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.

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.

Environmental Groups Call on FDA to Revoke Approval of Fluorinated Plastic for Food Contact

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A coalition of environmental and health groups led by the Environmental Defense Fund have petitioned the Food and Drug Administration (FDA) to revoke approval of fluorinated polyethylene as an indirect food additive.  According to the petition, manufacture of fluorinated polyethylene produces PFAS, including harmful perfluoroalkyl carboxylic acids if water or oxygen is present.

FDA approved fluorinated polyethylene as an indirect food additive—a substance that comes into contact with food, but is not intended to be added directly to food—in 1983.  Since then, according to the petition, the dangers of even minimal exposures to PFAS have become clear, and studies have demonstrated that fluorinated polyethylene results in PFAS migration into food.

The petitioners argue that the substance can no longer be considered “safe” as defined at 21 CFR 170.3(i), which requires “reasonable certainty in the minds of competent scientists that the substance is not harmful under the conditions of its intended use.”  The Agency must consider the following factors when determining whether this safety standard is met:

  • The probable consumption of the substance and any substance formed in or on food because of its use.
  • The cumulative effect of the substance in the diet, taking into account any chemically or pharmacologically related substance or substances in the diet.
  • Safety factors which, in the opinion of experts qualified by scientific training and experience to evaluate the safety of food ingredients, are generally recognized as appropriate.

The petitioners also claim that revoking approval for fluorinated polyethylene is the logical consequence of a previous FDA statement on the substance.  In a 2021 public letter to manufacturers, distributors, and users of fluorinated polyethylene food contact articles, the Agency stated that its regulations “[do] not authorize fluorination of polyethylene containers in the presence of water, oxygen, or gases other than nitrogen.”  The petition, however, alleges that all nitrogen gas contains water and oxygen as impurities.  “If FDA is serious about its claim that no oxygen or water may be present in the nitrogen gas, then the agency has effectively determined that the 1983 approval should be revoked,” the petitioners state.

The petition comes after a July 2022 FDA request for information on food contact uses of fluorinated polyethylene due to PFAS concerns.

DOD and FAA Approve Use of a PFAS-Free Fire Suppressant

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This September, the Department of Defense (DOD) announced the approval of the first PFAS-free foam for firefighting activities at military installations.  The approval is an important step in phasing out the use of PFAS-containing aqueous film forming foams (AFFFs), which are used to extinguish liquid fires.

The day after the foam received DOD approval, the Federal Aviation Administration (FAA) notified airports that they could use it.  FAA is not currently requiring exclusive use of the PFAS-free foam, however.

The transition away from PFAS-containing foams is required by section 322 of the 2020 National Defense Authorization Act.  Among other deadlines, the act prohibits DOD from purchasing fire-fighting foams containing more than 1 part per billion PFAS beginning October 1, 2023.

DOD issued a performance specification for PFAS-free (also known as fluorine-free) foams in January of this year.  According to DOD’s announcement, several other fluorine-free foams are currently being tested for conformance with the specifications.

 

 

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.

PFAS Class Action Brought Against Sports Drink Company

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A consumer class action lawsuit has been filed against Biosteel Sports Nutrition, Inc. in the Eastern District of New York, alleging that the company’s BioSteel Blue Raspberry flavored sports drink contains per- and polyfluoroalkyl substances (“PFAS”). Defendant’s products are marketed as healthy sports drinks, using language such as “clean, quality ingredients,” “designed with sustainability in mind,” “no artificial flavors/colors,” and “good for you and the environment.” The product packaging additionally claims that the product is “highly regarded for its premium ingredients and zero sugar formula.”

Plaintiffs claim that based on this language, they believed the product to be a healthy sports drink, but the presence of PFAS directly contradicts Biosteel Sports Nutrition’s marketing claims. The suit alleges violations of the New York General Business Law § 349, et seq., which prohibits deceptive acts and practices in business, violations of New York General Business Law § 350, et seq. prohibiting false advertising, breach of express warranty, fraud, constructive fraud, and unjust enrichment.

On August 4, 2023, the company filed a motion to dismiss, claiming that Plaintiff’s testing of its product was insufficient to demonstrate that PFAS substances are present in its products. The motion claims the testing allegations are “devoid of any details regarding the methodology or sample used.” Additionally, according to Biosteel Sports Nutrition, this information was not within the complaint or the amended complaint.

EPA Requests Information on Addressing PFAS in the Environment for the Superfund Program

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EPA has published a notice of proposed rulemaking, Addressing PFAS in the Environment, asking for public input, which the Agency will use to develop future per- and polyfluoroalkyl substance (PFAS) regulations under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). The Agency asked for information on the potential future hazardous substance designation of a number of PFAS, categories of PFAS, and several PFAS precursors.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Seven PFAS

EPA had previously proposed designating PFOA and PFOS and their salts and structural isomers as hazardous substances under CERLA. The present notice requested feedback as to whether the agency should initiate action designating an additional seven PFAS and their salts and structural isomers or a subset thereof as CERCLA hazardous substances as well. The seven PFAS being considered for designation are:

  • Perfluorobutanesulfonic acid (PFBS), CASRN 375–73–5
  • Perfluorohexanesulfonic acid (PFHxS), CASRN 355–46–4
  • Perfluorononanoic acid (PFNA), CASRN 375–95–1
  • Hexafluoropropylene oxide dimer acid (HFPO–DA), CASRN 13252–13–6
  • Perfluorobutanoic acid (PFBA) CASRN 375–22–4
  • Perfluorohexanoic acid (PFHxA) CASRN 307–24–4
  • Perfluorodecanoic acid (PFDA) CASRN 335–76–2

EPA asked interested parties to submit information on whether any of these compounds may present substantial danger to public health or welfare or the environment. Such information could include data on mobility, persistence, and prevalence.

Request for Public Input Regarding Potential Future Hazardous Substance Designation of Precursors to PFOA, PFOS, and PFAS

The Agency is also considering initiating action that would designate certain PFAS precursors as hazardous substances under CERCLA. To make this determination, EPA requested information to help the Agency identify compounds that degrade to these PFAS through environmental processes such as biodegradation and hydrolysis.

Request for Public Input Regarding Potential Designation, or Designations, of Categories of PFAS as Hazardous Substances

Additionally, EPA is considering initiating action that would designate groups or categories of PFAS as CERCLA hazardous substances. These groups or categories would be based on characteristics that determine risk to human health and the environment, such as chemical structure, physical and chemical properties, mode of toxicological action, and precursors or degradants. To inform its decision-making, the Agency solicited the following information:

  • Published scientific literature that can inform whether categories of PFAS could or could not be designated as hazardous substances. This could include findings on the similarities or differences of a specific characteristic among PFAS. Also useful would be data on the relationship between different characteristics, such as the relationship between chemical structure and specific chemical, physical, or toxicological properties.
  • Other information that could inform EPA’s determination of whether to designate one or more categories of PFAS as hazardous substances.
  • Information that would contribute to economic analysis of the potential costs and benefits, including impacts on small entities, associated with a potential rulemaking designating categories of PFAS as hazardous substances. (Although CERCLA section 102(a) precludes EPA from taking cost into account in the designation of a hazardous substance, the Agency is requesting this information to help the Agency understand the potential costs and benefits associated with any potential future regulatory action.)

The deadline for submitting comments was extended from June 12 to August 11, 2023, during which period over 600 comments were submitted. The comments can be reviewed here.

EPA Releases Draft IRIS Assessment of PFHxS and Related Salts

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On July 24, 2023, EPA released a draft IRIS Toxicological Review of Perfluorohexanesulfonic Acid (PFHxS) and Related Salts.  Comments on the draft assessment will be accepted through September 22, 2023.

The IRIS assessment found that, given sufficient exposure conditions, PFHxS is likely to cause thyroid and developmental immune effects in humans.  Other evidence suggests but is insufficient to infer that PFHxS exposure might cause teratological, hepatic, neurodevelopmental, and cardiometabolic effects in humans.  EPA concluded that there is inadequate information to assess whether PFHxS exposure can result in hematopoietic, reproductive, renal, and carcinogenic effects.

PFHxS is one of three PFAS currently undergoing IRIS assessments, along with PFNA and PFDA.  EPA previously published final IRIS assessments for two other PFAS: PFBA in December 2022 and PFHxA in April 2023.