EPA’s New TSCA PFAS Rule Requires Significant Data Submission by Manufacturers and Importers; Companies Must Report Information Known or Reasonably Ascertainable Since 2011

At a Glance

• This rule covers over 1,400 per- or polyfluoroalkyl substances (PFAS) and EPA estimates that this rule will impact over 130,000 companies.
• Companies that manufacture PFAS or import PFAS-containing articles must provide all PFAS information dating back to January 1, 2011, within 18 months of publication of the rule (24 months for small businesses).
• There are several exemptions from reporting including companies that solely process, distribute and/or use PFAS, and do not manufacture (or import) PFAS for commercial purposes.
• EPA requires companies report all “known or reasonably ascertainable” (KRA) information including providing PFAS exposure to people and the environment.
• KRA information includes information from anyone in the organization (including parent and subsidiary companies) and can include notes from discussions or conferences.

What happened?

On September 28, 2023, the U.S. Environmental Protection Agency (EPA) finalized a rule titled, “Toxic Substances Control Act Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances” (TSCA PFAS Reporting Rule).

The TSCA PFAS Reporting Rule was developed in response to Section 7321 of the National Defense Authorization Act for Fiscal Year 2020 (PL 116-92). Section 7321 of NDAA added section 8(a)(7) of the Toxic Substances Control Act (TSCA) that requires EPA to develop a rule that requires each person who has manufactured per- or polyfluoroalkyl substance (PFAS) in any year since January 1, 2011, to report to EPA.

What companies are covered by this rule?

If a company “manufactured for a commercial purpose” (or imported) PFAS in any year since January 1, 2011, the company is covered by the TSCA PFAS Reporting Rule. There is no de minimis, low volume or small business threshold. There is also no exemption for commercial research and development.

“Manufacture for commercial purposes” means to import, produce or manufacture with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer. However, “simply receiving PFAS from domestic suppliers or other domestic sources” is not considered manufacturing and thus would not require a company to report to EPA. In addition, companies that “process and/or use PFAS” only need to report on PFAS they have manufactured (including imported).

Therefore, a company that is just processing domestically sourced PFAS would not need to report to EPA, but a company that is processing imported PFAS would need to report on the imported PFAS (if it is known or reasonably ascertainable).

Imported PFAS-containing articles¹ are within the scope of the TSCA PFAS Reporting Rule to the extent the manufacturer (or importer) of the articles knows or can reasonably ascertain the requested information. Domestic PFAS-containing articles are exempt from reporting (unless they meet the requirements from manufacturing) in the final rule although included within the proposed rule.

EPA estimates that over 130,000 companies in the United States (of which 97 percent are small businesses) will need to analyze whether the products they manufacture or sell are covered by this rule.

According to EPA, only a significantly smaller subset of companies will be required to report to EPA; EPA estimated that about 10% of small businesses will need to report to EPA.

What companies or products are exempted from reporting under this rule?

EPA has exempted the following from requiring reporting under this rule.

• Companies that solely process, distribute and/or use PFAS, and do not manufacture (or import) PFAS for commercial purposes.
• Waste management activities involving importing municipal solid waste streams for the purpose of disposal or destruction.
• Non-commercial research and development activities such as scientific experimentation, research or analysis conducted by academic, government or independent not-for-profit research organizations, unless the activity is for eventual commercial purposes.
• Any pesticide (as defined in the Federal Insecticide, Fungicide, and Rodenticide Act) when manufactured, processed, or distributed in commerce for use as a pesticide².
• Tobacco or any tobacco product³.
• Any source material, special nuclear material or byproduct material (as defined in the Atomic Energy Act of 1954)⁴.
• Firearms and ammunition⁵.
• Food, food additive, drug, cosmetic or device (as defined in Section 201 of the Federal Food, Drug, and Cosmetic Act)⁶.

What chemicals are covered by this rule?

The final rule defines PFAS that must be reported to EPA as including at least one of these three structures:

• R-(CF2)-CF(R’)R”, where both 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.

Defining PFAS by structure as opposed to specific PFAS compounds is a departure from EPA’s prior regulations and reflects a more robust and aggressive approach to regulating the group of chemicals.

What does a manufacturer need to report?

For all years since January 1, 2011, that a company has manufactured PFAS during and has information that is known or reasonably ascertainable (KRA):

• Common or trade name, chemical identity and molecular structure of each chemical substance.
• Categories or proposed categories for use of each substance or mixture.
• 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.
• Descriptions of byproducts resulting from the manufacture, processing, use or disposal of each substance or mixture.
• All existing information concerning the environmental and health effects of each substance or mixture.
• 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.
• The manner or method of disposal of each substance or mixture, and any change in such manner or method.

EPA provides forms to assist in reporting under this rule included a streamlined reporting form option for research and development substances manufactured below 10 kilograms.

What does “known or reasonably ascertainable” (KRA) mean?

All companies are required to provide any information that is KRA. EPA has limited what investigation companies are required to undertake since the proposed rule, but the actions necessary are still expansive and unclear.

The formal definition of KRA is “all information in a person’s possession or control, plus all information that a reasonable person similarly situation might be expected to possess, control or know.⁷” According to EPA, this standard requires an exercise of due diligence and states that the information-gathering activities that may be necessary to achieve the KRA standard would vary from case to case.

EPA states that the KRA standard requires companies to:

• Conduct a “reasonable inquiry” within the full scope of the organization (not just the information known to managerial or supervisory employees).
• Conduct an inquiry outside the organization to fill gaps in the company’s knowledge — including phone calls or email inquiries to upstream suppliers or downstream users.

EPA explains that additional customer surveys are not necessary, but information already may be “known” to the company based on documented knowledge (e.g., notes) from discussions, conferences or technical publications.

If a company does not have the information, then EPA directs the company to consider providing “reasonable estimates” of the information that is requested.

Only if the company can show that they do not have KRA information and they cannot make reasonable estimates, can a company provide the information as not KRA (NKRA).

What does “all existing information concerning the environmental and health effects” mean?

According to EPA, this definition is supposed to be interpreted broadly and is defined as “any information of any effect of a chemical substance or mixture on health or the environment or both.”⁸ Information necessary is limited to information that is in “possession or control” of the company — including any data or files maintained by employees, subsidiaries or partnerships. There is no requirement to search open scientific literature that was not previously in possession or control of the company.

When are reports due to EPA?

Reports to EPA are due within 18 months from the effective date of the final rule, except for small article importers⁹. Small article importers are provided 24 months following the effective date of the final rule.