IR-4 Program Residue Programs, Databases, Tolerance Petitions. Daniel Kunkel IR-4 Headquarters Associate Director

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1 IR-4 Program Residue Programs, Databases, Tolerance Petitions Daniel Kunkel IR-4 Headquarters Associate Director

2 IR-4 Research Programs Food Crops Magnitude of Residue Crop Safety/Product Performance Ornamental and Non-food Use Crop Safety/ Product Performance Biopesticides Grants Supporting Early and Advanced Stage Research

The IR-4 Regulatory Clearance Process Stakeholder: Define Pest Problem

Starts with Requests Submitted from: Growers, Grower Groups, State/Federal

Workshop Requests Prioritized Top Priorities Researched ) That Year Second

Residue levels in Crops Top Priorities completed in 30 months Manufacturer

3 The IR-4 Regulatory Clearance Process Stakeholder: Define Pest Problem Identify Pest Management Solution Request Assistance from IR-4 The Process Starts with Requests Submitted from: Growers, Grower Groups, State/Federal Research & Extension Personnel Request Reviewed by Manufacturer IR-4 Workshop Requests Prioritized Top Priorities Researched ) That Year Second Priorities Researched as Money (Allows Field and Lab Research Measure Residue levels in Crops Top Priorities completed in 30 months Manufacturer Adds Crop to the Product Label Risk Assessment Tolerance Established by EPA Data Submitted to EPA

4 The IR-4 Regulatory Clearance Process Stage IV Food Crops Following the Annual Food Use Workshop National Research Planning Research projects are designated for the coming year

5 Guidance Documents OPPTS Harmonized Test Guidelines Series 860 Residue Chemistry Test Guidelines -- Final Guidelines The harmonized test guidelines have been developed for use in the testing of pesticides and toxic substances, and the development of test data that must be submitted to the Agency for review under Federal regulations Background (PDF) Chemical identity (PDF) Directions for use (PDF) Nature of the residue--plants, livestock (PDF) Residue analytical method (PDF) Multiresidue method (PDF) Storage stability data (PDF) Water, fish, irrigated crops (PDF) Food handling (PDF) Meat/milk/poultry/eggs (PDF) Crop field trials (PDF) Processed food/feed (PDF) Proposed tolerances (PDF) Reasonable grounds in support of the petition (PDF) Submittal of analytical reference standards (PDF) Confined accumulation in rotational crops (PDF) Field accumulation in rotational crops (

7 Field Trials and Lab Sites Across the U.S IR-4 HQ IR-4 Regional Program Office State Satellite Labs State Field Research Centers/Food Use State Field Research Centers/ Ornamentals and Non-food Use ARS Labs ARS Field Research Centers ARS Field Research Centers ARS Field Research Centers Hawaii = Puerto Rico =

8 Number of Field Trials with Present Scheme Summer Squash Zones 1/ 1A /5A /5B 6 7 7A Total Squash Crop Group

9 Required Numbers of Field Trials for Crop Groups (40 CFR ) Crop Group Rep Crop Trials for not part of crop group Trials as part of a crop group (9) Cucurbit Vegetables Summer squash 8 trials 5 trials Cucumber 8 trails 6 trials Melon 8 trials 6 trials

10 Crop Groups Criteria Maximum residues for the representative crops can not vary by more than a factor of 5 from the maximum value observed for any crop in the group The proposed or registered patterns of use for all crops in the group or subgroup must be similar before a group tolerance is established. The pattern of use consists of: the amount of pesticide applied, the number of times applied the timing of the first application the interval between applications the interval between the last application and harvest. type of application; for example, soil or foliar application, or application by ground or aerial equipment.

Representative Crops Group: Leafy vegetables (except Brassica): 25

Requires: 24 residue trials Amaranth (Chinese spinach); arugula

chrysanthemum, edible-leaved; chrysanthemum, garland; corn salad; cress,

fennel, Florence; lettuce, head & leaf; orach; parsley; purslane, garden;

11 Representative Crops Group: Leafy vegetables (except Brassica): 25 commodities Rep Crops: celery, head lettuce, leaf lettuce, spinach Requires: 24 residue trials Amaranth (Chinese spinach); arugula (roquette); cardoon; celery; celery, chinese; celtuce; chervil; chrysanthemum, edible-leaved; chrysanthemum, garland; corn salad; cress, garden; cress, upland; dandelion; dock (sorrel); endive (escarole); fennel, Florence; lettuce, head & leaf; orach; parsley; purslane, garden; purlane winter; radicchio (red chicory); rhubarb; spinach; spinach, New Zealand; spinach, vine; Swiss chard.

12 Data Development Laboratory and Field Protocols are developed Field Coordinators Study Directors Laboratory Analysis Protocols Lab Directors Quality Assurance Review Registrants + EPA Good Laboratory Practices (GLP) Field Trials

13 Benefits Of Crop Groups IR-4 benefits The structure of doing business Efficiently: Stakeholder Priorities are set around crop grouping Research centers set up around crop groupings. Very important for Perennial crops

14 Petition Preparation Lab Analysis QA Field Trials Lab and Field Data Study Directors Review QA Review Registrant Review Study Directors Prepare Petition to Submit to EPA

15 30 Month Timeline Project Initiation Analytical Phase Submission to EPA 0-month 10 th month 30 th month Field Phase 2 nd month Petition Prep 22 nd month

20 Final Reports and Petitions The Packaging of Data for EPA Review

21 Tolerance Petitions The final report must accurately reflect the data. Begin with the EPA Recommended Report Format Templates for Use in Developing Pesticide Study Documents As part of a cooperative NAFTA project, EPA s Office of Pesticide Programs (OPP) and the Canadian Pest Management Regulatory Agency (PMRA) developed standard data evaluation formats, or templates. Pesticide Registration (PR) Notice 86-5: Standard Format for Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) Subject: Standard Format for Data Submitted Under the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA) and Certain Provisions of the Federal Food, Drug, and Cosmetic Act (FFDCA) Crop field trials (PDF)

23 STUDY PROFILE Name of Chemical/Technical Study Type: Crop Field Trials OPPTS Guideline Number: Title of the Study: Study Identification

24 [Describe the residue values. Discuss the impact of farming practices and environmental conditions (i.e. soil types, geographical locations, weather conditions, etc.). The discussion should include the adequacy of the number of trials and geographic representation, and any special requirements for harvesting techniques. If residue decline data were submitted with the study, include a description of the behavior of the residue levels across the PHI time span. Do not discuss tolerance levels or harmonization issues in this review.] TABLE C.1. Summary of Concurrent Recoveries of [Chemical] from [matrix]. Matrix Spike level (mg/kg) Sample size (n) Recoveries (%) Mean std dev Analyte TABLE C.2. Summary of Storage Conditions [Note: Add columns for analytes as needed.] Matrix (RAC or Extract) Storage Temp. ( C) Actual Storage Duration (days or months) Interval of Demonstrated Storage Stability (days or months)

26 Label

27 SECTION D THE RESULTS OF TESTS ON THE AMOUNT OF SPIROMESIFEN REMAINING IN OR ON BEAN AND BEAN FOLIAGE

32 Final Reports and Petitions Reports include the complete write-up with DER tables Protocol, Analytical Report, Summary tables of field trials Analytical method Signatures - GLP, QA, Submitter, Sponsor Submitted electronically

33 Partnerships Make Things Happen Crop Protection Industry Project review Strategic Planning Provide test and reference material Review protocol, reports Submission information, label, Notice of Filing Provides and maintains final label

34 Partnerships Make Things Happen Environmental Protection Agency (EPA) Minor Minor Use Use Team Team Managers Managers for for IR-4 IR-4 Submissions Submissions ARIA ARIA Team Team Special Special Risk Risk assessment assessment team team for for minor minor uses uses HED HED and and EFED EFED Reviews Reviews Technical Technical Working Working Group Group Meetings Meetings PRIA PRIA implementation implementation EPA EPA reviews reviews workplans workplans Report Report Formats Formats Data Data Evaluation Evaluation Record/Summaries Record/Summaries prepared prepared for for final final reports reports Leadership Leadership with with agency agency on on electronic electronic petition petition submission submission

35 IR-4 Program Daniel L. Kunkel ext: 4616 Associate Director - Registrations IR-4 Headquarters, Rutgers, The State University of New Jersey 500 College Road East, Suite 201 W Princeton, NJ 08540, fax: ,

IR-4 Project & Registration Process: Residues and Good Laboratory Practices

IR-4 Project & Registration Process: Residues and Good Laboratory Practices THANK YOU! Global Minor Use Summit- Lucy Peter and Ranajit-Aflatoxin USDA/FAS- Jason Participants! IR-4 Mission: To provide pest