IR 4 What We Do Provide Safe and Effective

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

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

Specialty Crops • are high value/low acreage crops • make up about 46% of Specialty Crops • 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

Leading specialty crop production states (over $1 billion that also represents about half the Leading specialty crop production states (over $1 billion 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.

Importance of Specialty Crops to US Agriculture Top Specialty Crop States Does not include Importance of Specialty Crops to US Agriculture Top Specialty Crop States Does not include Ornamental crops 1997 – – – – – California Florida Washington Oregon North Carolina Georgia Michigan Texas Pennsylvania 2002 $14. 4 B $ 4. 7 B $ 2. 3 B $ 1. 4 B $ . 6 B $ 1. 1 B $ . 8 B $16. 8 B $ 4. 5 B $ 2. 6 B $ 1. 5 B $ 1. 4 B $ 1. 3 B $ 1. 2 B $ 1. 1 B $ 1. 0 B Source: 1997 & 2002 Census of Agriculture United States Summary Table 56

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

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

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

IR 4 Supporters IR 4 Supporters

IR 4 Milestones 1963 IR 4 Established – by the Directors of State Agricultural IR 4 Milestones 1963 IR 4 Established – by the Directors of State Agricultural Experiment Stations working with the U. S. Department of Agriculture Cooperative States Research Service 1975 Regional 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 1989 Established a GLP program Responded to 1988 FIFRA Amendments by IR 4 Milestones 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 2006 Revised Strategic Plan to Focus On: Revitalizing Existing Programs Initiating IR 4 Milestones 2006 Revised Strategic Plan to Focus On: Revitalizing Existing Programs Initiating New Programs

Field Trials and Residue Analyses Sites Across the U. S IR 4 HQ IR 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 ARS Labs ARS Field Research Centers Food Use ARS Field Research Centers Ornamental and Food Use Hawaii = Puerto Rico =

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

Partnerships Make Things Happen Crop Protection Industry § Partnerships with biopesticide and chemical companies 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 Challenges that are being managed well through IR 4

IR 4 Strategy Current Environment External Partners—Crop Protection Industry • Extensive consolidation (10 companies IR 4 Strategy 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 2 nd tier companies

IR 4 Strategy Current Environment External Partners—Crop Protection Industry • Companies with support from IR 4 Strategy 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 Future Challenges External Partners—Crop Protection Industry • Continued consolidation (especially Japanese IR 4 Strategy 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 Future Challenges External Partners—Crop Protection Industry • Diminishing level of new IR 4 Strategy 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

2006 IR 4 Food Use Program Companies and Products Company Products Crops Amvac 3 2006 IR 4 Food Use Program Companies and Products Company Products Crops Amvac 3 8 Arysta 3 4 BASF 5 6 Bayer Crop. Science 6 7 Cerexagri 2 4 Chemtura 4 8 Dow Agro. Sciences 6 9 Du. Pont 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 Summary: 16 Companies (vs 15 in 2005) 72 Products (vs 63 in 2005 and 52 in 2004) 132 Crops (vs 108 in 2005)

Crop Protection Industry Partnership Initiative Examples Arysta Life. Science Fenhexamid Strategy lodomethane/MBA Program Du. Crop Protection Industry Partnership Initiative Examples Arysta Life. Science Fenhexamid Strategy lodomethane/MBA Program Du. Pont Crop Protection Indoxacarb Strategy DPX E 2 Y 45 Strategy Secrecy Agreement on New Molecules BASF BAS 500/516 Strategy Funding for BAS 510/516 Efficacy program Strategic Discussions of IR 4 Involvement at Earlier Commercialization Stage Bayer Crop. Science (includes Aventis) Imidacloprid Strategy Thiacloprid Strategy US/Canada Minor Crop Use Meeting (Aventis) Secrecy Agreement on New Molecules

Crop Protection Industry Partnership Initiative Examples Dow Agro. Sciences (includes Rohm and Haas) • Crop Protection Industry Partnership Initiative Examples Dow Agro. Sciences (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 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

Partnerships Make Things Happen Commodity Liaison Committee (CLC) § Provide direct input to: Ø Partnerships Make Things Happen Commodity Liaison Committee (CLC) § Provide direct input to: Ø Project Management Committee Ø 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: Ø Field residue projects Ø Biopesticide and Ornamental programs Ø Analytical instrumentation and field equipment used to conduct GLP residue trials

Commodity Liaison Committee (CLC) Members § Micheal Aerts – Florida Fruit & Vegetable Assoc. 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.

Commodity Liaison Committee (CLC) Members § John Keeling National Potato Council § Phil Korson 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

Partnerships Make Things Happen Environmental Protection Agency (EPA) § EPA/IR 4 Technical Working Group: 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

Partnerships Make Things Happen Environmental Protection Agency (EPA) § Annual Work Plan coordination § 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

IR 4 Reduced Risk Classifications FY Year Product Crop 1999 Tebufenozide Berry Crop Group, IR 4 Reduced Risk Classifications FY Year Product Crop 1999 Tebufenozide Berry Crop Group, Canola, Turnip and Mint 2000 Glyphosate Over 200 Crops 2001 Pyriproxyfen Pistachio 2002 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

IR 4 Reduced Risk Classifications FY 2003 Products/Crops Azoxystrobin — Artichoke, Asparagus, Brassica Head 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

IR 4 Reduced Risk Classifications ü Total of 15 products and over 300 different IR 4 Reduced Risk Classifications ü Total of 15 products and over 300 different specialty crops ü 12 of 26 classifications in FY 2003 ü 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 18 months in FY 2003

IR 4 Program Track Record for Food Use Clearances 1110 1014 991 793 647 IR 4 Program Track Record for Food Use Clearances 1110 1014 991 793 647 564 538 212 281 1 9 19 7 8 9 99 1 0 0 20 2 1 00 2 2 00 3 0 20 5 0 4 00 20 2 6 0 20 7 0 20

Partnerships Make Things Happen California’s Department of Pesticide Regulation (CDPR) § Part of EPA/IR 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

Partnerships Make Things Happen Health Canada’s Pest Management Regulatory Agency (PMRA) and Agriculture and 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

IR 4…The Story Continues The IR 4 Research Process and Special Programs IR 4…The Story Continues The IR 4 Research Process and Special Programs

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

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

Track New Technology • Track and monitor over 300 pipeline and newly registered products 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

IR 4 Reduces Risk Strategy • Focus research efforts on Reduced Risk Products Reduced 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

Registration Strategy • Start research on new chemistries before the first food use tolerance 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

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

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

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

The IR 4 Regulatory Clearance Process Stage IV Food Crops Following the Annual Food 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

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

The IR 4 Regulatory Clearance Process Stage V Food Crops Field and Lab Research 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

The IR 4 Regulatory Clearance Process Stakeholder: Define Pest Problem Identify Pest Management Solution The IR 4 Regulatory Clearance Process Stakeholder: Define Pest Problem Identify Pest Management Solution Request Assistance from IR 4 The Process Starts with Requests Request Reviewed by Manufacturer Submitted from: • Growers, • Grower Groups, • State/Federal Research & Extension Personnel ( 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 Manufacturer Adds Crop to the Product Tolerance Established Label by EPA o t ta itted Da bm Su A EP

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

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

Biopesticide Research Formally Established in 1982 • Some activities prior to 1982: regulatory assistance 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)

Future Opportunities for Biopesticides • Many promising new products, but can biopesticides compete directly Future Opportunities for Biopesticides • Many promising new products, but can biopesticides compete directly with conventional crop protection chemicals? • IR 4’s strategy since 2003 has been to encourage research to integrate biopesticides in rotation with conventional materials.

Data Mining Pilot New Reduced Risk Products often lack good preliminary performance data to Data Mining Pilot New Reduced Risk Products often lack good preliminary performance data to support expansion of registration – Registrants do no have resources to fund research – Reduction of agriculture research infrastructure IR 4 has limited resources to directly fund preliminary research Data Mining effort was established to search for all available data, including world wide sources Data used to answer fundamental questions on crop safety/product performance – If data is good, start residue studies, or – Directly fund additional research trials

Crop Grouping Expansions Crop Grouping Expansions

Current Crop Grouping Scheme Published in 1995 40 CFR 180. 41 • • • Current Crop Grouping Scheme Published in 1995 40 CFR 180. 41 • • • Crop Groups – 19 Crop Subgroups – 18 Total commodities – 508 Commodity Definitions [180. 1(h)] – 20 Ornamental commodity or group 0

Why Need an Expansion? Many orphan crops don’t have groups – Why Need an Expansion? Many orphan crops don’t have groups –

Why Need an Expansion? • To facilitate Import tolerances • To harmonize the US Why Need an Expansion? • To facilitate Import tolerances • To harmonize the US & Codex System • To pursue an international harmonization of crop vocabulary and MRLs

Crop Grouping Proposals Existing Groups New Proposals Commodities 508 553 1061 > 2 fold Crop Grouping Proposals Existing Groups New Proposals Commodities 508 553 1061 > 2 fold Crop Groups 19* 19 38 2 fold Subgroups 18 72 90 4 fold Definitions 20 29 49 > 2 fold Ornamentals 0 900 New Ornamental Groups 0 15 15 New * Crop Group 20 Oilseed is approved by HED Chem. SAC Total Increased

Efficacy of Crop Groupings Crop Group Rep Groups Clearances Current Proposed Root and Tuber Efficacy of Crop Groupings Crop Group Rep Groups Clearances Current Proposed Root and Tuber 41 36 87 Leafy Vegetables 42 27 103 43 68 239 Herb and Spice 1 Carrot, Potato, Radish and Sugarbeet 2 Head Lettuce, Leaf Lettuce, Spinach and Celery 3 Basil, Chive, Celery or Dill Seed and Black Pepper

Crop Grouping & Food Use Tolerances • Prior to 1976: 1 study = 1 Crop Grouping & Food Use Tolerances • Prior to 1976: 1 study = 1 new use • Present: 1 study > 5 new uses • 2005: 201 tolerances = 991 new uses • Future: 1 study > 10 to 15 new uses

Reduced Data Sets for Reduced Risk Chemistries: Spinosad – 165 uses (K. Dorschner) Azoxystrobin Reduced Data Sets for Reduced Risk Chemistries: Spinosad – 165 uses (K. Dorschner) Azoxystrobin – 129 uses (D. Thompson) Glyphosate – over 200 uses (M. Braverman) Carfentrazone – over 200 uses (F. Salzman) Surrogate data petitions (utilizing logical associations): Fenhexamid/fruiting vegetables – European GH data (H. Chen) Conceived from ROTENONE reregistration: All crops except grains and cranberries (K. Samoil)

Crop Grouping Project Participants Over 170 members representing over 30 countries: EU Austria Belgium Crop Grouping Project Participants Over 170 members representing over 30 countries: EU Austria Belgium Cyprus Czech Republic Denmark Estonia Finland France Germany Greece Hungary Ireland Italy Latvia Lithuania Luxembourg Malta Netherlands Poland Portugal Slovakia Slovenia Spain Sweden UK

Crop Grouping Project Participants Australia East Asia China Japan South Korea South America Columbia Crop Grouping Project Participants Australia East Asia China Japan South Korea South America Columbia NAFTA Canada Mexico U. S Mid East Israel Lebanon

IR 4’s Impact on Section 18’s in the U. S. 1998 2005 Section 18’s IR 4’s Impact on Section 18’s in the U. S. 1998 2005 Section 18’s 1 Year Number Value 2 1998 1999 2000 2001 20023 20033 2004 2005 103 134 152 1801 134 128 2024 196 $ 475, 000 $1, 466, 000 $1, 580, 000 $2, 223, 000 $2, 245, 000 $1, 989, 000 $1, 549, 000 $1, 062, 000 Totals 12295 $12, 589, 000 1) Requested by states using IR 4 data 2) From state estimates/EPA submission, 47 states involved 3) 56 Section 18’s converted to Section 3 Permanent tolerances in both FY 2002 and FY 2003 4) 78 - Honey and Wax 5) 205 Section 18’s converted to permanent tolerances – 43 in 2005

IR 4’s Impact on Section 18’s and Economic Loss Avoidance State Specialty Crop Value IR 4’s Impact on Section 18’s and Economic Loss Avoidance State Specialty Crop Value 1 Economic Loss Avoidance 2 California Florida Georgia 16, 804, 416 4, 525, 253 1, 312, 543 2, 480, 900 2, 060, 000 187, 500 Idaho Michigan Oregon Texas Washington Others 837, 624 1, 163, 089 1, 546, 576 1, 125, 059 2, 578, 005 13, 635, 396 475, 500 683, 500 403, 300 369, 500 1, 798, 600 4, 130, 200 Total $43, 525, 021 $12, 589, 000 1 2002 Census of Agriculture 2 From 1998 -2005; estimates provided by states to EPA

Thank You! Thank You!




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