[Federal Register Volume 87, Number 32 (Wednesday, February 16, 2022)]
[Notices]
[Pages 8774-8780]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2022-03301]



[[Page 8774]]

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DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2019-0023]


Changes to the Salmonella Verification Testing Program: Proposed 
Performance Standards for Salmonella in Raw Comminuted Pork and Intact 
or Non-Intact Pork Cuts 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 proposed pathogen reduction performance 
standards for Salmonella in raw comminuted pork and raw intact or non-
intact pork cuts. The Agency is also announcing how it plans to assess 
whether establishments producing these products are effectively 
addressing Salmonella using a moving window of FSIS sampling results. 
Approximately one year (52 weeks) after the new performance standards 
are made final, the Agency plans to post online each establishment's 
performance category, based on the most recent 52 Salmonella sample 
results. The notice discusses other verification activities related to 
FSIS Salmonella sampling and testing of raw pork products. Finally, the 
notice provides a brief summary of the Agency's recent announcements 
concerning Salmonella in poultry products. FSIS will consider comments 
received on this notice before announcing the final performance 
standards in the Federal Register and assessing whether pork 
establishments meet them.

DATES: Submit comments on or before April 18, 2022.

ADDRESSES: FSIS invites interested persons to submit comments on this 
notice. Comments may be submitted by one of the following methods:
    <bullet> 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 
https://www.regulations.gov. Follow the on-line instructions at that 
site for submitting comments.
    <bullet> Mail: Send to Docket Clerk, U.S. Department of 
Agriculture, Food Safety and Inspection Service, 1400 Independence 
Avenue SW, Mailstop 3758, Washington, DC 20250-3700.
    <bullet> Hand- or courier-delivered submittals: Deliver to 1400 
Independence Avenue SW, Jamie L. Whitten Building, Room 350-E, 
Washington, DC 20250-3700.
    Instructions: All items submitted by mail or electronic mail must 
include the Agency name and docket number FSIS-2019-0023. Comments 
received in response to this docket will be made available for public 
inspection and posted without change, including any personal 
information, to https://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, Washington, DC 20250-3700.

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

SUPPLEMENTARY INFORMATION: FSIS administers a regulatory program under 
the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.) that is 
intended to ensure that meat and meat food products distributed in 
commerce are wholesome; not adulterated; and properly marked, labeled, 
and packaged. As part of its inspection program, FSIS collects samples 
of these products for laboratory analysis (21 U.S.C. 642(a)).
    Salmonella bacteria are among the most frequent causes of foodborne 
illness. These bacteria reside in the gastrointestinal tract and hide 
or hair 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 hair, or be transferred to the carcass, and can 
contaminate raw products during slaughter and subsequent fabrication 
and further processing). Currently, events that cause contamination of 
pork 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 pork 
carcasses into products, including raw comminuted pork and raw intact 
or non-intact pork cuts.\1\
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    \1\ FSIS defines ``comminuted pork'' as pork that has been 
ground, mechanically separated, or otherwise processed to reduce 
particle size; an ``intact pork cut'' as a smaller cut derived from 
a pork primal cut that has not been subjected to processing that 
renders it non-intact; and a ``non-intact pork cut'' also as a 
smaller cut but that has been injected, mechanical tenderized, 
reconstructed, vacuum-tumbled, scored and marinated, or otherwise 
processed to render it non-intact.
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    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 and/or that produce selected 
classes of raw meat products, including pork carcasses, based on FSIS 
baseline study data (9 CFR 310.25(b)).\2\ In 2012, FSIS stopped 
sampling and testing for Salmonella in pork carcasses because percent 
positive findings were very low \3\ and the carcass sampling was not a 
good use of Agency resources. In the 2019 rule to modernize swine 
slaughter, FSIS removed the Salmonella pathogen reduction performance 
standards associated with pork carcasses and sausages from the 
regulations (84 FR 52300; Oct. 1, 2019). In that rule, FSIS also noted 
that it is testing pork cuts and comminuted pork products for 
Salmonella and expected to decide in 2019 whether to develop new 
pathogen performance standards for these products (82 FR 52318).
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    \2\ As noted in Table 2 at 9 CFR 310.25(b), FSIS intended to add 
a pathogen reduction performance standard for fresh pork sausage. 
FSIS collected data in 1998 and 1999 but a performance standard for 
fresh pork sausage was never finalized.
    \3\ At the time, FSIS estimated the prevalence of Salmonella in 
market hogs was 1.66% with a 95% confidence interval between 0.82% 
and 2.51%. See the Nationwide Microbiological Baseline Data 
Collection Program: Market Hogs Survey August 2010-August 2011; 
available at https://www.fsis.usda.gov/sites/default/files/
media_file/2020-07/Baseline_Data_Market_Hogs_2010-
2011.pdf#:~:text=The%20Market%20Hogs%20Baseline%20Survey%20%28MHBS%29
%20was%20conducted,at%20pre-evisceration%20and%20post-
chill%20and%20between%20production%20shifts.
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    The Centers for Disease Control and Prevention (CDC) first 
estimated the role of pork products in salmonellosis cases by analyzing 
outbreak data collected between 1998 and 2008.\4\ The estimated 
percentage of foodborne illnesses attributed to pork for this time 
period was 6.2 percent, with lower- and upper-bound estimates of 3.6 
and 11.4 percent, respectively.\5\ In 2011, the CDC, Food

[[Page 8775]]

and Drug Administration, and FSIS teamed up to form the Interagency 
Food Safety Analytics Collaboration (IFSAC). Using outbreaks between 
1998 and 2017, the IFSAC estimates suggest pork is responsible for 10.3 
percent of domestic cases of salmonellosis among all foods, with lower- 
and upper-bound estimates of 7.7 and 13.1 percent, respectively.\6\ 
This represents about 30 percent of all domestic foodborne Salmonella 
illnesses among FSIS-regulated products. This makes pork the second 
highest contributor to Salmonella illnesses associated with products 
regulated by FSIS, behind chicken.
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    \4\ Painter, J.A., Ayers, T., Woodruff, R., Blanton, E., Perez, 
N., Hoekstra, R.M., Griffin, P.M., Braden, C., 2009. Recipes for 
foodborne outbreaks: A scheme for categorizing and grouping 
implicated foods. Foodborne Pathogens and Disease 6, 1259-1264.
    \5\ Painter, J.A., Hoekstra, R.M., Ayers, T., Tauxe, R.V., 
Braden, C.R., Angulo, F.J., Griffin, P.M., 2013. Attribution of 
foodborne illnesses, hospitalizations, and deaths to food 
commodities, United States, 1998-2008. Emerging Infectious Diseases 
19, 407-415.
    \6\ IFSAC, 2019; available at https://www.cdc.gov/foodsafety/ifsac/pdf/P19-2017-report-TriAgency-508-revised.pdf.
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    In 2013, FSIS committed to a 25-percent reduction in annual 
salmonellosis illnesses attributed to the products it regulates.\7\ The 
25-percent reduction goal was set to meet Healthy People 2020 
objectives. FSIS will continue to use a 25-percent reduction as its 
intended target for salmonellosis illness reductions to meet Healthy 
People 2030, under which the objectives are unchanged.\8\ FSIS requests 
comment on this intended target for salmonellosis illness reductions 
and whether the Agency should consider a more stringent reduction 
(e.g., 30 percent).
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    \7\ FSIS Salmonella Action Plan; available at https://www.fsis.usda.gov/sites/default/files/media_file/2020-10/SAP-120413.pdf.
    \8\ Available at https://health.gov/healthypeople.
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Recent Announcements Concerning Salmonella in Poultry

    On October 19, 2021, USDA announced that FSIS would be mobilizing a 
stronger and more comprehensive effort to reduce Salmonella illnesses 
associated with poultry products.\9\ A key component of this effort is 
identifying ways to incentivize use of preharvest controls to reduce 
Salmonella contamination coming into the slaughterhouse.
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    \9\ https://www.fsis.usda.gov/news-events/news-press-releases/special-alert-constituent-update-usda-launches-new-effort-reduce.
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    In November 2021, FSIS held roundtable listening sessions with 
industry and consumer groups to answer questions about establishment 
pilot projects. On December 3, in its Constituent Update, FSIS invited 
poultry slaughter and processing establishments to submit proposals for 
pilot projects that will test different control strategies for 
Salmonella contamination in poultry products.\10\ FSIS explained that 
Pilot projects will last for a defined period of time, during which 
establishments will experiment with new or existing pathogen control 
and measurement strategies and share data collected during the pilots 
with FSIS. FSIS also explained that data will be analyzed by FSIS to 
determine whether it supports changes to FSIS' existing Salmonella 
control strategies.
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    \10\ USDA FSIS Constituent Update, Dec. 3, 2021, available at: 
https://www.fsis.usda.gov/news-events/news-press-releases/constituent-update-december-3-2021.
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    In this notice, FSIS is proposing Salmonella performance standards 
for certain pork products. If we adopt a revised approach to 
performance standards for Salmonella in poultry, the Agency may also 
propose future changes to the pork standards.

Public Health Concerns

    There have been multiple outbreaks attributed to the consumption of 
pork in recent years. Between 2014 and 2016, CDC identified a total of 
approximately 772 persons sickened and 93 persons hospitalized with 
Salmonella resulting from 19 pork associated outbreaks. One individual 
died.\11\ Two of these outbreaks resulted in recalls. In 2015, the CDC 
confirmed a multi-state outbreak of Salmonella I 4,[5],12:i:- and 
Salmonella Infantis that resulted in 192 illnesses and 30 
hospitalizations.\12\ This outbreak led to a recall of approximately 
523,000 pounds of pork products.\13\ In 2016, the CDC confirmed a 
single-state outbreak of Salmonella I 4,[5],12:i:- that resulted in 15 
illnesses. This outbreak led to a recall of approximately 11,700 pounds 
of pork products.\14\ Between 2017 and 2019, a total of approximately 
475 persons were sickened and 93 persons hospitalized with Salmonella 
resulting from 15 pork associated outbreaks. One individual died.\15\
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    \11\ Available at https://www.cdc.gov/norsdashboard/.
    \12\ Available at https://www.cdc.gov/salmonella/pork-08-15/index.html.
    \13\ FSIS Recall 110-2015; available at Kapowsin Meats Recalls 
Pork Product Due To Possible Salmonella Contamination [verbar] Food 
Safety and Inspection Service (usda.gov).
    \14\ Available at Kapowsin Meats Inc. Recalls Pork Products Due 
To Possible Salmonella Contamination [verbar] Food Safety and 
Inspection Service (usda.gov).
    \15\ Available at https://www.cdc.gov/norsdashboard/.
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    The outbreaks referenced here suggest that Salmonella in raw pork 
is a continuing public health concern. The changes described below will 
apply to most of the pork consumed in the United States and will likely 
improve FSIS' ability to detect Salmonella by focusing increased 
sampling on the largest establishments that produce the greatest amount 
of product. Also discussed below, FSIS has developed performance 
standards that will likely lead establishments producing raw pork 
products to strengthen their own Salmonella control measures. Such 
changes at establishments will likely have a positive impact on public 
health.

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 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.\16\ FSIS intends to use this moving window approach for pork 
establishments that produce raw comminuted pork and/or raw intact or 
non-intact pork cuts that will be subject to the new Salmonella 
performance standards.
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    \16\ 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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    In preparation for the implementation of the new performance 
standards, FSIS has begun Salmonella sampling in all pork 
establishments that produce greater than 1,000 pounds of raw comminuted 
pork and greater than 1,000 pounds of raw intact or non-intact pork 
cuts per day.\17\ FSIS currently assigns samples five times per month 
in pork establishments producing greater than 6,000 pounds per day of 
raw comminuted pork and/or greater than 50,000 pounds per day of raw 
intact or non-intact pork cuts. FSIS samples less frequently in the 
lower-volume establishments.
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    \17\ FSIS Notice 41-19, Raw Pork Products Sampling Program; Oct. 
28, 2019.
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    FSIS will use the results of this sampling to gain additional 
information on the prevalence of Salmonella in these products and to 
make sure the data continue to support the standards. FSIS ensures that 
result information is made available to establishments. Note that FSIS 
does not recognize Salmonella in raw pork products as a pathogen that 
would ordinarily render the product injurious to health, and thus an 
adulterant within the meaning of 21 U.S.C. 601(m)(1). As such, 
currently and

[[Page 8776]]

when new standards are in place, individual Salmonella sample results 
will not result in regulatory control actions.

Illness Reduction Goals

    As explained above, FSIS has committed, with its public health 
partners, to a 25-percent reduction in annual cases of salmonellosis. 
Using published results,\18\ FSIS estimates a median of about 122,000 
annual cases of salmonellosis associated with the consumption of raw 
pork contaminated with Salmonella. FSIS estimates that approximately 
34,000 of these illnesses are associated with raw comminuted pork and 
88,000 of these illnesses are associated with raw intact or non-intact 
pork cuts. Thus, to meet the 25-percent reduction goal, there would 
need to be about 8,300 and 21,600 fewer annual Salmonella illnesses 
from raw comminuted pork and raw intact or non-intact pork cuts, 
respectively.
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    \18\ Scallan, et al., 2011; IFSAC 2019.
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Pathogen Reduction Performance Standards

    With the goal of reducing Salmonella in raw pork products, the 
Agency is proposing two new pathogen reduction performance standards--
one for Salmonella in raw comminuted pork and another for Salmonella in 
raw intact or non-intact pork cuts.\19\
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    \19\ Data collected during Phase 2 of the RPPESP showed the 
percentage of positive samples for raw comminuted pork, intact pork 
cuts, and non-intact cuts was 16.4, 9.4, and 6.3, respectively. 
However, FSIS found no significant difference in the percentage of 
positive samples from intact pork cuts and non-intact pork cuts, so 
the two product classes were combined into a single product class. 
The percentage of Salmonella-positive samples for the combined 
product class was 8.7%.
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    Sampling evidence suggests that these two pork product classes 
differ with respect to Salmonella contamination occurrence. The 
prevalence of Salmonella in raw comminuted is about 30% while the 
combined percent positive for raw intact or non-intact pork cuts is 
about nine percent. Therefore, FSIS is proposing separate performance 
standards for each of these product classes.
    The modeling methods for developing the proposed pathogen reduction 
performance standards and predictions for the public health effect of 
those standards are described in FSIS' Public Health Effects of 
Performance Standards for raw Comminuted Pork and raw Pork Cuts (2020 
Pork Risk Assessment)(cite when posts).
    Because the pork product industry is relatively concentrated by 
production volume, that is, a relatively small number of establishments 
produce most of the raw pork, FSIS developed pathogen reduction 
performance standards for each of the above product classes based on an 
average daily production volume threshold. The proposed performance 
standards would be applicable to establishments producing greater than 
6,000 pounds per day in the case of raw comminuted pork and/or greater 
than 50,000 pounds per day in the case of raw intact and/or non-intact 
pork cuts. This approach would account for approximately 96 percent of 
raw comminuted pork and 91 percent of raw intact and non-intact pork 
cuts produced annually. And as further explained in the 2020 Pork Risk 
Assessment, the approach would also focus Agency resources on that part 
of the pork industry where Salmonella contamination is most clustered.
    FSIS intends to collect and analyze 52 samples per year for each 
establishment subject to the performance standards. Analyzing this 
number of samples would provide strong evidence that an establishment 
is meeting the performance standard.
    FSIS has opted at this time not to propose pathogen reduction 
performance standards in lower-volume establishments (i.e., those 
producing less than or equal to 6,000 pounds per day of raw comminuted 
pork and/or less than or equal to 50,000 pounds per day of raw intact 
or non-intact pork cuts). A summary of the new performance standards is 
provided in Table 1.

 Table 1--New Performance Standards for Salmonella in Raw Comminuted (Ground) Pork and Raw Intact or Non-Intact
                                                    Pork Cuts
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                                                                                               Minimum number of
                                                                                               samples needed to
     Product (establishment volume (pounds/day))            Maximum number of  allowable            assess
                                                                 positive  samples               establishment
                                                                                                 performance *
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Raw Comminuted Pork (>6,000).........................  13 of 52.............................                  52
Raw Intact or Non-Intact Pork Cuts (>50,000).........  6 of 52..............................                  52
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* Any establishment with more than the maximum number of allowable positive samples for that product class in a
  52-week window would be categorized as Category 3 even when less than the minimum number of samples (52) are
  collected/analyzed.

Raw Comminuted Pork

    For raw comminuted pork, FSIS is proposing a pathogen reduction 
performance standard for Salmonella of 13 allowable positives out of 52 
samples. This standard would be applied to establishments producing 
greater than 6,000 pounds of raw comminuted pork per day (approximately 
10 percent of establishments that produce this product class, 138 
establishments). As mentioned above, FSIS would continue to assign 
samples five times per month in all establishments producing greater 
than 6,000 pounds of eligible product per day with the intention of 
collecting and analyzing 52 samples in a 52-week window.
    FSIS predicts that approximately 44 percent of establishments 
(about 61 establishments) would initially not meet this performance 
standard. Once implemented, if about half (45%) of the establishments 
producing greater than 6,000 pounds of raw comminuted pork 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 8,300 (95% uncertainty 
interval: 3,600-16,300).

Raw Intact or Non-Intact Pork Cuts

    For both raw intact and non-intact pork cuts, FSIS is proposing a 
single pathogen reduction performance standard for Salmonella of 6 
allowable positives out of 52 samples in a 52-week window. This 
standard would be applied to establishments producing greater than 
50,000 pounds of these products per day (approximately 4 percent of 
establishments producing

[[Page 8777]]

this product class, 38 establishments). Approximately 39 percent of 
these establishments (about 15 establishments) are predicted to 
initially not meet this performance standard (i.e., would be 
categorized as Category 3). Once implemented, if about half (45%) of 
the establishments producing greater than 50,000 pounds of raw intact 
or non-intact pork cuts 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 21,600 (95% uncertainty interval: 10,000-40,000).

Specifics of the 52-Week Window Approach and Categorizing 
Establishments

    As stated, the performance standard is intended to apply to 52 
samples in a 52-week window. If FSIS analyzes more than 52 samples in a 
52-week window, the most recent 52 sample results in that 52-week 
window would be used to categorize the establishment. Although 
unlikely, there may be rare occasions when fewer than 52 samples are 
analyzed in these establishments within a 52-week window. If fewer than 
52 samples are analyzed, the establishment's status would be reported 
as ``N/A,'' provided the establishment has fewer than the minimum 
number of allowable Salmonella positives for that product class in that 
window. Any establishment with more than the minimum number of 
allowable Salmonella positives for that product class in a 52-week 
window would be categorized as Category 3 (outlined below), regardless 
of the number of samples collected/analyzed in that window.

Web-Posting Establishment Performance

    Should FSIS move forward with finalizing the proposed pathogen 
reduction performance standards for Salmonella in raw comminuted pork 
and raw intact or non-intact pork cuts, FSIS would announce the final 
standards and the sample dates FSIS will use to assess whether 
establishments meet the standards in a subsequent Federal Register 
notice. About one year after FSIS starts assessing whether 
establishments meet the standards, FSIS would determine individual 
establishment performance based on the last 52 FSIS Salmonella sample 
results and then report on the FSIS website the category of each 
establishment subject to the performance standard using the following 
criteria:
    <bullet> Category 1: Establishments with 50% or less of the 
allowable number of positive Salmonella sample results for that product 
class during the most recent 52-week window, based on the last 52 FSIS 
Salmonella sample results.
    <bullet> Category 2: Establishments with greater than 50% but not 
more than the allowable number of positive Salmonella sample results 
for that product class during the most recent 52-week window, based on 
the last 52 FSIS Salmonella sample results.
    <bullet> Category 3: Establishments with more than the allowable 
number of positive Salmonella sample results for that product class 
during the most recent 52-week window, based on the last 52 FSIS 
Salmonella sample results.
    During the period after FSIS begins to make performance assessments 
based on the proposed standards, and before the performance standards 
are implemented, FSIS intends to make available monthly aggregate 
information relative to status (i.e., Category 1, Category 2, or 
Category 3) 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 comminuted pork 
and raw intact or non-intact pork cuts.

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 reasonably likely to occur 
(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)).
    When a pork 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 conduct follow-up sampling after the establishment is 
categorized as Category 3 to verify the adequacy of corrective actions 
taken by the establishment. 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 standard. Follow-up 
sampling for establishments that do not meet the raw comminuted pork 
and/or raw pork cuts 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.\20\
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    \20\ See also FSIS Notice 17-19, Follow-up Sampling in Raw 
Poultry Establishments Not Meeting Salmonella Performance Standards; 
June 4, 2019.
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    In addition, FSIS may conduct a Public Health Risk Evaluation 
(PHRE), a decision-making process that is used by Agency enforcement 
and investigation personnel, for any pork establishment that (a) does 
not meet a Salmonella pathogen reduction performance standard; (b) has 
produced products with repetitive Salmonella serotypes of public health 
concern \21\ or repetitive antibiotic-resistant Salmonella; and/or (c) 
has Salmonella whole-genome sequencing (WGS) matching those found in 
recent outbreaks or epidemiologically linked to illnesses (see FSIS 
Directive 5100.4 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) \22\ at the establishment.
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    \21\ 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.
    \22\ 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

[[Page 8778]]

practices,\23\ after notifying a pork establishment that it is in 
Category 3 (has not met a pathogen reduction performance standard), 
FSIS would conduct an assessment of the establishment's HACCP plan and 
Sanitation SOPs, 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 pork 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' follow-up and routine sampling and in some cases from the results 
of a PHRE or 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.
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    \23\ 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 7288).
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    Although establishments producing less than or equal to 6,000 
pounds per day of raw comminuted pork and/or less than or equal to 
50,000 pounds per day of raw intact or non-intact pork cuts would not 
be subject to the proposed performance standards, FSIS may initiate 
follow-up sampling and/or conduct a PHRE or a FSA in these 
establishments when there is evidence of a high level of Salmonella 
contamination and for any of the reasons listed above, other than 
failing to meet the performance standard.
    Establishments producing less than or equal to 1,000 pounds per day 
would not be sampled and are not eligible for performance standards. 
However, recognizing that establishments producing greater than 1,000 
pounds per day but less than or equal to 6,000 pounds per day of raw 
comminuted pork, and greater than 1,000 pounds per day but less than or 
equal to 50,000 pounds per day of raw intact or non-intact pork cuts, 
would not be subject to the proposed performance standards, FSIS would 
continue the current sampling program discussed above to monitor this 
population of lower volume establishments.\24\ FSIS would sample and 
test product from these establishments at a yearly rate that would 
allow the Agency to determine whether there has been a significant 
change in Salmonella prevalence at these establishments by +/-5 
percent. FSIS would review changes in prevalence over time in aggregate 
for this population of establishments and determine whether it is 
improving. If not, FSIS may increase sampling at that volume class in 
order to assess what is happening at the establishment level.
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    \24\ FSIS Notice 41-19, Raw Pork Products Sampling Program; Oct. 
28, 2019.
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    As previously announced in a 2012 Federal Register notice on Agency 
verification procedures, if any livestock establishment produces 
product associated with a Salmonella illness outbreak identified 
through epidemiological and/or traceback investigations, FSIS likely 
will consider the product to be adulterated under 21 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 \25\ 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, so as to focus its attention on 
the geographic area in which the affected product was distributed.
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    \25\ In microbiology, the term ``isolates'' refers to strains of 
microorganisms isolated for study.
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Cost-Benefit Analysis

    FSIS has considered the economic effects of the proposed pathogen 
reduction performance standards for Salmonella in raw comminuted pork 
and raw intact or non-intact pork cuts. The full analysis is published 
on the FSIS website as supporting documentation to this notice ([insert 
link]). FSIS is seeking comment on the information and assumptions used 
in the cost-benefit analysis. A summary of the analysis follows.

Industry Costs

    FSIS predicts that approximately 44 percent of the medium and 
higher-volume raw comminuted pork establishments (about 61 
establishments) and 39 percent of the higher-volume intact or non-
intact pork cuts establishments (about 15 establishments) would not 
initially meet the standards. Establishments meeting the performance 
standards would not have any cost associated with these standards. In 
order to ensure their HACCP systems are functioning correctly, 
establishments not meeting the performance standards would incur cost 
associated with a HACCP plan reassessment and possibly with an Agency 
Food Safety Assessment (FSA), the associated primary industry costs 
being $18,203 and $1,361, respectively, annualized at the 7 percent 
discount rate over 10 years.
    Establishments that initially do not meet the proposed standards 
but aspire to do so, would incur additional cost. For those 
establishments initially not meeting the performance standards, FSIS 
assumes approximately 45 percent would start making changes after one 
year and eventually would meet the standards in two years by making 
changes to their production process. Based on available information, 
FSIS expects that these establishments would most likely add 
antimicrobial interventions and equipment to their production process 
to meet the performance standard, with an associated primary cost of 
$1,236,391, annualized at the 7 percent discount rate over 10 years. 
These establishments may also add Salmonella testing to their existing 
sampling program or start Salmonella sampling and testing, with an 
associated primary cost of $122,451, annualized at the 7 percent 
discount rate over 10 years. These establishments would also likely 
validate their HACCP plans, and/or conduct training, with an associated 
total primary industry cost of $114,903 and $11,097, annualized at the

[[Page 8779]]

7 percent discount rate over 10 years, respectively.
    Total industry cost ranges from $1,163,796 to $1,842,518, with a 
primary estimate of $1,504,406, annualized at the 7 percent discount 
rate over 10 years, table 2. The majority of these costs are associated 
with antimicrobial equipment maintenance and labor incurred by 
establishments that initially do not meet the performance standards but 
attempt to meet the standards. Establishments that meet the performance 
standards would incur minimal cost associated with lost product due to 
FSIS Salmonella sampling.

Agency Costs

    The raw comminuted pork and raw intact or non-intact performance 
standards would require FSIS sampling, which would incur Agency cost 
for follow-up sampling. FSIS estimates that total sampling for the 
performance standards, including follow-up sampling and lower-volume 
sampling, would be 12,232 samples. However, in 2021 FSIS planned for 
8,640 raw comminuted pork Salmonella samples and 2,400 raw intact or 
non-intact pork cuts samples for a total of 11,040 samples \26\ for the 
Raw Pork Sampling Program.\27\ The raw comminuted pork and raw intact 
or non-intact performance standards would replace the Raw Pork Sampling 
Program, leading to a net increase of 1,192 samples, which are 
attributed to follow-up sampling. The primary cost estimate for the 
additional 1,192 follow-up samples is $81,508, annualized at the 7 
percent discount rate over ten years.
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    \26\ FSIS Annual Sampling Plan FY2021: Table A3: FY 2020 and FY 
2021 Sample Numbers for Raw Pork; available at https://www.fsis.usda.gov/sites/default/files/media_file/2021-02/fsis-annual-sampling-plan-fy2021.pdf.
    \27\ FSIS Notice: Raw Pork Parts Sampling Program; available at 
https://www.fsis.usda.gov/wps/wcm/connect/e2176090-7257-4d6e-9964-e9b8a512d8b5/41-19.pdf?MOD=AJPERES.
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    FSIS would also incur costs from PHREs and FSAs. Pork 
establishments that do not meet the Salmonella pathogen reduction 
performance standards would be prioritized for a PHRE. A portion of the 
establishments that receive a PHRE would also have an FSA.\28\ The 
combined PHRE and FSA primary cost estimate is $20,988, annualized at 
the 7 percent over 10 years.
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    \28\ EIAO Public Health Risk Evaluation (PHRE) methodology 
Implementation of FSIS Directive 5100.4 (September 2016) report. The 
FSA cost estimate includes travel cost to the establishment.
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    The total Agency cost for follow-up sampling, PHREs and FSAs ranges 
from $0.06 million to $0.18 million, with a primary estimate of $0.10 
million, annualized at the 7 percent over 10 years, table 2.

Public Health Benefits

    As pork establishments subject to the proposed performance 
standards make changes to their production processes and reduce the 
prevalence of Salmonella in raw comminuted pork and intact or non-
intact pork cuts, public health benefits would be realized in the form 
of averted illnesses. The Agency's policy of web-posting 
establishments' process control performance may stimulate improvement 
in industry performance. FSIS data show that sharing this information 
provides an incentive for establishments to further reduce Salmonella 
levels, which is necessary to reduce foodborne illness due to 
salmonellosis and protect consumers. For instance, in the poultry 
industry, after the Agency's announcement in 2006 that it was 
considering posting the names of broiler and turkey slaughter 
establishments with their respective performance standard categories 
based on Salmonella verification testing, the number of broiler 
slaughter establishments that had been in Category 3 decreased by 55 
percent.\29\ As discussed in the 2020 Risk Assessment, FSIS estimated 
the annual Salmonella foodborne illnesses associated with pork 
products. FSIS then estimated the number of annual illnesses attributed 
to products subject to the updated or new performance standards. 
Finally, FSIS estimated the number of illnesses averted if 45 percent 
of the establishments that do not initially 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 2020 Risk Assessment. The 
estimated public health benefits from the illnesses averted because of 
the proposed Salmonella pork performance standards ranges from $49.09 
million to $203.24 million, with a primary estimate of $107.94 million, 
annualized at the 7 percent discount rate over 10 years, table 2.
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    \29\ FSIS defined the following categories for broiler and 
turkey slaughter establishments in 2006: Category 1: Consistent 
Process Control: Establishments that have achieved 50 percent or 
less of the Salmonella maximum allowable percent positive during all 
completed 52-week moving windows over the last 3 months. Category 2. 
Variable Process Control: Establishments that meet the Salmonella 
maximum allowable percent positive for all completed 52-week moving 
windows but have results greater than 50 percent of the maximum 
allowable percent positive during any completed 52-week moving 
window over the last 3 months. Category 3. Highly Variable Process 
Control: Establishments that have exceeded the Salmonella maximum 
allowable percent positive during any completed 52-week moving 
window over the last 3 months. Changes to the Salmonella and 
Campylobacter Verification Testing Program, Federal Register, Vol. 
80, No. 16, January 26, 2015. Docket No. FSIS-2014-0023.
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Industry Benefits

    FSIS expects that industry would benefit from reduced outbreak-
related recalls. The negative impacts of recalls on industry include 
the loss of sales revenue, the loss of consumer confidence and 
consumers shifting away from meat products.\30\ Recalls negatively 
impact consumers by creating anxiety and time-consuming inconveniences 
(e.g., looking for recall information, checking the products purchased, 
returning or disposing of products identified by the recalls, and so 
on). FSIS expects the proposed raw comminuted pork and intact or non-
intact pork cuts performance standards would lead to fewer contaminated 
products, because of industry actions taken to reduce Salmonella in 
these products to meet the proposed performance standards. The 
reduction in Salmonella would result in less exposure to Salmonella for 
consumers that eat pork products and fewer illnesses, outbreaks, and 
recalls.
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    \30\ Marsh, T.L., T.C. Schroeder, J. Mintert. (2004). Impacts of 
Meat Product Recalls on Consumer Demand in the USA. Applied 
Economics. 36(9):897-909. URL accessed on July 1, 2020; available at 
http://ses.wsu.edu/publication/impacts-of-meat-product-recalls-on-consumer-demand-in-the-usa/.
---------------------------------------------------------------------------

Summary of Net Benefits

    Table 2 displays the total costs and benefits expected from the 
implementation of the performance standards for raw comminuted pork and 
raw intact or non-intact pork cuts establishments. There would be 138 
establishments subject to the raw comminuted pork performance standard 
and 38 establishments subject to the intact or non-intact pork cuts 
performance standard. These establishments represent 96 and 91 percent 
of total production volume, respectively. The proposed performance 
standards would lead to industry cost for these establishments and FSIS 
would incur Agency cost implementing these standards. Benefits would 
occur once establishments who initially do not meet the standard make 
changes to meet the performance standards. The net benefits are the 
public health benefits minus the industry and agency cost. The 
estimated net benefits associated with the proposed Salmonella pork 
performance standards range from $47.87 million to $201.22

[[Page 8780]]

million, with a primary estimate of $106.33 million, annualized at the 
7 percent discount rate over 10 years, table 2.

                                 Table 2--Summary of Estimated Net Benefits \1\
----------------------------------------------------------------------------------------------------------------
                                                                                      Primary
          Compliance rate \2\            Cost/benefit component    Low estimate      estimate      High estimate
                                                                      ($mil)          ($mil)          ($mil)
----------------------------------------------------------------------------------------------------------------
45%...................................  Industry Costs..........           $1.16           $1.50           $1.84
                                        Agency Cost.............            0.06            0.10            0.18
                                        Public Health Benefits..           49.09          107.94          203.24
                                        Net Benefits \3\........           47.87          106.33          201.22
----------------------------------------------------------------------------------------------------------------
\1\ All costs (savings) annualized at a discount rate of 7 percent over 10 years. Numbers in table may not sum
  to totals due to rounding.
\2\ Compliance rate for establishments initially not meeting the proposed standards, but then meeting the
  proposed standards over 2 years.
\3\ Numbers in the table may not sum to totals due to rounding.

USDA Non-Discrimination Statement

    In accordance with Federal civil rights law and U.S. Department of 
Agriculture (USDA) civil rights regulations and policies, the USDA, its 
Agencies, offices, and employees, and institutions participating in or 
administering USDA programs are prohibited from discriminating based on 
race, color, national origin, religion, sex, gender identity (including 
gender expression), sexual orientation, disability, age, marital 
status, family/parental status, income derived from a public assistance 
program, political beliefs, or reprisal or retaliation for prior civil 
rights activity, in any program or activity conducted or funded by USDA 
(not all bases apply to all programs). Remedies and complaint filing 
deadlines vary by program or incident.
    Persons with disabilities who require alternative means of 
communication for program information (e.g., Braille, large print, 
audiotape, American Sign Language, etc.) should contact the responsible 
Agency or USDA's TARGET Center at (202) 720-2600 (voice and TTY) or 
contact USDA through the Federal Relay Service at (800) 877-8339. 
Additionally, program information may be made available in languages 
other than English.
    To file a program discrimination complaint, complete the USDA 
Program Discrimination Complaint Form, AD-3027, found online at https://www.usda.gov/oascr/how-to-file-a-program-discrimination-complaint and 
at any USDA office or write a letter addressed to USDA and provide in 
the letter all of the information requested in the form. To request a 
copy of the complaint form, call (866) 632-9992. Submit your completed 
form or letter to USDA by: (1) Mail: U.S. Department of Agriculture, 
Office of the Assistant Secretary for Civil Rights, 1400 Independence 
Avenue SW, Washington, DC 20250-9410; (2) fax: (202) 690-7442; or (3) 
email: <a href="/cdn-cgi/l/email-protection#58282a373f2a39357631362c39333d18643978302a3d3e65" http: usda.gov">usda.gov</a>">program.intake@usda.gov</a>.
    USDA is an equal opportunity provider, employer, and lender.

Additional Public Notification

    Public awareness of all segments of rulemaking and policy 
development is important. Consequently, FSIS will announce this Federal 
Register publication online through the FSIS web page located at: 
https://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 https://www.fsis.usda.gov/subscribe. Options range from recalls to export 
information, regulations, directives, and notices. Customers can add or 
delete subscriptions themselves and have the option to password protect 
their accounts.

Paul Kiecker,
Administrator.
[FR Doc. 2022-03301 Filed 2-15-22; 8:45 am]
BILLING CODE 3410-DM-P


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