The Wrong Path
September 1, 2011
However, sometimes, things go down the wrong path. A case in point is the new drug residue sampling project that the Food and Drug Administration (FDA) is currently developing. For the past year, the FDA has been working on a special milk sampling project, separate and apart from the ongoing screening that it conducts with state regulators, and the industry itself. The existing program uses nearly four million tests a year, at least one on every tanker load of milk, to ensure that possibly harmful antibiotic residues don’t reach consumers. The number of positive tests is tiny – on the order of two one-hundredths of one percent annually – and declining.
But lately, the FDA has become concerned that a small percentage of dairy operations may have problems with imprudent veterinary drug use on their farms – not because of anything they’ve been finding in the milk supply, but because the USDA’s meat sampling program has found drugs in the muscles and organs of dairy cows headed for slaughter. And looking at the USDA data, the FDA is concerned that improper practices leading to the carcass residues in dairy cattle may also result in drug residues in milk.
So the FDA has developed a new testing project to target roughly 900 dairy producers who have sold cows for slaughter in the past few years that subsequently tested positive for drugs that shouldn’t have been in those tissues.
NMPF understands we must have a continual dialogue with producers about the proper uses, and potential misuses, of animal drugs. That’s one reason why we have in the past year issued an updated resource, the Milk and Dairy Beef Drug Residue Prevention Manual, which offers a review of appropriate antibiotic use in dairy animals. We certainly can't condone any bad actors who are willfully or continually negligent in using these drugs, and we agree with regulators that efforts need to be made to rectify any problems. All parties understand the need to educate producers about best practices, but we have to question an approach that FDA may take which needlessly interrupts the marketplace for producers and processors.
FDA drafted a first proposal last winter, which would have taken milk samples from hundreds of the past violators on the USDA meat residue list. The problem with that approach is it would have ensured that the milk from the farms that had been sampled would have been rendered suspect – no prudent processor would want to accept the liability of packaging milk that is being screened for possible safety violations – and thus all the milk from the sampled farms would have had to be destroyed. Such an outcome would have cost farmers millions of dollars, and only because the farms have previously had an animal test positive.
After our organization and others rightly raised concerns about this first approach, the FDA went back to the drawing board and devised a slightly different way to create a new screening project. As this column is being published at the start of September, we are currently awaiting details about the precise mechanics of the proposal. We hope that when FDA unveils plan B, these concerns have been addressed.
So what are the challenges to ensuring minimal marketplace disruption, while allowing FDA to conduct its inquiry? As outlined by NMPF in two letters to FDA in the past year, the big issues are sampling location, blinded samples with third parties, and the testing methodology. Collecting samples from the bulk tank at the farm would provide FDA with milk from specific producers in the target pool, while also allowing the industry to make informed decisions on the disposition of the milk sampled. A proper double-blinded protocol would include the involvement of a third party to prevent any traceback of a sample to an individual producer, cooperative, or processor. Finally, there is valid concern that the proposed testing methodology will lead to an overestimation of drug residues in milk, as well as a high false-positive rate, leading to poor conclusions drawn from an inaccurate set of data.
Farmers could be faced with a lose-lose scenario: either hand over evidence that could incriminate them, or don’t cooperate, and risk having the entire dairy sector labeled as being intransigent, with something to hide. Thus, we’re on a path where either fork in the road ahead is unappealing. FDA has stated that it hasn’t “previously held the view, nor does it now hold a view, that the nation’s milk supply is unsafe due to animal drug residues.” We agree, and the hope that FDA’s plan B reflects that.