. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/367
20 December 2000
(00-5575)
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:  Veterinary medicinal products
4. Title and number of pages of the notified document:  International Cooperation on
Harmonisation of Technical Requirements for Approval of Veterinary Medicinal Products
(VICH);  Draft Guidance for Industry on "Safety Studies for Veterinary Drug Residues in
Human Food: Genotoxicity Studies" (VICH GL23);  Availability;  Request for Comments
(2 pages plus draft guidance)
5. Description of content:  The Food and Drug Administra tion (FDA) is announcing the
availability for comment of a draft guidance document for industry (No. 116) entitled"Safety Studies for Veterinary Drug Residues in Human Food:  Genotoxicity Studies"
(VICH GL23).  This draft guidance document has been adapted for veterinary use by the
International Cooperation on Harmonisation 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 Harmonisation of
Technical Requirements for Approval of Pharmaceuticals for Human Use (ICH).  This draft
VICH guidance document recommends a basic battery of tests that can be used to evaluatethe genotoxicity of veterinary drug residues in human food in the European Union, Japan,
and the United States.
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, 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: 65 FR 79106,
18 December 2000 (Available in English)
9. Proposed date of adoption:  Will be published as future guidance.
10. Proposed date of entry into force:  Same as paragraph 9.G/SPS/N/USA/367
Page 2
11. Final date for comments:  17 January 2001
Agency or authority designated to handle comments:  US 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 Building
Stop 1027
1400 Independence Avenue, S.W.Washington, D.C. 20250
Phone:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov