On Sept. 28, 2023, the EPA released its final reporting and recordkeeping requirements for PFAS, scientifically known as per- and polyfluoroalkyl substances, under the Toxic Substances Control Act (TSCA). According to EPA, the final rule is the result of a statutory mandate in the National Defense Authorization Act for Fiscal Year 2020, which amended TSCA to add Section 8(a)(7) and requires all manufacturers — including importers — of PFAS and PFAS-containing articles in any year since Jan. 1, 2011, to submit to EPA information regarding PFAS uses, production volumes, byproducts, disposal, exposures, and existing information on environmental or health effects. The final rule’s purpose is to help EPA better characterize the sources and quantities of manufactured PFAS in the United States.
The final rule becomes effective 30 days after publication in the Federal Register. A pre-publication version is available here. For most companies, this one-time reporting will be due 18 months after the effective date. The reports must cover information in each year from 2011 through 2022. The following is a summary of the final rule.
Substances Covered by the Final Rule
Scope of PFAS for the Purpose of the Final Rule
Under TSCA Section 8(a)(7), EPA is required to collect information on chemical substances manufactured — including imported — for commercial purposes, including chemical substances present in a mixture that are “PFAS.” While Section 8(a)(7) does not define or characterize “PFAS,” for the purpose of the final rule, EPA is defining “PFAS” using a structural definition — as opposed to a discrete list of specifically identified substances. Specifically, “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.
Manufacturers of substances that do not meet this structural definition are not required to report under the final rule. EPA will provide a list of substances that meet this definition, gathered from the TSCA Inventory, Low Volume Exemptions, and the CompTox Chemicals Dashboard; the list will be available in the CompTox Chemicals Dashboard here. EPA notes, however, that a substance that is not on this list but still falls under the TSCA definition of a “chemical substance” and contains one of the above structures is subject to the final rule if the substance has been manufactured for a commercial purpose since 2011. EPA also affirms that fluoropolymers that meet the definition of “PFAS” are reportable.
Definition of “Chemical Substance” Under TSCA and PFAS in Mixtures
The final rule is limited to manufacturers — including importers — of PFAS that are considered a “chemical substance.” Under TSCA Section 3(2), “chemical substance” means any organic or inorganic substance of a particular molecular identity, including (1) any combination of such substances occurring as a result of a chemical reaction or occurring in nature, and (2) any element or uncombined radical. EPA states that the final rule does not require reporting on activities that are excluded from the definition of “chemical substance” in TSCA Section 3(2)(B) (i.e., pesticides, tobacco, specified nuclear material, firearms and ammunition, food, food additives, drugs, and cosmetics). There is, however, one notable exception to this — while the definition of “chemical substance” excludes mixtures, the final rule requires reporting on each chemical substance that falls under the structural definition of “PFAS,” including as a component of a mixture.
Entities Covered by the Final Rule
Scope of Covered Entities
Anyone who has manufactured — including imported — a PFAS for a commercial purpose in any year since Jan. 1, 2011, is covered by the final rule. “Manufacture for a commercial purpose” includes the coincidental manufacture of byproducts or impurities. EPA also states that the final rule extends to manufacturers — including importers — only and that importers of PFAS in articles are considered PFAS manufacturers.
Persons who have only processed, distributed in commerce, used, or disposed of PFAS are not required to report under the final rule unless they also have manufactured PFAS for a commercial purpose. EPA notes that TSCA Section 8(a)(7) only refers to manufacturers and that expanding the final rule to processors “would be pursuant to EPA’s separate rulemaking authority at TSCA section 8(a)(1), which the Agency is not pursuing at this time.”
Scope of “Manufacture for Commercial Purposes”
Under TSCA Section 8(f), the scope of “manufacturing” is limited to entities manufacturing for a commercial purpose. EPA states that it is defining “manufacture for commercial purposes” to align with definitions used in other rules. Specifically, “manufacture for commercial purposes” includes the import, production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer. This includes, but is not limited to, the manufacture of chemical substances or mixtures for commercial distribution, including test marketing, or for use by the manufacturer itself as an intermediate or for product research and development (R&D). “Manufacture for commercial purposes” also includes the coincidental manufacture of byproducts and impurities that are produced during the manufacture, processing, use, or disposal of another chemical substance or mixture. EPA clarifies that “simply receiving PFAS from domestic suppliers or other domestic sources is not, in itself, considered manufacturing PFAS for commercial purposes. Entities that process and/or use PFAS only need to report on PFAS they have manufactured (including imported), if any.” (Emphasis in original).
Entities who have manufactured PFAS for a commercial purpose include those who have imported PFAS — including in wastes — or those who have coincidentally produced PFAS during the manufacture, processing, use, or disposal of another chemical substance or mixture. In the proposed rule, EPA noted that this may include certain waste management companies if they have imported PFAS in a waste or produced PFAS at their site during the disposal of another chemical substance or mixture. Since no PFAS was listed as a hazardous waste and subject to notification requirements under the Resource Conservation and Recovery Act or other federal laws during the final rule’s lookback period (i.e., since Jan. 1, 2011), and due to general industry practices, EPA understands that importers of municipal solid waste streams for disposal or destruction would not have any records or data that they had imported PFAS or any other information relevant to TSCA Section 8(a)(7). Consequently, “EPA has determined that waste management activities involving importing municipal solid waste streams for the purpose of disposal or destruction are not within the scope of this rule’s reporting requirements, per EPA’s obligations under TSCA section 8(a)(5)(C).”
Notwithstanding, EPA is not broadly exempting all waste management facilities from the final rule. EPA states that facilities that have imported waste containing PFAS, other than in municipal solid waste streams for destruction or disposal, are likely to have information relevant to the final rule. Other waste management sites may have relevant information regarding PFAS contents in waste they have imported outside of municipal solid waste or for the purpose of recycling or reuse; therefore, “EPA is required to apply reporting requirements to such entities who may have relevant information, pursuant to TSCA section 8(a)(5)(C).” EPA notes that this would include waste management sites that import PFAS-containing waste — including in municipal solid waste — for the purpose of recycling or reuse for PFAS-containing products, as well as waste management sites that import PFAS in wastes that are not municipal solid waste streams.
Reporting Standard of the Final Rule
The final rule’s reporting standard is information “known to or reasonably ascertainable by” the manufacturer. This is the same standard used in other TSCA Section 8 rules, including Chemical Data Reporting. According to EPA, “known to or reasonably ascertainable by” is defined to include “all information in a person’s possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control, or know.” 40 CFR § 704.3. EPA states that this reporting standard requires reporting entities to evaluate their current level of knowledge of their manufactured products — including imports — as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control. This reporting standard “carries with it an exercise of due diligence, and the information-gathering activities that may be necessary for manufacturers to achieve this reporting standard may vary from case-to-case.”
This reporting standard requires that submitters conduct a reasonable inquiry within the full scope of their organization not just the information known to managerial or supervisory employees. It may also entail inquiries outside the organization to fill gaps in the submitter’s knowledge. Examples of types of information that are considered to be in a manufacturer’s possession or control or that a reasonable person similarly situated might be expected to possess, control, or know include files maintained by the manufacturer, such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a safety data sheet or a supplier notification; and information from the Chemical Abstracts Service or from Dun & Bradstreet. If particular information cannot be derived or reasonably estimated without conducting further customer surveys, it would not be “reasonably ascertainable” to the submitter.
EPA also notes that if a manufacturer — including importer — does not have actual data (e.g., measurements or monitoring data) to report, the manufacturer — including importer — should consider whether “reasonable estimates” of such information are ascertainable. “Reasonable estimates” may rely on approaches such as mass balance calculations, emissions factors, or best engineering judgment. If manufacturers do not know nor can reasonably make estimates for certain data elements, except for production volumes, they may indicate such information is “Not Known or Reasonably Ascertainable” to them in lieu of the requested estimate or range.
EPA will publish reporting instructions and a Small Entity Compliance Guide, which will include information related to this reporting standard and the activities that small entities, including article importers, may take to meet the due diligence requirement. These materials should be available on EPA’s website prior to the final rule’s effective date.
Information That Must Be Reported Under the Final Rule
The final rule requires that PFAS manufacturers submit the following information for each PFAS, for each year in which that substance was manufactured since Jan. 1, 2011, to the extent the information is known or reasonably ascertainable:
- Company and plant site information. Companies must report company and plant site information for each site at which a reportable chemical substance is manufactured.
- Chemical-specific information. Companies must identify the common or trade name, the chemical identity, the representative molecular structure, and the physical form(s) of each PFAS.
- Categories of use. Companies must report on industrial processing or use operation(s), consumer and commercial product category(ies), and concentrations of PFAS.
- Manufactured amounts. For each year since Jan. 1, 2011, companies must report the amounts manufactured, imported, and produced of each PFAS.
- Byproduct reporting. For each byproduct produced from the manufacture, processing, use, or disposal of a PFAS, companies must identify certain information (i.e., chemical identity, releases, volume).
- Environmental and health effects. Companies must provide all existing information in their possession or control concerning the environmental and health effects of each PFAS. The scope of this information is not limited to studies conducted or published since 2011.
- Worker exposure data. Companies must provide information on the number of individuals exposed to PFAS in their places of employment and the duration of such exposure.
- Disposal data. For the years in which the PFAS was manufactured, companies must report on the manners or methods of its disposal and any changes to the disposal methods or processes.
EPA is also finalizing a reporting option for article importers as well as manufacturers of R&D substances that were manufactured in volumes under 10 kilograms per year to provide information through a streamlined form.
Requirements for Submitting Confidential Business Information Claims
PFAS manufacturers reporting under the final rule may claim certain portions of the reporting form are confidential business information (CBI), consistent with TSCA Section 14, such as specific chemical identities that are not on the public TSCA Inventory, company identifier, and production volumes. EPA notes, however, that only confidentiality claims made through the final rule’s PFAS reporting tool “will be considered properly asserted; any additional TSCA CBI claims made elsewhere will be considered improperly presented and will not be treated as having asserted a CBI claim under TSCA, and the information may be disclosed to the public without further notice.” The final rule also outlines certain information that may not be CBI.
Electronic Reporting Requirements and Timing
The final rule requires all information to be submitted electronically, using EPA’s Central Data Exchange. EPA has decided to finalize a one-year information collection period following the final rule’s effective date, which will then be followed by a six-month reporting period. EPA is also granting an additional six months for reporting to “small manufacturers” (as defined at 40 CFR § 704.3) whose reporting obligations are exclusively from article import. Thus, reporting forms will be due 18 months following the effective date, except for small article importers, whose reporting forms are due 24 months following the effective date.
Each company that is subject to the reporting requirements must retain records that document any information reported to EPA for five years, beginning on the last date of the information submission period.
Any companies that are regulated by the final rule should not wait to comply. It is best to start early and analyze the final rule, develop a compliance strategy, and begin compiling the necessary information and identifying any information gaps. Given the extensive amount of information that must be reported under the final rule, companies are likely to need most or all of the time allocated for collecting and reporting information.