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Atrazine Human Health Risk Assessment D418316 Page 1 of 212 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 2046 Atrazine Human Health Risk Assessment D418316 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 OFFICE OF CHEMICAL SAFETY AND POLLUTION PREVENTION MEMORANDUM Date: July 10, 2018 SUBJECT: Atrazine. Draft Human Health Risk Assessment for Registration Review. PC Codes: 080803 DP Barcodes: D418316 Decision Nos.: 488213 Registration No.: NA Petition No.: NA Regulatory Action: Registration Review Risk Assessment Type: Single Chemical Case Nos.: 7279 TXR No.: NA CAS Nos.: 1912-24-9 MRID No.: NA 40 CFR: §180.220 FROM: Kristin Rickard, Biologist Danette Drew, Chemist/Risk Assessor William Donovan, Ph.D., Chemist John Liccione, Ph.D., Toxicologist Risk Assessment Branch V/VII (RAB V/VII) Health Effects Division (HED) (7509P) Office of Pesticide Programs (OPP) And David Miller, Chief, Toxicology and Epidemiology Branch (TEB) Elizabeth Mendez, Ph.D., Senior Scientist, Immediate Office Ashlee Aldridge, MPH, Epidemiologist, Toxicology and Epidemiology Branch Health Effects Division (HED) (7509P) Office of Pesticide Programs (OPP) And Anna Lowit, Ph.D., Senior Science Advisor Immediate Office Office of Pesticide Programs (OPP) And Cecilia Tan, Ph.D. National Exposure Research Laboratory (NERL) Office of Research and Development E-205-01 Research Triangle Park, NC THROUGH: Michael S. Metzger, Chief Risk Assessment Branch V/VII (RAB V/VII) Health Effects Division (HED) (7509P) Page 1 of 212 Atrazine Human Health Risk Assessment D418316 Office of Pesticide Programs (OPP) And Christina Swartz, Chief, RAB2 Shalu Shelat, Environmental Health Scientist HED Risk Assessment Review Committee (RARC) TO: Marianne A. Mannix, Chemical Review Manager Risk Management and Implementation Branch III Pesticide Re-Evaluation Division (7508P) As part of Registration Review, the Pesticide Re-Evaluation Division (PRD) of the Office of Pesticide Programs (OPP) has requested that HED evaluate the hazard and exposure data and conduct dietary (food and drinking water), residential, aggregate, and occupational exposure assessments to estimate the risk to human health that will result from the currently registered uses of pesticides. This memorandum serves as HED’s draft human health risk assessment (DRA) for atrazine to support Registration Review. The most recent human health risk assessment for the chlorotriazine herbicides (atrazine, simazine, and propazine) was completed in 2006 (J. Morales et al., D317976, 3/28/2006). A scoping document for Registration Review was completed in 2013 (W. Donovan et al., D407489, 06/04/2013). The following risk assessment updates have been included in the current risk assessment: The toxicity points of departure and uncertainty factors for the neuroendocrine effects have been updated using an atrazine rat and human physiologically-based pharmacokinetic (PBPK) model; The drinking water exposure assessment has been updated; Aggregate exposure assessments were completed, including updated dietary and residential exposure estimates; A non-occupational spray drift exposure assessment was completed; and An occupational exposure assessment for the registered uses was completed reflecting recent updates to the points of departure, and policy changes for body weight, unit exposure, and area/amount treated assumptions. Page 2 of 212 Atrazine Human Health Risk Assessment D418316 Executive Summary ............................................................................................................. 6 Risk Assessment Summary & Conclusions ....................................................................... 11 Data Deficiencies ........................................................................................................ 12 Tolerance Considerations ........................................................................................... 12 Enforcement Analytical Method ............................................................................. 12 Recommended & Established Tolerances .............................................................. 13 International Harmonization ................................................................................... 15 Label Recommendations ............................................................................................ 15 Recommendations from Residue Reviews ............................................................. 15 Recommendations from Occupational Assessment ................................................ 15 Recommendations from Residential Assessment ................................................... 15 Introduction ........................................................................................................................ 16 Chemical Identity ....................................................................................................... 16 Physical/Chemical Characteristics ............................................................................. 17 Pesticide Use Pattern .................................................................................................. 17 Anticipated Exposure Pathways ................................................................................. 20 Consideration of Environmental Justice ..................................................................... 20 Hazard Characterization and Dose-Response Assessment ................................................ 21 History of Toxicological & Epidemiologic Analysis and Peer Review ..................... 21 Toxicology Studies Available for Analysis ................................................................ 23 Absorption, Distribution, Metabolism, & Elimination (ADME) ............................... 24 Dermal Absorption ..................................................................................................... 26 Toxicological Effects .................................................................................................. 26 Mode of Action (MOA) .......................................................................................... 27 Hydroxyatrazine ...................................................................................................... 39 Epidemiology .......................................................................................................... 39 Atrazine: Toxicity Endpoint and Point of Departure Selections ............................... 43 Durations of Exposure, Critical Windows of Exposure, & Temporality of Effects 43 Dose-Response Assessment .................................................................................... 45 Recommendation for Combining Routes of Exposures for Risk Assessment ........ 60 Cancer Classification and Risk Assessment Recommendation .............................. 60 Hydroxyatrazine: Toxicity Endpoint and Point of Departure Selections ................. 62 Safety Factor for Infants and Children (FQPA Safety Factor) ................................... 63 Completeness of the Toxicology Database ............................................................. 67 Evidence of Neurotoxicity ...................................................................................... 67 Evidence of Sensitivity/Susceptibility in the Developing or Young Animal ......... 67 Residual Uncertainty in the Exposure Database ..................................................... 68 Endocrine Disruptor Screening Program .................................................................... 68 Dietary Exposure and Risk Assessment ............................................................................ 69 Metabolite/Degradate Residue Profile ........................................................................ 69 Page 3 of 212 Atrazine Human Health Risk Assessment D418316 Summary of Plant and Animal Metabolism Studies ............................................... 69 Summary of Environmental Degradation ............................................................... 70 Comparison of Metabolic Pathways ....................................................................... 70 Residues of Concern Summary and Rationale ........................................................ 71 Food Residue Profile .................................................................................................. 71 Water Residue Profile ................................................................................................. 72 Dietary Risk Assessment ............................................................................................ 74 Description of Residue Data Used in Dietary Assessment ..................................... 74 Summary of Toxicological Points of Departure for Dietary (Food) Assessment ... 75 Percent Crop Treated Used in Dietary Assessment ................................................ 76 Acute Dietary Risk Assessment .............................................................................. 77 4-Day Dietary Risk Assessment ............................................................................. 77 Background and Chronic Dietary Risk Assessment ............................................... 77 Cancer Dietary Risk Assessment ............................................................................ 78 Summary Tables ..................................................................................................... 78 Residential Exposure/Risk Characterization ...................................................................... 78 Residential Handler Exposure/Risk Estimates ..........................................................
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