. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/370
20 December 2000
(00-5566)
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 - 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:  Veterinary medicinal products
4. Title and number of pages of the notified document:  International Cooperation on
Harmonisation of Technical Requirements for Registration of Veterinary Medicinal
Products (VICH);  Draft Guidance on "Safety Studies for Veterinary Drug Residues in
Human Food: Reproduction Studies" (VICH GL22);  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(2 pages plus draft guidance)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availability for comment of a draft guidance for industry (#115) entitled "Safety Studies forVeterinary Drug Residues in Human Food:  Reproduction Studies" (VICH GL22).  This
draft guidance has been adapted for veterinary use by the International Cooperation on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 evaluate the reproduction safety ofveterinary drug residues in human food.  This draft guidance is intended to provide
harmonized guidance on the core recommendation for a multigeneration study for the safety
evaluation of veterinary drug residues in human food.  The current draft guidance is one of a
series of guidances developed to facilitate the mutual acceptance of safety data necessary
for the determination of acceptable daily intakes for veterinary drug residues in human foodby the relevant regulatory authorities.  Th e guidance on the overall strategy for the safety
evaluation of veterinary residues in human food (VICH Guidance on General Testing
Approach) will be made available at a later time. VICH GL22 was developed after
consideration of the existing ICH guidance for pharmaceuticals for human use on
"Detection of Toxicity to Reproduction for Medicinal Products" and its addendum,"Toxicity to Male Fertility" in conjunction with the current practices for evaluating
veterinary drug residues in human food in the European Union, Japan, the United States,
Australia, and New Zealand.G/SPS/N/USA/370
Page 2
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 79373,
19 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.
11. Final date for comments:  20 February 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 BuildingStop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Phone:  (202) 720-2239
Fax:  (202) 690-0677E-mail:  ofsts@fas.usda.gov