. /.  WORLD TRADE  
ORGANIZATION  G/SPS/N/USA/994 
28 September 2004 
 (04-4077) 
Committee on Sanitary a nd 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 
3. Products covered (provide tariff item numbe r(s) as specified in national schedules 
deposited with the WTO; ICS numbers should be provided in addition, where 
applicable):  Shell Eggs, HS 0407 
4. Regions or countries likely to be affected , to the extent relevant or practicable:  
Trading partners who import shell eggs for consumption in the United States.  
5. Title, language and number of pages of the notified document:   Proposed Rule: 
Prevention of Salmonella  enteritidis in Shell Eggs During Production (82 pages;  available in 
English). 
6. Description of content:  The U.S. Food and Drug Administration (FDA) is proposing to 
require shell egg producer s to implement Salmonella  enteritidis (SE) measures to prevent 
SE from contaminating eggs on the farm.  FDA is taking this action because of the number of outbreaks of foodborne illnesses and deaths cau sed by SE that are associated with the 
consumption of shell eggs that have not b een treated to destroy this pathogen.  FDA 
expects that the requirements that it is proposing in this rule, if fina lized as proposed, will 
result in a significant decrease in the number of SE-contaminated eggs produced on farms.  Ultimately, FDA expects that the proposed re quirements in this rule will generate public 
health benefits through a decrease in the numbers of SE-associated illnesses and deaths 
caused by consumption of shell eggs. 
7. 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 
8. International standard, guideline or recommendation:  
[ X ] Codex Alimentarius Commission, [   ] World Organization for Animal Health 
(OIE), [   ] International Plant Protection Convention, [   ] None  
If an international standard, guideline or recommendation exists, give the appropriate 
reference and briefly identify deviations:   :  Proposal is consistent with recommendations 
in the Codex Alimentarius Committee on Food Hygiene's "Recommended International Code 
of Hygienic Practice for Eg g Products" CAC/RCP 15-1976. G/SPS/N/USA/994 
Page 2  
 
 9. Relevant documents and language(s) in which these are available:  Proposed rule, 
"Prevention of Salmonella Enteritidis in She ll Eggs During Production", contained in the 
Federal Register (FR) 69 FR 56824-56906, (a vailable in English, 82 pages) at:  
http://www.fda.gov/OHRMS/DOC KETS/98fr/04-21219.pd.pdf
 
http://www.fda.gov/OHRMS/DOC KETS/98fr/04-21219.htm  
10. Proposed date of adoption:   The date on which any rulemaking based on this proposal is 
finalized. 
11. Proposed date of entry into force:   For farms with 50,000 or more laying hens, one year 
from the date of publication in the Federal Register  of any final rule based on this proposal.   
For farms with less than 50,000 but at least 3,000 laying hens, two years from the date of 
publication in the Federal Register of any final rule based on this proposal. 
12. Final date for comments:  21 December 2004 
Agency or authority designated to handle comments:  [   ] 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 Dr ug Administration, 5630 Fishers Lane, rm. 
1061, Rockville, MD 20852, U.S.A.  It is possible to su bmit electronic comments to:   
http://www.fda.gov/dockets/ecomments .  Submit comments by indicating DOCKET 
Number 2000N-0504 and "Prevention of Salmone lla Enteritidis in Shell Eggs During 
Production". 
13. Texts available from:  [   ] National notificati on authority, [ X ] National enquiry point, 
or address, fax number and E-mail address (if available) of other body:  U.S. Enquiry 
Point, U.S. Department of Agriculture, Stop 1027, Washington, DC  20250.  Tel:  (202) 720-0677;  E-mail address:  fstsd@usda.gov
.  Complete text can be also be found on the 
Internet by looking under DOCKET No. 2000N-0504 at: http://www.fda.gov/ohrms/docke ts/dockets/dockets.htm
 or at  
http://www.fda.gov/OHRMS/DOC KETS/98fr/04-21219.pd.pdf   or  
http://www.fda.gov/OHRMS/DOC KETS/98fr/04-21219.htm .