. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/536
7 January 2002
(02-0071)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
1. Member to Agreement notifying:  UNITED STATES
If applicable, name of local government involved:           
2. Agency responsible:  Food and Drug Administration - FDA
3. Products covered (provide tariff item number(s) as specified in national schedules
deposited with the WTO; ICS numbers may be provided in addition, whereapplicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Drug residues
4. Title and number of pages of the notified document:  Assessment of the Effects of
Antimicrobial Drug Residues From Food of Anim al Origin on the Human Intestinal Flora;
Availability (3 pages plus guidance document)
5. Description of content:   The Food and Drug Administ ration (FDA) is announcing the
availability for comment of draft guidance fo r industry entitled "Assessment of the Effects
of Antimicrobial Drug Residues from Food of  Animal Origin on the Human Intestinal
Flora''.  This draft guidance is a revision of the guidance document no. 52 entitled"Microbiological Testing of Antimicrobial Drug Residues in Food", which was
implemented in 1996.  In this draft guidance, the agency recommends a pathway approach
for assessing the microbiological safety of antimicrobial drug residues in food, rather than
the approach described in the 1996 version of the guidance.  The agency's decision to revise
this guidance is based on new information available to the agency.
6. Objective and rationale: [  X ] food safety,  [     ] animal health,  [     ] plant protection,
[    ] protect humans from animal/plant pest or disease, [     ] protect territory from
other damage from pests           
7. An international standard, guideline or recommendation does not exist [  X ].
If an international standard, guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
8. Relevant documents and language(s) in which these are available:  66 FR 66910,
27 December 2001 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.G/SPS/N/USA/536
Page 2
11. Final date for comments:  You should submit comments concerning this draft guidance by
27 March 2002.  Submit written or electronic comments on the collection of information by
25 February 2002.
Agency or authority designated to handle comments:  Food and Drug Administration
[    ] National notification authority, [     ] National enquiry point, or address, fax
number and E-mail address (if available) of other body:  The full text, which includes
instructions for commenting, and the guidance document will be sent upon request to the
address in paragraph 12.
12. Texts available from: [  X ] National notification authority, [  X ] National enquiry point
or address, fax number and E-mail address (if available) of other body:
United States SPS Enquiry Point/Notification Authority
Attn:  Carolyn F. Wilson
Room 5545 South Agriculture Building
Stop 10271400 Independence Avenue, S.W.
Washington, D.C.20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov