Manufacturers across all industries face a wide range of new and enhanced regulations concerning per- and polyfluoroalkyl substances (PFAS). These “forever chemicals” are of particular concern due to their persistence in the environment and their widespread use. TSCA Section 8(a)(7) is one of the most significant regulations targeting PFAS and imposes new reporting requirements for a broad range of organizations. This guide will help you determine if you must report and how you can approach that task.
Table of Contents
What Is TSCA Section 8(a)(7)?
When Is the TSCA Reporting Deadline?
How Does the TSCA Define PFAS for This Rule?
What Activities Does the EPA PFAS Reporting Rule Cover?
What Are the TSCA Reporting Requirements Under This Rule?
How Can Manufacturers Meet TSCA PFAS Reporting Requirements?
Is This Still Required for Organizations Already Reporting to the EPA?
How Do Manufacturers Submit Reports?
Take the Time to Understand Your Reporting Obligations Today
What Is TSCA Section 8(a)(7)?
The new rule is an addition to the Toxic Substances Control Act (TSCA), which already covers a wide range of chemical reporting requirements. The National Defense Authorization Act for Fiscal Year 2020 amended the TSCA, adding Section 8(a)(7) in 2019, tasking the US Environmental Protection Agency (EPA) with creating a back-dated PFAS reporting program extending back to 2011.
The new TSCA reporting requirements mean that manufacturers and importers must report all PFAS use, production, and import since 2011, with few exceptions. Reports are due by May 8th, 2025, for most manufacturers, leaving limited time to gather over a decade’s worth of data.
The EPA acknowledges the burden this places on manufacturers and makes a variety of concessions after the public comment period regarding scope and deadlines. However, the EPA’s own estimates put the total cost of reporting efforts by the public sector to meet these requirements at $843 million, accounting for hours spent by internal teams, hiring external consultants, and environmental reporting software.
When Is the TSCA Reporting Deadline?
The EPA has modified the timeline from their initial proposal to allow for a one-year information collection period after the effective date of the rule, followed by a six-month reporting period. The effective date of the rule is November 13th, 2024.
Manufacturers have until May 8th, 2025, to submit their use, production, and import of PFAS since 2011 to the EPA, with the reporting period first opening on November 12th, 2024.
However, the EPA has extended the deadline for small manufacturers by an additional six months, for a deadline of November 10th, 2025. This extended deadline is only available for small manufacturers as defined by 40 CFR 704.3.
How Does the TSCA Define PFAS for This Rule?
There are many different regulations concerning PFAS, and they rarely include the same definition. The specific chemicals to be included under the new rule have been a major point of contention, with the EPA opting for some of the broadest definitions of any regulation.
While many reporting requirements provide a list of specific PFAS chemicals, such as the Toxics Release Inventory (TRI), TSCA Section 8(a)(7) goes with a structural condition. This means that any chemical that satisfies any of these three conditions must be reported, regardless of its inclusion on any official lists:
- 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
The use of a structural definition greatly complicates the reporting process for manufacturers, especially where records only include common trade names and require additional investigation to arrive at the chemical structure.
The TSCA lists many chemicals falling under this definition, drawing from the US TSCA Inventory, Low Volume Exemptions (LVEs), and other lists within the CompTox database. Despite containing 12,697 entries, this list is not comprehensive. While it may be a useful resource to identify reportable chemicals, the structural definition is what matters. A chemical that meets the structural definition but is not on this list must still be reported.
What Activities Does the EPA PFAS Reporting Rule Cover?
TSCA 8(a)(7) is just as broad in terms of reportable activities. Any organization that has manufactured or imported PFAS in any year since 2011 must report, with only a few exemptions.
Activities that fall under this definition include:
- Manufacture, production, or import of PFAS or chemical substances containing PFAS for sale
- Manufacture of PFAS for distribution, test marketing, as an intermediate, or for commercial R&D
- Coincidental manufacture of PFAS as byproducts or impurities
- Import of PFAS as waste for recycling or reuse or from non-municipal solid waste streams.
Activities that DO NOT fall under this definition include:
- Processing, distribution, use, or disposal of PFAS unless also manufactured or imported
- Receipt of PFAS from a domestic source
- Manufacture of PFAS for strictly non-commercial purposes (Primarily academic and government organizations)
- Import of PFAS from municipal solid waste streams.
This broad scope means that manufacturers may be responsible for reporting even if the primary products they produce are not PFAS. Even minor concentrations and intermediates are also reportable, requiring detailed insight into chemical use at every stage of production.
What Are the TSCA Reporting Requirements Under This Rule?
The EPA provides complete reporting requirements for TSCA 8(a)(7) in 40 CFR Part 705. There are two distinct reporting options: the full reporting form and the streamlined reporting form. Both options require significant data on PFAS use.
The Streamlined Reporting Form
There are only two cases that qualify for the streamlined reporting form:
- Importers where articles imported contain PFAS, but no other manufacturing is done
- Commercial R&D where manufacture and import total less than 10 kg per year
If your organization meets either of these criteria and does not have other PFAS manufacture or import activities that fall outside of them, you may report using the streamlined form. The EPA has published a Small Entity Compliance Guidance document to facilitate this process for small businesses, although streamlined reporting is available for organizations of any size if they meet either criteria.
Each of these two categories has specific information that must be reported. Information in common between the two includes the following:
- Chemical identity (name, description)
- Chemical identification number (CAS, TSCA Accession, or LVE)
- Trade or common name
- Representative molecular structure
- Indication for imported PFAS that were never physically onsite
- Additional optional information
Organizations submitting the streamlined form because they are strictly importers must also include the following:
- Import production volume
- For industrial imports: sector and functional use
- For consumer and commercial imports: product category and functional use
- Maximum PFAS concentration in any product
- Indication for use in products intended for children
Organizations submitting the streamlined form under the R&D exemption must also include the following:
- Total production volume
- Production volume domestically manufactured vs. imported
While significantly less comprehensive than the full reporting form, many manufacturers and importers may still find compiling this data dating back to 2011 a significant challenge.
The Full Reporting Form
Manufacturers who do not fall under any exemptions must complete the full reporting form for each PFAS that they have manufactured or imported since 2011. A separate form submission is required for each chemical substance that is a PFAS. That includes submitting multiple forms for chemical mixtures that contain two or more different PFAS, with a form for each PFAS in the mixture.
The full reporting form requires a wide range of data for each PFAS, with categories covering:
- Chemical identity and structure
- Chemical identity and trade names
- Chemical categorization
- Use
- Production volumes
- Byproducts
- Disposal
- Exposures
- Environmental and health effects
This list comprises a wide range of information that manufacturers may or may not have straightforward access to. TSCA Section 8(a)(7) requires manufacturers to include any information that is “known or reasonably ascertainable.” The EPA expects organizations to make certain efforts to aggregate, calculate, or retrieve information where possible.
If records are not readily available, organizations must make reasonable inquiries throughout the full scope of the organization. This could entail inquiries outside the organization, such as to suppliers or downstream users.
Manufacturers can rely on a variety of analytical methods to arrive at reportable values, and they must disclose their methods in the report. Mass balance calculations, emissions factors, and best engineering judgment are all potential sources of data concerning production volumes, byproducts, and disposal.
The full reporting form also requires listing “all existing information concerning the environmental and health effects” of each PFAS. This isn’t information that manufacturers produce themselves, but instead existing information such as health and safety studies. Some examples include short and mid-term toxicity tests, ecological or other environmental impact studies, human exposure assessments, range-finding studies, and even preliminary studies.
Many of these details can be found within a substance’s safety data sheet (SDS). At the very least, the GHS hazard classifications found on an SDS can point manufacturers in the right direction by identifying the specific environmental and health effect categories to which a chemical belongs.
How Can Manufacturers Meet TSCA PFAS Reporting Requirements?
The broad scope of TSCA Section 8(a)(7) in terms of reportable chemicals and information to be reported presents a significant challenge for many manufacturers. An organization must determine which of its chemical substances, mixtures, and products qualify as or contain PFAS (even byproducts and impurities) and produce comprehensive use data dating back to 2011.
For production processes with any degree of complexity, this means rigorous calculations and modeling. Where records currently exist, they may not cover chemical composition, waste disposal volumes, and other key values in sufficient detail. When approaching this challenge at the scale of just one facility, much less multiple facilities across an organization, turning to a robust environmental management system could be the best course of action.
ERA’s Environmental Management System (EMS) provides the necessary insight into chemical use, byproducts, and waste to meet TSCA Section 8(a)(7) requirements. During the implementation process, we work with your team to model your facility – applying mass balance calculations, emissions factors, and more to trace PFAS and other chemicals from end to end.
Bulk data uploads from any source (Excel, APIs, ERPs, purchase orders, invoices, CMS, and more) automate the process of aggregating the back-dated information required for TSCA Section 8(a)(7). The EMS then calculates the values needed for the report, broken down by specific PFAS substance – or any other way you’d like to see the data.
Of course, determining which chemicals within products, byproducts, and waste must be reported is another major challenge. ERA's Master Chemical List (MCL) provides the foundation to overcome this problem. This extensive list of chemical and regulatory data is maintained and kept up-to-date by ERA's environmental scientists and regulatory experts. With entries on more than 216,000 chemicals, ERA's MCL ensures reporting accuracy under TSCA Section 8(a)(7) and an extensive range of other regulations.
Is This Still Required for Organizations Already Reporting to the EPA?
The broad scope of TSCA Section 8(a)(7) will make it the first time that some organizations report to the EPA. However, many manufacturers are well acquainted with regular EPA reporting and will have submitted information on some PFAS use through TRI, NEI, and other reporting programs.
It is important to stress that having already submitted information on PFAS through one reporting program does not mean that a manufacturer can overlook TSCA Section 8(a)(7). There are a few key reasons why:
- The scope of chemicals included is much higher compared to earlier programs
- Production and import thresholds found in some programs do not apply in this case
- Certain programs may not include byproducts, impurities, and waste
Even when an organization has submitted some information on PFAS use to the EPA through other reporting programs, they must still submit under TSCA Section 8(a)(7) to ensure that all information is reported for each PFAS.
How Do Manufacturers Submit Reports?
When the reporting period opens on November 12th, 2024, manufacturers will be able to submit reports through the EPA’s Central Data Exchange (CDX), which is already used for other reporting programs. A specific tool will be available within the platform’s Chemical Information Submission System (CISS).
Take the Time to Understand Your Reporting Obligations Today
TSCA Section 8(a)(7) is extensive in scope and requires detailed data dating back to 2011. While the May 8th, 2025, deadline might still seem far away, the time to evaluate your reporting obligations is today. Your team might be surprised at the mismatch between the data you need and the data you have on hand today. You don’t want to make that discovery when it’s too late to implement the solution you need.
If you’re looking for a solution to meet these new reporting requirements, the seasoned regulatory experts at ERA can help. Schedule a discovery call today to see how our software can handle your environmental reporting needs, whether for TSCA Section 8(a)(7) or the full range of reporting programs.
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