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.”
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.
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.
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.
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.
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.
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.