Dairy producers need to maintain drug
records and ship only residue-free animals
Wisconsin's dairy industry is proud of leading the nation in many ways - specialty cheese for example - but one area where state dairy producers have the top spot is nothing to be proud of. Wisconsin leads the nation in violative drug residues in cull cows and bob veal calves.
Kim Brown-Pokorny, of the Wisconsin Veterinary Medical Association, said this problem could be fixed with regulation and oversight by federal and state authorities, or it can be driven by positive change from within the industry - the latter being the choice she hopes producers take. She was part of a panel of experts talking about the problem during a Dairy Policy Summit sponsored by the Professional Dairy Producers of Wisconsin on Nov. 9 in Madison.
The two organizations are part of a program called "Meat Matters" that is trying to address the issue through outreach and education to dairy farmers, who may not think of themselves as beef producers, but who are when they sell cull cows or calves.
Brown-Pokorny said the issue of consumer confidence must be addressed and many consumers won't be happy to hear that residues "fall within legal tolerance levels." "They will want to hear that there are no drug residues," she said.
The issue of dairy producers shipping cattle containing illegal drug residues has the potential to spill over onto the milk production side and could produce some consumer confidence issues there, producers at the meeting heard.
Deborah Cera, with the U.S. Food and Drug Administration's Center for Veterinary Medicine, the agency's smallest center, said her staff is responsible for establishing tolerance levels of drugs used in animals. She told the dairy farm audience that "if any part of an animal is adulterated" when it goes to slaughter "the whole animal is considered to be adulterated" by the FDA.
When a dairy farmer ships an animal that turns up to have residues of drugs that are in violation of the established tolerances, the FDA investigates. Sometimes this means that the agency will contract with state officials to do investigations, Cera said. This means investigators will visit the farm to talk about how the problem happened and to take inventory of the drugs that are on the farm.
Cera said that 7.7 percent of U.S. cattle slaughtered are adult dairy cows, but they contain 67 percent of residue violations. She put the blame on poor management practices on the farm, including failure to maintain treatment records and failure to identify treated animals and follow stated withdrawal times.
It can also happen when farmers give cattle a dose of a drug greater than what's specified on the label or when they increase the time of the treatment or if they give the drug via an unapproved route - for example, a shot is given in the muscle when it's only approved to be given under the skin (sub-cutaneous).
Any practice that varies from the directions given on the label, she said, can result in a residue violation because it will affect withdrawal time - the amount of time it takes the animal's body to get rid of the drug residue in its meat.
On-farm records, Cera said, should include who gave the drug, what was given, when it was given and the route of administration. Having records is a pretty good assurance that the FDA won't fine a dairy producer. "I don't remember FDA taking action against a producer that has records. It would be unprecedented," she said.
The FDA and the states participate in the National Conference of Interstate Milk Shippers, a voluntary coalition of regulators that determines what goes into the Pasteurized Milk Ordinance (PMO). Currently the PMO only requires milk to be tested for the beta lactam (penicillin family) drugs, but the high incidence of drug residues in cull dairy cows has spurred the FDA to consider testing milk for other residues, she said.
"If producers don't have the records to know when meat is safe, there is concern that they don't have records to know when cow's milk can go back into the bulk tank," she said. That concern is highlighted at the agency by the fact that only one class of drug is being looked for in milk.
"Fifty percent of cull cow drug violations are from drugs other than beta lactam," she said.
In 2010 the FDA announced it had developed a milk sampling assignment to determine how many of these drugs could be found in milk. They had planned to go to the farms of those producers who had shipped meat that contained residues, get samples and test them for 31 different drugs. But input from various groups convinced the agency that it might be viewed as punitive to single out those meat violators.
It was also thought that this testing strategy might show an inaccurate picture of the dairy industry, she said.
A new strategy has been developed that will be more of a "survey" and will probably be done in the next couple of months. It will use the samples that are kept when each bulk milk sample is picked up on farms. Investigators will randomly select samples from those bulk tank samples, but the samples will not be identified as to which farm they came from.
The test will include farms with a residue history, but the industry asked for an equal number of cohort samples, Cera said, from farms that have no history of violations. These samples will be shipped frozen to the Institute for Food Safety, an independent private lab that was contracted to do the testing as another way to further "blind" the samples, that is, make sure that they are not pinpointed to any individual producer.
The testing protocol was put together by statisticians at the FDA, she said. Testing at the private lab will utilize liquid chromatography and tandem mass spectrometry for screening and confirmatory tests.
The sampling will include violators that have had tissue residues with the highest risk scores in culled dairy cows, Cera said. "All residues of drugs with established tolerances will be quantitated to confirm the level of drug present," she said.
When this sampling protocol gets underway, Cera said there will be a rollout with state regulatory officials to get them on board. States will be asked to participate.
The FDA official emphasized that there will not be enforcement actions taken as a result of the survey, but the findings will be used as information for the ongoing Milk Drug Residue Risk Assessment program. Producers will be informed about the survey test by letter from the FDA, she said.
"The FDA's sampling assignment is targeting the few members of an otherwise compliant industry in order to ensure that the public can have the utmost confidence in the dairy products that they consume," Cera said.
Dr. David Rhoda, a veterinarian with the University of Wisconsin's School of Veterinary Medicine, said he has been working with state veterinarians and the PDPW to get the word out to producers that "meat matters." They have been working to increase awareness among producers that dairy beef residues are a problem. "People didn't know how this system worked," he said.
Dairy producers are responsible for producing two wholesome and safe products, he said. "It might as well say meat and milk matters," Rhoda said.
He wants producers to understand how drug screening works at meat harvest and that solutions to the problem will involve one veterinarian working with one producer. Rhoda, who followed Cera in the panel discussion, said there is increased urgency surrounding the problem because the FDA is scrutinizing dairy farms as the source of many meat violations and because there is increased media attention to the problem.
"We are always going to be concerned about consumer confidence that could be affected," he added.
Rhoda said that the FDA cites three reasons for violations - no on-farm treatment records, increased dosage without adjusting withdrawal times and no individual animal identification. It is also important that there is a valid "veterinary client patient relationship" of VCPR, he said.
When cattle are singled out for testing at slaughter, said Rhoda, inspectors are much more likely to test cattle that have had a recent surgery, mastitis, metritis or pneumonia. But there are also randomized samples taken in slaughter plants.
The top violative residues being found are penicillin, flunixin (Banamine) and sulfa drugs in cull cows, he said, and 75 percent of the residues come from those top three drugs.
One of the things producers have to do in managing this problem is to change their thought process, Rhoda said, and this includes calf protocols. "You need to assume that all calves sent to market will be harvested and consumed," he said. Some hazards to consider include using waste milk from antibiotic treated cows and colostrum when the cow has had a short dry period.
Medicated calf starters can also cause problems, and Rhoda encouraged producers to read labels and make sure products are approved for use in veal calves. Similarly, certain drugs are not approved for use in calves that will be processed for veal.
So-called "extra-label" drug use - using drugs for unapproved purposes or in unapproved animals - can be done, but only with a valid VCPR, and this use "should be the exception rather than the rule," Rhoda said.
Farms need to work through a plan with their veterinarian that develops protocols and standard procedures for drug use on their animals because it will help them identify where their risk points are, Rhoda said.
Cera also told producers that European Union (EU) officials met with the U.S. Agriculture Secretary and the head of the FDA in September to talk about ending trade in milk, shell eggs, honey, farmed game meat, rabbits, bison and aquacultured seafood because they want additional testing of these products for residues of drugs and other compounds. Additional drug tests are asked of EU members when they market milk, she said, and EU officials want to make sure products that are shipped from the United States to European countries meet the same standards.
The U.S. officials managed to stave off the immediate ending of trade in those commodities, but will have to come up with a plan that will satisfy Europe that the products are safe. In addition to drugs, EU officials want U.S. milk tested for other compounds including carbamates, organophosphates, dioxins, PCBs, mycotoxins and others.