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• “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

0

200

400

600

800

1000

12001110

9911014

793

538564567

281212

19981999

20002001

20022003

20042005

20062007

647

999

20092008

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?):

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 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

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/ UK UK Canada USA UKCyprosulfamide

Saflufenacil*Australia peer review Canada Canada USA USA USA

Fluopyram*Japan peer review Germany USA USA Canada Germany

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

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 14-15JW 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

Thank You!

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