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Sampling and Testing Procedures for Escherichia coli O157:H7 in Beef Manufacturing Trimmings

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Food Safety and Inspection Service (FSIS), USDA.


Notice of public meeting.


The Food Safety and Inspection Service (FSIS) is announcing that it will hold a public meeting on October 14 and 15, 2008, to discuss sampling and testing procedures used by FSIS and industry for Escherichia coli (E. coli) O157:H7 in beef manufacturing trimmings and draft guidance to industry concerning this pathogen. Copies of the guidance materials are available on the FSIS Web site.


The public meeting will be held on October 14 and 15, 2008.


The public meeting will be held from 1 p.m. to 4:30 p.m. on October 14 and from 8:30 a.m. to 4 p.m. on October 15 at: L'Enfant Plaza Hotel, 480 L'Enfant Plaza, SW., Washington, DC 20024, (202) 484-1000. FSIS invites interested persons to submit comments on the issues addressed at the public meeting. FSIS will finalize an agenda on or before the meeting date and will post it on the FSIS Web page​News?​Meetings_​&​_​Events/​. The official transcript of the meeting will be available for viewing by the public in the FSIS Docket Room and on the FSIS Web site​News?​Meetings_​&​_​Events/​ when it becomes available.

Comments may be submitted by either of the following methods:

Federal eRulemaking Portal: Go to 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 Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, FSIS Docket Room, 1400 Independence Avenue, SW., Room 2534, Washington, DC 20250.

All submissions received must include the Agency name and docket number FSIS-2008-0035. Documents referred to in this notice, and all comments submitted in response to this notice will be available for public inspection in the FSIS Docket Room at the address listed above between 8:30 a.m. and 4:30 p.m., Monday through Friday, except Federal holidays. Comments also will be posted on the Agency's Web site at​regulations_​&​_​policies/​2008_​Notices_​Index/​index.asp.

Individuals who do not wish FSIS to post their personal contact information—mailing address, e-mail address, telephone number—on the Internet may leave this information off of their comments.

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Pre-registration for this meeting is recommended. To pre-register, go to the FSIS Web site at​News_​&​_​Events/​Reg_​Ecoli_​101408/​index.asp.

For additional information, please contact Keith Payne by telephone at (202) 690-6522 or by e-mail at Persons requiring a sign language interpreter or special accommodations should contact Keith Payne as soon as possible.

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The presence of E. coli O157:H7 in raw beef products continues to be a concern to FSIS. Based on E. coli O157:H7 test results from FSIS, other Federal and State entities, and industry, E. coli O157:H7 continues to contaminate finished product. Controls in food safety systems, including sanitary dressing procedures, do not consistently prevent, eliminate, or reduce E. coli O157:H7 to an undetectable level. Therefore, testing may be a means to ensure that contaminated product does not enter commerce. The meeting will focus on sampling and testing of beef manufacturing trimmings for E. coli O157:H7.

Issues To Be Discussed at the Public Meeting

FSIS will discuss the issues associated with the uniformity and Start Printed Page 60231consistency of sampling and testing procedures used by FSIS and industry for E. coli O157:H7 in beef manufacturing trimmings and to solicit comment on how to improve uniformity and consistency in such sampling and testing. FSIS will also discuss the laboratory enrichment procedure that it began using in January 2008 (73 FR 53406; September 16, 2008) and its likely impact on sensitivity for identifying more positives in beef.

The discussion will also include the draft “Compliance Guideline for Sampling Beef Trimmings for Escherichia coli O157:H7.” It can be found on the FSIS Web page at:​Significant_​Guidance/​index.asp. FSIS is particularly interested in discussing the importance of distinguishing the occasional or sporadic positive from a series of positive results that indicate a systemic cause or breakdown of the process controls (“high event days”). This determination is important for decisions regarding the microbiological independence of production lots and the disposition of product, as well as the necessary feedback loop between slaughter operations and further processing operations to ensure implementation of effective corrective and preventive actions.

FSIS will also discuss the draft guidance on the use of labels bearing E. coli O157:H7 testing claims (such as statements indicating that labeled product has been sampled under an N60 procedure). This guidance is also available on the FSIS Web page at​Significant_​Guidance/​index.asp. Such special label claims would be voluntary, and FSIS must approve the labels. The draft guidance provides information to establishments concerning the conditions they must meet to be able to use such claims on their raw beef products. Importantly, the use of such label claims could provide the further processor with greater assurance regarding prior controls for E. coli O157:H7 than certificates of analysis (COAs) currently provide. Many small and very small establishments have indicated that they have difficulty receiving COAs either from the distributor or supplier establishment.

In addition, presentations will be given on the training used by FSIS concerning proper sampling procedures for E. coli O157:H7 and the training developed by industry on N60 sampling procedures. FSIS also anticipates that the meeting will help identify issues of concern about pathogens other than E. coli O157:H7, including Listeria monocytogenes and Salmonella.

Additional Public Notification

Public awareness of all segments of rulemaking and policy development is important. Consequently, in an effort to ensure that minorities, women, and persons with disabilities are aware of this notice, FSIS will announce it on-line through the FSIS Web page located at​regulations/​2008_​Notices_​Index/​.

FSIS also will 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. Through the Listserv and the Web page, FSIS is able to provide information to a much broader and more diverse audience. In addition, FSIS offers an e mail subscription service which provides automatic and customized access to selected food safety news and information. This service is available at​news_​and_​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: October 7, 2008.

Alfred V. Almanza,


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[FR Doc. E8-24216 Filed 10-7-08; 4:15 pm]