80_FR_23843 80 FR 23761 - Risk-Based Sampling of Beef Manufacturing Trimmings for Escherichia coli (E. coli) O157:H7

80 FR 23761 - Risk-Based Sampling of Beef Manufacturing Trimmings for Escherichia coli (E. coli) O157:H7

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 80, Issue 82 (April 29, 2015)

Page Range23761-23765
FR Document2015-09957

The Food Safety and Inspection Service (FSIS) is responding to comments on the September 19, 2012, Federal Register notice, ``Risk- Based Sampling of Beef Manufacturing Trimmings for Escherichia coli O157:H7 and Plans for Beef Baseline'' and providing updates on how it is scheduling sampling for beef manufacturing trimmings. Additionally, the Agency is announcing that it is changing its existing algorithms for sampling of bench trim and raw ground beef components other than trim to make them more risk-based. Finally, the Agency is making available the following report: ``Effective Implementation of Beef Manufacturing Trimmings Sampling Redesign (MT60).''

Federal Register, Volume 80 Issue 82 (Wednesday, April 29, 2015)
[Federal Register Volume 80, Number 82 (Wednesday, April 29, 2015)]
[Notices]
[Pages 23761-23765]
From the Federal Register Online  [www.thefederalregister.org]
[FR Doc No: 2015-09957]


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Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / 
Notices

[[Page 23761]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2012-0020]


Risk-Based Sampling of Beef Manufacturing Trimmings for 
Escherichia coli (E. coli) O157:H7

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice: Response to comments.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is responding to 
comments on the September 19, 2012, Federal Register notice, ``Risk-
Based Sampling of Beef Manufacturing Trimmings for Escherichia coli 
O157:H7 and Plans for Beef Baseline'' and providing updates on how it 
is scheduling sampling for beef manufacturing trimmings. Additionally, 
the Agency is announcing that it is changing its existing algorithms 
for sampling of bench trim and raw ground beef components other than 
trim to make them more risk-based. Finally, the Agency is making 
available the following report: ``Effective Implementation of Beef 
Manufacturing Trimmings Sampling Redesign (MT60).''

DATES: On July 28, 2015, FSIS will implement design changes in bench 
trim and other ground beef components besides trimmings.

FOR FURTHER INFORMATION CONTACT: Daniel Engeljohn, Assistant 
Administrator, Office of Policy and Program Development, Food Safety 
and Inspection Service, U.S. Department of Agriculture, (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On September 19, 2012, FSIS published a Federal Register notice (77 
FR 58091) announcing its intention to redesign its E. coli O157:H7 
verification testing program for trimmings to make the program more 
risk-based and to enable the Agency to calculate on-going statistical 
prevalence estimates for E. coli O157:H7 in raw trimmings (http://www.fsis.usda.gov/wps/wcm/connect/15e75329-978f-43f0-b8fe-101845d898f0/Redesign_Beef_Trim_Sampling_Methodology.pdf?MOD=AJPERES). FSIS also 
announced additional changes to the trimmings sampling program to 
increase collection rates and the likelihood of finding positive E. 
coli O157:H7 sample results. FSIS discussed its plans to conduct a beef 
carcass baseline. Finally, FSIS explained it was planning to conduct a 
survey, using its employees that are assigned to beef slaughter and 
processing establishments, to gather information on establishment 
controls for Shiga toxin-producing Escherichia coli (STECs) in beef. 
Results of the survey are available at: http://www.fsis.usda.gov/wps/wcm/connect/fe95af5f-3271-41af-b92b-68490fa87cab/beef-operations-summary-results.pdf?MOD=AJPERES, which FSIS previously announced in the 
Federal Register notice announcing the availability of its analysis of 
the costs and benefits associated with FSIS's non-O157 STEC testing on 
November 19, 2014 (79 FR 68843) at http://www.fsis.usda.gov/wps/wcm/connect/ce564342-fa9c-44f4-a98a-a4a6b6797646/2010-0023.pdf?MOD=AJPERES.
    In June 2012, FSIS implemented the risk-based design and other 
changes discussed in the 2012 Federal Register notice. FSIS conducted 
analyses of the trimmings sampling program twelve months after 
implementation of the new risk-based design. Analyses show that the new 
design was successful at increasing the number of E. coli O157:H7 
positives detected and also significantly increased the collection 
rate. In the first twelve months of implementation, FSIS analysis of 
routine sampling of trimmings detected 1.8 times more E. coli O157:H7 
positives than FSIS had previously detected in this product. In the 
Federal Register notice FSIS estimated that the probability of 
obtaining E. coli O157:H7 results in trimmings during FSIS verification 
testing would increase by a factor of about 2.5. Possibilities for why 
FSIS did not detect an approximate 2.5 times as many E. coli O157:H7 
positives are numerous and include changes to the data systems and the 
frame available during analysis and modeling, changes to the laboratory 
tests implemented at about the same time as the new statistical design, 
and positives being collected under follow-up sampling rather than 
routine sampling. The new statistical design and overscheduling to 
adjust for nonresponse solved the historically low response rates 
associated with trimmings. The report is posted at http://www.fsis.usda.gov/wps/wcm/connect/31575c98-2c22-4e9c-a19d-b3511d106082/Analysis-Beef-Trim-Redesign.pdf?MOD=AJPERES.
    Therefore, FSIS has concluded that its change in sampling was 
effective. However, FSIS has not been able to estimate STEC prevalence 
in trimmings because it has not obtained a sufficient number of sample 
results. To address this issue, FSIS has increased the number of trim 
samples scheduled to be collected by inspectors for each month to that 
of the number of samples it had previously scheduled to be collected 
during months in the high prevalence season, effective November 2014. 
FSIS made this change to obtain the number of samples needed to allow 
on-going prevalence determinations to be made from the data collected.
    FSIS started conducting the Beef-Veal carcass baseline on August 1, 
2014, and will complete the survey July 31, 2015. As stated in the 
previous Federal Register notice discussed above, FSIS plans to use the 
results of the Beef-Veal carcass baseline and the results of the 
Pathogen Controls in Beef Operations survey data to conduct risk 
analyses to determine the relative impact of various establishment 
factors on the probability of E. coli O157:H7 contamination and 
subsequent illnesses, hospitalizations, and deaths. FSIS will post the 
survey results. In addition, now that FSIS also is analyzing beef 
samples for both STEC and Salmonella (79 FR 32436), FSIS is able to 
make statistically-based determinations about the on-going prevalence 
of these pathogens in beef samples at least on an annual basis.
    FSIS conducted a statistical analysis of the results from its 
sampling of bench trim program and its sampling of other ground beef 
components besides trimmings to identify factors that would lead to a 
higher probability of detecting E. coli O157:H7. FSIS did not find a 
higher probability of finding E. coli O157:H7 in particular 
establishments when it looked at the factors considered for these 
products. Because

[[Page 23762]]

establishments make different volumes of product, FSIS is changing its 
existing sampling algorithms for bench trim and other ground beef 
components besides trim to sample establishments proportional to 
production volume. Additionally, FSIS intends to overschedule to adjust 
for nonresponse under the redesigned programs, similar to how FSIS 
implemented changes to the trimmings program.

Comments and Responses

    FSIS received comments from seven industry and consumer 
organizations in response to the September 2012 notice. Both industry 
and consumer organizations supported the Agency's use of statistically 
significant data to make scientifically supported decisions regarding 
its sampling programs. Following is a discussion of these comments and 
FSIS's responses.

Sampling Programs

    Comment: Two consumer organizations requested that more funding be 
provided to maintain FSIS's sampling in the low prevalence season of 
the year in addition to maintaining the increased sampling during the 
high prevalence season.
    Response: As is stated above, the Agency has increased the number 
of trim samples. FSIS is now maintaining the high prevalence level of 
sampling throughout the entire year.
    Comment: One consumer group questioned the statistical validity of 
using an N-60 collection method for trimmings that the Agency has 
reported on its Web site and cited the findings of the 2012 OIG audit 
report.
    Response: FSIS's sampling and testing for E. coli O157:H7 is just 
one of the activities that FSIS conducts to verify that an 
establishment's food safety systems effectively address STEC. FSIS 
sampling of beef trim works along with other inspection and 
verification activities, including FSIS sampling of ground beef and 
other ground beef components and its review of establishment testing 
results, to detect and reduce E. coli O157:H7 in beef products.
    As FSIS explained in response to the Office of the Inspector 
General's report on the Agency's sampling protocol for testing beef 
trim for E. coli O157:H7,\1\ FSIS does not view a single N-60 sampling 
result apart from other verification activities. Note that along with 
sampling and carcass-by-carcass inspection, FSIS inspection personnel 
performed more than 839,000 inspection procedures in CY-2014 at roughly 
635 slaughter establishments that would also be subject to trim 
sampling. These inspection procedures, performed daily at slaughter 
establishments, play an important role in ensuring that establishments 
are producing safe and wholesome products.
---------------------------------------------------------------------------

    \1\ OIG Audit Report 24601-9-KC ``FSIS Sampling Protocol for 
Testing Beef Trim for E. coli O157:H7'' p. 31
---------------------------------------------------------------------------

    While a single N-60 sample result may not indicate definitively the 
success or failure of an establishment's process controls for beef 
trim, it can be an important part of the establishment's verification 
program, especially if the establishment or FSIS takes multiple N-60 
samples over time.
    FSIS' mission is not to screen the food supply through testing but 
to ensure the production of safe and wholesome food through inspection.
    Comment: One industry organization suggested that the Agency 
consider market class of animal, size of the establishment, and the 
historical rate of E. coli O157:H7 detection at the establishment in 
Agency testing when making risk-based sampling program decisions.
    Response: When considering the redesign of its trimmings sampling 
program, the Agency did consider establishment size in average pounds 
produced per day and historical positive sampling results over time. 
The Agency chose to consider the volume of product that an 
establishment produced to focus the Agency's resources on actual 
product produced.
    As explained in the 2012 Federal Register notice (77 FR 58091), 
FSIS redesigned the sampling algorithm to collect more samples from 
establishments in establishment size categories with the highest 
probability of producing trimmings contaminated with E. coli O157:H7. 
As a result, the Agency is focusing on small establishments that 
produce between 1001 and 50,000 pounds per day.
    At this time, FSIS does not have the means to collect different 
types of market class information other than to differentiate between 
beef and veal. FSIS will continue to report veal results separately 
from other beef results http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/positive-results-current-cy/positive-results-current-cy. In addition, FSIS will consider 
assessing the differences between veal and beef results and issuing 
necessary guidance and instructions to the field based on these results 
when appropriate. For example, based on its analysis of results, FSIS 
issued instructions, in 2011-2012, for inspectors to verify that 
establishments applied antimicrobial interventions to veal carcasses 
correctly, and that they maintained procedures to minimize cross-
contamination among veal carcasses.
    Comment: One industry organization encouraged FSIS to conduct risk-
based sampling for ground beef as well.
    Response: An FSIS risk assessment, presented in a public meeting on 
October 28, 1998, and updated thereafter, found that volume of 
production is a better determinant of risk for E. coli O157:H7 in 
ground beef than size of the establishment. Beginning on January 1, 
2008, FSIS initiated an enhanced risk-based sampling and testing 
program for E. coli O157:H7 in raw ground beef. The risk-based sampling 
program took into account establishment volume, and whether the 
establishment had any FSIS or Agriculture Marketing Service positive 
results within the past 120 days. The current sampling is proportional 
to ground beef production volume. Consequently, the program supports 
on-going prevalence estimates from the data.
    Comment: One industry organization commented that the Agency 
concluded that the rate of sanitary dressing procedure noncompliance 
reports could not be used to identify establishments that have a higher 
probability of E. coli O157:H7 positive tests result. The industry 
organization requested that FSIS determine whether the revised cattle 
sanitary dressing directive improved sanitary dressing procedures, and 
whether there is a correlation between sanitary dressing procedures and 
positive E. coli O157:H7 test results. The commenter stated that 
establishment size and animal market class should also be addressed in 
this review of sanitary dressing procedures.
    Response: When FSIS did the analysis for the statistical redesign, 
it found that there is no predictive relationship between higher 
sanitary dressing noncompliances and the probability of E. coli O157:H7 
positive sample results. Under the Public Health Inspection System 
(PHIS), the Agency tracks the inspection activities inspection 
personnel use to verify whether an establishment's food safety system 
meets regulatory requirements. The inspection activities tracked 
include the procedures used to verify whether establishments maintain 
effective sanitary dressing procedures. The Agency analyzes the PHIS 
data on inspection activities on a biannual basis.
    FSIS reviewed the data for the relevant inspection tasks performed 
and FSIS positive results at establishments sampled under the trimmings 
(MT50)

[[Page 23763]]

sampling program. FSIS did not find a correlation between sanitary 
dressing or sanitation NRs and MT50 percent positive in trimmings.
    Comment: One consumer organization recommended that FSIS take 
additional steps to improve the representativeness of the samples 
collected by eliminating FSIS's procedure of pre-notification of 
testing. The commenter stated that this notification allows 
establishments to adjust their operations before the sample is taken. 
The consumer group also recognized that FSIS mailed test kits to 
establishments before field personnel collected samples for chain of 
evidence reasons. The commenter stated that the arrival of a sample box 
would signal that a test is imminent and serves as a pre-notification. 
The consumer organization suggested that sample boxes be kept stocked 
by in-plant personnel.
    Response: FSIS requires establishments to hold product tested for 
an adulterant such as E. coli O157:H7 pending the results of FSIS 
testing. Establishment management needs sufficient pre-notification of 
sampling in order to hold production lots in a manner such that they 
are microbiologically independent. Otherwise, FSIS would be collecting 
samples from production lots that may already be distributed in 
commerce, resulting in preventable product recalls. FSIS has issued 
instructions to field personnel to notify establishment that FSIS will 
be collecting a sample, but that the notification should only provide 
enough time for the establishment to be able to hold all affected 
product.
    The Agency has a finite number of resources which makes stocking 
multiple sample boxes at establishments cost prohibitive. Additionally, 
some USDA offices in establishments are small and do not allow for 
storage of multiple sample boxes. If establishments change their food 
safety system on the days that FSIS collects samples in a manner to 
influence the sample result, FSIS has instructed inspection program 
personnel to notify their supervisory chain so that a determination can 
be made as to how to address this concern. In such circumstances, FSIS 
may decide to conduct additional sampling at the establishment or to 
conduct a Food Safety Assessment (which includes in-depth verification 
that the establishment meets regulatory requirements related to food 
safety).
    Comment: One consumer organization questioned whether the results 
for FSIS's sampling programs can be used to develop reliable prevalence 
estimates.
    Response: As noted above, FSIS has increased the number of trimming 
samples collected to achieve the number of samples needed to allow STEC 
on-going prevalence determinations to be made from the data collected. 
FSIS will make E. coli O157:H7 prevalence estimates for ground beef 
available in the near future. FSIS will make STEC prevalence (E. coli 
O157:H7 and other STEC) estimates for trim available in the first 
quarter of FY 2016.

Industry Survey

    Comment: One industry organization had several suggestions 
regarding the beef survey that FSIS announced in the 2012 Federal 
Register notice (77 FR 58091). The commenter stated that the survey 
should: (1) have clear goals and deliverables, (2) not put an economic 
burden on industry, (3) have questions based on data that pertain to 
the problem of E. coli O157:H7 contamination, (4) collect data on the 
volume of source material produced by establishments that test for E. 
coli O157:H7, and (5) present results as volume-based to address the 
results from the survey.
    Response: Through the survey described above, inspectors provided 
information on processing practices that establishments employ to 
reduce the likelihood of contamination of intact and non-intact raw 
beef products with STEC. FSIS did have clear goals when it put forth 
the survey. This survey was designed to gather information not 
collected in the Public Health Information System. FSIS is using the 
survey results to update the economic analysis to support the full 
implementation of its non-O157 STEC policy. Data from the 2013 Pathogen 
Controls in Beef Operations Survey (conducted in May-July 2013) allowed 
FSIS to estimate the number of non-O157 STEC tests conducted by the 
industry for a 12-month period. FSIS is also analyzing the survey 
results to develop targeted approaches for its risk-based verification 
testing program and to assist it in prioritizing the scheduling of Food 
Safety Assessments (FSA) by Enforcement, Investigations, and Analysis 
Officers (EIAO). FSIS did not collect production volume information in 
the survey and is not presenting the results as volume based. 
Establishment profiles contain production volume information in the 
Public Health Information System.
    FSIS has used the numbers obtained in the survey to estimate 
sampling numbers for industry testing as part of the economic analysis 
for STEC sampling in all of the Agency's raw beef microbiological 
sampling programs. The economic analysis is available at http://www.fsis.usda.gov/wps/wcm/connect/52afacbc-4780-4fba-a7ab-cde987ea1d45/STEC-cost-benefit-analysis.pdf?MOD=AJPERES. Additionally, FSIS plans to 
conduct risk analyses, as appropriate, to determine the relative impact 
of various establishment factors on the probability of E. coli O157:H7 
contamination and subsequent illnesses, hospitalizations, and deaths. 
FSIS intends to use the data generated by the actions listed above to 
assess and evaluate its trimmings sampling program and to make risk-
based changes as appropriate.
    FSIS implemented the survey in such a way as to not cause an undue 
economic burden on industry.
    Comment: One consumer group commented that FSIS should make plans 
to routinely repeat the survey to inform sampling decisions made by the 
Agency.
    Response: Conducting the survey is very time intensive for field 
personnel. FSIS must weigh the time spent completing a survey against 
the time spent conducting regular inspection duties. FSIS will conduct 
future surveys as necessary.

Carcass Baseline

    Comment: An industry organization commented that the beef carcass 
baseline should include the whole beef trimmings production process, 
and that it should also include veal.
    Response: The Beef-Veal carcass baseline began August 1, 2014. FSIS 
is including steers, heifers, cows, bulls, stag, dairy cows, and veal 
carcasses in the Beef-Veal carcass baseline. FSIS is collecting samples 
at two points in the process, immediately after hide removal (pre-
evisceration) and at pre-chill (after all antimicrobial interventions).
    Comment: An industry organization suggested that because FSIS is 
only testing for pathogenic organisms that are adulterants, the Agency 
should consider alternative baseline testing locations within the 
production supply chain. The commenter suggested that FSIS collect a 
post-hide removal sample to address the hide removal process, where 
cross-contamination is more likely to occur; a second sample site after 
antimicrobial interventions; and trim testing for E. coli O157:H7 for 
products that will be used in ground beef or veal production.
    Response: The Agency is obtaining samples at two points in the 
slaughter process for the baseline study: immediately after hide 
removal but before evisceration, and at pre-chill before the carcasses 
enter the chillers and after all antimicrobial applications.

[[Page 23764]]

This study addresses three distinct objectives: to estimate the 
prevalence and quantitative levels of selected foodborne 
microorganisms, to obtain data for use in the development of Agency 
programs, and to obtain data for informing industry guidance related to 
process control. The sample design and the resulting sample size are 
limited for this survey by practical constraints such as finite 
personnel and financial resources, and the problems with implementing 
scientific studies in real-world production settings. Considering these 
constraints, FSIS expects that the Beef-Veal carcass baseline study 
will achieve the stated objectives because FSIS will collect and 
analyze as many samples as possible to ensure an appropriate level of 
statistical confidence.
    With the two points that the Agency chose to use for sampling for 
the baseline carcass study, FSIS requires the establishment to hold or 
control the movement of sampled carcasses at pre-chill until the 
establishment is notified of STEC results. FSIS verifies that the 
establishment does not treat the sampled carcasses any differently than 
any of the other carcasses it is processing. In the event that a 
sampled carcass is treated differently, FSIS will randomly select 
another carcass during the same processing time and collect samples 
from that carcass.
    The results from samples collected during the baseline carcass 
study become available after all analyses for STEC and Salmonella are 
complete. Baseline sample results usually are reported in two to six 
days but may take longer depending on individual circumstances. Post-
hide/pre-evisceration and pre-chill sample results are reported through 
Laboratory Information Management System (LIMS) Direct.
    FSIS is not issuing noncompliance records (NRs) for STEC positive 
results during the baseline. In response to a positive result from the 
pre-chill sample only, field personnel perform a directed Slaughter 
HACCP Verification task to verify that the establishment has adequate 
slaughter controls (including antimicrobial intervention 
implementation) for the specific production lot represented by the 
positive STEC carcass result. Field personnel also verify that the 
establishment implements corrective actions that meet the applicable 
requirements in 9 CFR 417.3. Field personnel do not verify corrective 
actions in response to a positive STEC result from the post-hide/pre-
evisceration sample. Rather, FSIS verifies that establishments ensure 
that carcasses found positive for STECs during the pre-chill sampling 
and testing are not processed into raw non-intact product. The presence 
of STEC on a pre-chill carcass intended for use as raw non-intact 
product would adulterate the carcass. The presence of STEC on a carcass 
intended for use as raw intact product would not adulterate the carcass 
if the entire carcass is going for intact product. In the event that a 
carcass tests positive for STEC, establishments may take action to 
ensure that all products from the carcass go for cooking, or they may 
take action to recondition the carcass and ensure that the carcass goes 
for intact use only.
    In the event of a STEC positive on a post-hide removal/pre-
evisceration sample without a corresponding pre-chill sample on a 
carcass intended for raw non-intact use, the carcass would not be 
considered adulterated. The carcass presumably will undergo further 
interventions after post-hide removal/pre-evisceration. In the event of 
a STEC positive from a pre-chill test result on a carcass intended for 
raw non-intact use, the carcass is considered adulterated. The 
establishment is required to take corrective action.
    Comment: One industry organization recommended that FSIS conduct a 
``shakedown'' period at establishments representative of the industry 
in order to assess the logistics of sampling. The commenter stated that 
this shakedown should be done to provide a safe sampling environment 
for inspection personnel and to ensure that sampling will not interfere 
with the routine slaughter process.
    Response: FSIS agrees with the comment. The Agency did conduct a 
shakedown training period before the actual baseline and confirmed that 
baseline sampling will not interfere with the routine slaughter 
process.
    Comment: One industry organization commented that while the Agency 
is developing the baseline, the timeframe for the publication of study 
results should be outlined.
    Response: FSIS posted the study design and sampling plan on the 
FSIS Web site at http://www.fsis.usda.gov/wps/wcm/connect/5057f4ef-f924-422c-bafe-771b1ead78e4/Beef-Veal-Carcass-Baseline-Study-Design.pdf?MOD=AJPERES. FSIS will publish a final report with the 
national prevalence calculations after the completion of the survey.
    Comment: One industry organization commented that sampling 
immediately after de-hiding may not provide the most meaningful 
information as to the presence of the various organisms in the 
slaughter process. The commenter stated that although the sample may be 
taken before any on-line interventions, the condition of the carcass, 
in terms of potential microbial load, is not comparable across 
establishments. The commenter explained that some establishments have 
interventions and other practices that occur before de-hiding, such as 
bacteriophage sprays or hide washes. Likewise, the commenter stated 
that the effectiveness of hide removal in minimizing contamination of 
the carcass varies among establishments. If FSIS is seeking to use this 
baseline to assist establishments in assessing ``incoming'' 
contamination levels before on-line interventions, the commenter stated 
that not taking into account the steps that come before this sampling 
point at each establishment would likely limit the usability of the 
results.
    Response: FSIS agrees that the incoming microbial load may vary 
from establishment to establishment depending on whether establishments 
use bacteriophage sprays or hide washes, and that the effectiveness of 
establishments in preventing cross-contamination in hide removal may 
also vary. Nevertheless, FSIS expects that the Beef-Veal carcass 
baseline study will achieve the stated objectives by collecting and 
analyzing as many samples as possible to ensure an appropriate level of 
statistical confidence.
    Comment: Two commenters stated that carcass sampling immediately 
after de-hiding could pose a safety risk to inspection program 
personnel, as well as to establishment employees. According to the 
commenters, this location is in the middle of the harvest line, so 
taking a sample at this juncture will require inspection program 
personnel to enter an area of the process where hazards, such as 
dangerous equipment, are present and space is limited. Taking samples 
at this point could, in turn, also put establishment employees at risk.
    Response: FSIS discussed with establishment management before 
collecting samples for the shakedown the following: (1) Where 
supervisory personnel could safely collect post-hide removal/pre-
evisceration and pre-chill samples, (2) establishment safety 
requirements and protocols that supervisory field personnel must follow 
during sample collection, and (3) the potential need for line stoppages 
for supervisory field personnel to safely and properly collect the 
samples. FSIS also issued instructions to inspection program personnel 
for conducting sampling from a safe vantage point, especially when 
collecting the posterior

[[Page 23765]]

samples from the post-hide/pre-evisceration and pre-chill locations; 
following the same safety procedures provided for employees at that 
establishment which may require the use of a harness; slowing or 
stopping production lines; and acquiring needed tools to safely collect 
samples. Information on the Beef-Veal carcass baseline can be found at 
the following link http://www.fsis.usda.gov/wps/wcm/connect/5d3552e7-9b81-4b2c-aa20-cfaeef77f251/36-14.pdf?MOD=AJPERES.
    Comment: One industry organization asked what type of carcass 
sampling the Agency will use for the carcass baseline study.
    Response: As was done during the shakedown, FSIS is obtaining 
samples following the procedures described in the United States 
Department of Agriculture Agricultural Research Service Meat Animal 
Research Center Carcass Sampling Protocol \2\ available at the 
following link: http://www.ars.usda.gov/SP2UserFiles/Place/54380530/protocols/USMARC%20Carcass%20Sampling%20Protocol.pdf.
---------------------------------------------------------------------------

    \2\ U.S. Meat Animal Research Center (MARC) Carcass Sampling 
Protocol.
---------------------------------------------------------------------------

    Comment: One consumer organization stated that FSIS should conduct 
a baseline study to estimate the prevalence of E. coli O157:H7 in beef 
manufacturing trimmings and ground beef in order to improve the 
confidence in FSIS's efforts to detect contaminated product and 
effectively verify process controls.
    Response: FSIS decided to focus on sampling carcasses for this 
baseline and not trimmings and ground beef because of resource 
limitations. The Beef-Veal carcass baseline survey will provide FSIS 
the necessary data on percent positives and quantitative levels of 
select foodborne bacterial pathogens (e.g., Salmonella, STEC, and 
certain indicator organisms). FSIS will use the data from the Beef-Veal 
carcass baseline survey to estimate the national prevalence of select 
microorganisms in carcasses, not trimmings and ground beef; to develop 
industry performance guidelines; to assess process control across the 
industry; and to inform additional policy considerations. Results of 
this study will be used to estimate volume-weighted prevalence and 
bacterial loads immediately after hide removal and at pre-chill. 
Moreover, FSIS has made changes to both the trimmings and ground beef 
verification testing programs to be able to obtain on-going prevalence 
of both E. coli O157:H7 and Salmonella (79 FR 32437).

Other Topics

    The following comment topics that were received are outside the 
scope of this notice: disappearing schedule dates from PHIS, returned 
FedEx sample boxes, FSIS training materials, and purge studies.

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    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS Web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will make copies of this 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 our constituents and 
stakeholders. The Update is available on the FSIS Web page. Through the 
Web page, FSIS is able to provide information to a much broader, more 
diverse audience. In addition, FSIS offers an email 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/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves, and have the option to password 
protect their accounts.

Done, at Washington, DC.

    Dated: April 23, 2015.
Alfred V. Almanza,
Acting Administrator.
[FR Doc. 2015-09957 Filed 4-28-15; 8:45 am]
 BILLING CODE 3410-DM-P



                                                                                                                                                                                                 23761

                                                  Notices                                                                                                       Federal Register
                                                                                                                                                                Vol. 80, No. 82

                                                                                                                                                                Wednesday, April 29, 2015



                                                  This section of the FEDERAL REGISTER                    enable the Agency to calculate on-going               to the laboratory tests implemented at
                                                  contains documents other than rules or                  statistical prevalence estimates for E.               about the same time as the new
                                                  proposed rules that are applicable to the               coli O157:H7 in raw trimmings (http://                statistical design, and positives being
                                                  public. Notices of hearings and investigations,         www.fsis.usda.gov/wps/wcm/connect/                    collected under follow-up sampling
                                                  committee meetings, agency decisions and                15e75329-978f-43f0-b8fe-101845d898f0/                 rather than routine sampling. The new
                                                  rulings, delegations of authority, filing of
                                                  petitions and applications and agency
                                                                                                          Redesign_Beef_Trim_Sampling_                          statistical design and overscheduling to
                                                  statements of organization and functions are            Methodology.pdf?MOD=AJPERES). FSIS                    adjust for nonresponse solved the
                                                  examples of documents appearing in this                 also announced additional changes to                  historically low response rates
                                                  section.                                                the trimmings sampling program to                     associated with trimmings. The report is
                                                                                                          increase collection rates and the                     posted at http://www.fsis.usda.gov/wps/
                                                                                                          likelihood of finding positive E. coli                wcm/connect/31575c98-2c22-4e9c-
                                                  DEPARTMENT OF AGRICULTURE                               O157:H7 sample results. FSIS discussed                a19d-b3511d106082/Analysis-Beef-
                                                                                                          its plans to conduct a beef carcass                   Trim-Redesign.pdf?MOD=AJPERES.
                                                  Food Safety and Inspection Service                      baseline. Finally, FSIS explained it was                 Therefore, FSIS has concluded that its
                                                  [Docket No. FSIS–2012–0020]                             planning to conduct a survey, using its               change in sampling was effective.
                                                                                                          employees that are assigned to beef                   However, FSIS has not been able to
                                                  Risk-Based Sampling of Beef                             slaughter and processing                              estimate STEC prevalence in trimmings
                                                  Manufacturing Trimmings for                             establishments, to gather information on              because it has not obtained a sufficient
                                                  Escherichia coli (E. coli) O157:H7                      establishment controls for Shiga toxin-               number of sample results. To address
                                                                                                          producing Escherichia coli (STECs) in                 this issue, FSIS has increased the
                                                  AGENCY:  Food Safety and Inspection                     beef. Results of the survey are available             number of trim samples scheduled to be
                                                  Service, USDA.                                          at: http://www.fsis.usda.gov/wps/wcm/                 collected by inspectors for each month
                                                  ACTION: Notice: Response to comments.                   connect/fe95af5f-3271-41af-b92b-                      to that of the number of samples it had
                                                                                                          68490fa87cab/beef-operations-                         previously scheduled to be collected
                                                  SUMMARY:   The Food Safety and
                                                                                                          summary-results.pdf?MOD=AJPERES,                      during months in the high prevalence
                                                  Inspection Service (FSIS) is responding
                                                                                                          which FSIS previously announced in                    season, effective November 2014. FSIS
                                                  to comments on the September 19, 2012,
                                                                                                          the Federal Register notice announcing                made this change to obtain the number
                                                  Federal Register notice, ‘‘Risk-Based
                                                                                                          the availability of its analysis of the               of samples needed to allow on-going
                                                  Sampling of Beef Manufacturing
                                                                                                          costs and benefits associated with                    prevalence determinations to be made
                                                  Trimmings for Escherichia coli O157:H7
                                                                                                          FSIS’s non-O157 STEC testing on                       from the data collected.
                                                  and Plans for Beef Baseline’’ and
                                                                                                          November 19, 2014 (79 FR 68843) at                       FSIS started conducting the Beef-Veal
                                                  providing updates on how it is
                                                                                                          http://www.fsis.usda.gov/wps/wcm/                     carcass baseline on August 1, 2014, and
                                                  scheduling sampling for beef
                                                                                                          connect/ce564342-fa9c-44f4-a98a-                      will complete the survey July 31, 2015.
                                                  manufacturing trimmings. Additionally,
                                                                                                          a4a6b6797646/2010-0023.pdf?MOD=                       As stated in the previous Federal
                                                  the Agency is announcing that it is
                                                                                                          AJPERES.                                              Register notice discussed above, FSIS
                                                  changing its existing algorithms for
                                                                                                             In June 2012, FSIS implemented the                 plans to use the results of the Beef-Veal
                                                  sampling of bench trim and raw ground
                                                                                                          risk-based design and other changes                   carcass baseline and the results of the
                                                  beef components other than trim to
                                                                                                          discussed in the 2012 Federal Register                Pathogen Controls in Beef Operations
                                                  make them more risk-based. Finally, the
                                                                                                          notice. FSIS conducted analyses of the                survey data to conduct risk analyses to
                                                  Agency is making available the
                                                                                                          trimmings sampling program twelve                     determine the relative impact of various
                                                  following report: ‘‘Effective
                                                                                                          months after implementation of the new                establishment factors on the probability
                                                  Implementation of Beef Manufacturing
                                                                                                          risk-based design. Analyses show that                 of E. coli O157:H7 contamination and
                                                  Trimmings Sampling Redesign (MT60).’’
                                                                                                          the new design was successful at                      subsequent illnesses, hospitalizations,
                                                  DATES: On July 28, 2015, FSIS will                      increasing the number of E. coli                      and deaths. FSIS will post the survey
                                                  implement design changes in bench                       O157:H7 positives detected and also                   results. In addition, now that FSIS also
                                                  trim and other ground beef components                   significantly increased the collection                is analyzing beef samples for both STEC
                                                  besides trimmings.                                      rate. In the first twelve months of                   and Salmonella (79 FR 32436), FSIS is
                                                  FOR FURTHER INFORMATION CONTACT:                        implementation, FSIS analysis of                      able to make statistically-based
                                                  Daniel Engeljohn, Assistant                             routine sampling of trimmings detected                determinations about the on-going
                                                  Administrator, Office of Policy and                     1.8 times more E. coli O157:H7 positives              prevalence of these pathogens in beef
                                                  Program Development, Food Safety and                    than FSIS had previously detected in                  samples at least on an annual basis.
                                                  Inspection Service, U.S. Department of                  this product. In the Federal Register                    FSIS conducted a statistical analysis
                                                  Agriculture, (202) 205–0495.                            notice FSIS estimated that the                        of the results from its sampling of bench
                                                  SUPPLEMENTARY INFORMATION:                              probability of obtaining E. coli O157:H7              trim program and its sampling of other
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                                                                                                          results in trimmings during FSIS                      ground beef components besides
                                                  Background                                              verification testing would increase by a              trimmings to identify factors that would
                                                    On September 19, 2012, FSIS                           factor of about 2.5. Possibilities for why            lead to a higher probability of detecting
                                                  published a Federal Register notice (77                 FSIS did not detect an approximate 2.5                E. coli O157:H7. FSIS did not find a
                                                  FR 58091) announcing its intention to                   times as many E. coli O157:H7 positives               higher probability of finding E. coli
                                                  redesign its E. coli O157:H7 verification               are numerous and include changes to                   O157:H7 in particular establishments
                                                  testing program for trimmings to make                   the data systems and the frame available              when it looked at the factors considered
                                                  the program more risk-based and to                      during analysis and modeling, changes                 for these products. Because


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                                                  23762                        Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices

                                                  establishments make different volumes                   performed more than 839,000                           establishments applied antimicrobial
                                                  of product, FSIS is changing its existing               inspection procedures in CY-2014 at                   interventions to veal carcasses correctly,
                                                  sampling algorithms for bench trim and                  roughly 635 slaughter establishments                  and that they maintained procedures to
                                                  other ground beef components besides                    that would also be subject to trim                    minimize cross-contamination among
                                                  trim to sample establishments                           sampling. These inspection procedures,                veal carcasses.
                                                  proportional to production volume.                      performed daily at slaughter                             Comment: One industry organization
                                                  Additionally, FSIS intends to                           establishments, play an important role                encouraged FSIS to conduct risk-based
                                                  overschedule to adjust for nonresponse                  in ensuring that establishments are                   sampling for ground beef as well.
                                                  under the redesigned programs, similar                  producing safe and wholesome                             Response: An FSIS risk assessment,
                                                  to how FSIS implemented changes to                      products.                                             presented in a public meeting on
                                                  the trimmings program.                                    While a single N–60 sample result                   October 28, 1998, and updated
                                                                                                          may not indicate definitively the                     thereafter, found that volume of
                                                  Comments and Responses                                  success or failure of an establishment’s              production is a better determinant of
                                                    FSIS received comments from seven                     process controls for beef trim, it can be             risk for E. coli O157:H7 in ground beef
                                                  industry and consumer organizations in                  an important part of the establishment’s              than size of the establishment.
                                                  response to the September 2012 notice.                  verification program, especially if the               Beginning on January 1, 2008, FSIS
                                                  Both industry and consumer                              establishment or FSIS takes multiple N–               initiated an enhanced risk-based
                                                  organizations supported the Agency’s                    60 samples over time.                                 sampling and testing program for E. coli
                                                  use of statistically significant data to                  FSIS’ mission is not to screen the food             O157:H7 in raw ground beef. The risk-
                                                  make scientifically supported decisions                 supply through testing but to ensure the              based sampling program took into
                                                  regarding its sampling programs.                        production of safe and wholesome food                 account establishment volume, and
                                                  Following is a discussion of these                      through inspection.                                   whether the establishment had any FSIS
                                                  comments and FSIS’s responses.                            Comment: One industry organization                  or Agriculture Marketing Service
                                                                                                          suggested that the Agency consider                    positive results within the past 120
                                                  Sampling Programs                                       market class of animal, size of the                   days. The current sampling is
                                                     Comment: Two consumer                                establishment, and the historical rate of             proportional to ground beef production
                                                  organizations requested that more                       E. coli O157:H7 detection at the                      volume. Consequently, the program
                                                  funding be provided to maintain FSIS’s                  establishment in Agency testing when                  supports on-going prevalence estimates
                                                  sampling in the low prevalence season                   making risk-based sampling program                    from the data.
                                                  of the year in addition to maintaining                  decisions.                                               Comment: One industry organization
                                                  the increased sampling during the high                    Response: When considering the                      commented that the Agency concluded
                                                  prevalence season.                                      redesign of its trimmings sampling                    that the rate of sanitary dressing
                                                     Response: As is stated above, the                    program, the Agency did consider                      procedure noncompliance reports could
                                                  Agency has increased the number of                      establishment size in average pounds                  not be used to identify establishments
                                                  trim samples. FSIS is now maintaining                   produced per day and historical positive              that have a higher probability of E. coli
                                                  the high prevalence level of sampling                   sampling results over time. The Agency                O157:H7 positive tests result. The
                                                  throughout the entire year.                             chose to consider the volume of product               industry organization requested that
                                                     Comment: One consumer group                          that an establishment produced to focus               FSIS determine whether the revised
                                                  questioned the statistical validity of                  the Agency’s resources on actual                      cattle sanitary dressing directive
                                                  using an N–60 collection method for                     product produced.                                     improved sanitary dressing procedures,
                                                  trimmings that the Agency has reported                    As explained in the 2012 Federal                    and whether there is a correlation
                                                  on its Web site and cited the findings of               Register notice (77 FR 58091), FSIS                   between sanitary dressing procedures
                                                  the 2012 OIG audit report.                              redesigned the sampling algorithm to                  and positive E. coli O157:H7 test results.
                                                     Response: FSIS’s sampling and testing                collect more samples from                             The commenter stated that
                                                  for E. coli O157:H7 is just one of the                  establishments in establishment size                  establishment size and animal market
                                                  activities that FSIS conducts to verify                 categories with the highest probability               class should also be addressed in this
                                                  that an establishment’s food safety                     of producing trimmings contaminated                   review of sanitary dressing procedures.
                                                  systems effectively address STEC. FSIS                  with E. coli O157:H7. As a result, the                   Response: When FSIS did the analysis
                                                  sampling of beef trim works along with                  Agency is focusing on small                           for the statistical redesign, it found that
                                                  other inspection and verification                       establishments that produce between                   there is no predictive relationship
                                                  activities, including FSIS sampling of                  1001 and 50,000 pounds per day.                       between higher sanitary dressing
                                                                                                            At this time, FSIS does not have the                noncompliances and the probability of
                                                  ground beef and other ground beef
                                                                                                          means to collect different types of                   E. coli O157:H7 positive sample results.
                                                  components and its review of
                                                                                                          market class information other than to                Under the Public Health Inspection
                                                  establishment testing results, to detect
                                                                                                          differentiate between beef and veal.                  System (PHIS), the Agency tracks the
                                                  and reduce E. coli O157:H7 in beef
                                                                                                          FSIS will continue to report veal results             inspection activities inspection
                                                  products.
                                                     As FSIS explained in response to the                 separately from other beef results http://            personnel use to verify whether an
                                                  Office of the Inspector General’s report                www.fsis.usda.gov/wps/portal/fsis/                    establishment’s food safety system
                                                  on the Agency’s sampling protocol for                   topics/data-collection-and-reports/                   meets regulatory requirements. The
                                                  testing beef trim for E. coli O157:H7,1                 microbiology/ec/positive-results-                     inspection activities tracked include the
                                                                                                          current-cy/positive-results-current-cy. In            procedures used to verify whether
                                                  FSIS does not view a single N–60
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                                                                                                          addition, FSIS will consider assessing                establishments maintain effective
                                                  sampling result apart from other
                                                                                                          the differences between veal and beef                 sanitary dressing procedures. The
                                                  verification activities. Note that along
                                                                                                          results and issuing necessary guidance                Agency analyzes the PHIS data on
                                                  with sampling and carcass-by-carcass
                                                                                                          and instructions to the field based on                inspection activities on a biannual basis.
                                                  inspection, FSIS inspection personnel
                                                                                                          these results when appropriate. For                      FSIS reviewed the data for the
                                                    1 OIG Audit Report 24601–9–KC ‘‘FSIS Sampling         example, based on its analysis of results,            relevant inspection tasks performed and
                                                  Protocol for Testing Beef Trim for E. coli O157:H7’’    FSIS issued instructions, in 2011–2012,               FSIS positive results at establishments
                                                  p. 31                                                   for inspectors to verify that                         sampled under the trimmings (MT50)


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                                                                               Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices                                           23763

                                                  sampling program. FSIS did not find a                      Response: As noted above, FSIS has                 economic analysis is available at
                                                  correlation between sanitary dressing or                increased the number of trimming                      http://www.fsis.usda.gov/wps/wcm/
                                                  sanitation NRs and MT50 percent                         samples collected to achieve the number               connect/52afacbc-4780-4fba-a7ab-
                                                  positive in trimmings.                                  of samples needed to allow STEC on-                   cde987ea1d45/STEC-cost-benefit-
                                                     Comment: One consumer organization                   going prevalence determinations to be                 analysis.pdf?MOD=AJPERES.
                                                  recommended that FSIS take additional                   made from the data collected. FSIS will               Additionally, FSIS plans to conduct risk
                                                  steps to improve the representativeness                 make E. coli O157:H7 prevalence                       analyses, as appropriate, to determine
                                                  of the samples collected by eliminating                 estimates for ground beef available in                the relative impact of various
                                                  FSIS’s procedure of pre-notification of                 the near future. FSIS will make STEC                  establishment factors on the probability
                                                  testing. The commenter stated that this                 prevalence (E. coli O157:H7 and other                 of E. coli O157:H7 contamination and
                                                  notification allows establishments to                   STEC) estimates for trim available in the             subsequent illnesses, hospitalizations,
                                                  adjust their operations before the                      first quarter of FY 2016.                             and deaths. FSIS intends to use the data
                                                  sample is taken. The consumer group                                                                           generated by the actions listed above to
                                                  also recognized that FSIS mailed test                   Industry Survey
                                                                                                                                                                assess and evaluate its trimmings
                                                  kits to establishments before field                        Comment: One industry organization                 sampling program and to make risk-
                                                  personnel collected samples for chain of                had several suggestions regarding the                 based changes as appropriate.
                                                  evidence reasons. The commenter stated                  beef survey that FSIS announced in the                  FSIS implemented the survey in such
                                                  that the arrival of a sample box would                  2012 Federal Register notice (77 FR                   a way as to not cause an undue
                                                  signal that a test is imminent and serves               58091). The commenter stated that the                 economic burden on industry.
                                                  as a pre-notification. The consumer                     survey should: (1) have clear goals and                 Comment: One consumer group
                                                  organization suggested that sample                      deliverables, (2) not put an economic                 commented that FSIS should make
                                                  boxes be kept stocked by in-plant                       burden on industry, (3) have questions                plans to routinely repeat the survey to
                                                  personnel.                                              based on data that pertain to the                     inform sampling decisions made by the
                                                     Response: FSIS requires                              problem of E. coli O157:H7                            Agency.
                                                  establishments to hold product tested                   contamination, (4) collect data on the                  Response: Conducting the survey is
                                                  for an adulterant such as E. coli                       volume of source material produced by                 very time intensive for field personnel.
                                                  O157:H7 pending the results of FSIS                     establishments that test for E. coli                  FSIS must weigh the time spent
                                                  testing. Establishment management                       O157:H7, and (5) present results as                   completing a survey against the time
                                                  needs sufficient pre-notification of                    volume-based to address the results                   spent conducting regular inspection
                                                  sampling in order to hold production                    from the survey.                                      duties. FSIS will conduct future surveys
                                                  lots in a manner such that they are                        Response: Through the survey                       as necessary.
                                                  microbiologically independent.                          described above, inspectors provided
                                                  Otherwise, FSIS would be collecting                     information on processing practices that              Carcass Baseline
                                                  samples from production lots that may                   establishments employ to reduce the                      Comment: An industry organization
                                                  already be distributed in commerce,                     likelihood of contamination of intact                 commented that the beef carcass
                                                  resulting in preventable product recalls.               and non-intact raw beef products with                 baseline should include the whole beef
                                                  FSIS has issued instructions to field                   STEC. FSIS did have clear goals when                  trimmings production process, and that
                                                  personnel to notify establishment that                  it put forth the survey. This survey was              it should also include veal.
                                                  FSIS will be collecting a sample, but                   designed to gather information not                       Response: The Beef-Veal carcass
                                                  that the notification should only                       collected in the Public Health                        baseline began August 1, 2014. FSIS is
                                                  provide enough time for the                             Information System. FSIS is using the                 including steers, heifers, cows, bulls,
                                                  establishment to be able to hold all                    survey results to update the economic                 stag, dairy cows, and veal carcasses in
                                                  affected product.                                       analysis to support the full                          the Beef-Veal carcass baseline. FSIS is
                                                     The Agency has a finite number of                    implementation of its non-O157 STEC                   collecting samples at two points in the
                                                  resources which makes stocking                          policy. Data from the 2013 Pathogen                   process, immediately after hide removal
                                                  multiple sample boxes at establishments                 Controls in Beef Operations Survey                    (pre-evisceration) and at pre-chill (after
                                                  cost prohibitive. Additionally, some                    (conducted in May–July 2013) allowed                  all antimicrobial interventions).
                                                  USDA offices in establishments are                      FSIS to estimate the number of non-                      Comment: An industry organization
                                                  small and do not allow for storage of                   O157 STEC tests conducted by the                      suggested that because FSIS is only
                                                  multiple sample boxes. If                               industry for a 12-month period. FSIS is               testing for pathogenic organisms that are
                                                  establishments change their food safety                 also analyzing the survey results to                  adulterants, the Agency should consider
                                                  system on the days that FSIS collects                   develop targeted approaches for its risk-             alternative baseline testing locations
                                                  samples in a manner to influence the                    based verification testing program and                within the production supply chain.
                                                  sample result, FSIS has instructed                      to assist it in prioritizing the scheduling           The commenter suggested that FSIS
                                                  inspection program personnel to notify                  of Food Safety Assessments (FSA) by                   collect a post-hide removal sample to
                                                  their supervisory chain so that a                       Enforcement, Investigations, and                      address the hide removal process, where
                                                  determination can be made as to how to                  Analysis Officers (EIAO). FSIS did not                cross-contamination is more likely to
                                                  address this concern. In such                           collect production volume information                 occur; a second sample site after
                                                  circumstances, FSIS may decide to                       in the survey and is not presenting the               antimicrobial interventions; and trim
                                                  conduct additional sampling at the                      results as volume based. Establishment                testing for E. coli O157:H7 for products
                                                  establishment or to conduct a Food                      profiles contain production volume                    that will be used in ground beef or veal
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                                                  Safety Assessment (which includes in-                   information in the Public Health                      production.
                                                  depth verification that the establishment               Information System.                                      Response: The Agency is obtaining
                                                  meets regulatory requirements related to                   FSIS has used the numbers obtained                 samples at two points in the slaughter
                                                  food safety).                                           in the survey to estimate sampling                    process for the baseline study:
                                                     Comment: One consumer organization                   numbers for industry testing as part of               immediately after hide removal but
                                                  questioned whether the results for                      the economic analysis for STEC                        before evisceration, and at pre-chill
                                                  FSIS’s sampling programs can be used                    sampling in all of the Agency’s raw beef              before the carcasses enter the chillers
                                                  to develop reliable prevalence estimates.               microbiological sampling programs. The                and after all antimicrobial applications.


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                                                  23764                        Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices

                                                  This study addresses three distinct                     carcasses found positive for STECs                    stated that although the sample may be
                                                  objectives: to estimate the prevalence                  during the pre-chill sampling and                     taken before any on-line interventions,
                                                  and quantitative levels of selected                     testing are not processed into raw non-               the condition of the carcass, in terms of
                                                  foodborne microorganisms, to obtain                     intact product. The presence of STEC on               potential microbial load, is not
                                                  data for use in the development of                      a pre-chill carcass intended for use as               comparable across establishments. The
                                                  Agency programs, and to obtain data for                 raw non-intact product would                          commenter explained that some
                                                  informing industry guidance related to                  adulterate the carcass. The presence of               establishments have interventions and
                                                  process control. The sample design and                  STEC on a carcass intended for use as                 other practices that occur before de-
                                                  the resulting sample size are limited for               raw intact product would not adulterate               hiding, such as bacteriophage sprays or
                                                  this survey by practical constraints such               the carcass if the entire carcass is going            hide washes. Likewise, the commenter
                                                  as finite personnel and financial                       for intact product. In the event that a               stated that the effectiveness of hide
                                                  resources, and the problems with                        carcass tests positive for STEC,                      removal in minimizing contamination of
                                                  implementing scientific studies in real-                establishments may take action to                     the carcass varies among
                                                  world production settings. Considering                  ensure that all products from the carcass             establishments. If FSIS is seeking to use
                                                  these constraints, FSIS expects that the                go for cooking, or they may take action               this baseline to assist establishments in
                                                  Beef-Veal carcass baseline study will                   to recondition the carcass and ensure                 assessing ‘‘incoming’’ contamination
                                                  achieve the stated objectives because                   that the carcass goes for intact use only.            levels before on-line interventions, the
                                                  FSIS will collect and analyze as many                      In the event of a STEC positive on a               commenter stated that not taking into
                                                  samples as possible to ensure an                        post-hide removal/pre-evisceration                    account the steps that come before this
                                                  appropriate level of statistical                        sample without a corresponding pre-                   sampling point at each establishment
                                                  confidence.                                             chill sample on a carcass intended for                would likely limit the usability of the
                                                    With the two points that the Agency                   raw non-intact use, the carcass would                 results.
                                                  chose to use for sampling for the                       not be considered adulterated. The                       Response: FSIS agrees that the
                                                  baseline carcass study, FSIS requires the               carcass presumably will undergo further               incoming microbial load may vary from
                                                  establishment to hold or control the                    interventions after post-hide removal/                establishment to establishment
                                                  movement of sampled carcasses at pre-                   pre-evisceration. In the event of a STEC              depending on whether establishments
                                                  chill until the establishment is notified               positive from a pre-chill test result on a            use bacteriophage sprays or hide
                                                  of STEC results. FSIS verifies that the                 carcass intended for raw non-intact use,              washes, and that the effectiveness of
                                                  establishment does not treat the                        the carcass is considered adulterated.                establishments in preventing cross-
                                                  sampled carcasses any differently than                  The establishment is required to take                 contamination in hide removal may also
                                                  any of the other carcasses it is                        corrective action.                                    vary. Nevertheless, FSIS expects that the
                                                  processing. In the event that a sampled                    Comment: One industry organization                 Beef-Veal carcass baseline study will
                                                  carcass is treated differently, FSIS will               recommended that FSIS conduct a                       achieve the stated objectives by
                                                  randomly select another carcass during                  ‘‘shakedown’’ period at establishments                collecting and analyzing as many
                                                  the same processing time and collect                    representative of the industry in order to            samples as possible to ensure an
                                                  samples from that carcass.                              assess the logistics of sampling. The                 appropriate level of statistical
                                                    The results from samples collected                    commenter stated that this shakedown                  confidence.
                                                  during the baseline carcass study                       should be done to provide a safe                         Comment: Two commenters stated
                                                  become available after all analyses for                 sampling environment for inspection                   that carcass sampling immediately after
                                                  STEC and Salmonella are complete.                       personnel and to ensure that sampling                 de-hiding could pose a safety risk to
                                                  Baseline sample results usually are                     will not interfere with the routine                   inspection program personnel, as well
                                                  reported in two to six days but may take                slaughter process.                                    as to establishment employees.
                                                  longer depending on individual                             Response: FSIS agrees with the                     According to the commenters, this
                                                  circumstances. Post-hide/pre-                           comment. The Agency did conduct a                     location is in the middle of the harvest
                                                  evisceration and pre-chill sample results               shakedown training period before the                  line, so taking a sample at this juncture
                                                  are reported through Laboratory                         actual baseline and confirmed that                    will require inspection program
                                                  Information Management System (LIMS)                    baseline sampling will not interfere                  personnel to enter an area of the process
                                                  Direct.                                                 with the routine slaughter process.                   where hazards, such as dangerous
                                                    FSIS is not issuing noncompliance                        Comment: One industry organization                 equipment, are present and space is
                                                  records (NRs) for STEC positive results                 commented that while the Agency is                    limited. Taking samples at this point
                                                  during the baseline. In response to a                   developing the baseline, the timeframe                could, in turn, also put establishment
                                                  positive result from the pre-chill sample               for the publication of study results                  employees at risk.
                                                  only, field personnel perform a directed                should be outlined.                                      Response: FSIS discussed with
                                                  Slaughter HACCP Verification task to                       Response: FSIS posted the study                    establishment management before
                                                  verify that the establishment has                       design and sampling plan on the FSIS                  collecting samples for the shakedown
                                                  adequate slaughter controls (including                  Web site at http://www.fsis.usda.gov/                 the following: (1) Where supervisory
                                                  antimicrobial intervention                              wps/wcm/connect/5057f4ef-f924-422c-                   personnel could safely collect post-hide
                                                  implementation) for the specific                        bafe-771b1ead78e4/Beef-Veal-Carcass-                  removal/pre-evisceration and pre-chill
                                                  production lot represented by the                       Baseline-Study-Design.pdf?MOD=                        samples, (2) establishment safety
                                                  positive STEC carcass result. Field                     AJPERES. FSIS will publish a final                    requirements and protocols that
                                                  personnel also verify that the                          report with the national prevalence                   supervisory field personnel must follow
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                                                  establishment implements corrective                     calculations after the completion of the              during sample collection, and (3) the
                                                  actions that meet the applicable                        survey.                                               potential need for line stoppages for
                                                  requirements in 9 CFR 417.3. Field                         Comment: One industry organization                 supervisory field personnel to safely
                                                  personnel do not verify corrective                      commented that sampling immediately                   and properly collect the samples. FSIS
                                                  actions in response to a positive STEC                  after de-hiding may not provide the                   also issued instructions to inspection
                                                  result from the post-hide/pre-                          most meaningful information as to the                 program personnel for conducting
                                                  evisceration sample. Rather, FSIS                       presence of the various organisms in the              sampling from a safe vantage point,
                                                  verifies that establishments ensure that                slaughter process. The commenter                      especially when collecting the posterior


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                                                                               Federal Register / Vol. 80, No. 82 / Wednesday, April 29, 2015 / Notices                                                 23765

                                                  samples from the post-hide/pre-                         Other Topics                                          automatic and customized access to
                                                  evisceration and pre-chill locations;                     The following comment topics that                   selected food safety news and
                                                  following the same safety procedures                    were received are outside the scope of                information. This service is available at:
                                                  provided for employees at that                          this notice: disappearing schedule dates              http://www.fsis.usda.gov/subscribe.
                                                  establishment which may require the                     from PHIS, returned FedEx sample                      Options range from recalls to export
                                                  use of a harness; slowing or stopping                   boxes, FSIS training materials, and                   information, regulations, directives, and
                                                  production lines; and acquiring needed                  purge studies.                                        notices. Customers can add or delete
                                                  tools to safely collect samples.                                                                              subscriptions themselves, and have the
                                                  Information on the Beef-Veal carcass                    USDA Non-Discrimination Statement                     option to password protect their
                                                  baseline can be found at the following                    No agency, officer, or employee of the              accounts.
                                                  link http://www.fsis.usda.gov/wps/wcm/                  USDA shall, on the grounds of race,                   Done, at Washington, DC.
                                                  connect/5d3552e7-9b81-4b2c-aa20-                        color, national origin, religion, sex,                  Dated: April 23, 2015.
                                                  cfaeef77f251/36-14.pdf?MOD=AJPERES.                     gender identity, sexual orientation,                  Alfred V. Almanza,
                                                     Comment: One industry organization                   disability, age, marital status, family/              Acting Administrator.
                                                  asked what type of carcass sampling the                 parental status, income derived from a
                                                                                                                                                                [FR Doc. 2015–09957 Filed 4–28–15; 8:45 am]
                                                  Agency will use for the carcass baseline                public assistance program, or political
                                                                                                                                                                BILLING CODE 3410–DM–P
                                                  study.                                                  beliefs, exclude from participation in,
                                                                                                          deny the benefits of, or subject to
                                                     Response: As was done during the                     discrimination any person in the United
                                                  shakedown, FSIS is obtaining samples                                                                          DEPARTMENT OF AGRICULTURE
                                                                                                          States under any program or activity
                                                  following the procedures described in                   conducted by the USDA.                                Food and Nutrition Service
                                                  the United States Department of
                                                  Agriculture Agricultural Research                       How To File a Complaint of
                                                                                                          Discrimination                                        Agency Information Collection
                                                  Service Meat Animal Research Center                                                                           Activities: Proposed Collection;
                                                  Carcass Sampling Protocol 2 available at                   To file a complaint of discrimination,             Comment Request—Special Milk
                                                  the following link: http://www.ars.usda.                complete the USDA Program                             Program for Children
                                                  gov/SP2UserFiles/Place/54380530/                        Discrimination Complaint Form, which
                                                  protocols/USMARC%20Carcass%20                           may be accessed online at http://www.                 AGENCY: Food and Nutrition Service
                                                  Sampling%20Protocol.pdf.                                ocio.usda.gov/sites/default/files/docs/               (FNS), USDA.
                                                                                                          2012/Complain_combined_6_8_12.pdf,                    ACTION: Notice.
                                                     Comment: One consumer organization
                                                  stated that FSIS should conduct a                       or write a letter signed by you or your
                                                                                                                                                                SUMMARY:   In accordance with the
                                                  baseline study to estimate the                          authorized representative.
                                                                                                             Send your completed complaint form                 Paperwork Reduction Act of 1995, this
                                                  prevalence of E. coli O157:H7 in beef                                                                         notice invites the general public and
                                                  manufacturing trimmings and ground                      or letter to USDA by mail, fax, or email:
                                                                                                             Mail: U.S. Department of Agriculture,              other public agencies to comment on
                                                  beef in order to improve the confidence                                                                       this information collection. This
                                                  in FSIS’s efforts to detect contaminated                Director, Office of Adjudication, 1400
                                                                                                          Independence Avenue SW.,                              collection is a revision of a currently
                                                  product and effectively verify process                                                                        approved collection which FNS
                                                  controls.                                               Washington, DC 20250–9410, Fax: (202)
                                                                                                          690–7442, Email: program.intake@                      employs to determine public
                                                     Response: FSIS decided to focus on                   usda.gov.                                             participation in Special Milk Program
                                                  sampling carcasses for this baseline and                   Persons with disabilities who require              for Children.
                                                  not trimmings and ground beef because                   alternative means for communication                   DATES: Written comments must be
                                                  of resource limitations. The Beef–Veal                  (Braille, large print, audiotape, etc.),              received on or before June 29, 2015.
                                                  carcass baseline survey will provide                    should contact USDA’s TARGET Center                   ADDRESSES: Comments are invited on:
                                                  FSIS the necessary data on percent                      at (202) 720–2600 (voice and TDD).                    (a) Whether the proposed collection of
                                                  positives and quantitative levels of                                                                          information is necessary for the proper
                                                  select foodborne bacterial pathogens                    Additional Public Notification                        performance of the functions of the
                                                  (e.g., Salmonella, STEC, and certain                       Public awareness of all segments of                agency, including whether the
                                                  indicator organisms). FSIS will use the                 rulemaking and policy development is                  information shall have practical utility;
                                                  data from the Beef–Veal carcass baseline                important. Consequently, FSIS will                    (b) the accuracy of the agency’s estimate
                                                  survey to estimate the national                         announce this Federal Register                        of the burden of the proposed collection
                                                  prevalence of select microorganisms in                  publication on-line through the FSIS                  of information, including the validity of
                                                  carcasses, not trimmings and ground                     Web page located at: http://www.fsis.                 the methodology and assumptions that
                                                  beef; to develop industry performance                   usda.gov/federal-register.                            were used; (c) ways to enhance the
                                                  guidelines; to assess process control                      FSIS also will make copies of this                 quality, utility, and clarity of the
                                                  across the industry; and to inform                      publication available through the FSIS                information to be collected; and (d)
                                                  additional policy considerations.                       Constituent Update, which is used to                  ways to minimize the burden of the
                                                  Results of this study will be used to                   provide information regarding FSIS                    collection of information on those who
                                                  estimate volume-weighted prevalence                     policies, procedures, regulations,                    are to respond, including use of
                                                  and bacterial loads immediately after                   Federal Register notices, FSIS public                 appropriate automated, electronic,
                                                  hide removal and at pre-chill. Moreover,                meetings, and other types of information              mechanical, or other technological
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                                                  FSIS has made changes to both the                       that could affect or would be of interest             collection techniques or other forms of
                                                  trimmings and ground beef verification                  to our constituents and stakeholders.                 information technology.
                                                  testing programs to be able to obtain on-               The Update is available on the FSIS                      Comments may be sent to: Lynn
                                                  going prevalence of both E. coli                        Web page. Through the Web page, FSIS                  Rodgers-Kuperman, Branch Chief,
                                                  O157:H7 and Salmonella (79 FR 32437).                   is able to provide information to a much              Program Monitoring, Child Nutrition
                                                                                                          broader, more diverse audience. In                    Programs, Food and Nutrition Service,
                                                    2 U.S. Meat Animal Research Center (MARC)             addition, FSIS offers an email                        U.S. Department of Agriculture, 3101
                                                  Carcass Sampling Protocol.                              subscription service which provides                   Park Center Drive, Room 636,


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Document Created: 2015-12-16 08:26:28
Document Modified: 2015-12-16 08:26:28
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionNotice: Response to comments.
DatesOn July 28, 2015, FSIS will implement design changes in bench trim and other ground beef components besides trimmings.
ContactDaniel Engeljohn, Assistant Administrator, Office of Policy and Program Development, Food Safety and Inspection Service, U.S. Department of Agriculture, (202) 205-0495.
FR Citation80 FR 23761 

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