. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/384
24 January 2001
(01-0381)
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, whereapplicable).  Regions or countries likely to be affected, to the extent relevant or
practicable:  Bioengineered foods
4. Title and number of pages of the notified document: Premarket Notice Concerning
Bioengineered Foods (32 pages)
5. Description of content:  The Food and Drug Administration (FDA) is proposing to require
the submission to the agency of data and information regarding plant-derived bioengineered
foods that would be consumed by humans or animals.  FDA is proposing that this
submission be made at least 120 days prior to the commercial distribution of such foods.
FDA is taking this action to ensure that it has the appropriate amount of information aboutbioengineered foods to help to ensure that all market entry decisions by the industry are
made consistently and in full compliance with the law.  The proposed action will permit the
agency to assess on an ongoing basis whether plant-derived bioengineered foods comply
with the standards of the Federal Food, Drug, and Cosmetic Act (the act).
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 4706,
18 January 2001 (Available in English)
9. Proposed date of adoption:  To be determined.
10. Proposed date of entry into force:  To be determined.G/SPS/N/USA/384
Page 2
11. Final date for comments:  3 April 2001
Agency or authority designated to handle comments:  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 Building
Stop 1027
1400 Independence Avenue, S.W.Washington, D.C. 20250
Phone:  (202) 720-2239
Fax:  (202) 690-0677
E-mail:  ofsts@fas.usda.gov