On January 11, 2024, the U.S. Environmental Protection Agency (EPA) issued a final significant new use rule (SNUR) to prevent companies from starting or resuming the manufacture (including import) or processing of 329 per- and polyfluoroalkyl substances (PFAS) that are designated as inactive on the Toxic Substances Control Act (TSCA) Chemical Substance Inventory. 89 Fed. Reg. 1822. The final rule notes that persons subject to the final SNUR are required to notify EPA at least 90 days before commencing any manufacture (including import) or processing of the chemical substance for a significant new use. Once EPA receives a significant new use notification (SNUN), EPA must review and make an affirmative determination on the SNUN and take such action as is required by any such determination before the manufacture (including import) or processing for the significant new use can commence. EPA states that such a review “will assess whether the new use may present unreasonable risk to health or the environment and ensure that EPA takes appropriate action as required to protect health or the environment.” The SNUR will take effect March 11, 2024.
Chemicals Subject to the SNUR
The SNUR applies to chemical substances designated as inactive on the TSCA Inventory that are also PFAS, except that inactive PFAS already subject to a SNUR, including but not limited to the SNURs cited at 40 C.F.R. Sections 721.9582 and 721.10536, are not subject to notice requirements under this action to avoid potential redundancies or conflicts between the SNURs.
EPA states that for the purposes of the SNUR, the definition of “PFAS” includes chemicals that contain at least one of these three structures:
- R-(CF2)-CF(R′)Rʺ, 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; or
- CF3C(CF3)R′Rʺ, where R′ and Rʺ can either be F or saturated carbons.
According to the SNUR, EPA developed this definition to focus on substances most likely to be persistent in the environment. EPA notes that this definition may not be identical to other definitions of PFAS used within EPA or by other domestic or international organizations.
The chemical substances subject to the SNUR are the 329 PFAS that are both currently designated as inactive on the TSCA Inventory and that are not subject to an existing SNUR. According to EPA, the specific chemical identities for 30 of these substances that have been claimed as confidential business information (CBI) have generic names that do not contain “fluor” or “fluorine.” EPA states that it is providing a list of the 299 inactive PFAS that do not mask “fluor” or “fluorine” in the generic name in the public docket for the SNUR. Because EPA is providing a structural definition of PFAS for the SNUR, EPA “need not take additional steps to list the 30 inactive PFAS that are not subject to an existing SNUR and whose generic names do not contain ‘fluor’ or ‘fluorine.’”
On October 14, 2022, prior to publication of the proposed SNUR, EPA received a Notice of Activity for Chemical Abstracts Service Registry Number® (CAS RN®) 306-92-3. EPA states that it erroneously included this substance in the initial count and list of the 300 inactive PFAS that do not mask “fluor” or “fluorine” in the supplemental document, “List of Select Chemicals Subject to the Proposed Significant New Use Rule Per- and Poly-fluoroalkyl Chemical Substances Designated as Inactive on the TSCA Inventory.” The designation of this substance was “active” at the time of the proposed rule and, as such, it is not subject to the final SNUR rule and the correct number of chemical substances for which EPA is issuing a final SNUR is 329.
EPA notes that it received one Notice of Activity for CAS RN 35101-47-7 on March 2, 2023, after publication of the proposed rule. Uses arising after January 26, 2023, are significant new uses, however, and persons who began commercial manufacturing (including importing) or processing for a significant new use must cease upon the effective date of the final rule. To resume their activities, these persons must first comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacturing (including importing) or processing have been satisfied.
Significant New Use Determination
TSCA Section 5(a)(2) states that EPA’s determination that a use of a chemical substance is a significant new use must be made after consideration of all relevant factors, including:
- The projected volume of manufacturing and processing of a chemical substance;
- The extent to which a use changes the type or form of exposure of human beings or the environment to a chemical substance;
- The extent to which a use increases the magnitude and duration of exposure of human beings or the environment to a chemical substance; and
- The reasonably anticipated manner and methods of manufacturing (including importing), processing, distribution in commerce, and disposal of a chemical substance.
In addition to these factors, TSCA authorizes EPA to consider any other relevant factors. To determine what constitutes a significant new use of an inactive PFAS, EPA states that it considered relevant information about the toxicity or expected toxicity of these substances, likely human exposures and environmental releases associated with possible uses, and the four factors listed in TSCA Section 5(a)(2). According to EPA, since the manufacture (including import) and processing of inactive PFAS has been discontinued in the United States, exposure will decrease over time and as such, EPA expects their presence in humans and the environment to decline over time. If any new uses of inactive PFAS were to resume after being phased out, EPA “believes that such uses could both change the type and form and increase the magnitude and duration of human and environmental exposure to the substances, constituting a significant new use.”
EPA states that it “acknowledges that the reporting of commercial activity under the TSCA Inventory Notification (Active-Inactive) Requirements Rule (‘Active-Inactive rule’) was not required for several activities, including, but not limited to, importing or processing of inactive PFAS-containing articles, and manufacturing (including importing) or processing of inactive PFAS as impurities, byproducts not used for commercial purposes, small quantities solely for research and development [R&D], for test marketing purposes, as a non-isolated intermediate, or solely for export from the United States.” EPA states that it thus has determined that the designation of these PFAS as inactive “does not provide a sufficient basis to conclude that there are not ongoing uses of inactive PFAS for these activities, and because this SNUR is based on information obtained from the Active-Inactive rule, EPA is not at this time designating uses for these activities as significant new uses.” Based on its consideration of the statutory factors, EPA has determined as significant new uses: manufacture (including import) or processing of inactive PFAS for any use except:
- Importing or processing of inactive PFAS-containing articles; and/or
- Manufacture (including import) or processing of inactive PFAS:
- As impurities;
- As byproducts not used for commercial purposes;
- In small quantities solely for R&D;
- For test marketing purposes;
- For use as a non-isolated intermediate; or
- Solely for export from the United States.
- As impurities;
Applicability of SNUR to Uses Occurring before Effective Date of the Final Rule
EPA proposed the SNUR on January 26, 2023 (88 Fed. Reg. 4937). EPA distinguishes uses arising after publication of the proposed SNUR from uses that existed at publication of the proposed SNUR. The former would be new uses, the latter ongoing uses, except that uses that are ongoing as of the publication of the proposed SNUR would not be considered ongoing uses if they have ceased by the date of issuance of a final rule. EPA notes that it solicited public comment to identify any ongoing manufacturing or processing of inactive PFAS subject to the proposed SNUR. EPA received one ongoing use claim that it has determined is not ongoing.
Persons who began commercial manufacturing (including importing) or processing of the chemical substances for a significant new use identified as of January 26, 2023, must cease any such activity upon the effective date of the final SNUR. To resume their activities, these persons first have to comply with all applicable SNUR notification requirements and wait until all TSCA prerequisites for the commencement of manufacturing (including importing) or processing have been satisfied.
Development and Submission of Information
EPA states that it recognizes that TSCA Section 5 “does not usually require developing new information (e.g., generating test data) before submission of a SNUN.” EPA notes that there is an exception: development of information is required where the chemical substance subject to the SNUR is also subject to a rule, order, or consent agreement under TSCA Section 4. In the absence of a TSCA Section 4 test rule or order covering the chemical substance, persons are required to submit only information in their possession or control and to describe any other information known to or reasonably ascertainable by them. As a general matter, EPA “recommends that SNUN submitters include information that would permit a reasoned evaluation of risks posed by the chemical substance during its manufacture (including import), processing, distribution in commerce, use, or disposal,” however. According to EPA, potentially useful information includes physical-chemical property data and any information related to persistence, bioaccumulation, toxicity, and other characteristics that may help predict the impact of a chemical substance on health or the environment.
EPA notes that submitting a SNUN that does not include information sufficient to permit a reasoned evaluation may increase the likelihood that EPA will either respond with a determination that the information available is insufficient to permit a reasoned evaluation of the health and environmental effects of the significant new use or, alternatively, that in the absence of sufficient information, the manufacture, processing, distribution in commerce, use, or disposal of the chemical substance may present an unreasonable risk of injury. EPA states that SNUN submitters should be aware that it will be better able to evaluate SNUNs and define the terms of any potentially necessary controls if the submitter provides detailed information on human exposure and environmental releases that may result from the significant new use of the chemical substances.
SNUN Submissions
EPA recommends that submitters consult with it prior to submitting a SNUN to discuss what information may be useful for EPA’s evaluation. Discussions with EPA prior to submission “can afford ample time to conduct any tests that might be helpful in evaluating risks posed by the substance.” EPA notes that according to 40 C.F.R. Section 721.1(c), persons submitting a SNUN “must comply with the same notice requirements and EPA regulatory procedures as persons submitting a [premanufacture notice (PMN)], including submission of test data on health and environmental effects” as described in 40 C.F.R. Section 720.50.
Commentary
Bergeson & Campbell, P.C. (B&C®) welcomes EPA’s pragmatic approach for regulating PFAS that are inactive in commerce. EPA’s recognition that the lack of Form A reporting for these substances evinces only that there is no intentional manufacture or import for a commercial purpose, and nothing more. As many readers know, many of the standard PMN and Chemical Data Reporting (CDR) exemptions are also applied to Form A reporting, so EPA cannot credibly base any conclusion that activities exempt under Form A reporting for these PFAS (e.g., R&D, impurities, articles) was or is not now ongoing.
Entities that may wish to manufacture or import one of these inactive PFAS will be required to submit a SNUN that includes sufficient information to address EPA’s concerns for that PFAS. Below we provide projected timelines and costs for doing so. In addition to the substantial delays faced by most PMNs (see our Forecast for U.S. Federal and International Chemical Regulatory Policy 2024, the lead-in time for a PFAS will be much longer because the submitter will have to develop a robust data set to inform EPA’s assessment.
In October 2021, EPA released its “National PFAS Testing Strategy: Identification of Candidate Per- and Poly-fluoroalkyl Substances (PFAS) for Testing” (the “PFAS Testing Strategy”) that includes a tiered-testing strategy that EPA intends to require for PFAS that are notified as new chemical substances or new uses under TSCA Section 5. The PFAS Testing Strategy is, however, limited to evaluating potential human health hazards for PFAS. In a SNUN (or PMN), it is important to consider the timing and staging of testing to address potential human health hazard concerns that would be addressed by the tiered testing strategy. The first tier in EPA’s PFAS Testing Strategy will probably take 6-12 years and cost up to $250,000. Tier II and III testing could take up to seven years and cost over $5 million. It will also be important to address environmental hazard and fate concerns. Ecotoxicity and fate testing will add additional costs but could be performed in parallel with the mammalian testing.
It is of course true that testing is not required to submit a SNUN (or PMN). B&C expects, however, that absent extensive testing, EPA’s determination will likely be that EPA has insufficient information and will impose an order with an up-front ban pending testing to address the range of mammalian, ecotoxicity, and fate endpoints.
Extensive testing and extensive release and exposure controls informed by the testing will also help minimize future product liability claims. Testing can also inform proposals to designate other PFAS as hazardous substances under the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA).