[Federal Register Volume 77, Number 182 (Wednesday, September 19, 2012)]
[Notices]
[Pages 58091-58094]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2012-23078]


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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 and Plans for Beef Baseline

AGENCY: Food Safety and Inspection Service (FSIS), U.S. Department of 
Agriculture (USDA).

ACTION: Notice; Request for comments.

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SUMMARY: FSIS is announcing its intention to redesign its E. coli 
O157:H7 verification testing program for beef manufacturing 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 beef manufacturing trimmings. This notice also discusses FSIS's 
plans to perform a beef carcass baseline. FSIS seeks public comment on 
its plans, which have been developed in response to a 2011 audit by the 
U.S. Department of Agriculture's Office of Inspector General (OIG) of 
FSIS's protocol for N-60 sampling of beef manufacturing trimmings for 
E. coli O157:H7. This notice also announces changes that FSIS has made 
to its beef manufacturing trimmings program to increase both the 
collection rate and the likelihood that FSIS will find positive 
samples. Finally, this notice summarizes a 2012 OIG report and the 
actions that FSIS has taken to address the recommendations in that 
report.

DATES: Comments on this notice must be submitted on or before November 
19, 2012.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by either of the following methods:
     Federal eRulemaking Portal: This Web site provides the 
ability to type short comments directly into the comment field on the 
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the online instructions at that site for 
submitting comments.
     Mail, including floppy disks or CD-ROMs, and hand- or 
courier-delivered items: Send to Docket Clerk, U.S. Department of 
Agriculture (USDA), FSIS, OPPD, RIMD, Docket Clearance Unit, Patriots 
Plaza III, 1400 Independence Avenue SW., 8-163A, Mailstop 3287, 
Washington, DC 20024-3221.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2012-0020. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, go 
to the FSIS Docket Room at the address listed above between 8:30 a.m. 
and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Acting Assistant 
Administrator for the Office of Policy and Program Development, FSIS, 
USDA, Room 351-E, Jamie Whitten Building, 14th and Independence Avenue 
SW., Washington, DC 20250-3700; telephone (202) 720-0399, fax (202) 
720-2025; rachel.edelstein@fsis.usda.gov.

SUPPLEMENTARY INFORMATION:

Background

    In 1994, FSIS determined that E. coli O157:H7 adulterates raw 
ground beef product within the meaning of the Federal Meat Inspection 
Act (FMIA) (21 U.S.C. 601(m)(1)). FSIS began testing ground beef for E. 
coli O157:H7 in 1994. In 1999, FSIS determined that, besides ground 
beef, E. coli O157:H7 adulterated all non-intact raw beef product and 
intact raw beef product intended for use in raw, non-intact beef 
product (64 FR 2803; Jan. 19, 1999).
    Starting in 2007, FSIS began testing beef manufacturing trimmings 
and other raw ground beef components (raw esophagus (weasand) meat, 
head meat, cheek meat, beef from advanced meat recovery systems, low 
temperature rendered lean finely textured beef, partially defatted 
chopped beef, partially defatted beef fatty tissue, and heart meat) for 
E. coli O157:H7 at the originating slaughter establishment. FSIS also 
began verifying that grinders, fabricators, and supplying slaughter 
establishments had effective controls for E. coli O157:H7.
    FSIS sampled beef manufacturing trimmings under a simple random 
sampling plan in which each slaughter establishment had an equal chance 
of being scheduled for sampling, regardless of production volume or 
previous history. FSIS collects approximately 1,300 samples per year. 
From calendar year 2007 through June 2011, FSIS found an average of 
about seven E. coli positives per year, resulting in an average E. 
coli-positive rate of about 0.60% in beef manufacturing trimmings 
during this period. Each slaughter establishment producing beef 
manufacturing trimmings was sampled about 3.5 times per year.
    Inspection personnel collect beef trimmings samples for testing 
using N-60 procedures. Under these procedures, inspection personnel 
collect 60 slices of beef manufacturing trimmings cut to a specific 
size and also collect an additional, separate ``grab sample'' of 
smaller pieces of trim from the same production lot. FSIS laboratories 
use the 60 slices for the first part of the analysis for E. coli 
O157:H7. If the 60 slices are confirmed positive, laboratory personnel 
do quantitative (most probable number or MPN) analysis on the ``grab'' 
sample.\1\
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    \1\ FSIS's E. coli O157:H7 test results are reported on the 
Agency's Web site at: http://www.fsis.usda.gov/Science/Ecoli_Raw_Beef_Testing_Data_YTD/index.asp (accessed June 20, 2012).
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    When an FSIS beef manufacturing trimming sample tests positive, 
FSIS takes a number of steps including: Collecting follow-up samples at 
the establishment where the positive sample was found; documenting 
production of adulterated product in a noncompliance record when 
appropriate; conducting a food safety assessment (FSA) (a comprehensive 
review of the establishment's food safety

[[Page 58092]]

system); and verifying that the establishment accurately executed all 
steps in its Hazard Analysis and Critical Control Point (HACCP) plan 
for production of trim and implemented appropriate corrective actions.

OIG Audit

    OIG audited the efficacy of FSIS testing for E. coli O157:H7 in 
beef manufacturing trimmings in 2010 and reported the audit results in 
February 2011.\2\ On the basis of its audit, OIG recommended that FSIS:
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    \2\ U.S. Department of Agriculture, Office of Inspector General. 
February 2011. FSIS Sampling Protocol for Testing Beef Trim for E. 
coli O157:H7. Audit Report 24601-9-KC. Washington, DC. See this 
report at: http://www.usda.gov/oig/webdocs/24601-9-KC.pdf (accessed 
June 20, 2012).
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    (1) Develop a plan to perform baseline studies of beef 
manufacturing trimmings and ground beef to determine the estimated 
prevalence rate of E. coli O157:H7 for the purpose of redesigning 
FSIS's verification testing program. The report also recommended that 
the plan prescribe how often that initial prevalence estimate should be 
reassessed.
    (2) Re-evaluate sample parameters (size and confidence level) to 
provide a higher confidence level for FSIS' ability to detect 
contaminated product and to more effectively verify process controls at 
beef slaughter establishments.
    (3) Document the scientific support and rationale for the revised 
verification testing program design, including the contamination level 
that will be associated with the new sample parameters, and how the 
estimated prevalence rate has informed the redesigned verification 
testing program. Publish in the Federal Register FSIS's revised beef 
testing verification program and solicit public comment.
    (4) Focus E. coli O157:H7 sampling and testing resources at 
establishments that are likely to be of higher risk, and consider the 
use of specialized sample collection teams.
    In response to the first recommendation, FSIS plans to make changes 
in its E. coli O157:H7 verification testing programs for beef 
manufacturing trimmings and ground beef to calculate prevalence of the 
pathogen in these products. FSIS conducted an evaluation of the 
Agency's current sampling programs to determine whether they provide 
sufficient data to calculate prevalence estimates for pathogens in FSIS 
regulated product: http://www.fsis.usda.gov/PDF/Prevalence_Estimates_Report.pdf. FSIS is also considering implementing similar sampling 
designs in its programs for bench trim and other components, so that 
they are consistent with the sampling designs for ground beef and beef 
manufacturing trimmings. Should the Agency adopt and implement these 
changes, it will endeavor to generate statistical prevalence estimates 
in ground beef and beef manufacturing trimmings. Prevalence estimation 
in bench trim and other components may not be possible because of 
limited sampling resources and data concerns.
    In 2013, FSIS intends to initiate a beef carcass baseline survey to 
determine the presence and levels of the pathogenic E. coli, including 
O157:H7 and the six non-O157 Shiga toxin-producing E. coli (STEC) most 
commonly associated with illness in the United States; Salmonella 
species; and certain indicator organisms. As the Agency does with other 
baseline studies, FSIS will make the study design and sampling plans 
available on its Web site and will solicit comments on the study design 
and sampling plans before carrying out the study. In this survey, FSIS 
plans to collect samples from beef carcasses immediately after de-
hiding and before evisceration in order to identify the type and level 
of contamination before antimicrobial interventions are applied to the 
carcass. FSIS may also collect samples from carcasses slaughtered that 
same day, pre- and post-chill.
    As the Agency has done with previous baseline surveys, FSIS will 
report the results of this survey on its Web site and incorporate them 
into compliance guidance for industry to use in assessing individual 
establishment performance against the national performance. Controls to 
reduce the risk of enteric pathogen contamination at slaughter are 
crucial. Under 9 CFR 310.18(a), establishments must handle beef 
carcasses, organs, and other parts in a sanitary manner to prevent 
contamination with fecal material, urine, bile, hair, dirt, or foreign 
matter. Because these sources of contamination, whether visible or not, 
may contain pathogens, a principal objective of proper sanitary 
dressing and process control procedures is to reduce the potential for 
exposure of carcasses and parts to any contamination or food safety 
hazard during the removal of the hide, feet, head, gastrointestinal 
tract, and other internal organs. If establishments implement effective 
controls during sanitary dressing procedures, it is likely that it will 
prevent or reduce contamination significantly. This survey will be 
important to the Agency in assessing the prevalence of the load of 
pathogens and certain indicator organisms on carcasses throughout the 
slaughter process. In addition to informing the future Agency 
compliance guidance, FSIS will also use the baseline survey results to 
make changes to its sampling, testing, and other verification 
activities.
    In response to OIG recommendation 2, FSIS decided to 
revise the N-60 program to provide for more frequent sampling at 
establishments that the Agency determines have problems controlling E. 
coli O157:H7 in beef manufacturing trimmings. In changing the N-60 
program, FSIS considered sanitary dressing verification data, product 
traceback activities, and other inspection and data collection 
activities. The paper discussing this analysis is posted with this 
notice as a related document at (http://www.fsis.usda.gov/PDF/Redesign_Beef_Trim_Sampling_Methodology.pdf). In the analysis, FSIS 
examined E. coli O157:H7 test results as a function of beef 
manufacturing trimmings volume class from calendar year 2007 through 
June 2011. Establishments that produce beef manufacturing trimmings are 
grouped in four volume classes: Very small, producing less than 1001 
pounds per day; small, 1001 to 50,000 pounds per day; medium, 50,001 to 
250,000 pounds per day; and large, more than 250,000 pounds per day. 
FSIS found that the large-volume establishment class (total volume CY 
2007-2011: 13,500,000,000 pounds) has the lowest E. coli O157:H7 
percent positive, while the small-volume class (total volume CY 2007-
2011: 1,268,625,000 pounds) has the highest E. coli O157:H7 percent 
positive. The analysis found that sampling in the small volume class is 
twice as likely to yield an E. coli O157:H7-positive result as sampling 
in large volume establishments. FSIS found that sampling volume classes 
in proportion to the percent positive in the volume class is 
approximately 2 times as likely to yield an E. coli O157:H7-positive 
test result as is sampling under the simple random sampling program.
    FSIS also found that the percent-positive rate in the high-
prevalence season (now considered to be May through October, rather 
than April through September, on the basis of FSIS data) is about 2 
times as high as it is the rest of the year. Accordingly, the analysis 
concluded that increasing the sampling of beef manufacturing trimmings 
during May through October should increase the probability of detecting 
E. coli O157:H7 positives.
    FSIS determined that there are about 480 slaughter establishments 
in the beef manufacturing trimmings sampling frame that are eligible 
for sampling. FSIS selects between 200 and 250 establishments from the 
frame every month for sampling. Annually, FSIS

[[Page 58093]]

distributes approximately 2,600 sample forms to its personnel. However, 
in FY 2010, only 1,274 samples were successfully collected, a response 
rate of about 49 percent. One reason a sample request may not result in 
successful sample collection is that a sample may be taken but 
discarded because of, for example, late sample delivery to the 
laboratory or container leakage. Additionally, if establishments were 
not producing the product during the 30-day sample-collection period, 
FSIS field personnel were not able to collect the sample. To address 
the low collection rate that results when establishments are not 
producing the product at the time of sample collection, FSIS increased 
its sample collection window from 30 days to 60 days and has 
overscheduled sampling to adjust for non-response. The goal of these 
changes is to ensure that all 2,600 samples are collected.
    Based upon the results of its analysis, FSIS has already redesigned 
its E. coli O157:H7 testing program for beef manufacturing trimmings so 
that sampling is weighted by production volume and volume class-
specific risk factors. FSIS will ensure that each slaughter 
establishment producing beef manufacturing trimmings is sampled at 
least once per year. FSIS also increased sampling during the high 
prevalence season (May through October in the United States) by up to 
20 percent. Because of resource constraints, however, increased 
sampling during the high-prevalence season will require a decrease in 
sampling during the low prevalence season.
    FSIS will take measures to increase the number of samples that the 
Agency successfully collects. As stated above, FSIS has already 
increased the time during which field personnel may collect a sample 
from 30 days to 60 days. This increase allows field personnel 
additional time to collect samples for testing in establishments that 
infrequently produce manufacturing trimmings. FSIS also plans to over-
schedule the sampling to increase the total number of samples actually 
collected. On the basis of the changes FSIS has made to its N-60 
program to date, FSIS estimates that the probability of obtaining E. 
coli O157:H7-positive results in beef manufacturing trimmings during 
FSIS verification testing will increase by a factor of about 2.5.
    FSIS does not plan to increase the annual statistical sample size 
but will redistribute the samples on the basis of an analysis of the 
Agency's sampling program for beef manufacturing trimmings. The changes 
to the sampling program, however, may increase the number of follow-up 
samples collected as a consequence of finding more E. coli O157:H7-
positive samples. FSIS is also considering changes to its sampling 
programs for bench trim and other raw ground beef components. The 
changes are likely to be similar to those discussed above in its beef 
manufacturing trimmings program.
    In its response to OIG, FSIS suggested that sanitary dressing 
noncompliances may be related to E. coli O157:H7-positive results in 
beef trim because carcass contamination is the primary cause of ground 
beef component adulteration with the pathogen. FSIS reviewed and 
evaluated the sanitary dressing procedure noncompliance records for 
slaughter establishments that produce beef manufacturing trimmings 
found to have tested positive. The Agency concluded that it did not 
appear that the rate of sanitary dressing procedure noncompliances 
could be used to identify establishments that have a higher probability 
of having an E. coli O157:H7-positive test result.
    In November 2011, FSIS revised its sanitary dressing verification 
directive (FSIS Directive 6410.1) to improve and clarify for FSIS 
inspectors the procedures that they are to follow in verifying sanitary 
dressing compliance. This revision and the expected improvement in 
inspector verification of sanitary dressing procedures may result in a 
higher correlation between sanitary dressing noncompliances and E. coli 
O157:H7 positives in beef trim. FSIS intends to perform analyses of 
verification sampling results to determine whether the correlations 
have changed.
    As is discussed above, in responding to an Agency E. coli O157:H7-
positive finding in beef manufacturing trimmings, FSIS collects 
multiple follow-up samples and conducts verification activities at the 
originating slaughter establishment. FSIS intends to implement new 
traceback procedures at beef manufacturing trimming suppliers that 
provided source materials for ground product or bench trim (that is, 
trim derived from beef at an establishment other than the originating 
slaughter establishment) that FSIS finds positive.\3\ When FSIS 
implements these new traceback procedures, the Agency expects that the 
data gathered will enable it to better target sampling at slaughter 
establishments.
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    \3\ See the FR notice on traceback (77 FR 26725; May 7, 2012) 
at: http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp (accessed June 20, 2012).
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    OIG recommended that FSIS re-evaluate sample parameters (size and 
confidence level). Sample size calculations were not performed as part 
of the statistical assessment in order to stay resource neutral. FSIS 
intends to evaluate the allocation of sampling resources within the E. 
coli O157:H7 sampling program to estimate prevalence.
    Additionally, FSIS intends to better identify establishments likely 
to have problems with E. coli O157:H7 through analysis of data 
collected through sanitary dressing verification, new product traceback 
activities, Public Health Information System (PHIS) data (including any 
relevant data available through the Hazard Analysis Verification 
procedure and establishment profile), and other inspection and data 
collection activities. Because E. coli O157:H7 and the other STECs are 
enteric pathogens, analysis of FSIS sanitary dressing verification data 
may help the Agency to identify establishments that should be sampled 
more frequently for the pathogens. PHIS and hazard analysis 
verification (HAV) procedures will likely allow FSIS to gather more 
information on establishment-specific controls and how effective they 
are. Again, FSIS hopes to use this data to identify establishments that 
should be sampled more frequently for these pathogens.
    As the Agency announced in the September 11, 2011, notice on non-
O157 STEC (76 FR 58157), FSIS is also planning to conduct a survey, 
using its employees that are assigned to beef slaughter and processing 
establishments, to gather information on establishment controls for 
STECs in beef. This survey will be similar to a previous ``65-07 
Checklist'' survey.\4\ The results of the survey will provide FSIS with 
information regarding establishment practices that the Agency may be 
able to use to further develop risk-based sampling in the future. FSIS 
plans also 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 E. coli O157:H7 
beef manufacturing trimmings sampling program and make risk-based 
changes as appropriate.
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    \4\ Available at http://www.fsis.usda.gov/PDF/Ecoli_Reassement_&_Checklist.pdf (accessed June 20, 2012).
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    OIG recommended, and FSIS considered, the use of specialized

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sample collection teams for collecting N-60 samples in establishments. 
FSIS has concluded that the Agency does not have the resources to 
implement this recommendation. The use of the specialized sample 
collection teams would be cost-prohibitive.

2012 OIG Audit Report

    In a more recent audit, reported in May 2012, OIG studied the 
variation of the beef industry's E. coli O157:H7 sampling and testing 
protocols among slaughter plants, and how FSIS and the beef industry 
use the test results to improve food safety.\5\ OIG found that the beef 
industry was conducting thousands of tests daily and generally 
complying with FSIS's guidance for how to perform those tests.
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    \5\ U.S. Department of Agriculture. Office of Inspector General. 
May 2012. Application of FSIS Sampling Protocol for Testing Beef 
Trim for E. coli O157:H7. Audit Report 24601-0001-31. Washington, DC 
This report is posted at: http://www.usda.gov/oig/webdocs/24601-0001-31.pdf (accessed June 20, 2012).
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    OIG made several additional recommendations to FSIS, and the Agency 
has already responded to some of them. For example, OIG recommended 
that FSIS issue guidance for industry on sampling and how the industry 
might plan for and react to high-event periods (HEPs)--when slaughter 
establishments have a high rate of positive test results for E. coli 
O157:H7 or other STEC or virulence markers in trim samples.
    On May 7, 2012, FSIS announced the availability of compliance 
guidance for establishment sampling and testing for Shiga toxin-
producing E. coli (STEC) organisms or virulence markers (77 FR 26725). 
This guidance includes criteria that establishments can use to 
determine if they are experiencing an HEP. The document explains that 
extensive sampling of trimmings and careful evaluation of test results 
can help establishments identify places in their processes where 
controls are poor, and where they can take corrective actions. It 
recommends that establishments continually strive to reduce the 
percentage of test results that are positive for E. coli O157:H7 (or 
STEC organisms or virulence markers).
    During an HEP, adulteration may be more widespread than a positive-
testing lot of product may indicate. By following the guidance and 
withholding adulterated product from commerce during HEPs, 
establishments are more likely to avoid costly recalls. While 
establishments can use the guidance now, FSIS requested comments on it 
and will update it as necessary in response to the comments.
    OIG also recommended that FSIS re-evaluate and improve its policies 
on inspector collection of trim samples by, for example, ensuring that 
inspectors randomly select product for sampling, ensuring that 
inspectors collect samples of proper weight, and ensuring that they do 
not take multiple samples from single pieces of trim.
    To ensure that all raw ground beef, beef manufacturing trimmings, 
and bench trim samples are the necessary weight, FSIS recently issued 
instructions to inspection program personnel on the use of new sample 
collection bags that have fill-lines.\6\ In addition, in response to 
other recommendations, FSIS will evaluate its instructions for sampling 
and determine what other changes may be needed.
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    \6\ The notice is available at: http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/35-12.pdf (accessed June 20, 2012).
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    OIG recommended that FSIS improve communication with industry by 
issuing guidance to assist establishments in selecting laboratories 
according to the laboratories' testing capabilities. On March 8, 2012, 
FSIS announced the availability of guidance for establishments in the 
selection of commercial and private microbiological testing 
laboratories (77 FR 13999). The guidance includes a checklist for 
industry on the issues to consider and also the types of documents that 
establishments should maintain to support their testing programs.\7\ 
Establishments can use the guidance now. FSIS asked for comments on the 
guidance and will make any necessary changes to it after evaluating the 
comments.
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    \7\ The guidance is available at: http://www.fsis.usda.gov/PDF/Guidance_Selecting_Micro_Testing_Lab.pdf (accessed June 20, 
2012).
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    OIG further recommended that FSIS determine whether to increase 
sampling of trim, assess its performance measures for E. coli O157:H7, 
clarify current instructions to inspection personnel in its directive 
on verification of controls for the pathogen (FSIS Directive 10,010.1), 
and assess the quality of inspection in Talmadge-Aiken establishments. 
FSIS is evaluating these issues and will respond to these 
recommendations.

Additional Public Notification

    FSIS will announce this notice online through the FSIS Web page 
located at: http://www.fsis.usda.gov/regulations_&_policies/Federal_Register_Notices/index.asp.
    FSIS will also make copies of this Federal Register publication 
available through the FSIS Constituent Update, which is used to provide 
information regarding FSIS policies, procedures, regulations, Federal 
Register notices, FSIS public meetings, and other types of information 
that could affect or would be of interest to constituents and 
stakeholders. The Update is communicated via Listserv, a free 
electronic mail subscription service for industry, trade groups, 
consumer interest groups, health professionals, and other individuals 
who have asked to be included. The Update is also available on the FSIS 
Web page. In addition, FSIS offers an electronic mail subscription 
service which provides automatic and customized access to selected food 
safety news and information. This service is available at http://www.fsis.usda.gov/News_&_Events/Email_Subscription/. Options range 
from recalls to export information to regulations, directives and 
notices. Customers can add or delete subscriptions themselves, and have 
the option to password protect their accounts.

USDA Nondiscrimination Statement

    The U.S. Department of Agriculture (USDA) prohibits discrimination 
in all its programs and activities on the basis of race, color, 
national origin, gender, religion, age, disability, political beliefs, 
sexual orientation, and marital or family status. (Not all prohibited 
bases apply to all programs.)
    Persons with disabilities who require alternative means for 
communication of program information (Braille, large print, audiotape, 
etc.) should contact USDA's Target Center at 202-720-2600 (voice and 
TTY).
    To file a written complaint of discrimination, write USDA, Office 
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue 
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY). 
USDA is an equal opportunity provider and employer.

    Done at Washington, DC, on: September 13, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-23078 Filed 9-18-12; 8:45 am]
BILLING CODE 3410-DM-P