EPA Announces New Framework Intended to Prevent Unsafe New and New Uses of PFAS from Entering the Market
The U.S. Environmental Protection Agency (EPA) announced on June 29, 2023, a new framework (the Framework) for addressing new per- and polyfluoroalkyl substances (PFAS) and new uses of existing 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. Under Section 5 of the Toxic Substances Control Act (TSCA), 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.
EPA states that new PFAS present a challenge 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.” According to EPA, many PFAS are known to persist and bioaccumulate in the environment and in people and they pose potential risks not only to those who directly manufacture, process, distribute, use, and dispose of the chemical substances but also to the public, including communities that may be exposed to PFAS pollution or waste and already overburdened communities. EPA will use the Framework to assess qualitatively PFAS that are likely persistent, bioaccumulative, and toxic (PBT) chemicals.
EPA states that under the Framework, it 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. According to EPA, 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, 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 states that it “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, EPA will require additional testing and risk mitigation before moving forward.
For PBT PFAS that EPA expects 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 states that it “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, according to EPA, use of PFAS in spray-applied stain guards inherently involves releases to the environment. If the test results cause concern, EPA could require additional testing and risk mitigation before moving forward or could prevent the substance from being manufactured at all.
EPA states that by distinguishing uses that could result in environmental releases and those with expected worker, community, or consumer exposure, from those that will not, as well as requiring up-front testing for many PFAS, the application of the Framework will help ensure that any new PFAS will not harm human health and the environment. EPA notes that 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.” According to EPA, these policy changes are aligned with the EPA PFAS Strategic Roadmap and will help prevent any unsafe new PFAS from entering the environment or harming human health.
EPA states that the data it will obtain on physicochemical properties for any new PBT PFAS under the 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 its understanding of PFAS more broadly.
EPA will apply the Framework to new PFAS or new use notices that are currently under review, as well as to any that EPA may receive in the future. According to EPA, it will offer a public webinar about the Framework in summer 2023. EPA will announce the date, time, and registration information “soon.”
Commentary
Bergeson & Campbell, PC (B&C®) views EPA’s new PFAS Framework as a sensible implementation of its National PFAS Testing Strategy and a reasonable approach to EPA’s review and regulation of new PFAS. Not surprisingly, EPA will expect robust data, including data on physicochemical properties, fate, and toxicity, depending on the conditions of use. We note that entities that intend to submit premanufacture notices (PMN) and/or significant new use notices (SNUN) on PFAS should be mindful of EPA’s statements in the Framework that it “generally expects that most PFAS will be PBT” and that the Framework establishes a de facto ban pending up-front testing if data are not reasonably available. It is critical that submitters be aware of EPA’s expectations and develop the necessary data prior to submitting a PMN or SNUN. While not all PFAS are or will be PBTs, the burden will be on the submitter to demonstrate that the PFAS in question is not a PBT.
For example, EPA stated that PBT PFAS that have “Negligible Exposure and Environmental Release Scenario[s]” would still require physicochemical property testing on the PBT PFAS “prior to manufacture.” We note that EPA would include the physicochemical property tests specified in the National PFAS Testing Strategy, which include vapor pressure, water solubility, log Kow, particle size, and surface tension. These endpoints are, however, aimed at informing the conduct of test guideline protocols, as listed in the National PFAS Testing Strategy. Realistically, entities should anticipate completing applicable testing on the full suite of physicochemical properties EPA recently proposed (e.g., 40 C.F.R. Section 720.45(j)(1)). The full suite of endpoints under EPA’s proposed amendments to 40 C.F.R. Section 720.45(j)(1) include the following:
Boiling/sublimation temperature, density/relative density, dissociation constant, explodability, flammability, melting temperature, octanol/water partition coefficient, particle size distribution, particle size distribution analysis, the physical state of the neat substance, pH, solubility, vapor pressure, volatilization from water, volatilization from soil, spectra, UV-VIS absorption data, and surface tension.
EPA did not provide quantitative cutoffs for determining if the conditions of use for a PBT PFAS represent “Negligible Exposure and Environmental Release Scenario[s]”. Two thoughts come to mind. First, EPA announced on August 22, 2022, that it was discontinuing the use of exposure modeling thresholds when assessing health and environmental risks of new chemicals (for discussion, see our memorandum dated August 22, 2022). EPA established these low release and exposure (LoREX) thresholds (e.g., incineration air release criterion < 1 µg/m3) based on its “experience gained in conducting risk assessments on over 25,000 new chemical substances …” B&C anticipates that EPA’s interpretation of “Negligible” for PBT PFAS will likely be lower than the LoREX thresholds.
Second, EPA stated that for PBT PFAS with conditions of use that result in “Low Exposure and Environmental Release Scenario[s]” (no quantitative cutoffs were provided, but releases and exposures are not zero), it will likely require “both physical-chemical property testing and other testing (e.g., toxicokinetic testing) be completed and submitted to EPA prior to manufacture [emphasis in original].” This is an important consideration because the National PFAS Testing Strategy states the following:
In vivo toxicokinetic testing in rats and/or mice (OECD TG 417) with evaluation of metabolites. … In vivo toxicokinetic testing will be informed by Tier I in vitro metabolism and protein binding studies when feasible.
In other words, the testing will likely include additional Tier I testing from the National PFAS Testing Strategy, as well as toxicokinetic testing in rats and mice, and possibly a third species. We mention this, not to criticize the Framework, but rather to sensitize potential submitters that intend to submit PMNs and/or SNUNs on PFAS about the timing and costs of the up-front testing, which will likely take longer than two years to complete and cost in excess of $1 million. If EPA determines that additional mammalian/ecotoxicological testing and/or environmental fate testing is needed, the costs will increase significantly, as will the time it will take to complete the testing.
B&C was pleased to see that EPA issued its PFAS Framework and considered EPA’s approach pragmatic for gathering additional information on PFAS and for its intended regulatory approaches for new PFAS (i.e., PMNs) and/or new conditions of use for existing PFAS (i.e., SNUNs). We note, however, that EPA could be more transparent with how it intends to evaluate PFAS. It appears EPA will be using hazard and fate information, primarily, as the bases for its determinations. We mention this because EPA stated that:
Risk will be qualitatively evaluated due to factors associated with PBT PFAS that represent limitations to the standard New Chemicals Program risk calculation methods, including the known widespread background levels of PFAS present throughout both the environment and humans, as well as the highly persistent and bioaccumulative nature of most well-studied PFAS.
This is notable because TSCA is a risk-based statute. EPA should provide clear direction to entities intending to submit PFAS under TSCA Section 5. We recognize that EPA may lack specific data on novel PFAS chemistries, but it does have the authority to require testing to inform and reduce potential uncertainties it may have in its risk assessments. Further, EPA should have provided clearer direction on its testing requirements. As noted, EPA was not transparent on the specific types of data it would require as part of its up-front bans, pending testing, nor on the levels of exposure and/or release that it would consider “Negligible” or “Low” when making these determinations.
EPA has raised the bar to commercialize new PFAS and new uses of PFAS, but EPA has not entirely closed the door. Submitters will need to develop an extensive data set and deploy extensive release and exposure controls to ensure that a new PFAS or a new use of a PFAS is not going to be an unreasonable risk.