. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/576
11 April 2002
(02-1979)
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 biologics
4. Title and number of pages of the notified document:  Viruses, Serums, Toxins, and
Analogous Products;  Standard Requirements for Determination of Residual Free
Formaldehyde Content of Biological Products (3 pages).
5. Description of content:  The Animal and Plant Health Inspection Service, USDA, is
proposing to amend the Virus-Serum-Toxin Act regulations for the determination ofresidual free formaldehyde in veterinary biologics.  This amendment would specify that
such determinations be made using the ferric chloride method, and that the residual free
formaldehyde content be measured in grams per liter.  We are proposing this amendment
because the ferric chloride method has been adopted as an international standard by
scientific experts and regulatory authorities in the United States, Canada, Japan, and the
European Union.  The effect of the proposed amendment would be to reduce the differences
in technical requirements for veterinary biologics among regulatory agencies in differentcountries and further ensure the safety and shelf life of veterinary biologics by adopting a
method which has been standardized and accepted internationally.
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           
7. An international standard, guideline or recommendation does not exist [ X ]
APHIS is proposing this amendment because the ferric chloride method has been adopted as
an international standard by scientific experts and regulatory authorities in the United
States, Canada, Japan, and the European Union.
8. Relevant documents and language(s) in which these are available: 67 FR 16327,
5 April 2002 (Available in English)
9. Proposed date of adoption:  To be determined.G/SPS/N/USA/576
Page 2
10. Proposed date of entry into force:  To be determined.
11. Final date for comments:  APHIS will consider all comments we receive that are
postmarked, delivered or e-mailed by 4 June 2002.
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:  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