About FDA

Office of Research

"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."

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 radiolabelled materials laboratory, and many specialized laboratories designed for multidisciplinary studies. The animal research buildings accommodate beef cattle, dairy cattle, calves, swine, sheep, 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 specialized 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.

Investigators at the Office of Research possess expertise in a wide variety of scientific disciplines, including veterinary medicine, animal science, biology, chemistry, microbiology, immunology, epidemiology, pathology, and pharmacology.

The Division of Residue Chemistry, Office of Research, is responsible for the development and evaluation of analytical methods for drug residues in animal tissues, fluids, and feeds. These methods are used in regulatory programs and in research studies. The Division of Residue Chemistry conducts metabolism and pharmacokinetic studies that aid the Center for Veterinary Medicine in improving drug availability for minor uses and minor species. Regulatory scientists are able to develop better models for drug bioavailability, fate, and disposition. The division is also responsible for the review of drug residue diagnostic tests (screening tests) as well as determining accurate product labeling, suitable for use by industry and regulators of animal-derived foods such as milk.

The Division of Applied Veterinary Research (DAVR) conducts applied and basic research using terrestrial and aquatic 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.

The Division of Applied Veterinary Research (DAVR) conducts research to investigate the pharmacology of veterinary drugs, primarily in food-producing animals; the interactions between diet and drugs in food producing animals; the interactive effects of dietary, environmental, physiological, immunological, and genetic factors on drug metabolism; the regulatory problems associated with animal feeds; and new procedures and models to support the evaluation of the safety or efficacy of animal drugs. These research efforts support the scientific decision-making in the Center for Veterinary Medicine.

Current interests include developing new procedures and models for evaluating drug safety and efficacy, residue depletion of drugs in food producing animals, and pharmacological models for drug bioavailability. The Division uses a combination of approaches, including innovative proteomic and genomic models, microbiology, and analytical chemistry, in investigations into a variety of research areas for our stakeholders.

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 detection, identification, and characterization of microorganisms potentially harmful to animals and humans that may be present in food derived from animals or in animal feed as well as those organisms that cause animal diseases. DAFM's research focuses on the prevalence of bacterial pathogens in feed and on the development and spread of antimicrobial resistant bacteria in the food supply.

The Office of Research responsibilities include the following:

  • Develop and validate quantitative, qualitative analytical procedures for analyzing drugs, additives, and contaminants in animal tissues and feed.
  • Investigate the absorption, distribution, metabolism, and excretion of drugs, feed additives, and contaminants in food animals (including minor species).
  • Develop models for determining the safety and efficacy of veterinary drugs and food additives in domestic animals.
  • Determine the safety and efficacy of diagnostic agents and devices for animal use.
  • Investigate the effects of drugs, food additives, and contaminants on immunological and physiological functions of domestic animals.
  • Evaluate screening tests for drug residues in animal derived foods.
  • Investigate interactions between genetic factors and metabolism/disposition of drugs in food-producing animals.
  • Evaluate rapid screening tests for detecting foodborne pathogens in animal feed and the environment.
  • Develop programs for antibiotic sensitivity testing and molecular/genetic typing of bacteria.
  • Determine the characteristics of drug resistant pathogens in the environment.
  • Evaluate the general microbiological quality of feed/feedstuffs before and after processing.
  • Investigate potential biomarkers for animal diseases and for therapeutic response to pharmaceuticals.

Examples of Research

  • Methods that will allow for the detection of multiple classes of drugs and multiple drugs from 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 efficiency of regulatory laboratories at FDA and USDA. To date, Office of Research scientists have been successful in applying multiclass, multiresidue methodology based on liquid chromatography - tandem mass spectrometry for detecting up to thirty drugs in six drug classes in eggs, shrimp, finfish, honey, and animal feed.
  • Office of Research scientists are currently involved in several research projects focusing on the use of antimicrobials in the animal husbandry environment and the potential public health consequences. Research is needed to better understand foodborne bacteria at the genetic level, to identify features conferring survival in different environments, including exposure to antibiotics.  Projects currently in progress include: characterization of beta-lactam and quinolone resistance among veterinary and foodborne bacterial pathogens, and characterization of plasmids and other mobile genetic elements for their role as resistance gene transfer systems in foodborne bacterial pathogens.  In addition, OR directs the National Antimicrobial Resistance Monitoring System (NARMS) for enteric bacteria which examines trends in resistance among enteric pathogens from food animals, retail meat products and human clinical isolates.
  • The Office of Research is developing new ways to use genomic and proteomic information to identify biomarkers that will help in the diagnosis of disease and in the evaluation of drug efficacy.  The results of these research programs will aid in the development of targeted veterinary medical treatments and the monitoring of the response of individual animals.  Currently, Office of Research scientists are completing a proteomic analysis of milk proteins in cows with mastitis, and will soon initiate similar studies in goats.  The proteomic approach being developed in these models will help identify biomarkers that will aid in the assessment of therapeutic responses to anti-inflammatory and antimicrobial drugs.
  • The microbiology of feed commodities and finished feeds is not well characterized and its 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.
  • 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 in edible aquaculture species.  There are many drugs and chemicals that are used worldwide, but not approved for use in the United States.  Our scientists are working on methods to detect antimicrobials, hormones and other potential chemicals to ensure there are no harmful residues in the seafood we eat.
  • Research to facilitate the development of safe and effective therapeutic agents for use in aquaculture is being done by developing pharmacokinetic data in multiple 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 also conduct selected pivotal efficacy studies to facilitate approval of non-sponsored drugs.

 

Page Last Updated: 03/20/2015
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