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:
Greenhouse
Nursery
Landscape
Christmas Trees
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 $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.
Importance of Specialty Crops to US Agriculture
Top Specialty Crop States
Does not include Ornamental crops
–
–
–
–
–
–
–
–
–
California
Florida
Washington
Oregon
North Carolina
Georgia
Michigan
Texas
Pennsylvania
1997
2002
$14.4B
$ 4.7B
$ 2.3B
$ 1.4B
$ .6B
$ 1.1B
$ 1.1B
$ 1.1B
$ .8B
$16.8B
$ 4.5B
$ 2.6B
$ 1.5B
$ 1.4B
$ 1.3B
$ 1.2B
$ 1.1B
$ 1.0B
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 to EPA for
tolerances/clearances
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
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
$10,000,0001
• Private Sector/In-Kind
$ 2,000,0002
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 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 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 New Programs
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
ARS Labs
ARS Field Research Centers Food Use
ARS Field Research Centers Ornamental
ARS Field Research Centers Ornamental and Food Use
Hawaii =
Puerto Rico =
Hawaii =
Puerto Rico =
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
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 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 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
8
Arysta
3
4
BASF
5
6
Bayer CropScience
6
7
Cerexagri
2
4
Chemtura
4
8
72 Products
Dow AgroSciences
6
9
(vs 63 in 2005 and 52 in 2004)
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)
132 Crops (vs 108 in 2005)
Crop Protection Industry
Partnership Initiative Examples
Arysta LifeScience
Fenhexamid Strategy
lodomethane/MBA Program
DuPont Crop Protection
Indoxacarb Strategy
DPX-E2Y45 Strategy
Secrecy Agreement on New Molecules
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
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
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
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, 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 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
 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
1200
1110
1014 991
1000
793
800
647
567 564 538
600
400
212
200
281
1
0
1
2
3
4
5
6
7
8
9
10
11
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 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
Today’s Objectives
• Strategies
• Process in the Food and
Ornamental Programs
• Biopesticide Research
• Crop Grouping
• Global Harmonization
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
The IR-4 Regulatory Clearance Process
Stage I
Stakeholder:
Food Crops
 Define Pest Problem
 Identify Pest
Management Solution
 Request
Assistance
from IR-4
The IR-4 Regulatory Clearance Process
Stage II
 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
Submitted from:
• Growers
• Grower Groups
• State/Federal
Research &
Extension
Personnel
Request Reviewed by
Manufacturer
The IR-4 Regulatory Clearance Process
Stage III
Food Crops
Stakeholder:
Define Pest
Problem
Identify Pest
Management
Solution
Request
Assistance
from IR-4
 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 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
3
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
Request Assistance
from IR-4
The Process Starts
with Requests
Request Reviewed by
Manufacturer
Submitted from:
• Growers,
• Grower Groups,
• State/Federal Research &
Requests
Prioritized
Extension Personnel
(
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
Label
)
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
• Growers,
• Grower Groups,
• State/Federal Research &
Request Reviewed
by Manufacturer
Requests &
Survey Results
Prioritized
At Ornamentals
Workshop
Extension Personnel
Field and Lab Research
Research Is Completed
for Efficacy and Plant
Safety
Manufacturer Markets
Product with New Use
on Label
Data Submitted
to Registrant
Who Makes Label
Amendment(s)
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.
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
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?
• To facilitate Import tolerances
• To harmonize the US & Codex System
• To pursue an international harmonization
of crop vocabulary and MRLs
Crop Grouping Proposals
Proposals
Commodities
Existing Groups
New Proposals
Total
Increased
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
Ornamental
Groups
0
15
15
New
* Crop Group 20 - Oilseed is approved by HED ChemSAC
Efficacy of Crop Groupings
Crop Group
Rep Groups
Clearances
Current
Proposed
Root and Tuber
41
36
87
Leafy
Vegetables
42
27
103
Herb and Spice
43
68
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
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 – 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
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
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’s1
Year
Number
Value2
1998
1999
2000
2001
20023
20033
2004
2005
103
134
152
1801
134
128
2024
196
$ 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
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
Value1
Economic Loss
Avoidance2
California
Florida
Georgia
Idaho
Michigan
16,804,416
4,525,253
1,312,543
837,624
1,163,089
2,480,900
2,060,000
187,500
475,500
683,500
Oregon
Texas
Washington
Others
1,546,576
1,125,059
2,578,005
13,635,396
403,300
369,500
1,798,600
4,130,200
Total
$43,525,021
1 2002 Census of Agriculture
2 From 1998-2005; estimates provided by states to EPA
$12,589,000
Thank
You!