TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances
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Rule Summary
The Environmental Protection Agency (EPA) is proposing reporting and recordkeeping requirements for Per- and Polyfluoroalkyl Substances (PFAS) under the Toxic Substances Control Act (TSCA). In accordance with obligations under TSCA, as amended by the National Defense Authorization Act for Fiscal Year 2020, EPA proposes to require persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011, to electronically report information regarding PFAS uses, production volumes, disposal, exposures, and hazards.
In addition to fulfilling statutory obligations under TSCA, this proposed rule will enable EPA to better characterize the sources and quantities of manufactured PFAS in the United States.
In response to public comments and additional information received during the comment period, EPA is interested in convening an Small Business Advocacy Review (SBAR) Panel on this rulemaking. The Panel will include federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA.
Rule History
A. What is TSCA section 8(a)?
TSCA section 8(a) authorizes EPA to promulgate rules which require entities , that are not considered small manufacturers or processors, who manufacture, process, or propose to manufacture or process a chemical substance, to maintain such records and submit such reports as the EPA Administrator may reasonably require. Similarly, under those rules, entities who manufacture, process, or propose to manufacture or process a mixture or a chemical substance in small quantities (subject to limitations) must maintain records and submit reports to the extent necessary for the effective enforcement of TSCA.
Under TSCA section 8(a)(7), EPA must promulgate a rule to require each person who has manufactured PFAS in any year since 2011 to report certain data to EPA, including:
A. The covered common or trade name, chemical identity and molecular structure of each chemical substance or mixture;
B. Categories or proposed categories of use for each substance or mixture;
C. Total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use, and reasonable estimates of the respective proposed amounts;
D. Descriptions of byproducts resulting from the manufacture, processing, use, or disposal of each substance or mixture;
E. All existing information concerning the environmental and health effects of each substance or mixture;
F. The number of individuals exposed, and reasonable estimates on the number of individuals who will be exposed, to each substance or mixture in their places of work and the duration of their exposure, and;
G. The manner or method of disposal of each substance or mixture, and any change in such manner or method.
B. What are PFAS?
PFAS are synthetic organic compounds that do not occur naturally in the environment. PFAS contain an alkyl carbon on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. The strong carbon-fluorine bonds of PFAS make some of them resistant to degradation and thus highly persistent in the environment . Some of these chemicals have been used for decades in a wide variety of consumer and industrial products. Some PFAS have been detected in wildlife, including higher trophic organisms, indicating that at least some PFAS have the ability to bioaccumulate. Some PFAS can accumulate in humans and remain in the human body for long periods of time (e.g., months to years). Because of the widespread use of PFAS in commerce and their tendency to persist in the environment, most people in the United States have been exposed to PFAS. As a result, several PFAS have been detected in human blood serum.
Under TSCA section 8(b), EPA maintains the TSCA Chemical Substance Inventory (“Inventory”), which contains all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA. EPA has identified 1,364 PFAS that may be potentially covered by this rule as of April 2021, 669 of which are on the active Inventory (i.e., in U.S. commerce). The list of active chemicals includes those known to be in commerce after June 2006.
Additional Resources
Read the full federal register notice at docket EPA-HQ-OPPT-2020-0549 on www.regulations.gov.