. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/489
17 August 2001
(01-4043)
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:  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, where
applicable).  Imported food products of animal origin  Regions or countries likely to be
affected, to the extent relevant or practicable:           
4. Title and number of pages of the notified document:  Import Tolerances (4 pages)
5. Description of content: The Food and Drug Administration is soliciting comment on issues
related to the implementation of the import tolerances provision in section 4 of the Animal
Drug 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 import tolerance willnot be considered adulterated under the Federal Food, Drug, and Cosmetic Act (the act) and
may be imported into the United States. We plan to propose a regulation for establishing
import tolerances. We plan to hold a public meeting on import tolerances during the
comment period for this advance notice of proposed rulemaking (ANPRM) and intend to
consider the comments made at the meeting and in response to this ANPRM in writing the
proposed regulation. We also will work with the Food Safety Inspection Service of the
United States Department of Agriculture and other Federal agencies in the development ofthe proposed regulation.
6. Objective and rationale: [  X ] food safety,  [     ] 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:  66 FR 42167,
10 August 2001 (available in English)
9. Proposed date of adoption:  To be determined
10. Proposed date of entry into force:  To be determinedG/SPS/N/USA/489
Page 2
11. Final date for comments:  10 December 2001
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:  Food and Drug Administration
The full text, which includes instructions for commenting, will be sent upon request
to the address in paragraph 12.
12. Texts available from: [     ] National notification authority, [     ] 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 Address: ofsts@fas.usda.gov