US FDA laws -
Sec. 615.300 Responsibility for Illegal Drug Residues in Meat, Milk and Eggs (CPG 7125.05) -
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-300.html
Sec. 615.200 Proper Drug Use and Residue Avoidance by Non-Veterinarians (CPG 7125.37)
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-200.html
http://www.fsis.usda.gov/PDF/2007_Red_Book_Complete.pdf
Page 136 - Fast Antimicrobial Screen Test, only "6" horses were tested.
Pages 137 through 141 - Specific FAST Violative Residues - Antibiotic, Sulfonamide and Non-Sterioidal Anti-inflammatory (NSAID - bute) Compounds, "0" horses tested.
EU legislation provides that the Official Veterinarian must declare unfit for human consumption any meat containing residues of veterinary medicinal products if such residues exceed the permitted level laid down by Community rules. This applies to meat from domestic solipeds (e.g. horses) in exactly the same way as other meat from, more conventional, food-producing animals.
Please refer to the FDA's regulations covering food-producing animal medication restrictions and understand that horses, while not classified as food animals, are still liable for illegal and dangerous drug residues under commercial slaughter for human consumption (see below) laws.
Since there is no regulation of horses since they are not raised for meat, and since they receive drugs banned from food animals routinely in their care, there is no way to regulate horses in a manner that makes their meat safe for human consumption unless we implement the 'horse passport' program (see below) as is now done in the EU (where most US horsemeat is exported) onto the US population of 9 million horses just to accommodate those few who wish to slaughter 1% of the population for human consumption.
http://www.fda.gov/ora/compliance_ref/cpg/cpgvet/cpg615-300.html -
Our policy is to hold responsible any individual in the production and marketing chain who can be shown to have been responsible for having "caused" (by any act of commission or omission) illegal drug residues in edible animal products.
And -
http://ecfr.gpoaccess.gov/cgi/t/text/text-idx?c=ecfr&sid=208e61b130fef1a230c86ac93e2a3ac8&rgn=div8&view=text&node=9:2.0.2.1.2.0.22.2&idno=9
You see this throughout -
This term, as applied to food products of equines, shall have a meaning comparable to that provided in this paragraph with respect to cattle, sheep, swine, and goats.
Also, export of US horsemeat to the EU is in violation of FDA export regulations as medications used in US horses are banned from use in food animals in the EU (which includes horses).
See:
http://frwebgate.access.gpo.gov/cgi-bin/getdoc.cgi?dbname=browse_usc&docid=Cite:+21USC381 - Sec. 381. Imports and exports,(e) Exports, specifically: (1) A food, drug, device, or cosmetic intended for export shall not be deemed to be adulterated or misbranded under this chapter if it-- (B) is not in conflict with the laws of the country to which it is intended for export
US horsemeat is in conflict of the laws of the EU (see those laws below).
http://www.beva.org.uk/node/84Passports and Medicines – BEVA guidelinesThu, 12/21/2006 - 09:41 — Administrator2
The “Horse Passports ( England) Regulations 2004” came into force in June 2004. The regulations themselves can be seen
hereThe accompanying DEFRA guidance notes can be seen
here .
The equivalent Scottish legislation and guidance notes can be seen
here .
The Welsh legislation is available
here .
The only major differences between the legislations relates to the owner signing the declaration in Section IX of the passport. This must be done immediately on receipt of the passport under Scottish and Welsh legislation but can be delayed in England.– see also section 3c below . Veterinary Surgeons who are involved in seeing horses are strongly advised to download and read the full legislation and guidance notes as these contain much useful information. The Regulations will require veterinary surgeons to carry out certain actions when administering/prescribing/dispensing certain substances or medicines to a horse. In brief these are as follows…
Checking the passport1 If you intend to administer, prescribe or dispense any substance or medicine to a horse ask to be shown the horse’s passport (If there is no passport supplied proceed as in what to do with horse with no passport – see 6 below)
2. Check that you are satisfied the passport supplied relates to the horse in question. (If you are not satisfied proceed as in what to do with horse with no passport – see 6 below)
3. Note which of the categories below the horse falls into….. a) Declared as NOT INTENDED for human consumption (in passport Section IX part II) b) Declared as INTENDED for human consumption (in passport Section IX part IIIa) or c) the declaration at Section IX has not been signed in either part, in which case you will need to proceed as if the horse IS INTENDED for human consumption. (Note that in Scotland and Wales the passport declaration must be signed one way or the other. Leaving this section unsigned is only permissible in England. ) or d) The passport contains no Section IX pages in which case you will need to proceed as in what to do with horse with no passport – see 6 below Note that changes to the section IX declaration are generally the providence of the owner (not the vet) but the vet may alter the passport declaration if for example he/she has administered a substance that means the horse can never go for human consumption. The declaration can only be changed from “intended” or “undeclared” to “not intended” – and not the other way round.
THE HORSE “NOT INTENDED FOR HUMAN CONSUMPTION”
4. If the horse is declared in its passport as NOT intended for human consumption then it can be treated with drugs licenced for use in horses or under the cascade (see The Veterinary Medicines Regulations 2005 SI 2745 which can be seen
here and which are summarised on the BEVA website) There is no need to record ANY drug usage.
THE HORSE “INTENDED FOR HUMAN CONSUMPTION” OR UNDECLARED.
5. If the horse IS intended for human consumption or (in England) the declaration is unsigned then withdrawal periods or complete exclusions will apply following treatment. i) What medicines should not be used? Refrain from prescribing/dispensing/administering medicines which either a) Contain substances in Annex IV of European Council Regulation 2377/90. b) Contain substances NOT in Annexes I, II or III of European Council Regulation 2377/90
If substances in either of these categories are given the horse can NEVER go for human consumption. (Note: at least one of these substances,
Phenylbutazone,
we use regularly in the US, even in race horses)Substances in Annex IV (List 5 i) a)) Fortunately this list is short and the main substances that are likely to be considered for use in horses are Metronidazole and Chloramphenicol . The full list is ….
Metronidazole
Chloramphenicol
Chloroform
Chlorpromazine
Colchicine
Dapsone
Dimetridazole
Furazolidone
Nitrofurans
Ronidazole
Substances not in Annexes I,II or III of European Council Regulation 2377/90 that ARE components of UK licenced equine medicines (List 5 i) b) )
Phenylbutazone
Suxibuzone
Meclofenamic Acid
Eltenac
Methylprednisolone Acetate
Betamethasone
Griseofulvin
Acepromazine Maleate
Guaifenesin
Halothane
Etorphine Hydrochloride
Diprenorphine
Pethidine Hydrochloride
Polygeline (Haemaccel)
Succinylated Gelatin (Gelofusine Veterinary)
Pentobarbitone Sodium
Cinchocaine Hydrochloride
Quinalbarbitone Sodium
Pentobarbitone Sodium(
US FDA regs on: Phenylbutazone is a known carcinogen -- an agent capable of causing cancer -- as determined by the federal government's National Toxicology Program. "For animals, phenylbutazone is currently approved only for oral and injectable use in dogs and horses.
Use in horses is limited to use in horses not intended for food. There are currently no approved uses of phenylbutazone in food-producing animals.")If an Annex IV substance or a substances NOT in Annexes I, II or III is to be administered to a horse intended for human consumption (or undeclared) the owner should be advised that the declared status of the horse will have to be amended to NOT intended for human consumption. Once this is done there is no need to record anything in the passport. If the change to the declaration has not been made by the owner at the time of administration, despite such advice, and administration of such a substance is considered essential, the veterinary surgeon may make the alteration in the passport. ii) What medicines can be used WITHOUT any recording in the passport? If a medicine is prescribed/dispensed/administered which contains a substance which IS listed (for any food producing species) in Annexes I, II or III of European Council Regulation 2377/90 then it need NOT be recorded in the passport. a) Lists of Veterinary Medicinal products licenced for use in the horse in the UK which fall into this category are on the VMD website at www.vmd.gov.uk (under “publications” and then “horse medicines” then “Veterinary Medicinal Products Authorised for Use in Horses” then “Medicines that do not need to be listed in the passport (because the substances they contain are in Annexes I – III of Regulation 2377/90).”.). b) Where medicines are being used under the cascade reference will need to be made to the actual Annexes I, II or III of European Council Regulation 2377/90 to determine if the active substances are included (for any food producing species). There is a link to the Annex lists from the VMD website www.vmd.gov.uk (under “publications” and then “horse medicines” then “European Commission - Maximum Residue Limits of Veterinary medicinal Products in Foodstuffs of Animal Origin”) (iii) What medicines DO need to be recorded in the passport ? At present none ! In theory medicines containing substances which are NOT included (for any food producing species) in Annexes I-III of European Council Regulation 2377/90 (List 5 i) b) above) need to be recorded in the passport (in Section IX part IIIb) BY THE PERSON ADMINISTERING IT TO THE HORSE. Lists of Veterinary Medicinal products licenced for use in the horse in the UK which fall into this category are on the VMD website at www.vmd.gov.uk (under “publications” and then “horse medicines” then “Veterinary Medicinal Products Authorised for Use in Horses” then “Authorised veterinary medicinal products that must NEVER be used to treat horses that may, at any future time, be slaughtered for human consumption. “ However because administration of such substances means that the declaration needs to be changed to “not intended for human consumption” that then takes out the need to record their use.However, this will not be the case permanently. When the European Commission get round to producing their so called “positive list” of substances as set down in Article 10.3 of directive 2001/82 as amended by 2004/28, use of these substances will have to be recorded if administered to a horse declared as intended for human consumption. BEVA will provide further guidance at that time. iv) What withdrawal periods apply? A licenced VMP will either have a specific withdrawal period defined on its datasheet or, if not, a standard 6-month withdrawal period will apply. The list of licenced equine products for horses intended for human consumption on the VMD website referred to above is subdivided into those products that have a specific withdrawal period and those to which a standard 6-month withdrawal period applies. A 6-month withdrawal period will also apply to medicines not licenced for use in the horse and being used under the cascade. The client should be informed of the withdrawal period. Note that owners of horses declared as intended for human consumption or where the declaration is not signed have an existing separate legal obligation to keep a written record of ALL medicines or substances purchased for or administered to their horse (i.e. to keep a “medicines book”). This requirement now falls to them under The Veterinary Medicines Regulations 2005.
THE HORSE WITHOUT A PASSPORT
6. If the horse does not have a passport (e.g. is too young to require one, or does not have one available at the time, or the identification cannot be confirmed or has an “old” passport to which Section IX pages have not yet been added) then the veterinary surgeon should treat it as if it is intended for human consumption as described in section 5 above. The veterinary surgeon should thus avoid prescribing/dispensing/administering medicines containing substances in Annex IV of European Council Regulation 2377/90 as outlined above (5 (i)a) or medicines containing substances NOT in Annexes I, II or III of European Council Regulation 2377/90 for example those in List 5 i) b). 7. As far as records are concerned the veterinary surgeon should keep his own clinical record of the substances/medicines prescribed/dispensed/administered (including the date) and give a copy of this treatment record to the owner/keeper. If the medicines contain substances not included (for any food producing species) in Annexes I, II or III of Council Regulation 2377/90 or contain a substance in Annex IV of Council Regulation 2377/90 then the vet should give the owner/keeper written notification that the horse may NOT now be slaughtered for human consumption.
WHO DOES THE RECORDING IN THE PASSPORT?
8. The final responsibility for recording substance/medicine use in the passport should lie with the individual administering the substance/medicine. Thus in the case of …… i) Substances/medicines prescribed or dispensed by the veterinary surgeon but administered by the owner/keeper…. or ii) Substances/Medicines acquired by the owner/keeper and administered to the horse independently of the veterinary surgeon (e.g. POM-VPS, NFA-VPS and AVM-GSL products) ……….that responsibility for recording in the passport lies with the owner/keeper (despite the fact that many passport formats are likely to suggest the need for a veterinary signature in the relevant column in section IX part IIIb) If the veterinary surgeon administers a substance/medicine then the recording responsibility lies with him/her (hence with horses declared as intended for human consumption or undeclared if in doubt record medicines administered).
WHO IS RESPONSIBLE FOR A RESIDUE FREE CARCASE ?
BEVA have been told by DEFRA that if the horse is intended for human consumption it is the owner’s responsibility to present a residue free animal to the slaughterhouse.
POTENTIAL DATA SHEET CONFUSIONS
Note that VMD currently (September 2005) state on their website…… “We are aware that this section offers only limited guidance. Currently the marketing authorisations for the products intended for use in horses may carry a warning that they must not be used in horses for human consumption. This fulfils the requirements of UK and EC medicines and residues legislation but the implementation of the new Horse Passport Scheme leads to some difficulties in the interpretation of the legislation overall. This is because a conflict exists between the European laws covering on the one hand, horse passports and on the other hand, residues. We have therefore amended the UK legislation to harmonise it with the horse passport provisions so far as we can. Statutory Instrument No 2004/147 came into force on 23 February 2004 and permits the legislation on residues to be read in conjunction with the passport legislation. We are currently considering how this will impact on the individual marketing authorisations and this is likely to take some time as each authorisation has to be dealt with separately in conjunction with the marketing authorisation holder. In the meantime our working assumption in interpreting the conflicting EC laws will be that we can allow the use of a medicine which contains active substance(s) that have been entered into Annex I, II or III of Council Regulation 2377/90 for all horses provided that a full medicines record is maintained and either the specific product withdrawal period or a 6-month withdrawal period before slaughter can be demonstrated. Products which contain active substances which are not entered into one of those Annexes can never be used in horses which might be slaughtered for human consumption at a future point in time so may only be used in horses which have been declared as NOT intended for human consumption in their passport. We expect to update the lists regularly – at least once every month. Holders of marketing authorisations are invited to check the lists and let us know if they consider there are any omissions or inaccuracies. As we cannot guarantee the complete accuracy or completeness of the lists, you are also advised to consult the current NOAH Compendium of Data Sheets for Veterinary Products which lists and summarises data on most authorised veterinary medicinal products. In any event, anyone administering a veterinary medicine to a horse or supplying such a product should always familiarise himself or herself with the product information relating to the medicine, as set out on the label, packaging and any leaflet accompanying the medicine. Vets should also consult the relevant data sheet or Summary of Product Characteristics. Further enquiries in respect of the lists or this page may be made by e-mail to
horsemedicines@vmd.defra.gsi.gov.uk or by telephone to Veterinary Medicinal Products Branch on 01932 338321”.
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For more US info please refer to these websites -
Banned drugs -
http://www.fsis.usda.gov/Search/Search_Results/Index.asp?q=banned+drugs+&mode=simple&num=10&as_occt=any&site=FSIS&sort=rel&x=7&y=9
Food Safety Issues Affecting International Trade -
http://www.fsis.usda.gov/oa/speeches/2000/tb_apfs.htm
---------------------------
http://www.ers.usda.gov/Briefing/AnimalProducts/AnimalHealthWelfare.htm
http://www.fsis.usda.gov/Regulations_&_Policies/International_Affairs/index.asp
-----------------------
Federal Meat Inspection ActSubchapter I - Inspection Requirements; Adulteration & Misbranding -
http://www.fsis.usda.gov/regulations_&_policies/Federal_Meat_Inspection_Act/index.asp
------------------------
Federal Meat Inspection ActTitle 21 - Food and Drugs
Chapter 12 - Meat Inspection
http://www.fsis.usda.gov/Regulations_&_Policies/FMIA/index.asp#610FSIS information on the regulatory enforcement of food safety inspection regulations in domestic meat, poultry, and egg product processing establishments.
Residue Violators Alert List (PDF only) FSIS monthly list of individuals or firms responsible for repeat drug, pesticide, or other chemical residue violations in animals presented for slaughter.
Quarterly Enforcement Reports FSIS Quarterly Enforcement Reports provide a summary of the enforcement actions FSIS has taken to ensure that products that reach consumers are safe, wholesome, and properly labeled.
FSIS AdjudicationsFood Supply Veterinary MedicineAmerican Veterinary Medicine Association.A clearinghouse of information on food supply veterinary medicine, including videos, links to state information, statistics, and media coverage.
