The U.S. Environmental Protection Agency released a framework June 29 outlining its approach to reviewing new uses for per- and poly-fluoroalkyl substances, or PFAS.
The framework allows for uses of PFAS in certain applications if testing determines it poses a minimal threat to personal safety and the environment. This includes uses in industrial facilities, such as semiconductor plants, where occupational protections are already in place and human and environmental exposure are not expected.
“In such a negligible exposure and environmental release scenario, if EPA can ensure that such PBT (persistent, bioaccumulative and toxic) 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,” according to an EPA news release.
Under the Toxic Substances Control Act, or TSCA, the EPA must review new chemicals 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, the EPA must take action to mitigate those risks before the chemical can enter commerce.
But data quantifying current PFAS risks is lacking, which makes regulation of the substances challenging, the EPA noted in a June 29 news release. These substances are often called “forever chemicals” because they are known to persist and bioaccumulate in the environment.
The framework will be used to qualitatively assess PFAS that are likely persistent, bioaccumulative and toxic chemicals.
If the initial sampling data indicates a concern, the EPA will require additional testing and risk mitigation before permitting PFAS use.
For PFAS that demonstrate greater-than-negligible but low risk, the EPA expects to require test data in addition to physical chemical properties, such as toxicokinetic data, before allowing manufacturing to begin. If initial test results cause concern, the EPA will require additional testing and risk mitigation before moving forward.
If testing determines the presence of exposure or environmental release risks, the EPA will prohibit the substance from entering commerce pending more extensive examination of its physical/chemical properties, toxicity and fate, the EPA said.
“For example, use of PFAS in spray-applied stain guards inherently involves releases to the environment,” the EPA stated. “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.”
The only exception would be applications for critical use or military need, in which case the EPA would limit and restrict manufacturing, while testing continues.
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. The EPA plans to announce a public webinar this summer about the guidelines.
