CX/RVDF 13/21/11 - FAO.org

EAgenda Item 9(b) CX/RVDF 13/21/11May 2012JOINT FAO/WHO FOOD STANDARDS PROGRAMMECODEX COMMITTEE ON RESIDUES OF VETERINARY DRUGS IN FOODSTwenty-first SessionMinneapolis, Minnesota, United States of America, 26 – 30 August 2013DATABASE ON COUNTRIES’ NEEDS FOR MRLS(Draft Report of the Electronic Working Group on Countries’ Needs for MRLs)(Australia, Brazil, Canada, Chile, Croatia, France, India, Republic of Korea, Philippines, Thailand, UnitedStates of America, WHO and IFAH)Background1. The work on a database of Countries’ Needs for MRLs began in 2009 following the 18 th Session of theCodex Committee on Residues of Veterinary Drugs in Foods in Natal, Brazil. The vision for the databasewas to collect requests and information from countries in need of MRLs for specific veterinary drugs. Thepurpose was to create a list could help find sufficient data to permit an evaluation by JECFA. With therenewal of this effort by the 20 th Session of the CCRVDF in San Juan, Puerto Rico, the Committee createdan electronic Working Group to:(i)(ii)(iii)Continue its work on the database;Clearly identify country requirements taking into account what had already been done by JECFA;andIdentify data needs and define the exact request (e.g. MRLs species and tissue) for the threeveterinary drugs of common interest to many countries, namely: bacitracin, enrofloxacin andflorfenicol.Proceedings of the electronic Working Group2. The electronic Working Group worked through email. In continuing to develop and maintain the databaseof countries’ needs for MRLs, the electronic Working Group:a) Approached countries that had previously contributed to the database to confirm that the requestsalready in the database reflected current needs and to refine them as necessary with additionalinformation on species, tissues, and country registration;b) Expanded the database to include additional information on data gaps identified by JECFA whereveterinary drugs had previously been evaluated;c) Surveyed working group members for specific information regarding current country registrationand availability of data for bacitracin, enrofloxacin, florfenicol, and ivermectin; andd) Revised the database based on information collected, including any new requests.3. In some cases, the MRL requests included in the database were very broad. The electronic WorkingGroup worked with the country providing the request to narrow down each request to include only thosespecies in which the drug is being used, while striving to include as much information as possible that coulddefine the potential request to JECFA. In order to better define each request, members of this WorkingGroup contacted each country that had previously contributed to the database in order to gain moreinformation. Members from Australia, Canada, France, and the United States of America made efforts tocontact the original requesting countries. The Working Group updated the database incorporating newinformation from Argentina, Armenia, Kenya, Morocco, Philippines, and Uruguay. The Republic of Korea, asa member of the Working Group, provided additional specific requests to the database.4. The database on Countries’ Needs for MRLs included information on whether JECFA has previouslyevaluated each drug, and whether JECFA had established a full ADI or recommended MRLs. The WorkingGroup revised the database to include data gaps identified by the JECFA during past evaluations. Where

CX/RVDF 13/21/11 2JECFA has established an ADI and recommended MRLs in other species than what are being requested,the Working Group noted that residue data for the requested species is needed.5. The Working Group was asked to define the data needs and exact request for bacitracin, enrofloxacin,and florfenicol. The Working Group added ivermectin to this list as the need for a cattle muscle MRL hasbeen a topic of discussion at recent sessions of the CCRVDF and the database contains additional requestsfor ivermectin MRLs in other species. To facilitate defining data needs, members of the Working Group wereasked to provide information on veterinary use patterns for bacitracin, enrofloxacin, florfenicol, andivermectin from within their own country. Information received on the use of these four veterinary drugs wasadded to the Database on Countries’ Needs for MRLs.Discussion6. The Working Group and other member countries provided more information on tissues required anddosages for many of the veterinary drugs included in the Database on Countries’ Needs for MRLs. Theaddition of JECFA’s identified data gaps also helps to define the data needs for those veterinary drugs thatJECFA has already evaluated. While many of the MRL requests have been refined, some requests remaintoo broad.7. The Database on Countries’ Needs for MRLs contains requests for 83 veterinary drugs. JECFA haspreviously evaluated 29 of the requested veterinary drugs.Recommendations8. The electronic Working Group recommends that the Committee continue to develop and maintain theDatabase of Veterinary Drugs of Potential Interest to Developing Countries. The electronic Working Groupalso recommends that the Database on Countries’ Needs for MRLs be circulated to all member countriesseeking additional information for those veterinary drugs currently included in the database.

CX/RVDF 13/21/11 3AnnexDatabase on Countries’ Needs for MRLsNameAll Approveddrugs for largeanimalsCountriesRequestingEgypt,KenyaSpeciesCamelTissuesMeat /fatLiverKidneyMilkGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceNo data are availablefor any tissue or milkAminosydine Armenia Cattle MRLs (ppb) inArmenia: Muscle(1000), Liver(10,000), Kidney(20,000)Aminosydine Armenia Chicken MRLs (ppb) inArmenia: Muscle(1000), Liver(10,000), Kidney(20,000)Aminosydine Armenia Pig MRLs (ppb) inArmenia: Muscle(1000), Liver(10,000), Kidney(20,000)Aminosydine Armenia Rabbit MRLs (ppb) inArmenia: Muscle(1000), Liver(10,000), Kidney(20,000)AmoxicillinRepublic ofKoreaFish Muscle Republic of KoreaDosing Resimen:20-40 mg a.i./kg b.w.orally(in feed) for 4 -7 daysManufacturerUnknownUnknownUnknownUnknownRepublic of Korea:DaesungMircrobilogical LabsCo., Ltd.; DaoneChemical Co., Ltd.;WooGene B&G;KOPAVET Special,Inc.; Jin woomedicine; UbtechJECFAEvaluation75thJECFA,2011CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLin Cattle,Sheep, PigMemberCountryMRLsArmeniaArmeniaArmeniaArmeniaRepublic ofKorea (0.05-fish)COMMENTSCamel meat and milk arewidely used in Egypt andother countries especiallyrural areas and in Arabcountries. Camel meat andmilk are widely consumed inKenya in the arid and semiarid areas. Camel milk hasinherent nutritional andmedicinal benefits and hasgained popularity amongconsumers in urban areasand in the city. Demand forcamel milk in theinternational market hasincreased especially in SouthAfrica and European Union.Need more specific tissueinformationNeed more specific tissueinformationNeed more specific tissueinformationNeed more specific tissueinformationFish residue data needed

CX/RVDF 13/21/11 4NameCountriesRequestingSpeciesTissuesAmpicillin Armenia Cattle Muscle,Liver,Kidney, MilkAmpicillinRepublic ofKoreaGood Practice inthe Use ofVeterinary Drugs(GPVD)Fish Muscle Republic of KoreaDosing Resimen :5-20 mg a.i./kg b.w.Orally(in feed) for 5days;2-7 mg a.i./kg b.w.Orally(in feed) for 3-5days;0.05-0.1 mg a.i./kgb.w. Orally(in feed)for 3 days;20-80 mg a.i./kg b.w.Orally(in feed) for 5daysAmpicillin Armenia Sheep Muscle,Liver,Kidney, MilkAmpicillin Armenia Swine Muscle,Liver, KidneyExisting Data &SourceMRLs (ppb) inArmenia: Muscle 50,Fat, 50, Liver 50,Kidney 50, Milk 4MRLs (ppb) inArmenia: Muscle 50,Fat, 50, Liver 50,Kidney 50, Milk 4MRLs (ppb) inArmenia: Muscle 50,Fat, 50, Liver 50,Kidney 50Apramycin Armenia Cattle MRLs (ppb) inArmenia: Muscle(1000), Fat (1000),Liver (10,000),Kidney (20, 000)BacitracinDemocraticPeople'sRepublic ofKoreaAll animalsDemocratic People'sRepublic of KoreaDosing Regimen:Oral, 20 - 50 mg.kgin feed for 10 - 50daysWyethManufacturerRepublic of Korea:WooSung Vet.; JBSolution; KOPAVETSpecial, Inc.; Greencross veteritaryproducts; Koreathumb vet.; EWHAPHARMTEK;ChoongAng BiotechCo., Ltd.; Sung-WonCo., Ltd; SamyangAnipharm Co., Ltd.;HANDONG Co., Ltd.;Komi pharminternational Co.,Ltd; Samu MedianCo., Ltd; WooGeneB&G; Daehan NewPharm Coperation;Dongbu FarmHanong; ELTScience; Jin woomedicine; Chamshinpharma Co., Ltd; DaOne Chemical;UbtechWyethWyethElancoAlpharma, Inc.;Zoetis, Inc.JECFAEvaluationCodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsArmenia;Australia:milk;Canada; EU;USARepublic ofKorea (0.05-fish)Armenia;Canada; EU;USAArmenia; EUArmenia;Australia; EUAustralia:chicken;Canada:chicken,turkey, andpig; EU:COMMENTSNeed more specific tissueinformationNeed to better define speciesand tissues

CX/RVDF 13/21/11 5NameBacitracinBacitracinBacitracinCountriesRequestingArmenia,DemocraticPeople'sRepublic ofKorea, PeruCosta Rica,DemocraticPeople'sRepublic ofKorea, Peru,PhilippinesChile, CostaRica,DemocraticPeople'sRepublic ofKorea, Peru,PhilippinesSpeciesCattleChickenPigTissuesMuscle,Liver,Fat/Skin,KidneyAll tissues;Muscle,Liver,Kidney,EggMuscle, Fat,Liver, KidneyGood Practice inthe Use ofVeterinary Drugs(GPVD)Democratic People'sRepublic of KoreaDosing Regimen:Oral, 20 - 50 mg.kgin feed for 10 - 50days; Registered inPeruCosta Rica DosingRegimen: 275. ppm,55 ppm, 220 ppm,oral;Democratic People'sRepublic of KoreaDosing Regimen:Oral, 20 - 50 mg.kgin feed for 10 - 50days;Registered in Peru;Philippines Dosage:50-200ppm, 100-200ppmRegistered in Chile;Costa Rica DosingRegimen: 275. ppm,55 ppm, 220 ppm,oral;Democratic People'sRepublic of KoreaDosing Regimen:Oral, 20 - 50 mg.kgin feed for 10 - 50days;Registered in Peru;Philippines dosage:Existing Data &SourceMRLs (ppb) inArmenia: Milk (100),Muscle (150), Fat(150), Liver (150),Kidney (150)ManufacturerAlpharma, Inc.;Zoetis, Inc.Alpharma, Inc.Agri-Bio PhilippinesZoetis, Inc.Alpharma, Inc.Agri-Bio PhilippinesZoetis, Inc.JECFAEvaluation12thJECFA,1968;Full ADI12thJECFA,1968;Full ADI12thJECFA,1968;Full ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLscattle andrabbit; USA:cattle, swine,chicken,turkey, quail,pheasant,and quailArmenia;EU; USAAustralia,Canada;USACanada;USACOMMENTSSummary of 12th JECFAevaluation:If bacitracin is used, it shouldnot be allowed to give rise todetectable residues in foodfor consumption by humans.If the methods of analysisrecommended by theCommittee are used, it willbe possible to ensure thatthe residues in food will notexceed the following limits:Milk 0-1.2 IU/ml Meat, 0-0.7IU/g and Eggs 0-4.8 IU/g (1mg of bacitracin = 42 IU).Summary of 12th JECFAevaluation:If bacitracin is used, it shouldnot be allowed to give rise todetectable residues in foodfor consumption by humans.If the methods of analysisrecommended by theCommittee are used, it willbe possible to ensure thatthe residues in food will notexceed the following limits:Milk 0-1.2 IU/ml Meat, 0-0.7IU/g and Eggs 0-4.8 IU/g (1mg of bacitracin = 42 IU).Summary of 12th JECFAevaluation:If bacitracin is used, it shouldnot be allowed to give rise todetectable residues in foodfor consumption by humans.If the methods of analysisrecommended by theCommittee are used, it willbe possible to ensure thatthe residues in food will notexceed the following limits:Milk 0-1.2 IU/ml Meat, 0-0.7

CX/RVDF 13/21/11 6NameBacitracinBacitracinBacitracinCountriesRequestingChile,DemocraticPeople'sRepublic ofKoreaArmenia,DemocraticPeople'sRepublic ofKoreaChile,DemocraticPeople'sRepublic ofKoreaSpeciesPoultryRabbitTurkeyTissuesMuscle, Fat,Liver,Kidney,EggsMuscle, Fat,Liver, KidneyGood Practice inthe Use ofVeterinary Drugs(GPVD)50-100ppm, 250-275ppmRegistered in Chile;Democratic People'sRepublic of KoreaDosing Regimen:Oral, 20 - 50 mg.kgin feed for 10 - 50daysDemocratic People'sRepublic of KoreaDosing Regimen:Oral, 20 - 50 mg.kgin feed for 10 - 50daysRegistered in Chile;Democratic People'sRepublic of KoreaDosing Regimen:Oral, 20 - 50 mg.kgin feed for 10 - 50daysExisting Data &SourceMRLs (ppb) inArmenia: Muscle(150), Fat (150),Liver (150), Kidney(150)ManufacturerAlpharma, Inc.;Zoetis, Inc.Alpharma, Inc.Alpharma, Inc.;Zoetis, Inc.JECFAEvaluation12thJECFA,1968;Full ADI12thJECFA,1968;Full ADI12thJECFA,1968;Full ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsAustralia:chicken;Canada:chicken andturkey; USAArmenia; EUCanadaCOMMENTSIU/g and Eggs 0-4.8 IU/g (1mg of bacitracin = 42 IU).Summary of 12th JECFAevaluation:If bacitracin is used, it shouldnot be allowed to give rise todetectable residues in foodfor consumption by humans.If the methods of analysisrecommended by theCommittee are used, it willbe possible to ensure thatthe residues in food will notexceed the following limits:Milk 0-1.2 IU/ml Meat, 0-0.7IU/g and Eggs 0-4.8 IU/g (1mg of bacitracin = 42 IU).Need more specific tissueinformation;Summary of 12th JECFAevaluation:If bacitracin is used, it shouldnot be allowed to give rise todetectable residues in foodfor consumption by humans.If the methods of analysisrecommended by theCommittee are used, it willbe possible to ensure thatthe residues in food will notexceed the following limits:Milk 0-1.2 IU/ml Meat, 0-0.7IU/g and Eggs 0-4.8 IU/g (1mg of bacitracin = 42 IU).Summary of 12th JECFAevaluation:If bacitracin is used, it shouldnot be allowed to give rise todetectable residues in foodfor consumption by humans.If the methods of analysisrecommended by theCommittee are used, it willbe possible to ensure thatthe residues in food will notexceed the following limits:Milk 0-1.2 IU/ml Meat, 0-0.7IU/g and Eggs 0-4.8 IU/g (1mg of bacitracin = 42 IU).

CX/RVDF 13/21/11 7NameCountriesRequestingSpeciesTissuesBenzyl Penicillin Armenia Sheep Muscle,Liver,Kidney, MilkBoldenoneUndecylenateGuatemala NonespecifiedCarbadox Guatemala NonespecifiedGood Practice inthe Use ofVeterinary Drugs(GPVD)Cefoperazona Costa Rica Cattle Milk 25 mg/mL,intramammaryCefotaxim Egypt Chicken Meat5 mg/kgfat/ skin bw/dayLiverorallyKidneyEggsCephacetrile Armenia Cattle Muscle,Liver,Kidney, MilkCephalexine Armenia Cattle Muscle,Liver,Kidney, MilkCephalonium Armenia Cattle Muscle,Liver,Kidney, MilkCephazoline Armenia Cattle Muscle,Liver,Kidney, MilkCephazoline Armenia Goat Muscle,Liver,Kidney, MilkCephazoline Armenia Sheep Muscle,Liver,Kidney, MilkIntramammary UseonlyExisting Data &SourceMRLs (ppb) inArmenia: Muscle 50,Fat, 50, Liver 50,Kidney 50, Milk 4MRLs (ppb) inArmenia: Muscle200, Fat 200, Liver200, Kidney 200,Milk 1000MRLs (ppb) inArmenia: Milk 20MRLs (ppb) inArmenia: Milk 50MRLs (ppb) inArmenia: Milk 50MRLs (ppb) inArmenia: Milk 50ManufacturerWyeth, G. C.Hanford, WalcoInternational, Teva,Cross VetpharmWyethPhibroPfizer (Italy)PfizerUnknownUnknownUnknownUnknownUnknownUnknownJECFAEvaluation36thJECFA,1990;Full ADI;MRLsrecommended inallspecies(muscle,liver,kidney,milk)36thJECFA,1990;60thJECFA,2003;No ADICodexMRLsCodex MRLsin cattle, pig,and chickenNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsArmenia;Australia;Canada; EU;USA: zerotoleranceUSA: swineEU: cattleArmeniaArmenia:milkArmenia:milkArmenia:milkArmenia:milkCOMMENTSJECFA recommended MRLsin "all species," Codex MRLsadopted for cattle, pig, andchicken. May requireadditional sheep residue dataNeed to better define speciesand tissuesNeed to better define speciesand tissues.Codex MRLs withdrawn dueto human health concerns

CX/RVDF 13/21/11 8NameCountriesRequestingSpeciesTissuesChlorhexidine DemocraticPeople'sRepublic ofKoreaRabbitCloxacillin Armenia Cattle Muscle,Liver,Kidney, MilkCloxacillin Armenia Pig Muscle,Liver, KidneyCloxacillin Armenia Sheep Muscle,Liver,Kidney, MilkGood Practice inthe Use ofVeterinary Drugs(GPVD)Oral, 0.1% solutionfor 5 daysExisting Data &SourceMRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300,Milk 30MRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300MRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300,Milk 30Colistin Armenia All livestock MRLs (ppb) inArmenia: Fat (150),Muscle (150), Liver(150, Kidney (200),Milk (50), Egg (300)CoumaphosRepublic ofKoreaBeesRepublic of KoreaDosing Resimen :0.64 mg a.i./hive (12combs); 0.16 mga.i./hiveManufacturerWyeth, First PriorityPfizerPfizerPfizerUnknownRepublic of Korea:Bisen, Bayer KoreaLimited.JECFAEvaluation66thJECFA,2006;Full ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLsin cattle, pig,sheep, goat,rabbit,chicken, andturkeyNo CodexMRLsCoumaphos Costa Rica Cattle Tissues andmilk20% topically Bayer de Mejico No CodexMRLsCoumaphos Costa Rica Goat Tissues and 20% topically Bayer de Mejico No CodexmilkMRLsCoumaphos Costa Rica Pig Tissues 20% topically Bayer de Mejico No CodexMRLsCoumaphos Costa Rica Sheep Tissues and 20% topically Bayer de Mejico No CodexmilkMRLsCypermethrin Guatemala NoneUnknownspecified62ndJECFA,2004;Full ADICodex MRLsin cattle andsheepMemberCountryMRLsEU: all foodproducingspecies - notrequiredArmenia;Australia:milk;Canada; EU;USAArmenia; EUArmenia; EUArmenia;EU: all foodproducingspeciesRepublic ofKorea (0.1-honey)AustraliaAustralia:cattle, deer,goat, horse,pig, poultry,and sheep;EU: allruminantsandsalmonidsCOMMENTSNeed more specific tissueinformationNeed to better define speciesand tissuesNeed more specific tissueinformationNeed to better define speciesand tissues

CX/RVDF 13/21/11 9NameCountriesRequestingSpeciesTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Dexamethasone Iran Goat muscle 1 - 2.5 mL (2mg) IM,IV, SCDexamethasone Iran Sheep muscle 1 - 2.5 mL (2mg) IM,IV, SCDiazinon Guatemala NonespecifiedDiclazuril Guatemala NonespecifiedDicloxacillin Armenia Cattle Muscle,Liver,Kidney, MilkDicloxacillin Armenia Pig Muscle,Liver, KidneyDicloxacillin Armenia Sheep Muscle,Liver,Kidney, MilkDimetridazole Guatemala NonespecifiedExisting Data &SourceMRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300,Milk 30MRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300MRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300,Milk 30ManufacturerInterchemistry(Netherlands),Schering Plough,Teva, CrossVetpharmInterchemistry(Netherlands),Schering Plough,Teva, CrossVetpharmUnknownSchering PloughWyethWyethWyethUnknownJECFAEvaluation70thJECFA,2008;Full ADI70thJECFA,2008;Full ADI50thJECFA,1998;Full ADI34thJECFA,1989;No ADICodexMRLsCodex MRLsin cattle, pig,and horseCodex MRLsin cattle, pig,and horseNo CodexMRLsCodex MRLsin sheep,rabbit, andpoultryNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsEUMemberCountryMRLsAustralia:cattle; EU:cattle andgoatAustralia:mammalsand poultry;EU: cattle,sheep, goat,and pigCanada:chicken andturkey; EU:all ruminantsand pig;USA:chicken andturkeyArmenia; EUArmenia; EUArmenia; EUCOMMENTSGoat residue data neededSheep residue data neededNeed to better define speciesand tissuesNeed to better define speciesand tissuesNeed to better define speciesand tissues.34th JECFA:"Before reviewing thecompound again, theCommittee would wish to seeresults from the followingstudies:1. A long-term study in mice.2. Studies aimed atinvestigating the mechanismof tumorigenesis.

CX/RVDF 13/21/11 10NameCountriesRequestingSpeciesTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceDoxycycline Armenia Cattle MRLs (ppb) inArmenia: Muscle(100), Liver (300)DoxycyclineDoxycyclineEmamectinBenzoateArmeniaPhilippinesArmeniaPhilippinesChickenPigMuscle,Liver,Kidney,EggMuscle,Liver,KidneyChile, Peru Finfish Muscle andSkinPhilippines:1ml/10-15kg bw;100-200pp, Oral;50-100ppm, Oral;Philippines:1ml/20kg bw;1ml/10-15kg bw;100-200ppm, Oral;50-100ppm, Oral;10mg/kg BW, OralEnrofloxacin Belize, Peru Aquaculture Muscle Registered in Belize;Registered in PeruEnrofloxacinEnrofloxacinArmenia,PeruArmenia,Peru,PhilippinesCattleChickenMuscle, Fat,Liver,Kidney, MilkMuscle,Fat/Skin,Liver,Kidney, EggMRLs (ppb) inArmenia: Muscle(100), Skin and Fat(200), Liver (300),Kidney (600)MRLs (ppb) inArmenia: Muscle(100), Skin and Fat(200), Liver (300),Kidney (600)ManufacturerUnknownUnknown;Jickstar Pharma, Inc.Horizon Link, Inc.Carrington Trading,Inc.Unknown;Jickstar Pharma, Inc.Horizon Link, Inc.SupervetInternational, Inc.Carrington Trading,Inc.Hipra Phils., Inc.JECFAEvaluationCodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsArmenia; EUArmenia; EUArmenia; EURegistered in Chile Schering Canada:salmonids;EURegistered in PeruRegistered in Peru;Philippines:10mg/kg bw, Oral;0.1-0.2ml/kg bw,Oral;0.25ml/kg bw, Oral;100ppm, Oral;1ml/10-15kg bw, IMinjectionMRLs (ppb) inArmenia: Muscle100, Fat 100, Liver300, Kidney 200,Milk 100MRLs (ppb) inArmenia: Muscle100, Fat with Skin100, Liver 200,Kidney 300Various (Bayer,LaboratoriosCalifornia, Colombia)Anupco UKBayerBayer Health Care -Animal Health; FirstFil-Bio; ProvetInternationalCorporation;Transcend Phils.,Inc.; JickstarPharma, Inc.48thJECFA,1997;Full ADI48thJECFA,1997;Full ADI48thJECFA,1997;Full ADINo CodexMRLsNo CodexMRLsNo CodexMRLsEUArmenia;Canada; EU;USAArmenia; EUCOMMENTS3. Adequate studies of totalresidue depletion in poultryand swine using ring-labelled[14C]-dimetridazole.4. Metabolism studies inswine and poultry thatcharacterize the total boundresidues."Need more specific tissueinformationNeed more specific tissueinformation48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."

CX/RVDF 13/21/11 11NameEnrofloxacinEnrofloxacinCountriesRequestingArmenia,PeruArmenia,Peru,PhilippinesSpeciesGoatPigTissuesMuscle, Fat,Liver,Kidney, MilkMuscle, Fat,Liver, KidneyEnrofloxacin Belize, Syria Poultry Muscle, liver,kidney, fatEnrofloxacin Armenia Rabbit Muscle, Fat,Liver, KidneyEnrofloxacinArmenia,PeruSheepMuscle, Fat,Liver,Kidney, MilkGood Practice inthe Use ofVeterinary Drugs(GPVD)Registered in PeruRegistered in Peru;Philippines:0.25ml/10kg BW,Oral; 50-75ppm;1ml/10-15kg bw(piglet), IM injection;1ml/20kg bw (adult),IM injectionRegistered in Belize;Registered by theCodex NationalSyrian CommitteeRegistered in PeruExisting Data &SourceMRLs (ppb) inArmenia: Muscle100, Fat 100, Liver300, Kidney 200,Milk 100MRLs (ppb) inArmenia: Muscle100, Fat 100, Liver200, Kidney 300Temporary MRLs inSyria: Liver (200),Kidney (300), Muscle(100) (Studies underdevelopment)MRLs (ppb) inArmenia: Muscle100, Fat 100, Liver200, Kidney 300MRLs (ppb) inArmenia: Muscle100, Fat 100, Liver300, Kidney 200,Milk 100Erythromycin Armenia Cattle MRLs (ppb) inArmenia: Muscle(200), Fat (200),Liver (250), Kidney(220), Milk (40)(Studies underdevelopment)Erythromycin Armenia Goat MRLs (ppb) inArmenia: Muscle(200), Fat (200),Liver (250), Kidney(220), Milk (40)Erythromycin Armenia Pig MRLs (ppb) inArmenia: Muscle(200), Fat (200),Liver (250), Kidney(220), Milk (40)BayerManufacturerBayer;Provet InternationalCorporation;Transcend Phils.,Inc.;Jickstar Pharma, Inc.Enrosol; Various(Bayer,LaboratoriosCalifornia, Colombia)Anupco UKBayerBayerCross VetpharmCross VetpharmCross VetpharmJECFAEvaluation48thJECFA,1997;Full ADI48thJECFA,1997;Full ADI48thJECFA,1997;Full ADI48thJECFA,1997;Full ADI48thJECFA,1997;Full ADI66thJECFA,2006;Full ADI66thJECFA,2006;Full ADI66thJECFA,2006;Full ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLsin chickenand turkeyCodex MRLsin chickenand turkeyCodex MRLsin chickenand turkeyMemberCountryMRLsArmenia; EUArmenia;EU; USAEU; SyriaArmenia; EUArmenia; EUArmenia;Australia;Canada; EU;USA: cattletissuesArmenia;Australia; EUArmenia;Australia;Canada; EU;USACOMMENTS48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."48th JECFA requested:"studies to determine theantimicrobial activity of theresidues other thanenrofloxacin andciprofloxacin."Need more specific tissueinformationCattle residue data neededNeed more specific tissueinformationGoat residue data neededNeed more specific tissueinformationPig residue data needed

CX/RVDF 13/21/11 12NameCountriesRequestingSpeciesTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceManufacturerErythromycin Armenia Sheep MRLs (ppb) inArmenia: Muscle(200), Fat (200),Liver (250), Kidney(220), Milk (40)Cross VetpharmFlavophospholip Costa Rica Cattle All tissues 100 ppm oral Intervet InternationalolGmbhFlavophospholipolFlavophospholipolFlavophospholipolCosta Rica,PhilippinesCosta Rica,PhilippinesChickenPigAll tissues;Muscle,Liver,Kidney,EggAll tissues;Muscle,Liver,KidneyChile Poultry Muscle, Fat,Liver,Kidney,EggsCosta Rica: 100 ppmoralPhilippines:4ppm, Oral;2.6-5ppm, OralCosta Rica: 100 ppmoral;Philippines:5ppm, Oral;5-10ppm, Oral;10-20ppm, OralRegistered in ChileFlorfenicol Belize Aquaculture Muscle Registered in Belize Dossier Avi –Mex SAde CVFlorfenicol Peru Cattle Muscle,Liver,Fat/Skin,KidneyFlorfenicolFlorfenicolEgypt, Peru,PhilippinesPeru,Republic ofKoreaChickenMuscle,fat/ skin,Liver,Kidney,EggsRegistered in PeruEgypt DosageRegimen: 10 mg/kgbw/day orally;Registered in Peru;Philippines:20ppm, Oral;20mg/kg bw, OralFish Muscle Registered in Peru;Republic of KoreaDosing Regimen: 10mg/kg b.w. Orally(infeed) for 5 days;1 mg/kg b.w.Orally(in feed) for 5days;Intervet InternationalGmbh;APF Corporation;Inphilco, Inc.;RNSV CorporationIntervet InternationalGmbh;APF Corporation;Inphilco, Inc.;RNSV CorporationIntervet InternationalGmbhFlor-Blend Aquafrom Avi-Mex,Mexico; Intervet, Inc.Schering, Intervet,Inc.Schering;Carrington Trading,Inc.;Ceva Animal HealthPhils., Inc.Peru: ScheringRepublic of Korea:RNL Bio Co., Ltd; JBSolution; DaesungMircrobilogical LabsCo., Ltd.; SamuMedian Co., Ltd;Sung-Won Co., Ltd;JECFAEvaluation66thJECFA,2006;Full ADICodexMRLsCodex MRLsin chickenand turkeyNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsArmenia;Australia;Canada; EUAustraliaAustralia:fish;Canada:salmonids;EU: finfish;USA: catfishandsalmonidsAustralia;Canada; EU;USAEUAustralia;Canada:salmonids;EU: finfish;USA: catfishandsalmonids;Republic ofKorea (0.2-COMMENTSNeed more specific tissueinformationSheep residue data neededNeed more specific tissueinformationNeed more specific tissueinformationNeed more specific tissueinformationRepublic of Korea tradenames: MEGAFEN ㆍ FISHsolution, DANAPEN-C,Aqua Florfen, Aquaflor, Ultrafloro, etc.

CX/RVDF 13/21/11 13NameCountriesRequestingSpeciesTissuesFlorfenicol Peru Goat Muscle,Liver,Fat/Skin,KidneyFlorfenicolPeru,PhilippinesPigMuscle,Fat/Skin,Liver, KidneyFlorfenicol Syria Poultry LiverKidneyMuscleGood Practice inthe Use ofVeterinary Drugs(GPVD)10 a.i. mg/kg b.w.i.m. injection(Bastard halibut)Registered for use insalmon, yellowtail,eel, cherry salmon,Ayu sweetfish.Withdrawal times: 5day for oral productin yellowtail, 7 daysfor oral product ineel, 14 days for oralproduct in salmon,cherry salmon, Ayusweetfish, 40 daysfor i.m. injection inbastard halibutExisting Data &SourceManufacturerChamshin pharmaCo., Ltd; KBNP,INC.; Green crossveteritary products;Dongbu FarmHanong; Seoul vetpharma; Eaglevet;Daehan New PharmCoperation; SF., Inc;Samyang AnipharmCo., Ltd.; EWHAPHARMTEK; Jinwoo medicine; CTCbio Co., Ltd; Koreathumb vet.; Namjoonlocal products; ELTScience; WooGeneB&G; DaoneChemical; NELbiotech. Ltd; Ubtech;HANDONG Co., Ltd.USA: Intervet, Inc.JECFAEvaluationCodexMRLsRegistered in Peru Schering No CodexMRLsRegistered in Peru;Philippines: BroadSpectrum Antibiotic(Control of SwineRespiratoryDiseases),dosage: 20ppm,Oral; 40-80ppm,Oral; 20-40ppm Oral;20mg/kg bw, Oral;15mg/kg bw, IMinjectionproduct labelavailableRegistered by theCodex NationalSyrian CommitteeThe EuropeanAgency for theEvaluation ofMedicinal Products-Veterinary Medicinesand Inspections:Muscle (300μg/kg),Skin+Fat (500μg/kg),Liver (2000μg/kg)and Kidney(500μg/kg)Australian Pesticideand VeterinaryMedicine Authority-Muscle (0.5mg/kg),Skin+Fat (1mg/kg),Liver (3mg/kg) andKidney (1mg/kg)Temporary MRLs inSyria: Liver (2500),Kidney (750), Muscle(100) (Studies underdevelopment)Intervet ScheringPlough AnimalHealth Mexico;Carrington Trading,Inc., Plaridel, VirbacAnimal Health, CevaAnimal Health,Schering PloughAnimal Health,Intervet, Inc.FloridinNo CodexMRLsNo CodexMRLsMemberCountryMRLsfish)EUAustralia;Canada; EUEU; SyriaCOMMENTS

CX/RVDF 13/21/11 14NameCountriesRequestingSpeciesTissuesFlorfenicol Peru Sheep Muscle,Liver,Fat/Skin,KidneyGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceFlumequine Armenia Cattle Milk MRLs (ppb) inArmenia: Muscle200, Fat 300, Liver300, Kidney 500,Milk 50Flumequine Armenia Chicken Fat with Skin MRLs (ppb) inArmenia: Muscle400, Fat and Skin250, Liver 800,Kidney 1000Flumequine Chile Finfish Muscle and Registered in ChileSkinFlumequine Armenia Goat Muscle,Liver,Kidney, MilkManufacturerJECFAEvaluationCodexMRLsRegistered in Peru Schering No CodexMRLsMRLs (ppb) inArmenia: Muscle200, Fat 300, Liver300, Kidney 500,Milk 50Flumequine Armenia Sheep Milk MRLs (ppb) inArmenia: Muscle200, Fat 300, Liver300, Kidney 500,Milk 50Flumetrina(Flumethrin)FlunixinmeglumineUnknownUnknownUnknownUnknown48thJECFA,2006;Full ADI48thJECFA,2006;Full ADI66thJECFA,2006;Full ADI66thJECFA,2006;Full ADI66thJECFA,2006;Full ADICodex MRLsin fat,kidney, liver,and muscleCodex MRLsin fat,kidney, liver,and muscleCodex MRLsin cattle, pig,sheep,chicken, andtroutCodex MRLsin cattle, pig,sheep,chicken, andtroutCodex MRLsin fat,kidney, liver,and muscleGuatemala Bees Honey No CodexMRLsCosta Rica Cattle Tissues and 83 mg/mL parenteral Schering Plough,No CodexMilkCalox VenezuelaMRLsFlunixinmeglumineCosta Rica Pig Tissues andMilk83 mg/mL parenteral Schering Plough,Calox VenezuelaNo CodexMRLsFormic Acid Guatemala Bees Honey Unknown No CodexMRLsFosfomicina Costa Rica Chicken All tissues 300 - 500 ppm, oral Bedson deCentroamericaNo CodexMRLsFosfomicina Chile Poultry Fat, Muscle, Registered in Chile Bedson, Argentina No CodexLiver,MRLsKidney,EggsFumagillin Guatemala Bees Honey Unknown No CodexMRLsEUMemberCountryMRLsArmenia; EUArmenia; EUEUArmenia; EUArmenia; EUEU: notrequiredAustralia;Canada; EU;USACanada; EU;USAEU: all foodproducingspecies - notrequiredCOMMENTS48th JECFA did not receiveresidue data for milkNeed more specific tissueinformationCodex MRLs in trout,additional residue data maybe required to cover all finfishGoat residue data needed48th JECFA did not receiveresidue data for milkNeed more specific tissueinformation

CX/RVDF 13/21/11 15NameCountriesRequestingSpeciesTissuesGentamicin Egypt Chicken Meatfat/ skinLiverKidneyEggsHydrocortisone Democratic PigPeople'sRepublic ofKoreaIvermectinIvermectin19thCCRVDFUruguay,19thCCRVDFGood Practice inthe Use ofVeterinary Drugs(GPVD)5mg/kgbw/dayorallyOral, 0.1 - 0.3g threetimes a dayExisting Data &SourceManufacturerBayerADWIAUnknownJECFAEvaluation50thJECFA,1998;Full ADICamel all tissues 58thJECFA,2002;Full ADICattle Muscle Uruguay:Endectocide.Dosage regimen isparenteral (1% & 2%product): 0.2 mg/kgbw in cattle, sheep,horses, and goats;0.3 mg/kg bw inswine;3.15% product hasdose of 0.63 mg/kgin cattle;3.5% product hasdose of 0.75 mg/kgbw in cattle.Widely used in thecountry in foodproducing animals.Registered inUruguay: 80registered 1%Ivermectin, 1registered 2%Ivermectin, 18registered 3.15%Ivermectin, and 3registered 3.5%Ivermectin,Product labelavailableIvermectin Uruguay Horse Muscle Urugauay:Endectocide,Dosage regimen isparenteral 0.2 mg/kgbw, Widely used inthe country in foodproducing animals.MRLs (ppb) in US:Cattle Muscle (10).MRLs (ppb) in US:Cattle Muscle (10).MerialMerial58thJECFA,2002;Full ADI58thJECFA,2002;Full ADICodexMRLsCodex MRLsin cattle andpigNo CodexMRLsCodex MRLsin cattle, pig,and sheepCodex MRLsliver, fat, andmilkCodex MRLsin cattle, pig,and sheepMemberCountryMRLsCanada;USAEU: all foodproducingspecies - notrequiredEUAustralia;Canada; EU;USAAustralia; EUCOMMENTSChicken residue data neededNeed more specific tissueinformationNeed more specific tissueinformationCamel residue data needed36th JECFA recommendedMRLs in liver and fat onlybecause residues werehighest in these tissues andsuitable methods wereavailable.Horse residue data needed

CX/RVDF 13/21/11 16NameCountriesRequestingSpeciesIvermectin Guatemala NonespecifiedIvermectin19thCCRVDFTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Registered inUruguay: 80registered 1%Ivermectin, 1registered 2%Ivermectin, 18registered 3.15%Ivermectin, and 3registered 3.5%Ivermectin, productlabel availableExisting Data &SourceMerialManufacturerJECFAEvaluation58thJECFA,2002;Full ADIRabbit all tissues 58thJECFA,2002;Full ADIIvermectin Uruguay Sheep Muscle Urugauay:Endectocide,Dosage regimen isparenteral 0.2 mg/kgbw, Widely used inthe country in foodproducing animals.Registered inUruguay: 80registered 1%Ivermectin, 1registered 2%Ivermectin, 18registered 3.15%Ivermectin, and 3registered 3.5%MRLs (ppb) in US:Cattle Muscle (10).Merial58thJECFA,2002;Full ADICodexMRLsCodex MRLsin cattle, pig,and sheepCodex MRLsin cattle, pig,and sheepCodex MRLsin liver andfatMemberCountryMRLsAustralia:cattle, deer,horse, pig,and sheep;Canada:cattle,sheep, andpig; EU: allmammalianfoodproducingspecies;USA: cattle,swine,sheep,reindeer,andAmericanbisonEUAustralia;Canada; EU:fat, liver, andkidney; USA:liverCOMMENTSNeed to better define speciesand tissuesNeed more specific tissueinformationRabbit residue data needed36th JECFA recommendedMRLs in liver and fat onlybecause residues werehighest in these tissues andsuitable methods wereavailable.

CX/RVDF 13/21/11 17NameCountriesRequestingSpeciesKanamycin Armenia All livestockexcept fishTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Ivermectin, productlabel availableExisting Data &SourceMRLs in Armenia:Muscle (100), Fat(100), Liever (600),Kidney (2500), Milk(150)WyethManufacturerJECFAEvaluation12thJECFA,1968;No ADICodexMRLsNo CodexMRLsKitasamycin Costa Rica Chicken All tissues 110 - 330 ppm oral Anupco, Inglaterra No CodexMRLsKitasamycin Costa Rica Pig All tissues 110 - 330 ppm oral Anupco, Inglaterra No CodexMRLsLevamisole Morocco Goat Fat, Muscle, Registered in EU regulationLiver, Kidney Morocco37/2010Lincomycin Armenia Cattle MRLs (ppb) inArmenia: Muscle(100), Fat (50), Liver(500), Kidney (1500),Milk (150)Lincomycin Armenia Chicken MRLs (ppb) inArmenia: Muscle(100), Fat (50), Liver(500), Kidney (1500),Egg (50)Lincomycin Armenia Goat MRLs (ppb) inArmenia: Muscle(100), Fat (50), Liver(500), Kidney (1500),Milk (150)Lincomycin Armenia Sheep MRLs (ppb) inArmenia: Muscle(100), Fat (50), Liver(500), Kidney (1500),Milk (150)Marbofloxacin Armenia Cattle MRLs in Armenia:Muscle (150), Fat(50), Liver (!50),Kidney (150), Milk(75)ATLAS VétérinaireBCICEVAINTERVETCALIERPHARMA 5ECOMEDPfizerPfizerPfizerPfizerUnknown42ndJECFA,1994;Full ADI62ndJECFA,2004;Full ADI62ndJECFA,2004;Full ADI62ndJECFA,2004;Full ADI62ndJECFA,2004;Full ADICodex MRLsin cattle,sheep, andpoultry.Codex MRLin milkCodex MRLsin liver,kidney,muscle, fat,and fat withskinCodex MRLsin Cattlemilk, and pigand chickentissuesCodex MRLsin Cattlemilk, and pigand chickentissuesNo CodexMRLsMemberCountryMRLsArmenia;EU: all foodproducingspeciesexcept finfishAustraliaAustraliaAustralia;Canada:cattle andsheep; EU:cattle andsheep; USA:cattle andsheepArmenia;Australia; EUArmenia;Australia;Canada; EU;USAArmenia;Australia; EUArmenia; EUArmenia; EUCOMMENTSNeed to better define speciesand tissues12th JECFA reported:"Kanamycin could not befully evaluated toxicologicallyon the basis of the data thatwere made available."Need more specific tissueinformationNeed more specific tissueinformationGoat residue data neededNeed more specific tissueinformationNeed more specific tissueinformationNeed more specific tissueinformationGoat residue data neededNeed more specific tissueinformationGoat residue data neededNeed more specific tissueinformation

CX/RVDF 13/21/11 18NameCountriesRequestingSpeciesTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceManufacturerMarbofloxacin Armenia Goat MRLs (ppb) inArmenia: Muscle(150), Fat (50), Liver(!50), Kidney (150),Milk (75)UnknownMarbofloxacin Armenia Sheep MRLs in Armenia: UnknownMuscle (150), Fat(50), Liver (!50),Kidney (150), Milk(75)Mebendazole Costa Rica Cattle All tissues 500 - 600 ppm, oral Schering Plough,Cenavisa, EspanaMebendazoleMebendazoleCosta Rica,PhilippinesCosta Rica,PhilippinesChickenPigAll tissues;Muscle,Liver,Kidney,EggAll tissues;Muscle,Liver,KidneyMetronidazole Egypt Chicken Meatfat/ skinLiverKidneyEggsMonensin Guatemala NonespecifiedCosta Rica: 500 -600 ppm, oral;Philippines:60ppm, Oral;60-120ppm, OralCosta Rica: 500 -600 ppm, oral;Philippines:15-60ppm, Oral;30-60ppm, Oral;30-72ppm, Oral2mg/kg bw/dayorally, Used togetherwith colistinSchering Plough,Cenavisa, Espana;Equalivet; JCSChemical Industries,Inc.; TranscendPhils., Inc.; MasstockLaboratoriesSchering Plough,Cenavisa, Espana;Equalivet; JCSChemical Industries,Inc.; TranscendPhils., Inc.; MasstockLaboratoriesMarcyrlElancoJECFAEvaluation34thJECFA,1989;No ADI70thJECFA,2008;Full ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLsin quail,cattle,sheep, goat,chicken, andturkeyMemberCountryMRLsArmeniaArmeniaAustraliaAustraliaAustralia:cattle, goat,poultry, andsheep;Canada:cattle,chicken andturkey; EU:cattle; USA:cattle, goat,chicken,turkey, andquailCOMMENTSNeed more specific tissueinformationNeed more specific tissueinformationNeed more specific tissueinformationNeed more specific tissueinformationNeed more specific tissueinformation34th JECFA reported:"Metronidazole was notevaluated toxicologicallybecause the relevant datawere not made available tothe Committee.Studies on the depletion ofresidues of metronidazole infood-producing animals werenot made available to theCommittee."Need to better define speciesand tissues

CX/RVDF 13/21/11 19NameCountriesRequestingSpeciesNafcillin Armenia All ruminantanimalsTissuesMuscle,Liver,Kidney, MilkGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceMRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300,Milk 30ManufacturerUnknownNandrolone Guatemala NonespecifiedUnknownNitroimidazoles Guatemala NoneUnknownspecifiedNorfloxacin Belize Aquaculture Muscle Registered in Belize Various (Bayer,LaboratoriosCalifornia, Colombia)Anupco UKNorfloxacin Belize, PoultryPhilippinesMuscle, liver,kidney, fat,eggRegistered in Belize;Philippines:100ppm, Oral; 25-50ppm, OralNovobiocin Armenia Cattle MRLs (ppb) inArmenia: Milk (50)Olaquindox Guatemala NonespecifiedVarious (Bayer,LaboratoriosCalifornia, Colombia)Anupco UK; JickstarPharma, Inc.;Chemvet Products;Apt Vet Link, Inc.;Carrington Trading,Inc.PfizerUnknownJECFAEvaluation12thJECFA,1968;Full ADI42ndJECFA,1994;No ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsArmenia;EU: allruminantsArmenia:milk;Australia;Canada; EU;USAAustralia: pigand poultryCOMMENTSNeed to better define speciesNeed to better define speciesand tissuesNeed to better define speciesand tissuesNeed more specific tissueinformationSummary of 12th JECFA:"When novobiocin is used, itshould not be allowed to giverise to detectable residues infood for human consumption.The quantification limits ofthe analytical methodsrecommended by theCommittee are: milk 0-0.15mg/kg; meat 0-0.5mg/kg; andeggs 0-0.1 mg/kg."Need to better define speciesand tissues42nd JECFA requested: "TheCommittee requires forreview by 1996 the results ofstudies to determine residuesin liver and kidney of pigs,MQCA being used as themarker residue."Summary of 42nd JECFA:"The Committee concludedthat due to the genotoxicpotential of olaquindox and inthe absence of specifictoxicity studies on the

CX/RVDF 13/21/11 20NameCountriesRequestingSpeciesTissuesOlaquindox Belize Poultry Muscle,KidneyGood Practice inthe Use ofVeterinary Drugs(GPVD)Registered in BelizeExisting Data &SourceManufacturerHelm Mexico andCalier SpainJECFAEvaluation42ndJECFA,1994;No ADICodexMRLsNo CodexMRLsMemberCountryMRLsAustraliaCOMMENTSmetabolites, no ADI could beallocated. Noting that theparent compound wasabsent in muscle at theproposed withdrawal periodof 28 days and that themetabolites could partly beevaluated on the basis oftoxicity studies inexperimental animals, atemporary acceptance ofresidues resulting from theuse of olaquindox in pigs inaccordance with GoodPractice in the Use ofVeterinary Drugs wasrecommended."Need to better define speciesand tissues42nd JECFA requested: "TheCommittee requires forreview by 1996 the results ofstudies to determine residuesin liver and kidney of pigs,MQCA being used as themarker residue."Summary of 42nd JECFA:"The Committee concludedthat due to the genotoxicpotential of olaquindox and inthe absence of specifictoxicity studies on themetabolites, no ADI could beallocated. Noting that theparent compound wasabsent in muscle at theproposed withdrawal periodof 28 days and that themetabolites could partly beevaluated on the basis oftoxicity studies inexperimental animals, atemporary acceptance ofresidues resulting from theuse of olaquindox in pigs inaccordance with GoodPractice in the Use ofVeterinary Drugs wasrecommended."

CX/RVDF 13/21/11 21NameCountriesRequestingSpeciesOxacillin Armenia All ruminantanimalsTissuesMuscle,Liver,Kidney, MilkGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceMRLs (ppb) inArmenia: Muscle300, Fat 300, Liver300, Kidney 300,Milk 30ManufacturerUnknownJECFAEvaluationCodexMRLsNo CodexMRLsOxalic Acid Guatemala Bees Honey Unknown No CodexMRLsOxolinic Acid Chile, Finfish Muscle andNo CodexRepublic ofSkinMRLsKoreaRegistered in ChileRepublic of KoreaDosing Resimen: 5-10 a.i. mg/kg b.w.Orally(in feed) for 5-7days(carp,Aeromonashydrophila);5-20 a.i. mg/kg b.w. -Orally(in feed) for 3-5days(cherry salmon,Vivrio anguillarum);5-10 a.i. mg/kg,Orally (in feed) for 5-7 days(salmon,Aeromonassalmonicida)5-20 a.i. mg/kg b.w.Orally(in feed) for 4-6 days(eel,Aeromonashydrophila)5-20 a.i. mg/kg b.w.Orally(in feed) for 5-7 days(eel,Edwardsiella tarda)1-5 a.i. mg/kg b.w.Orally(in feed) for 3-5days(eel,Pseudomonassanguillaum)10-30 a.i. mg/kg b.w.Orally(in feed) for 5days(yellowtail,Pasteurella piscicida)5-20 a.i. mg/kg b.w.Orally(in feed) for 3-7 days(ayusweetfish, Vivrioanguillarum);5-20 a.i. mg/kg b.w.Orally(in feed) for 4-6 days(eel,Republic of Korea:Samyang AnipharmCo., Ltd.; Sung-WonCo., Ltd; DongbuFarm Hanong;HANDONG Co., Ltd.;WooGene B&G;WooSung Vet.;Samu Median Co.,Ltd; Chamshinpharma Co., Ltd;SF., Inc; BayerKorea Limited.;Seoul vet pharma;Daehan New PharmCoperation; Koreathumb vet.; Namjoonlocal products; NELbiotech. Ltd; EWHAPHARMTEK; Greencross veteritaryproducts; DawonChemical43rdJECFA,1994;No ADIMemberCountryMRLsArmenia;EU: all foodproducingspeciesEU: notrequiredEU; Republicof Korea(0.1-cherrysalmon,salmon,Yellowtail,eel, Ayusweetfish,carp)COMMENTSNeed to better define speciesSummary of 43rd JECFA: "Inview of the major deficienciesin the reporting and protocolsof thetoxicological studiesavailable for evaluation, andas a clear NOEL in thearthropathy study in dogscould not be identified, theCommittee was unable toestablish an ADI.The Committee was not ableto set MRLs for oxolinic acidbecause no ADI wasestablished. No additionalresidue data wererequested."

CX/RVDF 13/21/11 22NameCountriesRequestingSpeciesTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceAeromonashydrophila);10-30 a.i. mg/kg b.w.Orally(in feed) for 3-7days;10-20 a.i. mg/kg b.w.Orally(in feed) (eel,carp, cherry salmon);10-30 a.i. mg/kg b.w.Orally(in feed)(yellowtail);5-10 a.i. mg/kg b.w.Orally(in feed) for 5-7 days (salmon,Aeromonassalmonicida);5-20 a.i. mg/kg b.w.Orally(in feed) for 3-5days(salmon, Vivrioanguillarum);20 a.i. mg/kg b.w. -Orally(in feed) for 5days(eel,Edwardsiella trada);5-10 a.i. mg/kg b.w.Oral(in feed) for 3-7days; 4-10 a.i. mg/kgwater, Dip treatmentfor 5-8 hours; 1 a.i.g/kg water, Diptreatment for 24hours(carp,Aeromonas spp.)Oxytetracycline Armenia All livestock MRLs (ppb) inArmenia: Muscle(300), Liver (300),Kidney (100), Milk(100)ManufacturerPfizer, BoehringerIngeleheim, Phibro,PennfieldJECFAEvaluation50thJECFA,1998;58thJECFA,2002;Full ADICodexMRLsCodex MRLsin cattle, pig,sheep,poultry, fish,and giantprawnMemberCountryMRLsArmenia;Australia:fish, bees,cattle, goat,pig, sheep,mammals,poultry,shrimp, andprawns;Canada:cattle, pig,sheep,salmonids,lobster,chicken,turkey, andbees; EU: allCOMMENTSNeed to better define speciesand tissues

CX/RVDF 13/21/11 23NameOxytetracyclineCountriesRequestingArgentina,Republic ofKoreaSpeciesTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Bees Honey Registered inArgentina in cattle,sheep, goats, pigs,bees, fur bearinganimals, andaquacultureRepublic of KoreaDosing Resimen :0.03 g a.i./comb(3 combs-0.09 g, 5combs-0.15g, 8combs-0.24g)Oxytocin Costa Rica Cattle Tissues andmilkExisting Data &SourceManufacturerArgentina: UnknownRepublic of Korea:Ubtech10 IU/mL, parenteral BoehringerIngelheim, Wyeth,Teva, UnitedVaccines, CrossVetpharm, Intervet,Holanda,ApropharmaOxytocin Costa Rica Pig Tissues 10 IU/mL, parenteral BoehringerIngelheim, Wyeth,Teva, UnitedVaccines, CrossVetpharm, Intervet,Holanda,ApropharmaOxytocin Costa Rica Sheep Tissues andmilk10 IU/mL, parenteral BoehringerIngelheim, Wyeth,Teva, UnitedVaccines, CrossVetpharm, Intervet,Holanda,ApropharmaJECFAEvaluation50thJECFA,1998;58thJECFA,2002;Full ADICodexMRLsCodex MRLsin cattle, pig,sheep,poultry, fish,and giantprawnNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsfoodproducingspecies;USA: beefcattle, dairycattle,calves,swine,sheep,chicken,turkey,finfish, andlobsterAustralia;Canada;Republic ofKorea (0.3-honey)EU: notrequiredEU: notrequiredEU: notrequiredCOMMENTSHoney residue data neededNeed more specific tissueinformation

CX/RVDF 13/21/11 24NamePhenoxymethylpenicillinPhenoxymethylpenicillinPhenoxymethylpenicillinPhenoxymethylpenicillinCountriesRequestingSpeciesTissuesArmenia Cattle Muscle,Liver, Skin,Kidney, MilkArmenia Pig Muscle,Liver, Skin,Kidney, MilkArmenia Poultry Muscle,Liver, Skin,Kidney, MilkArmenia Sheep Muscle,Liver, Skin,Kidney, MilkPhosphomycin Argentina Aquaculture MuscleSkin and fatLiverKidneyMilkEggsPhosphomycin Argentina Cattle MuscleSkin and fatLiverKidneyMilkEggsPhosphomycin Argentina Pig MuscleSkin and fatLiverKidneyMilkEggsGood Practice inthe Use ofVeterinary Drugs(GPVD)IntrmuscularIntrmuscularIntrmuscularIntrmuscularDose in poultry andpigs: 10 mg/Kg Pv to40 mg /Kg Pv,Registered inArgentina in poultryand pigs, but notcattle andaquacultureDose in poultry andpigs: 10 mg/Kg Pv to40 mg /Kg Pv,Registered inArgentina in poultryand pigs, but notcattle andaquacultureDose in poultry andpigs: 10 mg/Kg Pv to40 mg /Kg Pv,Registered inArgentina in poultryand pigs, but notcattle andaquacultureExisting Data &SourceMRLs (ppb) inArmenia: Muscle 25,Skin and Fat: 25,Liver 25, Kidney 50,Milk 4MRLs (ppb) inArmenia: Muscle 25,Skin and Fat: 25,Liver 25, Kidney 50,Milk 4MRLs (ppb) inArmenia: Muscle 25,Skin and Fat: 25,Liver 25, Kidney 50,Milk 4MRLs (ppb) inArmenia: Muscle 25,Skin and Fat: 25,Liver 25, Kidney 50,Milk 4ADI Japan: 0.019mg/Kg Pv/dayADI Japan: 0.019mg/Kg Pv/dayADI Japan: 0.019mg/Kg Pv/dayManufacturerUnknownUnknownUnknownUnknownBedson S.A.Bedson S.A.Bedson S.A.JECFAEvaluationCodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsArmeniaArmenia; EUArmenia; EUArmeniaJapanJapanCOMMENTS

CX/RVDF 13/21/11 25NameCountriesRequestingSpeciesTissuesPhosphomycin Argentina Poultry MuscleSkin and fatLiverKidneyMilkEggsPiperazineDemocraticPeople'sRepublic ofKoreaPigGood Practice inthe Use ofVeterinary Drugs(GPVD)Dose in poultry andpigs: 10 mg/Kg Pv to40 mg /Kg Pv,Registered inArgentina in poultryand pigs, but notcattle andaquacultureOral, 0.4 g/kgBW/dayExisting Data &SourceADI Japan: 0.019mg/Kg Pv/dayPirlimycin Armenia Chicken MRLs (ppb) inArmenia: Muscle(100), Skin and Fat(50), Liver 500),Kidney (1500), Egg(50)Pirlimycin Armenia Pig MRls (ppb) inArmenia: Muscle(100), Skin and Fat(50), Liver (500),Kidney (1500)Ractopamine Guatemala NonespecifiedRafoxanide Morocco Cattle Muscle, Fat,Liver, KidneyRafoxanide Morocco Sheep Muscle, Fat,Liver, KidneyRegistered inMoroccoRegistered inMoroccoEU regulation37/2010EU regulation37/2010ManufacturerBedson S.A.Fleming LabsPfizerPfizerElancoATLAS VétérinaireBCICEVAINTERVETNOVOVETECOMEDATLAS VétérinaireBCICEVAINTERVETNOVOVETECOMEDJECFAEvaluation62ndJECFA,2004;Full ADI62ndJECFA,2004;Full ADIMostrecentevaluation byJECFAin 2010;Full ADI;MRLsrecommended incattleand pigCodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLsin cattleCodex MRLsin cattleCodex MRLsin cattle andpigNo CodexMRLsNo CodexMRLsMemberCountryMRLsEU; USAArmeniaArmeniaAustralia:pig; Canada:pig, cattle,and turkey;USA: cattle,swine, andturkeyEUEUCOMMENTSNeed more specific tissueinformationNeed more specific tissueinformationChicken residue data neededNeed more specific tissueinformationPig residue data neededNeed to better define speciesand tissues

CX/RVDF 13/21/11 26NameCountriesRequestingSpeciesTissuesRifamycine Egypt Chicken Meatfat/ skinLiverKidneyEggsGood Practice inthe Use ofVeterinary Drugs(GPVD)10 mg/kgbw/dayorallyExisting Data &SourceRifaximine Armenia Cattle MRLs (ppb) inArmenia: Milk (60)ManufacturerEl- NASRUnknownRobenidine Costa Rica Chicken Tissues 500 ppm, oral Alpharma, Inc.,FarivetRoxarsone Peru Chicken Muscle, Registered in PeruLiver,Fat/Skin,KidneyRoxarsone Belize Poultry Muscle, Registered in BelizeHelm Mexico andKidneyCalier SpainSalicylic acidDemocraticPeople'sRepublic ofKoreaAllTetter, Applied,Ointment (5-10%)Streptomycin Armenia Goat MRLs (ppb) inArmenia: Muscle(500), Fat (500),Liver (500), Kidney(1000), Milk (200)SulfadimethoxineSulfamerazineDemocraticPeople'sRepublic ofKoreaDemocraticPeople'sRepublic ofKoreaAllAllBacterial infection;Oral, 0.05-0.1g/kg·bw/day, orinjection, 15-30%solution(subcutaneous,intravenous)Bacterial infection,coccidiosis; Oral,0.05-0.1g/kg•bw/day,orinjection, 15-30%solution(subcutaneoDemocratic People'sRepublic of KoreaUnknownAlpharmaAlpharmaJECFAEvaluation58thJECFA,2002;Full ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLsin cattle, pig,sheep, andchickenNo CodexMRLsNo CodexMRLsMemberCountryMRLsArmenia:milk; EU: notrequiredAustralia;CanadaCanada;USACanada:chicken andturkey; USA:chicken andturkeyEU: notrequiredArmenia;Australia;Canada:cattle; EU;USA: calvesCanada:cattle, swine,horse,chicken, andturkey; EU:all foodproducingspecies;USA:chicken,turkey,cattle, duck,salmonids,catfish, andchukarpartridgesCanada:cattle,sheep, andpig; EU: allfoodproducingCOMMENTSNeed more specific tissueinformationNeed more specific tissueinformationNeed to better define speciesand tissuesNeed more specific tissueinformationGoat residue data neededNeed to better define speciesand tissuesNeed to better define speciesand tissues

CX/RVDF 13/21/11 27NameSulfamethoxypyridazinSulfaquinoxalineSulfaquinoxalineCountriesRequestingDemocraticPeople'sRepublic ofKoreaDemocraticPeople'sRepublic ofKoreaDemocraticPeople'sRepublic ofKoreaAllSpeciesPoultryRabbitSulfonamides Guatemala NonespecifiedTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)us, intravenous)Bacterial infection;Oral, 0.02-0.2 g/kg•bw/dayBacterial infection,coccidiosis; Oral,0.02-0.03% of thefeed for prevention,0.05-0.07% fortheraphy for 3 daysCoccidiosis; Oral,0.01-0.02% of thefeed for preventionfor 10 days, 0.05-0.07% for theraphyfor 3-5 daysExisting Data &SourceManufacturerUnknownTevaTevaUnknownTetracycline Guatemala Bees Honey Pfizer, Boehringer,Igelheim, Wyeth,Alpharma,Medpharmex, AgriLaboratories, TevaTetracycline Armenia Goat MRLs (ppb) inArmenia: Muscle(100), Liver (300),Kidney (600), Milk(100)Pfizer, Boehringer,Igelheim, Wyeth,Alpharma,Medpharmex, AgriLaboratories, TevaJECFAEvaluation50thJECFA,1998;Full ADI50thJECFA,1998;Full ADICodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLsin cattle milkand tissuesofunspecifiedspeciesCodex MRLsin cattle, pig,sheep,poultry, fish,and giantprawnCodex MRLsin cattle, pig,sheep,poultry, fish,and giantprawnThymol Guatemala Bees Honey Unknown No CodexMRLsTilmicosin Armenia Cattle MRLs (ppb) inArmenia: Milk (40)ElancoTilmicosin19thCCRVDF70thJECFA,2008;Full ADIChicken Eggs 70thJECFA,2008;Full ADICodex MRLsin fat,kidney, liver,and muscleCodex MRLsin cattle, pig,sheep,chicken, andturkeytissuesMemberCountryMRLsspeciesEU: all foodproducingspecies;USA: swineand cattleAustralia;Canada:chicken andturkey; EU;USA:chicken andturkeyCanada; EUEU: all foodproducingspeciesArmenia;Canada:cattle andsheep; EU;USA: calvesArmenia:milk;Australia;Canada; EU;USACOMMENTSNeed to better define speciesand tissuesNeed more specific tissueinformationNeed more specific tissueinformationNeed to better define speciesand tissuesHoney residue data neededNeed more specific tissueinformationGoat residue data neededIf seeking MRL for cattlemilk, residue data neededEgg residue data needed

CX/RVDF 13/21/11 28NameTilmicosinTolfinamic Acid(tolfin )CountriesRequesting19thCCRVDFSpeciesTissuesGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceManufacturerJECFAEvaluationTurkey Eggs 70thJECFA,2008;Full ADIEgypt Cattle Meat /fatLiverKidneyMilk2 mg/kgbw/dayi.m/i.vTriamcinolone Argentina Cattle Muscle Route ofadministration IM,7mg/300kg;Registered inArgentinaTriamcinolone Argentina Goat Muscle Route ofadministration IM,7mg/300kg;Registered inArgentinaTriamcinolone Argentina Pig Muscle Route ofadministration IM,7mg/300kg;Registered inArgentinaTriamcinolone Argentina Sheep Muscle Route ofadministration IM,7mg/300kg;Registered inArgentinaTriclabendazole Kenya, Iran Goat Liver,Kidney, Milk,MuscleTrimethoprim Peru Cattle Muscle,Liver,Fat/Skin,KidneyTrimethoprim Peru Chicken Muscle,Liver,Fat/Skin,KidneyTrimethoprim Morocco Everyproducingfood speciesFat, Muscle,Liver,Kidney, MilkIran dosage regimen:5 mg/kg oralEgg residue dataneededUnknownUnknownUnknownUnknownNovartis70thJECFA,2008;Full ADICodexMRLsCodex MRLsin cattle, pig,sheep,chicken, andturkeytissuesNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsCodex MRLsin cattle andsheepRegistered in Peru Roche No CodexMRLsRegistered in Peru Roche No CodexMRLsRegistered inMoroccoEU regulation37/2010ATLAS VétérinaireVIRBACCEVA SOPHAVETINTERVETNOVOVETBIMEDAUPHARFRANVETNo CodexMRLsEUMemberCountryMRLsAustralia; EUAustralia; EUAustralia; EUAustralia:mammalsand poultry;Canada:salmonids;EU: horseand all otherfoodCOMMENTSEgg residue data neededGoat residue data neededNeed more specific speciesinformation

CX/RVDF 13/21/11 29NameCountriesRequestingSpeciesTissuesTrimethoprim Peru Goat Muscle,Liver,Fat/Skin,KidneyTrimethoprim Peru Pig Muscle,Liver,Fat/Skin,KidneyTrimethoprim Peru Sheep Muscle,Liver,Fat/Skin,KidneyVirginiamycin Peru Cattle Muscle,Liver,Fat/Skin,KidneyVirginiamycin Peru Chicken Muscle,Liver,Fat/Skin,KidneyVirginiamycin Guatemala NonespecifiedVirginiamycin Peru Pig Muscle,Liver,Fat/Skin,KidneyGood Practice inthe Use ofVeterinary Drugs(GPVD)Existing Data &SourceManufacturerJECFAEvaluationCodexMRLsRegistered in Peru Roche No CodexMRLsRegistered in Peru Roche No CodexMRLsRegistered in Peru Roche No CodexMRLsRegistered in PeruRegistered in PeruRegistered in PeruPhibro, AlpharmaNo CodexMRLsNo CodexMRLsNo CodexMRLsNo CodexMRLsMemberCountryMRLsproducingspeciesAustralia; EUAustralia; EUAustralia; EUAustralia;USA: notrequiredAustralia;USA: broilerchickens -not requiredAustralia:cattle, pig,poultry, andsheep; USA:swineAustralia;USACOMMENTSNeed to better define speciesand tissues