[Federal Register Volume 78, Number 167 (Wednesday, August 28, 2013)]
[Rules and Regulations]
[Pages 53017-53020]
From the Federal Register Online via the Government Printing 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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