On June 29, 2023, EPA issued its “Framework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs)”—its latest effort to stop the environmental release of per- and polyfluoroalkyl substances (PFAS). This move targets PFAS at the industry source in order to eliminate risks before PFAS enter commerce.

PFAS are of great public and governmental interest because of their widespread use in a variety of products, ability to persist in the environment, and documented adverse human health and environmental effects. This past March, PFAS received exceptional public attention when EPA proposed its first-ever national drinking water standards for six PFAS. However, new PFAS entering the marketplace present a significant challenge for EPA to evaluate. Often, there is insufficient information on the new substance in order to quantify risk and make effective decisions regarding its regulation—there are thousands of different PFAS, but data for only a small fraction are available to the broader scientific community, regulators, and the public.

The new Framework issued by EPA will guide EPA’s New Chemicals Program with a planned approach for its review of new PFAS or significant new uses of existing PFAS. Under section 5 of the Toxic Substances Control Act (TSCA), the New Chemicals Program functions as a “gatekeeper” to regulate new chemicals before they enter commerce and new uses of existing chemicals in the marketplace. Before being distributed and used in commerce, new chemicals and significant new uses of existing chemicals are reviewed through premanufacture notices (PMNs) and significant new use notices (SNUNs) submitted to EPA. For each PMN and SNUN submission, TSCA requires the New Chemicals Program to make a finding pertaining to the risk of the new chemical or significant new use. Importantly, the Framework will not only apply to notices that EPA receives in the future, but to notices that are currently under EPA review.

The Framework

EPA’s new framework outlines a series of steps in evaluating new PFAS and new uses of PFAS.

  1. The first step in the Framework is to determine whether the substance under review falls into the chemical category definition of PFAS.
  2. If the substance submitted is a type of PFAS, EPA will determine the key components of interest (e.g., the substance itself, or potential metabolites or degradants) and will begin reviewing all available data on the PFAS. EPA will specifically assess whether the PFAS is a persistent, bioaccumulative, and toxic (PBT) chemical.
  3. If the PFAS is a PBT chemical, EPA will then not only consider potential exposure risk of those who come in direct contact with the substance but will also consider the risk to the general population, because PBT chemicals tend to persist and build up in the environment over time. If a PFAS is not found to be a PBT chemical, the chemical will go through the typical assessment process. However, EPA expects that most PFAS will be PBT.
  4. Next, TSCA requires EPA to review each PMN and SNUN submission and make a finding pertaining to the risk of the new chemical substance or significant new use. In general, TSCA provides five possible determinations:
DeterminationEPA Action  
1. The substance or significant new use may present unreasonable risk.  1. EPA must issue an order under section 5(e).
2. There is insufficient information to permit a reasoned evaluation of risk.  2. EPA must issue an order under section 5(e).
3. The substance or significant new use presents an unreasonable risk.  3. EPA must issue an order under section 5(f).
4. Substantial quantities of the substance may result in significant exposure.  4. EPA must issue an order under section 5(e).
5. The substance or significant new use is not likely to present an unreasonable risk.5. EPA notifies submitter of its decision and publishes its finding in the Federal Register.

Given EPA’s current understanding of PFAS, EPA believes that PBT PFAS are unlikely to receive the last determination of “not likely to present an unreasonable risk,” which is the only type of determination that does not require EPA to issue a section 5(e) order, which may include testing requirements and risk management measures, or a section 5(f) order, which may limit or prohibit use of the substance.

The risk management measures in a 5(e) order will largely be a function of the degree of expected exposures and environmental releases of the PBT PFAS. If negligible exposures and environmental release are expected, then EPA may allow the use of the substance after additional testing of the substance and review of the tests. Low exposure and environmental release may also permit the substance to be used in manufacturing after additional tests are submitted and reviewed by EPA and risk mitigation is implemented. However, if exposure and environmental releases are expected of the PBT PFAS, EPA will require extensive testing and review of the substance. Manufacturing with the substance may be prohibited after EPA’s review, or allowed with limitations and protections.

Taft attorneys have been at the forefront of PFAS litigation for more than two decades, and have tracked this chemical from before it was regulated to its current status as a focal point of state and federal environmental regulation. For help navigating EPA’s PFAS regulations, contact Taft attorneys.