. /.WORLD TRADE
ORGANIZATIONG/SPS/N/USA/173
16 July 1999
(99-2959)
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:  US Food and Drug Administration
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).
Regions or countries likely to be affected, to the extent relevant or practicable:  Shell
eggs
4. Title and number of pages of the notified document: "Food Labeling; Safe Handling
Statements; Labeling of Shell Eggs; Shell Eggs; Refrigeration of Shell Eggs Held for Retail
Distribution" (25 pages) and an additional related document "Preliminary Regulatory Impact
Analysis and Initial Regulatory Flexibility Analysis of the Proposed Rule to Require
Refrigeration of Shell Eggs at Retail and Safe Handling Labels" (18 pages).
5. Description of content: The Food and Drug Administration (FDA) is proposing to require
safe handling statements on labels of shell eggs that have not been treated to destroy
Salmonella microorganisms. The agency is also proposing to require that, when held by
retail establishments, shell eggs be stored and displayed under refrigeration at a temperature
of 7.2  deg.C (45  deg.F) or less. FDA is taking these actions because of the number ofoutbreaks of foodborne illnesses and deaths caused by Salmonella Enteritidis that are
associated with the consumption of shell eggs  that have not been treated to destroy this
pathogen. These actions complement regulations of the Food Safety and Inspection Service
(FSIS) that require that shell eggs be stored and transported at a temperature of 7.2  deg.C
(45  deg.F) or less and that the consumer containers of shell eggs be labeled to indicate that
refrigeration is required. FDA's proposal also responds, in part, to petitions from Rose Acres
Farm, Inc., and the Center for Science in the Public Interest (CSPI). FDA expects that byrequiring this information, consumers will be able to take measures to protect themselves
from illness or deaths associated with consumption of shell eggs that have not been treated
to destroy Salmonella Enteritidis.
6. Objective and rationale:  [  X ] food safety  [ X ] animal health [   ] plant protection
[  ] protect humans from animal/plant pest or disease  [  ]  protect territory from other
damage from pests
7. An international standard, guidelin e 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:  64 FR 36492,
6 July 1999;  21 CFR Parts 16, 101 and 115 (Available in English)
9. Proposed date of adoption:  To be determined.G/SPS/N/USA/173
Page 2
10. Proposed date of entry into force:  The date of adoption and entry into force will be
announced when the final rule is published in the Federal Register.
11. Final date for comments:   20 September 1999
Agency or authority designated to handle comme nts:  [  ] National notification authority,
[  ] National enquiry point, or address, fax number and E-mail address (if available) of
other body:   Food and Drug Administration
Detailed instruction on where and how to send commen ts is in the body of the full text – which
will be sent upon request to 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:
US SPS Enquiry Point/Notification Authority:
USDA/FAS/FSTD
Attn:  Carolyn F. Wilson
Room 5545 South Agriculture BuildingStop 1027
1400 Independence Avenue, S.W.
Washington, D.C. 20250
Tel:  (202) 720 2239
Fax::  (202) 690 0677E-mail address:  ofsts@fas.usda.gov