The EPA recently announced its framework for addressing new per- and poly-fluoroalkyl substances (PFAS) and new uses of PFAS and published its final rule adding nine new PFAS to the Toxics Release Inventory (TRI). These actions advance the goals of the Agency’s PFAS Strategic Framework.

New framework to prevent unsafe new PFAS from entering the market

The framework outlines the EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, the Agency will undertake an extensive evaluation to ensure they pose no harm to human health and the environment.

The new framework details the following steps to evaluate new PFAS and new PFAS uses:

1. Determine if the substance under review meets the PFAS chemical category definition.
2. If the substance is a PFAS, the EPA will then determine the components of interest (the substance or potential metabolites or degradants) and will begin to review the available data. It will also make a determination if the substance is a persistent, bioaccumulative, and toxic (PBT) chemical.
3. If the substance is determined to be a PBT chemical, the EPA will consider potential risk exposure for direct contact and for the general population because these types of chemicals don’t break down easily and build up and remain in the environment for long periods of time.

“Under the framework, EPA expects that some PBT PFAS will not result in worker, general population or consumer exposure and are not expected to result in releases to the environment, such as when PFAS are used in a closed system with occupational protections as is generally the practice in the manufacture of some semiconductors and other electronic components,” the Agency says in a news release. “In such a negligible exposure and environmental release scenario, if EPA can ensure that such PBT PFAS can be disposed of properly and no consumer exposure is expected, EPA generally expects to allow the PFAS or the new use of a PFAS to enter commerce after receiving basic information, such as physical-chemical property data, about the substance. If the initial data cause concern, then EPA will require additional testing and risk mitigation before moving forward.”

4. Next, the Toxic Substances Control Act (TSCA) requires the EPA to review new chemicals, including new PFAS and new uses of PFAS, within 90 days; assess the chemicals’ potential risks to human health and the environment; and make one of five possible risk determinations:

• Unreasonable risk: If it’s determined that a new chemical substance or significant new use presents an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency must take action under Section 5(f) to protect against the unreasonable risk.
• Insufficient information: If it’s determined that the available information is insufficient to allow the Agency to make a reasoned evaluation of the health and environmental effects of the new chemical substance or significant new use, the EPA must issue an order under Section 5(e). A Section 5(e) order prohibits or limits the manufacture, processing, distribution in commerce, use, or disposal to the extent necessary to protect against an unreasonable risk and may include testing requirements.
• Absence of sufficient information: If it’s determined that, in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical may present an unreasonable risk of injury to health or the environment without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation identified as relevant to the EPA administrator, the EPA must issue an order under Section 5(e).  
• Substantial quantities/potential significant or substantial exposure: If it’s determined that the substance is or will be produced in substantial quantities and either enters or may enter the environment in substantial quantities or there is or may be significant or substantial exposure to the substance, the EPA must issue an order under Section 5(e).  
• Unlikely risk: If it’s determined that a new chemical or significant new use isn’t likely to present an unreasonable risk of injury to health or the environment, without consideration of costs or other nonrisk factors, including an unreasonable risk to a potentially exposed or susceptible subpopulation under the conditions of use, the Agency will notify the submitter, and the submitter may commence manufacture of the chemical or manufacture or processing for a significant new use notwithstanding any remaining portion of the 90-day review period. The EPA will notify the submitter of its decision and publish its findings in a statement in the Federal Register.

“[N]ew PFAS entering the marketplace present a significant challenge for EPA to evaluate,” Taft Stettinius & Hollister LLP says in a Lexology article. “Often, there is insufficient information on the new substance in order to quantify risk and make effective decisions regarding its regulation—there are thousands of different PFAS, but data for only a small fraction are available to the broader scientific community, regulators, and the public. … The new Framework issued by EPA will guide EPA’s New Chemicals Program with a planned approach for its review of new PFAS or significant new uses of existing PFAS.”

Final rule adding nine new PFAS to TRI

On June 22, 2023, the EPA issued a final rule that identifies nine additional PFAS subject to reporting requirements. The addition of these PFAS to the TRI chemical list additionally marks progress on the EPA’s PFAS Strategic Roadmap.

“The Fiscal Year 2020 National Defense Authorization Act (NDAA) provides the framework for the addition of PFAS to the TRI each year. As previously announced, for TRI Reporting Year 2023 (reporting forms due by July 1, 2024), reporting is required for nine additional PFAS. In total, 189 PFAS are currently subject to TRI reporting requirements. [This]?final rule officially incorporates these requirements into the Code of Federal Regulations for TRI,” the Agency news release adds.

“TRI data are reported to EPA annually by facilities in certain industry sectors, including federal facilities, that manufacture, process, or otherwise use TRI-listed chemicals above certain quantities. The data include quantities of such chemicals that were released into the environment or otherwise managed as waste.”

Data collected assists the EPA’s efforts to better understand the listed substances and supports informed decision-making by companies, government agencies, nongovernmental organizations, and the public.

TRI—No longer confidential business information

The 2020 NDAA requires the EPA to review confidential business information (CBI) claims before adding a PFAS to TRI. The following four PFAS were declassified in February 2022 because at least one manufacturer didn’t claim them as confidential during prior reporting under the Chemical Data Reporting rule and have been added to the TRI list:

• Alcohols, C8-16, ?-?-perfluoro, reaction products with 1,6-diisocyanatohexane, glycidol and stearyl alc. (2728655-42-1)
• Acetamide, N-[3-(dimethylamino)propyl]-, 2-[(?-?-perfluoro-C4-20-alkyl)thio] derivs. (2738952-61-7)
• Acetic acid, 2-[(?-?-perfluoro-C4-20-alkyl)thio] derivs., 2-hydroxypropyl esters (2744262-09-5)
• Acetamide, N-(2-aminoethyl)-, 2-[(?-?-perfluoro-C4-20-alkyl)thio] derivs., polymers with N1,N1-dimethyl-1,3-propanediamine, epichlorohydrin and ethylenediamine, oxidized (2742694-36-4)

TRI—Addition of five PFAS with final toxicity values

The 2020 NDAA includes a provision that automatically adds PFAS to the TRI list upon the Agency’s finalization of a toxicity value. In December 2022, the EPA finalized a toxicity value for perfluorobutanoic acid (PFBA), its anion, and its related salts. Pursuant to the NDAA, the following five chemicals have been added to TRI:

• PFBA (375-22-4)
• Perfluorobutanoate (45048-62-2)
• Ammonium perfluorobutanoate (10495-86-0)
• Potassium perfluorobutanoate (2966-54-3)
• Sodium perfluorobutanoate (2218-54-4)

The due date for including these PFAS chemicals on a TRI report is July 1, 2024, for calendar year 2023 data.

“As part of EPA’s PFAS Strategic Roadmap, the Agency also?proposed a rule?in December 2022 to enhance PFAS reporting to TRI by eliminating an exemption that allows facilities to avoid reporting information on PFAS when those chemicals are used in small, or de minimis, concentrations,” continues the Agency press release. “Because PFAS are used at low concentrations in many products, that rule would ensure that covered industry sectors and federal facilities that make or use TRI-listed PFAS will no longer be able to rely on the de minimis exemption to avoid disclosing their PFAS releases and other waste management quantities for these chemicals.”