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IR-4…What We Do

IR-4…What We Do. Provide Safe and Effective Pest Management Solutions for Specialty Crop Growers. Specialty Crops Include:. Most: Vegetables Fruits Nuts Herbs Spices. Specialty Crops Include:.

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IR-4…What We Do

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  1. IR-4…What We Do Provide Safe and Effective Pest Management Solutions for Specialty Crop Growers

  2. Specialty Crops Include: Most: Vegetables Fruits Nuts Herbs Spices

  3. Specialty Crops Include: Most: Greenhouse Nursery Landscape Christmas Trees

  4. are high value/low acreage crops make up about 46% of U.S. agricultural production = $43 billion in sales 26 states derive more than 50% of agricultural crop sales from specialty crops 33 states derive more than 40% of agricultural crop sales from specialty crops Specialty Crops

  5. Leading specialty crop production states (over $1billion that also represents about half the total of all crops grown in the state) States where specialty crops represent about half the total value of all crops grown in the state Texas is a leading specialty crop state where specialty crops represent less than half of all crops produced in the state.

  6. Top Specialty Crop States Does not include Ornamental crops 19972002 California $14.4B $16.8B Florida $ 4.7B $ 4.5B Washington $ 2.3B $ 2.6B Oregon $ 1.4B $ 1.5B North Carolina $ .6B $ 1.4B Georgia $ 1.1B $ 1.3B Michigan $ 1.1B $ 1.2B Texas $ 1.1B $ 1.1B Pennsylvania $ .8B $ 1.0B Source: 1997 & 2002 Census of Agriculture United States Summary Table 56 Importance of Specialty Crops to US Agriculture

  7. IR-4… is the ONLY Publicly funded program that conducts research and submits petitions to EPA for tolerances/clearances

  8. Who Pays For It? • Major Funding for IR-4 is Provided By: • Special Research Grants and Hatch Act Funds • from USDA-CSREES, in cooperation with the • State Agricultural Experiment Stations • USDA-ARS • Additional Support Provided By: • Commodity & Industry Partners for Special Research Projects

  9. IR-4 Program FY 2006 Funding and Support • Funding SourceAmount • USDA-CSREES $10,677,000 • USDA-ARS $ 3,860,100 • NRSP-4 $ 481,182 • Private Sector/General $ 1,722,032 • Land Grant System/In-Kind $10,000,0001 • Private Sector/In-Kind $ 2,000,0002 Total $28,740,314 1 Labs, offices, research farms, infrastructure and administrative support 2 Lab analysis, QA support, analytical standards, technical support, etc.

  10. IR-4 Supporters

  11. 1963 IR-4 Established by the Directors of State Agricultural Experiment Stations working with the U.S. Department of Agriculture-Cooperative States Research Service 1975Regional Leader Laboratories to provide regional coordination and analytical services 1976 USDA-ARS established minor use program 1977 Ornamental Horticulture Added Expanded to cover nursery and greenhouse crops, forest seedlings, turfgrass, Christmas trees, and woody nursery stock 1982 Expanded to cover Biological Pest Control Agents IR-4 Milestones

  12. 1989 Established a GLP program Responded to 1988 FIFRA Amendments by focusing on re-registration of up to 1000 needed minor uses not supported by industry 1993 Initiated Quality Assurance Unit SOP’s and GLP guidelines and training Field Data Books started 1995 Updated Strategic Plan Focused on Completing Priority Re-registrations by 12/97 Reduced Risk Products, Biopesticides (dedicated research funds) 1997 Food Quality Protection Act (FQPA) Reduced Risk Strategy Promote the registration of Reduced Risk products Expand biopesticide programs, Form New Technology Team 2000 Revised Strategic Plan to focus on Accelerating Reduced Risk chemistry registration Gaining access to new chemistries IR-4 Milestones

  13. Revised Strategic Plan to Focus On: Revitalizing Existing Programs Initiating New Programs IR-4 Milestones

  14. Field Trials and Residue Analyses Sites Across the U.S Field Trials and Residue Analyses 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 Hawaii Hawaii = = ARS Labs ARS Field Research Centers Food Use Puerto Rico Puerto Rico = = ARS Field Research Centers Ornamental ARS Field Research Centers Ornamental and Food Use

  15. Partnerships Make Things Happen • Land Grant Universities • Land Grant System and In-Kind • support is valued at over • $10,000,000 annually • They provide: • 5 GLP Laboratories • Offices • Research Farms • Infrastructure and • Administrative Support • Expertise

  16. Partnerships Make Things Happen • Crop Protection Industry • Partnerships with biopesticide and chemical companies are crucial • Despite reorganizations within the chemical industry, companies continue to work with IR-4 to develop minor crop uses for their products • Alert chemical companies of potential market opportunities • Petition submission information sharing initiatives began in 2002 • PRIA presented New Petition Submission Challengesthat are being managed well through IR-4

  17. Current Environment External Partners—Crop Protection Industry • Extensive consolidation (10 companies gone since 1996) • Explosion of new products in the 1990’s • Fewer new products since 2000 • Newer/more effective biopesticides - but acceptance is limited • Generic producers selling specialty crop products and licensing new technologies - emerging 2nd tier companies IR-4 Strategy

  18. Current Environment External Partners—Crop Protection Industry • Companies with support from growers, commodity groups and the EPA have defended key FQPA vulnerable product uses for specialty crops • Discovery efforts are focused on Reduced Risk chemistries • Biotechnology licensed by seed companies such as Seminis for specialty crops - but optimism of late 1990’s has slowed dramatically IR-4 Strategy

  19. Future Challenges External Partners—Crop Protection Industry • Continued consolidation (especially Japanese companies) • Tracking second tier companies and product acquisitions / licenses • Continual removal of restrictions on older products ­ especially on specialty crops - FQPA impact IR-4 Strategy

  20. Future Challenges External Partners—Crop Protection Industry • Diminishing level of new product submissions (20 in 1996 and 9 each in 2002 and 2003) However, 15 new pipeline products on EPA’s 2006 Work Plan • Continual challenge of herbicides for specialty crops • Acceptance of Plant Biotechnology for specialty crops (Glyphosate tolerant lettuce, Glufosinate tolerant mint, Glyphosate tolerant sweet corn, etc) has been limited IR-4 Strategy

  21. Company Products Crops Amvac 3 8 Arysta 3 4 BASF 5 6 Bayer CropScience 6 7 Cerexagri 2 4 Chemtura 4 8 Dow AgroSciences 6 9 DuPont Crop Protection 9 13 FMC 4 6 Gowan 5 10 ISK Biosciences 2 5 Lonza 1 5 Makhteshim-Agan North America 4 9 Nichino America 1 3 Syngenta Crop Protection 11 20 Valent/Sumitomo 6 14 2006 IR-4 Food Use Program-Companies and Products Summary: 16 Companies (vs 15 in 2005) 72 Products (vs 63 in 2005 and 52 in 2004) 132 Crops (vs 108 in 2005)

  22. Partnership Initiative Examples Arysta LifeScience Fenhexamid Strategy lodomethane/MBA Program BASF BAS 500/510/516 Strategy Funding for BAS 510/516 Efficacy program Strategic Discussions of IR-4 Involvement at Earlier Commercialization Stage Bayer CropScience (includes Aventis) Imidacloprid Strategy Thiacloprid Strategy US/Canada Minor Crop Use Meeting (Aventis) Secrecy Agreement on New Molecules Crop Protection Industry DuPont Crop Protection Indoxacarb Strategy DPX-E2Y45 Strategy Secrecy Agreement on New Molecules

  23. Partnership Initiative Examples Dow AgroSciences (includes Rohm and Haas) • Spinosad Super Crop Group Concept • Quinoxyfen strategy • MAC Strategy (transition from Tebufenozide to Methoxyfenozide) • Analytical Equipment Purchase (LC/MS/MS) • DE-175 Strategy Gowan • Halosulfuron strategy Crop Protection Industry Syngenta Crop Protection • Azoxystrobin strategy • Numerous specialty crop strategies and meetings • Significant financial contributions Valent U.S.A. Corporation • Participation in company strategy meetings • Discussions on new molecules under secrecy agreement

  24. Partnerships Make Things Happen • Commodity Liaison • Committee (CLC) • Provide direct input to: • Project Management Committee • Workshops – Food Use and Ornamental • Provide key interface with House and Senate Agriculture Appropriations staff members • Efforts resulted in IR-4 budget increases for CSREES in FY 2005 and ARS prior to FY 2004 • Additional funding increases are needed to provide support for: • Field residue projects • Biopesticide and Ornamental programs • Analytical instrumentation and field equipment used to conduct GLP residue trials

  25. Commodity Liaison Committee (CLC) Members • Micheal Aerts – Florida Fruit & Vegetable Assoc. • Mark Arney – National Watermelon Promotion Board • Rich Bonanno – Bonanno Farm Trust • Bruce Buurma – Buurma Farms, Inc. • Thomas G. Davenport - National Grape Cooperative • Wally Ewart – CA Citrus Quality Council • Brian Flood – Del Monte USA • Rebecckah Freeman – American Farm Bureau Federation • Ann George – WA Hop Commission • Hank Giclas – Western Growers Assoc.

  26. Commodity Liaison Committee (CLC) Members • John Keeling - National Potato Council • Phil Korson – Cherry Marketing Institute • Rocky Lundy – Mint Industry Research Council (Chair) • Eric Maurer – Valent USA Corp. • Ken Melban – CA Pepper Commission • Reed Olszack – Tropical Fruit Growers of S. FL • Ray Prewett – Texas Vegetable Assoc. • Ray Ratto – Ratto Brothers • Lin Schmale – Society of American Florists • Todd Scholz – USA Dry Pea & Lentil Council • Marc Teffeau – American Nursery Landscape Assoc. • Dave Trinka – MBG Marketing

  27. Partnerships Make Things Happen • Environmental Protection Agency (EPA) • EPA/IR-4 Technical Working Group: Initiated in 1999, meets quarterly and holds 1 or 2 annual summer tours • Explores initiatives to facilitate minor crop tolerances; super crop group proposals on azoxystrobin and spinosad saved over $1 million • 3 year Work Plans provided by IR-4 in concert with 30-month timeline • EPA reviews annual IR-4 residue program • Data Evaluation Record/Summaries prepared for final reports -Leadership with agency on electronic petition submission

  28. Partnerships Make Things Happen • Environmental Protection Agency (EPA) • Annual Work Plan coordination • Sabbaticals by Dan Kunkel (2001), Michael Braverman/BPPD (2002) and Hong Chen (2003/2004) • 4548 clearances in last 6 years (567/2000, 654/2001, 531/2002, 793/2003, 1014/2004 and 991/2005) • Potential for over 900 clearances in 2006

  29. IR-4 Reduced Risk Classifications • FY YearProductCrop • Tebufenozide Berry Crop Group, Canola, Turnip and Mint • Glyphosate Over 200 Crops • Pyriproxyfen Pistachio • Pyriproxyfen Blueberry, Lychee and Guava • Diflufenzopyr Corn (pop and sweet) and Grasses (hay and forage) • Spinosad Berry group, Fig, Grape, Herbs, Peanut, Root and Tuber Vegetables

  30. IR-4 Reduced Risk Classifications FY 2003 Products/Crops Azoxystrobin — Artichoke, Asparagus, Brassica Head and Stem Vegetables and Herbs Bifenazate — Cucurbits, Fruiting Vegetables, Mint, Pistachio, Tomato (GH) and Tree Nuts Buprofezin — Beans, Lychee, and Pistachio Cyprodinil — Bushberry, Caneberry, Pistachio and Watercress, Brassica Leafy Vegetables, Carrot, Herbs, and Lychee Fenhexamid — Cucurbits, Fruiting Vegetables, Kiwi Fruit, Leafy Greens and Stone Fruit Mesotrione — Popcorn Methoxyfenozide — Cranberry, Cucurbits, Okra, Pea and Turnips Pyriproxyfen — Avocado, Fig, Okra and Sugar Apple Quinoxyfen — Cherry Trifloxystrobin — Leafy Petioles and Root Vegetables Thiamethoxam — Beans (succulent), Stone Fruit and Sunflower

  31. IR-4 Reduced Risk Classifications • Total of 15 products and over 300 different specialty crops • 12 of 26 classifications in FY 2003 • Thanks to the EPA Partnership, IR-4 credited with helping lower the reduced risk / OP alternative petition turnaround time from 28 months in FY 2002 to 18months in FY 2003

  32. 1110 1014 991 793 647 564 567 538 281 212 1 2000 2003 2005 1997 1998 1999 2001 2002 2004 2006 2007 IR-4 Program Track Record for Food Use Clearances

  33. Partnerships Make Things Happen • California’s Department of • Pesticide Regulation (CDPR) • Part of EPA/IR-4 Technical Working Group since 2001 • Partnership between EPA and CDPR facilitated by IR-4 resulted in workshare on 20 to 30 IR-4 petitions each year (2001-2004) • Expanded number of IR-4 petitions reviewed in 2005 and 2006 (50 to 60) • Great support from Senior Management and dedicated team led by David Supkoff

  34. Partnerships Make Things Happen • Health Canada’s • Pest Management • Regulatory Agency (PMRA) and • Agriculture and Agri-Food Canada’s Pest Management Centre • Partnership with IR-4 began in 1996 • First IR-4 work share petition with EPA was completed in 2002 • In 2003, the Canadian government made a major funding commitment to minor crop growers through PMRA and AAFC • 91 total cooperative projects — most since 2003  • 279 total cooperative Canadian field trials – 214 since 2003 • IR-4 workshare petitions with PMRA have been approved by NAFTA Technical Working Group

  35. IR-4…The Story Continues The IR-4 Research Process and Special Programs

  36. Today’s Objectives • Strategies • Process in the Food and • Ornamental Programs • Biopesticide Research • Crop Grouping • Global Harmonization

  37. IR-4 Strategies • Track new technology • Focus efforts on Reduced Risk products • Develop registration strategies with companies • Use of representative crops to obtain MRL’s for Crop Groups

  38. Track New Technology • Track and monitor over 300 pipeline and newly registered products • Many are or will be Reduced Risk • Pipeline is not robust but recovering • Fewer active ingredients being submitted for registration • Herbicide development for broadleaf crops is extremely limited • Roundup Ready Crops have significant share of major market crops • Glyphosate resistance has been discovered

  39. IR-4 Reduces Risk Strategy • Focus research efforts on Reduced Risk Products • Reduced Risk – 1993 EPA Policy to expedite the registration of products that pose less risk to human health and environment • Since 2000, over 80% of IR-4 research involved Reduced Risk Products • Reduced Risk use patterns for existing product registrations • Registration of new and support for existing pest control products essential to Integrated Pest Management • Registration of biologically - based pest control products

  40. Registration Strategy • Start research on new chemistries before the first food use tolerance • Use representative crops to obtain tolerance for entire Crop Group • Use “Super Crop Groups” for reduced risk chemistries to increase efficiencies • 30 month time frame for “Priority A” food Use projects – signing of protocol to submission to EPA

  41. The IR-4 Regulatory Clearance Process Stakeholder: • Define Pest Problem • Identify Pest Management Solution • Request Assistance from IR-4 Stage I Food Crops

  42. The IR-4 Regulatory Clearance Process • Submit a Project Clearance Request Form (PCR) Stage II Food Crops Request Reviewed by Manufacturer The Process Starts with Requests Submitted from: • Growers • Grower Groups • State/Federal Research & Extension Personnel Stakeholder: Define Pest Problem Identify Pest Management Solution Request Assistance from IR-4

  43. The IR-4 Regulatory Clearance Process • Priorities are Determined at Annual IR-4 Food Use and Ornamental Horticulture Workshops Stage III Food Crops The Process Starts with Requests Submitted from: • Growers, • Grower Groups, • State/Federal Research & Extension Personnel Request Reviewed by Manufacturer Requests Prioritized Stakeholder: Define Pest Problem Identify Pest Management Solution Request Assistance from IR-4 ( ) Top Priorities Researched That Year Second Priorities Researched as Money Allows

  44. The IR-4 Regulatory Clearance Process Stage IV Food Crops Following the Annual Food Use Workshop National Research Planning Meeting Research project field and laboratory sites are designated for the coming year

  45. EPA Regions 12 11 7 1 5 9 8 10 2 4 6 3 13

  46. The IR-4 Regulatory Clearance Process Stage V Food Crops • Field and Lab Research is completed following GLPs (Good Laboratory Practices) • Measure Residue levels in Crops • Top Priorities Completed in 30 months Data Submitted to EPA

  47. The IR-4 Regulatory Clearance Process The Process Starts with Requests Submitted from: • Growers, • Grower Groups, • State/Federal Research & Extension Personnel Stakeholder: Define Pest Problem Identify Pest Management Solution Request Assistance from IR-4 Request Reviewed by Manufacturer 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 Risk Assessment Data Submitted to EPA Manufacturer Adds Crop to the Product Label Tolerance Established by EPA

  48. The Process for Ornamentals and Non-Food Use Research The Process Starts with Requests /Survey Submitted from: • Growers, • Grower Groups, • State/Federal Research & Extension Personnel Requests & Survey Results Prioritized At Ornamentals Workshop Request Reviewed by Manufacturer Stakeholder: Define Pest Problem Identify Pest Management Solution Request Assistance from IR-4 Field and Lab Research Research Is Completed for Efficacy and Plant Safety Data Submitted to Registrant Who Makes Label Amendment(s) Manufacturer Markets Product with New Use on Label Label Approved by EPA

  49. Ornamental Horticulture Program • Super A Priorities for Efficacy Testing • Establishment of Industry and University/ARS Advisory Committee • More emphasis on efficacy testing vs. crop safety • Established guidelines on the acceptable numbers of trials for registrations • Criteria for establishing priorities • Established permanent funding for program ($400,000 in 2005 and $350,000 in 2006)

  50. Biopesticide Research • Formally Established in 1982 • Some activities prior to 1982: regulatory assistance w/Bt • 1982-1994 • Mostly regulatory assistance • Some funding of research • 1995-2003 • Regulatory assistance • Early stage research • Advance stage research (1999) • New initiative / Pilot Demonstration Program • First year was $100,000 program ($80,000 from BPPD) • Second and Third Years are $200,000 Program Each Year ($100,000 from BPPD)

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