Peroxy Compounds Human Health and Ecological Draft Risk Assessment DP 455445, 455446
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Peroxy Compounds Human Health and Ecological Draft Risk Assessment DP 455445, 455446 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM Date: March 11, 2020 SUBJECT: Registration Review Draft Risk Assessment for the Peroxy Compounds PC Code: 000595, 063201, 063604, 063607, DP Barcode: 455445, 455446 063209, 128860 Decision No: 558073, 558074 Docket No: EPA-HQ-OPP-2009-0546 Regulatory Action: Registration Review Case No: 6059, 4072, 5081 Risk Assessment Type: DRA CAS No: 7722-84-1, 79-21-0, 33734-57-5, 15630-89-4, 10058-23-8, 70693-62-8 TO: Kendall Ziner, Chemical Review Manager Rick Fehir, Ph.D., Team Lead Rose Kyprianou, Branch Chief Regulatory Management Branch (RMB) II Antimicrobials Division (7510P) Office of Pesticide Programs FROM: Andrew Byro, Ph.D., Chemist Kathryn Korthauer, Biologist Timothy Dole, Industrial Hygienist Deborah Burgin, Ph.D., DABT, Toxicologist Risk Assessment and Science Support Branch Antimicrobials Division (7510P) Office of Pesticide Programs THROUGH: Judy Facey, Ph.D., Human Health Risk Assessment Process Leader MP for JF Diana Hsieh, Ecological Risk Assessment Process Leader MP for DH Timothy Leighton, Senior Science Advisor MP for TL Laura Parsons, Associate Branch Chief Melissa Panger, Ph.D., Branch Chief Risk Assessment and Science Support Branch Antimicrobials Division (7510P) This document provides the draft human health and ecological risk assessment conducted in support of the antimicrobial use sites of the following peroxy compounds: hydrogen peroxide, peracetic acid, peroxyoctanoic acid, and sodium percarbonate. Page 1 of 74 Peroxy Compounds Human Health and Ecological Draft Risk Assessment DP 455445, 455446 Although the peroxymonosulfate compounds were included in the peroxy compounds Final Work Plan (FWP), they will not be included in this risk assessment. The mode of action for the peroxymonosulfate compounds is to create hypochlorous acid rather than to oxidize microbes or degrade into hydrogen peroxide; thus, it is more appropriate to address them with other pesticides which operate via a hypochlorous acid mode of action. The Agency plans to create a hypochlorous acid case which includes the peroxymonosulfate compounds in late 2020. Page 2 of 74 Peroxy Compounds Human Health and Ecological Draft Risk Assessment DP 455445, 455446 Table of Contents EXECUTIVE SUMMARY ............................................................................................................ 5 1. INTRODUCTION ...................................................................................................................... 8 1.1 Case Overview ...................................................................................................................... 8 1.3 Ingredient Profile ................................................................................................................ 10 1.4 Use Pattern .......................................................................................................................... 10 2.0 HUMAN HEALTH RISK ASSESSMENT ............................................................................ 13 2.1 Data Deficiencies ................................................................................................................ 13 2.2 Label Recommendations ..................................................................................................... 14 2.3 Anticipated Exposure Pathways ......................................................................................... 14 2.4 Hazard Characterization and Dose-Response Assessment ................................................. 14 2.4.1 Toxicology Studies Available for Analysis ................................................................. 14 2.4.2 Summary of Toxicological Effects .............................................................................. 14 2.4.3 Safety Factor for Infants and Children (FQPA Safety Factor) .................................... 17 2.5 Toxicity Endpoint and Point of Departure Selections ........................................................ 17 2.6 Dietary Exposure and Risk Assessment ............................................................................. 19 2.6.1 Tolerance and Clearance Considerations ..................................................................... 19 2.6.2 Food Exposure Profile ................................................................................................. 25 2.6.3 Water Exposure Profile ................................................................................................ 26 2.7 Residential Exposure/Risk Characterization ...................................................................... 27 2.7.1 Residential Handler Exposure/Risk Characterization .................................................. 28 2.7.2 Residential Post-Application Exposure ....................................................................... 30 2.8 Aggregate Exposure/Risk Characterization ........................................................................ 31 2.9 Cumulative Exposure/Risk Characterization ...................................................................... 31 2.10 Occupational Handler Exposure/Risk Characterization ................................................... 32 2.10.1 Occupational Handler Hard Surface Disinfection Uses ............................................. 32 2.10.2 Occupational Handler Industrial Process and Material Treatment Uses ................... 34 2.11 Occupational Post-Application Exposure/Risk Characterization ..................................... 35 2.11.1 Occupational Post-Application Exposure from Hospital Fogging Applications ....... 36 2.11.2 Occupational Post-Application Exposure from Food Processing Plant Fogging ...... 37 2.11.3 Occupational Post-Application Exposure from Enclosure Fogging .......................... 38 2.11.4 Occupational Post-Application Exposure from Poultry Premise Fogging ................ 39 2.12 Human Health Incident Report ......................................................................................... 40 3 ENVIRONMENTAL RISK ASSESSMENT ............................................................................ 40 3.1 Environmental Fate ............................................................................................................. 40 3.1.1 Available Data ............................................................................................................. 40 3.1.2 Degradates of Potential Concern ................................................................................. 42 3.1.3 Water Quality – Total Maximum Daily Load (TMDL) ............................................... 42 3.2 Aquatic Exposure ................................................................................................................ 42 3.3 Ecological Effects ............................................................................................................... 43 3.3.1 Ecotoxicity Data ........................................................................................................... 43 3.4 Ecological Risk Characterization and Conclusions ............................................................ 45 3.5 Major Uncertainties and Ecotoxicity Data Gaps ................................................................ 45 3.6 Ecological Incident Data ..................................................................................................... 46 4. LISTED SPECIES OF CONCERN .......................................................................................... 46 5. REFERENCES ......................................................................................................................... 46 Page 3 of 74 Peroxy Compounds Human Health and Ecological Draft Risk Assessment DP 455445, 455446 APPENDIX A: Toxicology Profile .............................................................................................. 54 APPENDIX B: Environmental Fate Profile ................................................................................ 58 APPENDIX C: Ecotoxicity Profile .............................................................................................. 62 List of Tables Table 1: Chemical and Physical Properties of the Peroxy Compounds........................................ 10 Table 2: Registered Uses of Hydrogen Peroxide and Peracetic Acid ........................................... 11 Table 3: Summary of Peroxyoctanoic Acid Registered Uses ....................................................... 12 Table 4: Summary of Sodium Percarbonate Registered Uses ...................................................... 13 Table 5: Microscopic Findings of the Respiratory Tract in the 28-day Rat Inhalation Study ..... 16 Table 6: Microscopic Observations of Lungs in the 90-day Inhalation Study ............................ 16 Table 7: Summary of Toxicological Doses and Endpoints for the Peroxy Compounds ............. 19 Table 8: FFDCA Clearances for Peroxy Compounds................................................................... 20 Table 9: Tolerances Established for Peroxy Compounds. ............................................................ 22 Table 10: Exemptions from Requirements for Tolerance for Peroxy Compounds. ..................... 23 Table 11: Residential Handler Inhalation MOEs for the Peroxy Compounds .............................. 28 Table 12: Residential Handler Inhalation MOEs (Vapor Exposures) .........................................