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New Study Demonstrates Vast Majority of Commercial Fluoropolymers Meet Criteria for Polymers of Low Concern Designation

Conclusions Provide Further Evidence that PFAS Chemistries Should Not Be All Grouped Together for Purposes of Regulation

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Erich Shea
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WASHINGTON, DC – June 14, 2022 – The vast majority and types of fluoropolymers, which are part of the per- and polyfluoroalkyl substance (PFAS) family, meet internationally recognized criteria for being considered polymers of low concern (PLC), a designation for compounds that are expected to have insignificant environmental and human health impacts, according to a new scientific paper. The conclusions of the study, conducted by the American Chemistry Council’s Performance Fluoropolymer Partnership (PFP), provide new evidence that PFAS regulations must clearly differentiate among the broad category of PFAS chemistries.

The paper, A Critical Review of the Application of Polymer of Low Concern Regulatory Criteria to Fluoropolymers II: Fluoroplastics and Fluoroelastomers, builds upon research conducted in 2018[1] that identified four fluoropolymers that met criteria for identifying polymers of low concern for potential adverse effects on human health or the environment. In this new paper, PFP researchers analyzed an additional 14 fluoropolymers and fluoroelastomers and determined they meet the PLC criteria, bringing the number to 18 fluoropolymers and representing approximately 96 percent of the global market for commercially available fluoropolymers.

Fluoropolymers and fluoroelastomers provide exceptional functionality and benefits across multiple critical end-use markets such as electronics, semiconductors, healthcare technology and devices, transportation, 5G telecommunications, and renewable energy. They are a key component driving the technologies used in cellphones, personal protective equipment, solar panels, medical devices, aircraft, and countless other products and industries.

Jay West, Executive Director of the PFP
“This paper provides conclusive evidence that an overwhelming percentage of the fluoropolymers in the products we rely on every day are of low concern for human health or the environment according to internationally recognized criteria. It also demonstrates even further that regulating the broad family of PFAS as one single category is neither scientifically sound nor appropriate.

There are 13 criteria used to determine PLC status: polymer composition, molecular weight, weight percentage of oligomers, electrical charge, reactive functional groups, functional group equivalent weight, low molecular weight leachables, water solubility, particle size, polymer stability, thermal stability, abiotic stability, and biotic stability.

While greatly increasing the number and scope of chemistries that meet the PLC criteria, the paper also demonstrates that in addition to fluoropolymers, several fluoroelastomers, ionomers, and amorphous fluoropolymers qualify as well. The result is that the most economically important fluoropolymers (by global market volume) pose minimal threats to humans or the environment.

The substances included in this study are: polyvinylidene fluoride (PVDF) homopolymer; PVDF copolymer; ethylene-chlorotrifluoroethylene (ECTFE) copolymer; ECTFE terpolymer; polychlorotrifluoroethylene (PCTFE); fluoroethylene-vinyl ether copolymer (FEVE); terpolymer of ethylene, tetrafluoroethylene, and hexafluoropropylene (EFEP); terpolymer of chlorotrifluoroethylene, tetrafluoroethene, and perfluoroalkyl-vinyl-ether (CPT); and terpolymer of tetrafluoroethylene, hexafluoropropylene and vinylidene fluoride (THV), as well as specialty fluoroplastics amorphous fluoropolymers and fluorinated ionomers. The fluoroelastomers included in this study include tetrafluoroethylene-propylene co-polymer (FEPM);  hexafluoropropene-vinylidene fluoride co- and terpolymers (FKM); and a  tetrafluoroethylene-perfluoromethyl vinyl ether perfluoroelastomer (FFKM).

The authors also note that segmentation that clearly differentiates the broad PFAS family according to their properties, rather than the presence of a carbon-fluorine bond, is required for a scientifically sound, risk-based regulatory approach. “Regulating all PFAS as one homogenous group absent consideration of their properties, particularly when the properties are so demonstrably different, neglects basic scientific consideration of these properties, that are the foundation of substance differentiation,” they write. “Therefore, we advocate for segmentation based on properties before performing any grouping-based risk assessment, placing stable, non-hazardous fluoropolymers, that meet the criteria to be considered polymers on low concern, in a separate category.”

The study was published and announced on June 14, 2022, in the scientific journal Integrated Environmental Assessment and Management and can be accessed at https://doi.org/10.1002/ieam.4646 (open access pending) or by contacting Erich Shea via the contact information below. Additional information about the new study can be found in the Q&A featured below.

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The American Chemistry Council’s Performance Fluoropolymer Partnership has published in an academic journal a brand new, peer-reviewed study that presents evidence that 96% of commercial fluoroplastics and fluoroelastomers on the global market meet internationally accepted criteria for identifying polymers of low concern (PLC).

By showing that the vast majority of fluorinated chemistries are of low concern to human health and the environment, the new study is a prime example of the diversity of PFAS chemistries and why they should not be regulated as one monolithic unit. With these conclusions, it is clear that all PFAS are not the same, and it is neither scientifically accurate or appropriate to regulate them as such. The paper has been peer-reviewed and published in the scientific journal Integrated Environmental Assessment and Management and can be accessed at https://doi.org/10.1002/ieam.4646 (open access pending) or by contacting Erich Shea via the contact information below.

Below are a series of questions and answers about the manuscript. All information provided may be attributed to the American Chemistry Council.
What new information does this study provide?

The manuscript demonstrates that 14 additional fluoropolymers and fluoroelastomers should be considered Polymers of Low Concern (PLC), which would bring the list to 18 different fluoropolymers, representing 96% of the global market of commercially available fluoropolymers.

Beyond the manuscript’s conclusions about numbers of fluoropolymers that meet the PLC criteria, what does this manuscript say about PFAS in general?

The manuscript states that the environmental and health profiles for fluoropolymers are significantly unique among the majority of PFAS chemistries, which illustrates that all PFAS are not the same. Therefore, attempts to group or regulate the wide universe of PFAS as one class of chemistries are neither scientifically appropriate nor accurate.

How did this research effort and manuscript originate?

Members of the Performance Fluoropolymer Partnership (PFP), which represent the global leaders in fluoropolymer manufacturing, sought to build upon a landmark 2018 study by Barbara Henry et al titled “A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers,” that found four fluoropolymers that qualify as PLCs. The authors of the 2022 manuscript believed that additional fluoropolymers, beyond those listed in the Henry et al 2018  paper, meet the PLC criteria as well, and as a result, they embarked upon this effort in 2020.

Does this manuscript agree or disagree with the conclusions of the 2018 Henry et al study?

This research effort and manuscript build upon the fluoropolymer research conducted by Henry et al (2018). By applying the criteria to other fluoropolymers and fluoroelastomers, the authors of this new study show that the 18 fluoropolymers that qualify as PLCs represent 96 percent of the global market volume.

What are the 14 new substances that can now be deemed to qualify as PLCs?

The substances included in this study are: polyvinylidene fluoride (PVDF) homopolymer; PVDF copolymer; ethylene-chlorotrifluoroethylene (ECTFE) copolymer; ECTFE terpolymer; polychlorotrifluoroethylene (PCTFE); fluoroethylene-vinyl ether copolymer (FEVE); terpolymer of ethylene, tetrafluoroethylene, and hexafluoropropylene (EFEP); terpolymer of chlorotrifluoroethylene, tetrafluoroethene, and perfluoroalkyl-vinyl-ether (CPT); and terpolymer of tetrafluoroethylene, hexafluoropropylene and vinylidene fluoride (THV), as well as specialty fluoroplastics amorphous fluoropolymers and fluorinated ionomers. The fluoroelastomers included in this study include tetrafluoroethylene-propylene co-polymer (FEPM);  hexafluoropropene-vinylidene fluoride co- and terpolymers (FKM); and a  tetrafluoroethylene-perfluoromethyl vinyl ether perfluoroelastomer (FFKM).

What percentage of the current market for commercial fluoropolymers now qualify as PLCs?

This study shows the 18 commercially available fluoropolymers and fluoroelastomers qualify as polymers of low concern and represent 96% of the global market volume.

What are the criteria used to determine whether a substance qualifies as a PLC?

There are 13 criteria used to determine PLC status: polymer composition, molecular weight, weight percentage of oligomers, electrical charge, reactive functional groups, functional group equivalent weight, low molecular weight leachables, water solubility, particle size, polymer stability, thermal stability, abiotic stability, and biotic stability.

Who or what established these PLC criteria?

The PLC criteria are based on an effort by an OECD Expert Group on Polymers, which reached consensus on the metrics and data required for a polymer to qualify as a PLC. More than a decade later in 2006, the OECD concurred that polymers of low concern have “insignificant environmental health and human health impacts.” Subsequently in a 2015 European Commission report, a number of countries agreed on the specific polymer properties that are predictive of adverse human health or environmental hazards as well as those that indicate a polymer does not present a hazard.

Which part of the fluoropolymer lifecycle does this manuscript address? Manufacture, in-use, or end-of-life?

The PLC criteria are intended to assess the “in-use” phase of the fluoropolymer lifecycle, they are not intended as a comprehensive life-cycle assessment tool. This manuscript focuses on the ‘middle cut’ of the fluoropolymer lifecycle and as such, is an important contribution to our understanding of the safety profiles of these chemistries. The manuscript does directly address the manufacturing and end-of-life phases, but the primary focus is on the in-use phase.

The study was published and announced on June 14, 2022, in the scientific journal Integrated Environmental Assessment and Management and can be accessed at https://doi.org/10.1002/ieam.4646 (open access pending) or by contacting Erich Shea via the contact information below. 

For more information, please contact:
Erich Shea, American Chemistry Council
Erich_Shea@americanchemistry.com
O: (202) 249-6510
C: (202) 669-3881

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[1] Henry, B. J., et al. A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers. Integrated Environmental Assessment and Management. Volume 14, number 3, pages 316-334. May 2018. Open Access.

American Chemistry Council

The American Chemistry Council (ACC) represents the leading companies engaged in the multibillion-dollar business of chemistry. ACC members apply the science of chemistry to make innovative products, technologies and services that make people's lives better, healthier and safer. ACC is committed to improved environmental, health, safety and security performance through Responsible Care®; common sense advocacy addressing major public policy issues; and health and environmental research and product testing. ACC members and chemistry companies are among the largest investors in research and development, and are advancing products, processes and technologies to address climate change, enhance air and water quality, and progress toward a more sustainable, circular economy.

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