On September 28, 2023, the U.S. Environmental Protection Agency (EPA) finalized the long-awaited one-time reporting rule for per- and polyfluoroalkyl substances (PFAS) that the Agency had proposed in June 2021 under Section 8(a)(7) of the Toxic Substances Control Act (TSCA). The finalization of this rule is one of the regulatory milestones set forth in the Biden EPA’s 2021 PFAS Strategic Roadmap. This rule will require businesses to provide the EPA information regarding their manufacture or importation of subject PFAS, as well as, most importantly, articles including covered PFAS, since January 1, 2011.
As explained below, the rule is designed to allow the EPA to identify manufacturers and importers of PFAS and PFAS-containing mixtures and articles to better understand exposure scenarios related to these chemicals—information that may be provide the foundation for future regulation. What is more, the PFAS rule does not include certain routine exemptions—most importantly, the one for articles—that usually apply to other TSCA notification/reporting requirements. Considering further the ubiquitous nature of PFAS, the PFAS rule applies to a vast array of commercial products, including electronics, paints, cookware and textiles, as well as the businesses that place them in U.S. commerce.
Definition of PFAS
The final rule defines PFAS using the structural definitions below:
- 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 structural definition contrasts with other broader definitions of PFAS, such as those used in state regulations. For example, Maine’s PFAS reporting law defines PFAS as “any member of the class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom”; this definition is in line with those in other consumer protection statutes. Notably, the final rule’s definition of PFAS applies to fluoropolymers, which are included in sophisticated commercial and industrial equipment, such as gaskets, tubing, wiring, cables, membranes and composite materials.
The definition of PFAS given in the final rule represents a modification from the proposed regulation. In its preamble, the EPA estimates that the modified definition would increase the number of PFAS subject to the regulation from 1,364 to 1,462 chemical identities. Assuming this to be the case, the final rule may be said to cover only a fraction of the total universe of PFAS chemicals, which the EPA’s most recent estimates place at approximately 15,000 substances. However, the sentiment among industry is that the EPA has underestimated the scope and impact of the PFAS rule.
The information that must be provided to the EPA is largely similar to that which the agency requires as part of its Chemical Data Reporting rule:
- The chemical identity, alternatively generic name or description, and molecular structure of each chemical substance or mixture;
- categories or proposed categories of use for each substance or mixture;
- total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use, and reasonable estimates of the respective proposed amounts;
- descriptions of byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture;
- the environmental and health effects of each substance or mixture;
- the number of individuals exposed, and reasonable estimates on the number of individuals who will be exposed, to each substance in the workplace, including reasonable estimates regarding the duration of such exposure; and
- the manner or method of disposal of each substance or mixture.
Given the limited exemptions from the reporting requirements obtaining this information, especially with respect to articles, may be difficult. (See below.) The EPA recognizes this and requires that subject companies report only information that is “known” or “reasonably ascertainable.” Despite the regulatory definition at 40 C.F.R. § 704.3, guidance on what is “reasonably ascertainable” is scarce. Therefore, the onus is on businesses to make determinations about what steps are adequate and to document those to avoid penalties. The volume and nature of PFAS-related operations or nexuses may drive the way companies approach this such as whether questionnaires are sufficient or if businesses should test products for PFAS.
The Final Rule Includes Limited Reporting Exemptions
As stated above, the PFAS rule lacks certain usual exemptions from TSCA reporting. Not only does this stand to subject a greater number of businesses to the regulation, but it stands to bring into the fold businesses that may not routinely engage with the statute—e.g., manufacturers of “articles” that do not import or manufacture bulk chemicals or mixtures.
No Reporting Threshold
For example, unlike the CDR rule, which predicates reporting on weight-based thresholds, the PFAS rule does not include such a trigger. Accordingly, companies that engage in even “the coincidental manufacture of PFAS as byproducts or impurities” will be subject. Albeit controversial, the EPA’s position in this regard is in line with its approach, evinced in other proposed regulations, that even small amounts of PFAS are potentially harmful.
Article Manufacturers and Importers
In addition to the lack of a reporting threshold, the absence of an article exemption is perhaps the most contentious aspect of the final rule. Numerous public comments in response to the proposed rule criticized the EPA’s approach in this regard. However, the agency held firm in excluding the exemption. As a result, in addition to manufacturers of bulk chemicals and importers, businesses that manufacture or import articles will have to obtain information from entities that are upstream in the supply chain. This may be particularly difficult in the case of articles, as unlike bulk chemicals and mixtures, manufactured parts and items typically are not distributed in commerce with Safety Data Sheets or specifications that enumerate all the chemicals present within them. The only relief that the final rule offers with respect to articles is a streamlined reporting option for article importers that do not know or cannot reasonably ascertain the amount of PFAS contained in an article. Such entities may report only the volume of the imported article rather than the volume of the PFAS in the article.
Research and Development (R&D) Substances Reporting Requirements
Whereas most TSCA notification/reporting requirements entirely exempt the manufacture and importation of substances used strictly for R&D, provided that certain conditions are met, the PFAS reporting rule does not. Instead, only a limited exemption applies in the case of R&D substance manufactured or imported in an amount of 10 kg or less.
Importers of Municipal Solid Waste
On the other hand, the reporting rule provides certain waste management companies some relief. Specifically, the final rule contains an exemption for businesses that import municipal solid waste for disposal or destruction because of the challenge to identify PFAS in these heterogeneous waste streams. In the preamble, the EPA underscores that this is not a broad exemption for all waste management facilities. Other waste importers, for example those importing waste for beneficial use, are obligated to report under the final rule.
Most entities will have 18 months from the publication of the final rule in the Federal Register to upload their reports to the EPA’s CDX database. Small manufacturers (as defined at 40 C.F.R. § 704.3) whose reporting obligations arise solely from article import will have an additional six months for reporting.
This rule creates a potentially time-consuming and onerous reporting obligation for any company that has manufactured or imported any of the defined PFAS chemicals, including those incorporated within mixtures and articles. The broad brush of the rule signals the importance that the EPA is attaching to PFAS and to gathering a further understanding of PFAS in commerce.
In terms of developing a strategy for complying with the rule, businesses may wish to consider how the information that they provide may be used. Aside from facilitating EPA efforts to prioritize specific PFAS for further investigation and restrictions, the information that the EPA receives will assist federal and state agencies in prioritizing specific operations for potential investigations and enforcement. Moreover, pursuant to the Freedom of Information Act, such information stands to be made available to the public, including environmental and consumer advocacy groups and plaintiffs’ firms. Such groups, as well as governmental agencies, may have a vested interest in tying certain businesses to known areas of PFAS contamination.
Given the stakes, companies may wish to consider the benefits of approaching the information-gathering that they have to perform along the lines of a due diligence exercise or internal investigation. Indeed, compliance with the rule may require a thorough review of historical operations and files, which may lead to identification of noncompliance with TSCA or other statutes. The early involvement of legal counsel can help maximize the degree of privilege and confidentiality that may be asserted over communications regarding potentially responsive information. It might also better situate companies to react promptly to any legal violations and to take advantage of the penalty relief offered under the EPA’s Audit Policy.