[Federal Register Volume 79, Number 108 (Thursday, June 5, 2014)]
[Rules and Regulations]
[Pages 32436-32440]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[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
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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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