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IR-4 Update from Headquarters Van Starner - Assist. Director, Research Planning & Outreach

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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IR-4 Update from Headquarters Van Starner - Assist. Director, Research Planning & Outreach

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  1. 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)

  2. -- 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

  3. “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

  4. 1110 1014 991 793 647 567 564 538 281 212 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 New Uses 999 956 2008 2009

  5. 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

  6. 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

  7. New Database/Website Searches IR-4 Website: http://ir4.rutgers.edu/

  8. Who pays for IR-4? Direct Contributions ~ $18 million USD • USDA-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

  9. 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

  10. 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 UK Cyprosulfamide Saflufenacil *Australia peer review Canada Canada USA USAUSA Fluopyram *Japan peer review Germany USA USA Canada Germany

  11. 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

  12. 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

  13. 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”

  14. 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)

  15. 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

  16. IR-4 CODEX/JMPR Activities • IR-4 2006 and 2007 JMPR reviews • Seven products for cranberry • Bifenazate: pomefruit, 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)

  17. 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

  18. 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

  19. 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

  20. 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

  21. 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

  22. 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

  23. Thank You! Van Starner: starner@aesop.rutgers.edu (732) 932-9575 ext 4621

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