Reregistration Status for Organophosphates IRED (PDF)[692]

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 EPA 738-R-01-010 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D.C. 20460 October 30, 2001 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL Dear Registrant: This is to inform you that the Environmental Protection Agency (hereafter referred to as EPA or the Agency) has completed its review of the available data and public comments received related to the preliminary and revised risk assessments for the organophosphate pesticide phosmet. The public comment period on the revised risk assessment phase of the reregistration process is closed. The Agency held a Technical Briefing on February 10, 2000, in Pasco, Washington, where the results of the revised human health and environmental effects risk assessments were presented to the general public. Based on comments received during the public comment period and additional data received from the registrant, the Agency revised the human health and environmental effects risk assessments and made them available to the public on March 20, 2000. This Technical Briefing concluded Phase 4 of the OP Public Participation Pilot Process developed by the Tolerance Reassessment Advisory Committee, and initiated Phase 5 of that process. During Phase 5, all interested parties were invited to participate and provide comments and suggestions on ways the Agency might mitigate the estimated risks presented in the revised risk assessments. This public participation and comment period commenced on March 20, 2000, and closed on May 19, 2000. Based on its review, EPA has identified risk mitigation measures that the Agency believes are necessary to address the human health and environmental risks associated with the current uses of phosmet. The EPA is now publishing its interim decision on the reregistration eligibility of and risk management decision for the 45 current uses of phosmet and its associated human health and environmental risks. The reregistration eligibility and tolerance reassessment decisions for phosmet will be finalized once the cumulative assessment for all of the organophosphate pesticides is considered. The enclosed “Interim Reregistration Eligibility Decision for Phosmet,” which was approved on October 30, 2001, contains the Agency’s decision on the individual chemical phosmet.” A Notice of Availability for this Interim Reregistration Eligibility Decision for phosmet is being published in the Federal Register. To obtain a copy of the interim RED document, please contact the OPP Public Regulatory Docket (7502C), US EPA, Ariel Rios Building, 1200 Pennsylvania Avenue NW, Washington, DC 20460, telephone (703) 305-5805. Electronic 1 copies of the interim RED and all supporting documents are available on the Internet. See http:www.epa.gov/pesticides/op. The interim RED is based on the updated technical information found in the phosmet public docket. The docket not only includes background information and comments on the Agency’s preliminary risk assessments, it also now includes the Agency’s revised risk assessments for phosmet, and a document summarizing the Agency’s Response to Comments. The Response to Comments document addresses corrections to the preliminary risk assessments submitted by chemical registrants, as well as responds to comments submitted by the general public and stakeholders during the comment period on the risk assessment. The docket will also include comments on the revised risk assessment, and any risk mitigation proposals submitted during Phase 5. For phosmet, a proposal was submitted by Gowan Company, the technical registrant. Comments on mitigation or mitigation suggestions were also submitted by environmental organizations, agricultural extension agents, and various other organizations. This document and the process used to develop it are the result of a pilot process to facilitate greater public involvement and participation in the reregistration and/or tolerance reassessment decisions for these pesticides. As part of the Agency’s effort to involve the public in the implementation of the Food Quality Protection Act of 1996 (FQPA), the Agency is undertaking a special effort to maintain open public dockets on the organophosphate pesticides and to engage the public in the reregistration and tolerance reassessment processes for these chemicals. This open process follows the guidance developed by the Tolerance Reassessment Advisory Committee (TRAC), a large multi-stakeholder advisory body that advised the Agency on implementing the new provisions of the FQPA. The reregistration and tolerance reassessment reviews for the organophosphate pesticides are following this new process. Please note that the phosmet risk assessment and the attached interim RED concern only this particular organophosphate. This interim RED presents the Agency’s conclusions on the dietary (food and drinking water) risks posed by exposure to phosmet alone. The Agency has also concluded its assessment of the ecological and worker risks associated with the use of phosmet. Because the FQPA directs the Agency to consider available information on the basis of cumulative risk from substances sharing a common mechanism of toxicity, such as the toxicity expressed by the organophosphates through a common biochemical interaction with cholinesterase enzyme, the Agency will evaluate the cumulative risk posed by the entire organophosphate class of chemicals after completing the risk assessments for the individual organophosphates. The Agency is working towards completion of a methodology to assess cumulative risk and the individual risk assessments for each organophosphate are likely to be necessary elements of any cumulative assessment. The Agency has decided to move forward with individual assessments and to identify mitigation measures necessary to address those human health and environmental risks associated with the current uses of phosmet. The Agency will issue the final tolerance reassessment decision for phosmet and finalize decisions on reregistration eligibility once the cumulative assessment for all of the organophophates is considered. 2 Interim RED DCIs: This document contains a generic and/or a product-specific Data CallIn(s) (DCI) that outline(s) further data requirements for this chemical. Note that a complete DCI, with all pertinent instructions, is being sent to registrants under separate cover. Additionally, for product-specific DCIs, the first set of required responses to is due 90 days from the receipt of the DCI letter. The second set of required responses is due eight months from the date of the DCI. In this interim RED, the Agency has determined that phosmet will be eligible for reregistration provided that all the conditions identified in this document are satisfied, including implementation of the risk mitigation measures outlined in Section IV of the document. This interim RED identifies risk concerns associated with current uses of phosmet. Other phosmet uses with remaining risks have been determined to have significant benefits associated with their continued use. These risks are mitigated to the extent possible. Accordingly, the Agency recommends that registrants implement these risk mitigation measures immediately. Sections IV and V of this interim RED describe labeling amendments for end-use products, data requirements necessary to implement these mitigation measures and discuss the benefits associated with the use of phosmet on various crops. Instructions for registrants on submitting the revised labeling can be found in the set of instructions for product-specific data that accompanies this interim RED. Should a registrant fail to implement any of the risk mitigation measures outlined in this document, even in light of the benefits derived from its use, the Agency will continue to have concerns about the risks posed by phosmet. Where the Agency has identified any unreasonable adverse effect to human health and the environment, the Agency may at any time initiate appropriate regulatory action to address this concern. Accordingly, pesticides containing phosmet may not be eligible for reregistration absent the labeling changes. If you have questions on this document or the label changes necessary for reregistration, please contact the Chemical Review Manager, Diane Isbell at (703) 308-8154. For questions about product reregistration and/or the Product DCI that accompanies this document, please contact Barbara Briscoe at (703) 308-8177. Lois A. Rossi, Director Special Review and Reregistration Division Attachment 3 Interim Reregistration Eligibility Decision for Phosmet Case No. 0242 TABLE OF CONTENTS Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . iv 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 Phosmet Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 A. Human Health Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 1. Dietary Risk from Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 a. Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 b. FQPA Safety Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 c. Population Adjusted Dose (PAD) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 d. Exposure Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 e. Food Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 2. Dietary Risk from Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 a. Surface Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 b. Ground Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 11 c. Drinking Water Levels of Comparison (DWLOCs) . . . . . . . . . . . . . . . 12 3. Occupational and Residential Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 a. Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 b. Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 c. Occupational & Residential Handler Risk Summary . . . . . . . . . . . . . . 18 (1) Occupational Handler Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 18 (2) Post-Application Occupational Risk . . . . . . . . . . . . . . . . . . . . . 31 (3) Occupational Reentry Risk Estimates for Phosmet . . . . . . . . . . 32 (4) Residential (Homeowner) Handler Risk . . . . . . . . . . . . . . . . . . . 35 (5) Residential Post-Application Risk . . . . . . . . . . . . . . . . . . . . . . . 37 4. Aggregate Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 5. Incident Data Review . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 B. Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 1. Environmental Fate and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 2. Risk to Birds and Mammals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 3. Risk to Aquatic Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 4. Risk to Honey Bees . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 40 Interim Risk Management and Reregistration Decision . . . . . . . . . . . . . . . . . . . . . . . . . . 40 A. Determination of Interim Reregistration Eligibility . . . . . . . . . . . . . . . . . . . . . . . . . 40 B. Summary of Phase 5 Comments and Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 C. Regulatory Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 1. FQPA Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 III. IV. D. E. a. “Risk Cup” Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 44 b. Tolerance Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 45 2. Endocrine Disruptor Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 3. Labels . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 48 Regulatory Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 1. Human Health Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 a. Dietary (food and water) Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 (1) Acute Dietary (Food) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 (2) Chronic Dietary (Food) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 (3) Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 b. Residential . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 c. Occupational Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 (1) Agricultural Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 (2) Animal Use Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 (3) Homeowner Use Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . 89 (4) Handler Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 (5) Post-Application Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . 89 2. Environmental Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 89 Other Labeling Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 1. Endangered Species Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 90 2. Spray Drift Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 91 V. What Registrants Need to Do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 93 A. Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 1. Additional Generic Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 94 2. Labeling for Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 B. End-Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 1. Additional Product-Specific Data Requirements . . . . . . . . . . . . . . . . . . . . . . 95 2. Labeling for End-Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 C. Existing Stocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 96 D. Labeling Changes Summary Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 97 VI. Related Documents and How to Access Them . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Appendix A Appendix B Appendix C PHOSMET TEAM Office of Pesticide Programs: Health Effects Risk Assessment Jerome Blondell Jeffrey Dawson Virginia Dobozy Christina Swartz Linda Taylor Environmental Fate Risk Assessment Sid Abel Dana Spatz Use and Usage Analysis Jihad Alsadek William Gross Registration Support Richard Gebken Risk Management Diane Isbell i GLOSSARY OF TERMS AND ABBREVIATIONS AGDCI a.i. aPAD AR BCF CFR cPAD CSF CSFII DCI DEEM DFR DWLOC EC EEC EPA EUP FDA FFDCA FIFRA FOB FQPA G GENEEC GLN HAFT IR LC50 LD50 LOAEL LOC LOD MATC mg/kg/day mg/L MOE MRID MUP NA NAWQA NOAEL NPDES NR OP Agricultural Data Call-In Active Ingredient Acute Population Adjusted Dose Anticipated Residue Bioconcentration Factor Code of Federal Regulations Chronic Population Adjusted Dose Confidential Statement of Formula USDA Continuing Surveys for Food Intake by Individuals Data Call-In Dietary Exposure Evaluation Model Dislodgeable Foliar Residue Drinking Water Level of Comparison. Emulsifiable Concentrate Formulation Estimated Environmental Concentration Environmental Protection Agency End-Use Product Food and Drug Administration Federal Food, Drug, and Cosmetic Act Federal Insecticide, Fungicide, and Rodenticide Act Functional Observation Battery Food Quality Protection Act Granular Formulation Tier I Surface Water Computer Model Guideline Number Highest Average Field Trial 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 Observed Adverse Effect Level Level of Concern Limit of Detection Maximum Acceptable Toxicant Concentration Milligram Per Kilogram Per Day Milligrams Per Liter Margin of Exposure Master Record Identification (number). EPA's system of recording and tracking studies submitted. Manufacturing-Use Product Not Applicable USGS National Water Quality Assessment No Observed Adverse Effect Level National Pollutant Discharge Elimination System Not Required Organophosphate ii OPP OPPTS PAD PCA PDP PHED PHI ppb PPE ppm PRZM/EXAMS Q1* RAC RED REI RfD RQ SAP SCI-GROW SF SLC SLN TGAI TRR UF USDA USGS UV WPS Fg/g Fg/L EPA Office of Pesticide Programs EPA Office of Prevention, Pesticides and Toxic Substances Population Adjusted Dose Percent Crop Area USDA Pesticide Data Program Pesticide Handler's Exposure Data Preharvest Interval Parts Per Billion Personal Protective Equipment Parts Per Million Tier II Surface Water Computer Model The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model Raw Agriculture Commodity Reregistration Eligibility Decision Restricted Entry Interval Reference Dose Risk Quotient Science Advisory Panel Tier I Ground Water Computer Model Safety Factor Single Layer Clothing Special Local Need (Registrations Under Section 24(c) of FIFRA) Technical Grade Active Ingredient Total Radioactive Residue Uncertainty Factor United States Department of Agriculture United States Geological Survey Ultraviolet Worker Protection Standard Micrograms Per Gram Micrograms Per Liter iii Executive Summary EPA has completed its review of public comments on the revised phosmet risk assessments and is issuing its risk management decisions for phosmet. This document supercedes the Partial Interim RED (PIRED) signed on August 31, 2001. This document contains both the 17 decisions in the PIRED as well as decisions on the 28 remaining uses. The decisions outlined in this document do not include the final tolerance reassessment decision for phosmet; however, some tolerance actions will be undertaken prior to completion of the final tolerance reassessment. Four tolerances will be revoked now, for corn commodities, because the registrant is not supporting these uses. It should be noted that the Partial Interim RED proposed that citrus tolerances would also be revoked. The Agency received a request from the State of Florida for a Special Local Need registration under FIFRA Section 24(c). The Agency is in the process of assessing the risks and benefits associated with this use. A final determination on the citrus use will be made at the close of the comment period on this IRED, scheduled to be completed 60 days after this document is issued. The final tolerance reassessment decision for this chemical will be issued once the cumulative assessment for all of the organophosphates is considered. The Agency may need to pursue further risk management measures for phosmet once the cumulative assessment is considered. The revised risk assessments are based on review of the required target data base supporting the use patterns of currently registered products and new information received. The Agency invited stakeholders to provide proposals, ideas or suggestions on appropriate mitigation measures before the Agency issued its risk mitigation decision on phosmet. The Agency considered the revised risk assessments and the mitigation options proposed by the Gowan Company, the technical registrant of phosmet, as well as comments and mitigation suggestions from other interested parties including Wellmark International, the Natural Resources Defense Council, several grower organizations, and an agricultural extension agent. After considering these comments and suggestions, the EPA developed its risk management decision for uses of phosmet. This decision is discussed fully in this document. Phosmet is an organophosphate insecticide used on a variety of insects, first registered in 1966 for use on the following crops: fruit trees (apple, pear, peach, nectarine, plum, prune, apricot, cherry) and nut trees (almond, walnut, pecan, filbert, pistachio), grapes, kiwi, blueberries, cotton, peas (succulent and dried), potato, and sweet potato (foliar and post-harvest). In addition, phosmet is registered for direct animal treatments to control fleas, lice, hornflies, sarcoptic mange, and ticks on cattle, swine, and dogs. There are other uses such as in forestry and for ornamentals, including residential sites, that can be treated by professional applicators. Phosmet can also be used by homeowners to treat trees, shrubs, ornamental plants, pets (dogs only) and home gardens. Use data from 1988 to 1997 indicate an average of approximately 1,000,000 pounds of phosmet are applied to approximately 402,000 acres per year. iv Overall Risk Summary EPA’s human health risk assessment for phosmet indicates some risk concerns. However, food risks, both acute and chronic, are well below the Agency’s level of concern. Similarly, drinking water risk estimates are based on screening models, from both ground and surface water for acute and chronic exposures, are not of concern for all populations. There are, however, concerns for workers who mix, handle or load phosmet in the wettable powder form for aerial and chemigation applications to fruit and nut trees, field and vegetable crops, grapes, and ornamental plants and forestry. Worker handler risks are largely due to dermal exposure. Following application of phosmet, there are also concerns for workers re-entering treated fields. Additionally, there are concerns for homeowners who apply phosmet to ornamental plants and fruit trees with a low pressure hand wand, and for adults and youth-aged children harvesting and maintaining these fruit trees. There are significant risk concerns for toddlers exposed to phosmet residues following contact with treated dogs. Phosmet was found to be moderately to practically non-toxic to avian species (acute); however, the application rates for some crops result in levels of concern that are slightly exceeded. Use on most crops appears to pose a chronic risk to birds and for all crops, there is a high chronic risk for mammals. For mammals, the acute levels of concern are exceeded mainly on short grass for smaller animals. Acute and chronic risk to both freshwater and estuarine/marine fish is relatively low. The acute risk to both freshwater and estuarine/marine invertebrates are of concern for some crops. All crops (with potential for marine exposure) appear to be a chronic concern for marine invertebrates. Use of phosmet on many crops appears to be a chronic risk to freshwater invertebrates. In addition, phosmet is highly toxic to honey bees, and incidents of honey bee toxicity have been reported. To mitigate risks of concern posed by the uses of phosmet, EPA considered the mitigation proposal submitted by the technical registrant, as well as comments and mitigation ideas from other interested parties, and has decided on a number of label amendments to address the worker, residential, and ecological concerns. Results of the risk assessments, and the necessary label amendments to mitigate those risks, are presented in this interim RED. Dietary Risk Acute and chronic dietary risk assessments for food and drinking water are not of concern; therefore, no mitigation is warranted at this time for any dietary exposure to phosmet. Occupational Risk Occupational exposure to phosmet is of concern to the Agency, and it has been determined that a number of mitigation measures are necessary. For the agricultural uses of phosmet, the Agency has risk concerns for occupational handlers mixing and loading wettable powder products for aerial and chemigation applications to fruit and nut trees, field and vegetable crops, grapes, and forestry, i.e., MOEs are less than 100. The EPA believes most of v these risks can be mitigated to an acceptable level by using additional personal protective equipment, or closed loading systems, in addition to label restrictions and amendments detailed in Section V of this document. The Agency also has concerns about workers re-entering the agricultural field within 24 hours after treatment with phosmet, which is the restricted entry interval on current labels. To mitigate those risks, the Agency is proposing to extend the current REIs for all crops. Even after taking into account all feasible mitigation for these uses, there are some phosmet uses with risks of concern. In situations where there are non-dietary risk concerns, FIFRA allows the Agency to consider benefits derived from using a pesticide when evaluating the risks. The EPA has conducted a benefits assessment for phosmet use on many crops, and considered the benefits of continued use, as well as the risks, in its risk management decisions. The crops with remaining risks have significant benefits associated with their continued use. The benefits associated with these uses are summarized in Section IV of this interim RED. Full benefits assessments are available in the docket and on the internet. Residential Risk Based on the phosmet use pattern, residential handler exposure is expected to occur through treatment of a dog or use on ornamental plants in a home garden. The homeowner handler scenarios that involve the use of a low-pressure handwand are of concern. There are concerns for continuous post-application exposure to adults and youth in residential settings over an extended period of time (greater than 30 days); however, there is little information to determine if such extended exposures actually occur. There are also concerns for short-term exposure to adults and youths harvesting and maintaining fruit trees. In addition, there are risk concerns for toddlers exposed to phosmet residues following contact with treated dogs, regardless of the duration of exposure. To mitigate the residential risks of concern, the registrant has agreed to cancel all products that are used in or around the home or on pets. Ecological Risk The Agency has some concerns with the estimated ecological risks. Studies suggest that on certain crops, where there is a high application rate and frequent application of phosmet, expected environmental concentrations can lead to acute risk for mammals; chronic risk for birds and mammals; and acute and chronic risks to invertebrates. In addition, phosmet is highly toxic to honey bees. With the implementation of the mitigation measures detailed in this document, the Agency has determined that, until the outcome of the cumulative assessment of all of the organophosphates has been considered, these uses may continue; the use on dogs and the homeowner use of phosmet on ornamentals and fruit trees and high pressure hose use on cattle will be voluntarily canceled. The Agency is issuing this interim Reregistration Eligibility Document (RED) for phosmet, 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 vi label changes for products containing phosmet. Note that there is a 60-day comment period for this document, and that the time frames for compliance with the label changes outlined in this document are shorter than those given in 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 phosmet have already been subject to numerous public comment periods. 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. In this case, because of demonstrated interest in the risk management decision and content of the benefits assessments, the Agency is allowing a 60-day public comment period. 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 eligibility decision for phosmet can be considered final, however, until the cumulative risk assessment for all organophosphate pesticides is complete. The cumulative assessment may result in further risk mitigation measures for phosmet. vii I. Introduction The Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) was amended in 1988 to accelerate the reregistration of products with active 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. Environmental Protection 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 potential hazards arising from the currently registered uses of the pesticide; to determine the need for additional data on health and environmental effects; 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 amends FIFRA to require tolerance reassessment of all existing tolerances. The Agency had decided that, for those chemicals that have tolerances and are undergoing reregistration, the tolerance reassessment will be initiated through this reregistration process. It also requires that by 2006, EPA must review all tolerances in effect on the day before the date of the enactment of the FQPA. FQPA also amends the FFDCA to require a safety finding in tolerance reassessment based on factors including an assessment of cumulative effects of chemicals with a common mechanism of toxicity. Phosmet 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 reregistration deadlines. Therefore, the Agency is 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 decision on the reregistration eligibility of phosmet. It is intended to be only the first phase in the reregistration process for phosmet. The Agency will eventually proceed with its assessment of the cumulative risk of the OP pesticides and issue a final reregistration eligibility decision for phosmet. 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 between the Agency and the Tolerance Reassessment Advisory Committee (TRAC), which was composed of representatives from industry, environmental groups, 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; 1 • • • • • • • Refining Dietary (Food) Exposure Estimates; 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; and 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 already been published for comment in the Federal Register and others will be published shortly. In addition to the policy issues that resulted from the TRAC process, the Agency issued, on September 29, 2000, a Pesticide Registration Notice (PR 2000-9) that presents EPA’s approach for managing risks from organophosphate pesticides to occupational users. The Worker PR Notice describes the Agency’s approach to managing risks to handlers and workers who may be exposed to organophosphate pesticides, and the Agency expects that other types of chemicals will be handled similarly. Generally, basic protective measures such as closed mixing and loading systems, enclosed cab equipment, or protective clothing, as well as increased reentry intervals will be necessary for most uses where current assessments indicate a risk and such protective measures are feasible. The 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 risks associated with the use of this chemical. The measures included in this interim RED are consistent with the Worker Pesticide Registration Notice. This document consists of six sections. Section I (this section) contains the regulatory framework for reregistration/tolerance reassessment as well as descriptions of the process developed by TRAC for public comment on science policy issues for the organophosphate pesticides and the worker risk management PR notice. Section II, Chemical Overview, provides a profile of the use and usage of the chemical. Section III, Summary of Phosmet Risk Assessment, gives an overview of the revised human health and environmental effects risk assessments resulting from public comments and other information. Section IV, Interim Risk Management and Reregistration Decision, presents the Agency's interim decision on reregistration eligibility and risk management decisions. Section V, What Registrants Need to Do, summarizes the label changes necessary to implement the risk mitigation measures outlined in Section IV, Related Documents and How to Access Them. Section VI provides information on how to access related documents. Finally, the Appendices list the uses that will be eligible for reregistration, pending the cumulative assessment for the organophosphate pesticides, data that support this decision and 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 2 www.epa.gov/pesticides/op, and in the Public Docket located in Room 119, Crystal Mall #2, 1921 Jefferson Davis Hwy., Arlington, VA. II. Chemical Overview A. Regulatory History Phosmet was first registered in the United States in 1966 as a broad-spectrum insecticide for control of a wide variety of pests including the alfalfa weevil, boll weevil, codling moth, grape berrymoth, leafrollers, plum curculio, and oriental fruit moth. In addition, phosmet is registered for direct animal treatments to control fleas, lice, hornflies, sarcoptic mange, and ticks on cattle, swine and dogs. There are other uses such as in forestry and for ornamental plants, including residential sites that can be treated by professional applicators. Phosmet can also be used by homeowners to treat trees, shrubs, ornamental plants, home gardens and dogs. Although there are existing tolerances for residues in sweet corn and citrus, the registrant had indicated these uses would not be supported. Therefore, they were excluded from the risk assessment. It should be noted that the Partial Interim RED proposed that citrus tolerances would also be revoked. The Agency received a request from the State of Florida for a Special Local Need registration for citrus under FIFRA Section 24(c). The Agency is in the process of assessing the risks and benefits associated with this use. A final determination on the citrus use will be made in the final IRED, after the 60-day comment period for this document has ended. B. Chemical Identification N-(mercaptomethyl) phthalimide-S-(O,O-dimethyl phosphorodithioate): O S P S OCH3 OCH3 O O S P OCH3 OCH3 N N O O Phosmet Phosmet oxon ! ! ! Common Name: Chemical Name: Phosmet N-(mercaptomethyl) phthalimide-S(O,O-dimethyl phosphorodithioate): Organophosphate 3 Chemical family: ! ! ! ! ! ! ! Case number: CAS registry number: OPP chemical code: Empirical formula: Molecular weight: Trade and other names: Basic manufacturer: 0242 732-11-6 059201 C11H12NO4PS2 317.32 Imidan Gowan Company and Schering-Plough Animal Health Inc. Technical phosmet is a pink to white crystalline solid with a melting point of 66-69 C. Phosmet is slightly soluble in water (20 mg/L at 20-25 C), more soluble in ethanol and kerosene (<1.0 g/100 mL), and readily soluble in acetone, chloroform, and xylene (>100 g/100 mL). Phosmet has a relatively low vapor pressure of 3.72 x 10-7 mm Hg at 25 C. C. Use Profile The following information is based on the currently registered uses of phosmet. Type of Pesticide: Insecticide. Summary of Use Sites: Food: Fruit trees (apple, pear, peach, nectarine, plum, apricot, tart cherry) and nut trees (almond, beechnut, brazil nut, butternut, cashew, chestnut, filbert, macadamia, pecan, pistachio, walnut), grapes, kiwi, blueberries, cranberries, cotton, peas (succulent and dried), potato, sweet potato (foliar and post-harvest), cattle, and swine. Residential: Trees, shrubs, ornamentals, pets (dogs only), home gardens and fire ant mounds. Public Health: Fire Ants. Other Nonfood: Forestry and ornamental plants. Direct animal treatments to dogs. Target Pests: Moths, various beetles, various weevils, leafrollers, plum curculio, lice, flies, ticks and sarcoptic mange. 4 Formulation Types Registered: Dust, emulsifiable concentrate, soluble concentrate, and wettable powder. Method and Rates of Application: Equipment - In agriculture, groundboom, airblast and aerial applications. Other applications, commercial dusting equipment, handheld equipment such as low pressure handwand sprayers and backpack sprayers. Postharvest application to sweet potatoes can be made by hand held dusting equipment. Direct dermal application to livestock is permitted via sprays and a backrubber. Dogs can be treated with a dip or a dust. Method and Rate - In agriculture, use rates range from 0.7 to 6 lb a.i./A, depending on the crop. Multiple foliar applications can be made to some crops in a growing season. Applications can generally be made up to 7 to 14 days prior to harvest. Post-harvest application of a dust formulation to sweet potatoes is permitted, using 0.0125 lb a.i./50 lb bushel. Direct dermal applications to livestock range from 0.4 - 2.0 lb a.i./100 gallons spray. Backrubber application to cattle rate range is 1 lb a.i./50 gallons fuel oil. The use rate for dusting dogs is 0.5 g dust/kg animal weight. The use rate for dipping dogs is 0.0076 lb a.i./gallon dip solution. Timing - Delayed dormant, foliar applications for agricultural crops and post-harvest use on sweet potatoes. Use Classification: D. General classification. Estimated Usage of Pesticide This section summarizes the best estimates available for many of the pesticide uses of phosmet, based on available pesticide usage information for 1990 to 1999. A full listing of all uses of phosmet, with the corresponding use and usage data for each site, has been completed and is in the “Quantitative Use Assessment” document, which is available in the public docket. The data, reported on an aggregate and site (crop) basis, reflect annual fluctuations in use patterns as well as the variability in using data from various information sources. Approximately 1,250,000 pounds active ingredient (a.i.) of phosmet are used annually, according to Agency and registrant estimates. 5 Table 1. Phosmet Estimated Usage for Representative Sites Crop Lbs. Active Ingredient Applied (Wt. Avg.)1 35,000 75,000 440,000 13,000 19,000 10,000 19,000 35,000 2,000 21,000 54 13,000 5,000 110,000 54,000 7,000 12,000 30,000 15,000 28,000 14,000 87,000 Percent Crop Treated (Likely Maximum) 0.5 16 38 42 0.22 30 - Percent Crop Treated (Wt. Avg.) 0.2 5.3 25 19 0.11 20 - Alfalfa Almonds Apples Apricots Beef Cattle Blueberries Canine (Dog) Cattle & Swine Cherries Cotton Dairy Herd Grapes Kiwifruit Nectarines Other Crops Peaches Pears Peas, Green Peas, Dry Pecans Plums & Prunes Potatoes Sweet Potatoes Walnuts 1 26 0.18 0.56 5 4 27 23 33 6 27 10 7 4 7 25 15 0.04 0.28 2 1 14 13 20 3 13 3 4 1 4 9 Woodland 0 0.02 0.01 Weighted Average is based on data for 1988 to 1997; the most recent years and more reliable data are weighted more heavily. 6 III. Summary of Phosmet Risk Assessment Following is a summary of EPA’s revised human health and ecological risk findings and conclusions for the organophosphate pesticide phosmet, as fully presented in the documents, “Phosmet (Chemical ID No. 059201/List A Reregistration Case No. 0242). HED Revised Human Health Risk Assessment for the Reregistration Eligibility Decision Document (RED). DP Barcode No. D262365,” dated February 9, 2000; “Phosmet: Revised Occupational PostApplication Exposure and Risk Calculations [DP Barcode D268141, Chemical Code 059201, Case 818976]”, dated August 15, 2000; and “Environmental Fate and Effects Division RED Chapter for Phosmet,” dated April 24, 1998. The purpose of this summary is to assist the reader by identifying the key features and findings of these risk assessments, and to better understand the conclusions reached in the assessments. These risk assessments for phosmet were presented at a February 10, 2000 Technical Briefing, which was followed by an opportunity for public comment on risk management for this pesticide. The risk assessments summarized here form the basis of the Agency’s risk management decision for phosmet only; the Agency must consider the cumulative assessment of the risks of all the organophosphate pesticides before any final decisions can be made. A. Human Health Risk Assessment EPA issued its preliminary risk assessments for phosmet on January 15, 1999, (Phase 3 of the TRAC process). In response to comments and studies submitted during Phase 3, the risk assessments were updated and refined. Major revisions to the human health risk assessment are based on the following data: USDA Pesticide Data Program; FDA Surveillance Monitoring Program Data; 21-day dermal toxicity study; the sub-chronic neurotoxicity study, a recalculation of restricted entry intervals based on new data from the Agricultural Reentry Task Force (ARTF) and inclusion of a worker risk assessment for the liquid formulations. The Agency has reviewed all toxicity studies submitted and has determined that the toxicity database is complete, and that it supports an interim reregistration eligibility determination for all currently registered uses. Further details on the toxicity of phosmet can be found in the February 9, 2000, Human Health Risk Assessment. Cancer Risk Based on all available data for phosmet, the HED Cancer Assessment Review Committee (CARC) concluded that phosmet should be classified as having “suggestive evidence of carcinogenicity, but not sufficient to assess human carcinogenic potential”. In a mouse carcinogenicity study, phosmet caused increases in liver carcinomas/adenomas in males and increased mammary gland tumors in females. Phosmet was not carcinogenic in rats. The CARC conducted a weight-of-evidence evaluation of the mutagenicity and carcinogenicity data for phosmet (in accordance with the 1997 draft Cancer Guidelines) on September 1, 1999. 7 Additional data regarding tumor counts in the mouse carcinogenicity study were discussed along with additional mutagenicity data submitted by the registrant. The CARC recommended against completing a quantitative cancer risk assessment for phosmet. This recommendation is consistent with the previous recommendation to use the reference dose (RfD) approach, in which chronic risks assessed using the RfD are considered to be protective of any carcinogenic effect, in addition to systemic or other chronic effects. Human Data The Agency is currently evaluating an acute (ascending single oral dose) study with phosmet in humans that was conducted by Inveresk Research in Scotland in 1999. The following observations can be made on the potential impact of these data on the phosmet risk assessment. Because the study is a single oral dose, it could be used in a weight-of evidence approach to inform the selection of the inter-species uncertainty factor for acute risk assessments. That is, assuming it was conducted according to appropriate scientific and ethical standards, the acute human study could be compared to existing acute animal data to determine if the full ten-fold inter-species uncertainty factor is needed to account for variation between species in the acute dietary assessment for phosmet and could provide a basis for reduction of the uncertainty factor for acute dietary risk. However, because of its limited duration, the human study would not likely be appropriate for use in short-term or intermediate-term assessments, such as those used to estimate worker risk from phosmet use, nor would it be appropriate for the chronic dietary assessment. 1. Dietary Risk from Food a. Toxicity A brief overview of the studies used for the dietary risk assessment is outlined in Table 2 below. b. FQPA Safety Factor The FQPA Safety Factor was reduced to 1 X. The toxicity database includes an acceptable two-generation reproduction study in rats and acceptable prenatal developmental toxicity studies 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 level drinking water exposure assessment. The assumptions and models used in the assessments do not underestimate the potential risk for infants and children. Therefore, the 10X factor as required by FQPA was reduced to 1, for both acute and chronic risk 8 assessments for all subpopulations. A developmental neurotoxicity study (DNT) study has been required and is considered confirmatory. c. Population Adjusted Dose (PAD) The PAD is a term that expresses the dietary risk of a chemical, and reflects the Reference Dose, either acute or chronic, that has been adjusted to account for the FQPA safety factor (i.e., RfD/FQPA safety factor). In the case of phosmet, the FQPA safety factor is 1; therefore, the acute or chronic RfD is equal to the acute or chronic PAD. A risk estimate that is less than 100% of the acute or chronic PAD does not exceed the Agency’s risk concern. Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary Risk Assessment of phosmet Assessment Dose Endpoint Study UF FQPA Safety Factor 1 PAD Acute Dietary LOAEL of 22.5 mg/kg/day NOAEL of 4.5 mg/kg/day Red blood cell, plasma and brain cholinesterease inhibition and decreased motor activity Red blood cell, and serum cholinesterease inhibition Oral Acute Neurotoxicity Study on Rats 100 0.045 mg/kg/day Chronic Dietary LOAEL of 1.8 mg/kg/day NOAEL of 1.1 mg/kg/day Oral Chronic Toxicity/ Carcinogenicity Study on Rats 100 1 0.011 mg/kg/day d. Exposure Assumptions Revised acute and chronic dietary risk analyses for phosmet were calculated using the Dietary Exposure Evaluation Model (DEEM™). The regulated residues consist of parent phosmet and its metabolite, phosmet oxygen analog (oxon). For the revised phosmet risk assessment, the Agency conducted highly refined (Tier 3) acute (probabilistic) and chronic dietary exposure analyses which were based almost entirely on the available monitoring data, and incorporated additional refinements such as processing and cooking factors and percent of crop treated. Typically, the Agency cannot use monitoring data which do not include all residues of toxicological concern. Although both the PDP and FDA monitoring programs reported data for parent phosmet only, these data have been used in the revised risk assessment for the following reasons: (i) field trial data indicate that oxon residues, when detected, are generally an order of magnitude lower than parent residues; (ii) residues in both PDP and FDA monitoring samples were significantly less than tolerance-level residues; and (iii) phosmet oxon is relatively unstable in numerous commodities. Using the monitoring data in acute and chronic dietary exposure analyses is not expected to underestimate risk. 9 The acute dietary risk analyses for phosmet were calculated using a probabilistic analysis (Monte Carlo), incorporating percent crop treated data, USDA’s Pesticide Data Program data (PDP monitoring data), the Food and Drug Administration’s monitoring data, residue field trial data, cooking study data, and processing factors, where available, and consumption information from USDA's Continuing Surveys of Food Intakes by Individuals (CSFII) from 1989 to 1991. Chronic dietary risk was calculated by using the average consumption and residue values for foods. e. Food Risk Characterization Generally, a dietary risk estimate that is less than 100% of the acute or chronic Population Adjusted Dose does not exceed the Agency’s risk concerns. The phosmet acute dietary risk from food is well below the Agency’s level of concern; that is, less than 100% of the acute PAD is utilized. For example, for the most exposed population subgroups, children (1-6 years) and infants (<1 year), the % acute PAD values are 7.5% and 6.5%, respectively, at the 99.9th percentile of exposure. The chronic dietary risk from food alone is well below the Agency’s level of concern. For the most exposed population subgroup, children (1 - 6 years), the % chronic PAD value is 0.7%. The Agency has refined the dietary analyses to the extent currently possible. 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. In the case of phosmet, only limited monitoring data for either ground or surface water were available; therefore, modeling was used to estimate drinking water risks from these sources. The PRZM-EXAMS model was used to estimate surface water concentrations, and SCI-GROW was used to estimate groundwater concentrations. Both models are considered to be screening models, with the PRZM-EXAMS model being somewhat more refined than SCI-GROW. Phosmet oxon is the only degradate of toxicological concern and was identified in a number of environmental fate studies conducted. Phosmet oxon appears to be less mobile than phosmet, as evidenced by its absence in leachates in the aged and unaged mobility study. In addition phosmet oxon was limited to the upper soil layer in the field studies while phosmet was detected as low as the 10.5-inch soil layer. Phosmet was found to be moderately mobile to mobile in four different soil classes. 10 The estimated concentrations for drinking water are for phosmet only. Phosmet oxon, which has been included in the tolerance expression, is not included in the modeling due to the absence of fate information. Considering the limited presence of phosmet oxon in the laboratory and field studies (soil extract of the mobility study and upper 0 - 3-inch soil layer in the field dissipation studies), phosmet oxon should not add appreciably to the concentration of parent compound in ground or surface water in most use areas. a. Surface Water A Tier II PRZM-EXAMS screening model was used to estimate the upper-bound concentrations of phosmet in drinking water derived from surface water. This model, in general, is based on more refined, less conservative assumptions than the Tier I GENEEC screening model. Phosmet can contaminate surface water via runoff if runoff-producing rain events occur within the first few days to weeks post application. Phosmet’s water solubility (25 mg/l) and its partition coefficient (Kads= 1.17 - 15.8) suggest that it will enter surface water via runoff. It appears that the persistence of phosmet in surface water may be limited by its susceptibility to biodegradation especially in water with moderate to high microbial activity and by abiotic hydrolysis under neutral to alkaline conditions. In flowing water, its persistence is limited by the flow rate of the system more than by either metabolism or hydrolysis. However, its persistence in lakes and reservoirs will be greater and controlled more by metabolism and hydrolysis. Limited monitoring data indicate that phosmet has been detected in surface water in known use areas. However, these data suggest that phosmet concentrations do not exceed the very low ppb range, well below the DWLOC. The three crops with the highest phosmet surface water concentrations are pears, kiwi and cotton applied at 5, 2 and 1 lb a.i./A, respectively. The EECs range from 0.4 ppb for application to apples at the western-low rate (1.5 lb a.i./A ) to 140 ppb for application to pears (5 lb a.i./A). b. Ground Water A Tier I screening model, SCI-GROW, was used to estimate the upper-bound drinking water concentrations of phosmet in ground water. The SCI-GROW model is based on the fate properties of the pesticide, the annual application rate, and the existing body of data from smallscale ground water monitoring studies. The model assumes that the pesticide is applied at its maximum rate in areas where ground water is particularly vulnerable to contamination. In most cases, a considerable portion of any use area will have ground water that is less vulnerable to contamination than the areas used to derive the SCI-GROW estimates. The estimated maximum concentration derived using these modeled estimates should be considered a high-end to bounding estimate of acute and chronic exposure. The maximum concentration (acute and chronic) for parent phosmet estimated using 11 SCI-GROW is approximately 0.4 ppb. No phosmet residues were reported in ground water monitoring data at concentrations above the detection limits of 0.1 and 10 ppb. Phosmet is not expected to pose a threat to ground water resources. c. Drinking Water Levels of Comparison (DWLOCs) To determine the maximum allowable contribution of 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 monitored levels exceed this level. The Agency uses the DWLOC as a surrogate to capture risk associated with exposure from pesticides in drinking water where sufficient water monitoring data are not available. The DWLOC is the maximum concentration in drinking water which, when considered together with dietary exposure, does not exceed a level of concern. The results of the Agency’s drinking water analysis are summarized here. Details of this analysis, which used screening models, are found in the Environmental Fate and Effects Assessment, dated April 24, 1998, and the Human Health Risk Assessment, dated February 9, 2000. For acute risk, the potential drinking water exposure derived from either ground or surface water is not of concern for all populations. The table below presents the calculations for the acute drinking water assessment. Table 3. Summary of DWLOC Calculations for Phosmet Acute Risk Population Subgroup U.S. Population Females 20+ Children 1-6 Ground Water EECs (ppb) (SCI-GROW) 0.4 0.4 0.4 Surface Water EECs (ppb) (PRZM-EXAMS) 3 - 140 3 - 140 3 - 140 DWLOC (ppb) 1523 1308 416 For chronic risk, potential exposure to drinking water derived from either groundwater or surface water is not of concern for all populations. The table below presents the calculations for the chronic drinking water assessments. 12 Table 4. Summary of DWLOC Calculations for Phosmet Chronic Risk Population Subgroup U.S. Population Children 1 - 6 Females 13 - 19 Ground Water EECs (ppb) (SCI-GROW) 0.4 0.4 0.4 Surface Water EECs (ppb) (PRZM-EXAMS) 1 1 1 DWLOC (ppb) 384 110 330 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. Residents or homeowners can be exposed to a pesticide through mixing, loading, or applying a pesticide, or through entering or performing other activities in treated areas. Occupational handlers of phosmet include: individual farmers or growers who mix, load, or apply pesticides, and professional or custom agricultural applicators. Residential handlers include homeowner applicators treating their own home garden or their dogs. Risk for all of these potentially exposed populations is measured by a Margin of Exposure (MOE) which determines how close the occupational or residential exposure comes to a No Observed Adverse Effect Level (NOAEL). Generally, MOEs greater than 100 do not exceed the Agency’s risk concern. a. Toxicity The toxicity of phosmet is integral to assessing the occupational and residential risk. All risk calculations are based on the most current toxicity information available for phosmet, including a 21-day dermal toxicity study in rats. An acceptable dermal absorption study conducted in rats indicates a dermal absorption factor of 10 percent is appropriate for the phosmet risk assessment. The toxicological endpoints, and other factors used in the occupational and residential risk assessments for phosmet are listed in Table 5a. In the preliminary risk assessment for phosmet, the Agency selected a LOAEL of 1.5 mg/kg/day established in the subchronic oral neurotoxicity study in rats for the intermediate-term dermal and inhalation exposures of >30 days in duration. In this study, a NOAEL was not established at the termination of the study. Therefore, the Agency used the LOAEL in the risk assessment and added an uncertainty factor of 3. The use of this uncertainty factor established the target MOE of 300 for these assessments and lead to a value (0.5 mg/kg/day) lower than the one used for the chronic dietary RfD (1.1 mg/kg/day). Based on a consideration of the entire toxicity database, EPA determined that the 0.5 mg/kg/day value was not a representative subchronic endpoint. For this reason, the Agency selected the chronic rat study with a NOAEL of 1.1 mg/kg/day for the intermediate term >30 days exposure in the risk assessment. This is appropriate because the same endpoint (cholinesterase inhibition) was observed in both studies in the same species (rat) and the LOAEL of 1.5 mg/kg/day in the subchronic study is comparable to the LOAEL of 1.8 mg./kg/day in the chronic study. 13 Table 5a. Summary of Toxicological Endpoints and Other Factors Used in the Human Occupational and Residential Risk Assessments for Phosmet Assessment Dose Endpoint Study Absorption Factor Short-term NOAEL = 15 dermal mg/kg/day (Up to 7 days) Intermediateterm dermal (>7 and #30 days) Intermediateterm dermal (>30 days) NOAEL = 15 mg/kg/day Cholinesterase Inhibition [brain (females), plasma (males)] at the LOAEL of 22.5 mg/kg/day Cholinesterase Inhibition [brain (females), plasma (males)] at the LOAEL of 22.5 mg/kg/day 21-Day Dermal Toxicity in Rats 21-Day Dermal Toxicity in Rats Not Relevant Not Relevant NOAEL = 1.1 mg/kg/day Cholinesterase Inhibition Oral Chronic (RBC and Serum) at the LOAEL of Toxicity/ 1.8 mg/kg/day Carcinogenicity in Rats Cholinesterase Inhibition (Plasma, RBC, Brain) and Decreased Motor Activity at the LOAEL of 22.5 mg/kg/day Cholinesterase Inhibition [brain (females), plasma (males)] at the LOAEL of 2.7 mg/kg/day Oral Acute Neurotoxicity in Rats 10% Short-term NOAEL= 4.5 inhalation mg/kg/day (Up to 7 days) Intermediate - NOAEL= 1.5 term inhalation mg/kg/day (>7 and # 30 days) (At 3 week interval) Intermediate - NOAEL= 1.1 term inhalation mg/kg/day (>30 days) Non-dietary ingestion Acute (children) NOAEL = 4.5 mg/kg/day 100 % Oral Subchronic 100 % Neurotoxicity in Rats Cholinesterase Inhibition (RBC and Serum) at the LOAEL of 1.8 mg/kg/day Cholinesterase Inhibition (Plasma, RBC, Brain) and Decreased Motor Activity at the LOAEL of 22.5 mg/kg/day Cholinesterase Inhibition (RBC and Serum) at the LOAEL of 1.8 mg/kg/day Oral Chronic Toxicity/ Carcinogenicity in Rats Oral Acute Neurotoxicity in Rats Oral Chronic Toxicity/ Carcinogenicity in Rats 100 % Not Relevant Non-dietary NOAEL = 1.1 ingestion mg/kg/day Intermediateterm (children) Not Relevant In acute toxicity studies, phosmet exhibits severe toxicity via the oral and inhalation routes of exposure. Phosmet is not acutely toxic in rats via the dermal route, is non-irritating to the skin, and is not an eye irritant in the rabbit. 14 Table 5b. Acute Toxicity Profile for Phosmet Guideline No. Study Type MRIDs # 00046189 LD50 = 113 mg/kg 00046190 LD50 >5000 mg/kg 00063197 LC50 >0.152 mg/L 00046192 moderate eye irritant 00046191 not a skin irritant no study Results Toxicity Category II III II III IV N/A N/A 870.1100/§81-1 Acute Oral - rat 870.1200/§81-2 Acute Dermal - rabbit 870.1300/§81-3 Acute Inhalation - rat 870.2400/§81-4 Primary Eye Irritation 870.2500/§81-5 Primary Skin Irritation 870.2600/§81-6 Dermal Sensitization 870.6100/§81-7 Delayed Neurotoxicity 44587601 unsteadiness, subdued behavior, recumbency, salivation; no ataxia; no decreases in brain or spinal cord NTE; brain ChE decreased 63%; no neuropathology. [All hens were dosed at 600 mg/kg by oral gavage] 870.6200/§81-8 Acute Neurotoxicity 44673301 NOAEL 4.5 mg/kg LOAEL 22.5 mg/kg, based on cholinesterase inhibition [plasma, RBC, brain] and decreased motor activity in both sexes. N/A b. Exposure Chemical-specific exposure data for pesticide handling activities were not submitted to the Agency for phosmet. Therefore, daily dermal and inhalation handler doses were calculated using the Pesticide Handlers Exposure Database (PHED), Version 1.1. The database contains exposure values for over 1,700 monitored exposure events, which have been evaluated by the Agency in order to characterize the quality of the data. The post-application risk assessment for phosmet has been developed using chemicalspecific dislodgeable foliar residue data on pears and grapes. In addition, the Agency used chemical-specific exposure data for homeowner exposures resulting from tending and harvesting treated pear trees. Residential Exposure Phosmet may be used for direct animal treatments on dogs. Dogs may be treated by either a dust or a dip solution. For the dog dust, the application rate is 0.5 grams of formulated dust per kilogram of animal body weight. For the dog dip, the application rate is 0.0076 lb a.i. per gallon of dip solution. For homeowner application, the rates are: 0.0098 lb a.i. per gallon and 10 gallons of water per fruit and nut tree; 0.012lb a.i. per 100 square feet for vegetables; 0.0075 lb a.i. per gallon on ornamental plants; and 0.009 lb a.i. per square foot of fire ant mound. In addition, dogs may be treated by homeowners; for the dust, the application rate is 0.5 grams of formulated 15 dust per kilogram of animal body weight and for the dog dip, the application rate is 0.0076 lb a.i. per gallon of dip solution. Because phosmet is used in a residential setting, post-application exposure could occur. Homeowners, other adults or children could be exposed to phosmet by entering treated areas, harvesting or maintaining fruit or nut trees, or gardens. In addition, toddlers and others could be exposed to phosmet after coming in contact with a treated dog. Agricultural Exposure The quality of the data and exposure factors represent the best sources of data currently available to the Agency for completing these kinds of assessments; the application rates are derived directly from phosmet labels. In addition, typical use rates are also represented in the assessment. The exposure factors (e.g., body weight, amount treated per day, protection factors, etc.) are all standard values that have been used by the Agency over several years, and the PHED unit exposure values are the best available estimates of exposure. Some PHED unit exposure values are high quality while others are considered low quality, but all are the best available data. The quality of the data used for each scenario assessed is discussed in the Revised Human Health Risk Assessment for Phosmet, dated February 9, 2000, which is available in the public docket. Anticipated use patterns and application methods, range of application rates, and daily amount treated were derived from current labeling and information on common practices, as provided by Gowan Company and various growers and research organizations. Application rates specified on phosmet labels range from 0.7 to 6 pounds of active ingredient per acre in agricultural settings. For agricultural applications, 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. Phosmet may be used for direct animal treatments on livestock. The application rates for the farm animal spray range from 0.4 to 2.0 lb a.i. per 100 gallons. For the cattle backrubber, the application rate is 1 lb a.i. per 50 gallons of fuel oil. Occupational handler exposure assessments are conducted by the Agency using different levels of personal protection. The Agency typically 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 minimal to 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)). The levels of protection that formed the basis for calculations of exposure from phosmet activities include: • • Baseline: Label: Long-sleeved shirt and long pants, shoes and socks. Long-sleeved shirt and long pants, waterproof gloves, shoes plus socks, chemical resistent headgear for overhead exposure, and dust/mist filtering respirator (most labels). 16 • • Minimum PPE: • Baseline + chemical resistant gloves and a PF 5 respirator (dust mist). Maximum PPE: Coveralls over long-sleeved shirt and long pants, chemical resistant gloves, chemical-resistent footwear plus socks, chemical resistant headgear for overhead exposures, and a PF 10 respirator (OV) if risk is driven by inhalation. Engineering controls: Engineering controls such as a closed cab tractor for application scenarios, or a closed mixing/loading system such as a closed mechanical transfer system for liquids or a packaged based system (e.g., water soluble packaging for wettable powders). Some engineering controls are not applicable for certain scenarios (e.g., for handheld application methods there are no known devices that can be used to routinely lower the exposures). In addition to the tasks and activities associated with pesticide application and postapplication exposures, the Agency considers the expected duration and route of exposure and the associated potential toxic effects as determined in the required toxicity testing. Based on the phosmet use pattern, short-and intermediate-term exposures are expected to occur. For the phosmet risk assessment, short-term exposures are from one to seven days; intermediate-term exposures were separated into two distinct time-frames of between eight and thirty days and greater than thirty days in duration. The reason for these distinctions is that the results of the toxicity testing indicate that effects associated with exposure to phosmet become more severe over time (greater than 30 days). For the residential handler risk assessment, all application of phosmet by homeowners to fruit and nut trees, ornamental plants, vegetable plants, fire ant mounds and dogs is considered to be short-term, and assumes that no protective clothing is used. The Agency does not require protective clothing for residential handlers because there is no mechanism to ensure that the protective clothing is cleaned and maintained appropriately or that it would routinely be used. Post-application exposure is a term used to describe those individuals who can be exposed to pesticides after entering areas previously treated with pesticides and performing certain tasks or activities. As with handler risk assessment, the Agency believes that there are distinct tasks that occur in areas previously treated with phosmet in addition to non-work related activities, e.g., children playing with a companion animal, that may contribute to exposure. The Agency also believes that the resulting exposures can vary depending upon the specifics of each task or activity and the levels of chemical residue available in the environment. The nature of the treated area such as the type of foliage on the plant or tree and the duration of activity can also cause exposure levels to differ in a manner specific to each setting considered. For occupational uses, the following post-application scenarios are assessed: adults harvesting tree fruits and nuts; adults harvesting and maintaining nuts; 17 c. Occupational & Residential Handler Risk Summary Based on the phosmet use pattern, a total of 23 occupational handler scenarios were identified. No chemical-specific handler exposure data were submitted for phosmet, and therefore daily dermal and inhalation handler doses were calculated using data from the Pesticide Handlers Exposure Database (PHED), Version 1.1. The database contains exposure values for over 1,700 monitored exposure events, which have been evaluated by the Agency in order to characterize the quality of the data. Assumptions regarding the application rate and acres treated (including an assumption of an 8-hour workday for occupational scenarios) were used in conjunction with the PHED unit exposure values to determine phosmet handler exposures. For agricultural handler scenarios, the number of acres treated per day assumed in the phosmet risk assessment are those typically used in risk assessments. For pet handler exposures (vets and professional groomers), the Agency assumed that a maximum of 8 dogs/day are dipped/dusted; risks were calculated for a range of dog body weights (5-120 lbs). In addition, it was assumed that 10% of the active ingredient applied during dipping/dusting represented the total dose; this is a standard assumption taken from the 1997 Draft Standard Operating Procedures (SOPs) for Residential Exposure Assessment. The average body weight of an adult handler was assumed to be 70 kg, which is standard for these risk assessments. The hose-end sprayer data were used to assess exposures associated with the fire ant mound treatment scenario. Since there were no data to assess potential handler exposure associated with “charging” the cattle backrubber, data for open mixing of liquids were used; however, the Agency believes this approach may underestimate exposure, based on information submitted about the operation of the cattle backrubber by the registrant, Schering-Plough Animal Health Inc. about the operation of the cattle backrubber. (1) Occupational Handler Risk The occupational handler scenarios are listed below: Mixing/Loader (1a) mixing/loading liquid formulations for high pressure handwand applications; (1b) mixing/loading liquid formulations for airblast sprayer application; (1c) mixing/loading liquid formulations for groundboom sprayer; (1d) mixing/loading liquid formulations for aerial application; (2) mixing/loading wettable powders for treating pine seedlings (2a) mixing/loading wettable powders for aerial application and chemigation; (2b) mixing/loading wettable powders for groundboom application (2c) mixing/loading wettable powders for airblast sprayer application; (2d) mixing/loading wettable powders for high pressure handwand applications; Applicator (3) applying sprays with an airblast sprayer (4) applying sprays with a groundboom sprayer; 18 (5) (6) (7) (8) aerial application of sprays with a fixed wing aircraft (fixed wing aircraft also accounts for helicopter pilot exposure); applying using a high-pressure handwand; applying using a right-of-way sprayer; dipping pine seedlings; Mixer/Loader/Applicator (9) mixing/loading/applying with dusting equipment; (10) dusting a dog; (11) dipping a dog; (12) use of a cattle backrubber; (13a) mixing/loading/applying liquids with a backpack sprayer; (13b) mixing/loading/applying wettable powders with a backpack sprayer; (14a) mixing/loading/applying liquids with a low pressure handwand; (14b) mixing/loading/applying wettable powders with a low pressure handwand; (15) mixing/loading/applying soluble concentrates for sprinkling; and Flagger (16) flagging for aerial spray application. The Agency completes occupational handler assessments using different levels of personal protection. Minimal protection is assumed at first, and a tiered approach to adding protective measures is used until an appropriate MOE is obtained, or until all options are exhausted. The lowest tier is defined as the baseline exposure scenario; higher tiers include measures such as personal protective equipment (PPE, e.g., gloves, extra clothing, and respirators) and engineering controls (e.g., closed cabs and closed loading systems). The most practical option for risk reduction is generally considered to be the minimal level of protection adequate to address the risks identified in the risk assessment. MOE calculations are shown in the table below. The footnotes describe the level of PPE used in the assessment. The last column of the table indicates the level of PPE or engineering controls required on labels. 19 Table 6. Occupational Uses: Risk Concerns (combined dermal & inhalation MOEs) Crop Type or Target Acres Treated or Gallons per Application Application Rate (lbs a.i./A) Combined MOEs (dermal and inhalation) Short Term < 7 days Intermediate Term < 30 days 75001 15001 1201 1201 7981 + gloves 3991 + gloves 3681 + gloves 4811 + gloves 1921 + gloves Intermediate Term > 30 days 55001 11001 73331 + gloves 73331 + gloves 5851 + gloves 2931 + gloves 2701 + gloves 3531 + gloves 1411 + gloves Necessary level of PPE or Engineering Controls Exposure Scenario Occupational Mixer/Loader Estimates for MOE 100 or Highest Achievable MOE livestock (1a) mixing/loading liquid formulations for high pressure handwand applications livestock ornamentals (1b) (1c) mixing/loading liquid formulations for airblast sprayer application mixing/loading liquid formulations for groundboom application ornamentals blueberries blueberries 1000 gal 1000 gal 400gal 50 80 80 0.004 0.02 0.008 0.06 0.47 0.94 1.02 0.78 0.78 97221 19941 1211 1211 10341 + gloves 5171 + gloves 4771 + gloves 6231 + gloves 2491 + gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves potatoes, alfalfa, 80 cotton alfalfa (1c) mixing/loading liquid formulations for groundboom application alfalfa 80 200 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 20 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 200 80 200 Application Rate (lbs a.i./A) 1.02 0.23 0.23 Combined MOEs (dermal and inhalation) Short Term < 7 days 1911 + gloves 21141 + gloves 8451 + gloves 2361 + gloves 1181 + gloves 1091 + gloves 1431 + gloves 1264 974 Intermediate Term < 30 days 1471 + gloves 16301 + gloves 6521 + gloves Intermediate Term > 30 days 1081 + gloves 11961 + gloves 4781 + gloves Necessary level of PPE or Engineering Controls Baseline + Gloves Baseline + Gloves Baseline + Gloves alfalfa, cotton Cotton Cotton (1d) mixing/loading liquid formulations Blueberries for aerial application and chemigation Blueberries 350 350 0.47 0.94 1.02 0.78 0.78 1.02 1821 + gloves 1262 1162 1101 + gloves 1194 914 1341 + gloves 1152 + double layer 1062 + double layer 1112 874 674 Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Potatoes, 350 Cotton, Alfalfa Alfalfa Alfalfa (1d) mixing/loading liquid formulations Alfalfa, Cotton for aerial application and chemigation 350 1200 1200 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 21 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 350 1200 100 Application Rate (lbs a.i./A) 0.23 0.23 0.35 5.95 5 4 3 1.5 Combined MOEs (dermal and inhalation) Short Term < 7 days 4831 + gloves 1411 + gloves 1512 234 284 344 464 924 Intermediate Term < 30 days 3731 + gloves 1091 + gloves 1172 224 264 324 434 864 Intermediate Term > 30 days 2731 + gloves 1102 1032 + respirator 164 194 244 314 634 Necessary level of PPE or Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls cotton cotton (2) (2a) mixing/loading wettable powders for pine seedlings high pressure handwand application mixing/loading wettable powders for various nut trees 350 aerial application and chemigation pears apples fruit & nuts grapes, fruit trees & vegetables 350 350 350 350 (2a) mixing/loading wettable powders for grapes, & aerial application and chemigation fruit trees cotton 350 1200 1 0.4 1384 1004 1284 944 944 694 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 22 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 1200 Application Rate (lbs a.i./A) 1 2 1.5 1 0.4 5.95 5 4 3 1.5 Combined MOEs (dermal and inhalation) Short Term < 7 days 404 1681 + gloves 4014 6024 6024 2024 2414 3014 4014 Intermediate Term < 30 days 374 2052 3744 5614 5614 1894 2244 2804 3744 Intermediate Term > 30 days 274 1502 2744 4114 4114 1384 1654 2064 2744 5484 Necessary level of PPE or Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls forestry (2b) mixing/loading wettable powders for noncrop/ 10 groundboom application field perimeters grapes, vegetables grapes, vegetables cotton 80 80 200 (2c) mixing/loading wettable powders for various nut trees 40 airblast sprayer application pears apples 40 40 (2c) mixing/loading wettable powders for fruit & nut trees 40 airblast sprayer application grapes, fruit trees & vegetables 40 1102 + 1013 double layer 1322 1032 grapes, tree fruit 40 1 1113 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 23 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 50 400 Application Rate (lbs a.i./A) 0.06 0.008 Combined MOEs (dermal and inhalation) Short Term < 7 days 11171 + gloves 11171 + gloves 2154 2564 3204 4274 8544 Intermediate Term < 30 days 5831 + gloves 5831 + gloves 1884 2234 2794 3724 7454 Intermediate Term > 30 days 4281 + gloves 4281 + gloves 1384 1644 2054 2734 5464 Necessary level of PPE or Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls ornamentals (2d) mixing/loading wettable powders for ornamentals high pressure handwand applications applying sprays with an airblast sprayer Occupational Applicator Estimates (3) various nut trees 40 pears apples fruit & nuts trees (3) applying sprays with an airblast sprayer grapes, fruit trees & vegetables grapes & tree fruit ornamentals 40 40 40 40 5.95 5 4 3 1.5 40 50 1 0.06 1031 + gloves 9331 1052 8641 8194 6341 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 24 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application Application Rate (lbs a.i./A) 2 Combined MOEs (dermal and inhalation) Short Term < 7 days 31881 Intermediate Term < 30 days 24531 4091 Intermediate Term > 30 days 17991 3001 Necessary level of PPE or Engineering Controls Baseline (4) applying sprays with a groundboom sprayer noncrop/ 10 field perimeters grapes, fruit trees & vegetables grapes & vegetables cotton blueberries blueberries 80 1.5 5311 Baseline 80 200 80 80 1 0.4 0.47 0.94 1.02 0.78 0.78 1.02 0.23 0.23 7971 7971 1696 848 781 1 1 1 6131 6131 1305 653 601 1 1 1 4501 4501 957 479 441 1 1 1 Baseline Baseline Baseline Baseline Baseline Baseline Baseline Baseline 1 potatoes, alfalfa, 80 cotton alfalfa alfalfa (4) applying sprays with a groundboom sprayer alfalfa, cotton cotton cotton 80 200 200 80 200 10221 409 313 1 1 1 1 7861 315 241 1 1 1 1 5771 230.6 176 782 1 3466 1386 2667 1067 1956 1 Baseline Baseline 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 25 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application Application Rate (lbs a.i./A) 5.95 5 3 1.5 Combined MOEs (dermal and inhalation) Short Term < 7 days 974 1154 1914 3834 Intermediate Term < 30 days 894 1064 1764 3524 Intermediate Term > 30 days 654 784 1294 2584 Necessary level of PPE or Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls (5) aerial application of sprays with a fixed wing aircraft (fixed wing aircraft also accounts for helicopter pilot exposure) various nut trees 350 pears fruit & nut trees grapes, fruit trees & vegetables grapes & fruit trees cotton forestry blueberries 350 350 350 350 1200 1200 350 350 1 0.4 1 0.47 0.94 1.02 0.78 5744 4184 1674 12214 6114 5634 7364 5284 3854 1544 11244 5624 5184 6774 3874 2824 1134 8244 4124 3804 4974 (5) aerial application of sprays with a fixed wing aircraft (fixed wing aircraft also accounts for helicopter pilot exposure) blueberries potatoes, alfalfa, 350 cotton alfalfa 350 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 26 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 1200 1200 350 1200 1200 1000 1000 400 400 100 Application Rate (lbs a.i./A) 0.78 1.02 0.23 0.23 1.02 0.004 0.02 0.008 0.008 0.35 Combined MOEs (dermal and inhalation) Short Term < 7 days 2154 1644 24964 7284 1644 1271 2 Intermediate Term < 30 days 1984 1514 22964 6704 1514 1011 2 Intermediate Term > 30 days 1454 1114 16844 4914 1114 1351 + gloves 88 3 Necessary level of PPE or Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Use Canceled Use Canceled Baseline + Gloves Baseline Maximum alfalfa alfalfa cotton cotton cotton (6) applying using a high-pressure handwand livestock livestock ornamentals (7) (8) applying using a right-of-way sprayer ornamentals dipping pine seedlings pine seedlings 127 + 101 + double double layer layer 1701 2671 no data 1351 2611 no data 1881 + gloves 1921 no data Occupational Mixer/Loader/Applicator Estimates (9) (10) mixing/loading/applying with a dusting equipment dusting on animal sweet potatoes dog no data 8 animals 0.013lb/a.i./ bushel 0.003 no data 468,7501 no data 468,7501 no data 343,7501 Maximum Use Canceled 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 27 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 8 animals 8 animals 50 animals 100 animals 100 animals 40 40 100 100 40 Application Rate (lbs a.i./A) 0.066 0.0076 0.02 0.004 0.02 0.008 0.008 0.004 0.02 0.008 Combined MOEs (dermal and inhalation) Short Term < 7 days 19,8861 172,697 362 1 1 1 Intermediate Term < 30 days 19,8861 172,697 361 1 1 1 1 1 1 Intermediate Term > 30 days 14,5831 126,645 264 1 1 1 1 1 1 Necessary level of PPE or Engineering Controls Use Canceled Use Canceled Baseline Baseline Baseline Baseline Baseline Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline + Gloves Baseline dog (11) (12) (13a) dipping a dog use of a cattle backrubber dog cattle mixing/loading/applying liquids with livestock a backpack sprayer livestock ornamentals mixing/loading/applying wettable powders with a backpack sprayer ornamentals 26,250 5250 1 8750 1750 6417 1283 8556 8556 35,000 35,000 49531 9911 66041 1 1 11,667 11,667 35961 7191 47951 (13b) (14a) mixing/loading/applying liquids with livestock a low pressure handwand livestock ornamentals 26371 5271 35161 (14b) mixing/loading/applying wettable powders with a low pressure handwand mixing/loading/applying soluble concentrates for sprinkling flagging for aerial spray application. ornamentals fire ants 40 24 0.008 0.009 2851 1581 1791 1581 1311 1151 (15) Occupational Flagger Estimates (16) various nut trees 350 5.95 20724 17394 12754 Engineering Controls 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 28 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 350 Application Rate (lbs a.i./A) 5 3 1.5 Combined MOEs (dermal and inhalation) Short Term < 7 days 24664 41104 1641 Intermediate Term < 30 days 20694 34484 1381 Intermediate Term > 30 days 15174 25294 1011 Necessary level of PPE or Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls pears fruit & nut trees 350 grapes, fruit trees & vegetables grapes & fruit trees cotton forestry blueberries (16) flagging for aerial spray application. blueberries potatoes alfalfa alfalfa 350 350 1200 1200 350 350 350 350 1200 1 0.4 1 0.47 0.94 1.02 0.78 0.78 2471 1801 35964 5251 2621 2421 3161 46104 2071 1511 30174 4401 2201 2031 2651 38684 1521 1111 22134 3231 1611 1491 1951 28374 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 29 Exposure Scenario Crop Type or Target Acres Treated or Gallons per Application 350 1200 350 1200 350 1200 Application Rate (lbs a.i./A) 1.02 1.02 0.23 0.23 1.02 1.02 Combined MOEs (dermal and inhalation) Short Term < 7 days 2421 35254 10721 3131 2421 35254 Intermediate Term < 30 days 2031 29584 9001 2621 2031 29584 Intermediate Term > 30 days 1491 21694 6601 1921 1491 21694 Necessary level of PPE or Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls Engineering Controls alfalfa alfalfa cotton cotton cotton cotton 1 Baseline PPE which represents typical work clothing with no respiratory protection. No chemical-resistant gloves are included in this scenario. 2 Minimum PPE which represents the baseline scenario with the use of chemical-resistant gloves and a dust/mist respirator with a protection factor of 5 (dust-mist respirator). 5. 3 Maximum PPE which represents the baseline scenario with the use of an additional layer of clothing, chemical-resistant gloves, and an air purifying respirator with a protection factor of 10 (OV respirator). 10. 4 Engineering controls which represent the use of an appropriate engineering control such as a closed tractor cab or closed loading system for granulars or liquids. Engineering controls are not applicable to handheld application methods. 30 (2) Post-Application Occupational Risk The post-application occupational risk assessment considered exposures to workers entering treated sites in agriculture. All of the post-application risk calculations completed in this assessment are included in the human health risk assessment and the August 15, 2000, update entitled “Phosmet: Revised Occupational Post-Application Exposure and Risk Calculations (DP Barcode D268141, Chemical Code 059201, case 818976)”, which takes into account the most recent revisions of the policy on agricultural transfer coefficients and information recently collected by the Gowan Company with regard to post-application exposures. Based on the phosmet use pattern, there is potential for both short-and intermediate-term (< 30 days) post-application exposure to phosmet residues for workers. Only dermal exposures were considered in the post-application assessment, since the physical properties of phosmet suggest post-application inhalation exposures would be minimal. Agricultural post-application scenarios assessed for phosmet consist of adults harvesting and maintaining fruit trees, grapes, field and vegetable crops. The MOEs were calculated using chemical specific residue dissipation data for pears and grapes. All of the chemical-specific data generated for post-application exposure and risk assessment included residues of phosmet and the oxygen analog metabolite, which were assumed to be equivalent in terms of toxicity. The results of the revised post-application assessment are summarized in Tables 7 through 13, this assessment reflects the updated transfer coefficients as established in the HED Science Policy for Exposure 3.1: Agricultural Transfer Coefficients, dated August 7, 2000. These calculations indicate a concern for workers reentering treated fields following the 24-hour REI on current labels for some scenarios. In addition, in the memorandum titled "Phosmet : Further Revisions to the Occupational Exposure and Risk Calculations [DP Barcode D277160, Chemical Code 059201, Case 818976]", dated August 20, 2001, the Agency discusses an additional change to the transfer coefficients used to calculate post-application exposure to workers performing thinning on fruit trees. It should be noted that the transfer coefficient being used for calculating exposure for fruit tree thinners is the same as that used for calculating fruit tree harvester exposure. However, the Agency does not believe, at this time, that fruit tree thinner data should be grouped with harvester data to calculate an overall weighted average transfer coefficient, as proposed by the ARTF and Bayer. 31 (3) Occupational Reentry Risk Estimates for Phosmet Table 7: Low Berry Transfer Coefficient Group: Post-application Risks For Phosmet On Low Bush Blueberries and Cranberries Days After Treatment (DAT) Dislodgeable Foliar Residue Source Pre-Harvest Interval on Current Label (days) MOEs (100 target) Low Exposure Activities: scouting, hand weeding, irrigation (early season, low foliage), hand pruning (early season, low foliage), and thinning (early season, low foliage) High Exposure Activities: hand pruning (late season, full foliage) and hand harvesting. Low Bush Blueberries and Cranberries 0 10 Grape data at 1 lb Blueberries - 3 a.i./acre, not Cranberries - 14 adjusted for application rate Cranberries 0 11 Grape data at 1 lb Cranberries - 14 a.i./acre, adjusted for application rate of 4 lb a.i./acre 48 102 Not Applicable Not Applicable 193 52 (blueberries only) 102 (blueberries only) Table 8: Field/Row Crop Transfer Coefficient Group (low/medium height): Post-application Risks For Phosmet on Alfalfa, Cotton and Peas Days After Treatment (DAT) Dislodgeable Foliar Residue Source Pre-Harvest Interval on Current Label (days) MOEs (100 target) Medium Exposure Low Exposure Activities: Activities: irrigation and irrigation and scouting of immature scouting of mature plants plants High Exposure Activities: hand harvesting 0 10 18 Grape data at 1 lb Alfalfa 7 - 14 a.i./acre, not adjusted Cotton - 21 for application rate Peas - 7 772 52 102 31 61 105 32 Table 9: Deciduous Tree Fruit Transfer Coefficient Group: Post-application Risks For Phosmet On Deciduous Tree Fruit Transfer Coefficient Group Crop Days After Treatment (DAT) Dislodgeable Foliar Residue Source Pre-Harvest Interval on Current Label (days) MOEs (100 target) Very Low Exposure Activities: propping Low Exposure Activities: irrigation & scouting High Exposure Activities: hand harvesting, & hand thinning Pears 0 21 37 Pear data at 5 lb a.i./acre, not adjusted for application rate Pear data at 5 lb a.i./acre, adjusted for application rate of 4 lb a.i./acre 7 260 26 105 9 101 7 325 33 100 103 434 43 103 105 868 87 106 102 29 15 11 West Coast Apples 0 17 34 Apricots, nectarines, peaches, plums/prunes East Coast Apples 0 13 30 0 3 19 Pear data at 5 lb Apricots - 14 a.i./acre, Nectarines - 14 adjusted for Peaches - 14 application rate Plums - 7 Prunes of 3 lb a.i./acre 7 Pear data at 5 lb a.i./acre, adjusted for application rate of 1.5 lb ai/acre 7 Table 10: Evergreen Tree Transfer Coefficient Group: Post-application Risks For Phosmet On Christmas Trees, Evergreen Trees and Pine Seed Orchards Days After Treatment Dislodgeable Foliar (DAT) Residue Source Pre-Harvest Interval on Current Label (days) MOEs (100 target) Medium Exposure Low Exposure Activities: Activities: Irrigation, scouting, hand pruning, thinning, cone weeding, thinning small pruning, cone harvesting, trees hand harvesting, shaking, topping, training 0 13 Pear data at 5 lb a.i./acre, adjusted for application rate of 1 lb a.i./acre Not Specified 130 43 103 33 Table 11: Tree Nut Transfer Coefficient Group: Post-application Risks For Phosmet on Tree Nut Transfer Coefficient Group Crop Days After Treatment (DAT) Dislodgeable Foliar Pre-Harvest Interval Residue on Source Current Label (days) MOEs (100 target) Low Exposure Activities: irrigation and scouting High Exposure Activities: hand harvesting, poling, pruning Beech nut, brazil nut, butternut, cashew, chestnut, macadamia, walnuts Almonds, pistachios, pecans 0 13 37 0 3 27 Pear data at 5 lb a.i./acre, adjusted for application rate of 5.95 lb a.i./acre Pear data at 5 lb a.i./acre, adjusted for application rate of 3 lb a.i./acre 14 44 104 9 101 Almonds - 30 Pistachios - 14 Pecans - 14 87 106 104 17 Table 12: Root Vegetable Transfer Coefficient Group: Post-application Risks For Phosmet On Potatoes and Sweet Potatoes Days After Treatment (DAT) Dislodgeable Foliar Residue Source Pre-Harvest Interval on Current Label (days) MOEs (100 target) Low Exposure Activities: irrigation and scouting of immature plants Medium Exposure Activities: irrigation and scouting of mature plants High Exposure Activities: hand harvesting only for sweet potatoes 0 10 18 Grape data at 1 lb a.i./acre, not adjusted for application rate Potatoes - 7 257 52 102 31 105 Table 13: Vine/trellis Transfer Coefficient Group: Post-application Risks For Phosmet On Highbush Blueberries, Grapes, Kiwi, and Trellised Sweet Peas Days After Dislodgeable Pre-Harvest MOEs (100 target) Treatment Foliar Interval on (DAT) Residue Current High Exposure Low Exposure Activities: Medium Exposure Source Label Activities: Activities: hedging, irrigation, (days) hand harvesting, grape/kiwi scouting blueberries, hand weeding, training/tying blueberries scouting, training grapes, tying kiwi Very High Exposure Activities: thinning, pruning, grape girdling and cane turning training/tying grapes 0 4 28 38 Grape data at Blueberries 1 lb a.i./A, 3 not adjusted Grapes 7 for 14 application Kiwi 21 rate Sweet Peas 7 154 77 101 15 8 104 103 34 (4) • Residential (Homeowner) Handler Risk The Agency is concerned about exposures associated with treatment of dogs because the majority of the serious cases reported in the incident data involved systemic illnesses to pet owners, groomers and veterinary assistants. EPA's comparative analysis of incident data shows that residential exposures to phosmet are more likely to result in treatment in a health care facility than other organophosphate insecticides; phosmet ranked third for hospitalizations, and first for admission to intensive care units. • In 1996 several mitigation measures were implemented in an attempt to reduce the number of incidents to homeowners, veterinary workers and pets, associated with the use of phosmet. Specifically, product labels were amended to discourage application to certain dog breeds, and to smaller dogs and specifically exclude use on cats. For homeowner handler exposure assessments, the Agency does not believe a tiered mitigation approach like that used for assessing occupational handler risk is appropriate. Homeowners often lack access to personal protective equipment (PPE) and also do not possess expertise in the proper use of PPE. As a result, homeowner handler assessments are completed using a single scenario based on the use of short-sleeved shirts and short pants (i.e., common homeowner attire during the pesticide application season). In addition, only short-term exposures were assessed, as the Agency does not believe homeowners who apply phosmet will be exposed for more than 7 days. The exposure scenarios are: Residential (homeowner) Direct Animal Treatments: (1) dusting a dog; (2) dipping a dog; Residential (homeowner) Use on Terrestrial Crops: (3b) mixing/loading/applying wettable powders with a backpack sprayer; (4b) mixing/loading/applying wettable powders with a low pressure handwand sprayer; (5b) mixing/loading/applying wettable powders with a hose-end sprayer; Residential (homeowner) Treatments on Ornamental Plants: (3a) mixing/loading/applying liquids with a backpack sprayer; (3b) mixing/loading/applying wettable powders with a backpack sprayer; (4a) mixing/loading/applying liquids with a low pressure handwand sprayer; (4b) mixing/loading/applying wettable powders with a low pressure handwand sprayer; (5a) mixing/loading/applying liquids with a hose-end sprayer; (5b) mixing/loading/applying wettable powders with a hose-end sprayer; and (6) mixing/loading/applying soluble concentrates to fire ant mounds. Combined dermal and inhalation MOEs for mixing/loading/applying phosmet to fruit trees and ornamentals using a low pressure handwand were of concern (42 and 83, respectively). Very 35 limited data were available to assess exposure risks for handlers for the direct application to dogs scenario (dip/dust); therefore, data and procedures specified in the 1997 SOPs for Residential Exposure Assessment were used. The SOPs assume combined dermal and inhalation exposure of 10% of the amount applied. This assessment estimated that handler risks for direct application to dogs (dip/dust) were not a concern. Table 14. Homeowner Uses: Phosmet MOEs Attributable to Combined Short-term Homeowner Handler Dermal and Inhalation Exposures Scenario Scenario Description Dusting an Animal Dipping a Dog Mixing/loading/applying Liquids With a Backpack Sprayer Mixing/loading/applying Wettable Powders With a Backpack Sprayer Assumptions Used in Assessment 1 dog/day 1 dog/day 1 dog/day 5 gallons Crop Type or Target Dog Dog Dog Ornamentals Dermal MOEs (Target 100) 3,750,000 159,091 1,381,579 5,490 Inhalation MOEs (Target 100) No Data No Data No Data 280,000 Combined MOEs (Target 100) No Data No Data No Data 5,385 1 2 3a 3b 5 gallons 150 ft2 250 ft2 10 gallons 5 gallons Ornamentals Peas Potatoes Fruit Trees Ornamentals 4,118 11,438 11,438 2,101 280 210,000 583,333 583,333 107,143 280,000 4,038 11,218 11,218 2,060 280 4a Mixing/loading/applying Liquids With a Low Pressure Handwand Mixing/loading/applying Wettable Powders With a Low Pressure Handwand 4b 5 gallons 150 ft 250 ft 2 2 Ornamentals Peas Potatoes Fruit Trees Ornamentals 84 233 233 43 933 5,727 15,909 15,909 2,922 884,211 83 230 230 42 932 10 gallons 5a Mixing/loading/applying Liquids With a Garden Hose-End Sprayer Mixing/loading/applying Wettable Powders With a Garden Hose-End Sprayer 5 gallons 5b 5 gallons 150 ft 250 ft 2 2 Ornamentals Peas Potatoes Fruit Trees Fire Ants 700 1,944 1,944 357 389 663,158 1,842,105 1,842,105 338,346 368,421 699 1,942 1,942 357 388 10 gallons 6 Mixing/loading/applying Soluble Concentrates For Sprinkling 20 gallons (5 - 2 ft2 mounds at 4 gallons per mound) 36 (5) Residential Post-Application Risk Phosmet can be used on residential fruit and nut trees, home gardens, ornamental plants, and dogs where exposure to adults and children may occur. Exposure may result from entering the treated garden; maintaining fruit or nut trees; harvesting fruits, nuts or vegetables; or petting treated dogs. As a result, both toddler and adult risks were considered in the risk assessment. Residential post-application scenarios assessed for phosmet consist of adult homeowners and children (aged 10-12) harvesting and maintaining pears and apples at maximum application rates, and toddlers after dermal contact with treated dogs, including incidental hand-to-mouth transfer. There are concerns for continuous post-application exposure to adults and youth in residential settings over an extended period of time (greater than 30 days); however, there is little information to determine if such extended exposures actually occur. There are also concerns for short-term post-application exposure to adults and youths harvesting and maintaining fruit trees. In addition, there are significant risk concerns for toddlers exposed to phosmet residues following contact with treated dogs, regardless of the duration of exposure. For short- and intermediate-term (less than 30 days) exposures to adults and youths harvesting and maintaining apples and pears in home gardens, the MOEs were less than 100 on the day of phosmet application, with the exception of apples treated at 1.5 lb a.i./A. An MOE greater than 100 was achieved 4-8 days after application for adults and 3-6 days after application for youths. For this residential post-application scenario, the Agency assumes that home gardening activities would take place for 0.67 hours per day. The Agency does not have enough information to determine if intermediate-term (more than 30 days) exposures to phosmet occur in home gardens. However, empirical dissipation data suggest that phosmet residues persist, and that it may be possible for individuals to be exposed over an extended period of time. The Agency has concerns for short- and immediate-term (less than 30 days) post-application risk for toddlers exposed to phosmet through dermal contact with treated dogs, as well as through non-dietary ingestion of residues associated with hand-to-mouth behaviors. For this assessment, the Agency has assumed that toddlers would engage in hand-to-mouth activity for 2 hours per day. The Day 0 MOEs calculated for petting small and large dogs ranged from <1 to 8, with the target MOE being 100. An MOE of more than 100 was not achieved even after 30 days, when retreatment could occur. For toddler mouthing behaviors, as well as for combined exposure to dogs ( i.e., dermal + hand-to-mouth exposures), Day 0 MOEs were 1 or less than one after contact with small and large dogs, and did not go above 100 after 30 days. Intermediate-term (more than 30 days) aggregate (i.e., dermal + hand-to-mouth) MOEs calculated for toddlers following contact with treated dogs were <1. 4. Aggregate Risk An aggregate risk assessment looks at the combined risk from dietary exposure (food and drinking water routes) and residential exposure (dermal exposure, inhalation exposure for homeowner applicators, and incidental oral exposure for toddlers who pet treated dogs and engage 37 in hand-to-mouth activities). The aggregate dietary (food and water) risks are not of concern. Generally, all risks from these exposures must have MOEs of greater than 100 to be not of concern to the Agency. Results of the aggregate risk assessment are summarized here, and are discussed extensively in the HED chapter, dated February 9, 2000. Aggregate risks including food, water, and residential exposure were not of concern except for the following residential scenarios: toddler contact with treated dogs; harvesting from home gardens treated at higher application rates; and homeowners applying wettable powder to ornamentals and fruit trees using low-pressure handwand sprayers. 5. Incident Data Review Incidents involving exposure to phosmet are reported in the four sources reviewed; OPP’s Incident Data System (IDS), Poison Control Centers (PCC), California Department of Pesticide Regulation (CDPR), and the National Pesticides Telecommunications Network (NPTN). In addition, the EPA has reviewed several literature studies, two of which describe an exposure incident in detail, and one which consists of a telephone survey of animal groomers/veterinary workers to determine the type of products used, PPE used, and incidents associated with exposure to flea control products. • The Agency is concerned about exposures associated with treatment of dogs because the majority of the serious cases reported in the incident data involved systemic illnesses to pet owners, groomers and veterinary assistants. EPA's comparative analysis of incident data shows that residential exposures to phosmet are more likely to result in treatment in a health care facility than other organophosphate insecticides; phosmet ranked third for hospitalizations, and first for admission to intensive care units. • In 1996 several mitigation measures were implemented in an attempt to reduce the number of incidents to homeowners, veterinary workers and pets, associated with the use of phosmet. Specifically, product labels were amended to discourage application to certain dog breeds, and to smaller dogs and specifically exclude use on cats. 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 April 24, 1998, available in the public docket. To estimate potential ecological risk, EPA integrates the results of exposure and ecotoxicity using the quotient method. Risk quotients (RQs) are calculated by dividing exposure estimates by ecotoxicity values, both acute and chronic, for various species. Risk characterization provides further information on the likelihood of adverse effects occurring by considering the fate of the 38 chemical in the environment, communities and species potentially at risk, their spatial and temporal distributions, and the nature of the effects observed in studies. The higher the RQ the greater the concern. Reported incidents to nontarget organisms, such as fish and birds, involving the use of a pesticide can provide meaningful information to confirm the results of risk assessments and to help characterize ecological risks. 1. Environmental Fate and Transport Phosmet is stable to soil photolysis and appears to be stable to aqueous photolysis. Phosmet is subject to rapid hydrolysis under alkaline and neutral conditions and to a much lesser extent, under acidic conditions. Microbial degradation is a major route of dissipation. In soils where microbial activity is minimal, leaching may be a significant route of dissipation for this chemical. Phosmet degrades rapidly under aerobic conditions in soil (3 days) and more slowly under anaerobic conditions (15 days). Phosmet was not detected below the 10.5-inch soil layer in any of three field dissipation studies and dissipated to, or below, the level of detection prior to the study’s completion. Phosmet oxon is the only known degradate of toxicological concern identified in a number of environmental fate studies conducted. Studies have indicated that phosmet oxon is less mobile than phosmet because it was not detected in the leachate in aged and unaged mobility studies. In addition, phosmet oxon was limited to the upper soil layer in field studies while phosmet was detected as low as the 10.5-inch soil layer. Based on laboratory studies and field studies, phosmet and phosmet oxon might appear to pose a threat to groundwater resources. However, the short time-frame in which these chemicals degrade, reduces the migration in most microbially active soils and it does not appear that phosmet or phosmet oxon will pose a significant threat to ground water resources. Phosmet and possibly phosmet oxon, may contaminate surface waters in the dissolved phase, mainly as a result of runoffproducing storm events shortly after field applications. Surface and ground water monitoring data were very limited for phosmet and were not used in the risk assessment. 2. Risk to Birds and Mammals Phosmet was found to be moderate to practically non-toxic to avian species (acute). However, the application rates and number of applications for various crops have produced acute RQ values that are in the 0.3 to 2.9 range. Use on most crops appears to pose a chronic risk to birds with RQ values that range from 0.3 (for alfalfa seed) to 19.9 (for apples at high rates in short grass). For mammals, the acute levels of concern are exceeded mainly on short grass for smaller animals. The highest acute RQs are for pears (RQ = 10) and walnuts (RQ = 12). The application rates and frequency of applications result in very high chronic risk concerns for all crops (RQs for short grass, the worst scenario, range from 13 - 73). 39 3. Risk to Aquatic Species Acute and chronic risk to both freshwater and estuarine/marine fish is relatively low. The highest RQ is 3.4, for chronic risk to estuarine/marine fish, using the eastern apple high application rates. The RQs for acute risk to both freshwater and estuarine/marine invertebrates range from 0.2 for apples (low western rate) to 13.4 for apples (high eastern rate), excluding the two highest values. The two highest RQ values are 68.7 and 70 for acute risk to freshwater invertebrates for application to kiwi and pears, respectively. All crops, which have the potential to expose marine environments, appear to be a chronic concern for marine invertebrates (except alfalfa and cherries) with RQs ranging from 0.39 to 10.5. Chronic risk to freshwater invertebrates appears to be of concern for the following crops: apples, grapes, kiwi, peaches, pears, pecans and sweet potatoes. 4. Risk to Honey Bees Phosmet is highly toxic to honey bees. Incidents of toxicity to honey bees have been reported. 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 are 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 phosmet active ingredients. The Agency has completed its assessment of the occupational and ecological risks associated with the use of pesticides containing the active ingredient phosmet, as well as a phosmetspecific dietary (food + drinking water) 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 phosmet, EPA has sufficient information on the human health and ecological effects of phosmet to make interim decisions as part of the tolerance reassessment process under FFDCA and reregistration under FIFRA, as amended by FQPA. Taking into account the benefits of phosmet use where appropriate, the Agency has determined that phosmet is eligible for reregistration provided 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 final reregistration eligibility decision. Label changes are described in 40 Section IV. Appendix B identifies the generic data requirements that the Agency reviewed as part of its interim determination of reregistration eligibility of phosmet, and lists the submitted studies that the Agency found acceptable. Although the Agency is in the process of conducting 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 phosmet. Based on its current evaluation of phosmet alone, the Agency has determined that phosmet products, unless labeled and used as specified in this document, would present risks inconsistent with FIFRA. Accordingly, should a registrant fail to implement any of the risk mitigation measures identified in this document, the Agency may take regulatory action to address the risk concerns from use of phosmet. At the time that a cumulative assessment is conducted, the Agency will address any outstanding risk concerns. For phosmet, if all changes outlined in this document are incorporated into the labels, then most 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 phosmet after assessing the cumulative risk of the organophosphate class. Such an incremental approach to the reregistration process 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 Agency is addressing the risks from the organophosphates in as timely a manner as possible. Because the Agency has not yet completed the cumulative risk assessment for the organophosphates, this reregistration eligibility decision does not fully satisfy the reassessment of the existing phosmet food residue tolerances as called for by the Food Quality Protection Act (FQPA). When the Agency has considered the cumulative assessment, phosmet tolerances will be reassessed in that light. At that time, the Agency will reassess phosmet along with the other organophosphate pesticides to complete the FQPA requirements and make a final reregistration eligibility determination. By publishing this interim decision on reregistration eligibility and requesting mitigation measures now for the individual chemical phosmet, the Agency is 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 Agency determines, before finalization of the RED, that any of the determinations described in this interim RED are no longer appropriate, the Agency will pursue appropriate action, including but not limited to, reconsideration of any portion of this interim RED. 41 B. Summary of Phase 5 Comments and Responses When making its interim reregistration decision, the Agency took into account all comments received during Phase 5 of the OP Pilot Process. These comments in their entirety are available in the docket. A brief summary of the comments and the Agency response is noted here. Fifty two comments were received during the public comment period that closed on May 19, 2000. Of these, comments specific to phosmet were received from the registrants (Gowan Company and Wellmark International Corporation), and the remaining fifty comments were from various organizations and private citizens. Many of these comments were testimonials to the effectiveness of phosmet. Commentors emphasized that phosmet is an important tool for integrated pest management, and that without it, resistance would develop quickly because of limited effective alternatives. Many commentors indicated that phosmet is not harmful to beneficial insects. In addition, the Natural Resources Defense Council submitted comments that were specific to phosmet, but also included comments related to other OPs being reviewed and to any pesticide used on food. A Partial IRED (PIRED)for phosmet was signed on August 31, 2001; a 60-day comment period for that document closes on October 30, 2001. Because the IRED for phosmet will be issued before the end of the comment period, and there would not be sufficient time to incorporate all comments before issuing the interim RED, there will be a 60-day comment period on this interim RED for phosmet. The comment period for this document ends 60 days after publication of the Notice of Availability in the Federal Register. One comment on the PIRED has been received to date. A summary of the comment is noted here. The state of Florida sent in a Special Local Need (SLN) request, consistent with Section 24(c) of FIFRA, to use phosmet on citrus to control the apopka weevil. There is an existing tolerance for phosmet use on citrus. The Agency will review the risks and benefits associated with phosmet use on citrus and include the results in the Agency's response to comments. Other comments on the benefits assessments have been received. These comments are being evaluated. Changes to the IRED resulting from these comments will be discussed in the Agency's response to comments. C. Regulatory Position EPA has determined that the continued use of phosmet is warranted under the conditions specified in this document. Dietary (food and drinking water) risks are not of concern. Residential risks have been addressed by voluntary cancellation of phosmet uses in the home. Further, the Agency finds that the risks posed to workers and the environment by the uses addressed in this document are currently acceptable taking into account mitigation measures and the benefits of phosmet use. In arriving at these decisions, EPA has considered all relevant risk mitigation options. In addition to personal protective equipment and engineering controls for workers, EPA has considered reductions in the rate and frequency of applications and precautionary labeling. Despite 42 these mitigation measures, residual risks are still of concern, (e.g.., MOEs <20) for some worker activities for nine uses (apples, crabapples, apricots, nectarines, peaches, pears, plums/prunes, highbush blueberries, and grapes). Although EPA has determined that the benefits of these uses currently exceed the mitigated risks, these mitigated risks are still high enough that they would outweigh the benefits if the benefits changed appreciably. EPA is, therefore, requiring that after October 30, 2006, the reentry intervals for phosmet products registered for these 9 uses shall be extended as specified in the risk mitigation tables below. These longer reentry intervals (13 to 29 days) should bring the MOEs to approximately 70, substantially easing EPA’s remaining risk concerns. According to EPA's worker risk management policy (PR Notice 2000- 9), when calculated MOEs are below the target MOE after all mitigation has been considered, in this case 100, EPA will characterize uncertainties in the risk assessment, assess the potential of additional data to reduce the uncertainty, and consider benefits, i.e., the cost, availability and relative risk of alternatives in making its regulatory decisions. These factors are addressed below. Uncertainty in the Occupational Risk Assessment In the case of phosmet, the uncertainty associated with its toxicity is relatively low. The endpoint used for the short and intermediate-term (< 30 days) worker assessment is cholinesterase inhibition in both blood and brain. The 21-day dermal rat study that was used for this assessment is appropriate both in terms of route and duration of likely exposures. There is less than a 2-fold difference between the LOAEL (22.5 mg/kg/day) and the NOAEL (15 mg/kg/day). Additional toxicity data such as biological monitoring or workers' cholinesterase levels could allow further refinement. On the exposure side, EPA's assessment reflects the most recently updated transfer coefficients based on the Agricultural Reentry Task Force data and dislodgeable foliar residue (DFR) data from a phosmet-specific study. Additional regional DFR data could impact exposure assessments. There are some protective assumptions built into the post-application exposure assessment for phosmet. For example, EPA assumes that no protective clothing is worn, that workers may be exposed for up to 30 days, and that every field a worker enters has been treated with phosmet at the same maximum rate. User survey information provided by the registrant and others indicates that the actual frequency and duration of some post application activities such as scouting and irrigation tasks may be more intermittent, i.e., generally less than standard assumptions, and that maximum application rates are not always used. For other activities such as hand thinning and hand harvesting, EPA's assumptions are less conservative. Data provided by growers and others confirm that these workers frequently enter recently treated areas and continually work 30 days, sometimes longer. 43 Benefits Table 16 contains a brief summary of benefits information for each site and proposed decision. The complete benefits assessments are available in the OPP public docket and on the Internet. In general, EPA’s assessments have found little or no impact on crop production from the measures proposed in this document. However, USDA, the registrant and others have voiced the concern that extending the REI for some uses could have the effect of growers shifting to more hazardous alternatives. Stakeholders are urged to provide EPA with factual information related to potential shifts in use and the impacts of these shifts, e.g., increased cost, increased pesticide use, environmental impacts, etc., as well as any appropriate documentation during the comment period. EPA is providing a 60-day public comment period on the risk management decisions contained in this interim RED. 1. FQPA Assessment a. “Risk Cup” Determination As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with this organophosphate. The assessment was for this individual organophosphate, and does not attempt to fully reassess these tolerances as required under FQPA. FQPA requires the Agency to evaluate food tolerances on the basis of cumulative risk from substances sharing a common mechanism of 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 from exposure to phosmet is within its own “risk cup.” In other words, if phosmet did not share a common mechanism of toxicity with other chemicals, EPA would be able to conclude today that the tolerances for phosmet 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, residential uses, and drinking water. Results of this aggregate assessment indicate that the human health risks from these combined exposures are considered to be within acceptable levels; that is, combined risks from all exposures to phosmet “fit” within the individual risk cup. Therefore, the phosmet tolerances remain in effect until a full reassessment of the cumulative risk from all organophosphates is considered. 44 b. Tolerance Summary In the individual assessment, tolerances for residues of phosmet in/on plant commodities [40 CFR §180.261] are presently expressed in terms of the combined residues of phosmet and its oxygen analog. Metabolism and field trial residue data indicate parent phosmet is the most significant residue in fruit; when detected, phosmet oxon residues are generally an order of magnitude less than the parent residues. Combined phosmet and oxon residues were below the limit of quantitation of 0.05 ppm in cottonseed, nuts and potatoes (following foliar use). Monitoring data indicate that residues in fruits and vegetables are expected to be significantly lower than the established tolerances. The residue chemistry database for phosmet is largely complete; additional studies are being reviewed to reassess the tolerance for residues in sweet potatoes following post harvest application of the dust formulation; supporting storage stability data must also be submitted. Geographically representative field trial data for blueberries are required. The data gaps do not preclude completion of a dietary exposure analysis, since there are adequate monitoring data available for these commodities. According to current Agency practice, the name for the tolerance “alfalfa” will be separated into two tolerance names, “alfalfa forage” and “alfalfa hay”. Likewise, the name for the tolerance “peas” will be separated into two tolerance names, “peas, dry” and “peas, succulent”. Table 15. Tolerance Summary for Phosmet Commodity Current Tolerance (ppm) Tolerance Reassessment* Comment/Correct Commodity Definition (ppm) Tolerances Listed Under 40 CFR §180.261 (a) 40 Alfalfa 40 Almond Hulls Apples Apricots Blueberries Cattle, fat Cattle, MBYP Cattle, meat 10 10 5 10 0.2 0.2 0.2 40 10 10 5 0.2 0.1 0.1 20 A separate tolerance is needed for residues in alfalfa hay/ alfalfa, forage. The tolerance is reduced to 20 ppm, consistent with the 1986 Registration Standard. [alfalfa, forage] A separate tolerance is needed for residues in alfalfa hay/ alfalfa, forage [alfalfa, hay] [almond, hulls] [apple] [apricot] [cattle, fat] The available data indicate that the tolerance should be reduced to 0.1 ppm. [cattle, meat byproducts] The available data indicate that the tolerance should be reduced to 0.1 ppm. [cattle, meat] To be determined Additional residue data required [blueberry] 45 Commodity Cherries Citrus Fruits Corn, fodder Corn, forage Corn, fresh Corn, grain Cotton, seed Cranberries Goats, fat Goats, MBYP Current Tolerance (ppm) 10 5 10 10 0.5 0.5 0.1 10 0.2 0.2 Tolerance Reassessment* Comment/Correct Commodity Definition (ppm) 10 TBD Revoke Revoke Revoke Revoke 0.1 10 0.1 0.1 [cherry] To Be Determined** Not Supported Not Supported Not Supported Not Supported [cotton seed, undelinted] [cranberry] The available data indicate that the tolerance should be reduced to 0.1 ppm. [goat, fat] The available data indicate that the tolerance should be reduced to 0.1 ppm. [goat, meat byproducts] The available data indicate that the tolerance should be reduced to 0.1 ppm. [goat, meat] [grape] Tolerance based on dermal treatment [hog, fat] Revised tolerances based on dermal treatment [hog, meat byproducts] Revised tolerances based on dermal treatment [hog, meat] The available data indicate that the tolerance should be reduced to 0.1 ppm. [horse, fat] The available data indicate that the tolerance should be reduced to 0.1 ppm. [horse, meat byproducts] The available data indicate that the tolerance should be reduced to 0.1 ppm. [horse, meat] [kiwifruit] [nectarine] It is current Agency administrative practice to remove the “N” designation, which means negligible residues, from all entries. [nut,tree,group] [peach] [pear] Separate tolerances are needed for residues in dry and succulent pea/dry pea. [pea, forage] Goats, meat Grapes Hogs, fat Hogs, MBYP Hogs, meat Horses, fat Horses, MBYP Horses, meat Kiwifruits Nectarines Nuts Peaches Pears 0.2 10 0.2 0.2 0.2 0.2 0.2 0.2 25 5 0.1 (N) 10 10 10 0.1 10 0.2 0.04 0.04 0.1 0.1 0.1 25 5 0.1 10 10 10 Peas 46 Commodity Current Tolerance (ppm) Tolerance Reassessment* Comment/Correct Commodity Definition (ppm) 20 Separate tolerances are needed for residues in dry and succulent pea/dry pea. The available data indicate that the tolerance should be increased to 20 ppm. [pea, hay] Separate tolerances are needed for residues in dry and succulent pea/dry pea. The available data indicate that the tolerance should be increased to 1 ppm. [pea, succulent ] Separate tolerances are needed for residues in dry and succulent pea/dry pea. [pea, dry] [plum] [potato] The available data indicate that the tolerance should be reduced to 0.1 ppm. [sheep, fat] The available data indicate that the tolerance should be reduced to 0.1 ppm. [sheep, meat by products] The available data indicate that the tolerance should be reduced to 0.1 ppm. [sheep, meat] Residue data is being developed by the registrant. 10 0.5 Peas 0.5 Plums Potatoes Sheep, fat Sheep, MBYP Sheep, meat Sweet Potatoes (post harvest) 5 0.1 0.2 0.2 0.2 10 1 0.5 5 0.1 0.1 0.1 0.1 To Be Determined Tolerances Needed under 40 CFR §180.261 (a) Cotton gin byproducts Cotton seed, refined oil Milk None None None To be determined Additional data required. 0.2 0.1 Based on the combined limits of quantitation (LOQs) for phosmet and phosmet oxon Tolerances Listed Under 40 CFR §180.261 (c) Crabapples Pistachios 20 0.1 20 Revoke [crabapple, (post harvest)] Tolerance should be revoked once a 0.1 ppm tolerance is established for nut, tree, group. * The term “reassessed” here is not meant to imply that the tolerance has been reassessed as required by FQPA, since this tolerance may be reassessed only upon completion of the cumulative risk assessment of all organophosphates, as required by this law. Rather, it provides a tolerance level for this single chemical, if no cumulative assessment was required, that is supported by all of the submitted residue data. **The Agency has received an application for a Special Local Need registration under FIFRA Section 24(c) from Florida for control of the Apopka Weevil in oranges and grapefruit. Additional data may be required for this use. The Agency will commence proceedings to revoke the four existing tolerances for phosmet use on corn. The establishment of a new tolerance or raising tolerances will be deferred, pending the consideration of the cumulative assessment. The Agency received a request from the State of 47 Florida for a Special Local Need registration under FIFRA Section 24(c). The Agency is in the process of assessing the risks and benefits associated with this use. A final determination on the citrus use will be made after the comment period. 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 androgen and thyroid hormone systems, in addition to the estrogen hormone system. EPA also adopted EDSTAC’s recommendation that the Program include evaluations of potential effects 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, phosmet may be subjected to additional screening and/or testing to better characterize effects related to endocrine disruption. 3. Labels The following risk mitigation measures are necessary to mitigate the risks identified in the phosmet risk assessment to workers who handle phosmet and workers re-entering fields treated with phosmet. Label amendments, in addition to the existing label requirements, are necessary in order for phosmet products to be eligible for reregistration. Provided the risk mitigation measures described in the following section are incorporated in their entirety into labels for phosmet-containing products, the Agency finds that 33 of the 45 currently registered uses of phosmet would be eligible for reregistration, and 9 uses are being reregistered on a time-limited basis, pending a cumulative assessment of the organophosphates. The registrant has requested voluntary cancellation of the remaining three uses of phosmet (pets, household ornamentals, household fruit trees, and high pressure hose application method to cattle). It should be noted that other application methods for cattle will remain. The regulatory rationale for each of the mitigation measures is also discussed. 48 D. Regulatory Rationale The following is a summary of the rationale for managing risks associated with the current use of phosmet. Where labeling revisions are warranted, specific language is set forth in the summary tables of Section V of this document. 1. Human Health Risk Mitigation a. Dietary (food and water) Mitigation (1) Acute Dietary (Food) Taking into account all currently registered uses of phosmet, dietary (food and water) risks are not of concern. However, additional studies have been required to reassess the tolerance for residues in sweet potatoes following post harvest application of the dust formulation. The Agency has received this data and is in the process of reviewing it. In addition, the following data is required: geographically representative field trial residue data for blueberries; representative storage stability studies for phosmet oxon in an oil seed or nut matrix; and residue data for cotton gin byproducts. (2) Chronic Dietary (Food) No risk mitigation is necessary. (3) Drinking Water No risk mitigation is necessary. b. Residential All residential uses of phosmet, including treatment of dogs, are being voluntarily canceled. However, Pest Control Operators will be permitted to apply phosmet to fire ant mounds in a residential setting, because fire ants are a public health pest and risks to mixers, loaders, applicators and residents are not of concern. c. Occupational Risk Mitigation (1) Agricultural Risk Mitigation To reduce risks to workers who mix and load phosmet, the Agency is requiring the use of closed mixing and loading systems, e.g., water soluble bags. The risks associated with the dipping of pine seedlings and post harvest application to sweet potatoes have not been quantified, but the Agency believes that it is prudent to require handlers to 49 wear a long-sleeved shirt and long pants, shoes, socks, an additional layer of clothing, an apron, chemical-resistant gloves, and an air purifying (OV) respirator to mitigate risks. To reduce risks to workers harvesting potatoes and sweet potatoes, phosmet is only to be used on potatoes and sweet potatoes that will be harvested by machine. Liquid products are limited to use on the following crops: alfalfa, cotton, blueberries, and potatoes, thus reducing exposure to workers who mix and load phosmet. EPA has determined that worker risks from exposure to phosmet in the scenarios listed below would be adequately mitigated through use of the following PPE: long-sleeved shirt and long pants, shoes and socks. • • • • • • Applying sprays with a groundboom sprayer; Applying using a right-of-way sprayer; Use of a cattle backrubber Mixing/loading/applying liquids with a backpack sprayer; Mixing/loading/applying wettable powders with a backpack sprayer; Mixing/loading/applying soluble concentrates for sprinkling. EPA has determined that worker risks from exposure to phosmet in the scenarios listed below would be adequately mitigated through use of the following PPE: long-sleeved shirt and long pants, shoes, socks and chemical-resistant gloves. • • • • • • Mixing/loading liquid formulations for high pressure handwand application; Mixing/loading liquid formulations for airblast sprayer application; Mixing/loading liquid formulations for groundboom application; Mixing/loading/applying wettable powders with a low pressure handwand; Mixing/loading/applying liquids with a low pressure handwand; and Applying using a high-pressure handwand. EPA has determined that worker risks from exposure to phosmet in the scenarios listed below would be adequately mitigated through use of the following PPE: long-sleeved shirt and long pants, shoes, additional layer of clothing, socks, chemical-resistant gloves, and an air purifying respirator (OV) to mitigate risks from exposure to phosmet. • • Dipping pine seedlings; and Mixing/loading/applying a dust formulation. EPA has determined that worker risks from exposure to phosmet in the scenarios listed below would be adequately mitigated through use of engineering controls such as a closed tractor cab or closed loading system for granulars or liquids. • Mixing/loading wettable powders for aerial application and chemigation; 50 • • • • • • • Mixing/loading wettable powders for groundboom application; Mixing/loading wettable powders for airblast sprayer application; Mixing/loading wettable powders for high pressure handwand application; Mixing/loading liquids for aerial application and chemigation; Applying sprays with an airblast sprayer; Aerial application of sprays with a fixed wing aircraft (fixed wing aircraft also accounts for helicopter pilot exposure); and Flagging for aerial spray application. The only mixer/loader/applicator scenarios that remain of concern after the standard mitigation of PPE and engineering controls are considered include: • • mixing/loading liquid formulations for aerial application and chemigation; and mixing/loading wettable powder formulations for aerial application and chemigation. The risks and benefits associated with these activities are discussed in greater detail in the table below in the context of each registered crop and use pattern. Postapplication Exposure EPA completes exposure assessments on postapplication workers for various crops and activities at intervals following the application until risk falls below a target level. For phosmet, the target level for dermal risk concerns is an MOE of 100 and for inhalation risk concerns, it is an MOE of 100. In order to determine the REI for a crop, EPA calculates the number of days that must elapse after pesticide application until residues dissipate and risk to a worker falls below the target MOE. Occupational risks are regulated under the FIFRA section 3(c)(5) standard - “without unreasonable adverse effects on the environment” - which means that both risks and benefits must be considered in making a risk management decision. This standard may be met at a level below the target MOE when there are significant benefits associated with a specific activity. As the worker exposure database has improved, risk assessments are now conducted for a variety of postapplication activities based on the level of exposure for each worker activity, see Tables 7 - 13, “Occupational Postapplication Risk from Phosmet: Days After Treatment at Which the MOE is $100". For a specific crop/pesticide combination, the duration required to achieve the target MOE can vary depending on the activity assessed. In general, EPA prefers to set a single REI for all activities related to a crop or crop group without additional activity-based labeling. This approach is favored because handlers and workers are more likely to understand and comply with simpler labels. Also, permitting entry for some activities during the REI could cause confusion and compromise the effectiveness of the Worker Protection Standard (WPS). However, when the consideration of risks and benefits indicate that a single REI is unworkable, EPA may consider either setting an REI with early entry exceptions for one or more critical tasks or establishing an entry prohibition for a specific task after the REI has 51 expired. For phosmet, no critical activities have been identified to warrant the use of an activitybased exception or prohibition. However, during the 60-day comment period for this interim RED, EPA will accept further comments from growers regarding needs for additional REI exceptions for specific activities, and will consider such exceptions where needed if there are adequate MOEs and/or benefits associated with such activities. In weighing worker risks and benefits, the Agency considered the timing of field activities that are critical to crop production. For many of the phosmet uses discussed below, scouting and irrigation are critical activities in crop production, and these activities routinely need to be performed soon after application. In evaluating the restricted entry intervals, the Agency considered the exceptions to the WPS that could inform the decision. EPA’s proposed REIs take into account the flexibility already provided by these exceptions. Scouting is a handler activity under the WPS, so anyone performing this activity may legally enter the treated field during the REI provided they use the handler personal protective equipment (PPE) specified on the label. In addition, if the scout is a certified crop advisor as defined in the WPS (40 CFR 170.204(b)), the individual can determine the appropriate PPE to be used. For many of these crops, irrigation equipment is not routinely moved by hand. For these methods, the primary activity involves entering the field to turn the watering equipment on and off. This activity is allowed during the REI under the no contact exception to WPS (40 CFR 170.112(b)). This exception also usually applies to mechanical harvesting, to tree shaking for nut crops using vehicles with enclosed cabs, and often applies to mowing. Should irrigation equipment need unexpected repairs during the REI, WPS allows workers to enter a treated field provided early entry PPE is used (40 CFR 170.112(c)). Time-Limited Registration EPA has designated 9 of the 45 phosmet decisions in the following table as time-limited. They are apples, crabapples, apricots, high-bush blueberries, peaches, pears, plums/prunes, nectarines, and grapes. These uses are eligible for reregistration, under the conditions specified in this IRED. However, despite imposition of all feasible risk mitigation measures, calculated re-entry worker risks remain high and are still of concern to the Agency. Although EPA has determined that the risks of these 9 phosmet uses (with the mitigation measures identified in this IRED) are currently reasonable, taking into account their economic, social, and environmental costs and benefits, EPA remains concerned about the worker risks. EPA believes that the worker risks for these 9 uses would outweigh the benefits if the benefits changed appreciably, and that the current benefits are likely to diminish over time as new, safer alternatives become available and are adopted by growers. The risk picture could also change with the development of monitoring or other toxicity data. For these reasons the Agency has reached agreement with the registrants, on a mechanism to reconsider both the risks and benefits of these 9 uses in five years. Under this agreement, the reentry intervals for phosmet products registered for these 9 uses shall be extended as specified in the Agreement with Gowan Company, effective October 30, 2006, unless the registrant or other stakeholders can demonstrate that a lesser REI would continue to meet the standards for registration. 52 The Agency has taken this approach for these 9 uses because both the risk to re-entry workers and the benefits of phosmet use on these crops are high. “High benefits” means that the withdrawal of phosmet from the market would result in significant economic impacts on the fruit industry. These impacts are largely determined by the lack of alternative methods to control pest pressure effectively and economically. In the case of phosmet, lengthening the REIs on these 9 crops to 13 - 29 days* would substantially address the Agency's risk concerns. However, under current cropping practices lengthening the restricted entry intervals beyond what is indicated in this document would preclude key activities and result in substantial losses. For a complete discussion of the benefits of phosmet use on these crops see EPA’s website: www.epa.gov/pesticides/op/phosmet.htm In order to ensure that risks are no greater than currently estimated, registrants have agreed to conduct a controlled study to provide data on reentry workers' cholinesterase levels under the conditions of use set forth in this IRED. They have also agreed to provide updated usage and benefits information related to phosmet, and investigate the feasibility and work on developing additional protective equipment, specifically, gloves, for reentry workers. While EPA considers data in these areas to be key, registrants may also provide other data that they believe would be relevant to the Agency’s risk-benefit deliberations. For the nine commodities that are included in the five-year reevaluation of phosmet, growers and commodity organizations are encouraged to develop Pest Management Strategic Plans (PMSPs), or expand existing plans. PMSPs are commodity-specific plans that identify current and emerging pest management practices. PMSPs also state a commodity's priorities for research, regulatory activities, and education/training programs to support transition to alternative pest management practices. For more information about PMSPs, see: http://www.pmcenters.org or contact USDA's Office of Pest Management Policy on (202) 720-4074. As appropriate, EPA, USDA and other stakeholders, including worker and growers groups, are encouraged to participate in discussions of feasibility of protective equipment, adequacy of alternatives and ways to overcome barriers to adoption of alternative pest control methods. Additionally, all affected stakeholders will be invited to comment on the design and implementation of the cholinesterase monitoring study. These key studies and any other relevant data must be completed and provided to EPA no later than October 30, 2005, in order for EPA to ensure their consideration prior to the deadline for reevaluation, October 30, 2006. *Apples (1.5 lb ai/A), REI=13-days; Apples (4 lb ai/A), REI=28-days; Pears, REI=28-days; Peaches, REI=24-days; Nectarines, REI=24-days; Apricots, REI=24-days; Plums/Prunes, REI=24-days; Grapes, REI=29-days; and Highbush Blueberries, REI=23-days. 53 Table 16: Risk Mitigation Crop Kiwifruit (1 lb a.i./A rate) Current PHI 21 Risks of Concern High exposure activities (hand harvesting): MOE = 17 at current REI of 24 hours MOE 100 @ 28 days MOE 65 @ 21 days Medium exposure activities (scouting and tying kiwifruit): MOE = 83 at current REI of 24 hours MOE 100 @4 days Benefits Proposed Mitigation Because the boxelder bug is an early 28-day PHI (high exposure: harvesting), season pest, a 28-day pre-harvest MOE >100) interval (PHI) is not expected to have an impact on kiwifruit production. 7-day REI (medium exposure: scouting and tying, MOE > 100) Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: For Kiwifruit, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. The boxelder bug sporadically appears in kiwifruit (CA), and no alternative controls exist. This pest can cause bud and fruit drop and malformation to the fruit, resulting in yield and quality losses. Because of the low volume of use (54 lbs of phosmet used estimated per year), benefits are generally considered to be low; however, for one sporadic but serious pest, there is no similarly efficacious alternative. With a 28-day pre-harvest interval, risks from harvesting are not of concern. With a 7-day REI for the remaining activities, risks from postapplication exposures are not of concern. Rationale for Ecological Risk Mitigation: Although only an average of 54 pounds of phosmet are applied to kiwifruit annually, spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 54 Crop Peas (Green) (1 lb a.i./A rate) Current PHI 7 Risks of Concern Benefits Proposed Mitigation 18 day PHI (MOE>100) 5-day REI (MOE = 72 for irrigation, scouting, all other worker activities >100) Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. High exposure activities (hand harvesting): Little phosmet use is reported on this MOE = 33 at current REI of 24 hours crop. Extending the PHI to 18 days MOE 100 @ 18 days is expected to have little impact on harvesting of green peas. Increasing Medium exposure activities (irrigation and the REI to 5 days for all activities scouting of mature plants): other than hand harvesting is MOE = 55 at current REI of 24 hours expected to have little impact on the MOE = 100 @ 10 days crop. Rationale for Worker Risk Mitigation: For green peas, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. With a 18-day PHI and a 5-day REI, risks from postapplication exposures are not of concern. Stakeholder comments have suggested that scouts have minimal contact with treated foliage because of use of all terrain vehicles during scouting activities. However, the Agency has received a study conducted in conjunction with the Agricultural Re-entry Task Force (ARTF) that indicates that there is exposure to scouts performing those activities. Therefore, scouting and irrigating mature plants is considered a "medium" exposure activity in the risk mitigation. Under the Worker Protection Standard, scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Irrigation is often fixed in place, which is a no contact activity as defined by the Worker Protection Standard. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 55 Crop Peas (Dry) (1 lb a.i./A rate) Current PHI 7 Risks of Concern Benefits Proposed Mitigation High exposure activities (hand harvesting): Use of phosmet on dry peas (ID) has 5-day REI (MOE = 72 for irrigation and MOE = 33 at current REI of 24 hours high benefits for control of the pea scouting of mature plants, all other worker MOE 100 @ 18 days weevil and the pea leaf weevil. activities >100) Medium exposure activities (irrigation and Increasing the REI to 5 days is scouting of mature plants): expected to have little impact on the MOE = 55 at current REI of 24 hours crop. MOE = 100 @ 10 days Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: For dry peas, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. With a 5-day restricted entry interval, risks from postapplication exposures are not of concern. Phosmet controls the pea weevil and the pea leaf weevil. Adult leaf weevils cause significant damage and economic loss by damaging leaves, terminate buds, and ultimately destroying the plants. Stakeholder comments have suggested that scouts have minimal contact with treated foliage because of use of all terrain vehicles during scouting activities. However, the Agency has received a study conducted in conjunction with the Agricultural Re-entry Task Force (ARTF) that indicates that there is exposure to scouts performing those activities. Therefore, scouting mature plants is considered a "medium" exposure activity in the risk mitigation. Phosmet use will be limited to dry peas that are mechanically harvested, which is a no contact activity as defined by the Worker Protection Standard Under the Worker Protection Standard. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Irrigation is often fixed in place, which is a no contact activity as defined by the Worker Protection Standard. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 56 Crop Sweet Potatoes (1 lb a.i./A rate) Current PHI 7 Risks of Concern Medium exposure activities (irrigation scouting of mature plants) MOE = 55 at current REI of 24 hours MOE 100 @ 10 days Benefits Benefits very high for control of the white fringe weevil, spotted and banded cucumber beetle. Quarantine use: for control of the sweet potato weevil. Increasing the REI to 5-days is expected to have little impact on the crop. Proposed Mitigation 5-day REI (medium. exposure: irrigation and scouting of mature plants, MOE = 72) Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: For sweet potatoes, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. Because sweet potatoes are mechanically harvested, the estimated risk for hand harvesting is not considered for setting the REI; therefore, exposures to individuals performing scouting tasks on mature plants have calculated MOEs <100. However, EPA believes a 5-day REI is acceptable with an MOE of 72 because of the low volume of phosmet use and scouting activities occur intermittently. Phosmet is essential in controlling the sweet potato weevil, white fringe weevil, banded and spotted cucumber beetle. All other worker exposures have MOEs over 100 and thus are not of concern. Phosmet is also used post-harvest on stored sweet potatoes for controlling the sweet potato weevil, a quarantine pest. Phosmet is the only effective pesticide for controlling the sweet potato weevil in stored sweet potatoes. The risks associated with the post-harvest application to sweet potatoes have not been quantified, but the Agency considers it prudent to require handlers to wear long-sleeved shirt and long pants, shoes, socks, an additional layer of clothing, an apron chemicalresistant gloves, and an air purifying (OV) respirator to mitigate applicator risks associated with the use of the 5% dust product. All sweet potatoes are mechanically harvested, which is a no contact activity as defined by the Worker Protection Standard Under the Worker Protection Standard, scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Little irrigation is needed for sweet potatoes. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 57 Crop Alfalfa/Clover (1 lb a.i./A rate) Current PHI 7-14 Risks of Concern M/L Aerial MOE = 97 @ 1 lbs. Benefits Proposed Mitigation Usage of phosmet on this field crop is 5-day REI (medium exposure: scouting and extremely low. irrigation of mature plants, MOE = 72) Medium exposure activities (irrigation and scouting of mature plants) Increasing the REI to 5 days is Limit spray drift; turn airblast spray nozzles MOE = 55 at current REI of 24 hours expected to have little impact on crop inward on row ends; and do not apply when MOE 100 @ 10 days production. bees are in the area. Rationale for Worker Risk Mitigation: For alfalfa or clover, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. For mixing and loading for aerial application, it is unlikely that the use of phosmet would exceed 7 days (MOE = 97) because of the low volume of phosmet used. Therefore, risks to mixers and loaders are not of concern. With a 5-day restricted entry interval (MOE=72), risks from postapplication exposures (scouting and irrigation of mature plants) are not of concern because phosmet is not frequently used on alfalfa or clover and most of the irrigation systems used are stationary thus resulting in no worker contact with treated foliage, allowing re-entry consistent with the Worker Protection Standard. No impact on alfalfa or clover production is expected from extending the REI to 5 days because of the limited use and few hand activities that would occur during this period. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 58 Crop Blueberries (lowbush) (1 lb a.i./A rate) Current PHI 3 Risks of Concern Benefits Proposed Mitigation High exposure activities (hand harvesting) Benefits are high to medium high, 7-day PHI (high exposure: hand harvesting MOE = 55 at current REI of 24 hours because alternatives are less effective MOE = 83) MOE 100 @ 10 days than phosmet. 3-day REI (MOE>100 for remaining activities) Limit phosmet applications to 2.8 lb a.i./A per year.* Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: For lowbush blueberries, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. Growers have indicated a need to re-enter treated fields to monitor pest infestations and replace pheromone traps, consistent with Integrated Pest Management Programs and that the use of alternatives (malathion and carbaryl) requires more frequent treatments. *The Agency has received comments indicating that the seasonal maximum application rate of 2.8 lb a.i./A per season is adequate if azinphos-methyl is available for pest control; however, the rate reduction would impact blueberry production if the use pattern for azinphos-methyl is changed. The Agency is interested in receiving additional comments on the seasonal maximum application rate for blueberries. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. 59 Crop Cherries, Sweet (1.5 lb a.i./A rate) Current PHI 7 Risks of Concern M/L Aerial MOE = 92 High exposure activities (hand harvesting): MOE = 31 at current REI of 24 hours MOE 100 @ 19 days Low exposure activities (irrigation and scouting): MOE = 93 at current REI of 24 hours MOE 100 @ 3 days Benefits Benefits are high to growers in OR for Syneta beetle use. Limited alternatives. (24(c) registration in OR) Proposed Mitigation 19-day PHI (MOE > 100) 3-day REI (remaining activities, MOE >100) Limit to 5.25 lb a.i./A per year. Increasing the PHI to 19 days and the REI to 3 days is expected to have Limit spray drift; turn airblast spray nozzles little impact on crop production. inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are performed, it is unlikely that they would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated short-term MOE of 92.Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Damage from syneta beetle is fruit-scarring, and causes deformed fruit. Application to control this beetle is early-season (end of bloom). Because critical activities are not anticipated in the early season, a 19-day pre-harvest interval is not expected to have an impact on sweet cherry production. With a 3-day REI, the risks are not of concern for all other activities. The 3-day REI is not expected to have any impact on sweet cherry production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. 60 Crop Cherries, Tart (1.5 lb a.i./A rate) Current PHI 7 Risks of Concern Benefits Proposed Mitigation M/L Aerial MOE = 92 Benefits are high for the use of 3-day REI (low exposure: irrigation and High exposure activities (hand harvesting): phosmet in tart cherries. Pests are the scouting) for all activities -no hand harvesting, MOE = 31 at current REI of 24 hours cherry fruit flies. MOE >100 MOE 100 @ 19 days Limit to 5.25 lb a.i./A per year. Low exposure activities (irrigation and scouting): Limit spray drift; turn airblast spray nozzles MOE = 93 at current REI of 24 hours inward on row ends; and do not apply when MOE 100 @ 3 days bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 92. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Pests are the cherry fruit flies. Truckloads with maggots are rejected at the distributor level. Many alternatives are less efficacious and most alternative pesticides result in outbreaks of secondary pests such as mites or scale. Stakeholder comments indicate that miticides are expensive ($45 - $50/acre) and their use significantly reduces the profit margin for tart cherry growers. In addition, scale infestations have become common in tart cherry orchards. The scale infestations cause lower yields, lower fruit quality, and most significantly, can kill cherry trees within two years if untrreated. Exposure to workers is limited because all tart cherries are mechanically harvested. Consequently, the re-entry exposures of concern are scouting and irrigation. With a 3-day REI, these risks are not of concern and the increased REI is not expected to have any impact on tart cherry production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. 61 Crop Apples/ Crabapples (Eastern U.S.) 1.5 lb a.i./A rate Current PHI 7 Risks of Concern M/L Aerial MOE = 92 High exposure activities (hand harvesting, hand thinning): MOE = 31 at current REI of 24 hours MOE 100 @ 19 days Low exposure activities (irrigation and scouting): MOE = 93 at current REI of 24 hours MOE 100 @ 3 days Benefits Benefits are very high for the use of phosmet in apples. Increasing the REI beyond 3 days is expected to significantly impact apple production by limiting the ability to perform critical activities, such as thinning and harvesting. Proposed Mitigation 3-day REI (high exposure: hand harvesting and hand thinning, MOE = 35; low exposure: irrigation and scouting, MOE>100) for all activities. Time-limited Registration (5 years) Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when Pests are: Eastern Region: codling moth, plum bees are in the area. curculio, apple maggot, oriental fruit moth, leafrollers, tarnished plant bug, European apple sawfly, and San Jose Scale. Western Region: codling moth, grape mealybug, green fruitworms, oblique-banded leafrollers, and Western tussock moth. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 92. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Phosmet is often used for early season control of pest outbreaks during thinning operations and late in the season because of the 7-day PHI, which is shorter than some alternatives. With the removal of methyl-parathion and the restrictions placed on chlorpyrifos limiting its use to before bloom, azinphos-methyl and phosmet are the only remaining organophosphate pesticides that provide effective control of key target pests. The benefits for phosmet use on apples are very high because there are few alternatives available that allow for timely entry into treated orchards to perform thinning and other orchard maintenance activities. None of the alternatives provide adequate control for the target pests. Thinning operations are completed early in the growing season. Many of the pests such as oriental fruit moth are most active during the thinning time-frame. If thinning is not completed in a timely manner, the apples do not grow large enough to be profitable. Most alternative pesticides result in outbreaks of secondary pests such as mites or scale. Stakeholder comments indicate that miticides are expensive ($45 $50/acre) and their use significantly reduces the profit margin for apple growers. Scale infestations cause lower yields, lower fruit quality, and most significantly, reduced orchard longevity. Orchards are typically productive for approximately 30 - 45 years (depending on the type of tree), taking from 2 - 10 years for the trees to bear fruit. Heavy scale infestations can shorten the productive life of the orchard by 1 to 2 years. 62 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Other stakeholder comments received by the Agency indicate that the timing of re-entry into treated orchards is critical because of the availability of labor to perform the tasks. Many growers participate with a program administered through the U.S. Department of Labor and the Department of Justice's Immigration and Naturalization Service (INS), called the H-2A program. For a complete discussion of the H-2A program, see the comment from Al Pearson, Big 6 Farm, in the public docket and the U.S Department of Labor website, http://workforcesecurity.doleta.gov/foreign/dflc.asp#h2a. Growers participating in the H2-A program must guarantee a percentage of workers pay. If workers are not effectively utilized for the time they are available, the cost of production increases. The re-entry exposures of concern for workers are scouting, irrigation, hand harvesting, and hand thinning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. With an REI longer than 3 days significant impacts are likely to apple production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. In light of the benefits of phosmet use on apples, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. Apples/ Crabapples (Western U.S.) 4 lb a.i./A rate 7 M/L Aerial MOE = 34 High exposure activities (hand harvesting, hand thinning): MOE = 12 at current REI of 24 hours MOE 100 @ 34 days Low exposure activities (irrigation and scouting): MOE = 35 at current REI of 24 hours MOE 100 @ 17 days Benefits are very high for the use of phosmet in apples. Increasing the REI beyond 3 days is expected to significantly impact apple production by limiting the ability to perform critical activities, such as thinning and harvesting. 3 day REI (high exposure: hand harvesting and hand thinning, MOE = 13; low exposure: irrigation and scouting, MOE = 40) for all activities. Time-limited Registration (5 years) Limit spray drift; turn airblast spray nozzles Pests are: inward on row ends; and do not apply when Eastern Region: codling moth, plum bees are in the area. curculio, apple maggot, oriental fruit moth, leafrollers, tarnished plant bug, European apple sawfly, and San Jose Scale. Western Region: codling moth, grape mealybug, green fruitworms, oblique-banded leafrollers, and Western tussock moth. 63 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 34. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. The pest complex for the Western United States is different from the pest complex in the Eastern United States. The most important pest in western apples is codling moth. For adequate control under heavy pest pressure, the 4 lb a.i./A rate is necessary; however, typical rates in the west range from 2.0 - 2.3 lb a.i./A. Phosmet is often used for early season control of pest outbreaks during thinning operations and late in the season because of the 7-day PHI, which is shorter than some alternatives. With the removal of methyl-parathion and the restrictions placed on chlorpyrifos limiting its use to before bloom, azinphos-methyl and phosmet are the only remaining organophosphate pesticides that provide effective control of key target pests. The benefits for phosmet use on apples are very high because there are few alternatives available that allow for timely entry into treated orchards to perform thinning and other orchard maintenance activities. None of the alternatives provide adequate control for the target pests. Thinning operations are completed early in the growing season. Many of the pests such as oriental fruit moth are most active during the thinning time-frame. If thinning is not completed in a timely manner, the apples do not grow large enough to be profitable. Most alternative pesticides result in outbreaks of secondary pests such as mites or scale. Stakeholder comments indicate that miticides are expensive ($45 $50/acre) and their use significantly reduces the profit margin for apple growers. Scale infestations cause lower yields, lower fruit quality, and most significantly, reduced orchard longevity. Orchards are typically productive for approximately 30 - 45 years (depending on the type of tree), taking from 2 - 10 years for the trees to bear fruit. Heavy scale infestations can shorten the productive life of the orchard by 1 to 2 years. Other stakeholder comments received by the Agency indicate that the timing of re-entry into treated orchards is critical because of the availability of labor to perform the tasks. Many growers participate with a program administered through the U.S. Department of Labor and the Department of Justice's Immigration and Naturalization Service (INS), called the H-2A program. For a complete discussion of the H-2A program, see the comment from Al Pearson, Big 6 Farm, in the public docket and the U.S Department of Labor website, http://workforcesecurity.doleta.gov/foreign/dflc.asp#h2a. Growers participating in the H2-A program must guarantee a percentage of workers pay. If workers are not effectively utilized for the time they are available, the cost of production increases. The re-entry exposures of concern for workers are scouting, irrigation, hand harvesting, and hand thinning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. With an REI longer than 3 days significant impacts are likely to apple production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. In light of the benefits of phosmet use on apples, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. 64 Crop Apricots 3 lb a.i./A rate Current PHI 14 Risks of Concern M/L Aerial MOE = 46 High exposure activities (hand harvesting, hand thinning): MOE = 16 at current REI of 24 hours MOE 100 @ 30 days Low exposure activities (irrigation and scouting): MOE = 46 at current REI of 24 hours MOE 100 @ 13 days Benefits Benefits are very high for the use of phosmet in apricots. Increasing the REI beyond 3 days is expected to significantly impact apricot production by limiting the ability to perform critical activities. Pests are: fruit tree leafroller, green fruitworm, orange tortrix, and peach twig borer. Proposed Mitigation 3 day REI (high exposure: hand harvesting and hand thinning, MOE = 18; low exposure: irrigation and scouting, MOE = 53) for all activities. Limit to 9.1 lbs a.i. per year. Time-limited Registration (5 years) Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than predicted by the calculated MOE of 46. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Phosmet is often used for early season control of pest outbreaks during thinning operations and late in the season because of the 14-day PHI, which is shorter than some alternatives. The benefits for phosmet use on apricots are very high because there are few alternatives available that allow for timely entry into treated orchards to perform thinning and other orchard maintenance activities. With the removal of methyl-parathion, azinphos-methyl and phosmet are the only remaining organophosphate pesticides that provide effective control of key target pests. None of the alternatives provide adequate control for the target pests. Thinning operations are completed early in the growing season. Many of the pests are most active during the thinning time-frame. If thinning is not completed in a timely manner, the apricots do not grow large enough to be competitive in the marketplace. Most alternative pesticides result in outbreaks of secondary pests such as mites or scale. Stakeholder comments indicate that miticides are expensive ($45 $50/acre) and their use significantly increases the cost of apricot production. Other stakeholder comments received by the Agency indicate that the timing of re-entry into treated orchards is critical because of the availability of labor to perform the tasks. Many growers participate with a program administered through the U.S. Department of Labor and the Department of Justice's Immigration and Naturalization Service (INS), called the H-2A program. For a complete discussion of the H-2A program, see the comment from Al Pearson, Big 6 Farm, in the public docket and the U.S Department of Labor website, http://workforcesecurity.doleta.gov/foreign/dflc.asp#h2a. Growers participating in the H2-A program must guarantee a percentage of workers pay. If workers are not effectively utilized for the time they are available, the cost of production increases. 65 Crop Current PHI Risks of Concern Benefits Proposed Mitigation The re-entry exposures of concern for workers are scouting, irrigation, hand harvesting, and hand thinning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. Thinning activities in apricots may be performed by hand or by using a handheld stick. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. With an REI longer than 3 days significant impacts are likely to apricot production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. In light of the benefits of phosmet use on apricots, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. Blueberries (high bush) 1 lb a.i./A rate 3 High exposure activities (hand harvesting) Benefits are very high for the use of phosmet in blueberries, many MOE = 17 at current REI of 24 hours MOE 100 @ 28 days alternatives are less effective than phosmet. Increasing the REI beyond 3 days is expected to significantly impact blueberry production by limiting the ability to perform critical activities. 3-day PHI (high exposure: hand harvesting) MOE = 19. 3-day REI (low exposure: irrigation, scouting, hand weeding, and training) MOE >100. Limit phosmet applications to 2.8 lb a.i./A per year.* Time-limited Registration (5 years) Pests: fruitworms, blueberry maggot, Japanese beetle, oblique banded leaf Limit spray drift; turn airblast spray nozzles rollers, plum curculio, and spanworm. inward on row ends; and do not apply when bees are in the area. 66 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Rationale for Worker Risk Mitigation: For high bush blueberries, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Growers have indicated a need to re-enter treated fields to monitor pest infestations and replace pheromone traps, consistent with Integrated Pest Management Programs and that the use of alternatives are not as effective. There is zero tolerance for blueberry maggot or Japanese beetle infestation. These pests have the potential to cause significant economic damage to blueberries. With a 3-day REI, there are significant benefits for using phosmet on high bush blueberries and risks of concern for re-entry workers. The re-entry exposure of concern for workers is hand harvesting. With an REI longer than 3 days significant impacts are likely to blueberry production. *The Agency has received comments indicating that the seasonal maximum application rate of 2.8 lb a.i./A per season is adequate if azinphos-methyl is available for pest control; however, the rate reduction would impact blueberry production if the use pattern for azinphos-methyl is changed. The Agency is interested in receiving additional comments on the seasonal maximum application rate for blueberries. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. In light of the benefits of phosmet use on blueberries, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. 67 Crop Cotton (1 lb a.i./A rate) Current PHI 21 Risks of Concern Aerial MOE M/L 97 @ 1 lb a.i./A Medium exposure activities (irrigation and scouting of mature plants): MOE = 55 at current REI of 24 hours MOE 100 @ 10 days Benefits Usage of phosmet on cotton is extremely low. No impact on cotton production is expected from extending the REI to 5 days. Proposed Mitigation 5-day REI (medium. exposure: scouting and irrigation, MOE = 72) Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Only 5000 acres are treated with phosmet. There is an interest in keeping this use for over wintering boll weevil. For cotton, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. For mixing and loading for aerial application, it is unlikely that the use of phosmet would exceed 7 days (w/ MOE=97) because of the limited use. Therefore, risk to mixers and loaders are not of concern. No field activities are critical within 5 days after application. Because of the extremely low use of phosmet, it is unlikely that a individual would be engaged in scouting and irrigation activities in phosmet treated fields for a number of consecutive days for eight hours a day, so the calculated MOE of 72 probably overstates the actual risk for this crop. No impact on cotton production is expected from extending the REI to 5 days because of the limited use and few hand activities that would occur during this period. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 68 Crop Cranberries (1 lb a.i./A rate) (2.8 lb a.i./A rate) Current PHI 14 Risks of Concern All activities (2.8 lbs a.i./A rate): MOE = 74 at current REI of 24 hours MOE 100 @ 6 days MOE 85 @ 3 days Benefits Proposed Mitigation New use registered in 2000. EPA has 3-day REI (all activities, MOE = 85) no data to determine the importance of phosmet in cranberries. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: For cranberries, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. With a 3-day restricted entry interval, risks from postapplication exposures are not of concern. The calculated MOE of 85 is based on the maximum rate of 2.8 pounds a.i. per acre. This is a new registration and EPA does not have use data for phosmet. Phosmet may be applied at a lower rate, which would result in lower worker exposure (MOEs > 85). The phosmet labeled use rates range from 0.93 to 2.8 lbs a.i. per acre. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 69 Crop Grapes (0.93 lb a.i./A rate) (1.5 lb a.i./A rate) Current PHI 14 days @ > 0.93 lb a.i./A Risks of Concern 1.5 lb a..i./A rate M/L Aerial MOE = 92 High exposure activities (hand harvesting, hand thinning, pruning, tying and vine training): MOE = 11 at current REI of 24 hours MOE 100 @ 34 days Medium exposure activities (scouting and vine training): MOE = 55 at current REI of 24 hours MOE 100@ 10 days 1 lb a.i./A rate High exposure activities (hand harvesting, hand thinning, pruning, tying and vine training): MOE = 17 at current REI of 24 hours MOE 100 @ 28 days Medium exposure activities (scouting and vine training): MOE = 83 at current REI of 24 hours Benefits High benefits for critical late season control of omnivorous leafroller in California, for grape berry moth in North Central and Midwestern regions and for control of Eastern grape leafhopper in Eastern regions. Also effective for controlling Japanese Beetles. Proposed Mitigation 1.5 lb a.i./A rate: 14-day REI (high exposure: hand harvesting, hand thinning, leaf pulling, pruning, tying and vine training MOE = 27; medium exposure: scouting and training, MOE > 100). 7 days @ < 0.93 lb a.i./A 1.0 lb ai/A rate: 14-day REI (high exposure: hand harvesting, hand thinning, pruning, tying and vine training Increasing the REI beyond 14 days is MOE = 40; medium exposure: scouting and expected to significantly impact grape training, MOE > 100). production by limiting the ability to Time-limited Registration (5 years) perform critical activities such as hand harvesting, pruning, tying, and vine training. Limit to 4.55 lb ai/A per year. Alternatives, other than azinphosmethyl, are more costly and not as effective. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. 70 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the vineyard floor to the extent that a tractor could not pass through the vineyard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 92. Therefore, risks to mixers and loaders are not of concern. The benefits for phosmet use on grapes are high because there are few alternatives available (with the removal of methyl-parathion use on grapes) and none, other than azinphos-methyl, provide adequate control for omnivorous leafroller, grape berry moth Western grape leaf skeletonizer, or Japanese Beetles, the primary target pests. Carbaryl is also used on grapes; this pesticide is currently undergoing reregistration. There are some risks of concern for the grape use. Because it is too early in the reregistration process, the Agency does not know what impact, if any, that the carbaryl IRED will have on grape production. This issue will be evaluated before the phosmet IRED is finalized. There are significant benefits for using phosmet on grapes and risks of concern for re-entry workers. The re-entry exposures of concern for workers are hand harvesting, hand thinning, pruning, tying and vine training. With an REI longer than 14 days significant impacts are likely to grape production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. In light of the benefits of phosmet use on grapes, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. 71 Crop Nectarines (3 lb a.i./A rate) Current PHI 14 Risks of Concern M/L Aerial MOE = 46 High exposure activities (hand harvesting, hand thinning): MOE = 16 at current REI of 24 hours MOE 100 @ 30 days Low exposure activities (irrigation and scouting): MOE = 46 at current REI of 24 hours MOE 100 @ 13 days Benefits Benefits are very high for the use of phosmet in nectarines. Increasing the REI beyond 3 days is expected to significantly impact nectarine production by limiting the ability to perform critical activities. Phosmet is used in IPM programs and for resistence management. Proposed Mitigation 3-day REI (high exposure: harvesting and hand thinning, MOE = 18; low exposure: irrigation and scouting, MOE = 53) for all activities. Time-limited Registration (5 years) Limit to 9.1 lb a.i./A per year. Pests: Limit spray drift; turn airblast spray nozzles oriental fruit moth, peach twig borer, inward on row ends; and do not apply when bees are in the area. San Jose scale, omnivorous leafrollers, and katydids. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 46. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Phosmet is often used for early season control of pest outbreaks during thinning operations and late in the season because of the 14-day PHI, which is shorter than some alternatives. The benefits for phosmet use on nectarines are very high because there are few alternatives available that allow for timely entry into treated orchards to perform thinning and other orchard maintenance activities. With the removal of methyl-parathion, azinphos-methyl and phosmet are the only remaining organophosphate pesticides that provide effective control of key target pests. Thinning operations are completed early in the growing season. Many of the pests such as oriental fruit moth are most active during the thinning time-frame. If thinning is not completed in a timely manner, the nectarines do not grow large enough to be competitive in the marketplace. 72 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Most alternative pesticides result in outbreaks of secondary pests such as mites or scale. Stakeholder comments indicate that miticides are expensive ($45 $50/acre) and their use significantly reduces the profit margin for nectarine growers. In addition, scale infestations have become common in nectarine orchards in the southeast. The scale infestations cause lower yields, lower fruit quality, and most significantly, reduced orchard longevity. Orchards are typically productive for approximately 20 years, taking from 5 to 7 of those years to recover the cost of orchard establishment. Heavy scale infestations can shorten the productive life of the orchard by 1 to 2 years. Other stakeholder comments received by the Agency indicate that the timing of re-entry into treated orchards is critical because of the availability of labor to perform the tasks. Many growers participate with a program administered through the U.S. Department of Labor and the Department of Justice's Immigration and Naturalization Service (INS), called the H-2A program. For a complete discussion of the H-2A program, see the comment from Al Pearson, Big 6 Farm, in the public docket and the U.S Department of Labor website, http://workforcesecurity.doleta.gov/foreign/dflc.asp#h2a. Growers participating in the H2-A program must guarantee a percentage of workers pay. If workers are not effectively utilized for the time they are available, the cost of production increases. The re-entry exposures of concern for workers are scouting, irrigation, hand harvesting, and hand thinning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Thinning activities in nectarines are often performed by hand. In addition, nectarine leaves around fruit may be removed to enhance color development in the fruit near harvest. With a 3-day REI, there are significant benefits for using phosmet on nectarines and risks of concern for re-entry workers. With an REI longer than 3 days significant impacts are likely to nectarine production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. In light of the benefits of phosmet use on nectarines, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. 73 Crop Peaches (3 lb a.i./A rate) Current PHI 14 Risks of Concern M/L Aerial MOE = 46 High exposure activities (hand harvesting, hand thinning): MOE = 16 at current REI of 24 hours MOE 100 @ 30 days Low exposure activities (irrigation and scouting): MOE = 46 at current REI of 24 hours MOE 100 @ 13 days Benefits Benefits are very high for the use of phosmet in peaches. Phosmet is used in IPM programs and for resistence management. Proposed Mitigation 3 day REI (high exposure: harvesting and hand thinning, MOE = 18; low exposure: irrigation and scouting, MOE = 53) for all activities. Pests: Time-limited Registration (5 years) oriental fruit moth, plum curculio, peach twig borer, San Jose scale, Limit spray drift; turn airblast spray nozzles omnivorous leafrollers, and katydids. inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 46. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Phosmet is often used for early season control of pest outbreaks during thinning operations and late in the season because of the 14-day PHI, which is shorter than some alternatives. The benefits for phosmet use on peaches are very high because there are few alternatives available that allow for timely entry into treated orchards to perform thinning and other orchard maintenance activities. With the removal of methyl-parathion, azinphos-methyl and phosmet are the only remaining organophosphate pesticides that provide effective control of key target pests. Thinning operations are completed early in the peach growing season. Many of the pests such as plum curculio are most active during the thinning time-frame. If thinning is not completed in a timely manner, the peaches do not grow large enough to be competitive in the marketplace. Peaches that are 1/8 inch smaller than the preferred 2 ½ to 2 3/4 inch fruit sell for approximately $4 - $8 less per ½ bushel. Therefore, the amount of profit is directly related to proper thinning of peach trees. 74 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Most alternative pesticides result in outbreaks of secondary pests such as mites or scale. Stakeholder comments indicate that miticides are expensive ($45 $50/acre) and their use significantly reduces the profit margin for peach growers. In addition, scale infestations have become common in peach orchards in the southeast. The scale infestations cause lower yields, lower fruit quality, and most significantly, reduced orchard longevity. Southeastern orchards are typically productive for 12 - 14 years, taking from 5 to 7 of those years to recover the cost of orchard establishment. Heavy scale infestations can shorten the productive life of the orchard by 1 to 2 years. Other stakeholder comments received by the Agency indicate that the timing of re-entry into treated orchards is critical because of the availability of labor to perform the tasks. Many growers participate with a program administered through the U.S. Department of Labor and the Department of Justice's Immigration and Naturalization Service (INS), called the H-2A program. For a complete discussion of the H-2A program, see the comment from Al Pearson, Big 6 Farm, in the public docket and the U.S Department of Labor website, http://workforcesecurity.doleta.gov/foreign/dflc.asp#h2a. Growers participating in the H2-A program must guarantee a percentage of workers pay. If workers are not effectively utilized for the time they are available, the cost of production increases. The re-entry exposures of concern for workers are scouting, irrigation, hand harvesting, and hand thinning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Thinning activities in nectarines are performed by hand. With a 3-day REI, there are significant benefits for using phosmet on nectarines and risks of concern for re-entry workers. With an REI longer than 3 days significant impacts are likely to peach production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. In light of the benefits of phosmet use on peaches, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. 75 Crop Pears (5 lb a.i./A rate) Current PHI 7 Risks of Concern M/L Aerial MOE = 28 M/L Aerial MOE = 34 @ 4 lb a.i./A rate High exposure activities (hand harvesting, hand thinning): MOE = 9 at current REI of 24 hours MOE 100 @ 37 days Benefits Benefits are very high for the use of phosmet in pears. Pests: codling moth and grape mealy bug (applied post-bloom) Proposed Mitigation 3-day REI (high exposure: harvesting and hand thinning, MOE = 13; low exposure: irrigation and scouting, MOE = 40) for all activities. Reduce application rate to 4 lb a.i./A with a maximum of 11.2 lb a.i./A applied per year. Time-limited Registration (5 years) Low exposure activities (irrigation and scouting): MOE = 28 at current REI of 24 hours MOE 100 @ 21 days Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 34 (includes rate reduction to 4 lb a.i./A). Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. The benefits for phosmet use on pears are very high because there are few alternatives available and none provide adequate control for the target pests. Most alternative pesticides result in outbreaks of secondary pests such as mites. Stakeholder comments indicate that miticides are expensive ($45 - $50/acre) and their use significantly reduces the profit margin for pear growers. With the removal of methyl-parathion, azinphos-methyl and phosmet are the only remaining organophosphate pesticides that provide effective control of key target pests. Phosmet is often used late in the season because of the 7-day PHI. Because of its short REI, phosmet use is preferred near the time for fire blight removal. There is little to no hand thinning in pears. If the REI for phosmet were extended beyond the 7-day time-frame, significant impacts such as lack of adequate 3rd generation codling moth control. The impacts may include yield losses of 5 - 7% and losses in fruit quality. As a result, growers in the Pacific Northwest region and California could face losses of $1,238 per acre and $918 per acre, respectively. This change would result in a reduction in profit of approximately 90%. Fire blight is a disease, which if not controlled by pruning diseased branches, could lead to tree loss and, therefore, significant yield loss. 76 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Other stakeholder comments received by the Agency indicate that the timing of re-entry into treated orchards is critical because of the availability of labor to perform the tasks. Many growers participate with a program administered through the U.S. Department of Labor and the Department of Justice's Immigration and Naturalization Service (INS), called the H-2A program. For a complete discussion of the H-2A program, see the comment from Al Pearson, Big 6 Farm, in the public docket and the U.S Department of Labor website, http://workforcesecurity.doleta.gov/foreign/dflc.asp#h2a. Growers participating in the H2-A program must guarantee a percentage of workers pay. If workers are not effectively utilized for the time they are available, the cost of production increases. The re-entry exposures of concern for workers are scouting, irrigation, pruning for fire blight removal, and hand harvesting. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. With a 3-day REI, there are significant benefits for using phosmet on pears and risks of concern for re-entry workers. With an REI longer than 3 days significant impacts are likely to pear production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. In light of the benefits of phosmet use on pears, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. 77 Crop Almonds (3 lb a.i./A rate) Current PHI 30 Risks of Concern M/L Aerial MOE = 46 High exposure activities (hand harvesting, poling and pruning): MOE = 19 at current REI of 24 hours MOE 100 @ 27 days Low exposure activities (irrigation and scouting): MOE = 93 at current REI of 24 hours MOE 100 @ 3 days Benefits Benefits are moderate for the use of phosmet on almonds, due to the availability of azinphos-methyl in treating many of the same key pests. Proposed Mitigation 30-day PHI (high exposure: harvesting, poling and pruning, MOE >100 3-day REI (low exposure: irrigation and scouting), MOE > 100 for all activities. Pests: navel orange worm, peach twig borer, Pruning must occur before dormant and San Jose scale. applications of phosmet. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 46. Therefore, risks to aerial mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Exposure to workers is limited because almonds are mechanically harvested. Exposures to workers re-entering treated almond orchards are not of concern to harvest or perform other activities associated with almond harvest because of the 30-day PHI. With a 3-day REI, low exposure tasks such as irrigation and scouting are not a risk concern and the increased REI is not expected to have any impact on almond production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 78 Crop Pistachios Pecans (3 lb a.i./A rate) Current PHI 14 14 Risks of Concern M/L Aerial MOE = 46 High exposure activities (hand harvesting, poling and pruning): MOE = 19 at current REI of 24 hours MOE 100 @ 27 days Low exposure activities (irrigation and scouting): MOE = 93 at current REI of 24 hours MOE 100 @ 3 days Benefits Benefits are moderate for the use of phosmet on pistachios, and pecans. Pistachio Pests: navel orange worm, flat mite, and leafrollers. Pecan Pests: pecan nut casebearer, hickory shuckworm, and black pecan aphid. Proposed Mitigation 14-day PHI (high exposure: harvesting, poling and pruning), MOE =44. 3-day REI (low exposure: irrigation and scouting), MOE > 100 for all activities. Limit applications to 12 lb a.i./A per year for pistachios. Limit applications to 7 lb a.i./A per year for pecans. Pruning must occur before dormant applications of phosmet. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 46. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Exposures to workers re-entering treated nut orchards are not of concern for harvesting or pruning activities because harvesting is performed mechanically and pruning activities are to be performed during the dormant phase and prior to phosmet treatments. There are some concerns for workers who perform poling activities; however, these activities only take place after harvest, and on a limited basis. The actual MOE is anticipated to be higher than the calculated MOE of 44. With a 3-day REI, low exposure tasks such as irrigation and scouting are not a risk concern. The increased REI is not expected to have any impact on pistachio or pecan production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. 79 Crop Walnuts (5.95 lb a.i./A rate) Current PHI 14 Risks of Concern M/L Aerial MOE = 23 High exposure activities (hand harvesting, poling and pruning): MOE = 9 at current REI of 24 hours MOE 100 @ 37 days Low exposure activities (irrigation and scouting): MOE = 47 at current REI of 24 hours MOE 100 @ 13 days Benefits Benefits are moderate for the use of phosmet in walnuts, provided that azinphos-methyl is available for use. Harvesting is mechanical and there are no poling activities in walnuts. Pests: codling moth, navel orange worm, walnut husk fly, fall webworm, and redhumped caterpillar. Proposed Mitigation 14-day PHI (high exposure: harvesting and pruning); no high exposure activities are anticipated; (low exposure: irrigation and scouting), MOE = >100 for all activities. 7-day REI (low exposure: irrigation and scouting), MOE = 70 for all activities. Pruning must occur before dormant applications of phosmet. Limit applications to 12 lb a.i./A per year. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 46. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. The re-entry exposures of concern for workers are hand harvesting, poling and pruning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Exposures to workers re-entering treated walnut orchards are not of concern for harvesting or pruning activities because harvesting is performed mechanically and pruning activities are to be performed during the dormant season and prior to phosmet treatments. There is no poling in walnut trees. With a 7-day REI, low exposure tasks such as irrigation and scouting, there are some concerns for workers. However, irrigation is often a no contact activity, as defined by the WPS and scouting is performed on a limited basis. The increased REI is not expected to have any impact on walnut production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. 80 Crop Filberts Brazil nuts Beechnuts Butternuts Cashew Chestnut Chinquapin Hickory nuts Macadamia nuts (5.95 lb a.i./A rate) Current PHI 14 Risks of Concern M/L Aerial MOE = 23 High exposure activities (hand harvesting, poling and pruning): MOE = 9 at current REI of 24 hours MOE 100 @ 37 days Low exposure activities (irrigation and scouting): MOE = 47 at current REI of 24 hours MOE 100 @ 13 days Benefits Benefits not assessed. Proposed Mitigation 28-day PHI (high exposure: harvesting and pruning), MOE = 60; (low exposure: irrigation and scouting), MOE >100. 7-day REI for all activities (low exposure: irrigation and scouting), MOE = 70; (note: high exposure harvesting and pruning take place after 28-day PHI) Pruning must occur before dormant applications of phosmet. Limit applications to 12 lb a.i./A per year. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. 81 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than the calculated MOE of 46. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. The re-entry exposures of concern for workers are hand harvesting, poling and pruning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Exposures to workers re-entering treated nut orchards are not of concern for harvesting or pruning activities because harvesting is likely to be performed mechanically and pruning activities are to be performed prior to phosmet treatments. There are some concerns for workers who perform poling activities in the various nut trees. Poling activities only take place after harvest (28-day PHI), and on a limited basis, the anticipated MOE is anticipated to be higher than the calculated MOE of 56. With a 7-day REI, low exposure tasks such as irrigation and scouting, there are some concerns for workers. However, irrigation is often a no contact activity, as defined by the WPS and scouting is performed on a limited basis. In addition, the Agency does not have much information on how much phosmet is used on these nut crops. Given the types of activities that are performed in a nut orchard, the increased REI is not expected to have any impact on nut production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. 82 Crop Plums/Prunes (3 lb a.i./A rate) Current PHI 7 Risks of Concern M/L Aerial MOE = 46 High exposure activities (hand harvesting, hand thinning): MOE = 16 at current REI of 24 hours MOE 100 @ 30 days Low exposure activities (irrigation and scouting): MOE = 46 at current REI of 24 hours MOE 100 @ 13 days Benefits Benefits are very high for the use of phosmet in plums and prunes. Phosmet is used in IPM programs and for resistence management. Proposed Mitigation 3 day REI (high exposure: harvesting and hand thinning, MOE = 18; low exposure: irrigation and scouting, MOE = 53) for all activities. Western Pests: Limit to 9.1 lb a.i./A per year. oriental fruit moth, peach twig borer, codling moth, and citrus cutworm. Time-limited Registration (5 years) Eastern Pests: plum curculio and apple maggot. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: Aerial application (using engineering controls) only occurs when rain has softened the orchard floor to the extent that a tractor could not pass through the orchard without damaging the orchard. Given that aerial applications are rarely performed, and when aerial applications are preformed, it is unlikely that it would occur for up to seven consecutive days, actual risk is anticipated to be lower than that predicted by the calculated MOE of 46. Therefore, risks to mixers and loaders are not unreasonable given the occasional, yet critical need for aerial application. Phosmet is often used for early season control of pest outbreaks during thinning operations and late in the season because of the 7-day PHI, which is shorter than some alternatives. The benefits for phosmet use on plums and prunes are very high because there are few alternatives available that allow for timely entry into treated orchards to perform thinning and other orchard maintenance activities. With the removal of methyl-parathion, azinphos-methyl and phosmet are the only remaining organophosphate pesticides that provide effective control of key target pests. Thinning operations are completed early in the plum growing season, it should be noted that prunes are often mechanically thinned. If thinning is not completed in a timely manner, the plums and prunes do not grow large enough to be profitable. The amount of profit is directly related to proper thinning of plum and prune trees. 83 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Most alternative pesticides result in outbreaks of secondary pests such as mites or scale. Stakeholder comments indicate that miticides are expensive ($45 $50/acre) and their use significantly reduces the profit margin for plum and prune growers. The scale infestations cause lower yields, lower fruit quality, and most significantly, reduced orchard longevity. Southeastern orchards are typically productive for 15 - 20 years, taking from 4 - 5 of those years for the trees to bear fruit. Heavy scale infestations can shorten the productive life of the orchard by 1 to 2 years. Other stakeholder comments received by the Agency indicate that the timing of re-entry into treated orchards is critical because of the availability of labor to perform the tasks. Many growers participate with a program administered through the U.S. Department of Labor and the Department of Justice's Immigration and Naturalization Service (INS), called the H-2A program. For a complete discussion of the H-2A program, see the comment from Al Pearson, Big 6 Farm, in the public docket and the U.S Department of Labor website, http://workforcesecurity.doleta.gov/foreign/dflc.asp#h2a. Growers participating in the H2-A program must guarantee a percentage of workers pay. If workers are not effectively utilized for the time they are available, the cost of production increases. The re-entry exposures of concern for workers are scouting, irrigation, hand harvesting, and hand thinning. Scouting is a handler activity which means that scouting can be performed during the REI provided the appropriate handler PPE is used. In addition, certified crop advisors can determine the appropriate level of PPE used during the REI. Thinning activities in plums are often performed by hand, while prunes are generally thinned by mechanical shaking. With a 3-day REI, there are significant benefits for using phosmet on plums and prunes and risks of concern for re-entry workers. With an REI longer than 3 days significant impacts are likely to plum and prune production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited application rate as well as the application method and timing modifications. In light of the benefits of phosmet use on plums and prunes, EPA finds the continued use to be warranted in the near term. A time-limited registration of 5 years with interim mitigation will be allowed. 84 Crop Potatoes (1 lb a.i./A rate) Current PHI 7 Risks of Concern Medium exposure activities (scouting and irrigation of mature plants): MOE = 55 at current REI of 24 hours MOE 100 @ 10 days Benefits Proposed Mitigation Usage of phosmet is low. No impact 5-day REI (medium. exposure: irrigation and on potato production is expected from scouting of mature plants, MOE =72) extending the REI to 5 days. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Rationale for Worker Risk Mitigation: For potatoes, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. Because potatoes are mechanically harvested, the estimated risk for hand harvesting is not relevant for setting the REI; therefore, exposures to individuals performing scouting tasks on mature plants have the risk of greatest concern. The Agency has received comments indicating that scouting has limited exposure because the workers drive around the perimeter of the field, stopping to sample for pests at 3 or 4 sites. Therefore, EPA believes that the calculated MOE of 72 at 5 days may overstate the actual risk to scouts. In addition, comments have indicated that the warm climate would prohibit workers from wearing full PPE to enter treated fields for scouting and irrigating purposes as provided for by the existing low contact exemption in the Worker Protection Standard. No impact on potato production is expected from extending the REI to 5 days. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from these modifications. 85 Crop Christmas Trees/ Evergreen Trees (1 lb a.i./A rate) Current PHI N/A Risks of Concern M/L Aerial MOE = 40, 1,200 acres treated M/L Aerial MOE >100, 350 acres treated High exposure activities (harvesting, staking, topping, and training): MOE = 46 at current REI of 24 hours MOE 100 @ 13 days Low exposure activities (pruning, thinning, cone pruning, and cone harvesting): MOE = 46 at current REI of 24 hours MOE 100 @ 13 days Benefits Benefits not assessed. Proposed Mitigation 13-day REI (high exposure: harvesting, staking, topping, and training) MOE > 100. Limit spray drift; turn airblast spray nozzles inward on row ends; and do not apply when bees are in the area. Limit to 3 applications per year. Rationale for Worker Risk Mitigation: For Christmas Trees, the risks for workers mixing and loading phosmet for aerial applicators are not of concern, assuming 350 acres or less are treated per day. The Agency has received comments that indicate Christmas Tree farms are generally 350 acres or less. For evergreen trees, the handler risks of concern are for workers mixing and loading phosmet for aerial applications to forestry. Exposure would be reduced provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. These estimates are based on the value for aerial application of 1,200 acres treated per day which is a high-end estimate of the number of acres treated and may not be representative of the actual acreage an applicator would treat in a day. There is not much phosmet use on Christmas trees or evergreen trees. With a 13-day REI, the risks to workers re-entering treated orchards to perform harvesting, staking, topping, and training tasks are not of concern and the increased REI is not expected to have any impact on Christmas tree or evergreen production. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area, during the bloom phase. Reduced environmental exposure from phosmet use will result from the limited number of applications as well as the application method and timing modifications. 86 Crop Pine Seedlings (0.35 lb a.i./A rate) Current PHI N/A Risks of Concern M/L/A: No data to assess the risks of this application. Benefits Benefits not assessed. Proposed Mitigation Long-sleeved shirt and long pants, shoes, socks, additional layer of clothing, chemicalresistant gloves, and an air purifying respirator (OV). Rationale for Worker Risk Mitigation: The risks associated with the dipping of pine seedlings have not been quantified, but the Agency believes it is prudent to require handlers to wear: long-sleeved shirt and long pants; shoes; socks; additional layer of clothing; apron; chemical-resistant gloves; and an air purifying (OV) respirator to mitigate risks. Cattle/Swine Cattle 3 day There are numerous incidents involving the Benefits not assessed. (0.02 lb a.i./A prehigh pressure hose application method. rate) slaughter; (0.004 lb a.i./A Swine 1 day rate) pre-slaughter Remove the high pressure hose application method from the labels. Do not apply to the point of runoff. Rationale for Worker Risk Mitigation: Because of the incidents involving workers applying phosmet with a high pressure hose, the registrant has agreed to remove this application method from the labels. The cattle backrubber use will be retained. Removing the high pressure hose from the labels will reduce worker exposure and incidents. Pine Seed Orchards (1 lb a.i./A rate) NA High exposure activities (hand pollination, New use registered in 2001. EPA has 13-day REI harvesting, staking, topping, and training): no data to determine the importance of phosmet in pine seed orchards. Limit spray drift; turn airblast spray nozzles MOE = 46 at current REI of 24 hours inward on row ends; and do not apply when MOE 100 @ 13 days bees are in the area. Medium exposure activities (pruning, thinning, cone pruning, and cone harvesting): MOE = 46 at current REI of 24 hours MOE 100 @ 13 days Rationale for Worker Risk Mitigation: For pine seed orchards, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. These estimates are based on the value for aerial application of 150 - 300 acres treated per day which is a reasonable high-end estimate of the number of acres treated. With a 13-day restricted entry interval, risks from postapplication exposures are not of concern. In pine seed orchards, mowing is a no contact activity and thus could be performed during the REI. The Agency understands that there are some critical low exposure activities that may need to be performed during the 13-day REI. The need for exceptions for such activities will be considered in the comment period. Rationale for Ecological Risk Mitigation: Spray drift will be reduced through turning airblast spray nozzles inward on row ends and incidents to honey bees will be avoided if phosmet is not applied when bees are likely to be in the area. Reduced environmental exposure from phosmet use will result from these modifications. 87 Crop Current PHI Risks of Concern Benefits Proposed Mitigation Acceptable with engineering controls Limit to 3 applications per year. Ornamental NA (Nursery) (0.008 lb a.i./A rate) MOE > 100 at current REI of 24 hours for Benefits not assessed, risks not of low exposure activities concern. Rationale for Worker Risk Mitigation: For ornamental trees in nurseries, handler risks are not of concern provided engineering controls are employed; that is, water soluble bags for wettable powder formulations and closed mixing/loading systems for liquid formulations. Postapplication risks are not of concern at the current 24 hour REI. Rationale for Ecological Risk Mitigation: Reduced environmental exposure from phosmet use will result from the limited number of applications. Fire Ant Control (0.009 lb a.i./A rate) Household Ornamental Household Fruit Tree Domestic Pet NA Mixer/loader MOEs on day of treatment range from 115 - 158 Public health use. Retain this use on agricultural label, limited to use by a pest control operator Voluntary Use Cancellation NA Mixing/loading/applying wettable powders Not assessed with a low pressure handwand: MOEs = 42 - 83 Mixing/loading/applying wettable powders Not assessed with a low pressure handwand: MOEs = 42 - 83 Post application risk to children is high. Not assessed Accept cancellation NA Accept cancellation Accept cancellation 88 (2) Animal Use Risk Mitigation All products used on dogs will be voluntarily canceled. The high pressure hose application to cattle and swine will be removed from labels. (3) Homeowner Use Risk Mitigation All products used in home garden (except fire ant treatments) and all products used on dogs will be voluntarily canceled. Fire ant treatment products in a residential setting will be permitted only when applied by a pest control operator. (4) Handler Risk Mitigation To reduce exposure to handlers, application rates will be reduced, where feasible; and a time-limited registration will be implemented for nine crops, see Table 16 for details, and the high pressure hose application to cattle and swine will be removed from labels. In addition, all products used in home garden and all products used on dogs will be voluntarily canceled. Fire ant treatment products in a residential setting will be permitted only when applied by a pest control operator. (5) Post-Application Risk Mitigation All products used in home garden and all products used on dogs will be voluntarily canceled. Re-entry intervals for workers entering treated orchards, fields or vineyards will be increased; application rates will be reduced, where feasible; and a time-limited registration will be implemented for nine crops, see Table 16 for details. 2. Environmental Risk Mitigation The number of Applications per season will be reduced to three, unless specified in this document or current labels specify fewer. Registrants will also be required to add a precautionary statement on all labels indicating that phosmet is highly toxic to bees. The following statements need to be added to end use product labels: “This pesticide is toxic to fish and aquatic invertebrates. Do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high-water mark. Drift and runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment washwater or rinsate.” “This product is highly toxic to bees exposed directly to treatment of residues on crops. Do not apply this product or allow it to drift to blooming crops or weeds if bees are visiting the treatment area. Protective information may be obtained from your cooperative Agricultural Extension Service.” 89 “This chemical can contaminate surface water through aerial and ground spray applications. Under some conditions, it may also have a high potential for runoff into surface water after application. These include poorly draining or wet soils with readily visible slopes toward adjacent surface waters, frequently flooded areas, areas overlying 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, and areas overlying tile drainage systems that drain to surface water.” The following statements need to be added to manufacturing use product labels: “This pesticide is toxic to fish and aquatic invertebrates. Do not discharge effluent containing this product into lakes, streams, ponds, estuaries, oceans or other waters unless the action is 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 the 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.” E. Other Labeling Requirements In order to remain eligible for reregistration, other use and safety information need to be placed on the labeling of all end-use products containing phosmet. For the specific labeling statements, refer to Section V of this document 1. Endangered Species Statement The Agency has developed the Endangered Species Protection Program to identify pesticides whose use may cause adverse impacts on endangered and threatened species, and to implement mitigation measures that address these impacts. The Endangered Species Act requires federal agencies to ensure that their actions are not likely to jeopardize listed species or adversely modify designated critical habitat. To analyze the potential of registered pesticide uses to affect any particular species, EPA puts basic toxicity and exposure data developed for REDs into context for individual listed species and their locations by evaluating important ecological parameters, pesticide use information, the geographic relationship between specific pesticide uses and species locations, and biological requirements and behavioral aspects of the particular species. This analysis will take into consideration any regulatory changes recommended in this RED that are being implemented at this time. A determination that there is a likelihood of potential impact to a listed species may result in limitations on use of the pesticide, other measures to mitigate any potential impact, or consultations with the Fish and Wildlife Service and/or the National Marine Fisheries Service as necessary. The Endangered Species Protection Program as described in a Federal Register notice (54 FR 27984-28008, July 3, 1989) is currently being implemented on an interim basis. As part of the interim program, the Agency has developed County Specific Pamphlets that articulate many of the 90 specific measures outlined in the Biological Opinions issued to date. The Pamphlets are available for voluntary use by pesticide applicators on EPA’s website at www.epa.gov/espp. A final Endangered Species Protection Program, which may be altered from the interim program, is scheduled to be proposed for public comment in the Federal Register before the end of 2001. 2. Spray Drift Management The Agency is in the process of developing more appropriate label statements for spray, and dust drift control to ensure that public health, and the environment is protected from unreasonable adverse effects. In August 2001, EPA published draft guidance for label statements in a pesticide registration (PR) notice (“Draft PR Notice 2001-X” http://www.epa.gov/ PR_Notices/#2001). A Federal Register notice was published on August 22, 2001 (http://www.epa.gov/fedrgstr) announcing the availability of this draft guidance for a 90-day public comment period. After receipt, and review of the comments, the Agency will publish final guidance in a PR notice for registrants to use when labeling their products. Until EPA decides upon, and publishes the final label guidance for spray, and dust drift, registrants (and applicants) may choose to use the statements proposed in the draft PR notice. Registrants should refer to, and read the draft PR notice to obtain a full understanding of the proposed guidance, and its intended applicability, exemptions for certain products, and the Agency's willingness to consider other versions of the statements. For purposes of complying with the deadlines for label submission outlined in this document, registrants (and applicants) may elect to adopt the appropriate sections of the proposed language below, or a version that is equally protective, for their end-use product labeling. For products applied outdoors as liquids (except mosquito adulticides): “Do not allow spray to drift from the application site and contact people, structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals.” “For ground boom applications, apply with nozzle height no more than 4 feet above the ground or crop canopy, and when wind speed is 10 mph or less at the application site as measured by an anemometer. Use (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles.” “For orchard and vineyard airblast applications, do not direct spray above trees and vines, and turn off outward pointing nozzles at row ends and outer rows. Apply only when wind speed is 3 -10 mph at the application site as measured by an anemometer outside of the orchard or vineyard on the upwind side.” 91 “For aerial applications, the boom width must not exceed 75% of the wingspan or 90% of the rotary blade. Use upwind swath displacement, and apply only when wind speed is 3 - 10 mph as measured by an anemometer. Use (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles. If application includes a no-spray zone, do not release spray at a height greater than 10 feet above the ground or the crop canopy.” For overhead chemigation: “Apply only when wind speed is 10 mph or less.” On all product labels: “The applicator also must use all other measures necessary to control drift.” For products applied as dusts–all affected products, except home and garden products: “Do not allow dust to drift from the application site, and contact people, structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals. “For ground rig applications, apply product no more than 4 feet above the ground or the crop canopy, and only when wind speed is 10 mph or less at the application site as measured by an anemometer.” “For orchard and vineyard ground applications, do not direct dust above trees and vines, and shut off application at row ends, and toward outer rows. Apply only when wind speed is 3 10 mph at the application site as measured by an anemometer outside of the orchard or vineyard on the upwind side.” “For aerial applications, use upwind swath displacement, and apply only when wind speed is 3 - 10 mph as measured by an anemometer. If application includes a no-spray zone, do not release dust at a height greater than 10 feet above the ground or the crop canopy.” On all product labels: “The applicator also must use all other measures necessary to control drift.” For hand-applied products, including home and garden products, to be applied as sprays or dusts: “Do not allow spray or dust to drift from the application site, and contact people, structures people occupy at any time, and the associated property, parks and recreation areas, 92 nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals. Apply only when wind speed is not more than 10 mph. For sprays, apply largest size droplets possible.” Alternatively, registrants may elect to use the following language, which is the current Agency policy on drift labeling: For products that are applied outdoors in liquid sprays, regardless of application method, the following must be added to the labels: “Do not allow this product to drift.” The Agency recognizes that the above option does not address other application types. Registrants may therefore wish to adapt some variation of the old, and proposed new language for their particular products, depending on their application methods. V. What Registrants Need to Do In order to be eligible for reregistration, registrants need to implement the risk mitigation measures outlined in Section IV and V, which include, among other things, submission of the following: For products containing phosmet, registrants need to submit the following items for each product within eight months of the date of the PDCI: (1) an application for reregistration (EPA Form 8570-1, filled in, with a description on the application, such as, "Responding to Interim Reregistration Eligibility Decision” document); (2) responses to the generic and/or product specific Data Call-Ins (DCIs) as instructed in the enclosed DCIs; (3) two copies of the Confidential Statement of Formula (CSF); and (4) a certification with respect to data compensation requirements. Note that the first set of required responses for the product-specific DCI is due 90 days from the receipt of the DCI. The second set of required responses is due eight months from the date of the DCI. For questions about product reregistration and/or the product-specific DCI, please contact Barbara Briscoe at (703) 308-8177. Labels: For each product containing phosmet, registrants need to submit five copies of the draft label incorporating all label amendments outlined in Table 17 of this document, within 120 days of the date of this interim RED. For the generic DCI, the following items are due: 93 (1) DCI response form, due 90 days from the receipt of the DCI; (2) Registrant response form, due 90 days from the receipt of the DCI; (3) the actual generic data in response to the DCI. A. Manufacturing Use Products 1. Additional Generic Data Requirements The generic data base supporting the reregistration of phosmet for the above eligible uses has been reviewed and determined to be substantially complete. The following data gaps remain: • 21-Day Dermal Toxicity. The submitted 21-day dermal toxicity study [MRID 44795801] is considered to be acceptable, and satisfies the guideline requirement [870.3200] for a 21-day dermal toxicity study; however, the use of a control group run specifically to obtain cholinesterase data for comparison with the phosmet-treated groups in the study is inappropriate. In order to verify the NOAEL, historical control data for cholinesterase activity [plasma and brain] must be submitted; in addition, the registrant should conduct a statistical analysis of the combined control cholinesterase data. Subchronic Neurotoxicity. To confirm the lack of neuropathology for phosmet, additional data are required to fully characterize the severity of the digestion chambers (lesions) in the sciatic and peroneal nerves observed in high-dose male rats. Specifically, the registrant should provide data concerning the number of fibers affected in each case, compared with the same information for historical controls. Incidence of these and similar lesions in historical controls should be fully described. Residue Chemistry. Representative storage stability studies for phosmet oxon in an oil seed or nut matrix. Residue Chemistry. Grographically representative field trial residue data for blueberries. Residue Chemistry. Residue data for cotton gin byproducts (a new requirement under OPPTS 860.1550). Environmental Fate. To better understand the persistence and mobility of phosmet in the environment, an Aerobic Soil Metabolism study, [835.4100] and LeachingAdsorption/Desorption studies [835.1230 and 835.1240] on the toxic degradate phosmet oxon are required. • • • • • 94 • Spray Drift. The following guideline studies are required because phosmet is applied aerially: A.Background for Pesticide Aerial Drift Evaluation, [840.1000]; B.Spray Droplet Size Spectrum, [840.1100]; and C.Spray Drift Field Deposition, [840.1200]. Gowan Company has agreed to submit the following studies under an agreement reached with the Agency: • • • Biomonitoring of workers; Study of the feasibility of gloves suitable for field workers; and Updated benefits information. 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; due dates are 9/2001. Registrant responses are under review. 2. Labeling for Manufacturing Use Products To remain in compliance with FIFRA, manufacturing use product (MUP) labeling should be revised to comply with all current EPA regulations, PR Notices and applicable policies. The MUP labeling should bear the labeling contained in Table 17 at the end of this section. B. End-Use Products 1. Additional Product-Specific 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. 95 2. Labeling for End-Use Products Labeling changes are necessary to implement the mitigation measures outlined in Section IV above. Specific language to incorporate these changes is specified in the Table 17 at the end of this section. C. Existing Stocks The Agency has determined that all phosmet products sold or distributed after June 30, 2002, must bear labeling that is approved by the EPA and is consistent with the risk mitigation measures identified in this interim RED. In addition, EPA has reached an agreement with Gowan Company that provides for the reevaluation of phosmet in five years. Gowan Company has committed to develop certain data during this time. All products produced after October 30, 2006, will bear labeling with extended REIs, as specified in the agreement, for nine crops unless data are submitted in a timely fashion and EPA decides to extend the existing REIs or establish a lesser one. 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. 96 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. Table 17: Summary of Labeling Changes for Phosmet Description 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 Amended Labeling Language Manufacturing Use Products “Only for formulation into an insecticide for the following use(s) [fill blank only with those uses that are being supported by MP registrant].” Directions for Use Placement on Label D. “This product may be used to formulate products for specific use(s) not listed on the MP label if the Directions for Use 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).” Formulation Restriction This product may only be used to formulate wettable powder end-use products that are packaged in water soluble packaging. Directions for Use Environmental Hazards This pesticide is toxic to fish and aquatic invertebrates. Do not discharge effluent containing this product Precautionary Statements Statements Required by the into lakes, streams, ponds, estuaries oceans or other waters unless in accordance with the requirements of a RED and Agency Label Policies 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. End Use Products Intended for Occupational Use (WPS and Non-WPS Uses) Handler PPE requirements (all formulations) Note the following information when preparing labeling for all end use products: For sole-active-ingredient end-use products that contain Phosmet, the product label must be revised to adopt the handler personal protective equipment (PPE)/engineering control requirements set forth in this section. Any conflicting PPE requirements on the current label must be removed. For multiple-active-ingredient end-use products that contain Phosmet, the handler PPE/engineering control requirements set forth in this section must be compared with the requirements on the current label, 97 Description Amended Labeling Language and the more protective language must be retained. For guidance on which requirements are considered to be more protective, see PR Notice 93-7. PPE that is established on the basis of Acute Toxicity testing with the end-use products must be compared with the active ingredient PPE specified below in this document. The more protective PPE must be placed in the product labeling. For example, the Handler PPE in this RED does not require protective eyewear which may be required by the Acute Toxicity testing for the end-use product. For guidance on which PPE is considered more protective, see PR Notice 93-7. Placement on Label PPE Requirements Established by the IRED For Liquid Products “Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are” (registrant inserts correct chemical resistant material). “If you want more options, follow the instructions for category” [registrant inserts A, B, C, D, E, F, G, H] “on an EPA chemical-resistance category selection chart.” “Mixers, loaders, applicators and other handlers must wear: - Long-sleeved shirt and long pants; - Shoes plus socks; - Chemical-resistant gloves for mixers and loaders, applicators using hand held equipment and persons exposed to the concentrate; and - Chemical resistant apron for mixers and loaders, and persons exposed to the concentrate. See Engineering Controls for additional requirements.” Immediately following/below Precautionary Statements: Hazards to Humans and Domestic Animals 98 Description PPE Requirements Established by the IRED for wettable powder products The registrant has agreed that only wettable powder products packaged in water soluble packaging will be eligible for reregistration. Amended Labeling Language “Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are” (registrant inserts correct chemical resistent material). “If you want more options, follow the instructions for category” [registrant inserts A, B, C, D, E, F, G, H] “on an EPA chemical-resistance category selection chart.” "Applicators performing pine seedling dipping must wear: - Coveralls over long-sleeved shirt and long pants; - Chemical-resistant gloves; - Chemical-resistant footwear plus socks; - Chemical-resistant apron; and - A respirator with an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or a NIOSH-approved respirator with an organic vapor (OV) cartridge or canister with any N, R or P or He prefilter.” “Mixers, loaders, all other applicators and other handlers must wear: - Long-sleeved shirt and long pants; - Socks and shoes; - Chemical-resistant gloves for mixers and loaders, applicators using hand held equipment; - Chemical resistant apron for mixers and loaders. Placement on Label Immediately following/below Precautionary Statements: Hazards to Humans and Domestic Animals See Engineering Controls for further requirements.” Note: If the product contains oil or bears instructions that will allow application with an oil-containing material, the “N” designation in the above respirator statement must be dropped. 99 Description PPE Requirements Established by the IRED for Formulations Applied as Dust Amended Labeling Language “Personal Protective Equipment (PPE)” “Some materials that are chemical-resistant to this product are” (registrant inserts correct chemical resistant material). “If you want more options, follow the instructions for category” [registrant inserts A, B, C, D, E, F, G, H] “on an EPA chemical-resistance category selection chart.” “Mixers, loaders, applicators, and other handlers must wear: - Coveralls over long-sleeved shirt and long pants; - Chemical-resistant gloves; - Chemical-resistant footwear plus socks; - Chemical-resistant apron; - Chemical-resistant headgear if overhead exposure; and - A respirator with an organic-vapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or a NIOSH-approved respirator with an organic vapor (OV) cartridge or canister with any N, R or P or He prefilter.” Note: If the product contains oil or bears instructions that will allow application with an oil-containing material, the “N” designation in the above respirator statement must be dropped. Placement on Label Immediately following/below Precautionary Statements: Hazards to Humans and Domestic Animals User Safety Requirements “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.” Precautionary Statements: Hazards to Humans and Add the following statement for liquid, dust and wettable powder formulations: Domestic Animals (immediately following the “Discard clothing and other absorbent materials that have been drenched or heavily contaminated with this PPE Requirements) product’s concentrate. Do not reuse them.” 100 Description Amended Labeling Language Placement on Label Engineering Controls for Liquid “Engineering Controls” Formulations “Mixers and loaders supporting aerial or chemigation applications must use a mechanical transfer system that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(4)], and must: - wear the personal protective equipment required above for mixers/loaders; - wear protective eyewear if the system operates under pressure; and - be provided and have immediately available for use in an emergency, such as a broken package, spill, or equipment breakdown: coveralls and chemical-resistant footwear.” "Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)]." “Applicators using airblast equipment and flaggers supporting aerial applications must use an enclosed cab that meets the definition in the Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In addition, such applicators and flaggers must: - wear the personal protective equipment required above for applicators using motorized ground equipment and flaggers; - be provided and must have immediately available for use in an emergency when they must exit the cab in the treated area: coveralls, chemical-resistant gloves, chemical-resistant footwear, and chemical-resistant headgear, if overhead exposure; - take off any PPE that was worn in the treated area before reentering the cab; and - store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of the inside of the cab.” 101 Description Engineering Controls Wettable Powder Formulations “Engineering Controls” Amended Labeling Language Placement on Label Precautionary Statements: Hazards to Humans and Domestic Animals (immediately following PPE and User Safety Requirements.) “Water-soluble packets when used correctly qualify as a closed mixing/loading system under the Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(4)]. Mixers and loaders using watersoluble packets must: - wear the personal protective equipment required above for mixers/ loaders; and - be provided and must have immediately available for use in an emergency, such as a broken package, spill, or equipment breakdown: coveralls, chemical-resistant footwear, and a respirator with an organicvapor removing cartridge with a prefilter approved for pesticides (MSHA/NIOSH approval number prefix TC-23C), or a canister approved for pesticides (MSHA/NIOSH approval number prefix TC-14G), or a NIOSH-approved respirator with an organic vapor (OV) cartridge or canister with any N, R or P or He prefilter.” “Pilots must use an enclosed cockpit in a manner that meets the requirements listed in the Worker Protection Standard (WPS) for agricultural pesticides [40 CFR 170.240(d)(6)].” “Applicators using airblast equipment and flaggers supporting aerial applications must use an enclosed cab that meets the definition in the Worker Protection Standard for Agricultural Pesticides [40 CFR 170.240(d)(5)] for dermal protection. In addition, such applicators and flaggers must: -- wear the personal protective equipment required above for airblast applicators and flaggers; -- be provided and must have immediately available for use in an emergency when they must exit the cab in the treated area: coveralls, chemical-resistant gloves, chemical-resistant footwear, and chemical-resistant headgear if overhead exposure; -- take off any PPE that was worn in the treated area before reentering the cab; and -- store all such PPE in a chemical-resistant container, such as a plastic bag, to prevent contamination of the inside of the cab.” User Safety Recommendations Precautionary Statements. Hazards to Humans and Users should wash hands before eating, drinking, chewing gum, using tobacco, or using the toilet. Domestic Animals (immediately following Users should remove clothing/PPE immediately if pesticide gets inside. Then wash thoroughly and put on Engineering Controls) 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.” (Must be placed in a box.) “User Safety Recommendations. 102 Description Environmental Hazards Amended Labeling Language “This chemical can contaminate surface water through aerial and ground spray applications. Under some conditions, it may also have a high potential for runoff into surface water after application. These include poorly draining or wet soils with readily visible slopes toward adjacent surface waters, frequently flooded areas, areas overlaying 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, and areas overlaying tile drainage systems that drain to surface water. Limit spray drift. This pesticide is toxic to fish and aquatic invertebrates. Do not apply directly to water or to areas where surface water is present or to intertidal areas below the mean high-water mark. Drift and runoff may be hazardous to aquatic organisms in neighboring areas. Do not contaminate water when disposing of equipment washwater or rinsate. This product is highly toxic to bees exposed directly to treatment of residues on crops. Do not apply this product or allow it to drift to blooming crops or weeds if bees are visiting the treatment area. Protective information may be obtained from your cooperative Agricultural Extension Service.” Placement on Label Precautionary Statements (immediately following the User Safety Recommendations) Restricted Entry Interval “Do not enter or allow entry into treated areas during the restricted entry interval (REI). The REI for each crop is listed in the directions for use associated with each crop.” Directions for Use, Agricultural Use Requirements Box 103 Description Restricted-Entry Interval Liquid and Wettable Powder Formulations Amended Labeling Language The following crops have an REI of 3 days: Apples, Crabapples, Peaches, Pears, Apricots, Plums/Prunes, Nectarines, Sweet Cherries, Tart Cherries, Almonds, Pecans, Pistachios, Lowbush Blueberries, Highbush Blueberries, and Cranberries. The following crops have an REI of 5 days: Sweet Potatoes, Potatoes, Alfalfa, Clover, Cotton, Dry Peas, and Green Peas. The following crops have an REI of 7 days: Walnuts, Beechnut, Brazil Nut, Butternut, Cashew, Chestnut, Chinquapin, Filberts, Hickory Nuts or Macadamia Nuts, and Kiwifruit. The following crops have an REI of 13 days: Christmas Trees, Evergreen Trees, and Pine Seed Orchards. Grapes: REI=14 days. Placement on Label Directions for Use, Application Instructions 104 Description Early Re-entry Personal Protective Equipment Established by the IRED. 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: - coveralls; - shoes plus socks; and - chemical-resistant gloves made of any waterproof material.” “Notify workers of the application by warning them orally and by posting warning signs at entrances to treated area.” “Do not enter or allow entry until dusts have settled.” “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.” Placement on Label Directions for Use, Agricultural Use Requirements Box Double Notification Directions for Use, Agricultural Use Requirements Box Directions for Use, under Application Restrictions Place in the Directions for Use, directly above the Agricultural Use Box. Entry Restrictions for Dust Formulations General Application Restrictions 105 Description Additional Restrictions Amended Labeling Language Registrants amend labels of all products to reflect the following: All formulations: “Use in residential, park or recreational areas is prohibited. Liquid Products: These products are limited to use on the following crops: alfalfa, cotton, blueberries, and potatoes. Fire Ant treatment is limited to use by a pest control operator only. Potatoes must be harvested mechanically. Sweet potatoes must be harvested mechanically. Alfalfa: Do not apply more than once per cutting. Blueberries, low bush: PHI=7 days Limit phosmet applications to 2.8 lb a.i./A per year. Blueberries, highbush: Limit phosmet applications to 2.8 lb a.i./A per year. Placement on Label Directions for Use 106 Description Additional Restrictions Amended Labeling Language Wettable Powder Products: “Potatoes must be harvested mechanically.” “Sweet potatoes must be harvested mechanically.” Kiwifruit: PHI=28 days Peas (green): PHI= 18 days Apricots, Plums/Prunes and Nectarines: Limit phosmet applications to 9.1 lb a.i./A per year. Pears: Use rate for pears reduced from 5 lb a.i./A to 4 lb a.i./A. Limit phosmet applications to 11.2 lb a.i./A per year. Grapes: Limit phosmet applications to 4.55 lb a.i./A per year. Blueberries, low bush: PHI=7 days Limit phosmet applications to 2.8 lb a.i./A per year. Blueberries, highbush: Limit phosmet applications to 2.8 lb a.i./A per year. Cherries, sweet: PHI=19 days Limit phosmet applications to 5.25 lb a.i./A per year. Cherries, tart: Limit phosmet applications to 5.25 lb a.i./A per year. Placement on Label 107 Description Additional Restrictions Amended Labeling Language For all nut crops: “Nuts must be harvested mechanically.” “Pruning in nut crops must occur before dormant applications of phosmet.” Pistachios: Limit phosmet applications to 12 lb a.i./A per year. Pecans: Limit phosmet applications to 7 lb a.i./A per year. Walnuts: Limit phosmet applications to 12 lb a.i./A per year. Beechnut, Brazil Nut, Butternut, Cashew, Chestnut, Chinquapin, Filberts, Hickory Nuts or Macadamia Nuts: PHI=28 Limit phosmet applications to 12 lb a.i./A per year. Christmas trees and evergreen trees: Limit phosmet applications to 3 per year. Cattle, Swine: "Do not apply to the point of runoff." No high pressure hose application method allowed. Limit phosmet applications to 3 per year for the following crops: Ornamental (nursery), Christmas Trees, Evergreen Trees, Dust Products: Do not apply to grapes. Placement on Label 108 Description Spray Drift Restrictions for Outdoor Products Applied as a Liquid Amended Labeling Language For purposes of complying with the deadlines for label submission outlined in this document, registrants (and applicants) may elect to adopt the appropriate sections of the proposed language below, or a version that is equally protective, for their end-use product labeling. For products applied outdoors as sprays: “Do not allow spray to drift from the application site and contact people, structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals.” “For ground boom applications, apply with nozzle height no more than 4 feet above the ground or crop canopy, and when wind speed is 10 mph or less at the application site as measured by an anemometer. Use _____ (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles.” Placement on Label Directions for Use in General Precautions and “For orchard and vineyard airblast applications, do not direct spray above trees Restrictions and vines, and turn off outward pointing nozzles at row ends and outer rows. Apply only when wind speed is 3 -10 mph at the application site as measured by an anemometer outside of the orchard or vineyard on the upwind side.” “For aerial applications, the boom width must not exceed 75% of the wingspan or 90% of the rotary blade. Use upwind swath displacement, and apply only when wind speed is 3 - 10 mph as measured by an anemometer. Use _____ (registrant to fill in blank with spray quality, e.g. fine or medium) or coarser spray according to ASAE 572 definition for standard nozzles or VMD for spinning atomizer nozzles. If application includes a no-spray zone, do not release spray at a height greater than 10 feet above the ground or the crop canopy.” “The applicator also must use all other measures necessary to control drift.” For overhead chemigation: “Apply only when wind speed is 10 mph or less.” 109 Description Spray Drift Restrictions for Outdoor Products Applied as a Dust For products applied as dusts: Amended Labeling Language Placement on Label Directions for Use “Do not allow dust to drift from the application site, and contact people, structures people occupy at any time and the associated property, parks and recreation areas, nontarget crops, aquatic and wetland areas, woodlands, pastures, rangelands, or animals.” “The applicator also must use all other measures necessary to control drift.” Instructions in the Labeling section appearing in quotations represent the exact language that should appear on the label. Instructions in the Labeling section not in quotes represents actions that the registrant should take to amend their labels or product registrations. 110 VI. Related Documents and How to Access Them This interim Reregistration Eligibility Document 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 preliminary risk assessments and related documents as of January 15, 1999. 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 March 20, 2000. 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/op." 111 APPENDIX B Data Supporting Guideline Requirements for the Reregistration of Phosmet REQUIREMENT USE PATTERN CITATION(S) PRODUCT CHEMISTRY New Guideline Number 830.1550 830.1600 830.1620 830.1670 830.1700 830.1750 830.1800 61-2B 62-1 62-2 62-3 Old Guideline Number 61-1 61-2A Product Identity and Composition Start. Mat. & M nfg. Process Description of Pro duction Process Formation of Impurities Preliminar y Analysis Certification o f limits Analytical Method All All All All All All All 40510801, 40274801, 43868002 00075996, 00112317 40510802, 43868002 40510802, 43868002 40510801, 43868001 40510801, 43868001 00112 263, 00 11231 4, 0011 2317, 00126567, 40510801, 43868001 40274801 40274801 40274801 All 40274801 40274801 All All 40274801 40344401, 40274801 830.6302 830.6303 830.6304 830.6313 830.7200 830.7300 830.7840 830.7860 830.7950 830.7550 830.7000 63-2 63-3 63-4 Color Physical State Odor Stability 63-5 63-7 63-8 Melting Point Density Solubility 63-9 63-11 63-12 Vapor Pressure Octanol/Water Partition Coefficient pH All All All 40344401 40344401 40274801 123 Data Supporting Guideline Requirements for the Reregistration of Phosmet REQUIREMENT 830.6313 830.6314 830.6316 830.6317 830.7100 830.6320 63-13 63-14 63-16 63-17 63-18 63-20 Stability Oxidizing/Reducing Action Explod ability Storage S tability Viscosity Corrosion chara cteristics USE PATTERN All All All All All All CITATION(S) 40274801 41909901 41909901 41909901 41909901 41909901 ECOLOGICAL EFFECTS 850.2100 850.2200 850.2200 850.2400 850.2300 850.2300 850.1075 850.1075 71-1 71-2A 71-2B 71-3 71-4A 71-4B 72-1A 72-1C Avian Ac ute Oral T oxicity Avian Die tary Toxic ity - Quail Avian Dietary Toxicity - Duck Wild M ammal T oxicity Avian Re produc tion - Quail Avian Reproduction - Duck Fish Tox icity Bluegill Fish Toxicity Rainbow Trout, Fathead Minnow, Cha nnel Catfish Invertebra te Toxicity Invertebrate Toxicity - TEP Estuarine/Marine T oxicity - Fish Estuarine/Marine T oxicity - Mollusk Estuarine/Marine Toxicity - Shrimp Fish- Early Life Stage A, B A, B A, B A, B A, B A, B A, B A, B 00084460 00022923, 0013707 00022923, 00109135 0046189 00125786 00105999 00063194, 112306 00109135, 00063194 850.1010 850.1010 None None None None 72-2A 72-2B 72-3A 72-3B 72-3C 72-4A A, B A, B A, B A, B A, B A, B 00063194, 00085219, 43752603 40612701, 43752603 40612702 40098001 40098001 40094602, 40657201 40938701, 40652801 124 Data Supporting Guideline Requirements for the Reregistration of Phosmet REQUIREMENT None 72-4B Estuarine/M arine Inverte brate Life Cycle Non-target Insect Acute Contact Toxicity USE PATTERN A, B CITATION(S) 42724901 850.3020 141-1 A, B 00132710, 05000837, 00060625 TOXICOLOGY 870.1100 870.1200 870.1300 870.2400 870.2500 870.6100 870.6200 870.3100 870.3200 870.4100 870.4200 870.3700 870.3700 870.3800 870.4300 81-1 81-2 81-3 81-4 81-5 81-7 81-8 82-1A 82-2 83-1B 83-2B 83-3A 83-3B 83-4 83-5 Acute Oral Toxicity-Rat Acute D ermal To xicity-Rabb it Acute Inhalation Toxicity-Rat Primary E ye Irritation-Ra bbit Primary Skin Irritation Acute Delayed Neurotoxicity - Hen Acute Neurotoxicity Screen 90-Day Feeding - Rodent 21-Day Dermal - Rat Chronic Feeding Toxicity Oncogenicity - Mo use Developmental Toxicity - Rat Develo pmental T oxicity - Rabb it 2-Generation Reproduction - Rat Comb ined Chro nic Toxic ity/ Carcinog enicity Mutage nicity Dog A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B 00046189 00046190 00063197 00046192 00046191 44587601 Data Gap, 44673301, 44811801, 41916401 44811801 Data Gap (confirmatory), 44795801 00076436 00141659 41962902 41962901 41520001 41916401, 00141659, 00160114 870.5140 84-2A A, B 00164884, 00164885, 00164886, 00164887, 00164888, 40199401 41296001, 41425701 870.7485 85-1 General M etabolism A, B 125 Data Supporting Guideline Requirements for the Reregistration of Phosmet REQUIREMENT 870.7600 85-2 Dermal Absorption Human Data USE PATTERN A, B A, B CITATION(S) 40122201 44851001 OCCUPATIONAL/RESIDENTIAL EXPOSURE 875.2100 132-1A Foliar Residue Dissipation Food and Ornamental Uses Food and Ornamental Uses Food and Ornamental Uses 40425 301, 40 12230 1, Agricultural R eentry Tas k Force D ata 40425 301, 42 59580 1, 4012 2301, Agricultural R eentry Tas k Force D ata 40122 301, Ag ricultural Ree ntry Task F orce Da ta 875.2400 133-3 Dermal Passive Dosimetry Exposure 875.2500 133-4 Inhalation Passive Dosimetry Exposure ENVIRONMENTAL FATE None 835.2120 835.2240 835.2410 835.4100 835.4200 835.1230 835.1240 835.6100 835.1850 160-5 161-1 161-2 161-3 162-1 162-2 163-1 163-1 164-1 165-1 Chemica l Identity Hydrolysis Photodegradation - Water Photod egradatio n - Soil Aerobic Soil M etabolism Anaerobic So il Metabolism Soil/Sediment Absorption/Desorption Leaching/Absorption/Desorption Terrestrial Field Dissipation Confined Rotational Crop A, B A, B A, B A, B A, B A,B A, B A, B A, B 40510801, 40274801, 43868002 40394301, 40510801, 40274801, 43868002 42607901 40759801 00112304, D ata Gap (phosmet oxon) 41497801 40599002, 41 142701, Data Gap (phosmet oxon) 40599002, 41 142701, Data Gap (phosmet oxon) 41464902, 40599003 42837901, 44356201 RESIDUE CHEMISTRY None 860.1300 171-2 171-4A Chemica l Identity Nature o f Residue - P lants A, B A, B 40510801, 40274801, 43868002 00037167, 00112312, 41257801, 41990101, 42617601, 42617701, 42621401, 44356001, 44356101, 44404801 126 Data Supporting Guideline Requirements for the Reregistration of Phosmet REQUIREMENT 860.1300 171-4B Nature of Residue - Livestock USE PATTERN A, B CITATION(S) 00112241, 42640201, 42646801, 44061301, 44061302 860.1340 171-4C Residue A nalytical Me thod - Plants A, B 00037165, 00056852, 00087762, 00112274, 00037166, 00056862, 00095485, 00112296, 00037167, 00037168, 00056849, 00067069, 00078567, 00084808, 00112241, 00112262, 00112265, 00112313 860.1340 860.1380 171-4D 171-4E Residue A nalytical Me thod - Anim als Storage S tability A, B A, B 00112241, 44244401, 44281101 00056850, 00056851, 00084815, 00097846, 00112279, 41100701, 41211401, 43556301, 43556 302, Data Gap 860.1480 171-4J Magnitude of Residues - Meat/Milk/Poultry/Egg Fat, Mea t and Me at of Cattle Goats Hogs Sheep Milk Eggs and the Fat M eat and M eat Byproducts of Poultry Byprodu cts Horses and A, B 00037155, 00037161, 00037162, 00056860, 00078568, 00078569, 00078570, 00112249, 00112316, 00112325, 05012698, 44244401, 44281101 05012698 00112310 A, B A, B 860.1500 171-4K Crop Field T rials (Berries G roup - Blu eberry) Crop Field Trials (Cereal Grains Group - Corn, grain) Crop Field Trials (Cereal Grains Group - Corn, swee t) Crop Field Trials (Forage Fodder and Straw of Cereal Gra ins) Crop Field Trials (Citrus Fruits Group) Crop Field Trials (Non-grass Animal Feeds - Alfalfa) A, B 00084809, 41971301, Data Gap 860.1500 171-4K A, B 00084811, 00112283 860.1500 171-4K A, B 00084811, 00112283 860.1500 171-4K A, B 00037157, 00084811 860.1500 860.1500 171-4K 171-4K A, B A, B 00084810, 00112283, Data Gap 00056858, 00095485 127 Data Supporting Guideline Requirements for the Reregistration of Phosmet REQUIREMENT 860.1500 171-4K Crop Field Trials (Fruiting Vegetables - Tomato) Crop Field Trials (Peas, forage) Crop Field Trials (Peas, succulent and dried) Crop Field T rials (Pome Fruits Apple) Crop Field T rials (Pome Fruits Crabapple) Crop Field Trials (Pome Fruits - Pear) Crop Field Trials (Potato) Crop Field Trials (Stone Fruits Group Apricot) Crop Field Trials (Stone Fruits Group Cherry) Crop Field Trials (Stone Fruits Group Nectarine) Crop Field Trials (Stone Fruits Group Peach) Crop Field Trials (Stone Fruits Group Plum) Crop Field Trials (Sweet Potato) USE PATTERN A, B CITATION(S) 00081616 860.1500 860.1500 171-4K 171-4K A, B A, B 00061721, 00084814, 00112283, 43536601 00084814, 43536601 860.1500 171-4K A, B 00044198, 00056854, 00056858, 00093486, 00106602, 00112302 40557401 860.1500 171-4K A, B 860.1500 860.1500 860.1500 171-4K 171-4K 171-4K A, B A, B A, B 00093486 40557401 00037173 860.1500 171-4K A, B 00037174 860.1500 171-4K A, B 00037173, 00093486 860.1500 171-4K A, B 00037173, 00056854, 00093486, 00106602 860.1500 171-4K A, B 00037174, 00093486, 43377501, 43377502 860.1500 171-4K A, B 00093486, 00116602, 45436801 860.1500 171-4K Crop Field Trials (Tree Nuts Group Almond, hulls) Crop Field T rials (Nuts) A, B 00044198, 00056858, 00084813, 0093486 860.1500 171-4K A, B 43536901 Miscellaneous Commodities 128 Data Supporting Guideline Requirements for the Reregistration of Phosmet REQUIREMENT Cottonseed Cotton, gin b yproduc ts Cranberry Grape Kiwifruit Pistachio 860.1520 860.1520 860.1520 860.1520 860.1520 860.1520 860.1850 171-4L 171-4L 171-4L 171-4L 171-4L 171-4L 165-1 Processed Food (Apple) Processed Fo od (Citrus) Processed Food (Cottonseed) Processed Food (Grape) Processed Food (Plum/prune) Processed Food (Potato) Confined Rotational Crops USE PATTERN A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B A, B CITATION(S) 00067068, 00112245, 00112281, 40111101 Data Gap 00084812, 00112283 00037175, 00112247 00112279 00160755 41840401 00112283, 00084810, Data Gap 40111101 43391801 43391802 43401301 42837901, 44356201 OTHER 810.1000 90-1 201-1 202-1 Use/Usa ge Data Droplet Size Spectrum Drift Field Evaluation A, B A, B A, B Data Gap Data Gap Data Gap 129