TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances

The Environmental Protection Agency (EPA) has finalized 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 is requiring any person that manufactures (including import) or has manufactured (including imported) PFAS or PFAS-containing articles 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 rule enables EPA to better characterize the sources and quantities of manufactured PFAS in the United States.

Any entities, including small entities, that have manufactured (including imported) PFAS in any year since 2011 will need to report their data to EPA through Central Data Exchange (CDX). When the submission period begins, manufacturers will have six months to provide their data.

Small manufacturers (as defined at 40 CFR 704.3) whose reporting obligations under this rule are exclusively from imported articles will have an additional six months to report PFAS to EPA.

Read the final rule.

Update to Reporting Period

In September 2024, EPA announced a direct final rule and a parallel proposed rule to delay the reporting period for this rule. The reporting period was scheduled to begin on November 12, 2024, but the final rule delays the beginning of the reporting period until July 2025 due to budgetary constraints.

EPA's TSCA program has had resource constraints for years, which has delayed a number of important efforts, including full implementation of this rule. In March 2024, the Fiscal Year (FY) 2024 program area budget that includes EPA’s TSCA program was reduced by $5 million compared to what was enacted in the FY 2023 budget, and the agency needed to make difficult choices to ensure that it would be able to continue its work to protect human health and the environment from the risks presented by toxic chemicals.

As a result of competing priorities, many of which related to meeting statutory deadlines, EPA’s TSCA program significantly reduced its IT operating budget in FY 2024 to prevent overspending of resources, which resulted in less funding for the contractual support EPA relies on for much of its IT efforts.

The budget reductions stopped ongoing software development and negatively impacted operations and maintenance activities associated with both CDX and TSCA CBI-based applications, which are critical to the Agency’s TSCA data collections, including for this rule. As a result, the agency software application that will collect the PFAS data will not be ready by the original November 2024 reporting period opening date and it will thus be impossible for submitters to begin to submit data on that date.

This direct final rule changes the data submission period to open on July 11, 2025 when the Agency expects the software reporting application to be fully functional. Most reporters would be required to complete all reporting by January 11, 2026. Small businesses reporting data solely on importing PFAS contained in articles will have until July 11, 2026 to submit reports.

Read the direct final rule.

Rule History

A. What is TSCA section 8(a)?

Under TSCA section 8(a)(7), EPA must promulgate a rule to require each person who has manufactured (including imported) 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.

For the purpose of this rule, EPA has defined “PFAS” as a chemical substance that contains at least one of the following three structures:

R-(CF₂)-CF(R′)R″, where both the CF₂ and CF moieties are saturated carbons.
R-CF₂OCF₂-R′, where R and R′ can either be F, O, or saturated carbons.
CF₃C(CF₃)R′R″, where R′ and R″ can either be F or saturated carbons.

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 at least 1,462 PFAS currently covered by TSCA that may be covered by this rule as of February 2023, 770 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.

C. How did EPA consult with small businesses in the development of this rue?

In April 2022, EPA convened a Small Business Advocacy Review (SBAR) Panel on this rulemaking. The SBAR Panel included federal representatives from the Small Business Administration (SBA), the Office of Management and Budget (OMB), and EPA. Small businesses and trade associations served as small Entity Representatives (SERs) to provide advice and recommendations to the panel.

Learn more about the SBAR panel.

In November 2022, EPA released an Initial Regulatory Flexibility Analysis (IRFA) on this rule for public comment.

The IRFA 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 considered the SBAR panel’s feedback in the IRFA . The 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 potential small entity burden and costs (and underlying assumptions to develop those costs) in the IRFA.

Initial Regulatory Flexibility Analysis and Updated Economic Analysis for TSCA Section 8(a)(7) Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances (pdf) (1.22 MB)