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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 International Development of Regulatory Globalization
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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.

Dec 15, 2015

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

IDRG

Imme Gerke, PhD & Jacques Drolet, PhD

Global Regulatory Strategists

Replacing the Use

of Carbendazim in

Citrus Production

in Brazil

December 2013

International Developmentof Regulatory Globalization

Page 2: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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

Page 3: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

1. All Carbendazim Uses in BrazilCrop (commodity) Pest Latin CompanyBEANS(PHASEOLUS LUNATUS L.) ALTERNARIA ALTERNATA GLOMERELLA CINGULATA NORTOXCITRUS: OTHER(CITRUS L. SPP.) ALTERNARIA SPP GUIGNARDIA CITRICARPA BAYER-CROPSCIENCECLEMENTINES(CITRUS CLEMENTINA) ASPERGILLUS FLAVUS HELMINTHOSPORIUM MAYDIS NUFARMCORN/MAIZE(ZEA MAYS L. SPP.) ASPERGILLUS SPP HELMINTHOSPORIUM TRITICI-R DVA-AGRO-BRASILCOTTON(GOSSYPIUM HIRSUTUM) BIPOLARIS SOROKINIANA MICROSPHAERA DIFFUSA BOHUS-PETER-DR.GRAPEFRUIT(CITRUS PARADISI) BIPOLARIS SPP PENICILLIUM SPP DE-SANGOSSELEMONS(CITRUS LIMON) BOTRYODIPLODIA THEOBROMAE PHAEOISARIOPSIS GRISEOLA CROPCHEMLIMES(CITRUS AURANTIFOLIA) BOTRYOSPHAERIA RHODINA PHAKOPSORA PACHYRHIZI HELMMANDARINS(CITRUS RETICULATA SENSU STRICTO) CERCOSPORA KIKUCHI PHOMA SPP OURO-FINO

ORANGES(CITRUS SINENSIS) CERCOSPORA SOJINA PUCCINIA GRAMINIS SINON-CORPORATIONPOMELO(CITRUS MAXIMA) COLLETOTRICHUM ACUTATUM PUCCINIA TRITICANA ROTAMRICE(ORYZA SATIVA L.) COLLETOTRICHUM DEMATIUM PYRICULARIA GRISEA DUPONTSOYBEANS(GLYCINE MAX) COLLETOTRICHUM GOSSYPII RAMULARIA AREOLA POLAND-QUIMICA

TANGERINES(CITRUS TANGERINA)COLLETOTRICHUM LINDEMUTHIANUM RHIZOCTONIA SOLANI CHEMINOVA

UNSPECIFIED COLLETOTRICHUM TRUNCATUM RHYNCHOSPORIUM SECALIS FMCWHEAT(TRITICUM AESTIVUM L.) COLLETOTRICHUM VICIAE SCLEROTINIA SCLEROTIORUM MILENIA

CORYNESPORA CASSIICOLA SEPTORIA GLYCINES SYNGENTADIAPORTHE PHASEOLORUM SEPTORIA TRITICI CCAB-AGRO

DIAPORTHE PHASEOLORUM-SOJAE STAGONOSPORA NODORUM

NOVOZYMES-BIOLOGICALS

ELSINOE FAWCETTI UNSPECIFIED CONSAGROELSINOE SPP UNSPECIFIED-DISEASESERYSIPHE GRAMINIS TRITICI UROMYCES APPENDICULATUSERYSIPHE SPPFUSARIUM GRAMINEARUMFUSARIUM MONILIFORME

FUSARIUM OXYSPORUM VASINFECTUM

FUSARIUM SEMITECTUMFUSARIUM SOLANIFUSARIUM SPP

Page 4: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

2. All Carbendazim Citrus Uses in Brazil

Crop (commodity) Pest Latin Company

CITRUS: OTHER(CITRUS L. SPP.) GUIGNARDIA CITRICARPA NUFARM

GRAPEFRUIT(CITRUS PARADISI) ELSINOE FAWCETTI DVA-AGRO-BRASIL

LEMONS(CITRUS LIMON) ELSINOE SPP NORTOX

LIMES(CITRUS AURANTIFOLIA) COLLETOTRICHUM ACUTATUM BOHUS-PETER-DR.

CLEMENTINES(CITRUS CLEMENTINA) GLOMERELLA CINGULATA DE-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

Page 5: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

3. All Citrus Fungicide Uses in BrazilA.i.Combination Pest Latin CompanyACIBENZOLAR-S-M ALTERNARIA CITRI AGRIPECAZOXYSTROBIN BOTRYOSPHAERIA RHODINA ALLIER-BRASIL-AGROAZOXYSTROBIN*/DIFENOCONAZOLE* BOTRYTIS CINEREA ARYSTA-LIFESCIENCECAPTAN COLLETOTRICHUM ACUTATUM ATAR-DO-BRASILCARBENDAZIM COLLETOTRICHUM GLOEOSPOR BASFCHLOROTHALONIL-(TPN) CORTICIUM SALMONICOLOR BAYER-CROPSCIENCECHLOROTHALONIL*/THIOPHANATE-M* DIAPHORINA CITRI BOHUS-PETER-DR.COPPER-HYDROXIDE DIAPORTHE CITRI CONSAGROCOPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE) DIAPORTHE SPP CROPCHEMCOPPER-OXYCHLORIDE ELSINOE FAWCETTI DE-SANGOSSECOPPER-SULFATE ELSINOE SPP DOW-AGROSCIENCESCOPPER-SULFATE-TRIBASIC GLOMERELLA CINGULATA DUPONTCU-OXYCHLORIDE*/MANCOZEB* GUIGNARDIA CITRICARPA DVA-AGRO-BRASILDIFENOCONAZOLE PENICILLIUM DIGITATUM FERSOLFAMOXADONE*/MANCOZEB* PENICILLIUM ITALICUM FUNGURAN-GIULINIFOLPET PHOMOPSIS CITRI GRIFFINFOSETYL-AL (AL-TRI-PHOSPHONATE)/FOSETYL PHYLLOCOPTRUTA OLEIVORA HELMIMAZALIL (ENILCONAZOLE) PHYTOPHTHORA CITROPHTHORA IHARABRASMANCOZEB (VONDOZEB) PHYTOPHTHORA NICOTIANAE PARASI ISAGROPYRACLOSTROBIN PHYTOPHTHORA SPP MCM-QUIMICAQUINTOZENE-(PCNB/PENTACHLORONITROBENZENE) PYTHIUM APHANIDERMATUM MILENIATEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE) SCLEROTIUM ROLFSII NORTOXTEBUCONAZOLE*/TRIFLOXYSTROBIN* XYLELLA FASTIDIOSA NUFARMTHIABENDAZOLE OURO-FINOTHIOPHANATE-M OXIQUIMICATRIFLOXYSTROBIN PFIZER

PILARQUIM-CORPPROPHYTORIZZIROTAMSINON-CORPORATIONSIPCAMSTOLLERSYNGENTATRADECORP-BRASIL-COM.-INS.-AGRUNITED-PHOSPHORUS

Page 6: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

4. All Citrus Carbendazim Alternatives in Brazil

PestsCOLLETOTRICHUM ACUTATUM ELSINOE FAWCETTI ELSINOE SPP

GLOMERELLA CINGULATA

GUIGNARDIA CITRICARPA

Active Substances

AZOXYSTROBIN

AZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*

CAPTAN CAPTAN

CHLOROTHALONIL-(TPN)

CHLOROTHALONIL*/THIOPHANATE-M*

COPPER-HYDROXIDE COPPER-HYDROXIDE COPPER-HYDROXIDE

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXYCHLORIDE COPPER-OXYCHLORIDE COPPER-OXYCHLORIDE COPPER-OXYCHLORIDECOPPER-SULFATE-TRIBASIC COPPER-SULFATE COPPER-SULFATE

CU-OXYCHLORIDE*/MANCOZEB*

DIFENOCONAZOLE DIFENOCONAZOLE

MANCOZEB (VONDOZEB)

MANCOZEB (VONDOZEB)

MANCOZEB (VONDOZEB)

PYRACLOSTROBIN PYRACLOSTROBIN

TEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE)

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

THIOPHANATE-M THIOPHANATE-M THIOPHANATE-M THIOPHANATE-M

TRIFLOXYSTROBIN TRIFLOXYSTROBIN

Page 7: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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

COLLETOTRICHUM ACUTATUM

ELSINOE FAWCETTI ELSINOE SPP GLOMERELLA CINGULATAGUIGNARDIA CITRICARPA

AZOXYSTROBIN AZOXYSTROBIN AZOXYSTROBIN AZOXYSTROBIN AZOXYSTROBINAZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*AZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*AZOXYSTROBIN*/DIFENOCONAZOLE*AZOXYSTROBIN*/KRESOXIM-M*

BACILLUS SUBTILIS BACILLUS SUBTILISBORDEAUX-MIXTURE (COPPER-CALCIUM-SULPHATE)

BORDEAUX-MIXTURE (COPPER-CALCIUM-SULPHATE)

BROMOTHALONIL*/CARBENDAZIM*BOSCALID*/PYRACLOSTROBIN*CAPTAN CAPTAN

CARBENDAZIM CARBENDAZIM CARBENDAZIM CARBENDAZIM CARBENDAZIMCARBENDAZIM*/MANCOZEB*

CHLOROTHALONIL-(TPN) CHITOSAN*/PROCHLORAZ*CHLOROTHALONIL*/HEXACONAZOLE*CHLOROTHALONIL*/THIOPHANATE-M*COPPER-AMMONIUM-CARBONATECOPPER-AMMONIUM-COMPLEX

COPPER-DEHYDROABIETATE (DEHYDROABIETATE-ACID)

COPPER-HYDROXIDE COPPER-HYDROXIDE COPPER-HYDROXIDECOPPER-OCTANATE

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXYCHLORIDECOPPER-OXYCHLORIDE

COPPER-OXYCHLORIDECOPPER-OXYCHLORIDE

CU-OXYCHLORIDE*/MANCOZEB*

COPPER-SULFATE COPPER-SULFATE COPPER-SULFATECOPPER-SULFATE-ANHYDRIDE

COPPER-SULFATE-PENTAHYDRATE(CUPRIC-SULFATE)

COPPER-SULFATE-TRIBASIC COPPER-SULFATE-TRIBASICDIFENOCONAZOLE DIFENOCONAZOLE

EPOXICONAZOLEFENBUCONAZOLE

FLUSILAZOLEGUAZATINE

Page 8: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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

COLLETOTRICHUM ACUTATUM

ELSINOE FAWCETTI ELSINOE SPP GLOMERELLA CINGULATA GUIGNARDIA CITRICARPA

KRESOXIM-M

MANCOZEB (VONDOZEB) MANCOZEB (VONDOZEB) MANCOZEB (VONDOZEB)

MANEB*/ZINC-OXIDE*

MYCLOBUTANIL

POTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN-CARBONATE)

POTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN-CARBONATE)

PROCHLORAZ

PROCHLORAZ-MN

PROPICONAZOLE

PROPINEB (METIRAM-M)

PYRACLOSTROBIN PYRACLOSTROBIN PYRACLOSTROBIN PYRACLOSTROBIN

REYNOUTRIA SACHALINENSIS

REYNOUTRIA SACHALINENSIS

TEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE)

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

THIOPHANATE-M THIOPHANATE-M THIOPHANATE-M THIOPHANATE-M

TRIFLOXYSTROBIN TRIFLOXYSTROBIN TRIFLOXYSTROBIN TRIFLOXYSTROBIN

TRIADIMEFON

ZINEB ZINEB ZINEB

Page 9: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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

COLLETOTRICHUM ACUTATUM ELSINOE FAWCETTI ELSINOE SPP GLOMERELLA CINGULATA GUIGNARDIA CITRICARPA

AZOXYSTROBIN AZOXYSTROBIN AZOXYSTROBIN AZOXYSTROBIN AZOXYSTROBINAZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*

AZOXYSTROBIN*/DIFENOCONAZOLE*

BACILLUS SUBTILIS BACILLUS SUBTILISBOSCALID*/PYRACLOSTROBIN*CAPTAN CAPTANCHLOROTHALONIL-(TPN) CHITOSAN*/PROCHLORAZ*CHLOROTHALONIL*/HEXACONAZOLE*CHLOROTHALONIL*/THIOPHANATE-M*COPPER-HYDROXIDE COPPER-HYDROXIDE COPPER-HYDROXIDE

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE)

COPPER-OXYCHLORIDE COPPER-OXYCHLORIDE COPPER-OXYCHLORIDE COPPER-OXYCHLORIDECU-OXYCHLORIDE*/MANCOZEB*COPPER-SULFATE COPPER-SULFATE COPPER-SULFATE COPPER-SULFATE-ANHYDRIDE

COPPER-SULFATE-TRIBASIC COPPER-SULFATE-TRIBASICDIFENOCONAZOLE DIFENOCONAZOLE

EPOXICONAZOLEKRESOXIM-M

MANCOZEB (VONDOZEB) MANCOZEB (VONDOZEB) MANCOZEB (VONDOZEB)MYCLOBUTANIL

POTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN-CARBONATE)

POTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN-CARBONATE)PROCHLORAZ

PROPICONAZOLEPROPINEB (METIRAM-M)

PYRACLOSTROBIN PYRACLOSTROBIN PYRACLOSTROBIN PYRACLOSTROBINTEBUCONAZOLE (FENETRAZOLE)(TERBUTRAZOLE)

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

TEBUCONAZOLE*/TRIFLOXYSTROBIN*

THIOPHANATE-M THIOPHANATE-M THIOPHANATE-M THIOPHANATE-MTRIFLOXYSTROBIN TRIFLOXYSTROBIN TRIFLOXYSTROBIN TRIFLOXYSTROBIN

TRIADIMEFONZINEB ZINEB ZINEB

Page 10: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

The companies that hold registrations for these products in BrazilAZOXYSTROBIN SYNGENTAAZOXYSTROBIN*/DIFENOCONAZOLE* SYNGENTABACILLUS SUBTILIS BASFBOSCALID*/PYRACLOSTROBIN* BASF

CAPTAN ARYSTA-LIFESCIENCE, MILENIA, AGRICUR-DEFENSIVOS-AGRICOLAS, FERSOL

CHLOROTHALONIL-(TPN) SYNGENTA, ARYSTA-LIFESCIENCE, SIPCAM-ISAGRO, SIPCAM, PILARQUIM-CORP, IHARABRAS, MILENIA

CHLOROTHALONIL*/HEXACONAZOLE* SYNGENTACHLOROTHALONIL*/THIOPHANATE-M* SIPCAM-ISAGRO, IHARABRAS, SIPCAMCOPPER-HYDROXIDE DUPONT, GRIFFIN, OXIQUIMICA, ISAGRO, BASFCOPPER-OXIDE (COPPER-I-OXIDE/CUPROUS-OXIDE) ATAR-DO-BRASIL, STOLLER

COPPER-OXYCHLORIDEAGRIPEC, BASF, ATAR-DO-BRASIL, ARYSTA-LIFESCIENCE, FUNGURAN-GIULINI, BAYER-CROPSCIENCE, DUPONT, NUFARM, OXIQUIMICA, GRIFFIN, ISAGRO, SIPCAM, FERSOL, RIZZI, NOVAQUIM

CU-OXYCHLORIDE*/MANCOZEB* SIPCAMCOPPER-SULFATE MCM-QUIMICA, RIZZI, MICROSAL-INDUSTRIACOPPER-SULFATE-TRIBASIC PFIZERDIFENOCONAZOLE SYNGENTA, HELMEPOXICONAZOLE MILENIA, BASF, CHEMINOVAKRESOXIM-M BASF

MANCOZEB (VONDOZEB) UNITED-PHOSPHORUS, DUPONT, SIPCAM, DOW-AGROSCIENCES, OURO-FINO, ARYSTA-LIFESCIENCE, SABERO, ALLIER-BRASIL-AGRO, PROPHYTO

MYCLOBUTANIL DOW-AGROSCIENCESPOTASSIUM-BICARBONATE (POTASSIUM-HYDROGEN-CARBONATE) ARYSTA-LIFESCIENCE

PROCHLORAZ MILENIA, FMCPROPICONAZOLE NORTOX, SYNGENTA, MILENIA, DVA-AGRO-BRASILPROPINEB (METIRAM-M) BAYER-CROPSCIENCEPYRACLOSTROBIN BASF

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

TRIFLOXYSTROBIN BAYER-CROPSCIENCE, TRADECORP-BRASIL-COM.-INS.-AGRTRIADIMEFON BAYER-CROPSCIENCE

Page 11: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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

COLLETOTRICHUM ACUTATUM

ELSINOE FAWCETTI ELSINOE SPP GLOMERELLA CINGULATA GUIGNARDIA CITRICARPA

BORDEAUX-MIXTURE (COPPER-CALCIUM-SULPHATE)

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

REYNOUTRIA SACHALINENSIS

TRIADIMEFON*/TRIFLOXYSTROBIN*

ZINEB ZINEB ZINEB

Page 12: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

8. Import countries for Brazilian citrusImport Country Value in 000 euros PCT value

ALGERIA 1,340.73 0.10%ARGENTINA 3,020.76 0.20%AUSTRALIA 25,602.01 1.40%BELGIUM 745,838.96 41.90%CANADA 1,102.03 0.10%CHILE 10,534.88 0.60%CHINA 67,144.19 3.80%COLOMBIA 1,248.30 0.10%CYPRUS 1,707.62 0.10%GERMANY 4,674.94 0.30%INDONESIA 2,495.66 0.10%IRELAND 7,059.10 0.40%ISRAEL 13,490.03 0.80%ITALY 2,120.41 0.10%JAPAN 112,031.60 6.30%KOREA-SOUTH 5,291.07 0.30%KUWAIT 1,141.04 0.10%LEBANON 1,042.31 0.10%MALAYSIA 2,465.52 0.10%NETHERLANDS 416,324.43 23.40%NEW ZEALAND 2,688.35 0.20%PANAMA 923.37 0.10%PHILIPPINES 1,630.88 0.10%SAUDI-ARABIA 1,162.85 0.10%SINGAPORE 1,871.67 0.10%SPAIN 2,831.33 0.20%SWITZERLAND 39,401.63 2.20%THAILAND 3,108.24 0.20%TURKEY 1,683.86 0.10%U.ARAB-E. 4,322.83 0.20%U.KINGDOM 81,636.15 4.60%USA 210,979.24 11.90%VIETNAM 1,896.48 0.10%

Page 13: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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

Crop name A.I. BRA ARG AUS CAN CMA CODEX EU JAP ASE USA EU reg

CITRUS-HYBRIDS(CITRUS L. SPP.) AZOXYSTROBIN 10 15 ANNEX I

CITRUS: OIL AZOXYSTROBIN 40 ANNEX I

CITRUS: OTHER(CITRUS L. SPP.) AZOXYSTROBIN 0.5 10 1 15 15 10 15 ANNEX I

CITRUS: PULP-DRY(CITRUS L. PULP) AZOXYSTROBIN 20 ANNEX I

CLEMENTINES(CITRUS CLEMENTINA) AZOXYSTROBIN 0.5 15 ANNEX I

GRAPEFRUIT HYBRIDS: OTHER AZOXYSTROBIN 15 ANNEX I

GRAPEFRUIT(CITRUS PARADISI) AZOXYSTROBIN 0.5 10 10 1 15 15 10 15 ANNEX I

LEMONS(CITRUS LIMON) AZOXYSTROBIN 0.5 0.5 10 10 1 15 15 10 15 ANNEX ILIME-SPANISH/GENIP/HONEY-BERRY(MELICOCCUS BIJUGATUS) AZOXYSTROBIN 2 ANNEX I

LIMES(CITRUS AURANTIFOLIA) AZOXYSTROBIN 0.5 10 10 15 15 10 15 ANNEX I

MANDARINS(CITRUS RETICULATA SENSU STRICTO) AZOXYSTROBIN 0.5 0.5 10 10 1 15 15 15 ANNEX I

MANDARINS/OTHER-HYBRIDS(CITRUS RETICULATA) AZOXYSTROBIN 15 ANNEX I

ORANGE HYBRIDS: OTHER AZOXYSTROBIN 15 ANNEX I

ORANGE-SOUR/BITTER(CITRUS AURANTIUM VAR. AMARA) AZOXYSTROBIN 10 15 15 15 ANNEX I

ORANGES(CITRUS SINENSIS) AZOXYSTROBIN 0.5 0.5 10 10 1 15 15 10 15 ANNEX I

ORANGES-SWEET(CITRUS SINENSIS) AZOXYSTROBIN 15 ANNEX I

ORANGES: OIL(CITRUS RETICULATA I C.SINENSIS) AZOXYSTROBIN 3.3 ANNEX I

POMELO(CITRUS MAXIMA) AZOXYSTROBIN 0.5 10 1 15 15 15 ANNEX I

SHADDOCK/POMELO(CITRUS MAXIMA) AZOXYSTROBIN 10 15 ANNEX I

SOUR-ORANGE-CHINOTTO(CITRUS AURANTIUM) AZOXYSTROBIN 15 ANNEX ISUMMER-ORANGE-NATSUDAIDAI(CITRUS NATSUDAIDAI HAYATA) AZOXYSTROBIN 10 ANNEX I

TANGERINES(CITRUS TANGERINA) AZOXYSTROBIN 0.5 10 1 15 15 ANNEX I

Page 14: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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

Crop name A.I. BRA ARG AUS CAN CMA CODEX EU JAP ASE USA EU reg

CITRUS-HYBRIDS(CITRUS L. SPP.) PYRACLOSTROBIN 2 ANNEX I

CITRUS: OIL PYRACLOSTROBIN 9 10 9 ANNEX I

CITRUS: OTHER(CITRUS L. SPP.) PYRACLOSTROBIN 0.5 2 1 1 2 ANNEX I

CITRUS: PULP-DRY(CITRUS L. PULP) PYRACLOSTROBIN 12.5 ANNEX I

CLEMENTINES(CITRUS CLEMENTINA) PYRACLOSTROBIN 0.5 1 ANNEX I

GRAPEFRUIT HYBRIDS: OTHER PYRACLOSTROBIN 1 ANNEX I

GRAPEFRUIT(CITRUS PARADISI) PYRACLOSTROBIN 0.5 2 2 1 1 2 ANNEX I

LEMONS(CITRUS LIMON) PYRACLOSTROBIN 0.5 1 2 2 1 1 2 ANNEX I

LIMES(CITRUS AURANTIFOLIA) PYRACLOSTROBIN 0.5 2 2 1 1 2 ANNEX I

MANDARINS(CITRUS RETICULATA SENSU STRICTO)

PYRACLOSTROBIN 0.5 0.5 2 1 2 ANNEX I

MANDARINS/OTHER-HYBRIDS(CITRUS RETICULATA)

PYRACLOSTROBIN 1 ANNEX I

ORANGE HYBRIDS: OTHER PYRACLOSTROBIN 2 ANNEX I

ORANGE-SOUR/BITTER(CITRUS AURANTIUM) PYRACLOSTROBIN 2 2 2 ANNEX I

ORANGES(CITRUS SINENSIS) PYRACLOSTROBIN 0.5 1 2 2 2 1 2 ANNEX I

ORANGES-SWEET(CITRUS SINENSIS) PYRACLOSTROBIN 2 ANNEX I

ORANGES: OIL(CITRUS RETICULATA I C.SINENSIS) PYRACLOSTROBIN 10 ANNEX I

POMELO(CITRUS MAXIMA) PYRACLOSTROBIN 1 2 2 1 2 ANNEX I

SHADDOCK/POMELO(CITRUS MAXIMA) PYRACLOSTROBIN 1 ANNEX I

SOUR-ORANGE-CHINOTTO(CITRUS AURANTIUM) PYRACLOSTROBIN 2 ANNEX I

SUMMER-ORANGE-NATSUDAIDAI PYRACLOSTROBIN 1 ANNEX I

TANGERINES(CITRUS TANGERINA) PYRACLOSTROBIN 0.5 2 1 2 ANNEX I

Page 15: IDRG Imme Gerke, PhD & Jacques Drolet, PhD Global Regulatory Strategists Replacing the Use of Carbendazim in Citrus Production in Brazil December 2013.

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