. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/389
29 January 2001
(01-0459)
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:  Department of Agriculture, Animal and Plant Health Inspection
Service - APHIS
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 vaccines
4. Title and number of pages of the notified document:  Draft Guidelines for Testing of
Residual Formaldehyde (VIC H Topic GL25) and Testing of Residual Moisture (VICH
Topic GL26); Notice of availability and request for comments (2 pages plus guidelines)
5. Description of content: Two draft guidelines, titled "Testing of Residual Formaldehyde"
and "Testing of Residual Moisture" have been developed by the International Cooperation
on Harmonization of Requirements for Registration of Veterinary Medicinal Products(VICH).  These draft guidelines provide, respectively, general requirements for residual
formaldehyde and residual moisture testing.  Because the guidelines apply to final product
testing for formaldehyde-containing veterinary vaccines and final product testing for
residual moisture in veterinary vaccines regulated by the Animal and Plant Health
Inspection Service under the Virus-Serum-Toxin Act, we are requesting comments on the
scope of each guideline and its provisions so that we may include any relevant public input
on the draft in the agency's comments to the VICH Steering Committee.
The International Cooperation on Harmonization of Technical Requirements for the
Registration of Veterinary Medicinal Products (VICH) is a unique project that brings
together the regulatory authorities of the European Union, Japan, and the United States and
representatives from the animal health industry in the three regions.  The purpose of VICH
is to harmonize technical requirements for veterinary products (both drugs and biologics).Regulatory authorities and industry experts from Australia and New Zealand participate in
an observer capacity.  The VICH initiative is conducted under the auspices of the
International Office of Epizootics.  The World Federation of the Animal Health Industry
(COMISA, the Confédération Mondiale de L'Indus trie de la Santé Animale) provides the
secretarial and administrative support for VICH activities.
6. Objective and rationale: [     ] food safety,  [  X ] animal health,  [    ] plant protection,
[    ] protect humans from animal/plant pest or disease, [     ] protect territory from
other damage from pests           G/SPS/N/USA/389
Page 2
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 7614,
24 January 2001 (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:  26 March 2001
Agency or authority designated to handle comments:  Animal and Plant Health
Inspection Service  [    ] 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 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 Building
Stop 10271400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov