Document 6RDYk9y3Op1MrLmq22qYkpXbo

HFOS AND TFA: THE FACTS 1) HFOs break down in the environment within a short time span of 10-26 days, leading to their low-global-warming potential (GWP)and low environmental impact.1,3,4 1. US EPA, Section 612 of United States Clean Air Act. Final Rule 16 - Protection of 2016 Stratospheric Ozone; Significant Alternative Policy Program New and Changed Listing, May, 2012; https://www.epa.gov/snap/overview-snap 3. U.S. EPA SNAP: 40 CFR Part 82, Volume 77, Number 155 (Friday, August 10, 2012), pp 47768-47779 4. U.S. EPA SNAP: 40 CFR Part 82, Volume 77, Number 58 (Monday, March 26, 2012), pp 17344-17347 2) One of the breakdown products of HFOs is TFA (trifluoroacetic acid).10,12,13 10. Sulbaek Andersen, M. P.; Schmidt, J. A.; Volkova, A.; Wuebbles, D. J., A three-dimensional model of the atmospheri chemistry of E and Z-CF3CH=CHCl (HCFO-1233(zd) (E/Z)). Atmospheric Environment 2018, 179, 250-259. 12. UNEP; Feb 2016; Sources, Fates, Toxicity, and Risks of Trifluoroacetic Acid and Its Salts: Relevance to Substances Regulated Under the Montreal and Kyoto Protocols 13. Effects and Interactions of Stratospheric Ozone Depletion, UV Radiation, and Climate Change: 2018 Assessment Report, https://ozone.unep.org/science/assessment/eeapEnvironmental 3) TFA has been present in our environment for thousands of years with no indication of impact on human health.12 12. UNEP; Feb 2016; Sources, Fates, Toxicity, and Risks of Trifluoroacetic Acid and Its Salts: Relevance 4) Manmade sources of TFA come from various industries: pharma, pesticides and herbicides, intentional production12 (as a reagent in analytical chemistry such as COVID-19 testing22) or fluorocarbons. 12. UNEP; Feb 2016; Sources, Fates, Toxicity, and Risks of Trifluoroacetic Acid and Its Salts: Relevance 5) Unlike PFOS and PFOA, TFA does not bioaccumulate, does not biomagnify and is non-toxic at levels seen in the environment.12,13 WHILE PERSISTENT, TFA: 1) DOES NOT BIOACCUMULATE IN MAMMALS, FOOD OR AQUATIC LIFE 12 12. UNEP; Feb 2016; Sources, Fates, Toxicity, and Risks of Trifluoroacetic Acid and Its Salts: Relevance 2) DOES NOT IMPOSE HEALTH RISKS OR ENVIRONMENTAL CONCERN AT REPORTED ENVIRONMENTAL CONCENTRATIONS 12 TFA: ECOLOGICAL AND HUMAN HEALTH ASSESSMENT 1) Key areas that need to be evaluated to determine risks of a persistent molecule are environmental and human health impact. 2) Unlike many PFAS, TFA is not classified as a carcinogen, mutagen, or repro-developmental toxicant per Globally Harmonized System of Classification and Labeling of Chemicals (GHS) guideline.14 3) Multiple United Nations Environment Programme (UNEP) evaluations 12,13 of peer reviewed literature conclude that current concentrations of TFA from the degradation of HCFCs, HFCs and HFOs do not present a risk to humans and the environment. 4) European Food Safety Authority (EFSA) has assessed the human health risks from exposure to TFA arising from pesticide applications. They found the risks to be acceptable without any concerns.18 5) Per the US EPA's 2021 PFAS Strategic Roadmap, TFA is not a PFAS.21 6) Current levels of TFA in the rainwater in Germany are 26 times lower than the German EPA (UBA) health-based target level.19,20 1. US EPA, Section 612 of United States Clean Air Act. Final Rule 16 - Protection of 2016 Stratospheric Ozone; Significant Alternative Policy Program New and Changed Listing, May, 2012; https://www.epa.gov/snap/overview-snap 2. IPCC, 2021: Climate Change 2021: The Physical Science Basis. Contribution of Working Group I to the Sixth Assessment Report of the Intergovernmental Panel on Climate Change. Cambridge University Press, Cambridge, United Kingdom and New York, NY, USA, 2391 pp. doi:10.1017/9781009157896 3. U.S. EPA SNAP: 40 CFR Part 82, Volume 77, Number 155 (Friday, August 10, 2012), pp 47768-47779 4. U.S. EPA SNAP: 40 CFR Part 82, Volume 77, Number 58 (Monday, March 26, 2012), pp 17344-17347 5. ISO 817: 2014. Refrigerants -- Designation and safety classification. International Organization for Standardization (ISO) 6. WEEL - https://tera.org 7. 1234ze (E): ECHA 2022: https://echa.europa.eu/brief-profile/-/briefprofile/100.104.972 8. 1234yf: ECHA 2022 https://echa.europa.eu/brief-profile/-/briefprofile/100.104.879 9. 1233zd (E): ECHA 2022 https://echa.europa.eu/brief-profile/-/briefprofile/100.149.148 10. Sulbaek Andersen, M. P.; Schmidt, J. A.; Volkova, A.; Wuebbles, D. J., A three-dimensional model of the atmospheric chemistry of E and Z-CF3CH=CHCl (HCFO-1233(zd) (E/Z)). Atmospheric Environment 2018, 179, 250-259. 11. Buck et al: Perfluoroalkyl and Polyfluoroalkyl Substances in the Environment: Terminology, Classification, and Origins, Integrated Environmental Assessment and Management -- Volume 7, Number 4--pp. 513-541, 2011 12. UNEP; Feb 2016; Sources, Fates, Toxicity, and Risks of Trifluoroacetic Acid and Its Salts: Relevance to Substances Regulated Under the Montreal and Kyoto Protocols 13. Effects and Interactions of Stratospheric Ozone Depletion, UV Radiation, and Climate Change: 2018 Assessment Report, https://ozone.unep.org/science/assessment/eeapEnvironmental 14. https://echa.europa.eu/registration-dossier/-/registered-dossier/5203/2/1 15. PFOS - https://echa.europa.eu/substance-information/-/substanceinfo/100.015.618; PFOA - https:// echa.europa.eu/substance-information/-/substanceinfo/100.005.817 16. OECD, Reconciling Terminology of the Universe of Per- and Poly-fluoroalkyl Substances: Recommendations and Practical Guidance, Series on Risk Management No. 61 (https://www.oecd.org/officialdocuments/publicdisplaydocumentpdf/?cote=ENV/CBC/MONO(2021)25&docLanguage=En) 17. Williams, A., L. Gaines, G. Sinclair, C. Lowe, I. Thillainadarajah, B. Meyer, G.Patlewicz, AND A. Richard. Comparison of list of per- and polyfluoroalkylsubstances (PFAS) based on different definitions. Fall ACS, Chicago, IL, August21 - 25, 2022. https://doi.org/10.23645/epacomptox.20518380 18. EFSA, Reasoned opinion on the setting of MRLs for saflufenacil in various crops, considering the risk related to the metabolite trifluoroacetic acid (TFA)1 EFSA Journal 2014;12(2):3585 DOI: https://doi.org/10.2903/j.efsa.2014.3585 19. Umwelt Bundesamt Reducing the input of chemicals into waters :trifluoroacetate(TFA) as a persistent and mobile substance with many sources, November 2021. 20. Freeling et al: Trifluoroacetate in Precipitation: Deriving a Benchmark Data Set https://pubs.acs.org/doi/10.1021/acs.est.0c02910 21. Identification of Candidate Per- and Poly-fluoroalkyl Substances (PFAS) for Testing October 2021, U.S. Environmental Protection Agency, available at National PFAS Testing Strategy (epa.gov) 22. https://pubs.acs.org/doi/pdf/10.1021/acs.jproteome.1c00320?ref=vi-chemistry_coronavirus_research