Per- and polyfluoroalkyl substances, known collectively as “PFAS,” are synthetic organic compounds that do not occur naturally in the environment. Some of these chemicals have been used for decades in a wide variety of consumer and industrial products. Legislative or regulatory action related to PFAS continues to be a focus of the Biden administration, Congress, and EPA Administrator Michael Regan. Multiple bills are pending at the state and federal levels that would address PFAS in various ways, often with the most immediate focus on perfluorooctanoic acid and perfluorooctane sulfonic acid (known as “PFOA” and “PFOS”), the two chemicals which have so far been the most well-studied of the PFAS class. For the myriad of other PFAS chemicals, the evidence on potential health and environmental effects is sparse. To respond to this lack of information, a new proposed rulemaking from EPA seeks to begin collecting data from PFAS manufacturers that may pave the way for future rules that could apply to PFAS chemicals. The rule covers at least 1,364 types of PFAS, and EPA predicts that this proposed rule will affect the petroleum, coal, chemical, plastics, car, and machinery manufacturing industries, as well as chemical wholesalers, gas stations, and many others.
The proposed rule comes pursuant to the Toxic Substances Control Act (“TSCA”), a law that provides EPA with authority to require reporting, recordkeeping, and testing requirements related to “chemical substances.” Section 8 of the TSCA contains the TSCA Inventory, a list of over 83,000 chemicals that entities which manufacture or process them over the reporting threshold are required to report information on to EPA.1 These reports are submitted electronically on a four-year cycle through the Chemical Data Reporting (“CDR”) process, which many manufacturers will already be familiar with for various non-PFAS chemicals. The data collected is used to support EPA’s risk evaluation and management activities and allow the agency to develop an understanding of how chemicals are used, in what amounts, and possible points of exposure in commerce.
In 2019, Congress passed the National Defense Authorization Act for Fiscal Year 2020, which, among other provisions, amended TSCA’s section 8(a) to add section 8(a)(7), entitled “PFAS Data.” Section 8(a)(7) requires EPA to promulgate a rule requiring “each person who has manufactured a chemical substance that is a [PFAS] in any year since January 1, 2011” to report information to EPA as described in TSCA section 8(a)(2)(A)-(G).
While many aspects of the new PFAS rule are the same as those for CDR regulations, EPA has noted that there are important differences — primarily the lack of a reporting threshold — which means that small manufacturers are not excluded from the reporting requirements. Additionally, while the proposed rule states that it will use the same knowledge standard as CDR regulations, the description of this standard is broad, suggesting that inquiries to entities outside the manufacturer and use of customer surveys may be required.
On June 10, 2021, EPA announced a proposed rulemaking under the TSCA that would represent the first-ever recordkeeping and reporting requirements for PFAS chemicals. The rule would require those who currently or previously manufactured or imported PFAS since 2011 as a “chemical substance,” including as a byproduct, to provide information to EPA on the types, amounts, and environmental and health effects of the PFAS they produce.
EPA has stated that there are no exemptions to the reporting obligations of this rule, allowing it to create a comprehensive dataset. Unlike TSCA section 8(a)(1), which specifically provides an exemption for small manufacturers and processors, TSCA section 8(a)(7) has no reporting threshold and provides no such exemption. Therefore, this proposed rule under TSCA section 8(a)(7) does not exempt small manufacturers from reporting and recordkeeping requirements. However, the TSCA itself covers only manufacturers that produce a “chemical substance”–a definition that contains a number of exclusions, including, but not limited to, mixtures, pesticides, foods, drugs, cosmetics, and tobacco products.2 Under this rule, any person who has produced any amount of PFAS as a chemical substance since 2011 will have to make a report.
The rule also covers the manufacture of PFAS as a byproduct, including items (or imported “articles”) containing PFAS (for example, as a surface coating). Throughout the proposed rule, “manufacturers” and “importers” are considered the same for purposes of their obligations under the rule. This means that many importers who had been excluded from reporting on PFAS in previous CDR cycles will now be required to report on them under the new rule. EPA predicts that the rule will primarily affect industries such as petroleum, coal, chemical, plastics, and machinery manufacturing, but notes that this is not a comprehensive list of potentially affected industries.
The proposed rule requires a report containing specific information described in the TSCA, including chemical identity, categories of use, production volume, byproducts, environmental and health effects, number of persons exposed and duration of exposure, and disposal. To the extent that manufacturers have already reported this information to EPA under the CDR reporting process, they will not be required to duplicate their reports. However, the expanded scope of the rule means that there may be compliance difficulties for small manufacturers and processors who are exempt from, and therefore unfamiliar with, the CDR process. Importers, who often have less comprehensive knowledge of PFAS presence in imported articles than manufacturers do, may additionally face difficulties with gathering the required information.
The scope of inquiry is the same as is required by CDR reports under the TSCA, but EPA’s description of this scope is broad. The report must cover that which is “known to or is reasonably ascertainable by” the manufacturer, which requires the manufacturer to make a “reasonable inquiry” into the full scope of their organization. EPA notes that it may be necessary for some manufacturers and processors to communicate with upstream suppliers or downstream users to fully comply with the reporting requirements. Relevant information may be found in company files such as marketing studies, sales reports, customer surveys, and Safety Data Sheets, as well as knowledge gained through discussions, conferences, and technical publications. As with CDR reporting, entities that are unable to gather the required information should document their efforts to meet this standard in line with previous EPA guidance on the CDR process.
The rule covers at least 1,364 types of PFAS identified by EPA, as well as any PFAS that fall within EPA’s “structural definition.” However, EPA acknowledges that this is a working definition and anticipates that the list of reportable PFAS will be revised in response to public comment and as a result of other actions by EPA between April 2021 and the publication of the final rule. EPA is also seeking comment on the time period given to manufacturers to begin complying with the rule, which is currently a total of one year from the publication of the final rule.3 The report would be submitted electronically on a tool developed on the same platform used for CDR reporting.
While Congress did not direct EPA to use the data collected under the new rule in any particular manner, EPA states in its proposed rule that it intends to use the information to “support assessments of new and existing chemicals under TSCA.” It also indicates that the information may be used to “inform regulatory activities” under other laws such as the Safe Drinking Water Act, the Resource Conservation and Recovery Act, and the Comprehensive Environmental Response, Compensation, and Liability Act (“CERCLA,” also known as “Superfund”).
As we discussed earlier this year, this is another signal that EPA may eventually take action to designate a variety of PFAS as “hazardous substances” under CERCLA, or otherwise regulate these chemicals under environmental laws. In particular, this data will likely be used to inform EPA’s determinations under the PFAS Action Act of 2021, if it is passed. The act, currently pending in the House Energy & Commerce Committee, directs EPA to immediately designate PFOA and PFOS as hazardous substances under CERCLA, and gives EPA five years from the date of enactment to make determinations on designating other PFAS.
The proposed rule was published in the Federal Register on June 28, 2021. The public will have 60 days to provide comment on the proposed rule.
EPA is seeking comment on the following aspects:
EPA will consider and respond to public comments in its development of the final rule, which Congress has directed it to promulgate no later than January 1, 2023.
1 15 U.S.C. § 2607(a).
2 15 U.S.C. § 2602(2)(B).
3 Following a delay of six months after the final rule is published to allow both EPA and manufacturers time to prepare for submissions, there will be a six-month submissions period for the new reports.