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U.S. Department of Health and Human Services

Animal & Veterinary

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FDA Veterinarian Newsletter September/October 1999 Volume XIV, No V

FDA's Center for Veterinary Medicine (CVM) will sponsor a workshop entitled "Microbiological Safety of Drug Residues in Food" to be held on September 20-21, 1999. The Workshop will be held at the Doubletree Hotel, 1750 Rockville Pike, Rockville, Maryland 20852, from 8:00 a.m. to 6:00 p.m. on Monday, September 20, and from 8:00 a.m. to 2:00 p.m. on Tuesday, September 21. It will discuss the use of model systems to establish Acceptable Daily Intakes (ADIs) for antimicrobial drug residues in food.

The Workshop will focus on human consumption of new animal drug residues in food and direct effects on human intestinal microflora. The document 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" (CVM's Framework document) will not be discussed at the September 20-21 Workshop. Information about workshops on the Framework document will be announced in a future CVM UPDATE(s) and from CVM's Antimicrobial Resistance Page.

In January 1996, CVM published the availability of a guidance document entitled "Microbiological Testing of Antimicrobial Drug Residues in Food." This guidance document defines when antimicrobial drugs would be exempt from additional microbiological testing and when additional testing would be required. The document also establishes 1.5 mg/person/day as the ADI of microbiologically active residues that would be allowed in food without additional microbiological testing. The Center also expressed the intention of validating model systems that could be used to evaluate the effect of low levels of antimicrobial drugs on the human intestinal microflora. The guidance document, Micribiological Testing of Antimicrobial Drug Residues in Food, is available by calling or writing the FDA Veterinarian.

In 1995 and 1996, CVM funded research to validate an in vitro and an in vivo model system that could be used to set ADIs for antimicrobial drug residues in food based on perturbations of the human intestinal microflora. The results of this research will be presented at the September workshop. In addition, other methods for determining ADIs for antimicrobial residues used internationally and in Europe will also be presented and discussed. Based on the information presented and discussed at the workshop, CVM intends to reevaluate its guidance document for testing microbiological effects of antimicrobial residues on the human intestinal microflora.

Registration for the workshop is free. However, registration is required. For additional information and registration form, please contact Ms. Lynda Cowatch, CVM, FDA, HFV-150, 7500 Standish Place, Rockville, MD, 20855, telephone: (301) 827-5281 or FAX (301) 594-2298. A copy of the registration form is also available on the Home Page.

A limited number of rooms at a special rate have been set aside at the Doubletree Hotel for workshop participants. Due to this limited number, workshop participants are urged to contact the hotel as soon as possible to make their reservations. Please mention that you are planning to attend the "FDA Microbiological Safety Workshop," code B583, at the hotel. The telephone number for the Doubletree Hotel is 1-800-222-8733 or 301-468-1100, and the Fax number is 301-468-0163.