U.S. Food and Drug Administration

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1 U.S. Food and Drug Administration Notice: Archived Document The content in this document is provided on the FDA s website for reference purposes only. It was current when produced, but is no longer maintained and may be outdated.

2 Statement of J. RUSSELL BISHOP, Ph.D. DIRECTOR CENTER FOR DAIRY RESEARCH UNIVERSITY OF WISCONSIN-MADISON Before the FOOD AND DRUG ADMINISTRATION VETERINARY MEDICINE ADVISORY COMMITTEE Regarding NCIMS DRUG RESIDUE AVOIDANCE PROGRAM March 31, 1993

3 FDA VETERINARY MEDICINE ADVISORY COMMITIEE Good Afternoon my name is Dr. J. Russell Bishop, and I am the Director of the Center for Dairy Research at the University of Wisconsin-Madison, a member of the Executive Board of the National Conference on Interstate Milk Shipments (NCIMS), and a member of the NCIMS Drug Residue Committee. The National Conference on Interstate Milk Shipments is the cooperative program established by FDA, the States, and Industry which regulates the grade A milk supply in the United States. This program has been in existence for over forty years. I am here today to discuss the extensive monitoring network established by NCIMS to prevent and eliminate animal drug residues in our nation's milk f". supply. I believe my discussion today will provide an important element in your deliberations so that unnecessary fear about increased levels of animal drug residues reaching the consumer as a result of the pending approval of bst may be allayed. The monitoring network in prevention of animal drug residues is designed to provide a series of checks and balances so that milk containing harmful residues of animal drugs does not reach the consumer. Much effort and resources have gone into making the monitoring system what it is today. Let me describe some of the key elements of this vast network. NCIMS ESTABLISHES STRATEGIC PLAN In the spring of 1990 the Milk Industry Foundation (which represents 90% of the processing milk plants) joined with the National Dairy Board (who is responsible for milk 1

4 promotion) and the National Milk Producers Federation (who represent the producers and milk cooperatives) in sponsoring a research project at Virginia Polytechnic Institute and State University (VPI) to evaluate the efficacy of the screening test kits on the market. The research project at VPI had one simple goal: identify those tests that could detect the target levels for the seven classes of drugs commonly used to treat dairy cows, in order to provide the industry with accurate and economical tests which could then be used to improve and increase our milk monitoring efforts. It was the strategic plan of the National Conference on Interstate Milk Shipments (NCIMS) to recognize these tests for use by industry and to recommend a change in the Pasteurized Milk Ordinance (PMO) which would require each incoming milk tanker to be screened for animal drug residues prior to processing. The PMO is the uniform set of sanitary regulations which govern the sale of interstate grade A milk in the United States. The disc assay method which was previously used to detect betalactam drugs requires approximately 2 Y2 hours to provide results, making it difficult to test each incoming milk tanker in a timely manner. Current dairy plant receiving practices require rapid and reliable screening methods. VPI completed the research effort by conducting more than 20,870 evaluations on these test kits. Some tests methods were unsuccessful, while others were proven effective for detecting at or below the established "safe levels." CHANGES TO THE PASTEURIZED MILK ORDINANCE (PMO) 2

5 In May of 1991, the NCIMS adopted many significant changes to the PMO. These changes were fully endorsed by the states and the milk industry. The most significant changes were as follows: 1) Each incoming milk tanker is now required to be screened for beta-lactams prior to processing. Beta-lactams (e.g. penicillin) are the most commonly used medications on dairy cows and are especially effective in treating mastitis. 2) The industry is now required to immediately notify the state regulatory agency of any milk tanker found to test positive for an animal drug residue. This ensures proper disposition and trace back to the violative producer. 3) Language has been adopted in the PMO that requires industry to institute a random screening program for other classes of animal drugs if the Commissioner of FDA has reason to believe a potential public health problem exists with a particular drug class. FDA has established a national monitoring network of sampling using specific tests to determine potential problems. Immediately after the May 1991 conference, the industry advised their member companies to implement the testing of every incoming tanker using these methods. NCIMS encouraged the milk industry to begin using these tests, even before the mandated date, since the VPI results demonstrated that they were reasonably accurate and efficient. 3

6 NEW TESTING IMPLEMENTED These new requirements were mandated as of January 1, 1992, and I am pleased to report that this massive effort was implemented in a timely manner, and is presently in place. The new requirements present a significant milestone in assuring the public that the dairy industry is committed to employing the most stringent preventive health and safety requirements of any food product in our country. FARM QUALI1Y ASSURANCE PROGRAM INITIATED At the same time, NCIMS recognized that testing and monitoring is not the sole solution to controlling drug residues. The National Milk Producers Federation and the American Veterinary Medical Association jointly instituted a "10 point Milk and Dairy Beef Quality Assurance Program" designed to properly instruct farmers and veterinarians in the proper use of animal drugs and herd health management. The milk industry believes that information and education of producers and veterinarians will bring understanding and acceptance. Milk quality entails much more than screening for drug residues, and that prevention on the farm is the long term solution. Much hard work and effort have gone into implementing this program, thousands of quality assurance kits have been distributed to farmers, veterinarians and processors. It is the NCIMS strategic plan to one day replace the 4

7 philosophy of massive screening at the plant level and replace it with a quality assurance program accompanied by cowside testing on each dairy farm. However, until the dairy industry is satisfied with the efficacy of this type of program, we will continue to maintain a preventive barrier of testing at processing operations. INDUSTRY REPORTING SYSTEM The second part of the NCIMS plan was to set up a national reporting system to provide the results of federal, state and industry efforts. It was agreed that it is important to compile statistically relevant information concerning the extensive testing effort in order to reflect the safety of dairy products. In May of 1991, the NCIMS passed a requirement to establish a third party reporting system which was fully endorsed by the milk industry in order to eliminate any doubt about the integrity of industry screening results. This third party data collection requires states and industry to report the results of their screening efforts to a third party contractor established by FDA. While this system was being established, it was also important for the industry to institute their own reporting system in the interim. This was accomplished in early I would like to report to you the results of the Milk Industry Foundation's screening efforts for 1990 and Results of 1992 are presently being compiled. 5

8 RESULTS OF INDUSTRY SURVEY FOR 1990/1991 During each of the calendar years 1990 and 1991, MIF completed a survey of its member companies who process fluid milks in order to compile and assess the effectiveness of current screening efforts on incoming milk tankers. The surveys were also initiated to ascertain the extent to which newer, more sensitive screening methods were being utilized by the dairy processing industry. It should be noted that the results of the surveys reflect screening efforts before the mandated changes in the PMO, which began on January 1, Results of 1992 will be available very shortly. The surveys included responses from 264 Grade A plants out of 346 (76% response rate) processing plants in 1990, and 283 out of 367 (77% response rate) plants in In 1990, the volume of milk processed by the survey respondents represented 5.4 billion gallons, or 90% of the total volume of fluid milk processed, whereas, the 1991 survey represented 5.9 billion gallons or 92% of the total volume. The survey included plants in 46 states since there were no MIF plants in Alaska, Delaware, Rhode Island or Wyoming. The total number of tests conducted by MIF members in 1990 was 2,130,397 (2.1 million), and 2,195,321 (2.2 million) in 1991 (an increase of over 65,000 tests performed from the previous year). Of these totals, 2,540 (0.12%) were rejected as being positive in1990 and 1,797 (0.08%) w_e_r_e_z:.~j~<;ted as being positive in 1991 for animal drug residues. This represents a 33% reduction in the rejection rate from 1990 to Consequently, the milk 6

9 from these rejected tankers did not enter the milk processing chain. Of the responding processing plants, 100% of the plants were testing each incoming tanker before processing as compared to 96% the previous year. Again, these represent industry efforts prior to the new requirements which began on January 1, The results of the survey in 1991 showed that 99% of all the respondents were testing each milk tanker for beta-lactams (penicillin) compared to 98% in In addition plants have instituted random screening programs for other classes of the most commonly used animal drugs. In 1991, 45% were screening for sulfonamides, 42% for sulfamethazine and 36% for tetracyclines. It is expected that these numbers were significantly increased in More importantly, the results demonstrate that all of the plants have switched from using (\ 1 1 the disc assay method for screening drugs to those tests which VPI demonstrated were I --_ I I capable of detecting these specific classes of drugs at or below the targeted safe levels ( j established by NCIMS ~..J I believe that these results demonstrate the extensive progress made by NCIMS to meet the challenges of preventing animal drug residues in our nation's milk supply. NCIMS believes that we have the safest milk supply in the world and is committed to maintaining confidence in our nation's milk supply. The results of our efforts prove that without a ~oubt, our milk is safe and we believe that the protective screening barrier established will ensure that no harmful animal drug residues will reach the consumer. The dairy industry has taken 7

10 great strides to instill consumer confidence in our milk supply with dedication to product safety. However, we are concerned that allegations about increased use of animal drugs in relation to use of bst will once again cause unnecessary fear and negative publicity concerning the safety of milk. It is our contention that the massive monitoring network established by NCIMS provides an unparalleled level of safety for the nation's milk supply and consumers should remain confident that milk will remain safe. 8