JMPR submissions and establishing Codex MRLs for specialty crops, their importance in global trade

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1 JMPR submissions and establishing Codex MRLs for specialty crops, their importance in global trade Johannes Corley, Daniel Kunkel, Jerry Baron IR-4 HQ, Rutgers the State University of New Jersey 500 College Rd. East # 201 W. Princeton, NJ jcorley@aesop.rutgers.edu

2 Overview of Presentation Greener Chemistries available but not used Codex Alimentarius Commission (CAC) & Joint Meeting on Pesticide Residue (JMPR) IR-4 involvement with Codex & JMPR, Assisting U.S Growers List of submissions made to JMPR and MRL s established Studies conducted by IR-4 to allow US growers to export Global residue study Harmonization of Residue Expressions Harmonization of guidelines & trial requirements NAFTA Harmonization a success story

3 Greener chemistries registered in U.S. but Table 1: MRLs for a few newer chemistries established in the U.S.A., Canada, EU, Australia, Japan & Codex. Pesticide U.S.A. 1 Canada,2 EU 3 Australia 3 Japan 3 Codex 4, Buprofezin > Clothianidin > > Cyazofamid Etoxazole Fenamidone > 50 (56) Fenpyroximate > 50 (56) Fluazinam > 50 (51) Indoxacarb > Methoxyfenozide > > > Novaluron > [1] Title 40 of the US Code of Federal Regulation, part 180 (40CFR180) [2] Pest Management Regulatory Agency (PMRA), Health Canada website, [3] Pesticide MRL Database maintained by the Foreign Agriculture Service (FAS) of the USDA, [4] Codex Alimentarius website on MRLs, [5] Including MRLs established/recommended based on IR-4 data submitted to JMPR.

4 Reasons for reluctance of U.S. growers to use the newer chemistries Inability to export treated RAC s due to lack of MRLs in importing countries MRL s significantly different Due to different residue expressions / analytes monitored Due to different use patterns dependent on differing pest issues U.S.A. Canada EU Australia Japan Codex Clothianidin Apple Peach Methoxyfenozide Apple Avocado Tomato

5 Codex Alimentarius Commission The Codex Alimentarius Commission (CAC) was created in 1963 by FAO and WHO to develop food standards, guidelines and related texts such as codes of practice under the Joint FAO/WHO Food Standards Program. One of the tasks of the Codex Commission on Pesticide Residues (CCPR) is to advise the CAC on matters relating to pesticide residues affecting international trade, primarily by recommending draft Codex MRLs in food and animal feeds. The main purposes of these programs is protecting health of the consumers and ensuring fair trade practices in the food trade, and promoting coordination of all food standards work undertaken by international governmental and non-governmental organizations.

6 Joint Meetings on Pesticide Residues (JMPR) The Joint FAO/WHO Meetings on Pesticide Residues (JMPR) provide independent scientific expert advice to the CAC and its specialist Committee on Pesticide Residues. The JMPR provides expert advice and resources on human risk factors, environmental fate, etc. resulting from pesticide use to nations that do not have their own regulatory authorities.

7 IR-4 Involvement with Codex, JMPR, etc Year Compound Crops Submitted # of MRL's established/ recommended 2008 Imidacloprid Avocado, Banana, Blueberry, Caneberry, Root Veg., Coffee, Peas, Peanuts, 10 Pomagranate, Strawberry, Sugar Apple, Sunflower, Tree Nuts & Pistachio Spinosad Banana, Cranberry, Hops, All Crops (bait) Buprofezin Fruiting Veg., Cucurbit Veg, Stone Fruit, Pome Fruit, Berry (low growing), Avocado, 7 Lychee, Papaya, Snap Bean, Olive, Grapes, Almond & Pistachio, Coffee Indoxacarb Cucurbit Veg., Stone Fruit, Cranberry, Southern Pea, Mint 5 Methoxyfenozide Root Veg., Tub. & Corm Veg., Edible-podded Legume Veg., Succulent Shelled 11 Peas & Beans, Bean (dry), Cucurbit Veg., Bushberry, Cranberry, Strawberry, Peanut, Avocado, Papaya, Citrus, Soybean Etoxazole Cucumber, Melons, Stone Fruit, Tomatoes, Mint, Hops 3 Fenpyroximate Fruiting Vegetables, Okra, Melons, Cucumber, Hops 5 Novaluron Berries, Beans, Brassica Veg., Cucurbits, Fruiting Veg., Stone Fruit, Sugarcane, Swiss Chard Acetamiprid Grape, Strawberry, Small fruit & berries, Stone Fruit, Beans with pods, Canola, Tree Nuts & Pistachio, Bulb Veg. Legume Veg. Leafy Veg. Fruiting Veg., Cucurbit Veg. Propylene Oxide Tree Nuts & Pistachio, Dried Fruit.

8 MOR Studies conducted to support Intl. MRLs Sometimes, in spite of established Codex MRL s, U.S. growers are unable to export RACs because of a lack of an MRL (or lower MRL in the importing country) IR-4 has conducted studies to support import MRL s so that U.S. growers can export treated crops. Examples: Etoxazole/Hops Propiconazole/Several Triflumizole/Hops

9 Etoxazole / Hops U.S. Tolerance (MRL): 7 ppm EU MRL: 0.05 ppm To permit U.S. growers to export hops treated with etoxazole as per the U.S. GAP / Label, IR-4 has to conduct MOR studies and submit to the EU requesting an import MRL.

10 Propiconazole / Several U.S. Residue Expression: 1-[[2-(2,4-dichlorophenyl)-4-propyl-1,3-dioxolan-2-yl] methyl]-1h-1,2,4- triazole (Propiconazole) and its metabolites determined as 2,4- dichlorobenzoic acid and expressed as parent compound Canadian Residue of interest: Propiconazole only (as determined by LC-MS/MS) In order to permit U.S. growers use this pesticide and export treated crops IR-4 has to determine both residue values (2 methods) resulting in significantly higher costs.

11 Triflumizole / Hops U.S. Tolerance (MRL): 50 ppm EU MRL: 0.1 ppm EU the residue definition: For enforcement: Triflumizole and metabolite FM-6-1(N-(4-chloro-2-trifluoromethylphenyl)-n-propoxyacetamidine), expressed as Triflumizole For risk assessment: Sum of triflumizole and metabolites containing the 4-chloro-2- (trifluoromethyl)phenyl group U.S. residue definition: triflumizole, 1-(1-((4-chloro-2-(trifluoromethyl)phenyl)imino)-2-propoxyethyl )-1 H - imidazole, and its metabolites containing the 4-chloro-2-trifluoromethylaniline IR-4 has to analyze for both residue definitions

12 IR-4 Global Residue Study The purpose of the Global Residue study is to compare residues across a wide variety of geographical and subsequently, environmental zones. The project was initiated to compare residues on a global basis of four active ingredients on tomato. A total of 27 residue studies (trials) are currently underway in 22 different countries.

13 IR-4 Global Residue Study In order to minimize differences: Identical spray equipment was shipped to each location. Test substances were pre-measured and utilized the same calibration and spray volume. All work was conducted under the same protocol with a single foliar application and A training video on how to conduct the study was posted on YouTube. Single foliar application of REVUS TOP (Mandipropamid/ Difenoconazole), ENDIGO (Thiamethoxam/Lambda -cyhalothrin) Sampled at time zero sample and at 24 and 72 hours after application.

14 Zoning (Koppen-Geiger climate map)

15 IR-4 GLOBAL RESIDUE STUDY englobal RESIDUE STUDY 22 Sample sets in US 4 Completed, samples not shipped 2 Repeated in 2011

16 Zero time sample collection

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20 Harmonization of Regulatory Requirements Some important factors to be considered in simplifying global food trade: Harmonization of residue testing guidelines Harmonization of residue expressions Harmonization of trial requirements Using a standardized method to calculate MRL s Greater acceptance of Codex MRL s at least for import/export purposes

21 NAFTA Harmonization, a Success Story

22 Globally harmonized field trial regions???

23 For the Global Residue Study: Many thanks to Field Researchers from around the world USDA Foreign Agricultural Service - sponsorship and communications Syngenta Crop Protection, LLC - shipping test samples and equipment contacting country representatives to help Cornell IR-4 Laboratory EPA for their support in protocol development, analytical, and statistics Many agricultural ministry officials for helping with permitting Embassy representatives for logistical support.

24 Acknowledgements Funding for IR-4 is received from: USDA-NIFA USDA-FAS Additional support for IR-4 research is received from: USDA-ARS U.S. State Land Grant Universities