. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/172
14 July 1999
(99-2917)
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, where applicable).
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:  Animal Drug Availability Act;
Veterinary Feed Directive (7 pages)
5. Description of content: The Food and Drug Administration (FDA) has determined that
certain new animal drugs, vital to animal health, should be approved for use in animal feed,but only if such medicated feeds are administered under a veterinarian’s order and
supervision.  This limitation is important for a number of reasons.  For example, control of
the usage of certain antimicrobials is critical to reducing unnecessary use of such drugs in
animals and to slowing or preventing the development of bacterial resistance to
antimicrobial drugs.  FDA is proposing to amend the animal drug regulations to implementthe Veterinary Feed Directive (VFD) drugs section of the animal Drug Availability Act
(ADAA).  A VFD drug is intended for use in animal feeds, and such use of the VFD drug is
permitted only under the professional supervision of a licensed veterinarian.  The proposed
regulation would establish the requirements relating to the distribution and use of VFD
drugs and animal feeds containing VFD drugs.
6. Objective and rationale:  [  X ] food safety  [ X ] animal health [   ] plant protection
[  ] protect humans from animal/plant pest or disease  [  ]  protect territory from other
damage from pests
7. An international standard, guidelin e 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:  64 FR 35966,
2 July 1999;  21 CFR Parts 510, 514 and 558 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  The date of adoption and entry into force will be
announced when the final rule is published in the Federal Register.G/SPS/N/USA/172
Page 2
11. Final date for comments:   30 September 1999
Agency or authority designated to handle comme nts:  [  ] National notification authority,
[  ] National enquiry point, or address, fax number and E-mail address (if available) of
other body:   Food and Drug Administration
Detailed instruction on where and how to send commen ts is in the body of the full text – which
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:
US SPS Enquiry Point/Notification Authority:
USDA/FAS/FSTD
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 address:  ofsts@fas.usda.gov