. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/347
3 November 2000
(00-4653)
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:  US Food and Drug Administration
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:  Animal drugs
4. Title and number of pages of the notified document:  Enrofloxacin for Poultry;
Opportunity for Hearing (13 pages)
5. Description of content:
The Food and Drug Administration (FDA), Center for Veterinary Medicine (CVM), is
proposing to withdraw approval of the new an imal drug application (NADA) for use of the
fluoroquinolone enrofloxacin in poultry. This action is based on CVM's determinations that
the use of fluoroquinolones in poultry causes the development of fluoroquinolone-resistantCampylobacter, a human pathogen, in poultry; this resistant Campylobacter is transferred to
humans and is a significant cause of the development of resistant Campylobacter infections
in humans; and resistant Campylobacter infections are a human health hazard. Therefore,
CVM is proposing to withdraw the approval of  the new animal drug application for use of
enrofloxacin in poultry on the grounds that new evidence shows that the product has not
been shown to be safe as provided for in the Federal Food, Drug, and Cosmetic Act (the
act).
The full text of this 13 page Federal Register notice has nine sections including:
I. Fluoroquinolones Approved for Poultry Use;  II. Summary of the Bases for Withdrawing
the Approval;  III. Legal Context of th e Proposed Action;  IV. Development of
Antimicrobial Resistance As a Result of Drug Use in Animals;  V. Antimicrobial Resistance
Resulting From the Use of Fluoroquinolones in Poultry;  VI. Other Considerations;VII. Notice of Opportunity for a Hearing;  VIII. Environmental Impact; and IX. References.
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:G/SPS/N/USA/347
Page 2
8. Relevant documents and language(s) in which these are available: 65 FR 64954,
31 October 2000 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.
11. Final date for comments: Submit written appearances and a request for a hearing by
30 November 2000.  Submit all data and analysis upon which a request for a hearing reliesby 2 January 2001.
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:  Detailed instruction on where
and how to send comments is in the body of the full text - which will be sent upon requestto 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
USDA/FAS/FSTSD
ATTN: Carolyn F. Wilson
Room 5545 South Agriculture BuildingStop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Phone (202) 720-2239
Fax (202) 690-0677E-mail Address: ofsts@fas.usda.gov