Changes to FSIS Traceback, Recall Procedures for Escherichia coli O157:H7 Positive Raw Beef Product, and Availability of Compliance Guidelines, 26725-26732 [2012-10904]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 77, Number 88 (Monday, May 7, 2012)]
[Notices]
[Pages 26725-26732]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[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 https://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 https://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\ https://origin-www.fsis.usda.gov/PDF/Transcript_031010_Traceability.pdf.
    \2\ https://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: https://www.fsis.usda.gov/Regulations_&_Policies/2010_Notices_Index/index.asp.
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    \4\ https://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
------------------------------------------------------------------------

    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 https://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: https://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: https://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 https://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 https://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