[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Rules and Regulations]
[Pages 53017-53020]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2013-20995]
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Rules and Regulations
Federal Register
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Federal Register / Vol. 78, No. 167 / Wednesday, August 28, 2013 /
Rules and Regulations
[[Page 53017]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Part 310
[Docket No. FSIS-2012-0038]
Changes to the Salmonella Verification Sampling Program: Analysis
of Raw Beef for Shiga Toxin-Producin Escherichia coli and Salmonella
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Request for comments.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
changes to its procedures for Salmonella verification sampling program
of raw beef products. On the date that FSIS will announce in the
Federal Register document that responds to any comments on this
document, FSIS will discontinue Salmonella sampling set procedures
(``HC01'') in ground beef products, except in establishments with
results that exceeded the standard for Salmonella in that
establishment's most recently completed sample set (i.e., in those
establishments in Category 3). At the same time, FSIS will begin
analyzing for Salmonella all raw beef samples that it collects for
Shiga toxin-producing Escherichia coli (STEC) analysis. Therefore, FSIS
will begin analyzing for Salmonella all samples of raw ground beef,
beef manufacturing trimmings, bench trim, and other raw ground beef
components that it collects for STEC testing. To be consistent with the
Agency's STEC analytic sample portions, FSIS laboratories will increase
the raw ground beef analytic sample portion for Salmonella analysis
from 25 grams to 325 grams. This notice describes how FSIS intends to
use the results from its verification sampling program to develop new
Salmonella performance standards for ground beef product and to
estimate Salmonella prevalence in raw ground beef and beef
manufacturing trimmings products. Finally, this document discusses
changes that the Agency is considering related to FSIS Salmonella
sampling and testing of other products.
DATES: Submit comments on or before September 27, 2013. Interested
parties need to get their comments in on time because the Agency does
not intend to grant any extensions of the comment period.
ADDRESSES: FSIS invites interested persons to submit comments on this
document. Comments may be submitted by one 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/. Follow the on-line instructions at that site for
submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Patriots
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163B,
Washington, DC 20250-3700.
Hand- or courier-delivered submittals: Deliver to Patriots Plaza 3,
355 E. Street SW., Room 8-163B, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2012-0038. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or to comments received,
go to the FSIS Docket Room at Patriots Plaza 3, 355 E. Street SW., Room
164, Washington, DC 20250-3700 between 8 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495; or by Fax: (202) 720-2025.
SUPPLEMENTARY INFORMATION: FSIS administers a regulatory program under
the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) that is
intended to ensure that meat and meat food products distributed in
commerce are wholesome; not adulterated; and properly marked, labeled,
and packaged. As part of its inspection program, FSIS collects samples
of these products for laboratory analysis (21 U.S.C. 642(a)).
History of the Salmonella Verification Sampling Program
The Salmonella verification sampling program formally began with
the Agency's final rule, entitled ``Pathogen Reduction; Hazard Analysis
and Critical Control Point (PR/HACCP) Systems,'' which FSIS published
on July 25, 1996 (61 FR 38805-38989; http://www.fsis.usda.gov/OPPDE/rdad/FRPubs/93-016F.pdf). Among other things, the PR/HACCP rule set
Salmonella performance standards for establishments producing selected
classes of raw meat products, including ground beef, steers and
heifers, and cows and bulls (9 CFR 310.25(b)). In 2011, FSIS stopped
sampling and testing for Salmonella in steers and heifers and cows and
bulls because percent positive findings were very low (less than one
percent), and this carcass sampling was expensive for the Agency. As
stated in the PR/HACCP rule (at 61 FR 38835), FSIS selected Salmonella
for the performance standard because it is the most common cause of
foodborne illness associated with meat and poultry products; it is
present to varying degrees in all major species; and the interventions
targeted at reducing Salmonella may help reduce contamination by other
enteric pathogens.
FSIS uses the Salmonella performance standards to verify process
control in slaughter and certain processing operations. The performance
standard for ground beef is based on the industry average (percent
positive samples) estimated from baseline surveys conducted before PR/
HACCP was implemented.
Under the existing Salmonella verification sampling program, the
Agency assesses whether establishments meet the Salmonella standard by
collecting randomly selected product samples using the risk-based, 3-
category establishment classification system announced on February 27,
2006 (71 FR 9772). FSIS inspection program personnel collect samples
and submit them to FSIS laboratories for analysis over a defined number
of sequential
[[Page 53018]]
days of production to complete a sample set. As detailed in the
February 2006 notice, the maximum number of positive samples per set
for the ground beef product category is 5 of 53.
FSIS presently categorizes establishment performance as follows:
I. Category 1. Consistent Process Control: Establishments with
percent positive Salmonella samples at 50 percent or less of the
performance standard in the two most recently completed sample sets.
II. Category 2T. Variable Process Control but Transitioning Towards
Consistent Process Control: Establishments with percent positive
Salmonella samples at 50 percent or less of the performance standard
in the most recently completed sample set, but greater than 50
percent of the performance standard in the previously completed
sample set.
III. Category 2. Variable Process Control: Establishments with
percent positive Salmonella samples above 50 percent but not
exceeding the standard in the most recently completed sample set.
IV. Category 3. Highly Variable Process Control: Establishments with
percent positive Salmonella samples exceeding the performance
standard in the most recently completed sample set.
FSIS collects ground beef samples under project code ``HC01'' as
part of the Salmonella verification sampling program and under project
code ``MT43'' as part of the E. coli O157:H7 verification sampling
program.
Following the implementation of PR/HACCP, FSIS analyzed only one
pathogen per sample. Then, in 2008, FSIS began analyzing for Salmonella
and E. coli O157:H7 ground beef samples from establishments producing
less than 1,000 pounds of product per day (under the MT43S code). Using
this approach, FSIS effectively gained sampling efficiencies without
overly burdening the establishment with additional sample collection.
Public Health Concerns
Salmonella bacteria are among the most frequently reported causes
of foodborne illness. In December 2011, a multi-state outbreak linked
to a multi-drug resistant strain of Salmonella sickened 19 people in
the Northeast United States (http://www.cdc.gov/salmonella/typhimurium-groundbeef/010512/index.html). In June 2012, FSIS was notified of a
cluster of Salmonella enteriditis illnesses linked to ground beef
consumption with approximately 50 case-patients across nine states
(http://www.cdc.gov/salmonella/enteritidis-07-12/index.html). The
outbreaks referenced here and others suggest that Salmonella in ground
beef is a continuing public health concern.
The changes described below will likely improve FSIS's ability to
detect Salmonella by increasing the raw ground beef analytic sample
portion for Salmonella analysis and increasing the number of
establishments being sampled at any given time. As is also discussed
below, FSIS intends to develop new performance standards that will
likely lead establishments producing ground beef to strengthen their
own Salmonella control measures. Such changes at establishments will
likely have a positive impact on public health.
Changes to Salmonella Verification Sampling Programs for Raw Ground
Beef Products
Beginning on the date FSIS will announce in the Federal Register
notice that responds to any comments on this notice, FSIS will
discontinue Salmonella sampling sets (``HC01'') for ground beef product
except for establishments in Category 3. At the same time, FSIS will
begin analyzing for Salmonella all raw beef samples it collects for
STEC testing. Therefore, FSIS will begin analyzing for Salmonella all
samples of raw ground beef, beef manufacturing trimmings, bench trim,
and other raw ground beef components that its personnel collect for
STEC testing, including raw ground beef products FSIS samples at retail
stores and ground beef, trim, and other raw ground beef components FSIS
samples at import establishments.
Whenever FSIS finds a product sample positive for E. coli O157:H7
or a non-O157 STEC, FSIS conducts follow-up sampling of product from
the establishment that produced the positive product and at all
suppliers that provided the source materials for the product. When FSIS
begins analyzing for Salmonella the product collected for STEC
analysis, FSIS will also begin analyzing for Salmonella the follow-up
samples it collects in response to STEC positive results.
FSIS analyzes beef manufacturing trimmings for E. coli O157:H7 and
the following non-O157 STECs: O26, O45, O103, O111, O121, and O145.
FSIS analyzes raw ground beef and raw ground beef components other than
beef manufacturing trimmings for E. coli O157:H7 only. FSIS is not
making any changes to the STEC sampling and testing programs at this
time.
The changes that FSIS is announcing to its Salmonella sampling
procedures will permit FSIS to analyze more samples at the same time
for lower Agency costs than the present method. Also, as noted above,
FSIS stopped testing beef carcasses for Salmonella because the Agency
sampling costs did not justify the results FSIS was able to obtain.
Through this new approach, FSIS will be able to analyze for Salmonella
beef manufacturing trimmings and other raw ground beef components at
slaughter establishments. FSIS believes sampling these products will
provide FSIS more information about Salmonella at these establishments
than FSIS was able to gather through carcass testing.
FSIS will increase the raw ground beef analytic portion for
Salmonella analysis from 25 grams to 325 grams to be consistent with
the STEC analytic sample portions. To support an increase in the sample
size analyzed, FSIS evaluated the FSIS Salmonella detection method
(FSIS Microbiology Laboratory Guidebook Chapter 4.06) using 325 gram
samples. Based on this analysis, FSIS expects the increase in the
analytical portion size to have at least the same, but likely more of a
positive, impact on public health because the likelihood of detecting
positive samples increases with the analytical portion size. As is
explained above, FSIS will continue to schedule sets for raw ground
beef in those establishments in Category 3. FSIS laboratories will
continue to evaluate raw ground beef product samples collected as part
of a set using a 25-gram analytic sample portion.
FSIS intends to enumerate samples that confirm Salmonella-positive
using the Most Probable Number (MPN) quantitative procedure. FSIS will
continue to evaluate Salmonella isolates from the screen-positive
samples for multi-drug resistance, to serotype the samples, and to use
pulsed-field gel electrophoresis (PFGE) to identify specific strains of
Salmonella.
Through this analysis, FSIS will determine whether Agency-positive
Salmonella results are associated with illnesses or serotypes of human
health significance. As is currently the case, if FSIS finds that
establishments have produced product associated with illness, FSIS will
typically conduct an Incident Investigation Team Review or Food Safety
Assessment at the establishment.
Estimating Prevalence
In developing all of its prevalence estimates, FSIS defines
prevalence as the proportion of applicable product that would test
positive for a given pathogen if the entire population were sampled and
analyzed during a specified time period. Although it provides a useful
indication of process control within that establishment, set-based
verification sampling that FSIS currently uses for Salmonella sampling
and testing in many products is not
[[Page 53019]]
designed to estimate national prevalence of Salmonella by class of
products. As is discussed above, under the set-based approach, FSIS
collects samples from the same establishment on a daily basis until it
has collected the necessary number of samples in the applicable
performance standard. In 2012, FSIS evaluated many of its sampling
programs as a means to calculate prevalence estimates for pathogens in
FSIS-regulated products (http://www.fsis.usda.gov/wps/wcm/connect/56b2ccbd-ad57-4311-b6df-289822d28115/Prevalence_Estimates_Report.pdf?MOD=AJPERES). The Agency concluded, given the construction
of the FSIS pathogen verification sampling programs at that time, that
it was only possible to utilize the E. coli O157:H7 pathogen
verification testing program for raw ground beef (``MT43'') to estimate
national prevalence. Since that time, FSIS has redesigned its beef
manufacturing trimmings verification sampling program such that, with a
larger number of analyzed samples, it too is suitable for estimating
prevalence (http://www.fsis.usda.gov/wps/wcm/connect/15e75329-978f-43f0-b8fe-101845d898f0/Redesign_Beef_Trim_Sampling_Methodology.pdf?MOD=AJPERES).
When FSIS begins analyzing all STEC samples for Salmonella, FSIS
will be able to estimate the prevalence of Salmonella in raw ground
beef and beef manufacturing trimmings. Therefore, FSIS will avoid the
added expense of conducting separate baseline studies at periodic
intervals to determine Salmonella prevalence in these products and will
enhance the use of inspection resources. In addition, by using these
continuous sampling programs rather than scheduled sets, FSIS will be
able to analyze findings over time to determine trends and evaluate
program effectiveness.
Because of the limited number of available samples scheduled and
collected, FSIS does not believe it is possible to estimate prevalence
for Salmonella in raw ground beef components other than beef
manufacturing trimmings (such as bench trim).
New Performance Standards
After collecting at least three months of data using the new
sampling and testing procedures, FSIS intends to conduct a risk
assessment and develop a revised Salmonella performance standard for
raw ground beef at a 325 gram sample size. FSIS will publish the
revised Salmonella performance standard in the Federal Register before
implementing the standard.
In 2011, FSIS estimated the national prevalence of Salmonella in
beef manufacturing trimmings (http://www.fsis.usda.gov/wps/wcm/connect/f07f5e1d-63f2-4ec8-a83a-e1661307b2c3/Baseline_Data_Domestic_Beef_Trimmings_Rev.pdf?MOD=AJPERES). After careful consideration, FSIS does
not believe the low incidence of Salmonella on beef manufacturing
trimmings supports development of a Salmonella performance standard for
beef manufacturing trimmings. FSIS is considering using the results of
this estimation to develop guidance that will assist establishments in
preventing Salmonella contamination in beef manufacturing trimmings.
FSIS recently revised other existing Salmonella performance
standards to achieve a public health objective. In July 2011, FSIS
implemented new performance standards for both Salmonella and
Campylobacter for chilled carcasses in young chicken (broilers) and
turkey slaughter establishments (76 FR 15282; March 21, 2011). By
December 2011, the young chicken industry was meeting the acceptable
Campylobacter percent positive reflected in the new standard at 9.43
percent (10.4 percent acceptable). Should FSIS develop new Salmonella
performance standards for ground beef, FSIS believes that ground beef
establishments would improve process control to meet the new
performance standard in a similar manner.
Except for Category 3 establishments, FSIS will discontinue set
testing at least until it establishes a revised Salmonella performance
standard for ground beef. Meanwhile, FSIS is considering alternative
sampling plans. One option that FSIS is considering is a ``moving
window'' sampling plan in which FSIS would evaluate a set number of
sequential results from single establishment to assess process control.
For example, if FSIS chose to evaluate 20 results under the moving
window approach, FSIS would assess the most recent 20 FSIS results for
a particular establishment. This new approach would allow for on-going
scheduled FSIS Salmonella sampling, similar to the approach FSIS uses
for STEC testing, as compared to a set-based approach in which FSIS
schedules a large number of sequential samples at an establishment as
part of a set. The ``moving window'' approach would provide FSIS with
more flexibility for scheduling sample collection at different
establishments. The Agency requests comment on the ``moving window''
approach.
Other Sampling Procedures
Consistent with current sampling procedures, when an establishment
either processes all raw ground beef product into ready-to-eat (RTE)
product or moves it to another federally-inspected establishment for
further processing into RTE product, the product will be excluded from
Agency verification sampling for E. coli O157:H7 and Salmonella.
Individual sample results generated from this program will be
reported through the Agency's Public Health Information System. FSIS
will ensure that result information is made available to
establishments. Because FSIS does not recognize Salmonella as a
pathogen that would ordinarily render the product injurious to health,
and thus as an adulterant within the meaning of 21 U.S.C. 601(m)(1),
individual Salmonella sample results will not result in regulatory
control actions. Therefore, after receiving STEC (O157:H7 and non-O157)
results, establishments will not need to continue to hold product that
has tested negative for STEC. If raw, non-intact beef product or raw,
intact beef product that is intended for use as raw, non-intact product
tests positive for STEC, the product is adulterated within the meaning
of 21 U.S.C. 601(m)(1) (76 FR 58157; Sep. 20, 2011) unless further
processed to destroy the pathogen.
Other Changes Under Consideration
In addition to ground beef, FSIS is considering moving Salmonella
sampling from a set-based approach to a continuous sampling and
``moving window'' approach for all classes of products subject to FSIS
sampling and testing for Salmonella. As is discussed above, this
approach will allow FSIS more flexibility in scheduling and collecting
samples.
In addition, FSIS is considering implementing new sampling of
product classes not subject to FSIS sampling and testing for
Salmonella. For example, FSIS is contemplating initiating sampling and
testing for Salmonella in pork trim, pork parts, ground pork, chicken
parts, and lamb carcasses.
Before FSIS makes any change of this type in its testing, it will
provide notice and an opportunity for comment in the Federal Register.
Should FSIS decide to start testing new products for Salmonella, it
would begin by sampling to assess the prevalence of Salmonella in each
of the new products sampled. Upon completion of the exploratory
sampling period (at least three months and possibly longer), FSIS would
develop
[[Page 53020]]
new performance standards. FSIS would announce the tentative standards
in the Federal Register and request comment on them before finalizing.
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
FSIS will announce this notice online through the FSIS Web page
located at http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register.
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, 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. In addition, FSIS offers an electronic 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/wps/portal/fsis/programs-and-services/email-subscription-service. 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: August 16, 2013.
Alfred V. Almanza,
Administrator.
[FR Doc. 2013-20995 Filed 8-27-13; 8:45 am]
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