WORLD TRADE
ORGANIZATIONG/SPS/N/USA/489/Add.1
11 December 2001
(01-6275)
Committee on Sanitary and Phytosanitary Measures Original:  English
NOTIFICATION
Addendum
The following communication, dated 7 December 2001, has been received from the
United States.
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Import Tolerances for Animal Drugs;  Extension of Comment Period
The Food and Drug Administration (FDA) is extending to 11 March 2002, the comment
period for the advance notice of proposed rulemaking (ANPRM) that appeared in the Federal Register
of 10 August 2001 and was notified as G/SPS/N/U SA/489.  The ANPRM gave notice that FDA was
proposing a regulation for establishing import tolerances.  The ANPRM was soliciting comments on
issues related to the implementation of the import tolerances provision in section 4 of the AnimalDrug Availability Act of 1996 (ADAA).  The ADAA authorizes FDA to establish drug residue
tolerances (import tolerances) for imported food products of animal origin for drugs that are used in
other countries, but that are unapproved new animal drugs in the United States.  Food products of
animal origin that are in compliance with the im port tolerance will not be considered adulterated
under the Federal Food, Drug, and Cosmetic Act and may be imported into the United States.  FDA is
taking action because it has rescheduled the public meeting on the issue and wishes to allow time for
the consideration of comments made after the meeting.
Submit written or electronic comments by 11 March 2002.The addendum, including instructions for commenting, is available from the address below:
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
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