There are many questions about the PFAS reporting rule under TSCA Section 8(a)(7), which requires manufacturers and importers to report PFAS usage, including data from as far back as 2011, starting in 2025. In a webinar, we addressed key concerns from businesses preparing for these requirements. Continue reading for detailed answers to common questions and explore additional resources to help simplify compliance.
Who oversees TSCA Section 8(a)(7)?
The United States (U.S.) Environmental Protection Agency (EPA) oversees the implementation and enforcement of the TSCA PFAS reporting rule.
What companies are in scope?
Any company that has manufactured or imported PFAS and/or PFAS-containing articles since January 1, 2011, is in scope. The EPA specifically mentions construction and manufacturing companies, retail and wholesale traders, and waste management services; however, this is not an exclusive list.
Which PFAS are in scope?
The EPA has identified substances from the TSCA Inventory and Low-Volume Exemptions (LVEs)/CBI ID Claims that meet the proposed structural definition. Reference lists can be found on the EPA website and the CompTox Chemicals dashboard; however, these lists are non-exhaustive. Any substance that meets the structural definition is in the scope of the reporting requirements.
What is the covered timeframe?
The TSCA 8(a)(7) reporting rule covers a "lookback period" from January 1, 2011, through December 31, 2022, spanning 12 years. Unlike CDR reporting, all years within this period are treated equally, and the same data must be reported for each year. However, the reporting software allows companies to select specific years if PFAS were not manufactured or imported every year during this timeframe.
When is the TSCA Section 8(a)(7) reporting deadline?
The EPA has extended deadlines for two key compliance reporting rules, allowing businesses more time to submit required data while the agency finalizes its PFAS data collection software.
The final reporting deadline is now January 11, 2026, for most businesses. Small manufacturers (as defined by the regulation) who are reporting data solely on importing PFAS contained in articles will have until July 11, 2026. The electronic portal for reporting will open on July 11, 2025, allowing companies to begin submissions.
What information must be submitted to the EPA for PFAS reporting under TSCA?
The following checklist of information must be submitted to the EPA:
- Name of the PFAS
- Chemical Abstracts Service (CAS) number
- Structural definition
- Categories of use
- Amount produced or used
- PFAS byproducts
- Existing information on environmental and health effects
- Number of people exposed
- Manner of disposal for each PFAS
What’s the threshold for reporting PFAS under TSCA 8a7?
There is no minimum reporting threshold or concentration for PFAS under this rule. Any amount of PFAS manufactured or imported for commercial purposes since January 1, 2011, must be reported.
What exemptions apply under the TSCA 8(a)(7) reporting rule?
The TSCA Section 8(a)(7) reporting rule provides limited exemptions. Companies are exempt if they have not manufactured or imported PFAS since 2011, as are most municipal solid waste facilities. Products regulated by other agencies, such as food, drugs, cosmetics, tobacco, specified nuclear material, firearms, ammunition, and pesticides, are generally excluded from TSCA. However, all other PFAS used in articles, mixtures, or waste streams must be reported.
If a company purchases products containing PFAS from a U.S. supplier, are they still required to report to the EPA?
If your company purchases products containing PFAS from a U.S. company, you may still need to report to the EPA. The reporting rule covers both PFAS production and use, meaning companies down the supply chain could be responsible. Joint submissions are an option, where the original manufacturer, such as a resin producer, reports the relevant PFAS data. It’s important to assess your role in the supply chain to determine your reporting obligations under TSCA Section 8(a)(7). All parties involved in the import transaction should consider the definition of “importer” when determining who may be responsible for reporting under this rule.
If you did not manufacture (including import) a PFAS, you do not have reporting requirements under this rule. Under 40 CFR 705, the manufacturer (including importer) of the PFAS must report. 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/importer and would not report on that substance.
Do TSCA and EPA rules apply to medical devices regulated by the FDA?
No, medical devices regulated by the FDA are exempt from TSCA and EPA rules. TSCA excludes substances overseen by other agencies, such as food, drugs, cosmetics (FDA), pesticides (FIFRA), and radioactive materials (NRC). Small quantities used for research and development may also be exempt. Companies handling these products must comply with the relevant agency’s regulations instead of TSCA requirements.
How can companies determine due diligence for reporting?
To support companies with TSCA Section 8(a)(7) reporting, the EPA provides a detailed due diligence guide, including examples of how to apply the “known or reasonably ascertainable” standard. A small entity compliance guide further outlines reporting obligations, helping businesses meet regulatory requirements. By using these resources, companies can ensure their due diligence aligns with EPA standards.
Which PFAS chemical list should I refer to for TSCA 8(a)(7) reporting?
There is no comprehensive or definitive list of PFAS that must be reported under TSCA 8(a)(7). However, the TSCA 8(a)(7) PFAS Chemicals Substance List is particularly useful as it aligns closely with the rule's requirements. While this list is the most relevant CompTox resource for this rule, other lists, such as PFASDEV and PFASSTRUCT, were developed for different purposes and are not applicable. Additionally, the TSCA 8(a)(7) Public List is relevant but may exclude some chemicals due to Confidential Business Information (CBI) claims. Importantly, these lists are only examples of PFAS substances, and the absence of a substance from these lists does not necessarily mean it is not reportable. Among the CompTox resources, the Chemicals Dashboard PFAS8a7 list remains the most pertinent for this rule.
For the purposes of the section 8(a)(7) rule, “PFAS” refers to all chemical substances covered by the structural definition of “PFAS” for this rule:Any chemical substance or mixture containing a chemical substance that structurally contains at least one of the following three sub-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.
Any PFAS that meets this rule’s definition, and which had been manufactured (including imported) for commercial purposes in any year from 2011-2022, must be reported.
Can I access CDX for TSCA 8(a)(7) PFAS reporting without an Authorized Official’s ID?
No, access to the CDX platform for TSCA 8(a)(7) PFAS reporting is currently unavailable. While the EPA’s CDX webpage will direct users to the correct platform, the application launch has been delayed. Originally set to begin in November 2024, the reporting period was pushed to July 2025 due to budget constraints, postponing the software’s release until the new start date.
Will a user guide be available for non-CDX users to understand the portal and reporting process?
Yes, the EPA has provided a CDX registration guide that is accessible to the public. However, the reporting application for the TSCA 8(a)(7) rule will only be available at the start of the submission period. In the meantime, PFAS manufacturers are encouraged to register with CDX and add the CSPP program to their accounts.
Where can the Streamlined Reporting Form for articles be found?
Guidance on streamlined reporting eligibility under TSCA Section 8(a)(7) is available in Section 2.2 of the official instructions. This document outlines the criteria and process for streamlined reporting. Companies must access the reporting form through the EPA’s CDX portal and review the instructions carefully to ensure compliance with all requirements.
How does reporting on industrial use work for articles?
Reporting on industrial use for articles under the PFAS rule depends on how the PFAS are used. Companies must report if PFAS are present in articles for industrial purposes, as the rule covers PFAS manufactured or imported for commercial use. Evaluating the specific use within each article is essential to determine whether it meets the reporting criteria under TSCA Section 8(a)(7).
If you are manufacturing a PFAS and then using it to manufacture an article, then three of the following possible codes could apply: PA (incorporation into an article), PC (processing as a reactant), or PF (incorporation into formulation, mixture, or reaction product) depending upon the specific situation. If the PFAS is mixed with other substances and then incorporated into an article, a site might need to report both PF and PA as different processing steps.
Can third parties submit reports on behalf of their clients in CDX?
Yes, but the process must begin with the organization’s Primary Authorized Official (AO), who sponsors the third-party agent. Once sponsored, the consultant can complete the form up to the point of submission. The EPA’s CDX CSPP user guide provides further details on user roles and registration requirements.
Are the Excel files the actual submission documents?
No. Manufacturers are required to submit all information to EPA through the CDX reporting application interface.
Will any bulk upload or system integration be enabled?
Not at this time. However, the EPA is investigating options to enable bulk upload functionality.
Will chemical structures need to be uploaded in a specific format?
Molecular structures must be uploaded as attachments, though no specific file format is required. However, if the PFAS is a Class 1 substance listed on the TSCA Inventory, submitting the molecular structure is not mandatory.
Are there concerns that FMDs will not cover PFAS in small quantities or under proprietary labels?
Yes, concerns exist that Full Material Declarations (FMDs) may not capture PFAS, especially in small quantities or within proprietary materials that do not disclose all components. To mitigate this, obtaining an absence declaration alongside the FMD is recommended. This ensures any potential PFAS use, even in trace amounts or hidden under proprietary labels, is accounted for, reducing the risk of non-compliance.
Other than FMD and SDS, are there declarations that a manufacturer can provide?
In addition to FMDs and Safety Data Sheets (SDS), manufacturers can provide formal no-PFAS-use statements. These declarations offer further assurance but should ideally be paired with FMDs or SDS for products where PFAS may be present. This combination helps ensure transparency and regulatory compliance.
Does TSCA Section 8(a)(7) require companies to test their products for the presence of PFAS?
No, TSCA Section 8(a)(7) does not require companies to perform new PFAS testing. However, any existing PFAS test data must be reported. Companies are expected to review their records and include relevant data to ensure compliance with the regulation. If they do not know nor can reasonably ascertain that they have manufactured (including imported) PFAS, including in their packaging material, they do not need to report.
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