The FDA is taking notice of the disproportionately high numbers of dairy cows on USDA’s Food Safety and Inspection Service tissue residue violator list.
How’s this for a nightmare scenario:
• An overseas importer of whey protein concentrate discovers that the baby formula it has just manufactured contains Florfenicol, and decides to destroy $63 million of baby formula. The company calls the Midwest manufacturer of the whey protein concentrate, informing it of the problem and demanding $63 million reimbursement.
• The whey protein manufacturer checks bulk tank samples of the milk that went into the whey product, and discovers that one of the samples contains Florfenicol. The plant then calls the producer, and informs him that he is liable for the $63 million product recall.
• The producer calls his lawyer, who suggests the producer’s veterinarian prescribed milk withhold time for Florfenicol-treated cows apparently was not long enough. Note: Florfenicol is not recommended for lactating cows because no studies have been conducted to determine milk withdrawal. But it is sometimes prescribed by veterinarians on an extra-label drug usage basis. The veterinarian must include milk and meat withhold times in his prescription.
• So the producer calls his veterinarian, saying he withheld the milk according to the prescription directions and that the veterinarian is thus responsible for the $63 million recall. Suffice it to say, after two years, the case is still in litigation.
The scary thing, if you use drugs extra label, is that you could get a similar phone call. Dairy cows are disproportionately represented on USDA’s Food Safety Inspection Service tissue residue violator list. In 2008, for example, some 33 million head of cattle moved through slaughter. Of the 27 million fed cattle that went through, 16 had tissue violations. Of the 3.6 million beef cows that went, 52 had tissue violations. But of the 2.6 million dairy cows, 788 had tissue violations. That means cull dairy cows had 400 times the tissue residue rate of fed cattle and 20 times that of beef cows.
The Food and Drug Administration is taking notice. If there are this many residues in dairy cow tissue, are there residues in milk that the beta-lactam tests are missing? FDA has held three industry meetings already this spring—in California, Minnesota, New York—to determine the best way to sample bulk tanks for non-penicillin drugs that are purchased over-the-counter or via veterinary prescription.
FDA’s plan is to test the bulk tanks of all dairy producers on the FSIS tissue violator list. But since many of the residue tests for non-penicillin drugs can take several days to complete, processors worry what they’ll do with the producers’ milk while they wait for test results. One Northeast processor has threatened to simply dump all of the producer’s milk (at the producer’s expense) from the time of sampling until test results clear.
Hopefully, FDA, processors and producer groups can come up with reasonable testing regime that doesn’t disrupt milk or cash flow.
But the bigger message is this: Any extra label drug use is a gamble. Even if you purchase over-the-counter drugs at your local farm & fleet store, any administration of that drug not given exactly according to label is extra-label usage and you are liable for any residues that occur.
“Producers making their own extra-label decisions may be in for some unexpected outcomes,” says Mike Lormore, a veterinarian with Pfizer Animal Health.
Lormore says that 90% of drug residues are “silly human mistakes.” Seventy percent of the time there is poor or no record keeping. Often there is no veterinarian involved in treatment decisions.
“Protocols and prescriptions [for extra label drug use] are a legal document between the veterinarian and the herd owner,” he says. “Directions must be followed. Meat and milk withholds must be followed. And protocol changes are not allowed without the authorization of the veterinarian.”
For a list of the top eights causes of drug residues in carcasses, click here. The list was compiled by Michael Payne, a veterinarian with the University of California School of Veterinary Medicine.
As a reminder from the American Association of Bovine Practitioners (AABP), here is a list of antibiotics that are prohibited for use in food-producing animals:
· Nitroimidazoles (including metronidazole)
· Nitrofurans (including topical use)
· Gentian violet
· Phenylbutazone in dairy cattle over 20 months of age
Drugs prohibited from extra label use in food-producing animals include sulfonamides in dairy cattle over 20 months of age (sulfadimethoxine can be used in adult dairy cattle but only according to label), Fluoroquinolones and medicated feeds. AABP also strongly discourages the use of Aminoglycosides (Gentamycin and Neomycin) .
And the Pasteurized Milk Ordinance prohibits the presence of non-medical grade dimethyl sulfoxide (DMSO) and colloidal silver. Also note that compounding drugs from bulk substances is illegal.