[Federal Register: October 10, 2008 (Volume 73, Number 198)]
[Page 60230-60231]
From the Federal Register Online via GPO Access [wais.access.gpo.gov]



Food Safety Inspection Service

[Docket No. FSIS 2008-0035]

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

AGENCY: Food Safety and Inspection Service (FSIS), USDA.

ACTION: Notice of public meeting.


SUMMARY: 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draft guidance to industry concerning this pathogen.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.

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

ADDRESSES: 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 http://www.fsis.usda.gov/News_&_Events/
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 http://www.fsis.usda.gov/News_&_Events/
Meetings_&_Events/ when it becomes available.
    Comments may be submitted by either of the following methods:
    Federal eRulemaking Portal: Go to http://www.regulations.gov. 
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 
    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.

FOR FURTHER INFORMATION CONTACT: Pre-registration for this meeting is 
recommended. To pre-register, go to the FSIS Web site at http://
    For additional information, please contact Keith Payne by telephone 
at (202) 690-6522 or by e-mail at keith.payne@fsis.usda.gov. Persons 
requiring a sign language interpreter or special accommodations should 
contact Keith Payne as soon as possible.



    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

[[Page 60231]]

consistency 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: http://www.fsis.usda.gov/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 http://
www.fsis.usda.gov/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 http://www.fsis.usda.gov/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 http://www.fsis.usda.gov/
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.

    Done at Washington, DC on: October 7, 2008.
Alfred V. Almanza,
 [FR Doc. E8-24216 Filed 10-7-08; 4:15 pm]