New Brazilian Rules for MRLs Extrapolation(Minor Uses)

San Francisco, June/2010

Registration system (agriculture uses)

Registration

ANVISA-MSToxicology

Final approval by Ministryof Agriculture

IBAMA-MMAEnviormental fate

andEcototoxicology

MAPARegistration/Inspections

Dossier

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

Registered pesticides

0

100

200

300

400

500

600

Active Ingredients Commercial Products

Soybean

Bean

Corn

Sugarcane

Pepper

Pumpkin

Beet

Brocco li

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: Phytosanitaryproblems.

Minor Uses in Brazil: Concept

Pesticidesmisuses

Agronomists: pesticides

recommendation

Companies:Costs

Learning from other 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 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)

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)

How to use the annex?

Include new crops

ExtrapolateMRLs

System of inclusion for a new pesticides for minor uses in Brazil

MRLs extrapolation

Basic informations:

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 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.

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 TeixeiraE-mail: marcella.teixeira@agricultura.gov.br

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