Introducing new PFAS into the market or using existing ones for new purposes likely just got much harder as the EPA has established a new framework requiring an intensive scientific review process that likely will result in restrictions or even bans. The “Framework for TSCA New Chemicals Review of PFAS Premanufacture Notices (PMNs) and Significant New Use Notices (SNUNs)” comes under the TSCA New Chemicals Program, which “regulates chemicals in a manner that promotes technological innovation while ensuring that chemicals are safe to humans and the environment.” The New Chemicals Program functions as a “gatekeeper” that can identify and evaluate potential risks of a new chemical before it enters into commerce or before a significant new use of an existing chemical is commenced.
“Once persistent and bioaccumulative chemicals are released into the environment, they are often difficult or impossible to remediate,” the EPA said in its Framework. “As such, the new [Framework] is designed to stop the environmental release of PBT PFAS at the source and eliminate unreasonable risks before any manufacturing activity can commence.” The Framework is “generally expected to largely preclude intentional environmental releases or expected exposures of new PFAS or those associated with significant new uses of PFAS, while identifying appropriate risk mitigation (including banning manufacture if warranted) and required testing.”
The first step in the Framework is to determine whether the substance under review (as a PMN or SNUN) falls into the chemical category definition of PFAS. The Framework considers PFAS to include substances with “alkyl and alkyl ether structures where all of the saturated carbons are fully fluorinated (i.e., perfluorinated) or chemical structures with a mixture of fully fluorinated, partially fluorinated, and/or non-fluorinated saturated carbons.” According to the EPA, because “natural processes have been shown to break down PFAS that are precursor compounds (e.g., fluorotelomer alcohols) into other PFAS … EPA not only considers the substance itself but also focuses on potential metabolites or degradants when reviewing a PFAS under TSCA section 5.”
After the EPA has concluded that the substance submitted as a PMN or SNUN is a PFAS and determined the key components of interest (e.g., the substance itself, or potential metabolites or degradants), the EPA will begin reviewing all available hazard information on the PFAS in an effort to determine whether the PFAS is a PBT chemical (a persistent, bioaccumulative, and toxic chemical). Importantly, the submitted PMN or SNUN must include all information in the possession or control of the submitter that can inform the evaluation of the human health or environmental effects of the chemical substance. The EPA will make a PBT determination based on a “weight of evidence” standard, which may also include testing if the available data is insufficient for such an evaluation. However, the EPA states that “There is a large body of evidence that most PFAS are PBT chemicals.” The EPA also acknowledges that although “there are thousands of different PFAS, only a small fraction has been well studied.”
Further, under the Framework, the EPA will consider the intended conditions of use of the PFAS to determine if exposure is likely to a subpopulation (e.g., consumers, workers), the general population, and/or the environment. For PFAS that are determined to be PBT, the EPA typically will assess both environmental releases and worker exposures; understanding the expected sources of releases and worker exposures is important for managing risks. If a PFAS is not found to be a PBT chemical, the chemical will go through the typical New Chemicals assessment process and the EPA will conduct a quantitative risk assessment, where appropriate. For each PFAS reviewed, the EPA’s assessment will consider the opportunities for exposure throughout the lifecycle of the PFAS. The Framework states that the EPA generally expects that most PFAS will be PBT.
The TSCA requires the 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. “Regardless of whether EPA determines that the new chemical substance or significant new use may present unreasonable risk – or determines that there is insufficient information to permit a reasoned evaluation of risk from the new chemical substance or the significant new use – or determines that there will be substantial quantities produced and there may be significant or substantial human and/or environmental exposure – the action required by EPA under TSCA is the same: The Agency must issue a section 5(e) order to protect against unreasonable risk to human health and the environment.” The section 5(e) order may include testing requirements. Stated in the Framework, “Given EPA’s current understanding of PFAS, EPA believes that PBT PFAS are unlikely to receive a determination of “not likely” to present an unreasonable risk.”
Where EPA makes a determination for a PBT PFAS that results in the need for testing and risk management measures under a section 5(e) order, the Framework lays out three exposure/release scenarios and the corresponding likely requirements: (1) negligible exposure and environmental release (only physical-chemical property data required prior to manufacture); (2) low exposure and environmental release (physical-chemical property testing and other testing – e.g., toxicokinetic testing – likely required prior to manufacture); and (3) expected exposure and environmental release (full suite of testing likely required prior to manufacture). The full suite of required testing may include physical-chemical property testing, other testing such as toxicokinetic, and human health and/or environmental toxicity testing.
EPA’s new Framework is “designed to stop the environmental release of PBT PFAS at the source and eliminate unreasonable risks before any manufacturing activity can commence.” However, while it describes how the EPA currently intends to consider the assessment and management of PFAS submitted as a PMN or SNUN for review (including PFAS PMNs or SNUNs already under review and any that the EPA receives in the future), it does not itself impose legally binding requirements on the EPA or the regulated community.