. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/495
4 September 2001
(01-4205)
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
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:  Veterinary drug residues
4. Title and number of pages of the notified document:  International Cooperation on
Harmonization of Technical Requirements for Approval of Veterinary Medicinal Products(VICH);  Draft Guidance for Industry on "Studies to Evaluate the Safety of Residues of
Veterinary Drugs in Human Food:  Carcinogenicity Testing" (VICH GL28);  Request for
Comments;  Availability (2 pages and draft guidance)
5. Description of content:  The Food and Drug Administra tion (FDA) is announcing the
availability of a draft guidance for industry (#141) entitled "Studies to Evaluate the Safety
of Residues of Veterinary Drugs in Human Food:  Carcinogenicity Testing" (VICH GL28).
This draft guidance has been adapted for veterinary use by the International Cooperation onHarmonization of Technical Requirements for Registration of Veterinary Medicinal
Products (VICH) from a guidance regarding pharmaceuticals for human use, which was
adopted by the International Conference on Harmonization of Technical Requirements for
Approval of Pharmaceuticals for Human Use (ICH).  The objective of this draft VICH
guidance document, when final, will be to help ensure that the assessment of carcinogenic
potential is appropriate to human exposure through residues of veterinary drugs in food in
the European Union, Japan and the United States.
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 45319,
28 August 2001 (available in English)
9. Proposed date of adoption:  To be determined
10. Proposed date of entry into force: To be determinedG/SPS/N/USA/495
Page 2
11. Final date for comments:  Submit comments on the draft guidance by 28 September 2001.
Comments should be submitted through your own VICH representative.
Agency or authority designated to handle comments:  [     ] National notification
authority, [     ] National enquiry point, or address, fax number and E-mail address (if
available) of other body:
The Food and Drug Administration.
The full text which includes instructions for commenting 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
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) 690-0677
E-mail address:  ofsts@fas.usda.gov