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R E G U L A T I O N S

R E G U L A T I O N S

RESIDUES & RECORDS

"I KNOW WHAT I'VE TREATED MY ANIMALS WITH."

HENRIETTA PRICE MRCVS, CHEMICAL SURVEILLANCE BRANCH, VETERINARY SCIENCES DIVISION, DARD, DISCUSSES THE 2005 VETERINARY MEDICINE REGULATIONS

hy should farmers and veterinary surgeons record at the time of treatment the medicines that they give to food-producing animals? They are required to do so under the Veterinary Medicines Regulations 2005 (1). Under European and national residues legislation (2), member states sample animals on farm and at slaughter for residues of veterinary medicines inter alia. Random and targeted sampling, and investigation of non-compliant results are carried out, in order to identify and exclude produce that contains unacceptable residues. Recent results for carcases tested at the Veterinary Science Division's Chemical Surveillance Branch, and the Veterinary Service's field follow-up reports, indicate that time-of-use medicines records are indeed worth keeping for foodproducing animals;

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preceding six months to the casualty when considering fitness for on-farm slaughter or to travel for slaughter. This period more accurately reflects the current range of withdrawal times for cattle medicines (see tables below), than the 28 days that could be inferred from previous declaration forms. Is it likely that even the most meticulous farmer will remember whether the tilmicosin was given at least two months ago, or exactly when which individuals last received what oxytetracycline preparation? A casualty-slaughtered beef carcase that is condemned for a non-compliant antibiotic residue will have been a very expensive animal.

without carcass detention. If the results are non-compliant, the producer is allocated to more intensive phase 2 sampling; · A minimum of five pigs from each subsequent consignment are screened for antibiotics inter alia · The carcases are detained, enabling condemnation (and prosecution) Inadequate withdrawal of chlortetracycline from pigs is likely to be expensive. (After three compliant consignments, the producer is returned to phase 1 sampling). A somewhat different residues issue for owners and veterinary surgeons surrounds the widespread use of a medicine that is unlicensed for food-producing animals, in a potentially dual purpose species;

withdrawal period, has not yet been implemented. The "residues" regulations (2) prohibit the use of drugs such as phenylbutazone at any stage in horses that are slaughtered for human consumption. Hence the Veterinary Medicines Directorate and British Equine Veterinary Association advise that phenylbutazone should not currently be given to horses that might be slaughtered. That is, it should not be given to horses whose passports are signed "intended" or remain unsigned ­ unless section IX is amended to "not intended". When phenylbutazone is prescribed to these horses, the BEVA advises that the prescribing veterinary surgeon should ensure that the passport declaration is amended, or if this is unavailable, advises in writing that it must be amended.

Medical treatment need not be recorded in the passport once section IX is signed "not intended". The passport will be scrutinised at ante mortem inspection. In view of the emerging residues problem in this dualpurpose species, we wish to bring to the attention of veterinary practitioners and horse keepers that · The consignor has a duty to present horses for slaughter that are free of unacceptable drugs residues, and is held responsible if any are found · Phenylbutazone must not be given to horses that may be slaughtered for human consumption · When it is given, the passport must be checked and the declaration amended to "not intended", and this amendment is irreversible.

For detailed advice on the recording of medical treatments in the the passport see the BEVA website (7). For information about the licensing of horse medicines see the VMD website (8)

National legislation is available at http://www.opsi.gov.uk/ EU legislation is available at http://europa.eu.int/eur-lex/ (1) The Veterinary Medicines Regulations 2005; (2) Council Directive 96/23/EC; the Animals & Animal Products (Examination for Residues and Maximum Residue Limits) Regulations (N Ireland) 1998 (3) The 2004 results for Northern Ireland are available on the AFSNI website; http://www.afsni.ac.uk/Divisions/Veterinary/CSBIntro.htm (4) Guidance for veterinary surgeons and farmers on the slaughter of cattle which are injured or showing signs of abnormalities. British Cattle Veterinary Association 2005. Copies available from the BCVA email [email protected] and the Food Standards Agency email [email protected] (5) Horse Passport Regulations (Northern Ireland) 2004 (6) Directive 2001/82/EC amended by Directive 2004/28/EC (7) www.beva.org.uk (8) www.vmd.gov.uk

CATTLE MEDICINES WITHDRAWL TIMES

Cattle Systemic Antibiotics

TRADE NAME & MANUFACTURER ACTIVE INGREDIENT(S)

The tables were collated from the NOAH and Norbrook websites on the 16th February 2006; the information on these websites is liable to change

ADMIN ROUTE

MEAT withdrawal 18days 60d!!! 18d 18d 23d 10d 18d 23d 18d 23d 21d 21d 21d 18d 21d 42d 42d 42d 4d 5d 10d, 21d 4d 23d 23d 7d 7d 7d

MILK withdrawal 24hours NFU not for use 24h 24h 79h 24h 79h 24h 84h 72h 48h 96h 24h 60h 60h 80h 60h 60h 5d 72h 132h 84h 84h 72h

2. Chlortetracycline residues in pigs the Pigs scheme

There may be an analogous problem associated with the use of chlortetracycline in pig production. In 2004, chlortetracycline was found above the Maximum Residue Limit in pigs from six producers. Four of these were recording treatments with other antibiotics, but not with chlortetracycline. This is formulated for in-feed or in-water administration to pigs but there is no licensed injectable; it may not always be appreciated that · Chlortetracycline is a prescription antibiotic (POM-V, formerly MFS), subject to the same rules on recording treatment that govern the use of other antibiotics in farm animals · Withdrawal times for the pig preparations range from 6 to 14 days Phase 1 of the supplementary Pigs Scheme operating in Northern Ireland comprises the random, stratified (by producer) sampling of pigs at slaughter,

3. Phenylbutazone residues in horsemeat and the horse passport regulations

Within the last year, the VSD has found residues of phenylbutazone on several occasions in horses consigned for slaughter in Northern Ireland for export as food for human consumption. As no Maximum Residue Limit has been set for phenylbutazone in meat, subsequent consignments will be sampled and the carcases condemned if found to contain it. Under the recently implemented passport regulations (5), horses may be consigned for slaughter if accompanied by their passport and if section IX of the passport is signed "intended to be slaughtered for human consumption". The derogation within the "cascade" directives (6) that would permit phenylbutazone to be given to horses prior to slaughter for human consumption, subject to an extended, six-month default

1. Antibiotics residues in casualty cattle - the Meat Inspection scheme

Casualties are over-represented in the total number of cattle condemned for excessive antibiotics residues (3). Whilst dealing with a crisis, it may not be appreciated that · The withdrawal time listed in the medicine's product data sheet leaves little if any margin for time error · Under the Meat Inspection scheme, every casualty carcase is screened for antibiotics (inter alia) · Carcases are detained, enabling condemnation (and prosecution) The British Cattle Veterinary Association's advisory booklet and declaration forms (4) emphasize the need to check treatments given within the

Norobrittin Norbrook Amfipen LA Intervet Duphacillin Fort Dodge Betamox Norbrook Betamox LA Norbrook Betamox 400 tabs Norbrook Amoxypen inj Intervet Amoxypen LA Intervet Amoxycare inj Animalcare Amoxycare LA inj Animalcare Bimoxyl LA Bimeda Clamoxyl RTU inj Pfizer Clamoxyl LA Pfizer Duphamox FD Duphamox LA FD Nisamox injection FD Noroclav Inj Norbrook Synulox RTU inj Pfizer Synulox 500mg bolus Pfizer Norocillin Norbrook Ultrapen LA Norbrook Depocillin Intervet Duphapen fort FD Duphapen FD Penacare Animalcare Mamyzin Boehringer Ingelheim

Ampicillin

Amoxycillin

Amoxycillin + clavulanate

Procaine penicillin

Penethamate

Im Im Im Im Im Oral calf Im Im Im Im Im Im Im Im Im Im Im Im Oral calf Im Sc, im Im Sc nonlact im Im Im im

Reproduced Courtesy of NORTHERN IRELAND VETERINARY TODAY

Reproduced Courtesy of NORTHERN IRELAND VETERINARY TODAY

R E G U L A T I O N S

TRADE NAME & MANUFACTURER

ACTIVE INGREDIENT(S)

ADMIN ROUTE

MEAT withdrawal 4-5d 19d 48h 8d 1d 25d 15d 25d 15d 31d 28-35d 35d 15d 31d 35d 35d 31d 14d 15d 31d 14d 10d 10d 14d 21d 14d 31d 35d 8d 5d 8d 14d 14d 6d 6d 6d 28d 14d 49d 60d 32d 30d 44d 28d 49d 21d 23d 23d 23d 14d 28d 10d

MILK withdrawal Discard 1st +/- 2nd NIL NIL NIL NIL 60h 10d 10d 8d 60h 10d 10d 6d 10d 60h 10d 7d Not during tx Not during tx 120h 7d 7d NFU NFU 4d 48h NFU 84h 36h 108h NFU; NFU 2m < calving NFU; NFU 60d < calving NFU; NFU in bulls 56h milk 48h 60h 60h 60h 48h 36h 60h

Cephaguard Intervet Ceporex injectionS-P Metricure Intervet Excenel RTU Pfizer Excenel sterile powder Pfizer Aureomycin soluble pdr FD Aurofac 200 MA FD Aureomycin sol oblets FD Alamycin 10 Norbrook Alamycin LA Norbrook Alamycin LA300 Norbrook Cyclosol LA Ceva Duphacycline 100 FD Duphacycline LA FD Duphacycline XL FD Engemycin 5%, 10%, 10% farm Intervet Engemycin LA Intervet Occrycetin bolus FD Oxycare 10% Animalcare Oxycare 20/LA Animalcare Oxytetrin 20 LA S-P Terramycin sol pdr 5% Pfizer Terramycin sol pdr 20% Pfizer Terramycin Q-100 inj Pfizer Terramycin LA Pfizer Tetroxy LA Bimeda Oxycomplex NS Bimeda Hexasol LA Norbrook Advocin 180 Pfizer Advocin injectable Pfizer Baytril 2.5% Bayer Baytril 5% inj Bayer Baytril 10%, Max Bayer Marbocyl 2% Vetoquinol Marbocyl 10% Vetoquinol Marbocyl bolus Vetoquinol Tylan 200 Elanco Tylan soluble Elanco Draxxin Pfizer Micotil Elanco Spectam injectable Ceva Nuflor injectable soln S -P Apralan soluble pdr Elanco Framomycin 15% inj Novartis Devomycin D Norbrook Duphapen + Strep FD Pen + Strep Norbrook Streptacare Animalcare Devomycin Norbrook Utocyl Novartis Bimotrim co inj Bimeda

Cephquinome Cefalexin Cephapirin Ceftiofur Chlortetracycline

Oxytetracycline

Oxytet+flunixin Danofloxacin Enrofloxacin

Marbofloxacin

Tylosin Tulathromycin Tilmicosin Spectinomycin Florfenicol Apramycin Framycetin Streptomycin, dihydrostreptomycin Dhstrep, ppenicillin

Im Im I uterine Sc Im Water calf Milk calf Oral calf Im Im Im Im Im iv Im Im Im iv Im Oral calf Im iv Im Im Water Water Im Im iv Im Iv < im Im Sc Sc Oral calf Sc Sc Iv sc calf Iv im sc Oral calf Im Oral calf Sc Sc Im calf Im Sc Water, milk calf Im Im Im Im Im Im I uterine Iv im

Streptomycin Dhstrep, pen, f-sulfathiazole Trimethroprim, sulfadiazine

Reproduced Courtesy of NORTHERN IRELAND VETERINARY TODAY

R E G U L A T I O N S

TRADE NAME & MANUFACTURER

ACTIVE INGREDIENT(S)

ADMIN ROUTE

MEAT withdrawal 10d 15d (CI rum) 12d 12d 15d 34d 10d 28d 15d 12d 42d

MILK withdrawal 48h 48h 48h 6.5d 60h 48h 156h

Borgal 24% soln Intervet Duphatrim bolus FD Duphatrim IS inj soln FD Norodine 24% Norbrook Strinacin Merial Tribrissen 48% S-P Trimacare 24% Animalcare Trimacare bolus Animalcare Trimedoxine 4S Vetoquinol Trinacol Inj Boe Ing Intradine Norbrook

Key Purple Blue Yellow

Sulfadimidine

Im iv Oral calf Im iv Im iv Oral calf Im Im iv Oral calf Oral calf Im iv Iv sc

- withdrawal times > 28 days - meat withdrawal times for drugs with NIL milk withdrawal - oxytetracycline preparations licensed for cattle

Cattle Intramammaries

TRADE NAME & MANUFACTURER

ACTIVE INGREDIENT(S)

MEAT withdrawal 7d 7d 28days 28d 28d 7d 28d 28d 4d 28d 28d 7d 7d 28d 7d 21d 2d 48h; 5d with Cephaguard im 2d 23d 3d 7d

MILK withdrawal 60h 60h 120 hours +/- 28days 60h +/- 28d 90h +/- 28d 60h 96h +/- 45d, 49d 156h +/- 49d 60h 96h +/- 28d; NFU not for use < 28d of calving. 96h +/- 42d; NFU < 42d of calving 84h 72h 108h +/- 28d 84h 96h +/- 54d 84h 96h 49d if dry < 7w 1d after calving if dry >7w 5d 84h 72h

Noroclav lact. cow Norbrook Synulox lactating cow Pfizer Chanamast DC Chanelle Kloxerate DC Fort Dodge Noroclox DC Norbrook Lactaclox Norbrook Bovaclox DC, DC Extra Norbrook Kloxerate plus DC, gold DC FD Kloxerate plus milking cow FD Orbenin dry cow Pfizer Orbenin extra dry cow Pfizer Orbenin LA Pfizer Synermast lactating cow Bimeda Nafpenzal DC Intervet Nafpenzal MC Intervet Cepravin Dry Cow Schering-Plough Pathocef I-mam susp Pfizer Cephaguard LC Intervet Cephaguard DC Intervet Pirsue Pfizer Lincocin forte S Pfizer Tetra-Delta Pfizer

Amoxycillin, clavulanate Cloxacillin

Cloxacillin, ampicillin

Nafcillin, procaine penicillin, dihydrostreptomycin Cefalonium Cefoperazone Cefquinome

Leo Red Dry Cow Boehringer Ingelheim Leo Yellow Milking Cow Boe Ing Lactratrim MC Elanco

Key Purple - withdrawal times > 28 days

Pirlymycin Lincomycin Novobiocin, neomycin, ppenicillin, dhstrep, prednisolone Framycetin, penethamate, procaine penicillin Fram, peneth, dhstretp, prednisolone Trimethoprim, sulfadiazine

28d 28d 7d

84h; or 28d + 72h 84h 48h

Reproduced Courtesy of NORTHERN IRELAND VETERINARY TODAY

R E G U L A T I O N S

R E G U L A T I O N S

Cattle Parasiticides

TRADE NAME & MANUFACTURER ACTIVE INGREDIENT(S) ADMIN ROUTE MEAT withdrawal 14 days 14d 14d 14d 14d 20d 200d 19d 14d 12d 14d 12d 6, 7, 8 months 19d 21d 28d 10d 56d 56d 56d 60d 20d 18d 20d 22d 14,14, 28d 28d 5d 28d 42d 28d, 42d 28d, 35d 28d 28, 35d 35d 28d 42d 28d, 35d 28d 35 80d 35, 56d 15d 14d, 65d 108d 213d NIL MILK withdrawal 60 hours 60h 60h 60h 60h 72h NFU not for use; NFU < 200d calving 7d 5d 5d 96h 5d NFU; NFU < 6,7,8 months of calving 84h NFU 5d 48h NFU ; NFU < 2m of calving NFU ; NFU < 7d of calving NFU ; tx start of dry period NFU NFU NFU NFU NFU NFU NFU NFU NFU; NFU < 7d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NFU; NFU < 60d of calving NIL NFU; NFU < 60d of calving NFU; NFU < 80d of calving 21d NIL

TRADE NAME & MANUFACTURER

ACTIVE INGREDIENT(S)

ADMIN ROUTE

MEAT withdrawal 3d 3d 20d 17d 28d NIL 4d

MILK withdrawal NIL; tx 6h < milk NIL; tx 6h < milk NIL NIL NIL NIL 96h

Albenil low dose, sc Virbac Albensure 2.5% SC, 10% Animax Albex 2.5% SC, 10% Chanelle Endospec SC 2.5%, SC 10% Bimeda Ovispec s & c 2.5%, 10% Janssen Valbazen 10% Pfizer Panacur bolus Intervet Panacur 1.5% pellets Intervet Panacur 4% powder Intervet Panacur 2.5%, 10%, sc 5% Intervet Zerofen 2.5%, 10% Chanelle Fenzol Norbrook Autoworm finisher, ready pulse, first grazer Schering-Plough Bovex 2.265% Chanelle Parafend LV Norbrook Systamex 2.265 Schering-Plough Hapadex cattle wormer S-P Endofluke 10 Bimeda Fasinex 10% Novartis Tribex 10% sus for cattle Chanelle Trodax 34% Merial Chanaverm 7.5% Chanelle Levacur sc 3% Intervet Levasure 7.5% Animax Ripercol pour-on Janssen Levacide 3%, low vol, inj Norbrook Nilzan drench super, gold S-P Levafas diamond Norbrook Combinex cattle Novartis L + triclabendazole Alstomec injection, Alstoe Animec pour-on, injection Chanelle Bimectin pour-on, injection Bimeda Depidex pour-on Novartis Ivomec classic p/o, classic inj, Merial Panomec injection Merial Qualimintic pour-on Janssen Qualimintic 1% injection Janssen Virbamec p-o, inj soln Virbac Noromectin pour-on Norbrook Ivomec super injection Merial Virbamec super Virbac Dectomax pour-on, injection Pfizer Eprinex p/o for beef & dairy cattle Merial Cydectin 0.5% p-o, 1% inj Fort Dodge Cydectin 10% Fort Dodge Imizol injection S-P Auriplak Virbac

Albendazole

Fenbendazole

Oral O O O O O Bolus O Premix O O O B O O O O O O O sc O O O Topical O, o, sc O O O Sc T, sc T, sc T, sc T, sc Sc T sc T, sc T sc Sc T, sc T T, sc Sc ear Sc once Eartag

Flypor Novartis Ridect pour-on Pfizer Butox swish Intervet Coopers spot on insecticide S-P Dysect pour-on Fort Dodge Flectron fly tags Fort Dodge Taktic Intervet

Key

Deltamethrin Alphacypermethrin Cypermethrin Amitraz

T T T T T E T

Purple - withdrawal times > 28 days Blue - meat withdrawal times for drugs with NIL milk withdrawal Italics - NIL meat and milk withdrawal

Cattle Miscellaneous

TRADE NAME & MANUFACTURER ACTIVE INGREDIENT(S) ADMIN ROUTE MEAT withdrawal 24 hours > insertion; 6h>removal 28 days 24h 3d 28d 24h 4d 7d 48d 21d 21d 55d 21d 8d 8d 5d 14d 7d 1d 4d 15d 3d, 7d 9d 28d, 2d Unlisted MILK withdrawal NIL 48h > 2nd NIL NIL NIL NIL 12h 60h 6d 48h 72h 48h NFU not for use 12h 12h 24h 2d 36h NIL 5d Discard 1 milk NFU NFU Discard 2 milks

Oxfendazole

Prid Ceva* PMSG Intervet (for superovulation) prostaglandin Estrumate Schering-Plough Enzaprost Ceva Lutalyse Pfizer Noroprost Norbrook Prosolvin Intervet Dexadreson Intervet Dexafort Intervet Duphacort Q Fort Dodge Colvasone Norbrook Voren suspension Boehringer Ingelheim Rimadyl LA sol Pfizer Binixin Bayer Cronyxin inj Bimeda Finadyne solution S-P Flunixin inj Norbrook Meflosyl 5% Fort Dodge Ketofen 10% Merial Metacam 20mg.ml BI Tolfine Vetoquinol Buscopan Boehringer Ingelheim Bisolvon inj, pdr Boe Ing Dimazon Intervet

Key Purple Blue Yellow

Netobimin Triclabendazole

Progesterone, oestradiol benzoate Serum gonadotrophin Cloprostenol Dinoprost

Vaginal coil Sc im im im im im im im im im iv im iv im iv sc iv iv iv iv iv iv iv im sc iv Iv, sc Iv, im Im, oral iv

Nitroxynil Levamisole

Luprostiol Dexamethasone

L + oxyclosanide

Ivermectin

Carprofen Flunixin

Ketoprofen Meloxicam Tolfenamic acid Butylscopolamine & metamizole Bromhexine Frusemide

I + chlorsulon Doramectin Eprinectin Moxidectin Imidocarb Permethrin

- withdrawal times > 28 days - meat withdrawal times for drugs with NIL milk withdrawal - oxytetracycline preparations licensed for cattle

Notes * To be withdrawn, and replaced with progesterone-only coils (CIDR etc) Omitted: 1. Receptal, Fertagyl, Chorulon and Oxytocin-S have NIL meat and milk withdrawals 2. Leo Yellow milking cow, Synulox lactating cow & Tetra-Delta contain prednisolone; see intramammary table 2. 3. Oxycomplex and Hexasol injections contain flunixin; see systemic antibiotic table 1.

Reproduced Courtesy of NORTHERN IRELAND VETERINARY TODAY

Reproduced Courtesy of NORTHERN IRELAND VETERINARY TODAY

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