EPA Publishes Comprehensive PFAS Reporting Rule Under TSCA
The Final Rule Will Present Significant Compliance Challenges for Manufacturers and Importers of PFAS
- The U.S. Environmental Protection Agency (EPA) published a final rule that requires comprehensive reporting by manufacturers and importers of the more than 1,000 per- and polyfluoroalkyl substances (PFAS) manufactured and imported in the United States since 2011 under the Toxic Substances Control Act (TSCA).
- Reporting entities are likely to need all 18 months allocated by EPA to come close to meeting the reporting obligation, as well as to build compliance systems to address ongoing requirements.
- The final rule will require an investigation across the entire enterprise, as well as upstream supply chains and downstream end-users, given its broad language and breadth; it contains no volume exemptions and requires reporting of information known or reasonably ascertainable by the reporting entity.
- This Holland & Knight alert describes what PFAS are covered by the final rule, which entities are required to report, what must be reported, recordkeeping obligations, how to address confidential business information and deadlines.
The U.S. Environmental Protection Agency (EPA) published a far-reaching and enormously important final rule (Rule) on Oct. 11, 2023, requiring comprehensive reporting of per- and polyfluoroalkyl substances (PFAS) manufactured and imported in the United States under the Toxic Substances Control Act (TSCA). Given the breadth of information required to be provided, the scope of inquiry necessary and the timeframe covered by the Rule, persons and entities affected by the Rule as discussed below are likely to need all of the time EPA has allocated for reporting to attempt to meet the Rule's requirements. Data is required to be submitted to EPA within 18 months of the Rule's Nov. 13, 2023, effective date.
Promulgated under Section 8(a)(7) of TSCA (15 U.S.C. §2607(a)(7)), the Rule is mandated by Section 7321 the Fiscal Year 2020 National Defense Authorization Act (2020 NDAA), which amended Section 8(a) of TSCA (15 U.S.C. 2607(a)).
EPA published the proposed rule on June 28, 2021. The proposed rule stated that EPA expected the rule would impact around 234 respondents, take about 120,000 hours of effort to comply and cost respondents about $10.8 million. These estimates turned out to be spectacularly low. EPA now expects the rule will cost affected entities up to $843 million, burden those entities with 11.6 million hours of effort and involve 131,410 respondents.
The remainder of this alert describes what PFAS are covered by the Rule, which entities are required to report, what must be reported, recordkeeping obligations, how to address confidential business information and deadlines.
What Chemicals Are Covered by the Rule?
PFAS are a group of synthetic organic chemicals that contain an alkyl carbon on which the hydrogen atoms have been partially or completely replaced by fluorine atoms. These carbon-fluorine bonds are some of the strongest chemical bonds; accordingly, most PFAS do not readily degrade and they persist in the environment, leading to their colloquial description as "forever chemicals." PFAS were first developed in the 1940s, and today, they are widely used in a variety of industrial processes and found in an enormous range of industrial and consumer products, ranging from firefighting foams to coatings for clothes and furniture, as well as in manufacturing of other chemicals and products. PFAS are used in a huge number of product categories, including electronics, wire and cable, pipe, cooking and bakeware, textiles, automotive applications, toys and many others. Many of these items may be imported into the United States as finished products.
In the final Rule, EPA expanded the definition of PFAS from the original proposal. As in the proposal, the Rule relies on a structural definition of PFAS but now includes compounds with at least one of the following three structures:
- R-(CF2)-CF(R')R'', where both the CF2 and CF moieties are saturated carbons
- R-CF2OCF2-R', where R and R' can either be F, O or saturated carbons
- CF3C(CF3)R'R'', where R' and R'' can either be F or saturated carbons
Based on these definitions, EPA estimates that at least 1,462 PFAS that are known to have been made or used in the United States since 2011 will be subject to the Rule.
EPA has affirmed that fluoropolymers that meet the above definitions are subject to the Rule. It is important to note that the definition of PFAS in the Rule is not necessarily identical to other definitions of PFAS used elsewhere by EPA or by other organizations.
Who Must Report Under the Rule?
Any person or entity that manufactured or imported (as defined in 15 U.S.C. 2602(9)) PFAS for a commercial purpose at any time since Jan. 1, 2011, must report the information required under the Rule. The term "manufacture for a commercial purpose" is defined as "the import [including in waste, except for municipal solid waste (MSW) specifically imported for the purpose of destruction or disposal], production, or manufacturing of a chemical substance or mixture containing a chemical substance with the purpose of obtaining an immediate or eventual commercial advantage for the manufacturer." This definition includes, but is not limited to, manufacture for commercial distribution, including test marketing, or use by the manufacturer itself as an intermediate or for product research and development (R&D). The term also includes the incidental manufacture of byproducts and impurities that are produced during the manufacture, processing, use or disposal of another chemical substance or mixture. However, an entity that simply receives PFAS from domestic suppliers or other domestic sources is not considered to manufacture PFAS for commercial purposes.
Waste management facilities are not broadly exempted under the Rule. EPA states that facilities that import waste – except for municipal solid waste specifically imported for destruction or disposal – are likely to have relevant information regarding PFAS. Recycling facilities that imported waste containing PFAS are also subject to the Rule.
Persons and entities that have merely processed, distributed in commerce, used and/or disposed of PFAS are not subject to the Rule. An example from EPA of such an entity is a wastewater treatment plant, because it processed PFAS received but does not manufacture PFAS.
What Must Be Reported Under the Rule?
TSCA Section 8(a)(7) requires that EPA collect a wide range of data on PFAS, including:
- the covered common or trade name, chemical identity and molecular structure of each chemical substance or mixture
- categories or proposed categories of use for each substance or mixture
- total amount of each substance or mixture manufactured or processed, the amounts manufactured or processed for each category of use and reasonable estimates of the respective proposed amounts
- descriptions of byproducts resulting from the manufacture, processing, use or disposal of each substance or mixture
- all existing information concerning the environmental and health effects of each substance or mixture
- the number of individuals exposed – and reasonable estimates on the number of individuals who will be exposed – to each substance or mixture in their places of work and the duration of their exposure
- the manner or method of disposal of each substance or mixture, along with any change in such manner or method
EPA is requiring reporting on a separate form for each PFAS that a manufacturer (including an importer) manufactured for each year since 2011, including each PFAS in a mixture. EPA explained that a mixture containing multiple PFAS would require a reporting form for each PFAS. EPA recognizes, however, that a single form is appropriate for certain substances of unknown or variable composition, complex reaction products, biological materials and polymers.
In addition to the general reporting form, EPA has developed two optional streamlined reporting form options for 1) article importers and 2) manufacturers of small volumes of R&D substances (below 10 kilograms). Although importers of articles are not exempt from the Rule, EPA recognizes that it cannot know what information will be "reasonably ascertainable" to article importers without knowing the full range of information available to them. If importers have a covered substance as part of an article, they will have to report information on the substance's chemical identity, processing and use, and production volume (although this may be the volume of the article rather than of the substance itself). An importer will have the option of providing other information that it may have.
EPA is requiring that all reporting under the Rule be submitted electronically through the Chemical Information Submission System (CISS) that is housed within its Central Data Exchange (CDX). EPA is in the process of developing a rule-specific reporting tool within CISS for Section 8(a)(7) PFAS reporting.
The standard for what information must be reported under the Rule is extremely broad. Covered entities will be required to conduct a "reasonable inquiry" across their organization, including not only management and supervisory personnel but all employees. In addition, EPA has indicated that information should be requested from upstream suppliers and downstream users, as well as requests for information to persons involved in R&D, import, production and marketing of covered PFAS. The Rule requires reporting of information that is "known to or reasonably ascertainable by" the company. This standard includes "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."
How Does the Rule Deal with Confidential Business Information (CBI)?
Although the Rule allows CBI claims consistent with TSCA Section 14, the Rule states that only confidentiality claims made through the Rule's electronic reporting tool at the time of reporting will be considered properly asserted; any additional TSCA CBI claims made elsewhere will be considered improperly presented and will not be treated as an assertion of CBI under TSCA. Additionally, the Rule specifically disallows assertion of CBI for certain information, including the identity of chemicals and Chemical Abstracts Service Registry Number (CASRN) for chemicals on the public TSCA Inventory, and any generic chemical name. For PFAS on the confidential TSCA Inventory, the Inventory Accession Number cannot be claimed as CBI, but the underlying chemical identity can.
If an entity claims that a specific chemical name is CBI, the entity must also submit a generic chemical name under TSCA Section 14(c)(1)(c). EPA states that if the generic name does not contain "fluor," it is inconsistent with the Rule and will be rejected. In addition, if a generic name reported under the Rule lacks the structural unit "fluor," EPA will publicly identify the chemical substance as a PFAS.
What Is the Deadline for Making Reports Under the Rule?
Data is required to be submitted to EPA within 18 months of the effective date of the Rule – based on a 12-month data collection period and a six-month reporting period (this is lengthened from the originally proposed six-month reporting period). The effective date of the Rule is Nov. 13, 2023. In addition, "small manufacturers" that are solely reporting data on imported PFAS contained in manufactured articles have an additional six months to report. A "small manufacturer" is defined as "(1) a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $120 million, and the annual production volume of a chemical substance is less than 100,000 lbs; or (2) a manufacturer (including importer) whose total annual sales, when combined with those of its parent company, are less than $12 million."
What Records Must Be Kept Under the Rule?
Entities subject to the reporting requirements of the Rule must retain records that document any information reported to EPA for five years, beginning on the last date of the information submission period. EPA asserts that this five-year retention period is consistent with the Chemical Data Reporting (CDR) Rule and corresponds with the statute of limitations for violations. EPA also believes that the five-year retention period will support any future regulatory actions that follow the information gathering mandated by the Rule, and that the burden of retaining the likely electronic data is slight.
For more information or any questions about the Rule or other matters related to PFAS, please contact the authors or another member of Holland & Knight's Environmental Team.
Information contained in this alert is for the general education and knowledge of our readers. It is not designed to be, and should not be used as, the sole source of information when analyzing and resolving a legal problem, and it should not be substituted for legal advice, which relies on a specific factual analysis. Moreover, the laws of each jurisdiction are different and are constantly changing. This information is not intended to create, and receipt of it does not constitute, an attorney-client relationship. If you have specific questions regarding a particular fact situation, we urge you to consult the authors of this publication, your Holland & Knight representative or other competent legal counsel.