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Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013. IDRG. International Development of Regulatory Globalization. Imme Gerke, PhD & Jacques Drolet , PhD Global Regulatory Strategists. FACT FINDING. all carbendazim uses in Brazil

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  1. Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013 IDRG International Development of Regulatory Globalization Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists

  2. FACT FINDING all carbendazim uses in Brazil all carbendazim citrus in Brazil all citrus uses in Brazil alternatives for carbendazim uses in Brazil citrus uses in other countries for same pests products that are already approved in Brazil = label expansions (addition of pest, of crop or crop/pest) which of these products have to be approved in Brazil = new actives/products import countries for Brazilian citrus MRL comparisons for citrus for Brazil and importers

  3. 1. All Carbendazim Uses in Brazil

  4. 2. All Carbendazim Citrus Uses in Brazil

  5. 3. All Citrus Fungicide Uses in Brazil

  6. 4. All Citrus Carbendazim Alternatives in Brazil

  7. 5. Citrus Uses in other Countries for the same pests (1 of 2)

  8. 5. Citrus Uses in other Countries for same pests (2 of 2)

  9. 6. Products that are already approved in Brazil label expansions (addition of pest, of crop or crop/pest)

  10. The companies that hold registrations for these products in Brazil

  11. 7. These products would have to be approved in Brazil(= new actives/products)

  12. 8. Import countries for Brazilian citrus

  13. 9a. MRL comparisons for citrus for Brazil and importers(example AZOXYSTROBIN)

  14. 9b. MRL comparisons for citrus for Brazil and importers (example PYRACLOSTROBIN)

  15. Strategy • Several fungicides are registered in Brazil that could fill the gap that the disappearance of carbendazim will leave for citrus production. • Some of these products are already approved for use on citrus but the five specific pathogens that are being controlled by carbendazim need to be added to the label. • Other fungicides are approved for the control of these pathogens on crops other than citrus. In these cases the citrus crops have to added to the label and an MRL has to be set. • When adding citrus crops to existing labels, product specific MRLs will have to set. • The use patterns of the products on citrus should follow those in countries with low MRLs so that Brazil can continue to ship their citrus crops to these countries. • The next steps are: • asking the regulator for crop/pest/product specific data requirements for the label additions of crops, pests or crop/pest combinations • based on these requirements ask the compan(ies) to add the new uses to their labels; residue trials might be required if data from other countries are not acceptable; these trials would not necessarily have to be conducted by the registrants but could be financed by growers, food traders or food processors • search Homologa/GPPD for the use patterns in countries with similar MRLs • based on the level of simplicity of regulatory requirements and the toxicological footprint of the active substance, a task force has to select the products they wish to be me available to them

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