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

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


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


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


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


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


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


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


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


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


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


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



Request Reviewed by Manufacturer

Submit a Project Clearance Request Form (PCR)Stage IIFood Crops


Stakeholder:

Define Pest Problem



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



• 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


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



• Growers,

• Grower Groups,


Extension Personnel

Stakeholder:

Define Pest Problem




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

)(



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,


Extension Personnel

Stakeholder:

Define Pest Problem



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!

Documents

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