Docket No. FSIS-2011-0009

[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26725-26732]
From the Federal Register Online via the Government Printing Office
[FR Doc No: 2012-10904]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2011-0009]

Changes to FSIS Traceback, Recall Procedures for Escherichia coli
O157:H7 Positive Raw Beef Product, and Availability of Compliance
Guidelines

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
proposed new procedures that it intends to implement when FSIS or other
Federal or State agencies find raw ground beef presumptive positive for
Escherichia coli (E. coli) O157:H7. This methodology will enable FSIS
to better determine whether the establishments that produced the source
materials for contaminated product have produced other product that may
not be microbiologically independent from the contaminated product. The
Agency is also announcing its intention to now, as a matter of routine
policy, request a recall if an establishment was the sole supplier of
beef trim source materials for ground product that FSIS or other
Federal or State agencies find positive for E. coli O157:H7, evidence
suggests that contamination most likely occurred at the supplier
establishment, and a portion of the product from the originating source
lot was sent to other establishments. This notice also explains that
FSIS intends to determine whether it can make better use of
establishment results and also intends to conduct a study to help it
identify the source of E. coli O157:H7 positive ground beef when the
material from multiple suppliers was used to produce positive product.
Finally, this notice announces the availability of compliance
guidelines concerning establishment sampling and testing for shiga
toxin-producing E. coli (STEC) organisms or virulence markers and
compliance guidelines for E. coli O157:H7 sampled and tested labeling
claims.

DATES: FSIS requests comments on policies and procedures in this notice
by July 6, 2012. FSIS intends to evaluate comments, make any necessary
changes to policies and procedures based on

[[Page 26726]]

comments and announce final policies, procedures, and implementation
dates in a subsequent Federal Register notice.

ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by one of the following methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to http://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Patriots
Plaza 3, 1400 Independence Avenue SW., Mailstop 3782, Room 8-163A,
Washington, DC 20250-3700.
Hand- or courier-delivered submittals: Deliver to Patriots
Plaza 3, 355 E. Street SW., Room 8-163A, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2011-0009. 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 Patriots Plaza 3, 355 E. Street SW., Room 8-
164, Washington, DC 20250-3700 between 8:00 a.m. and 4:30 p.m., Monday
through Friday.

SUPPLEMENTARY INFORMATION:

Background

Public Meeting

On March 10, 2010, FSIS held a public meeting to discuss the
Agency's ongoing efforts to improve product traceback related to E.
coli O157:H7.\1\ Noting that the July 2009 Key Findings Report of the
President's Food Safety Working Group identified the ability to trace
contaminants back to their source as a high priority for ensuring a
safe food supply,\2\ FSIS officials described the Agency's current
traceback policy and discussed changes the Agency was considering to
improve its traceback efforts.
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\1\ http://origin-www.fsis.usda.gov/PDF/Transcript_031010_Traceability.pdf.
\2\ http://www.foodsafetyworkinggroup.gov/FSWG_Key_Findings.pdf.
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Under FSIS's current traceback policy, FSIS does not begin
conducting any investigations or follow up activities until positive
results based on FSIS testing are identified or until outbreaks occur.
Based on FSIS positive test results or other Federal or State Agency
positive test results, FSIS conducts Food Safety Assessments (FSAs) at
establishments that produce product (ground beef, beef manufacturing
trimmings, or other raw ground beef components) that is positive for E.
coli O157:H7. FSAs are complete investigations concerning the
establishment's entire HACCP system. FSIS also conducts FSAs at
supplier establishments that are sole source suppliers for product that
FSIS or another Federal or State Agency has found positive for O157:H7,
or at establishments that FSIS has found provided source materials for
product that FSIS or another Federal or State Agency has found positive
more than once in the last 120 days. FSIS Enforcement, Investigations,
and Analysis Officers (EIAOs) conduct these FSAs and are trained
specifically for these assessments. FSIS also conducts investigations
in response to outbreaks, working with CDC and State or local Agencies.
The contemplated changes discussed at the March 10, 2010, public
meeting focused on improving FSIS's ability to quickly trace all
adulterated products that are implicated by an E. coli O157:H7 positive
test of raw ground beef or bench trim (defined as, beef manufacturing
trimmings derived from cattle not slaughtered on site at the
establishment). For example, Agency officials explained that FSIS
intends to implement new investigations of production practices at
establishments that produced product FSIS finds presumptive positive
for E. coli O157:H7. Similarly, based on presumptive positive results,
Agency officials stated that FSIS intends to implement new
investigations of production practices at the establishments'
suppliers. FSIS officials explained that FSIS did not intend to wait
for confirmation results before initiating these investigations because
the Agency believes it is imperative to more quickly identify all
affected product and all potential suppliers.
Agency officials also discussed the importance of focusing on
slaughter and dressing operations--where contamination is most likely
to occur--in mitigating the risk of E. coli O157:H7 contamination of
raw ground beef products.
Finally, Agency officials described the role played by identifying
high event periods (HEPs) in determining whether a systemic breakdown
of process control at a slaughter establishment may have led to cross-
contamination between multiple production lots. Agency officials
explained that this type of loss of process control and cross-
contamination would create insanitary conditions that may affect the
disposition of intact (primal and subprimal) cuts of beef, in addition
to beef manufacturing trimmings. If loss of control leads to insanitary
conditions, more product may be adulterated than just the product found
positive for the pathogen. In this situation, it is very important that
establishments identify all product that may be adulterated and hold
that product back from commerce to avoid expensive recalls. FSIS notes
that recalls can result in costs of $3-5 million.\3\
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\3\ As reported by Food and Drug Administration (FDA)
``Preliminary Regulatory Impact Analysis and Initial Regulatory
Flexibility Analysis of the Proposed Rules to Ensure the Safety of
Juice and Juice Products'' (63 FR 24258; May 1, 1998). The cost
covers manufacturer, retailers and State, local, and Federal
authorities.
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Agency officials also described draft compliance guidelines issued
by FSIS on August 12, 2008, that included the Agency's then current
thinking regarding HEPs.\4\ They noted that the Agency had received and
considered comments related to that draft guidance document. The
transcript to the public meeting and materials presented at the public
meeting is available at the following site: http://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp.
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\4\ http://www.fsis.usda.gov/PDF/Draft_Guidelines_Sampling_Beef_Trimmings_Ecoli.pdf.
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Public comments made during the meeting and others submitted later
stated that FSIS needed to take additional actions related to traceback
in instances involving sole source suppliers of E. coli O157:H7
positive product. These commenters emphasized the need to identify
these sole source suppliers in order to better protect the public. One
comment specifically stated that FSIS should take action to better
identify the source of contamination and to remove associated
adulterated product from commerce.
Other commenters stated that additional steps could also be taken
to improve traceback methodology in cases where a positive sample is
taken from a production lot of ground beef created from multiple
sources. Specifically, some commenters suggested that when a production
lot of ground beef that was produced from multiple source lots tests
positive, FSIS should test any remaining unopened trim from the source
production lots to identify which source lot is implicated by the
positive ground beef sample.

[[Page 26727]]

Other commenters asked questions about the new traceback
methodology and requested that FSIS continue to share information about
the new methodology and clarify issues concerning the new methodology.
Several commenters agreed that establishments should develop or use
process control procedures based on HEP criteria that indicate higher
than expected rates of positive E. coli O157:H7 test results. Some
commenters raised questions concerning whether N60 sampling procedures
are capable of detecting contaminated product on a routine basis.
Finally, some commenters recommended that FSIS collect information on
suppliers at the time of sample collection, rather than after the
sample is confirmed positive for E. coli O157:H7 to expedite all
necessary investigation and traceback activities.
Improved Traceback Procedures: On October 8, 2010, in response to
comments received at the public meeting, FSIS issued instructions to
inspection program personnel to record information on the source
materials and on the suppliers at the time they sample ground beef or
bench trim for E. coli O157:H7 (FSIS Notice 58-10). With issuance of
the October 8, 2010 notice, FSIS changed its procedures so that
inspection program personnel no longer wait for a positive test result
before they gather supplier information. FSIS agreed with comments that
had been submitted in response to the public meeting that collecting
supplier information at the time the sample is collected would better
serve FSIS's goal to respond to FSIS presumptive positive results by
identifying all affected product and all potential suppliers as quickly
as possible to protect public health.
FSIS intends to implement additional improved procedures consistent
with the procedures it discussed at the public meeting. As is discussed
above, inspection program personnel will continue to collect and
document information on suppliers at the time of sample collection.
Using the supplier information, EIAOs will then conduct traceback
investigations at establishments that produced the E. coli O157:H7
positive product and at suppliers that provided source materials for
ground beef or bench trim that FSIS has found positive. These traceback
investigations will begin as soon as possible, based on presumptive
positive results and supplier information from the producing
establishment. EIAOs will visit both the establishment that produced
the positive product and the supplier slaughter establishment and
gather relevant information about the production of the product,
including use of anti-microbials and prevention of cross contamination,
sanitary conditions, and relevant purchase specifications.
As part of their traceback investigations, EIAOs will review
establishment test results to determine whether the establishment has
experienced a HEP. If the establishment has developed its own
supportable HEP criteria, the EIAOs will determine whether it has
experienced a HEP based on the establishment's HEP criteria. If it has
not, EIAOs will determine whether the establishment has experienced a
HEP based on the FSIS criteria discussed below. The occurrence, or lack
of occurrence, of a HEP will be one factor that EIAOs will consider
when investigating at the establishment that produced positive product
or supplied product to an establishment that produced positive product.
Based on all the information gathered, EIAOs will present findings
to the District Manager on which to determine whether adulterated
product has entered commerce. The EIAO will also make recommendations
concerning whether regulatory and enforcement actions are warranted.
The District Manager will then determine whether adulterated product
entered commerce, and if it has, whether to contact the FSIS Recall
Management Staff and whether enforcement actions are appropriate.
Consistent with Agency procedures, the Recall Management Staff will
lead any Agency requests that establishments recall product.
As is discussed above, EIAOs do not do this type of investigation
now until they conduct FSAs. FSAs are scheduled approximately 30 days
after the confirmed positive results become available, so they are much
later than the investigations FSIS intends to conduct. Also, during the
FSAs at this time, EIAOs do not ask all the focused questions FSIS
intends to instruct them to ask as part of this new procedure. Finally,
EIAOs do not currently evaluate whether the establishment has
experienced a HEP on a consistent basis.
Recalls from sole source suppliers: Also in response to comments to
the public meeting concerning the need to eliminate contaminated source
material from commerce, FSIS intends to implement a new recall policy
to request that supplier establishments recall product if all of the
following circumstances occur:
(1) FSIS or other Federal or State agencies find raw ground beef
positive for E. coli O157:H7 at a grinding establishment;
(2) FSIS determines that E. coli O157:H7 cross-contamination was
unlikely to have occurred at the grinding establishment where the
sample was taken (based on FSIS's assessment of the grinding
establishment's handling practices);
(3) FSIS determines that the grinding establishment did not combine
material from multiple source lots to create the lot of product that
tested positive;
(4) After conducting traceback to identify the slaughter and trim
fabrication supplier that provided the sole source material, FSIS
determines that the supplier or downstream users split the implicated
lot before sending it to the establishment where the positive sample
was taken; and
(5) Some portion of the split lot sent to the grinder was sent into
commerce for further processing into product that does not receive a
full lethality to eliminate E. coli O157:H7 in a federally inspected
establishment.
If all of these circumstances occur, FSIS intends to request a
recall from the slaughter or trim supplier establishment. If cross
contamination did not occur at the grinding establishment, the source
materials would be considered adulterated because, based on evidence
and available data, contamination occurred at the slaughter or trim
establishment.
In the two-year period between January 1, 2009, and December 31,
2010, 65 Agency samples of ground beef (collected as part of the
routine and follow-up sampling programs) tested positive for E. coli
O157:H7. Of those 65 positive samples, 41 of them (63.1%) were taken
from production lots created using source material from a sole
supplier. Twelve of the 41 sole suppliers were self suppliers, meaning
that slaughter, trim fabrication, and grinding were done at the same
establishment. Out of the 41 sole suppliers, 29 were external supplier
establishments. The remaining 24 of the 65 positive samples (36.9%)
were taken from production lots created using source material from
multiple suppliers. Therefore, there were 29 external sole suppliers
that provided the source materials for positive ground product. If all
the criteria for a recall were in place, FSIS would have requested 29
additional recalls. However, it is likely that some of these suppliers
did not split lots, so all of the source materials from the production
lot involved would have gone to the grinder that produced the positive
product. If the suppliers did not split the lot, this policy would not
result in any additional recalls. Any additional recalls under these
circumstances are likely to better prevent the public from consuming
adulterated product.

[[Page 26728]]

Based on the 2009-2010 data, a significant number of ground product
lots that FSIS found positive were produced from source materials from
sole source suppliers. However, in some circumstances, the grinding
establishment may have combined material from multiple source lots to
create the lot of product that tested positive. Under these
circumstances, the new recall policy would not apply.
FSIS agrees with commenters to the public meeting that removing
from commerce source materials that may be contaminated with E. coli
O157:H7 is critically important. In situations where contamination most
likely occurred at the slaughter establishment that produced the source
materials, removing from commerce those source materials used to
produce E. coli O157:H7 positive product is scientifically sound. E.
coli O157:H7 is an enteric pathogen; therefore, contamination may occur
during the slaughter process, from transfer of contamination from the
hides, hooves, and gut of cattle. Contamination may occur through cross
contamination at the grinder; however, if there is no evidence of cross
contamination at the grinder, contamination most likely occurred at the
slaughter or trim establishment. FSIS is not aware of any circumstance
in which a split lot contributed to a reported illness. Regardless,
FSIS believes that this new recall policy will better protect the
public from consumption of E. coli O157:H7 contaminated product because
it will better ensure that source materials that are contaminated with
E. coli O157:H7 are removed from commerce. FSIS has requested recalls
from sole suppliers that provided source materials for product found
positive at grinders under specific, special circumstances, but not as
a general rule. FSIS requests comment on this new recall policy before
implementing it as a standard procedure and requests comment on the
costs that would result from this recall policy.
High event periods: Most establishments use testing that includes
an enrichment step followed by differential screening specific to STEC
organisms, particularly E. coli O157:H7 or their associated virulence
markers (e.g., eae and stx genes). Positive results during these
screening tests require further testing to detect E. coli O157:H7. If
an establishment does not perform additional testing, it should treat
lots that test positive in screen tests as positive. Similarly, FSIS
considers those results positive for E. coli O157:H7 if not confirmed
negative. Therefore, the discussion below refers to shiga toxin-
producing E. coli (STEC) organisms or virulence markers, in addition to
E. coli O157:H7.
HEPs are periods in which slaughter establishments experience a
high rate of E. coli O157:H7 (or STEC organisms or virulence markers)
in trim samples from production lots containing the same-source
materials. That is, the trim was produced from one or more carcasses
slaughtered and dressed consecutively or intermittently within a
defined period of time (e.g., shift). E. coli O157:H7 contamination is
generally point-source contamination that occurs sporadically as a
consequence of handling during hide removal and dressing of the
carcass. However, during HEPs, the contamination has become more
widespread. HEPs may stem from a higher than expected level of
contamination on hides, a failure of prevention mitigations, or cross
contamination of product. A high rate of positives in trim is
problematic because the trim is typically used across multiple
production lots, is handled by employees, and is therefore likely to
contaminate common conveyor belts and equipment. Also, such high rates
of positives or HEPs may mean that a systemic breakdown of the
establishment's production process may have occurred, and that
insanitary conditions existed at the establishment during these
periods. Such insanitary conditions may affect the safety of intact
(primal and subprimal) cuts, trim, and other beef components used in
the production of ground beef. In response to comments from the public
meeting that supported the implementation of new traceback procedures
to better identify contaminated source materials, FSIS intends to
provide more specific instructions to EIAOs concerning HEPs that may
occur at slaughter establishments that produced source materials for
product that FSIS has found positive for E. coli O157:H7. FSIS will
issue the new instructions as a notice or directive to its personnel.
The new procedures it intends to implement are discussed below. As is
discussed below, FSIS is also providing updated guidance to
establishments on how to identify HEPs. FSIS considered comments
submitted on the guidance and believes that the guidance is now more
useful to industry to help it identify HEPs, avoid recalls, and prevent
adulterated product from entering commerce.
To help develop the operational criteria for industry to use to
identify HEPs and for EIAOs to consider when conducting traceback
procedures, FSIS examined industry data collected by FSIS inspection
personnel from the top 33 slaughter establishments, representing 80
percent of industry production volume (number of cattle slaughtered).
The data from the 33 establishments show clustering of positives
results. Of the 33 establishments, 32 responses were received, 19 had
clear definitions of a HEP, 2 had definitions that were incomplete
because they did not specify a frame of time (which we interpreted to
be a day), 10 had unclear definitions of a HEP, and 1 did not have a
definition. Of the 21 establishments that had clear definitions, 7 were
using a 5 percent threshold definition; \5\ 9 indicated a threshold of
1-3 positive results a day or shift; 2 used between 5-10%; and 3 had
definitions greater than 10%.
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\5\ Establishments generally do not wait for confirmation of
positive results, which can take up to 8 days; rather establishments
respond to presumptive positive results that have not been confirmed
for E. coli O157:H7.
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Based on these results, FSIS selected a target of 5% for the HEP
criteria. Because FSIS did not want to define HEP criteria that would
be more rigorous than those of a large number of establishments, we did
not select a lower target. FSIS set criteria to help identify
exceptional events of poor processing. FSIS did not select a higher
target (e.g., 10%) because such a target we believe could result in
many cases where poor processing, as defined by most of the industry,
would not be detected as HEP.
FSIS intends to identify in the guidance and in instructions to
EIAOs two types of HEP that may indicate out-of-control situations in
the establishment's production process based on establishment results.
As noted above, 10 of the establishments had unclear definitions of
HEPs, and one had no definition. If establishments use FSIS's criteria,
FSIS would find their HEP definitions supportable. Below are the two
types of HEPs.

1. A HEP that indicates a localized out-of-control event in
which some specific occurrence or event causes a clustering of E.
coli O157:H7 (or STEC organisms or virulence markers) that indicate
contamination in product. The event would not indicate, necessarily,
a severe or global systemic break-down or inherent weakness of the
process or food safety system. Generally, intact primal and
subprimal cuts would not be affected if such cuts routinely undergo
a pathogen reduction treatment.
2. A HEP that indicates a systemic break-down or inherent
weakness of the process or food safety system. Virtually all raw
beef product would likely be affected.

During a systemic break-down situation, establishments may identify

[[Page 26729]]

more product that needs to be assessed to determine whether it may be
adulterated than in a localized HEP. A localized HEP may affect only
the production of one lot, while a systemic break-down may affect more
product. Also, a localized HEP may indicate an isolated problem (such
as improper application of an anti-microbial in one lot); a systemic
HEP may indicate a broader problem (such as systemic failure to prevent
cross contamination among carcasses).
FSIS is setting out criteria for identifying HEPs. These criteria
will be especially useful for establishments that have rigorous testing
programs. Beef slaughter and fabrication establishments that
manufacture 50,000 pounds or more of trimmings daily are likely to
conduct sufficient verification testing on same source materials to be
able to determine whether a HEP occurred based on the criteria below.
Lower volume establishments may choose to test frequently enough to use
these criteria. If not, the guidance includes general information for
lower volume establishments.

1. For a local HEP: 3 or more E. coli O157:H7 (or STEC organisms
or virulence markers) positive results out of 10 consecutive samples
from production lots containing same-source materials; and
2. For a systemic HEP:
A. 7 or more E. coli O157:H7 (or STEC organisms or virulence
markers) positive results out of 30 consecutive samples from
production lots containing same-source materials.
B. At establishments that test more than 60 samples per day,
from production lots containing same-source materials, the number of
E. coli O157:H7 (or STEC organisms or virulence markers) positive
samples below within the samples tested in the table:

------------------------------------------------------------------------
Unacceptable number positives Within samples tested
------------------------------------------------------------------------
8 61
9 74
10 86
11 100
12 113
13 127
14 141
15 155
16 169
17 184
18 198
19 213
20 228
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The above criteria are based on high degrees of confidence
(establishing sufficient statistical evidence) that the process
percentage exceeded 5% during some period. For the systemic HEP based
on daily testing of at least 60 samples \6\ and the local HEP guidance,
FSIS used close to 99 percent confidence for establishing sufficient
statistical evidence.\7\ For the systematic short-term HEP (based on 30
samples), FSIS selected about 99.95% confidence for asserting
sufficient statistical evidence. The reason for this high degree of
confidence is that FSIS wanted to have a short-term HEP criterion to
help establishments identify periods of serious processing problems.
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\6\ FSIS selected a minimum of 60 samples for identifying daily
HEP because the purpose of this was to determine inconsistencies
over a large amount of product produced during the day. The other
two criteria apply for less product or shorter periods. FSIS
identified the day-specific criterion for large volume
establishments that often test more than 100 lots a day.
\7\ For the local HEP involving 3 positive results from 10
samples, the confidence is 98.849644%, which FSIS considers to be
close to 99%.
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Establishments may use the guidance that FSIS has provided as
criteria for determining whether they have experienced a HEP. However,
the establishment-specific process percent positive could be different
than the FSIS criteria (assuming that the sampling plan and analyses
are described as above). Consequently, a specified percent positive for
a given establishment should be identified and justified if other than
that stated by FSIS if past results indicate that a different percent
positive was being achieved consistently, and product has low
likelihood of being adulterated. Deviations from the previously
obtained percent positive should be construed as presumptive evidence
that the process is out of control and would warrant investigation to
find and eliminate any potential causes for the positive results. As
part of their supporting documentation for their hazard analysis (9 CFR
417.5 (a)), FSIS recommends that establishments document the criteria
they use to identify HEPs.
Consistent with information FSIS presented at the March 2010 public
meeting discussed above, FSIS intends to instruct EIAOs to conduct an
investigation at establishments that produced positive E. coli O157:H7
product and at establishments that provided the source materials used
to produce that product. These traceback investigations will begin as
soon as possible, based on presumptive positive results and supplier
information at the producing establishment. Through these new
procedures, FSIS will investigate the reasons for positive results on a
more timely and thorough basis than the Agency does currently. At
slaughter establishments that produced positive product or source
materials used in the production of positive product, EIAOS will
consider whether the establishment has experienced a HEP.
A HEP indicates that production lots of same source material that
are presumed to be microbiologically independent (based on test results
or other criteria) may no longer be microbiologically independent. As
noted above, in such cases, these production lots may be considered to
be potentially contaminated with E. coli O157:H7, even if the
establishment has negative test results. During their investigations,
EIAOs will look at establishment test results and will determine
whether the establishment has its own HEP criteria. FSIS intends to
instruct EIAOs that when a HEP has occurred based on the
establishment's criteria or FSIS criteria, they are to determine
whether the establishment considered whether negative tested lots of
trimmings are releasable, and whether primal and sub-primal product
produced from the same source materials as the trimmings may be
positive for E. coli O157:H7, particularly if the establishment does
not have controls in place to ensure that the primal and sub-primal
product is not used for non-intact purposes.
If a HEP has occurred, FSIS intends to instruct the EIAO to
evaluate whether the establishment verified that all controls in place
in the slaughter process that are necessary to prevent E. coli O157:H7
are working as intended. Such controls may include measures to reduce
the pathogen load on incoming animals, measures to ensure that
contamination of the carcass is prevented during slaughter or dressing
procedures, effective decontamination or pathogen reduction treatments
(also referred to as ``antimicrobial treatments''), and measures to
minimize carcass-to-carcass contact and cross contamination.
Also, if a HEP has occurred, FSIS intends to instruct the EIAO to
evaluate whether the establishment found the cause for the HEP and has
taken corrective action to prevent future HEPs from recurring.
Finally, if the establishment has experienced a HEP during a ``high
prevalence season'' (from spring into early autumn), FSIS intends to
instruct the EIAO to determine whether the establishment increased the
frequency of monitoring and verification of both slaughter and dressing
procedures and pathogen reduction treatments, and whether the
establishment modified its sampling and verification testing programs
during the high prevalence season to increase the likelihood of finding
the pathogen.

[[Page 26730]]

As stated above, the EIAO will present to the District Manager the
findings concerning HEPs and all other findings and recommendations,
including any evidence indicating that adulterated product has likely
entered commerce. Similarly, based on the HEP information, as well as
other information collected, the EIAO will make recommendations
concerning what regulatory or enforcement actions may be warranted. In
addition, if the District Manager determines that adulterated product
entered commerce, the Recall Management Staff will lead any Agency
requests that establishments recall product. FSIS expects to complete
the investigation and take all necessary enforcement actions within one
month.
We note that this Notice imposes no new requirements for
establishments related to HEPs. The new EIAO instructions and
investigation procedures described are only intended to improve and
expedite FSIS traceback procedures.
Possible New Procedures To Identify Suppliers: In response to
comments, FSIS intends to assess the merits and resource implications
of conducting additional traceback activities. For example, FSIS
intends to determine whether it can make better use of the results of
establishment (versus FSIS) testing for E. coli O157:H7 and other
microorganisms and other establishment data that they may collect to
evaluate their sanitary dressing procedures. FSIS requests comment on
how the Agency could better evaluate this data and use it to inform
establishments that problems may be developing or to advise
establishments to take action to prevent the creation of insanitary
conditions or the production of adulterated product in the future.
Inspection program personnel currently review establishment test
results on a weekly basis (FSIS Directive 5000.2). FSIS is considering
issuing clarifying instructions to these personnel to look for
increasing positive results that should be raised to the
establishment's attention. FSIS also intends to conduct a study to test
product from unopened containers or purge material (that is, remaining
liquid, fat, and meat particles in containers or combo bins after trim
contents have been removed) from suppliers' product for E. coli
O157:H7. The purpose of this study will be to identify the source of E.
coli O157:H7 positive raw ground beef when material from multiple
suppliers was used to create the sampled ground beef that FSIS has
found positive for E. coli O157:H7.

Availability of Guidance Material

In October 2008, FSIS issued draft guidance entitled, ``Label
Policy Guidance for N60 Testing Claims for Boneless Beef Manufacturing
Trimmings (`Trim') Concerning E. coli O157:H7,'' and draft guidance
entitled, ``Compliance Guideline for Sampling Beef Trimmings for
Escherichia coli O157:H7'' and requested comments on these documents.
FSIS also held a public meeting to discuss the guidance and other
topics concerning E. coli O157:H7. FSIS carefully considered the
comments received and has responded to comments below.
FSIS has posted the revised guidance on its Significant Guidance
Documents Web page http://www.fsis.usda.gov/Significant_Guidance/index.asp. FSIS encourages those who are interested in using sampled
and tested claims to avail themselves of this guidance document when
preparing applications for sketch approval, and when using a sketch
approved sampled and tested claim. Similarly, FSIS encourages
establishments to begin using the trim sampling guidance. FSIS welcomes
comments on this guidance document. The Agency will consider carefully
all comments submitted and will revise the guidance document as
warranted.

Sampling and Testing Guidelines

This guidance, entitled ``Compliance Guideline for Establishments
Sampling Beef Trimmings for Shiga Toxin-Producing Escherichia coli
(STEC) Organisms or Virulence Markers,'' is meant to help slaughter
establishments develop and implement sampling and testing programs for
E. coli O157:H7 (or STEC organisms or virulence markers) in beef
manufacturing trimmings that are sampled using the N60 sampling method
or similar methods. FSIS recommends that establishments identify HEP
criteria so that they can determine whether they need to withhold
product from commerce when a HEP has occurred, because a HEP may
indicate more widespread adulteration of product, beyond the product
found positive. If establishments identify and respond to HEPs, they
will minimize the chance that they release adulterated product into
commerce.
Although this document also provides general information for non-
slaughter establishments that produce or receive trimmings, the HEP
information in the guidance only applies to slaughter establishments
that manufacture trim. The HEP guidance will be most useful to
slaughter and fabrication establishments that manufacture 50,000 pounds
or more of trimmings daily because they are likely to conduct
sufficient testing on same source trimmings to be able to determine
whether a HEP has occurred. Smaller volume slaughter and fabrication
establishments can also use the FSIS suggested criteria, particularly
those that involve 10 and 30 samples. Non-slaughter establishments will
not know if problems with slaughter and dressing procedures have
contributed to a HEP because they do not have the necessary information
from the establishment that slaughtered the cattle. FSIS recommends
that a slaughter and fabrication establishment conduct sampling and
testing of trim at a frequency sufficient to find evidence of
contamination surviving the slaughter and dressing operation (optimally
every production lot) to best ensure that adulterated product does not
enter commerce. Verification testing results on trim are likely the
best available information a slaughter establishment can use to
determine the effectiveness of its slaughter and dressing operation.
Comment: Industry commenters disagreed with the ``event day'' or
``hot day'' discussion FSIS presented in the guidance to illustrate the
number of positive results within a set number of samples that would
indicate that a process is out of control. These commenters were
concerned that the criteria would trigger regulatory criteria and
recalls. A consumer group was concerned that the compliance guide
suggested establishments would not have to investigate every positive
but could, instead, just investigate positives during HEPs.
Response: Identifying a HEP is an adequate basis for determining
whether a process is out of control. A high number of positives within
a limited number of samples may indicate that a systemic problem may
have occurred. To ensure that FSIS provides guidance for identifying
HEPs that would be useful to establishments, FSIS has gathered
information from inspectors at the 33 largest beef slaughter
establishments and revised the guidance to reflect this information.
The guidance clarifies that establishments are required to
investigate all positive results based on 9 CFR 417.3. In addition, the
guidance recommends that establishments take additional actions in
response to HEPs. The guidance explains that if the establishment has
experienced a HEP, it should carefully investigate to find all
contributing causes. This type of investigation would be more involved
than a follow-up investigation when an occasional positive result is
found.

[[Page 26731]]

Comment: Consumer organizations stated that establishments' testing
cannot replace effective prevention strategies and process control.
Industry commenters noted that microbiological testing is not designed
to test the safety of beef products, but rather, such testing is to
verify that controls are in place. One commenter submitted the Beef
Industry and Food Safety Council (BIFSCo) ``Best Practices for Using
Microbiological Sampling,'' a guidance document in conjunction with its
comments.
Response: FSIS agrees with the comments that establishment testing
is just one verification activity that establishments can use to verify
that their food safety system adequately addresses E. coli O157:H7.
Nonetheless, it is important to underscore that microbiological testing
is likely the best method for system verification as it relates to
microbial hazards. FSIS agrees that the BIFSCo guidance is useful and
has included a link to it in the compliance guidelines so that users
can quickly access that guidance.
Comment: A consumer group commented that FSIS's N60 program for
sampling beef manufacturing trimmings is ineffective because it is not
based on an accurately measured prevalence rate. The commenter also
stated that N60 sampling does not allow the Agency's testing to detect
E. coli O157:H7 and, therefore, should not be used to verify product
safety or that a process is in control.
Response: FSIS agrees that information on national prevalence is
important for properly designing a sampling program.\8\ However, a
national prevalence estimate is not sufficient information to determine
how to collect a sample from a lot, owing to the distinction between
determining how many lots to test and how to collect a sample from each
lot. In other words, prevalence data could inform how many lots to test
nationwide, but not how to collect a sample from each lot. A sampling
program, such as FSIS's trim sampling program, is a different concept
than a sample collection method, such as N60.
---------------------------------------------------------------------------

\8\ FSIS recently published the national prevalence estimate of
pathogen contamination of trim based on the 2005-07 beef trim
baseline study: http://www.fsis.usda.gov/PDF/Baseline_Data_Domestic_Beef_Trimmings_Rev.pdf.
---------------------------------------------------------------------------

FSIS's N60 sampling of beef trim and testing of trim for E. coli
O157:H7 is only one of a number of verification activities that FSIS
conducts regarding establishment process controls for E. coli O157:H7.
FSIS sampling of beef trim works along with inspection and other
verification activities, including FSIS sampling of ground beef and
other ground beef components and the review of establishment testing
results, to detect and reduce E. coli O157:H7 in beef products. FSIS's
mission is not to screen the food supply through testing but to verify
that safe and wholesome food is produced through inspection activities.
Comment: Another industry commenter disagreed that aerobic plate
counts (APCs) are an indicator of process control for reducing E. coli
O157:H7. The commenter stated that there is no significant correlation
between E. coli O157:H7 and APCs.
Response: FSIS agrees that there is not a significant correlation
between E. coli O157:H7 and APCs. However, as is stated in the
guidance, FSIS continues to believe that it is useful for beef
establishments to conduct verification testing for associated organisms
that include E. coli O157:H7 (e.g., a screen methodology for pathogenic
E. coli) and to maintain records of results as a quality control
activity. Measurements of ubiquitous organisms such as
Enterobacteriacea, APC, or generic E. coli can be used to evaluate the
effectiveness of process controls in limiting or eliminating microbial
contamination. Frequent measurements of APC counts may represent a
short-term trend, which would be useful for quality control, both
before and after the sanitary dressing processes. However, such
measurements, while helpful for ensuring microbial process control,
cannot be used as a substitute for determining the actual presence or
absence of E. coli O157:H7 in the final product.
Comment: Some comments supported changes to traceback activities
discussed above. For example, one consumer group supported FSIS
capturing information for all positive results, including results for
industry sampling programs.
Response: See discussion above under ``Improved Traceback
Procedures.''
Sampled and Tested Claims Guidance: This document provides guidance
on the use of labels bearing an FSIS sketch approved E. coli O157:H7
sampled and tested claim on beef trim. As is explained in the guidance,
such special labeling claims are voluntary. An establishment may use
such claims when it demonstrates that they are truthful and not
misleading (9 CFR 317.8(a)). FSIS must approve such claims before the
establishment may use them on labels (9 CFR 317.4(a)). This guidance
document addresses label claims that are not intended to be displayed
to consumers. FSIS may approve E. coli O157:H7 sampled and tested
claims on trim that goes to retail stores, for example to a retailer
who purchases the trim for grinding. However, FSIS will not approve
such a label claim for display to consumers because it may be
misleading to consumers by suggesting that the end product is free of
the pathogen or may not need to be cooked thoroughly.
A labeling claim asserting that beef trim has been sampled, tested,
and found negative for E. coli O157:H7 will provide receiving
establishments with information regarding the sampling and testing of
beef trim for that pathogen conducted by supplier establishments.
Sampling and testing for E. coli O157:H7 is intended to provide
evidence regarding the effectiveness of HACCP measures in addressing
the pathogen. Therefore, in order for a sampled and tested claim to be
truthful and not misleading, the establishment asserting the claim must
have incorporated into its HACCP system measures designed to control
for E. coli O157:H7, and it must use sampling and testing methodologies
that are designed to verify the effectiveness of those measures.
The final guidance document provides assistance to establishments
on the use of labels bearing an FSIS sketch approved sampled and tested
claim. It provides several examples of labeling claim language that may
be appropriate under different circumstances. The final guidance also
suggests the kind of documentation that establishments seeking sketch
approval may submit to demonstrate that a sampled and tested claim
would be truthful and not misleading.
Comment: Several members of industry questioned the connection
between documentation of HACCP measures related to E. coli O157:H7 and
the truthfulness of a sampled and tested claim. These comments argued
that it is not necessary to provide such extensive documentation in
order to demonstrate that a sampled and tested claim is truthful and
not misleading. They also stated that including extensive documentation
as part of an application for sketch approval would be burdensome.
Response: A labeling claim that beef trim has been sampled, tested,
and found to be negative for E. coli O157:H7 is not a representation
that the labeled beef trim is free of E. coli O157:H7; rather, it is a
representation that sampling and testing of the production lot from
which the beef trim was derived has demonstrated that the production
lot was produced under a HACCP system with measures in place that
effectively control for the pathogen.

[[Page 26732]]

Accordingly, a sampled and tested claim is only truthful and not
misleading if indeed such measures are in place, and if the sampling
and testing program is designed to verify the effectiveness of those
measures.
To assist interested establishments to obtain sketch approval of
sampled and tested claims, the final guidance retains a description of
the HACCP system-related documentation that FSIS believes would
demonstrate that a sampled and tested claim is truthful and not
misleading. FSIS made some revisions to the guidance for the sake of
clarity.
Comment: Several industry representatives argued that the
information to be included on a label bearing a sampled and tested
claim should be simpler than what was described in the draft guidance.
Some specific examples of information the commenters argued need not be
included are: (1) Lot size information; (2) lot identification
information; and (3) information indicating whether a production lot
which was formed by combining beef trim from two or more source
production lots was sampled after the source lots were combined.
Response: In response to the three specific concerns raised above:
(1) Lot size information has been removed from the final version of the
labeling guidance. This information was initially included as a
suggested means of indicating to receiving establishments whether the
labeled beef trim they receive consists of all or only a portion of a
sampled production lot. In light of industry comments reflecting the
practical difficulty of regularly changing labeling text to reflect the
varying sizes of production lots, this suggestion has been replaced
with guidance recommending a simple statement informing receiving
establishments whether the labeled beef trim consists of an entire
production lot or a portion of a split lot. (2) Including lot
identification information on labels containing sampled and tested
claims is important to ensure that such claims are truthful and not
misleading because this information allows the labeled beef trim to be
traced to a specific production lot. Therefore, the final version of
the policy guidance document retains this suggested labeling
information. (3) FSIS believes that it is important for a sampled and
tested claim to include a statement specifying whether (a) the final
formulation of labeled beef trim was sampled and tested, or (b) the
source lots were sampled and tested before being combined. This
information is relevant to whether a claim is truthful and not
misleading because it identifies which production lot or lots have been
produced using HACCP measures that effectively control for E. coli
O157:H7. FSIS agrees with several comments that the Agency needs to
clarify this portion of the draft guidance. Therefore, FSIS has removed
the ``twice tested'' discussion and replaced it with a suggestion that
sampled and tested claims asserted on beef trim product formulated by
combining two or more source lots state whether sampling and testing
was conducted on the final formulation or on the source lots.
Comment: Many comments argued that the guidance should better
define what constitutes N60 sampling methodology, and what constitutes
an FSIS-equivalent testing method.
Response: The draft guidance referred specifically to the use of
N60 sampling in connection with use of a sampled and tested claim. The
final guidance does not specify that N60 sampling must be done in order
to use a sampled and tested claim. Instead, the final guidance
emphasizes that, in order for the claim to be truthful and not
misleading, the sampling and testing program must be designed to verify
the effectiveness of an establishment's HACCP measures that control for
E. coli O157:H7. FSIS believes that the sampling and testing
methodologies it uses, including N60 sampling, achieve this goal.
Therefore, the final policy guidance refers to documents that provide
detailed descriptions of FSIS sampling and testing methodologies.
However, if an establishment uses different sampling or testing
methodologies that the establishment believes provide reliable
verification of the effectiveness of HACCP measures designed to control
for E. coli O157:H7, and therefore that use of those methodologies will
ensure that a sampled and tested claim is truthful and not misleading,
then the establishment may include in its application for sketch
approval documentation describing why its methodologies are equivalent
to FSIS methodologies. To assist establishments wishing to demonstrate
the equivalence of their sampling or testing methodologies, the final
policy guidance refers to a separate guidance document that provides
assistance to industry in conducting validation studies for pathogen
detection methods: http://www.fsis.usda.gov/PDF/Validation_Studies_Pathogen_Detection_Methods.pdf.

USDA Nondiscrimination Statement

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, or
audiotape.) should contact USDA's Target Center at 202-720-2600 (voice
and TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.

Additional Public Notification

FSIS will announce this notice online through the FSIS Web page
located at http://www.fsis.usda.gov/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 passwordprotect their accounts.

Done at Washington, DC, on April 24, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-10904 Filed 5-4-12; 8:45 am]
BILLING CODE 3410-DM-P