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The US EPA has released the PFAS definition and review management framework!


Time:

2023-07-28

The US EPA has released the PFAS definition and review management framework!

Recently, the US Environmental Protection Agency (EPA) released a review framework for perfluoroalkyl and polyfluoroalkyl substances (PFAS). This framework outlines the methods adopted by the EPA in reviewing new PFAS and new uses of PFAS, with the aim of conducting more effective and efficient reviews of significant new uses of new or existing PFAS through pre production notifications (PMNs) and important new use notifications (SNUNs), ensuring that these chemicals have undergone a comprehensive assessment by the EPA before being allowed into the commercial field to protect human health and the environment from their hazards.


The specific content of the new framework is as follows:


1. Clarify the definition of PFAS:

The first step of the PFAS framework is to determine whether the substance under review (as PMN or SNUN) meets the definition of the PFAS chemical category. The EPA Office of Pollution Prevention and Toxicology (OPPT) defines PFAS as a substance with alkyl and alkyl ether structures, where all saturated carbon atoms are completely fluorinated (i.e. perfluorinated) or a mixture of fully fluorinated, partially fluorinated, and/or non fluorinated saturated carbon atoms.

According to the definition of EPA, PFAS substances refer to chemical substances that contain at least one of the following three structures:
(1) R - (CF2) - CF (R ′) R ″, where both CF2 and CF are saturated carbon atoms
(2) R-CF2OCF2-R ', where R and R' can be F, O, or saturated carbon atoms
(3) CF3C (CF3) R'R ", where R 'and R" can be F or saturated carbon atoms

Given that scientific research has confirmed that precursor compounds of PFAS, such as fluoroester alcohols, can decompose into other PFAS substances that are more stable but harmful to human health and the environment during natural processes. In addition, in some cases, volatile PFAS may be affected by long-range atmospheric transport, leading to degradation into stable, bioaccumulative final products. Therefore, when reviewing PFAS under Article 5 of the Toxic Substances Control Act (TSCA), the EPA not only focuses on the substance itself, but also focuses on its potential metabolites or degradation products.

 

2. Evaluate information and determine the PBT status of PFAS:

According to the requirements of this framework, when the submitted substance is PFAS, the PMN or SNUN must include all the information possessed by the submitter in order for the EPA to assess the potential impact of the chemical substance on human health or the environment. EPA will determine whether PFAS may belong to persistent, Bioaccumulation and toxic (PBT) substances according to the information, simulation data and/or supplementary information provided by the PMN or SNUN submitter.

If it is confirmed that the submitted PFAS is a PBT chemical, the EPA will determine its exposure pathway and receptor, and conduct a qualitative risk assessment.

If it is confirmed that the submitted PFAS does not belong to PBT chemicals, a quantitative risk assessment will be conducted according to the conventional new chemical assessment process. However, the EPA believes that most PFAS typically belong to PBT chemicals.

 

3. Risk management methods for PBT PFAS:

The framework categorizes PBT PFAS into three scenarios based on the use that may lead to environmental release and exposure to workers, communities, or consumers, as well as the use that will not have the aforementioned effects:

a) Negligible environmental release and potential exposure of PFAS:
Enterprises only need to submit the physical and chemical property data of the substance for EPA review before allowing production. If the EPA confirms that this PBT PFAS can be properly handled and has no exposed risks, it is allowed to enter the commercial field. If the preliminary data review attracts EPA attention, the EPA may require companies to conduct additional testing and take additional risk mitigation measures.

b) Low environmental release and potential exposure of PFAS:
Enterprises are required to submit physical and chemical property data and other tests (such as toxicokinetic tests) of the substance for EPA review before allowing production. Based on the preliminary data review results, the EPA may require companies to take necessary limiting measures during production to reduce exposure and environmental releases, or require companies to conduct additional testing (such as human health and/or environmental toxicity testing) and take additional risk mitigation measures.

c) Expected to lead to exposure and environmental release:
Enterprises are required to submit a complete set of test data for EPA review before allowing production, including physical and chemical property testing, toxicity kinetics testing, and human health and/or environmental toxicity testing. Based on the preliminary data review results, the EPA may require companies to take necessary restrictive measures during production to reduce exposure and environmental releases, or prohibit the production of the substance.

 

The application of this framework not only ensures that any new PFAS does not pose a threat to human health and the environment, but also allows the use of certain PFAS in situations that can mitigate exposure and environmental releases, such as in critical industries such as semiconductors.

Since the beginning of 2021, the EPA has taken a series of measures to ensure strict review and appropriate protective measures for new PFAS, including improving policies and processes for reviewing new chemicals to better align with the requirements of the 2016 TSCA amendment. Current scientific research indicates that exposure to certain PFAS, even at extremely low concentrations, may have adverse effects on health and the environment, and most PFAS are persistent and bioaccumulative chemicals. Once persistent and bioaccumulative chemicals are released into the environment, remediation is often difficult or impossible. Therefore, the PFAS framework aims to stop the environmental release of PBT PFAS from the source and eliminate unreasonable risks before any manufacturing activities begin. In addition, by utilizing the testing powers of Article 5 of the TSCA, the implementation of the PFAS framework will ensure that EPA uses the best available information in PFAS assessments, while also helping to advance understanding of this large and diverse collection of chemical substances.

The EPA plans to hold a public webinar on the framework this summer. The date, time, and registration information of the seminar will be announced soon.

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