Rebecca Coons 2023-07-06 23:46:25
The US Environmental Protection Agency (EPA) has outlined the framework it will use to evaluate new per- and polyfluoroalkyl substances (PFAS) to determine if there are any threats of harm to human health and the environment before granting approval. The guidance, which also applies to new uses for PFAS, comes amid increasing regulatory pressure on PFAS and a lack of clarity for producers.
Under the framework, EPA “generally expects” to approve some persistent, bioaccumulative and toxic (PBT) PFAS for uses that will not result in exposure or releases into the environment — such as PFAS used in closed systems with occupational protections, as is the case with semiconductor manufacturing — and where proper disposal can be ensured after receiving basic information such as physical-chemical property data. If the initial data causes concern, then EPA will require additional testing and risk mitigation before moving forward.
For PBT PFAS 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 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. 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 framework comes amid mounting regulatory pressure on PFAS that led 3M Co. to announce in late 2022 that it would exit the business entirely.
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