On November 25, 2022, EPA released an Initial Regulatory Flexibility Analysis (IRFA) for public comment as part of its development of a rule to collect information about PFAS. The IRFA follows the Agency’s June 2021 proposed rule, which would require all manufacturers and importers of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. In the proposed rule, EPA certified that the rule would not have a significant impact on a substantial number of small entities under the Regulatory Flexibility Act (RFA). In response to public comments from the June 2021 proposed rule and additional data sources on PFAS-containing imports, EPA convened a Small Business Advocacy Review Panel and prepared the IRFA to investigate further the burdens the proposed rule would place on small businesses.
EPA significantly increased its cost estimates for the proposed rule, stating social costs would be approximately $875 million, from the original $10.8 million estimate, and Agency costs would be approximately $1.5M, from the originally estimated $948,078. The IRFA anticipates that in order to report years of production and importation data, small businesses would be expected to pay the lion’s share of these costs, $863.5 million, not the originally anticipated $1.8 million. Additionally, the IRFA details the percentage of small firms that will be impacted by the rule, finding that approximately 93% of manufacturers and 97.3% of article importers affected by the proposed rule are small businesses. The total number of small businesses expected to be impacted is 127,794.
In the IRFA, EPA proposed and requested comment on a variety of regulatory flexibility alternatives, including:
- Exemptions for businesses with less than $12 million in sales.
- Exemptions for businesses with less than $6 million in sales.
- Exemptions for article importers with less than $6 million in sales.
- Exemptions for article importers with less than $2 million in sales.
- Limiting the scope of PFAS subject to the rule to a finite list of PFAS, removing the structural definition. (Although EPA expressed concern over the Agency’s inability to list substance identities based on CBI claims.)
- Exemption for reporting thresholds of either 2,500 lbs. per year or 25,000 lbs. per year.
- Allow for small businesses, providing a six-month deferral of data submission.
- Simplified reporting forms for R&D substances manufactured in volumes less than 10 kg. per year — including limiting reporting to company information, generic chemical name, and production volume.
- Simplified reporting forms for article importers– excluding requiring information on existing environmental and health effects data, environmental release and disposal data, or occupational exposure data.
- Exemptions for R&D substances, byproducts, impurities, recyclers, and intermediates. (However, EPA stated that these exemptions would limit the Agency’s ability to achieve its goal of better understanding the entire scope of existing information on PFAS.)
The Agency also requested information and comment on items pertaining to CBI, including treatment of chemical identity claims, notice prior to publication on the public TSCA Inventory, and the generic naming of PFAS. These issues were not included in the IRFA and the Updated Economic Analysis. Regarding the treatment of CBI claims, EPA sought to clarify language related to an entity’s knowledge of a specific chemical identity stating:
[A]n entity that does not have knowledge of a specific chemical identity must initiate a joint submission with its supplier or other manufacturer. In these cases, the secondary submitter would be responsible for providing the specific chemical identity and for asserting and substantiating any CBI claims concerning the specific chemical identity. See, e.g.,40 CFR 711.15(b)(3); 711.30(c).
Regarding notice prior to publication on the public TSCA Inventory, EPA sought to clarify that if a submitter reports a PFAS substance by a specific chemical identity and does not assert CBI, that chemical identity will be published on the public Inventory without notice to the submitter. Importantly, EPA requested comment on aligning this provision with the language in the proposed CBI Procedures rule indicating that persons who previously made a CBI claim for the same specific chemical identity will not receive prior notice before the specific chemical identity is moved to the public Inventory. Lastly, EPA clarified that generic names must sufficiently identify the chemical as a PFAS; for example, under TSCA Section 14(c)(1)(C), a generic name for a PFAS that does not contain “fluor” would be rejected as insufficient.