. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/703
15 May 2003
(03-2585)
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:  U.S. 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 consumption in the United States and certain food for animal
consumption in the United States, except fo r meat, poultry and egg products that are
exclusively regulated by the U.S. Department of Agriculture.
4. Regions or countries likely to be affected, to the extent relevant or practicable:
Trading partners who manufacture, process, p ack, or hold food intended for human or animal
consumption in the United States.
5. Title, language and number of pages of the notified document : Establishment and
Maintenance of Records Under the Public Health Security and Bioterrorism Preparedness
and Response Act of 2002 (52 pages;  available in English)
6. Description of content:  The U.S. Food and Drug Admi nistration (FDA) has issued a
proposed rule that would require domestic persons  that manufacture, process, pack, transport,
distribute, receive, hold or import food, and certain foreign facilities that manufacture,
process, pack or hold food intended for human or  animal consumption in the United States to
establish and maintain records.  Such record s are to identify the immediate previous sources
and immediate subsequent recipients of food.  The final version of the regulation would
implement section 306 of the Public Health Security and Bioterrorism Preparedness and
Response Act of 2002, which directs FDA to implement a final regulation establishing
recordkeeping requirements by 12 December 2003.  The establishment and maintenance of
records requirement is one of several tools th at will enable FDA to act quickly in responding
to a threatened or actual terrorist attack  on the U.S. food supply or other food-related
emergency by giving FDA information about a ll immediate previous sources and subsequent
recipients of food in a tracing investigation.  In  the event of an outbreak of food-borne illness,
such information will help FDA determine the source and cause of the event.  In addition, the
information contained in the records will enab le FDA to locate and notify the recipients of
the implicated food who might be impacted by  the outbreak.  Following publication of the
proposed rule, FDA will provide for a 60-day comment period.  FDA will consider these
comments as it develops the final rule, which will explain the final establishment and
maintenance of records requirement.  FDA plan s to issue the final rule by 12 December 2003.G/SPS/N/USA/703
Page 2
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 pests
The establishment and maintenance of records requirement 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 or other food related emergency by  allowing FDA to identify the immediate
previous sources and immediate subsequent recipients of food in a tracing investigation.
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 in the Federal Register  (FR), 68 FR No.90,  page 25187-25240 (9 May 2003)
(available in English)http://a257.g.akamaitech.net/7/257/2422/ 14mar20010800/edocket.access.gpo.gov/2003/pdf
/03-11460.pdf
10. Proposed date of adoption:   12 December 2003
11. Proposed date of entry into force:   The proposed rule would require all businesses, except
small and very small businesses, to comply w ith the final rule 6 months from its publication
in the Federal Register .  Small businesses (fewer than 500 but more than 10 full-time
equivalent employees) would have to comply within 12 months from publication of the final
rule, and very small businesses (10 or fewer full-time equivalent employees) would have to
comply within 18 months from publication of the final rule.
12. Final date for comments:  Submit written or electronic comments by 8 July 2003.
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:
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-0277 and Title of document:  Establishment and Maintenance of Records Under
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 Janis
U.S. Department of Agriculture, Stop 1027
Washington, DC  20250
Tel:  (202) 720-9047  Fax: (202) 720-0677E-mail:  fstsd@usda.gov
Complete text can also be found on the Internet at:
http://www.accessdata.fda.gov/scripts/oc/ohrms/index.cfm  by looking under DOCKET
No. 02N-0277 and at http://www.fda.gov/OHRMS/DOCKETS/98fr/03-11460.pdf