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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter July/August 2001 Volume XVI, No IV

FDA's Center for Veterinary Medicine (CVM) contracted with Exponent of Alexandria, Virginia to conduct a review of published literature on the effect of using antimicrobials in food-producing animals on pathogen load. This review has been completed, and the report is available on the CVM Home Page. Requests for paper copies of this document may be submitted to the FDA Veterinarian.

In November 1998, FDA's CVM published in the Federal Register a notice of availability for the draft guidance document entitled "Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" (Guidance for Industry #78). In this guidance document, CVM stated that the Agency intended to consider the potential human health impact of the microbial effects associated with all uses of all classes of antimicrobial new animal drugs intended for use in food-producing animals. The guidance said that in order to assess this impact, it may be necessary to evaluate the following two separate, but related aspects: 1) the rate and extent of development of antimicrobial drug resistant enteric bacteria formed in the animal's intestinal tract following exposure to the antimicrobial new animal drug (resistance); and 2) changes in the number of enteric bacteria in the animal's intestinal tract that cause human illness (pathogen load).

On February 22-24, 2000, CVM held a public scientific meeting on pre-approval studies in antimicrobial resistance and pathogen load. The purpose of this workshop was to discuss the appropriate designs for pre-approval studies to evaluate the potential microbial effects associated with the use of antimicrobial drugs in food-producing animals. The slide presentations from this meeting as well as the complete transcripts are available on the CVM Home Page). At the February 2000, meeting, CVM received numerous comments questioning the relevance of conducting studies to try to assess the impact of drug effects on pathogen load.

CVM recognizes that scientific information in this area is limited and acknowledges the concerns raised at the February 2000 public meeting. Therefore, in an attempt to gather additional information on the topic, CVM contracted with Exponent to conduct this literature review entitled "Effect of the use of antimicrobials in food-producing animals on pathogen load: Systematic review of the published literature."

This report represents just one component of CVM's ongoing effort to complete a thorough review of the pathogen load issue and to develop appropriate policy in this area. CVM is planning to seek further scientific input on this issue and will announce its intentions in the near future. Additional comments on the pathogen load issue or comments on the report may be submitted to FDA's Dockets Management Branch, (HFA-305), Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD, 20852; or faxed to (301) 827-6870. Please refer to Docket No. 98D-0969 in your submission.

Further information on the report is available from Dr. William T. Flynn, Center for Veterinary Medicine (HFV-1), Food and Drug Administration, 7519 Standish Place, Rockville, MD 20855, 301-827-4514.