A critical review of the application of polymer of low concern regulatory criteria to fluoropolymers II: Fluoroplastics and fluoroelastomers

Fluoropolymers are a distinct class of per‐ and polyfluoroalkyl substances (PFAS), high molecular weight (MW) polymers with fluorine attached to their carbon‐only backbone. Fluoropolymers possess a unique combination of properties and unmatched functional performance critical to the products and manufacturing processes they enable and are irreplaceable in many uses. Fluoropolymers have documented safety profiles; are thermally, biologically, and chemically stable, negligibly soluble in water, nonmobile, nonbioavailable, nonbioaccumulative, and nontoxic. Although fluoropolymers fit the PFAS structural definition, they have very different physical, chemical, environmental, and toxicological properties when compared with other PFAS. This study describes the composition, uses, performance properties, and functionalities of 14 fluoropolymers, including fluoroplastics and fluoroelastomers, and presents data to demonstrate that they satisfy the widely accepted polymer hazard assessment criteria to be considered polymers of low concern (PLC). The PLC criteria include physicochemical properties, such as molecular weight, which determine bioavailability and warn of potential hazard. Fluoropolymers are insoluble (e.g., water, octanol) solids too large to migrate into the cell membrane making them nonbioavailable, and therefore, of low concern from a human and environmental health standpoint. Further, the study results demonstrate that fluoropolymers are a distinct and different group of PFAS and should not be grouped with other PFAS for hazard assessment or regulatory purposes. When combined with an earlier publication by Henry et al., this study demonstrates that commercial fluoropolymers are available from the seven participating companies that meet the criteria to be considered PLC, which represent approximately 96% of the global commercial fluoropolymer market. Integr Environ Assess Manag 2023;19:326–354. © 2022 The Authors. Integrated Environmental Assessment and Management published by Wiley Periodicals LLC on behalf of Society of Environmental Toxicology & Chemistry (SETAC).

[1]  Tchetin Kazak.  European Green Deal , 2022, Yearbook of the Law Department.

[2]  O. Nielsen,et al.  The case for a more precise definition of regulated PFAS. , 2021, Environmental science. Processes & impacts.

[3]  Richard H Anderson,et al.  Environmental Sources, Chemistry, Fate, and Transport of Per- and Polyfluoroalkyl Substances: State of the Science, Key Knowledge Gaps, and Recommendations Presented at the August 2019 SETAC Focus Topic Meeting , 2021, Environmental toxicology and chemistry.

[4]  C. Huang,et al.  Combustion operating conditions for municipal Waste-to-Energy facilities in the U.S. , 2021, Waste management.

[5]  S. Ebnesajjad,et al.  Fluoroelastomers , 2021, Introduction to Fluoropolymers.

[6]  W. Grot.  Fluorinated Ionomers: History, Properties, and Applications , 2021, Introduction to Fluoropolymers.

[7]  Carla A. Ng,et al.  Are Fluoropolymers Really of Low Concern for Human and Environmental Health and Separate from Other PFAS? , 2020, Environmental science & technology.

[8]  H. Fiedler,et al.  A Critical Review of a Recommended Analytical and Classification Approach for Organic Fluorinated Compounds with an Emphasis on Per‐ and Polyfluoroalkyl Substances , 2020, Integrated environmental assessment and management.

[9]  Katherine E Pelch,et al.  Scientific Basis for Managing PFAS as a Chemical Class. , 2020, Environmental science & technology letters.

[10]  B. Améduri.  The Promising Future of Fluoropolymers , 2020, Macromolecular Chemistry and Physics.

[11]  T. Reemtsma,et al.  Persistent, mobile and toxic substances in the environment: a spotlight on current research and regulatory activities , 2020, Environmental Sciences Europe.

[12]  Zhanyun Wang,et al.  Exploring open cheminformatics approaches for categorizing per- and polyfluoroalkyl substances (PFASs). , 2019, Environmental science. Processes & impacts.

[13]  H. Mätzing,et al.  Waste incineration of Polytetrafluoroethylene (PTFE) to evaluate potential formation of per- and Poly-Fluorinated Alkyl Substances (PFAS) in flue gas. , 2019, Chemosphere.

[14]  Simon Atkinson,et al.  Essential high-purity sealing materials for semiconductor manufacturing , 2018, Sealing Technology.

[15]  Joseph P. Carlin,et al.  A critical review of the application of polymer of low concern and regulatory criteria to fluoropolymers , 2018, Integrated environmental assessment and management.

[16]  R. Dams,et al.  Chapter 1:Industrial Aspects of Fluorinated Oligomers and Polymers , 2016 .

[17]  Y. Morizawa,et al.  Chapter 5:Fluorinated Specialty Chemicals – Fluorinated Copolymers for Paints and Perfluoropolyethers for Coatings , 2016 .

[18]  Jakub Kostal,et al.  Computational Chemistry in Predictive Toxicology: status quo et quo vadis? , 2016 .

[19]  R. Parker,et al.  Fluoroethylene Vinyl Ether Resins for High-Performance Coatings , 2015 .

[20]  K. Hintzer,et al.  Fluoropolymers—Environmental Aspects , 2014 .

[21]  Closing the Recycling Loop Up-Cycling of End-of-Life Fluoroplastics , 2014 .

[22]  Zeng Gan,et al.  A Critical Review of the Application of Languaging in Foreign Language Teaching Abroad , 2014 .

[23]  S. Ebnesajjad.  Introduction to Fluoropolymers , 2011 .

[24]  Gjalt Huppes,et al.  Life cycle assessment: past, present, and future. , 2011, Environmental science & technology.

[25]  Abhishek Asthana,et al.  THERMODYNAMIC STUDY OF HEAVY METALS BEHAVIOUR DURING MUNICIPAL WASTE INCINERATION , 2006 .

[26]  Alison Willis,et al.  Mode of Action , 2005 .

[27]  W. H. Buck,et al.  Teflon® AF: A Family of Amorphous Fluoropolymers with Extraordinary Properties , 2002 .

[28]  B. Améduri,et al.  Fluoroelastomers: synthesis, properties and applications , 2001 .

[29]  F. Lombardo,et al.  Experimental and computational approaches to estimate solubility and permeability in drug discovery and development settings. , 2001, Advanced drug delivery reviews.

[30]  M. Rossi,et al.  The blister packaging , 1998 .

[31]  J. Scheirs.  Modern fluoropolymers : high performance polymers for diverse applications , 1997 .

[32]  P. Kořínek.  Amorphous fluoropolymers ‐ a new generation of products , 1994 .

[33]  A. Zimmermann,et al.  What is the lowest refractive index of an organic polymer , 1991 .

[34]  J V Nabholz,et al.  Mode of action and the assessment of chemical hazards in the presence of limited data: use of structure-activity relationships (SAR) under TSCA, Section 5. , 1990, Environmental health perspectives.

[35]  H. Hiller.  In: Ullmann''''s Encyclopedia of Industrial Chemistry , 1989 .

[36]  M. Yamabe,et al.  A Solvent-Soluble Fluororesin for Paint , 1984 .

[37]  H. Kojima,et al.  A New Fluoroelastomer Derived from Tetrafluoroethylene and Propylene , 1977 .