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Proposed Rule

Shiga Toxin-Producing Escherichia coli in Certain Raw Beef Products

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Food Safety and Inspection Service, USDA.


Public meeting; extension of comment period.


The Food Safety and Inspection Service (FSIS) is announcing that it will hold a public meeting on the Agency's implementation plans and methods for controlling non-O157 Shiga toxin-producing Escherichia coli in raw, intact and non-intact beef products and product components. To provide stakeholders with ready access to the public meeting, FSIS will conduct the meeting by teleconference. This document provides information on the meeting.

In the Agency's September 20, 2011, document announcing these plans and methods (76 FR 58157), FSIS asked for comments on a variety of issues (76 FR 58164). That comment period, which was originally scheduled to end on November 21, 2011, is now being extended and will end on December 21, 2011.


The teleconference will be held on December 1, 2011, from 1 p.m. to 3 p.m. EST. Submit comments on or before December 21, 2011.


Registration: Pre-registration for this meeting is required. To pre-register, access the FSIS Web site, at​News/​Meetings_​&​_​Events/​. We are asking that anyone interested in making a public comment during the teleconference indicate so on the registration form. Call-in information for the teleconference will be provided and will be available on the FSIS Web site at the link listed above.

Public Comment: In addition to this teleconference, interested persons may submit comments on the Agency's implementation plans and methods for controlling non-O157 Shiga toxin-producing Escherichia coli in raw, intact and non-intact beef products and product components on or before December 21, 2011, using either of the following methods:

Federal eRulemaking Portal: Go to and follow the online instructions at that site for submitting comments. Mail, including floppy disks or CD-ROMs, and hand- or courier-delivered items: Send to U.S. Department of Agriculture (USDA), FSIS, OPPD, RIMD, Docket Clearance Unit, Patriots Plaza III, 8-164, 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 posted without change, including any personal information, to:

Docket: For access to background documents or comments received, go to the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday.

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For technical information: Contact Daniel Engeljohn, Assistant Administrator, Office of Policy and Program Development, at (202) 205-0495, or by fax at (202) 720-2025.

For teleconference information: Contact Joan Lindenberger, Public Affairs Specialist, Congressional and Public Affairs Office, by telephone at (202) 720-6755, or by email to

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I. Background

On September 20, 2011, FSIS published a document regarding non-O157 Shiga toxin-producing (STEC) Escherichia coli (E. coli). The document also requested comments regarding the Agency's implementation plans and methods for controlling these pathogens in raw, non-intact beef products and product components (76 FR 58157). The comment period was set to end on November 21, 2011.

In the September document, FSIS announced that it intends to carry out verification procedures, including sampling and testing of manufacturing trim and other raw ground beef components, to ensure control of both E. coli O157:H7 and six other serogroups of STEC E. coli (O26, O45, O103, O111, O121, and O145). FSIS has determined that they, as well as O157:H7, are adulterants of non-intact raw beef products and product components within the meaning of the Federal Meat Inspection Act. The Agency also announced that it is publishing guidance for use in validating commercial pathogen detection test kits that may be capable of detecting the STEC of concern.

Finally, FSIS stated that it is planning a survey of its field personnel who are stationed in beef slaughtering and processing establishments, similar to the 2007 “checklist” survey, to determine the processing practices that are employed to reduce the likelihood of contamination of intact and non-intact beef product with these STEC.

In October 2011, the Agency announced its planned revision to the FSIS Microbiology Laboratory Guidebook (MLG) 5B, “Detection and Isolation of Non-O157 Shiga-Toxin Producing Escherichia coli (STEC) from Meat Products,” to expand laboratory testing for the detection of the six targeted serogroups. Chapters MLG 5B.01, MLG 5B Appendix 1.00, MLG 5B Appendix 2.00 and MLG Appendix 1.06 are now available at​Science/​Microbiological_​lab_​guidebook/​index.asp.

FSIS intends to use these methods, beginning March 5, 2012, in testing raw ground beef or in source material used to make ground beef, as well as mechanically tenderized steaks and roasts, for E. coli serogroups O26, O45, O103, O111, O121 and O145. If the Agency finds any of those serogroups in these types of products, it will prohibit the product from entering commerce. Like E. coli O157:H7, these serogroups can cause severe illness and even death; young children and the elderly are at highest risk. The Centers for Disease Control and Prevention also identifies these particular serogroups as those responsible for the greatest numbers of non-O157 STEC illnesses, Start Printed Page 72332hospitalizations and deaths in the United States.

Beef slaughter and further processing plants should now begin to assess their food safety systems to ensure that they are capable of controlling these pathogens. Given FSIS's planned course of action, establishments that produce the listed products should take steps to ensure that the laboratory test they use to verify the controls they employ is effective in reliably detecting the presence of these pathogens. Establishments can rely upon the FSIS laboratory methodology released in October and updated on November 4, 2011, which has been demonstrated to reliably identify these pathogens, or they can use an equivalent methodology of their choice.

II. Purpose of the Meeting and Agenda

To provide the public with an opportunity to comment on the Agency's implementation plans and methods for controlling non-O157 STEC in raw, intact and non-intact beef products and product components, FSIS will hold a public meeting by teleconference. The meeting will be held on December 1, 2011. Submit comments on or before December 21, 2011. The teleconference format is being used to provide individuals with easier access to the meeting, particularly those who may lack the resources or time to attend a meeting in person. Access to the 800 number for the teleconference number should be toll free for both domestic and international callers.

Interested persons are encouraged to join the teleconference at or near the start time. FSIS may end the teleconference early if participants are no longer calling in to make comments.

III. Transcripts

As soon as the meeting transcripts are available, they will be accessible at The transcripts may be viewed at the FSIS Docket Room, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza III, 8-164, 355 E Street SW., Washington, DC 20024-3221.

Additional Public Notification

FSIS will announce this document online through the FSIS Web page located at​regulations_​&​_​policies/​Federal_​Register_​Notices/​index.asp.

FSIS will also make copies of this Federal Register publication available through the FSIS Constituent Update, which is used to provide information regarding FSIS policies, procedures, regulations, Federal Register notices, FSIS public meetings, and other types of information that could affect or would be of interest to constituents and stakeholders. The Update is communicated via Listserv, a free electronic mail subscription service for industry, trade groups, consumer interest groups, health professionals, and other individuals who have asked to be included. The Update is also available on the FSIS Web page. In addition, FSIS offers an electronic mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at​News_​&​_​Events/​Email_​Subscription/​. Options range from recalls to export information to regulations, directives and notices. Customers can add or delete subscriptions themselves, and have the option to password protect their accounts.

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Done at Washington, DC, on November 18, 2011.

Alfred V. Almanza,

Administrator, FSIS.

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[FR Doc. 2011-30271 Filed 11-18-11; 4:15 pm]