IR-4
Western Region
IR-4
Stephen Flanagan
IR-4!What We Do
Provide Safe and Effective
Pest Management Solutions for
Specialty Crop Growers
IR-4 Food Use Research
!! Food Crops
"! Magnitude of Residue
"! Setting tolerances for pesticides in
specialty crops
"! (Maximum Residue Limits (MRLs))
"! Fruits & Vegetables
Magnitude of Residue – “The Food Use Program”
!! To Support the Establishment of Food Use
Tolerances/Clearances for:
Section 3 registrations
“Full registration”
24(c) registrations
“Special Local Need” (SLN) registration
Section 18 Time limited tolerances
“Emergency Use Exemption”
The IR-4 Regulatory Clearance Process
The Process Starts
with Requests
Stakeholder:
Define Pest
Problem
Identify Pest
Management
Solution
Request
Assistance
from IR-4
Submitted from:
Request Reviewed by
Manufacturer
•! Growers,
•! Grower Groups,
•! State/Federal Research &
Requests
Prioritized
( )
Top Priority
Researched
That Year
Extension Personnel
Second
Priorities
Researched as
Money Allows
Field and Lab Research
•!Measure Residue levels in Crop/
Crop Group
•!Top Priorities completed in 30
months
Risk Assessment
Manufacturer
Adds Crop to
the Product
Label
Tolerance Established by
EPA
The IR-4 Regulatory Clearance Process
Stage I
Food Crops
Stakeholder:
!!Define Pest Problem
!!Identify Pest
Management Solution
!!Request
Assistance
from IR-4
The IR-4 Regulatory Clearance Process
Stage II
Food Crops
!! Submit a Project Clearance Request Form (PCR)
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 Workshop
The Process Starts
with Requests
Submitted from:
•! Growers,
•! Grower Groups,
•! State/Federal Research &
Extension Personnel
Request Reviewed by
Manufacturer
Requests
Prioritized
( )
Top Priority
Researched
That Year
Second
Priorities
Researched as
Money Allows
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 Crop/Crop Group
•! Top Priorities
Completed in 30
months
Regulatory Guidance!.
!! Protocol Development
!!Follows requirements as outlined
!!Use pattern as per commercial field use
!!Grow “commercial” crop
!!Application Interval
!!Number of applications per crop
!!Rate per application
!!Rate per crop
!!Duplicate samples per location
Regulatory Guidance!.
!! Protocol Development
!!Preharvest interval - PHI
!!Certain number of fruit and size of sample
!!Page 456 -
!!Sample integrity
Green Book – Attachment 8
!!Frozen from sampling to analysis
!!Sample Preparation
!!Analytical Methods
!!Records and Results
Getting started!
!! Location of Trials
!!Based on Commercial Production
!!Where
!!Table 6 – Green Book
!!Regional Distribution of Crop Production
Page 325 in the !Green Book"
Regulatory Guidance!.
!! Location of Trials
!!Based on Commercial Production
!!Where
!!Table 6 – Green Book
!!Regional Distribution of Crop Production
!!How many
!!Table 5 – Green Book
IR4! Western Research Cooperators
Analytical Labs & Field Research Centers
Analytical Labs
State Field Research Centers/Food Use
Hawaii
Puerto Rico
=
=
The IR-4 Regulatory Clearance Process
The Process Starts
with Requests
Stakeholder:
Define Pest
Problem
Identify Pest
Management
Solution
Request
Assistance
from IR-4
Submitted from:
Request Reviewed by
Manufacturer
•! Growers,
•! Grower Groups,
•! State/Federal Research &
Requests
Prioritized
( )
Top Priority
Researched
That Year
Extension Personnel
Second
Priorities
Researched as
Money Allows
Field and Lab Research
•!Measure Residue levels in Crop/
Crop Group
•!Top Priorities completed in 30
months
Risk Assessment
Manufacturer
Adds Crop to
the Product
Label
Tolerance Established by
EPA
Registration
!!Federal (National) Tolerance
!!Regional Tolerance
!!Federal Label
!!State Registrations
!!State Label
!!Available for use by Growers
Crop Groupings
!! Green Book – Page 332
!!Currently under Revision
!! http://www.ir4.rutgers.edu/Other/CropGroup.htm
!!Efficient use of resources
!!Appropriate bridging of tolerances across
similar crops
Partnerships Make Things Happen
United States Environmental Protection Agency
US EPA
!! The Technical Working Group (TWG) partnership with
IR-4 began in 1999
!!Work with EPA to coordinate petitions
!!Coordinate effort and resources
!!More timely registrations
Partnerships Make Things Happen
Crop Protection Industry
#! Partnerships with biopesticide
and chemical companies is
crucial
#! Without registrant support we would not be successful in
conducting the trials (they provide GLP test material) or getting the
label in the hands of the user community
#! We in turn can help alert chemical companies of potential
specialty crop market opportunities – grower needs
#! Bundle/Time registrant and IR-4 petitions for review and
registration efficiencies
Questions???
Thank you.
For More Information Contact !
Northeast
Region
Ms. Edith Lurvey
Regional Field
Coordinator
Cornell University
315.787.2308
[email protected]
North Central
Region
Dr. Satoru Miyazaki
Regional Field Coordinator
517-432-3100 ext. 150
[email protected]
IR-4
Headquarters
Jerry Baron
Executive Director
732.932.9575
[email protected]
Southern
Region
Western
Region
Dr. Charles Meister
Regional Field
Coordinator
352.392.2399
[email protected]
Ms. Rebecca Sisco
Regional Field
Coordinator
530.752.7634
[email protected]
USDA-ARS Office
of Minor Use
Pesticides
Dr. Paul H. Schwartz
Staff Scientist
301.504.8256
[email protected]
Each State has an IR-4 State Liaison.
Visit the IR-4 Web Site To Learn More!
ir4.rutgers.edu
Regulatory challenges and opportunities then and now!.
!! Good Laboratory Practices (GLPs)
!!It’s the Law
!!All regulatory studies submitted to EPA MUST
be conducted under these rules
!!It’s about good documentation and accurately
recreating the study
!!Could someone do exactly what the researcher
did by following the documentation
!!The only “real” record is the documentation
!!If it isn’t documented it didn’t happen
!!What actually happened not what was
intended to happen