. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/690
6 February 2003
(03-0780)
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 should be provided in addition, where
applicable):  Food for human and animal consumption, except for meat, poultry and egg
products that are exclusively regulated by the US Department of Agriculture
4. Regions or countries likely to be affected, to the extent relevant or practicable:
US trading partners, specifically US impor ters or purchasers of imported food for
consumption in the United States
5. Title, language and number of pages of the notified document:  Prior Notice of Imported
Food Under  the Public Health Security and Bioterrorism Preparedness and Response Act of
2002 (41 pages; available in English)
6. Description of content:   FDA has issued a proposed rule that would require US importers
or purchasers of imported food for human or animal consumption in the US to provide prior
notice to FDA of imported food shipments beginning on 12 December 2003.  The finalizedversion of the regulation would implement the Public Health Security and Bioterrorism
Preparedness and Response Act of 2002, which requires prior notice of imported food to
FDA to begin on 12 December 2003, even in the absence of final regulations.  Prior Notice
is one of several tools that will enable FDA to act quickly in responding to a threatened or
actual terrorist attack on the US food supply by giving FDA information about all importedfood for consumption in the United States.  Requiring prior notice of imported food
shipments will improve FDA's ability to detect accidental and deliberate contamination of
food and deter deliberate contamination.  In the event of an outbreak of food-borne illness,
such information will help both FDA and ot her authorities determine the source and cause
of the event.  Following publication of the proposed rule, FDA will provide for a 60-daycomment period.  FDA will incorporate its consideration of these comments into a final
rule, which will explain the finalized prior notice requirements.  FDA plans to issue the
final rule by 12 October 2003.
7. Objective and rationale:  [  X ] food safety, [ X ] animal health, [   ] plant protection,
[ X ] protect humans from animal/plant pest or disease, [   ] protect territory from other
damage from pestsG/SPS/N/USA/690
Page 2
8. International standard, gu ideline or recommendation:
[   ] Codex Alimentarius Commission, [   ] Office International des Epizooties,
[   ] International Plant Prot ection Convention, [ X ] None
If an international standard , guideline or recommendation exists, give the appropriate
reference and briefly identify deviations:
9. Relevant documents and language(s) in which these are available:  Notice of Proposed
Rulemaking published in the Federal Register at 68 FR 5428-5468 (available in English)
10. Proposed date of adoption:  12 December 2003.
11. Proposed date of entry into force:  12 December 2003.
12. Final date for comments:  Submit written or electronic comments by 4 April 2003
Agency or authority designated to handle comments:  Food and Drug Administration
[   ] National notification authority, [ X ] National enquiry point, or address, fax number
and E-mail address (if available) of other body:
Submit written comments on the document to the Dockets Management Branch (HFA-
305), Food and Drug Administration, 5630 Fishers Lane, rm. 1061, Rockville, MD 20852,
U.S.A.  It is possible to submit electronic comments to:
http://www.fda.gov/dockets/ecomments .  Submit comments by indicating DOCKET
No. 02N-0278 and TITLE Prior Notice of Imported Food Under  the Public Health Security
and Bioterrorism Preparedness and Response Act of 2002.
13. Texts available from:  [   ] 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 Point
Mr. William JanisU.S. Department of Agriculture
Stop 1027
Washington, DC 20250
Tel:  (202) 720-9047
Fax:  (202) 720-0677E-mail:  fstsd@usda.gov
Complete text can be also be found on the Internet at:
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  looking under DOCKET
No. 02N-0278 and at http://www.fda.gov/OHRMS/DOCKETS/98fr/03-2444.pdf