[Federal Register Volume 77, Number 105 (Thursday, May 31, 2012)]
[Rules and Regulations]
[Pages 31975-31981]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-13283]

Rules and Regulations
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Federal Register / Vol. 77, No. 105 / Thursday, May 31, 2012 / Rules 
and Regulations

[[Page 31975]]


Food Safety and Inspection Service

9 CFR Parts 416, 417, and 430

[Docket No. FSIS-2010-0023]

Shiga Toxin-Producing Escherichia coli in Certain Raw Beef 

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Response to comments on final determination; planned 
implementation for testing raw beef manufacturing trimmings.


SUMMARY: The Food Safety and Inspection Service (FSIS) is confirming 
that it will implement routine verification testing for six Shiga 
toxin-producing Escherichia coli (STEC), in addition to E. coli 
O157:H7, in raw beef manufacturing trimmings beginning June 4, 2012. 
FSIS is also responding to comments on the final determination 
published September 20, 2011, in the Federal Register regarding the 
June 4, 2012, implementation of STEC sampling and related issues.

DATES: Beginning June 4, 2012, FSIS will implement routine verification 
testing for the six additional STECs discussed in this document (O26, 
O45, O103, O111, O121, and O145), in raw beef manufacturing trimmings 
(domestic or imported) derived from cattle slaughtered on or after June 
4, 2012. To allow industry time to implement any appropriate changes in 
food safety systems, including control procedures in their processes, 
FSIS will generally not regard raw, non-intact beef products or the 
components of these products found to have these pathogens as 
adulterated until June 4, 2012. FSIS will announce in a future Federal 
Register document the date it intends to implement routine verification 
testing for the specified STECs in additional raw beef products tested 
by FSIS for E. coli O157:H7, including ground beef.

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



    On September 20, 2011, FSIS published a document in the Federal 
Register announcing its determination that raw, non-intact beef 
products, or raw, intact beef products that are intended for use in raw 
non-intact product, that are contaminated with Shiga toxin-producing 
Escherichia coli (STEC) O26, O45, O103, O111, O121, and O145 are 
adulterated within the meaning of 21 U.S.C. 601(m)(1) (76 FR 58157; 
Sep. 20, 2011). The products are adulterated because they contain a 
poisonous or deleterious substance that may render them injurious to 
health. FSIS stated that raw, non-intact beef products that are 
contaminated with these STEC are also unhealthful and unwholesome 
(under 21 U.S.C. 601(m)(1) and (m)(3)) (76 FR 58157 at 76 FR 58159). 
FSIS also considers intact cuts that are contaminated with these 
pathogens to be adulterated, unhealthful, and unfit for human food if 
they are to be further processed into raw, non-intact products before 
being distributed for consumption (76 FR 58157 at 76 FR 58159).
    FSIS announced that it intended to implement sampling and testing 
for the six non-O157 STEC, as it already does for E. coli O157:H7. The 
Agency said that it would begin this verification and testing program 
on March 5, 2012. The Agency noted that it would initially sample only 
raw beef manufacturing trimmings and other ground beef components for 
the six non-O157 STEC, but that it would consider other products, 
including raw ground beef contaminated with these STEC, to be 
adulterated (at 76 FR 58160). The Agency asked for comments on its 
plans for implementing the program (at 76 FR 58157, 58164).
    In addition, FSIS asked for comments on Agency plans for a baseline 
survey of the prevalence of the specified STEC in raw beef products, 
whether to hold technical or other public meetings, various cost 
estimates, the type of outreach and information that would be most 
useful to establishments preparing for implementation by the Agency of 
its sampling and verification testing program, and information that 
foreign governments might need to address inspection equivalency or 
implementation concerns.
    FSIS extended the public comment period from November 21, 2011, to 
December 21, 2011, and held a public meeting by teleconference on 
December 1, 2011. (76 FR 72331; Nov. 23, 2011).
    In response to comments received from industry, FSIS issued a 
Federal Register notice (77 FR 9888; Feb. 21, 2012) in which FSIS moved 
the implementation date to June 4, 2012, for routine verification 
activities, including testing, for the six specified STEC in raw beef 
manufacturing trimmings derived from cattle slaughtered on or after 
June 4, 2012. To allow establishments time to implement appropriate 
changes in their food safety systems, including changes in process 
control procedures, FSIS will generally not treat as adulterated raw 
beef products found to have these pathogens until June 4, 2012. 
Additionally, FSIS will begin conducting for-cause food safety 
assessments (FSAs) in response to FSIS positive non-O157 STEC results 
approximately 90 days after FSIS implements non-O157 STEC sampling and 
testing in beef manufacturing trimmings. This 90-day period will 
provide establishments sufficient time to make any necessary changes to 
their food safety systems.
    When FSIS laboratories analyze the samples, FSIS anticipates that 
there will be some samples that will, in the first stage of the FSIS 
screen test, test positive for Shiga toxin gene (stx) and for the 
intimin gene (eae) but screen negative for all the target O-groups 
(O26, O45, O103, O111, O121, and O145). Such samples will be referred 
to the USDA-Agricultural Research Service (ARS) for further 
microbiological analysis to determine whether they are positive for 
other target O-groups. FSIS expects to collect and analyze these screen 
results from its verification tests for at least the first year of 
testing. FSIS will not consider the product associated with non-
confirmed results to be adulterated. FSIS believes that the information 
on these screen results will be useful to establishments in enhancing 
the preventive controls in

[[Page 31976]]

their food safety systems and believes that establishments will benefit 
from knowing whether they have screen-positive but not confirmed sample 
results for E. coli O157:H7 or the specified non-O157 STECs. Therefore, 
FSIS is contemplating providing individual establishments with this 
information every quarter. In addition, FSIS expects to regularly make 
aggregate information known to stakeholders in order for stakeholders 
to be aware of and to consider the relevance of the information.
    FSIS, as a public health regulatory agency, has adopted a 
preventive, risk mitigation strategy that takes into consideration the 
fact that the specified STECs are adulterants of certain raw beef 
products. In support of this strategy, FSIS has finalized its risk 
profile to reflect comments, the results in a recent article on thermal 
resistance of STEC-inoculated non-intact beef steaks with strains of E. 
coli O157:H7 and non-O157 STEC (a pooled composite of STEC serogroups 
O45, O103, O111, O121, and O145) by USDA-ARS (Luchansky et al., 2012), 
and information from articles on how much more common non-O157 STEC 
infections are compared to E. coli O157:H7 infections (Blanco et al., 
2004; Elliott et al., 2001; Nielsen et al., 2006; Vally et al., 2012). 
The final risk profile is available on the FSIS Web site at http://www.fsis.usda.gov/Science/Risk_Assessments/index.asp
    In the September 20, 2011, Federal Register, FSIS also announced 
the availability of, and requested comments on, the guidance document, 
Validation Guidance for Pathogen Detection Test Kits. FSIS explained 
that the Agency prepared this guidance for the validation of test kits 
for the detection of pathogens, including both E. coli O157:H7 and non-
O157 STEC. FSIS encouraged organizations that design or conduct 
validation studies to avail themselves of this guidance document in 
meeting the pertinent regulatory requirements. FSIS received numerous 
comments on this document, will update it as necessary in response to 
comments, and will announce the availability of the updated guidance 
document when it is ready.

I. Implementation plan

    In finalizing the plan for implementing its verification 
activities, including the sampling and testing program for the 
specified STECs, FSIS considered all comments submitted in response to 
the September 2011 final determination, as well as comments provided at 
the December 1 teleconference, and is clarifying certain aspects of the 
implementation of the verification activities.
    FSIS will issue a Federal Register notice announcing when FSIS will 
begin routine sampling and testing for the seven STECs of all raw beef 
products subject to Agency E. coli O157:H7 sampling and testing, from 
both domestic and international sources, regardless of the slaughter 
date of cattle from which the product is derived. When expanded testing 
begins, mixtures of raw beef derived from cattle slaughtered either 
before or after June 4, 2012, whether the production lot contains raw 
beef manufacturing trimmings, other raw ground beef components, bench 
trim, or ground beef, will be subject to testing for the seven 
specified STECs.
    The Agency is updating the economic analysis published in the 
September 20, 2011, Federal Register notice in response to public 
comments received. To respond more thoroughly to the comments, FSIS 
will incorporate any additional data on establishment and Agency 
testing for the specified STECs that may be available upon FSIS's 
implementation of routine testing for non-O157 STECs in beef 
manufacturing trimmings. As indicated in the September 20 notice (at 76 
FR 58163), the Agency will update and revise the September 20, 2011, 
economic analysis, will respond to comments received on the earlier 
analysis, and will assess the economic effects of testing for the 
specified STECs on raw beef manufacturing trimmings, other raw ground 
beef components, and ground beef. When the Agency completes the updated 
analysis, FSIS will announce its availability and request comments on 
the analysis. The Agency will then assess comments and make any 
necessary changes before finalizing the economic analysis and before 
expanding FSIS testing to include other raw ground beef components and 
ground product.

II. Comments and Responses

    FSIS received approximately 34 comments in response to the 
September 2011 notice. Comments received from consumer groups supported 
the implementation of the final determination that six additional STEC 
serotypes are considered adulterants in non-intact raw beef products 
and intact beef products used to produce such products and encouraged 
FSIS to resist delaying the implementation date. Several consumer 
advocacy groups, citing the incidence of foodborne disease caused by 
these organisms, expressed support for FSIS's final determination. 
Comments submitted by industry, trade associations, and foreign 
countries expressed concerns about the final determination and 
implementation of the verification sampling and testing program.
    Following is a discussion of comments that requested more 
information or clarification regarding the verification testing program 
that will begin on June 4, 2012.

Delay Implementation

    Comment: Many commenters requested a delay of the implementation 
date for the testing of the specified STECs for various reasons, 
including their view that FSIS needs to conduct a baseline of non-O157 
STECs on beef products, needs to wait until commercially available test 
kits for these organisms become available and can be validated, needs 
to hold a technical meeting, and needs to conduct a risk assessment.
    Response: FSIS has concluded that a baseline is neither necessary 
nor warranted before implementation of the FSIS verification sampling 
and testing program. These organisms are present in beef products in 
the United States; the evidence for this is presented in the risk 
profile. FSIS considers the data on non-O157 STECs obtained by the 
Agricultural Research Service (ARS) at a limited number of slaughter 
establishments to be evidence that the pathogens should be considered 
adulterants and are capable of causing illness. FSIS also considered 
data collected by the person who petitioned the Agency to declare these 
pathogens to be adulterants in a limited geographical retail area. The 
Agency has concluded, on the basis of information in a report from the 
Centers for Disease Control and Prevention (CDC), that these organisms 
pose a significant public health burden in the United States.\1\ FSIS 
and the CDC believe that there are more unreported and unconfirmed 
illnesses associated with the specified non-O157 STECs than with E. 
coli O157:H7.

    \1\ Scallan E, Hoekstra RM, Angulo FJ, Tauxe RV, Widdowson M-A, 
Roy SL, Jones JL, and Griffin PM. 2011. Foodborne illness acquired 
in the United States--major pathogens. Emerg Infect Dis.

    Nonetheless, in 2013 FSIS intends to conduct the carcass baseline 
survey discussed in the September 20, 2011 Federal Register notice. 
This microbiological survey will analyze samples from carcasses for the 
presence of the pathogens E. coli O157:H7 and the specified STECs, 
Salmonella, and indicator bacteria (generic E. coli, coliforms, and 
Enterobacteriaceae). This baseline will be designed to identify the 
type, level, and frequency of

[[Page 31977]]

contamination of carcasses immediately after hide removal but before 
decontamination treatments and evisceration. When the baseline study is 
being developed, FSIS will share the study design with stakeholders.
    Regarding a baseline for raw beef manufacturing trimmings, other 
raw ground beef components, and ground beef, FSIS is assessing its 
current verification testing programs to see how those programs can be 
modified to yield on-going baseline information and obviate the need 
for stand-alone baseline studies.
    At this time, FSIS is not planning to host a technical meeting 
relating to non-O157 STEC. Commenters did not identify any specific 
need for a technical meeting. If there is evidence that a technical 
meeting would be helpful to industry, FSIS will, of course, reconsider 
this issue.
    Screening and confirmation methods for non-O157 STEC are available 
to industry. In addition, reagents are commercially available to those 
companies planning to use the FSIS method. Some establishments have 
been testing for non-O157 STECs for a year or more.
    Several companies have submitted test kits to detect at least the 
six specified STEC O-groups for review by validation bodies. Using the 
FSIS compliance guidelines related to validating test kits, FSIS has 
reviewed validation data from test kits and issued no-objection-letters 
(NOLs) to several manufacturers. The NOLs provide establishments with 
supporting documentation regarding the reliability of verification 
testing results. Confirmation testing is available to industry through 
commercial reagents.
    Regarding the contention that a risk assessment is needed, the 
Agency has assessed scientific data from several fields on the risk 
posed by non-O157 STECs and determined that these pathogens are 
adulterants under the FMIA. To make this determination, the Agency 
prepared a risk profile, which has been independently peer reviewed in 
accordance with Office of Management and Budget (OMB) guidelines. Both, 
the CDC and the Food and Drug Administration (FDA)/Center for Food 
Safety and Applied Nutrition reviewed the document and provided input 
on FSIS' approach. The risk profile lays out all available information 
on the public health concerns posed by these organisms and supports the 
adulteration determination regarding these E. coli serogroups.

FSIS Sampling Plan

    Comment: Several commenters stated that FSIS has not adequately 
justified the initiation of the non-O157 STEC sampling program, given 
that non-O157 STECs are found at levels comparable to E. coli O157:H7, 
and infection from the non-O157 STEC tends to be less severe than that 
from E. coli O157:H7. One commenter questioned whether FSIS's testing 
program will be adequate for determining process control and stated 
that FSIS's end-product testing will have no impact other than to 
consume resources that could be better spent on food safety research.
    Response: The FSIS verification testing program is intended to 
assess whether the industry, collectively, is controlling for the 
presence of a designated food safety hazard in products regulated by 
FSIS. Adding the six non-O157 STECs to the group of pathogens for which 
FSIS tests will help in improving food safety. The purpose of the new 
testing program for non-O157 STECs is to verify that establishments 
producing raw beef products have adequately addressed these pathogens.
    FSIS acknowledges that the best approach to reducing STEC 
contamination lies not in comprehensive end-product testing but in the 
development and implementation of science-based preventive controls, 
with end-product testing to verify process control. FSIS's non-O157 
STEC testing program will improve food safety because FSIS anticipates 
that establishments may voluntarily make changes to their food safety 
systems in response to the new testing. For example, establishments may 
initiate a testing program for non-O157 STECs or may add new 
interventions to address pathogens. FSIS is aware that some companies 
have added new bacteriophage interventions to address non-O157 STEC. 
FSIS is not requiring such changes but anticipates establishments may 
make these types of changes in response to the testing.
    The non-O157 STECs may cause illnesses of varying severity. Though 
limited data are available on dose-response, there is evidence that the 
infectious doses of the pathogens are relatively low. Hence, their 
potential to cause illness is relatively high. Although there is 
variability in virulence severity of non-O157 STECs, the six specified 
non-O157 STEC organisms can cause severe foodborne illness requiring 
hospitalization. Numerous illnesses in the United States have resulted 
from all six of the non-O157 STECs. CDC data show that the six STEC 
organisms for which FSIS will be testing are known to cause more than 
80 percent of human illnesses attributed to non-O157 STEC.
    The number of illnesses and deaths caused by non-O157 STECs and 
associated with beef consumption or a beef source is likely to decline 
if establishments voluntarily make changes to their food safety system 
that result in greater public health protection. Also, FSIS's current 
testing for E. coli O157:H7 may not detect other STECs that may be 
present in the product.
    Comment: One industry commenter asked whether FSIS intends to 
collect two samples for N-60 sampling, and if so, would E. coli O157:H7 
testing be performed on one sample and non-O157 STEC testing on the 
other sample. Another commenter noted that FSIS does not specify the 
number of samples it intends to collect in the sampling plan.
    Response: FSIS inspection personnel will collect one N-60 sample 
(in multiple containers) that will be tested for all the STECs, 
including E. coli O157:H7. Eventually, FSIS will analyze all the raw 
beef samples collected for both E. coli O157:H7 and non-O157 STEC.
    Comment: Several commenters stated that FSIS's sampling plan should 
be designed to estimate prevalence of the STEC pathogens in raw beef 
    Response: FSIS verification testing programs are not designed at 
this time to assess statistically-based national prevalence for select 
organisms. FSIS verification testing assesses establishment control of 
a food safety hazard in products regulated by FSIS. The number of tests 
FSIS will annually conduct for non-O157 STECs will exceed the number 
typically analyzed in a structured baseline. Although FSIS's testing 
will not provide a true prevalence estimate upon implementation, it 
will provide helpful information about whether establishments' food 
safety systems adequately address food safety.
    Comment: One commenter asked how FSIS intends to increase its 
collection rates for its beef manufacturing trimmings testing program.
    Response: The Agency has a number of different initiatives underway 
to increase its collection rates for the beef manufacturing trimmings 
testing programs. Importantly, the new Public Health Information System 
(PHIS), which is now implemented nationwide, can schedule samples for 
laboratory analysis. PHIS does so in a way that ensures that requests 
are sent only to establishments whose profiles (information on 

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characteristics) indicate that they are producing the targeted product 
at the time of sample scheduling. In addition, if an establishment no 
longer makes the product, PHIS allows inspection program personnel to 
modify the establishment profile (information on establishment 
characteristics) to reflect this change so that future samples are not 
scheduled for that establishment.

FSIS Testing Method

    Comment: One association questioned whether the FSIS method 
published in the Microbiology Laboratory Guidebook (MLG) on November 4, 
2011, was appropriately peer-reviewed. Commenters questioned whether 
industry is required to test for non-O157 STECs, and whether industry 
would be required to use the FSIS method.
    Response: Initial results from the method-development phase were 
published in a peer-reviewed journal with ARS and FSIS authors.\2\ The 
MLG method was validated and then verified for internal use by FSIS 
Laboratory Services. In addition, when designing the screening and 
confirmatory strategy for the regulatory test, FSIS sought input from 
the CDC, ARS, and the FDA and worked closely with ARS in transferring 
the method to use in the FSIS laboratories.

    \2\ Fratamico, P.M., Bagi, L.K., Cray Jr, W.C., Narang, N., 
Medina, M.B., Liu, Y. Detection by multiplex real-time PCR assays 
and isolation of Shiga toxin-producing Escherichia coli serogroups 
O26, O45, O103, O111, O121, and O145 in ground beef. Foodborne 
Pathogens and Disease 2011; 8(5):601-7.

    FSIS is not requiring STEC testing by industry, nor will it 
establish a requirement for the FSIS testing methodology to be used. 
Also, foreign government central competent authorities and foreign 
establishments can determine what testing to conduct and can use any 
test that they determine is sufficient to identify the presence of the 
specified STECs. As with the domestic beef establishments, foreign 
government central competent authorities and foreign establishments are 
expected to ensure that raw beef product is controlled for the presence 
of the specified non-O157 STECs.
    Comment: One commenter asked whether the most-probable-number (MPN) 
enumeration was included in the FSIS method.
    Response: No, the FSIS MLG method 5B.01 as described does not 
include an MPN method for enumerating non-O157 STEC in positive 
    Comment: Several commenters questioned the Agency's statement 
referring to expected establishment actions following stx- or eae-
positive first-stage screen results (at 76 FR 58161, col. 3): ``A 
first-stage screen positive (stx and eae) is evidence of the presence 
of Shiga toxin and intimin and may indicate that an establishment is 
not adequately addressing hazards reasonably likely to occur. 
Establishments should reassess their HACCP plans, Sanitation Standard 
Operating Procedures, or other prerequisite programs on the basis of 
this evidence.'' Commenters were concerned that an establishment would 
be required to reassess its Hazard Analysis and Critical Control Point 
(HACCP) plan after such results.
    Response: The Agency regrets any confusion that this statement 
created. The first- and second-stage screening steps of the FSIS method 
are performed concurrently, not sequentially. Establishments are not 
required to take corrective actions or reassess their HACCP plans in 
response to positive FSIS screen results. However, establishments would 
be required to take corrective actions or reassess their HACCP plans in 
response to FSIS confirmed positive results for the specified non-O157 
    Some establishments may use the FSIS laboratory method or another 
method that could indicate the presence of stx or eae genes or the 
presence of one of the relevant ``O'' subgroups. Such screen-positive 
results indicate the presence of an organism capable of causing 
illness. If an establishment does not perform additional testing, it 
should treat lots that test positive in screen tests as positive. 
Similarly, FSIS will consider those results positive for non-O157 STEC 
if not confirmed negative. This is consistent with how FSIS regards 
positive E. coli O157:H7 screen results.
    Therefore, if an establishment finds product positive for any of 
the specified non-O157 STECs in screen testing, does not confirm the 
finding as negative, and has not addressed the hazard in its HACCP 
system, the establishment would be required to take corrective actions, 
including reassessing its HACCP plan (9 CFR 417.3).
    Comment: Commenters stated that a large number of samples will 
screen positive using the screening method described in MLG 5B.01. 
Commenters also stated that the isolation and confirmation process 
takes a long time to complete and that producers cannot hold fresh 
product pending the completion of isolation and confirmation described 
in the MLG 5B.01.
    Response: FSIS does not agree with these assertions. Based on 
available data, FSIS estimates that 2 percent of raw beef samples 
tested using the FSIS method would test positive for non-O157 STEC in 
screen tests, with a significantly lower percentage being confirmed. 
This is comparable to what FSIS has found with the FSIS screening 
method for E. coli O157:H7. The amount of time to obtain a confirmation 
result from the new FSIS non-O157 STEC method is the same as that for 
the current E. coli O157:H7 method. The reagents for the FSIS test 
method, including the confirmation method, are commercially available 
to industry.

Establishment Testing

    Comment: One commenter asked whether, if an establishment only 
tested for stx (Shiga toxin) and eae (intimin) genes using a 
polymerase-chain-reaction (PCR) screening test, and the sample tested 
negative, FSIS would accept this result as negative for E. coli O157:H7 
and the specified non-O157 STECs.
    Response: FSIS would accept as negative for E. coli O157:H7 and the 
specified non-O157 STECs a sample that tests negative for eae and stx 
on a screening test performed by an establishment.
    FSIS recognizes that industry uses non-culture methods that detect 
alternative target analytes for E. coli O157:H7 including, but not 
limited to, eae and stx. An establishment may increase the likelihood 
of detecting all hypothetical strains and low-levels of contamination 
with these pathogens in a variety of ways, including but not limited to 
using a test method that is also used by a regulatory body, or that is 
validated and certified by an independent body (e.g., AOAC 
International, the French Association for Standardization (AFNOR), the 
European organization for the validation and certification of 
alternative methods for the microbiological analysis of food and 
beverages (MicroVal), or the Nordic system for validation of 
alternative microbiological methods (NordVal)). An establishment may 
also opt to use a test method for detecting the specified STECs that is 
subjected to a robust validation using the FSIS cultural method as a 
reference. In this case, a test kit manufacturer may choose to ask the 
Agency through AskFSIS to review the method. If the method is found to 
be adequate, FSIS will issue a NOL to the test kit manufacturer for 
filing with the establishment.
    Comment: A law firm representing beef industry clients asked 
whether, during the transition period (until June 4, 2012), when 
establishments are ``beta testing'' STEC analytical methods and 
possibly refining their food safety

[[Page 31979]]

system, a stage-one positive test result would be considered positive.
    Response: No, after the June 4 implementation date for the FSIS 
verification testing program, positive ``beta tests'' will not be 
considered by FSIS to be conclusive evidence that one or more specified 
STECs is present in the sample. However, if product from the 
establishment is associated with a non-O157 STEC outbreak, FSIS will 
take steps to ensure that associated product is removed from commerce 
and will expect the establishment to take corrective actions, including 
reassessment of its HACCP plan, if necessary, to prevent a recurrence 
of this food safety hazard.
    FSIS encourages establishments to maintain records from ``beta 
testing'' as part of the documentation of the development of their food 
safety systems. Establishments may use these records to show the 
controls they have in place and the disposition of their products.
    Comment: An industry commenter asked where industry can obtain the 
non-O157 STEC strains for testing purposes.
    Response: Non-O157 STEC strains may be obtained from public 
collections, including the STEC collection at Michigan State 
University, the E. coli Center at Penn State University, the American 
Type Culture Collection in Manassas, Virginia, and at other locations.
    Comment: One trade association asked whether E. coli O157:H7 could 
be used as both an indicator and an index organism for non-O157 STEC in 
beef production.
    Response: If source materials are sampled at a sufficiently high 
frequency and in a consistent manner, test results for the presence of 
E. coli O157:H7 or non-O157 STEC can serve as indicators of process 
control during beef production. In fact, in data \3\ from inspection 
personnel at the top 33 (by volume) beef slaughter establishments, 60 
percent of establishments had defined high-event periods when the 
establishments could discern subtle changes in the percent-positive 
screening test results as evidence of a process out of control. FSIS 
believes that the screening tests that the industry has been using are 
capable of indicating the presence of more than just E. coli O157:H7.

    \3\ To help develop the operational criteria for industry to use 
to identify high-event periods and for Enforcement, Investigations, 
and Analysis Officers 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 

    Because both E. coli O157:H7 and non-O157 STECs occur in raw beef 
at low levels and at low prevalence, however, positive tests for these 
pathogens are not likely to be highly correlated. Therefore, neither E. 
coli O157:H7 nor non-O157 STEC are expected to provide reliable index 
measurements. An index organism is one whose concentration or frequency 
correlates with the concentration or frequency of another organism.

FSIS-Recommended Cooking Temperatures

    Comment: One commenter stated that if STECs can survive 
``ordinary'' or ``typical'' cooking, FSIS should reconsider its cooking 
temperature recommendations. Another commenter stated that there is 
insufficient data regarding heat tolerance of non-O157 STECs.
    Response: FSIS's temperature recommendation for consumers to cook 
ground beef to 160 degrees Fahrenheit is adequate to achieve a safe 
product. There is no reason to believe that a higher temperature is 
necessary (http://www.fsis.usda.gov/Fact_Sheets/Ground_Beef_and_Food_Safety/index.asp). However, FSIS is well aware that some 
consumers ordinarily or typically do not cook ground beef to 160 
degrees Fahrenheit, in spite of the extensive outreach and education 
efforts conducted by the Agency and its public health partners to 
change behaviors.\4\ In addition, FSIS believes that most consumers do 
not use a thermometer to confirm the end-point temperature for safety. 
Consequently, the handling and preparation practices of many consumers 
are not ``ordinarily'' or ``typically'' capable of rendering the cooked 
ground beef safe without further risk mitigation.

    \4\ Ecosure. 2007 U.S. Cold Temperature Evaluation. October 15, 

    The September 20, 2011, Federal Register notice cited the August 
2010 STEC O26 outbreak and other evidence (at 76 FR 58159--Luchansky et 
al., published in 74 J. Food Prot. (2011)7:1054-1064) that demonstrates 
that the strain survives ``typical'' cooking employed by some 
consumers, and that further risk mitigation was necessary. Researchers 
at USDA-ARS examined the effect of various cooking temperatures on 
strains of five serogroups (O45, O103, O111, O121, and O145) and E. 
coli O157:H7 inoculated into beef steaks that were then tenderized. 
Results show that the non-O157 STECs exhibited thermal inactivation 
similar to that for E. coli O157:H7.\5\ In another study (Duffy et al., 
2006), STEC O26 also showed similar thermal tolerance to E. coli 

    \5\ Luchansky J.B., Shoyer B.A., Call J., Schlosser W., Shaw W., 
Bauer N., Latimer H., Porto-Fett A. 2012. Fate of Shiga-toxin 
producing O157:H7 and non-O157:H7 Escherichia coli cells within 
blade-tenderized beef steaks after cooking on a commercial open-
flame gas grill. Journal of Food Protection. 75:62-70.

Equivalency and Implementation Concerns of Foreign Governments

    Comment: Several commenters noted that the September 20, 2011, 
Federal Register notice states (at 76 FR 58161, col. 1-2): ``For 
imported products tested at port of entry, if the product tests 
positive at the second stage and has not been held at the import 
establishment, it will be subject to recall. If the product has been 
held, the product will be refused entry. As always, product 
subsequently presented for import inspection from the same foreign 
country and establishment will be held at the official import 
establishment pending results.'' These commenters asked whether FSIS 
intended to treat imported product tested for non-O157 STEC differently 
from such product tested for E. coli O157:H7.
    Several trade associations and foreign governments addressed 
various topics relating to the treatment of imported products at port 
of entry, the equivalency of foreign inspection systems, and United 
States obligations under World Trade Organization agreements. 
Governments and industry trade groups expressed concern that the new 
non-O157 STEC policy may violate the United States' obligations under 
the Agreement on Sanitary and Phytosanitary (SPS) Measures. Finally, 
governments and trade associations questioned the adequacy of the FSIS 
risk profile with respect to how it addresses characteristics of non-
O157 STEC.
    Response: Consistent with FSIS's procedures for testing for E. coli 
O157:H7 in imported product, if a product offered for import tests 
positive at port of entry for non-O157 STEC in the screen test and has 
not been held at the import establishment, it will not be subject to 
recall. However, if the product is still at the import establishment, 
FSIS will retain the product until it is confirmed negative.
    If the product is confirmed positive and has been held by the 
establishment or retained by FSIS at the import establishment, FSIS 
will refuse entry of the product. If the confirmed-positive product has 
not been held at the import

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establishment, FSIS will request that the importer of record recall the 
    FSIS has notified its trading partners about the new non-O157 STEC 
testing policy. The Agency has committed to video conferencing and 
teleconferencing exchanges to assist foreign governments in 
understanding the policy and how it applies to them. The Agency expects 
countries that export products to the United States to address non-O157 
STEC under existing agreements and to prevent contamination of their 
raw beef products with these adulterants. Foreign countries may use any 
method that will ensure, with reasonable confidence, that products that 
they export to the United States will not be contaminated with 
detectable non-O157 STEC. Because of the nature of non-O157 STECs, FSIS 
would not exclude any country importing product subject to testing from 
non-O157 STEC verification testing by FSIS.
    Finally, the Agency has assessed scientific data from several 
fields on the risk posed by non-O157 STECs and determined that these 
pathogens are adulterants under the FMIA. To make this determination, 
the Agency prepared a risk profile, which has been independently peer-
reviewed in accordance with Office of Management and Budget (OMB) 
guidelines. Both CDC and FDA reviewed the document and supported FSIS's 
    The risk profile, in its final version, incorporates CDC data that 
show that the organisms for which FSIS will be testing are known to 
cause more than 80 percent of human illnesses attributable to non-O157 
STECs in the United States.
    In addition, FSIS refined the risk profile substantially in 
response to comments that were received during peer review. 
Accordingly, the risk profile represents the best characterization of 
the science associated with the risk from the specified non-O157 STECs.
    One commenter raised a concern about the attribution of a non-O157 
STEC outbreak in 2007 to a beef product. This outbreak was included in 
the risk profile.
    CDC has information, including a May 21, 2010, memo, stating that, 
``The preliminary data in the table were obtained primarily from 
reports voluntarily made by state health departments to CDC. In 2010, 
we supplemented NORS [National Outbreak Reporting System] data from the 
on non-O157 STEC outbreaks by contacting state and federal health 
agencies, by reviewing the scientific literature, and by other 
methods.'' The data reported in the memo may be more complete than the 
data submitted by the reporting agency to the Foodborne Disease 
Outbreak Surveillance System (FDOSS), which is a component of NORS. In 
the memo, CDC listed the confirmed or suspected vehicle for this 
outbreak as ground beef. This was based on a posting on the North 
Dakota State Health Department Web site.
    FSIS recognizes that the availability of attribution data for the 
non-O157 STECs is partially a function of the number of clinical 
laboratories that test for the pathogens, as well as of the robustness 
of epidemiological investigations. In this case, however, the only 
available information suggests that the non-O157 STEC outbreak may have 
been linked to a beef product.

Summary of Changes and Clarifications Made in Response to Comments

    As noted earlier in this document, in response to comments on the 
September 20, 2011, notice (76 FR 58157), FSIS extended the public 
comment period from November 21, 2011, to December 21, 2011 (76 FR 
72331; Nov. 23, 2011). Also in response to public comments, FSIS held a 
technical meeting December 1, 2011, to solicit additional comments. 
FSIS later moved the implementation date of the non-O157 STEC 
verification policy for beef manufacturing trimmings to June 4, 2012 
(77 FR 9888; Feb. 21, 2012). The purpose of the delay in implementation 
was to allow the regulated establishments time to effect any necessary 
changes in their food safety systems, including process control 
procedures, and to allow time for improvements in testing methods.
    In addition, in response to comments, the Agency made available to 
foreign governments reagents used in the FSIS method. To allay other 
concerns of foreign governments, the Agency affirmed that it would 
treat incoming foreign product in the same way that it treats such 
product FSIS tests for E. coli O157:H7.
    On the matter of using indicator organisms, FSIS has affirmed that 
testing of source materials of raw, non-intact beef products for STEC 
to verify process controls can be effective if the materials are 
sampled at sufficiently high frequencies. However, FSIS has clarified 
that E. coli O157:H7 is not an index organism for non-O157 STEC.
    In response to questions, FSIS has clarified that establishments 
are not required to take corrective actions in response to FSIS screen 
positive results. However, FSIS has also clarified that if 
establishments find product positive for non-O157 STECs in their screen 
tests and do not conduct further testing to confirm that the product is 
negative, FSIS will consider the product positive for non-O157 STECs, 
just as FSIS considers product that screens positive for E. coli 
O157:H7 to be positive if an establishment does not conduct further 
    Finally, the Agency has finalized the risk profile on the non-O157 
STECs and has incorporated relevant information conveyed by commenters.

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

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce it on-line 
through the FSIS Web page located at--http://www.fsis.usda.gov/regulations_&_policies/Interim_&_Final_Rules/index.asp.
    FSIS also will 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 our constituents and 
stakeholders. The Update is communicated via Listserv, a free email 
subscription service consisting of industry, trade, and farm groups, 
consumer interest groups, allied health professionals, scientific 
professionals, and other individuals who have requested to be included. 
The Update also is available on the FSIS Web page. Through Listserv and 
the Web page, FSIS is able to provide information to a much broader, 
more diverse audience. In addition, FSIS offers an email subscription 
service which provides

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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, 
export information, regulations, directives, and notices. Customers can 
add or delete subscriptions themselves, and have the option to 
password-protect their accounts.

    Done at Washington, DC, May 25, 2012.
Alfred V. Almanza,
[FR Doc. 2012-13283 Filed 5-29-12; 4:15 pm]