[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