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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:. - PowerPoint PPT Presentation
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IR-4…What We Do
Provide Safe and Effective
Pest Management Solutions for
Specialty Crop Growers
Specialty Crops Include:
Most:VegetablesFruitsNuts Herbs Spices
Specialty Crops Include:
Most: Greenhouse Nursery Landscape Christmas Trees
• 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
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.
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
Publicly funded program that conducts research and submits petitions to EPA for tolerances/clearances
IR-4… is the ONLY
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
Who Pays For It?
Additional Support Provided By:
Commodity & Industry Partners
for Special Research Projects
IR-4 Program FY 2006 Funding and Support
Funding Source Amount
•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
$28,740,314Total
1 Labs, offices, research farms, infrastructure and administrative support2 Lab analysis, QA support, analytical standards, technical support, etc.
IR-4 Supporters
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 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 12/97Reduced Risk Products, Biopesticides (dedicated research funds)
1997 Food Quality Protection Act (FQPA) Reduced Risk StrategyPromote the registration of Reduced Risk productsExpand biopesticide programs, Form New Technology Team
2000 Revised Strategic Plan to focus onAccelerating Reduced Risk chemistry registrationGaining access to new chemistries
IR-4 Milestones
2006 Revised Strategic Plan to Focus On: Revitalizing Existing Programs
Initiating New Programs
IR-4 Milestones
Field Trials and Residue Analyses Sites Across the U.S
Puerto Rico =
Hawaii =
Field Trials and Residue Analyses Sites Across the U.S
Puerto Rico =
Hawaii =
IR-4 HQ
IR-4 Regional Program Office
State Satellite Labs
State Field Research Centers/Food Use
ARS Labs
ARS Field Research Centers Food Use
State Field Research Centers/ Ornamentals and Non-food Use
ARS Field Research Centers Ornamental and Food Use
ARS Field Research Centers Ornamental
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
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
Current EnvironmentExternal 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
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 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 ChallengesExternal 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
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
Summary:
16 Companies (vs 15 in 2005)
72 Products
(vs 63 in 2005 and 52 in
2004)
132 Crops (vs 108 in 2005)
2006 IR-4 Food Use Program-Companies and Products
Partnership Initiative ExamplesArysta 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 ProtectionIndoxacarb StrategyDPX-E2Y45 Strategy
Secrecy Agreement on New Molecules
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
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
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 – 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: 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
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
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
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, 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
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
FY 2003 Products/Crops
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 18 months in FY 2003
IR-4 Program Track Record for Food Use Clearances
0
200
400
600
800
1000
1200
1 2 3 4 5 6 7 8 9 10 11
11109911014
793
538564567
281212
1
1997
19981999
2000
20012002
2003
20042005
20062007
647
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
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) andAgriculture 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
Health Canada’s Pest Management Regulatory Agency (PMRA) andAgriculture 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
The IR-4 Research Process and
Special Programs
IR-4…The Story Continues
• Strategies• Process in the Food and Ornamental Programs• Biopesticide Research• Crop Grouping• Global Harmonization
Today’s Objectives
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
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 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
• 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
Stakeholder:
Define Pest Problem
Identify Pest Management Solution
Request Assistance from IR-4
The IR-4 Regulatory Clearance Process
Stage I Food Crops
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
Submit a Project Clearance Request Form (PCR)Stage IIFood Crops
The IR-4 Regulatory Clearance Process
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
)
Priorities are Determined at Annual IR-4 Food Use and Ornamental Horticulture Workshops
(
Stage IIIFood Crops
The IR-4 Regulatory Clearance Process
The Process Starts with Requests Submitted from:
• Growers,
• Grower Groups,
• State/Federal Research &
Extension Personnel
National Research Planning Meeting
Research project field and laboratory sites are designated for the coming year
Following the Annual Food Use WorkshopStage IVFood Crops
The IR-4 Regulatory Clearance Process
EPA Regions
1
2
9
34
5
6
8
7
10
11
12
13
Data Submitted to EPA
Field and Lab Research is completed following GLPs (Good Laboratory Practices)
• Measure Residue levels in Crops
• Top Priorities Completed in 30 months
Stage VFood Crops
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
Data
Submitted to
EPA
Risk Assessment
Tolerance Established by EPA
Field and Lab Research•Measure Residue levels in Crops
•Top Priorities completed in 30 months
Manufacturer Adds Crop to the Product
Label
Top Priorities Researched That Year
Second Priorities Researched as Money Allows
)(
The IR-4 Regulatory Clearance Process
Request Reviewed by Manufacturer
Requests & Survey Results Prioritized
At Ornamentals Workshop
Field and Lab Research
Research Is Completed for Efficacy and Plant Safety
Manufacturer Markets Product with New Use
on Label
The Process for Ornamentals and Non-Food Use Research
Label Approved by EPA
Data Submitted to Registrant
Who Makes Label Amendment(s)
The Process Starts with Requests /SurveySubmitted from:
• Growers,
• Grower Groups,
• State/Federal Research &
Extension Personnel
Stakeholder:
Define Pest Problem
Identify Pest Management Solution
Request Assistance from IR-4
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)
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 with conventional crop protection chemicals?
• IR-4’s strategy since 2003 has been to encourage research to integrate biopesticides in rotation with conventional materials.
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
Data Mining Pilot
Crop Grouping Expansions
• Crop Groups – 19• Crop Subgroups – 18• Total commodities – 508• Commodity Definitions [180.1(h)] – 20• Ornamental commodity or group - 0
Current Crop Grouping Scheme
- Published in 1995 40 CFR 180.41
Why Need an Expansion?
Many orphan crops don’t have groups –
Why Need an Expansion?
• To facilitate Import tolerances
• To harmonize the US & Codex System
• To pursue an international harmonization of crop vocabulary and MRLs
Proposals Existing Groups New Proposals Total Increased
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 0 900 900 New
OrnamentalGroups
0 15 15 New
* Crop Group 20 - Oilseed is approved by HED ChemSAC
Crop Grouping Proposals
Efficacy of Crop Groupings
Crop Group Rep Groups
Clearances
Current Proposed
Root and Tuber
Leafy Vegetables
Herb and Spice
41
42
43
36
27
68
87
103
239
1 Carrot, Potato, Radish and Sugarbeet
2 Head Lettuce, Leaf Lettuce, Spinach and Celery
3 Basil, Chive, Celery or Dill Seed and Black Pepper
• 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
Crop Grouping & Food Use Tolerances
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)
EU Austria Belgium Cyprus Czech Republic DenmarkEstonia FinlandFrance GermanyGreeceHungaryIrelandItaly
Latvia LithuaniaLuxembourgMaltaNetherlands PolandPortugalSlovakiaSloveniaSpain Sweden UK
Crop Grouping Project Participants
Over 170 members representing over 30 countries:
Australia NAFTACanada Mexico U.S
East AsiaChinaJapan South Korea
South AmericaColumbia
Mid EastIsrael Lebanon
Crop Grouping Project Participants
IR-4’s Impact on Section 18’s in the U.S. 1998-2005
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
Section 18’s1
Year
199819992000200120023
20033
20042005
1031341521801
1341282024
196
Number Value2
$ 475,000,000$1,466,000,000$1,580,000,000$2,223,000,000$2,245,000,000$1,989,000,000$1,549,000,000$1,062,000,000
Totals 12295 $12,589,000,000
IR-4’s Impact on Section 18’s and Economic Loss Avoidance
State Specialty Crop Economic LossValue1 Avoidance2
California 16,804,416 2,480,900
Florida 4,525,253 2,060,000
Georgia 1,312,543 187,500
Idaho 837,624 475,500
Michigan 1,163,089 683,500
Oregon 1,546,576 403,300
Texas 1,125,059 369,500
Washington 2,578,005 1,798,600
Others 13,635,396 4,130,200
Total $43,525,021 $12,589,0001 2002 Census of Agriculture2 From 1998-2005; estimates provided by states to EPA
Thank You!