new brazilian rules for mrls extrapolation (minor uses) - teixeira brazilian mrls.pdf · final...
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New Brazilian Rules for MRLs Extrapolation(Minor Uses)
San Francisco, June/2010
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Registration system (agriculture uses)
Registration
ANVISA-MSToxicology
Final approval by Ministryof Agriculture
IBAMA-MMAEnviormental fate
andEcototoxicology
MAPARegistration/Inspections
Dossier
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Exports from Brazil
-
5.000
10.000
15.000
20.000
1997
1998
1999
2000
2001
2002
2003
2004
2005
2006
2007
2008
2009
Milh
ões
Fiscal Year
US
$
SOYBEAN SUGARCANE FORESTRY COFFEE TOBACO
CEREALS COTTON AND TEXTILES FRUITS OTHER COCOA
TEA AND SPECYALTIES VEGETABLES OIL SEEDS PLANTS
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Registered pesticides
0
100
200
300
400
500
600
Active Ingredients Commercial Products
Soybean
Bean
Corn
Sugarcane
Pepper
Pumpkin
Beet
Brocco li
Asparagus
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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)
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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: Phytosanitaryproblems.
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Minor Uses in Brazil: Concept
Pesticidesmisuses
Agronomists: pesticides
recommendation
Companies:Costs
Learning from other institutions:Crops with unsufficient phytosanitary support
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“Minor Crops” Working Group
International references
Codex Alimentarius, EPA, USDA/IR4
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Target
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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
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Specific rules for minor uses
• Tools: International directives, extrapolation and
temporary MRLs establishment.
• Goal: Standardize the label inclusion process for
minor uses pesticides.
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Minor Crops Working Group
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Annex Parameters
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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
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Annex I TablesGroups Representatives crops Crop grouping
1. Fruit with non-edible peel Citrus (Citrus sp.),
Melon (Cucumis melo).
Water melon (Citrullus vulgaris), Papaya (Carica papaya).
2. Fruit with edible peel Apple (Malus domestica),
Grape (Vitis vinifera).
Amora (Morus sp.), Peach (Prunuspersica), Guava (Psidium guajava), Kiwi (Actinidia chinensis)
3. Roots, tubers and bulbs Potato (Solanum tuberosum), Carrot (Daucus carota ).
Beterraba (Beta vulgaris), Inhame(Dioscorea spp.)
4. Leafed vegetables Lettuce (Lactuca sativa), Cabbage(Brassica oleracea var. capitata),
Wild Cabbage (Brassica oleracea)
Agrião (Nasturtium officinale), Brócolos(Brassica oleracea),
5. Non-leafed vegetables Tomato (Solanum licopersici), Cucumber (Cucumis sativus), Bellpepper (Capsicum annuum).
Abóbora (Curcubita moschata), Pimenta(Capsicum sp.)
6. Fabaceae and Oil-plants Bean (Phaseolus vulgaris), Soybean (Glycine max).
Lentilha (Ervum lens), Girassol(Ligustrum lucidum)
7. Palms and nuts Coconut (Cocus nucifera) Dendê (Elaeis guineensis)
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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 (Diospyroskaki).
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)
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How to use the annex?
Include new crops
ExtrapolateMRLs
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System of inclusion for a new pesticides for minor uses in Brazil
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MRLs extrapolation
Basic informations:
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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
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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.
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Monitoring Programs
• Definitive MRLs will be defined after data check
from monitoring programs. Government will check
the compatibility between MRLs from reference crop
and minor crop .
• If MRLs are then incompatible, new residues data
will be asked/generated by authorities.
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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.
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Thanks for your attention!
Marcella TeixeiraE-mail: [email protected]
Phone: +55 (61) 3218-2445 Fax: +55 (61) 3225-5345
General Coordination of PesticidesAgriculture Inputs Inspection Department
Secretariat of Animal and Plant Health and Inspecti onMinistry of Agriculture, Livestock and Food Supply