[Federal Register Volume 73, Number 180 (Tuesday, September 16, 2008)]
[Notices]
[Pages 53406-53407]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: E8-21575]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 73, No. 180 / Tuesday, September 16, 2008 /
Notices
[[Page 53406]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2008-0007]
Revised FSIS Testing Methodology for Escherichia coli (E. coli)
O157:H7
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
that, since January 28, 2008, its laboratories have implemented a
revised laboratory methodology for detecting and identifying E. coli
O157:H7 in regulatory verification samples. This new method can be
found in the Microbiology Laboratory Guidebook (MLG), Chapter 5.04.
DATES: Submit comments by November 17, 2008.
ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by any of the following methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov and, in the ``Search Documents'' box type the
docket number, FSIS-2008-0007. After accessing the docket, click on
``Send a Comment or Submission.''
Mail, including floppy disks or CD-ROMs, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, 1400 Independence Avenue, SW., Room 2534
South Building, Washington, DC 20250.
All submissions received must include the Agency name and docket
number FSIS-2008-0007.
All comments submitted in response to this notice will be posted to
Agency's Web site at http://www.fsis.usda.gov/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. Comments will also 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.
FOR FURTHER INFORMATION CONTACT: For further information contact
William K. Shaw, Jr., Ph.D., Office of Policy and Program Development,
FSIS, USDA, Room 3533, South Building, 14th and Independence, SW.,
Washington, DC 20250-3700; Telephone (202) 205-0695, Fax (202) 720-
7027, E-mail: [email protected].
SUPPLEMENTARY INFORMATION:
Background
FSIS' revised laboratory methodology for detecting and identifying
E. coli O157:H7 in regulatory verification samples can be found in the
Microbiology Laboratory Guidebook (MLG), Chapter 5.04 protocol, now
available on the FSIS Web site at the following URL: http://www.fsis.usda.gov/Science/Microbiological_Lab_Guidebook/index.asp.
The revised MLG 5.04 describes the use of an improved enrichment broth
and confirmatory identification procedures for E. coli O157:H7. The
revisions to the protocol include an updated limit of the level at
which E. coli O157:H7 can be detected for various products, and new
instructions for preparing sub-samples of beef manufacturing trimmings
and other ground beef components, and for preparing environmental
sponge samples for E. coli O157:H7 analysis.
In recent months, FSIS, in collaboration with the USDA Agricultural
Research Service, has conducted an extensive validation of an
enrichment broth, mTSB+n (also known as Modified Tryptone Soya Broth
with Novobiocin and casamino acids or Modified Trypticase Soy with
Novobiocin and casamino acids) to replace the broth that it had been
using for detection of E. coli O157:H7. This broth has been found to
support more rapid growth of E. coli O157:H7 than the mEC+n broth that
FSIS laboratories have been using in past years. Moreover, the mTSB+n
broth is cost-effective and is used by many laboratories around the
world for detection of E. coli O157:H7.
The use of mTSB+n will allow FSIS laboratories greater flexibility
in the conducting of screening test procedures because it allows for
greater flexibility in incubation time than does the broth FSIS
previously used. Also, for some samples, its use will allow screening
tests to be conducted earlier on the second day of analysis because the
incubation period using this broth can be less than the broth FSIS
previously used. The ability to conduct screening test procedures
earlier can assist in more efficient laboratory staffing. Use of the
replacement enrichment broth will also allow FSIS to obtain results
faster for some samples. In addition, its use will reduce the number of
samples that need to be discarded when there are shipping problems that
delay the arrival of samples.
Based on testing with inoculated samples, FSIS believes the new
enrichment procedure is likely to provide increased sensitivity for
detection in some samples. Therefore, there may be some increase in the
number of E. coli O157:H7-positive samples found by FSIS laboratories.
FSIS is also implementing new technologies to make its confirmatory
identification testing procedures more robust and comprehensive for
accurately identifying E. coli O157:H7, including variant strains that
react in an atypical manner. Because serological testing procedures may
not provide reliable identification for some strains of E. coli
O157:H7, the revised protocol in the MLG 5.04 includes the use in FSIS
laboratories of genetic testing to determine ``O157'' and ``H7''
identity in circumstances where atypical serology or other reactions
are encountered. FSIS will use genetic testing to determine if the E.
coli isolate is positive for Shiga toxin production, positive for the
Shiga toxin gene, or genetically determined to be ``H7''.
Since January 28, 2008, FSIS laboratories have been using the
following terminology and criteria in the MLG 5.04 in reporting E. coli
O157:H7 sample results:
Potential Positive--a sample that causes a positive
reaction with the screen test.
Presumptive Positive--a sample that has typical colonies,
observed on
[[Page 53407]]
Rainbow Agar, and reacts specifically with O157 antiserum.
Confirmed Positive--a biochemically-identified Escherichia
coli isolate that is serologically or genetically determined to be
``O157'' that meets at least one of the following criteria:
(1) Positive for Shiga toxin (ST) production
(2) Positive for the Shiga toxin gene (stx)
(3) Genetically determined to be ``H7''
If an FSIS laboratory's confirmatory test results are insufficient
to allow identification of E. coli O157:H7, then the isolate is
transferred to the Outbreaks Section of the Eastern Laboratory
Microbiology Branch (OSEL), or to an FSIS reference laboratory, for
further testing prior to issuance of a report of the test results.
State Programs and Foreign Government Programs
States that have their own meat inspection programs for meat
products produced and transported solely within the State are required
to have mandatory ante mortem and post mortem inspection, reinspection,
and sanitation requirements that are at least equal to those in the
Federal Meat Inspection Act (21 U.S.C. 661(a)(1)). Therefore, these
States' sampling procedures and testing methods for E. coli O157:H7 in
raw beef products must be at least as sensitive as FSIS' procedures and
testing methods for E. coli O157:H7.
Foreign countries that are eligible to export meat products to the
United States must apply inspection, sanitary, and other standards that
are equivalent to those that FSIS applies to those products (21 U.S.C.
620). Thus, in evaluating a foreign country's meat inspection system to
determine the country's eligibility to export products to the United
States, FSIS considers whether the testing methods and procedures for
E. coli O157:H7 that the country applies are equivalent to those that
FSIS uses.
Establishment Testing or Testing on Behalf of Establishments (Non-FSIS
Laboratories)
As discussed above, FSIS will use genetic testing to determine
``O157'' and ``H7'' identity in circumstances where atypical serology
or other reactions are encountered. The genetic testing now used by
FSIS laboratories for identification of certain strains of E. coli
O157:H7 detected in FSIS laboratories may pose some difficulties for
non-FSIS laboratories. Some non-FSIS laboratories may not be able to
conduct genetic analyses because they do not have the necessary
resources. Moreover, the improper application of a less robust or
inadequately validated genetic test by a laboratory might lead to a
false negative or other misleading results.
FSIS believes that alternative criteria for confirmatory
identification of E. coli O157:H7 or E. coli O157:H7-like bacteria may
be appropriate if it is equivalent to the criteria used by FSIS. To be
regarded as equivalent to the FSIS criteria, a test would have to
detect all hypothetical E. coli O157:H7 strains, typical or variant,
that would be identified using FSIS' confirmatory testing procedures
and criteria.
For establishment testing or testing on behalf of an establishment,
FSIS recognizes that other criteria, while not used specifically by
FSIS for identification of E. coli O157:H7, may be a significant and
expedient indicator of the presence of E. coli O157:H7 in products.
Such tests might be applied as rapid screening procedures to expedite
analyses. If an establishment uses or contracts with a laboratory that
uses such rapid screening procedures, and product is found positive by
that test, FSIS expects the establishment to take appropriate
corrective action and to ensure the proper disposition of adulterated
products following a positive test result (9 CFR 417.3).
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 online through the FSIS Web page located
at http://www.fsis.usda.gov/regulations/2008_Notices_Index/. 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, 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 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/. Information is available about a variety of topics
including recalls, exports, regulations, directives, and notices.
Customers can add or delete subscriptions themselves, and they have the
option to password protect their accounts.
Done at Washington, DC, on September 4, 2008.
Alfred V. Almanza,
Administrator.
[FR Doc. E8-21575 Filed 9-15-08; 8:45 am]
BILLING CODE 3410-DM-P