The US Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for Per- and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA). The EPA has published in the Federal Register the document it originally released in draft. This triggers the beginning and duration of the comment period.
EPA proposes to require certain persons that manufacture (including import) or have manufactured these chemical substances in any year since 1 January 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards. EPA is requesting public comment on all aspects of this proposed rule and has also identified items of particular interest for public input. In addition to fulfilling statutory obligations under TSCA, this document will enable EPA to better characterize the sources and quantities of manufactured PFAS in the United States.
Comments must be received on or before 27 August 2021. Comments on the information collection provisions are best assured of consideration if the Office of Management and Budget (OMB) receives a copy of your comments on or before 28 July 2021.
What is reportable?
Under TSCA section 8(a)(7), EPA must collect information on chemical substances that are “perfluoroalkyl or polyfluoroalkyl” substances or PFAS. EPA has determined that any PFAS that fall within the structural definition, described below, are the PFAS referred to in TSCA section 8(a)(7). For this proposed rule, EPA has identified at least 1,364 chemical substances and mixtures that are PFAS and would potentially be subject to reporting under the final rule, if they have been manufactured in any year since 1 January 2011.
The manufacture of PFAS as a byproduct is not exempt for the purpose of this proposed rule. Unlike TSCA section 8(a)(1), which specifically provides an exemption for small manufacturers and processors, TSCA section 8(a)(7) provides no such exemption. Therefore, this proposed rule under TSCA section 8(a)(7) does not exempt small manufacturers from reporting and recordkeeping requirements.
Any use of the term “manufacture” in this document will encompass “import” and the term “manufacturer” will encompass “importer.”
EPA is proposing that manufacturers will report information to the extent that the information is known to or reasonably ascertainable by the manufacturer (see TSCA section 8(b)(2)). This standard would require that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). This standard may also entail inquiries outside the organization to fill gaps in the submitter's knowledge. In the event that a manufacturer does not have actual data (e.g., measurements or monitoring data) to report to EPA, the manufacturer would be required to make “reasonable estimates” of such information.
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