[Federal Register Volume 85, Number 108 (Thursday, June 4, 2020)]
[Notices]
[Pages 34397-34402]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2020-12073]


 ========================================================================
 Notices
                                                 Federal Register
 ________________________________________________________________________
 
 This section of the FEDERAL REGISTER contains documents other than rules 
 or proposed rules that are applicable to the public. Notices of hearings 
 and investigations, committee meetings, agency decisions and rulings, 
 delegations of authority, filing of petitions and applications and agency 
 statements of organization and functions are examples of documents 
 appearing in this section.
 
 ========================================================================
 

  Federal Register / Vol. 85, No. 108 / Thursday, June 4, 2020 / 
Notices  

[[Page 34397]]



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 and request for comments.

-----------------------------------------------------------------------

SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
plans to expand its routine verification testing for six Shiga toxin-
producing Escherichia coli (non-O157 STEC; O26, O45, O103, O111, O121, 
or O145) that are adulterants, in addition to the adulterant 
Escherichia coli (E. coli) O157:H7, to ground beef, bench trim, and raw 
ground beef components other than raw beef manufacturing trimmings 
(i.e., head meat, cheek meat, weasand (esophagus) meat, product from 
advanced meat recovery (AMR) systems, partially defatted chopped beef 
and partially defatted beef fatty tissue, low temperature rendered lean 
finely textured beef, and heart meat)(hereafter ``other raw ground beef 
components'') for samples collected at official establishments. STEC 
includes non-O157 STEC; O26, O45, O103, O111, O121, or O145, that are 
adulterants, and E. coli O157:H7. Currently, FSIS tests only its beef 
manufacturing trimmings samples for these six non-O157 STEC and E. coli 
O157:H7; all other aforementioned raw beef products are presently 
tested for E. coli O157:H7 only. FSIS also intends to 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 is requesting comments on the proposed sampling and testing of 
ground beef, bench trim, and other raw ground beef components. FSIS 
will announce the date it will implement the new testing in a 
subsequent Federal Register notice.
    Additionally, FSIS is responding to comments on the November 19, 
2014, Federal Register notice titled ``Shiga Toxin-Producing 
Escherichia coli (STEC) in Certain Raw Beef Products.'' FSIS is also 
making available its updated analysis of the estimated costs and 
benefits associated with 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 (https://www.fsis.usda.gov/wps/wcm/connect/c37a7129-639c-41fa-ab75-be6dddcd1c44/placeholder-link?MOD=AJPERES&useDefaultText=0&useDefaultDesc=0).

DATES: Submit comments on or before August 3, 2020.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by one of the following methods:
     Federal eRulemaking Portal: This website provides 
commenters the ability to type short comments directly into the comment 
field on the web page or to attach a file for lengthier comments. Go to 
http://www.regulations.gov. Follow the on-line instructions at that 
site for submitting comments.
     Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S. 
Department of Agriculture, Food Safety and Inspection Service, 1400 
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
     Hand- or Courier-Delivered Submittals: Deliver to 1400 
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2010-0023. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to http://www.regulations.gov.
    Docket: For access to background documents or comments received, 
call (202)720-5627 to schedule a time to visit the FSIS Docket Room at 
1400 Independence Avenue SW, Room 6065, Washington, DC 20250-3700.

FOR FURTHER INFORMATION CONTACT: Rachel Edelstein, Acting Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 720-0399.

SUPPLEMENTARY INFORMATION: 

Background

    On September 20, 2011, FSIS announced in the Federal Register, its 
determination that raw, non-intact beef products and raw, intact beef 
products that are intended for use in raw, non-intact beef products 
contaminated with non-O157 STEC (O26, O45, O103, O111, O121, or O145) 
are adulterated under the Federal Meat Inspection Act (21 U.S.C. 
601(m)(1)) because they bear or contain a deleterious substance that 
may be injurious to health (76 FR 58157). In support of this 
determination, the Agency cited evidence of these non-O157 STEC 
organisms' high pathogenicity, low infectious dose, transmissibility 
from person to person, and thermal resistance high enough to survive 
ordinary cooking (76 FR 58157, 58158-58159). FSIS also stated that raw, 
non-intact beef products and raw, intact beef products that are 
intended for use in raw, non-intact beef products, contaminated with 
non-O157 STEC are adulterated because they are unhealthful and 
unwholesome (21 U.S.C. 601(m)(3)) (76 FR 58157, 58159). FSIS also 
included information on when the Agency considers an isolate to be 
``confirmed positive for non-O157 STEC,'' which is when the isolate 
contains a stx gene, an eae gene, and one of the target O-groups (O26, 
O45, O103, O111, O121, or O145) and when the isolate is biochemically 
confirmed to be E. coli.
    In the 2011 Federal Register notice, FSIS included a costs and 
benefits estimate for non-O157 STEC testing in raw beef manufacturing 
trimmings (76 FR 58157, 58162-58164). The Agency asked for comments on 
this costs and benefits estimate (76 FR 58157, 58164).
    FSIS implemented a verification testing program for the six non-
O157 STEC in raw beef manufacturing trimmings on June 4, 2012 (77 FR 
9888). Beef manufacturing trimmings include beef parts of any size, 
including primal cuts, subprimal cuts, and smaller pieces of trimmings 
from subprimal cuts, that the producing slaughter establishment intends 
for raw, non-intact use (FSIS Directive 10,010.1, Sampling

[[Page 34398]]

Verification Activities for Shiga Toxin-Producing Escherichia coli 
(STEC) in Raw Beef Products https://www.fsis.usda.gov/wps/wcm/connect/c100dd64-e2e7-408a-8b27-ebb378959071/10010.1.pdf?MOD=AJPERES). FSIS did 
not implement verification testing for non-O157 STEC to ground beef, 
bench trim, and other raw ground beef components at that time, because 
the Agency needed to establish additional laboratory capacity to test 
these products and the Agency wanted to evaluate data gathered from 
sampling raw beef manufacturing trimmings before expanding its 
verification testing to include other products (76 FR 58157, 58160).
    On May 31, 2012, the Agency announced in the Federal Register (77 
FR 31975) that it would update and revise the costs and benefits 
estimate accompanying the September 20, 2011, determination, respond to 
comments received on the costs and benefits estimate, and assess the 
economic effects of testing raw beef manufacturing trimmings, ground 
beef, bench trim, and other raw ground beef components for non-O157 
STEC. FSIS also announced that, when the updated costs and benefits 
estimate was complete, the Agency would announce its availability, 
request comments on it, assess the comments, and make any necessary 
changes to the costs and benefits estimate before finalizing it and 
expanding FSIS non-O157 STEC testing to include other products in 
addition to beef manufacturing trimmings.
    On November 19, 2014, FSIS announced in the Federal Register that 
it had updated the costs and benefits estimate in the 2014 cost benefit 
analysis (CBA) associated with the implementation of its non-O157 STEC 
testing on raw beef manufacturing trimmings (79 FR 68843). In the 2014 
CBA, FSIS also reported the costs and benefits associated with the 
potential expansion of its non-O157 STEC testing to other raw beef 
products. The estimated annual cost for testing beef manufacturing 
trimmings for non-O157 STEC was $1.37 million ($0.48 million to the 
Agency and $0.89 million to the industry) in 2013 dollars. The 
expansion of non-O157 STEC testing to all other raw beef products was 
estimated to cost $1.0 million ($0.9 million to the Agency and $0.1 
million to the industry) in 2013 dollars.\1\ FSIS also responded to 
comments that it had received on the previous, September 20, 2011, 
costs and benefits estimate.
---------------------------------------------------------------------------

    \1\ The 2014 CBA is available at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices.
---------------------------------------------------------------------------

Summary of the Updated Costs and Benefits Analysis

    This notice announces updates to the CBA FSIS published on November 
19, 2014. In this revision to the 2014 CBA, FSIS made the following 
changes:
    1. The false-positive rate for industry's screening test was 
updated and an estimate of product loss value was included as a cost to 
the industry, in response to industry comments.
    2. Agency cost was updated to reflect the change in FSIS' 
laboratory method for STEC testing; the new method screens enriched 
samples for both E. coli O157:H7 and non-O157 STEC at the same time, 
which reduces the Agency's testing costs.
    3. Agency cost for conducting for-cause Food Safety Assessments 
(FSAs) was updated using data from the Agency's analysis of the new FSA 
methodology.\2\
---------------------------------------------------------------------------

    \2\ In June 2015, FSIS changed the methodology for conducting 
FSAs. For details, see FSIS Directive 5100.4. Enforcement, 
Investigations and Analysis Officer (EIAO) Public Health Risk 
Evaluation (PHRE) Methodology Implementation, 5/22/2015, available 
at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

    4. We quantified the benefit from prevented outbreak-related 
recalls, in response to comments, using survey data from the Grocery 
Manufacturers Association (whose name changed to Consumer Brands 
Association in January 2020).
    When including all of the aforementioned updates, the estimated 
annual cost for testing beef manufacturing trimmings for non-O157 STEC 
is $42.2 million ($0.1 million to the Agency, and $42.1 million to the 
industry). The estimated cost of expanding non-O157 STEC testing to all 
other raw beef products is $6.4 million ($0.5 million to the Agency and 
$5.9 million to the industry). Most of the increase in estimated costs 
above the cost estimates in the 2014 CBA is from the inclusion of the 
lost value of products to the industry. When establishments do not do 
confirmation testing, there is a loss of value from disposed of beef 
products after they have screened positive because some of these are 
false positives.
    The estimated benefits of the new testing are reduced illnesses and 
deaths, reduced outbreak-related recalls, and improved business 
practices. Through recall investigations, FSIS and industry are able to 
determine process failures to help establishments take corrective 
actions to prevent future contamination and investigation can serve as 
the basis for education that will benefit the entire industry as well 
as regulatory organizations. The Agency estimated the benefit from 
reduced outbreak-related recalls to be at least $51.6 million per year. 
There are also benefits from reduced illnesses and improved industry 
practices, which were not quantified. Therefore, the total benefit of 
FSIS testing for non-O157 STEC outweighs the total cost.

Expanding FSIS Non-O157 STEC Testing to Ground Beef, Bench Trim, and 
Other Raw Ground Beef Components

    FSIS intends to expand its non-O157 STEC verification testing to 
ground beef, bench trim, and other raw ground beef components. 
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. Processing establishments that receive product for 
grinding also have an important role in addressing non-O157 STEC. 
Hazard Analysis and Critical Control Point (HACCP) regulations require 
establishments to conduct a hazard analysis to determine the food 
safety hazards that are reasonably likely to occur in their production 
processes and to identify the preventive measures an establishment can 
apply to control those hazards in the production of particular products 
(see 9 CFR 417.2(a)). Processing establishments can control or reduce 
STEC to below detectable levels by using preventive measures, including 
validated antimicrobial interventions. Processing establishments can 
also establish as a preventive measure purchase specification that 
requires suppliers to provide source materials with no detectable STEC. 
Processing establishments can then verify that these control measures 
are working as intended through their own product testing (see 67 FR 
62326).
    Exposure to non-O157 STEC is linked to serious, life-threatening 
human illnesses. On March 28, 2019, FSIS was notified of an outbreak of 
E. coli O103 illnesses.\3\ One hundred and ninety-six (196) case-
patients in ten (10) states were linked to this outbreak. Twenty-eight 
(28) case-patients were hospitalized. Case-patient and traceback 
information indicated raw ground beef as the likely source of this 
outbreak and prompted two recalls (Recall #047-2019

[[Page 34399]]

and Recall #048-2019). Additionally, on August 16, 2018, FSIS was 
notified of an outbreak of E. coli O26 illnesses.\4\ Eighteen (18) 
case-patients in four (4) states were linked to this outbreak. Six (6) 
people were hospitalized, and one (1) died. Case-patient and traceback 
information for this outbreak also indicated raw ground beef as the 
likely source, prompting two recalls (Recall #072-2018 and Recall #081-
2018). Because of these recent outbreaks, illnesses and a death, FSIS 
is moving ahead with its plans to expand its non-O157 STEC sampling to 
ground beef, bench trim, and other raw ground beef components.
---------------------------------------------------------------------------

    \3\ More information on this outbreak is available at https://www.cdc.gov/ecoli/2019/o103-04-19/index.html.
    \4\ More information on this outbreak is available at https://www.cdc.gov/ecoli/2018/o26-09-18/index.html.
---------------------------------------------------------------------------

    Product sampling and testing is one of several activities 
establishments conduct to verify the effectiveness of their HACCP 
systems. Since the initiation of FSIS's non-O157 STEC testing program, 
many grinders and suppliers of raw ground beef components have 
instituted programs to routinely test their raw beef products for both 
E. coli O157:H7 and for non-O157 STEC.
    Before a foreign country can export meat products to the United 
States, it must demonstrate that its meat inspection system is 
equivalent to the system FSIS has established under the FMIA and its 
implementing regulations. After FSIS expands its STEC verification 
sampling, FSIS will require foreign countries to test the same products 
for non-O157 STEC and verify that the establishments address STEC as a 
hazard through an establishments hazard analysis and HACCP plans. If a 
country chooses to take a different approach, then the country would 
need to submit an Individual Sanitary Measure (ISM) equivalence 
determination.

Sampling Beef Manufacturing Trimmings, Ground Beef, Bench Trim, and 
Other Raw Ground Beef Components

    To sample beef manufacturing trimmings and bench trim, FSIS 
inspection program personnel (IPP) use the N60 technique to collect 60 
pieces of meat from across a production lot (see FSIS Directive 
10,010.1, https://www.fsis.usda.gov/wps/wcm/connect/c100dd64-e2e7-408a-8b27-ebb378959071/10010.1.pdf?MOD=AJPERES). To sample other raw ground 
beef components, FSIS IPP randomly select one component type that the 
establishment produces and aseptically collect a grab sample from one 
or more components from a production lot consisting of many boxes 
(typically 100 boxes in very large establishments) (see FSIS Directive 
10,010.1). The sampling protocol used for other raw ground beef 
components, specifically collecting samples from a limited number of 
units from a given production lot, may reduce the chance of getting a 
positive since pathogens are not homogeneously distributed throughout a 
production lot.
    FSIS is aware that some establishments are collecting samples of 
beef manufacturing trimmings and other raw ground beef components using 
a sponge or cloth device that is either attached to a conveyor belt 
that comes into direct, continuous contact with product, or that is 
used by establishment employees to rub products in boxes or combos. 
More surface area is sampled using these techniques which theoretically 
may yield results that better represent the production lot as compared 
to the sampling methods currently used by FSIS for sampling beef 
manufacturing trimmings and other raw ground beef components. FSIS is 
evaluating alternatives to FSIS's current sampling procedures for beef 
manufacturing trimmings, bench trim, and other raw ground beef 
components; the Agency is looking for alternatives that provide samples 
that are more representative of production lots and that are less time 
intensive and more user-friendly for IPP to use. If FSIS makes changes 
to its sampling methodology for beef manufacturing trimmings, bench 
trim and/or other raw ground beef components, it will issue updated 
sampling instructions to field personnel.

Recent Changes to FSIS's Laboratory Method

    On February 4, 2019, FSIS began using a new laboratory method for 
the initial screening of regulatory samples for STEC.\5\ The 
instructions for using this method are found in Chapter 5C of the 
Microbiology Laboratory Guidebook (MLG) and associated appendices.\6\ 
This updated laboratory method allows FSIS to utilize 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). Merging the screening for these seven STEC 
adulterants into a single laboratory workflow saves time, money, and 
resources for the Agency without sacrificing sensitivity and 
specificity.
---------------------------------------------------------------------------

    \5\ See https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/newsletters/constituent-updates/archive/2019/ConstUpdate020119.
    \6\ The FSIS MLG can be found at: https://www.fsis.usda.gov/wps/portal/fsis/topics/science/laboratories-and-procedures/guidebooks-and-methods/microbiology-laboratory-guidebook/microbiology-laboratory-guidebook.
---------------------------------------------------------------------------

Planned Changes in Scheduling Samples

    As FSIS announced with its proposed Salmonella performance 
standards for ground beef and beef manufacturing trimmings (84 FR 
57688, 57690), FSIS's goal is to collect and analyze at least 48 
samples per year for each establishment producing greater than 50,000 
pounds per day of ground beef or beef manufacturing trimmings by 
increasing the sample collection frequency from a maximum of four times 
per month to once per week for these product classes. To achieve this 
goal, FSIS plans to change how it assigns STEC samples and thus 
Salmonella samples (as all raw beef samples currently are analyzed for 
STEC and Salmonella) in higher-volume beef establishments producing 
ground beef and/or beef manufacturing trimmings by increasing the 
sample collection frequency to once per week or four samples per month 
for these product classes. FSIS intends to implement this change by 
reallocating resources from lower-volume beef establishments (i.e., 
those producing 50,000 pounds or less per day) in a manner that is 
resource--neutral. The Agency requests comments on the proposed change 
in sampling frequency.

Response to Comments

    FSIS received three comment letters in response to the 2014 Federal 
Register notice on the CBA associated with testing raw beef 
manufacturing trimmings for non-O157 STEC and the potential costs and 
benefits of testing raw ground beef, bench trim, and all other raw 
ground beef components for non-O157 STEC. Specifically, FSIS received 
comments from a beef-producing company, a testing provider, and an 
industry organization. The three comment letters FSIS received on the 
notice did not support the expansion of non-O157 STEC testing by the 
Agency. Commenters stated that testing just for E. coli O157:H7, rather 
than for both E. coli O157:H7 and non-O157 STEC, was adequate. A 
summary of the comments received and responses to the comments is 
below.

Quantify Benefits and Recalls

    Comment: Both the company and the industry organization questioned 
why FSIS did not quantify the benefits of its non-O157 STEC testing. 
These commenters also questioned the use in the CBA of two non-O157 
STEC-related recalls (Recall #045-2013 and Recall

[[Page 34400]]

#010-2014) as evidence of public-health benefits because they were not 
outbreak-related.
    Response: FSIS has now quantified the estimated benefit from 
prevented outbreak-related recalls in the CBA associated with this 
Federal Register notice, using survey data from the Grocery 
Manufacturers Association \7\ (whose name changed to Consumer Brands 
Association in January 2020), and Agency recall data. The Agency 
estimated the benefit from reduced outbreak-related recalls to be at 
least $51.6 million per year. There are also benefits from reduced 
illnesses and improved industry practices, which are not quantified. 
Therefore, the total benefit of FSIS testing for non-O157 STEC 
outweighs the total cost.
---------------------------------------------------------------------------

    \7\ Grocery Manufacturers Association. 2011. Capturing Recall 
Costs: Measuring and Recovering the Losses. Retrieved from https://www.gma.maxx.matrixdev.net/forms/store/ProductFormPublic/capturing-recall-costs.
---------------------------------------------------------------------------

    The recalls of products contaminated with non-O157 STEC exemplify 
the preventive approach FSIS takes with respect to product 
contamination events, as the recalled products could have potentially 
led to illnesses and outbreaks. While the historical frequency of 
outbreaks attributable to non-O157 STEC may be lower than that for 
outbreaks attributable to E. coli O157:H7, clinical methods are being 
developed to better detect and identify non-O157 STEC illnesses 
(discussed later). In testing beef manufacturing trimmings for STEC, 
FSIS has found more positive non-O157 STEC than O157 STEC. FSIS 
conducts verification sampling and testing and other inspection 
activities to ensure establishments have appropriate controls and 
verification procedures in place to prevent such illnesses. Since FSIS 
started its non-O157 STEC verification testing, there have been 19 
Class-I recalls associated with raw beef products contaminated with 
these STEC.\8\ Four of these recalls were associated with a ground beef 
outbreak. Two of the recalls were associated with the O103 serogroup 
and the other two with the O26 serogroup. The other 15 recalls were 
conducted based on positive non-O157 STEC results obtained through 
testing by FSIS, establishments, or various states; these recalls 
occurred before any attributed illnesses were reported.\9\
---------------------------------------------------------------------------

    \8\ The list of recalls is available at: http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/current-recalls-and-alerts/current-recalls-and-alerts.
    \9\ The list of recalls is available at: http://www.fsis.usda.gov/wps/portal/fsis/topics/recalls-and-public-health-alerts/current-recalls-and-alerts/current-recalls-and-alerts.
---------------------------------------------------------------------------

    On February 8, 2013, FSIS implemented a new policy that requires 
official establishments and importers of record to maintain control of 
products produced from livestock that are sampled and tested by FSIS 
for adulterants and not allow such products to enter commerce until 
negative test results have been received. This policy, often referred 
to as FSIS's ``hold and test'' policy, has reduced the number of 
recalls conducted due to FSIS raw ground beef verification samples that 
test positive for STEC. This policy applies to non-intact raw beef 
product or intact raw beef product intended for non-intact use that is 
sampled and tested by FSIS for STEC (77 FR 73401; Dec. 10, 2012).

False-Positive Rate

    Comment: A major concern of both the company and the industry 
organization that commented on the proposal was the high false-positive 
rate for non-O157 STEC screening tests used by industry. The company 
stated that it was concerned about the rate of false positives obtained 
using available non-O157 STEC screening tests because of the decisions 
that are made immediately after and on the basis of the initial 
screening test results. According to the commenters, industry may hold 
lots of product with screen-positive test results for non-O157 STEC 
while waiting for confirmation of the results.
    Industry may also conduct product traceback in response to non-O157 
STEC screen-positive test results, take action during high-event 
periods based on non-O157 STEC screen-positive test results, and may 
have difficulty filling orders on time because of screen-positive test 
results that limit the availability of raw beef. Also, the commenters 
were concerned about FSIS conducting additional FSAs in response to 
industry's non-O157 STEC screen-positive test results. The same 
commenters stated that screen-positive test results may result in loss 
of product value. Therefore, the commenters stated, the Agency 
underestimated the costs of the false-positive rate on industry in the 
CBA for the proposal.
    Response: The Agency's 2018 data show, before the February 2019 
change in technology, that 90 percent of the FSIS non-O157 STEC 
presumptive positive test results are confirmed positive.\10\ A 
presumptive positive result in FSIS testing means the sample has first 
been determined to be a non-O157 STEC potential positive (equivalent to 
an industry screen-positive non-O157 STEC test result) and then an FSIS 
microbiologist identifies an isolate from the enriched sample. Note 
that FSIS confirmed only 7 percent of the Agency's non-O157 STEC 
potential positive test results before the February 2019 change in 
technology. FSIS's revised cost estimate, using a range of false-
positive rates equivalent to the Agency's 2018 range of false positive 
rates of STEC potential positive test results of 81 to 100 
percent,11 12 showed that the lost product value from 
industry's testing of raw beef products would be high--about $47.0 
million. However, there are more sensitive screening tests available to 
industry that have lower false-positive rates for non-O157 STEC, and 
industry may choose the test that has the desired cost and benefit 
result.\13\ (FSIS expects that, over time, the cost of both STEC 
screening and confirmatory tests will decrease as the industry conducts 
more tests and as the test kits improve. Since implementing STEC 
testing, FSIS has taken steps to improve the effectiveness of its 
microbiological testing program for E. coli O157:H7 and non-O157 STEC, 
including implementing the new laboratory method mentioned above. Also, 
FSIS does not conduct FSAs at establishments based solely on positive 
industry test results.
---------------------------------------------------------------------------

    \10\ Data are from the Office of Public Health Science (OPHS), 
FSIS.
    \11\ Since we assumed that the industry would not change to 
FSIS's new laboratory method in the near future, FSIS used the most 
recent false positive rates of the Agency's laboratory method before 
February 2019 to estimate industry costs.
    \12\ Data are from the Office of Public Health Science (OPHS), 
FSIS for 2018. The false positive rates of the potential screening 
are as follows: 93 percent for beef manufacturing trimming, 100 
percent for bench trim, 94 percent for other raw ground beef 
components, and 81 percent for ground beef.
    \13\ Examples of test kits can be found on the FSIS website: 
https://www.fsis.usda.gov/wps/wcm/connect/f97532f4-9c28-4ecc-9aee-0e1e6cde1a89/validated-test-kit.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

Morbidity and Mortality Weekly Report

    Comment: In reference to the Centers for Disease Control and 
Prevention (CDC) Foodborne Diseases Active Surveillance Network 
(FoodNet) program Morbidity and Mortality Weekly Report (MMWR) (http://www.cdc.gov/mmwr/preview/mmwrhtml/mm6418a4.htm), the company and 
industry organization asked if the report would affect FSIS's proposed 
expansion of non-O157 STEC testing.
    Response: At this time, the information in the report does not 
change the Agency's plans to move forward with expanding non-O157 STEC 
testing. According to the summary

[[Page 34401]]

of the most recent MMWR,\14\ compared with the 2015-2018 average annual 
STEC incidence (infections), the 2018 incidence of STEC was higher when 
compared to the 2015-2017 rates. Various factors contribute to the 
increase in reported illnesses. This includes the use of updated 
clinical laboratory methods. Further, the illnesses reported by the 
FoodNet program are not specific to FSIS-regulated products; reported 
data encompasses all reported illnesses, regardless of food source.
---------------------------------------------------------------------------

    \14\ https://www.cdc.gov/mmwr/volumes/68/wr/mm6816a2.htm?s_cid=mm6816a2_w.
---------------------------------------------------------------------------

E. coli O157:H7 as Indicator of Non-O157 STEC and Collection of Data by 
FSIS

    Comment: The industry organization asserted that E. coli O157:H7 
can serve as an indicator organism for non-O157 STEC. The industry 
organization also commented that E. coli O157:H7 is a logical indicator 
organism for non-O157 STEC, if one uses the definition of an indicator 
organism presented in a research paper by Saini and others. This 
research paper states, ``the term `indicator' implies that common 
causes affect the levels of both indicator microorganisms and pathogens 
and that these causes can be identified and controlled. The use of 
measured levels of an indicator organism within statistical process 
control (SPC) is based on the basic premise that the process can be 
improved over time, by identifying a cause of higher-than-expected 
indicator organism levels and taking an action that would result in a 
decrease of levels of the indicator organism, which in turn could also 
decrease levels and incidence of pathogens on the product.'' \15\ The 
commenter also stated that, given the history of non-O157 STEC 
outbreaks and the industry's success in reducing E. coli O157:H7 
prevalence in beef products, E. coli O157:H7 is likely the best 
microorganism to target in reducing risk when consuming beef products 
because the number of confirmed illnesses within the U.S. has been 
attributed more to E. coli O157:H7 than to non-O157 STEC.
---------------------------------------------------------------------------

    \15\ Saini PK, Marks HK, Dreyfuss MS, Evans P, Cook Jr LV, and 
Dessai U. 2011. Indicator organisms in meat and poultry slaughter 
operations; their potential use in process control and the role of 
emerging technologies. J. Food Prot. 74: 1387-1394.
---------------------------------------------------------------------------

    Additionally, the industry organization stated that FSIS has 
collected data on non-O157 STEC through testing since 2012. The 
commenter stated that the data should be reviewed to ascertain the 
costs and benefits of expanded testing for the six non-O157 STEC 
adulterants to include raw ground beef and other components used in raw 
ground beef in addition to raw beef manufacturing trimmings.
    Response: FSIS has reviewed its STEC verification sampling results 
obtained since 2012; positive samples for E. coli O157:H7 and non-O157 
STEC have been observed. While FSIS screening and confirmation methods 
used collectively permit detection of both E. coli O157:H7 and non-O157 
STEC in an isolate from a sample, our data indicates that an isolate 
from a sample is rarely positive for both E. coli O157:H7 and non-O157 
STEC. Therefore, FSIS verification sample results do not support using 
E. coli O157:H7 as an indicator organism for non-O157 STEC. Rather, the 
results indicate a need for FSIS to conduct additional verification 
testing of products for non-O157 STEC.
    Analysis of FSIS raw beef manufacturing trimmings STEC verification 
sample results indicate that positive samples are not occurring in 
clusters, and are distributed among various states and regions of the 
U.S. Specifically, between June 2012 and December 2018, raw beef 
manufacturing trimming sample positives for E. coli O157:H7 were from 
47 individual establishments in 25 States, while raw beef manufacturing 
trimming sample positives for non-O157 STEC were from 87 individual 
establishments in 34 States.
    FSIS began verification testing of raw beef manufacturing trimmings 
(MT60 sampling project) for non-O157 STEC (in addition to E. coli 
O157:H7) in June 2012. Aggregate data by calendar year are publicly 
available on FSIS's website. In calendar year (CY) 2012, 17 of 32 STEC 
positive beef manufacturing trimmings samples were positive for non-
O157 STEC (see http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/stec-annual-report/stec-annual-report-2012, Table 2, Trim Verification [MT60] data). Similarly, in CY 
2013, 16 of 25 STEC positive beef manufacturing trimmings samples were 
positive for non-O157 STEC (see http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/stec-annual-report/stec-annual-report-2013, Table 2, Trim Verification data). Non-
O157 STEC were found in both samples identified as just ``beef'' and in 
beef products identified as ``veal.'' Forty-eight (48) of 69 (70 
percent) and 23 of 39 (58 percent) of STEC positive samples of raw beef 
manufacturing trimmings (MT60 sampling project), raw ground beef 
follow-up samples (MT44 sampling project) and follow-up samples from 
originating slaughter suppliers (MT52 sampling project) collected in CY 
2012 and CY 2013, respectively were positive for non-O157 STEC. From CY 
2014-CY 2018 (see https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/ec/positive-results-current-cy/2015-ecoli-positives), 105 beef manufacturing trimmings (MT60) 
samples were positive for non-O157 STEC, and 32 samples were positive 
for E. coli O157:H7.
    The Agency has incorporated data from Agency testing in the updated 
CBA, including an updated false positive rate and Agency testing costs.

Antimicrobial Use and Multiple Interventions

    Comment: The industry organization commented that according to 
three studies funded by the North American Meat Institute, current 
antimicrobial compounds used by the meat industry to destroy E. coli 
O157:H7 are effective against non-O157 STEC.
    Response: FSIS considers controls for E. coli O157:H7 to be 
effective against non-O157 STEC when implemented appropriately. 
However, FSIS testing finds both E. coli O157:H7 and non-O157 STEC 
positive results in its verification testing programs. As stated above, 
FSIS laboratories rarely find positives for E. coli O157:H7 and non-
O157 STEC in the same sample. With the sporadic nature of STEC 
contamination, FSIS believes these results support the need for the 
Agency to conduct verification testing for non-O157 STEC in additional 
raw beef products.

Products To Sample

    Comment: The company and industry organization commented that FSIS 
should not sample and test raw ground beef and bench trim for non-O157 
STEC. While conceding that verification sampling of raw beef 
manufacturing trimmings yields data that provides insights into the 
slaughter process, these commenters stated that verification sampling 
of raw ground beef products is not useful. According to these 
commenters, FSIS most often takes samples of raw ground beef product 
that is a blend of raw ground beef components from multiple suppliers; 
therefore, the commenters stated it is not possible to know which 
component was contaminated or to provide feedback of any value to the 
source establishments.
    The company and the industry organization also stated that FSIS may 
question beef manufacturing trimmings and other raw ground beef 
component suppliers when downstream

[[Page 34402]]

establishments that grind raw beef components from multiple suppliers 
produce product that tests positive for non-O157 STEC.
    Response: The Agency agrees that FSIS verification sampling and 
testing of product from slaughter establishments for non-O157 STEC 
provides useful information on the establishment's process control. The 
Agency also recognizes that traceback of ground beef made using raw 
beef components from multiple suppliers to a single slaughter 
establishment is more difficult than traceback of product made with raw 
beef components from a single supplier. Moreover, FSIS notes that the 
2018 and 2019 outbreaks involved non-O157 STEC from ground beef. Thus, 
the Agency intends to expand non-O157 STEC sampling and testing to 
include ground beef, bench trim, and other raw ground beef components, 
which comprise the other 75 percent of the samples analyzed annually 
for E. coli O157:H7. This will help FSIS verify that certain products 
(such as bench trim) are not adulterated before they are ground, and 
that the resulting ground beef is not adulterated.

Food Safety Assessment Estimate

    Comment: With expanded non-O157 STEC testing, the industry 
organization commented that FSAs based on FSIS non-O157 STEC positive 
test results alone will unnecessarily increase FSIS and industry 
expenses. The industry organization noted that FSIS estimated the cost 
of an FSA to FSIS at $1,400 in 2014 but in September 2011 estimated 
that the Agency's FSA cost was $14,000.
    Response: The $14,000 estimate for FSAs in 2011 resulted from high 
assumptions regarding the resources needed to conduct FSAs related to 
non-O157 STECs (76 FR 58157) before 2014. For example, it used to take 
an Enforcement, Investigation, and Analysis Officer (EIAO) over 30 days 
to complete the in-plant portion of the investigation. The Agency 
modified the assumptions and the cost estimates for the 2014 CBA based 
on the new FSA methodology, using the Public Health Risk Evaluation to 
determine whether an FSA is necessary, which reduced the total number 
of FSAs. With the new methodology, an EIAO can complete the in-plant 
portion of the FSA in 5 to 7 days, instead of an average of 38 days, 
leading to a significant reduction in FSA cost to FSIS. Data collected 
for FY 2016 suggest that the average STEC-related FSA under the new 
methodology costs the Agency about $4,800.\16\ FSIS has updated the CBA 
using this new number.
---------------------------------------------------------------------------

    \16\ Based on OCFO (Office of Chief Financial Officer) 
preliminary analysis of average cost per FSA under new FSA 
methodology, FY 2016.
---------------------------------------------------------------------------

USDA Non-Discrimination Statement

    No agency, officer, or employee of the USDA shall, on the grounds 
of race, color, national origin, religion, sex, gender identity, sexual 
orientation, disability, age, marital status, family/parental status, 
income derived from a public assistance program, or political beliefs, 
exclude from participation in, deny the benefits of, or subject to 
discrimination any person in the United States under any program or 
activity conducted by the USDA.

How To File a Complaint of Discrimination

    To file a complaint of discrimination, complete the USDA Program 
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your 
authorized representative.
    Send your completed complaint form or letter to USDA by mail, fax, 
or email:
    Mail: U.S. Department of Agriculture, Director, Office of 
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
    Fax: (202) 690-7442.
    Email: [email protected].
    Persons with disabilities who require alternative means for 
communication (Braille, large print, audiotape, etc.), should contact 
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

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: 
http://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: http://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 in Washington, DC.
Paul Kiecker,
Administrator.
[FR Doc. 2020-12073 Filed 6-3-20; 8:45 am]
 BILLING CODE 3410-DM-P