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Sulfometuron Methyl (OUST) - FINAL DRAFT

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Sulfometuron Methyl (OUST) - FINAL DRAFT SERA TR 98-21-09-02d Sulfometuron methyl (OUST) - FINAL DRAFT Prepared for: USDA, Forest Service Task No. 9 USDA/FS Contract No. 53-3187-5-12 USDA/FS Order No. 43-3187-7-0408 Submitted to: Leslie Rubin, COTR Animal and Plant Health Inspection Service (APHIS) Biotechnology, Biologics and Environmental Protection Environmental Analysis and Documentation United States Department of Agriculture Suite 5B05 4700 River Road Riverdale, MD 20737 Submitted by: Syracuse Environmental Research Associates, Inc. 5100 Highbridge St., 42C Fayetteville, New York 13066-0950 Telephone: (315) 637-9560 Fax: (315) 637-0445 Internet: [email protected] Report Date: September 11, 1998 PDF File Date: April 25, 1999 TABLE OF CONTENTS LIST OF TABLES ......................................................... v LIST OF FIGURES ........................................................ vi ACRONYMS, ABBREVIATIONS, AND SYMBOLS ............................. vii COMMON UNIT CONVERSIONS AND ABBREVIATIONS ....................... viii CONVERSION OF SCIENTIFIC NOTATION ................................... ix EXECUTIVE SUMMARY ................................................... xi 1. INTRODUCTION ...................................................... 1-1 2. PROGRAM DESCRIPTION .............................................. 2-1 2.1. OVERVIEW ...................................................... 2-1 2.2. CHEMICAL DESCRIPTION AND COMMERCIAL FORMULATIONS ........ 2-1 2.3. APPLICATION METHODS .......................................... 2-3 2.4. MIXING AND APPLICATION RATES ................................. 2-4 3. HUMAN HEALTH RISK ASSESSMENT ................................... 3-1 3.1. HAZARD IDENTIFICATION ......................................... 3-1 3.1.1. Overview .................................................. 3-1 3.1.2. Acute Toxicity .............................................. 3-2 3.1.3. Subchronic or Chronic Systemic Toxic Effects ...................... 3-2 3.1.4. Reproductive and Teratogenic Effects ............................ 3-3 3.1.5. Carcinogenicity and Mutagenicity ................................ 3-3 3.1.6. Effects on the Skin and Eyes ................................... 3-4 3.1.7. Systemic Toxic Effects from Dermal Exposure ...................... 3-4 3.1.8. Inhalation Exposure .......................................... 3-5 3.1.9 Impurities and Metabolites ..................................... 3-6 3.1.10. Toxicological Interactions ..................................... 3-7 3.1.11. Mechanism of Action ......................................... 3-8 3.2. EXPOSURE ASSESSMENT .......................................... 3-8 ii TABLE OF CONTENTS (continued) 3.2.1. Overview .................................................. 3-8 3.2.2. Workers ................................................... 3-9 3.2.3. General Public ............................................. 3-13 3.3. DOSE-RESPONSE ASSESSMENT ................................... 3-19 3.3.1. Overview ................................................. 3-19 3.3.2. Existing Guidelines .......................................... 3-20 3.3.3. Dose-Response and Dose-Severity Relationships ................... 3-20 3.4. RISK CHARACTERIZATION ....................................... 3-27 3.4.1. Overview ................................................. 3-27 3.4.2. Workers .................................................. 3-28 3.4.3. General Public ............................................. 3-30 3.4.4. Sensitive Subgroups ......................................... 3-32 3.4.5. Connected Actions .......................................... 3-32 3.4.6. Cumulative Effects .......................................... 3-32 4. ECOLOGICAL RISK ASSESSMENT ...................................... 4-1 4.1. HAZARD IDENTIFICATION ......................................... 4-1 4.1.1. Overview .................................................. 4-1 4.1.2. Toxicity to Terrestrial Organisms ................................ 4-2 4.1.3. Aquatic Organisms ........................................... 4-5 4.2. EXPOSURE ASSESSMENT .......................................... 4-6 4.2.1. Terrestrial Animals ........................................... 4-6 4.2.2. Terrestrial Plants ........................................... 4-10 4.2.3. Aquatic Organisms .......................................... 4-14 4.3. DOSE-RESPONSE ASSESSMENT ................................... 4-15 4.3.1. Overview ................................................. 4-15 4.3.2. Toxicity to Terrestrial Animals ................................. 4-16 4.3.3. Aquatic Organisms .......................................... 4-20 iii TABLE OF CONTENTS (continued) 4.4. RISK CHARACTERIZATION ....................................... 4-21 4.4.1. Overview ................................................. 4-21 4.4.2. Terrestrial Organisms ........................................ 4-23 4.4.3. Aquatic Organisms .......................................... 4-30 5. REFERENCES ........................................................ 5-1 6. GLOSSARY ......................................................... 6-1 7. SUBJECT INDEX ...................................................... 7-1 APPENDICES Appendix 1: Laboratory and simulation studies on environmental sulfometuron methyl. Appendix 2: Field studies on the environment fate of sulfometuron methyl. Appendix 3: Toxicity of sulfometuron methyl and Oust to experimental mammals Appendix 4: Toxicity to experimental birds. Appendix 5: Bioassays of sulfometuron methyl toxicity in terrestrial plants. Appendix 6: Toxicity to fish, aquatic invertebrates, and aquatic plants. WORKSHEETS iv LIST OF TABLES Table 2-1. Selected physical and chemical properties of sulfometuron methyl with selected additional properties for the commercial formulation, OUST ........................ 2-2 Table 2-2. Uses of sulfometuron methyl by the Forest Service in 1997 ................. 2-3 Table 2-3. Application rates and concentrations of sulfometuron methyl in applied solutions of Oust ........................ 2-5 Table 3-1. Summary of worker exposure scenarios .............................. 3-10 Table 3-2. Summary of exposure scenarios for the general public .................... 3-15 Table 3-3. Summary of dose/response/severity data for sulfometuron methyl ............................................. 3-21 Table 3-4. Summary of teratology studies in rabbits .............................. 3-25 Table 3-5. Summary of risk characterization for workers .......................... 3-29 Table 3-6. Summary of risk characterization for the general public .................................................. 3-31 Table 4-1. Summary of exposure scenarios for terrestrial animals ................................................ 4-8 Table 4-2. Summary of quantitative risk characterization for terrestrial animals ............................................ 4-24 v LIST OF FIGURES Figure 3-1. Proposed metabolic pathway of sulfometuron methyl in the goat ...................................................... 3-6 Figure 3-2. Dose/severity relationships for sulfometuron methyl ..................... 3-22 Figure 3-3. Categorical regression of dose/severity relationships for sulfometuron methyl using all data in Table 3-3 and combining AELs and FELs ..................................... 3-27 Figure 4-1. Relationship of application rate to severity of effects in broadleaf and grass crop species in the study by Drake 1990 .................................................... 4-17 Figure 4-2. Relationship of application rate to severity of effects in broadleaf and grass weed species in the study by Drake 1990 .................................................... 4-18 Figure 4-3. Frequency of observations of different severity levels from the study by Drake 1990 for all species and application rates ................................................ 4-18 Figure 4-4. Summary of categroical regression analyses of crops and weeds from the study by Drake 1990 ............................. 4-19 Figure 4-5. Summary of categorical regression analyses of grasses and broadleaves from the study by Drake 1990 ......................... 4-19 vi ACRONYMS, ABBREVIATIONS, AND SYMBOLS a.e. acid equivalents a.i. active ingredient AEL adverse-effect level ACGIH American Conference of Governmental Industrial Hygienists AChE acetylcholinesterase ATSDR Agency for Toxic Substances and Disease Registry BCF bioconcentration factor bw body weight CBI confidential business information cm centimeter CNS central nervous system DAA days after application DF dry flowable d.f. degrees of freedom EC25 concentration causing 25% inhibition of a process EC50 concentration causing 50% inhibition of a process F female F1 first filial generation g gram HQ hazard quotient ka absorption coefficient ke elimination coefficient kg kilogram Ko/c organic carbon partition coefficient Ko/w octanol-water partition coefficient Kp skin permeability coefficient L liter lb pound LC50 lethal concentration, 50% kill LD50 lethal dose, 50% kill LOAEL lowest-observed-adverse-effect level m meter M male MCS multiple chemical sensitivity mg milligram mg/kg/day milligrams of agent per kilogram of body weight per day mL milliliter mM millimole MW molecular weight MOS margin of safety MSDS material safety data sheet NCI National Cancer Institute vii ACRONYMS, ABBREVIATIONS, AND SYMBOLS (continued) NOAEL no-observed-adverse-effect level NOEL no-observed-effect level NRC National Research Council OPPTS Office of Pesticide Planning and Toxic Substances ppm parts per million PSP phenolsulfonphthalein
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