The U.S. Environmental Protection Agency (EPA) announced on June 10, 2021, three actions intended to protect communities from per- and polyfluoroalkyl substances (PFAS). The actions include proposing a rule designed to obtain comprehensive data on more than 1,000 PFAS manufactured in the United States, withdrawing guidance that EPA believes weakened its July 2020 significant new use rule (SNUR) restricting certain long-chain PFAS, and publishing a final rule that incorporates three additional PFAS into the Toxics Release Inventory (TRI) maintained under the Emergency Planning and Community Right-to-Know Act (EPCRA).
Proposed TSCA Rule to Require Reporting on PFAS Manufactured in the United States
The fiscal year 2020 (FY2020) National Defense Authorization Act (NDAA) amended the Toxic Substances Control Act (TSCA) to add Section 8(a)(7), mandating that EPA 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 certain information. EPA’s proposed rule would require all manufacturers (including importers) of PFAS in any year since 2011 to report information related to chemical identity, categories of use, volumes manufactured and processed, byproducts, environmental and health effects, worker exposure, and disposal. EPA states that the proposed rule will help it better understand the sources and quantities of PFAS manufactured in the United States and support its research, monitoring, and regulatory efforts.
EPA proposes that manufacturers report information to the extent that the information is known to or reasonably ascertainable by the manufacturer. The proposed rule states that “known to or reasonably ascertainable by” would be defined to include “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.” This would require reporting entities to evaluate their current level of knowledge of their manufactured products (including imports), as well as evaluate whether there is additional information that a reasonable person, similarly situated, would be expected to know, possess, or control.
This reporting standard would require submitters to conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). This standard may also entail inquiries outside the organization to fill gaps in the submitter’s knowledge. According to the proposed rule, such activities may include phone calls or e-mail 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.” Examples of types of information that are considered to be in a manufacturer’s possession or control, or that a reasonable person similarly situated might be expected to possess, control, or know include files maintained by the manufacturer, such as marketing studies, sales reports, or customer surveys; information contained in standard references showing use information or concentrations of chemical substances in mixtures, such as a safety data sheet (SDS) or a supplier notification; and information from the Chemical Abstracts Service (CAS) or from Dun & Bradstreet. The proposed rule states that this information may also include knowledge gained through discussions, conferences, and technical publications. EPA notes in the proposed rule that this definition is identical to the definition of the same term at 40 C.F.R. Section 704.3, which appears incorrect, given the inclusion of information obtained more informally, as noted immediately above here. In addition, this is the same reporting standard employed in the TSCA Section 8(a) Chemical Data Reporting (CDR) rule.
According to the proposed rule, EPA intends to use the reported information to support assessments of new and existing chemicals under TSCA. EPA will also use the information to fulfill additional environmental protection mandates beyond the TSCA program, such as regulatory activities under the Safe Drinking Water Act (SDWA), the Resource Conservation and Recovery Act (RCRA), and the Comprehensive Environmental Response, Compensation, and Liability Act (CERCLA). EPA states that data on PFAS manufacturing sites and disposal methods may support contaminant characterizations conducted to support contaminated site work and solid waste management programs.
To assist stakeholders in determining whether they have manufactured PFAS during the reporting period and therefore would be subject to the proposed rule, the proposed rule provides examples of PFAS from the TSCA Inventory and new chemical low-volume exemption (LVE) notices. EPA also provides structural diagram examples of additional PFAS that cannot be identified on the aforementioned lists due to confidentiality claims.
Importantly, EPA states in the proposed rule that the manufacture of PFAS as a byproduct would not be exempt for the purpose of the proposed rule. The proposed rule notes that unlike TSCA Section 8(a)(1), which specifically provides an exemption for small manufacturers and processors, TSCA Section 8(a)(7) provides no such exemption. Therefore, the proposed rule would not exempt small manufacturers from reporting and recordkeeping requirements.
The proposed deadline for reporting PFAS data to EPA is one year following the effective date of the final rule. Publication of the proposed rule in the Federal Register will begin a 60-day comment period.
Withdrawing Compliance Guide on PFAS SNUR
In accordance with the Biden-Harris Administration’s Executive Orders and other directives, including those on environmental justice, scientific integrity, and regulatory review, EPA states that it has withdrawn a compliance guide that EPA believes weakened the July 27, 2020, final SNUR for long-chain perfluoroalkyl carboxylate (LCPFAC) and perfluoroalkyl sulfonate chemical substances (85 Fed. Reg. 45109). The final rule prohibits companies from importing certain long-chain PFAS as part of a “surface coating” on articles without prior EPA review and approval. EPA states that examples of articles that could contain these PFAS as part of a surface coating include, but are not limited to, automotive parts, carpet, furniture, and electronic components.
As reported in our January 20, 2021, blog item, EPA issued the compliance guide in January 2021 in the last days of the previous Administration and limited what would be considered a “surface coating” subject to the SNUR. EPA states that “[t]he guide was never deemed necessary by career staff and its development was directed by political officials serving in the last Administration.” Additionally, EPA prepared the final guide without considering or addressing comments submitted by the public. After further review, EPA “determined that the guide inappropriately narrowed the scope and weakened the prohibitions included in the SNUR.”
EPA states that it has removed the January 2021 compliance guide from its website and that it is no longer in effect. The July 2020 SNUR continues to be in effect, however. Articles containing certain long-chain PFAS as a surface coating cannot be imported into the United States without EPA review. Importers of articles, but not processors of articles, are subject to the SNUR. According to EPA, although the SNUR did not include a regulatory definition of “surface coating,” the rule provides information on the intended meaning of the phrase. EPA states that it does not intend to issue a new guidance document.
More information on the July 2020 SNUR is available in our July 27, 2020, memorandum, “EPA Issues Final SNUR for LCPFAC and Perfluoroalkyl Sulfonate Chemical Substances.” EPA has posted information on the SNUR requirements, including the applicability of those requirements to the import of articles, on its website.
Implementing NDAA Requirements to Report PFAS to TRI
The NDAA provided a framework for additional PFAS to be added to TRI on an annual basis. For TRI Reporting Year 2021 (reporting forms due by July 1, 2022), the NDAA automatically added three PFAS to the TRI list because they are now subject to a SNUR under TSCA. EPA issued a final rule on June 3, 2021, incorporating these requirements into the Code of Federal Regulations for TRI (86 Fed. Reg. 29698). Per the NDAA requirements, the PFAS additions became effective as of January 1, 2021. Reporting forms for these PFAS will be due to EPA by July 1, 2022, for calendar year 2021 data.
EPA’s withdrawal of the LCPFAC compliance guide and EPA adding PFAS substances to TRI are not particularly surprising or likely to inspire significant commercial disruption. The Section 8(a) reporting rule is another story and includes several significant surprises.
EPA has proposed the expected rule on PFAS reporting as required by TSCA Section 8(a)(7). This rule proposal answers the question of what a PFAS is. In this rule, EPA is proposing that a PFAS includes any substance that has at least two fluorine atoms on one saturated carbon and at least one fluorine on an adjacent saturated carbon, with neither carbon bound to a hydrogen.
where none of R1, R2, or R3 is H
Based on this definition, EPA provides a list of substances listed on the TSCA Inventory and a list of LVE substances that would be subject to reporting. EPA is also clear that its list is not a complete list -- rather individual manufacturers and importers must evaluate substances against the categorical definition to determine if reporting is required.
The requested information is similar to but more comprehensive than typical CDR. EPA offers that information that has been submitted under CDR may be referenced rather than re-submitted, which is a helpful addition. Only information submitted for the primary reporting years is likely to be sufficient, however, to satisfy the reporting requirement under this rule.
There are several major departures from CDR reporting standards in the proposed rule:
It is also not clear if the standard of “known or reasonably ascertainable” used for CDR reporting will apply. In contrast to CDR guidance, the proposed rule expresses an intent that:
This standard would require that submitters conduct a reasonable inquiry within the full scope of their organization (not just the information known to managerial or supervisory employees). 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.
In contrast, EPA’s Instructions for Reporting 2020 TSCA Chemical Data Reporting guidance states:
For further clarity, submitters are not required to conduct a new or additional customer survey (i.e., to pose a comprehensive set of identical questions to multiple customers) under this standard. If particular information cannot be derived or reasonably estimated from the information available to the company without conducting further customer surveys, it is not “known to or reasonably ascertainable” to the submitter for purposes of the CDR.
EPA may be significantly underestimating the costs of compliance with the rule. EPA estimates that importers of articles (who may have never before had to respond to a TSCA data reporting rule) will only need about $70 to familiarize themselves with the rule, and will spend less than $2,000 to identify the types of articles that potentially use PFAS; $1,200 to identify suppliers involved; no more than $644 to collect data from suppliers, and $12 to keep records. That EPA estimates a mere $70 for any firm to familiarize itself with the rule is, in our view, deeply misguided and reflects a profound lack of understanding of the burden of complying with such a rule.
EPA also seems to be missing a wide variety of North American Industry Classification System (NAICS) codes that are potentially affected, given that EPA is proposing to have the reporting rule apply to articles. If EPA hopes to avoid the significant disarray that occurred early in 2021 related to EPA’s persistent, bioaccumulative, and toxic (PBT) chemicals rule providing a very short timeline for applicability of the prohibitions on distribution of articles, we hope that EPA will undertake much broader outreach with this rule during the comment period. Similarly, we hope trade associations and other industry stakeholders engage in suitable outreach efforts to avoid the phenol, isopropylated, phosphate (3:1) (PIP (3:1)) experience of earlier this year.
EPA’s proposed reporting period is six months. While this timeframe may seem to be generous, especially as compared to CDR reporting, given how much more broadly this rule applies compared to CDR, we suspect that commenters will urge EPA to provide additional time to understand the final rule and obtain the information that must be submitted.
We also hope that EPA will test more thoroughly the Central Data Exchange (CDX) reporting tool to avoid the major disruptions that were found in the last round of CDR reporting.