Dairy Food Safety Researcher (Continued from Pago A2l) However, the history of how the tests came to be is telling in the reluctance of the political and reg ulatory sectors to give up the recently devised testing system. In recounting the history, Cullor hit upon several key facts that seem to indicate that science, fair ness and reason was overruled by political and public relations ploys. the key reason the tests were developed was to provide a tool that would allow the regulatory structure within the dairy industry to screen raw milk for antibiotic residues, as part of a goal of having no traces of man-made antibiotics in milk. Whether or not that should be the goal has been and continues to be debated. Nevertheless, with tests in hand, the industry began in January to use new tests to screen for any trace of antibiotic residues. According to Cullor, since mid-1994 there have been antibio tic residue assays used in practice that have never been “scientifical ly field tested” nor received NMC Inc. Research Committee recom mended validation protocol. These same tests, Cullor said, are “accepted” by the Center of Veterinary Medicine/Food and Drug Administration, “perfor mance tested” by the Association of Official Analytical Chemists, and “recommended” by the National Conference On Interstate Milk Shipments (NCIMS). According to Cullor, these tests are used for tanker milk, for trace back on bulk tank milk, and rou tinely used on individual animal milk samples, although they have not been field tested on tanker loads, on bulk tank milk, and never received the NMC Inc. validation protocol. “During late 1990, the Govern ment Accounting Office (the GAO is an agency of and answerable to the U.S. House ofßeprcsentatives) reported that, in their opinion, the Food and Drug Administration did notpossess the appropriate techno logies to assure consumers that the nation’s milk supply was free of antibiotic residues. “In respondingto this report, the FDA pulled together a mechanism to cerfity such assays.” According to Cullor, the assays (or tests) which were developed were done through an “interpretive memorandum issued by the FDA (milk branch)” that summarized the laboratory evaluations of the proposed beta-lactam antibiotic residue tests. According to Cullor, this method of testing tests is a protocol that calls “for the evaluation of manufacturer’s label claims by using spiked milk samples with the parent compound of the antibiotic under study.” In simpler terms, this means that the Center For Veterinary Medicine/FDA accepted tests devised by test manufacturers and tested them by seeing if they would react to milk purposefully spiked with the parent chemicals in anti biotics (not the residues). They repeated this elementary procedure from 30 to 60 times per test being evaluated, and at diffe rent dose levels in the milk. That’s it According to Cullor, no field research was done and no tests were done to determine the num ber of false positive reactions to other substances. In other words, the tests were never checked to see what else would cause a positive reaction. Cullor said that in his laboratory’s study using these same tests the cow’s natural antibodies could cause a positive reaction for drug residues. As a chemical antibiotic breaks down in the cow’s system, por tions of the chemical called residues linger. They are called “violative” because they inhibit growth. The residue tests were never evaluated as residue tests, accord ing to Cullor. “They had to do something in a hurry and this is what they did. And for me to say, ‘Now you need to start all over,’ is not popular.” His suggestion for the industry and government to either adopt his recommendation of sharing responsibility so that milk produc ers stop being financially hurt and put out of business on the basis of un-scientifically proven tests, or start all over and conduct the tests Mlanco CONCRETE WALLS WE DO SCS WORK - ALL TYPES OF POURED WALLS • Retaining Walla • Bunker Silos • Manure Pits (circular or rectangular) • Slatted Floor Deep Pits • Footers • network t CONTACT STEVE PETERSHEIM, JR. P.O. Box 256, Bird-In-Hand, PA 17505 717-291-4585 • (FAX) 717-291-4686 lancaatar Farming, Saturday, September 2, 1995-A23 on these residue tests that good sci ence dictates. “What they did was fine. It was a good start,” he said of the FDA tests. “But you ought to go into the field and see how it works in the real world. That’s what bothers __ _ >» me. He said that,"... from a scientif ic point of view, (what needs to be done) is to really put together a protocol to validate these tests that includes field trials.” He said that, as a scientist, he would “... call time out and go back and fix (the testing procedures) according to scientific principles.” However, because of the politi cal and business ramifications, Cullor said he doesn’t think that abandoning the tests is possible. That’s why he suggested a system for using the current tests as screens only, backed up by precise third-party validation tests. Currently, validation of the tests is to have the same lab repeat the same residue test on the same milk sample. That ensures that the residue test is consistent, not correct. “If you really believe the tests are good, fine, keep it as a screen ing test and then send it to a third party. Let the processing plant pay for it (if the screening test was a false positive and the milk was dumped).” He said that he has heard quoted prices for conducting a precise residue test ranging from $2OO to $4OO per sample. But that compares to the thou sands of dollars an individual pro ducer can lose based on the current residue tests. To the individual, a loss of that can mean the end of the dairy farm. “Instead of a little freckled-face guy in California yelling and screaming,” Cullor said about his call for changes in residue testing procedures, if processors were to find out how expensive it is to pay for the false positives, then a group with strong political clout might be able to form that could get some thing done to correct the situation. “If tests perform then fine,” he said about his suggestion for pro cessors using backup testing and reimbursing the producer for wrongfully dumped milk, etc. "It spreads risk, responsibility, helps producers, and the consum er, it stills keep them protected. “But we can keep that vital resource, the dairy producer. They can maintain their ability to sup port their families and support the rest of the country that consumes their dairy products. “If you don’t do that, the insur ance industry is already con cerned,” he said. That statement was reinforced during the meeting in a talk by Robert Moser, a representative for Nationwide Insurance Co. In his presentation, Moser said, ‘Toward the end of January, I noticed a number of losses coming through with milk identified as a problem and the description of the loss indicating the cuase of the (as) antibiotics in the milk. “Our past history shows wc would have eight to 10 of these types of claims durmg a year. In January, we had more than this number in about three weeks.” He said he had all claims sent to him instead of going to an adjuster. Then he started making direct calls on the fanners making the claims. (The insurance policy covered these losses) And Moser started calculating the insurance company’s losses because of the laige number of milk dumpings. \ “With most of the trucks being two com partment trucks, this means that we would have to dump around 20,000 pounds and we looked at an average loss of around $2,500. “With this year’s esti -1 male of 100 claims, very j quickly our anticipated loss appears to be $230,000 this year. “This is in contrast to 1 10 claims in 1994 for a total loss of approxi mately $25,000.” He said that while in the past a farmer might tell him that he treated a , cow and her milk acci dently got in the tank, “When I started contact ing farmers this January and February, the story changed drastically. Most of the farmers said that they had not treated any of the animals recently and had no idea of what the problems were. “Some of the farmers even went so far as buy ing locks for their barns (Turn to Pago A2B)
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