[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57688-57695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23473]


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 Notices
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  Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / 
Notices  

[[Page 57688]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0045]


Changes to the Salmonella Verification Testing Program: Proposed 
Performance Standards for Salmonella in Raw Ground Beef and Beef 
Manufacturing Trimmings and Related Agency Verification Procedures

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Notice and request for comments.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing 
and requesting comment on new pathogen reduction performance standards 
for Salmonella in raw ground beef and beef manufacturing trimmings.
    The Agency is also announcing how it plans to assess whether 
establishments producing raw ground beef and/or beef manufacturing 
trimmings are effectively addressing Salmonella, using a 52-week moving 
window of FSIS sampling results and other related verification 
activities. Approximately one year (52 weeks) after the new standards 
are made final, the Agency plans to post individual establishment 
performance as either ``meeting'' or ``not meeting'' the pathogen 
reduction performance standard on the FSIS website, based on the most 
recent 48 Salmonella sample results.
    Finally, FSIS is also announcing that it intends to increase 
Salmonella sampling to once per week in beef establishments that 
produce greater than 50,000 pounds of raw ground beef and beef 
manufacturing trimmings per day, so that a sufficient number of 
Salmonella samples (i.e., 48) are collected to assess these 
establishments' performance against the new Salmonella performance 
standards. Note that FSIS will continue to analyze these beef 
manufacturing trimmings samples for Escherichia coli O517:H7 and 
applicable non-O157 Shiga-toxin producing E. coli (STEC); FSIS will 
continue to analyze these ground beef samples for E. coli O157:H7. 
Although unlikely with this change, if fewer than 48 samples are 
collected or analyzed in a 52-week window at an establishment, its 
status would be reported as ``N/A,'' provided the establishment has two 
or fewer Salmonella positives in that window.
    FSIS will consider comments received on this notice before 
announcing the final performance standards in the Federal Register and 
assessing whether establishments meet them.

DATES: Submit comments on or before December 27, 2019.

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-2018-0045. 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: Terri Nintemann, Assistant 
Administrator, Office of Policy and Program Development by telephone at 
(202) 205-0495.

SUPPLEMENTARY INFORMATION: FSIS is responsible for verifying that the 
nation's commercial supply of meat, poultry, and egg products is safe, 
wholesome, and properly labeled and packaged.
    Salmonella bacteria are among the most frequent causes of foodborne 
illness. These bacteria reside in the gastrointestinal tract and other 
organs of food animals; therefore, they also are good indicators for 
food product contamination with enteric pathogens. Salmonella are often 
introduced during the rearing of live animals, e.g., Salmonella may 
contaminate the exterior of an animal on the farm, remain attached to 
the animal's hide or carcass, and can contaminate raw beef products 
during slaughter and subsequent fabrication and further processing. 
Currently, events that cause contamination of beef carcasses cannot be 
completely eliminated from commercial slaughter, fabrication, or 
further processing operations. Contamination can be minimized, however, 
with the use of proper sanitary dressing procedures and through the 
application of antimicrobial interventions during the slaughter, 
fabrication, and further processing of carcasses into beef products, 
including ground beef.
    FSIS began its Salmonella verification testing program with the 
final rule entitled ``Pathogen Reduction; Hazard Analysis and Critical 
Control Point Systems'' (PR/HACCP Rule), published on July 25, 1996 (61 
FR 38805). Among other things, the PR/HACCP Rule established Salmonella 
pathogen reduction performance standards for establishments that 
slaughter selected classes of food animals \1\ and/or that produce 
selected classes of raw ground products. FSIS continues to use pathogen 
reduction performance standards as a measure of process control and to 
ensure that establishments are consistently controlling or reducing 
harmful bacteria not ordinarily considered adulterants in raw meat and 
poultry products.\2\
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    \1\ In 2011, FSIS stopped sampling and testing for Salmonella in 
beef carcasses (steers and heifers and cows and bulls) because 
percent positive findings were very low; less than one percent. FSIS 
sampling and testing for Salmonella in raw ground beef continued, 
however.
    \2\ The Agency's ability to directly enforce the pathogen 
reduction performance standards in 9 CFR 310.25 has been limited 
since 2001, after a ruling by the U.S. Court of Appeals for the 
Fifth Circuit in Supreme Beef Processors, Inc. v. USDA. In that 
case, the court enjoined FSIS from suspending inspection services 
against a meat grinding operation for failure to meet the Salmonella 
performance standards. Since that time, FSIS has used Salmonella 
failures as a basis to conduct an in-depth evaluation of the 
establishment's Hazard Analysis and Critical Control Point systems, 
including its HACCP plan and Sanitation Standard Operating 
Procedures.

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[[Page 57689]]

    Because of continued outbreaks of Salmonella illness associated 
with the consumption of ground beef products, FSIS is proposing to 
update its Salmonella performance standard for raw ground beef and 
establish a new performance standard for beef manufacturing 
trimmings,\3\ the primary component of raw ground beef. These updated 
and new performance standards would address the market failure from 
information asymmetry between producers and buyers. Absent these 
standards, buyers could not readily identify the difference in 
Salmonella levels across producers. A summary of the most recent 
Salmonella outbreaks linked to ground beef and FSIS's responses to 
these outbreaks that ultimately led to the development of the new 
performance standards follows.
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    \3\ FSIS defines ``beef manufacturing trimmings'' as trim 
produced from cattle (including veal) that are slaughtered at the 
establishment where the FSIS sampling is occurring. Beef 
manufacturing trimmings include trim of any size and primal or 
subprimal cuts, such as chucks, rounds, or shanks, or boneless beef 
of any size used at the slaughter establishment for non-intact use, 
or that is intended for raw non-intact use by other establishments.
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    In 2011, FSIS investigated a multi-State outbreak of 20 Salmonella 
Typhimurium infections linked to the consumption of ground beef.\4\ 
Eight people were hospitalized, and the outbreak strain was resistant 
to at least seven antibiotics. In 2012, an establishment recalled 
approximately 30,000 pounds of raw ground beef linked to a multi-state 
outbreak of Salmonella Enteritidis with 46 persons infected.\5\ Twelve 
people were hospitalized. Also, in 2012, the Centers for Disease 
Control and Prevention (CDC) confirmed a single-State outbreak from 
ground beef contaminated with Salmonella Enteritidis that resulted in 
24 illnesses. Two people were hospitalized. In 2013, 22 persons from 
six States were infected with Salmonella Typhimurium linked to ground 
beef.\6\ Seven people were hospitalized.
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    \4\ https://www.cdc.gov/salmonella/2011/ground-beef-2-1-2012.html.
    \5\ http://www.cdc.gov/salmonella/enteritidis-07-12/index.html; 
FSIS Recall 045-2012.
    \6\ http://www.cdc.gov/salmonella/typhimurium-01-13/index.html; 
FSIS Recalls 008-2013 and 009-2013.
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    In response to these outbreaks, on August 28, 2013, FSIS published 
in the Federal Register a notice announcing changes it was making to 
its Salmonella verification testing program for raw beef products 
intended for non-intact use (78 FR 53017). Specifically, FSIS announced 
that it would begin analyzing for Salmonella all samples of raw ground 
beef, beef manufacturing trimmings, bench trim, and other raw ground 
beef components that it already collects for STEC testing, including 
raw ground beef products that FSIS samples at retail stores, and 
imported shipments of raw ground beef, trim, and other raw ground beef 
components that FSIS samples at official import inspection 
establishments. In addition, FSIS announced that it was increasing the 
raw ground beef analytical sample portion from 25 grams to 325 
grams.\7\ FSIS explained that the likelihood of detecting positive 
samples increases with the analytical portion size. FSIS also described 
how it intended to use the results generated from its raw ground beef 
(``MT43'') and beef manufacturing trimmings (``MT60'') verification 
testing programs to estimate the Salmonella prevalence in those 
products and to develop updated or new pathogen reduction performance 
standards.
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    \7\ After the Agency increased the analytical sample portion 
from 25 grams to 325 grams, FSIS stopped using the Salmonella 
performance standard for ground beef Table 2 in 9 CFR 310.25(b) 
because it was established on the basis of prevalence as measured by 
a 25-gram sample.
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    Finally, FSIS stated in this notice that it was considering 
alternatives to set-based sampling for Salmonella, including routine 
sampling throughout the year used in conjunction with a ``moving 
window'' approach to assess process control in establishments subject 
to performance standards. FSIS explained that this approach would allow 
for on-going scheduled Salmonella sampling, similar to the approach 
FSIS has used for STEC sampling and would provide FSIS with more 
flexibility for scheduling sample collections at different 
establishments.
    After reviewing the comments received on the August 2013 notice, 
FSIS announced in the Federal Register that it was implementing the 
plans in that notice on June 5, 2014 (79 FR 32436). Thus, on June 29, 
2014, FSIS discontinued Salmonella sampling set procedures for raw 
ground beef products (the ``HC01'' sampling program) and stopped 
assessing whether establishments met the codified pathogen reduction 
performance standards for ground product, except in those 
establishments in Category 3.8 9 At the same time, FSIS 
began co-analyzing for Salmonella all samples of raw beef products it 
collects for STEC analysis (including imported raw beef products) using 
the larger analytical sample portion. FSIS collects raw beef products 
for STEC analysis and Salmonella analysis regardless of production 
volume; FSIS did not establish a low volume exemption for beef 
establishments for FSIS STEC or Salmonella verification testing. FSIS 
has posted the aggregate results of this testing as part of its 
quarterly sampling project results reporting.\10\
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    \8\ An establishment in Category 3 is exceeding the Salmonella 
performance standard. FSIS Notice 28-14 instructed FSIS inspectors 
to continue set testing at establishments in Category 3 until the 
establishment is in Category 1 or 2.
    \9\ FSIS discontinued all sampling sets for ground beef products 
in establishments in Category 3 in June 2015.
    \10\ http://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/sampling-project-results.
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    Notably, in 2015, the CDC published an analysis of beef-related 
outbreaks from 1973-2011 and reported that ground beef is now a 
significant source of Salmonella outbreaks and that stronger measures 
are needed to decrease contamination of raw ground beef with 
Salmonella.\11\
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    \11\ Laufer, A., Grass, J., Holt, K., Whichard, J., Griffin, P., 
Gould, L., 2015. Outbreaks of Salmonella infections attributed to 
beef--United States, 1973-2011. Epidemiology and Infection 143, 
2003-2013.
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    Beginning in 2016 and ending in 2017, the CDC reported 106 
illnesses in 21 States associated with Salmonella Newport from ground 
beef.\12\ One person died, and 42 people were hospitalized. Notably, 
the CDC is currently investigating a multi-State illness outbreak from 
beef products contaminated with Salmonella Newport.\13\ To date, this 
outbreak has resulted in 403 illnesses from 30 States, with 117 people 
hospitalized. On October 4, 2018, approximately 6.5 million pounds of 
beef products, including ground beef, were recalled due to this 
outbreak and an expansion of the recall with an additional 5.2 million 
pounds of beef products occurred on December 4, 2018.\14\
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    \12\ https://www.cdc.gov/mmwr/volumes/67/wr/mm6715a2.htm.
    \13\ https://www.cdc.gov/salmonella/newport-10-18/index.html.
    \14\ FSIS Recall 085-2018.
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Moving Window Approach

    On February 11, 2016, the Agency explained how it would assess 
performance using a moving window of FSIS sampling results in poultry 
establishments subject to Salmonella and Campylobacter pathogen 
reduction performance standards (81 FR 7285). FSIS stated that the 
moving window would be 52 weeks and that the Agency

[[Page 57690]]

would collect samples more frequently in higher-volume establishments 
and less frequently in lower-volume establishments. The 52-week window 
obviates the need to account directly for seasonal fluctuations in 
contamination frequency.\15\ FSIS intends to use a similar approach for 
beef establishments that produce raw ground beef and/or beef 
manufacturing trimmings that will be subject to the updated or new 
Salmonella performance standards. As further explained below, the 
category reported for each establishment would be based on the last 48 
FSIS Salmonella sample results during the most recent 52-week window.
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    \15\ FSIS (2015). Public health effects of raw chicken parts and 
comminuted chicken and poultry performance standards. Washington, 
DC, United States Department of Agriculture; Williams, M.S., Ebel, 
E.D., Golden, N.J., Schlosser, W.D. (2014). Temporal patterns in the 
occurrence of Salmonella in raw meat and poultry products and their 
relationship to human illnesses in the United States. Food Control 
35(1): 267-273.
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Healthy People 2020 (HP2020) Goals

    Food safety is a key component of the Healthy People (HP) 
initiative, with an entire focus area dedicated to joint FSIS, Food and 
Drug Administration (FDA), and CDC efforts to reduce foodborne illness, 
including salmonellosis, in the population. Under the HP2020 goals, 
FSIS committed, with its public health partners, to a 25-percent 
reduction in annual cases of salmonellosis.\16\ Using published results 
from the CDC,\17\ FSIS estimates a median of about 80,000 annual cases 
of salmonellosis associated with the consumption of cuts of intact beef 
and ground beef contaminated with Salmonella. FSIS estimates that 
approximately 53 percent of these illnesses are associated with ground 
beef. Thus, to meet the 25-percent reduction goal, there would need to 
be 10,600 fewer annual illnesses caused by raw ground beef contaminated 
with Salmonella.\18\
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    \16\ Once the Healthy People 2030 objectives have been 
finalized, FSIS intends to assess whether changes to its performance 
standards are warranted.
    \17\ Scallan et al., 2011; Painter et al., 2013
    \18\ Moving forward, FSIS plans to utilize more recent estimates 
of foodborne illness source attribution to estimate cases of 
foodborne illness attributed to FSIS-regulated products. These 
estimates, produced by the Interagency Food Safety Analytics 
Collaboration (IFSAC), a tri-agency group with representatives from 
the CDC, FDA, and FSIS, uses foodborne outbreak data to produce 
harmonized, annual attribution estimates for Salmonella, Escherichia 
coli O157, Listeria monocytogenes, and Campylobacter.
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Pathogen Reduction Performance Standards

    With the goal of reducing Salmonella in raw ground beef products, 
the Agency is proposing an updated and a new pathogen reduction 
performance standard for Salmonella in raw ground beef and in beef 
manufacturing trimmings (the primary component of ground beef), 
respectively. Because the ground beef industry is highly concentrated 
by production volume, FSIS developed pathogen reduction performance 
standards for each product class based on a daily production volume 
threshold. Both proposed performance standards would be applicable to 
higher-volume establishments (i.e., those producing greater than 50,000 
pounds of these products per day). This approach would account for 
approximately 91 percent of the total raw ground beef and 96 percent of 
the total beef manufacturing trimmings production volume annually. And 
as further explained in FSIS's Public Health Effects of Performance 
Standards for Ground Beef and Beef Manufacturing Trimmings (2019 Risk 
Assessment),\19\ the approach would also focus Agency resources on raw 
ground beef establishments shown to have the highest Salmonella 
prevalence. FSIS predicts that most higher-volume beef establishments 
would meet the proposed performance standards.
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    \19\ Available at http://www.fsis.usda.gov/wps/wcm/connect/8a38566a-6d6c-4c96-85ce-41fd02050358/beef-ps-aug-2019.pdf?MOD=AJPERES.
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    FSIS's goal is to collect and analyze at least 48 samples per year 
for each establishment producing greater than 50,000 pounds of ground 
beef or beef manufacturing trimmings per day. Analyzing this number of 
samples would provide strong evidence that an establishment is either 
meeting or not meeting the performance standards. To achieve this goal, 
FSIS plans to change how it currently assigns STEC sampling and thus 
Salmonella sampling in higher-volume beef establishments producing 
ground beef and/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. FSIS intends to implement this 
change in a resource neutral manner by reallocating resources from 
lower-volume beef establishments (i.e., those producing 50,000 pounds 
or less per day). As noted above, FSIS samples less frequently in the 
lower-volume establishments. The Agency requests comments on the 
proposed changes.
    The methods for developing the proposed pathogen reduction 
performance standards and predictions for the public health effect of 
those standards are described in the 2019 Risk Assessment. FSIS used 
the same methodology to estimate the public health effects for the 
young chicken and turkey carcass Salmonella and Campylobacter 
performance standards in 2011 \20\ and to develop pathogen reduction 
performance standards for Salmonella and Campylobacter in raw chicken 
parts and not-ready-to-eat (NRTE) comminuted chicken and turkey 
products in 2015.\21\
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    \20\ 76 FR 15282; Mar. 14, 2011.
    \21\ 80 FR at 3940; Jan. 26, 2015.
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    FSIS has opted not to propose pathogen reduction performance 
standards for raw ground beef and/or beef manufacturing trimmings in 
lower-volume establishments (i.e., those producing 50,000 pounds or 
less per day of these products) at this time. FSIS will, however, 
continue co-analyzing for Salmonella in all samples it collects for 
STEC analysis from these establishments to monitor ongoing pathogen 
prevalence. A summary of the updated or new performance standards is 
provided in Table 1.
    Since there are not enough data (i.e., samples collected and 
tested) for components of ground beef other than beef manufacturing 
trimmings, e.g., esophagus (weasand) meat, head meat, and cheek meat to 
estimate a national prevalence, FSIS is not proposing a pathogen 
reduction performance standard for such products at this time. With 
that said, FSIS will continue to analyze its testing data to better 
understand the potential for contamination in these products. Such 
information could be used by the Agency to decide whether a pathogen 
reduction performance standard for one or more of these components is 
also necessary. FSIS is seeking comment on the merits of developing a 
pathogen reduction performance standard for components of raw ground 
beef other than beef manufacturing trimmings.

[[Page 57691]]



   Table 1--Updated or New Performance Standards for Salmonella in Raw
              Ground Beef and Beef Manufacturing Trimmings
------------------------------------------------------------------------
                                                       Minimum number of
                                   Maximum number of   samples needed to
  Product (establishment volume   allowable positive        assess
           (lbs./day))                  samples          establishment
                                                         performance *
------------------------------------------------------------------------
Raw Ground Beef (>50,000).......  2 of 48...........                  48
Beef Manufacturing Trimmings      2 of 48...........                  48
 (>50,000).
------------------------------------------------------------------------
* Any establishment with three or more Salmonella positives in a 52-week
  window would be categorized as not meeting the performance standard
  even when less than the minimum number of samples (48) are collected/
  analyzed.

Raw Ground Beef

    For raw ground beef, FSIS is proposing a pathogen reduction 
performance standard for Salmonella of two allowable positives out of 
48 samples. This standard would be applied to all higher-volume 
establishments, which includes those producing more than 50,000 pounds 
of raw ground beef product per day (approximately 75 establishments). 
As mentioned above, FSIS intends to assign samples weekly in all 
establishments producing more than 50,000 pounds of eligible product 
per day with the goal of collecting and analyzing 48 samples in a 52-
week window.
    FSIS predicts that approximately 18 percent of establishments 
(about 14 establishments) would initially not meet this performance 
standard. Once implemented, if about half of the establishments 
producing more than 50,000 pounds of raw ground beef per day that are 
not meeting the proposed performance standard subsequently begin to 
meet this standard, this should result in about a 25-percent reduction 
in Salmonella illnesses from that product. The median expected number 
of illnesses avoided per year would be about 8,900 (90% Uncertainty 
Interval: 2,000-20,000).

Specifics of the 52-Week Window Approach and Categorizing 
Establishments

    As stated, the performance standard is intended to apply to 48 
samples in a 52-week window. If FSIS collects and analyzes more than 48 
samples in a 52-week window, the most recent 48 sample results in that 
52-week window would be used to categorize the establishment. Although 
unlikely with the proposed reallocation of sampling resources, there 
may be rare occasions when fewer than 48 samples are collected and 
analyzed in these establishments within a 52-week window. If fewer than 
48 samples are collected or analyzed, the establishment's status would 
be reported as ``N/A,'' provided the establishment has two or fewer 
Salmonella positives in that window. Any establishment with three or 
more Salmonella positives in a 52-week window would be categorized as 
not meeting the performance standard regardless of the number of 
samples collected/analyzed in that window.

Beef Manufacturing Trimmings

    For beef manufacturing trimmings, FSIS is also proposing a pathogen 
reduction performance standard for Salmonella of two allowable 
positives out of 48 samples in a 52-week window that would be applied 
to eligible establishments producing more than 50,000 pounds of this 
product per day (approximately 49 establishments). Approximately 20 
percent of establishments (about 10 establishments) are predicted to 
initially not meet this performance standard.
    The specifics of the 52-week window and categorizing establishments 
are the same as above. Each establishment's category status (i.e., 
meeting, not meeting, or N/A) for beef manufacturing trimmings would be 
reported as described above for raw ground beef.
    FSIS has chosen not to attribute any averted illnesses resulting 
from the proposed performance standard for beef manufacturing trimmings 
because this product is not consumed directly. FSIS believes, however, 
that a performance standard is needed for beef manufacturing trimmings 
to assist grinding establishments that purchase this product for 
further processing in managing Salmonella contamination in their ground 
beef. For example, a grinding operation may opt to change beef 
manufacturing trimmings suppliers if its current supplier is 
categorized as not meeting the beef manufacturing trimmings Salmonella 
performance standard and has not taken actions to reduce Salmonella 
contamination in its product; this is especially true if the grinding 
operation is concerned about not meeting the raw ground beef Salmonella 
performance standard and wants to mitigate the chances of that outcome. 
Although reductions in Salmonella surface contamination on beef 
manufacturing trimmings should reduce contamination of raw ground beef, 
the specific magnitude of this reduction is uncertain.

Web-Posting Establishment Performance

    FSIS announced that it intended to post the category status for all 
establishments subject to pathogen reduction performance standards 
because web posting delivers greater transparency, thereby providing 
the public with the tools and information it needs to make informed 
food safety decisions (80 FR at 3948; Jan. 26, 2015). FSIS intends to 
post the category status for all beef establishments subject to the 
pathogen reduction performance standards announced in this notice upon 
implementation.
    FSIS currently assesses poultry establishment performance weekly 
based on the most recent 52-week window of FSIS sample results (83 FR 
56046; Nov. 9, 2018). As explained in the November 2018 Federal 
Register notice, FSIS no longer includes follow-up sampling results 
when calculating an establishment's category. On or about the 20th of 
the month, FSIS posts the category of individual establishments 
producing an eligible product on the FSIS website.\22\
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    \22\ Individual establishment category information is posted on 
FSIS's website at https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/salmonella-verification-testing-program.
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    Should FSIS move forward with finalizing the proposed pathogen 
reduction performance standards for Salmonella in raw ground beef and 
beef manufacturing trimmings, FSIS would announce the final standards 
and an effective date in a subsequent Federal Register notice. About 
one year after the final standards go into effect, FSIS would determine 
individual establishment performance based on the last 48 FSIS 
Salmonella sample results and then report on the FSIS website the 
status of each establishment subject to the performance standards as 
either

[[Page 57692]]

meeting or not meeting the particular standard using the following 
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criteria:

    Meeting. Establishments with no more than the allowable number 
of positive Salmonella sample results for that product class during 
the 52-week window ending the last Saturday of the previous month, 
based on the last 48 FSIS Salmonella sample results.
    Not Meeting. Establishments with more than the allowable number 
of positive Salmonella sample results for that product class during 
the 52-week window ending the last Saturday of the previous month, 
based on the last 48 FSIS Salmonella sample results.

    In the interim between the final standards becoming effective and 
when the status of individual establishments is posted, FSIS intends to 
make available monthly aggregate information relative to status (i.e., 
meeting or not meeting the performance standard) for all establishments 
subject to sampling under the final performance standards, using the 
most recent FSIS Salmonella sample results. This information will be 
aggregated and will not identify any specific establishment. FSIS would 
make this information available to give industry and other stakeholders 
timely information about progress being made to reduce Salmonella 
contamination in raw ground beef and beef manufacturing trimmings.

Related Agency Verification Actions

    An establishment that does not meet a pathogen reduction 
performance standard or produces product that has been associated with 
an outbreak may not have adequately addressed the food safety hazard, 
Salmonella, in its HACCP system. If the establishment considers 
Salmonella reasonably likely to occur and addresses Salmonella in its 
HACCP plan, it must take corrective actions as required in 9 CFR 
417.3(a). If the establishment considers Salmonella not reasonably 
likely to occur, it must take corrective actions and reassess its HACCP 
plan for that product to determine whether the plan needs to be 
modified to address Salmonella as a hazard (9 CFR 417.3(b)). To 
maintain an adequate HACCP system, the establishment may need to 
address the pathogen Salmonella in its HACCP plan, rather than through 
Sanitation Standard Operating Procedures (Sanitation SOPs) or another 
prerequisite program. Corrective actions taken in response to exceeding 
a pathogen reduction performance standard would need to be documented 
in records subject to verification by FSIS as required in 9 CFR 
417.3(c)).
    Consistent with FSIS inspection program personnel instructions for 
poultry establishments currently subject to performance standards, when 
a beef establishment does not meet a Salmonella performance standard 
(i.e., when the number of positive samples within a specified timeframe 
exceeds the number of allowable positives for that product class), FSIS 
may initiate follow-up sampling after the establishment is first 
categorized as not meeting the performance standard to verify the 
adequacy of corrective actions taken by the establishment. FSIS would 
likely co-analyze any follow-up samples for STEC, as applicable to that 
product class. The follow-up samples would not count towards the 
samples collected as part of the moving window procedure for assessing 
whether the establishment meets the standards, which is consistent with 
FSIS procedures for poultry performance standards (83 FR at 56048). 
Follow-up sampling for establishments that do not meet the raw ground 
beef and/or beef manufacturing performance standard for an extended 
period of time, or that fluctuate between meeting or not meeting one or 
both of these performance standards, would occur at a frequency 
determined by FSIS.\23\
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    \23\ See FSIS Notice 17-19 for additional information on follow-
up sampling in poultry establishments, available at https://www.fsis.usda.gov/wps/wcm/connect/e16cfd59-8f8a-48a5-a607-999c9eecfec2/17-19.pdf?MOD=AJPERES.
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    In addition, FSIS would schedule a Public Health Risk Evaluation 
(PHRE) for any beef establishment that (a) does not meet a Salmonella 
pathogen reduction performance standard; (b) has produced products with 
repetitive Salmonella serotypes of public health concern \24\ or 
repetitive antibiotic-resistant Salmonella; and/or (c) has Salmonella 
whole-genome sequencing (WGS) and/or pulsed-field gel electrophoresis 
patterns matching those found in recent outbreaks or epidemiologically 
linked to illnesses (see FSIS Directive 5100.1 at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES). FSIS would use the results of the PHRE to 
determine whether to schedule a Food Safety Assessment (FSA) \25\ at 
the establishment.
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    \24\ Information about the 20 most frequently reported 
Salmonella serotypes reported to the CDC's Laboratory-based Enteric 
Disease Surveillance system is available at https://www.cdc.gov/nationalsurveillance/pdfs/2016-Salmonella-report-508.pdf.
    \25\ The purpose of an FSA is to assess and analyze an 
establishment's food safety system to verify that the establishment 
is able to produce safe and wholesome meat or poultry products in 
accordance with FSIS statutory and regulatory requirements.
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    As explained above, and also consistent with existing FSIS 
practices,\26\ after notifying a beef establishment that it has not met 
a pathogen reduction performance standard, FSIS would conduct an 
assessment of the establishment's HACCP plan and SSOPs, through a PHRE 
and possible subsequent FSA, focusing on the establishment's corrective 
actions, HACCP plan reassessment (if applicable), and the effectiveness 
of the establishment's system for controlling Salmonella in raw beef 
products. In addition, when necessary, FSIS would develop a plan to 
verify whether the establishment implemented corrective actions. If, 
after 120 days from not meeting the standard, the establishment has not 
been able to demonstrate reduced variability of process control, as 
determined from FSIS's follow-up and routine sampling and from the 
results of the PHRE and in some cases an FSA, and the establishment has 
not taken corrective actions, FSIS would likely take an enforcement 
action, such as issuing a Notice of Intended Enforcement (NOIE) or 
suspending inspection, under the conditions and according to the 
procedures described in 9 CFR part 500. FSIS would not issue an NOIE or 
suspend inspection based solely on the fact that an establishment did 
not meet a pathogen reduction performance standard for Salmonella.
---------------------------------------------------------------------------

    \26\ FSIS stated in a Federal Register notice published April 
16, 2003 (68 FR 18593), that it was using Salmonella sample-set 
failures ``as an indication that there is something wrong in the 
establishment's HACCP system, and that the system needs to be 
carefully evaluated by the Agency.'' More recently, FSIS announced 
the same course of action for poultry products subject to pathogen 
reduction performance standards on February 11, 2016 (81 FR at 
7288).
---------------------------------------------------------------------------

    Although establishments producing 50,000 pounds or less of raw 
ground beef or beef manufacturing trimmings per day would not be 
subject to the proposed performance standards, FSIS would initiate 
follow-up sampling and/or conduct a PHRE or a FSA in these 
establishments when there is evidence of high levels of Salmonella 
contamination, e.g., three or more positive Salmonella sample results 
within a 52-week time period, and for any of the other reasons listed 
above. Recognizing that these lower-volume establishments are sampled 
much less frequently than the higher-volume establishments, FSIS 
requests comments on this approach.
    As previously announced, if any beef establishment produces product 
associated with a Salmonella illness outbreak identified minimally 
through epidemiological and/or traceback investigations, FSIS likely 
will consider the product to be adulterated under 21

[[Page 57693]]

U.S.C. 601(m)(3) because the product is ``* * * unsound, unhealthful, 
unwholesome, or otherwise unfit for human food'' (77 FR at 72689; Dec. 
6, 2012). In such cases, the Agency would request that the 
establishment recall the product if it is still in commerce. 
Additionally, in such situations, even if the establishment is meeting 
a Salmonella performance standard, FSIS will scrutinize its corrective 
actions closely and may conduct an Incident Investigation Team review 
(see FSIS Directive 5500.3 at https://www.fsis.usda.gov/wps/wcm/connect/bf3095f8-c6aa-4ed7-b819-45668c05c44b/5500.3.pdf?MOD=AJPERES).
    FSIS monitors relevant databases (e.g., those maintained by the CDC 
and the National Institutes of Health) for clinical isolates \27\ that 
match (via WGS) food isolates obtained by FSIS in its sampling of 
products produced by official establishments. This monitoring gives 
FSIS early warning that an outbreak involving an establishment's 
product could be developing. FSIS may alert its public health partners 
if it appears there are human illness (clinical isolates) and food 
isolate matches indicating a potential emerging outbreak. In such 
situations, FSIS may also collect distribution information (e.g., the 
consignee list) for product produced to be able to focus attention on 
the geographic area in which the affected product was distributed.
---------------------------------------------------------------------------

    \27\ In microbiology, the term ``isolates'' refers to strains of 
microorganisms isolated for study.
---------------------------------------------------------------------------

Cost-Benefit Analysis

    FSIS has considered the economic effects of the proposed pathogen 
reduction performance standards for Salmonella in raw ground beef and 
beef manufacturing trimmings. The full analysis is published on the 
FSIS website as supporting documentation to this notice. FSIS is 
seeking comment on the information and assumptions used in the cost-
benefit analysis. A summary of the analysis follows.

Industry Costs

    Establishments would incur costs as they make changes to their 
processes to meet the new performance standards. FSIS predicts that 
approximately 18 percent of the higher-volume raw ground beef 
establishments (about 14 establishments) and 20 percent of the higher-
volume beef manufacturing trimmings establishments (about 10 
establishments) would not initially meet the standards. As discussed 
above, higher-volume establishments produce more than 50,000 pounds of 
that particular product per day.
    Some establishments that initially do not meet the performance 
standards but aspire to do so would need to make changes to their 
production processes to lower the prevalence of Salmonella in their 
products. For example, affected establishments may conduct Salmonella 
sampling, apply antimicrobial interventions (including purchasing 
necessary capital equipment), reassess their HACCP plans and/or conduct 
training. FSIS expects that higher-volume raw ground beef and beef 
manufacturing trimmings establishments would be most likely to begin 
collecting samples for Salmonella testing in an effort to assure they 
would meet the updated or new performance standards. As an example, if 
the establishment currently collects samples to test for other 
pathogens, the establishment may begin including testing for Salmonella 
in its current sampling programs. Or, if the establishment does not 
currently collect any samples for pathogen testing, the establishment 
may begin collecting samples for Salmonella testing.
    Based on available information, FSIS expects that beef 
manufacturing trimmings establishments subject to the performance 
standard would be most likely to add antimicrobial interventions and 
equipment to their production process to meet the performance standard.
    FSIS estimates that not all establishments would make changes after 
not meeting the performance standards. For those establishments 
initially not meeting the performance standards, FSIS assumes 
approximately 50 percent would start making changes after one year and 
eventually would meet the standards in two years by making changes to 
their production process. To ensure a conservative cost estimate, FSIS 
assumes that those establishments making changes to their production 
processes would validate those changes and conduct employee training. 
For HACCP re-assessment, FSIS assumes that all establishments (100 
percent) that do not meet the standard will re-assess their HACCP plan. 
These costs are summarized and annualized over 10 years at a discount 
rate of 7 percent in Table 2.

                                       Table 2--Industry Costs Annualized
----------------------------------------------------------------------------------------------------------------
                                                                                      Primary
                         Cost component                            Low estimate      estimate      High estimate
----------------------------------------------------------------------------------------------------------------
Capital Equipment...............................................          $1,002          $1,002          $1,002
Antimicrobial Intervention......................................         147,998         147,998         147,998
Sampling........................................................       3,393,114       3,393,114       3,393,114
HACCP Reassessment..............................................          10,781          21,562          32,344
Employee Training...............................................           2,701           2,701           2,701
                                                                 -----------------------------------------------
    Total Costs *...............................................       3,555,596       3,556,377       3,577,159
----------------------------------------------------------------------------------------------------------------

Agency Costs

    FSIS does not expect the Agency to incur any budgetary impacts as a 
result of implementing the new or updated performance standards. FSIS 
intends to implement the two major components of the performance 
standards, product sampling/testing and follow-up actions, in such a 
way that they are resource neutral. At this time, FSIS is not expanding 
the overall number of samples it would analyze or collect. Instead, it 
would reallocate samples from lower-volume beef establishments. 
Moreover, since FSIS has already transitioned to continuous sampling 
for Salmonella in beef manufacturing trimmings and in raw ground beef, 
the number of samples FSIS would collect and analyze after the 
performance standard is implemented would remain the same. FSIS would 
not need to invest in additional laboratory equipment or additional 
personnel.
    The resources required for follow-up actions, namely PHREs, which 
may lead to FSAs, would also remain unchanged because very few 
establishments are expected to continue to not meet the

[[Page 57694]]

performance standards. In addition, in 2015, the FSA methodology was 
updated to include a PHRE. The PHRE is a remote evaluation performed by 
FSIS personnel to determine if an establishment's food safety system is 
effective. Information learned during the PHRE would be used to 
determine if an onsite FSA is warranted. FSIS personnel have been able 
to evaluate a greater number of establishments under the updated FSA 
methodology. FSIS intends to maintain its current FSA scheduling 
protocol, which combines risk-based and routine PHREs.

Benefits

    As beef establishments subject to the proposed performance 
standards make changes to their production processes and reduce the 
prevalence of Salmonella in raw ground beef and beef manufacturing 
trimmings, public health benefits would be realized in the form of 
averted illnesses. As discussed in the 2019 Risk Assessment, FSIS 
estimated the annual Salmonella foodborne illnesses associated with 
beef products. FSIS then estimated the number of annual illnesses 
attributed to products under the updated or new performance standards. 
Finally, FSIS estimated the number of illnesses averted if 50 percent 
of the establishments that do not meet the standards, meet the 
standards over the course of two years. Additionally, FSIS estimated 
the cost savings associated with the percentage reduction in human 
illnesses as calculated in the 2019 Risk Assessment. The estimated 
public health benefits from the illnesses averted as a result of the 
proposed Salmonella beef performance standards are summarized and 
annualized over 10 years at a discount rate of 7 percent in Table 3.

                                   Table 3--Public Health Benefits Annualized
----------------------------------------------------------------------------------------------------------------
                                    Percentage of
                                   establishments
                                    initially not
                                     meeting the     Averted illnesses
             Product               standards, but    due to salmonella             Cost of illness \*\
                                    then meet the
                                  standards over 2
                                        years
----------------------------------------------------------------------------------------------------------------
Raw Ground Beef and Beef                        50  8,900..............  $29,265,796.
 Manufacturing Trimmings.
                                                    (2,000-20,000) (5th- ($6,576,583-$65,765,834).
                                                     95th percentile).
----------------------------------------------------------------------------------------------------------------
* Cost of Illness annualized at a discount rate of 7% over 10 years, occurring one year after establishments
  would begin making changes.

Industry Benefits

    FSIS expects that industry would benefit from reduced Salmonella 
outbreak-related recalls. The negative impacts of recalls on industry 
include the loss of sales revenue, the cost to dispose of recalled 
products, and the loss of consumer confidence and business reputation. 
Recalls negatively impact consumers by creating anxiety and time-
consuming inconveniences (e.g., looking for recall information, 
checking products purchased to determine if they are part of the 
recall, returning or disposing of products identified by the recalls, 
and so on).
    FSIS expects the raw ground beef and beef manufacturing trimmings 
performance standards would lead to less contaminated products, because 
of industry actions taken to reduce Salmonella in products to meet the 
performance standards. The reduction in Salmonella would result in less 
exposure to the consumers that eat beef products and fewer illnesses, 
outbreaks and recalls.

Summary of Net Benefits

    Table 4 displays the total costs and benefits expected from the 
implementation of the performance standards for beef manufacturing 
trimmings and raw ground beef. FSIS annualized all values over 10 years 
at a 7 percent discount rate.

                                   Table 4--Summary of Estimated Net Benefits
----------------------------------------------------------------------------------------------------------------
                                                                                      Primary
  Compliance rate for establishments     Cost/benefit component    Low estimate      estimate      High estimate
  initially not meeting the standard                                  ($mil)          ($mil)          ($mil)
----------------------------------------------------------------------------------------------------------------
50%...................................  Industry Costs..........            3.56            3.57            3.58
                                        Public Health Benefits..            6.58           29.27           65.77
                                        Net Benefits............            3.02           25.70           62.19
----------------------------------------------------------------------------------------------------------------

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].

[[Page 57695]]

    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 online through the FSIS web page located at: 
http://www.fsis.usda.gov/federal-register.
    FSIS also will 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 at Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-23473 Filed 10-25-19; 8:45 am]
 BILLING CODE 3410-DM-P