Reregistration Status for Organophosphates RED (PDF)[398]

US Environmental Protection Agency Office of Pesticide Programs Reregistration Eligibility Decision for Phorate When EPA concluded the organophosphate (OP) cumulative risk assessment in July 2006, all tolerance reassessment and reregistration eligibility decisions for individual OP pesticides were considered complete. OP Interim Reregistration Eligibility Decisions (IREDs), therefore, are considered completed REDs. OP tolerance reassessment decisions (TREDs) also are considered completed. Combined PDF document consists of the following: • Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides (July 31, 2006) • Phorate IRED UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON D.C., 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES MEMORANDUM DATE: SUBJECT: July 31, 2006 Finalization of Interim Reregistration Eligibility Decisions (IREDs) and Interim Tolerance Reassessment and Risk Management Decisions (TREDs) for the Organophosphate Pesticides, and Completion of the Tolerance Reassessment and Reregistration Eligibility Process for the Organophosphate Pesticides Debra Edwards, Director Special Review and Reregistration Division Office of Pesticide Programs Jim Jones, Director Office of Pesticide Programs FROM: TO: As you know, EPA has completed its assessment of the cumulative risks from the organophosphate (OP) class of pesticides as required by the Food Quality Protection Act of 1996. In addition, the individual OPs have also been subject to review through the individualchemical review process. The Agency’s review of individual OPs has resulted in the issuance of Interim Reregistration Eligibility Decisions (IREDs) for 22 OPs, interim Tolerance Reassessment and Risk Management Decisions (TREDs) for 8 OPs, and a Reregistration Eligibility Decision (RED) for one OP, malathion. 1 These 31 OPs are listed in Appendix A. EPA has concluded, after completing its assessment of the cumulative risks associated with exposures to all of the OPs, that: (1) the pesticides covered by the IREDs that were pending the results of the OP cumulative assessment (listed in Attachment A) are indeed eligible for reregistration; and 1 Malathion is included in the OP cumulative assessment. However, the Agency has issued a RED for malathion, rather than an IRED, because the decision was signed on the same day as the completion of the OP cumulative assessment. Page 1 of 3 (2) the pesticide tolerances covered by the IREDs and TREDs that were pending the results of the OP cumulative assessment (listed in Attachment A) meet the safety standard under Section 408(b)(2) of the FFDCA. Thus, with regard to the OPs, EPA has fulfilled its obligations as to FFDCA tolerance reassessment and FIFRA reregistration, other than product-specific reregistration. The Special Review and Reregistration Division will be issuing data call-in notices for confirmatory data on two OPs, methidathion and phorate, for the reasons described in detail in the OP cumulative assessment. The specific studies that will be required are: − 28-day repeated-dose toxicity study with methidathion oxon; and − Drinking water monitoring study for phorate, phorate sulfoxide, and phorate sulfone in both source water (at the intake) and treated water for five community water systems in Palm Beach County, Florida and two near Lake Okechobee, Florida. The cumulative risk assessment and supporting documents are available on the Agency’s website at www.epa.gov/pesticides/cumulative and in the docket (EPA-HQ-OPP-2006-0618). Page 2 of 3 Attachment A: Organophosphates included in the OP Cumulative Assessment Chemical Acephate Azinphos-methyl (AZM) Bensulide Cadusafos Chlorethoxyphos Chlorpyrifos Coumaphos DDVP (Dichlorvos) Diazinon Dicrotophos Dimethoate Disulfoton Ethoprop Fenitrothion Malathion Methamidophos Methidathion Methyl Parathion Naled Oxydemeton-methyl Phorate Phosalone Phosmet Phostebupirim Pirimiphos-methyl Profenofos Propetamphos Terbufos Tetrachlorvinphos Tribufos Trichlorfon Decision Document IRED IRED IRED TRED TRED IRED TRED IRED IRED IRED IRED IRED IRED TRED RED IRED IRED IRED IRED IRED IRED TRED IRED TRED IRED IRED IRED IRED TRED IRED TRED Status IRED completed 9/2001 IRED completed 10/2001 IRED completed 9/2000 TRED completed 9/2000 TRED completed 9/2000 IRED completed 9/2001 TRED completed 2/2000 IRED completed 6/2006 IRED completed 7/2002 IRED completed 4/2002 IRED completed 6/2006 IRED completed 3/2002 IRED completed 9/2001 IRED addendum completed 2/2006 TRED completed 10/2000 RED completed 8/2006 IRED completed 4/2002 IRED completed 4/2002 IRED completed 5/2003 IRED completed 1/2002 IRED completed 8/2002 IRED completed 3/2001 TRED completed 1/2001 IRED completed 10/2001 TRED completed 12/2000 IRED completed 6/2001 IRED completed 9/2000 IRED completed 12/2000 IRED completed 9/2001 TRED completed 12/2002 IRED completed 12/2000 TRED completed 9/2001 Page 3 of 3 Interim Reregistration Eligibility Decision for Phorate Case # 0103 List B TABLE OF CONTENTS Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . v I. II. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 1 Chemical Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 A. Regulatory History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 B. Chemical Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 3 C. Use Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 4 D. Estimated Usage of Pesticide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 5 Summary of Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 A. Human Health Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 1. Dietary Risk from Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 a. Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 b. FQPA Safety Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 c. Population Adjusted Dose (PAD) . . . . . . . . . . . . . . . . . . . . . . . . 10 d. Exposure Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 e. Food Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 2. Dietary Risk from Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 a. Surface Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 b. Ground Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 c. Drinking Water Levels of Comparison (DWLOCs) . . . . . . . . . 13 3. Occupational and Residential Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 a. Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 b. Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 c. Occupational Handler Risk Summary . . . . . . . . . . . . . . . . . . . . 17 (1) Agricultural Handler Risk . . . . . . . . . . . . . . . . . . . . . . . 17 (2) Post-Application Occupational Risk . . . . . . . . . . . . . . . . 18 4. Human Incident Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 5. Aggregate Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 B. Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 1. Environmental Fate and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 2. Risk to Birds, Mammals and Nontarget Terrestrial Organisms . . . . . 20 a. Nontarget Terrestrial Organisms Incidents . . . . . . . . . . . . . . . 21 3. Risk to Aquatic Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 Interim Risk Management and Reregistration Decision . . . . . . . . . . . . . . . . . . . . . . . 22 A. Determination of Interim Reregistration Eligibility . . . . . . . . . . . . . . . . . . . . . 22 1. Summary of Phase 5 Comments and Responses . . . . . . . . . . . . . . . . . . 23 B. Regulatory Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 1. FQPA Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 III. IV. C. D. a. “Risk Cup” Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 24 b. Tolerance Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 25 2. Endocrine Disruptor Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 3. Label Modifications . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 30 Regulatory Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 1. Human Health Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 a. Dietary Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 (1) Acute Dietary (Food) . . . . . . . . . . . . . . . . . . . . . . . . . . . 32 (2) Chronic Dietary (Food) . . . . . . . . . . . . . . . . . . . . . . . . . . 32 (3) Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 (4) Residential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 (5) Aggregate . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 b. Occupational Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . 34 (1) Loaders . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 (2) Applicators and Flaggers . . . . . . . . . . . . . . . . . . . . . . . . 35 (3) Other Handlers . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 (4) Postapplication Workers . . . . . . . . . . . . . . . . . . . . . . . . . 36 (5) Other Information Considered . . . . . . . . . . . . . . . . . . . . 36 2. Environmental Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 a. Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 (1) Aquatic Animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 (2) Nontarget Terrestrial Organisms . . . . . . . . . . . . . . . . . . 37 b. Mitigation Measures . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 (1) Aquatic animals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 (2) Birds and Mammals . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 c. Other Options Considered . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 Labeling . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 1. Endangered Species Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 2. Spray Drift Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 V. What Registrants Need to Do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 A. Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 1. Additional Generic Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 40 2. Labeling for Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . 40 B. End-Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 1. Additional Generic Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . 41 2. Labeling for End-Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 C. Existing Stocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 D. Labeling Changes Summary Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 Related Documents and How to Access Them . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 47 APPENDICES . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 VI. VII. Appendix A. Table of Use Patterns Eligible for Reregistration . . . . . . . . . . . . . . . . . 49 Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 55 Appendix C. Technical Support Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 61 Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim Reregistration Decision (Bibliography) . . . . . . . . . . . . . . . . . . 64 Appendix E. Generic Data Call-In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Appendix F. Product Specific Data Call-In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 81 Appendix G. EPA’S Batching of Phorate Products for Meeting Acute Toxicity Data Requirements for Reregistration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 87 Appendix H. List of Registrants Sent This Data Call-In . . . . . . . . . . . . . . . . . . . . . . 90 Appendix I. List of Available Related Documents and Electronically Available Forms . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 92 GLOSSARY OF TERMS AND ABBREVIATIONS AE a.i. AGDCI ai aPAD AR ARC BCF CAS CI CNS cPAD CSF CFR CSFII DCI DEEM DFR DRES DWEL DWLOC EC EEC EP EPA FAO FDA FIFRA FFDCA FQPA FOB G GENEEC GLC GLN GM Acid Equivalent Active Ingredient Agricultural Data Call-In Active Ingredient Acute Population Adjusted Dose Anticipated Residue Anticipated Residue Contribution Bioconcentration Factor Chemical Abstracts Service Cation Central Nervous System Chronic Population Adjusted Dose Confidential Statement of Formula Code of Federal Regulations USDA Continuing Surveys for Food Intake by Individuals Data Call-In Dietary Exposure Evaluation Model Dislodgeable Foliar Residue Dietary Risk Evaluation System Drinking Water Equivalent Level (DWEL) The DWEL represents a medium specific (i.e., drinking water) lifetime exposure at which adverse, noncarcinogenic health effects are not anticipated to occur. Drinking Water Level of Comparison. Emulsifiable Concentrate Formulation Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a terrestrial ecosystem. End-Use Product U.S. Environmental Protection Agency Food and Agriculture Organization Food and Drug Administration Federal Insecticide, Fungicide, and Rodenticide Act Federal Food, Drug, and Cosmetic Act Food Quality Protection Act Functional Observation Battery Granular Formulation Tier I Surface Water Computer Model Gas Liquid Chromatography Guideline Number Geometric Mean i GRAS HA HAFT HDT IR LC50 LD50 LEL LOC LOD LOAEL MATC MCLG mg/kg/day mg/L MOE MP MPI MRID NA N/A NAWQA NOEC NOEL NOAEL NPDES NR OP OPP OPPTS Pa PAD PADI Generally Recognized as Safe as Designated by FDA Health Advisory (HA). The HA values are used as informal guidance to municipalities and other organizations when emergency spills or contamination situations occur. Highest Average Field Trial Highest Dose Tested Index Reservoir Median Lethal Concentration. A statistically derived concentration of a substance that can be expected to cause death in 50% of test animals. It is usually expressed as the weight of substance per weight or volume of water, air or feed, e.g., mg/l, mg/kg or ppm. Median Lethal Dose. A statistically derived single dose that can be expected to cause death in 50% of the test animals when administered by the route indicated (oral, dermal, inhalation). It is expressed as a weight of substance per unit weight of animal, e.g., mg/kg. Lowest Effect Level Level of Concern Limit of Detection Lowest Observed Adverse Effect Level Maximum Acceptable Toxicant Concentration Maximum Contaminant Level Goal (MCLG) The MCLG is used by the Agency to regulate contaminants in drinking water under the Safe Drinking Water Act. Milligram Per Kilogram Per Day Milligrams Per Liter Margin of Exposure Manufacturing-Use Product Maximum Permissible Intake Master Record Identification (number). EPA's system of recording and tracking studies submitted. Not Applicable Not Applicable USGS National Water Quality Assessment No Observable Effect Concentration No Observed Effect Level No Observed Adverse Effect Level National Pollutant Discharge Elimination System Not Required Organophosphate EPA Office of Pesticide Programs EPA Office of Prevention, Pesticides and Toxic Substances pascal, the pressure exerted by a force of one newton acting on an area of one square meter. Population Adjusted Dose Provisional Acceptable Daily Intake ii PAG PAM PCA PDP PHED PHI ppb PPE ppm PRN PRZM/ EXAMS Q1* Pesticide Assessment Guideline Pesticide Analytical Method Percent Crop Area USDA Pesticide Data Program Pesticide Handler's Exposure Data Preharvest Interval Parts Per Billion Personal Protective Equipment Parts Per Million Pesticide Registration Notice Tier II Surface Water Computer Model The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model RAC Raw Agriculture Commodity RBC Red Blood Cell RED Reregistration Eligibility Decision REI Restricted Entry Interval RfD Reference Dose RQ Risk Quotient RS Registration Standard RUP Restricted Use Pesticide SAP Science Advisory Panel SCI-GROW Tier I Ground Water Computer Model SF Safety Factor SLC Single Layer Clothing SLN Special Local Need (Registrations Under Section 24(c) of FIFRA) TC Toxic Concentration. The concentration at which a substance produces a toxic effect. TD Toxic Dose. The dose at which a substance produces a toxic effect. TEP Typical End-Use Product TGAI Technical Grade Active Ingredient TLC Thin Layer Chromatography TMRC Theoretical Maximum Residue Contribution torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions. TRR Total Radioactive Residue UF Uncertainty Factor µg/g Micrograms Per Gram µg/L Micrograms Per Liter USDA United States Department of Agriculture USGS United States Geological Survey UV Ultraviolet iii WHO WP WPS World Health Organization Wettable Powder Worker Protection Standard Phorate TEAM Office of Pesticide Programs: Health Effects Risk Assessment Christine Olinger Jeffery Dawson Christina Swartz Michael Metzger Whang Phang Yung Yang Environmental Fate (Drinking Water and Ecological) Risk Assessment James Breithaupt David Farrar Use and Usage Analysis Virginia Dietrich Jihad Alsadek Registration Support Marilyn Mautz Risk Management Ben Chambliss Stephanie Willett Mark Hartman John Leahy iv Executive Summary EPA has completed its review of public comments on the revised risk assessments and is issuing its risk management decisions for phorate. The decisions outlined in this document do not include the final tolerance reassessment decision for phorate; however, some tolerance actions will be undertaken prior to completionof the finaltolerance reassessment. EPAhasproposed to revoke tolerances in or on meat, milk, poultry and eggs for residues of phorate because the Agencyhas determined that there are no reasonable expectations of finite residues and the tolerances are not necessary. Some tolerance reassessment actions such as revocations on alfalfa and barley have already been finalized while other tolerance reassessment decisions for this chemical will be issued once the cumulative assessment for all of the organophosphates is complete. The Agency may need to pursue further risk management measures for phorate once the cumulative assessment is finalized. The revised risk assessments are based on review of the required target data base supporting the use patterns of currently registered products and new informationreceived. In a continuing effort to make meaningful and practical reduction in risk, the Agencyinvited stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures before the Agency issued its risk mitigation decision on phorate. After considering the revised risks assessments, mitigation proposed by BASF and Aceto Agricultural Chemicals Corporation the technical registrants of phorate, comments and mitigation suggestions from other interested parties including the Natural Resources Defense Council, and several agricultural user groups, EPA developed its risk management decisionfor uses of phorate that pose risks of concern. This decision is discussed fully in this document. First registered in 1959, phorate is an organophosphate insecticide and nematicide primarily used on a variety of field agriculturalcrops. Phorate is a restricted use pesticide based on its high dermal, oral, and inhalation toxicity. It is applied using ground equipment only since the technicalregistrants, BASF and Aceto AgriculturalChemicals Corporation, have agreed to cancel the aerialuse. About three millionpounds are used annually, of which 80 % is applied to corn, potatoes, and cotton. Overall Risk Summary EPA’s human healthrisk assessment for phorate indicates some risk concerns. Dietary risk from food treated withphorate is not of concern. The aggregate dietary risk from combined food and drinking water exposure may pose concerns, based on modeling results. There are no residential uses of phorate, and therefore no residential risks were considered in the aggregate risk from such uses. The risks of applying phorate using ground equipment are below our level of concern for loaders, handlers, and applicators when closed loading and application systems are used. Risks to aerial applicators are of concern but this application method will be prohibited because registrants have agreed to restrict this method. Phorate ranks high in the number of occupational incidents resulting in adverse health effects. Dietary Risk v Acute and chronic dietary risks from food alone do not exceed the Agency’s level of concern, however for dietary risk from drinking water, based on modeling (SCI-GROW), the maximum estimated concentrations ofphorate and metabolites (sulfoxide and sulfone) in groundwater are slightly greater than the Agency’s DrinkingWater Levelof Comparison (DWLOC) for chronic drinking water exposure. Also, the estimated concentrations of phorate and its metabolites in surface water slightly exceed EPA’s DWLOC for acute exposure. However, the conservative nature of the food assessment together with extensive risk mitigation proposed in this document lead the Agency to believe that the dietary risk from food and drinking water exposure for phorate and its degradates will be below the Agency’s level of concern following implementation of mitigation measures. Residential Risk There are no concerns because phorate does not have any residential uses. Aggregate Risk Since there are no residentialuses forphorate, aggregaterisk will only consider exposure fromfood and water. Acute and chronic dietary risks fromfood alone do not exceed the Agency’s level of concern, however, for dietary risk from drinking water, the maximum estimated concentrations of phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly exceed EPA’s level of concern. As noted above, the conservative nature of the food assessment together with extensive risk mitigation proposed in this document lead the Agency to believe that the aggregate risk from food and drinking water exposure for phorate and its degradates will be below the Agency’s level of concern following implementation of mitigation measures. Occupational Risk Worker risks are of concern for the mixer/loader/applicator when using open bags, open cab ground equipment and minimum Personal Protective Equipment. EPA believes these risks can be mitigated to an acceptable level with the following requirements: use of closed systems/lock-n-load (LNL), use of closed cabs, additional precautionary label language limiting use to only one application per season and requiring soil incorporation. Current labeluse rates should be reduced by 25 % unless efficacydata shows that lowering use rates reduces the pesticidal effectiveness. This would also reduce worker risks when implemented. Aerialapplicators and flaggers (without engineering controls) also have risks above the level of concern but prohibition of aerial application will eliminate this concern. Since phorate use on wheat is applied by aerial application, the technical registrants have also volunteered to cancel use on wheat. The Agency is also requesting submission of agricultural practice information to further evaluate post application exposure, if any. Based on the current use pattern, when phorate is applied (generally at plant), and the way it is applied (granulars that are soil incorporated) does not indicate a need for new post application studies. Until the Agency has completed the cumulative risk vi assessment for all organophosphates, all currently registered uses of phorate, except wheat, may continue with the incorporation of the risk mitigation measures identified in this document. Ecological Risk Ecological risks are also of concern to the Agency. Risks to birds, fish, and mammals are high. Study results indicate that ingestionof phorate poses acute and chronic risks to birds. Additionally several bird kills, some involving large numbers of birds, have been reported and linked to the use of phorate on winter wheat. Fall application seems to pose a particular risk because during winter, degradation and downward movement is expected to be slow and in the following spring concentrations of phorate and its metabolites can occur at hazardous levels in pools on the soil surface. Acute and chronic risks to aquatic organisms resulting fromsurface run-off to rivers, streams and coastal areas is high based on study results. Additionally, a few fish kill incidents have been reportedly and indirectly linked to phorate. Risks to mammals mayresult fromagricultural use, based on study results. Phorate is moderately to highly toxic to honeybees on an acute basis. Cancellation of use on winter wheat, prohibiting aerial application, requiring soil incorporation, requiring additional environmental hazard labeling language and limiting use to once per season will reduce ecological exposure to phorate. The Agency is issuing this interim Reregistration Eligibility Document (IRED) for phorate, as announced in a Notice of Availability published in the Federal Register. This interim RED document includes guidance and time frames for complying with any necessary label changes for products containing phorate. Note that there is no comment period for this document, and that the time frames for compliance with the required changes outlined in this document are shorter than those givenin previous REDs. As part of the process discussed by the TRAC, which sought to open up the process to interested parties, the Agency’s risk assessments for phorate have already been subject to numerous public comment periods, and a further comment period for phorate was deemed unnecessary. The Phase 6 of the pilot process did not include a public comment period; however, for some chemicals, the Agency may provide for another comment period, depending on the content of the risk management decision. With regard to complying with the risk mitigation measures outlined in this document, the Agency has shortened this time period so that the risks identified herein are mitigated as quickly as possible. Neither the tolerance reassessment nor the reregistration eligibilitydecisionfor phorate can be considered final, however, until the cumulative risk assessment for all organophosphate pesticides is complete. The cumulative assessment may result in further required risk mitigation measures for phorate. vii I. Introduction The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to accelerate the reregistrationof products withactive ingredients registered prior to November 1, 1984. The amended Act calls for the development and submission of data to support the reregistration of an active ingredient, as well as a review of all submitted data by the U.S. EnvironmentalProtection Agency(referred to as EPA or “the Agency”). Reregistration involves a thorough review of the scientific database underlying a pesticide’s registration. The purpose of the Agency’s review is to reassess the potentialhazards arising from the currently registered uses of the pesticide; to determine the need for additionaldata on health and environmentaleffects; and to determine whether the pesticide meets the “no unreasonable adverse effects” criteria of FIFRA. On August 3, 1996, the Food Quality Protection Act of 1996 (FQPA) was signed into law. This Act amended FIFRA to requiretolerance reassessment during reregistration. It also requires that by 2006, EPA must review all tolerances in effect on the day before the date ofthe enactment of the FQPA, which was August 3, 1996. FQPA also amended the FFDCA to require a safety finding in tolerance reassessment based on factors including an assessment of cumulative effects ofchemicals witha common mechanism of toxicity. Phorate belongs to a group of pesticides called organophosphates, which share a common mechanism of toxicity - they all affect the nervous system by inhibiting cholinesterase. Although FQPA significantly affects the Agency’s reregistration process, it does not amend any of the existing reregistrationdeadlines. Therefore, the Agencyis continuing its reregistration program while it resolves the remaining issues associated with the implementation of FQPA. This document presents the Agency’s revised human health and ecological risk assessments; its progress toward tolerance reassessment; and the interim decisionon the reregistrationeligibilityofphorate. It is intended to be only the first phase in the reregistrationprocess for phorate. The Agency will eventually proceed with its assessment of the cumulative risk of the OP pesticides and issue a final reregistration eligibility decision for phorate. The implementation of FQPA has required the Agency to revisit some of its existing policies relating to the determination and regulation of dietary risk, and has also raised a number of new issues for which policies need to be created. These issues were refined and developed through collaboration betweenthe Agencyand the Tolerance Reassessment AdvisoryCommittee(TRAC), whichwas composed of representatives fromindustry, environmentalgroups, and other interested parties. The TRAC identified the following science policy issues it believed were key to the implementation of FQPA and tolerance reassessment: ! ! ! ! Applying the FQPA 10-Fold Safety Factor Whether and How to Use "Monte Carlo" Analyses in Dietary Exposure Assessments How to Interpret "No Detectable Residues" in Dietary Exposure Assessments Refining Dietary (Food) Exposure Estimates 1 ! ! ! ! ! ! Refining Dietary (Drinking Water) Exposure Estimates Assessing Residential Exposure Aggregating Exposure from all Non-Occupational Sources How to Conduct a Cumulative Risk Assessment for Organophosphate or Other Pesticides with a Common Mechanism of Toxicity Selection of Appropriate Toxicity Endpoints for Risk Assessments of Organophosphates Whether and How to Use Data Derived from Human Studies The process developed by the TRAC calls for EPA to provide one or more documents for public comment on each of the policy issues described above. Each of these issues is evolving and in a different stage of refinement. Some issue papers have alreadybeen published for comment in the Federal Register and others will be published shortly. In addition to the policyissues that resulted fromthe TRAC process, the Agency published in the Federal Register on August 12, 1999 a draft Pesticide RegistrationNotice that presents EPA’s proposed approach formanagingrisksfromorganophosphate pesticides to occupationalusers. This notice describes the Agency’s baseline approach to managing risks to handlersand workers oforganophosphate pesticides. Generally, basic protective measures such as closed mixing and loading systems, enclosed cab equipment, or protective clothing, as well as increased restricted entryintervals will be necessary for most uses where current risk assessments indicate a risk and such protective measures are feasible. The draft guidance policy also states that the Agency will assess each pesticide individually, and based upon the risk assessment, determine the need for specific measures tailored to the potential risks of the chemical. The measures included in this interim RED are consistent with that draft Pesticide Registration Notice. This document consists of six sections. Section I contains the regulatory framework for reregistration/tolerance reassessment as well as descriptions ofthe process developed by TRAC for public comment on science policyissues for the organophosphate pesticides and the worker risk management PR notice. Section II provides a profile of the use and usage of the chemical. Section III gives an overview of the revised humanhealthand environmentaleffects risk assessments resulting frompublic comments and other information. Section IV presents the Agency's interim decision on reregistration eligibility and risk management decisions. Section V summarizes the label changes necessary to implement the risk mitigation measures outlined in Section IV. Section VI provides information on how to access related documents. Finally, the Appendices lists Data Call-In (DCI) information. The revised risk assessments and related addenda are not included in this document, but are available on the Agency's web page www.epa.gov/pesticides/op/phorate.htm, and in the Public Docket. 2 II. Chemical Overview A. Regulatory History Phorate was first registered in the United States in 1959. In August 1979, all emulsifiable concentrate formulations containing 65% or more a.i., as well as all granular products used on rice, were classified as restricted use pesticides. In August 1984, the Registration Standard was issued. The RegistrationStandard expanded the restricted use classification to include all granular products containing 5 % or more active ingredient. Registrants of products containing less than 5 % a.i. were required to submit additional data. In December 1988, the Registration Standard was amended and restricted use classificationwas imposed on all phorate products based on acute dermaland oral toxicityas well as avian hazards. The Agency sent a preliminary notification (letter dated 12/88) to BASF based on risk concerns to nontarget organisms including birds, wild animals and endangered species. A second notification letter was sent to the registrant in August 1990 indicating continued concern about nontarget organisms and adding risks to aquatic organisms as further basis for a Special Review. In addition to the data requirements imposedinthe 1984 Phorate RegistrationStandard and its 1988 Amendment, additionaldata requirements including humanincident data, neurotoxicity, foliar residue dissipation, dermal and inhalation passive dosimetry data were imposed in Data Call-In Notices in October 1992, August 1993, October 1995, and neurotoxicity studies (acute, subchronic and developmental) in 1999 . B. Chemical Identification Phorate: S H 3C S S OC2H 5 OC2H 5 P ! ! ! ! ! ! Common Name: Chemical Name: Phorate O,O-diethyl S[(ethylthio)methyl] phosphorothioate Organophosphate 298-02-2 057201 C7H17O2PS3 3 Chemical Family: CAS Registry Number: OPP Chemical Code: Empirical Formula: ! ! ! Molecular Weight: Trade and Other Names: Basic Manufacturers: 260.4 Thimet BASF and Aceto Agricultural Chemical Corp. Technical phorate is a colorless to light yellow clear liquid with a boiling point of 118-120 C. Phorate is slightly soluble in water at 20-50 ppm and soluble in most organic solvents, such as acetone and xylene. It is miscible in alcohols, ethers, ketones, esters, carbon tetrachloride, and vegetable oils. Phorate is subject to hydrolysis under alkaline conditions, but is stable under neutral and acidic conditions. C. Use Profile The following information is based on the currently registered use of phorate. Type of Pesticide: Summary of Use: Food: Residential: Other Nonfood: Target Pests: Potatoes, Corn (fresh, sweet, field)), Peanuts, Cotton, Sugarcane, Wheat (spring/winter), Soybeans, Beans, Sorghum, and Sugar Beets. No residential uses. Lilies (field grown), Daffodils, Radishes grown for seed. Phorate is used to control Mexican bean beetle, corn rootworm, mites, Europeancornborers, wireworms, whitegrubs,cornleafaphids, seedcorn beetles, leafminers, thrips, black cutworms, leafhoppers, white flies, nematodes, southern corn rootworm, flea beetle larvae, psyllids, wireworms, Colorado potato beetle, lygus, chinchbug nymphs, Banks grass mites, seedcorn maggots, sugar beet root maggot, sugar beet leafhopper, grasshoppers, and Hessian Fly. Insecticide/nematicide Formulation Types: Registered: Formulated as 10%, 15% and 20% granular end-use formulations and 92-95 % emulsifiable concentrate manufacturing use product. 4 Method and Rates of Application: Equipment ­ Method and Rate Ground and aerial equipment Aerialapplication; soiland foliar applications (band, broadcast, in-furrow, and drilling). Use rates vary from a minimum of 0.66 lbs ai/acre to a maximum of 3.9 lbs ai/acre per single application with a maximum of 2 applications per year for some uses. Generally at planting with soil incorporation, but can be applied at cultivation(corn), late in the season to irrigated cotton (cotton), late in the season witha side dress-application (lillies/daffodils), at pegging withsoil incorporation(peanuts), post-emergence at hilling with soil incorporation (potatoes), at bolting (radishes), post emergence at cultivation with soil incorporation (sorghum), and over the plant later in season (wheat). Timing ­ Use Classification: Phorate is a “restricted use" chemical based on acute dermal and oral toxicity as well as avian hazards. D. Estimated Usage of Pesticide An estimated 3 millionpounds are produced annually. Crops with the highest usage with reference to pounds produced are corn (46%), potatoes (21%) and cotton (13%). Almost 2.5 million acres are treated annually. Crops with the highest percentage ofacres treated include potatoes (20%), fresh sweet corn (10%) and peanuts (9%). Most of the usage is in FL, WI, CA, GA, MS, AL, TX, ID, MT, and MI. Crops with a high percentage of the total U.S. planted acres treated include potatoes (20%), fresh sweet corn (10%), peanuts (9%), and vegetables, cotton, and sugarcane (4%). 5 Table 1: Usage Analysis Site Acres Grown (000) 23,949 429 572 7,505 2,181 723 313 72,284 12,689 285 33,427 40 24,815 368 6,133 867 2,515 Acres Treated (000) Wtd Avg 1 0 0 3 29 12 0 1,249 536 0 0 1 0 0 0 0 0 62 Est Max 3 1 0 10 57 29 0 2,392 877 0 2 2 0 0 2 1 0 127 % of Crop Treated Wtd Avg 0.00 0.04 0.00 0.04 1.32 1.62 0.01 1.73 4.23 0.01 0.00 1.00 0 0.00 0.12 0.00 0.01 2.45 Est Max 0.01 0.21 0.01 0.13 2.63 3.98 0.02 3.31 6.91 0.02 0.01 2.00 0 0.00 0.48 0.01 0.03 5.06 LB AI Applied (000) Wtd Avg 1 0 0 2 32 14 0 1,410 410 0 1 2 3 0 0 0 0 140 Est Max 3 1 0 4 51 32 0 2,690 744 0 3 4 4 0 1 1 0 324 Average Application Rate lb ai/ acre/yr 0.9 1.0 1.0 0.6 1.1 1.2 1.0 1.1 0.8 1.0 1.1 3.0 1.0 0.9 1.8 0.6 2.3 #appl / yr 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.2 1.0 1.0 1.0 1.0 1.0 1.0 1.4 1.1 States of Most Usage lb ai/ A/appl (% of total lb ai used on this site) 0.9 1.0 1.0 0.6 1.1 1.2 1.0 1.0 0.8 1.0 1.1 1.0 0.9 1.8 0.4 2.2 AZ WI 83% CA 100% WI 100% WY ID NE 91% MI WA CO ID NE PA 88% MD NY MI WI VA FL 86% AL 100% NE IL IA WI MN IN 67% TX CA GA MS AR NC 75% TX 100% TX ID 95% WA OR 100% CA 100% MT TX 100% CA GA FL 89% MN NC 89% FL 100% FL ID WY 81% Alfalfa Almonds Apples Barley Beans/Peas, Dry Beans/Peas, Green Cole Crops Corn Cotton Cucurbits Hay, Other Hops Lilies Lots/Farmsteads/etc Melons Oats/Rye Oranges Other Crops 6 Site Acres Grown (000) 1,610 488 1,421 46 113 11,280 62,879 1,415 852 233 544 695 286 20,799 45,854 62,825 Acres Treated (000) Wtd Avg 145 0 284 0 ERR 25 17 34 33 23 9 0 12 2 22 0 2,499 Est Max 180 1 336 5 ERR 78 34 71 82 45 31 1 27 3 46 0 3,471 % of Crop Treated Wtd Avg 8.99 0.05 20.01 0.29 ?? 0.22 0.03 2.38 3.91 9.73 1.61 0.05 4.05 0.01 0.05 0.00 Est Max 11.18 0.19 23.68 10.98 •0 0.69 0.05 5.00 9.62 19.08 5.65 0.18 9.58 0.02 0.10 0.00 LB AI Applied (000) Wtd Avg 160 0 630 0 0 27 15 45 110 21 7 1 14 1 13 0 3060.19 Est Max 210 1 1,215 5 80 31 89 286 41 26 3 31 2 30 1 4486.2573 Average Application Rate lb ai/ acre/yr 1.1 1.5 2.2 1.0 1.1 0.9 1.3 3.3 0.9 0.9 2.2 1.2 0.8 0.6 1.8 #appl / yr 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.0 1.3 1.0 1.0 1.0 1.0 1.2 1.0 States of Most Usage lb ai/ A/appl (% of total lb ai used on this site) 1.1 1.5 2.2 1.0 1.1 0.9 1.3 3.3 0.7 0.9 2.2 1.2 0.7 0.5 1.8 KS TX NE NM SD 84% MN IN IL WI NC 84% ID CA WY 83% FL 90% FL 100% WI 100% VA 87% MD NY MI WI VA FL 82% ID MT 95% WA ID NC GA CA SC 82% MI 100% GA NC TX AL VA 86% GA MS 100% ID WA ND OR MN CA 69% ID MT 100% Peanuts Pecans Potatoes Radishes Safflower Sorghum Soybeans Sugar Beets Sugarcane Sweet Corn, Fresh Sweet Corn, Proc. Tobacco Vegetables, Other Wheat, Spring Wheat, Winter Woodland Total 7 III. Summary of Risk Assessment Following is a summaryofEPA’s revisedhumanhealthand ecologicalrisk findings and conclusions for the organophosphate pesticide phorate, whichare fully presented in the documents, “Phorate Revised HED Chapter for the Reregistration Eligibility Decision Document,” dated September 2, 1999, and “Revised EFED Chapter for Phorate,” dated August 30, 1999 (and addendums thereto). The purpose of this summary is to assist the reader by identifying the key features and findings of these risk assessments, and to enhance understanding of the conclusions reached in the assessments. These risk assessments for phorate were presented at a September 2, 1999, Technical Briefing, whichwas followed by an opportunityfor public comment on risk management for this pesticide. The risk assessments presented here formthe basis of the Agency’s interim risk management decision for phorate only; the Agencymust complete a cumulative assessment of the risks of all the organophosphate pesticides before other final decisions can be made. Using relevant data submitted under section 4(g)(2)(A) of FIFRA, published scientific literature, and available surrogate data, the Agency assessed the human health and ecological risks associated with using phorate. The primary endpoint of concern is cholinesterase inhibition as measured in red blood cell and brain cholinesterase inhibitionfollowingexposure to phorate. The Agencycalculated humanhealthrisks from food, water, and occupational exposures. Acute and chronic dietary risk from residues in or on food were below the Agencylevelof concern forallsubpopulations. For dietary risk from drinking water, based on modeling (SCI-GROW), the maximum estimated concentrations of phorate and metabolites (sulfoxide and sulfone) in groundwater are slightly greater than the Agency’s Drinking Water Level of Comparison (DWLOC) for chronic drinking water exposure and the estimated concentrations of phorate and its metabolites in surface water slightly exceed EPA’s DWLOC for acute exposure. However, the conservative nature of the food assessment together with extensive risk mitigation proposed in this document lead the Agency to believe that the dietary risk from food and drinking water exposure for phorate and its degradates will be belowthe Agency’slevelof concern withimplementationof the following mitigationmeasures prohibiting use on peanuts at pegging, restricting cotton sidedress use to California and Arizona only, allowing only one applicationper year, requiring soil incorporation, requiring useofvegetated buffer strips and reducing application rates where efficacy tests show rate reductions are feasible. Since there are no residentialor non-occupational uses for phorate, a non-occupational/residential exposure and risk assessment is not applicable. Inquantifyingaggregaterisks, the Agencywill only consider exposure from food and water. Acute and chronic dietary risks from food alone do not exceed the Agency’s level of concern. However, for dietary risk from drinking water, the maximum estimated concentrations of phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly exceed EPA’s level of concern. Again the conservative nature of the food assessment together with extensive risk mitigationproposed in this document lead the Agencyto believe that the aggregate risk from food and drinking water exposure for phorate and its degradates will be below the Agency’s level of concern following implementation of mitigation measures. 8 In regard to the ecological risk assessment, risks to birds, mammals, fishand aquatic invertebrates are high. Fall applications in the northern wheat growing states appear to pose a particular risk to birds. During the winter in these regions, degradation and downward movement in soil is expected to be slow. The incident information indicates that in spring the concentrations of phorate and/or phorate degradates sometimes occur at hazardous levels in pools on the soil surface. In terms of the environmental fate assessment for phorate, surface water contaminationmayoccur fromthe sulfoxide and sulfone degradates of phorate as well as fromparent phorate. The risk of ground water contamination is primarily associated with phorate sulfone and phorate sulfoxide rather than parent phorate. A. Human Health Risk Assessment EPA issued its preliminaryrisk assessments for phorate in February 1999 (Phase 3 of the TRAC process). In response to studies received during Phase 3, the risks assessments were updated and refined. The revisions are listed below: -The revised risk assessment incorporates the results of a new rat acute neurotoxicitystudy which leads to the establishment of a new acute dietary endpoint. -New dietary risk analyses utilizing a Monte Carlo (probabilistic) approach have been conducted byBASF and EPAto further characterize the acute risk and to identify commodities that contribute most significantly to the risk. -The revised occupational exposure and risk assessment considers a new subchronic dermal toxicity study on rats using a granular formulation, and an occupational exposure study was conducted using a similar chemical, terbufos, that reflects loading witha closed systemand varying levels of PPE. 1. Dietary Risk from Food a. Toxicity The Agency has reviewed all toxicity studies submitted and has determined that the toxicity database is complete, and that it supports the interim reregistration eligibility determination for all currently registered uses. Further details on the toxicity of phorate can be found in the September 2, 1999 Human Health Risk Assessment and subsequent addenda. A briefoverview of the studies used for the dietary risk assessment is outlined in Table 2 in this document. b. FQPA Safety Factor 9 Both acute neurotoxicity and subchronic neurotoxicity data in rats have been evaluated and found acceptable, however, the FQPA Safety Factor was reduced to 3X, based on the outstanding developmental neurotoxicity data requirement. The acute screening study findings of nerve degeneration in young rats after only a single dose trigger the requirement for developmental neurotoxicity data. The registrant provided a short summary of some historical data but the submitted historicalcontrol data were judged to be insufficient to support a determination of non-compound related histological changes in the isolatedperipheral nerve fibers. The toxicity database includes an acceptable two-generation reproduction study in rats and acceptable prenatal developmentaltoxicitystudies in rats and rabbits. These studies show no increased sensitivity to fetuses as compared to maternal animals following acute in utero exposure in the developmental rat and rabbit studies and no increased sensitivity to pups as compared to adults in a multi-generation reproduction study in rats. There was no evidence of abnormalities in the development of the fetal nervous system in the pre/post-natal studies. Adequate actual data, surrogate data, and/or modeling outputs are available to satisfactorily assess dietary and residential exposure and to provide a screening leveldrinking water exposure assessment. The assumptions and models used in the assessments do not underestimate the potential risks for infants and children. c. Population Adjusted Dose (PAD) The PAD is a relatively new term that characterizes the dietary risk of a chemical, and reflects the Reference Dose, either acute or chronic,thathasbeen adjusted to account for the FQPA safety factor (i.e., RfD/FQPA safety factor). A risk estimate that is less than 100% of the acute or chronic PAD does not exceed the Agency’s risk concern. d. Exposure Assumptions The dietary risk analysis used food consumptiondata fromthe 1989-1992 USDA CSFII Survey, Agency validated percent crop treated information, and data from field trial studies. FDA and USDA monitoring data showed non-detectable residues in all commodities with the exception of potatoes. Table 2. Summary of Toxicological Endpoints andOtherFactors Usedin the HumanDietary Risk Assessment of Phorate Exposure Dose (mg/kg/day) NOAEL = 0.25 Acute RfD Endpoint Miosis and brain cholinesterase inhibition Study Acute Neurotoxicity - Rat UF =100 Acute RfD = 0.0025 mg/kg FQPA Population Adjusted Dose = 0.00083 mg/kg NOAEL = 0.05 Red blood cell and brain cholinesterase inhibition UF =100 Chronic RfD = 0.0005 mg/kg/day FQPA Population Adjusted Dose = 0.00017 mg/kg/day Chronic - Dog Chronic RfD e. Food Risk Characterization 10 Generally, a dietary risk estimate that is less than 100% ofthe acute or chronic PopulationAdjusted Dose does not exceed the Agency’s risk concerns. The Agency conducted a probabilistic (Monte Carlo) acute dietary risk assessment using Tier 3 (highly refined) exposure estimates. The assessment considers the distribution of food consumption values and the distributionof residue values found in food. Using this approach, the acute dietary risk from residues of phorate in food alone is below the Agency’s level of concern at the 99.9th percentile. The most highly exposed subgroup is children 1 to 6 years old with 68 % of the acute Population Adjusted Dose (aPAD) consumed. The chronic dietary risk from phorate residues in food alone is also below the Agency’s level of concern. The most highly exposed subgroup is children1 to 6 years old with9% of the chronic Population Adjusted Dose (cPAD) consumed. The dietary exposure and risk estimates for food are not based onresidue monitoring data and thus are considered to be relatively conservative. Exposure estimates for each of the major contributors to dietary exposure (sweet corn, potatoes and peanuts) are based upon either tolerance levelresidues (sweet corn) or field trial data. It is expected that if suitable monitoring data were available the exposure and risk estimatesconcerningresidueson/in food would be significantly lower allowing for additionspace inthe “risk cup” for exposures to phorate. In summary, both acute and chronic dietary exposure and risk associated with phorate-treated foods are considered to be well below the Agency’s levelof concern. Refinements to the dietary analyses could be made by acquiring monitoring data and/or market basket survey data, rather than relying on assumptions that are likely to overestimate dietary exposure fromfood. However, the Agencydetermined that further refinements are not warranted at this time since dietary risk is not of concern based on our current estimates. Refinements will be considered when the cumulative assessment for all of the organophosphates is conducted. 2. Dietary Risk from Drinking Water Drinking water exposure to pesticides can occur through ground water and surface water contamination. EPA considers both acute (one day) and chronic (lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. Modeling is considered to be an unrefined assessment and provides a high-end estimate of risk. In the case of phorate, monitoring data for ground or surface water were insufficient as there were very limited data and the available data did not measure the degradates. Therefore modeling was used to estimate drinking water risks from these sources. The GENEEC and PRZM-EXAMS models were used to estimate surface water concentrations, and SCI-GROW was used to estimate groundwater concentrations. All of these are considered to be screening models, with the PRZM-EXAMS model being somewhat more refined than the other two. The recently implemented Index Reservoir and Percent Crop Area modifications to the PRZM-EXAMS model were also utilized in developing estimated surface water concentrations. 11 Based on environmental fate data, hydrolysis and microbial degradation appear to be the most important means of phorate dissipationin the environment. Phorate is very unstable to photolysis in water, but photolysis in the field may not be important since phorate degrades rapidly by hydrolysis and aerobic soil metabolism. Phorate rapidly photolyses in water to form formaldehyde and phorate sulfoxide. Parent phorate degrades in water withhalf-lives of 3 days at pH’s 5, 7, and 9. Parent phorate is verymobile to essentially immobile in soil depending on the soil organic carbon content, but is notpersistent in aerobic soil. In soil, parent phorate degrades into the oxidized metabolites phorate sulfoxide and sulfone. These degradates are more persistent than parent phorate, more mobile, and are more likely to be present in water resources than parent phorate because they are slightly more persistent and mobile. a. Surface Water The Agency has estimated the concentration of phorate alone, and phorate plus degradates in surface water using the PRZM/EXAMS model. Model estimates for both the parent and the parent plus metabolites exceed the level of concern for acute and chronic exposure for some use scenarios (see tables 3a and 3b). The estimated maximum peak concentration of phorate and degradates prior to mitigation is 53.2 ppb, and the maximum annual mean is 1.85 ppb based on use rates and patterns for field and sweet corn, peanuts, cotton, potatoes, and grain sorghum. Monitoring studies have been conducted for phorate only in the Mississippi Basin, Illinois, Colorado, and Florida. Analyses from an Illinois study were reported as total phorate + sulfoxide + sulfone. Only two detects were noted for the Colorado agricultural watershed (out of 25) at concentrations ranging from 0.08 ppb to 0.6 ppb. Phorate was not detected in any of the other samples from any of the other studies. The monitoring data are likely to be of little utility for dietary risk assessment, since the oxidized metabolites are more likely to be present than the parent, but in almost all of the studies, analyses for the degradates were not conducted. b. Ground Water The SCI-GROW model provides a screening concentration, an estimate of likely groundwater concentrations if the pesticide is used at the maximum allowed label rate in areas with groundwater exceptionally vulnerable to contamination. In most cases, a majority of the use area will have groundwater that is less vulnerable to contamination than the areas used to derive the SCI-GROW estimate. The SCI­ GROW model is based on scaled groundwater concentrations from groundwater monitoring studies, environmentalfate properties (aerobic soil half-lives and organic carbon partitioning coefficients (Koc's)) and applicationrates. The model is based on permeable soils that are vulnerable to leaching and on shallow groundwater (10-30 feet). Results from the SCI-GROW screening model predict that the maximum acute and chronic concentrations of total toxic residues (parent + sulfoxide+ sulfone) in shallow groundwater is not expected to exceed 13.5 ppb for peanuts prior to mitigation. EPA’s "Pesticides in Groundwater Database" reports no detections in 3,341 samples that have been submitted to date for parent phorate. 12 c. Drinking Water Levels of Comparison (DWLOCs) To determine the maximumallowable contributionof water-containing pesticide residues permitted in the diet, EPA first looks at how much of the overall allowable risk is contributed by food (and if appropriate, residential uses) then determines a “drinking water level of comparison”(DWLOC) to determine whether modeled or monitoring levels exceed this level. The Agency uses the DWLOC as a surrogate to capture risk associated with exposure frompesticides in drinking water. The DWLOC is the maximum concentration in drinking water which, when considered together with dietary exposure, does not exceed a level of concern. The estimated acute and chronic concentrations of phorate and degradates of concern in groundwater is 13.5 ppb; for the purposes of the screening-level assessment, the maximum and average concentrations in groundwater are not believed to vary significantly. Prior to mitigation, the estimated peak (acute) concentration of phorate and metabolites of concern in surface water is 53.2 ppb, and the annual mean (chronic) is 1.85 ppb. When these estimated concentrations are compared to the DWLOC, the comparison indicates that phorate in drinking water may contribute to aggregate risk. The table below presents the comparison of model estimated drinking water residue levels both prior to and after mitigation and DWLOCs. Additional estimates of drinking water exposure were developed taking into account several mitigationmeasures (reduced numberofapplications per season, soilincorporationand reduced application rates) that have been agreed to by the registrants and are contained in this document. This was done to characterize the potential for exposure to phorate in drinking water after these mitigation measures have been implemented. As the tables below show, these mitigationmeasures significantly reduce the estimated concentrations of phorate and its degradates in drinking water however, there is still concern for some use patterns. 13 Table 3a. Acute Drinking Water Risk Crop Scenario SCI-GROW (All residues, ppb) PRZM/ EXAMS (Parent Only, ppb) PRZM/ EXAMS (All residues, ppb) SCI-GROW (Including mitigation2) (All residues, ppb) 3.4 6.0 5.09 5.09 9.41 9.41 2.9 2.9 3.7 4.8 PRZM/ EXAMS (Including mitigation2) (Parent Only, ppb) NE 26.8 4.0 3.6 8.1 10.4 PRZM/ EXAMS (Including mitigation2) (All residues, ppb) NE 36.1 6.0 5.5 7.8 22.6 2.7 DWLOC (Acute) (ppb) (Children 1-6) Peanuts at plant Peanuts at pegging Corn at plant Corn at cultivation Cotton at plant Cotton sidedress 13.5 13.5 7.8 7.8 11.4 11.4 39.51 53.211 9.081 12.231 Table 3b. Chronic Drinking Water Risk Crop Scenario SCI-GROW (All residues, ppb) PRZM/ EXAMS (Parent Only, ppb) PRZM/ EXAMS (All residues, ppb) SCI-GROW (Including mitigation2) (All residues, ppb) 3.4 6.0 0.04 0.04 0.061 0.6 0.6 0.351 2.9 2.9 3.7 4.8 PRZM/ EXAMS (Including mitigation2) (Parent Only, ppb) NE 0.17 0.03 0.02 0.08 0.62 PRZM/ EXAMS (Including mitigation2) (All residues, ppb) NE 1.3 0.41 0.25 0.6 1.8 1.6 DWLOC (Acute) (ppb) (Children 1-6) Peanuts at plant Peanuts at pegging Corn at plant Corn at cultivation Cotton at plant Cotton sidedress 1 2 13.5 13.5 7.8 7.8 11.4 11.4 0.251 1.851 Modeling assumes currently labels multiple applications per season Mitigation includes limiting application frequency to once per season, requiring soil incorporation and reducing rates by 25%. 3. Occupational and Residential Risk Occupational workers can be exposed to a pesticide through mixing, loading, and/or applying a pesticide, or re-entering treated sites. There are no residentialor other non-occupational uses of phorate. 14 Additionally, since phorate is not used in a manner that would lead to exposure in the general population, the Agency did not consider residential exposure in the assessment. a. Toxicity The toxicity of phorate is integral to assessing the occupational risk. Technical phorate is highly toxic on an acute oral, dermaland inhalationbasis (ToxicityCategory I). All risk calculations are based on the most current toxicityinformationavailable for phorate, including a 28-day dermaltoxicitystudythatwas completed using the granular end-use product. The toxicological endpoints, and other factors used in the occupational risk assessments for phorate are listed below. Table 4. Acute Toxicity Values for Technical Phorate Study Oral LD 50 - Rat Dermal LD 50 - Rat Inhalation LC50 - Rat Eye Irritation Dermal Irritation Dermal Sensitization Results 3.7 mg/kg (M) 1.4 mg/kg (F) 9.3 mg/kg (M) 3.9 mg/kg (F) 0.06 mg/L (M) 0.011 mg/L Waived Waived Waived Category I I I N/A N/A N/A MRID # 00126343 00139479 00126343 N/A N/A N/A Table 5. Summary of Toxicological Endpoints and Other Factors Used in the Human Occupational and Residential Risk Assessments for Phorate Assessment Short-term dermal Intermediate- term dermal Long-term dermal Short-term inhalation Intermediate -term inhalation Long term inhalation Dose (mg/kg/day) NOAEL = 0.406 NOAEL = 0.406 Oral NOAEL = 0.05 Oral NOAEL= 0.25 Oral NOAEL= 0.05 Oral NOAEL = 0.05 Endpoint RBC, brain ChE inhibition RBC, brain ChE inhibition RBC, brain ChE inhibition Miosis and brain ChE inhibition RBC, brain ChE inhibition RBC, brain ChE Study Type 28-day dermal rat 28-day dermal rat Chronic Dog Acute Neurotoxicity - Rat Chronic Dog Chronic Dog Absorption factor N/A N/A 100% 100% 100% 100% b. Exposure 15 Chemical-specific exposure data were notavailable forphorate, however, short- and intermediateterm from dermal exposures to phorate were estimated using the recently submitted terbufos exposure monitoring study completed by BASF. This terbufos exposure monitoring study used a clay-based granular formulationsimilar to phorate formulations. EPA has used the exposure data fromthis study as a surrogate for phorate-specific exposure data in the phorate risk assessment as is common Agency practice with occupational exposure monitoring data when exposure scenarios are similar. Agencypolicyrequirescombiningchemical-specific data withgeneric estimates fromthe Pesticide Handlers Exposure Database (PHED), the database the Agency routinely uses for handler risk assessments when there is no study data available. The database calculates exposures and uses standard assumptions such as average body weight, work day hours, and acres treated daily, combined with label application use rates to calculate exposure estimates. The quality of the PHED data and exposure factors varies, but it represents the best exposure data for pesticide handlerscurrentlyavailable to the Agency. The qualityof the data used for each scenario assessed is discussed in the HumanHealthAssessment document for phorate, which is available in the public docket. Anticipated use patterns and application methods, range of application rates, and daily amount treated were derived fromcurrent labeling. Application rates specified on phorate labels range from 0.66 to 3.9 pounds of active ingredient per acre in agricultural settings with typical use rates ranging from 1 to 3.3 pounds per acre. The Agency typically uses acres treated per day values that are thought to represent 8 solid hours of application work for specific types of application equipment. Occupational handler exposure assessments are conducted by the Agencyusing different levels of personal protection. The Agencytypically evaluates all exposures with minimal protection and then adds additional protective measures using a tiered approach to obtain an appropriate MOE (i.e., going from minimalto maximum levels of protection). The lowest tier is represented by the baseline exposure scenario, followed by, if required (i.e., MOEs are less than 100), increasing levels of risk mitigation (personal protective equipment (PPE) and engineering controls (EC)). Typically, the current labels for phorate require maximum PPE. The levels of protection that formed the basis for calculations of exposure from phorate activities include: • • • • • Baseline: Long-sleeved shirt and long pants, shoes and socks. Label: baseline + chemical resistant gloves. Minimum PPE: Baseline + chemical resistant gloves and a respirator. Maximum PPE:Baseline + coveralls, chemical resistant gloves, and a respirator. Engineering controls: Engineeringcontrols such as a closed cab tractor or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods; there are no known devices that can be used to routinely lower the exposures for these methods. Different combinations of items listed above. • 16 For handlers, short-term, intermediate-term, and long term assessments were conducted for phorate, to reflect exposures of 1-7 days, one week to 28 days, and greater than 28 day durations, respectively. Although phorate is appliedmostlyonce per season, some applicators mayapply phorate over a period of up to 12 weeks because they need to cover large acreage, or they may be custom or professionalapplicators. Additionally, the potential for exposure to workers through entry into agricultural fields treated with phorate was also considered. c. Occupational Handler Risk Summary Risks for handlers were assessed using separate toxicological endpoints for both dermal and inhalationexposures. The resulting risks (MOE values) were then added in order to obtain an overall risk for each handler that accounted for both dermaland inhalationexposures because the effects are the same. Additionally, where it was logical, the risks associated with certain job functions were combined (e.g., a grower loading and then applying phorate granular to their own crops). Dermal and inhalation risks are mitigated using different types of protective equipment, so it maybe acceptable to add a pair of gloves and not a respirator, and vice versa. All of the risk calculations for handlers completed in this assessment are included in the HED chapter, dated September 2, 1999. For agricultural uses of phorate, six different exposure scenarios were assessed at different levels of personal protection. Within each of the scenarios, further analyses were conducted to determine the MOE at minimum and maximum applicationrates, and at maximum and typicalacreage, where applicable. Each of these analyses is included in the HED chapter. The reader is referred to this chapter for more information on this comprehensive assessment. Table 6 summarizesthe riskconcerns afterall assessments were revised using the most current data and assumptions for occupational handlers, based on combined dermal and inhalation exposures. The shaded areas represent the scenarios where risk is not of concern. The unshaded represent the scenarios where the Agency assessments indicate risk mitigation is necessary (i.e., MOEs < 100). (1) Agricultural Handler Risk For phorate, the Agency has determined that there are potentialexposures to workers as a result of mixing, loading, and applying phorate, as well as flagger activities. Risk estimates have been derived for the following scenarios: (1a) loading granular formulations (completed using PHED data at varying levels of personal protection); (1b) loading 20G formulation in “Lock-N-Load” packaging (completed using chemical-specific data); (2a) applying granular formulations using ground-based equipment (completed using PHED data at varying levels of personal protection); 17 (2b) applying 20G formulationusing in-the-row planters and closed tractor cabs (completed using chemical-specific data); (3) applying granular formulations with aerial equipment (completed using PHED data only with closed cabs); (4) flagging for the application of granular formulations with aerial equipment (completed using PHED data at varying levels of personal protection) Based on these estimates, occupational risks do not exceed the Agency’s level of concern when closed loading systems and enclosed application equipment (cabs) are used. Ifminimal PPE is used, open cabs are used, and products are loaded using bags that must be ripped open prior to loading, then risks exceed the Agency’s level of concern. Table 6: Occupational Risk Estimates for Phorate Exposure Scenario Data Source Range of Combined Dermal and Inhalation MOEs Baseline PPE1 Short and Intermediate term 7 - 285 4 -14 Minimum PPE2 Short and Intermediate term 11- 43 8 - 33 Maximum PPE3 Short and Intermediate term 22- 86 17- 66 Engineering Controls4 Short and Intermediate term N/A N/A Loading open bag granules for ground application Loading granules with a closed system for aerial application Loading granules with a closed system for ground application Applying granules with ground equipment application Mixing/loading/ applying granules for ground application Flagger for aerial granular application 1 2 PHED PHED N/A N/A N/A N/A N/A N/A 354 -1419 178 - 714 chemical specific study chemical specific study or *PHED chemical specific study PHED N/A N/A N/A N/A N/A N/A 1220 ­ 4895 682 - 2739 *11- 43 *8 -33 *10 - 42 *9 - 35 *18 - 72 *15 -61 2022 8114 1440 5778 N/A N/A N/A N/A 889 - 3569 827 ­ 3320 49 - 195 761 - 3053 463 1858 382 - 3943 26 -104 20 - 79 29 - 115 27 - 108 46 - 184 1297 ­ 5205 Baseline PPE assumes typical work clothing (long sleeved shirt , long pants, shoes and socks). Minimum PPE: Baseline + chemical resistant gloves and a respirator 3 Maximum PPE: Baseline + coveralls, chemical resistant gloves and respirator. 4 Engineering controls: closed cab tractor or closed loading system 5 Ranges of MOEs reflect 69 to 213 acres treated, 90 to 360 lb. ai. Handled daily, and application rates of 1 to 4 lbs. ai/A * PHED source (2) Post-Application Occupational Risk 18 Restricted-entry intervals (REIs) are calculated to determine the minimum length oftime required following an application before workers are allowed to reenter a treated area. Entry restrictions are calculated to determine the minimum lengthof time required following an application before crop workers are allowed to reenter a treated area with, or without the use of personal protective equipment to mitigate risks. REIs and entry restrictions are estimated in hours or days. The Agencydid not complete a quantitative assessment of post-application worker riskforphorate because the use pattern (early season, soil incorporated) suggests that significant exposure to reentry workers is not likely. However, the Agency reviewed two soil residue dissipation studies conducted in peanuts and potatoes which indicate phorate residues maypersist for many weeks after application. The Agencyis requestingadditionalinformationregarding culturalpractices, includingefficacydata, to determine the extent of reentry worker exposure. 4. Human Incident Data In addition to use of margins of exposure to estimate the risk, incident data are considered. The following databases were consulted for poisoning incident data on the active ingredient phorate: • • • • OPP Incident Data System (IDS); Poison Control Centers - (data received in response to 1993 Data-Call-In covering the years 1985 to 1992 ); California of Pesticide Regulation ; and, National Pesticide Telecommunication Network (NPTN). IDS (as of 8/99) received seven separate incident reports involving human exposure. Poison Control Centers Data (1985 to 1992) showed 109 cases of occupational and 82 cases of non­ occupational exposure to phorate. Poison Control Centers data for the interval 1993-1996 showed a decrease in the rate of incidences, 33 cases of occupational and 27 cases of non-occupational exposure. California data (1982-1993) showed 22 cases of adverse reactions to phorate. NPTN (1985-1991) handled 116 calls on phorate involving 39 incidents (29 humans, 5 animals, and 5 other, e.g. plants, wildlife). The risk from phorate exposure tended to be higher than other cholinesterase inhibitors. Of the 28 insecticides withPoisonControlCenter data (1985-1992), phorate ranked 6 for occupationalexposure and 7 fornon-occupational exposure, withnumber 1 being most frequently associated withadverse effects. This suggests that phorate is above average in its ability to cause adverse effects. When using the California data and calculating ratios for the number of systemic poisonings per 1,000 applications, the calculations for phorate are higher than the median score for the 28 other insecticides. Note, however, that California calculations were based on a relatively small number of cases. Applicators and mixer/loaders are the most frequently affected activity categories. 19 Phorate is currently only used in granular formulations. Some of the above average ratios or measures of hazard (described above) suggest that handlers may not fully observe precautions because of the perception that poisoning is much less likely with a granular than liquid formulation. 5. Aggregate Risk An aggregate risk assessment looks at the combined riskfromdietary exposure (food and drinking water routes) and residentialexposure to a particular pesticide. There are no residential uses for phorate, therefore an aggregate assessment would only consider exposure fromfood and water. Generally, all risks from these exposures must not exceed 100% of the acute and chronic PADs to be below the Agency‘s level of concern. Results of the aggregate risk assessment are summarized here, and are discussed extensively in the September 2, 1999 HED chapter. Since there are no residentialuses for phorate, aggregateriskwillonlyconsider exposure fromfood and water. Acute and chronic dietary risks fromfood alone do not exceed the Agency’s level of concern, however, for dietary risk from drinking water, the maximum estimated concentrations of phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly exceed EPA’s level of concern. The conservative nature of the food assessment together withextensive risk mitigationproposed in this document lead the Agencyto believe that the aggregate risk from food and drinking water exposure for phorate and its degradates will be below the Agency’s level of concern following implementation of mitigation measures. B. Environmental Risk Assessment A summary of the Agency’s environmental risk assessment is presented below. For detailed discussions of all aspects of the environmental risk assessment, see the Environmental Fate and Effects Division chapter, dated August 31, 1999, which is available in the public docket. 1. Environmental Fate and Transport The environmental fate database for phorate is essentially complete. Study data indicate that phorate parent is not persistent in the environment. It has been shown to degrade in soil by chemical and microbial action and to dissipate in the field with a half-life of 2-15 days. It is moderately mobile in soil, and may leach in sandy loam soils. Phorate is likely to hydrolyze rapidly. The probable environmental degradates, phorate sulfoxide, and phorate sulfone, are more persistent and moremobile inthe environment then the parent. 2. Risk to Birds, Mammals and Nontarget Terrestrial Organisms To estimate potentialecologicalrisk, EPA uses a risk quotient method which divides the toxicity of the compound by the estimated exposure. The risk quotient is then compared to levels of concern for general populations or endangered species. Exposure is calculated by integrating application rates, 20 informationabout applications, and chemicalspecific data suchas degradation rates. Risk characterization provides further information on the likelihood of adverse effects occurring by considering the fate of the chemical in the environment, communities and species potentially at risk, their spatial and temporal distributions, and the nature of the effects observed in studies. Phorate is highly toxic to birds and small mammals when applied at label rates. The R Q values for terrestrial animals exceed the acute risk level of concern for all species, crops, and application rates. Endangered species levels of concern are exceeded for birds and small mammals from the use of a single application rate. The greatest exceedances were calculated for small mammals. Risk quotient values suggest that songbirds are the birds most at risk. The RQ value ranged from two to three orders of magnitude greater than the level of concern for all uses and all application methods. Adverse effects are considered to be very likely for all small mammals with broadcast applications for corn and hops, banded or in-furrow applications for potatoes, and banded or in-furrow applications for radishes. Risk to avian species is likely for songbirds with broadcast use in corn and hops and is less likely, but still a concern, for upland game birds for soil in-furrow use in wheat. Due to higher assumed food consumption, calculations suggest that songbirds are the most sensitive ofthe species tested. There are indications that phorate may also pose a chronic risk to birds and mammals especially due to the apparent length of time required for phorate residues and degradates to degrade. The Agency has also identified both acute and chronic concerns for bird and smallmammalianendangered species resulting from the use of phorate. Several bird kills, some involving large numbers of birds, have been reported and linked to phorate use. Fall applications in the northern wheat growing states appear to pose a particular risk. During the winter in these regions, degradation and downward movement in soil is expected to be slow. The incident information indicates that in spring the concentrations of phorate and/or phorate degradates sometimes occurs at hazardous levels in pools on the soil surface. a. Nontarget Terrestrial Organisms Incidents Phorate risks exceed the acute risk level of concern for terrestrial animals. The absence of documented incidents involving nontarget terrestrial organisms does not necessarily mean that such incidents do not exist. Mortality incidents must be seen, reported, investigated, and submitted to EPA in order to be recorded in the database. Incidents may not be noted because the carcasses decayed in the field, were removed by scavengers, or were in out-of-the-way or hard-to-see locations. Poisoned birds may fly off-site to less conspicuous areas before dying. An incident also may not be reported to appropriate authorities capable of investigating it. 3. Risk to Aquatic Species 21 Phorate is highly toxic to fish and aquatic invertebrates. All acute risk quotients exceed high risk criteria and most chronic risk quotients exceed levels of concern. Field studies and incidents confirm risk to aquatic organisms.Estimatedwater concentrations fromthe PRZM-EXAMS modelindicate that regular labeluse of phorate mayresult inphorate contaminationof water sources except for certain in-furrowuses. However, these in-furrow uses may not be adequately simulated bythe PRZM-EXAMS model because it does not account for upward movement of pesticide residues in soil. Adverse effects are expected in some instances and this concern is confirmed by field studies and fish kill incidents which are discussed in the EFED Risk Assessment Chapter. Simulated field studies also suggest that contaminated water maybe a route of exposure. The original risk quotients using the PRZM-EXAMS model exceeded levels of concern for fish and aquatic invertebrates. Many studies submitted on the mobility, hydrolysis, adsorption/desorption, and volatilityofphorate and its degradates represented only alkaline or neutralsoils. Based solely on this information, the Agencycould not conclusively determine that phorate was necessarily of high concern. However, the Agency also assessed several fish kill incident reports which indicated phorate was either one of the potential pesticides or the only pesticide implicated in the fish kills. No reports of misuse were associated with any of the fish kill incidents. The Agencyhas also identified a concern for aquatic endangered species, on an acute and chronic basis from the use of phorate. IV. Interim Risk Management and Reregistration Decision A. Determination of Interim Reregistration Eligibility Section 4(g)(2)(A) of FIFRA calls for the Agency to determine, after submissions of relevant data concerning an active ingredient, whether products containing the active ingredient is eligible for reregistration. The Agency has previously identified and required the submission of the generic (i.e., an active ingredient specific) data required to support reregistration of products containing phorate active ingredients. The Agencyhas completed its assessment of the occupational and ecologicalrisks associated with the use of pesticides containing the active ingredient phorate, as well as a phorate-specific dietary risk assessment that has not considered the cumulative effects of organophosphates as a class. Based on a review of these data and public comments on the Agency’s assessments for the active ingredient phorate, EPA has sufficient information on the human health and ecological effects of phorate to make interim decisions as part of the tolerance reassessment process under FFDCA and reregistration under FIFRA, as amended by FQPA. The Agency has determined that phorate is eligible for reregistrationprovided that: (i) current data gaps and additional data needs are addressed; (ii) the risk mitigation measures outlined in this document are adopted, and label amendments are made to reflect these measures; and (iii) the cumulative risk assessment for the organophosphates support a finalreregistrationeligibilitydecision. Label changes are described in Section IV. Appendix B identifies the generic data requirements that the Agency 22 reviewed as part of its interim determination of reregistration eligibility of phorate, and lists the submitted studies that the Agency found acceptable. Although the Agency has not yet completed its cumulative risk assessment for the organophosphates, the Agency is issuing this interim assessment now in order to identify risk reduction measures that are necessary to support the continued use of phorate. Based on its current evaluation of phorate alone, the Agency has determined that phorate products, unless labeled and used as specified in this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any ofthe risk mitigationmeasures identified in this document, the Agency may take regulatory action to address the risk concerns from use of phorate. At the time thata cumulative assessment is conducted, the Agencywill address any outstanding risk concerns. For phorate, if all changes outlined in this document are incorporated into the labels, then all current risks will be mitigated. But, because this is an interim RED, the Agency may take further actions, if warranted, to finalize the reregistration eligibility decision for phorate after assessing the cumulative risk of the organophosphate class. Such an incrementalapproach to the reregistrationprocess is consistent with the Agency’s goal of improving the transparency of the reregistration and tolerance reassessment processes. By evaluating each organophosphate in turn and identifying appropriate risk reduction measures, the Agencyis addressing the risks fromthe organophosphates in as timely a manner as possible. Because the Agency has not yet completed the cumulative risk assessment for the organophosphates, this reregistrationeligibilitydecisiondoes notfullysatisfythe reassessment ofthe existing phorate food residue tolerances as called for by the Food Quality Protection Act (FQPA). When the Agency has completed the cumulative assessment, phorate tolerances will be reassessed in that light. At that time, the Agency will reassess phorate along with the other organophosphate pesticides to complete the FQPA requirements and make a final reregistration determination. By publishing this interim reregistration eligibility decision and requiring risk mitigation now for the individual chemical phorate, the Agencyis not deferring or postponing FQPA requirements; rather, EPA is taking steps to assure that uses which exceed FIFRA’s unreasonable risk standard do not remain on the label indefinitely, pending completion of assessment required under the FQPA. This decision does not preclude the Agency from making further FQPA determinations and tolerance-related rulemakings that may be required on this pesticide or any other in the future. If the Agencydetermines, before finalizationof the RED, that any of the determinations described in this interim RED are no longer appropriate, the Agencywill pursue appropriate action, including but not limited to, reconsideration of any portion of this interim RED. 1. Summary of Phase 5 Comments and Responses 23 When making its interim reregistration decision, the Agency took into account all comments received during Phase 5 of the OP Pilot Process. As stated previously, a mitigation proposal was received from BASF and Aceto Agricultural Chemicals Corporation; details of this proposal are discussed in the next section. Several other comments on mitigation were also received from private citizens, trade groups/associations, colleges/ universitiesand fromnongovernment environmentalorganizations. Generally speaking these comments were testimonialin nature, expressing the sender’s opinionrelative to the benefits and safety (low risk) of phorate use. Although these comments require no Agency response, EPA considered the views expressed and has taken the information into account when making this regulatory decision concerning phorate use. These comments in their entirety are available in the public docket. B. Regulatory Position 1. FQPA Assessment a. “Risk Cup” Determination As part of the FQPA tolerance reassessment process, EPA assessed the risks associated withthis organophosphate. The assessment was for this individual organophosphate, and does not attempt to fully reassess tolerances as required under FQPA. FQPA requires the Agencyto evaluate food tolerances on the basis of cumulative risk from substances sharing a commonmechanismof toxicity, such as the toxicity expressed by the organophosphates through a common biochemical interaction with the cholinesterase enzyme. The Agency will evaluate the cumulative risk posed by the entire class of organophosphates once the methodology is developed and the policy concerning cumulative assessments is resolved. EPA has determined that risk fromdietary (food sources only) exposure to phorate is withinitsown “risk cup.” In other words, if phorate did not share a common mechanism of toxicity with other chemicals and if drinking water is not a significant source of phorate exposure, EPA would be able to conclude today that the tolerances for phorate meet the FQPA safety standards. In reaching this determination EPA has considered the available information on the special sensitivity of infants and children, as well as the chronic and acute food exposure. An aggregate assessment was conducted for exposures through food and drinking water exposure only since there are no residential uses for phorate. Results of this aggregate assessment indicate that the humanhealthrisks fromthese combined exposures maybe slightlygreater than the acceptable levels; that is, combined risks from all exposures to phorate “do not fit”within the individual risk cup. However, the conservative nature of the food assessment together with extensive risk mitigation proposed in this document lead the Agencyto believe that the aggregate risk from food and drinking water exposure for phorate and its degradates will be below the Agency’s level of concern after implementing the following mitigation measures. The Agencyfurther refined its drinking water estimates by taking into considerationthe impacts of several key mitigation measures such as reducing the maximum number of applications per season from 2 to 1, requiring soil incorporation and reductions in the maximum application rates for major use patterns. 24 When these steps were incorporated into the models the maximum estimated concentrations were significantly reduced. The revised estimated concentrations in ground water, including mitigation, range from 2.9 ppb to 6.0 ppb for both acute and chronic exposures. The estimated concentrations in surface water after mitigationrange from5.5 ppb to 36.1 ppb for acute exposures and range from0.25 ppb to 1.8 ppb for chronic exposures. Two specific use patterns account for the high-end estimates in these ranges; use on peanuts at pegging (36.1 ppb for surface water and 6.0 for groundwater forthe acute scenario), and use as a sidedress for cotton (22.6 ppb for surface water and 4.8 ppb for groundwater for the acute scenario). Based on these results the Agency determined that additional mitigation was needed to address these risks. This additional mitigation includes prohibiting use on peanuts at pegging and restricting the use as a sidedress to cotton in CA and AZ only. The rationale for restricting the cotton sidedress to these states is that, giventhe arid climate and cultural practices in these areas, contamination of water resources is very unlikely to result from this use. The restrictions on the cotton and peanut use patterns mentioned earlier in this section would result in maximum estimated water concentrations in ground water ranging from 2.9 ppb to 3.7 ppb for both acute and chronic exposures. The estimated concentrations in surface water range from 5.5 ppb to 7.8 ppb for acute exposures following all mitigation and range from 0.25 ppb to 0.6 ppb for chronic exposures. These concentrations, with the exception of chronic exposure to surface water residues, continue to slightly exceed the DWLOCs. However, it is important to note that the dietary exposure and risk estimates for food are not based on residue monitoring data and thus are considered to be relatively conservative. Exposure estimates for each of the major contributors to dietary exposure (sweet corn, potatoes and peanuts) are based upon either tolerance level residues (sweet corn) or field trial data. It is expected thatif suitable monitoring data were available the exposure and risk estimatesconcerningresidues on/in food would be significantly lower allowing for additional space in the “risk cup” for exposures to phorate and its degradates in drinking water. In addition to the mitigation mentioned above, the Agency believes that additional mitigation proposed for protecting surface water resources (e.g. vegetative buffer strips, 50 foot setbacks from drinking water wells for application and equipment cleaning) will additionally reduce the potential for significant exposure from drinking water. Drinking water treatment processes (coagulation-flocculation, sedimentation and activated carbon filtering) will likely further reduce the potentialfor exposure to phorate and its degradates in drinking water. Based on all of these considerations, the Agencybelievesthatthe riskfromdrinkingwater exposure for phorate and its degradates will be below the Agency’s levelof concern. It should be noted that, in the event that efficacy tests indicate that the proposed rate reductions would not be feasible, additional mitigationwould be necessary to address drinking water risks. Therefore, the phorate tolerances will need amendments now and possibly in the future after the full reassessment of the cumulative risk from all organophosphates is completed. b. Tolerance Summary 25 The tolerances listed in 40 CFR §180.206 are expressed interms ofphorate and its cholinesterase­ inhibiting metabolites. To harmonize with the expression for Codex MRLs for residues of phorate, the tolerance expression should be revised as follows: the tolerances listed in 40 CFR §180.206 are for the combined residues of the insecticide phorate (O,O-diethyl S[(ethylthio) methyl]phosphorodithioate), phorate sulfoxide, phorate sulfone, phorate oxygen analog, phorate oxygenanalogsulfoxide, and phorate oxygen analog sulfone. Tolerances Listed Under 40 CFR §180.206: Sufficient field trial data reflecting the maximum registered use patterns are available to ascertain the adequacy of the established tolerances for: coffee, beans, green; corn, field, forage; corn, sweet, forage; cottonseed; hops, cones, dried; peanuts; sorghum, fodder; sugar beet, roots; sugar beet, tops; wheat, forage;wheat, grain; and wheat, straw. The available data indicate that the tolerance levels can be reduced for the following commodities: beans (succulent and dry); field corn grain; sweet corn (kernel plus cob with husk removed or K+CWHR); potatoes; sorghum grain; soybeans; and sugarcane. The established tolerances for milk, eggs, and the fat, meat, and meat byproducts of cattle, goats, hogs, horses, sheep, and poultrycan be revoked. It is not possible to establish with certainty that finite residues of phorate occur in these commodities and there is no reasonable expectation that finite residues will occur. Therefore the Agencyhas determined that pursuant to §180.6(a)(3) tolerances are not required for these commodities. The tolerance levelfor hops must be increased to reflect that fact that the raw agriculturalcommodity(RAC )is now considered to be dried hops and not fresh hops. Adequate data are available to support a dried hops tolerance. Because the Agencyno longer considers bean vines and peanut vines to be significant livestock feed items, the established tolerances for these commodities should be revoked. The established tolerance for peanut hay should also be revoked since a restriction against the feeding of treated peanut hay exists on current product labels. No registered uses of phorate currently exist on the following crops for which tolerances have been established: alfalfa, barley, Bermuda grass, lettuce, rice, and tomatoes. The established tolerances for the commodities of these crops should be revoked. Sufficient data are available to assess the adequacy of the established tolerances for dried sugar beet pulp. These data indicate that phorate residues of concern do not concentrate in dried sugar beet pulp; therefore, the established feed additive tolerance should be revoked. Tolerances To Be Proposed: 26 When adequate field trialdata have been submitted, the registrant[s] must propose a tolerance for field and sweet corn stover (fodder), cotton gin byproducts, sorghum forage, and wheat hay. A summary of phorate tolerance reassessments is presented in Table 7. Table 7. Tolerance Reassessment Summary for Phorate. Commodity Current Tolerance (ppm) 0.5 1 0.1 0.1 0.5 0.1 Tolerance Reassessment (ppm) Revoke Revoke Revoke Revoke Revoke 0.05 Comment/ [Correct Commodity Definition] No registered uses. No registered uses. No registered uses. No registered uses. Not considered a significant feed item (Table 1, 860.1000). Residues from the registered uses do not exceed the 0.05 ppm level [Beans, succulent and dry] No registered uses. 180.6(a)(3) Tolerances Listed Under 40 CFR §180.206: Alfalfa (fresh) Alfalfa hay Barley grain Barley straw Bean vines Beans Bermuda grass straw Cattle, fat Cattle, meat Cattle, meat byproducts Coffee beans Corn grain 0.5 0.05 0.05 0.05 0.02 0.1 Revoke Revoke 0.02 0.05 [Coffee, beans, green] Residues from registered uses do not exceed 0.05 ppm for Codex harmonization. [Corn, field, grain] [Corn, field, forage] [Corn, sweet, forage] [Cotton, undelinted seed] 180.6(a)(3) 180.6(a)(3) Corn forage Cottonseed Eggs Goats, fat Goats, meat Goats, meat byproducts Hogs, fat Hogs, meat Hogs, meat byproducts 0.5 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.05 0.5 0.05 Revoke Revoke Revoke 180.6(a)(3) 27 Commodity Hops Horses, fat Horses, meat Horses, meat byproducts Lettuce Milk Peanut vines Peanut hay Peanuts Potatoes Poultry, fat Poultry, meat Poultry, meat byproducts Rice Sheep, fat Sheep, meat Sheep, meat byproducts Sorghum fodder Sorghum grain Current Tolerance (ppm) 0.5 0.05 0.05 0.05 0.1 0.02 0.3 0.3 0.1 0.5 0.05 0.05 0.05 0.1 0.05 0.05 0.05 0.1 0.1 Tolerance Reassessment (ppm) 2 Revoke Comment/ [Correct Commodity Definition] [Hops, cones, dried] 180.6(a)(3) Revoke Revoke Revoke Revoke 0.1 0.2 Revoke No registered uses. 180.6(a)(3) Not considered a significant feed item (Table 1, 860.1000). Feeding restriction exists. Residues from the registered uses do not exceed 0.2 ppm for Codex harmonization. 180.6(a)(3) Revoke Revoke No registered uses. 180.6(a)(3) 0.1 0.05 [Sorghum, fodder] Residues from the registered uses do not exceed 0.05 ppm for Codex harmonization. [Sorghum, grain] Residues from registered uses do not exceed 0.05 ppm for Codex harmonization. [Sugar beets, roots] [Sugar beets, tops] Residues from the registered uses do not exceed 0.05 ppm. Residues from the registered uses do not exceed 0.05 ppm. [Corn, sweet (K+CWHR)] No registered uses. [Wheat, grain] [Wheat, forage] [Wheat, straw] Available data indicate that residues do not concentrate. Soybeans Sugar beet roots Sugar beet tops Sugarcane Sweet corn (K+CWHR) 0.1 0.3 3 0.1 0.1 0.05 0.3 3 0.05 0.05 Tomatoes Wheat grain Wheat (green fodder) Wheat straw Dried sugarbeet pulp 0.1 0.05 1.5 0.05 1 Revoke 0.05 1.5 0.05 Revoke Tolerances Listed Under 40 CFR §186.4750: 28 Commodity Tolerances to be Proposed: Corn, field, stover (fodder) Corn, sweet, stover (fodder) Cotton, gin byproducts Sorghum, forage Wheat, hay 1 Current Tolerance (ppm) ------ Tolerance Reassessment (ppm) TBD1 TBD TBD TBD TBD Comment/ [Correct Commodity Definition] TBD = To be determined. Residue data are outstanding. Codex Harmonization The Codex Alimentarius Commissionhas established several maximum residue limits (MRLs) for phorate residues in various commodities (see Guide to Codex Maximum Limits For Pesticide Residues, Part 2, FAO CX/PR, 4/91). The Codex and U.S. tolerance expressions will be in harmony when the U.S. tolerance expression is revised to specify phorate, phorate sulfoxide, phorate sulfone, phorate oxygen analog, phorate oxygenanalogsulfoxide, and phorate oxygenanalogsulfone. A comparison of the Codex MRLs and the corresponding reassessed U.S. tolerances is presented in Table 7. The following conclusions can be made regarding efforts to harmonize the U.S. tolerances with the Codex MRLs with respect to MRL/tolerance level: (i) compatibility between the U.S. tolerances and Codex MRLs exists for beans, cottonseed, eggs, field corn grain (maize), potatoes, sorghum, soybeans, and wheat; and (ii) incompatibility of the U.S. tolerances and Codex MRLs remains for field corn forage, peanuts, and sugar beet roots and tops because of differences in agricultural practices; no questions of compatibility exist with respect to commodities where Codex MRLs have been established but U.S. tolerances do not exist or will be revoked. Table 8. Codex MRLs and Applicable U.S. Tolerances. Recommendations for Compatibility are Based on Conclusions Following Reassessment of U.S. Tolerances (see Table 6). Codex Commodity (As Defined) Barley Carrot Common bean (pods and/or immature seeds) Cotton seed Eggs Beet fodder Maize Maize fodder MRL (mg/kg) 0.05 0.2 0.1 0.05 0.05 * 0.05 0.05 0.2 2 1 Reassessed U.S. Tolerance (ppm) Revoke -0.05 0.05 Revoke – 0.05 TBD 3 Recommendation And Comments No registered uses in U.S. No registered uses in U.S. Compatibility exists. No registered uses in U.S. Compatibility exists. 29 Codex Commodity (As Defined) Maize forage Meat Milk Peanut Peanut oil, crude Peanut oil, edible Potato Rape seed Sorghum Soya bean (dry) Sugar beet Sugar beet leaves or tops Tomato Wheat 1 2 3 MRL (mg/kg) 0.1 0.05 * 0.05 * 0.05 0.05 * 0.05 * 0.2 0.1 0.05 0.05 0.05 1 0.1 0.05 1 Reassessed U.S. Tolerance (ppm) 0.5 Revoke Revoke 0.1 --0.2 – 0.05 0.05 0.3 3 Revoke 0.05 Recommendation And Comments Compatibility exists. No registered uses in U.S. Compatibility exists. Compatibility exists. No registered uses in U.S. Compatibility exists. An asterisk (*) signifies that the MRL was established at or about the limit of detection. Decreased from 0.5 ppm by 1993 JMPR. TBD = To be determined. Residue data are outstanding. 2. Endocrine Disruptor Effects EPA is required under the FFDCA, as amended by FQPA, to develop a screening program to determine whether certain substances (including all pesticide active and other ingredients) "may have an effect in humans that is similar to an effect produced by a naturally occurring estrogen, or other such endocrine effects as the Administrator may designate." Following the recommendations of its Endocrine Disruptor Screening and Testing Advisory Committee (EDSTAC), EPA determined that there were scientific bases for including, as part of the program, the androgenand thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s recommendation that the Program include evaluations of potentialeffects in wildlife. For pesticide chemicals, EPA will use FIFRA and, to the extent that effects in wildlife may help determine whether a substance may have an effect in humans, FFDCA authority to require the wildlife evaluations. As the science develops and resources allow, screening of additional hormone systems may be added to the Endocrine Disruptor Screening Program (EDSP). When the appropriate screening and/or testing protocols being considered under the Agency’s EDSP have been developed, phorate may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. 3. Label Modifications 30 Currently the maximum estimated concentrations ofphorate and metabolites(sulfoxideand sulfone) in groundwater are slightly greater than the Agency’s Drinking Water Level of Comparison(DWLOC) for chronic drinking water exposure. Also, the estimated concentrations of phorate and its metabolites in surface water slightly exceed EPA’s DWLOC for acute exposure. However, the conservative nature of the food assessment together with extensive risk mitigation proposed in this document lead the Agencyto believe that the dietary risk from food and drinking water exposure for phorate and its degradates will be below the Agency’s level of concern following implementation of mitigation measures. As an interim measure to address the concern for the potentialcontaminationof drinking water resources, the following label language modifications are needed: • • • • • • • Prohibit aerial application. Prohibit use of phorate on peanuts at pegging. Require soil incorporation. Allow sidedress use on cotton only in Arizona and California. Allow only one application per season. Reduce application rates by 25 % unless efficacydata demonstrates that desired pesticidaleffects are prohibited by the reduction in use rates. Environmental Hazard Statement: This pesticide is very highly toxic to fish and wildlife. Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the meanhigh-water mark. Runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment wastewater or rinsate. Birds and mammals may be killed if granules are not properly covered with soil in all areas of the treated field and in loading areas. Do not apply in wet soil conditions that may prevent the equipment from covering pesticide granules. Under some conditions phorate may have a high potentialfor runoff into surface water for several days post application. Do not apply in the following situations: Frequently flooded areas Areas where intense or sustained rainfall is forecasted to occur within 48 hours Use Best Management Practices for minimizing surface runoff in the following areas: Poorly draining or wet soils with readily visible slopes toward adjacent surface water Areas over-laying extremely shallow ground water Areas with in-field canals or ditches that drain to surface water 31 • • • Areas not separated from adjacent surface waters with vegetated filter strips Areas over-laying tile drainage systems that drain to surface water • • • • When used onerodible soils,best management practices for minimizing runoff should be employed. Consult your local soil conservation service for recommendations in your use area. In particular, where highly erodible land (HEL) is adjacent to aquatic bodies, a 66 foot buffer/ setback area should be left in grass or other natural vegetation. Do not apply within 50 feet of any drinking water well to minimize potential contamination. Do not wash, load, or empty application equipment near any well, as this practice is a potential source of ground water contamination. The Agency has determined that there are potential exposures to workers as a result of mixing, loading and applying phorate. In addition to mitigation measures necessary to reduce occupational risk such as enclosed loading and enclosed application equipment, phase out of open bag use, voluntary cancellation of aerialapplication, and PPE, the Agency wants the following additional precautionary label language since incident data on phorate shows above average ratios or measures of hazard (see Human Incident Data section chapter III)) suggest that handlers maynot fully observe precautions because of the perception that poisoning is much less likely to occur with a granular formulation.: Failure to follow precautions including wearing proper Personal Protective Equipment (PPE) may result in serious or even life threatening poisoning requiring immediate medical attention. The active ingredient of this granular formulation can be absorbed across the skin to cause poisoning. C. Regulatory Rationale The following is a summary of the rationale for managing risks associated with the use of phorate. Where labeling revisions are necessary, specific language is set forth in the summary tables of Section V of this document. 1. Human Health Risk Mitigation a. Dietary Mitigation (1) Acute Dietary (Food) The acute dietary risk (food) of phorate is belowthe Agency’s levelof concern for the generalU.S. population and all population subgroups, including infants and children at the 99.9 percentile. The most highly exposed subgroup is children 1-6 with 70% of the acute Population Adjusted Dose (aPAD) consumed. No mitigation is necessary for acute dietary exposure. 32 (2) Chronic Dietary (Food) The chronic dietaryrisk for phorate does not exceed the Agency’s level of concern (i.e., less than 100% of the chronic PAD is utilized) for all subpopulations. The most exposed subgroup is children (1-6 years), with 9.0% of the population adjusted dose consumed. No mitigation is necessary for chronic dietary exposure. (3) Drinking Water The maximum estimated drinking water concentrations for phorate and its degradates prior to consideration of mitigation exceed the DWLOCs for both acute and chronic exposures from both groundwater and surface water sources. The DWLOC for acute exposure is 2.7 ppb for the most exposed sub-population (children 1-6). The chronic DWLOC is 1.6 ppb for that same sub-population. The estimated concentrations in ground water prior to mitigationrange from7.8 ppb to 13.5 ppb for both acute and chronic exposures. The estimated concentrations in surface water prior to mitigation range from 9.41 ppb to 53.21 ppb for acute exposures and range from 0.35 ppb to 1.85 ppb for chronic exposures. The Agencyfurther refined its drinking water estimates by taking into consideration the impacts of several key mitigationmeasures that are proposed inthis document includingreducingthe maximum number of applications per season from 2 to 1, requiring soil incorporation and reductions in the maximum applicationrates for major use patterns. When these steps were incorporated into the models the maximum estimatedconcentrations were significantly reduced. The revised estimated concentrations in ground water including mitigation range from 2.9 ppb to 6.0 ppb for both acute and chronic exposures. The estimated concentrations in surface water after mitigation range from 5.5 ppb to 36.1 ppb for acute exposures and range from0.25 ppb to 1.8 ppb for chronic exposures. Two specific use patterns account for the high-end estimates in these ranges; use on peanuts at pegging (36.1 ppb for surface water and 6.0 for groundwater for the acute scenario), and use as a sidedress for cotton (22.6 ppb for surface water and 4.8 ppb for groundwater for the acute scenario). Based on these results the Agency determined that additional mitigationwas needed to address these risks. This additional mitigation includes prohibiting use on peanuts at pegging and restricting the use as a sidedress to cotton to CA and AZ only. The rationale for restricting the cotton sidedress to these states is that, given the arid climate and cultural practices in these areas, contamination of water resources is very unlikely to result from this use. The restrictions on the cotton and peanut use patterns together withthe mitigationmentionedearlier in this section would result in maximum estimated water concentrations in ground water including all mitigation ranging from 2.9 ppb to 3.7 ppb for both acute and chronic exposures. The estimated concentrations in surface water range from 5.5 ppb to 7.8 ppb for acute exposures following all mitigation and range from 0.25 ppb to 0.6 ppb for chronic exposures. These concentrations, withthe exception of 33 chronic exposure to surface water residues, continue to slightly exceed the DWLOCs. However, it is important to note that the dietary exposure and risk estimates for food are not based on residue monitoring data and thus are considered to be relatively conservative. Exposure estimates for each of the major contributors to dietary exposure (sweet corn, potatoes and peanuts) are based upon either tolerance level residues (sweet corn) or field trial data. It is expected that if suitable monitoring data were available the exposure and risk estimates concerning residues on/in food would be significantly lower allowing for additional space in the “risk cup” for exposures to phorate and its degradates in drinking water. In addition to the mitigation mentioned above, the Agency believes that additional mitigation proposed for protecting surface water resources (e.g. vegetative buffer strips, 50 foot setbacks from drinking water wells for application and equipment cleaning) will additionally reduce the potential for significant exposure from drinking water. Drinking water treatment processes (coagulation-flocculation, sedimentationand activated carbon filtering) will likely further reduce the potentialfor exposure to phorate and its degradates in drinking water. Based on all of these considerations, the Agencybelievesthatthe riskfromdrinkingwater exposure for phorate and its degradates will be below the Agency’s level of concern. It should be noted that, in the event that efficacy tests indicate that the proposed rate reductions would not be feasible, additional mitigation would be necessary to address drinking water risks. (4) Residential The Agencyis not considering mitigationoptions for phorate since there are no residentialor other non-occupational sources of exposure. (5) Aggregate Since there are no residentialuses for phorate, aggregateriskwillonlyconsider exposure fromfood and water. Acute and chronic dietary risks from food alone do not exceed the Agency’s levelof concern, however, for dietary risk from drinking water, the maximum estimated concentrations of phorate and metabolites (sulfoxide and sulfone) in groundwater and surface water slightly exceed EPA’s level of concern. The conservative nature of the food assessment together with extensive risk mitigation proposed in this document lead the Agency to believe that the aggregate risk fromfood and drinking water exposure for phorate and its degradates will be below the Agency’s level of concern following implementation of mitigation measures. These measures are described in the drinking water discussion presented above. b. Occupational Risk Mitigation Occupational risks do not exceed the Agency’s level of concern whenclosed loading systems and enclosed applicationequipment (cabs) are used. If minimal PPE is used, open cabs are used, and products 34 are loaded using bags that must be ripped open prior to loading, then risks exceed the Agency’s level of concern. Based on the Agency’s revised occupationalrisk assessment, handlers of phorate are exposed by dermal and inhalation routes, with dermal exposure being the most significant route. Handler risks are not of concern whenexposure is reduced through the use of closed loading systems and enclosed application equipment. (1) Loaders Ground equipment: The MOEs for short term exposure (1 to 7 days), for intermediate term exposure (8 to 28 days) and for mid to long term exposure (>28 days) to loaders do not exceed the Agency’s level of concern. Although the data used in the assessment were done using an LNL system, gloves, apron and respirator, the Agency believes that adequate protection will be afforded with a LNL system, long sleeve shirt, long pants and chemical resistant gloves. The MOEs for short term exposure to loaders usingopenbags, double layered clothing, gloves and respirator ranged from 22 to 86; from17 to 66 for intermediate term exposure; and from 3 to 11 for mid­ to long term exposure. It should be noted that the Agency fully anticipates that the duration of the majority of exposures will be less than 28 days and that the population exposed to phorate for greater than 28 days will be small. Based on our estimates, use of phorate in open bags presents a potential concern when phorate is used on some crops. Because of the concern for open bag use, as of January 1, 2002, only products marketed in lockn-load systems will be reregistered and labels will limit use to only one application per season. Aerial Equipment: The MOEs for loaders of aerialequipment (closed systems) ranged from 48 to 193 for long term exposures. This application method, however, is being voluntarily canceled by the registrants. The proposed cancellation eliminates this risk to workers. (2) Applicators and Flaggers Ground Equipment Applicators:Based on chemicalspecific study data, MOEs for applicators from short term, intermediate term and long term exposure are not of concern where open cabs and no respirators are used. Based on chemical specific study data, for combined loader and applicators using closed loading systems, aprons, gloves, open cabs and no respirator, again, the risk are not of Agency concern for all terms of exposure. 35 However, when estimates are derived from PHED and assumes use of claybased formulations in open bags and the maximum protection of engineering controls (enclosed cabs), risk estimatesrangedfrom 32 to 129 for short term exposures; from 20 to 82 for intermediate term exposure; and from 4 to 17 for long term exposure. These risk estimates indicate a concern for applicators exposed in such situations and further warrant the discontinuation of use of open bags. Based on the applicator concerns for short, intermediate, and long term exposure plus the fact that technical phorate is classified as Toxicity Category I for acute oral, dermal and inhalation EPA is believes applicators should be in enclosed cabs. Aerial: Aerial application use is being voluntarily canceled by the registrants due to ecological concerns. However, the MOEs for aerial applicators are of concern based on risk estimates derived from PHED. Thus the proposed cancellation eliminates this risk to workers. Flaggers: According to the Agency’s estimates which are based on PHED, risk to flaggers is of concern for some crop use scenarios (see table 6). However since the registrants are voluntarily canceling aerial applications, risk to these workers is eliminated. (3) Other Handlers No other handling scenarios are expected. (4) Postapplication Workers Current phorate labels specify re-entry intervals of 48 to 72 hours, and specify the PPE required by the Worker Protection Standard (WPS), 40 CFR 170. Based on the results of soil dissipationstudies on peanuts and potatoes that indicated phorate residuescould persist for many weeks after application, the Agency now believes that a more thorough assessment of exposure to re-entry workers is needed. The Agency is requiring efficacy data and additional agricultural practice data to help define if any activities could be associated withpost applicationexposure. Pending review of the efficacydata EPA, believes that application rates should be reduced up to 25 % unless the studies show that the reduced rates are not effective to the levels needed. After reviewing the additional agricultural practice data, EPAalso reserves the right to require guideline 132-1 (foliar residue dissipation study) and 133-3 (dermal exposure upon reentry study) data. In the interim, the reentry intervals will remain unchanged since several of the uses are preplant and we expect very little opportunity for exposure . (5) Other Information Considered The Agency requested the public to submit any mitigation proposals or comments to address the potential worker risks identified in the risk assessment for phorate at the technical briefing held on September 2, 1999. The Agency did receive proposals or input that affected the risk mitigation for phorate from the registrants BASF and Aceto Agricultural Chemicals Corporation The mitigation proposals mentioned above reflect the Agency's recommendations as well as recommendations of the registrants. 36 2. Environmental Risk Mitigation a. Risk Characterization (1) Aquatic Animals All acute risk quotients exceed high risk criteria and most chronic risk quotients exceed levels of concern. Field studies and incidents confirm risk to aquatic organisms. Simulated field studies also suggest that contaminated water maybe a route of exposure. The originalrisk quotients using the PRZM-EXAMS model exceeded levels of concern for fish and aquatic invertebrates. Many studies submitted on the mobility, hydrolysis, adsorption/desorption, and volatility of phorate and its degradates represented only alkaline or neutralsoils. Based solely on this information, the Agency could not conclusively determine that phorate was necessarily of high concern. However, the Agency also assessed several fish kill incident reports which indicated phorate was either one of the potential pesticides or the only pesticide implicated in the fish kills. No reports of misuse were associated with any of the fish kill incidents. Phorate is highly toxic to fish and aquatic invertebrates. Estimated water concentrations from the PRZM-EXAMS model indicate that regular label use of phorate may result in phorate contamination of water sources except for certain in-furrow uses. However, these in-furrow uses may not be adequately simulated by the PRZM-EXAMS model because it does not account for upward movement of pesticide residues in soil. Adverse effects are expected in some instances and this concern is confirmed by field studies and fish kill incidents which are discussed in the EFED Risk Assessment Chapter. (2) Nontarget Terrestrial Organisms Phorate is highly toxic to bees and birds and small mammals based on test results. The Risk Quotient values for terrestrial animals exceed the acute risk level of concern for all species, crops, and application rates. Endangered species levels of concernare exceeded for birds and small mammals from the use of a single application rate. The greatest exceedances were calculated for small mammals. Risk quotient values suggest that songbirds are the birds most at risk. The RQ value ranged from two to three orders of magnitude greater than the level of concern for all uses and all application methods. The absence of documented incidents involving nontargetterrestrialorganisms does not necessarily mean that such incidents do not exist. Mortality incidents must be seen, reported, investigated, and submitted to EPA to be recorded in the database. Incidents may not be noted because the carcasses decayed in the field, were removed by scavengers, or were in out-of-the-way or hard-to-see locations. Poisoned birds may fly off-site to less conspicuous areas before dying. An incident may not be reported to appropriate authorities capable of investigating it because the finder maynot be aware of the importance of reporting incidents, may not know who to call, or may be hesitant to call because of lack of time or desire or because the kill occurred on their property. 37 b. Mitigation Measures (1) Aquatic animals To protect nontarget aquatic animals and reduce risk to nonterrestrial animals: • Use vegetative buffer strips as a means of protecting water bodies from runoff. The label should state that buffer width determination should be made in consultation with the local United States Department ofAgriculture/NaturalResource Conservation Service officials, taking into account the fact that phorate sulfoxide and sulfone metabolites have limited adsorption characteristics of phorate. Prohibit application of phorate in saturated soils. Do not treat while precipitation is occurring, or while conditions favor runoff from the treated area. Reductionin the number of applications, reduction in use rates, restricting cotton sidedress use to Arizona and California as well as prohibiting use on peanuts at pegging will reduce the amount of pesticide used thereby reducing potential exposure by eliminating the 2 greatest contributors to water. Limit to only one application per season. Application must be incorporated into the soil. (2) Birds and Mammals • • • • The Agency has concerns about the effects of phorate on birds and small mammals. The Agency believes there are unreasonable adverse effects to the environment when phorate is used as currently labeled and applied using aerial equipment. Currently, aerial equipment is only used for wheat. The registrants have voluntarily agreed to remove use on wheat and aerial equipment from the current labels. The Agency believes sufficient alternatives exist for wheat and expects the proposed mitigation measures discussed above may have some effect on exposure for terrestrial animals. The proposed measures will reduce drift to off-field habitats and, thus, reduce exposure via food sources at and beyond the edge of the field. Also, allowing only a single use per season with soil incorporation should reduce the amount of pesticide applied and would have the effect of reducing the level of exposure. The Agency typically receives fewer incident reports for terrestrial organisms unless the exposure involves immediate mortality to large numbers of birds. Such incidents are not usually observed or reported. Should additional information come to the Agency's attentionindicating birds or small animals are being adversely impacted, the Agency will take appropriate action at that time. Additional Measures 38 The registrants support two voluntary educational programs that are available to growers and provide valuable information on the use of phorate and potential hazards. The Delta program provides information to growers in Mississippi on a case-by-case basis what best management practices to implement to avoid runoff into surface waters. The other program known as the Stewardship program is a website sponsored by the National Cotton Council that provides information on how to use phorate to prevent impacts on the environment. The information is important because it advises the user on ways to minimize risks to aquatic life and prevent future fish kills. The registrants have agreed to expand the Stewardship program to ensure that all growers are aware of the label/use requirements and the potential impacts of phorate on aquatic animals. The programexpansionwill require the registrants to take the following steps: • • • • Provide information at the various grower meetings. Link company website to cotton council website on Stewardship program. Include information on the label concerning the website (address, information on use practices). Maintain the website until the Agency receives information confirming that there are no further unacceptable risks to aquatic animals; and coordinate with State Agencies, Universities and special interest groups to provide outreach programs. Periodically (annually) evaluate the website use to determine the percentage of users that are accessing the information as a gauge of its utility. c. Other Options Considered The Agency requested the public to submit any mitigationproposals or comments to address the potential worker risks identified in the risk assessment for phorate at the technical briefing held on September 2, 1999. The Agency did receive proposals or input that affected the risk mitigation for phorate from the registrants BASF and Aceto Agricultural Chemicals Corporation The mitigation proposals mentioned above reflect the Agency's recommendations as well as recommendations of the registrants. D. Labeling 1. Endangered Species Statement The Agency has developed the Endangered Species Protection Program to identify pesticides whose use maycause adverse impacts on endangered and threatened species, and to implement mitigation measures that will eliminate the adverse impacts. At present, the program is being implemented on an interim basis as described in a Federal Register notice (54 FR 27984-28008, July 3, 1989), and is providing information to pesticide users to help them protect these species on a voluntary basis. As 39 currently planned, but subject to change as the final program is developed, the final program will call for labelmodifications referringto requiredlimitations onpesticide uses, typically as depicted in county-specific bulletins or byother site-specific mechanisms as specified by state partners. A final program, which may be altered from the interim program, will be described in a future Federal Register notice. The Agency is not imposing label modifications at this time through the RED. Rather, any requirements for product use modifications will occur in the future under the Endangered Species Protection Program. 2. Spray Drift Management Phorate is currently labeled for aerial application but the registrants have agreed to voluntarily cancel all aerialapplicationuses. Additionally, all phorate end use products are applied as granulars rather than liquid sprays, therefore, spray drift management is no longer applicable. V. What Registrants Need to Do In order to be eligible for reregistration, registrants need to implement the risk mitigationmeasures outlined in Section IV, by submitting labelamendments and meeting the data requirements described in this section. A. Manufacturing Use Products 1. Additional Generic Data Requirements The generic data base supporting the reregistrationof phorate for the above eligible uses has been reviewed and determined to be substantially complete. The following data gaps remain: Guideline 830.7050 UV/Visible Absorption Guideline 860.1200 Directions for Use Guideline 860.1340 Residue Analytical Methods- Livestock commodities Guideline 860.1500 Crop Field Trials Guideline 860.1900 Field Rotational Crop Regarding the “Post Application Occupational Risk,” the Agency is requesting that the technical registrant submit efficacy data using lower application rates (rates reduced up to 25 %) and further information on agricultural practices that will allow EPA to reassess reentry scenarios for post application exposure. Based on the review of such data the Agency reserves the right to reduce application rates by up to 25 % and require foliar residue dissipationdata (guideline 132-1) and dermalexposure upon reentry data (guideline 133-3) at a later time. Also, a Data Call-In Notice (DCI) was recently sent to registrants of organophosphate pesticides currently registered under FIFRA (August 6, 1999 64FR42945-42947, August 18 64FR44922-44923). DCI requirements included acute, subchronic, and developmental neurotoxicity studies. The acute and subchronic studies have been submitted, reviewed and classified as acceptable. The registrant has committed to submit developmental neurotoxicity data by 9/2001. 40 2. Labeling for Manufacturing Use Products To remainin compliance withFIFRA, manufacturing use product (MUP) labelingshould be revised to comply with all current EPA regulations, PR Notices and applicable policies. Allregistrants need to submit applications for amended registration. This application should include the following items:EPA application form 8570-1 (filled in), five copies of the draft label with all required labelamendments outlined in Table 8 of this document incorporated, and a descriptionon the application, such as, "Responding to Interim Reregistration Eligibility Decision” document. All amended labels need to be submitted within 90 days of signature of this document. The Product ReregistrationBranch contact for phorate is Ms. Barbara Briscoe . Her phone number is (703) 308-8177. B. End-Use Products 1. Additional Generic Data Requirements Section 4(g)(2)(B) of FIFRA calls for the Agency to obtain any needed product-specific data regarding the pesticide after a determination of eligibility has been made. Registrants must review previous data submissions to ensure that they meet current EPA acceptance criteria and if not, commit to conduct new studies. If a registrant believes that previously submitted data meet current testing standards, then the study MRID numbers should be cited according to the instructions in the Requirement Status and Registrants Response Form provided for each product. A product-specific data call-in, outlining specific data requirements, accompanies this interim RED. 2. Labeling for End-Use Products Labeling changes are necessary to implement the mitigationmeasuresoutlinedin Section IV above. Specific language to incorporate these changes is specified in the Table 10 at the end of this section. Registrants need to submit applications for amended registration. This application should include the following items: EPA application form 8570-1 (filled in), five copies of the draft label with all label amendments outlined in Table 11 of this document incorporated, and a description on the application, such as, "Responding to Interim Reregistration Eligibility Decision” document. All amended labels need to be submitted within 90 days of signature of this document. The Product ReregistrationBranch contact is Ms. Barbara Briscoe. Her phone number is (703) 308-8177. C. Existing Stocks Registrants maygenerally distribute and sell products bearingold labels/labelingfor12 months from the date of the issuance of this Interim ReregistrationEligibilityDecisiondocument. Persons other than the registrant may generally distribute or sell such products for 24 months fromthe date of the issuance of this interim RED. However, existing stocks time frames will be established case-by-case, depending on the number of products involved, the number of label changes, and other factors. Refer to “Existing Stocks of Pesticide Products; Statement of Policy”; Federal Register, Volume 56, No. 123, June 26, 1991. 41 The Agency has determined that registrant may distribute and sell phorate products bearing old labels/labeling for 12 months from the date of issuance of this interim RED. Persons other than the registrant may distribute or sell such products for 24 months from the date of the issuance of this interim RED. Registrants and persons other than the registrant remain obligated to meet pre-existing label requirements and existing stocks requirements applicable to products they sell or distribute. D. Labeling Changes Summary Table In order to be eligible for reregistration, amend all product labels to incorporate the risk mitigation measures outlined in Section IV. The following table describes how language on the labels should be amended. 42 Table 8: Summary of Labeling Changes for Phorate Description Amended Labeling language Manufacturing Use Products One of these statements may be added to a label to allow reformulation of the product for a specific use or all additional uses supported by a formulator or user group “Only for formulation into an insecticide for the following use(s) [fill blank only with those uses that are being supported by MP registrant].” “This product may be used to formulate products for specific use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s).” “This product may be used to formulate products for any additional use(s) not listed on the MP label if the formulator, user group, or grower has complied with U.S. EPA submission requirements regarding support of such use(s).” Environmental Hazards Statements Required by the RED and Agency Label Policies "This chemical is very highly toxic to fish and wildlife Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or other waters unless in accordance with the requirements of a National Pollutant Discharge Elimination System (NPDES) permit and the permitting authority has been notified in writing prior to discharge. Do not discharge effluent containing this product to sewer systems without previously notifying the local sewage treatment plant authority. For guidance contact your state Water Board or Regional Office of the EPA.” (Insert any additional chemical specific manufacturing use environmental hazards here) End Use Products Intended for Occupational Use (WPS) Restricted Use Pesticide Statement “RESTRICTED USE PESTICIDE Due to acute oral, dermal, and inhalation toxicity and avian hazards. For retail sale to and use only by certified applicators or persons under their direct supervision and only for those uses covered by the certified applicator’s certificate.” “Personal Protective Equipment (PPE) Some materials that are chemical-resistant to this product are” (registrant inserts correct material as per supplements 3 of PR Notice 93-7). “ If you want more options, follow the instructions for category” [insert A,B,C,D,E,F,G,or H] “on an EPA chemical-resistance category selection chart.” “Loaders, applicators and other handlers must wear: * long-sleeved shirt and long pants, * shoes plus socks In addition loaders must wear: * chemical resistant gloves Front panel at top of page Directions for Use Directions for Use Placement on Label Directions for Use PPE Requirements Established by the RED 1 Precautionary Statements under Hazards to Humans and Domestic Animals 43 Description User Safety Requirements Amended Labeling language “Follow manufacturer's instructions for cleaning/maintaining PPE. If no such instructions for washables exist, use detergent and hot water. Keep and wash PPE separately from other laundry.” Placement on Label Precautionary Statements: Hazards to Humans and Domestic Animals (Immediately following the PPE requirements) Precautionary Statements: Hazards to Human and Domestic Animals (Immediately following PPE and User Safety Requirements) (Immediately following PPE and User Safety Requirements) Engineering Controls This product is formulated into an enclosed system that meets the definition of a closed loading system as defined by the Worker Protection Standard for Agricultural Pesticides. In addition to wearing the required PPE specified above, loaders must be provided and must have immediately available for use in case of an accident or spill: chemical-resistant apron, chemical resistant footwear, and a NIOSH-approved dust/mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or a NIOSH approved respirator with any N2 , R, P, or HE filter. Engineering Controls (Continued) Applicators must use an enclosed cab that meets the definition in the Worker Protection Standard for Agricultural Pesticides for dermal protection. In addition the applicator: C must wear PPE specified above, C must either use an enclosed cab that also provides equivalent respiratory protection to a dust/mist filtering respirator or wear a NIOSH-approved dust/mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or a NIOSH approved respirator with any N2, R, P, or HE filter. C must be provided and must have immediately available for use in case they must exit the cab in the treated area: coveralls, chemical-resistant gloves, chemical resistant footwear, and if using an enclosed cab that provides respiratory protection NIOSH-approved dust/mist filtering respirator with MSHA/NIOSH approval number prefix TC-21C or a NIOSH approved respirator with any N2, R, P, or HE filter. 44 Description User Safety Recommendations “User Safety Recommendations” Amended Labeling language Placement on Label Precautionary Statements under: Hazards to Humans and Domestic Animals immediately following Engineering Controls (Must be placed in a box.) “Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet.” “Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on clean clothing.” “Users should remove PPE immediately after handling this product. Wash the outside of gloves before removing. As soon as possible, wash thoroughly and change into clean clothing.” “Failure to follow precautions including wearing proper Personal Protective Equipment (PPE) may result in serious or even life threatening poisoning requiring immediate medical attention. The active ingredient of this granular formulation can be absorbed across the skin to cause poisoning.” Environmental Hazards “Environmental Hazards” “This pesticide is very highly toxic to fish and wildlife. Do not apply directly to water, or to areas where surface water is present or to intertidal areas below the mean high-water mark. Runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment wastewater or rinsate. Birds and mammals may be killed if granules are not properly covered with soil in all areas of the treated field and in loading areas. Precautionary Statements following the User Safety Recommendations under the Heading “Environmental Hazards” Restricted-Entry Interval “Do not enter or allow entry into treated areas for 48 hours during the restricted entry interval (REI) of 48 hours. Each 48- hour REI is increased to 72 hours in outdoor areas where the average rainfall is less than 25 inches per year. Exception: If the product is soil-injected or soil incorporated, the Worker Protection Standard, under certain circumstances, will allow workers to enter the treated areas without restriction if there will be no contact with anything that has been treated. Directions for Use, Agricultural Use Requirements Box 45 Description Early Re-entry Personal Protective Equipment established by the RED. Amended Labeling language “PPE required for early entry to treated areas that is permitted under the Worker Protection Standard and that involves contact with anything that has been treated, such as plants, soil, or water, is: Placement on Label Directions for Use, Agricultural Use Requirements Box C C C C coveralls worn over long-sleeve shirt and long pants chemical-resistant gloves chemical-resistant footwear plus socks protective eye wear” Notify workers of the application by warning them orally and by posting signs at entrances to treated areas. 46 Description General Application Restrictions Amended Labeling language Use on peanuts at pegging is prohibited. Cotton sidedress use is restricted to only Arizona and California. Only one application per season is allowed. Aerial application must be removed from all labels. Application must be incorporated into the soil. Prohibit application of phorate in saturated soils. Do not treat while precipitation is occurring or while conditions favor runoff from the treated area. “Do not apply this product in a way that will contact workers or other persons, either directly or through drift. Only protected handlers may be in the area during application.” “Do not apply in wet soil conditions that may prevent the equipment from covering pesticide granules.” “ Under some conditions phorate may have a high potential for runoff into surface water for several days post application. Do not apply in the following areas: Frequently flooded areas Areas where intense or sustained rainfall is forecasted to occur within 48 hours” Use Best Management Practices for minimizing surface runoff in the following areas: Poorly draining or wet soils with readily visible slopes toward adjacent surface water Areas over-laying extremely shallow ground water Areas with in-field canals or ditches that drain to surface water Areas not separated from adjacent surface waters with vegetated filter strips Areas over-laying tile drainage systems that drain to surface water Placement on Label Place in the Direction for Use directly above the Agricultural Use Box. General Application Restrictions (continued) “When used on erodible soils, best management practices for minimizing runoff should be employed. Consult your local soil conservation service for recommendations in your use area.” “In particular, where highly erodible land (HEL) is adjacent to aquatic bodies, a 66 foot buffer/setback area should be left in grass or other natural vegetation.” “Do not apply within 50 feet of any drinking water well to minimize potential contamination.” “Do not wash, load, or empty application equipment near any well, as this practice is a potential source of ground water contamination.” Place in the Direction for Use directly above the Agricultural Use Box. 47 Description Other 1 Amended Labeling language “For additional best management practices to avoid runoff to surface waters, see the following website (insert website address). Placement on Label Directions for Use PPE that is established on the basis of Acute Toxicity of the end-use product must be compared to the active ingredient PPE in this document. The more protective PPE must be placed in the product labeling. For guidance on which PPE is considered more protective, see PR Notice 93-7. 2 If the product contains oil or bears instructions that will allow application with an oil-containing material, the “N” designation must be dropped. Instructions in the Labeling Required section appearing in quotations represent the exact language that should appear on the label. Instructions in the Labeling Required section not in quotes represents actions that the registrant should take to amend their labels or product registrations. 48 VI. Related Documents and How to Access Them This interim ReregistrationEligibilityDocument is supported by documents that are presently maintained in the OPP docket. The OPP docket is located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays from 8:30 am to 4 pm. The docket initially contained preliminaryrisk assessments and related documents as of September 10, 1998. Sixty days later the first public comment period closed. The EPA then considered comments, revised the risk assessment, and added the formal “Response to Comments”document and the revised risk assessment to the docket on July 7, 1999. All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the Internet at the following site: "http://www.epa.gov/pesticides." 49 VII. APPENDICES 50 Appendix A. Table of Use Patterns Eligible for Reregistration Site Application Type Application Timing Application Equipment Beans Soil drilled At planting Ground 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257 1.9 oz./1000 ft of row (minimum 30-inch row spacing); or 2.0 lb/A 1 60 The grazing or feeding of treated hay or forage to livestock is prohibited. Formulation [EPA Reg. No.] Maximum Single Application Rate (ai) Maximum Number of Applications Preharvest Interval (Days) Use Limitations 1 Soil drilled or banded At planting Ground 1.4 oz/1000 ft of row (minimum 30-inch row spacing); or 1.5 lb/A 1 60 Corn, Field Soil banded incorporated At planting Ground 1.2 oz/1000 ft of row (minimum 30-inch row spacing); or 1.3 lb/A 1 N/A In -furrow application is prohibited. Soil banded At cultivation Ground 1.2 oz/1000 ft of row (minimum 30-inch row spacing); or 1.3 lb/A 1 30 Application after cultivation treatment is prohibited. 2 51 Site Application Type Application Timing Application Equipment Corn, Sweet Soil banded incorporated At planting Ground Formulation [EPA Reg. No.] Maximum Single Application Rate (ai) 1.2 oz/1000 ft of row (minimum 30-inch row spacing); or 1.3 lb/A Maximum Number of Applications 1 Preharvest Interval (Days) N/A Use Limitations 1 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [OR880002] [WA830021] [WA930010] In-furrow application is prohibited. Soil banded At cultivation Ground 1.2 oz/1000 ft of row (minimum 30-inch row spacing); or 1.3 lb/A 1 30 Application after cultivation treatment is prohibited. Cotton In furrow At planting Ground 1.5 oz/1000 ft of row (minimum 30-inch row spacing); 1.8 oz/1000 ft of row (minimum 36-inch row spacing); or 1.6 lb/A 2.0 oz/1000 ft of row (minimum 30-inch row spacing); 2.4 oz/1000 ft of row (minimum 36-inch row spacing); or 2.2 lb/A 1 N/A The grazing or feeding of treated hay or forage to livestock is prohibited. Soil incorporated Side-dressing Ground 1 60 The grazing or feeding of treated hay or forage to livestock is prohibited. Application is to be made to irrigated cotton only. Hops Soil banded Post-emergence Ground 3.0 lb/A 1 42 The feeding of crop refuse to livestock is prohibited. 52 Site Application Type Application Timing Application Equipment Peanuts In furrow At planting Ground Formulation [EPA Reg. No.] Maximum Single Application Rate (ai) 1.1 oz/1000 ft of row (minimum 24-inch row spacing); or 1.5 lb/A Maximum Number of Applications 1 Preharvest Interval (Days) 90 Use Limitations 1 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] [MT910004] [OR890005] [WA870010] [WA920005] [WI870003] [WI910004] 12% G [ME910001] [NC910006] [OR920025] [WA910007] The grazing or feeding of treated hay or forage to livestock is prohibited. Potatoes In furrow or soil banded At planting Ground Light or sandy soils: 2.3 oz/1000 ft of row (minimum 32-inch row spacing); or 2.3 lb/A Heavy or clay soils: 3.5 oz/1000 ft of row (minimum 32-inch row spacing); or 3.5 lb/A 1 90 Use for Colorado potato beetle control in the Del Marva Peninsula is prohibited. For SLNs MT910004, OR890005, WA870010, WA920005, WI870003, and WI910004, a maximum seasonal rate of 3 lb ai/A has been established. Soil banded At planting Ground 3.0 lb/A; or 2.9-3.5 oz/1000 ft of row (32- to 38-inch row spacing) 1 120 53 Site Application Type Application Timing Application Equipment Soil banded/side-dress Post-emergence Ground Formulation [EPA Reg. No.] 20% G [241-257] [MT910004] [WA920005] [WI910006] Maximum Single Application Rate (ai) 2.3 oz/1000 ft of row (minimum 32-inch row spacing) MT910004 and WA920005 only: Heavy or clay soils: 3.5 oz/1000 ft of row (any row spacing) 3.0 lb/A Maximum Number of Applications 1 Preharvest Interval (Days) 90 Use Limitations 1 Use for Colorado potato beetle control in the Del Marva Peninsula is prohibited. Post-emergence application is prohibited if phorate was applied at planting. Apply within 4 to 6 weeks of planting. Radishes grown for seed Soil banded At bolting Ground Lilies and Daffodils (field grown) Soil incorporated at plant or as side dressing after planting (For State Registrations Only) Sorghum Soil drilled or banded At planting Ground 10% G [241-53] 15% G [241-145] 20% G [241-257] 1.2 oz/1000 ft of row (minimum 30-inch row spacing); or 1.3 lb/A 1 N/A 10% G [CA87006900] 8.0 lb/A 1 N/A 10% G [WA900019] 20% G [WA910013] 1 60 54 Site Application Type Application Timing Application Equipment Soil banded At cultivation Ground Formulation [EPA Reg. No.] 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] 10% G [241-53] 15% G [241-145] 20% G [241-257] 12% G [MT910002] 10% G [241-53] 15% G [241-145] 20% G [241-257] Maximum Single Application Rate (ai) 1.2 oz/1000 ft of row (minimum 30-inch row spacing); or 1.3 lb/A Maximum Number of Applications 1 Preharvest Interval (Days) 30 Use Limitations 1 Use limited to CO, KS, and NE. A 30-day pre-grazing interval has been established. Applications after cultivation treatment are prohibited. Soybeans Soil drilled or banded At planting Ground 1.8 oz/1000 ft of row (minimum 30-inch row spacing); or 2.0 lb/A 1 N/A The feeding of treated foliage to livestock is prohibited. Sugar beets Soil drilled or banded At planting Ground 0.9 oz/1000 ft of row (minimum 20-inch row spacing); or 1.5 lb/A 1 30 Soil banded At planting Ground Foliar Post-emergence Ground 1.0 oz/1000 ft of row; (minimum 22-inch row spacing) or 1.4 lb/A 1.5 lb/A 1 N/A 1 30 The feeding of treated sugar beet tops or silage to dairy cattle is prohibited. Broadcast applications are prohibited. 55 Site Application Type Application Timing Application Equipment Sugarcane Soil banded Before covering Ground Formulation [EPA Reg. No.] Maximum Single Application Rate (ai) 3.9 lb/A Maximum Number of Applications 1 Preharvest Interval (Days) N/A Use Limitations 1 10% G [241-53] 15% G [241-145] 20% G [241-257] 20% G [LA920011] [LA920014] Use limited to FL. The grazing or feeding of treated forage or hay to livestock is prohibited. Soil banded At planting Ground 3.9 lb/A 1 N/A Use limited to LA. The grazing or feeding of treated forage or hay to livestock is prohibited. 1. PHI = Preharvest interval. A 48-hour reentry interval has been established for the 10%, 12%, 15%, and 20% G formulations. Applications of the 10%, 15%, and 20% G formulations (EPA Reg. Nos. 241-53, 241-145, and 241-257, respectively) to any crop on Long Island, NY or using aerial equipment is prohibited. 2. Cultivation application may be made to control corn rootworms or chinch bug nymphs. in AR, CO, KS, LA, MS, NE, OK, TN, and TX and a 30-day PHI/PGI has been established. When made to control chinch bug nymphs, application may only be made 56 Appendix B. Table of Generic Data Requirements and Studies Used to Make the Reregistration Decision GUIDE TO APPENDIX B Appendix B contains listing of data requirements whichsupport the reregistration for active ingredients within the case EPTC covered by this RED. It contains generic data requirements that apply EPTC in all products, including data requirements for which a "typical formulation" is the test substance. The data table is organized in the following formats: 1. Data Requirement (Column 1). The data requirements are listed in the order in which they appear in 40 CFR part 158. the reference numbers accompanying each test refer to the test protocols set in the Pesticide Assessment Guidance, which are available from the National technicalInformationService, 5285 Port RoyalRoad, Springfield,VA22161 (703) 487-4650. Use Pattern (Column 2). This column indicates the use patterns for which the data requirements apply. The following letter designations are used for the given use patterns. A. B. C. D. E. F. G. H. I. J. K. L. M. N. O. 3. Terrestrial food Terrestrial feed Terrestrial non-food Aquatic food Aquatic non-food outdoor Aquatic non-food industrial Aquatic non-food residential Greenhouse food Greenhouse non-food Forestry Residential Indoor food Indoor non-food Indoor medical Indoor residential 2. Bibliographic Citation (Column 3). If the Agency has acceptable data in its files, this column list the identify number of each study. This normally is the Master Record Identification (MIRD) number, but may be a "GS" number if no MRID number has been assigned. Refer to the Bibliography appendix for a complete citation of the study. 57 Appendix B: Data Supporting Guideline Requirements for the Reregistration of Phorate DATA REQUIREMENTS PRODUCT CHEMISTRY 61-1 61-2(a) 61-2(b) 62-1 Chemical Identity Starting Material & Mnfg. Process Formation of Impurities Preliminary Analysis 43109401 43381601 41348501 43381601 42655501 43381601 41391001 43109401 43381601 43109401 43109401 41348502 41348502 41348502 41348502 41348502 41348502 41348502 41348502 A, B A, B A, B A, B A, B A, B A, B A, B 20560 160000 N/A 22923 22923 5014313 43961101 158333 41131114 158334 7534 74623 74624 40165901 40094602 40098001 USE PATTERN BIBLIOGRAPHIC CITATION(S) 62-2 62-3 63-6 63-8 63-9 63-11 63-13 63-17 63-18 63-20 71-1(a) 71-1(b) 71-2(a) 71-2(b) 71-3 71-4(a) 71-4(b) 71-5(a) Certification of Limits Analytical Method Boiling Point Solubility Vapor Pressure Octanol/Water Partition Coefficient Stability Storage Stability Viscosity Corrosion Characteristics Acute Avian Oral, Quail/Duck (TGAI) Acute Avian Oral, Quail/Duck (TEP) Acute Avian Diet, Quail Acute Avian Diet, Duck Wild Mammal Toxicity Avian Reproduction Quail Avian reproduction Duck Simulated Terrestrial Field Study ECOLOGICAL EFFECTS 71-5(b) 72-1(a) Actual Terrestrial Field Study Acute Fish Toxicity Bluegill (TGAI) A, B A, B 58 DATA REQUIREMENTS 72-1(b) 72-1(c) 72-1(d) 72-2(a) Acute Fish Toxicity Bluegill (TEP) Acute Fish Toxicity Rainbow Trout (TGAI) Acute Fish Toxicity Rainbow Trout (TEP) Acute Aquatic Invertebrate Toxicity (TGAI) Acute Aquatic Invertebrate Toxicity (TEP) Acute Estu/Mari Tox Fish (TGAI) USE PATTERN A, B A, B A, B A, B BIBLIOGRAPHIC CITATION(S) 161823 40094602 90490 161822 97842 5017538 42000000 161825 161826 165000 40001801 40228401 41803804 40228401 40228401 40001801 40004201 40001802 41803804 158335 40228401 41131115 41803806 42227102 158335 41131115 42227102 42227129 43730501 Reserved Reserved 42227101 43957801 Waived 42227101 72-2(b) A, B 72-3(a) A, B 72-3(b) 72-3(c) 72-3(d) 72-3(e) 72-3(f) 72-4(a) Acute Estu/Mari Tox Mollusk (TGAI) Acute Estu/Mari Tox Shrimp (TGAI) Acute Estu/Mari Tox Fish (TEP) Acute Estu/Mari Tox Mollusk (TEP) Acute Estu/Mari ox Shrimp (TEP) Early Life-Stage Fish A, B A, B A, B A, B A, B A, B 72-4(b) Live-Cycle Aquatic Invertebrate A, B 72-5 72-6 72-7(a) 72-7(b) 122-1(a) 122-1(b) 122-2 123-1(a) 123-1(b) Life-Cycle Fish Aquatic Org. Accumulation Simulated Aquatic Field Study Actual Aquatic Field Study Seed Germ./Seedling Emerg . Vegetative Vigor Aquatic Plant Growth Seed Germ./Seedling Emerg. Vegetative Vigor A, B A, B A, B A, B A, B A, B A, B A, B A, B 40228401 59 DATA REQUIREMENTS 123-2 124-1 124-2 141-1 141-2 141-5 81-1 81-2 81-3 81-4 81-5 81-6 81-7 81-8 82-1(a) 82-1(b) 82-2 82-3 82-5(b) 83-1 83-2 83-2(b) 83-3 Aquatic Plant Growth Terrestrial Field Study Aquatic Field Study Honey Bee Acute Contact Honey Bee residue on Foliage Field Test for Pollinators Acute Oral Toxicity Acute Dermal Toxicity Acute Inhalation Toxicity Primary Eye Irritation Dermal Irritation Primary Dermal Sensitization Delayed Neurotoxicity Neurotoxicity Screening 90-Day Oral Neurotoxicity Subchronic Non-Rodent Oral Tox. Repeated Dose Derm.Tox.-21/28-Day Subchronic Dermal Toxicity- 90-Day 90-Day Neurotoxicity- Mammal Chronic Toxicity Carcinogenicity Oncogenicity- Mouse Prenatal Developmental Tox. Study USE PATTERN A, B A, B A, B A, A, B A, B BIBLIOGRAPHIC CITATION(S) (36935 & 5001991); not required for granular formulated products. TOXICOLOGY 126343 126343 139479 126343 Waived Waived Waived 152640 44719901 92873 92873 Waived 44794201 Waived 192475 (protocol) 40174527 124845 124845 41616101 122775 40174528 44422301 44422302 125233 Reserved 124901 151633 155597 41803803 83-4 83-5 83-6 84-2 Reproduction and Fertility Effects Combined Chronic Tox./ Carcinogen. Developmental Neurotoxicity Study Chronic Toxicity Studies 85-1 General Metabolism 60 DATA REQUIREMENTS USE PATTERN BIBLIOGRAPHIC CITATION(S) OCCUPATIONAL/RESIDENTIAL EXPOSURE 132-1(a) 132-1(b) Foliar Residue Dissipation Soil Residue Dissipation Reserved Reserved 41616102 41616103 Reserved 146524 41348502 (waiver granted) 133-3 133-4 Dermal Passive Dosimetry Inhalation Passive Dosimetry ENVIRONMENTAL FATE 161-1 161-2 161-3 161-4 162-1 162-2 162-4 163-1 163-2 163-3 164-1 164-5 165-1 165-2 165-4 Hydrolysis Photodegradation- Water Photodegradation- Soil Photodegradation- Air Aerobic Soil Metabolism Anaerobic Soil Metabolism Aerobic Aquatic Metabolism Adsorption/Desorption Studies Volatility- Lab Volatility- Field Terrestrial Field Dissipation Long Term Soil Dissipation Confined Rotational Crop Field Rotational Crop Bioaccumulation in Fish 41348507 44863001 41348508 Waived Reserved 41131112 41936002 44863002 44671204 44671205 42930301 Waived 41348506 42547701 Reserved 42657001 Reserved; exceptions apply to various individual crops. 42701101 RESIDUE CHEMISTRY 171-4(a) Nature of Residue- Plants Satisfied per science chapter 153487 61 DATA REQUIREMENTS USE PATTERN BIBLIOGRAPHIC CITATION(S) 171-4(b) 171-4(c) 171-4(d) 171-4(e) 171-4(j) 171-4(k) Nature of Residue- Livestock Residue Analytical Method- Plant Residue Analytical Method- Animal Storage Stability Mag. of Residue in Meat/Milk/ Poultry/Eggs Crop Field Trials 42093501 42597003 42093501 43861801 43763901 43861802 43861803 43281605 43661701 43730502 42337901 42597001 42597002 42597003 43730502 171-4(l) Processed Food/Feed OTHER SUBMISSIONS (Special Study) 80-A-SS 81-8-SS 82-B-SS 82-C-SS 85-2-SS Acute Eye Oral Rat Study Acute Neurotoxicity- Rat Subchronic Eye Rat Study Short Term Mouse Study Six Month Eye Study Reserved 192475 (protocol) Reserved 41616101 Reserved 62 Appendix C. Technical Support Documents Additional documentation in support of this RED is maintained in the OPP docket, located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Highway, Arlington, VA. It is open Monday through Friday, excluding legal holidays, from 8:30 am to 4 pm. The docket initially contained preliminary risk assessments and related documents as of August 10, 1998. Sixty days later the first public comment period closed. The EPA then considered comments, revised the risk assessment, and added the formal “Response to Comments” document and the revised risk assessment to the docket on June 16, 1999. All documents, in hard copy form, may be viewed in the OPP docket room or downloaded or viewed via the Internet at the following site: www.epa.gov/pesticides/op These documents include: HED Documents: 1. 2. 3. 4. 5. 6. 7. Dobozy, Virginia (USEPA/OPPTS/HED) Phorate: Review of Pesticide Poisoning Incident Data. No date provided. Miller, David (USEPA/OPPTS/HED) Phorate: Evaluation of Novigen Chronic and Acute Monte-Carlo Analyses. January 29, 1998. Odiott, Olga (USEPA/OPPTS/HED) Occupational and Residential Exposure Assessment and Recommendations for the R.E.D. for Phorate. March 13, 1995. Olinger, Christine (USEPA/OPP/HED) Human Health Risk Assessment: Phorate. September 2, 1999. Olinger, Christine (USEPA/OPPTS/HED) Phorate: Revised HED Chapter of the R.E.D. Document. March 12, 1998. Robertson, Jason (USEPA/OPPTS/SRRD) Phorate: revised HED Science Chapter. March 17, 1998. Rowland, Jess (USEPA/OPPTS/HED) Phorate-FQPA Requirement: Report of the Hazard Identification Assessment review Committee. September 25, 1997. 63 8. 9. 10. 11. 12. 13. 14. Smith, Jane (USEPA/OPPTS/HED) Phorate: HED Chapter of the R.E.D. Smith, (USEPA/OPPTS/HED) Phorate: HED Chapter of the R.E.D. April 6, 1996. Steinwand, Brian (USEPA/OPPTS/HED) Acute Dietary Exposure Analysis for Phorate in Support of the R.E.D. May 9, 1996. Steinwand, Brian (USEPA/OPPTS/HED) Dietary Exposure Analysis for Phorate in Support of the R.E.D. July, 29, 1998. Tarplee, Brenda (USEPA/OPPTS/HED) FQPA Safety Factor Recommendations for the Organophosphates. August 6, 1998. USEPA/OPP/SRRD. Overview of Phorate Revised Risk Assessment. September 2, 1999. USEPA/OPP/SRRD. Phorate Summary. September 2, 1999. EFED Documents: 1. 2. American Cyanamid, Ecological Risk Assessment for THIMET Soil and Systemic Insecticide. December 1, 1997. Farrar, David (USEPA/OPP/EFED) Updated EFED RED Chapter/Revisions of Exposure Estimates/Response to comments from American Cyanamid. August 30, 1999. Wagner, Pauline (USEPA/OPPTS/EFED) EFED Science Chapter for Phorate R.E.D. July, 18, 1998. 3. Other Related Documents: 1. 2. Alsadek, Jihad (USEPA/OPP/BEAD) Quantitative Usage Analysis. January 8, 1998. American Cyanamid, Amercian Cyanamid Rebuttal to EPA’s Health Effects Division Draft Chapter of the Red for Phorate. July, 29, 1998. 64 3. 4. 5. 6. Angulo, Karen (USEPA/OPPTS/SRRD) Increasing Transparency for the Tolerance Reassessment Process: Phorate. August 12, 1998. Chambliss, Ben (USEPA/OPP/SRRD) Response to Comments on the Preliminary Risk Assessment for the Organophosphate Phorate. September 2, 1999. Hazard Assessments of the Organophosphates. (USEPA/OPPTS/HED). July 22, 1998. Wrubel, (American Cyanamid) Transmittal letter: Phorate Reregistration Case #103 Response to Draft Science Chapter and Submissions of Acute and Chronic... December 1, 1998. Wrubel, (Amercian Cyanamid) Phorate Response to the US EPA’s Draft Science Chapter and FQPA Requirements. Wrubel, (Amercian Cyanamid) Phorate Reregistration Request for “Monte Carlo” Acute Dietary Risk Assessment EPA Letter dated August 14, 1997. Wrubel, John (American Cyanamid) Partial Response to the Draft Environmental Fate and Effects Science Chapter. December 17, 1997. Wrubel, John (American Cyanamid) Phorate and Its Potential Environmental Risk in Perspective. December 17, 1997. 7. 8. 9. 10. . 11. Various Authors, Public Comments regarding Phorate. July 23, 1998 thru August 21, 1998. 12. Various Authors, Comments regarding Preliminary risk Assessment for Phorate. October 8, 1998 thru November 13, 1998. 65 Appendix D. Citations Considered to be Part of the Data Base Supporting the Interim Reregistration Decision (Bibliography) GUIDE TO APPENDIX D 1. CONTENTS OF BIBLIOGRAPHY. This bibliography contains citations of all studies considered relevant by EPA in arriving at the positions and conclusions stated elsewhere in the Reregistration Eligibility Document. Primary sources for studies in this bibliography have been the body of data submitted to EPA and its predecessor agencies in support of past regulatory decisions. Selections from other sources including the published literature, in those instances where they have been considered, are included. UNITS OF ENTRY. The unit of entry in this bibliography is called a "study". In the case of published materials, this corresponds closely to an article. In the case of unpublished materials submitted to the Agency, the Agency has sought to identify documents at a level parallel to the published article from within the typically larger volumes in which they were submitted. The resulting "studies" generally have a distinct title (or at least a single subject), can stand alone for purposes of review and can be described with a conventional bibliographic citation. The Agency has also attempted to unite basic documents and commentaries upon them, treating them as a single study. IDENTIFICATION OF ENTRIES. The entries in this bibliography are sorted numerically by Master Record Identifier, or "MRID” number. This number is unique to the citation, and should be used whenever a specific reference is required. It is not related to the six-digit "Accession Number" which has been used to identify volumes of submitted studies (see paragraph 4(d)(4) below for further explanation). In a few cases, entries added to the bibliography late in the review may be preceded by a nine character temporary identifier. These entries are listed after all MRID entries. This temporary identifying number is also to be used whenever specific reference is needed. FORM OF ENTRY. In addition to the Master Record Identifier (MRID), each entry consists of a citation containing standard elements followed, in the case of material submitted to EPA, by a description of the earliest known submission. Bibliographic conventions used reflect the standard of the American National Standards Institute (ANSI), expanded to provide for certain special needs. a Author. Whenever the author could confidently be identified, the Agency has chosen to show a personal author. When no individual was identified, the Agency has shown an identifiable laboratory or testing facility as the author. When no author or laboratory could be identified, the Agency has shown the first submitter as the author. Document date. The date of the study is taken directly from the document. When the date is followed by a question mark, the bibliographer has deduced the date from the evidence 2. 3. 4. b. 66 contained in the document. When the date appears as (1999), the Agency was unable to determine or estimate the date of the document. c. Title. In some cases, it has been necessary for the Agency bibliographers to create or enhance a document title. Any such editorial insertions are contained between square brackets. Trailing parentheses. For studies submitted to the Agency in the past, the trailing parentheses include (in addition to any self-explanatory text) the following elements describing the earliest known submission: (1) (2) Submission date. The date of the earliest known submission appears immediately following the word "received." Administrative number. The next element immediately following the word "under" is the registration number, experimental use permit number, petition number, or other administrative number associated with the earliest known submission. Submitter. The third element is the submitter. When authorship is defaulted to the submitter, this element is omitted. Volume Identification (Accession Numbers). The final element in the trailing parentheses identifies the EPA accession number of the volume in which the original submission of the study appears. The six-digit accession number follows the symbol "CDL," which stands for "Company Data Library." This accession number is in turn followed by an alphabetic suffix which shows the relative position of the study within the volume. d. (3) (4) 67 BIBLIOGRAPHY MRID 7534 ____________________________________________________________________ Industrial Bio-Test Laboratories, Incorporated (1961) Halane Toxicological Studies. (Unpublished study received May 5, 1969 under 8556-1; submitted by San O Matic Manufacturing Co. Schafer, E.W. (1972) The acute oral toxicity of 369 pesticidal, pharmaceutical and other chemicals to wild birds. Toxicology and Applied Pharmacology 21(?):315-330. (Also in unpublished submission received Apr 25, 1978 under 476-2180; submitted by Stauffer Chemical Co., Richmond, Calif.; CDL:233577-C) Hill, E.F.; Heath, R.G.; Spann, J.W.; et al. (1975) Lethal Dietary Toxicities of Environmental Pollutants to Birds: Special Scientific report-Wildlife No. 191. (U.S. Dept. of the Interior, fish and Wildlife Service, Patuxent Wildlife research Center; unpublished report) Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study--Bobwhite Quail: Project No. 130-131A. (Unpublished study received May 21, 1981 under 241-257; prepared by Wildlife International Ltd., submitted by American Cyanamid Co., Princeton, N.J.; CDL:245263-B) Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study--Bobwhite Quail: Project No. 130-131B. (Unpublished study received May 21, 1981 under 241-257; prepared by Wildlife Intenational Ltd., submitted by American Cyanamid Co., Princeton, N.J.; CDL:245263-C) Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study--Bobwhite Quail: Project No. 130-131C. (Unpublished study received May 21, 1981 under 241-257; prepared by Wildlife International Ltd., submitted by American Cyanamid Co., Princeton, N.J.; CDL:245263-D) Fink, R.; Beskid, J.C. (1981) Final Report: Simulated Field Study--Bobwhite Quail: Project No. 130-131D. (Unpublished study received May 21, 1981 under 241-257; prepared by Wildlife International Ltd., submitted by American Cyanamid Co., Princeton, N.J.; CDL:245263-E) Tusing, T.W. (1956) Progress Report: Repeated Oral Administration--Dogs. (Unpublished study, including letter dated Jan 25, 1956 from T.W. Tusing to D.O. Hamblin, received Feb 20, 1956 under 241-36; prepared by Hazleton Laboratories, submitted by American Cyanamid Co., Princeton, N.J.; CDL:092661-M) 68 CITATION 20560 22923 74623 74624 74625 74626 92873 BIBLIOGRAPHY MRID 97842 ____________________________________________________________________ (Study is a duplicate of MRID# 108338) 122775 Beliles, R. (1979) Teratology Study in Rats: Thimet Phorate: LBI Project No. 20819. Final rept. (Unpublished study received Dec 30, 1982 under 0E2391; prepared by Litton Bionetics, submitted by American Cyanamid Co., Princeton, NJ; CDL:071332-A) Manus, A.; Goldsmith, L.; Sekerke, H.; et al. (1981) 18-month Chronic Toxicity and Potential Carcinogenicity Study in Mice: Phorate: LBI Project No. 20820. Final rept. (Unpublished study received Oct 13, 1982 under 241-53; prepared by Litton Bionetics, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL:248780-A) Simmon, V.; Mitchell, A.; Jorgenson, T. (1977) Evaluation of Selected Pesticides as Chemical Mutagens: In vitro and in vivo studies: EPA-600/1-77-028: Pre RPAR Review Submission #3. (Unpublished study received Sep 14, 1977 under 1471-35; prepared by Stanford Research Institute, Environmental Toxicology Div., Health Effects Research Laboratory, and U.S. Environmental Protection Agency, Office of Research and Development, submitted by Elanco Products Co., Div. of Eli Lilly and Co., Indianapolis, IN; CDL:233222-L) Manus, A.; Goldsmith, L.; Maloney, D.; et al. (1981) 24-month Chronic Toxicity and Potential Carcinogenicity Study in rats: Phorate: LBI Project No. 20821. Final rept. (Unpublished study received Oct 13, 1982 under 241-53; prepared by Litton Bionetics, Inc., submitted by American Cyanamid Co., Princeton, NJ; CDL: 248778-A; 238779) Newell, G.; Dilley, J. (1978) Teratology and Acute Toxicology of Selected Chemical Pesticides Administered by Inhalation. By Stanford Research Institute. Research Triangle Park, NC: U.S. Environmental Protection Agency, Office of Research and Development, Health Effects Research Laboratory. (EPA-600/1-78-003; contract no. 68-02-1751; available from: NTIS: PB277077; also In unpublished submission received Mar 10, 1983 under 352-325; submitted by E.I. du Pont de Nemours & Co., Inc., Wilmington, DE; CDL:249679-I) Shaffer, C.B. (1960) Thimet and Formulations: Toxicity by Skin Absorption: Report No. 58-11. (Unpublished study received on unknown date under unknown admin. no.; submitted by American Cyanamid Co., Princeton, N.J.; CDL:103361-F) CITATION 124845 124901 125233 126343 139479 69 BIBLIOGRAPHY MRID 146524 151633 ____________________________________________________________________ American Cyanamid Co. (19??) Product Chemistry: ?Thimet Technical and Thimet MC-85F. Unpublished compilation. 59 p. CITATION Thilagar, A. (1985) Test for Chemical Induction of Gene Mutation at the HGPRT Locus in Cultured Chinese Hamster Ovary (CHO) Cells with and without Metabolic Activation: AC 35,024: Sitek's Study No. 0007-2500. Unpublished American Cyanamid Co.s Study No. 980-85-133 prepared by Sitek Research Laboratories. 53 p. Fletcher, D. (1984) 42-day Neurotoxicity Study with Phorate in Mature White Leghorn Chickens: BLAL No. 83 DN 103. Unpublished study prepared by Bio-Life Associates, Ltd. 51 p. American Cyanamid Co. (1984) ?Thimet Residue and Metabolism Data. Unpublished compilation. 122 p. Ivett, J. (1986) Chromosomal Aberrations in vivo in Mammalian Bone Marrow Cells on AC 35,024: Second Amended Final Report: LBI Project No. 22202. Unpublished study prepared by Litton Bionetics. 50 p. Beavers, J. (1986) Phorate Technical: A One-generation Reproduction Study with the Bobwhite (Colinus virginianus):Final Report Project No.130-141. Unpublished study prepared by Wildlife International Ltd. 102 p. Beavers, J. (1986) Phorate Technical: A One-generation Reproduction Study with the Mallard (Anas platyrhynchos):Final Report: Project No.130-142. Unpublished study prepared by Wildlife International Ltd. 104 p. Surprenant, D. (1986) The Toxicity of ?Carbon-14F-AC35,024 to Rainbow Trout (Salmo gairdneri) Embryos and Larvae: Report No. BW-86-3-1-1968. Unpublished study prepared by Springborn Bionomics, Inc. 57 p. Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet 20G to Rainbow Trout (Salmo gairdneri): Report #BW-86-6-2051; Study#451.1285.6108.103. Unpublished study prepared by Springborn Bionomics, Inc. 34 p. 152640 153487 155597 158333 158334 158335 161822 70 BIBLIOGRAPHY MRID 161823 ____________________________________________________________________ Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet 20G to Bluegill (Lepomis macrochirus): Report #BW-86-6-2052; Study #451.1285.6108.100. Unpublished study prepared by Springborn Bionomics, Inc. 33 p. Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet 20G to Daphnids (Daphnia magna): Report #BW-86-6-2055; Study #451.1285. 6108.110. Unpublished study prepared by Springborn Bionomics, Inc. 32 p. Nicholson, R.; McNabb, T. (1986) Acute Toxicity of Thimet 20G to Midge Larvae (Paratanytarsus parthenogenica): Report #BW-86-6-2057; Study #451.1285.6108.111. Unpublished study prepared by Springborn Bionomics, Inc. 32 p. Suprenant, D. (1986) Acute Toxicity of Thimet 20G to Sheepshead Minnow (Cyprinodon variegatus): Acute Toxicity - Estuarine and Marine Organism: Project ID: BW-86-8-2133. Unpublished study prepared by Springborn Bionomics, Inc. 37 p. Suprenant, D. (1986) Acute Toxicity of Thimet 20G to Mysid Shrimp (Mysidopsis bahia): Acute Toxicity - Estuarine and Marine Organisms: Project ID: BW-86-6-2135. Unpublished study prepared by Springborn Bionomics, Inc. 39 p. Suprenant, D. (1986) Acute Toxicity of Thimet 20G to Quahog Clam (Mercenaria mercenaria): Acute Toxicity--Estuarine and Marine Organisms: Laboratory Project ID: BW-86-6-2139. Unpublished study prepared by Springborn Bionomics, Inc. 31 p. Lavin, M. (1986) Anaerobic Soil Metabolism of ?Carbon 14F- Phorate: Final Report: Project ID: #33730. Unpublished study prepared by Analytical Bio-Chemistry Laboratories, Inc. 592 p. Johnson, W.; Finley, M. (1980) Handbook of Acute Toxicity of Chemicals to Fish and Aquatic Invertebrates: Resource Publication 137. US Fish and Wildlife Service, Washington, D.C. 106 p. Mayer, F.; Ellersieck, M. (1986) Manual of Acute Toxicity: Interpretation and Data Base for 410 Chemicals and 66 Species of Freshwater Animals. US Fish and Wildlife Service, Resource Publication 160. 579 p. CITATION 161825 161826 40001801 40001802 40004201 40077302 40094602 40098001 71 BIBLIOGRAPHY MRID ____________________________________________________________________ 40165901 Dingledine, J.; Jaber, M. (1987) An Evaluation of the Effects of Thimet 20-G upon Terrestrial Wildlife Species under Actual Use Conditions: Laboratory Project ID: 130-139. Unpublished study prepared by Wildlife International, Ltd. 494 p. CITATION 40174525 Sanders, P. (1987) Thimet Insecticide, Phorate (AC 35,024): Aged Soil Column Leaching: Project No. 0109: Report No. PD-M Volume 24-17. Unpublished study prepared by American Cyanamid Co. 142 p. Lowe, C.; Fischer, J. (1987) Acute Oral Toxicity of AC 180,296--A Metabolite of AC 35,024 in Male and Female Rats: Report No. A87- 11. Unpublished study prepared by American Cyanamid Co. 5 p. study prepared by Bio-Life Associates, Ltd. 51 p. Shellenberger, T.; Tegeris, A. (1987) One-year Oral Toxicity Study in Purebred Beagle Dogs with AC 35,024: Laboratory Project Id: 85015. Unpublished study prepared by Tegeris Laboratories, Inc. 881 p. Schroeder, R. (1987) A Teratology Study with Phorate in Rabbits: Project No. 86-3039. Unpublished study prepared by Bio/Dynamics, Inc. 359 p. (Study is a duplicate of MRID# 40098001) Hussain, M. (1987) Thimet Insecticide, Phorate (CL 35, 024): Disposition and Metabolic Fate of Carbon-14 Labeled CL 35, 024 in the Rat: General Metabolism--Rat: Project No. 0109; Report No. PD-M Volume 24-23. Unpublished study prepared by American Cyanamid Co. 135 p. Potts, C. (1987) Thimet Phorate (CL 35,024): Freezer Stability of Total CL 35,024--Related Residues in Refined Corn Oil and Corn Meal. Freezer Stability of Residues: Laboratory Project ID: 0109. Unpublished study prepared by American Cyanamid Co. 9 p. American Cyanamid Co. (1988) Submission of Chemistry and Environmental Data in Support of Thimet. Transmittal of 7 studies. 40174526 40174527 40174528 40228401 40291601 40386304 40586500 72 BIBLIOGRAPHY MRID ____________________________________________________________________ 40586501 Potts, C. (1987) Thimet phorate (CL35,024/20-G): Residues of Total CL35,024-Related Compounds in Peanut Soapstock: Project 0109: Report C-3007. Unpublished study prepared by American Cyanamid Co. 11 p. CITATION 40586503 Peterson, R. (1987) Thimet Insecticide phorate (CL35,024): Freezer Stability of Total CL 35,024-Related Residues in Sugar Beet Roots and Tops: Project 0109: Report C-3000. Unpublished study prepared by American Cyanamid Co. 8 p. Higham, J.; Roman, M.; Shimel, K. (1988) Thimet phorate (CL35,024/20-G): Residues of CL 35,024 and Its Metabolites in Soil: Project 0109. Unpublished study prepared by American Cyanamid Co.157 p. Roman, M. (1985) CL35,024 (Phorate): Freezer Stability of Total CL35,024-Related Residues in Corn Commodities: Green Plants, Straw and Grain (Final Report) (C-2657,C-2682): Report No. C-3102. Unpublished study prepared by American Cyanamid Co. 36 p. Bohn, W. (1986) Thimet Phorate (CL35,024): Freezer Stability of Total CL35,024-Related Residues in Wheat Grain, Straw and Green Plants (C-2744): Report No. C-3004. Unpublished study prepared American Cyanamid Co. 21 p. Bohn, W. (1985) Thimet Phorate (CL35,024): Freezer Stability of Total CL35,024-Related Residues in Potato Tubers (C-2710): Report No. C-3005. Unpublished study prepared by American Cyanamid Co. 13 p Cranor, W. (1989) Additional Data for the Aerobic Soil Metabolism Study with [carbon 14]-Phorate: Report No. ABC Project No. 33733. Unpublished study prepared by ABC Labs. 5 p. Wildlife International Ltd (1989) Response to EPA Comments on the Bobwhite Reproduction Study with Phorate: Project No. 130-141. Unpublished study. 5 p. Suprenant, D. (1989) Addendum: Thimet Insecticide Fish Early Life Stage and Aquatic Invertebrate Life-Cycle Studies. Unpublished study prepared by Springborn Life Science, Inc. 18 p. 40586506 41131108 41131109 41131110 41131112 41131114 41131115 73 BIBLIOGRAPHY MRID ____________________________________________________________________ 41348501 Luckhowec, J. (1989) Product Chemistry: Description of Beginning Materials and Manufacturing Process for the Technical Grade Active Ingredient (TGAI) and Manufacturing Use Product (MP) THIMET Phorate. Unpublished study prepared by American Cyanamid Co. 50 p. CITATION 41348502 Luckhowec, J. (1989) Product Chemistry Requirements for the Technical Grade Active Ingredient (TGAI) and Manufacturing Use Product (MP) THIMET Phorate: Physical and Chemical Characteristics: Lab Project Number: 29/12. Unpublished study prepared by American Cyanamid Co. 119 p. Roman, M. (1990) Addendum to CL 35,024 Phorate (20-G): Residues of CL 35,024 and Its Metabolites in Soil (Corn, BAND, IA, 1987): Lab Project No,: C-3071. Unpublished study prepared by American Cyanamid Co. 30 p. Mangels, G. (1989) Phorate AC 35,024: Hydrolysis: Lab Project Number: E/89/12. Unpublished study prepared by American Cyanamid Co. 117 p. Mangels, G. (1989) Phorate (AC 35,024): Photodegradation in Water: Lab Project Number: E/89/13. Unpublished study prepared by American Cyanamid Co. 66 p. Kirzecky, N. (1990) Preliminary Analysis of Technical Thimet Insecticide: O,O-diethyl S-?(ethylthio) methylF Phosphorodithioate (...): Lab Project Number: C-3310. Unpublished study prepared by American Cyanamid Co. 48 p. Trutter, J. (1990) 13-Week Dietary Toxicity Study in Albino Mice with AC35,024: Lab Project Number: 362-201. Unpublished study prepared by Hazleton Laboratories America, Inc. 180 p. Leonard, R.; Sund, K.; Burkart, S. (1990) CL35,024(Phorate/15G): Residues of CL35,024,CL18,177, and CL18,161 in Soil from a Peanut Plot at-Harvest: Lab Project Number: C-3409. Unpublished study prepared by American Cyanamid Co. 100 p. Leonard, R.; Sund, K.; Burkart, S. (1990) CL35,024(Phorate/20G): Residues of CL35,024,CL18,177 and CL18,161 in Soil from a Potato Plot at-Harvest: Lab Project Number: C-3415. Unpublished study prepared by American Cyanamid Co. 92 p. 41348506 41348507 41348508 41391001 41616101 41616102 41616103 74 BIBLIOGRAPHY MRID ____________________________________________________________________ 41803801 Roman, M. (1985) Thimet Phorate (CL 35,024): Validation of GC Meth- od M-1599 for the Determination of Total CL3 35,024-Related Residues in Corn Grain: Lab Project Number:C-2657. Unpublished Study prepared by American Cyanamid Co.18 p. CITATION 41803803 Miller, P.; Wu, D. (1991) Phorate(CL 35,024)(Phorate/20G): Adsorpion, Distribution, Elimination and Metabolic Fate of Carbon-14 CL 35,024 in the Female Rat: Lab Project Number: 27-59: RPT0043. Unpublished study prepared by American Cyanamid Company 127 p. Sousa, J. (1991) Thimet 20G--Acute Toxicity to Mysid Shrimp (Mysidopsis bahia) Under Flow-through Conditions: Lab Project Number: 90-10-3496. Unpublished study prepared by Springborn Laboratories Inc. 53 p. Sousa, J. (1991) AC 35,024--Toxicity Test with Sheepshead Minnow (Cyprinodon variegatus) Embroys and Larvae: Lab Project Number: 90-7-3369: 451.0889.6112.505. Unpublished study prepared by Springborn Laboratories, Inc. 113 p. Daly, D. (1991) Anaerobic Soil Metabolism of [carbon 14]-Phorate: Final Report: Lab Project Number: 38415. Unpublished study prepared by ABC Laboratories, Inc. 43 p Baumann, G. (1991) Phorate (...): Metabolic Fate of Carbon-14 Labeled CL 35,024 in Tissues and Eggs of the Laying Hen: Lab Project Number: 28-39. Unpublished study prepared by XenoBiotic Labs, Inc. 228 p. Krueger, K.; Schneider, S. (1992) An Evaluation of Thimet 20G Soil and Systemic Insecticide Exposure to Selected Aquatic Ecosystems: (Treatment Year--1989): Lab Project Number: 130-144. Unpublished study prepared by Wildlife International Ltd. 957 p. Yurk, J., Wisk, J. (1992) Chronic Toxicity of [Carbon 14] AC 35,024 to Daphnia magna under Static-Renewal Conditions: Lab Project Number: 3913016-0200-3140: 941-91-101. Unpublished study prepared by ESE, Inc. 129 p. Biehn, W. (1992) Phorate: Magnitude of Residue in or on Hops (Fresh and Dried): Lab Project Number: 3575. Unpublished study prepared by Washington State Dept. of AG. Chemical & Hop Lab. 82 p. 75 41803804 41803806 41936002 . 42093501 42227101 42227102 42337901 BIBLIOGRAPHY MRID ____________________________________________________________________ 42547701 Leonard, R. (1992) CL 35,024 (Phorate): Residues of CL 35,024, CL 18,177 and CL 18,161 in Soil Treated with a PPI Application to Peanuts of Thimet 20G Soil and Systematic Insecticide (...) (Georgia-1990): Second Round Review Additional Data: Lab Project Number: C-3771. Unpublished study prepared by Huntingdon Analytical Services. 144 p. Leonard, R. (1992) CL 35,024 (Phorate): Effects of Processing Potato into Wet and Dry Peels, Granules and Chips, and the Effects of Cooking on Residues of Total CL 35,024 Related Compounds in Potatoes Treated with a 5X Application of THIMET 20-G Soil and Systemic Insecticide: Lab Project Number: C-3895: C-3896. Unpublished study prepared by American Cyanamid Co. 224 p. Leonard, R. (1992) CL 35,024 (Phorate): Residue of Total CL 35,024-related Residues in Cannery Waste from Snap Beans Treated with a 5X Application of THIMET 20-G Soil and Systemic Insecticide: Lab Project Number: C-3809: C-3810. Unpublished study prepared by American Cyanamid Co. 110 p. Gross, J. (1990) Phorate (CL 35,024): Characteristics of Phorate and Its Phosphorylated Metabolites Through FDA Multiresidue Methods: Lab Project Number: C-3378. Unpublished study prepared by American Cyanamid Co. 5 p. Allemang, D. (1993) Letter Sent to OPP dated Feb. 8, 1993: Regarding results of magnitude of residue study of ethyl parathion on canola. Prepared by Cheminova Agro A/S. 2 p. Brindle, P. (1992) CL 35,024: Confined Accumulation Study of Carbon-14 Labeled CL 35,024 Using Barley, Carrots, Lettuce and Peas as Rotational Crops: Lab Project Number: M90P024CA2. Unpublished study prepared by American Cyanamid Co. and Pan-Agricultural Labs, Inc. 500 p. Robertson, R. (1993) Uptake, Depuration, Bioconcentration and Metabolism of (carbon 14) CL 35,024 in Bluegill Sunfish (Lepomis macrochirus) Under Flow-Through Test Conditions: Lab Project Number: XBL 92014: RPT00121: M92B024M01. Unpublished study prepared by ABC Laboratories, Inc. and XenoBiotic Laboratories, Inc. 187 p. CITATION 42597001 42597002 42597003 42655501 42657001 42701101 76 BIBLIOGRAPHY MRID ____________________________________________________________________ 42930301 43109401 Cady, C. (1993) Laboratory Volatility of Phorate from Soil: Lab Project Number: ENV93-024: 40111. Unpublished study prepared by ABC Laboratories. 60 p. CITATION Kirzecky, N. (1993) Product Identity, Certified Limits and Analytical Methods for Phorate Technical: Lab Project Number: APBR:299. Unpublished study prepared by American Cyanamid Co. 20 p. Leonard, R. (1994) THIMET 20G: Residues of Total CL 35,024 Related Compounds in Grain Sorghum After 5X Applications of THIMET 20G Soil and Systemic Insecticide at Planting and at Cultivation: Lab Project Number: RES/94/056: RES/94/057: RES/94/058. Unpublished study prepared by American Cyanamid Co. 206 p. Brindle, P. (1994) CL 35,024: Confined Accumulation Study of Carbon-14 Labeled CL 35,024 Using Barley, Carrots, Lettuce and Peas (sic) as Rotational Crops: Lab Project Number: MET/94/006. Unpublished study prepared by American Cyanamid Co. and PanAgricultural Labs., Inc. 424 p. Wise, J. (1994) Phorate-Product Chemistry: Preliminary Analysis, Certification (of) Limits and Enforcement Analytical Method: Lab Project Number: 4372-94-0092-AS-001: 4372-94-0058-AS-001: 4372-94-0059-AS-001. Unpublished study prepared by John Wise & Associates, Ltd. 421 p. Leonard, R. (1994) Total CL 35,024 Related Residues in Snap Beans After a Single Banded or Side-Dressed Application of THIMET 20G Soil and Systemic Insecticide Made at Planting: Lab Project Numbers: RES 94-060.01: RES 94-061.01: RES 94-062.01. Unpublished study prepared by American Cyanamid Co. 247 p. Overman, M.; Wisk, J.; Wiber, P. et al. (1995) Chronic Toxicity of PHORATE to the Mysid, Mysidopsis bahia Under Flow-Through Test Conditions and Validation of an Analytical Method for the Determination of (Carbon 14)-Phorate (CL,35,024) Residues in Seawater: Lab Project Number: 954-93-206: 954-94-128: ASG-91-01. Unpublished study prepared by Environmental Science & Engineering Co. 175 p. Leonard, R. (1995) THIMET 20G: Crop Residue Study: Total Apparent CL 35,024-Related Residues in Field Corn Grain After Sequential At Planting and At 43281605 43365901 43381601 43661701 43730501 43730502 77 BIBLIOGRAPHY MRID ____________________________________________________________________ CITATION Cultivation 10X Maximum Labeled Use Rate Banded Application of THIMET 20G Soil and Systemic Insecticide at 60 oz. Formulated Product per 1000 Foot Row per Application: Lab Project Number: RES 95-073: TH94IA01: CL 35,024. Unpublished study prepared by ABC Labs, Inc. and American Cyanamid Co. 76 p. Higham, J. (1995) Phorate (CL 35,024): Freezer Stability of Residues of Phorate and Related Compounds (CL 35,024; CL 18,177; CL 18,161; CL 4,259; CL 18,162; and CL 18,061) in Dry Beans: Lab Project Number: RES 95-114: TH93PT04. Unpublished study prepared by American Cyanamid Co. 34 p. Relates to the 12 month study 43281604. Dieter, C.; Flake, L.; Duffy, W. (1995) Effects of phorate on ducklings in northern prairie wetlands. J. Wildlife Management 59(3):498-505. Khunachak, A.; Witkonton, S. (1995) Phorate (CL 35,024): Independent Laboratory Validation of Method M 2461 for the Determination of Total CL 35,024-Related Residues in Cattle Muscle, Liver, Kidney, and Fat and Method M 2469 for the Determination of Total CL 35,024-Related Residues in Cow's Milk by ABC Laboratories, Incorporated: Lab Project Number: RES 95-150: 42632: TH94PT01. Unpublished study. 89 p. Khunachak, A. (1995) CL 35,024: Refrigerator and Freezer Storage Stability of Total CL 35,024-Related Residues in Cow's Milk (Interim Report): Lab Project Number: RES 95-161: 95-161: 42685. Unpublished study prepared by ABC Labs, Inc. 43 p. Leonard, R. (1995) Phorate (CL 35,024): Magnitude of CL 35,024 and its Cholinesterase Inhibiting Metabolites in Milk and Edible Tissues (Muscle, Liver, Kidney, and Fat) from Dairy Cattle after Oral Administration of Phorate for 28 Consecutive Days: Lab Project Number: RES 95-143: 95-143: 42634. Unpublished study prepared by ABC Labs, Inc. 174 p. Dieter, C.; Duffy, W.; Flake, L. (1996) The effect of phorate on wetland macroinvertebrates. Environmental Toxicology and Chemistry 15(3):308-312. McCann, J.; Teeters, W.; Urban, D. et al. (1981) A short-term dietary toxicity test on small mammals. p. 132-142 of the Second Conference of Avian and Mammalian Wildlife Toxicology, Lamb, D.; Kenaga, E. Eds.; Published in American Society for Testing and Materials, ASTM STP 757; 1981. 78 43763901 43819501 43861801 43861802 43861803 43957801 43961101 BIBLIOGRAPHY MRID ____________________________________________________________________ 44422301 CITATION Lochry, E. (1990) An Oral Toxicity (Embryo-Fetal Toxicity/Teratogenicity) Definitive Study with AC 35024 in Rats: Lab Project Number: 101-012P: ARGUS 101-012: 971-90-112. Unpublished study prepared by Argus Research Laboratories, Inc.436 p. Schroeder, R. (1991) A Two-Generation (Two Litters) Reproduction Study with AC 35024 to Rats: Lab Project Number: 88-3350: A-8 88-3350: 88-3350A. Unpublished study prepared by Bio/dynamics Inc. 2281 p. Mangels, G. (1998) Phorate Sulfoxide (CL 18177): Adsorption/Desorption on Soil: Lab Project Number: PD-M 27-8: E88-9: 0109. Unpublished study prepared by American Cyanamid Company. 37 p. {OPPTS 835.1230} Mangels, G. (1998) Phorate Sulfone (CL 18177): Adsorption/Desorption on Soil: Lab Project Number: PD-3 27-7: 0109: E88-22. Unpublished study prepared by American Cyanamid Company. 36 p. {OPPTS 835.1230} Mandella, R. (1998) An Acute Neurotoxicity Study with AC 35024 in the Rat via Oral Gavage Administration: Phorate: Lab Project Number: 97-4520: 97-4519: 971-97-159. Unpublished study prepared by Huntingdon Life Sciences. 782 p. {OPPTS 870.6200}. Mangels, G. (1999) Analysis of the Degradation Kinetics of Phorate, Phorate Sulfoxide, and Phorate Sulfone in Soils Under Laboratory and Field Conditions: Lab Project Number: EXA 98-021. Unpublished study prepared by American Cyanamid Co. 93 p. Compton, D. (1999) A Four-Week Rat Dermal Toxicity Study with AC350254 20G (Thimet 20G Soil and Systemic Insecticide): Lab Project Number: 96-2495: 971-97-141. Unpublished study prepared by Huntingdon Life Sciences. 565 p. {OPPTS 870.3200} Martin, C.; Heim, D. (1999) (Carbon-14)-Phorate(AC 35024) and its Sulfoxide(AC 18177) and Sulfone(AC 18161) Metabolites: Hydrolysis in Sterile pH 5,7, and 9 Buffers: Lab Project Number: ENV 97-019: ENV 97-019.01. Unpublished study prepared by ABC Labs., Inc. 383 p. {OPPTS 835.2120} Martin, C.; Xia, C. (1999) (Carbon-14)-Phorate(AC 35024) and its Sulfoxide(AC 18177) and Sulfone(AC 18161) Metabolites: Degradation in Natural Pond Water: Lab Project 44422302 44671204 44671205 44719901 44754301 44794201 44863001 44863002 79 BIBLIOGRAPHY MRID ____________________________________________________________________ Number: ENV 97-020. Unpublished study prepared by ABC Labs., Inc. 160 p.{OPPTS 835.2120, 835.4300} CITATION 80 Appendix E. Generic Data Call-In See attached table for a list of generic data requirements. Note that a complete Data Call-In (DCI), with all pertinent instructions, is being sent to registrants under separate cover. 81 Requirements Status and Registrant’s RESPONSE Page 1 of 1 82 Comments for Guideline Requirements PAGE 1 of 1 83 Appendix F. Product Specific Data Call-In See attached table for a list of product-specific data requirements. Note that a complete Data CallIn (DCI), with all pertinent instructions, is being sent to registrants under separate cover. 84 Product Specific DATA CALL-IN RESPONSE page 1 of 1 85 Product Specific REQUIREMENTS STATUS AND REGISTRANT’S RESPONSE pg. 1 of 2 86 Requirements Status And Registrant's Response Page 2 of 2 87 Product Specific Footnotes and Key Definitions for Guideline Requirements Page 1 of 2 88 Product Specific Footnotes and Key Definitions for Guideline Requirements Page 2 of 2 89 Appendix G. EPA’S Batching of Phorate Products for Meeting Acute Toxicity Data Requirements for Reregistration In an effort to reduce the time, resources and number of animals needed to fulfill the acute toxicity data requirements for reregistration of products containing phorate as the active ingredient, the Agency has batched products which can be considered similar for purposes of acute toxicity. Factors considered in the sorting process include each product's active and inert ingredients (identity, percent composition and biological activity), type of formulation (e.g., emulsifiable concentrate, aerosol, wettable powder, granular, etc.), and labeling (e.g., signal word, use classification, precautionary labeling, etc.). Note that the Agency is not describing batched products as "substantially similar" since some products within a batch may not be considered chemically similar or have identical use patterns. Using available information, batching has been accomplished by the process described in the preceding paragraph. Notwithstanding the batching process, the Agency reserves the right to require, at any time, acute toxicity data for an individual product should the need arise. Registrants of products within a batch may choose to cooperatively generate, submit or cite a single battery of six acute toxicological studies to represent all the products within that batch. It is the registrants' option to participate in the process with all other registrants, only some of the other registrants, or only their own products within a batch, or to generate all the required acute toxicological studies for each of their own products. If a registrant chooses to generate the data for a batch, he/she must use one of the products within the batch as the test material. If a registrant chooses to rely upon previously submitted acute toxicity data, he/she may do so provided that the data base is complete and valid by today's standards (see acceptance criteria attached), the formulation tested is considered by EPA to be similar for acute toxicity, and the formulation has not been significantly altered since submission and acceptance of the acute toxicity data. Regardless of whether new data is generated or existing data is referenced, registrants must clearly identify the test material by EPA Registration Number. If more than one confidential statement of formula (CSF) exists for a product, the registrant must indicate the formulation actually tested by identifying the corresponding CSF. In deciding how to meet the product specific data requirements, registrants must follow the directions given in the Data Call-In Notice and its attachments appended to the RED. The DCI Notice contains two response forms which are to be completed and submitted to the Agency within 90 days of receipt. The first form, "Data Call-In Response," asks whether the registrant will meet the data requirements for each product. The second form, "Requirements Status and Registrant's Response," lists the product specific data required for each product, including the standard six acute toxicity tests. A registrant who wishes to participate in a batch must decide whether he/she will provide the data or depend on someone else to do so. If a registrant supplies the data to support a batch of products, he/she must select one of the following options: Developing Data (Option 1), Submitting an Existing Study (Option 4), Upgrading an Existing Study (Option 5) or Citing an Existing Study (Option 6). If a registrant depends on another's data, he/she must choose among: Cost Sharing (Option 2), Offers to Cost Share (Option 3) or Citing an Existing 90 Study (Option 6). If a registrant does not want to participate in a batch, the choices are Options 1, 4, 5 or 6. However, a registrant should know that choosing not to participate in a batch does not preclude other registrants in the batch from citing his/her studies and offering to cost share (Option 3) those studies. Twelve products were found which contain Phorate as the active ingredient. These products have been placed into seven batches in accordance with the active and inert ingredients and type of formulation. C C C C C C The products in Batch 2 may be supported by citing/submitting the acute data from Batch 1. The products in Batch 3 may be supported by citing/submitting the acute data from Batch 1. The products in Batch 4 may be supported by citing/submitting the acute data from Batch 1. The products in Batch 5 may be supported by citing/submitting the acute data from Batch 1. The products in Batch 6 may be supported by citing/submitting the acute data from Batch 1. The products in Batch 7 may be supported by citing/submitting the acute data from Batch 1. NOTE: The technical acute toxicity values included in this document are for informational purposes only. The data supporting these values may or may not meet the current acceptance criteria. Batch 1 EPA Reg. No. 2749-106 % Active Ingredient 95.0 Formulation Type Solid Batch 2 EPA Reg. No. 241-212 241-213 % Active Ingredient 85.0 85.0 Formulation Type Solid Solid Batch 3 EPA Reg. No. 241-257 9779-293 34704-259 % Active Ingredient 20.0 20.0 20.0 Formulation Type Solid Solid Solid Batch 4 EPA Reg. No. 241-145 % Active Ingredient 15.0 Formulation Type Solid 91 Batch 5 EPA Reg. No. 241-53 34704-712 % Active Ingredient 10.0 10.0 Formulation Type Solid Solid Batch 6 EPA Reg. No. 264-521 34704-710 % Active Ingredient 10.0 10.0 Formulation Type Solid Solid Batch 7 EPA Reg. No. 400-412 % Active Ingredient 6.5 Formulation Type Solid 92 Appendix H. List of Registrants Sent This Data Call-In 93 Insert List–Page 1 of 1 94 Appendix I. List of Available Related Documents and Electronically Available Forms Pesticide Registration Forms are available at the following EPA internet site: http://www.epa.gov/opprd001/forms/. Pesticide Registration Forms (These forms are in PDF format and require the Acrobat reader) Instructions 1. 2. 3. Print out and complete the forms. (Note: Form numbers that are bolded can be filled out on your computer then printed.) The completed form(s) should be submitted in hardcopy in accord with the existing policy. Mail the forms, along with any additional documents necessary to comply with EPA regulations covering your request, to the address below for the Document Processing Desk. DO NOT fax or e-mail any form containing 'Confidential Business Information' or 'Sensitive Information.' If you have any problems accessing these forms, please contact Nicole Williams at (703) 308-5551 or by e-mail at williams.nicole@epamail.epa.gov. The following Agency Pesticide Registration Forms are currently available via the internet: at the following locations: 8570-1 8570-4 8570-5 8570-17 8570-25 Application for Pesticide Registration/Amendment Confidential Statement of Formula Notice of Supplemental Registration of Distribution of a Registered Pesticide Product Application for an Experimental Use Permit Application for/Notification of State Registration of a Pesticide To Meet a Special Local Need Formulator's Exemption Statement Certification of Compliance with Data Gap Procedures Pesticide Registration Maintenance Fee Filing Certification of Attempt to Enter into an Agreement with other Registrants for Development of Data Certification with Respect to Citations of Data (in PR Notice 98-5) http://www.epa.gov/opprd001/forms/8570-1.pdf. http://www.epa.gov/opprd001/forms/8570-4.pdf. http://www.epa.gov/opprd001/forms/8570-5.pdf. http://www.epa.gov/opprd001/forms/8570-17.pdf. http://www.epa.gov/opprd001/forms/8570-25.pdf. 8570-27 8570-28 8570-30 8570-32 http://www.epa.gov/opprd001/forms/8570-27.pdf. http://www.epa.gov/opprd001/forms/8570-28.pdf. http://www.epa.gov/opprd001/forms/8570-30.pdf. http://www.epa.gov/opprd001/forms/8570-32.pdf. 8570-34 http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf. 95 8570-35 8570-36 8570-37 Data Matrix (in PR Notice 98-5) Summary of the Physical/Chemical Properties (in PR Notice 98-1) Self-Certification Statement for the Physical/Chemical Properties (in PR Notice 98-1) http://www.epa.gov/opppmsd1/PR_Notices/pr98-5.pdf. http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf. http://www.epa.gov/opppmsd1/PR_Notices/pr98-1.pdf. Pesticide Registration Kit Dear Registrant: www.epa.gov/pesticides/registrationkit/. For your convenience, we have assembled an online registration kit which contains the following pertinent forms and information needed to register a pesticide product with the U.S. Environmental Protection Agency's Office of Pesticide Programs (OPP): 1. The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and the Federal Food, Drug and Cosmetic Act (FFDCA) as Amended by the Food Quality Protection Act (FQPA) of 1996. Pesticide Registration (PR) Notices a. b. c. d. e. f. g. h. 83-3 Label Improvement Program--Storage and Disposal Statements 84-1 Clarification of Label Improvement Program 86-5 Standard Format for Data Submitted under FIFRA 87-1 Label Improvement Program for Pesticides Applied through Irrigation Systems (Chemigation) 87-6 Inert Ingredients in Pesticide Products Policy Statement 90-1 Inert Ingredients in Pesticide Products; Revised Policy Statement 95-2 Notifications, Non-notifications, and Minor Formulation Amendments 98-1 Self Certification of Product Chemistry Data with Attachments (This document is in PDF format and requires the Acrobat reader.) 2. Other PR Notices can be found at http://www.epa.gov/opppmsd1/PR_Notices. 3. Pesticide Product Registration Application Forms (These forms are in PDF format and will require the Acrobat reader.) a. b. c. d. e. EPA Form No. 8570-1, Application for Pesticide Registration/Amendment EPA Form No. 8570-4, Confidential Statement of Formula EPA Form No. 8570-27, Formulator's Exemption Statement EPA Form No. 8570-34, Certification with Respect to Citations of Data EPA Form No. 8570-35, Data Matrix 96 4. General Pesticide Information (Some of these forms are in PDF format and will require the Acrobat reader.) a. A. B. d. e. f.. g.. Registration Division Personnel Contact List Biopesticides and Pollution Prevention Division (BPPD) Contacts Antimicrobials Division Organizational Structure/Contact List 53 F.R. 15952, Pesticide Registration Procedures; Pesticide Data Requirements (PDF format) 40 CFR Part 156, Labeling Requirements for Pesticides and Devices (PDF format) 40 CFR Part 158, Data Requirements for Registration (PDF format) 50 F.R. 48833, Disclosure of Reviews of Pesticide Data (November 27, 1985) Before submitting your application for registration, you may wish to consult some additional sources of information. These include: 1. 2. The Office of Pesticide Programs' Web Site The booklet "General Information on Applying for Registration of Pesticides in the United States", PB92-221811, available through the National Technical Information Service (NTIS) at the following address: National Technical Information Service (NTIS) 5285 Port Royal Road Springfield, VA 22161 The telephone number for NTIS is (703) 605-6000. Please note that EPA is currently in the process of updating this booklet to reflect the changes in the registration program resulting from the passage of the FQPA and the reorganization of the Office of Pesticide Programs. We anticipate that this publication will become available during the Fall of 1998. 3. The National Pesticide Information Retrieval System (NPIRS) of Purdue University's Center for Environmental and Regulatory Information Systems. This service does charge a fee for subscriptions and custom searches. You can contact NPIRS by telephone at (765) 494-6614 or through their Web site. The National Pesticide Telecommunications Network (NPTN) can provide information on active ingredients, uses, toxicology, and chemistry of pesticides. You can contact NPTN by telephone at (800) 858-7378 or through their Web site: ace.orst.edu/info/nptn. The Agency will return a notice of receipt of an application for registration or amended registration, experimental use permit, or amendment to a petition if the applicant or petitioner encloses with his submission a stamped, self-addressed postcard. The postcard must contain the following entries to be completed by OPP: Date of receipt EPA identifying number Product Manager assignment 97 4. Other identifying information may be included by the applicant to link the acknowledgment of receipt to the specific application submitted. EPA will stamp the date of receipt and provide the EPA identifying File Symbol or petition number for the new submission. The identifying number should be used whenever you contact the Agency concerning an application for registration, experimental use permit, or tolerance petition. To assist us in ensuring that all data you have submitted for the chemical are properly coded and assigned to your company, please include a list of all synonyms, common and trade names, company experimental codes, and other names which identify the chemical (including "blind" codes used when a sample was submitted for testing by commercial or academic facilities). Please provide a CAS number if one has been assigned. Documents Associated with this RED The following documents are part of the Administrative Record for this RED document and may included in the EPA's Office of Pesticide Programs Public Docket. Copies of these documents are not available electronically, but may be obtained by contacting the person listed on the respective Chemical Status Sheet. 1. 2. Health and Environmental Effects Science Chapters. Detailed Label Usage Information System (LUIS) Report. 98