EPA Finalizes Rules for PFAS Data Reporting under TSCA

On October 11, 2023, the USA’s Environmental Protection Agency (EPA) published a finalized rule to require reporting and recordkeeping for per- and polyfluoroalkyl substances (PFAS) under the Toxic Substances Control Act (TSCA). This rule builds on over two years of progress on the Biden-Harris Administration’s action plan to combat PFAS pollution, safeguarding public health and advancing environmental justice, and is a key action in EPA’s PFAS Strategic Roadmap. It shall be effective on November 13, 2023.

As mandated by the statutory obligations under TSCA, persons that manufacture (including import) or have manufactured these chemical substances in any year since January 1, 2011 are required to submit information to EPA regarding PFAS uses, production volumes, byproducts, disposal, exposures, and existing information on environmental or health effects. The information collected will enable EPA to better characterize the sources and quantities of manufactured PFAS in the United States.

Substances covered by this rule

For the purpose of this reporting rule, EPA defines PFAS using a structural definition rather than a discrete list of specifically identified substances. PFAS is defined as including at least one of these 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; and

• CF₃C(CF₃)R′R″, where R′ and R″ can either be F or saturated carbons.

This rule also limits PFAS as a “chemical substances”, which means any organic or inorganic substance of a particular molecular identity, including:

• Any combination of such substances occurring in whole or in part as a result of a chemical reaction or occurring in nature; and

• Any element or uncombined radical.

Even though the definition of chemical substance excludes mixtures, PFAS as a chemical substance may be present in a mixture. Therefore, this rule requires reporting on each chemical substance that is a PFAS, including as a component of a mixture.

To assist in the PFAS identification, EPA is providing a list of substances that meet this definition, gathered from the Inventory, LVEs, and the CompTox Chemicals Dashboard; this list will be available in the CompTox Chemicals Dashboard. It is worth noting that the list merely serves as a reference. Instead, if a substance that is not on this list but still falls under the of a “chemical substance” under TSCA is subject to this rule if the substance has been manufactured for a commercial purpose since 2011.

Reporting requirements

For each PFAS and for each year in which that substance was manufactured since January 1, 2011, to the extent the information is known or reasonably ascertainable, PFAS manufacturers shall submit the following information:

1. Company and plant site information. The information must be reported for each site at which a reportable chemical substance is manufactured.

2. Chemical-specific information, including the common or trade name, the chemical identity, molecular structure, physical form, etc.

3. Categories of use. For each PFAS imported in an article, information on industrial processing and use, consumer and commercial use as well as estimated maximum concentration shall be reported.

4. Manufactured amounts. The total amounts manufactured in each calendar year for each category of use should be reported.

5. Byproduct reporting. A description of the byproducts resulting from the manufacture, processing, use, or disposal of each PFAS shall be reported.

6. Environmental and health effects. All existing information concerning the environmental and health effects of such substance or mixture containing a chemical substance in the manufacturer's possession or control should be reported.

7. Work exposure data. The number of individuals exposed to PFAS in their places of employment and the duration of such exposure should be reported.

8. Disposal data. During the years in which the PFAS was manufactured, the manners or methods of its disposal, and any changes to the disposal methods or processes should be reported.

For a manufacturer who has imported a PFAS within an article or a manufacturer of R&D substance in volumes no greater than 10 kg per year, EPA provides the option to submit information using a streamlined reporting form.

Recordkeeping requirements

PFAS manufacturers who are subject to the reporting requirements must retain records that document any information reported to EPA. Relevant records must be retained for a period of 5 years beginning on the last day of the submission period.

Confidential business information

PFAS manufacturers may apply for confidentiality claim when submitting the information. The following information cannot be asserted for the confidentiality claim:

1. Specific chemical identity if the chemical is on the public (non-confidential) TSCA Inventory or reported as non-confidential in an LVE;

2. For processing and use data elements;

3. When a response is left blank or designated as “not known or reasonably ascertainable”;

4. For specific chemical identity by submitters of article importer forms;

5. For all generic chemical names;

6. For any PFAS that are on the public (non-confidential) TSCA Inventory, the chemical's CASRN;

7. For the Inventory Accession Numbers for PFAS that are on the confidential TSCA Inventory; or

8. For LVE numbers.