December 8, 1999
ANTIMICROBIAL RESISTANCE DOCUMENTS AVAILABLE
FDA has made available three documents on antimicrobial resistance in food-producing animals. The first document is a "Risk Assessment on the Human Health Impact of Fluoroquinolone Resistant Campylobacter Associated with the Consumption of Chicken." To assist in evaluating the human health impact of antimicrobial use in animals, the Center contracted with a risk assessment expert to develop a risk assessment model. The risk assessment was intended to determine the feasibility of estimating risk to human health from resistant foodborne pathogens associated with the use of antimicrobials in food-producing animals. Specifically, a mathematical model was derived to relate the prevalence of fluoroquinolone resistant Campylobacter infections in humans associated with the consumption of chicken to the prevalence of fluoroquinolone resistant Campylobacter in chickens. The model could become a regulatory tool for assessing such risks in the future.
The second document is a revision of the "Guidance for Industry: Consideration of the Human Health Impact of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals" (CVM guidance document 78.) This guidance document now states that FDA believes it is necessary 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. To assess this impact, it may be necessary to evaluate 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.)
Many of the changes to the guidance document were made in the "conclusion" section, but lesser changes were made to other parts.
The third document is "FDA Response to Comments on A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals." FDA had published a notice of availability of "A Proposed Framework for Evaluating and Assuring the Human Safety of the Microbial Effects of Antimicrobial New Animal Drugs Intended for Use in Food-Producing Animals," also known as the Framework Document, in the January 6, 1999, Federal Register. FDA made the Framework Document available to the public to initiate discussions with the scientific community and other interested parties on the agency's thinking about appropriate underlying concepts to be used to develop microbial safety policies protective of the public health. On January 25 and 26, 1999, the FDA held a meeting of the Veterinary Medicine Advisory Committee (VMAC) on the Framework Document to allow members to publicly consider answers to specific questions.
FDA stated that it would review the transcript of the VMAC meeting and any comments on the Framework Document that were submitted to FDA Dockets Management Branch (Dockets) and publish an analysis. This document is the Agency analysis of the transcript from the VMAC meeting and more than 50 comments to the Docket on Guidance Document #78 and the Framework Document.
Individuals interested in these documents who do not have access to the internet may receive single copies of these documents by calling or writing CVM's Communications Staff at FDA/Center for Veterinary Medicine, HFV-12, 7500 Standish Place, Rockville, MD 20855, 301-594-1755. Send one self-addressed adhesive label to assist in processing your requests.
Issued by:
FDA, Center for Veterinary Medicine,
Communications Staff, HFV-12
7519 Standish Place, Rockville, MD 20855
Telephone: (240) 276-9300 FAX: (240) 276-9115
Internet Web Site: http://www.fda.gov/cvm
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