[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]]
-----------------------------------------------------------------------
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.
-----------------------------------------------------------------------
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:
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.
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.
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\
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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).
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\9\ https://www.fsis.usda.gov/news-events/news-press-releases/special-alert-constituent-update-usda-launches-new-effort-reduce.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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/.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\17\ FSIS Notice 41-19, Raw Pork Products Sampling Program; Oct.
28, 2019.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\18\ Scallan, et al., 2011; IFSAC 2019.
---------------------------------------------------------------------------
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\
---------------------------------------------------------------------------
\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%.
---------------------------------------------------------------------------
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
----------------------------------------------------------------------------------------------------------------
Minimum number of
samples needed to
Product (establishment volume (pounds/day)) Maximum number of allowable assess
positive samples establishment
performance *
----------------------------------------------------------------------------------------------------------------
Raw Comminuted Pork (>6,000)......................... 13 of 52............................. 52
Raw Intact or Non-Intact Pork Cuts (>50,000)......... 6 of 52.............................. 52
----------------------------------------------------------------------------------------------------------------
* 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:
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.
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.
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\
---------------------------------------------------------------------------
\20\ See also FSIS Notice 17-19, Follow-up Sampling in Raw
Poultry Establishments Not Meeting Salmonella Performance Standards;
June 4, 2019.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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).
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\24\ FSIS Notice 41-19, Raw Pork Products Sampling Program; Oct.
28, 2019.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\25\ 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 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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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.
---------------------------------------------------------------------------
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.
---------------------------------------------------------------------------
\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: usda.gov">program.intake@usda.gov.
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