumer Product Safety Commission (CPSC) published a request for information (RFI) in the Federal Register for information on PFAS in consumer products. The RFI requests information from all stakeholders, including “consumers, manufacturers and importers, government agencies, non-governmental organizations, and researchers.”

The requested information falls into three categories:

  1. Use or potential use of PFAS in consumer products, including information about the definition of PFAS, identification of specific PFAS potentially used or present in consumer products, and information about which PFAS or consumer products CPSC should prioritize in future assessments, among other information;
  2. Potential human exposures to PFAS associated with consumer products use, including information about the potential for exposure and risk from the presence of PFAS in consumer products, among other information; and
  3. Potential adverse human health effects informed by toxicological data, including reports that could inform whether individual PFAS or categories of PFAS have the potential for adverse human health effects, and information on additional data sources that CPSC should consider.

The Federal Register notice also announced the availability of a contract report that CPSC commissioned to characterize the use of PFAS in consumer products, identify PFAS regulations and restrictions, and summarize recent hazard, exposure, and risk assessments on PFAS. The contract report ultimately identified 863 PFAS with reported use or detection in consumer products. The RFI instructs reporting entities to consider information already available to CPSC in the contract report when reporting information.

CPSC does not explicitly state what it plans to do with the collected data in the RFI but states that the contract report “identif[ies] possible next steps.” The next steps identified by the contract report include research (such as developing a consensus on the definition of PFAS), new regulations, and consumer awareness.

The RFI comes after Minnesota, Maine, and other states passed regulations limiting the use of PFAS in consumer products. CPSC will accept the requested information through November 20, 2023.