On September 5, 2024, the EPA published a direct final rule granting a deadline extension for per- and polyfluoroalkyl substances (PFAS) reporting requirements under the Toxic Substances Control Act (TSCA) Section 8 (a)(7).
The reporting period was scheduled to begin on November 12, 2024, but the final rule delays the beginning of the reporting period until July 2025 due to budgetary constraints, according to the EPA.
Budget issues
The EPA’s TSCA program has suffered from funding shortages for years, which has plagued the program’s effectiveness, including the implementation of this reporting rule.
After several previous deadline extensions, the EPA released its final PFAS data reporting rule in late September 2023. Data gathered under this regulation is expected to provide the “EPA, its partners, and the public with the largest-ever dataset of [PFAS] manufactured and used in the United States,” according to an Agency news release. “This rule builds on over two years of progress on the Biden-Harris Administration’s action plan to combat PFAS pollution, safeguarding public health and advancing environmental justice, and is a key action in EPA’s PFAS Strategic Roadmap.”
“In March 2024, the Fiscal Year (FY) 2024 program area budget that includes EPA’s TSCA program was reduced by $5 million compared to what was enacted in the FY 2023 budget, and the agency needed to make difficult choices to ensure that it would be able to continue its work to protect human health and the environment from the risks presented by toxic chemicals,” states the EPA’s Section 8 (a)(7) website. “As a result of competing priorities, many of which related to meeting statutory deadlines, EPA’s TSCA program significantly reduced its IT (information technology) operating budget in FY 2024 to prevent overspending of resources, which resulted in less funding for the contractual support EPA relies on for much of its IT efforts.
“The budget reductions stopped ongoing software development and negatively impacted operations, and maintenance activities associated with both CDX (Central Data Exchange) and TSCA CBI- (confidential business information-) based applications, which are critical to the Agency’s TSCA data collections, including for this rule. As a result, the agency software application that will collect the PFAS data will not be ready by the original November 2024 reporting period opening date and it will thus be impossible for submitters to begin to submit data on that date.”
This extension changes the data submission period to open on July 11, 2025, when the Agency expects the software reporting application to be fully functional.
“Most reporters would be required to complete all reporting by January 11, 2026,” the EPA website adds.
When the reporting rule was proposed, many were surprised it didn’t include an exception for small businesses. This was reflected in many comments received that noted the economic and regulatory burden it would place on industry, particularly on small businesses.
The final rule includes an additional extension until July 11, 2026, for small businesses reporting data solely on importing PFAS contained in articles.
Industry response to PFAS reporting rule
Regulatory compliance is a significant expense.
“To further complicate matters, there are a significant number of different and emerging PFAS regulations being developed and finalized. Many possess different requirements and impact different jurisdictions, and often they lead to added complexity and cost for equipment manufacturers,” according to the Association of Equipment Manufacturers (AEM).
“It means that you, as an organization, need to spend more money trying to understand a rule, collect different forms of data, and perform different kinds of activities in whatever jurisdiction you’re trying to sell into at the moment,” said AEM Senior Director of Safety and Product Leadership Jason Malcore.
“Another significant concern for equipment manufacturers is the implications of replacing PFAS with alternative substances,” AEM notes. “According to Malcore and Assent Vice President of Sustainability Cally Edgren, companies are starting to shorten their warranties because they lack confidence in the quality and durability of redesigned products with replacement parts.”
Other industry organizations are relieved the EPA has granted additional time to prepare to comply with “this unprecedented and significant reporting,” the American Chemistry Council (ACC) said in a statement.
“As we have communicated to the EPA, there are substantial concerns that the CDX system and the 8(a)(7) reporting platform have not been comprehensively tested to help ensure their functionality. The 8(a)(7) reporting is expected to involve a large number of submitters, many of whom are unfamiliar with TSCA reporting and the CDX, inputting vast amounts of data elements into this system. It is critical that this system functions properly to help ensure high data quality and protect [CBI], including trade secrets and national security interests,” the ACC says. “The EPA’s proposal to delay the implementation of this reporting period can allow industry and the value chain time to beta test the reporting tool and to provide feedback on the functionality of the system and tools. The EPA must assure stakeholders that its systems are fully functional and will not compromise [CBI] or trade secrets during these submission processes.
“ACC and its members are committed to enhancing the quantity and quality of information on PFAS, but we remain concerned with the overly broad approach and the unprecedented breadth of information being requested by this rule. PFAS are a diverse group of chemistries integral to thousands of products we use daily. They are an essential enabling technology for key sectors of the economy, including defense, automotive, semiconductors, electronics, alternative energy, pharmaceuticals, healthcare, building and construction, and agriculture.”
PFAS to report
PFAS are a group of manufactured chemicals, including chemicals known as perfluorooctane sulfonate (PFOS), perfluorooctanoic acid (PFOA), and GenX. They’re sometimes referred to as “forever chemicals” because they break down very slowly and can build up in people, animals, and the environment over time. Exposure at certain levels to specific PFAS can adversely impact human health and other living things. There are nearly 5,000 different types of PFAS, some of which have been more widely used and studied than others, according to the U.S. Food and Drug Administration (FDA).
The PFAS data reporting rule is a statutory requirement under the FY2020 National Defense Authorization Act (NDAA) that requires all manufacturers (including importers) of PFAS and PFAS-containing articles in any year since 2011 to report information related to chemical identity, uses, volumes made and processed, byproducts, environmental and health effects, worker exposure, and disposal to the EPA.
For this rule, the EPA has defined “PFAS” as a chemical substance that contains at least one of the following three structures:
- “R-(CF2)-CF(R′)R,″ where both the CF2 and the CF moieties are saturated carbons
- “R-CF2OCF2-R,′ where R and R′ can be either F, O, or saturated carbons
- “CF3C(CF3)R′R,″ where R′ and R″ can be either F or saturated carbons
“Under TSCA section 8(b), EPA maintains the TSCA Chemical Substance Inventory (Inventory), which contains all existing chemical substances manufactured, processed, or imported in the United States that do not qualify for an exemption or exclusion under TSCA,” states the EPA Section 8 (a)(7) website.
As of February 2023, the EPA had “identified at least 1,462 PFAS currently covered by TSCA that may be covered by this rule.”
Of the 1,462 PFAS currently on the TSCA Inventory, approximately 770 of these PFAS are on the active Inventory, meaning they’re currently in use in U.S. commerce.
“The list of active chemicals includes those known to be in commerce after June 2006,” according to the EPA Section 8(a)(7) webpage.
What information is to be reported?
To effectively research, monitor, and regulate PFAS, data gathered under this final rule is expected to help the EPA better understand who is using PFAS, how they’re being used, and in what quantities.
“The data we’ll receive from this rule will be a game-changer in advancing our ability to understand and effectively protect people from PFAS,” said Assistant Administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff in the EPA news release.
Under TSCA Section 8(a)(7), the final rule requires each person who has manufactured (including imported) PFAS in any year since January 1, 2011, to electronically report certain data to the EPA, 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;
- The 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; and
- The manner or method of disposal of each substance or mixture and any change in such manner or method.
“Information submitted under this data call may be claimed as confidential; however, such claims must be made at the time of submission and substantiated in accordance with TSCA and the PFAS data reporting rule,” notes an EPA Fact Sheet. “Submitters must provide upfront substantiation of all confidentiality claims except for claims made for import or yearly production volume information. Submitters who do not know the underlying identity of the chemical other than a generic chemical name (i.e., do not know a CASRN, or TSCA Accession or LVE numbers) are not required to assert and substantiate a CBI claim for chemical identity. Reporters using the article importer form also are not required to assert and substantiate a CBI claim for specific chemical identity.” Certain processing and use data elements or a response that’s designated as “not known or reasonably ascertainable” may not be claimed as confidential.
Although the reporting requirements seem fairly straightforward, regulated industry should expect to expend significant time and resources to ensure compliance.
Who is required to report?
“Under 40 CFR 705, the manufacturer (including importer) of the PFAS must report,” states an EPA Frequently Asked Questions document on the rule. “If you purchased multiple PFAS from a domestic source (i.e., did not import the PFAS) for subsequent processing or use, then you are not the PFAS manufacturer and would not report on that substance. If you process or use PFAS in your operations, however, be sure to account for any coincidentally manufactured PFAS such as byproducts and impurities, as those are reportable to the extent known or reasonably ascertainable.”
For the purposes of this rule, an “importer” is defined as:
- Any person who imports any chemical substance or any chemical substance as part of a mixture or an article into the customs territory of the United States and includes:
- The person primarily liable for the payment of any duties on the merchandise, or
- An authorized agent acting on the person’s behalf.
- Importer also includes, as appropriate:
- The consignee,
- The importer of record,
- The actual owner if an actual owner’s declaration and superseding bond have been filed in accordance with 19 Code of Federal Regulations (CFR) 141.20, and
- The transferee if the right to draw merchandise in a bonded warehouse has been transferred in accordance with subpart C of 19 CFR part 144.
- For the purposes of this definition, the customs territory of the United States consists of the 50 states, Puerto Rico, and the District of Columbia.
Joint reporting
“In response to public comments, EPA is permitting joint submissions for certain PFAS when suppliers will not disclose the identity of the chemicals to the manufacturer. The joint submission process allows suppliers or other entities to submit the required data to the EPA without sharing confidential chemical information with customers,” according to a Jones Day Insights article.
Takeaway
In addition to those entities that are already required to comply with TSCA, this regulation is likely to apply to manufacturers and importers who have not previously been required to comply with TSCA regulations. Although the six-month submission period has now been extended, industry “should start preparing and collecting the necessary information without delay to ensure there is sufficient time to compile and report,” Jones Day advises.
Numerous resources are available from the EPA to assist in compliance: