IR-4 Update from
Headquarters
Van Starner - Assist. Director, Research
Planning & Outreach
(w/J. Baron, Executive Director & D. Kunkel, Assoc. Director)
(2010 IR-4 Western Region SLR/CLC Meeting 3/16-17, Univ. of Arizona, Yuma, AZ)
-- IR-4 2009 Deliverables
•
•
•
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“Big picture” project successes
New uses obtained
Crop group revisions
New database/improved website searching
-- Organization and Changes
• Budget (who pays for IR-4?)
• New Headquarters org chart
-- International Initiatives/Public Health
• Global residue study; global reviews
• NAFTA/OECD/Codex/JMPR activities
• Public Health cooperative project
-- Regulatory Challenges
-- 2010 Food Use Workshop
“Big Picture” Project Successes
2009-2014 Strategic Plan published 4/2009
Successful USDA/SAES IR-4 Peer Review
5/2009
NRSP-4 Reauthorization; Proposal for
Continued Hatch Act Funding 10/2010 to
9/2015; unanimous Agr. Exp. Station
Directors support
ARS part of IR-4 Peer Review 3/2010
New Uses
1200
1014 991
1110
999
1000
793
800
647
567 564
600
400
200
0
212
281
538
956
Crop Grouping Expansion and Harmonization
Multiyear Joint Project with EPA, International Crop
Grouping Consultants Committee (ICGCC) and
Codex to evaluate crop groups and extrapolation
• Validate US and Canadian crop groupings/add new crops to
existing groups and/or new groups/subgroups
• Work with International stakeholders to modify Codex
groups to better support global trade via extrapolation
• Global harmonization of crop groups is ultimate goal
Crop Group Revision Status
Will be codified soon – proposed FR rule
published 1/6/2010 (expect final rule June 2010?):



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Oilseed group 20 (new - will harmonize with Canada)
Citrus Fruit group 10
Pome Fruit group 11
Fruiting Vegetables group 8
Ready for next FR notice: Stone Fruit group 12
In Review at EPA: Tree Nut group 14
In Preparation (IR-4 & ICGCC):
 Herbs and Spices group 19
 Tropical/subtropical edible & inedible peel groups
 Leafy Vegetables group 4 & Brassica Vegetables group 5
New Database/Website Searches
IR-4 Website:
http://ir4.rutgers.edu/
Who pays for IR-4?
Direct Contributions ~ $18 million USD
USDA-NIFA
USDA-ARS
State Ag. Exp. Stations
Grants from Industry
$12,180,000
$ 4,000,000
$ 481,182
~$ 1,000,000
Indirect Contributions: about equal to direct $s
(from industry and university site hosts)
Test Chemicals
Technical Support
Employee Benefits
Utilities/Land Use
Other miscellaneous research costs
IR-4 International Initiatives
Global leadership
- Global Minor Use Summit (2007 & 2011)
- global residue study (27 trials in 22
countries)
- harmonization of crop groups and MRLs
- involved in multi-national submissions and
global registrations
GLOBAL RESIDUE STUDY
EXAMPLE GLOBAL JOINT REVIEWS
Chemical
Toxicology Residue Chem
Eco-tox
E-Fate Product Chemistry
Pyrasulfatole
Australia
Canada
USA
USA
Australia
Pyroxsulam
USA
Australia
Australia
Canada
USA
Chlorantraniliprole
USA
Australia
UK
Ireland
Canada
Spirotetramat
USA
Canada
Austria
Austria
Canada
Thiencarbazone/
Cyprosulfamide
UK
UK
Canada
USA
UK
Canada
USA
USA
USA
USA
USA
Canada
Germany
Saflufenacil
*Australia peer review
Canada
Fluopyram
*Japan peer review
Germany
NAFTA Minor Use Cooperative
Objectives:
• To address grower pest control needs with safe
effective products in a manner that does not affect
trade markets
• To provide simultaneous submissions to both
regulatory agencies (EPA and PMRA)
• Submissions reviewed and registrations approved in
both countries at approximately the same time with
harmonized tolerances/MRLs
NAFTA “Win-Win” Model
•
Cooperative research with Canada
started in 1996
–
–
•
Mutual projects conducted jointly on both
sides of the border - reduced trials needed
in each country; Canada as Study Director
and Sponsor; common protocol/data book
Supported by EPA/PMRA joint reviews and
workshare
Major funding and expansion for “IR-4
North” in 2003
NAFTA Minor Use Joint Review Projects
Progress Report:
– Joint Review program to date
• 18 submissions/petitions completed
• Currently 5 in review
• 7 more submissions in 2009
– Minor Use Joint Review results
• More than 60 new uses
• Reduced timeframe (~12 months)
– Other submissions/petitions will be submitted
as “work share”
OECD Activities
• IR-4
Serves on Expert Group on Minor
Uses (EGMU)
– Establishment endorsed in June 2007
– Work plan:
• Develop mechanisms to enable work sharing
• Collaborate with the Residue Expert Working Group
• Promote work of OECD
• Report to Registration Steering Group (RSG)
IR-4 Codex Activities
• Work with commodity groups and EPA
to add uses to JMPR work plan
• Review JMPR work plan and dovetail
IR-4 data with chemicals scheduled for
review
• Work with EPA and Registrants to
submit data to JMPR
IR-4 CODEX/JMPR Activities
• IR-4 2006 and 2007 JMPR reviews
– Seven products for cranberry
– Bifenazate: pome fruit, stone fruit, berries and other
small fruits, nuts and seeds, fruiting vegetables,
cucurbits root crops, dried herbs (hops and mint)
– Quinoxyfen: lettuce, melon, strawberry and peppers
• IR-4 2008 JMPR reviews
– Imidacloprid (11 crops), spinosad (3 crops)
– Azoxystrobin, Chlorantraniliprole, Boscalid,
Tebuconazole (Mfg. submitted IR-4 data)
IR-4 CODEX/JMPR Activities
• IR-4 submitted data in 2009 for JMPR review
– Indoxacarb – stone fruit, cucurbits, Southern pea,
mint, cranberry
– Methoxyfenozide – citrus, root veggies, peas and
beans, cucurbits, bushberry, cranberry, strawberry,
peanut, tropical fruits
– Buprofezin – grape, fruiting veggies, pomefruit,
stonefruit, berries, tropical fruits, bean, olive, almond,
cucurbits
– IR-4 data submitted by Mfg.
– For Spirodiclofen, Fenbuconazole,Thiamethoxam
• IR-4 submissions to JMPR in 2010 and beyond
– Fenpyroximate, Acetamiprid, Etoxazole
History & Status of Public Health
Pesticides (PHP) Program
• June 2008: ARS & IR-4 Co-op agreement
signed
– $160,000 / yr for 3 years
– Funded by DoD’s Deployed Warfighter
Protection Program (DWFP; 2004), funds
passing through ARS
– Objective: Register pesticides (including
repellents, attractants, and toxicants) for
public health use
History & Status of Public Health
Pesticides (PHP) Program (p2)
• 2008-2009: Initiation & Recruitment
– Keith Dorschner initiates etofenprox residue
trial
• April 2009: ARS & IR-4 Co-op amendment
– Total funding $250,000/yr through June 25,
2013
– Salary, benefits, travel, some research
• Summer 2009: Program Manager Hired
– Karl Malamud-Roam begins Sept 15, 2009
Regulatory & Litigation Challenges
-- Clean Water Act (pesticide applications deemed point
sources of pollution/need for permits)
-- Endangered Species Act assessments (Fish and Wildlife)
-- Endocrine disruption & immunotox data requirements
-- Additional safety factors (impact on tolerances and risk cups)
-- Disclosure of inert ingredients in commercial formulations
-- EPA “Notice of Registration” postings in the Federal Register
-- Inclusion of adjuvants on product labels
-- Challenges to IR-4 submission fee exemption under PRIA II
Prep for Food Use Workshop 2010
HQ deadline for receipt of new PCRs to be
considered at Sept. workshop Aug 18
Website Project Nominations: Aug 23-Sept 6
 CHANGE FOR 2009
PARTICIPANTS WILL PRIORITIZE NEEDS FOR
EFFICACY & CROP SAFETY RESEARCH FOR 2011
Food Use Workshop 2010
September 14-15
JW Marriott Las Vegas Resort & Spa
(http://www.marriott.com/hotels/travel/lasjw-jw-marriott-las-vegas-resort-spa-and-golf/)
 Sept. 13: 8:00 – 10:00 p.m. Dessert Reception/Mixer
 Sept. 14: 8:00 – 5:00 p.m.
Welcome/“State of IR-4”
Weed Science discussions/prioritization
Begin Plant Pathology discussions/prioritization
 Sept. 14: 5:30-7:30 pm reception
 Sept. 15: 8:00 – 5:15 p.m.
Complete Plant Pathology
Entomology discussions/prioritization
 Sept. 17 – FUW prioritization results will be posted on the IR-4 website
Thank
You!
Van Starner:
starner@aesop.rutgers.edu
(732) 932-9575 ext 4621