Overview of TSCA’s New PFAS Requirements

Effective January 1, 1977, the Toxic Substances Control Act (TSCA) mandates the Environmental Protection Agency (EPA) to secure information on all new and existing chemical substances, as well as to control through regulatory restrictions and measures any substances determined to cause "unreasonable risk to public health or the environment."

To that end, the EPA is authorized to issue rules requiring the testing of specific chemicals and to establish regulations that restrict the manufacturing, processing, distribution in commerce, use and disposal of chemicals and mixtures. 

Additionally, the Act manages the TSCA Chemical Substance Inventory, an exhaustive list that contains all existing chemical substances imported, manufactured or processed in the United States that do not qualify for an exemption or exclusion under TSCA. Initially published in 1979, "The Inventory" now consists of more than 86,000 chemicals referred to as "existing chemicals" (chemicals not on the list are referred to as new chemicals).

In accordance with its mandate, on October 11, 2023, the agency published a final rule under the Toxic Substances Control Act Section 8(a)(7), Reporting and Recordkeeping Requirements for Perfluoroalkyl and Polyfluoroalkyl Substances. It's important to note, however, that the rule does not represent new ongoing compliance responsibilities but is a one-time TSCA compliance obligation designed to assist the EPA in gaining a better understanding of the pervasiveness of PFAS usage in the United States.

Does the new rule apply to you?

This action may apply to you if you have manufactured or imported PFAS for a commercial purpose at any time since January 1, 2011. 

Potentially affected entities include:

• Construction

• Manufacturing

• Wholesale trade

• Retail trade

• Waste management and remediation services

However, other business entities could also be regulated. If you're unsure of whether the Act applies to a specific entity, we have included contact information at the bottom of this post.

What do you need to do if the rule does apply to you?

The new rule requires companies to retroactively report their PFAS usage from January 1, 2011, to December 31, 2022.

What is considered "PFAS" under the new rule?

To enforce the new TSCA regulations, the EPA has proposed the use of a structural definition of PFAS rather than a discreet list. 

The definition of "PFAS" includes chemical substances that contain at least one of these three structures:

1.  R-(CF2)-CF(R′)R″, where both the CF2 and CF moieties are saturated carbons
2.  R-CF2OCF2-R′, where R and R′ can either be F, O, or saturated carbons; 
3. CF3C(CF3)R′R″, where R′ and R″ can either be F or saturated carbons.

What do you need to report?

To achieve TSCA compliance, manufacturers (including importers) subject to the rule must submit a wide scope of information regarding each PFAS compound they manufactured (to the point that it is known or reasonably ascertainable, see further details below). This includes but is not limited to:

• chemical identifying information, such as the chemical's common name and CAS number
• composition of the PFAS
• total volume of the substance manufactured or processed amounts
• maximum concentrations of the compound within the specific product
• descriptions of any manufacturing or processing byproducts and their corresponding disposal methods
• details on any worker exposure to the substance 
• any known environmental and health effects of the PFAS in use

Compliance obligations vary. To understand the full scope of your responsibilities, verify requirements by your specific classification. 

To assist covered entities with requirements, EPA has published reporting instructions, which include what information is to be reported as well as guidance on streamlined reporting "available for importers of articles and for manufacturers of less than 10 kg of a substance used solely for research and development."

How do you report?

Reporting is to be submitted through EPA's reporting site, Central Data Exchange.

How long must you retain your records?

Retain all records documenting any information reported to the EPA for a minimum of five years, starting on the final date of the submission period.

Do you need to re-report?

"If EPA has identified the reporting as duplicative, your site is not required to re-report duplicative information but must submit a report and include all information required by this data call that has not been previously reported to EPA." See section 1.2 Duplicative reporting in Instructions for Reporting PFAS Under TSCA Section 8(a)(7) for more information.

When do you need to report?

For most covered entities, the EPA submission period begins on November 12, 2024, and closes on May 8, 2025

However, small manufacturers (as defined under 40 CFR 704.3) whose PFAS reporting obligations are exclusively due to article import are given an additional six months, with the reporting window for these entities closing on November 10, 2025. 

But what if you don't know everything?

The full scope of information and data being requested through the new TSCA regulations is vast. The EPA understands that some entities may not have access to the full breadth of information being asked. To accommodate this, the agency has included a "Not Known or Reasonably Ascertainable" (NKRA) option on many of the reporting forms. If manufacturers do not know or can not reasonably make estimates for certain data elements (except for production volumes), they may indicate the information as NKRA. 

However, reporting NKRA should only happen when data are truly not reasonably ascertainable or are unattainable. See below for further details on expectations, estimates and ranges.

So, what does "reasonably ascertainable" mean?

According to the EPA, for the purpose of this rule, "Known to or reasonably ascertainable by" is 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" (40 CFR 704.3).

The expectation is that manufacturers and importers do their due diligence in fulfilling their TSCA compliance obligations. 

What is considered "due diligence"?

To garner a more comprehensive picture of the PFAS in their manufacturing processes, products and materials and help fill knowledge gaps, companies should plan to collaborate with business partners along the supply chain. This could 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."

Examples of types of information that are considered to be in a manufacturer's possession or reasonably ascertainable 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
• information from the CAS or from Dun & Bradstreet (D–U–N–S)
• documented knowledge gained through discussions, conferences, and technical publications
• existing survey data

However, If specific information can not be reasonably estimated or derived without conducting customer surveys, for example, then the information would not be considered "reasonably ascertainable" to the submitter. 

Again, what if you don't have the actual data?

Rather than reporting information as NKRA, estimate! 

"Reasonable estimates" may rely on approaches such as mass balance calculations, emissions factors, or "best engineering judgment." For example, information on worker exposure can be provided by estimating "a range of number of workers reasonably likely to be exposed for each commercial use based on the manufacturer's knowledge of the commercial sites' sizes."

For manufacturers and importers interested in mitigating risks while meeting regulation requirements, more extensive processes may be considered. Material reviews and third-party testing, for instance, can help a company assess the likelihood that a component, product or material contains PFAS and provide more definitive determinations.

Significant New Use Rule for PFAS

On January 8, 2024, the EPA finalized a significant new use rule (SNUR) to further strengthen the regulation of PFAS and tackle the impacts of forever chemicals.

The SNUR prevents companies operating in the U.S. from resuming manufacture or processing of inactive PFAS without EPA review of the significant new use and applies to all PFAS designated as "inactive" (defined as not having been manufactured, processed, or imported since June 21, 2006) on the TSCA Inventory and not subject to a preexisting SNUR. 

The rule "reflects the Biden-Harris Administration's commitment to address the impacts of these forever chemicals and is a key action in EPA's PFAS Strategic Roadmap," states the agency.