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Scanned Document Medi fll Specialties Group, LLC did personally appear before me and execute the above document Halohydantoins RED United States Preven tion, Pesticides EPA 739-R-07-001 Environmental Protection and Toxic Substances September 2007 Agency (7510P) Reregistration Eligibility Decision for Halohydantoins (Case 3055) Halohydantoins RED TABLE OF CONTENTS Glossary of Terms and Abbreviations……………………………… … … ……….. v Halohydantoins Reregistration Team……………………………… … … ………. iv Abstract ………….……………………………………………………………….... 1 I. Introduction…………………………………………………………… ………….. 2 II. Chemical Overview A. Regulatory History……………… …………………………………….. 4 B. Chemical Identification ……………………………… …… … ……….. 4 C. Use Profile………………………………………………………………... 7 III. Summary of Halohydantoins Risk Assessments A. Human Health Risk Assessment……………………………… ……… 12 1. Toxicity of Halohydantoins……………………… … … ………. 12 2. FQPA Safety ………………………………………… … ………… 17 3. Population Adjusted Dose (PAD)………………… …… ………... 17 a. Acute PAD………………………………… … … ………… 17 b. Chronic PAD………………………..…………… …… 17 4. Dietary Exposure Assumptions……………..…… … … ……… 18 5. Dieta ry (Food) Risk 18 Ass ssme t……e n ……………………………. a. Dietary Risk from Drinking Water……… … … ……….. 20 6. Resi dential Exposure...…………………………… … …………… 20 a. Toxicity…………………………………… … …… ………. 20 i Halohydantoins RED b. Residential Handler…...………………… … …… ……….. 21 i. Exposure Scenarios, Data and Ass um ions……..pt 22 ii. Residential Handler Risk ……..…………….. 22 c. Residential Post-application ….………………… ………. 25 i. Exposure Scenarios, Data and As sum ions……..pt 25 ii. Residential Post-Application Risk … … ……...…. 25 7. Aggregate Risk…………………………………………………… 28 a. Acute Dietary Aggregate Risk.………………. ....…….. 28 b. Short and Intermediate Aggregate Risk …………..….. 28 c. Chronic Dietary Aggregate Risk….………………….. 31 8. Occupational Exposure and Risk………………………………... 31 a. Occupational Toxicity……………………………………. 32 b. Occupational Handler Exposure……………………… 32 c. Occupational Post-Application Exposure……………… 35 d. Human Incident Data…………………………… ……….. 35 B. Environmental Risk Assessment……………………………………….. 37 1. Environmental Fate and Transport…………………… ………... 37 2. Ecological Risk………………………………………… ………… 37 3. Environmental Exposure Modeling …………………………….. 39 4. Listed Species Consideration ……………………………………. 41 a. The Endangered Species Act…….……… … … …………. 41 IV. Risk Management, Reregistration, and Tolerance Reassessment De cision A. Determination of Reregistration Eligibility…………………………… 42 B. Public Comments and Responses……………………………… ………. 42 C. Regulatory Position……………………………………… … … ………… 43 1. Food Quality Protection Act Considerations…………………... 43 a. "Risk Cup" Determination……………………… ………. 43 b. Determination of Safety to U.S. Populati on …… ………. 43 c. Determination of Safety to Infants and Ch ldrei n……… 43 ii Halohydantoins RED d. Endocrine Disruptor Effects…………………… ……….. 44 e. Cumulative Risks………………………………… ………. 44 2. Tolerance Summary……………………………… … … ……….. 45 3. Codex Harmonization…………………………………… …….… 45 D. Regulatory Rationale…………………………………………………….. 45 1. Human Health Risk Management………………………………. 45 a. Dietary (Food) Risk Mitigation………………… ………. 45 b. Drinking Water Risk Mitigation………… … ………….. 45 c. Residential Risk Mitigation……………… … … ………… 45 d. Occupational Risk Mitigation…………… … …………… 46 i. Handler Mitigation ………………………………. 46 ii Post-application Risk Mitigation… … … ………… 46 2. Environmental Risk Management……………… … …… ….. 47 3. Other Labeling Requirements…………………… … … ………… 47 4. Threatened and Endangered Species Considerations… ……….. 47 a. The Endangered Species Program………… … …………. 47 V. What Registrants Need to Do………………………………………………….. 49 A. Manufacturing Use-Products…………………………………………… 51 1. Additional Generic Data Requirements……………………….. 51 2. Labeling for Technical and Manufacturing-Use Products…….. 52 B. End-Use Products…………………………………………………….. 52 1. Additional Product Specific Data 52 Requirements………….......... 2. Labeling for End-Use Products………………………………….. 53 a. Label Changes Summary Table…………………………. 54 VI. Appendices iii Halohydantoins RED A. Table of Use Patterns for Halohydantoins…………………… ……… 58 B. Table of Generic Data Requirements and Studies Used o Mt ake the Regulatory Decision…………………………… …….. 110 C. Technical Support Documents………………………………… ……… 119 D. Bibliography Citations………………………………………… ………. 121 E. Generic Data Call-In…………………………………………… ………. 135 F. Product Specific Data Call- In…………………………………………… 136 G. Batching of End-Use Products…………………………………………. 137 H. List of All Registrants Sent the Data Call-In………………………….. 146 iv Halohydantoins RED CHEMICAL TEAM Science Team Tim McMa hon Michelle Centra Najm Shami m Timothy Leighton Jonathan Chen Kathryn Montague Sanyvette Williams-Foy Regulatory Team ShaRon Carlisle Heather Garvie Diane Isbell v GLOSSARY OF TERMS AND ABBREVIATIONS LD50 a.i. aPAD APHIS LOAEC LOAEL AR F T LOC LOEC mg/kg/day MOE Active Ingredient Acute Population Adjusted Dose BCF Animal and Plant Health Inspection Service CDC Agricultural Re-entry Task Force Bioconcentration CDP R Factor CFR Centers for Disease Co ntrol ChEI California Department o f Pesticide Regulation CMBS Code of Federal Regulations Cholinesterase cPAD In hibition Carbamate Market Basket Survey CSFII Chronic Population Adjusted Do se USDA Continuing Surveys for Food Intake by Individuals Community CWS Water System DCI Data Call-In DEEM Dietary Exposure Evaluation Model Double DL layer clothing {i.e., coveralls over SL} DWLOC Drinking Water Level of Comparison EC Emulsifiable Concentrate Fo rmulation EDSP Endocrine Disruptor Screening Program ED T S Endocrine Disruptor Screening and Testing Advisory Committee AC Estimated Environmental Concentrati on. The estimated pesticide concentration in an environment, EEC such as a terrestrial ecosystem. End-Use Product EP U.S. Environmental Protection Agency EPA Tier II Surface Water Computer Model EXAMS Food and Drug Administration FDA Federal Food, Drug, and Cosmetic Act FFDCA Federal Insecticide , Fungicide, and Rodenticide Act FIFRA Functional Observation Battery FOB Food Quality Protection Act FQ A P Federal Register FR With gloves GL Global Positioning System GPS Hazard Identification Assessment Review Committee Incident HIARC Data System ID S F Insect Growth Regulator Integrated Pest Management IGR Reregistration Eligibility Decision Lifetime IPM A verage Daily Dose RED Median Lethal Concentration. Statistically derived concentration of a substance expected to cause LADD death in 50% of test animals, usually expressed as the weight of substance per weight or volume of LC50 water, air or feed, e.g., mg/l, mg/kg or ppm. Lawn Care Operator Median Lethal Dose. Statistically derived single dose causing death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation), expressed as a weight of substance per LCO unit weight of animal, e.g., mg/kg. Halohydantoins RED L Adverse Effect Level o Level of Concern w Lowest Observed Effect Concentration e Milligram Per Kilogram Per Day Margin s of Exposure t O v b MP s MRID MRL e N/A r NASS v NAWQA e NG d NMFS NOAEC NOAEL NPIC A NR d OP v OPP e OR T E F r PAD s PCA e PDCI PDP PF10 E PF5 PHED f PHI ppb PPE PRZM RBC RED REI f RfD e RPA c RPM t RQ C RTU o RUP n SCI-GROW c SF e SL n SLN t STORET r TEP TGAI TRAC a UF t USDA USFWS USGS i WPS Halohydantoins RED Manufacturing-Use Product o Master Record Identification (number). EPA’s system of recording and tracking studies submitted. n Maximum Residue Level L Not Applicable o National Agricultural Statistical Service w USGS National Water Quality A ssessment e No Gloves s National Marine Fisheries Service t No Observed A dverse Effect Concentration O No Observed Adverse Effect Level b National Pesticide Information Center s No respirator e Organophosphorus r EPA Office of Pestic ide Programs v Outdoor Residential Exposure Task Force e Population Adjusted Dose d Percent Crop Area P ections factor 10 respirator r Protection factor 5 respirator o Pesticide Handler’s Exposure Data Pre- d harvest Interva l u Parts Per Billion c Personal Protective Equipment t Pesticide Root Zone Model S Red Blood Cell p Reregistration Eligibility D ecision e Restricted Entry Interval c Reference D ose i Reasonable and Prudent Alternatives f Reasonable and Prudent Measures i Risk Quotient c (Ready-to-use) D Restricted Use Pesticide a Tier I Ground Water Comput er Model t Safety Factor a Single layer clothing C Special Local Need (Registrations Under Section 24C of FIFRA) a Storage and Retrieval l Typical End-Use Product l Technical Grade Active Ingredient - Tolerance Reassessment Advisory Committee I Uncertainty Factor n United States Department of Agriculture U United States Fish and Wildlife Service S United States Geological Survey D Worker Protection Standard A P e s t i c i vi d e D a t a P r o g r a m P r o t Halohydantoins RED ABSTRACT The Environmental Protection Agency (EPA or the Agency) has comp leted the human health and environmental risk assessments for halohydantoins and is issui ng its risk management decision and tolerance reassessment. The risk assessments, which are summarized below, are based on the review of the required target database supporting the use patterns of currently registered products and additional information received through the public dock et. After considering the risks identified in the revised risk assessments, comments re ceived, and mitigation suggestions from interested parties, the Agency developed its risk management decision for uses of halohydantoins that pose risks of concern. As a result of this
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