[Federal Register Volume 77, Number 34 (Tuesday, February 21, 2012)]
[Notices]
[Pages 9888-9889]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2012-3888]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2010-0023]


Shiga Toxin-Producing Escherichia coli in Certain Raw Beef 
Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: New schedule for implementation of routine testing and 
verification activities.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing a 
new date for when it will implement routine verification sampling and 
testing for raw beef manufacturing trimmings for six non-O157 Shiga 
toxin-producing Escherichia coli (STEC) serogroups (O26, O45, O103, 
O111, O121, and O145). This new date will provide additional time for 
establishments and laboratories to validate their test methods. FSIS 
announced in September 2011 plans to test certain raw beef products for 
these six STEC serogroups in addition to O157:H7. FSIS has determined 
that these organisms are adulterants of raw ground beef products and 
product components under the Federal Meat Inspection Act (FMIA).

DATES: Beginning June 4, 2012, FSIS will implement routine verification 
activities, including testing, for the six additional STEC discussed in 
this document (O26, O45, O103, O111, O121, and O145), of raw beef 
manufacturing trimmings (domestic or imported) derived from cattle 
slaughtered on or after June 4, 2012. To facilitate compliance with the 
policy, and to allow industry time to implement any necessary changes 
in their food safety systems, FSIS will generally not regard raw, non-
intact beef products or the components of these products found to have 
these pathogens as adulterated until June 4, 2012.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Ph.D., Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture, (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On September 20, 2011, FSIS published a Federal Register notice 
announcing a final determination that raw, non-intact beef products or 
raw, intact beef products that are intended for use in raw, non-intact 
product, that are contaminated with Shiga toxin-producing Escherichia 
coli (STEC) O26, O45, O103, O111, O121, and O145, are adulterated 
within the meaning of 21 U.S.C. 601(m)(1) and (m)(3)(76 FR 58157; Sep. 
20, 2011).
    FSIS announced that it intended to implement a verification 
sampling and testing program for the six non-O157 STEC, as it already 
does for E. coli O157:H7. The Agency intended to begin this 
verification sampling and testing on March 5, 2012. The Agency noted 
that it would initially sample raw beef manufacturing trimmings and 
other ground beef components for the six non-O157 STEC, but that it 
would consider other products, including raw ground beef, contaminated 
with these STEC to be adulterated (76 FR 58160). The Agency asked for 
comments on its plans for implementing the program (76 FR 58157, 
58164).
    In addition, FSIS asked for comments on: Agency plans for a 
baseline survey of relevant STEC prevalence in raw beef products, 
whether to hold technical or other public meetings, validation guidance 
for pathogen detection test kits, various cost estimates, the type of 
outreach and information that would be most useful to establishments 
preparing for implementation of the Agency's policy, and information 
that foreign governments might need to address inspection equivalency 
or implementation concerns.
    In response to comments, FSIS extended the public comment period 
from November 21, 2011, to December 21, 2011, and held a public meeting 
by teleconference on December 1, 2011 to solicit comments (76 FR 72331; 
Nov. 23, 2011). FSIS intends to publish a Federal Register notice 
discussing and responding to the comments that it received.
    Many of the comments requested a delay of the implementation date 
for testing for the relevant STECs for various reasons, including the 
need for test kits to detect these organisms to become more widely 
available.
    While FSIS is confident that reliable test kits will be available 
for commercial use before March 5, allowing additional time for beef 
establishments to begin sampling and testing with these new

[[Page 9889]]

kits will facilitate compliance with the non-O157 STEC policy. 
Accordingly, beginning the week of June 4, 2012, rather than on March 
5, FSIS will begin scheduling verification tasks for non-O157 STEC 
control of raw beef manufacturing trimmings. FSIS will collect excision 
(N60) samples for testing raw beef manufacturing trimmings derived from 
cattle slaughtered on or after June 4, 2012, for the seven relevant 
STECs (O157:H7 plus O26, O45, O103, O111, O121, and O145). For 
production lots of raw beef manufacturing trimmings not accompanied by 
documentation showing the date of slaughter of the cattle from which 
the beef was derived, or for production lots that contain mixtures of 
raw beef manufacturing trimmings derived from cattle slaughtered before 
and after June 4, 2012, FSIS will sample the production lot only for 
O157-STEC. For production lots of raw beef manufacturing trimmings not 
accompanied by documentation showing that the date of slaughter of the 
cattle from which the beef was derived, or for production lots that 
contain mixtures of raw beef manufacturing trimmings derived from 
cattle slaughtered before and after June 4, 2012, FSIS will sample the 
production lot only for O157 STEC. For production lots with 
documentation that the beef in the production lot contains only product 
derived from cattle slaughtered on or after June 4, 2012, FSIS will 
test the samples for the seven relevant STECs. The slaughter date of 
June 4, 2012, is important for implementing the verification testing 
program for raw beef manufacturing trimmings because FSIS can be 
certain that, as of this date, trimmings derived from cattle 
slaughtered on or after this date will have been produced under a 
slaughter and further processing system that the Agency expects to 
control for the six additional STEC.
    With the implementation of verification testing for beef 
manufacturing trimmings on June 4, FSIS will also consider raw, non-
intact beef products or raw, intact products intended for use in non-
intact beef products that are contaminated with STEC O26, O45, O103, 
O111, O121, and O145, to be adulterated within the meaning of 21 U.S.C. 
601(m)(1) and (m)(3). FSIS will generally not regard raw, non-intact 
beef products found to have these pathogens as adulterated until it 
implements this verification testing program. However, if product is 
associated with an STEC outbreak before that time, the product will be 
deemed adulterated and subject to recall, consistent with current FSIS 
practice.
    Finally, the Agency notes that in February 2012, it contacted 
foreign governments already approved for the export of raw beef to the 
United States and informed them that FSIS would make a limited amount 
of reagents used in the FSIS laboratory method for non-O157 STECs 
available to a foreign government if that government wanted to conduct 
a comparative analysis of its method and methods used with test kits 
assessed by FSIS. Although these comparative analyses are not a 
necessary precondition for FSIS to begin verification testing of raw 
beef manufacturing trimmings on June 4, 2012, FSIS believes that the 
results of such comparative analyses could be useful.

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.) Persons with disabilities who require 
alternative means for communication of program information (Braille, 
large print, audiotape, etc.) should contact USDA's Target Center at 
202-720-2600 (voice and TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce it on-line 
through the FSIS Web page located at: http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
    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 our constituents and 
stakeholders. The Update is communicated via Listserv, a free email 
subscription service consisting of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals who have requested to be included. 
The Update also is available on the FSIS Web page. Through Listserv and 
the Web page, FSIS is able to provide information to a much broader, 
more diverse audience. In addition, FSIS offers an email 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_&_Events/Email_Subscription/. Options range 
from recalls, export information, 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 February 14, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-3888 Filed 2-17-12; 8:45 am]
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