[Federal Register Volume 64, Number 163 (Tuesday, August 24, 1999)]
[Notices]
[Page 46205]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 99-21854]


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DEPARTMENT OF HEALTH AND HUMAN SERVICES

Food and Drug Administration


Microbiological Safety of Drug Residues in Food; Public Workshop

AGENCY: Food and Drug Administration, HHS.

ACTION: Notice of workshop.

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     The Food and Drug Administration (FDA), Center for Veterinary 
Medicine (CVM) will sponsor a workshop entitled ``Microbiological 
Safety of Drug Residues in Food.'' The workshop will discuss the use of 
model systems to establish acceptable daily intakes (ADI's) for 
antimicrobial drug residues in food. The workshop will focus on human 
consumption of new animal drug residues in food and their 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'' (the 
``framework'' document) will not be discussed at this workshop. 
Information about workshops on the framework document will be announced 
in a future Federal Register notice, CVM update(s), and on CVM's 
Internet home page, at ``http://www.fda.gov/cvm/fda/mappgs/
antitoc.html''.
    Date and Time: The workshop will be held on Monday and Tuesday, 
September 20 to 21, 1999, from 8 a.m to 6 p.m. on Monday and from 8 
a.m. to 2 p.m. on Tuesday.
    Location: The workshop will be held at The DoubleTree Hotel, 1750 
Rockville Pike, Rockville, MD, 20852, 301-468-1100.
    Contact: Lynda W. Cowatch, Center for Veterinary Medicine (HFV-
150), Food and Drug Administration, 7500 Standish Pl., Rockville, MD 
20855, 301-827-5281.
    Registration: The registration for the workshop is free. However, 
registration is required. For additional information and a registration 
form, please contact Lynda W. Cowatch at the above address. A 
registration form is also available on the CVM home page at ``http://
www.fda.gov/cvm/fda/mappqs/registration.html''.
     If you need special accommodations for a disability, please 
contact the DoubleTree Hotel at least 7 days in advance.
SUPPLEMENTARY INFORMATION: In the Federal Register of January 30, 1996 
(61 FR 3043), CVM published a notice of 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 may be necessary to establish the safety of 
antimicrobial drug residues in food. The document also establishes 1.5 
milligrams/person/day as the ADI of microbiologically active residues 
that would be allowed in food without additional microbiological 
testing. CVM 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.
     In 1995 and 1996, CVM initiated research to validate an in vitro 
and an in vivo model system that could be used to set ADI's 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 
ADI's for antimicrobial residues used internationally and in Europe 
will 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.

    Dated: August 17, 1999.
 Margaret M. Dotzel,
 Acting Associate Commissioner for Policy.
[FR Doc. 99-21854 Filed 8-23-99; 8:45 am]
BILLING CODE 4160-01-F