The U.S. Environmental Protection Agency (EPA) has announced its framework for addressing new and new uses of per- and poly-fluoroalkyl substances (PFAS). The framework outlines EPA’s planned approach when reviewing new PFAS and new uses of PFAS to ensure that, before these chemicals are allowed to enter into commerce, EPA will undertake an extensive evaluation to ensure they pose no harm 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 pollution.
“For decades, PFAS have been released into the environment without the necessary measures in place to protect people’s health – but with this framework, EPA is working to reduce the risk posed by these persistent contaminants,” said assistant administrator for the Office of Chemical Safety and Pollution Prevention Michal Freedhoff. “EPA’s new framework will ensure that before any new PFAS enter the market, these chemicals are extensively evaluated and pose no risk to people’s health or the environment.”
Under the Toxic Substances Control Act (TSCA) section 5, EPA is required to review new chemicals, including new PFAS and new uses of PFAS, within 90 days, assess the potential risks to human health and the environment of the chemical, and make one of five possible risk determinations. When potential risks are identified, EPA must take action to mitigate those risks before the chemical can enter commerce.
New PFAS present a challenge for EPA to evaluate because there is often insufficient information to quantify the risk they may pose and consequently to 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 pose potential risks not only to those who directly manufacture, process, distribute, use, and dispose of the chemical substance but also to the public, including communities who may be exposed to PFAS pollution or waste and already overburdened communities. This framework will be used to qualitatively assess PFAS that are likely persistent, bioaccumulative and toxic (PBT) chemicals.
The New Framework
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 when PFAS are used in a closed system with occupational protections as is generally the practice in the manufacture of some semiconductors and 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 the 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 use 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 spray-applied stain guards inherently involves 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 could result in environmental releases and those with expected worker, community, or consumer exposure, from those that won’t, as well as requiring upfront testing for many PFAS, the application of the framework will help ensure that any new PFAS won’t harm human health and the environment. At the same time, it also will allow certain PFAS to be used when exposures and releases can be mitigated, and where such use is critical for important sectors like semiconductors. These policy changes are aligned with the EPA PFAS Strategic Roadmap and help prevent any unsafe new PFAS from entering the environment or harming human health.
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 may receive in the future. This summer, EPA will offer a public webinar about the framework. The date, time, and registration information will be announced soon. Learn more about the framework.