April 19, 2000
CVM REQUESTS INFORMATION AND COMMENTS ON ANTIMICROBIAL RESISTANCE RISK ASSESSMENT
FDA's Center for Veterinary Medicine (CVM) plans to develop a prototypic risk assessment (RA) model that accounts for the transfer of resistance determinants from bacteria in food-producing animals to bacteria in humans via food. FDA's CVM is asking for comments on its approach to the RA, and requesting scientific data and information relevant to the conduct of the RA. This will be CVM's second antimicrobial resistance risk assessment.
A draft of the Center’s first antimicrobial resistance risk assessment model and associated documents are available on the Internet. The first risk assessment modeled the human health impact of fluoroquinolone resistant Campylobacter infections associated with the consumption of chicken. It assessed the direct transfer of resistance. FDA's CVM plans to finalize the draft risk assessment by early summer.
This second risk assessment would account for both the direct and indirect transfer of resistance, i.e., acquisition of resistant bacteria and the transfer of resistance determinants from bacteria in food-producing animals to bacteria in humans. Specifically it will attempt to assess the association between the presence of streptogramin (quinupristin/dalfopristin) resistant Enterococcus faecium in humans and the use of streptogramins (virginiamycin) in food-producing animals.
FDA's CVM is asking for comments and data to help the Agency develop a science-based RA model. For the RA to become a useful regulatory tool, it must be based on high quality, historical and contemporaneous data gathered in the U.S. or from populations demonstrated to be representative of the U.S. population.
In the January 6, 1999, Federal Register, FDA published a notice of availability of a discussion paper entitled "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" (Framework Document). This document sets out a conceptual risk-based process for evaluating the microbial safety of antimicrobial drugs intended for use in food-producing animals. The proposed RA furthers the tenets of the Framework Document by developing a risk assessment model to quantify the potential human health impact of resistance development in human bacteria as a result of the transfer of resistance determinants to human bacteria from those of food-animal origin.
Single copies of the Framework Document are available through CVM’s Home Page. Copies also may be obtained by writing to the Communications Staff (HFV-12), Center for Veterinary Medicine, Food and Drug Administration, 7500 Standish Place, Rockville, MD 20855.
Additional information about this request for information and comments is included in an April 19, 2000, Federal Register, and from Dr. Nicholas Weber, Center for Veterinary Medicine (HFV-150), Food and Drug Administration, 7500 Standish Place, Rockville, MD, 20855, 301-827-6986, FAX 301-594-2298, or e-mail nweber@cvm.fda.gov.
Comments, scientific data, and information should be submitted by June 19, 2000. Please note that FDA will accept comments, data, and information after the deadline, but to assure consideration by the Agency, we must receive them by that date. Comments, scientific data, and information should be sent to the Dockets Management Branch (HFA-305) Food and Drug Administration, 5630 Fishers Lane, Room 1061, Rockville, MD 20852.
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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