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."

CVM is fortunate to have a state-of-the-art research complex containing offices, laboratories, animal buildings, and pastures. This facility includes mass spectrometry, microbiology, whole-genome sequencing, and stem cell  laboratories; analytical instrument rooms; a radiolabeled 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.

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

The Division of Residue Chemistry develops and evaluates analytical methods for drug residues in animal tissues, fluids, and feeds. These methods are used in regulatory programs and in research studies. The division conducts metabolism and pharmacokinetic studies that aid the Center for Veterinary Medicine in improving drug availability for minor uses and minor species. Using state-of-the-art instrumentation, regulatory scientists are able to develop better models for drug bioavailability, fate, and disposition. The division is also responsible for reviewing drug residue diagnostic tests (screening tests) and for determining accurate product labeling.

The Division of Applied Veterinary Research conducts 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.

DAVR conducts research to investigate the pharmacology of veterinary drugs, primarily in food-producing animals; interactions between diet and drugs in food producing animals; interactive effects of dietary, environmental, physiological, immunological, and genetic factors on drug metabolism; animal and public health problems associated with animal feeds; growth requirements and behavior of cultured stem cells, development of methods to differentiate tissues from genetically engineered animals, and new procedures and models to support the evaluation of the safety or efficacy of animal drugs. These research efforts support scientific and regulatory decision-making by the Center for Veterinary Medicine.

The research our division conducts to support our stakeholders spans a variety of disciplines including microbiology and analytical chemistry, and we employ innovative proteomic, genomic, and molecular methodologies, as well as advanced pharmacokinetic modeling, in our investigations. Current efforts include developing new procedures and models for evaluating drug safety and efficacy, conducting residue depletion of drugs in food-producing animals to address food safety concerns, developing bioassays to predict the efficacy of veterinary stem cells, and developing innovative pharmacological models for drug bioavailability assessments.

Aquaculture
The division houses a large aquaculture facility with multiple cold- and warm-water fishes. The aquaculture team performs drug incursion studies to determine the fate of approved and unapproved drugs in edible fish tissues, and standardizes antimicrobial susceptibility testing methods for aquatic bacterial pathogens to improve monitoring for antimicrobial resistance and to foster more judicious use of antimicrobials by the aquaculture industry. They study chemical and drug pharmacokinetics in edible tissues and organs from farmed fish species, develop identification methods for aquatic pathogens, and develop models of fish diseases to study drug effectiveness. This group of scientists also maintains the internationally used Phish-Pharm Database, which consists of close to 600 articles that include data from 175 aquatic species (fish and shellfish). This database is a valuable resource to investigators of drug metabolism in aquatic species as well as government and private organizations involved in the drug approval process for aquatic species.
 

The mission of the Division of Animal and Food Microbiology is to conduct basic and applied research to support regulatory decision-making by the Center for Veterinary Medicine. DAFM research programs seek to better understand the emergence, persistence, and spread of antimicrobial resistance, and to develop improved detection methods for pathogens and antimicrobial resistance. This research focuses on the detection, identification, and characterization of microorganisms potentially harmful to humans that may be present in food derived from animals or in animal feed, as well as those organisms that cause animal diseases.

In particular, DAFM's research explores how the use of antimicrobials in animals affects

  • Efficacy against pathogens
  • Changes in the host and environmental microbial ecology
  • Development of antimicrobial resistance in pathogenic and commensal microorganisms

Scientists in DAFM also provide laboratory support to the National Antimicrobial Resistance Monitoring System (NARMS). DAFM scientists perform phenotypic and genotypic tests to characterize bacteria isolated from retail meats. DAFM and NARMS scientists then use these data to evaluate and describe trends in the prevalence of antimicrobial resistance over time, which are included in the NARMS reports. In addition to the routine NARMS surveillance activities, DAFM scientists conduct pilot and other small surveillance studies designed to detect pathogens present in specific food commodities.
 

The Office of Research's responsibilities include the following:

  • Develop and validate quantitative and 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.
  • 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 methods for in vitro antimicrobial sensitivity testing and phenotypic and genotypic characteristics of bacteria.
  • Investigate mechanisms of antimicrobial resistance.
  • Investigate the effects of antimicrobial use in animals on
    • Efficacy against pathogens.
    • Changes in the microbial ecology of the host and environment.
    • Development of antimicrobial resistance in pathogenic and commensal microorganisms.
  • 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.
  • Develop methods for the identification of genetically engineered animals and animal products.
  • Investigate the physiology and growth of stem cells to ultimately use in veterinary therapeutics and stem cell therapies.
     

 

Page Last Updated: 07/03/2017
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