The U.S. Environmental Protection Agency's new PFAS reporting rule takes effect
Partner, Global Co-Head International Trade and Regulatory Law Group, and Global Head of the firm's Environmental Law Group
Maria Christopher Bell
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On November 13, 2023, the U.S. Environmental Protection Agency (EPA)’s final rule broadening reporting requirements for the “manufacture” of per- and polyfluoroalky substances (PFAS) (the PFAS Reporting Rule)l took effect. The PFAS Reporting Rule requires manufacturers (including importers) of PFAS and PFAS-containing articles in any year since 2011 to report to EPA information related to the chemical identity, uses, volumes made and processed, by-products, environmental and health effects, worker exposure, and disposal thereof.
This bulletin briefly summarizes the key aspects of this new rule.
What are PFAS
PFAS have been around since the 1940s and are pervasive in modern consumer products and industry. They are a class of chemicals containing a strong carbon-fluorine bond that gives them a number of useful and unique properties, such as thermal and chemical stability and water and stain resistance. These substances perform critical functions across a variety of applications and industries, from waterproofing raincoats to improving thermal stability in semiconductor packaging materials. For example, PFAS are commonly found in, among other things:
- ski wax;
- food packaging; and
- fire-fighting foam.
Why EPA (and other governments) are targeting PFAS
The strong carbon-fluorine bond that gives PFAS their unique properties is also the primary reason that these substances are now in regulators’ crosshairs. PFAS do not breakdown easily and have the capacity to travel through the environment2. As a result, many PFAS are bio-accumulative in humans and animals, highly persistent in various environmental media, and found all over the globe3. Scientific studies also suggest that exposure to PFAS may result in detrimental effects to human health (including cancer and birth defects).
EPA’s new rule
EPA has authority pursuant to the Toxic Substances and Control Act (TSCA)4 to promulgate rules imposing reporting, recordkeeping and testing requirements, and restrictions relating to chemical substances and/or mixtures. The National Defense Authorization Act of 2020 amended TSCA by, among other things, requiring EPA to promulgate a rule imposing reporting obligations on PFAS “manufacturers.”
The key elements of the resulting PFAS Reporting Rule are as follows.
Who must report
Anyone who has “manufactured [a] PFAS for commercial purposes” (manufacturers) in any year since January 1, 2011, is covered by the PFAS Reporting Rule. “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. Importers of articles containing PFAS are still covered by the rule but will be allowed to report pursuant to streamlined reporting requirements (still being finalized by EPA).
Persons that have only processed, distributed in commerce, used, and/or disposed of PFAS are not required to report under the PFAS Reporting Rule, unless they also have manufactured PFAS for a commercial purpose.
What must be reported
Manufacturers will be required to report a number of data elements (i) regarding each individual PFAS they manufactured (ii) for each year since 2011. These elements (identified in an EPA-published spreadsheet) generally include information regarding the PFAS’s:
- processing and use;
- consumer and commercial use;
- production, processing, and disposal/recycling;
- byproducts; and
- exposure to the manufacturer’s workers.
As noted above, “article importers” will be subject to more streamlined reporting requirements (i.e., a truncated form of the general reporting requirements).
Reporting is required to the extent information on the manufacture of these chemicals was “known to or reasonably ascertainable by the manufacturer,” which includes “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.” This requires manufacturers to assess (i) what they know, and (ii) what they reasonably should know. EPA has stated that this standard would require submitters to conduct “a reasonable inquiry within the full scope of their organization.”
Which PFAS are covered
The PFAS Reporting Rule will use a “structural definition” for PFAS rather than a discrete list of specifically identified substances, and will require reporting on at least 1,462 PFAS known to have been made or used in the United States since 2011. The three relevant structures comprise:
- 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 generally will be required to report this data to EPA within 12 –- 18 months of the PFAS Reporting Rule’s effective date (i.e., November 12, 2024 – May 8, 2025). “Small manufacturers” (as defined at 40 CFR 704.3) will have an additional six months to report (i.e., November 12, 2024 – November 10, 2025).
How to report
Reports must be completed and submitted using EPA’s Central Data Exchange (CDX).
Businesses that engage with PFAS are on the clock to internally review their past and present importation, production, or manufacture of PFAS and to assess the applicability of the PFAS Reporting Rule to their operations. Although the PFAS Reporting Rule provides covered entities time to submit reports (i.e., 12 – 24 months, depending on the nature of the entity), identification of relevant data and the preparation of reports likely will require time, labor, and cost-intensive internal review processes that businesses should be considering sooner rather than later.
Our US and global team have extensive experience advising on all aspects of PFAS liability and risk. For additional information, please reach out to one of the A&O contacts listed here.