On September 28, 2023, EPA released a long-anticipated final rule aimed at gathering information on products in commerce that contain PFAS chemicals. As defined in the regulation, the term “PFAS” includes a group of materials known as fluoropolymers, which are widely used in gaskets, tubing, electrical wiring, composite materials, printed circuit boards, membranes and many other manufactured articles. Under EPA’s new regulation, any company that has imported any of these types of articles containing fluoropolymers (or any other PFAS chemical) at any time since 2011 will be required to submit extensive information to EPA regarding those products and activities. The pre-publication version of the final rule can be found here.
Who is Covered
EPA’s 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. For purposes of the rule, the term PFAS is defined broadly, to include thousands of different compounds with vastly different properties. Because the definition of PFAS includes fluoropolymers, and because fluoropolymers are prevalent in many types of complex articles, including automotive, aerospace, electronics, and manufacturing equipment, a broad swath of industry is likely to be impacted by this rule.
Importantly, the new PFAS reporting 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. Thus, a company will be subject to the reporting requirements of the rule if, at any time since January 1, 2011, the company imported a piece of equipment containing one or more PFAS compounds, regardless of number of pieces of equipment imported (i.e., the quantity of PFAS imported) and regardless of the level or concentration of PFAS in each piece of equipment.
What Information Must be Reported
Companies that are subject to the new rule will be required to provide EPA with the information listed below, at a minimum, for each facility that imported an article containing components with one or more PFAS compounds:
- The identities of the PFAS substances in the article;
- The categories of use of the PFAS substances in the article;
- The specific functions of the PFAS substances in the article;
- The estimated maximum concentrations of the PFAS substances in the article; and
- The annual import volume of the article containing the PFAS substance(s).
Importantly, this information must be reported for each year, starting in 2011, that articles with PFAS-containing components were imported by the facility. In addition, the information must be reported 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, 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
Submitters must also maintain records documenting the information submitted to EPA under this rule for at least five years.
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. 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.
EPA’s new PFAS reporting rule will impact companies in a wide range of industries, including companies that import machinery and equipment containing gaskets, tubing, electrical wiring, composite materials, printed circuit boards, membranes and other types of components that are frequently made with fluoropolymers.
To ascertain the information required to be reported under this rule, companies may be required to navigate multi-tiered global supply chains to identify which components of a manufactured article contain PFAS compounds, the specific identities those PFAS compounds, and the quantities of those compounds that might be present in an article. This is a highly complicated and time-consuming process, and the obligation to collect this information for every year since 2011 makes this task even more complex.
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.