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On January 25, 2024, the U.S. Environmental Protection Agency (EPA) held a webinar on EPA’s Toxic Substances Control Act (TSCA) Section 8(a)(7) rule on the reporting and recordkeeping requirements for per- and polyfluoroalkyl substances (PFAS). During the webinar, EPA provided an overview of the rule’s requirements. EPA also answered questions from webinar participants and stated that it is preparing a frequently asked questions (FAQ) document that it intends to circulate in early summer 2024. EPA will post the slides and recording of the webinar on its website.
EPA posted a public list of TSCA PFAS for the Section 8(a)(7) rule on January 29, 2024. The list includes known PFAS from the TSCA Inventory. Those claimed confidential business information (CBI) or granted a low volume exemption (LVE) are identified by generic name and accession or LVE number. This is not a complete list of PFAS subject to reporting, however, and during the webinar, EPA referred stakeholders to the final rule’s structural definition of reportable PFAS. EPA stated that it has received several requests for a list of articles that contain PFAS. According to EPA, it depends on whether the specific item meets the definition of article and not everything that is an article may contain PFAS. Examples of articles that might contain PFAS are textiles, wires, electrical equipment, cookware, and transportation equipment. EPA suggested that stakeholders check the economic analysis for the final rule for more information. Appendix B of the economic analysis includes a crosswalk of Harmonized Tariff System (HTS) codes and PFAS uses in articles.
EPA noted that it received hundreds of questions before the webinar, as well as questions submitted during the webinar. Below are some of the questions submitted during the webinar and EPA’s responses.
| Q: | If you simply process materials that contain PFAS are you required to report? Example purchase elastomers that [contain] PFAS and extrude or mold into customer product. |
| A: | Domestic purchases of materials containing PFAS does not require reporting unless activities involving such PFAS cause PFAS to be manufactured. Import of articles/mixtures/products containing covered PFAS would be regulated by this rule and reporting would be required. |
| Q: | Please comment on the scope of due diligence required. Specifically, what additional steps must a company that purchases articles that may contain PFAS take, if it conducted a survey of its first-tier suppliers and certain of these failed to respond to such surveys? |
| A: | Without specific details, EPA cannot definitively respond. Note that the rule’s [known to or reasonably ascertainable by (KRA)] standard includes information that “a reasonable person similarly situated might be expected to possess, control, or know.” EPA does not expect the scope of information to look the same for all entities. Factors influencing this scope include (but are not limited to) the importer’s size and resources, the number of suppliers, the importer’s current relationship with suppliers, the supplier’s responsiveness. |
| Q: | None of our suppliers have divulged the structure of fluorinated materials that we buy from them. If there is no [Chemical Abstracts Service Registry Number® (CAS RN®)] associated with a raw material, how can we determine whether such items are reportable? |
| A: | EPA has provided a few sources you can consult regarding example PFAS that are regulated pursuant to this rule. https://comptox.epa.gov/dashboard/chemical-lists/PFAS8a7 and see https://www.epa.gov/assessing-and-managing-chemicals-under-tsca/tsca-section-8a7-reporting-and-recordkeeping (where an Excel will be posted). |
| Q: | Are finished consumer goods (such as toys) placed in commerce considered “articles”? |
| A: | Generally, yes. |
| Q: | Are refrigerants within the scope of the rule? |
| A: | If they meet the definition being used then yes. You can consider the definitions as well as example lists that EPA is providing for guidance. |
| Q: | If all that is known or ascertainable is that a PFAS MAY be present in an imported article, is a submitter required to report this information? |
| A: | If an entity does not know nor can reasonably ascertain they have manufactured (including [imported]) any specific PFAS for any year between 2011-2022, they’re not subject to the rule. If the presence of the PFAS is reasonably ascertainable then reporting would be required. |
| Q: | Can you please confirm if a PFAS component [imported] into the US to be manufactured into a medical device needs to be reported. The end use of this component will be in a medical device, but when the component [is] imported into the US, it is not a medical device. |
| A: | The determination of whether a substance is excluded from the definition of “chemical substance” under TSCA because it falls under the [Federal Food, Drug, and Cosmetic Act’s (FFDCA)] definition is product specific and is made on a case-by-case basis in a fact-specific inquiry. Companies may consider consulting with [the U.S. Food and Drug Administration (FDA)] as to whether a specific device packaging is covered by FFDCA, and thus exempt from TSCA. Similarly, we welcome you to share more specifics of your scenario to us directly outside of this webinar for us to consider. |
| Q: | Does PFAS rule reporting include packaging of imported articles? |
| A: | Packaging is included in the scope of the rule. |
| Q: | How should retailers that may have imported PFAS containing articles consider the language about “known to or reasonably ascertainable by” (as defined in 40 CFR 705.3) since retailers would have had little knowledge of PFAS through sell sheets or other vendor documentation until around 2018 – and even then the PFAS info would not have been provided or asked for until the last few years? |
| A: | The rule’s “known to or reasonably ascertainable by” (KRA) reporting standard includes information that “a reasonable person similarly situated might be expected to possess, control, or know.” In other words, EPA does not expect the scope of information to look the same for all entities. Factors influencing this scope include (but are not limited to) the importer’s size and resources, the number of suppliers, the importer’s current relationship with suppliers, the supplier’s responsiveness. |
| Q: | We import articles from Mexico where they go to a warehouse. Then they are shipped out globally. Do we report the PFAS in the articles? |
| A: | If these articles contain PFAS regulated by the rule then this import activity would be a covered activity for which reporting responsibilities would exist. |
| Q: | Does this rule is including liquid product? or just article product? |
| A: | This rule covers PFAS in any form (i.e., not just articles). With the exclusion relating to PFAS not regulated by TSCA due to, a s an example, being regulated pursuant to the FFDCA or [the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA)]. |
| Q: | Will [Central Data Exchange (CDX)] be working? Not working [for] Polymer [Exemption] reporting due now. And Section 5 not working — my LVE won’t “migrate”. Will the CBI functions work [correctly]. Currently not working correctly in Section 5. |
| A: | The reporting application is being created and EPA plans to test the application extensively, including inviting external stakeholders to assist in the testing. We plan to release a functioning application. |
| Q: | Regarding “small [manufacturer]” at 40 CFR 704.3, are the $120 million and $12 million annual sales metrics tied to sales of applicable materials imported or are they measured regardless of PFAS and PFAS-containing articles and are simply total company sales for everything a company does? |
| A: | They are based on the company not just their PFAS-related activities. |
Commentary
The Acta Group (Acta®) attended the webinar presented by EPA to inform stakeholders regarding PFAS TSCA Section 8(a)(7) reporting. EPA’s public communication regarding the increased reporting requirements provided is helpful, and stakeholders are urged to review company operations now and prepare for the increased reporting burdens.
EPA’s requirement that all manufacturers (including importers) report information for PFAS and PFAS-containing articles in any year since 2011 has significant impact on the regulated community. EPA seeks to guide stakeholders by providing chemical substance information from the existing TSCA Inventory, both on the public and confidential portion, to supplement its structural definition of PFAS provided in the regulation. Although not exclusive of other PFAS compounds, EPA posted a list of 1,462 chemical substances it believes to be in active commerce that meet the PFAS definition.
We are hopeful that EPA will continue to develop guidance by publishing the promised FAQ document and organizing a future webinar and associated materials for the CDX reporting tool.
Resources
More information on the final rule is available in our October 3, 2023, memorandum. Below is a list of additional resources.
- EPA, Instructions for Reporting PFAS Under TSCA Section 8(a)(7) (Oct. 2023);