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Table of Contents
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"The Office of Research conducts applied research in support of current and evolving FDA regulatory issues. We work with our customers to provide research solutions that ensure the safety of animal derived food and animal health products. We seek to develop an internationally recognized research program in these areas."
Division of Residue Chemistry (DRC)
"DRC conducts analytical research for compounds which pose a potential health risk if found in animal tissue or feed. We develop and validate methods for official and research uses. We determine the fate of xenobiotics in animals to answer questions about their safety or efficacy."
The following methods for detection of melamine/cyanuric acid were developed by FDA's Office of Regulatory Affairs. For additional information or questions regarding them, please contact:
Jonathan Litzau, Forensic Chemistry Center (FCC), US FDA
(513) 679-2700 Ext. 268
Email: jonathan.litzau@fda.hhs.gov
Greg Mercer, Pacific Regional Laboratory – Northwest (PRL-NW), US FDA
(425) 483-4755
Email: greg.mercer@fda.hhs.gov
(Primary contact for “QEdit” reporting option)
Kevin Mulligan, Forensic Chemistry Center (FCC), US FDA
(513) 679-2700 Ext. 238
Email: kevin.mulligan@fda.hhs.gov
Division of Animal Research (DAR)
"The Division of Animal Research (DAR) conducts applied and basic research using animals and animal systems in support of current and evolving regulatory issues. We provide research solutions to issues of animal health, food safety of animal derived products, and other animal industry associated technologies."
Division of Food and Animal Microbiology (DAFM)
"The mission of the Division of Animal and Food Microbiology (DAFM) is to conduct basic and applied research to support regulatory decision-making by the Center for Veterinary Medicine. This research involves the isolation, identification and characterization of microorganisms potentially harmful to animals and humans. In particular, DAFM's research explores the effects of antimicrobial use in animals on: 1) efficacy against pathogens, 2) changes in the environmental microbial ecology, and 3) the development of antimicrobial resistance in pathogenic and commensal microorganisms."
CVM is fortunate to have a state-of-the-art research complex containing offices, laboratories, animal buildings, and pastures. This facility includes a mass spectrometry laboratory, analytical instrument rooms, a radioactive materials laboratory, and specialized laboratories designed for multi disciplinary studies. The animal research buildings accommodate beef cattle, dairy cattle, calves, swine, sheep, dogs, poultry, and a variety of aquatic species.
The Office of Research offers a unique combination of staff expertise and animal and laboratory facilities which enable the conduct of unparalleled food safety research. As a result, CVM welcomes the opportunity to work with other organizations through Cooperative Research and Development Agreements (CRADAs), Cooperative Agreements, Interagency Agreements, and Memoranda of Understanding.
The research group's responsibilities include the following:
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Develops and validates quantitative, qualitative analytical procedures for analyzing drugs, additives, and contaminants in animal tissues and feed.
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Investigates the absorption, distribution, metabolism, and excretion of drugs, feed additives, and contaminants in food animals (including minor species).
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Develops models for determining the safety and efficacy of veterinary drugs and food additives in domestic animals.
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Determines the safety and efficacy of diagnostic agents and devices for animal use.
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Investigates the effects of drugs, food additives, and contaminants on immunological and physiological functions of domestic animals.
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Evaluates screening tests for drug residues in animal derived foods.
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Investigates interactions between diet and drugs in food-producing animals.
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Evaluates rapid screening tests for detecting foodborne pathogens in animal feed and the environment.
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Develops programs for antibiotic sensitivity testing and molecular/genetic typing of bacteria.
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Determines the characteristics of drug resistant pathogens in the environment.
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Evaluates the general microbiological quality of feed/feedstuffs before and after processing.
Examples of Research
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Violative residues of neomycin have been detected in tissues of veal calves at slaughter. Producers of these calves have indicated that the calves had not been treated therapeutically with neomycin at any time during the production period. Neomycin is used in some milk replacers commonly fed to veal calves. The rationale for this use of neomycin has been that the drug is not absorbed from the gastrointestinal tract of animals and therefore will not cause a residue problem. Researchers found that neomycin is absorbed in young calves orally exposed to the drug and can result in residues of neomycin above tolerance in kidneys during the first few days following withdrawal of the medicated milk replacer.
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Metabolism studies utilizing radiolabelled drugs are conducted to determine if the drugs appear in the edible tissues and do they appear as the parent drug or as a metabolite. These studies are an important first step in the methods development process. Such a study was conducted with radiolabelled sarafloxacin in laying hens. Sarafloxacin was the major radioactive component found in both egg yolks and albumen. The radioactive residues declined rapidly (within two days) in egg albumen, but more slowly (seven days) in egg yolk.
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Methods that will allow for the detection of several classes of drugs as well as several drugs in each class are important to the monitoring of drug residues in animal tissues, milk, and eggs. These methods have the potential to greatly increase the number of samples regulatory laboratories of the FDA and USDA can analyze. To date, Office of Research scientists have been successful in combining over thirty drugs in four drug classes into a single method using liquid chromatography - tandem mass spectrometry.
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In response to the President’s Food Safety Initiatives, Office of Research scientists are currently involved in several research projects focusing on the use of antimicrobials in the animal husbandry environment and possible public health implications. Research is needed to determine if there are genetic mechanisms present among foodborne and veterinary bacterial pathogens that could confer cross-resistance to antimicrobials of public health concern. Projects currently in progress include: characterization of fluoroquinolone resistance among veterinary and foodborne bacterial pathogens; characterization of integrons as possible gene transfer systems among foodborne bacterial pathogens; and several microbiological surveys aimed at determining antimicrobial susceptibility data relevant to foodborne bacterial pathogens and commensals of interest in feeds, retail meats and the animal production environment.
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The microbiology of feed commodities and finished feeds is not well characterized and it’s connection to potential contamination of animal derived foods is not understood. OR's research is directed toward better understanding of the role feeds may play in transmission of foodborne pathogens into the animal production environment and their survival and dissemination within that environment. This research also involves examination of bacteria isolated from feed for their susceptibility to antibiotics. This activity may provide information about feed as a source of resistance determinants and also to indicate methods for mitigation of resistance associated with animal production.
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In the area of aquaculture research, our scientists are developing methods and models to facilitate surveillance of domestic and imported seafood products for the presence of illegal drugs/chemicals resulting from use in aquaculture. This involves developing methods for detecting residues of antimicrobial drugs and hormones that may be used in aquaculture and end up contaminating products derived from aquaculture Studies are also underway to determine pharmacokinetics of therapeutic drugs in multiple fish species in order to predict appropriate dosage regimens and withdrawal times.
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Research to facilitate the development of safe and effective therapeutic agents for use in aquaculture is being done by developing pharmacokinetic models for grouping different fish species. This will enable CVM and producer groups to predict the pharmacokinetics and thus, withdrawal times for numerous minor fish species for which drug approvals may be sought. Researchers at CVM will also be conducting selected pivotal studies to facilitate approval of non-sponsored drugs.
Hidden Powerpoint Slides
Web Page Updated by hd - October 17, 2008, 2:48 PM ET
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