1 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES December 15, 2005 Dear Reader:

The Reregistration Eligibility Decision ( RED) document for was signed on September 28, 2001. A post signature comment period opened April 18, 2002 and closed June 17, 2002. The risk assessments, benefit assessments, and public comments can be found on the FDMS docket system, available at http:// www. regulations. gov ( docket # OPP 2002 0009). The Environmental Protection Agency has reviewed and responded to the public comments. These responses are also available for viewing in the FDMS docket. As a result of its review of the public comments, the Agency revised the Propargite RED, where appropriate. The following changes were made to the September 28, 2001 version of the RED; these changes are incorporated in this December 15, 2005 version.

( 1) Walnut: 21 day restricted entry interval ( REI) exemption granted for tree shaking; ( 2) Citrus ( bearing): REI for all activities changed to 20 days;

( 3) Mint: REIs for all activities reduced to 7 days;

( 4) Potato: maximum per season use rate increased from 3.7 to 4.1 pounds active ingredient per acre (" lbs. a. i./ A") acre per season;

( 5) Potato: spray interval reduced from 21 days to 14 days for Washington State;

( 6) Mint: spray interval reduced from 21 days to 14 days.

In addition to the substantive changes listed above, the Agency has also reformatted Appendix B, Appendix D and Appendix I for clarity, and has made technical changes to Table 15 to conform to current labeling language. 2 The revised document attached to this letter represents the EPA's reregistration decision for propargite. If you have questions on this RED or any of the revisions listed above, please contact the Chemical Review Manager, Dayton Eckerson, at ( 703) 308 8038. For questions about product reregistration, please contact Bonnie Adler ( 703) 308 8523.

Sincerely,

Debra Edwards, Ph. D. Director, Special Review and Reregistration Division Attachment 3 UNITED STATES ENVIRONMENTAL PROTECTION AGENCY WASHINGTON, D. C. 20460 OFFICE OF PREVENTION, PESTICIDES AND TOXIC SUBSTANCES CERTIFIED MAIL September 28, 2001 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 risk assessment for the miticide propargite. The Agency has revised the human health and environmental effects risk assessments based on the comments received during the public comment period and additional data received from the registrant. Based on the EPA's revised risk assessments for propargite, EPA has identified risk mitigation measures that the Agency believes are necessary to address the human health and environmental risks associated with the current use of propargite. EPA is now publishing its reregistration eligibility, risk management, and tolerance reassessment decisions for the current uses of propargite, and its associated human health and environmental risks. The Agency's decision on the individual chemical propargite can be found in the attached document entitled, " Reregistration Eligibility Decision for Propargite" which was approved on September 28, 2001.

A Notice of Availability for the Reregistration Eligibility Decision for Propargite is being published in the Federal Register. To obtain copies of the RED document, please contact the Pesticide Docket, Public Response and Program Resources Branch, Field Operations Division ( 7506C), Office of Pesticide Programs ( OPP), USEPA, Washington, DC 20460, telephone ( 703) 305 5805. Electronic copies of the RED and all supporting documents are available on the Internet. See http:// www. epa. gov/ pesticides/ reregistration/ status. htm 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 and to engage the public in the reregistration and tolerance reassessment processes. In cooperation with the U. S. Department of Agriculture, the Agency held a teleconference on July 19, 2000, during which the results of the human health and environmental effects risk assessments were presented to interested stakeholders. Information discussed during the call, such as propargite usage and occupational practices, are reflected in this RED. Also, a close out conference call was conducted on September 25, 2001 with many of the same participants from the July 19 conference call, to discuss the risk management decisions and resultant changes to the propargite labels. 4 A risk mitigation proposal for propargite was submitted by Uniroyal Chemical, the technical registrant. During the public comment period provided for the preliminary risk assessment, EPA also received comments from the Almond Hullers and Processors Association and the National Agricultural Aviation Association ( NAAA). Subsequent to the comment period for the propargite preliminary risk assessment, EPA also received a series of letters and e mails from several growers groups and extension services attesting to the benefits of propargite. These comments can also be found in the public docket for propargite.

Please note that the propargite risk assessment and the attached RED concern only this particular pesticide. The Food Quality Protection Act ( FQPA) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." At this time, the Agency does not believe that propargite shares a common mechanism of toxicity with other pesticides. Therefore, propargite is not subject to any cumulative risk assessment as required by the Food Quality Protection Act ( FQPA).

This document contains a generic and/ or a product specific Data Call In( s) ( DCI) that outline( s) further data requirements for this chemical. Note that registrants of propargite must respond to DCIs issued by the Agency within 90 days of receipt of this letter. This RED also contains labeling requirements for propargite products. End use product labels must be revised by the manufacturer to adopt the changes set forth in Section IV of this document. Instructions for registrants on submitting revised labeling and the time frame established to do so can be found in Section V of this document.

Should a registrant fail to implement any of the risk mitigation measures outlined in this document, the Agency will continue to have concerns about the risks posed by propargite. 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. At that time, any affected person( s) may challenge the Agency's action.

There will be a 60 day public comment period for this document, commencing on the day the Notice of Availability publishes in the Federal Register.

If you have questions on this document or the proposed label changes, please contact the Special Review and Reregistration Division representative, Dayton Eckerson at ( 703) 308 8038. For questions about product reregistration and/ or the Product DCI that accompanies this document, please contact Bonnie Adler at ( 703) 308 8523.

Lois A. Rossi, Director Special Review and Reregistration Division Attachment 5 Reregistration Eligibility Decision ( RED) for Propargite Case No. 0243 Effective: September 28, 2001 Amended: December 15, 2005____ 6 TABLE OF CONTENTS Executive Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 2 I. Introduction . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 7 II. Chemical Overview . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 A. Regulatory History . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 8 B. Chemical Identification . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 9 C. Use Profile . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 D. Estimated Usage of Pesticide . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 10 III. Summary of Propargite Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 A. Human Health Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 1. Dietary Risk from Food . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 a. Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 12 b. FQPA Safety Factor . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 13 c. Population Adjusted Dose ( PAD) . . . . . . . . . . . . . . . . . . . . . 13 d. Exposure Assumptions . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 e. Food Risk Characterization . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 14 2. Dietary Risk from Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 15 a. Surface Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 b. Ground Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 16 c. Drinking Water Levels of Comparison ( DWLOCs) . . . . . . . . . . . . . . . . . . . 17 i. DWLOCs for Acute Exposure . . . . . . . . . . . . . . . . . . . 17 ii. DWLOCs for Chronic Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 17 iii. DWLOCs for Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . 18 3. Aggregate Risks ( Food and Water) . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 a. Acute Aggregate Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 b. Chronic ( Non Cancer) Aggregate Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 c. Aggregate Risk for Cancer . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 19 4. Occupational Risk . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 a. Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 20 b. Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 21 c. Occupational Handler Risk Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 23 i. Agricultural Handler Risk . . . . . . . . . . . . . . . . . . . . . . 24 ii. Post Application Occupational Risk . . . . . . . . . . . . . . 31 5. Human Incident Data . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 33 7 B. Environmental Risk Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 1. Environmental Fate and Transport . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 34 2. Ecological Toxicity . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 a. Risk to Birds and Mammals . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 35 b. Risk to Aquatic Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 36 c. Endangered Species . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 37 3. Ecological Incidents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 38 IV. Risk Management and Reregistration Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 A. Determination of Reregistration Eligibility . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 B. Summary of Public Comments and Responses . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 39 C. Regulatory Position . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 1. FQPA Assessment . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 a. " Risk Cup" Determination . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 41 b. Determination of Safety for U. S. Population . . . . . . . . . . . . . . . . . . . . . . . . . 41 c. Determination of Safety for Infants and Children . . . . . . . . . . . . . . . . . . . . 42 d. Endocrine Disruptor Effects . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 42 e. Cumulative Risks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 f. Tolerances Summary . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 43 i. Tolerances Listed Under 40 CFR § 180.259( a) . . . . . . 43 ii. Tolerances to be Proposed Under 40 CFR § 180.259( a) 45 iii. Tolerances Listed Under 40 CFR § 180.259( b) . . . . . . 45 iv. Codex Harmonization . . 48 D. Regulatory Rationale . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 1. Human Health Risk Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 a. Dietary ( Food) Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 49 i. Acute Dietary ( Food) . . . . . . . . . . . . . . . . . . . . . . . . . . 49 ii. Chronic Dietary ( Food) . . . . . . . . . . . . . . . . . . . . . . . . 50 iii. Chronic Cancer Dietary ( Food) . . . . . . . . . . . . . . . . . 50 iv. Drinking Water . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 50 v. Aggregate Risk Mitigation ( acute and chronic) . . . . 52 b. Occupational Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 i. Handler Exposure . . . . . . . . . . . . . . . . . . . . . . . . . . . . 53 ii. Post application Exposure . . . . . . . . . . . . . . . . . . . . . . 54 2. Environmental Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 a. Avian and Mammalian Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . 58 b. Aquatic Risk Mitigation . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 59 c. Benefits . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 60 3. Other Label Statements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 a. Endangered Species Statement . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 b. Spray Drift Management . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 62 V. What Registrants Need To Do . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 8 A. Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 1. Additional Generic Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 2. Labeling for Manufacturing Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 64 B. End Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 1. Additional Generic Data Requirements . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 2. Labeling for End Use Products . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 C. Existing Stocks . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 D. Labeling Changes Summary Table . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 65 VI. Related Documents and How To Access Them . . . . . . . . . . . . . . . . . . . . . . . . . . . . 78 Appendix A: Propargite Use Patterns Eligible for Reregistration . . . . . . . . . . . . . . . . . . . 79 Appendix B: Table of Generic Data Requirements and Studies Used To Make the Reregistration Eligibility Decision . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 95 Appendix C: Technical Support Documents . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 105 Appendix D: Citations Considered To Be Part Of The Database Supporting the Interim Reregistration Eligibility Decision ( Bibliography) . . . . . . . . . . . . . . . . . . . 106 Appendix E: Generic Data Call In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 108 Appendix F: Product Specific Data Call In . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 110 Appendix G: EPA Batching of End Use Products for Meeting Data Requirements for Reregistration . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . . 111 Appendix H: List of Registrants Sent this Data Call In . . . . . . . . . . . . . . . . . . . . 113 Appendix I: List of Available Documents and Electronically Available Forms . . . . . . . 115 9 PROPARGITE TEAM Office of Pesticide Programs:

Health Effects Risk Assessment Thurston G. Morton Lori Brunsman Suhair Shallal Jerry Stokes Seyed Tadayon Environmental Fate Risk Assessment Richard Mahler James Hetrick Edward Odenkirchen Sid Abel Dana Spatz Kevin Costello Use and Usage Analysis Jihad Alsadek David Brassard Registration Support Kevin Sweeney Risk Management Dayton Eckerson Daniel Helfgott Diane Sherman 10 GLOSSARY OF TERMS AND ABBREVIATIONS AE Acid Equivalent a. i. Active Ingredient AGDCI Agricultural Data Call In ai Active Ingredient aPAD Acute Population Adjusted Dose AR Anticipated Residue ARC Anticipated Residue Contribution BCF Bioconcentration Factor CAS Chemical Abstracts Service CI Cation CNS Central Nervous System cPAD Chronic Population Adjusted Dose CSF Confidential Statement of Formula CFR Code of Federal Regulations CSFII USDA Continuing Surveys for Food Intake by Individuals DCI Data Call In DEEM Dietary Exposure Evaluation Model DFR Dislodgeable Foliar Residue DRES Dietary Risk Evaluation System DWEL Drinking Water Equivalent Level ( DWEL) The DWEL represents a medium specific ( i. e., drinking water) lifetime exposure at which adverse, noncarcinogenic health effects are not anticipated to occur. DWLOC Drinking Water Level of Comparison. EC Emulsifiable Concentrate Formulation EEC Estimated Environmental Concentration. The estimated pesticide concentration in an environment, such as a terrestrial ecosystem. EP End Use Product EPA U. S. Environmental Protection Agency FAO Food and Agriculture Organization FDA Food and Drug Administration FIFRA Federal Insecticide, Fungicide, and Rodenticide Act FFDCA Federal Food, Drug, and Cosmetic Act FQPA Food Quality Protection Act FOB Functional Observation Battery G Granular Formulation GENEEC Tier I Surface Water Computer Model GLC Gas Liquid Chromatography GLN Guideline Number GM Geometric Mean GRAS Generally Recognized as Safe as Designated by FDA HA Health Advisory ( HA). The HA values are used as informal guidance to municipalities and other organizations when emergency spills or contamination 11 situations occur. HAFT Highest Average Field Trial HDT Highest Dose Tested IR Index Reservoir LC 50 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. LD 50 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. LEL Lowest Effect Level LOC Level of Concern LOD Limit of Detection LOAEL Lowest Observed Adverse Effect Level MATC Maximum Acceptable Toxicant Concentration MCLG Maximum Contaminant Level Goal ( MCLG) The MCLG is used by the Agency to regulate contaminants in drinking water under the Safe Drinking Water Act. mg/ kg/ day Milligram Per Kilogram Per Day mg/ L Milligrams Per Liter MOE Margin of Exposure MP Manufacturing Use Product MPI Maximum Permissible Intake MRID Master Record Identification ( number). EPA's system of recording and tracking studies submitted. NA Not Applicable N/ A Not Applicable NAWQA USGS National Water Quality Assessment NOEC No Observable Effect Concentration NOEL No Observed Effect Level NOAEL No Observed Adverse Effect Level NPDES National Pollutant Discharge Elimination System NR Not Required OP Organophosphate OPP EPA Office of Pesticide Programs OPPTS EPA Office of Prevention, Pesticides and Toxic Substances Pa pascal, the pressure exerted by a force of one newton acting on an area of one square meter. PAD Population Adjusted Dose PADI Provisional Acceptable Daily Intake PAG Pesticide Assessment Guideline PAM Pesticide Analytical Method PCA Percent Crop Area 12 PDP USDA Pesticide Data Program PHED Pesticide Handler's Exposure Data PHI Preharvest Interval ppb Parts Per Billion PPE Personal Protective Equipment ppm Parts Per Million PRN Pesticide Registration Notice PRZM/ EXAMS Tier II Surface Water Computer Model Q 1 * The Carcinogenic Potential of a Compound, Quantified by the EPA's Cancer Risk Model RAC Raw Agriculture Commodity RBC Red Blood Cell RED Reregistration Eligibility Decision REI Restricted Entry Interval RfD Reference Dose RQ Risk Quotient RS Registration Standard RUP Restricted Use Pesticide SAP Science Advisory Panel SCI GROW Tier I Ground Water Computer Model SF Safety Factor SLC Single Layer Clothing SLN Special Local Need ( Registrations Under Section 24( c) of FIFRA) TC Toxic Concentration. The concentration at which a substance produces a toxic effect. TD Toxic Dose. The dose at which a substance produces a toxic effect. TEP Typical End Use Product TGAI Technical Grade Active Ingredient TLC Thin Layer Chromatography TMRC Theoretical Maximum Residue Contribution torr A unit of pressure needed to support a column of mercury 1 mm high under standard conditions. TRR Total Radioactive Residue UF Uncertainty Factor µ g/ g Micrograms Per Gram µ g/ L Micrograms Per Liter USDA United States Department of Agriculture USGS United States Geological Survey UV Ultraviolet WHO World Health Organization WP Wettable Powder WPS Worker Protection Standard 13 14 Executive Summary EPA has completed its review of public comments on the preliminary risk assessments and is issuing its risk management decision for propargite. The revised risk assessments are based on review of the required target data base supporting the use patterns of currently registered products and additional 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 propargite. After considering the risks identified in the revised risk assessment, mitigation measures proposed by Uniroyal Chemical Company, the technical registrant of propargite, and comments and mitigation suggestions from other interested parties, EPA developed its risk management decision for uses of propargite that pose risks of concern. This decision is discussed fully in this document.

Propargite is an organosulfur miticide/ acaricide used on a variety of bearing and non bearing agricultural food crops, as well as non food agricultural sites. It was first registered in 1969. Approximately 2 million pounds of propargite active ingredient are applied annually. Sites on which propargite has the highest percent of crop treated include grapes, walnuts, almonds, nectarines, and mint.

The Food Quality Protection Act ( FQPA) requires that, when considering whether to establish, modify, or revoke a tolerance, the Agency consider " available information" concerning the cumulative effects of a particular pesticide's residues and " other substances that have a common mechanism of toxicity." The Agency does not believe that propargite shares a common mechanism of toxicity with other chemicals. Although chemical class is not necessarily synonymous with a common mechanism of toxicity, structurally similar chemical substances do frequently exhibit common modes of toxicity and may be considered together by EPA for purposes of cumulative risk assessment. Propargite is the only organosulfur chemical that is subject to reregistration under FIFRA and tolerance reassessment under the FQPA. Therefore, propargite is not subject to any cumulative risk assessment as required by the Food Quality Protection Act ( FQPA).

Overall Risk Summary EPA's human health risk assessment for propargite indicates that food risk, both acute and chronic, are not a concern ( 2% of aPAD and < 1% of cPAD). The drinking water risk estimates for acute and chronic exposures, based on screening models and USGS monitoring data, are also not of concern for either ground or surface waters. Propargite is classified as a B2 chemical carcinogen based on the appearance of intestinal tumors in test animals. The cancer dietary risk from food alone is 1.8 x 10  7 for the general U. S. population, and is not a concern for the Agency. However, the cancer drinking water risk from surface water alone may be of concern, based on the screening models and USGS/ NAWQA monitoring data. There are also concerns for workers who mix, load, and apply propargite to agricultural sites. Finally, EPA has identified a chronic reproductive risk of concern to birds and mammals, and some risk to aquatic species.

To mitigate risks of concern posed by the uses of propargite, EPA considered the mitigation 15 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, and ecological concerns. Results of the risk assessments, and required label amendments to mitigate those risks, are presented in this RED.

Dietary Risk   Food EPA's dietary risk analysis consists of three parts: acute dietary risk, chronic ( non cancer) dietary risk, and chronic cancer risk. The acute dietary exposure analysis was performed using a refined Tier 3 approach based on the Dietary Exposure Evaluation Model ( DEEM   ) . The DEEM   analysis evaluated the individual food consumption as reported by respondents in the USDA 1989 91 Continuing Surveys for Food Intake by Individuals ( CSFII) and accumulated exposure to the chemical for each commodity. Under this analysis, a risk estimate that is less than 100% of the acute Population Adjusted Dose (" aPAD") ( the dose at which an individual could be exposed on any given day and no adverse health effects would be expected) does not exceed the Agency's level of concern. Based on the estimates for acute exposure to propargite, the percentage of aPAD utilized is 2 percent; therefore the acute dietary ( food) risk estimate for propargite is not of concern.

For the chronic ( non cancer) dietary risk assessment, an average of consumption values for each sub population is combined with average residue values in/ on commodities over a 70 year lifetime to determine average exposure. A risk estimate that is less than 100% of the chronic PAD ( the dose at which an individual could be exposed over the course of a lifetime and no adverse health effects would be expected) does not exceed the Agency's level of concern.

The chronic dietary analysis utilized USDA Pesticide Data Program ( PDP) monitoring data, field trial data, calculated livestock anticipated residues, and percent crop treated information. Based on that analysis, the percentage of cPAD utilized is expected to be less than 1 percent for the U. S. population and all subpopulations. Therefore, the chronic dietary ( food) risk estimate is also not of concern.

Chronic ( cancer) dietary risk is also calculated by using the average consumption values for food and average residue values for those foods over a 70 year lifetime. The chronic exposure value is combined with a linear low dose risk model (" Q 1 *") to determine the lifetime ( cancer) risk estimate. The Agency generally considers risks greater than 1 x 10 6 ( 1 in 1 million) to exceed its level of concern for cancer dietary exposure. Propargite is classified as a B2 chemical carcinogen ( likely human carcinogen), based on the appearance of intestinal tumors in rats. The results of the Q 1 * model indicate that the cancer dietary risk from food alone is 1.8 x 10 7 for the general U. S. population. Therefore, the cancer dietary risk from food alone is not a concern.

Dietary Risk   Drinking Water Drinking water exposure to pesticides can occur through groundwater and surface water contamination. EPA considers acute ( one day) and chronic ( lifetime) drinking water risks and uses either modeling or actual monitoring data, if available, to estimate those risks. To determine the 16 maximum allowable contribution from water allowed in the diet, EPA first looks at how much of the overall allowable risk is contributed by food and then determines a " drinking water level of comparison" ( DWLOC) to determine whether modeled or monitoring estimated environmental concentration ( EEC) levels exceed this level. EECs that are above the corresponding DWLOC exceed the Agency's level of concern. Modeling is generally considered to be an unrefined assessment and provides high end estimates.

Based on modeling data, the acute drinking water exposures for females 13 50 years old for surface water and groundwater were less than the acute DWLOC of 2400 ppb. Since the EEC of 34 ppb for surface water and 0.006 for groundwater is less than the DWLOC, the acute dietary risk from food and drinking water are not a concern. Similarly, modeling data for chronic drinking water concentrations for surface water and groundwater exposures also indicated that chronic dietary risk from food and drinking water are not of concern. The DWLOCs were 1400 ppb for the U. S. population and 400 ppb for infants and children compared to a chronic EEC of 8.7 for surface water and 0.006 for groundwater. However, modeling data does indicate a concern for cancer. The EECs for surface water of 4.8 ppb exceed the cancer DWLOC of 0.71 ppb.

Although the cancer drinking water risk estimates from surface water is above the Agency's level of concern, the Agency believes the modeling estimates and monitoring data upon which the assessment is based are conservative. Actual drinking water exposure to propargite from surface water sources is expected to be less. Moreover, the registrant has agreed to add label statements prohibiting application of propargite by ground within 50 feet or by air within 75 feet of aquatic areas to mitigate the drinking water ( and ecological) risk concerns. The registrant has also agreed to conduct a drinking water monitoring study to confirm the Agency's belief that drinking water exposures will not exceed the level of concern.

Residential Risk Use of propargite in residential settings is not permitted. Therefore, the Agency does not expect residential exposures to propargite.

Aggregate Risk An aggregate risk assessment looks at the combined risk from dietary exposure ( food and drinking water routes) as well as exposures from non occupational sources ( e. g., residential uses). Generally, all risks from these exposures must have MOEs of greater than 100 to be not of concern to the Agency. Because there are no residential uses of propargite, the aggregate risks are limited to dietary ( food and water) exposure. The risks from those combined exposures are discussed above in the preceding " Dietary Risk  Drinking Water" section.

Occupational Risk Occupational exposure to propargite is of concern to the Agency, and it has been determined 17 that a number of mitigation measures are required. For the agricultural uses of propargite, several mixer/ loader/ applicator risk scenarios currently exceed the Agency's level of concern ( i. e., dermal MOEs are less than 100) at baseline level of protection ( shoes, socks, long sleeved shirts and long pants, and no gloves) for acute and chronic health effects. Also, mixer and loader cancer risks, when calculated without personal protective equipment or engineering controls, can range up to 1 x 10 3. That estimate also exceeds the Agency's level of concern. EPA believes these risks can be mitigated to an acceptable level with the following label restrictions: ( 1) requiring use of personal protective equipment for certain scenarios; ( 2) requiring engineering controls for certain scenarios; ( 3) increasing restricted entry intervals for certain uses, and ( 4) reclassifying propargite as a restricted use pesticide.

Ecological Risk Ecological risks are of concern to the Agency. Based on toxicity studies submitted by the Registrant, propargite poses a potential for adverse effects on reproduction in birds and mammals. Risk to aquatic organisms and plants is generally lower than the risk for birds and mammals; however, the chronic risk concern levels for freshwater invertebrates and freshwater fish are either approached or exceeded for over 60 days from multiple propargite applications. Propargite is also expected to be highly toxic to amphibians. To address these ecological risks, the registrant has agreed to:

° Decrease seasonal maximum rates for several high use crops. See Table 11. ° Add spray intervals of 21 days for most food crops ( 28 days for citrus). See Table 12. ° Decrease the number of annual applications for cotton. ° Add label statements prohibiting application of propargite by ground within 50 feet or by air within 75 feet of aquatic areas. ° Add label requirements to minimize spray drift exposures. ° Conduct testing to better characterize exposure and risk to birds.

The reclassification of propargite to restricted use may also help address the concerns related to runoff to aquatic areas. Additionally, as noted in the drinking water description above, the registrant will be conducting a surface water monitoring study to address drinking water concerns. Although that study will not be directed specifically at ecological risk, it is expected to produce data useful to assessing ecological risks as well.

Conclusions The Agency is issuing this Reregistration Eligibility Document ( RED) for Propargite, as announced in a Notice of Availability published in the Federal Register. This RED document includes guidance and time frames for complying with any required label changes for products containing propargite. With the addition of the label restrictions and amendments detailed in this document, the Agency has determined that all currently registered uses of propargite are eligible for reregistration.

There is a 60 day public comment period for this document. 18 19 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 during reregistration. 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, which was August 3, 1996. 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. Propargite is an organosulfur chemical, and is the only chemical in this class that is subject to tolerance assessment under FQPA. Although chemical class is not necessarily equivalent to a common mechanism of action, in some cases, chemicals within the same class have been shown to share a common mechanism of action and are being considered together for purposes of a cumulative assessment ( e. g., the organophosphates). For propargite, there are no other organosulfur chemicals being reviewed under FQPA, and the Agency does not believe that propargite shares a common mechanism of toxicity with other chemicals. Therefore, propargite is not subject to any cumulative risk assessment as required by the FQPA.

This document presents the Agency's revised human health and ecological risk assessments; the tolerance reassessment; and the reregistration eligibility decision for propargite.

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:

C Applying the FQPA 10 fold safety factor C Whether and how to use probabilistic analyses in dietary exposure assessments C How to interpret " no detectable residues" in dietary exposure assessments C Refining dietary ( food) exposure estimates C Refining dietary ( drinking water) exposure estimates C Assessing residential exposure C Aggregating exposure from all non occupational sources 20 C How to conduct a cumulative risk assessment for organophosphate or other pesticides with a common mechanism of toxicity C Selection of appropriate toxicity endpoints for risk assessments of organophosphates C 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.

This document consists of six sections. Section I contains the regulatory framework for reregistration/ tolerance reassessment . Section II provides a profile of the use and usage of the chemical. Section III gives an overview of the revised human health and environmental effects risk assessments resulting from public comments and other information. Section IV presents the Agency's reregistration eligibility and risk management decisions. Section V summarizes required label changes based on the risk mitigation measures outlined in Section IV. Section VI provides information on how to access related documents. Finally, the Appendices lists Data Call In ( DCI) information. The revised risk assessments and related addenda are not included in this document, but are available on the Agency's web page www. epa. gov/ pesticides, and in the Public Docket.

II. Chemical Overview A. Regulatory History Propargite was first registered in the United States in 1969 for control of mites on a variety of field, fruit, and vegetable crops, as well as ornamentals. It is manufactured by Uniroyal Chemical, the sole propargite registrant, under the trade names Omite and Comite. EPA issued a Registration Standard for Propargite on September 30, 1986 ( PB 87 139358). A data call in was issued on October 13, 1995. In April 5, 1996, the Agency and the registrant signed an agreement under which the registrant voluntarily canceled certain uses of the pesticide. The uses canceled under the agreement included those for apricots, apples, peaches, pears, plums, figs, cranberries, strawberries, green beans, and lima beans. Based on Agency analysis of submitted residue monitoring data, those uses were believed to pose an unacceptable carcinogenicity dietary risk. Tolerances for these 10 uses were subsequently revoked ( 64 FR 39068; July 21, 1999).

In an effort to promote transparency of the reregistration process and public understanding of regulatory decisions, the Agency, in cooperation with the U. S. Department of Agriculture ( USDA) modified the reregistration and tolerance reassessment process in 1998. This modified process provides opportunities for stakeholders to ask questions about and provide input to the risk assessment and risk mitigation strategies, via conference calls and other formats. Consistent with this process, a conference call was conducted on July 19, 2000 with EPA, USDA, the registrant, and other stakeholders ( i. e., growers, commodity groups, and others) to discuss the basis of the calculated risks of propargite, and the Agency's resultant risk concerns. Information discussed during the call, such as propargite usage and occupational practices, are reflected in this RED. The August 2, 2000 21 CH 3 C H 3 CH 3 O O S O O CH risk assessments were made publically available. Also, a close out conference call was conducted on September 25, 2001 with many of the same participants from the July 19, 2000 conference call, to discuss the risk management decisions and resultant changes to the propargite labels.

This RED was signed on September 28, 2001. A post signature comment period opened April 18, 2002 and closed June 17, 2002. The Environmental Protection Agency has reviewed and responded to the public comments. As a result of its review of the public comments, the Agency revised this Propargite RED, where appropriate. The comments and the Agency's responses are available for viewing on the FDMS docket system, available at http:// www. regulations. gov ( docket # OPP 2002 0009). The following changes were made to the September 28, 2001 version of the RED; these changes are incorporated in this December 15, 2005 version.

( 1) Walnut: 21 day restricted entry interval ( REI) exemption granted for tree shaking;

( 2) Citrus: REI for all activities changed to 20 days;

( 3) Mint: REIs for all activities reduced to 7 days;

( 4) Potato: maximum per season use rate increased from 3.7 to 4.1 pounds of active ingredient per acre (" lbs. a. i./ A") per season;

( 5) Potato: spray interval reduced from 21 days to 14 days for Washington State;

( 6) Mint: spray interval reduced from 21 days to 14 days.

In addition to the substantive changes listed above, the Agency has also reformatted Appendix B, Appendix D and Appendix I for clarity.

B. Chemical Identification ! Common Name: Propargite ! Chemical Name: 2( p tert butylphenoxy) cyclohexyl 2 propynyl sulfite ! Chemical family: Organosulphite 22 ! Case number: 0243 ! CAS registry number: 2312 35 8 ! OPP chemical code: 097601 ! Empirical formula: C 19 H 26 O 4 S ! Molecular weight: 350.5 g/ mole ! Trade and other names: Omite, Comite ! Basic manufacturer: Uniroyal Chemical Propargite technical is a light to dark brown viscous liquid which decomposes ( 200 B C) before boiling, has a specific gravity of 1.10 at 20 B C, octanol/ water partition coefficient ( log K ow ) of 5.8 at 25 B C, and vapor pressure of 4.49 x 10 9 mm Hg at 25 B C. Propargite is only slightly soluble in water ( 1.9 ppm at 25 B C), but is soluble in most organic solvents (> 200 g/ L in acetone, dichloromethane, hexane, methanol, and toluene).

C. Use Profile The following information is based on the currently registered uses of propargite:

Type of Pesticide: Miticide/ Acaricide Summary of Use Sites:

Food: The use sites for propargite include alfalfa, almond, avocado, beans ( dry, including dry lima beans), boysenberry, carrot, cherry, corn ( field, pop, sweet), currant, date, filbert, grapefruit, jojoba, grapes, hazel nut, hops, lemon, lime, macadamia nut, mint, nectarine, orange, peanuts, pecan, persimmon, pistachio, potato ( white, Irish), quince, raspberry, sorghum, sugar beets, tangerines, and walnut.

Other agricultural sites : Christmas tree plantations, clover, conifers, cotton, and ornamental ( shade trees, herbaceous plants, woody shrubs and vines).

Residential: None.

Public Health: None.

Target Pests: The common mites controlled by propargite include among others panonychus, tetranychus, eotetranychus, bryobia, oligonychus, and typhlodromus. 23 Formulation Types Registered: Propargite is formulated as an emulsifiable concentrate liquid and as a wettable powder.

Application Methods and Equipment Aerial ( spray) Equipment: Foliar applications to fruit/ nut trees, field crops ( e. g., alfalfa, sorghum, corn), cotton, vegetable crops, specialty crops ( e. g., Christmas trees, mint, peanuts), roots and tuber vegetable ( e. g., carrot, sugar beet). Chemigation Equipment: Roots and vegetable ( e. g., potatoes) and field crops. Groundboom Equipment: Fruit/ nut orchard floors, field crops, cotton, and vegetable crops. Airblast Equipment: Fruit/ nut/ ornamental tree foliage. High Pressure Handwand Equipment: Non bearing nursery stock.

Application Rates and Frequency: 0.5 to 4.8 lbs active ingredient/ acre ; 2 to 3 times per year Use Classification: Not classified.

D. Estimated Usage of Pesticide This section summarizes the best estimates available for many of the pesticide uses of propargite, based on available pesticide usage information for a 10 year period. A full listing of all uses of propargite, with the corresponding use and usage data for each site, has been completed and is in the " Quantitative Use Analysis" 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 2 million lbs. a. i. of propargite are used annually, according to Agency and registrant estimates.

Table 1. Propargite Estimated Usage for Representative Sites1 Crop Lbs. Active Ingredient Applied ( Wt. Avg.) 2 Percent Crop Treated ( Likely Maximum) Percent Crop Treated ( Wt. Avg.)

Alfalfa 54,900 0.3 % 0.1 %

Almonds 320,000 58.9% 34.5%

Beans, Dry 50,400 4.0 % 2.0 %

Corn 460,000 0.7 % 0.4 %

Cotton 360,000 2.9 % 1.6 %

Grapes 350,000 30.1% 21.7%

Mint Not Available 34.0% 22.0%

Nectarines 20,000 44.4% 22.2%

Oranges 43,400 1.4 % 0.7 % 24 Peanuts 22,500 2.9 % 0.78 %

Potatoes 43,000 5.9 % 2.1 %

Sorghum 2,800 0.4 % 0.2 %

Sugar Beets 5,000 0.2 % 0.1 %

Walnuts 120,000 46.3% 25.3%

1 Uses with more than 1,000,000 acres grown or over 20% crop treated were selected as representative sites. 2 Weighted Average is based on data for 1988 through 1998; the most recent years and more reliable data are weighted more heavily. 25 III. Summary of Propargite Risk Assessment Following is a summary of EPA's revised human health and ecological risk findings and conclusions for the organosulfite pesticide propargite, as fully presented in the documents, " Propargite; Chemical No. 097601. Revised Human Health Risk Assessment for Propargite," dated June 6, 2000, as amended by the " Revised Human Health Risk Assesment for Propargite", dated September 13, 2001, and " Environmental Fate and Effects Division Science Chapter for Reregistration Eligibility Document for Propargite," dated June 7, 2000. 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.

The original risk assessments for propargite were made available in the public docket and on the internet on August 2, 2000. The Agency reviewed and addressed all comments on the risk assessment documents. There is a discussion of these comments in Section IV, later in this document.

A. Human Health Risk Assessment In response to comments and studies submitted, the risk assessments were updated and refined. The conclusions of the risk assessment are summarized below.

1. Dietary Risk from Food a. Toxicity The Agency has reviewed all toxicity studies submitted and has determined that the toxicity database is sufficiently complete, and that it supports a reregistration eligibility determination for all currently registered uses.

Propargite is classified as a B2 chemical carcinogen based on the appearance of intestinal tumors in test animals. The cancer concern was based on a 2 year cancer bioassay conducted on Sprague Dawley (" SD") rats. In that study, propargite caused fatal tumors of the intestine in both male and female rats. In other studies on mice and Wistar rats, propargite did not exhibit carcinogenicity or mutagenicity. In the SD rat study, there was a greater response in males and therefore, intestinal tumors in male rats were selected for dose response modeling. Statistical analysis conducted on the survival data indicated that there was a dose related increase in mortality. The usual Agency practice in such instances is to use the Weibull time to tumor model which takes into account both time and dose in estimating probability of tumor occurrence to calculate the cancer risk in humans. After discussions with the Registrant and Agency experts on alternative approaches to statistical cancer modeling, the Agency concluded that it's initial analysis, based on the time to tumor model, had not correctly accounted for the survival data and that the simpler Quantal model, which estimates tumor incidence only as a function of dose, should be used instead.

A time to tumor model is appropriate when there is dose related mortality in test animals from 26 non cancer toxicity. When such dose related responses occur, animals dying early from non cancer causes would presumably not be at risk for developing a tumor. In the present case, however, the Agency realized that the early deaths occurring in the study were explained by animals dying from the intestinal tumors before the end of the study, and therefore, those animals were clearly at risk for developing tumors. Thus, the more complex time to tumor model was not appropriate. Additionally, further statistical analysis performed by the registrant clearly demonstrated that the Quantal model fit the data from the study very well, while the fit of the time to tumor was poor. The net effect of the use of the Quantal Model for propargite is that the estimated cancer potency of propargite is approximately 6 times lower than that presented in the preliminary risk assessment of June 6, 2000.

Further details on the toxicity of propargite can be found in the September 13, 2001 Human Health Risk Assessment, and the August 14, 2001 Memorandum " Recommendation for Selection of Cancer Dose Response Model and Q 1 * for Propargite". A brief overview of the studies used for the dietary risk assessment and other relevant information is outlined in Table 2 .

b. FQPA Safety Factor The FQPA Safety Factor was reduced to 1X based on the following factors: first, 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. Although propargite produced developmental effects in the rabbit, these effects were observed at the maternally toxic dose. Second, the Agency believes that its exposure assessments will not underestimate the potential dietary exposures for infants and children from the use of propargite. Third, there are currently no approved residential uses of propargite. Based on these factors, the additional 10X factor as required by FQPA was reduced to 1X.

c. Population Adjusted Dose ( PAD)

The PAD is a risk expression describing 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 propargite, the FQPA safety factor is 1; therefore, the acute RfD equals the acute PAD and the chronic RfD equals the chronic PAD. A risk estimate that is less than 100% of the acute or chronic PAD does not exceed the Agency's risk concern. The Agency's acute assessment concerns women of child bearing age only, since the toxicological endpoint relates to developmental toxicity. No suitable acute toxicological endpoint was identified for the general population. 27 Table 2. Summary of Toxicological Endpoints and Other Factors Used in the Human Dietary Risk Assessment of Propargite Assessment Dose ( mg/ kg/ day) Endpoint Study/ MRID Uncertainty Factor FQPA Safety Factor PAD ( mg/ kg/ day)

Acute Dietaryfemales 13 50 NOAEL= 8 Increased incidence of fused sternebrae in fetuses at 10 mg/ kg/ day ( LOAEL). Developmental Toxicity in Rabbits 41336301 100 1 aPAD = 0.08 Acute Dietarygeneral population NOAEL= N/ A No relevant single exposure endpoint was identified. N/ A N/ A 1 N/ A Chronic Dietary NOAEL = 4 Decreased body weight/ body weight gain and increased mortality at 19 mg/ kg/ day( LOAEL) for males. Chronic Feeding and Carcinogenicity in Rats 41750901 & 42837201 100 1 cPAD = 0.04 Cancer Risk Jejunal Tumors in Sprague Dawley rat [ Same as above] Q1* = 0.033 X 10  1 ( mg/ kg/ day) 1 d. Exposure Assumptions Revised acute and chronic dietary risk analyses for propargite were conducted with the Dietary Exposure Evaluation Model ( DEEM   ) . DEEM incorporates consumption data generated in USDA's Continuing Surveys of Food Intakes by Individuals ( CSFII), 1989 91. For the acute dietary risk assessment, the entire distribution of single day food consumption events was combined with a distribution of residues. This is known as a probabilistic analysis. Risk is reported at the 99.9 th percentile of exposure to obtain a distribution of exposure in mg/ kg/ day. For the chronic dietary risk assessment, the three day average of consumption for each sub population is combined with residues in commodities to determine average exposure in mg/ kg/ day.

In the case of propargite, a probabilistic acute dietary analysis was conducted utilizing USDA Pesticide Data Program ( PDP) monitoring data, field trial data, calculated livestock anticipated residues, and percent crop treated information.

e. Food Risk Characterization Because no relevant effects following a single dose of propargite were identified for the U. S. general population, an acute dietary risk assessment for the entire U. S. population was not conducted. However, an assessment was conducted for the subpopulation of women of childbearing age (" females 13 50 years old") because developmental effects ( birth defects) in rats were noted in one developmental rat toxicity study. The effects, skeletal malformations, are presumed to occur after a single exposure ( dose), and thus, are appropriate for the acute risk assessment. There was no increased susceptibility to infants or children. Estimated acute dietary exposure is below EPA's level of concern at the 99.9th percentile ( the maximum dietary risk estimate of 2 percent of the aPAD). 28 Estimated chronic dietary risk estimate is also below EPA's level of concern. Less than 1 percent of the chronic PAD for the U. S. general population and all population subgroups is estimated.

The maximum lifetime cancer dietary risk is estimated to be 1.8 x 10 7 for the general U. S. population. Therefore, the cancer risk from food is also not a concern since the risk is less than 1 x 10 6.

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, if available, actual monitoring data to estimate those risks. Modeling is generally considered to be an unrefined assessment and provides a high end estimate of risk.

The GENEEC and PRZM EXAMS models were used to estimate surface water concentrations, and SCI GROW was used to estimate groundwater concentrations. Both of these models are considered to be screening tools, with the PRZM EXAMS model being somewhat more refined than the other two. In addition, the Agency used time weighted annual mean for propargite concentrations in surface water samples from the United States Geologic Survey National Water Quality Assessment (" USGS / NAWQA") ( Oristimba Creek Watershed) for the years 1992 and 1993.

Propargite is moderately persistent ( metabolism half lives = 38 168 days) and immobile ( K d s ranged from 60 to 218 mL/ g, while K oc s ranged from 2963 to 57966 mL/ g) . It degrades rapidly under alkaline hydrolytic conditions ( half life = 2.2 days) and is moderately persistent to persistent under neutral ( half lives = 75 days) and acid ( pH 5; half life = 120 days) hydrolytic conditions. Soil and aquatic photolysis and aerobic and anaerobic metabolism occur at moderate rates ( half lives = 39 168 days). Because of its high affinity for soil and sediment, propargite has the potential to move off the site of application during rainfall, irrigation, erosion, runoff on soil particles and by drift. Given the moderate to slow degradation rates for metabolism and photolysis, and the high K oc values, propargite will probably be adsorbed to sediments and organic material if transported to surface waters. The Agency Metabolism Assessment Review Committee has concluded that the residue of concern in plants and animals is propargite per se and not its metabolites or degradate products. 29 a. Surface Water PRZM EXAMS (" Tier II") modeling was conducted as a refinement to the drinking water exposure assessment because the GENEEC (" Tier I") surface water modeling predicted that the 56 day average propargite concentrations in surface water were likely to exceed the cancer drinking water level of comparison ( DWLOC).

The Tier II modeling simulated average propargite a peak residue of 34 ppb for the acute value, and average residues of 8.7 ppb for the chronic value, and 4.8 for the cancer value. Since the cancer value exceeded the cancer DWLOC of 0.71, EPA investigated the United States Geologic Survey (" USGS") National Water Quality Assessment (" NAWQA") monitoring data further to evaluate how it compared to the modeling results. In that monitoring program, propargite was detected in 175 of 5196 samples for the period 1991 to 1995, with a maximum concentration of 20.0 ppb. The next highest concentration was 3.7 ppb. Out of the total 5196 samples, propargite was detected in 53 of 1000 samples taken from agricultural streams. Propargite was detected in 1 of 327 samples taken from urban streams, at a concentration of 0.015 ppb. Propargite was detected in 8 of 245 samples taken from 14 integrator sites on large streams and rivers, with a maximum concentration of 2.0 ppb.

Propargite detections in the NAWQA study were predominantly associated with the San Joaquin Tulare study unit at intensive fixed monitoring sites. This region corresponds with high propargite use (> 1.526 lb propargite/ mile2/ year) in the San Joaquin region and is associated primarily with beans, cotton, and almond production.

Although the cancer drinking water risk estimates from surface water is above the Agency's level of concern, the Agency believes, in the case of propargite, the modeling and monitoring data upon which the estimates are based are conservative and overestimates of actual exposure to propargite in drinking water from surface water sources. The reasons for this are described in the next section under " DWLOCs for Cancer."

b. Ground Water A Tier I screening model, SCI GROW, was used to provide an upper end estimate of drinking water concentrations derived from ground water. The Agency's default body weights and water consumption values used to calculate drinking water exposures are as follows: 70 kg/ 2L ( adult male), 60 kg/ 2L ( adult female), and 10 kg/ 1L ( child). The predicted groundwater concentration is 0.006 ppb. Fate studies also suggest that propargite has a low potential to reach groundwater. Therefore, the Agency does not have a concern for human exposure to propargite for drinking water from ground water sources. 30 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 monitoring levels exceed this level. The Agency uses the DWLOC as a surrogate to capture risk associated with exposure from pesticides in drinking water. The DWLOC is the maximum concentration in drinking water which, when considered together with dietary exposure, does not exceed a level of concern. In the case of propargite, there are no residential uses, therefore, only food and drinking water contributions were considered.

The results of the Agency's drinking water analysis are summarized here. Details of this analysis, which used screening models and actual monitoring data, are found in the Revised Human Health Risk Assessment for Propargite, dated September 13, 2001.

i. DWLOCs for Acute Exposure The DWLOC for acute exposure is 2400 ppb. Table 3 below presents the calculations for the acute drinking water assessment.

Table 3. Drinking Water Levels of Comparison for Acute Dietary Exposure.

Population Subgroup Acute PAD ( mg/ kg/ day) Food Exposure ( mg/ kg/ day) Max. Water Exposure ( mg/ kg/ day) DWLOCacute ( ppb) Surface Water EEC ( ppb) ( PRZMEXAMS Groundwater EEC ( ppb) ( SCI GROW)

Females 13 50 yrs. 0.08 0.001 0.08 2400 34 0.006 ii. DWLOCs for Chronic Exposure The DWLOC for chronic exposures are 400 ppb for infants and children and 1400 ppb for the general U. S. population. Table 4 below presents the calculations for the chronic drinking water assessment. 31 Table 4. Drinking Water Levels of Comparison for Chronic ( Non Cancer) Dietary Exposure.

Population Subgroup Chronic PAD ( mg/ kg/ day) Food Exposure ( mg/ kg/ day) Max. Water Exposure ( mg/ kg/ day) DWLOCchronic ( ppb) Surface Water EEC ( ppb) ( PRZMEXAMS Groundwater EEC ( ppb) ( SCI GROW)

US Population 0.04 0.00001 0.04 1400 8.7 0.006 All Infants 0.04 0.00001 0.04 400 8.7 0.006 Children 1 6 0.04 0.00001 0.04 400 8.7 0.006 Children 7 12 0.04 0.00001 0.04 400 8.7 0.006 Females 13 50 yrs. 0.04 0.00001 0.04 1200 8.7 0.006 Males 20+ yrs 0.04 0.00001 0.04 1400 8.7 0.006 iii. DWLOCs for Cancer The cancer DWLOC is the concentration of a pesticide in drinking water as a part of the aggregate chronic exposure that results in a negligible cancer risk ( 1 x 10  6 or less). The surface water EECs are 4.8 ppb based on PRZM EXAMS modeling and the groundwater EECs are 0.006 ppb based on SCI GROW. The Cancer DWLOC is 0.71.

Table 5. Propargite Cancer Dietary Exposure/ Risk. Population Subgroup Lifetime Risk ( Q 1 * = .033) Target Max Exposure2 mg. kg. day Chronic Food Exposure mg/ kg/ day Max Water Exposure3 mg/ kg/ day Exposure ( mg/ kg/ day) Groundwater EEC ( ppb) ( SCI GROW) Surface Water EEC ( ppb) ( PRZMEXAMS DWLOC cancer ( ppb)

U. S. Population 1.8 X 10 7 0.0000303 0.00001 0.0000203 0.000006 0.006 4.8 0.71 1DWLOCcancerwas calculated for US population only. Default body weight and consumption value for calculation of the DWLOC were: 2L/ 70 kg. 2Target Maximum Exposure ( mg/ kg/ day) = [ neglible risk/ Q*] 3Maximum Water Exposure ( mg/ kg/ day) = [ Target Maximum Exposure  ( Chronic Food Exposure + Residential Exposure ( Lifetime Average Daily Dose))] 4Cancer DWLOC 9ppb) = [ maximum water exposure ( mg/ kg/ day) x body weight ( kg)] [ water consumption ( L) x 10 3mg/ µ g] 2 32 3. Aggregate Risks ( Food and Water)

An aggregate risk assessment considers the combined risk from dietary exposure ( food and drinking water) and residential risk or other non occupational exposures, when appropriate. The Food Quality Protection Act amendments to the Federal Food, Drug, and Cosmetic Act ( FFDCA, Section 408( b)( 2)( A)( ii)) require that for establishing a pesticide tolerance " that there is reasonable certainty that no harm will result from aggregate exposure to pesticide chemical residue, including all anticipated dietary exposures and other exposures for which there are reliable information." Aggregate exposure will typically include exposures from food, drinking water, and residential uses of a pesticide, and other non occupational sources of exposure. When appropriate, aggregate risk assessments are conducted for acute ( one day), short term ( one to seven days), intermediate term ( seven days to several months), and chronic ( lifetime) exposure. Occupational exposure is not considered in any aggregate exposure assessment.

a. Acute Aggregate Risk The acute aggregate risk estimates for propargite address exposure from food and drinking water. There are no residential uses of propargite. Acute exposure is considered to occur in a oneday time frame via the oral route of exposure. Acute dietary risks are below the Agency's level of concern if less than 100 % of the aPAD. The estimated concentrations of propargite in drinking water, which are 34 ppb for surface water and 0.006 ppb for groundwater, are below the Agency's level of concern for all subpopulations including children 1 6 years ( DWLOC = 2400 ppb). The Agency is, therefore, not concerned with aggregate risks associated with propargite use.

b. Chronic ( Non Cancer) Aggregate Risk A chronic aggregate assessment estimates risk from long term exposure to food and water. There are no residential uses of propargite. The chronic DWLOC for infants and Children is 400 ppb and 1400 ppb for the general population, while the EEC in surface water is 8.7 ppb and ground water is 0.006 ppb. The chronic EEC s are less than than the chronic DWLOCs. The Agency is, therefore, not concerned with aggregate risks associated with propargite use.

c. Aggregate Risk for Cancer The EECs for surface water ( 4.8 ppb) were greater than the cancer DWLOC ( 0.71 ppb), indicating that the chronic exposure to propargite in food and water is greater than the Agency's level of concern. Surface water concentrations below 1.0 ppb would result in cancer risks below 1 x 10 6 for drinking water alone when back calculated. Based on monitoring data, the time weighted average propargite concentration in ambient surface water samples from the USGS/ NAWQA ( Oristimba Creek Watershed) for the years 1992 and1993 were 0.30 and 1.24 ppb, respectively. Therefore, there is a potential cancer risk of concern when ambient monitoring data are used to estimate drinking water exposure to propargite from surface water sources.

The EECs for groundwater were less than the cancer DWLOC, and therefore not a concern. 4. Occupational Risk 33 Occupational workers can be exposed to a pesticide through mixing, loading, and/ or applying a pesticide, or re entering treated sites. Occupational handlers of propargite include: individual farmers or growers who mix, load, and/ or apply pesticides, and professional or custom agricultural applicators. Risk for all of these potentially exposed populations is measured by a Margin of Exposure ( MOE) which determines how close the occupational exposure comes to a No Observed Adverse Effect Level ( NOAEL). In the case of propargite, MOEs greater than 100 for dermal and 1000 for inhalation do not exceed the Agency's risk concern.

a. Toxicity The toxicity of propargite is integral to assessing the occupational risk. All risk calculations are based on the most current toxicity information available for propargite. The toxicological endpoints, and other factors used in the occupational and residential risk assessments for propargite are listed below in table 6.

Table 6. Summary of Toxicological Endpoints and Other Factors Used in the Human Occupational Assessments for Propargite Assessment Dose ( mg/ kg/ day) Endpoint Study/ MRID Short Term 1 ( Dermal) NOAEL= 6 MOE = 100 Decreased maternal body weight gain at 8 mg/ kg/ day ( LOAEL). Developmental Toxicity in Rabbits 41336301 Intermediate Term 1 ( Dermal) NOAEL= 4 MOE = 100 Reduction in body weight gain and food consumption at 20 mg/ kg/ day ( parental LOAEL). Reproductive Toxicity in Rats 41352401 Short Term 2 ( Inhalation) LOAEL= 0.31mg/ L or 50 mg/ kg MOE = 1000 Increased mortality at 0.31 mg/ L ( LOAEL) in males. Acute Inhalation in Rats 42857003 Intermediate Term 2 ( Inhalation)

Cancer Q1 * 1 0.033x10 1 ( mg/ kg/ day Jejunal ( intestinal) tumors at 400 and 800 ppm dose levels. Mouse  18 month Rat  24 month 42837201 1 A 14% dermal absorption factor was used for risk assessment based on highest absorption/ elimination noted in submitted studies. Dermal MOE used for risk assessment of 100 based on use of animal toxicity studies. 2 Separate MOEs for dermal and inhalation were used because of different endpoints. An MOE of 1000 was selected for inhalation, including a 10X factor due to lack of a NOAEL, severity of effects at the lowest dose tested, and 4 hour duration. A 100% inhalation absorption factor was used.

Propargite is considered corrosive and has been placed in Category I for both eye and dermal irritation in rabbits. There have also been documented reports of dermal and eye irritation developing in workers exposed to propargite in the field. Evidence for its dermal sensitization potential have been noted; a study that provides conclusive results of this effect has not been possible due to the irritating properties of this chemical. 34 Table 7: Acute Toxicity of Propargite.

Guideline No. Study Type MRID #( S). Results Toxicity Category 870.1100 Acute Oral Rat 42857001 LD50 = 2639 mg/ kg for males 2947 mg/ kg for females 2800 mg/ kg combined III 870.1200 Acute Dermal Rabbit 42857002 LD50 > 2000 mg/ kg III 870.1300 Acute Inhalation Rat 42857003 LC50 = 0.95 mg/ L for males 0.95 mg/ L for females 0.89 mg/ L combined III 870.1400 Primary Eye Irritation Rabbit 42857004 Corrosive I 870.1500 Primary Skin Irritation Rabbit 42857005 Corrosive I 870.1600 Dermal Sensitization Guinea Pig 42857006 Sensitizer N/ A b. Exposure Uniroyal submitted applicator exposure studies in support of the reregistration process for propargite. These studies include:

° Airblast applicator exposure studies ( MRID Nos. 418486 05 and 420997 02) ° Groundboom applicator exposure study ( MRID No. 418486 05 )

It is EPA's policy to combine chemical specific studies with similar surrogate data from the Pesticide Handlers Exposure Database ( PHED) to assess handler exposures for regulatory actions. This policy is in effect because individual chemical specific studies do not necessarily encompass the variety of equipment in use throughout the country and the large variability of exposures among handlers. While data from PHED provides the best available information on handler exposures, it should be noted that some aspects of the included studies ( e. g., duration, acres treated, pounds of active ingredient handled) may not accurately represent labeled uses in all cases. PHED was designed by a Task Force of representatives from the U. S. EPA, Health Canada, the California Department of Pesticide Regulation, and member companies of the American Crop Protection Association. The quality of the data and exposure factors represents the best sources of data currently available to the Agency for completing these kinds of assessments; the application rates are derived directly from propargite labels. 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 represent low quality, but are the best available data. The quality of the data used for each scenario assessed is discussed in the September 13, 2001, Revised Human Health Assessment document for Propargite, which is available in the public docket. 35 Anticipated use patterns and application methods, range of application rates, and daily amount of acres treated were derived from current product labeling. Application rates specified on propargite labels range from 0.5 to 4.5 pounds of active ingredient per acre in agricultural settings. The Agency typically uses acres treated per day values that are thought to represent 8 hours of application work for specific types of application equipment.

EPA calculated the baseline MOE ( short term and intermediate term) and cancer risk for each of the exposure scenarios using the following baseline PPE assumptions: Long sleeved shirt, long pants, shoes ( or boots) and socks ( no gloves).

If the short term or intermediate term MOE calculated using this baseline PPE was 100 or greater for an exposure scenario, then no further calculations were made. If the baseline short term or intermediate term MOE was less than 100 for any exposure scenario, an additional short term or intermediate term MOE was calculated based on increasing the levels of protection ( additional PPE). EPA calculated a short term and/ or intermediate term MOE using additional PPE for each occupational exposure scenario that had baseline total MOE of less than 100, using the following additional PPE assumptions:

° Baseline PPE + chemical resistant gloves.

° Coveralls over long sleeved shirt and long pants, chemical resistant gloves, chemical resistant footwear plus socks, and chemical resistant headgear for over head exposures ( such as airblast applications).

If the short term or intermediate term MOE calculated using this additional PPE was 100 or greater for an exposure scenario, then no further calculations were made. If MOE remained less than 100 for any occupational exposure scenario, a short term or intermediate term MOE was calculated based on the mandatory use of engineering controls, where feasible. Engineering controls needed to address identified risks are noted in the final column of Table 8. EPA calculated the engineeringcontrol short term or intermediate term MOE for each occupational exposure scenario with an additional PPE short term or intermediate term MOE of less than 100, using the following engineering control assumptions:

° Occupational mixers and loaders handling liquid formulations using a closed system are wearing baseline PPE, chemical resistant gloves and chemical resistant apron. 36 ° Occupational mixers and loaders handling wettable powders using a closed system ( water soluble packages) are wearing baseline PPE, chemical resistant gloves and chemical resistant apron.

° Occupational applicators who use aerial, airblast, or tractor driven application equipment and handlers flagging for aerial applications are located in enclosed cabs or cockpits and wearing baseline PPE.

Finally, exposure to workers through post application entry into agricultural fields treated with propargite, were also assessed. The assumptions used in that analysis are described under section 3. c. ii. below.

c. Occupational Handler Risk Summary EPA has determined that there are potential exposures to mixers, loaders, applicators, or other handlers during usual use patterns associated with propargite. Based on the use patterns and potential exposures described above, 14 major agricultural exposure scenarios are identified in this document to represent the extent of propargite uses.

Agricultural exposure scenarios include: ( 1a) mixing/ loading liquids for aerial application, ( 1b) mixing/ loading liquids for chemigation, ( 1c) mixing/ loading liquids for groundboom application, ( 1d) mixing/ loading liquids for orchard airblast sprayer application, ( 1e) mixing/ loading liquids for application of high pressure handwand, ( 2a) mixing/ loading wettable powder for aerial application, ( 2b) mixing/ loading wettable powder for groundboom application, ( 2c) mixing/ loading wettable powder for orchard airblast sprayer application, ( 2d) mixing/ loading wettable powder for application of high pressure handwand, ( 3) applying sprays with fixed wing aircraft, ( 4) applying sprays using a groundboom sprayer, ( 5) applying sprays with an airblast sprayer, ( 6) applying liquids with a high pressure handwand and ( 7) flagging during aerial spray application.

In most cases, EPA assesses the exposure and risk to mixer/ loaders and applicators separately for tractor drawn applications ( i. e., airblast, groundboom, and granular spreaders). This practice has evolved, not because it is believed that there are always separate job functions, but rather because of the limited amount of information regarding these practices along with limited exposure data.

EPA has adopted a methodology to present the risks separately for some scenarios and combine others. Most of the hand held equipment such as backpack sprayers, and push type granular spreaders are assessed as a combined function. With these types of small operations the mixing, loading, and applying are almost always carried out by the same individual and there are data available to estimate exposure from these activities. For equipment such as fixed wing aircraft, groundboom tractors, and airblast sprayers the applications are assessed separately from the individual who mixes and loads the formulated product. EPA assumes that the pilots are rarely involved in the mixing/ loading. By separating the two job functions, EPA can determine the most appropriate PPE 37 or engineering control without requiring the handler to wear PPE throughout the entire workday or engineering controls that are not needed.

The potential handler exposures are assessed using the toxicological endpoints and uncertainty factors associated with the active ingredient. Therefore, the PPE and engineering controls are determined by the assessment of the active ingredient and not the currently required risk mitigation measures on propargite labels. This distinction of determining risk mitigation measures based on the active ingredient instead of the label required PPE is also important because of the nature of the enduse products. For example, some end use products require additional PPE that are not necessary for the active ingredient but rather because of the end use product's potential for eye and/ or skin irritation based on other ingredients of the formulation. Conversely, the Agency does not want to mandate additional PPE ( e. g., heat stress issues) if the PPE ensemble is not required based on the endpoint and uncertainty factors.

i. Agricultural Handler Risk Table 8 below summarizes the numeric MOE values for both the short and intermediate term exposure durations as well as cancer risk estimates. In the majority of cases, dermal exposure rather than inhalation exposure contributes relatively more exposure ( dermal and inhalation exposures were not combined in this assessment for the short and intermediate term MOEs. However, dermal and inhalation exposures were added for the cancer risk estimates). The MOEs are presented for baseline, PPE and engineering controls. Cancer risk estimates are also summarized at different levels of mitigation. MOEs 100 or above are not a concern for dermal exposure, while MOEs 1000 or above are required to be above the Agency's level of concern for inhalation exposure ( and extra10X factor is included due to lack of a NOAEL, severity of effects at the lowest dose tested, and 4 hour duration). The target for cancer risk is 1 x 10 6, however, the Agency will not accept risks above 1 x 10 4. For risks between 1 x 10 6 and 1 x 10 4, the Agency will pursue risk mitigation where feasible. 38 Table 8: Exposure Variables, MOEs and Cancer for Agricultural uses of Propargite Exposure Scenario ( Scenario #) Crop Group Crop Application Rates ( lb ai/ acre) Daily Acres Treated Short Term Dermal MOEsb Intermediate Term Dermal MOEsc Inhalation MOEse Cancerf Base linea PPE Eng Control Base linea PPE Eng. Control Base lined PPE Eng. Control Base line PPE Eng. control Mixer/ Loader Exposure Mixing/ Loading Liquids for Aerial Application ( 1a) Roots and Tuber Vegetable carrot, sugar beet,

potatoes, dry beans,

mint Min 2.0 350 1 160 NA < 1 125 NA 4135 NA NA 1.3E 3/

2.7E 3 1.4E 5/

2.8E 5 4.0E 6/

8.0E 6 Legume Vegetable Max 2.5 1 130 NA < 1 100 NA 3305 NA NA 1.6E 3/

3.2E 3 1.7E 5/

3.5E 5 5.0E 6/

9.9E 6 Herbs & Spices hops Max 2.5 80 4 560 NA 3 435 NA 14465 NA NA 3.6E 4/

7.3E 4 4.0E 6/

7.9E 5 1.2E 6/

2.3E 6 Citrus Fruits grapefruit, orange Max 2.5 125 3 360 NA 2 280 NA 9260 NA NA 5.6E 4/

1.1E 3 6.3E 6/

1.3E 5 1.8E 6/

3.6E 6 Tree Nuts almond, walnut Min 2.5 125 3 360 NA 2 280 NA 9260 NA NA 5.6E 4/

1.1E 3 6.3E 6/

1.3E 5 1.8E 6/

3.6E 6 Max 4.5 2 200 NA 1 155 NA 5145 NA NA 1.0E 3/

2.0E 3 1.1E 5/

2.2E 5 3.3E 6/

6.5E 6 Cereal Grains corn ( field, pop,

sweet), sorghum grain, alfalfa, clover Min 1.5 350 2 215 NA 1 165 NA 5510 NA NA 9.6E 4/

1.9E 3 1.1E 5/

2.1E 5 3.1E 6/

6.1E 6 1200 < 1 60 170 < 1 50 130 1600 NA NA 3.3E 3/

6.6E 3 3.8E 5/

7.5E 5 1.1E 5/

2.2E 5 Non grass Animal Feed Max 2.5 350 1 130 NA < 1 100 NA 3305 NA NA 1.6E 3/

3.2E 3 1.7E 5/

3.5E 5 5.0E 6/

9.9E 6 1200 < 1 35 100 < 1 30 80 960 1400 NA 5.5E 3/

1.1E 2 5.8E 5/

1.2E 4 1.7E 5/

3.4E 5 Oil Seed cotton Max 1.6 350 2 200 NA 1 155 NA 5165 NA NA 1.0E 3/

2.0E 3 1.1E 5/

2.2E 5 3.3E 6/

6.5E 6 1200 < 1 60 155 < 1 45 120 1505 NA NA 3.6E 4/

7.3E 4 4.0E 5/

7.9E 5 1.1E 5/

2.2E 5 peanut, jojoba Min 1.5 350 2 215 NA 1 165 NA 5510 NA NA 9.6E 4/

1.9E 3 1.1E 5/

2.1E 5 3.1E 6/

6.1E 6 Max 2.5 1 130 NA < 1 100 NA 3305 NA NA 1.6E 3/

3.2E 3 1.7E 5/

3.5E 5 5.0E 6/

9.9E 5 Ornamental plants Christmas Tree conifer seed Max 2.5 125 3 360 NA 2 280 NA 9260 NA NA 5.6E 4/

1.1E 3 6.3E 6/

1.. 3E 5 1.8E 6/

3.6E 6 Mixing/ Loading Liquids for Chemigation ( 1b) Roots and vegetable potatoes, corn ( sweet) Min 2.0 350 1 160 NA 1 125 NA 4135 NA NA 1.3E 3/

2.6E 3 1.4E 5/

2.8E 5 4.0E 6/

7.9. E 6 Cereal Grains Max 2.5 1 130 NA < 1 100 NA 3305 NA NA 1.6E 3/

3.2E 3 1.7E 5/

3.5E 5 5.0E 6/

9.9E 6 Table 8: Exposure Variables, MOEs and Cancer for Agricultural uses of Propargite Exposure Scenario ( Scenario #) Crop Group Crop Application Rates ( lb ai/ acre) Daily Acres Treated Short Term Dermal MOEsb Intermediate Term Dermal MOEsc Inhalation MOEse Cancerf Base linea PPE Eng Control Base linea PPE Eng. Control Base lined PPE Eng. Control Base line PPE Eng. control 39 Mixing/ Loading Liquids for Groundboom Application ( 1c) Roots and Vegetable potatoes, corn ( field,

pop, sweet)

sorghum grain,

alfalfa, clover,

cotton, peanut,

jojoba and mint Min 1.5 80 7 930 NA 6 725 NA 24110 NA NA 2.2E 4/

4.4E 4 2.4E 6/

4.8E 6 6.9E 7/

1.4E 6 Cereal Grains Non grass Animal Feed Oil Seed Max 2.5 4 560 NA 3 435 NA 14465 NA NA 3.6E 4/

7.3E 4 4.0E 6/

7.9E 6 1.2E 6/

2.3E 6 Herbs and Spices Mixing/ Loading Liquids for Airblast Sprayer Application ( 1d) Pome Fruits quince, cherry,

prunes, orange,

grapefruit lemon,

lime, tangerine,

boysenberry,

current, date raspberry, hops,

persimmons, 1.5 40 15 1865 NA 10 1450 NA 48220 NA NA 1.1E 4/

2.2E 4 1.2E 6/

2.4E 6 3.6E 7/

7.3E 7 Stone fruits Citrus Fruits Berries Herbs and Spices Tropical and Subtropical Fruits Tree Nuts almond, filbert,

macadamia nut,

pecan, pistachio Min 1.5 15 1865 NA 10 1450 NA 48220 NA NA 1.1E 4/

2.2E 4 1.2E 6/

2.4E 6 3.6E 7/

7.3E 7 Max 3.0 7 930 NA 6 725 NA 24110 NA NA 2.2E 4/

4.4E 4 2.4E 6/

4.8E 6 6.9E 7/

1.4E 6 walnut Max 4.5 5 620 NA 4 485 NA 16075 NA NA 3.3E 4/

6.6E 4 3.6E 6/

7.3E 6 1.1E 6/

2.1E 6 Ornamental plants Christmas Tree plantation, conifers,

shade trees Max 2.5 9 1120 NA 7 870 NA 28935 NA NA 1.9E 4/

3.7E 4 2.0E 6/

4.0E 6 5.9E 7/

1.2E 6 Mixing/ Loading Liquids for Application of High Pressure Handwand ( 1e) Non bearing nursery stock all crops Max 1.5 5 120 NA NA 90 11595 NA 385780 NA NA 1.4E 5/

2.8E 5 5.0E 6/

9.9E 6 6.9E 8/

1.4E 7 Mixing/ Loading Wettable Powder for Aerial Application ( 2a) Stone fruits nectarine Max 3.0 125 2 40 325 1 30 255 215 2155 NA 9.6E 4/

1.9E 3 1.0E 4/

2.0E 4 5.3E 6/

1.1E 5 Tree Nuts walnut Max 4.0 1 30 245 1 25 190 160 1615 NA 1.3E 3/

2.6E 3 1.4E 4/

2.8E 4 7.9E 6/

1.6E 5 Ornamental plants Christmas Tree Max 2.5 125 2 50 390 2 40 305 255 2585 NA 7.9E 4/

1.6E 3 8.6E 5/

1.7E 4 4.6E 6/

9.2E 6 Table 8: Exposure Variables, MOEs and Cancer for Agricultural uses of Propargite Exposure Scenario ( Scenario #) Crop Group Crop Application Rates ( lb ai/ acre) Daily Acres Treated Short Term Dermal MOEsb Intermediate Term Dermal MOEsc Inhalation MOEse Cancerf Base linea PPE Eng Control Base linea PPE Eng. Control Base lined PPE Eng. Control Base line PPE Eng. control 40 Mixing/ Loading Wettable Powder for Groundboom Application ( 2b) Oil Seed peanut Max 1.6 80 5 120 NA 4 90 745 625 6310 NA 3.2E 6/

6.5E 4 4.0E 5/

7.9E 5 1.8E 6/

3.6E 6 Mixing/ Loading Wettable Powder for Airblast Sprayer Application ( 2c) Citrus fruits grapefruit, orange,

lemon, avocado Min 3.0 40 6 125 NA 5 100 NA 665 6730 NA 3.0E 4/

6.0E 4 3.6E 5/

7.3E 5 1.7E 6/

3.4E 6 Tropical and subtropical fruits Max 4.5 4 85 680 3 65 530 445 4485 NA 4.6E 4/

9.2E 4 5.3E 5/

1.1E 4 2.6E 6/

5.1E 6 Herbs & spices hops Min 2.0 9 190 NA 7 145 NA 1000 NA NA 2.0E 4/

4.0E 4 2.4E 5/

4.8E 5 1.2E 6/

2.3E 6 Max 2.5 7 150 NA 5 120 NA 800 8075 NA 2.5E 4/

5.0E 4 3.0E 5/

5.9E 5 1.5E 6/

2.9E 6 Small Fruits grapes Max 3.0 6 125 NA 5 100 NA 665 6730 NA 3.0E 4/

6.0E 4 3.6E 5/

7.3E 5 1.7E 6/

3.4E 6 Mixing/ Loading Wettable Powder for Application of High Pressure Handwand ( 2d) Non bearing Nursery Stock all crops Min 0.5 5 280 NA NA 215 NA NA 32000 NA NA 6.6E 6/

1.3E 5 2.7E 7/

5.3E 7 NA Max 2.5 55 1210 NA 45 940 NA 6400 NA NA 3.2E 5/

6.3E 5 1.4E 6/

2.7E 6 NA Applicator Exposure Applying Sprays with Fixed Wing Aircraft  Enclosed Cockpit ( 3) Roots and Tuber Vegetable carrot, sugar beet,

potatoes, dry beans,

mint Min 2.0 350 NA NA 735 NA NA 570 NA NA 72940 NA NA 2.4E 6/

4.9E 6 Max 2.5 NA NA 585 NA NA 455 NA NA 58355 NA NA 3.0E 5/

6.1E 5 Legume Vegetable Herbs and Spices hops Max 2.5 80 NA NA 2570 NA NA 2000 NA NA 255295 NA NA 6.9E 7/

1.4E 6 Citrus fruits grapefruit, orange Max 2.5 125 NA NA 1645 NA NA 1280 NA NA 163390 NA NA 1.1E 6/

2.2E 6 Tree Nuts almond, walnut Min 2.5 NA NA 1645 NA NA 1280 NA NA 163390 NA NA 1.1E 6/

2.2E 6 Max 4.5 NA NA 915 NA NA 710 NA NA 90770 NA NA 1.9E 6/

3.9E 6 Cereal Grains corn ( field, pop,

sweet), sorghum grain, alfalfa, clover Min 1.5 350 NA NA 980 NA NA 760 NA NA 97255 NA NA 1.8E 6/

3.6E 6 Table 8: Exposure Variables, MOEs and Cancer for Agricultural uses of Propargite Exposure Scenario ( Scenario #) Crop Group Crop Application Rates ( lb ai/ acre) Daily Acres Treated Short Term Dermal MOEsb Intermediate Term Dermal MOEsc Inhalation MOEse Cancerf Base linea PPE Eng Control Base linea PPE Eng. Control Base lined PPE Eng. Control Base line PPE Eng. control 41 1200 NA NA 290 NA NA 220 NA NA 28000 NA NA 6.2E 6/

1.3E 5 Non Grass animal Feed Max 2.5 350 NA NA 590 NA NA 455 NA NA 58355 NA NA 3.0E 6/

6.1E 6 1200 NA NA 170 NA NA 130 NA NA 17000 NA NA 1.1E 5/

2.2E 5 Oil Seed peanut, jojoba Min 1.5 350 NA NA 980 NA NA 760 NA NA 97255 NA NA 1.9E 6/

3.9E 6 Max 2.5 NA NA 590 NA NA 455 NA NA 583550 NA NA 6.6E 6/

1.3E 5 cotton Max 1.6 350 NA NA 920 NA NA 715 NA NA 91175 NA NA 1.8E 6/

3.6E 6 1200 NA NA 270 NA NA 210 NA NA 26595 NA NA 3.0E 6/

6.1E 6 Stone fruit nectarine Max 3.0 125 NA NA 1370 NA NA 1065 NA NA 136155 NA NA 1.3E 6/

2.6E 6 Ornamental plants Christmas tree,

conifer seed Max 2.5 125 NA NA 1645 NA NA 1280 NA NA 163390 NA NA 1.1E 6/

2.2E 6 Applying Sprays with a Groundboom Sprayer ( 4) Roots and Vegetable potatoes, corn ( field,

pop, sweet)

sorghum grain,

alfalfa, clover,

cotton, peanut,

jojoba and mint Min 1.5 80 1530 NA NA 1190 NA NA 39100 NA NA 1.4E 6/

2.7E 6 1.2E 6/

2.4E 6 4.0E 7/

7.9E 7 Cereal Grain Non grass animal feed Max 2.5 920 NA NA 715 NA NA 23460 NA NA 2.4E 6/

4.9E 6 2.0E 6/

4.1E 6 6.9E 7/

1.4E 6 oil seed herbs and spices Table 8: Exposure Variables, MOEs and Cancer for Agricultural uses of Propargite Exposure Scenario ( Scenario #) Crop Group Crop Application Rates ( lb ai/ acre) Daily Acres Treated Short Term Dermal MOEsb Intermediate Term Dermal MOEsc Inhalation MOEse Cancerf Base linea PPE Eng Control Base linea PPE Eng. Control Base lined PPE Eng. Control Base line PPE Eng. control 42 Applying Sprays with an Airblast Sprayer ( 5) pome fruits quince, cherry,

prunes, orange,

grapefruit, lemon,

lime, tangerine,

boysenberry,

current, hops,

raspberry, date,

persimmons,

almond, filbert,

macadamia nut,

pecan, pistachio,

walnut, Christmas Tree plantation,

conifers, shade trees Min 1.5 40 120 NA NA 95 140 NA 12860 NA NA 1.5E 5/

3.0E 5 1.1E 5/

2.1E 5 2.0E 6/

4.0E 6 stone fruits citrus fruits berries tropical & subtropical fruits Max 4.5 40 120 750 30 90 570 4285 NA NA 4.6E 5/

9.2E 5 3.1E 5/

6.2E 5 6.9E 6/

1.4E 5 small fruits tree nuts ornamental plants Applying Liquids with a High Pressure Handwand ( 6) non bearing nursery stock all crops Min 0.5 5 570 NA NA 445 NA NA 17580 NA NA 3.6E 6/

7.3E 6 1.9E 6/

3.8E 6 NA Max 2.5 115 NA NA 90 250 NA 3515 NA NA 1.9E 5/

3.8E 5 9.6E 6/

1.9E 5 NA Table 8: Exposure Variables, MOEs and Cancer for Agricultural uses of Propargite Exposure Scenario ( Scenario #) Crop Group Crop Application Rates ( lb ai/ acre) Daily Acres Treated Short Term Dermal MOEsb Intermediate Term Dermal MOEsc Inhalation MOEse Cancerf Base linea PPE Eng Control Base linea PPE Eng. Control Base lined PPE Eng. Control Base line PPE Eng. control 43 Flagger Exposure Flagging During Aerial Spray Application ( 7) Roots & tuber Vegetable carrot, sugar beet,

potatoes, dry beans,

mint Min 2.0 350 335 NA NA 260 NA NA 14170 NA NA 5.9E 6/

1.2E 5 4.6E 6/

9.1E 6 1.2E 7/

2.4E 7 legume vegetable Max 2.5 265 NA NA 210 NA NA 11335 NA NA 7.6E 6/

1.5E 5 5.7E 6/

1.1E 5 1.5E 7/

3.0E 7 herbs and spices hops Ma 2.5 80 1170 NA NA 910 NA NA 49600 NA NA 1.7E 6/

3.4E 6 1.3E 6/

2.6E 6 3.4E 8/

6.9E 8 Citrus fruits grapefruit, orange Max 2.5 125 750 NA NA 580 NA NA 31745 NA NA 2.7E 6/

5.4E 6 2.0E 6/

4.1E 6 5.3E 8/

1.1E 7 Tree Nut almond, walnut Min 2.5 125 750 NA NA 580 NA NA 31745 NA NA 2.7E 6/

5.4E 6 2.0E 6/

4.1E 6 5.3E 8/

1.1E 7 Max 4.5 415 NA NA 325 NA NA 17635 NA NA 5.0E 6/

9.9E 6 3.7E 6/

7.3E 6 9.6E 8/

1.9E 7 cereal grain ( field, pop, sweet),

sorghum grain,

alfalfa, clover Min 1.5 350 445 NA NA 345 NA NA 18895 NA NA 4.6E 6/

9.2E 6 3.4E 6/

6.8E 6 9.0E 8/

1.8E 7 non grass animal feed Max 2.5 265 NA NA 210 NA NA 11335 NA NA 7.6E 6/

1.5E 5 5.7E 6/

1.1E 5 1.5E 7/

3.0E 7 oil seed cotton Max 1.6 350 415 NA NA 325 NA NA 17715 NA NA 5.0E 6/

9.9E 6 3.6E 6/

7.3E 6 9.6E 8/

1.9E 7 1200 120 NA NA 100 NF NA 5165 NA NA 1.7E 5/

3.3E 5 1.2E 5/

2.5E 5 3.3E 7/

6.6E 7 Peanut, jojoba Min 1.5 350 445 NA NA 345 NA NA 18895 NA NA 4.6E 6/

9.2E 6 3.4E 6/

6.8E 6 9.0E 8/

1.8E 7 Max 2.5 265 NA NA 210 NA NA 11335 NA NA 7.6E 6/

1.5E 5 5.7E 6/

1.1E 5 1.5E 7/

3.0E 7 Stone fruits nectarine Max 3.0 125 625 NA NA 485 NA NA 26455 NA NA 3.2E 6/

6.4E 6 1.1E 6/

2.2E 6 6.4E 8/

1.3E 7 Ornamental plants Christmas tree conifer seed Max 2.5 125 750 NA NA 580 NA NA 31745 NA NA 2.7E 5/

5.4E 5 2.0E 6/

4.1E 6 5.3E 8/

1.1E 7 a Baseline dermal unit exposure represents long pants, long sleeved shirt, no gloves, open mixing/ loading, open cab tractor.

b Short term Dermal MOE = NOAEL ( 6 mg/ kg/ day)/ Short term Daily Dermal Dose ( mg/ kg/ day).

c Intermediate term MOE = NOAEL ( 4 mg/ kg/ day)/ Intermediate term Daily Dermal Dose ( mg/ kg/ day)

d Baseline inhalation unit exposure represents no respirator e Inhalation MOE = LOAEL ( 49.6 mg/ kg/ day)/ Daily Inhalation Dose ( mg/ kg/ day).

f the lower end of the range represents 7 days of exposure for a private applicator. The higher end of the range represents 14 days of exposure for a commercial applicator. 44 ii. Post Application Occupational Risk The post application occupational risk assessment considered exposures to workers entering treated sites. EPA has determined that there are potentially significant short and intermediate term post application exposures to workers entering treated fields for post treatment activities, e. g., weeding, pruning, irrigating, harvesting.

Table 9 below summarizes the Agency's risk assessment for workers, based on various activities and application rates for each crop. This table shows the number of days that must pass after propargite is applied before the risk is above the Agency's level of concern ( MOE $ 100 for intermediate term dermal exposure). The table also shows the life time cancer risk that would result if workers were to re enter a propargite treated field on the first day the MOE $ 100 for 35 years.

The re entry interval ( REI) is the period of time after propargite application ( expressed in days) that must elapse before an unprotected worker may re enter the field to perform a given operation. The REI is established for a crop by considering the worker activities associated with the crop and determining the number of days after treatment must elapse before a the risk is no longer a concern. Typically, the activity with the highest risk will drive the selection of the appropriate REI for the crop. All of the post application risk calculations for handlers completed in this assessment are included in the July 31, 2001 document entitled, " Revised Occupational and Residential Exposure Assessment and Recommendations for the Reregistration Eligibility Decision Document for Propargite."

Table 9. Occupational Postapplication Risk from Propargite; Days After Treatment at Which the MOE is $ 100 Crop grouping Crop Activity Intermediate  Term ( days) Cancer Risk at First Day MOE $ 100 Roots and Tuber Vegetable Crop 1.5 lb ai/ A 2.5 lb ai/ A 1.5 lb ai/ A 2.5 lb ai/ A Potato Hand Harvesting Not available Not available Not available Not available Carrot, Sugar beet Hand Harvesting 9 13 5.28E 5 5.51E 5 Potato, Carrot, Sugar beet all other activities 0 0 1.81E 5 3.01E 5 Legume Vegetables Dry beans Weeding and Hoeing 0 0 3.60E 5 5.91E 6 Irrigation, Scouting 5 9 5.05E 5 5.18E 5 Hand Harvesting 9 13 5.28E 5 5.41E 5 Non grass Animal Feed Alfalfa, Clover Hand Harvesting, Mechanized harvesting Not available Not available Not available Not available Irrigation, Scouting 5 9 5.05E 5 5.28E 5 Crop grouping Crop Activity Intermediate  Term ( days) Cancer Risk at First Day MOE $ 100 45 Citrus Fruits Crop 2.5 lb ai/ A 3.15 lb ai/ A 4.5 lb ai/ A 2.5 lb ai/ A 3.15 lb ai/ A 4.5 lb ai/ A Orange, Lemon, Lime, Tangerine, Grapefruit Irrigation, Scouting, Hand weeding 0 2 8 4.82E 5 5.35E 5 5.28E 5 Pruning 16 20 26 5.35E 5 5.28E 5 5.18E 5 Harvesting 32 36 42 5.31E 5 5.21E 5 5.15E 5 Pome Fruits Crop 0.5 lb ai/ A 1.5lb ai/ A 2.5 lb ai/ A 4.5 lb ai/ A 0.5 lb ai/ A 1.5 lb ai/ A 2.5 lb ai/ A 4.5 lb ai/ A Quince, Cherry, Nectarine, Prune, Avocado, Date, Persimmons, X mas Tree, Ornamental and/ or shade trees Ornamental, Herbaceous Plants Irrigation, Scouting, Hand weeding 0 0 0 0 5.97 E 6 1.97 E 5 2.98 E 5 5.38 E 5 Stone Fruits Pruning 0 0 5 11 1.97 E 5 5.38 E 5 5.28 E 5 5.05 E 5 Tropical and Subtropical Fruits Harvesting 0 9 14 20 4.75 E 5 5.54 E 5 5.45 E 5 5.21 E 5 Ornamental Plants Berries Crop 2.0 lb ai/ A 2.0 lb ai/ A Boysenberry, Currant, Raspberry Irrigation, Hand weeding 0 9.74E 6 Scouting 0 1.95E 5 Harvesting, Pruning, tying 10 5.25E 5 Small fruits Crop 3.0 lb ai/ acre 3.0 ai/ A Grape Irrigation, Hand weeding 0 1.46E 5 Scouting 0 2.92E 5 Harvesting, Pruning , tying 16 5.41E 5 Cane turning 27 5.48E 5 Tree Nuts Crop 3.0 lb ai/ A 4.5 lb ai/ A 3.0 lb ai/ A 4.5 ai/ A Almond, Filbert, Macadamia , Pecan Pistachio, Walnut Sweeping and blowing the nuts Not available Not available Not available Not available Tree shakers 0 0 3.12E 6 4.69E 6 Scouting, Weeding, Irrigation 0 0 3.33E 5 4.98E 5 Pruning, Hand harvesting 22 30 5.38E 5 5.35E 5 Cereal grains Crop 2.5 lb ai/ A 2.5 lb ai/ A Corn ( unspecified), Corn, field, Corn, Pop Corn, Sweet, Sorghum, grain Irrigation, Scouting 0 3.83E 5 Crop grouping Crop Activity Intermediate  Term ( days) Cancer Risk at First Day MOE $ 100 46 Corn ( unspecified), Corn, field, Corn, Pop Corn, Sweet Hand harvesting, Detasseling 13 4.95E 5 Herbs and Spices Crop 2.5 lb ai/ A 2.5 lb ai/ A Mint Irrigation, Scouting, Hand weeding 9 5.28E 5 Hops Irrigation, Hand weeding, Scouting 0 1.06E 5 Harvesting, Training 33 5.51E 5 Oil seed Crop 1.5 lb ai/ A Cotton Weeding and hoeing 0 2.53E 6 Harvesting 6 4.98E 5 Cotton Peanut, Jojoba Irrigation, Scouting 1 5.35E 5 5. Human Incident Data The Agency consulted and reviewed several sources of information on health incidents involving human exposure, finding a history of propargite cases mostly related to handler and worker exposure. The general incident trend, however, appears to be downward. The four sources of information are OPP's Incident Data System ( IDS), American Association of Poison Control Centers ( PCC), California Department of Pesticide Regulation ( CDPR), and the National Pesticides Telecommunication Network. CDPR and OPP data tend to provide the most insight into propargite's association with human health incidents. Detailed descriptions of the above sources and the cases involving propargite are provided in the human health risk assessment.

The incident data contain cases showing propargite poses skin illness and eye irritation concerns for handlers and post application workers. From CDPR data, field residue exposure was associated with the majority ( 66%) of the exposures cases in California. A large proportion of cases resulted from field reentry and worker activities involving extensive contact with treated foliage such as turning cane for grapes and harvesting citrus. Applicators and other handlers accounted for the bulk of the balance ( 28%). These data illustrate that human incidents have historically occurred mostly among workers and handlers.

Propargite usually effects the skin in human exposure cases. Of the confirmed propargite cases reported to the CDPR between 1982 and 1996, 79% of the individuals developed skin illnesses as a result of exposure ( 528 of 671 persons). Data covering the years 1982 1989 found that propargite was the leading cause of skin related injuries among all pesticides in California. For the years 1990 1994, propargite dropped to seventh place among pesticides. The drop in the frequency 47 of illnesses in the early 1990' s is apparently attributable to increasing restricted entry intervals ( REI), which were put into place in 1989. Depending on the crop, REIs were extended from 2 7 days to 14 42 days. Promulgation of the final Worker Protection Standard regulations in the 1990' s may have also contributed to the reduction of incidents. In addition, the registrant fielded a voluntary product stewardship program during this same time frame, presumably facilitating greater compliance with labels by educating handlers and workers.

Notwithstanding the number and types of exposure cases, both PCC and CDPR data indicate that incidents rarely result in hospitalization or long, prolonged absences from work. In some cases, the skin effects may be severe and absences from work are significant. Nonetheless, compared to all other pesticides, propargite has a favorable profile suggesting low risk of moderate or serious effects. Despite the downward trend in exposure cases, incidents still occur on a regular basis involving field workers, suggesting additional mitigation may be warranted on certain crops.

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 Science Chapter for Reregistration Eligibility Document for Propargite, dated June 7, 2000, available in the public docket.

1. Environmental Fate and Transport Propargite is moderately persistent ( metabolism half lives = 38 168 days) and immobile ( K d s ranged from 60 to 218 mL/ g, while K oc s ranged from 2963 to 57966 mL/ g) . It degrades rapidly under alkaline hydrolytic conditions ( half life = 2.2 days) and is moderately persistent to persistent under neutral ( half lives = 75 days) and acid ( pH 5 half life = 120 days) hydrolytic conditions. Soil and aquatic photolysis and aerobic and anaerobic metabolism occur at moderate rates ( half lives = 39 168 days). Degradates are carbon dioxide, propargite glycol ether ( TBPC, 2[ 4( 1,1 dimethylethyl) phenoxy] cyclohexane 1 ol, also identified as 2( p tertiarybutyl phenoxycyclohexanol and PTBP ( p tertiary butylphenoxy cyclohexanol. However, the Agency Metabolism Assessment Review Committee has concluded that the residue of concern in plants and animals is propargite per se and not its metabolites or degradate products. Because of its high affinity for soil and sediment, propargite has the potential to move off the site of application during rainfall/ irrigation by erosion/ runoff on soil particles and by drift. Given the moderate to slow degradation rates for metabolism and photolysis, and the high K oc values, propargite will probably be adsorbed to sediments and organic material if transported to surface waters. 48 2. Ecological Toxicity The Agency's ecological risk assessment compares toxicity endpoints from ecological toxicity studies to estimated environmental concentrations based on environmental fate characteristics, pesticide use, and/ or monitoring data. To evaluate the potential risk to nontarget organisms from the use of propargite products, EPA calculates a Risk Quotient ( RQ), which is the ratio of the estimated exposure concentration to the toxicity endpoint values, such as the LC 50 ( the median concentration of a substance which causes death to 50% of the test animals). The RQ is simply a means of integrating the results of ecological exposure and ecological toxicity. These RQ values are compared to levels of concern ( LOCs), which provide an indication of the relative risk the particular pesticide and/ or use may pose for nontarget organisms. If the RQ does not exceed the LOC, it is unlikely that the pesticide will pose a significant risk. Similarly, when RQs are equal to or greater than the LOC, additional refinements or mitigation may be necessary. Use, toxicity, fate, and exposure are considered to characterize the risk as well as the level of certainty and uncertainty in the assessment. EPA further characterizes ecological risk based on any reported aquatic or terrestrial incidents to nontarget organisms in the field ( e. g., fish or bird kills).

Based on toxicity studies submitted by the Registrant, propargite poses a potential for adverse effects on reproduction in birds and mammals. Risk to aquatic organisms and plants is generally lower than the risk for birds and mammals; however, the chronic risk concern levels for freshwater invertebrates and freshwater fish are either approached or exceeded for over 60 days from multiple propargite applications.

a. Risk to Birds and Mammals EPA's assessment suggests that the most significant ecological risk posed by the use of propargite is the potential for adverse effects on reproduction in birds and mammals. The assessment indicates that reproduction risk to birds may occur where propargite is applied a single time at 0.5 lb active ingredient per acre or greater. Concerns for reproduction risk to mammals are triggered at application rates of 1.6 lb ai/ A or greater. These concerns are heightened when multiple applications of propargite are factored into the assessment. Multiple applications of a pesticide may raise the risk to an organism by increasing the concentration of residues on food items and by extending the period during which these residues may be present. EPA's conclusions for propargite's potential effects to birds and mammals are based on the following labeled use rates and numbers of applications: 2 applications at 4.5 lb ai/ A; 2 applications at 3 lb ai/ A; 2 applications at 2 lb ai/ A; and 2 or 3 applications at 1.6 lb ai/ A.

The timing of propargite applications to control target pests coincides with breeding seasons of some birds common to the labeled crop areas. This could expose nesting birds and their developing young to residues which could negatively impact their reproductive success. The chronic effects to birds reported in registrant submitted studies included reductions in mean numbers of eggs laid/ female( mallard and bobwhite), viable embryos ( mallard), live 3 week embryos ( mallard), hatch success ( mallard), hatchling survival and weight ( mallard and bobwhite), and adult body weight 49 change ( mallard) at dietary concentration of 288 ppm. At a dietary concentration of 84.7 ppm, slight reductions were also observed in adult body weight change ( bobwhite and mallard), eggs laid/ female, live embryos, and hatchling survival.

With the exception of multiple applications at 4.5 lb ai/ A ( RQ = 0.59 for species expected to ingest high amounts of short grass or foliage), avian acute risk assessment scenarios for propargite did not exceed acute risk level of concern ( LOC = 3401 ppm) for birds. LOCs for acute risk are approached, but not exceeded for multiple applications at 3 lb ai/ A. Shorter application intervals could increase exposure and risk for these scenarios. A number of application scenarios triggered the restricted use criteria at rates of 1.6 lb ai/ A and above ( RQ> 0.2). For acute toxicity to endangered avian species, all multiple application scenarios assessed exceeded the LOC ( RQ> 0.1) for short and tall grass and broadleaf plants. RQs for acute effects to birds ingesting primarily fruits and seeds were below levels of concern for acute risk, restricted use, and endangered species.

The assessment suggests the potential for acute effects to mammals for multiple applications at the highest labeled rate of ~ 4.5 lb ai/ A ( walnut, and avocado). Levels of concern for acute risk are approached but not exceeded for multiple applications at 3 lb ai/ A. Mammalian chronic levels of concern ( 400 ppm exposure levels) may be exceeded at single application rates over 1.6 lb ai/ A ( which is allowed for many crop uses of propargite) and at multiple application rates above 0.75 lb ai/ A which are allowed for all crop uses. However, there were a number of LOCs for the acute restricted use that were exceeded for herbivorous or herbivorous/ insectivorous mammals ( RQs > 0.2) based on terrestrial exposure scenarios. There are acute endangered species risk concerns for herbivorous or herbivorous/ insectivorous mammals ( RQs> 0.1) for many uses. Granivorous mammals are not predicted to be exposed to residues that could result in acute effects.

The lack of data on propargite persistence on foliage and other avian and mammalian food items is a source of uncertainty in the terrestrial risk assessment. Because no data were available, a default foliar half life of 30 days was assumed. Foliar dissipation is not expected to be rapid, however, because of propargite's photolytic stability, slow hydrolysis at neutral pH values, and low vapor pressure. Rainfall could result in residue washoff thereby reducing terrestrial exposure. Reapplication could result in repeated exposure of terrestrial organisms to propargite residues.

b. Risk to Aquatic Species The standard method for assessing aquatic risk results in concern for potential chronic effects to freshwater fish and invertebrates. Although EPA's criteria for acute risk to freshwater invertebrates and estuarine fish were not exceeded, the assessment suggests that adverse effects could occur in shallow bodies of water that are not represented by standard scenarios. No data are available to assess risk to estuarine and marine organisms. Also, as noted for the terrestrial risk assessment, an element of uncertainty is added to the aquatic risk assessment by the lack of established application intervals on propargite labels. The time between applications could have an impact on exposure levels used to assess aquatic risk. 50 Chronic toxicity effect levels were low for freshwater aquatic invertebrates and fish. Given the persistence characteristics of propargite, the potential for chronic effects is most likely if residues reach aquatic habitats in concentrations exceeding 9 16 ug/ L ( the Daphnia magna No Observable Effect Concentration [ NOEC] = 9 ug/ L; fathead minnow NOEC = 16 ug/ L). Chronic LOCs for invertebrates were exceeded in three of the five scenarios in Tier II modeling simulations. There were no data available to assess potential chronic effects to estuarine and marine organisms. In aerobic and anaerobic aquatic metabolism studies, propargite half lives were 38 and 46 days, respectively. These data, along with hydrolysis half lives of 75 and 120 days at pH 7 and 5, respectively, suggest that propargite will be relatively persistent in aquatic environments. Any impact on aquatic life, then, is likely to be greatest where neutral to acidic conditions predominate ( pH 5.0 to 7.0). This could include tributaries fed by acid drainage or that receive runoff from watersheds where highly organic soils predominate. Because aqueous photolysis of residues is not an important process, water clarity is not likely to play an important role in degradation. Because of its high affinity for soil, propargite has the potential to move into aquatic habitats through runoff or wind erosion of soil particles. Other offsite transport is possible by spray drift from aerial, airblast, or ground boom applications. Given the moderate to slow degradation rates for metabolism and photolysis, and the high K oc values, propargite is likely to partition to sediment and organic material found in surface waters. Thus, impacts to benthic dwelling organisms from prolonged exposure to contaminated sediments must be a consideration when characterizing long term risk potential for exposed aquatic areas. Toxicity to these organisms from residues on sediment is uncertain because relevant data are not available.

Though propargite is highly toxic to all fish and invertebrate species tested ( 96 hour LC 50 values for 7 aquatic species were below 168 ug/ L), the RQs calculated from EECs derived from Tier II simulations suggest little potential for acute risk to fish or invertebrates. However, several RQs ranged between 0.2 and 0.5 suggesting that exposure in small, shallow water bodies ( i. e., those not represented by EPA's standard aquatic risk scenario) could result in adverse effects to organisms present. Acute restricted use exceedences ( RQ= 0.2) for fish and invertebrates are noted for a number of application scenarios. For endangered aquatic species, all modeled scenarios exceeded Agency acute levels of concern ( RQ> 0.05).

c. Endangered Species At currently proposed rates, endangered species risk presumption levels are exceeded for both freshwater and estuarine/ marine fish and invertebrates at the label permitted application scenarios for propargite. Although concern levels for estuarine invertebrates are exceeded, there are no federally listed estuarine invertebrates. Mammalian and avian acute risk for endangered species is exceeded for certain species which may feed heavily on vegetation or insects. Chronic risk concern levels for listed birds and mammals are indicated for many uses.

The Agency consulted with the US Fish and Wildlife Service ( FWS or the Service) on the corn use of propargite as part of the corn cluster analysis in 1983 and on several agricultural uses of propargite in the " reinitiation" of the cluster assessments in 1988. The resulting Opinions found 51 jeopardy to one amphibian species, eight fish species and one invertebrate species. The Service proposed Reasonable and Prudent Alternatives ( RPAs) to avoid the likelihood of jeopardizing the continued existence of these species. In addition, the Service had Reasonable and Prudent Measures ( RPMs) to reduce incidental take of 22 fish and one aquatic invertebrate species. These consultations and the findings expressed in the Opinions, however, are based on old labels and application methods, less refined risk assessment procedures, and an older approach to consultation which is currently being revised through interagency collaboration.

EPA's current assessment of ecological risks uses both more refined methods to define ecological risks of pesticides and new data, such as that for spray drift. Therefore, the Reasonable and Prudent Measures ( RPMs) in the Biological Opinion( s) may need to be reassessed and modified based on these new approaches.

The Agency is currently engaged in a Proactive Conservation Review with FWS and the National Marine Fisheries Service under section 7( a)( 1) of the Endangered Species Act. The objective of this review is to clarify and develop consistent processes for endangered species risk assessments and consultations. Subsequent to the completion of this process, the Agency will reassess the potential effects of propargite use to federally listed threatened and endangered species. At that time, the Agency will also consider any regulatory changes recommended in the RED that are being implemented. Until such time as this analysis is completed, the overall environmental effects mitigation strategy articulated in this document and any County Specific Pamphlets described below which address propargite, will serve as interim protection measures to reduce the likelihood that endangered and threatened species may be exposed to propargite at levels of concern.

3. Ecological Incidents The Agency incident database contains a single incident with propargite. The incident involved crop injury to 82 acres of newly planted cotton crops in Arvin, CA. Propargite, chlorpyrifos, and amitraz were all applied. Propargite ( Comite) labels warn against possible phytotoxicity to young cotton plants.

No mortality incidents with wildlife, non target insects, or aquatic organisms have been reported for propargite. However, the types of chronic concerns for birds and mammals expressed for propargite are unlikely to be observed in normal usage. Also, acute mortality to non target invertebrates ( terrestrial or aquatic) is generally not observed or reported in incident reports, even when high mortality is reported for birds, mammals, amphibians or fish. 52 IV. Risk Management and Reregistration Decision A. Determination of 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 the active ingredient propargite.

The Agency has completed its assessment of the occupational, non occupational, and ecological risks associated with the use of pesticides containing the active ingredient propargite, as well as a propargite specific dietary risk assessment. Based on a review of these data and on public comments on the Agency's assessments for the active ingredient propargite, EPA has sufficient information on the human health and ecological effects of propargite to make decisions as part of the tolerance reassessment process under FFDCA and reregistration process under FIFRA, as amended by FQPA. The Agency has determined that propargite products are eligible for reregistration provided that: ( i) current data gaps and additional confirmatory data needs are addressed; ( ii) the risk mitigation measures outlined in this document are adopted, and ( iii) label amendments are made to reflect these measures. Label changes are described in Section V. Appendix A summarizes the uses of propargite that are eligible for reregistration. Appendix B identifies the generic data requirements that the Agency reviewed as part of its determination of reregistration eligibility of propargite, and lists the submitted studies that the Agency found acceptable. Data gaps are identified as generic data requirements that have not been satisfied with acceptable data.

Based on its evaluation of propargite, the Agency has determined that propargite 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 propargite. If all changes outlined in this document are incorporated into the product labels, then all current risks for propargite will be adequately mitigated for the purposes of this determination.

B. Summary of Public Comments and Responses When making its initial reregistration decision in 2001, the Agency took into account all comments received after opening of the public docket. These comments in their entirety are available in the docket. A summary of the comments and the Agency response is noted below.

Comment: During the public comment period provided for the preliminary risk assessment, EPA received comments from the Almond Hullers and Processors Association and the National Agricultural Aviation Association ( NAAA). The Almond Hullers and Processors Association questioned the appropriateness of the transfer coefficients that EPA used to determine postapplication risks. The Almond Hullers also expressed concern that the 31 day REI that was proposed 53 in the preliminary risk assessment was too long. The Almond Hullers also asked for guidance on what activities would be restricted by the REI.

Response: EPA has revised the post application risk assessment using new transfer coefficients derived from the Agricultural Reentry Task Force ( ARTF). These new transfer coefficients can be found in the Science Advisory Council for Exposure, Policy number 3.1 dated August 7, 2000. The propargite RED uses the standard values found in this new policy unless a chemical/ crop specific study is available, as was the case for tree shakers for nut crops ( MRID 418486 04). As a result of using the new transfer coefficients, the REI for almonds ( at maximum use rate of 3lbs ai/ A) is now 22 days. Many of the other activities of concern to almond growers can be accommodated with existing exemptions under the Worker Protection Standard. 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 ( 40CFR170.112( e)), 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 ( 40CFR170.112( b)). Should irrigation equipment need unexpected repairs during the REI, WPS allows workers to enter a treated field provided early entry PPE is used ( 40CFR170.112( c)). This exception also applies to mechanical harvesting, tree shaking or winrowing for nut crops in enclosed cabs, and often applies to mowing.

Comment: The NAAA was concerned that EPA's occupational risk assessment for propargite is based on out of date data that are not reflective of current practices. Their comments specifically mentioned that technological advances such as use of Global Positioning Satellite ( GPS) and automatic flagging systems have replaced human flagging; and mixers/ loaders for aerial applicators routinely use personal protective equipment and engineering controls, such as closed mixing loading systems, body suits, respirators and other equipment.

Response: The risk mitigation measures outlined in this RED are consistent with the standard practices that are currently followed in the industry, as described by the NAAA comments on propargite. Based on the risk assessment, there will be no new requirements for human flaggers; closed mixing/ loading systems will be required for aerial applications of propargite for corn and cotton; and enclosed cockpits will be required. With these risk mitigation measures in place, EPA believes that risks will not be unreasonable.

Other Comments: Subsequent to the comment period for the propargite preliminary risk assessment, EPA also received a series of letters and e mails attesting to the benefits of propargite. Comments were received from: the Allied Grape Growers; California Association of Wine Grape Growers; California Grape and Tree Fruit League; Allied Grape Growers; Washington Association of Wine Grape Growers; Sun Maid Growers of California on the benefits of propargite use for raisin production; University of California Cooperative Extension regarding alfalfa seed production; the Northwest Alfalfa Seed Growers Association; the Oregon Alfalfa Seed Commission; University of 54 California, Davis in support of propargite use on almonds, cotton, corn and dry beans; Washington Mint Commission; the California Cotton Growers Association; the Texas Corn Producers Board and the Texas Agricultural Extension Service on the benefits of propargite on corn grown in Texas; U. S. Hop Industry Plant Protection Committee; Oregon Hop Commission; Western Growers Association regarding the benefits of the use of propargite on fresh fruits, nuts and vegetables; Washington State Potato Commission regarding the benefits of propargite for use on potatoes and the need to lower the PHI from the current 7 days to 5 days.

C. Regulatory Position 1. FQPA Assessment a. " Risk Cup" Determination As part of the FQPA tolerance reassessment process, EPA assessed the risks associated with this pesticide. EPA has determined that risk from dietary ( food sources only) exposure to propargite is within its own " risk cup." In other words, EPA has concluded that the tolerances for propargite 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 acute and chronic food exposure. An aggregate assessment was conducted for exposures through food and drinking water exposure only since there are no residential uses of propargite. Results of this aggregate assessment indicate that the human health risks from these combined exposures are within acceptable levels; that is, that is, when aggregated, propargite exposures fit within the risk cup.

Therefore, there are no changes in propargite tolerances due to risk concerns and most tolerances will remain in effect ( except the dried citrus pulp, poultry meat and meat by products tolerances are no longer needed for other reasons discussed below). The Agency will establish tolerances for aspirated grain fractions; cotton gin byproducrts, and citrus oil.

b. Determination of Safety for U. S. Population EPA has determined that the established tolerances for propargite, with amendments and changes as specified in this document, meet the safety standards under the FQPA amendments to section 408( b)( 2)( D) of the FFDCA, that there is a reasonable certainty of no harm for the general population. In reaching this determination, EPA has considered all available information on the toxicity, use practices, and scenarios, and the environmental behavior of propargite. As discussed in chapter 3, the acute and chronic dietary ( food alone) risk is below the level of concern, as is the cancer dietary risk from food alone. Regarding risks from drinking water exposures, acute and chronic risks from drinking water are not of concern for surface or groundwater supplies, and although the projected surface water concentrations exceed the Agency's cancer concern level, the Agency believes that those projections are conservative and over estimate the human exposure to propargite that will result from drinking water sources from surface water ( See Regulatory Rationale 55 under Drinking Water in section IV. D. 1. a. iv.).

c. Determination of Safety for Infants and Children EPA has determined that the established tolerances for propargite, with amendments and changes as specified in this document, meet the safety standards under the FQPA amendments to section 408( b)( 2)( C) of the FFDCA, that there is a reasonable certainty of no harm for infants and children. The safety determination for infants and children considers the factors noted above for the general population, but also takes into account the possibility of increased dietary exposure due to the specific consumption patterns of infants and children, as well as the possibility of increased susceptibility to the toxic effects of propargite residues in this population subgroup.