New Brazilian Rules for MRLs Extrapolation (Minor Uses) San Francisco, June/2010
Registration system (agriculture uses) Dossier MAPA Registration/Inspections IBAMA-MMA Enviormental fate and Ecototoxicology Final approval by Ministry of Agriculture Registration ANVISA-MS Toxicology
Exports from Brazil Milhões 20.000 15.000 US$ 10.000 5.000-1997 1998 1999 2000 2001 2002 2003 2004 Fiscal Year 2005 2006 2007 2008 2009 SOYBEAN SUGARCANE FORESTRY COFFEE TOBACO CEREALS COTTON AND TEXTILES FRUITS OTHER COCOA TEA AND SPECYALTIES VEGETABLES OIL SEEDS PLANTS
Registered pesticides 600 500 400 Soybean Bean Corn 300 200 100 0 Active Ingredients Commercial Products Sugarcane Pepper Pumpkin Beet Broccoli Asparagus
Brazilian Context: Minor Crops Production Production value: US$ 6.5 billion Production: 17,5 million of tons Jobs generated : 6 to 10 employees per acre 60% of production: small or medium farms (< 25 acres) (Brazil Sensus, 2007)
Brazilian s vegetables cultivation Sensibility to adverse climate conditions Consumer profile: Quality assurance for taste, appearance and MRLs control Agriculture as a high risk activity: Phytosanitary problems.
Minor Uses in Brazil: Concept Pesticides misuses Companies: Costs Agronomists: pesticides Learning from other recommendation institutions: Crops with unsufficient phytosanitary support
Minor Crops Working Group International references Codex Alimentarius, EPA, USDA/IR4
Target
Why did we do what we did? Nowadays: Registration depends exclusively on companies and from their perception of economic and commercial facts Goal: To create a fair system of registration and use of pesticides Government role: Economic and social demand Phytosanitary emergencies Government programs
Specific rules for minor uses Tools: International directives, extrapolation and temporary MRLs establishment. Goal: Standardize the label inclusion process for minor uses pesticides.
Minor Crops Working Group
Annex Parameters
Crops grouping 1- Fruit with non-edible peel 2- Fruit with edible peel 3- Roots, tubers and bulbs 4- Leafed vegetables 5- Non-leafed vegetables 6- Fabaceae and oil plants 7- Palms and nuts
Annex I Tables Groups Representatives crops Crop grouping 1. Fruit with non-edible peel Citrus (Citrus sp.), Melon (Cucumis melo). 2. Fruit with edible peel Apple (Malus domestica), Grape (Vitis vinifera). 3. Roots, tubers and bulbs Potato (Solanum tuberosum), Carrot (Daucus carota ). 4. Leafed vegetables Lettuce (Lactuca sativa), Cabbage(Brassica oleracea var. capitata), Wild Cabbage (Brassica oleracea) 5. Non-leafed vegetables Tomato (Solanum licopersici), Cucumber (Cucumis sativus), Bellpepper (Capsicum annuum). 6. Fabaceae and Oil-plants Bean (Phaseolus vulgaris), Soybean (Glycine max). Water melon (Citrullus vulgaris), Papaya (Carica papaya). Amora (Morus sp.), Peach (Prunus persica), Guava (Psidium guajava), Kiwi (Actinidia chinensis) Beterraba (Beta vulgaris), Inhame (Dioscorea spp.) Agrião (Nasturtium officinale), Brócolos (Brassica oleracea), Abóbora (Curcubita moschata), Pimenta (Capsicum sp.) Lentilha (Ervum lens), Girassol (Ligustrum lucidum) 7. Palms and nuts Coconut (Cocus nucifera) Dendê (Elaeis guineensis)
Annex I Tables (II) Sub-groups Representative Crop Low phytossanitary support crops Sub-group 1A Pineapple (Ananas comosus). Melancia (Citrullus vulgaris) Sub-group 1B Papaya (Carica papaya), Avocado (Persea americana), Passion fruit (Passiflora sp.). Cupuaçu (Theobroma grandiflorum) Sub-group 2A Strawberry (Fragaria vesca) Amora (Morus sp.) Sub-group 2B Guava (Psidium guajava), Asian Persimon (Diospyros kaki). Kiwi (Actinidia chinensis) Sub-group 2C Peach (Prunus persica), Stone fruit(prunus salicina). Nêspera (Eriobotrya japonica) Sub-group 3A Beets (Beta vulgaris), Rabanete (Raphanus sativus) Batata doce (Ipomoea batatas) Sub-group 4A Lettuce (Lactuca sativa) Agrião (Nasturtium officinale) Sub-group 4B Repolho (Brassica oleracea var. capitata), Couve (Brassica oleracea). Brócolos (Brassica oleracea var. Italica) Sub-group 5A Pepper (Capsicum annuum) Pimenta (Capsicum sp.) Sub-group 5B Cucumber (Cucumis sativus) Abóbora (Curcubita moschata) Sub-group 6A Ervilha (Pisum sativum) Lentilha (Ervum lens) Sub-group 6B Sunflower (Ligustrum lucidum) Linhaça (Linum usitatissimum) Sub-group 7A Coconut (Cocus nucifera) Dendê (Elaeis guineensis)
How to use the annex? Include new crops Extrapolate MRLs
System of inclusion for a new pesticides for minor uses in Brazil
Basicinformations: MRLs extrapolation
Final authorization for minor crop inclusion on pesticide label The MRLs and GAP will be defined by the government authorities based on representative crop data Phytotoxicity will cancel indications and new field data will be conduced
Pesticides Indications uses on label Representative crop need to be on pesticide label; Quantity of A.I./ha needs to be lower or equal to representative crop. Safety period will be longer or equal to representative crop.
Monitoring Programs Definitive MRLswill be defined after data check from monitoring programs. Government will check the compatibility between MRLsfrom reference crop and minor crop. If MRLsare then incompatible, new residues data will be asked/generated by authorities.
What are we doing now? Getting information from growers; Working on plant x active ingredient combinations; Working on the combinations that will be supported by the government; Contacting producers, EMBRAPA, Universities and Research Centers.
Thanks for your attention! Marcella Teixeira E-mail: marcella.teixeira@agricultura.gov.br Phone: +55 (61) 3218-2445 Fax: +55 (61) 3225-5345 General Coordination of Pesticides Agriculture Inputs Inspection Department Secretariat of Animal and Plant Health and Inspection Ministry of Agriculture, Livestock and Food Supply