[Federal Register Volume 87, Number 222 (Friday, November 18, 2022)]
[Notices]
[Pages 69242-69249]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-25140]


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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2010-0023]


Expansion of FSIS Shiga Toxin-Producing Escherichia coli (STEC) 
Testing to Additional Raw Beef Products

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
that on February 1, 2023, the Agency will expand its routine 
verification testing for six Shiga toxin-producing Escherichia coli 
that are adulterants (non-O157 STEC; O26, O45, O103, O111, O121, or 
O145), in addition to the adulterant Escherichia coli (E. coli) 
O157:H7, to ground beef, bench trim, and other raw ground beef 
components in addition to raw beef manufacturing trimmings in official 
establishments. The raw ground beef components to be tested for these 
six non-O157 STEC, hereafter ``other raw ground beef components,'' are: 
head meat, cheek meat, weasand (esophagus) meat, product from advanced 
meat recovery (AMR) systems, partially defatted

[[Page 69243]]

chopped beef and partially defatted beef fatty tissue, low temperature 
rendered lean finely textured beef, and heart meat. Currently, FSIS 
tests only its beef manufacturing trimmings samples for these six non-
O157 STEC and E. coli O157:H7. Otherwise, all other raw beef products 
are tested only for E. coli O157:H7 and Salmonella. FSIS also will 
begin testing for these non-O157 STEC in ground beef samples that it 
collects at retail stores and in applicable samples it collects of 
imported raw beef products. Additionally, FSIS is responding to 
comments regarding the STEC testing expansion and the costs and 
benefits analysis (CBA), as well as its updated STEC laboratory testing 
criteria for determining whether a result is positive.

DATES: Beginning February 1, 2023, FSIS will implement routine 
verification testing for the six additional STECs discussed in this 
document (O26, O45, O103, O111, O121, and O145) in raw ground beef, 
bench trim, and other raw ground beef components. At this time, FSIS 
also will implement testing for these non-O157 STEC in ground beef 
samples that it collects at retail stores and in applicable samples it 
collects of imported raw beef products.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On June 4, 2020, FSIS announced in the Federal Register its plans 
to expand its routine verification testing for six non-O157 STEC (O26, 
O45, O103, O111, O121, or O145) that are adulterants in applicable raw 
beef products, in addition to the adulterant E. coli O157:H7, to ground 
beef, bench trim, and other raw ground beef components for samples 
collected at official establishments (85 FR 34397). FSIS also announced 
that it would test for these non-O157 STEC in ground beef samples that 
it collects at retail stores and in applicable samples it collects of 
imported raw beef products. FSIS stated that it would announce the date 
for implementation of the new testing in a subsequent Federal Register 
notice. Additionally, FSIS responded to comments on the November 19, 
2014, Federal Register notice titled, ``Shiga Toxin-Producing 
Escherichia coli (STEC) in Certain Raw Beef Products (79 FR 68843).'' 
FSIS also made available its updated CBA on the implementation of its 
non-O157 STEC testing on raw beef manufacturing trimmings and the costs 
and benefits associated with the expansion of its non-O157 STEC testing 
to ground beef, bench trim, and other raw ground beef components.\1\
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    \1\ The CBA is available at: https://www.fsis.usda.gov/sites/default/files/media_file/2020-07/FSIS-Non-0157-STEC-Testing-CBA-June-2020.pdf.
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Recent Changes to FSIS' Laboratory Testing Criteria for Determining 
Positives

    On April 16, 2021, FSIS announced in the Constituent Update changes 
to the laboratory testing criteria for E. coli O157:H7.\2\ FSIS 
explained that it had fully aligned the testing criteria for E. coli 
O157:H7 with that for non-O157 STEC. FSIS also explained that 
identifying specific bacterial genes associated with human illness is 
important for detecting STECs in food. Under the updated method, 
consistent with laboratory testing for non-O157 STEC, an E. coli 
O157:H7 isolate is confirmed positive if it has a stx gene, an eae 
gene, and is identified by the laboratory as O157. Further, under the 
new method, FSIS no longer performs H7 gene testing for certain O157:H7 
isolates. Harmonizing STEC laboratory testing creates a more efficient 
FSIS laboratory workflow where all regulated STECs are treated the same 
from initial laboratory screening to full isolate characterization. 
This update did not affect current FSIS laboratory protocols leading to 
the reporting of potential and presumptive positive results. To 
implement this change, FSIS updated the Microbiology Laboratory 
Guidebook (MLG) Chapter 5C, ``Detection, Isolation, and Identification 
of Top Seven Shiga Toxin-Producing Escherichia coli (STECs) from Meat 
Products and Carcass and Environmental Sponges,'' \3\ and began using 
the updated STEC method on samples received on or after May 17, 2021.
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    \2\ https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-april-16-2021.
    \3\ https://www.fsis.usda.gov/sites/default/files/media_file/2021-04/MLG-5C.01.pdf.
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    Aligning the criteria for identifying positives for the top seven 
STECs of public health interest does not affect FSIS' public health 
priorities, will not require establishments, or public health partners, 
or equivalent countries that ship beef to the United States to change 
their existing STEC laboratory methods that met the previous two 
separate STEC definitions, and may facilitate commercial test kit 
technology development.

Implementation

    Currently, the only raw beef products FSIS routinely tests for non-
O157 STEC are beef manufacturing trimmings. On February 1, 2023, FSIS 
plans to implement its expansion of its routine verification testing 
for the six non-O157 STEC that are adulterants to ground beef, bench 
trim, and other raw ground beef components for samples collected at 
official establishments. Once FSIS expands its non-O157 sampling to all 
raw beef products, for any positive results during routine verification 
testing, FSIS will conduct follow-up testing. FSIS will analyze all 
follow-up samples for all seven adulterant STEC and Salmonella.

Responses to Comments

    In response to a request from multiple industry associations for 
more time to submit comments on the June 4, 2020 Federal Register 
notice, FSIS extended the comment period by an additional 30 days to 
September 3, 2020.\4\ FSIS received 10 comments. Specifically, FSIS 
received comments from a small establishment owner and an industry 
organization opposed to the expanded testing; while a food industry 
group, a consumer group coalition, and a college organization supported 
the expansion of testing. A foreign country and a laboratory testing 
representative also commented on the proposal. Two comments were 
outside the scope of this document.
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    \4\ https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-june-19-2020.
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    In response to comments, FSIS added clarification on the new 
laboratory method, and a new table showing the additional cost of the 
expansion; but made no fundamental changes to the CBA. The Agency still 
plans to expand STEC testing to ground beef, bench trim, and other raw 
ground beef components. A summary of the issues raised by commenters 
and the Agency's responses follows.

Cost and Benefits Analysis

    Comment: An industry organization stated that the Agency did not 
adequately explain how it calculated an annual savings of $51.6 million 
from reduced non-O157 STEC outbreak-related recalls. Also, the 
commenter stated that the Agency did not provide data to support that 
the proposal will prevent two outbreak-related recalls per year 
because, according to the commenter, there were only a few non-O157 
STEC outbreak-related recalls before 2012 and they are still rare.
    The industry organization argued that FSIS' contention in the CBA 
that detection can prevent recalls does not include supporting data. 
According to the commenter, the Agency started

[[Page 69244]]

testing beef manufacturing trimmings for non-O157 STECs in 2012; 
therefore, FSIS should compare the number of non-O157 STEC outbreak 
related recalls before and after implementing this testing program to 
determine whether the theory has merit.
    Response: In the 2020 CBA, FSIS explained how it determined that 
the proposed policy was likely to prevent, on average, two recalls per 
year at an estimated cost of $25.6 million per recall. It described the 
reasoning in detail in section 3.b ``Benefits from reduced outbreak-
related recalls'' and section 4 ``Net benefit'' (pp. 19-23). FSIS 
clarified that the estimate was based on Public Health Information 
System (PHIS) data related to non-O157 STEC contamination and 
prevalence (i.e., Agency sampling data), not solely on the historical 
number of non-O157 STEC outbreak-related recalls.
    Before 2012, FSIS did not routinely test raw beef products for non-
O157 STEC, so it is not possible to make the proposed comparison 
between the number of recalls associated with beef products 
contaminated with non-O157 STEC versus recalls caused by E. coli 
O157:H7. The first non-O157 STEC investigation that led to a recall of 
ground beef product in the U.S. occurred in 2010. Once the Agency began 
testing for non-O157 STEC in raw beef manufacturing trimmings, the 
Agency prevented contaminated raw beef products from entering commerce. 
Beginning February 8, 2013, FSIS began to withhold its determination as 
to whether meat and poultry products are not adulterated, and thus 
eligible to enter commerce, until all test results that bear on the 
determination have been received (77 FR 73401). A substantial number of 
recalls (93 recalls) of raw beef products adulterated with STEC 
occurred between August 2012 and December 2020. Of these recalls 
approximately 20.0 percent (19 recalls) were caused by non-O157 STEC. 
Six of the 19 recalls were a result of outbreak investigations and 
seven were from routine FSIS verification testing. The remaining six 
recalls were results of: establishment-product testing (four), 
Agricultural Marketing Service (AMS) testing (one), and a notification 
from U.S. Food and Drug Administration (FDA) about contaminated flour 
used to produce a USDA regulated product (one).
    As is stated above, currently, the only raw beef products FSIS 
routinely tests for non-O157 STEC are beef manufacturing trimmings. 
However, of the 19 non-O157 STEC recalls, 15 of them involved raw non-
intact and ground beef products containing non-O157 STEC. Five of the 
15 beef products recalled occurred as a result of FSIS routine and 
follow-up sampling of beef manufacturing trimmings and follow-up 
sampling verification programs. FSIS may have detected the other ten if 
FSIS had sampled the product through a routine verification sampling 
project. Analysis of the Agency's historical testing data indicates 
that the number of beef manufacturing trimming samples positive for 
non-O157 STEC (0.71 percent) exceeded samples positive for E. coli 
O157:H7 (0.23 percent). Therefore, other beef samples subject to FSIS 
testing for E. coli O157:H7 may contain non-O157 STEC. As such, we 
believe it is reasonable to derive the estimate of prevented outbreak-
related recalls from the detected prevalence of the pathogen.
    Comment: An industry organization commented that the proposed 
expansion would not contribute to overall lower numbers of positive 
non-O157 test results. The commenter stated that there have been only 
two outbreaks of non-O157 STEC attributed to raw beef products since 
2006 that resulted in recalls. In the same timeframe, the commenter 
stated that there have been eight E. coli O157:H7 outbreaks. In 
addition, the commenter stated that from 2006 to present, there have 
been 129 recalls for O157, compared to 20 for non-O157 STEC. Finally, 
the commenter stated that the vast majority of recalls for STEC are not 
associated with illnesses, because the presence of the pathogen is only 
part of the equation. Virulence, consumer health, handling, and 
preparation all play a part.
    Response: The STEC pathogen must be present for an individual to 
show symptoms of the disease caused by that pathogen. FSIS has 
previously determined 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 STEC are adulterated within the meaning of 
21 U.S.C. 601(m)(1) (76 FR 58157; Sep. 20, 2011). Virulence, consumer 
health, handling, and preparation may play a part in causing illness, 
but the key point is that the pathogen must be present.
    Between August 2012 and December 2020 approximately 45 million 
pounds of contaminated raw beef products were prevented from entering 
commerce by FSIS because of STEC adulteration. Over this timeframe, 
FSIS tested a total of 167,073 raw beef samples for E. coli O157:H7 and 
220 (0.13 percent) of these samples were positive. Analysis of the data 
tested for O157:H7 and non-O157 STEC by FSIS between August 2012 and 
December 2020 showed that non-O157 STEC were more frequently recovered 
from verification beef manufacturing trimming samples.
    Specifically, FSIS tested 44,457 samples over the same timeframe as 
above. See table 1 below for the percent of positive samples for the 
different STEC.

       Table 1--Percent of Positive Samples in Various Serogroups
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                                                            Percent of
                        Serogroup                            positive
                                                              samples
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Non-O157................................................             .71
O103....................................................             .42
O157:H7.................................................             .23
O26.....................................................             .15
O111....................................................             .11
O145....................................................            .022
O45.....................................................            .020
O121....................................................            .016
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    FSIS raw beef verification testing has been effective in helping to 
protect the public by detecting E. coli O157:H7 and non-O157 STEC 
adulterants and preventing these products from entering commerce.
    As mentioned, in response to a previous comment, between August 
2012 and December 2020, there were 19 recalls of FSIS regulated 
products that were caused by adulteration of product by non-O157 STEC 
serogroups. These recalls show that non-O157 STEC can be present in 
products intended for commerce and represents a threat to public 
health.
    According to the CDC, the number of culture-confirmed illnesses 
caused by non-O157 STEC have increased, and outpaced illnesses caused 
by O157:H7 STEC.\5\ Surveillance data presented by the CDC revealed 
that the percentage change in incidence of STEC infections in 2019 
compared with the annual average incidence from 2016 to 2018 showed 
that O157:H7 decreased by 20 percent and non-O157 STEC increased by 35 
percent.
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    \5\ Ibid.
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    Comment: An industry organization commented that the CBA relies on 
the outdated 2013 Pathogen Controls in Beef Operations Survey to 
evaluate the potential costs from expanded industry sampling in 
response to the proposal. According to the commenter, this survey may 
not accurately represent industry sampling practices, and, therefore, 
costs to industry may be underestimated due to outdated data. The 
commenter stated that the Agency should conduct an updated survey, with 
specific questions related to the proposal, and update the CBA before

[[Page 69245]]

finalizing any changes to its STEC sampling program.
    Response: FSIS does not require industry testing for STEC. Under 
the Hazard Analysis and Critical Control Point (HACCP) regulations, the 
establishment is required to identify the intended use of the product 
(9 CFR 417.2(a)(2)), conduct the hazard analysis (9 CFR 417.2(a)), 
determine the hazard(s) reasonably likely to occur (9 CFR 417.2(a)(1)), 
and support the decision(s)made (9 CFR 417.5(a)(1)). Also, all 
establishments are required to conduct on-going verification activities 
to ensure that their HACCP plans are effectively implemented (9 CFR 
417.4(a)(2)). Establishments are required to conduct ongoing 
verification activities to ensure that any critical control point (CCP) 
is adequately addressing STEC, or that purchase specifications continue 
to prevent the pathogen from entering the facility. FSIS recommends 
that establishments' verification activities include testing for STEC 
(67 FR 62325, 62331).
    Lastly, the HACCP regulations in 9 CFR part 417 require that 
establishments validate the HACCP plan's adequacy to control the food 
safety hazards identified by the hazard analysis (9 CFR 417.4(a)). 
These regulations prescribe requirements for the initial validation of 
an establishment's HACCP plan and require that establishments ``conduct 
activities designed to determine that the HACCP plan is functioning as 
intended.'' Validation under 9 CFR 417.4(a)(1) requires that 
establishments assemble two types of data: (1) The scientific or 
technical support for the judgments made in designing the HACCP system, 
and (2) evidence derived from the HACCP plan in operation to 
demonstrate that the establishment is able to implement the critical 
operational parameters necessary to achieve the results documented in 
the scientific or technical support. Thus, validation of the HACCP 
system involves validation of the critical control points in the HACCP 
plan, as well as of any interventions or processes used to support 
decisions in the hazard analysis (80 FR 27557).
    In 2012, FSIS explained in a Federal Register notice (77 FR 31979) 
how E. coli O157:H7 results can be used for non-O157 STEC HACCP 
decision-making. FSIS considers controls for E. coli O157:H7 to be 
effective against non-O157 STEC when implemented appropriately (85 FR 
34397). How each establishment designs and supports their unique HACCP 
system can vary, and in-plant testing may or may not be conducted. When 
employed, testing can be conducted for different reasons, including to 
establish microbiological independence between lots, fulfill customer 
purchase specifications for specific products, validate HACCP controls, 
verify the HACCP system is functioning as intended, or other reasons. 
The frequency of sampling, products sampled, lot size, sampling method 
used, and laboratory testing methodology can vary from establishment to 
establishment based on the purpose sampling serves in each 
establishment's HACCP system.
    In 2013, FSIS conducted a survey of industry practices of STEC 
controls to evaluate the potential costs to industry of expanding 
sampling in response to the 2012 change. Since that survey in 2013, the 
above HACCP requirements have not changed, the Agency's method of 
verification has not changed, and the Agency's policy regarding the use 
of E. coli O157:H7 as an indicator for STEC has not changed. Though an 
establishment may conduct STEC testing for a variety of reasons as 
noted above, FSIS does not have reason to believe the data obtained in 
the 2013 survey is no longer reliable nor indicative (on the aggregate) 
of industry practices. Further, innovations in testing methodology have 
since occurred that can reduce the costs of STEC analysis (see Section 
of Recent Changes to FSIS' Laboratory Method (85 FR 34397, 34399)). If 
FSIS assumes establishments do not adopt these cost-saving innovations, 
the results of the 2013 survey remain valid for cost estimations.
    In response to the comments regarding the use of E. coli O157:H7 
testing results for non-O157 STEC decision-making, under HACCP, 
establishments may be able to support using a single STEC serogroup 
(e.g., E. coli O157:H7) as an ``indicator'' of all STEC as one 
component for demonstrating overall process control over STEC. If this 
approach is used, the decision-making for how E. coli O157:H7 results 
indicate control over non-O157 STEC is to be included in the hazard 
analysis and appropriately supported. Testing for E. coli O157:H7 as an 
indicator of STEC control may be acceptable for validation, 
verification, and process control because often the same controls 
address all STEC.
    However, as explained in the Federal Register notice referenced 
above, both E. coli O157:H7 and non-O157 STECs occur in raw beef at low 
levels and at low prevalence, and positive tests for these pathogens 
are not likely to be highly correlated. For this reason, testing for a 
single STEC serogroup alone cannot serve as an ``index'' organism for 
any other STEC, meaning an E. coli O157:H7 result alone does not 
provide direct evidence about the actual presence or absence of any 
other STEC serogroups in a specific lot. If an establishment produces 2 
lots of product from the same source material and if one lot is 
positive for a non-O157 STEC serogroup, then an E. coli O157:H7 
negative test in the second lot of product would not be sufficient to 
show microbiological independence even with additional process control 
information. Such microbiological independence determination would 
include consideration of numerous other factors, including 
commonalities in the source materials used, sanitation practices 
employed, antimicrobial interventions applied, any process control 
information, other sample results, and illness reports. E. coli O157:H7 
testing results alone are not sufficient evidence for microbiological 
independence following a non-O157 positive.
    In addressing corrective actions after a positive STEC result, FSIS 
personnel are to consider the impact one or more non-O157 STEC 
positives may have on the adequacy of the HACCP system to control STEC 
but should not automatically expect establishments to begin non-O157 
STEC testing. When a product tests positive for non-O157 STEC, it is 
important for the establishment to recognize that even though the E. 
coli O157:H7 results and other processing CCP records may indicate 
process control was maintained, identification of non-O157 STEC 
contamination in the production process questions whether design or 
implementation of the establishment's unique food safety system is 
sufficient to control STEC. In response to one or more non-O157 STEC 
positives, establishments must ensure any additional testing conducted 
includes non-O157 as part of the validation, verification, and 
reassessment requirements of 9 CFR 417.4 and supporting documentation 
requirements of 9 CFR 417.5(a)(1), until the establishment is able to 
demonstrate control over STEC in their unique HACCP system, or the 
HACCP system may be deemed inadequate (9 CFR 417.6). For example, it is 
particularly important in veal establishments to demonstrate control 
over STEC because FSIS data and other peer-reviewed research shows a 
higher incidence of

[[Page 69246]]

non-O157 STEC as compared to E. coli O157:H7.\6\
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    \6\ https://ask.usda.gov/s/article/When-an-establishment-only-conducts-product-testing-for-E-coli-what-factors-does-the-establi.
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    Comment: An industry organization stated that after FSIS starts 
testing for non-O157 STEC in additional raw beef products, AMS will 
likely similarly expand its purchase program requirements as it has 
done in the past in response to FSIS sampling programs, which could 
increase industry costs.
    Response: AMS has a Federal Purchase Program and vendors that 
choose to participate in that program must comply with AMS's 
requirements, including any testing requirements. The requirements of 
AMS's Federal Purchase Program are outside the scope of this Federal 
Register notice about FSIS' non-O157 STEC testing program.

Response to Positive Test Result

    Comment: An industry organization commented that the proposal 
should not affect practices that have proven successful in the 
industry's continued improvement on STEC control. These practices have 
predominantly applied to beef manufacturing trimmings but should be 
accepted for any additional products that FSIS samples and tests when 
it implements expanded testing.
    Response: If an establishment uses the same controls for STEC on 
beef manufacturing trimmings as it does on its other raw beef products, 
even if the other raw beef products were not slaughtered on-site, it 
should be able to support the decisions made in the use of such 
controls. How each establishment designs and supports their HACCP 
system may vary depending on the establishment and its hazard analysis, 
HACCP plan and the decisions made to support them.
    Comment: A consumer group and a college organization commented that 
they did not support the use of E. coli O157:H7 testing results for 
non-O157 STEC decision-making and encouraged FSIS to amend its 
instructions to inspection personnel to require establishment non-O157 
STEC testing to the same degree as E. coli O157:H7 testing. However, an 
industry organization's comments did support using E. coli O157:H7 
testing results for non-O157 STEC process control decision-making.
    Additionally, an industry organization commented that the Agency 
and industry must appropriately understand and respond to positive STEC 
results, regardless of the serovar.
    Response: FSIS does not require industry testing for STEC. Under 
the Hazard Analysis and Critical Control Point (HACCP) regulations, the 
establishment is required to identify the intended use (9 CFR 
417.2(a)(2)), conduct the hazard analysis (9 CFR 417.2(a)), determine 
the hazard(s) reasonably likely to occur (9 CFR 417.2(a)(1)), and 
support the decision(s)-made (9 CFR 417.5(a)(1)). To be clear: this 
notice announces the expansion of non-O157 STEC testing by FSIS when it 
conducts routine verification testing. It does not impose testing 
requirements on industry.
    As is stated above, FSIS considers controls for E. coli O157:H7 to 
be effective against non-O157 STEC when implemented appropriately (85 
FR 34397). As mentioned above, in 2012, FSIS explained in a Federal 
Register notice (77 FR 31979) how E. coli O157:H7 results can be used 
for non-O157 STEC HACCP decision-making.

International

    Comment: A foreign government questioned whether FSIS would provide 
a reasonable interval between the publication of the final Federal 
Register notice and when foreign countries would be required to 
implement new testing for non-O157 STEC.
    Response: After FSIS expands its non-O157 STEC verification 
sampling and testing, FSIS will require foreign countries that ship 
beef product to the United States to implement equivalent government 
verification testing for non-O157 STEC in the same products included in 
FSIS' new expanded verification testing program. FSIS acknowledges that 
foreign countries will need additional time to implement changes to 
their testing requirements and to provide applicable supporting 
documentation. FSIS will continue to use the existing equivalence 
process \7\ to ensure that foreign countries implement a government 
microbiological sampling and testing program equivalent to FSIS' 
verification testing program for raw beef products within a reasonable 
time period. In addition, FSIS will begin testing imported ground beef, 
bench trim, and other raw ground beef components for non-O157 STEC at 
the same time as FSIS implements its domestic non-O157 STEC testing 
program (i.e., on this notice's effective date).
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    \7\ https://www.fsis.usda.gov/inspection/import-export/equivalence.
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Test Only for Other Raw Ground Beef Components at Slaughter

    Comment: Two industry organizations commented that FSIS should only 
expand testing to other raw ground beef components produced in 
slaughter establishments because STEC are introduced, and therefore 
most effectively controlled, at slaughter. Also, conducting the testing 
at slaughter establishments allows establishments to identify positive 
product before it enters commerce. The commenters argued that testing 
other raw ground beef components for non-O157 STEC at slaughter would 
prevent recalls and allow establishments to address the underlying 
cause at the source.
    The commenters also stated that sampling and testing at further 
processing establishments makes it more difficult to identify the cause 
of the positive result and may increase the amount of product 
implicated in a recall. Also, according to the commenters, sampling 
ground beef does not provide feedback to either the processing 
establishments or slaughter establishments on process control. The 
commenters stated that the Agency should not include ground beef in the 
Agency's expanded non-O157 STEC testing.
    Also, one commenter disagreed with the Agency's argument that by 
sampling bench trim, the Agency is verifying the product is not 
adulterated before it is ground. The commenter argued that instead of 
sampling for non-O157 STEC, FSIS should consider verification tasks at 
grinding establishments to ensure they maintain effective programs, 
such as purchase specifications or validated antimicrobial 
interventions.
    Response: FSIS agrees that slaughter establishments are in the best 
position to prevent non-O157 STEC contamination because the 
introduction of the contaminant to the exterior surface of beef 
products can occur during the slaughter and dressing operation. 
However, processing establishments that receive product for grinding 
also have an important role in addressing non-O157 STEC. As explained 
above, the HACCP regulations require establishments to conduct a hazard 
analysis to determine the food safety hazards that are reasonably 
likely to occur in their processes and to identify the preventive 
measures they can apply to control those hazards in the production of 
particular products (see 9 CFR 417.2(a)). Consistent with the HACCP 
regulations, processing establishments can control or reduce non-O157 
STEC to below detectable levels by using preventive measures, including 
validated antimicrobial interventions. Processing establishments can 
also establish as a preventive measure a purchase specification that 
requires suppliers to provide source materials with no detectable STEC.

[[Page 69247]]

Processing establishments can then verify that these control measures 
are working as intended through their own product testing (see 67 FR 
62325).
    As stated earlier in the document, currently, the only raw beef 
products routinely tested for non-O157 STEC by the Agency are beef 
manufacturing trimmings, and beef manufacturing trimmings are produced 
at the slaughter establishment. However, of the 19 non-O157 STEC 
recalls, 15 of them were a result of raw non-intact and ground beef 
products containing non-O157 STEC. These 15 recalls support that 
expansion of routine non-O157 testing to other raw beef products, such 
as ground beef and other raw ground beef components, is necessary so 
that adulterated products do not reach the consumer.

Testing Based on Production Volume

    Comment: An industry organization commented that FSIS should 
conduct sampling and testing for non-O157 STEC in applicable product in 
all establishments, regardless of production volume, for at least one 
year, and then FSIS should evaluate the data to determine whether 
continued sampling is warranted. This approach would allow additional 
components to be tested for non-O157 STECs at all establishment sizes 
for all products used as components for ground beef.
    Response: Currently, per FSIS Directive 10,010.1, all 
establishments that produce raw beef products are subject to FSIS 
sampling and testing for STEC and Salmonella, regardless of 
establishment size. Consistent with the sampling frequency set in the 
directive, FSIS will sample each establishment that produces raw ground 
beef products at least three times per year. FSIS also samples 
establishments that produce bench trim, other raw ground beef 
components, or beef manufacturing trimmings at least once per year for 
each product. FSIS will continue to assess results and make necessary 
changes to its sampling and testing program. However, FSIS anticipates 
that it will continue this sampling and testing on an ongoing basis 
beyond one year of sampling and testing.

Testing Methods

    Comment: One individual commented that STEC testing is much more 
sensitive than E. coli O157:H7 testing. The commenter stated that the 
STEC test is a presence or absence test that will show positive results 
with just a couple of cells. The commenter also stated that test 
results showing low numbers for Aerobic Plate Count (APC) and generic 
E. coli would also test positive for STEC.
    Response: As discussed earlier in the document, FSIS updated its 
laboratory method in 2019 to use a single, combined workflow to screen 
samples for the presence of E. coli O157:H7 and the six non-O157 STEC 
that FSIS considers adulterants (O26, O45, O103, O111, O121, or O145). 
The technology used for screening samples allows all seven STEC 
serogroups to be screened identically. FSIS utilizes the following 
performance criteria and definitions when evaluating the suitability of 
an alternative laboratory method for a given analyte and sampling 
matrix pair: \8\
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    \8\ MLG 1.01- https://www.fsis.usda.gov/sites/default/files/media_file/2021-03/MLG-1.01_0.pdf.
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     Sensitivity of 90 percent or greater,
     Specificity of 90 percent or greater,
     Accuracy of 90 percent or greater,
     Positive Predictive Value of 90 percent or greater, and
     Negative Predictive Value of 90 percent or greater. FSIS' 
internal verification work during the selection of new technologies in 
2018 found a sensitivity of 92 percent in STEC samples inoculated with 
approximately 1 CFU in a 325g sample for that technology.\9\ The 
manufacturer determined the average limit of detection 
(LOD50) of the iQ-Check STEC VIrX and SerO II method was 0.7 
(range: 0.4-1.2) CFU/sample for O157 and other adulterant STEC.\10\ 
There is no difference in sensitivity for E. coli O157 and other non-
O157 adulterant STEC serogroups. Additional information for using this 
method may be found in Chapter 5C of the MLG and associated 
appendices.\11\
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    \9\ https://www.fsis.usda.gov/sites/default/files/media_file/2021-09/Molecular-Screen-Evaluation-2018-White-Paper.pdf.
    \10\ https://www.bio-rad.com/sites/default/files/2021-08/Bulletin_3213.pdf.
    \11\ https://www.fsis.usda.gov/sites/default/files/media_file/2021-04/MLG-5C.01.pdf.
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Testing Results

    Comment: An industry organization commented that follow-up sampling 
conducted by the Agency in response to an E. coli O157:H7 positive in 
products only subject to E. coli O157:H7 testing should continue to be 
tested for all STEC, but the results should not be included in baseline 
and routine verification data (prevalence). According to the commenter, 
the Agency also incorrectly included follow-up sampling as part of the 
aggregated prevalence data in the proposed expansion of products tested 
for STEC. The commenter noted that FSIS previously reported follow-up 
sampling independently from routine sampling data and, according to the 
commenter, should consistently do so moving forward. According to the 
commenter, follow-up samples should never be included in overall 
prevalence calculations of O157 or non-O157 STEC. According to the 
commenter, follow-up sampling is conducted in response to a positive 
sampling result, which may indicate issues with process control at that 
establishment and can therefore skew the data.
    Response: FSIS collects follow-up samples as a result of a positive 
from a routine verification sample. The purpose of scheduling these 
follow-up samples is to determine whether the establishment effectively 
addresses STEC. As mentioned above, once FSIS expands its non-O157 
sampling to all raw beef products, FSIS will analyze all follow-up 
samples for all 7 adulterant STEC and Salmonella. FSIS posts the 
follow-up sampling results separately on its website.
    When calculating prevalence, FSIS does not use follow-up sampling 
in its prevalence calculations. Also, FSIS does not typically use 
follow-up samples in its baseline studies.

Reallocating Resources

    Comment: Two organizations commented that the Agency should explain 
its reasoning for changing its allocation of resources for sampling 
STECs. According to the commenters, the Agency intends to sample once 
per week in higher volume establishments, a slight increase from four 
samples per month, by reallocating resources from lower-volume 
establishments. The commenters argued that the slight increase will 
likely not cause significant issues in high volume establishments, but 
there is not enough information about the reallocation to understand 
the potential impact of decreased sampling at lower volume 
establishments. The commenters argued that the shift in sampling may 
represent a significant reduction or elimination of sampling in lower 
volume establishments. According to the commenters, the data should be 
analyzed by volume to determine whether a decrease in sampling 
frequency at lower volume establishments will inhibit the Agency from 
identifying establishments that may have issues with STEC control.
    A college organization noted that diverting current testing 
resources from lower-volume establishments will result in extending the 
time required for determining establishment performance, potentially 
increasing the risk of contaminated products entering the marketplace. 
According to the commenter, until FSIS has demonstrated that 
reallocating samples

[[Page 69248]]

among beef processors will not negatively impact public health, the 
Agency should focus on requesting additional resources from Congress 
for sampling and laboratory testing. The commenter encouraged FSIS to 
consider how microbial distribution within a product and/or false-
positive test results may affect Agency verification results.
    Response: FSIS may address allocating resources for sampling in a 
future Federal Register document, but FSIS believes the Agency has 
sufficient resources to conduct sampling and testing for STEC, ensuring 
that the nation's commercial supply of raw beef products, whether 
domestic or imported, is safe, wholesome and unadulterated.
    After implementation, the Agency may adjust the numbers of samples 
collected and tested +/- by approximately 10 percent. FSIS has a set 
minimum sampling frequency for each establishment. FSIS will sample 
each establishment that produces raw ground beef products at least 
three times per year. FSIS also samples establishments that produce 
bench trim, other raw ground beef components, or beef manufacturing 
trimmings at least once per year for each product.

Sampling Methodology

    Comment: An industry organization noted that FSIS is evaluating 
alternatives to its sampling procedures (e.g., assessing sampling using 
a surface swabbing with a cloth vs. N60 incision sampling). According 
to the commenter, methodology often has a significant impact on 
baseline results, which are used to inform the public health decisions 
of local, state, and federal bodies and other private entities, and 
support Agency decisions. The commenter argued that the Agency should 
conduct a short-term, targeted baseline sampling program after a change 
in methodology and make the new information public with explanations. 
According to the commenter, this approach will help provide context to 
preclude public uncertainty if prevalence seemingly increases because 
the new methodology increases sensitivity and detectability.
    Additionally, the same commenter argued that potential changes to 
sampling methodology for pathogen sampling should be available for 
public comment. According to the commenter, the industry and other 
interested parties need time to consider impacts of the new methodology 
and provide information to the Agency to inform its decision-making. 
Also, an industry association and an individual commented that FSIS 
should continue to explore rapid and accurate methods to test for all 
pathogens of concern. One commenter encouraged FSIS to continue to work 
with industry and academia to develop rapid tests using the latest 
technology available to identify STEC and other pathogens in FSIS 
regulated products.
    Response: FSIS continues to update its laboratory criteria and 
posts changes to its laboratory method in the MLG Chapter 5C titled 
``Detection, Isolation, and Identification of Top Seven Shiga Toxin-
Producing Escherichia coli (STECs) from Meat Products and Carcass and 
Environmental.'' FSIS also usually announces these changes in the 
Constituent Update.
    FSIS recognizes the importance of keeping abreast of the latest 
scientific endeavors as well as its role in promoting research in areas 
important to the FSIS mission. FSIS food safety research priorities 
\12\ are presented as suggestions for researchers interested in 
pursuing food safety objectives that are relevant to FSIS regulated 
products. This list of research areas of interest may be useful to 
researchers who are preparing grants for submission to agencies that 
fund food safety research (e.g., USDA National Institute of Food and 
Agriculture (https://www.nifa.usda.gov), National Institutes of Health 
(https://www.nih.gov/), Grants.gov (https://www.grants.gov), or 
researchers with resources to conduct such research. In 2021 FSIS added 
a study titled, ``Develop a method to detect Shiga toxin-producing 
Escherichia coli (STEC) based on virulence factors,'' to the Food 
Safety Research Priority list.
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    \12\ https://www.fsis.usda.gov/science-data/research-priorities.
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    As mentioned in its June 4, 2020 Federal Register notice (85 FR 
34397), FSIS is conducting an in-field surface sampling study to 
determine the feasibility of a non-destructive surface sample 
collection method to collect raw beef manufacturing trimmings 
verification samples. FSIS will announce any changes to the sample 
collection method for the beef manufacturing trimmings project in a 
future Federal Register notice.

Data for Agency Policy

    Comment: An industry organization commented that FSIS should use 
relevant scientific data for Agency policy. Specifically, the 
aggregated data by calendar year publicly available on FSIS' website 
incorrectly includes sample results from multiple slaughter classes of 
cattle, different sampling categories, and is not appropriately 
stratified. In the aggregated data, the commenter stated that the 
Agency does not separate samples attributed to different slaughter 
classes of cattle, such as veal. The commenter stated that different 
slaughter classes of cattle have varying risks of O157 and non-O157 
STEC contamination, and FSIS should evaluate the risk of these 
different slaughter classes separately.
    Response: In the discussion regarding aggregated data, FSIS stated 
the sampling results from FSIS verification testing programs includes 
data from veal establishments and follow-up sampling results.\13\ Using 
aggregated sampling results is appropriate because FSIS is not 
proposing any changes to sampling allocations by slaughter class as 
part of the lab testing change. Therefore, the portion of samples 
collected from each slaughter class and the overall aggregate sampling 
is expected to remain consistent. The information showed that FSIS was 
finding non-O157 positive results in its verification sampling programs 
across all slaughter classes.
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    \13\ https://www.fsis.usda.gov/science-data/data-sets-visualizations/microbiology/microbiological-testing-program-escherichia-coli.
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USDA's Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, USDA, its 
Mission Areas, agencies, staff offices, employees, and institutions 
participating in or administering USDA programs are prohibited from 
discriminating based on race, color, national origin, religion, sex, 
gender identity (including gender expression), sexual orientation, 
disability, age, marital status, family/parental status, income derived 
from a public assistance program, political beliefs, or reprisal or 
retaliation for prior civil rights activity, in any program or activity 
conducted or funded by USDA (not all bases apply to all programs). 
Remedies and complaint filing deadlines vary by program or incident.
    Program information may be made available in languages other than 
English. Persons with disabilities who require alternative means of 
communication to obtain program information (e.g., Braille, large 
print, audiotape, American Sign Language) should contact the 
responsible Mission Area, agency, or staff office; the USDA TARGET 
Center at (202) 720-2600 (voice and TTY); or the Federal Relay Service 
at (800) 877-8339.
    To file a program discrimination complaint, a complainant should 
complete a Form AD-3027, USDA

[[Page 69249]]

Program Discrimination Complaint Form, which can be obtained online at 
https://www.ocio.usda.gov/document/ad-3027, from any USDA office, by 
calling (866) 632-9992, or by writing a letter addressed to USDA. The 
letter must contain the complainant's name, address, telephone number, 
and a written description of the alleged discriminatory action in 
sufficient detail to inform the Assistant Secretary for Civil Rights 
(ASCR) about the nature and date of an alleged civil rights violation. 
The completed AD-3027 form or letter must be submitted to USDA by:
    (1) Mail: U.S. Department of Agriculture, Office of the Assistant 
Secretary for Civil Rights, 1400 Independence Avenue SW, Washington, DC 
20250-9410; or
    (2) Fax: (833) 256-1665 or (202) 690-7442; or
    (3) Email: [email protected].
    USDA is an equal opportunity provider, employer, and lender.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication on-line through the FSIS web page located at: 
https://www.fsis.usda.gov/federal-register.
    FSIS will also announce and provide a link to it 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 
Constituent Update is available on the FSIS web page. Through 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 automatic and customized access to selected food 
safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to 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.
Paul Kiecker,
Administrator.
[FR Doc. 2022-25140 Filed 11-17-22; 8:45 am]
BILLING CODE 3410-DM-P