Framework for Addressing New PFAS and New Uses of PFAS
EPA's Framework for Addressing New PFAS and New Uses of PFAS outlines EPA’s planned approach when reviewing new PFAS and new uses of existing PFAS to ensure that, if allowed to enter into commerce, they will not be harmful to human health and the environment. The Framework supports the Biden-Harris Administration’s commitment to address the impacts of these forever chemicals, and advances EPA’s PFAS Strategic Roadmap to confront the human health and environmental risks of PFAS.
New PFAS present a challenge for EPA to evaluate because there is often insufficient information to quantify the risk they may pose and consequently make effective decisions about how to regulate them. Many PFAS are known to persist and bioaccumulate (i.e., build up) in the environment and people and have the potential risk not only to those who directly manufacture, process, distribute, use, and dispose of the chemical substance but also to the general population because these chemicals may be released and build up in the environment over time. This Framework will be used to qualitatively assess PFAS that are likely persistent, bioaccumulative and toxic (PBT) chemicals.
Under the Framework, EPA expects that some PBT PFAS will not result in worker, general population or consumer exposure and are not expected to result in releases to the environment, such as PFAS used in a closed system to make semiconductors or other electronic components. In such a negligible exposure and environmental release scenario, if EPA can ensure that such PBT PFAS can be disposed of properly and no consumer exposure is expected, EPA generally expects to allow the PFAS or the new use of a PFAS to enter commerce after receiving basic information, such as physical-chemical property data, about the substance. If this initial data cause concern, then EPA will require additional testing and risk mitigation before moving forward.
For PBT PFAS that are expected to have a low - but greater than negligible - potential for release and environmental exposure, EPA generally expects to require test data in addition to physical chemical properties, such as toxicokinetic data, before allowing manufacturing to commence. If initial test results cause concern, then EPA will require additional testing and risk mitigation before moving forward.
For PBT PFAS that are expected to lead to exposure and environmental releases, and absent a critical or military need for the substance that necessitates limited and restricted manufacture while testing is ongoing, EPA generally expects that the substance would not be allowed to enter commerce before extensive testing is conducted on physical/chemical properties, toxicity and fate. For example, use of PFAS in PFAS in spray-applied stain guards inherently involve releases to the environment. If the test results cause concern, then EPA could require additional testing and risk mitigation before moving forward, or could prevent the substance from being manufactured at all.
By distinguishing uses that result in environmental releases and/or potential worker or consumer exposure from those that don’t, as well as requiring upfront testing for many PFAS, the application of the Framework will help ensure that new PFAS won’t harm human health and the environment. At the same time, it also allows certain PFAS to be used when exposures and releases can be mitigated, which is critical for important sectors like semiconductors. These policy changes are aligned with the EPA PFAS Strategic Roadmap and help prevent unsafe new PFAS from entering the environment.
The data EPA will obtain on physical/chemical properties for any new PBT PFAS under this Framework and more extensive toxicity and fate data for PFAS with potential exposures or releases will also support EPA’s efforts under the National PFAS Testing Strategy and advance the Agency’s understanding of PFAS more broadly.
The Framework will apply to new PFAS or new use notices that are currently under EPA review, as well as any that EPA receives in the future.
EPA held a webinar on the Framework on September 6, 2023. Slides from PFAS Framework Webinar, September 2023 (pdf)