July 14, 1999
FDA SPONSORS WORKSHOP ON MICROBIOLOGICAL SAFETY OF DRUG RESIDUES IN FOOD
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. The workshop 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 on CVM's Internet Home 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. A copy of this guidance document may also be obtained 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. Please include a self-addressed adhesive label to assist in processing your request.
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.
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.
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
![]() |
||||||
![]() |
||||||
![]() |