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

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Presentation on theme: "IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013."— Presentation transcript:

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

2 FACT FINDING 1.all carbendazim uses in Brazil 2.all carbendazim citrus in Brazil 3.all citrus uses in Brazil 4.alternatives for carbendazim uses in Brazil 5.citrus uses in other countries for same pests 6.products that are already approved in Brazil = label expansions (addition of pest, of crop or crop/pest) 7.which of these products have to be approved in Brazil = new actives/products 8.import countries for Brazilian citrus 9.MRL comparisons for citrus for Brazil and importers

3 1. All Carbendazim Uses in Brazil Crop (commodity)Pest LatinCompany BEANS(PHASEOLUS LUNATUS L.)ALTERNARIA ALTERNATAGLOMERELLA CINGULATANORTOX CITRUS: OTHER(CITRUS L. SPP.)ALTERNARIA SPPGUIGNARDIA CITRICARPABAYER-CROPSCIENCE CLEMENTINES(CITRUS CLEMENTINA)ASPERGILLUS FLAVUSHELMINTHOSPORIUM MAYDISNUFARM CORN/MAIZE(ZEA MAYS L. SPP.)ASPERGILLUS SPPHELMINTHOSPORIUM TRITICI-RDVA-AGRO-BRASIL COTTON(GOSSYPIUM HIRSUTUM)BIPOLARIS SOROKINIANAMICROSPHAERA DIFFUSABOHUS-PETER-DR. GRAPEFRUIT(CITRUS PARADISI)BIPOLARIS SPPPENICILLIUM SPPDE-SANGOSSE LEMONS(CITRUS LIMON)BOTRYODIPLODIA THEOBROMAEPHAEOISARIOPSIS GRISEOLACROPCHEM LIMES(CITRUS AURANTIFOLIA)BOTRYOSPHAERIA RHODINAPHAKOPSORA PACHYRHIZIHELM MANDARINS(CITRUS RETICULATA SENSU STRICTO)CERCOSPORA KIKUCHIPHOMA SPPOURO-FINO ORANGES(CITRUS SINENSIS)CERCOSPORA SOJINAPUCCINIA GRAMINISSINON-CORPORATION POMELO(CITRUS MAXIMA)COLLETOTRICHUM ACUTATUMPUCCINIA TRITICANAROTAM RICE(ORYZA SATIVA L.)COLLETOTRICHUM DEMATIUMPYRICULARIA GRISEADUPONT SOYBEANS(GLYCINE MAX)COLLETOTRICHUM GOSSYPIIRAMULARIA AREOLAPOLAND-QUIMICA TANGERINES(CITRUS TANGERINA) COLLETOTRICHUM LINDEMUTHIANUM RHIZOCTONIA SOLANICHEMINOVA UNSPECIFIEDCOLLETOTRICHUM TRUNCATUMRHYNCHOSPORIUM SECALISFMC WHEAT(TRITICUM AESTIVUM L.)COLLETOTRICHUM VICIAESCLEROTINIA SCLEROTIORUMMILENIA CORYNESPORA CASSIICOLASEPTORIA GLYCINESSYNGENTA DIAPORTHE PHASEOLORUMSEPTORIA TRITICICCAB-AGRO DIAPORTHE PHASEOLORUM-SOJAESTAGONOSPORA NODORUM NOVOZYMES- BIOLOGICALS ELSINOE FAWCETTIUNSPECIFIEDCONSAGRO ELSINOE SPPUNSPECIFIED-DISEASES ERYSIPHE GRAMINIS TRITICIUROMYCES APPENDICULATUS ERYSIPHE SPP FUSARIUM GRAMINEARUM FUSARIUM MONILIFORME FUSARIUM OXYSPORUM VASINFECTUM FUSARIUM SEMITECTUM FUSARIUM SOLANI FUSARIUM SPP

4 2. All Carbendazim Citrus Uses in Brazil Crop (commodity)Pest LatinCompany CITRUS: OTHER(CITRUS L. SPP.)GUIGNARDIA CITRICARPANUFARM GRAPEFRUIT(CITRUS PARADISI)ELSINOE FAWCETTIDVA-AGRO-BRASIL LEMONS(CITRUS LIMON)ELSINOE SPPNORTOX LIMES(CITRUS AURANTIFOLIA)COLLETOTRICHUM ACUTATUMBOHUS-PETER-DR. CLEMENTINES(CITRUS CLEMENTINA)GLOMERELLA CINGULATADE-SANGOSSE MANDARINS(CITRUS RETICULATA SENSU STRICTO)BAYER-CROPSCIENCE ORANGES(CITRUS SINENSIS)CROPCHEM POMELO(CITRUS MAXIMA)HELM TANGERINES(CITRUS TANGERINA)OURO-FINO SINON-CORPORATION ROTAM DUPONT

5 3. All Citrus Fungicide Uses in Brazil A.i.Combination Pest Latin Company ACIBENZOLAR-S-M ALTERNARIA CITRI AGRIPEC AZOXYSTROBIN BOTRYOSPHAERIA RHODINA ALLIER-BRASIL-AGRO AZOXYSTROBIN*/DIFENOCONAZOLE* BOTRYTIS CINEREA ARYSTA-LIFESCIENCE CAPTAN COLLETOTRICHUM ACUTATUM ATAR-DO-BRASIL CARBENDAZIM COLLETOTRICHUM GLOEOSPOR BASF CHLOROTHALONIL-(TPN) CORTICIUM SALMONICOLOR BAYER-CROPSCIENCE CHLOROTHALONIL*/THIOPHANATE-M* DIAPHORINA CITRI BOHUS-PETER-DR. COPPER-HYDROXIDE DIAPORTHE CITRI CONSAGRO COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE) DIAPORTHE SPP CROPCHEM COPPER-OXYCHLORIDE ELSINOE FAWCETTI DE-SANGOSSE COPPER-SULFATE ELSINOE SPP DOW-AGROSCIENCES COPPER-SULFATE-TRIBASIC GLOMERELLA CINGULATA DUPONT CU-OXYCHLORIDE*/MANCOZEB* GUIGNARDIA CITRICARPA DVA-AGRO-BRASIL DIFENOCONAZOLE PENICILLIUM DIGITATUM FERSOL FAMOXADONE*/MANCOZEB* PENICILLIUM ITALICUM FUNGURAN-GIULINI FOLPET PHOMOPSIS CITRI GRIFFIN FOSETYL-AL (AL-TRI-PHOSPHONATE)/FOSETYL PHYLLOCOPTRUTA OLEIVORA HELM IMAZALIL (ENILCONAZOLE) PHYTOPHTHORA CITROPHTHORA IHARABRAS MANCOZEB (VONDOZEB) PHYTOPHTHORA NICOTIANAE PARASI ISAGRO PYRACLOSTROBIN PHYTOPHTHORA SPP MCM-QUIMICA QUINTOZENE-(PCNB/PENTACHLORONITROBENZENE) PYTHIUM APHANIDERMATUM MILENIA TEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE) SCLEROTIUM ROLFSII NORTOX TEBUCONAZOLE*/TRIFLOXYSTROBIN* XYLELLA FASTIDIOSA NUFARM THIABENDAZOLEOURO-FINO THIOPHANATE-MOXIQUIMICA TRIFLOXYSTROBINPFIZER PILARQUIM-CORP PROPHYTO RIZZI ROTAM SINON-CORPORATION SIPCAM STOLLER SYNGENTA TRADECORP-BRASIL-COM.-INS.-AGR UNITED-PHOSPHORUS

6 4. All Citrus Carbendazim Alternatives in Brazil Pests COLLETOTRICHUM ACUTATUM ELSINOE FAWCETTIELSINOE SPP GLOMERELLA CINGULATA GUIGNARDIA CITRICARPA Active Substances AZOXYSTROBIN AZOXYSTROBIN*/DIFENOCON AZOLE* CAPTAN CHLOROTHALONIL-(TPN) CHLOROTHALONIL*/THIOPHA NATE-M* COPPER-HYDROXIDE COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS- OXIDE) COPPER-OXYCHLORIDE COPPER-SULFATE-TRIBASICCOPPER-SULFATE CU- OXYCHLORIDE*/MANCOZEB* DIFENOCONAZOLE MANCOZEB (VONDOZEB) PYRACLOSTROBIN TEBUCONAZOLE (FENETRAZOLE)(TERBUTR AZOLE) TEBUCONAZOLE*/ TRIFLOXYSTROBIN* THIOPHANATE-M TRIFLOXYSTROBIN

7 5. Citrus Uses in other Countries for the same pests (1 of 2) COLLETOTRICHUM ACUTATUMELSINOE FAWCETTIELSINOE SPPGLOMERELLA CINGULATA GUIGNARDIA CITRICARPA AZOXYSTROBIN AZOXYSTROBIN*/DIFENOCONA ZOLE* AZOXYSTROBIN*/KRES OXIM-M* BACILLUS SUBTILIS BORDEAUX-MIXTURE (COPPER- CALCIUM-SULPHATE) BROMOTHALONIL*/CARBENDAZIM* BOSCALID*/PYRACLOSTROBIN* CAPTAN CARBENDAZIM CARBENDAZIM*/MANCOZEB* CHLOROTHALONIL-(TPN)CHITOSAN*/PROCHLORAZ* CHLOROTHALONIL*/HEXACONAZOLE* CHLOROTHALONIL*/THIOPHANATE-M* COPPER-AMMONIUM-CARBONATE COPPER-AMMONIUM-COMPLEX COPPER-DEHYDROABIETATE (DEHYDROABIETATE-ACID) COPPER-HYDROXIDE COPPER-OCTANATE COPPER-OXIDE (COPPER-I- OXIDE/CUPROUS-OXIDE) COPPER-OXYCHLORIDE CU-OXYCHLORIDE*/MANCOZEB* COPPER-SULFATE COPPER-SULFATE- ANHYDRIDE COPPER-SULFATE- PENTAHYDRATE(CUPRIC-SULFATE) COPPER-SULFATE-TRIBASIC DIFENOCONAZOLE EPOXICONAZOLE FENBUCONAZOLE FLUSILAZOLE GUAZATINE

8 5. Citrus Uses in other Countries for same pests (2 of 2) COLLETOTRICHUM ACUTATUM ELSINOE FAWCETTIELSINOE SPPGLOMERELLA CINGULATAGUIGNARDIA CITRICARPA KRESOXIM-M MANCOZEB (VONDOZEB) MANEB*/ZINC-OXIDE* MYCLOBUTANIL POTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN- CARBONATE) PROCHLORAZ PROCHLORAZ-MN PROPICONAZOLE PROPINEB (METIRAM-M) PYRACLOSTROBIN REYNOUTRIA SACHALINENSIS TEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE) TEBUCONAZOLE*/TRIFL OXYSTROBIN* THIOPHANATE-M TRIFLOXYSTROBIN TRIADIMEFON ZINEB

9 6. Products that are already approved in Brazil label expansions (addition of pest, of crop or crop/pest) COLLETOTRICHUM ACUTATUMELSINOE FAWCETTIELSINOE SPPGLOMERELLA CINGULATAGUIGNARDIA CITRICARPA AZOXYSTROBIN AZOXYSTROBIN*/DIFENOCONA ZOLE* BACILLUS SUBTILIS BOSCALID*/PYRACLOSTROBIN* CAPTAN CHLOROTHALONIL-(TPN)CHITOSAN*/PROCHLORAZ* CHLOROTHALONIL*/HEXACON AZOLE* CHLOROTHALONIL*/THIOPHAN ATE-M* COPPER-HYDROXIDE COPPER-OXIDE (COPPER-I- OXIDE/CUPROUS-OXIDE) COPPER-OXYCHLORIDE CU- OXYCHLORIDE*/MANCOZEB* COPPER-SULFATE COPPER-SULFATE-ANHYDRIDE COPPER-SULFATE-TRIBASIC DIFENOCONAZOLE EPOXICONAZOLE KRESOXIM-M MANCOZEB (VONDOZEB) MYCLOBUTANIL POTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN- CARBONATE) PROCHLORAZ PROPICONAZOLE PROPINEB (METIRAM-M) PYRACLOSTROBIN TEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE) TEBUCONAZOLE*/TRIFLOXYSTR OBIN* THIOPHANATE-M TRIFLOXYSTROBIN TRIADIMEFON ZINEB

10 The companies that hold registrations for these products in Brazil AZOXYSTROBINSYNGENTA AZOXYSTROBIN*/DIFENOCONAZOLE*SYNGENTA BACILLUS SUBTILISBASF BOSCALID*/PYRACLOSTROBIN*BASF CAPTAN ARYSTA-LIFESCIENCE, MILENIA, AGRICUR-DEFENSIVOS-AGRICOLAS, FERSOL CHLOROTHALONIL-(TPN) SYNGENTA, ARYSTA-LIFESCIENCE, SIPCAM-ISAGRO, SIPCAM, PILARQUIM- CORP, IHARABRAS, MILENIA CHLOROTHALONIL*/HEXACONAZOLE* SYNGENTA CHLOROTHALONIL*/THIOPHANATE-M* SIPCAM-ISAGRO, IHARABRAS, SIPCAM COPPER-HYDROXIDE DUPONT, GRIFFIN, OXIQUIMICA, ISAGRO, BASF COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE) ATAR-DO-BRASIL, STOLLER COPPER-OXYCHLORIDE AGRIPEC, BASF, ATAR-DO-BRASIL, ARYSTA-LIFESCIENCE, FUNGURAN- GIULINI, BAYER-CROPSCIENCE, DUPONT, NUFARM, OXIQUIMICA, GRIFFIN, ISAGRO, SIPCAM, FERSOL, RIZZI, NOVAQUIM CU-OXYCHLORIDE*/MANCOZEB* SIPCAM COPPER-SULFATE MCM-QUIMICA, RIZZI, MICROSAL-INDUSTRIA COPPER-SULFATE-TRIBASICPFIZER DIFENOCONAZOLESYNGENTA, HELM EPOXICONAZOLEMILENIA, BASF, CHEMINOVA KRESOXIM-MBASF MANCOZEB (VONDOZEB) UNITED-PHOSPHORUS, DUPONT, SIPCAM, DOW-AGROSCIENCES, OURO- FINO, ARYSTA-LIFESCIENCE, SABERO, ALLIER-BRASIL-AGRO, PROPHYTO MYCLOBUTANILDOW-AGROSCIENCES POTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN-CARBONATE)ARYSTA-LIFESCIENCE PROCHLORAZ MILENIA, FMC PROPICONAZOLE NORTOX, SYNGENTA, MILENIA, DVA-AGRO-BRASIL PROPINEB (METIRAM-M)BAYER-CROPSCIENCE PYRACLOSTROBINBASF TEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE) BAYER-CROPSCIENCE, CCAB-AGRO,MILENIA, NORTOX, CHEMINOVA, CONSAGRO, OURO-FINO, NUFARM, VOLCANO-AGROSCIENCE, UPL, ROTAM, HELM, SHARDA, UNITED-PHOSPHORUS, CROSS-LINK, RED-SURCOS TEBUCONAZOLE*/TRIFLOXYSTROBIN*BAYER-CROPSCIENCE THIOPHANATE-M IHARABRAS, PILARQUIM-CORP, DOW-AGROSCIENCES, SIPCAM, HELM, SIPCAM-ISAGRO TRIFLOXYSTROBINBAYER-CROPSCIENCE, TRADECORP-BRASIL-COM.-INS.-AGR TRIADIMEFONBAYER-CROPSCIENCE

11 7. These products would have to be approved in Brazil (= new actives/products) COLLETOTRICHUM ACUTATUMELSINOE FAWCETTIELSINOE SPPGLOMERELLA CINGULATAGUIGNARDIA CITRICARPA BORDEAUX-MIXTURE (COPPER-CALCIUM- SULPHATE) COPPER-AMMONIUM- CARBONATE COPPER-AMMONIUM- COMPLEX COPPER-DEHYDROABIETATE (DEHYDROABIETATE-ACID) COPPER-OCTANATE COPPER-SULFATE- PENTAHYDRATE(CUPRIC- SULFATE) FENBUCONAZOLE FLUSILAZOLE GUAZATINE MANEB*/ZINC-OXIDE* PROCHLORAZ-MN REYNOUTRIA SACHALINENSIS TRIADIMEFON*/TRIFLOXYSTRO BIN* ZINEB

12 8. Import countries for Brazilian citrus Import CountryValue in 000 eurosPCT value ALGERIA1, % ARGENTINA3, % AUSTRALIA25, % BELGIUM745, % CANADA1, % CHILE10, % CHINA67, % COLOMBIA1, % CYPRUS1, % GERMANY4, % INDONESIA2, % IRELAND7, % ISRAEL13, % ITALY2, % JAPAN112, % KOREA-SOUTH5, % KUWAIT1, % LEBANON1, % MALAYSIA2, % NETHERLANDS416, % NEW ZEALAND2, % PANAMA % PHILIPPINES1, % SAUDI-ARABIA1, % SINGAPORE1, % SPAIN2, % SWITZERLAND39, % THAILAND3, % TURKEY1, % U.ARAB-E.4, % U.KINGDOM81, % USA210, % VIETNAM1, %

13 9a. MRL comparisons for citrus for Brazil and importers (example AZOXYSTROBIN) Crop nameA.I.BRAARGAUSCANCMACODEXEUJAPASEUSAEU reg CITRUS-HYBRIDS(CITRUS L. SPP.)AZOXYSTROBIN1015ANNEX I CITRUS: OILAZOXYSTROBIN40ANNEX I CITRUS: OTHER(CITRUS L. SPP.)AZOXYSTROBIN ANNEX I CITRUS: PULP-DRY(CITRUS L. PULP)AZOXYSTROBIN20ANNEX I CLEMENTINES(CITRUS CLEMENTINA)AZOXYSTROBIN0.515ANNEX I GRAPEFRUIT HYBRIDS: OTHERAZOXYSTROBIN15ANNEX I GRAPEFRUIT(CITRUS PARADISI)AZOXYSTROBIN ANNEX I LEMONS(CITRUS LIMON)AZOXYSTROBIN ANNEX I LIME-SPANISH/GENIP/HONEY-BERRY(MELICOCCUS BIJUGATUS)AZOXYSTROBIN2ANNEX I LIMES(CITRUS AURANTIFOLIA)AZOXYSTROBIN ANNEX I MANDARINS(CITRUS RETICULATA SENSU STRICTO)AZOXYSTROBIN ANNEX I MANDARINS/OTHER-HYBRIDS(CITRUS RETICULATA)AZOXYSTROBIN15ANNEX I ORANGE HYBRIDS: OTHERAZOXYSTROBIN15ANNEX I ORANGE-SOUR/BITTER(CITRUS AURANTIUM VAR. AMARA)AZOXYSTROBIN1015 ANNEX I ORANGES(CITRUS SINENSIS)AZOXYSTROBIN ANNEX I ORANGES-SWEET(CITRUS SINENSIS)AZOXYSTROBIN15ANNEX I ORANGES: OIL(CITRUS RETICULATA I C.SINENSIS)AZOXYSTROBIN3.3ANNEX I POMELO(CITRUS MAXIMA)AZOXYSTROBIN ANNEX I SHADDOCK/POMELO(CITRUS MAXIMA)AZOXYSTROBIN1015ANNEX I SOUR-ORANGE-CHINOTTO(CITRUS AURANTIUM)AZOXYSTROBIN15ANNEX I SUMMER-ORANGE-NATSUDAIDAI(CITRUS NATSUDAIDAI HAYATA)AZOXYSTROBIN10ANNEX I TANGERINES(CITRUS TANGERINA)AZOXYSTROBIN ANNEX I

14 9b. MRL comparisons for citrus for Brazil and importers (example PYRACLOSTROBIN) Crop nameA.I.BRAARGAUSCANCMACODEXEUJAPASEUSAEU reg CITRUS-HYBRIDS(CITRUS L. SPP.)PYRACLOSTROBIN2ANNEX I CITRUS: OILPYRACLOSTROBIN9109ANNEX I CITRUS: OTHER(CITRUS L. SPP.)PYRACLOSTROBIN ANNEX I CITRUS: PULP-DRY(CITRUS L. PULP)PYRACLOSTROBIN12.5ANNEX I CLEMENTINES(CITRUS CLEMENTINA)PYRACLOSTROBIN0.51ANNEX I GRAPEFRUIT HYBRIDS: OTHERPYRACLOSTROBIN1ANNEX I GRAPEFRUIT(CITRUS PARADISI)PYRACLOSTROBIN ANNEX I LEMONS(CITRUS LIMON)PYRACLOSTROBIN ANNEX I LIMES(CITRUS AURANTIFOLIA)PYRACLOSTROBIN ANNEX I MANDARINS(CITRUS RETICULATA SENSU STRICTO)PYRACLOSTROBIN ANNEX I MANDARINS/OTHER-HYBRIDS(CITRUS RETICULATA)PYRACLOSTROBIN1ANNEX I ORANGE HYBRIDS: OTHERPYRACLOSTROBIN2ANNEX I ORANGE-SOUR/BITTER(CITRUS AURANTIUM)PYRACLOSTROBIN222ANNEX I ORANGES(CITRUS SINENSIS)PYRACLOSTROBIN ANNEX I ORANGES-SWEET(CITRUS SINENSIS)PYRACLOSTROBIN2ANNEX I ORANGES: OIL(CITRUS RETICULATA I C.SINENSIS)PYRACLOSTROBIN10ANNEX I POMELO(CITRUS MAXIMA)PYRACLOSTROBIN12212ANNEX I SHADDOCK/POMELO(CITRUS MAXIMA)PYRACLOSTROBIN1ANNEX I SOUR-ORANGE-CHINOTTO(CITRUS AURANTIUM)PYRACLOSTROBIN2ANNEX I SUMMER-ORANGE-NATSUDAIDAIPYRACLOSTROBIN1ANNEX I TANGERINES(CITRUS TANGERINA)PYRACLOSTROBIN0.5212ANNEX I

15 Strategy 1.Several fungicides are registered in Brazil that could fill the gap that the disappearance of carbendazim will leave for citrus production. 2.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. 3.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. 4.When adding citrus crops to existing labels, product specific MRLs will have to set. 5.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. 6.The next steps are: i.asking the regulator for crop/pest/product specific data requirements for the label additions of crops, pests or crop/pest combinations ii.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 iii.search Homologa/GPPD for the use patterns in countries with similar MRLs iv.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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