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OFFICE OF SCIENCE -- FY 95 by Karen A. Kandra Objectives of CVM Research Programs The Center for Veterinary Medicine's Office of Science (OS) initiates research programs, both intramural and extramural, designed to provide a scientific basis for FDA decisionmaking. The objectives of these research activities are to provide the following:
Intramural Research Intramural research is conducted in response to a variety of needs such as, a) to develop, improve, or validate analytical methods and techniques; b) to develop better research methodology, procedures, or models to support the evaluation of the safety or efficacy of new animal drugs; c) to provide qualitative or quantitative assessments of risks associated with animal drugs, feed additives, or other xenobiotics; or d) to provide information for dissemination to the general public under the Center's education initiatives. In addition, OS provides a source of scientific expertise in specialized disciplines. Personnel engage in cooperative research studies with other research facilities, such as U. S. Department of Agriculture (USDA), FDA's National Center for Toxicological Research (NCTR), and the Animal Drug Research Center (ADRC) in Denver, CO. OS scientists are recognized by their peers, and often are requested to collaborate on research projects with scientists from institutions such as Georgetown University Medical Center, University of Maryland at Baltimore, and Auburn University. OS experts often serve as Project Officers and reviewers for scientific publications, or participate on scientific committees relating to their specific area of expertise. In FY 95, method trials of determinative procedures for gentamicin, ceftiofur, and thionin in milk were completed, and trials for spectinomycin, tilmicosin, pirlimycin, and phenylbutazone in milk were initiated. OS scientists expanded their efforts in evaluating applications for commercially available milk residue screening tests. The evaluations consist of intensive review and a 100 percent audit of all of the data submitted by the manufacturers and the independent laboratories. Approval of the tests by the AOAC-RI and CVM will gain acceptance of the use of the screening test by the National Conference on Interstate Milk Shipments and State regulatory laboratories. Since more than 4 million tests are used to evaluate the potential presence of beta-lactams in milk, the validity of the screening test results is critical for the milk industry to ensure the safety of the Nation's milk supply. During FY 95, intensive reviews were completed for screening tests for beta-lactams. Two specific tests for cloxacillin and one multiresidue sulfonamide test were evaluated and accepted, and evaluations of two additional beta-lactam tests were still ongoing at the end of the Fiscal Year. In addition, OS scientists addressed problems that arose with already marketed tests, due to complaints received. Intensive evaluations of screening tests for cow-side testing were continued under an interagency agreement with USDA's Agricultural Research Service. The ability to quantify sulfonamide residues in milk was developed at OS several years ago. In FY 95, a multiresidue confirmatory procedure capable of confirming the identity of all nine sulfonamides quantified by the official determinative procedure was developed at OS. Included in the nine sulfonamides are the four major ones detected by screening tests accepted by FDA for use on tanker truck milk. This provides the Agency with the most specific tool for identification, mass spectrometry, in a system that most regulatory laboratories already possess, GC/MS. This tool uses a well-defined extraction system that minimizes hazardous waste. Extramural Research Programs in extramural research are initiated to extend the intramural capability or develop new areas of research for which intramural resources are not available. This may be accomplished via contracts, grants, conference grants, cooperative agreements, and interagency agreements with universities, other government agencies, or private laboratories. In FY 95, the extramural research program consisted of 18 research-related projects, with a total budget of $1,410,412. The highest priority program areas in FY 95 were analytical methods development and drug metabolism/residue studies in aquatic animal species. Another high priority area involved the development of models for evaluating the effects of antimicrobials on human intestinal microflora. The primary objectives of the analytical methods program are: a) to develop multiresidue procedures that can reliably quantitate and confirm the identity of classes of drug residues, b) to develop methods for residues of unapproved drugs that may be used illegally in food-producing animals, and c) to develop chemical-based methods of analysis that can be used to confirm analytical results obtained with currently available antimicrobial screening assays for several approved classes of antibiotics used in food-producing animals. For FY 95, there were 6 projects in the analytical methods development program. There were also 4 projects in the aquatic animal species research program. Methods Development Program This research program is a coordinated effort involving intramural resources of FDA, USDA, and State regulatory agencies. The Methods Development Program conducts research on the development of regulatory methods of analysis for residues in animal-derived human food. Laboratories utilized are from Universities, FDA District offices, USDA's Agricultural Research Service and Food Safety Inspection Service, animal drug sponsors, and the Department of Health and Welfare in Canada. For FY 95, two mass spectrometric confirmatory procedures for tetracyclines and sulfonamides were developed. In addition, method trials of determinative procedures for gentamicin, ceftiofur, and thionin, were completed, and trials for spectinomycin, tilmicosin, pirlimycin, and phenylbutazone were initiated. These are just a few of the many scientific accomplishments by OS in FY 95. OS is looking forward to moving into its new state-of-the-art large animal research facility early in FY 97. Information about this new facility will be included in a future issue of the FDA Veterinarian.
prev | next Source: May/June 1996 FDA Veterinarian Newsletter |
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