In 2021, we alerted our readers to a concerning expansive TSCA proposed reporting requirement that could apply to a range of manufacturers and importers of products containing PFAS, potentially scooping up everyone from manufacturers and importers of such products as water-repellant t-shirts, nonstick cooking ware and high performance mountain gear and more. This new Part 705 to the Toxic Substances Control Act (TSCA) regulation (TSCA PFAS Reporting Rule) seeks to impose a one-time reporting requirement on all manufacturers and importers of PFAS or finished products containing PFAS to provide a wide variety of information regarding the PFAS dating back to January 1, 2011. We followed up in 2022 when it appeared that EPA, prompted by comments and concerns of the Small Business Administration, was taking a look at the scope of the rule and its anticipated costs. Our hope was that EPA would retreat from its previous broad applicability and look to include exemptions found under other TSCA programs, such as a minimum quantity threshold or an exemption for small businesses.
However, our high hopes for EPA were not to be fulfilled. EPA issued the final rule on October 11, 2023. The TSCA PFAS Reporting Rule continues in its broad form, making only slight modifications around the edges; none of which will provide material relief to the majority of entities subject to the rule. As a result, the TSCA Reporting Rule could reach a huge universe of potential reporters, many of which have never been subject to TSCA requirements.
Who is subject to the TSCA PFAS Reporting Rule?
The TSCA PFAS Reporting Rule applies to manufacturers and importers of PFAS including manufacturers and importers of articles (i.e., finished products) containing PFAS, in any year since January 1, 2011. Unlike other TSCA programs, the TSCA PFAS Reporting Rule applies to all manufacturers and importers – big and small - and all articles (i.e., finished products) containing PFAS – no matter the quantity, even if it is an impurity or byproduct. Despite numerous comments supporting inclusion of standard TSCA exemptions, EPA only included very narrow exemptions in the final rule for imported municipal solid waste streams slated for disposal and non-commercial imports by a federal agency.[1]
Further, although the preamble to the final rule identifies the categories from which it expects the majority of PFAS information to emanate, it is not limited to these categories. Research has found PFAS present in a vast array of products including nonstick cookware, food packaging, stain resistant carpet, high performance technical gear, exercise clothing, toys, sporting equipment and more.[2] Significantly, EPA estimates the TSCA Reporting Rule will apply to approximately 130,000 small business importers. As noted, for many of these entities it will be their first encounter to the complex TSCA regulations and it is likely that many, especially importers of consumer products, are likely to be caught unaware.
Which PFAS are covered by the Rule?
“PFAS” generally has been used as a catch-all term to cover the broad universe of per- and polyfluoroalkyl substances. A number of federal regulations are being developed to address PFAS including, most recently, the Safe Drinking Water Act and the Comprehensive Environmental Response Compensation and Liability Act, as well as a slew of state regulations most often directed at PFAS in products. Most of this emerging law addresses a subset of PFAS. In comparison, the TSCA PFAS Reporting Rule defines PFAS based on a structural classification (as compared to a discrete list), which EPA estimates will cover, at least, between 1364 and 1462 PFAS substances.
What must be reported?
Manufacturers and importers of PFAS must report information on PFAS uses, production volumes, byproducts, disposal, exposures, and existing data on environmental or health effects. This information must be provided for each year since January 1, 2011 through December 31, 2022 in which PFAS was manufactured or imported – a ten year reporting period. EPA has provided draft instructions regarding reporting under the rule, which is available on the docket for the rule. As apparent from the separate 118 pages of “instructions,” reporting will be complex and time consuming.
Information must be reported if it is “known or reasonably ascertainable,” which is the standard criteria for TSCA Section 8 reporting requirements. This is further defined to require an entity to report “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.” 40 C.F.R. 704.3. EPA indicates that a company must exercise due diligence to make reasonable inquiries both within and outside the entity, including suppliers. EPA states that it does not require testing or creation of new information, such as health studies. EPA also stated that there are no reporting or recordkeeping requirements IF a manufacturer or importer has no relevant information to report (but also advises that such companies keep records of their “due diligence”).
EPA has prepared draft guidance to assist small entities’ compliance efforts with the TSCA PFAS Reporting Rule. A draft version of this September 2023 guidance is available on the Rule docket. While much of the guidance simply regurgitates the rule, it does provide helpful instruction regarding when a small business, including importers, have exercised the appropriate due diligence through a series of hypotheticals. For example, the guidance indicates that an importer of stain resistant clothing which generally knows that PFAS may be used in such clothing, would satisfy the “known or reasonably ascertainable” standard by contacting its supplier and would not satisfy the standard if it did not contact its supplier. The draft instructions noted above also contain hypothetical examples for more complex scenarios beyond those encountered by importers.
EPA will issue a standard form to submit the requested PFAS information. However, in those cases where article importers do not know or cannot reasonably ascertain the specific detailed information requested on the longer standard form EPA will provide a “streamlined form” to provide PFAS information (although, based on the detailed list of information to be provided on this form, it is only “streamlined” in the most generous sense of the term).
When is the report due?
The effective date of the TSCA PFAS Reporting Rule is November 13, 2023. The submission period begins one year after the effective date, on November 12, 2024, and lasts six months (through May 8, 2025). Small business importers have an extra 6 months through November 10, 2025.
Our same closing thought – What to do when the dog catches the car?
Even with the deep dive taken over the past year in reviewing the comments and undertaking the analysis request by the small business administration, it appears to us that it is still unlikely that EPA really understands what it is asking for. The huge field of potential reporters and requested data will likely result in a cumbersome and unwieldy set of information that will be difficult to manipulate to understand true PFAS risks. It is anticipated that EPA will need to wade through a sea of non-responsive data (e.g., importers that have limited data on the articles resulting in “not known or reasonably ascertainable” responses) to assemble a usable subset of information. EPA would be well advised to recall the cliché “garbage in – garbage out.” Allowing some of the exemptions found under other TSCA programs, as well as refining the list of PFAS subject to the reporting requirement, could have resulted in a more usable set of information to support the “benefits” espoused by EPA. However, that did not come to pass and thus manufacturers and importers face a monumental task. Of course, it is possible that the final rule may be challenged and compliance obligations may be delayed. Regardless, manufacturers and importers are well-advised to developing their due diligence tasks, including an understanding of potential products covered by the TSCA PFAS Reporting Rule, as well as identifying its suppliers.
[1] Manufacturers and importers of articles for food, medical and cosmetic uses continue to be statutorily excluded as these products are regulated by other federal statutes.
[2] See Environmental Science: Processes & Impacts (2020) for an overview of the vast array of uses of and products containing PFAS.
