On September 28, 2023, U.S. EPA released a long-awaited final rule aimed at gathering information on products that contain PFAS chemicals. This new regulation, which was promulgated under Section 8(a)(7) of the Toxic Substances Control Act (TSCA), applies to any company that, at any time since 2011, manufactured or imported any PFAS chemical, including PFAS chemicals imported as part of manufactured articles. The definition of PFAS is broad and includes fluoropolymers that are common in many types of products, including automotive, electric, and manufacturing equipment; therefore many companies in various industries will find themselves encompassed by this new reporting rule.
Under some existing reporting regulations under TSCA, there are exemptions for materials imported only for research and development purposes, or a de minimis threshold level of production that would trigger the reporting. However, with this new PFAS reporting regulation, a company will be subject to the reporting requirement if, at any time since January 1, 2011, the company imported a piece of equipment containing one or more PFAS compounds, regardless of the number of pieces of equipment imported and regardless of the level or concentration of PFAS in the equipment.
What Information Must Be Reported?
If a company has previously filed reports under the TSCA Chemical Data Reporting rule, the type of information that must be submitted may seem familiar. They include:
- Chemical identity
- Categories of use for which the substance is manufactured or imported, including the industry sector(s) within which the substance is used and the function(s) of the PFAS substances within each industry section; and the categories of consumer and commercial products within which the substance is used, the function(s) of the PFAS substances within each product category, and the concentration(s) in which the PFAS substance is used
- The annual production or import volume of each substance
- A description of the byproducts produced during manufacture of the PFAS substance
- Employee exposure information, including the number of workers, types of activities leading to exposure, and the frequency and duration of exposure
- Disposal method and volumes.
What Is Different About This TSCA Reporting Requirement?
While the types of information to be reported might be familiar to those who operate in chemical manufacturing and importing industries, the extent of this reporting rule and the diligence required might be remarkable. First, the standard for the items of information to be reported to EPA is the extent to which such information is “known to or reasonably ascertainable by” the party submitting the report. This would be defined as all information in the person’s “possession or control, plus all information that a reasonable person similarly situated might be expected to possess, control or know.”
The rule explains that under this standard there is an obligation of the company to conduct a “reasonable inquiry” both within and outside of its organization to fill any gaps in the submitter’s knowledge, such as email and telephone calls to upstream suppliers or downstream users or “other agents of the manufacturer, including persons involved in the research and development, import or production or marketing.” Essentially, if the company imports a product that exhibits a performance characteristic associated with fluoropolymers (such as stain resistance) there is an obligation to reach out to the suppliers of the product to determine if it contains PFAS. While this requires some
diligence on the part of the submitting company, importantly this rule does not require any “surveys” or product testing.
This new regulation, as indicated above, does not have the typical exemptions found in TSCA reporting rules, additionally, the 12-year “look back” period is atypical and will present compliance challenges.
When Must Companies Comply?
The final reporting rule was published in the Federal Register on October 11, 2023, and will be effective as of November 13, 2023. Companies subject to the rule have one year to collect the information to be reported, followed by a six-month period during which the reports must be submitted to EPA. This 18-month period puts the deadline for reporting on or around May 8, 2023. While there is no “small business” exception to the requirement to report, there is an additional six months in the reporting deadline for small manufacturers.
What Should Companies Do Now?
Companies should soon move forward with developing a compliance strategy for the rule, including the preparation of a plan for determining what PFAS-related information is known to or reasonably ascertainable by the company. If there are any questions about the applicability of, obligations of, or the investigations needed to be initiated under the new rule, contact an attorney from Calfee’s Environmental Practice Group.