[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Rules and Regulations]
[Pages 32436-32440]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2014-13064]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

9 CFR Part 310

[Docket No. FSIS-2012-0038]


Changes to Salmonella Verification Sampling Program: Analysis of 
Raw Beef for Shiga Toxin-Producing Escherichia coli and Salmonella

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Response to comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is responding to 
comments on an August 28, 2013, Federal Register document, ``Changes to 
Salmonella Verification Sampling Program: Analysis of Raw Beef for 
Shiga Toxin-Producing Escherichia coli and Salmonella'' and announcing 
its plans to begin analyzing for Salmonella all beef product it 
analyzes for Shiga toxin- producing Escherichia coli (STEC). After 
reviewing the comments received on the August 2013 document, FSIS is 
affirming the plans for addressing Salmonella in raw beef products that 
it announced in that document and will proceed with implementing those 
plans.

DATES: On June 29, 2014, 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 set (i.e., in those 
establishments in Category 3). At the same time, FSIS will begin 
analyzing for Salmonella all raw beef samples it collects for STEC 
analysis and will increase the raw ground beef sample portion for 
Salmonella analysis from 25 grams to 325 grams.

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: 

Background

    On August 28, 2013, FSIS published in the Federal Register a 
document announcing changes that it intended to make in its Salmonella 
sampling program for raw beef products (78 FR 53017). The Agency 
requested comment on these changes, with the aim of assessing whether 
it should alter any of its plans on the basis of the information or 
data it received.
    FSIS announced that it would 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, 
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. FSIS also explained that when it begins 
analyzing for Salmonella the product collected for STEC analysis, the 
Agency will also begin analyzing for Salmonella the follow-up samples 
it collects in response to STEC positive results. FSIS further 
explained that it is not making any changes to the STEC sampling and 
testing programs at this time.
    FSIS announced that, once the ``co-analysis'' begins, it would 
increase the raw ground beef sample portion for Salmonella analysis 
from 25 grams to 325 grams. FSIS explained that to support an increase 
in the sample size analyzed, FSIS evaluated the FSIS

[[Page 32437]]

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.
    FSIS described how it intends to use results generated from its raw 
ground beef (MT43) and beef manufacturing trimming (MT60) verification 
sampling programs to estimate the Salmonella prevalence in those 
products and to develop a new Salmonella performance standard for 
ground beef product. FSIS explained that the low incidence of 
Salmonella on beef manufacturing trimmings does not support development 
of a Salmonella performance standard for those trimmings. FSIS also 
explained that, because of the limited number of available samples 
scheduled and collected, the Agency 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).
    FSIS explained that it intends to develop a new performance 
standard 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.
    FSIS also announced that it intends to enumerate samples that 
confirm Salmonella-positive using the Most Probable Number (MPN) 
quantitative procedure, and that it 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. FSIS 
explained that, through this analysis, FSIS will determine whether 
Agency-positive Salmonella results are associated with illnesses or 
serotypes of human health significance. 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.
    FSIS also announced in the same document that, except for 
establishments with results that exceeded the standard for Salmonella 
in that establishment's most recently completed set (i.e., those 
establishments in category 3), it would discontinue Salmonella sampling 
sets for ground beef products at least until it establishes a revised 
Salmonella performance standard for ground beef. FSIS explained that, 
when collecting samples for a Salmonella set, FSIS inspection program 
personnel submit the samples to FSIS laboratories for analysis over a 
defined number of sequential days of production to complete the sample 
set.
    FSIS stated that it would consider alternatives to set-based 
testing for Salmonella, including a ``moving window'' approach to 
process control, to be put into effect when the revised performance 
standard is implemented. FSIS explained that under a ``moving window'' 
approach, the Agency would evaluate a certain number of sequential 
results from a single establishment to assess process control. For 
example, if the Agency chose to evaluate 20 results under the ``moving 
window'' approach, it would assess the most recent 20 FSIS results for 
a particular establishment. FSIS explained that this new approach would 
allow for on-going scheduled Salmonella sampling, similar to the 
approach FSIS uses for STEC testing, and would provide FSIS with more 
flexibility for scheduling sample collection at different 
establishments. The Agency requested comment on the ``moving window'' 
approach.
    In addition, FSIS explained that it is considering implementing new 
sampling of product classes not subject to the Agency's sampling and 
testing for Salmonella. The Agency stated that it was considering 
sampling and testing for Salmonella in pork trim, pork parts, ground 
pork, chicken parts, and lamb carcasses.
    FSIS explained that the changes that it announced to its Salmonella 
sampling procedures would permit it to analyze more samples at the same 
time at lower cost to the Agency than does the current method. Through 
this new approach, FSIS will be able to analyze for Salmonella beef 
manufacturing trimmings and other raw ground beef components at 
slaughter establishments. Sampling these products will provide FSIS 
more information about Salmonella at these establishments than FSIS was 
able to gather through carcass testing.
    The final rule ``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), 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.
    After carefully considering all comments received, FSIS has 
determined that no changes are needed in the plans it announced in the 
August 2013 Federal Register document. Thus, on June 29, 2014, FSIS 
will discontinue Salmonella sampling set procedures in ground beef 
products (``HC01''), except in those establishments in Category 3. At 
the same time, FSIS will begin analyzing for Salmonella all raw beef 
samples it collects for STEC analysis and will increase the raw ground 
beef sample portion for Salmonella analysis from 25 grams to 325 grams.
    Also, consistent with what the Agency announced in the August 2013 
Federal Register document, FSIS intends to use the results from its 
verification sampling program to estimate Salmonella prevalence in raw 
ground beef and beef manufacturing trimmings and to develop a new 
Salmonella performance standard for ground beef product. FSIS will 
announce any new standard in the Federal Register and request comment 
on it before implementing it. FSIS intends to develop and propose the 
new standard next fiscal year.
    In addition, FSIS announced its Salmonella Action Plan on December 
4, 2013.\1\ According to the plan, FSIS intends to complete a risk 
assessment and develop Salmonella performance standards for comminuted 
poultry and poultry parts this fiscal year and performance standards 
and, if needed, sampling programs for hog carcasses and pork products 
next fiscal year.
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    \1\ http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education/get-answers/food-safety-fact-sheets/foodborne-illness-and-disease/salmonella/sap.
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    The following is a summary of the relevant comments received and 
FSIS's responses.

Summary of Comments and Responses

    FSIS received ten comments in response to the August 2013 Federal 
Register document. The comments were from trade associations, private 
citizens, consumer advocacy associations, including a joint submission 
from two consumer advocacy organizations, a large meat processor, and a 
foreign government.

A. General Support for the Proposed Changes

    Comments: Most of the comments supported the proposed changes to 
procedures for Salmonella verification

[[Page 32438]]

sampling and testing of raw beef products because the changes will 
improve Agency efficiencies. In addition, several comments supported 
the Agency's intent to estimate Salmonella prevalence in raw beef 
products, to serotype or enumerate positive samples, to identify 
specific strains of Salmonella, and to develop a new Salmonella 
performance standard for ground beef.

B. General Opposition to Verification Sampling and Testing of Raw Beef 
Products

    Comment: One private citizen opposed FSIS verification sampling and 
testing for Salmonella in raw beef products because of recent research 
suggesting that Salmonella may naturally occur in the lymph nodes of 
cattle. According to the commenter, this detail makes it impossible for 
establishments to completely eliminate Salmonella from any raw beef 
product. The commenter recommended that, rather than focusing on 
verification sampling at the establishment, FSIS focus its resources on 
researching pre-harvest controls for Salmonella in cattle and educating 
consumers on how to properly handle and cook raw beef products.
    Response: FSIS collects samples of meat and poultry products from 
an establishment for pathogen testing to verify whether the 
establishment is effectively addressing the pathogen. When FSIS 
collects product for Salmonella analysis as part of a set, FSIS 
verifies whether the establishment is maintaining process control in 
slaughter or certain processing operations. FSIS uses the results of 
these and other verification tasks to guide policy development and 
focus Agency resources on those activities that will best protect 
public health.
    In May 2010, FSIS issued guidance to beef slaughter establishments 
on pre-harvest management controls for reducing Escherichia coli (E. 
coli) O157:H7 shedding in beef cattle.\2\ FSIS is updating this 
guidance to include other STEC and intends to make the updated guidance 
available to the establishments soon. Similarly, in November 2011, FSIS 
met with stakeholders to discuss pre-harvest pathogen control 
strategies for reducing prevalence of STEC and of Salmonella in and on 
cattle (76 FR 63901; Oct. 14, 2011). In addition, FSIS conducts 
multiple consumer education campaigns to inform the American public of 
the proper methods for handling and cooking meat and poultry, so that 
any potential food-safety hazard is reduced to a minimum.\3\
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    \2\ Available at http://www.fsis.usda.gov/wps/wcm/connect/d5314cc7-1ef7-4586-bca2-f2ed86d9532f/Reducing_Ecoli_Shedding_In_Cattle_0510.pdf?MOD=AJPERES.
    \3\ See http://www.fsis.usda.gov/wps/portal/fsis/topics/food-safety-education.
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    Comment: A large meat processor generally opposed FSIS verification 
sampling and testing of portioned fine and coarse ground beef products 
that are ground at a primary establishment and subsequently portioned 
at a second establishment because sampling and testing of product from 
the second establishment is potentially duplicative.
    Response: FSIS collects samples of ground product at establishments 
that grind product or form patties. FSIS does not collect samples of 
ground beef products for E. coli O157:H7 (or other STEC) analysis at 
establishments that only pack or portion and do not grind or form 
patties. When FSIS begins analyzing all raw beef samples collected for 
STEC analysis for Salmonella, FSIS would also analyze any raw ground 
beef product samples (e.g., formed raw beef patties) collected for E. 
coli O157:H7 for Salmonella.

C. Larger Analytical Sample Portion

    Comment: Two trade associations requested additional information on 
the protocol for obtaining the larger 325-gram analytical portion used 
for Salmonella testing.
    Response: FSIS inspection program personnel will continue to 
collect samples of raw beef products for FSIS verification testing 
using the collection protocols outlined in FSIS Directive 10,010.1 \4\ 
and associated FSIS Notices. FSIS has determined that the amount of 
product inspectors currently collect (about 2 lb or 907 g) will provide 
the FSIS laboratories with sufficient product to analyze the samples 
using the larger analytical portion (325 g) for both Salmonella and 
STEC.
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    \4\ Available at http://www.fsis.usda.gov/wps/wcm/connect/c100dd64-e2e7-408a-8b27-ebb378959071/10010.1Rev3.pdf?MOD=AJPERES.
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    Comment: A trade association and a large meat processor requested 
that the Agency consider and make note of the larger portion for 
Salmonella analysis when reporting program results because the larger 
analytical portion will likely yield more positive results.
    Response: When FSIS begins posting on its Web page the results 
obtained using the larger analytical portion, FSIS will note that the 
results are from samples it analyzed using the larger portion size. In 
addition, the Agency will report periodically to each establishment 
whose product the Agency collects the establishment's test results 
compared with industry-wide results. FSIS will also post aggregate 
results of this testing as part of its quarterly report on Salmonella.
    Comment: Another trade association suggested that FSIS evaluate 
whether increasing the analytical portion from 25 to 325 grams 
increases the likelihood of detecting Salmonella positive samples.
    Response: As noted above, based on the analysis discussed in the 
2013 Federal Register document, 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.
    Comment: One trade association noted that many of its members 
supply raw beef products to the Agricultural Marketing Service (AMS) 
for various Federal food and nutrition assistance programs. The 
association asked FSIS to coordinate with AMS on related sampling 
protocol requirements to ensure a seamless transition.
    Response: FSIS has notified AMS of its intent to make changes in 
its Salmonella verification sampling program for raw beef products.

D. Estimating Prevalence

    Comment: The consumer group joint submission stated that FSIS 
failed to address two critical statistical requirements when estimating 
prevalence of Salmonella in ground beef: the sampling must be 
representative of population and the sampling must provide desired 
precision.
    Response: The statistical sampling design for FSIS's raw ground 
beef verification sampling program is detailed in the Report on the 
Food Safety and Inspection Service's Microbiological and Residue 
Sampling Programs (FSIS, 2011).\5\ The sampling design is volume-
weighted (i.e., probability is proportional to sample size) to provide 
for sampling that is representative of national production volume.
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    \5\ Available at http://www.fsis.usda.gov/wps/wcm/connect/0816b926-c7ee-4c24-9222-34ac674ec047/FSIS_Sampling_Programs_Report.pdf?MOD= AJPERES.
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    In 2012, FSIS determined that its MT43 sampling program is 
sufficiently representative and provides the needed precision to 
compute prevalence of E. coli O157:H7 in raw ground beef.\6\ Moreover, 
FSIS expects that Salmonella will occur in raw beef products at a rate

[[Page 32439]]

higher than that for E. coli in raw ground beef. For these reasons, 
FSIS's ground beef verification sampling program will adequately 
support the development of an estimate of the prevalence of Salmonella 
in raw beef products.
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    \6\ Available at http://www.fsis.usda.gov/wps/wcm/connect/56b2ccbd-ad57-4311-b6df-289822d28115/Prevalence_Estimates_Report.pdf?MOD=AJPERES.
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E. Risk Assessment

    Comment: A trade association requested that FSIS also conduct a 
risk assessment that addresses the risk that Salmonella presents in 
pork, chicken, turkey, and ready-to-eat products.
    Response: As previously stated, FSIS intends to complete a risk 
assessment for Salmonella in comminuted poultry and poultry parts this 
fiscal year. FSIS will develop additional risk assessments concerning 
Salmonella and other products as necessary, for example, should FSIS 
decide to evaluate whether to propose performance standards for 
additional products.

F. Development of a Salmonella Performance Standard

    Comment: Because beef products have the greatest seasonal variation 
among the products subject to FSIS verification sampling and testing, 
several industry trade associations and a large meat processor asked 
that FSIS ensure it has data from at least a 12-month period before 
conducting the risk assessment and developing a performance standard.
    Response: As the new ground beef data are collected, FSIS will 
evaluate the suitability of those data for use in performance standard 
development. It should be noted, however, that the current ground beef 
performance standard was developed using approximately 7 months of 
data.\7\
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    \7\ Available at http://www.fsis.usda.gov/wps/wcm/connect/317ae862-1980-4c87-9bea-85bf4491b420/rwgrbeef.pdf?MOD=AJPERES.
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G. ``Moving Window'' Approach

    Comment: Several comments requested a more detailed explanation of 
how the ``moving window'' approach will work. More specifically, the 
joint submission requested additional information on how big the window 
would be, how often the Agency would sample product at a single 
establishment, and the Agency's analytical capacity to adequately take 
such an approach. An industry trade association requested that FSIS 
develop a written protocol for this approach and make the protocol 
available for review and comment prior to implementation.
    Response: As explained in the August 2013 Federal Register 
document, FSIS intends to take a ``moving window'' approach when 
scheduling sampling and evaluating results generated by its Salmonella 
verification testing program for ground beef products under a new 
performance standard. With a ``moving window'' approach, FSIS will 
evaluate a predetermined number of sequential results for ground beef 
product from a single establishment to assess process control. The size 
of the moving window and the threshold for positives within that window 
will be included in the performance standard developed. At the same 
time it announces the new performance standard for raw ground beef, 
FSIS will detail its plans for the new approach in the Federal Register 
and consider any comments received on it prior to implementation. FSIS 
is considering using this approach for all Salmonella performance 
standards and will provide more explanation of how the approach will 
work for all classes of product.
    Comment: Several trade associations requested clarification on how 
the Agency will respond with follow-up sampling in the event of a 
positive Salmonella result when the sample is negative for STEC.
    Response: As FSIS explained in the 2013 Federal Register document, 
because FSIS does not typically consider Salmonella an adulterant in 
raw beef, when FSIS begins analyzing samples collected for STEC 
analysis for Salmonella, FSIS will not routinely conduct follow-up 
sampling in response to a single positive Salmonella result. However, 
if FSIS Salmonella testing data from an establishment show a high 
number of positives, high levels of Salmonella for each positive, or 
serotypes of human health significance, FSIS may perform follow-up 
testing or conduct a for-cause Food Safety Assessment that includes 
follow-up testing or take other appropriate actions, such as additional 
sanitary dressing verification procedures, at the establishment that 
produced the product.

H. Import Inspection

    Comment: A foreign government requested clarification on regulatory 
control actions the Agency will take when raw beef product imported 
into the United States is sampled by FSIS at the port of entry and 
tests positive for Salmonella.
    Response: As stated above, Salmonella is not an adulterant in raw 
meat products. Therefore, a positive test result for Salmonella in 
imported raw beef product sampled by FSIS import inspection personnel 
would not result in regulatory control actions at port-of-entry.
    FSIS does not collect imported raw products for Salmonella 
analysis. FSIS stated that it intended to begin testing for Salmonella 
imported raw beef products it samples for STEC in the August 2013 
Federal Register document. On June 29, 2014, FSIS will begin analyzing 
for Salmonella all imported raw beef samples it collects for STEC 
analysis. FSIS will post aggregate results of this testing on the FSIS 
Web site as part of its quarterly report on Salmonella. In addition, 
FSIS will use enumeration and serotype data of this testing to identify 
trends within the sampling data, to determine whether an isolate has a 
historical association with human illness, and to identify clusters of 
patterns.

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 document online through the FSIS Web page 
located at http://www.fsis.usda.gov/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

[[Page 32440]]

selected food safety news and information. This service is available at 
http://www.fsis.usda.gov/subscribe. 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 June 2, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-13064 Filed 6-4-14; 8:45 am]
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