[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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