Quality control and safety of animal products

This paper discusses the new animal drug approval process regulated by the Center for Veterinary Medicine (CVM), Food and Drug Administration (FDA) of the United States. The Center for Veterinary Medicine of FDA considers two criteria in ensuring the human food safety of edible animal products: i) safety of the chemical residues and ii) for antimicrobial products, microbiological safety including changes in bacterial pathogen load and resistance pattern. The hazard associated with animal drug products of non-carcinogenic compounds is assessed by conducting a standard battery of toxicology test, whereas the hazard from the carcinogenic potential of compounds is evaluated based on structure, results of genetic toxicity tests, and toxicology studies. Post approval monitoring is carried out to ensure that the animal drugs are being used properly after their approval. Particular concern is given to those eliciting an an "acute" toxic reaction at relatively low levels. The other aspect of food safety regulated by CVM of FDA is microbiological safety, especially to antimicrobial drugs used at subtherapeutic levels in feeds. The studies are designed by FDA to ensure that antibiotic treatment of food-producing animals does not alter pathogen load or resistance pattern of pathogens. Two studies are generally performed: i) the salmonella shedding study, which addresses the effect of drug treatment on the excretion of salmonella in the feces of animals artificially infected with salmonella; and ii) the coliform resistance study, which monitors the effect of the drug on the resistance pattern of E. coli present in the endogenous fecal flora. After a retrospective study of the microbiological safety over past 20 yr, CVM of FDA is planning to revise some microbiological safety studies with focuses on: i) pathogen load, pathogen excretion and microorganism resistance pattern at the time of slaughter; and ii) susceptibility studies on products that have utility in human medicine.