Do any of the articles, or article components, that your company imports contain PFAS? If so, your company may become subject to extensive reporting requirements proposed by EPA under the Toxic Substances Control Act (TSCA). The proposal was published on June 28, 86 Fed. Reg. 33926. It would establish a new Part 705 of 40 C.F.R., “Reporting and Recordkeeping Requirements for Certain Per- and Polyfluoroalkyl Substances.” Reports would likely be due in the second half of 2023. Comments on the proposed rule are due August 27, 2021. EPA notes, however, that if stakeholders submit comments by July 28, OMB will be able to consider them as it evaluates the paperwork burdens of the proposed rule.
EPA proposes to require all manufacturers of PFAS to respond to a one-time reporting requirement that would seek detailed information. Under TSCA, the term “manufacturer” includes importers. The proposed rule contains no exception for articles, so importers of articles would be required to report. EPA defines “article” in 40 C.F.R. § 704.3 to mean:
a manufactured item (1) which is formed to a specific shape or design during manufacture, (2) which has end use function(s) dependent in whole or in part upon its shape or design during end use, and (3) which has either no change of chemical composition during its end use or only those changes of composition which have no commercial purpose separate from that of the article, and that result from a chemical reaction that occurs upon end use of other chemical substances, mixtures, or articles; except that fluids and particles are not considered articles regardless of shape or design.
In December 2019, Congress directed EPA to adopt a PFAS reporting rule. It added section 8(a)(7) to TSCA, which provides:
PFAS Data.—Not later than January 1, 2023, the Administrator shall promulgate a rule in accordance with this subsection requiring each person who has manufactured a chemical substance that is a perfluoroalkyl or polyfluoroalkyl substance in any year since January 1, 2011, to submit to the Administrator a report that includes, for each year since January 1, 2011, the information described in subparagraphs (A) through (G) of paragraph (2).
This section was added by the PFAS Act of 2019, which was title LXXIII of the National Defense Authorization Act for Fiscal Year 2020, Public Law 116-92. That statute also required EPA to issue final PFAS significant new use rules by June 2, 2020, and automatically added certain PFAS to the Toxics Release Inventory. For more background, see our alert here.
Who Would Have to Report?
The proposed section on who must report simply refers to manufacturers of PFAS:
§ 705.10 Persons who must report.
Persons who have manufactured a chemical substance identified in § 705.5 at any period from January 1, 2011 to the effective date of this rule.
The preamble to the proposed rule makes clear that it would apply to importers of articles containing PFAS:
For the purposes of this proposed rule, articles containing PFAS, including imported articles containing PFAS (such as articles containing PFAS as part of surface coatings), are included in the scope of reportable chemical substances. TSCA does not define articles, nor does the statute define articles as a category of substances exclusive of chemical substances. EPA therefore considers its ability to regulate chemical substances to encompass authority to regulate articles containing such chemical substances. Additionally, the Agency would benefit from collecting the requested information on PFAS-containing articles (including articles containing PFAS as part of surface coatings) because the information would improve the Agency’s knowledge of various products which may contain PFAS, their categories of use, production volumes, and exposure data. Such data are not currently known to EPA.
Which PFAS Would Be Relevant?
EPA has offered the following definition of PFAS in proposed section 705.3:
Per- and polyfluoroalkyl substances or PFAS, for the purpose of this part, means any chemical substance or mixture that structurally contains the unit R-(CF2)-C(F)(R’)R”. Both the CF2 and CF moieties are saturated carbons. None of the R groups (R, R’ or R”) can be hydrogen.
This structural definition is a working definition that EPA has used when identifying PFAS on the TSCA Inventory. It is a narrower definition than that used by some other EPA offices and that adopted by some states. For example, Vermont’s PFAS statute defines “PFAS” to mean “a class of fluorinated organic chemicals containing at least one fully fluorinated carbon atom.” Vt. Stat. Ann. tit. 31, § 1661(5).
The proposed section 705.3 definition is not particularly useful for the regulated community. To help specify which PFAS would be covered, proposed section 705.5 provides five different lists, although it cautions that the rule is not limited to these specific PFAS. The first four lists are: the PFAS on the TSCA Inventory by CAS Number; the PFAS on the confidential Inventory by Accession Number; the low volume exemptions (LVEs) with non-confidential CAS Numbers; and the LVEs without non-confidential CAS Numbers (including withdrawn LVEs). (EPA plans to update these lists with additional chemicals resulting from actions since April 2021 up until the date of the final rule.) The fifth is a list of structural diagram examples. The preamble notes that 1,346 PFAS are currently on the Inventory, of which roughly half – 669 – are on the active Inventory.
What Information Would Manufacturers Have to Report?
The proposed rule would require each person who has manufactured a PFAS in any year since 2011 to submit a report that includes, for each year since 2011, detailed information on that PFAS. At a high level, the information that a PFAS manufacturer would have to provide would include, for each PFAS, most of the information identified in TSCA section 8(a)(2), such as:
- Its common or trade name, chemical identity, and molecular structure.
- Its categories or proposed categories of use.
- The total amount manufactured or processed, reasonable estimates of the total amount to be manufactured or processed, the amount manufactured or processed for each of its categories of use, and reasonable estimates of the amount to be manufactured or processed for each of its categories of use or proposed categories of use.
- A description of the byproducts resulting from its manufacture, processing, use, or disposal.
- All existing information concerning its environmental and health effects.
- The number of individuals exposed to it, and reasonable estimates of the number who will be exposed to it in their places of employment and the duration of such exposure.
- The manner or method of its disposal.
The proposed rule provides considerably more detail about the specific information to be reported in proposed 40 C.F.R. § 705.15. This information is similar to that required by the Chemical Data Reporting rule (CDR), 40 C.F.R. § 711.15, but has additional detail and some additional topics. For example, the CDR does not address environmental or health effects, but the proposed rule would require submission of “all health and safety studies.” It would also require submission of information on “assessments of human and environmental exposure, including workplace exposure” and “monitoring data, when they have been aggregated and analyzed to measure the exposure of humans or the environment to a chemical substance or mixture.”
Notably, the proposed rule would not provide any exemptions. There would be no exemptions for impurities, byproducts, or research and development; neither would it exempt small manufacturers from reporting obligations. The proposal would define “manufacture” to include “manufacture for commercial purposes,” which would be further defined to apply to:
substances that are produced coincidentally during the manufacture, processing, use, or disposal of another substance or mixture, including both byproducts that are separated from that other substance or mixture and impurities that remain in that substance or mixture. Such byproducts and impurities may, or may not, in themselves have commercial value. They are nonetheless produced for the purpose of obtaining a commercial advantage since they are part of the manufacture of a chemical product for a commercial purpose.
Proposed 40 C.F.R. § 705.3.
What Standard of Knowledge Would Apply?
The preamble recognized that article manufacturers may not be able to provide all the requested information:
However, EPA acknowledges that some article manufacturers, including article importers, may not have such information known to or reasonably ascertainable by them and may not meet the reporting standard as described in Unit II.C. To this end, information that helps EPA better understand data gaps is useful information for EPA to have. Therefore, articles are within the scope of reportable substances under this proposed rule, though EPA is requesting comments on whether imported articles containing PFAS should be within scope (see Unit IV.1).
The requested information is subject to the section 8(a)(2) standard of “known to or reasonably ascertainable by” persons subject to the final rule. EPA has defined “known to or reasonably ascertainable by” in 40 C.F.R. § 704.3 and elsewhere as follows:
Known to or reasonably ascertainable by means 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.
The related term “possession or control” is defined there as follows:
Possession or control means in the possession or control of any person, or of any subsidiary, partnership in which the person is a general partner, parent company, or any company or partnership which the parent company owns or controls, if the subsidiary, parent company, or other company or partnership is associated with the person in the research, development, test marketing, or commercial marketing of the substance in question. Information is in the possession or control of a person if it is:
(1) In the person's own files including files maintained by employees of the person in the course of their employment.
(2) In commercially available data bases to which the person has purchased access.
(3) Maintained in the files in the course of employment by other agents of the person who are associated with research, development, test marketing, or commercial marketing of the chemical substance in question.
EPA has asked for reasonably ascertainable information to fill data gaps to help determine the extent to which article importers know that PFAS are in or on their articles, including on surface coatings. The “reasonably ascertainable” phrase implies some effort to find out if PFAS are in the articles importers import. The preamble explains:
This standard may also entail inquiries outside the organization to fill gaps in the submitter’s knowledge. Such activities may, though not necessarily, 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 of the PFAS.
This statement is consistent with EPA guidance in section 4.2 of the CDR Instructions for 2020.
When Would Reports Be Due?
The Spring 2021 Regulatory Agenda predicts a final reporting rule by July 2022. Section 8(a)(7) requires EPA to adopt a final PFAS reporting rule by January 1, 2023, suggesting that EPA will actually issue a final rule in late 2022. Under proposed section 705.20, the reporting period would begin six months after the rule’s effective date and last for six months. This means that reports would be probably be due in the second half of 2023.
Another TSCA Requirement Applicable to Importers of Articles
Article manufacturers should take note. This proposal is the fourth EPA action or proposed action relating to chemicals in articles since January 2020. The first was EPA’s original implementation of the TSCA fees rule in January 2020 (later abandoned). The second was the June 2020 PFAS significant new use rule (SNUR) and its waiver of the article exemption for PFOA and its salts (and a few other PFAS) present in surface coatings in imported articles. The third action was four of the five PBT rules, adopted in January 2021, particularly the PIP (3:1) rule. Now comes the June 2021 proposed PFAS reporting rule.
One difference with the proposed PFAS reporting rule as compared with the SNUR (section 5) and PBT rules (section 6) is that the proposed PFAS reporting rule (section 8) is not, like the others, subject to strict liability under section 15(1). However, all these rules have the potential to impact importers of articles.