EPA’s New PFAS Reporting Rule Part 2 – Chemical Manufacturers and Importers Face Daunting Compliance Obligations

In a recent Client Alert we introduced readers to EPA’s new PFAS reporting rule under Section 8(a)(7) of the Toxic Substances Control Act (TSCA), highlighting the rule’s impacts on companies that are typically not regulated under TSCA, such as importers of equipment, machinery, electronics and other types of manufactured articles.  In this follow-up alert we examine how the new PFAS reporting rule will apply to manufacturers and importers of chemical products.  Although chemical manufacturers are likely to be well-acquainted with regulations under TSCA, EPA’s new PFAS reporting rule is unprecedented in scope and will present unusual compliance challenges for many companies that manufacture or import chemical products.

The final rule was published in the Federal Register on October 11, 2023 and can be found here.

Information Required to be Submitted Under the Rule

EPA’s new regulation applies to any company that, at any time since 2011, manufactured or imported any PFAS chemical. The types of information to be reported will be familiar to companies that have previously filed reports under the TSCA Chemical Data Reporting (CDR) rule.  In addition to supplying company and facility identification information, the following items of information will be required for each PFAS substance manufactured or imported by a facility (including PFAS substances imported as part of a formulated product or article):

• • 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 substance within each industry sector; and
    • The categories of consumer and commercial products within which the substance is used, the function(s) of the PFAS substance within each product category, and the concentration(s) in which the PFAS substance is used
  • The annual production (or import) volume for each substance, and the percent of production used in each of the product categories identified above
  • A description of the byproducts produced during manufacture of the PFAS substance and information on their releases into the environment
  • Employee exposure information, including number of workers, types of activities leading to exposure, and frequency and duration of exposure
  • Disposal methods and volumes.

Importantly, this information must be reported for each year, starting in 2011, that a PFAS substance was manufactured or imported and reporting must be accomplished using EPA’s Central Data Exchange (CDX) web portal.  The regulations also specify detailed requirements that must be followed to protect confidential business information (CBI) that may be included in the facility’s report.

Finally, in addition to the items of information described above, the submitter must also provide EPA with all existing information in the submitter’s possession or control concerning the health or environmental effects of the substance, regardless of when the information was developed or published.

Degree of Diligence Required

The items of information listed above must be reported to EPA to the extent that such information is “known to or reasonably ascertainable by” the submitter.  The regulations define this to mean “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.”  EPA further explains in the preamble to the final rule that the “known to or reasonably ascertainable” standard requires submitters to conduct a reasonable inquiry within the full scope of their organization and may also require:

inquiries outside the organization to fill gaps in the submitter's knowledge. Such activities may include phone calls or email inquiries to upstream suppliers or downstream users or employees or other agents of the manufacturer, including persons involved in the research and development, import or production, or marketing

In guidance documents issued simultaneously with publication of the final rule, EPA indicates that if a company imports a product that exhibits a performance characteristic known to be associated with fluorinated chemicals (such as stain-resistance), the company has an obligation to reach out to its supplier(s) of the product to ascertain whether that product contains a PFAS chemical.

Unprecedented Breadth of the Reporting Requirement

Although the items of information required to be reported under the new rule are similar to the types of information required under CDR, the breadth of the new rule is remarkable in several respects.

• • • Instead of including a list of specific compounds subject to reporting (e.g., by chemical name or CAS number), the final rule uses a structural definition to describe the PFAS compounds that are subject to the rule. According to EPA, this structural definition encompasses approximately 9,400 discrete chemical substances, which far eclipses the number of substances subject to any previous chemical-specific reporting rule under TSCA.
    • The regulation does not include many of the exemptions that are typically found in regulations issued under TSCA. For example, there is no exemption for substances manufactured or imported as impurities or byproducts and no broad exemption for materials manufactured or imported only for research and development (R&D) purposes.  In addition, there is no minimum production (or import) threshold that triggers reporting and no “de minimis” level of PFAS content below which reporting is not required.
    • The 12-year “look-back” period of the final rule is extraordinary, and will present significant compliance challenges when combined with the lack of exemptions in the final rule. For example, a manufacturer or importer will be required to report on every PFAS chemical the company manufactured or imported at any time since January 1, 2011, even if the PFAS chemical was an impurity or byproduct that was otherwise exempt from regulation at the time it was manufactured or imported.

Timeline for Compliance

Under the final rule, companies will have one year to collect the information required to be reported, followed by a six-month period during which reports must be submitted to EPA.  Thus, the required information must be submitted no later than 18 months following publication of the final rule (May 8, 2025).  Companies that qualify as “small manufacturers” and that only import articles containing PFAS compounds are provided with an extra six months for submitting their reports (until November 10, 2025).

Challenges and Opportunities

Because of its expansive scope and extraordinary look-back period, the new PFAS reporting rule presents unique compliance challenges, as companies will need to piece together information on past “manufacture” and import activities – including the production and import of byproducts and impurities – that they previously were not required to document or report on.

In the course of gathering information to comply with this rule, it is conceivable, if not likely, that companies will uncover information that implicates past failures to comply with TSCA.  For example, in searching for health and safety information in its possession or control, a company may discover information that should have previously been reported to EPA under Section 8(e).  Or a company may determine that it previously manufactured a substance that was not listed on the TSCA Inventory or that it failed to report production information as required every four years under CDR.  In light of these types of concerns, companies subject to the new PFAS reporting rule may want to initiate an audit, to take advantage of the penalty mitigation available under EPA’s voluntary self-disclosure policies.  This will require careful assessment of the eligibility criteria for these policies as well as thorough planning for any anticipated audit and potential self-disclosure.

Finally, it is important to recognize that many aspects of the PFAS reporting rule may overlap with similar, but not identical, reporting requirements being enacted in various states, such as Maine and Minnesota. Companies will want to think strategically about how to most efficiently comply with multiple overlapping but not necessarily consistent reporting obligations under State and federal law.

Conclusions

EPA’s new PFAS reporting rule is unprecedented in its scope and breadth, and, as a consequence, compliance with this regulation may be complicated and time consuming. Therefore, affected companies should act without delay to understand their obligations and initiate the investigations that will be needed to assure compliance with this new rule.