ir-4 update from headquarters van starner - assist. director, research planning & outreach (w/j....
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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)
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-- IR-4 2009 Deliverables• “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
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“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
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New Uses
0
200
400
600
800
1000
12001110
9911014
793
538564567
281212
19981999
20002001
20022003
20042005
20062007
647
999
20092008
956
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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
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Crop Group Revision Status
Will be codified soon – proposed FR rule published 1/6/2010 (expect final rule June 2010?):
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
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Who pays for IR-4?
Direct Contributions ~ $18 million USDUSDA-NIFA $12,180,000
USDA-ARS $ 4,000,000
State Ag. Exp. Stations $ 481,182
Grants from Industry ~$ 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
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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
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GLOBAL RESIDUE STUDY
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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/ UK UK Canada USA UKCyprosulfamide
Saflufenacil*Australia peer review Canada Canada USA USA USA
Fluopyram*Japan peer review Germany USA USA Canada Germany
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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 Minor Use Cooperative
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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
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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”
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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)
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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
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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)
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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
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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
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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
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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
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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
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Food Use Workshop 2010
September 14-15JW 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/prioritizationBegin Plant Pathology discussions/prioritization
Sept. 14: 5:30-7:30 pm reception Sept. 15: 8:00 – 5:15 p.m.
Complete Plant PathologyEntomology discussions/prioritization
Sept. 17 – FUW prioritization results will be posted on the IR-4 website