WORLD TRADE  
ORGANIZATION   
G/SPS/N/USA/2280 
5 October 2011  
 (11-4821) 
Committee on Sanitary and Phytosanitary Measures Original:   English 
  
 
NOTIFICATION 
 
1. Notifying Member:  UNITED STATES 
If applicable, name of local government involved:    
2. Agency responsible:  Food Safety and Inspection Service, USDA 
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):  Specific raw beef products 
4. Regions or countries likely to be affected, to the extent relevant or practicable: 
[X] All trading partners   
[ ] Specific regions or countries:    
5. Title of the notified document:  Shiga Toxin-Producing Escherichia coli in Certain Raw 
Beef Products   Language(s):  English  Number of pages:  14  (pgs 58157-58165) 
 http://www.gpo.gov/fdsys/pkg/FR-2011-09-20/html/2011-24043.htm  
6. Description of content:  The Food Safety and Inspection Service (FSIS) intends to carry 
out verification procedures to ensure control of both Escherichia coli O157:H7 (E. coli O157:H7) and six other serogroups of Shiga toxin-producing E. coli (STEC) (O26, O45, 
O103, O111, O121, and O145).  The Agency in tends to implement sampling and testing for 
the additional STEC.  FSIS has determined that these six serogroups, as well as O157:H7, are adulterants of non-intact raw beef produc ts and product components within the meaning 
of the Federal Meat Inspection Act (FMIA). FSIS will initially sample raw beef manufacturing trimmings and other gr ound beef product components produced 
domestically and imported, and test the samples for these serogroups. FSIS is requesting 
comment on the following specific subjects: (1) FSIS regulatory sampling plan for non-O157 STEC for the above serogroups; (2) Sugges tions for baseline survey of non-O157 
STEC prevalence in certain raw beef products; (3) Whether a technical meeting on methods 
for controlling non-O157 STEC should be held during the comment period; (4) Whether to 
hold an additional public meeting on the plan for implementing the policy on non-O157 
STEC; (5) Validation guidance for pathogen detec tion test kits; (6) Preliminary estimates of 
the cost per test for non-O157 STEC; (7)  Esti mates of the loss to industry of diverting 
positive-testing product to cooking; (8) The u sefulness of technical workshops for small 
and very small establishments; (9) What obstacles might prevent establishments from 
adjusting to the FSIS policy on non-O157 STEC by March 5, 2012 and what alternative 
implementation date would be mo re practical; (10) What education, outreach, or training 
materials would be of greatest assistance to establishments in preparing for implementation 
of the Agency's policy; (11) For foreign gove rnments, what additional information would 
be helpful in addressing equiva lency or implementation concerns not already addressed in G/SPS/N/USA/2280 
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  this document and accompanying materials; (12) We are also requesting comment on the 
DRAFT Risk Profile for Pathogenic Non-O 157 Shiga Toxin-Producing Escherichia coli 
that we are making available at http://www.fsis.usda.gov/PDF/ Non_0157_STEC_Risk_Profile.pdf . 
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. Is there a relevant international stan dard?  If so, identify the standard:  
[ ] Codex Alimentarius Commission (e.g.  title or serial number of Codex standard 
or related text)   
[ ] World Organization for Animal Health (OIE) (e.g. Terrestrial or Aquatic 
Animal Health Code, chapter number)    
[ ] International Plant Protection Convention (e.g. ISPM number)    
[X] None Does this proposed regulation conform to the relevant international standard?   
 [ ] Yes   [ ] No 
 If no, describe, whenever possible, how and why it deviates from the 
international standard:    
9. Other relevant documents and language(s ) in which these are available:   
http://www.fsis.usda.gov/PDF/Validation_S tudies_Pathogen_Detection_Methods.pdf  
http://www.fsis.usda.gov/PDF/N on_O157_STEC_Risk_Profile.pdf  
10. Proposed date of adoption (dd/mm/yy) :  Not applicable 
Proposed date of publication (dd/mm/yy) :  Not applicable 
11. Proposed date of entry into force:  [ ] Six months from date of publication , and/or  
(dd/mm/yy) :  5 March 2012 
[ ] Trade facilitating measure   
12. Final date for comments:  [ ] Sixty days from the date of circulation of the notification 
and/or (dd/mm/yy) :  21 November 2011 
Agency or authority designated to handl e comments:  [ ] National Notification 
Authority, [ ] National Enquiry Point.  Address, fax number and e-mail address (if 
available) of other body:  Federal eRulemaking Portal: This Web site provides the ability 
to type short comments directly into the comment  field on this Web page or attach a file for 
lengthier comments. Go to http://www.regulations.gov . Follow the online instructions at 
that site for submitting comments. 
Mail, including floppy disks or CD-ROMs, a nd hand- or courier-delivered items: Send to 
Docket Clerk, US Department of Agriculture (USDA), FSIS, Docket Clearance Unit, 8-164, Patriots Plaza III, 355 E Street , SW, Washington, DC 20024-3221. 
Instructions: All items submitted by mail or electronic mail must include the Agency name 
and docket number FSIS-2010-0023. Comments received in response to this docket will be 
made available for public inspection and post ed without change, including any personal 
information, to http://www.regulations.gov .  G/SPS/N/USA/2280 
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  13. Texts available from:  [X] National Notification Authority, [ ] National Enquiry Point.  
Address, fax number and e-mail address (if available) of other body:   United States 
SPS National Notification Authority, USDA Fore ign Agricultural Service, International 
Regulations and Standards Division (IRSD), Stop 1014, Washington D.C. 20250;  Tel:  +(1 202) 720 1301;  Fax:  +(1 202) 720 0433;  E-mail:  us.s psenquirypoint@fas.usda.gov