Today, the U.S. Environmental Protection Agency (EPA) released an Initial Regulatory Flexibility Analysis (IRFA) for public comment as part of its development of a rule to gather information about per- and polyfluoroalkyl substances (PFAS). The IRFA made available today examines the type and number of small entities that may be impacted by the proposed rule, the estimated burden and costs of the proposed rule on small entities, and potential regulatory flexibility alternatives.
EPA proposed the rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA) in June 2021, as required under the 2020 National Defense Authorization Act. The proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information to EPA. The covered entities would be required to report on PFAS chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure and disposal.
When EPA proposed the rule, the agency certified that it would not have a significant economic impact on a substantial number of small entities (“No SISNOSE”), based on information available at the time.
However, since the proposed rule published, EPA has received additional data and feedback through public comments to update its small entity impact analysis, including estimating the number of PFAS article importers.
This updated information does not support a No SISNOSE certification. Given the potential impact on some small entities, EPA convened a Small Business Advocacy Review (SBAR) panel for the proposed rule, which EPA announced in February 2022 and concluded on August 2, 2022. The panel included representatives from the Small Business Administration, the Office of Management and Budget and EPA. Small businesses and trade associations served as Small Entity Representatives (SERs) to provide advice and recommendations.
EPA considered the SBAR panel’s feedback in the IRFA released today. SERs and panel members helped shape the discussion, including the regulatory flexibility alternatives examined in section 7 of the IRFA. SERs’ input also helped describe the universe of small entities and the potential small entity burden and costs (and underlying assumptions to develop those costs) in the IRFA.
EPA welcomes public comment on all aspects of the IRFA, including underlying data and assumptions in developing its estimates, and has noted within the IRFA certain areas on which it is seeking additional comments.
EPA will accept public comments for 30 days following publication in the Federal Register via docket EPA-HQ-OPPT-2020-0549 at www.regulations.gov.
Original source can be found here.
