[Federal Register Volume 79, Number 156 (Wednesday, August 13, 2014)]
[Notices]
[Pages 47417-47424]
From the Federal Register Online via the Government Printing Office 
[FR Doc No: 2014-19141]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2011-0009]


Implementation of FSIS Traceback and Recall Procedures for 
Escherichia coli O157:H7 Positive Raw Beef Product

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice: Response to comments; planned implementation for 
traceback and recall procedures.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that it will implement new traceback procedures when FSIS or another 
Federal or State agency finds raw ground beef or bench trim presumptive 
positive for Escherichia coli O157:H7. FSIS is also announcing that it 
will begin requesting an establishment to recall product if an 
establishment was the sole supplier of beef manufacturing trimmings 
source materials for ground beef product that FSIS or another Federal 
or State agency finds positive for E. coli O157:H7, evidence suggests 
that the contamination most likely occurred at the supplier 
establishment, and a portion of the product from the originating source 
lot produced by the supplier establishment was sent to other 
establishments. FSIS is also clarifying circumstances when the Agency 
will ask suppliers of product used in bench trim to recall the product. 
FSIS is also announcing the availability of updated guidance documents. 
Finally, FSIS is responding to comments on the May 7, 2012, Federal 
Register notice, ``Changes to FSIS Traceback, Recall Procedures for 
Escherichia coli O157:H7 Positive Raw Beef Product, and Availability of 
final Compliance Guidelines''.

DATES: Beginning October 14, 2014, FSIS Enforcement, Investigations, 
and Analysis Officers (EIAOs) will conduct traceback investigations 
described in this notice. Additionally, beginning October 14, 2014, 
FSIS will implement new recall procedures described in this notice.

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

SUPPLEMENTARY INFORMATION: 

Background

    On May 7, 2012, FSIS published a Federal Register notice (77 FR 
26725) announcing new traceback procedures that it intended to 
implement when FSIS or other Federal or State agencies find a 
presumptive positive for Escherichia coli (E. coli) O157:H7 in raw 
ground beef or bench trim. FSIS explained that these new procedures 
would 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 also announced its intention to 
request that an establishment recall product if the establishment was 
the sole supplier of beef manufacturing trimmings 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 from the supplier establishment 
was sent to other establishments (77 FR 26725). Finally, this notice 
announced the availability of compliance guidelines concerning 
establishment sampling for Shiga toxin-producing E. coli (STEC) 
organisms or virulence markers and compliance guidelines for STEC 
sampled and tested labeling claims.
    FSIS has summarized and responded to the comments on the Federal 
Register notice and guidance below. In response to the comments, FSIS 
has not made any significant changes to the policies, procedures, or 
guidance announced in 2012. However, FSIS has updated the policies, 
procedures, and guidance to reflect the changes that apply to E. coli 
O157:H7 and would appropriately apply to non-O157 STEC.
    On September 20, 2011, FSIS declared six STEC organisms, in 
addition to E. coli O157:H7, adulterants in raw non-intact beef product 
or raw intact beef product intended for use in raw non-intact beef 
product (76 FR 58157). On June 4, 2012, FSIS started testing beef 
manufacturing trimmings for these six non-O157 STEC organisms. FSIS is 
gathering information to assess the economic effects of testing for the 
non-O157 STECs in raw ground beef components and ground beef. As noted 
in the May 31, 2012 Federal Register, when the Agency completes the 
updated analysis, FSIS will announce its availability and request 
comments on the analysis (77 FR 31976). As FSIS also stated in the May 
31, 2012 Notice, the Agency will then assess comments and make any 
necessary changes before finalizing the economic analysis and before 
making a determination on expanding FSIS testing to include ground 
product and raw ground beef components other than beef manufacturing 
trimmings. Below, FSIS has discussed how FSIS would implement the 
traceback and recall policies based on non-O157 STEC positive results 
in ground beef and bench trim should FSIS start testing these products 
for the adulterant non-O157 STEC.
    FSIS will use high event period (HEP) criteria in determining 
whether a systemic breakdown of process control at a slaughter 
establishment led to cross-contamination between multiple production 
lots. A systemic breakdown of process control and the resulting 
contamination would create insanitary conditions that may affect the 
disposition of intact lots of beef in addition to beef manufacturing 
trimmings and could lead to more product becoming adulterated than the 
product found positive for the pathogen. As is discussed below, FSIS 
has revised the FSIS Compliance Guideline For Establishments Sampling 
Beef Trimmings for Shiga Toxin-Producing Escherichia coli (STEC) 
Organisms or

[[Page 47418]]

Virulence Markers (http://www.fsis.usda.gov/wps/wcm/connect/e0f06d97-9026-4e1e-a0c2-1ac60b836fa6/Compliance_Guide_Est_Sampling_STEC_0512.pdf?MOD=AJPERES) to include the six additional adulterant STEC 
such that if an establishment's sample testing shows that it has 
experienced a HEP, then the establishment has likely experienced a HEP 
for non-O157 STEC as well as for E. coli O157:H7. Similarly, FSIS has 
revised the Compliance Guideline for E. coli O157:H7 Sampled and Tested 
Claims for Boneless Beef Manufacturing Trimmings (Trim) (http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index/!ut/p/a1/04_Sj9CPykssy0xPLMnMz0vMAfGjzOINAg3MDC2dDbwMDIHQ08842MTDy8_YwMgYqCASWYG_paEbUEFYoL-3s7OBhZ8xkfpxAEcDQvq9iLDAqMjX2TddP6ogsSRDNzMvLV8_Ijk_tyAnMzEvOVU3vTQzJbUYKJ6SWqEfrh-F10B_E3QFWHwMUYDbSwW5oRFVPmnBnumKigBJZmxC/#Ecoli) to address the data that 
FSIS would need to see to approve labels bearing statements that 
product has been sampled and tested for non-O157 STEC, in addition to 
E. coli O157:H7.

Final Traceback Policy

    FSIS will implement the traceback procedures announced in the May 
7, 2012 Federal Register on October 14, 2014. Under these new traceback 
procedures, Enforcement, Investigations, and Analysis Officers (EIAOs) 
will conduct traceback investigations at establishments that produced 
the E. coli O157:H7 presumptive positive product and at suppliers that 
provided source materials for the ground beef or bench trim that FSIS 
or other Federal or State agencies find presumptive positive. These 
traceback investigations will begin as soon as possible in response to 
presumptive positive results and supplier information from the 
producing establishment. During these investigations, EIAOs will gather 
relevant information about the production of the product, including use 
of antimicrobials and prevention of cross-contamination, sanitary 
conditions, and relevant purchase specifications.
    Furthermore, as part of their traceback investigations, EIAOs will 
review slaughter establishment test results to determine whether the 
establishment has experienced a HEP.
    HEPs in beef manufacturing trimmings at slaughter establishments 
are periods in which the establishment experiences a high percentage of 
positive results for E. coli O157:H7 or Shiga toxin-producing E. coli 
(STEC) organisms or virulence markers in beef manufacturing trimmings 
samples from production lots containing the same source materials. In 
this situation, the beef manufacturing trimmings were produced from one 
or more carcasses slaughtered and dressed consecutively or 
intermittently within a defined period of time (e.g., shift).
    There are two types of HEP that may indicate out-of-control 
situations in the establishment's production process. A HEP may 
indicate an event in which some specific occurrence or event causes a 
clustering of STEC organisms or virulence markers that indicate 
contamination in product, or a HEP may mean that a systemic breakdown 
of the slaughter dressing operation has occurred and has created an 
insanitary condition that may be applicable to all parts of the beef 
carcass (e.g., primal cuts in addition to the beef manufacturing 
trimmings and other raw ground beef and patty components). If the 
establishment has developed its own supportable HEP criteria, then the 
EIAOs will determine whether it has experienced a HEP based on the 
establishment's HEP criteria and will determine whether the 
establishment's HEP criteria are appropriately supported. Accordingly, 
FSIS recommends that as part of their supporting documentation for 
their hazard analysis (9 CFR 417.5(a)), establishments document the 
criteria they use to identify HEPs. If the establishment has not 
developed its own HEP criteria, EIAOs will determine whether the 
establishment has experienced a HEP based on the FSIS criteria 
discussed below.
    In the May 7, 2012 Federal Register, FSIS provided criteria for 
identifying a localized out-of-control event in which some specific 
occurrence caused a clustering of STEC contamination in product. The 
event would not indicate, necessarily, a severe or global systemic 
breakdown or inherent weakness of the process or food safety system. 
During a localized HEP, intact primal and subprimal cuts would not be 
affected if such cuts routinely undergo a complete pathogen reduction 
treatment on all exposed surfaces.
    FSIS also provided criteria for identifying a systemic HEP that 
indicates a systemic breakdown or inherent weakness of the process or 
food safety system. Virtually all raw beef product produced during the 
period of the systemic HEP would likely be affected, regardless of 
whether antimicrobial treatments were applied such as to primal cuts.
    FSIS is not making any changes to the HEP criteria described in the 
May 7, 2012 Federal Register. The final HEP criteria are:
    1. For a local HEP: 3 or more STEC organism (or virulence marker) 
positive results out of 10 consecutive samples from production lots 
containing same-source materials; and
    2. For a systemic HEP:
    A. 7 or more STEC organism (or virulence marker) 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 organism or virulence marker) positive samples below 
within the samples tested in the table:

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                                                          Within samples
            Unacceptable  positives                  tested
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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 percent during some period. The 5 percent 
represents a value that is definitively higher than the expected 
percent positive found when an establishment is operating under good 
manufacturing practices. For the systemic HEP based on daily testing of 
more than 60 samples \1\ and the local HEP guidance, FSIS used close to 
99 percent confidence for establishing sufficient statistical 
evidence.\2\ For the systemic short-term HEP (based on 30 samples), 
FSIS selected about 99.95 percent confidence for asserting sufficient 
statistical evidence. The reason for this high degree of confidence is 
that FSIS wanted to have a short-term HEP

[[Page 47419]]

criterion to help establishments identify periods of serious processing 
problems.
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    \1\ FSIS selected a minimum of 60 samples for identifying daily 
HEP because the purpose of this criterion is 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.
    \2\ 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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    As FSIS explained in the May 7, 2012 Federal Register, based on all 
the information gathered during traceback investigations, 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; if it has, whether to contact the 
FSIS Recall Management and Technical Analysis Staff; and whether 
enforcement actions are appropriate.
    At this time, EIAOs will perform the traceback procedures at 
establishments that produce raw ground beef products and bench trim 
products that FSIS or other Federal or State agencies find presumptive 
positive for E. coli O157:H7 and EIAOs will perform the traceback 
procedures at establishments that supply the source materials for these 
products. Should FSIS begin testing raw ground beef products and bench 
trim products for the six adulterant non-O157:H7 STEC, EIAOs would 
perform the traceback procedures at establishments that produce raw 
ground beef and bench trim products that FSIS or other Federal or state 
agencies find presumptive positive for any STEC organism that FSIS has 
declared to be an adulterant and EIAOs would perform traceback 
procedures at the supplying establishments that provided source 
materials for these products. These traceback procedures will allow 
FSIS to identify problems that occurred at the establishments that 
produced the non-O157 STEC positive product and at their suppliers on a 
timely basis.
    As is explained in the May 7, 2012 Federal Register, 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 (77 FR 26728). Positive 
results during screening tests require further testing to detect E. 
coli O157:H7. If the establishment does not perform the additional 
testing, it should treat lots that test positive in screen tests as 
positive for E. coli O157:H7. Similarly, FSIS considers these results 
positive for STEC. STEC includes E. coli O157:H7 and the non-O157 STEC. 
If establishments test beef manufacturing trimmings for E. coli 
organisms and virulence markers rather than for specific STEC 
organisms, and their results indicate that they have experienced a HEP 
based on the HEP criteria above, they will have likely experienced a 
HEP for E. coli O157:H7 and the non-O157 STEC. Therefore, during 
traceback investigations, if EIAOs determine that a slaughter 
establishment has experienced a HEP based on establishment results for 
beef manufacturing trimmings and based on the establishment's HEP 
criteria, or based on the FSIS HEP criteria, EIAOs will likely find 
that the establishment has experienced a HEP for non-O157 STEC in 
addition to E. coli O157:H7. The HEP criteria above would apply to non-
O157 STEC, as well as E. coli O157:H7. The actions EIAOs will take in 
response to finding that an establishment has experienced a HEP for 
non-O157 STEC would be the same they would take in response to an E. 
coli O157:H7 HEP.
    This notice imposes no new requirements for establishments related 
to HEPs. The new EIAO instructions and investigations are only intended 
to improve and expedite FSIS traceback procedures. As FSIS explained in 
the May 7, 2012 Federal Register, EIAOs do not conduct this type of 
traceback investigation now until they conduct Food Safety Assessments 
(FSAs). FSAs are scheduled approximately 30 days after the confirmed 
positive results become available, so FSAs are much later than the 
traceback investigations EIAOs will now conduct. As noted above, the 
new traceback investigations will begin as soon as possible in response 
to presumptive positive results. Also, during FSAs, EIAOs do not ask 
all the focused questions that they will ask as part of this new 
procedure. Finally, EIAOs do not currently evaluate whether an 
establishment has experienced a HEP when performing an assessment (77 
FR 26727).

Recall Policy

    FSIS will also implement the recall procedures announced in the May 
7, 2012 Notice on October 14, 2014. Under these procedures, FSIS will 
request that supplier establishments recall product if:
    (1) FSIS or another Federal or State agency finds raw ground beef 
positive for E. coli O157:H7 at a grinding establishment;
    (2) FSIS determines that E. coli O157:H7 introduction, such as 
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 beef 
manufacturing trimmings 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 treatment to eliminate E. coli O157:H7 in a federally 
inspected establishment.

If all of the foregoing occurs, FSIS will request the establishment to 
initiate a recall from the slaughter or beef manufacturing trimmings 
supplier establishment.
    At this time, when the criteria listed above occur, the recall 
procedures will apply to suppliers of materials of raw ground beef 
products that FSIS or another Federal or State agency finds positive 
for E. coli O157:H7. Should FSIS begin testing ground beef for the six 
non-O157:H7 STEC that are adulterants, and the criteria listed above 
occur, those recall procedures would apply to suppliers of materials of 
raw ground beef products that FSIS or another Federal or State agency 
finds positive for any of the STEC organisms that FSIS has declared an 
adulterant. Contamination with any of these STEC organisms is most 
likely to occur at the supplying slaughter establishment, so it is 
appropriate that the Agency request a recall of any source materials 
still in commerce if a slaughter establishment was the sole supplier of 
source materials for ground product that FSIS or another Federal or 
State agency finds positive for these STEC organisms. In addition, 
these recall policies and procedures are appropriate because STEC 
organisms are enteric pathogens. 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 beef manufacturing trimmings establishment (77 FR 
26728).
    FSIS requested comments on costs that would result from this recall 
policy but did not receive specific comments on this issue. As 
explained in the May 7, 2012 Federal Register, had this recall policy 
been in place, FSIS may have requested 29 additional recalls in the

[[Page 47420]]

two year period between January 1, 2009 and December 31, 2010, if 
suppliers had split their lots and sent source materials to other 
establishments in addition to the grinder where FSIS found the positive 
source material.\3\ Any additional recalls under these circumstances 
are likely to better prevent the public from consuming adulterated 
product (77 FR 26727). Removing from commerce source materials that may 
be contaminated with STEC organisms is critically important. This new 
recall policy will better protect the public from consumption of STEC 
contaminated product because it will better ensure that source 
materials that are contaminated with STEC organisms are removed from 
commerce.
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    \3\ Data are from the Policy Analysis Staff, the Office of 
Policy and Program Development, FSIS.
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    FSIS samples beef manufacturing trimmings and most other raw ground 
beef components at the slaughter establishment. Therefore, if FSIS 
finds a positive in these products, it does not have to trace product 
back to a different slaughter supplier establishment because all the 
source materials are typically from the slaughter establishment that 
produced the positive product. However, FSIS samples ``bench trim'' at 
establishments that did not slaughter the cattle used to produce the 
source materials. Bench trim materials are materials that the receiving 
establishment uses as entire cuts to produce nonintact product or uses 
to derive trimmings for use in non-intact product.
    When FSIS finds bench trim positive, FSIS does not typically 
request the recall of source materials from suppliers of the bench 
trim. In many cases, receiving establishments use primal or subprimal 
products as bench trim in their entirety to produce non-intact product. 
In this situation, the primal or subprimal products or trimmings would 
typically constitute an independent lot. Therefore, if FSIS finds the 
subprimal or primal product, or trim derived from the subprimal or 
primal product, positive for E. coli O157:H7, FSIS would not typically 
request a recall from the supplier slaughter establishment because 
there would likely be no product to recall related to the primal or 
subprimal product. Also, based on FSIS's experience with bench trim 
sampling, bench trim is usually combined with multiple lots at the 
grinding establishment. So again, FSIS would not request a recall at 
the supplier establishment in this situation.
    Bench trim is typically primal or subprimal product that the 
slaughter establishment did not intend for use in ground or other non-
intact, raw product. Many slaughter establishments maintain information 
on their Web sites or provide information to receiving establishments 
explaining that this product is not intended for grinding or use in 
other non-intact, raw product. However, receiving establishments may 
use some portion of the primal or subprimal product to produce non-
intact, raw product. When they do so, many of these receiving 
establishments employ additional antimicrobial treatments to the primal 
or subprimal product or test the non-intact product or trimmings 
derived from the primal or subprimal product.
    If FSIS finds the bench trim product positive and the slaughter 
establishment did not intend the primal or subprimal product to be used 
in non-intact product, the positive result does not necessarily 
represent a problem with the slaughter establishment's food safety 
system. The slaughter establishment designated the primal or subprimal 
product for intact use and its food safety system likely addressed the 
hazards associated with intact product, rather than non-intact product.
    However, should FSIS find bench trim positive, it would conduct the 
type of traceback investigation that is described in this notice and 
activities, including sampling and testing of primal and subprimal 
product, to verify that the establishment is meeting all HACCP 
requirements. In most cases, FSIS would not request that the slaughter 
establishment recall subprimal or primal product because the positive 
product was not intended for grinding or other non-intact use.
    If data show that the slaughter establishment experienced a HEP, 
FSIS may request a recall. If FSIS finds that the slaughter 
establishment experienced a high event period and did not take action 
to reduce possible E. coli O157:H7 contamination in primal and 
subprimal products; that the slaughter establishment was the sole 
supplier for the bench trim; that contamination did not occur at the 
receiving bench trim establishment; and that the supplier co-mingled 
primal or subprimal cuts and then sent some of the same lot used to 
produce the bench trim that FSIS found positive to additional 
establishments, FSIS would ask the slaughter supplier establishment to 
recall the product.

Final Guidance

    The May 7, 2012 Federal Register notice announced the availability 
of guidance, FSIS Compliance Guideline for Establishments Sampling Beef 
Trimmings for Shiga Toxin-Producing Escherichia coli (STEC) Organisms 
or Virulence Markers and Compliance Guideline for E. coli O157:H7 
Sampled and Tested Claims for Boneless Beef Manufacturing Trimmings 
(Trim).
    FSIS has revised the establishment sampling guidance to reflect the 
Agency's recent policy developments relating to the six adulterant non-
O157 STECs. As is discussed above, most establishments generally test 
for pathogenic E. coli organisms and virulence markers rather than for 
specific STEC organisms. Therefore, the criteria that FSIS has provided 
in the guidance are general and would indicate that the establishment 
may be experiencing problems controlling any of the STEC organisms. The 
guideline is meant to help slaughter establishments develop and 
implement sampling and testing programs for STECs in beef manufacturing 
trimmings. The HEP guidance will be most useful to slaughter and 
fabrication establishments that manufacture 50,000 pounds or more of 
beef manufacturing trimmings daily because they are likely to conduct 
sufficient testing on same source beef manufacturing trimmings to be 
able to determine whether a HEP has occurred. Smaller volume slaughter 
and fabrication establishments can also use the HEP criteria in the 
guidance, particularly those that take 10 or 30 samples. Non-slaughter 
establishments will not know whether 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. As is stated in the May 7, 2012 Federal Register, FSIS 
recommends that slaughter and fabrication establishments conduct 
sampling and testing of beef manufacturing trimmings at a frequency to 
find evidence of contamination surviving the slaughter and dressing 
operation (optimally every production lot) to best protect against 
adulterated product entering commerce. Establishment verification 
testing results on beef manufacturing trimmings are likely the best 
available information a slaughter establishment can use to determine 
the effectiveness of its slaughter and dressing operation (77 FR 
26730).
    FSIS also has revised the guidance to include a more detailed 
explanation of FSIS's HEP criteria, to make clear that establishments 
have flexibility in designing and supporting HEP criteria that is 
different from FSIS's HEP criteria, and to cite askFSIS as a resource 
for providing feedback to establishments on the design of HEP criteria 
that is different than FSIS's criteria.

[[Page 47421]]

    FSIS recommends that establishments identify HEP criteria so 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 will release adulterated product into commerce.
    The sampled and tested claims guidance continues to provide 
information on the use of labels bearing an FSIS sketch approved E. 
coli O157:H7 sampled and tested claim on beef manufacturing trimmings. 
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)). FSIS has updated the guidance to recognize that 
establishments may want to submit a request for a labeling claim 
stating that product has been tested for the six adulterant non-O157:H7 
STEC in addition to E. coli O157:H7. In the final guidance, FSIS has 
explained that the Agency would need to see the same type of 
information to approve sampled and tested claims for the other 
adulterant STEC organisms as it would need to see for sampled and 
tested claims concerning E. coli O157:H7.
    As is explained in the May 7, 2012 Federal Register, this guidance 
document addresses label claims that are not intended to be displayed 
to consumers. FSIS may approve STEC organisms sampled and tested claims 
on beef manufacturing trimmings that goes to, for example, a retailer 
who purchases the beef manufacturing trimmings for grinding. However, 
FSIS will not approve such a label claim for display to consumers 
because it may be misleading to them by suggesting that the end product 
is free of pathogens or may not need to be cooked thoroughly.
    These labeling claims will provide receiving establishments or 
retailers with information regarding the sampling and testing of beef 
manufacturing trimmings for STEC organisms conducted by supplier 
establishments.
    In order for a sampled and tested claim to be truthful and not 
misleading, the establishment making the claim must have incorporated 
into its HACCP systems measures designed to control for the STEC 
organisms addressed in the claim, and it must use sampling and testing 
methodologies that are designed to verify the effectiveness of those 
measures.

Plans for Future Study

    The May 7, 2012 Federal Register notice stated that FSIS 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 beef manufacturing trimmings contents 
have been removed) from suppliers' product for E. coli O157:H7 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.
    Based on research, FSIS has concluded that source traceback by 
testing purge material cannot be accomplished because of the 
insufficiency of purge material available for testing purposes. At this 
time, FSIS is not starting a study on unopened packages to identify the 
source of E. coli O157:H7 positive raw ground beef when material from 
multiple suppliers was used to create the positive product. However, 
FSIS continues to believe that there may be merit in pursuing this type 
of study and will further explore whether analyzing unopened packages 
will assist FSIS to effectively identify suppliers of STEC positive 
products. Based on the results of these findings and the availability 
of necessary resources, FSIS may conduct this study in the future. FSIS 
will also continue to review available data related to multiple sources 
of ground beef products.
    The May 7, 2012 Federal Register also stated that the Agency 
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 data that establishments may collect to 
evaluate their sanitary dressing procedures. FSIS requested 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.
    FSIS did not receive any comments on this issue. As noted in the 
May 7, 2012 Federal Register, inspection program personnel review 
establishment test results on a weekly basis (FSIS Directive 5000.2). 
FSIS intends to issue clarifying instructions to these personnel to 
look for increasing positive results that should be raised to the 
establishment's attention. For example, FSIS intends to revise the 
directive to instruct inspection program personnel to review the 
current results of any testing that the establishment has performed and 
compare them to the previous 30-days' results to determine whether an 
adverse trend is developing. Through this review and these clarifying 
instructions, FSIS personnel may be better able to advise 
establishments that problems may be developing. Similarly, 
establishments need to assess their verification testing results on a 
regular basis to ensure that their food safety systems effectively 
address hazards, including the STEC organisms.

Comments and Responses

    FSIS received comments from five industry and consumer 
organizations in response to the May 7, 2012 Federal Register notice. 
Some consumer groups and industry supported the HEP guidance. Following 
is a discussion of these comments and FSIS's responses.

Recall and Traceback Procedures

    Comment: Two industry organizations commented that FSIS should not 
take samples of ground product produced from sole source materials for 
E. coli O157:H7 testing. To reduce costs of recalls, commenters 
suggested alternative FSIS sampling schemes. For example, one commenter 
stated that if the grinder combines product from multiple suppliers, 
FSIS should sample the product at the suppliers, not the grinder. 
Similarly, another commenter stated that if the product to be sampled 
is from a single source supplier, the sample should be collected at the 
supplying establishment, not the grinder.
    Response: The Agency conducts routine sampling and testing for E. 
coli O157:H7 at all establishments that produce raw ground beef in 
order to ensure that all such establishments implement their own 
procedures to control for this pathogen. FSIS intends to continue 
collecting and testing samples at all establishments that produce raw 
ground beef product to verify that they have controls necessary to 
address E. coli O157:H7. As is noted above, FSIS may begin analyzing 
ground beef samples for non-O157 STEC in the future.
    In response to these comments, FSIS is assessing whether it can 
routinely identify which grinders grind product from sole suppliers on 
a consistent basis as a defined practice in their food safety system, 
and whether it would be appropriate to reduce Agency sampling and 
testing at such establishments.
    FSIS will continue to collect samples at slaughter establishments 
that produce beef manufacturing trimmings for use in ground beef or 
other non-intact products and will continue to analyze these

[[Page 47422]]

samples for E. coli O157:H7 and the adulterant non-O157 STEC. 
Similarly, FSIS will continue to collect samples of other raw ground 
beef components and to analyze them for E. coli O157:H7. In the future, 
FSIS may analyze samples of these products for the non-O157 STEC also. 
FSIS samples raw ground beef components to ensure that producers also 
have controls necessary to address STEC organisms. It is necessary that 
FSIS collect and analyze samples at both grinding processing 
establishments and at supplying establishments to verify that all 
establishments maintain adequate controls to address STEC organisms in 
their food safety systems.
    Comment: An industry organization wanted to know how FSIS would 
complete the traceback review and asked what records would FSIS review 
to determine whether the recall criteria discussed in the Federal 
Register notice apply. Another industry organization stated that the 
EIAO's traceback methodology should be made available to all 
stakeholders.
    Response: FSIS will review FSIS and establishment testing records, 
establishment lotting records, and supplier information to determine 
what product may be affected. FSIS will issue instructions to its field 
personnel on how to determine whether introduction of E. coli O157:H7 
or cross-contamination likely occurred at the grinder. The instructions 
to the field personnel will include the criteria FSIS personnel are to 
use to determine whether product should be recalled. Information 
concerning Agency thinking for instructions to FSIS field personnel is 
at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices/notices-2010/!ut/p/a1/jZBBC4JAEIV_Sz9AZlZF9GgLlpaKRLbtJZZabcFUVDr061PqYiU5p5nH93i8AQ4MeCnuKhedqkpRDDe3TpigRRyKQey5HvqR4aV2tCJokh44jgCHDECaxBtK0Y6Mmf6JcfGfP5gRoDchDXPgteiumiqzClgmL7IRhdbIXLWdbL4Vraw6dZYtsPei6UgQDsDHib1IhsSduQ4iA2PzE_jxkhcw3bm-7dlju3R85S6eyWLScQ!!/?1dmy&current=true&urile=wcm%3apath%3a/fsis-archives-content/internet/main/newsroom/meetings/past-meetings/ct_index202. FSIS provided this information during the March 2010 public 
meeting on traceback activities.
    FSIS will instruct EIAOs to consider the following:
    1. Was the supplier a sole supplier?
    2. Was the supplied product beef manufacturing trimmings, coarse 
ground, or another raw ground beef component?
    3. Are there data (e.g., testing results) to indicate that 
contamination likely did not occur at the receiving establishment?
    4. Did the supplier send part of the same lot that was used to 
produce the positive product to another establishment?

If the answer to all of these questions is yes, FSIS will instruct 
EIAOs to inform the District Office that there is evidence that 
adulterated product is in commerce.
    Instructions to FSIS field personnel to conduct traceback from the 
grinder or bench trim establishment will include asking a series of 
questions designed to identify all source materials and potential 
suppliers of beef components used as source materials in the production 
of the sampled lot of ground beef or bench trim. When finalized, these 
instructions will be available on the FSIS Web site where the public 
may access the information.
    Comment: While the proposed changes to the recall policy address 
product from a sole-source supplier, two consumer groups encouraged 
FSIS to continue to work towards developing improved traceback 
procedures for product from multiple suppliers.
    Response: As is explained above, FSIS intends to further explore if 
analyzing unopened packages will assist FSIS to effectively identify 
suppliers of STEC positive products. Any such methodology likely would 
consider whether the grinding or bench trim establishment has its own 
verification program that includes testing of these source materials.
    Comment: An industry organization commented that FSIS should verify 
that grinders maintain accurate recordkeeping, so that FSIS can 
identify the actual supplier of the contaminated product. This 
commenter stated that grinders need to maintain information that links 
the supplier of the raw materials to the sampled lot. This commenter 
also stated that the Agency should routinely verify that grinders 
maintain adequate records rather than wait until conducting a traceback 
investigation.
    Response: Inspection program personnel collect information about 
the source materials and about the suppliers at the time they sample 
ground beef or bench trim at official establishments. Additionally, 
FSIS has made available compliance guidelines, Sanitation Guidance for 
Beef Grinders, that provides examples of good recordkeeping for 
grinders and includes recommendations that they maintain information 
about suppliers of source materials used in the manufacture of ground 
beef. The compliance guideline may be accessed at the following link: 
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
    Finally, FSIS intends to publish a proposed rule to specify the 
information concerning suppliers and source materials that 
establishment and retail grinders would be required to maintain. Should 
this rule become final, FSIS would issue instructions to inspectors to 
verify that establishments maintain required records.
    Comment: One industry organization commented that recall 
determinations should be made after intensive investigations are 
carried out by the establishment where the positive result occurred and 
by FSIS. In addition, the organization recommended that the Agency's 
recall policy include a provision for FSIS and an establishment to 
agree on what product would be implicated by a positive finding before 
the sample is even taken. The commenter stated that many recent recalls 
resulted not from the failure to hold any product, but from the failure 
to hold all the implicated product.
    Response: Establishments are now required to maintain control of 
all product that FSIS samples for adulterants, including ground beef 
that FSIS samples and tests for E. coli O157:H7 and beef manufacturing 
trimmings that FSIS samples and tests for STEC organisms (77 FR 73401; 
Dec. 10, 2012). Therefore, FSIS verifies that establishments maintain 
control of raw beef product that FSIS samples and tests for STEC 
organisms.
    Establishments are responsible for defining the sampled lot. FSIS 
has informed establishments that they should have a supportable basis 
for determining the microbiological independence of one production lot 
of product from another, particularly when same source materials may be 
included in multiple product lots. In the ``Compliance Guideline For 
Establishments Sampling Beef Trimmings for Shiga Toxin-Producing 
Escherichia coli (STEC) Organisms or Virulence Markers,'' FSIS has 
recommended that establishments define their lots so that if a positive 
result is found from one lot, the product in other lots is 
microbiologically independent and is not implicated.
    In the guideline, FSIS goes on to explain that when FSIS requests 
that establishments recall product, FSIS looks at several factors to 
determine the scope of a recall, including the establishment's 
processing and sanitation procedures, and whether

[[Page 47423]]

there is any finished product reincorporated into fresh product 
(rework). In these guidelines, FSIS has recommended that establishments 
consider all these factors when defining a lot.
    Comment: One industry organization commented that FSIS should take 
samples from product that is routinely manufactured and representative 
of the establishment's process. For instance, the commenter stated that 
if the grinder is making ground beef and routinely uses bench trim, 
then FSIS should sample and test ground product from bench trim.
    Response: Consistent with the instructions in Directive 10,010.1, 
FSIS field personnel randomly select a day, shift, and time within the 
sampling timeframe to collect samples from all shifts the establishment 
operates. These procedures provide for random FSIS sampling of the 
product and ensure that FSIS samples and tests all types of product the 
establishment produces.

 Compliance Guideline for STEC Sampled-and-Tested Claims for Boneless 
Beef Manufacturing Trimmings

    Comment: Industry organizations asked whether all labels that will 
carry the sampled-and-tested claim need to be submitted separately to 
FSIS. Additionally, the organizations asked how long it takes to 
receive label approval with this sampled-and-tested claim.
    Response: All labels bearing STEC sampled-and-tested claims need to 
be submitted to FSIS. The Office of Public Health Science and various 
staffs in the Office of Policy and Program Development will review 
these labels. Because reviews of these labels will involve Agency 
staffs besides the Labeling and Program Delivery Staff, the reviews 
will probably take longer than those for other types of labels bearing 
special claims. As FSIS explained in the May 7, 2012 Federal Register, 
as part of the label review process, FSIS will verify that the 
establishment submitted evidence that demonstrates that the 
establishment's HACCP measures related to the adulterant STEC organisms 
are effective in reducing the pathogen to non-detectable levels, and 
that the results of the establishment's sampling and testing 
demonstrate that those HACCP measures are effective (77 FR 26725). The 
Agency will try to ensure that the approval process is as timely as 
possible.
    Comment: An industry organization suggested that FSIS develop 
labeling guidance based on the intended use of a product that contains 
beef manufacturing trimmings. The commenter stated that if the raw beef 
manufacturing trimmings have tested positive or presumptive-positive 
for E. coli O157:H7 and are diverted to be cooked, the beef 
manufacturing trimmings should be labeled ``for cooking only.''
    Response: FSIS reviews labels bearing instructional statements such 
as ``for cooking only'' and verifies that establishments use such 
labels appropriately (i.e., for product going to another Federal 
establishment).
    It is important to recognize that a ``for cooking only'' label is 
not sufficient to move adulterated product to another establishment for 
cooking or other full lethality treatment (e.g., high pressure 
processing or irradiation). Such product is adulterated and would need 
to move to other Federal establishments under company control.
    Comment: A consumer group suggested that FSIS require, on a label 
bearing a sampled-and-tested claim, a statement that further clarifies 
that the claim does not mean that the labeled beef manufacturing 
trimmings are free of E. coli O157:H7.
    Response: These sampled-and-tested claims on labels are not 
intended for use on product sold directly to consumers. FSIS would only 
approve labels with these claims if they include the relevant material 
facts; that is, a statement of limited use such as ``not for sale at 
retail.'' Industry is aware of the limitations of the labeling terms or 
statements used regarding STEC organisms, and thus further explanation 
is not necessary.
    Comment: One industry organization commented that the labeling was 
not feasible or practical. This commenter stated that printing out a 
label with the full sampled-and-tested claim and placing production lot 
information on each label would be costly. The organization requested 
that FSIS consider alternatives. For example, the commenter stated that 
information contained on the label could be included in sales receipts 
or other records received from the supplier without label approval.
    Response: These labeling claims are voluntary, not required. If an 
establishment finds the claims to be costly or impractical, they will 
not use them. As is explained above, sampled and tested claims need to 
be submitted to FSIS for review before use on labels. Therefore, an 
establishment could not print sampled or tested claims that FSIS had 
not reviewed and approved on sales receipts or other records.

Compliance Guideline for Establishment Sampling of Beef Trimmings for 
Shiga Toxin-Producing E. coli (STEC) or for Virulence; High-Event 
Periods (HEPs)

    Comment: An industry association recommended that the Agency 
provide criteria for establishments that produce fewer than 50,000 
pounds of beef manufacturing trimmings per day. One consumer group 
stated that, because FSIS based its HEP criteria on establishment data 
that already exists, FSIS should periodically review and revise its 
criteria, as appropriate, on the basis of industry data and 
performance. Another consumer asked whether the Agency would consider 
higher than 5 percent positive samples to be indicative of a problem in 
the establishment.
    Response: The HEP guidance will be most useful to beef slaughter 
establishments that manufacture 50,000 pounds or more of beef 
manufacturing trimmings daily. Such establishments are likely to 
conduct sufficient verification testing on same source materials to be 
able to determine whether a HEP occurred. Through FSAs and outbreak 
investigations, FSIS has found that these establishments typically 
sample every combo bin or grouping of combo bins so that all product is 
subject to testing. Testing at this level is sufficient to determine 
whether a HEP occurred. Small volume establishments are unlikely to 
conduct sufficient verification testing to reliably detect the 
occurrence of a HEP. Through FSAs and outbreak investigations, FSIS has 
found that these establishments typically sample once per day or once 
per week. This testing frequency would most likely not detect a HEP. 
However, the document includes some general guidance concerning 
verification testing that small volume establishments will find useful 
and discusses, in general terms, ways for smaller volume 
establishments, including those that produce less than 50,000 pounds 
per day, to define HEPs.
    When FSIS conducts traceback verification activities at 
establishments that do not have their own HEP criteria, FSIS will use 
the Agency HEP criteria in the guidance discussed above to determine 
whether establishments are taking appropriate actions to keep 
adulterated product out of commerce during a HEP. If establishments set 
their own appropriate HEP criteria, FSIS will also assess whether 
establishments are taking appropriate actions to keep adulterated 
product out of commerce during a HEP, based on the establishments' HEP 
criteria.

[[Page 47424]]

    The Agency is concerned about beef manufacturing trimmings 
(including those that tested negative) and primal and subprimal 
products produced during the HEP when the percent positive is greater 
than 5 percent with a high degree of statistical confidence. If an 
establishment defines a HEP based on a percent positive over 5 percent, 
it will need to have strong support for its HEP. For example, if an 
establishment analyzes for more or broader indicators than those 
typically used to screen for E. coli O157:H7 and the six adulterant 
non-O157 STEC, the establishment may be able to support a HEP based on 
a higher percent positive. The establishment may be able to show that 
it is screening for additional non-O157 STEC. Therefore, the 
establishment may identify more HEPs in its production based on its 
testing than other establishments. If an establishment does not have 
strong support for a HEP over 5 percent, FSIS will not use the 
establishment's criteria in its assessment.
    To develop recommendations for identifying HEPs, FSIS examined data 
collected in 2010 by FSIS inspection personnel from the top 33 
slaughter establishments, based on production volume (heads 
slaughtered). Based on the results, FSIS selected a target of 5 
percent. FSIS did not want to define HEP criteria that would be more 
rigorous than those of a large number of establishments and, therefore, 
did not select a lower target. Based on its analysis of outbreak-
related recalls and the HEP criteria that establishments and FSIS used 
to identify the HEPs that led to these recalls, FSIS determined that 
the 5 percent target was sufficient to identify situations in which 
significant problems in slaughter dressing operations occurred that led 
to insanitary conditions. FSIS did not select a higher target (e.g., 10 
percent) because, again based on the analysis of outbreak-related 
recalls, a higher target would not be sufficient to identify such 
situations.
    FSIS intends to assess the effectiveness of its new traceback 
procedures and to assess establishment HEP criteria again in the future 
if necessary to ensure that the criteria remain effective in preventing 
illness and remain useful to establishments. For example, if new, more 
sensitive screening test methods or new real time confirmation test 
methods become available, and establishments begin using them, FSIS 
will assess establishment results and changes in establishment HEP 
criteria to determine whether to change the FSIS HEP criteria.
    Comment: An industry organization asked whether the occurrence of a 
HEP would cause sampled-and-tested labels to be rescinded.
    Response: FSIS may decide to rescind a label if it determines that 
the occurrence of the HEP rendered the label incorrect, and the product 
misbranded. FSIS would consider all circumstances before rescinding a 
label.

Executive Order 13175

    The policy discussed in this notice does not have Tribal 
Implications that preempt Tribal Law.

USDA Nondiscrimination Statement

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

Additional Public Notification

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

    Done at Washington, DC, August 8, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-19141 Filed 8-12-14; 8:45 am]
BILLING CODE 3410-DM-P