Changes to the Salmonella Verification Testing Program: Proposed Performance Standards for Salmonella in Raw Ground Beef and Beef Manufacturing Trimmings and Related Agency Verification Procedures, 57688-57695 [2019-23473]
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Notices
Federal Register
Vol. 84, No. 208
Monday, October 28, 2019
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS–2018–0045]
Changes to the Salmonella Verification
Testing Program: Proposed
Performance Standards for Salmonella
in Raw Ground Beef and Beef
Manufacturing Trimmings and Related
Agency Verification Procedures
Food Safety and Inspection
Service, USDA.
ACTION: Notice and request for
comments.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is announcing
and requesting comment on new
pathogen reduction performance
standards for Salmonella in raw ground
beef and beef manufacturing trimmings.
The Agency is also announcing how
it plans to assess whether
establishments producing raw ground
beef and/or beef manufacturing
trimmings are effectively addressing
Salmonella, using a 52-week moving
window of FSIS sampling results and
other related verification activities.
Approximately one year (52 weeks) after
the new standards are made final, the
Agency plans to post individual
establishment performance as either
‘‘meeting’’ or ‘‘not meeting’’ the
pathogen reduction performance
standard on the FSIS website, based on
the most recent 48 Salmonella sample
results.
Finally, FSIS is also announcing that
it intends to increase Salmonella
sampling to once per week in beef
establishments that produce greater than
50,000 pounds of raw ground beef and
beef manufacturing trimmings per day,
so that a sufficient number of
Salmonella samples (i.e., 48) are
collected to assess these establishments’
performance against the new
Salmonella performance standards.
Note that FSIS will continue to analyze
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SUMMARY:
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these beef manufacturing trimmings
samples for Escherichia coli O517:H7
and applicable non-O157 Shiga-toxin
producing E. coli (STEC); FSIS will
continue to analyze these ground beef
samples for E. coli O157:H7. Although
unlikely with this change, if fewer than
48 samples are collected or analyzed in
a 52-week window at an establishment,
its status would be reported as ‘‘N/A,’’
provided the establishment has two or
fewer Salmonella positives in that
window.
FSIS will consider comments received
on this notice before announcing the
final performance standards in the
Federal Register and assessing whether
establishments meet them.
DATES: Submit comments on or before
December 27, 2019.
ADDRESSES: FSIS invites interested
persons to submit comments on this
notice. Comments may be submitted by
one of the following methods:
• Federal eRulemaking Portal: This
website provides commenters the ability
to type short comments directly into the
comment field on the web page or to
attach a file for lengthier comments. Go
to https://www.regulations.gov. Follow
the on-line instructions at that site for
submitting comments.
• Mail, including CD–ROMs, etc.:
Send to Docket Clerk, U.S. Department
of Agriculture, Food Safety and
Inspection Service, 1400 Independence
Avenue SW, Mailstop 3758, Room 6065,
Washington, DC 20250–3700.
• Hand- or courier-delivered
submittals: Deliver to 1400
Independence Avenue SW, Room 6065,
Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2018–0045. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to 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, Room 6065,
Washington, DC 20250–3700.
FOR FURTHER INFORMATION CONTACT:
Terri Nintemann, Assistant
Administrator, Office of Policy and
Program Development by telephone at
(202) 205–0495.
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FSIS is
responsible for verifying that the
nation’s commercial supply of meat,
poultry, and egg products is safe,
wholesome, and properly labeled and
packaged.
Salmonella bacteria are among the
most frequent causes of foodborne
illness. These bacteria reside in the
gastrointestinal tract and other organs of
food animals; therefore, they also are
good indicators for food product
contamination with enteric pathogens.
Salmonella are often introduced during
the rearing of live animals, e.g.,
Salmonella may contaminate the
exterior of an animal on the farm,
remain attached to the animal’s hide or
carcass, and can contaminate raw beef
products during slaughter and
subsequent fabrication and further
processing. Currently, events that cause
contamination of beef carcasses cannot
be completely eliminated from
commercial slaughter, fabrication, or
further processing operations.
Contamination can be minimized,
however, with the use of proper sanitary
dressing procedures and through the
application of antimicrobial
interventions during the slaughter,
fabrication, and further processing of
carcasses into beef products, including
ground beef.
FSIS began its Salmonella verification
testing program with the final rule
entitled ‘‘Pathogen Reduction; Hazard
Analysis and Critical Control Point
Systems’’ (PR/HACCP Rule), published
on July 25, 1996 (61 FR 38805). Among
other things, the PR/HACCP Rule
established Salmonella pathogen
reduction performance standards for
establishments that slaughter selected
classes of food animals 1 and/or that
produce selected classes of raw ground
products. FSIS continues to use
pathogen reduction performance
standards as a measure of process
control and to ensure that
establishments are consistently
controlling or reducing harmful bacteria
not ordinarily considered adulterants in
raw meat and poultry products.2
SUPPLEMENTARY INFORMATION:
1 In 2011, FSIS stopped sampling and testing for
Salmonella in beef carcasses (steers and heifers and
cows and bulls) because percent positive findings
were very low; less than one percent. FSIS sampling
and testing for Salmonella in raw ground beef
continued, however.
2 The Agency’s ability to directly enforce the
pathogen reduction performance standards in 9 CFR
310.25 has been limited since 2001, after a ruling
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Because of continued outbreaks of
Salmonella illness associated with the
consumption of ground beef products,
FSIS is proposing to update its
Salmonella performance standard for
raw ground beef and establish a new
performance standard for beef
manufacturing trimmings,3 the primary
component of raw ground beef. These
updated and new performance
standards would address the market
failure from information asymmetry
between producers and buyers. Absent
these standards, buyers could not
readily identify the difference in
Salmonella levels across producers. A
summary of the most recent Salmonella
outbreaks linked to ground beef and
FSIS’s responses to these outbreaks that
ultimately led to the development of the
new performance standards follows.
In 2011, FSIS investigated a multiState outbreak of 20 Salmonella
Typhimurium infections linked to the
consumption of ground beef.4 Eight
people were hospitalized, and the
outbreak strain was resistant to at least
seven antibiotics. In 2012, an
establishment recalled approximately
30,000 pounds of raw ground beef
linked to a multi-state outbreak of
Salmonella Enteritidis with 46 persons
infected.5 Twelve people were
hospitalized. Also, in 2012, the Centers
for Disease Control and Prevention
(CDC) confirmed a single-State outbreak
from ground beef contaminated with
Salmonella Enteritidis that resulted in
24 illnesses. Two people were
hospitalized. In 2013, 22 persons from
six States were infected with
Salmonella Typhimurium linked to
ground beef.6 Seven people were
hospitalized.
In response to these outbreaks, on
August 28, 2013, FSIS published in the
by the U.S. Court of Appeals for the Fifth Circuit
in Supreme Beef Processors, Inc. v. USDA. In that
case, the court enjoined FSIS from suspending
inspection services against a meat grinding
operation for failure to meet the Salmonella
performance standards. Since that time, FSIS has
used Salmonella failures as a basis to conduct an
in-depth evaluation of the establishment’s Hazard
Analysis and Critical Control Point systems,
including its HACCP plan and Sanitation Standard
Operating Procedures.
3 FSIS defines ‘‘beef manufacturing trimmings’’ as
trim produced from cattle (including veal) that are
slaughtered at the establishment where the FSIS
sampling is occurring. Beef manufacturing
trimmings include trim of any size and primal or
subprimal cuts, such as chucks, rounds, or shanks,
or boneless beef of any size used at the slaughter
establishment for non-intact use, or that is intended
for raw non-intact use by other establishments.
4 https://www.cdc.gov/salmonella/2011/groundbeef-2-1-2012.html.
5 https://www.cdc.gov/salmonella/enteritidis-0712/; FSIS Recall 045–2012.
6 https://www.cdc.gov/salmonella/typhimurium01-13/; FSIS Recalls 008–2013 and 009–
2013.
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Federal Register a notice announcing
changes it was making to its Salmonella
verification testing program for raw beef
products intended for non-intact use (78
FR 53017). Specifically, FSIS
announced that it would begin
analyzing for Salmonella all samples of
raw ground beef, beef manufacturing
trimmings, bench trim, and other raw
ground beef components that it already
collects for STEC testing, including raw
ground beef products that FSIS samples
at retail stores, and imported shipments
of raw ground beef, trim, and other raw
ground beef components that FSIS
samples at official import inspection
establishments. In addition, FSIS
announced that it was increasing the
raw ground beef analytical sample
portion from 25 grams to 325 grams.7
FSIS explained that the likelihood of
detecting positive samples increases
with the analytical portion size. FSIS
also described how it intended to use
the results generated from its raw
ground beef (‘‘MT43’’) and beef
manufacturing trimmings (‘‘MT60’’)
verification testing programs to estimate
the Salmonella prevalence in those
products and to develop updated or new
pathogen reduction performance
standards.
Finally, FSIS stated in this notice that
it was considering alternatives to setbased sampling for Salmonella,
including routine sampling throughout
the year used in conjunction with a
‘‘moving window’’ approach to assess
process control in establishments
subject to performance standards. FSIS
explained that this approach would
allow for on-going scheduled
Salmonella sampling, similar to the
approach FSIS has used for STEC
sampling and would provide FSIS with
more flexibility for scheduling sample
collections at different establishments.
After reviewing the comments
received on the August 2013 notice,
FSIS announced in the Federal Register
that it was implementing the plans in
that notice on June 5, 2014 (79 FR
32436). Thus, on June 29, 2014, FSIS
discontinued Salmonella sampling set
procedures for raw ground beef
products (the ‘‘HC01’’ sampling
program) and stopped assessing whether
establishments met the codified
pathogen reduction performance
standards for ground product, except in
those establishments in Category 3.8 9 At
7 After the Agency increased the analytical
sample portion from 25 grams to 325 grams, FSIS
stopped using the Salmonella performance standard
for ground beef Table 2 in 9 CFR 310.25(b) because
it was established on the basis of prevalence as
measured by a 25-gram sample.
8 An establishment in Category 3 is exceeding the
Salmonella performance standard. FSIS Notice 28–
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the same time, FSIS began co-analyzing
for Salmonella all samples of raw beef
products it collects for STEC analysis
(including imported raw beef products)
using the larger analytical sample
portion. FSIS collects raw beef products
for STEC analysis and Salmonella
analysis regardless of production
volume; FSIS did not establish a low
volume exemption for beef
establishments for FSIS STEC or
Salmonella verification testing. FSIS has
posted the aggregate results of this
testing as part of its quarterly sampling
project results reporting.10
Notably, in 2015, the CDC published
an analysis of beef-related outbreaks
from 1973–2011 and reported that
ground beef is now a significant source
of Salmonella outbreaks and that
stronger measures are needed to
decrease contamination of raw ground
beef with Salmonella.11
Beginning in 2016 and ending in
2017, the CDC reported 106 illnesses in
21 States associated with Salmonella
Newport from ground beef.12 One
person died, and 42 people were
hospitalized. Notably, the CDC is
currently investigating a multi-State
illness outbreak from beef products
contaminated with Salmonella
Newport.13 To date, this outbreak has
resulted in 403 illnesses from 30 States,
with 117 people hospitalized. On
October 4, 2018, approximately 6.5
million pounds of beef products,
including ground beef, were recalled
due to this outbreak and an expansion
of the recall with an additional 5.2
million pounds of beef products
occurred on December 4, 2018.14
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
14 instructed FSIS inspectors to continue set testing
at establishments in Category 3 until the
establishment is in Category 1 or 2.
9 FSIS discontinued all sampling sets for ground
beef products in establishments in Category 3 in
June 2015.
10 https://www.fsis.usda.gov/wps/portal/fsis/
topics/data-collection-and-reports/microbiology/
sampling-project-results.
11 Laufer, A., Grass, J., Holt, K., Whichard, J.,
Griffin, P., Gould, L., 2015. Outbreaks of Salmonella
infections attributed to beef—United States, 1973–
2011. Epidemiology and Infection 143, 2003–2013.
12 https://www.cdc.gov/mmwr/volumes/67/wr/
mm6715a2.htm.
13 https://www.cdc.gov/salmonella/newport-1018/.
14 FSIS Recall 085–2018.
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would collect samples more frequently
in higher-volume establishments and
less frequently in lower-volume
establishments. The 52-week window
obviates the need to account directly for
seasonal fluctuations in contamination
frequency.15 FSIS intends to use a
similar approach for beef establishments
that produce raw ground beef and/or
beef manufacturing trimmings that will
be subject to the updated or new
Salmonella performance standards. As
further explained below, the category
reported for each establishment would
be based on the last 48 FSIS Salmonella
sample results during the most recent
52-week window.
Healthy People 2020 (HP2020) Goals
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Food safety is a key component of the
Healthy People (HP) initiative, with an
entire focus area dedicated to joint FSIS,
Food and Drug Administration (FDA),
and CDC efforts to reduce foodborne
illness, including salmonellosis, in the
population. Under the HP2020 goals,
FSIS committed, with its public health
partners, to a 25-percent reduction in
annual cases of salmonellosis.16 Using
published results from the CDC,17 FSIS
estimates a median of about 80,000
annual cases of salmonellosis associated
with the consumption of cuts of intact
beef and ground beef contaminated with
Salmonella. FSIS estimates that
approximately 53 percent of these
illnesses are associated with ground
beef. Thus, to meet the 25-percent
reduction goal, there would need to be
10,600 fewer annual illnesses caused by
raw ground beef contaminated with
Salmonella.18
15 FSIS (2015). Public health effects of raw
chicken parts and comminuted chicken and poultry
performance standards. Washington, DC, United
States Department of Agriculture; Williams, M.S.,
Ebel, E.D., Golden, N.J., Schlosser, W.D. (2014).
Temporal patterns in the occurrence of Salmonella
in raw meat and poultry products and their
relationship to human illnesses in the United
States. Food Control 35(1): 267–273.
16 Once the Healthy People 2030 objectives have
been finalized, FSIS intends to assess whether
changes to its performance standards are warranted.
17 Scallan et al., 2011; Painter et al., 2013
18 Moving forward, FSIS plans to utilize more
recent estimates of foodborne illness source
attribution to estimate cases of foodborne illness
attributed to FSIS-regulated products. These
estimates, produced by the Interagency Food Safety
Analytics Collaboration (IFSAC), a tri-agency group
with representatives from the CDC, FDA, and FSIS,
uses foodborne outbreak data to produce
harmonized, annual attribution estimates for
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Pathogen Reduction Performance
Standards
With the goal of reducing Salmonella
in raw ground beef products, the
Agency is proposing an updated and a
new pathogen reduction performance
standard for Salmonella in raw ground
beef and in beef manufacturing
trimmings (the primary component of
ground beef), respectively. Because the
ground beef industry is highly
concentrated by production volume,
FSIS developed pathogen reduction
performance standards for each product
class based on a daily production
volume threshold. Both proposed
performance standards would be
applicable to higher-volume
establishments (i.e., those producing
greater than 50,000 pounds of these
products per day). This approach would
account for approximately 91 percent of
the total raw ground beef and 96 percent
of the total beef manufacturing
trimmings production volume annually.
And as further explained in FSIS’s
Public Health Effects of Performance
Standards for Ground Beef and Beef
Manufacturing Trimmings (2019 Risk
Assessment),19 the approach would also
focus Agency resources on raw ground
beef establishments shown to have the
highest Salmonella prevalence. FSIS
predicts that most higher-volume beef
establishments would meet the
proposed performance standards.
FSIS’s goal is to collect and analyze
at least 48 samples per year for each
establishment producing greater than
50,000 pounds of ground beef or beef
manufacturing trimmings per day.
Analyzing this number of samples
would provide strong evidence that an
establishment is either meeting or not
meeting the performance standards. To
achieve this goal, FSIS plans to change
how it currently assigns STEC sampling
and thus Salmonella sampling in
higher-volume beef establishments
producing ground beef and/or beef
manufacturing trimmings by increasing
the sample collection frequency from a
maximum of four times per month to
once per week for these product classes.
FSIS intends to implement this change
in a resource neutral manner by
Salmonella, Escherichia coli O157, Listeria
monocytogenes, and Campylobacter.
19 Available at https://www.fsis.usda.gov/wps/
wcm/connect/8a38566a-6d6c-4c96-85ce41fd02050358/beef-ps-aug2019.pdf?MOD=AJPERES.
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reallocating resources from lowervolume beef establishments (i.e., those
producing 50,000 pounds or less per
day). As noted above, FSIS samples less
frequently in the lower-volume
establishments. The Agency requests
comments on the proposed changes.
The methods for developing the
proposed pathogen reduction
performance standards and predictions
for the public health effect of those
standards are described in the 2019 Risk
Assessment. FSIS used the same
methodology to estimate the public
health effects for the young chicken and
turkey carcass Salmonella and
Campylobacter performance standards
in 2011 20 and to develop pathogen
reduction performance standards for
Salmonella and Campylobacter in raw
chicken parts and not-ready-to-eat
(NRTE) comminuted chicken and turkey
products in 2015.21
FSIS has opted not to propose
pathogen reduction performance
standards for raw ground beef and/or
beef manufacturing trimmings in lowervolume establishments (i.e., those
producing 50,000 pounds or less per
day of these products) at this time. FSIS
will, however, continue co-analyzing for
Salmonella in all samples it collects for
STEC analysis from these
establishments to monitor ongoing
pathogen prevalence. A summary of the
updated or new performance standards
is provided in Table 1.
Since there are not enough data (i.e.,
samples collected and tested) for
components of ground beef other than
beef manufacturing trimmings, e.g.,
esophagus (weasand) meat, head meat,
and cheek meat to estimate a national
prevalence, FSIS is not proposing a
pathogen reduction performance
standard for such products at this time.
With that said, FSIS will continue to
analyze its testing data to better
understand the potential for
contamination in these products. Such
information could be used by the
Agency to decide whether a pathogen
reduction performance standard for one
or more of these components is also
necessary. FSIS is seeking comment on
the merits of developing a pathogen
reduction performance standard for
components of raw ground beef other
than beef manufacturing trimmings.
20 76
21 80
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FR 15282; Mar. 14, 2011.
FR at 3940; Jan. 26, 2015.
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57691
TABLE 1—UPDATED OR NEW PERFORMANCE STANDARDS FOR SALMONELLA IN RAW GROUND BEEF AND BEEF
MANUFACTURING TRIMMINGS
Product (establishment volume
(lbs./day))
Maximum number of allowable positive samples
Raw Ground Beef (>50,000) ..................................................
Beef Manufacturing Trimmings (>50,000) ..............................
2 of 48 ....................................................................................
2 of 48 ....................................................................................
Minimum number
of samples
needed to assess
establishment
performance *
48
48
* Any establishment with three or more Salmonella positives in a 52-week window would be categorized as not meeting the performance
standard even when less than the minimum number of samples (48) are collected/analyzed.
Raw Ground Beef
For raw ground beef, FSIS is
proposing a pathogen reduction
performance standard for Salmonella of
two allowable positives out of 48
samples. This standard would be
applied to all higher-volume
establishments, which includes those
producing more than 50,000 pounds of
raw ground beef product per day
(approximately 75 establishments). As
mentioned above, FSIS intends to assign
samples weekly in all establishments
producing more than 50,000 pounds of
eligible product per day with the goal of
collecting and analyzing 48 samples in
a 52-week window.
FSIS predicts that approximately 18
percent of establishments (about 14
establishments) would initially not meet
this performance standard. Once
implemented, if about half of the
establishments producing more than
50,000 pounds of raw ground beef per
day that are not meeting the proposed
performance standard subsequently
begin to meet this standard, this should
result in about a 25-percent reduction in
Salmonella illnesses from that product.
The median expected number of
illnesses avoided per year would be
about 8,900 (90% Uncertainty Interval:
2,000–20,000).
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Specifics of the 52-Week Window
Approach and Categorizing
Establishments
As stated, the performance standard is
intended to apply to 48 samples in a 52week window. If FSIS collects and
analyzes more than 48 samples in a 52week window, the most recent 48
sample results in that 52-week window
would be used to categorize the
establishment. Although unlikely with
the proposed reallocation of sampling
resources, there may be rare occasions
when fewer than 48 samples are
collected and analyzed in these
establishments within a 52-week
window. If fewer than 48 samples are
collected or analyzed, the
establishment’s status would be
reported as ‘‘N/A,’’ provided the
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establishment has two or fewer
Salmonella positives in that window.
Any establishment with three or more
Salmonella positives in a 52-week
window would be categorized as not
meeting the performance standard
regardless of the number of samples
collected/analyzed in that window.
Beef Manufacturing Trimmings
For beef manufacturing trimmings,
FSIS is also proposing a pathogen
reduction performance standard for
Salmonella of two allowable positives
out of 48 samples in a 52-week window
that would be applied to eligible
establishments producing more than
50,000 pounds of this product per day
(approximately 49 establishments).
Approximately 20 percent of
establishments (about 10
establishments) are predicted to initially
not meet this performance standard.
The specifics of the 52-week window
and categorizing establishments are the
same as above. Each establishment’s
category status (i.e., meeting, not
meeting, or N/A) for beef manufacturing
trimmings would be reported as
described above for raw ground beef.
FSIS has chosen not to attribute any
averted illnesses resulting from the
proposed performance standard for beef
manufacturing trimmings because this
product is not consumed directly. FSIS
believes, however, that a performance
standard is needed for beef
manufacturing trimmings to assist
grinding establishments that purchase
this product for further processing in
managing Salmonella contamination in
their ground beef. For example, a
grinding operation may opt to change
beef manufacturing trimmings suppliers
if its current supplier is categorized as
not meeting the beef manufacturing
trimmings Salmonella performance
standard and has not taken actions to
reduce Salmonella contamination in its
product; this is especially true if the
grinding operation is concerned about
not meeting the raw ground beef
Salmonella performance standard and
wants to mitigate the chances of that
outcome. Although reductions in
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Salmonella surface contamination on
beef manufacturing trimmings should
reduce contamination of raw ground
beef, the specific magnitude of this
reduction is uncertain.
Web-Posting Establishment Performance
FSIS announced that it intended to
post the category status for all
establishments subject to pathogen
reduction performance standards
because web posting delivers greater
transparency, thereby providing the
public with the tools and information it
needs to make informed food safety
decisions (80 FR at 3948; Jan. 26, 2015).
FSIS intends to post the category status
for all beef establishments subject to the
pathogen reduction performance
standards announced in this notice
upon implementation.
FSIS currently assesses poultry
establishment performance weekly
based on the most recent 52-week
window of FSIS sample results (83 FR
56046; Nov. 9, 2018). As explained in
the November 2018 Federal Register
notice, FSIS no longer includes followup sampling results when calculating an
establishment’s category. On or about
the 20th of the month, FSIS posts the
category of individual establishments
producing an eligible product on the
FSIS website.22
Should FSIS move forward with
finalizing the proposed pathogen
reduction performance standards for
Salmonella in raw ground beef and beef
manufacturing trimmings, FSIS would
announce the final standards and an
effective date in a subsequent Federal
Register notice. About one year after the
final standards go into effect, FSIS
would determine individual
establishment performance based on the
last 48 FSIS Salmonella sample results
and then report on the FSIS website the
status of each establishment subject to
the performance standards as either
22 Individual establishment category information
is posted on FSIS’s website at https://
www.fsis.usda.gov/wps/portal/fsis/topics/datacollection-and-reports/microbiology/salmonellaverification-testing-program/salmonellaverification-testing-program.
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meeting or not meeting the particular
standard using the following criteria:
Meeting. Establishments with no more than
the allowable number of positive Salmonella
sample results for that product class during
the 52-week window ending the last
Saturday of the previous month, based on the
last 48 FSIS Salmonella sample results.
Not Meeting. Establishments with more
than the allowable number of positive
Salmonella sample results for that product
class during the 52-week window ending the
last Saturday of the previous month, based
on the last 48 FSIS Salmonella sample
results.
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In the interim between the final
standards becoming effective and when
the status of individual establishments
is posted, FSIS intends to make
available monthly aggregate information
relative to status (i.e., meeting or not
meeting the performance standard) for
all establishments subject to sampling
under the final performance standards,
using the most recent FSIS Salmonella
sample results. This information will be
aggregated and will not identify any
specific establishment. FSIS would
make this information available to give
industry and other stakeholders timely
information about progress being made
to reduce Salmonella contamination in
raw ground beef and beef manufacturing
trimmings.
Related Agency Verification Actions
An establishment that does not meet
a pathogen reduction performance
standard or produces product that has
been associated with an outbreak may
not have adequately addressed the food
safety hazard, Salmonella, in its HACCP
system. If the establishment considers
Salmonella reasonably likely to occur
and addresses Salmonella in its HACCP
plan, it must take corrective actions as
required in 9 CFR 417.3(a). If the
establishment considers Salmonella not
reasonably likely to occur, it must take
corrective actions and reassess its
HACCP plan for that product to
determine whether the plan needs to be
modified to address Salmonella as a
hazard (9 CFR 417.3(b)). To maintain an
adequate HACCP system, the
establishment may need to address the
pathogen Salmonella in its HACCP
plan, rather than through Sanitation
Standard Operating Procedures
(Sanitation SOPs) or another
prerequisite program. Corrective actions
taken in response to exceeding a
pathogen reduction performance
standard would need to be documented
in records subject to verification by FSIS
as required in 9 CFR 417.3(c)).
Consistent with FSIS inspection
program personnel instructions for
poultry establishments currently subject
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to performance standards, when a beef
establishment does not meet a
Salmonella performance standard (i.e.,
when the number of positive samples
within a specified timeframe exceeds
the number of allowable positives for
that product class), FSIS may initiate
follow-up sampling after the
establishment is first categorized as not
meeting the performance standard to
verify the adequacy of corrective actions
taken by the establishment. FSIS would
likely co-analyze any follow-up samples
for STEC, as applicable to that product
class. The follow-up samples would not
count towards the samples collected as
part of the moving window procedure
for assessing whether the establishment
meets the standards, which is consistent
with FSIS procedures for poultry
performance standards (83 FR at 56048).
Follow-up sampling for establishments
that do not meet the raw ground beef
and/or beef manufacturing performance
standard for an extended period of time,
or that fluctuate between meeting or not
meeting one or both of these
performance standards, would occur at
a frequency determined by FSIS.23
In addition, FSIS would schedule a
Public Health Risk Evaluation (PHRE)
for any beef establishment that (a) does
not meet a Salmonella pathogen
reduction performance standard; (b) has
produced products with repetitive
Salmonella serotypes of public health
concern 24 or repetitive antibioticresistant Salmonella; and/or (c) has
Salmonella whole-genome sequencing
(WGS) and/or pulsed-field gel
electrophoresis patterns matching those
found in recent outbreaks or
epidemiologically linked to illnesses
(see FSIS Directive 5100.1 at https://
www.fsis.usda.gov/wps/wcm/connect/
6c30c8b0-ab6a-4a3c-bd87fbce9bd71001/5100.4.pdf?
MOD=AJPERES). FSIS would use the
results of the PHRE to determine
whether to schedule a Food Safety
Assessment (FSA) 25 at the
establishment.
As explained above, and also
consistent with existing FSIS
23 See FSIS Notice 17–19 for additional
information on follow-up sampling in poultry
establishments, available at https://
www.fsis.usda.gov/wps/wcm/connect/e16cfd598f8a-48a5-a607-999c9eecfec2/1719.pdf?MOD=AJPERES.
24 Information about the 20 most frequently
reported Salmonella serotypes reported to the
CDC’s Laboratory-based Enteric Disease
Surveillance system is available at https://
www.cdc.gov/nationalsurveillance/pdfs/2016Salmonella-report-508.pdf.
25 The purpose of an FSA is to assess and analyze
an establishment’s food safety system to verify that
the establishment is able to produce safe and
wholesome meat or poultry products in accordance
with FSIS statutory and regulatory requirements.
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Frm 00005
Fmt 4703
Sfmt 4703
practices,26 after notifying a beef
establishment that it has not met a
pathogen reduction performance
standard, FSIS would conduct an
assessment of the establishment’s
HACCP plan and SSOPs, through a
PHRE and possible subsequent FSA,
focusing on the establishment’s
corrective actions, HACCP plan
reassessment (if applicable), and the
effectiveness of the establishment’s
system for controlling Salmonella in
raw beef products. In addition, when
necessary, FSIS would develop a plan to
verify whether the establishment
implemented corrective actions. If, after
120 days from not meeting the standard,
the establishment has not been able to
demonstrate reduced variability of
process control, as determined from
FSIS’s follow-up and routine sampling
and from the results of the PHRE and in
some cases an FSA, and the
establishment has not taken corrective
actions, FSIS would likely take an
enforcement action, such as issuing a
Notice of Intended Enforcement (NOIE)
or suspending inspection, under the
conditions and according to the
procedures described in 9 CFR part 500.
FSIS would not issue an NOIE or
suspend inspection based solely on the
fact that an establishment did not meet
a pathogen reduction performance
standard for Salmonella.
Although establishments producing
50,000 pounds or less of raw ground
beef or beef manufacturing trimmings
per day would not be subject to the
proposed performance standards, FSIS
would initiate follow-up sampling and/
or conduct a PHRE or a FSA in these
establishments when there is evidence
of high levels of Salmonella
contamination, e.g., three or more
positive Salmonella sample results
within a 52-week time period, and for
any of the other reasons listed above.
Recognizing that these lower-volume
establishments are sampled much less
frequently than the higher-volume
establishments, FSIS requests comments
on this approach.
As previously announced, if any beef
establishment produces product
associated with a Salmonella illness
outbreak identified minimally through
epidemiological and/or traceback
investigations, FSIS likely will consider
the product to be adulterated under 21
26 FSIS stated in a Federal Register notice
published April 16, 2003 (68 FR 18593), that it was
using Salmonella sample-set failures ‘‘as an
indication that there is something wrong in the
establishment’s HACCP system, and that the system
needs to be carefully evaluated by the Agency.’’
More recently, FSIS announced the same course of
action for poultry products subject to pathogen
reduction performance standards on February 11,
2016 (81 FR at 7288).
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Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices
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-b81945668c05c44b/5500.3.pdf?
MOD=AJPERES).
FSIS monitors relevant databases (e.g.,
those maintained by the CDC and the
National Institutes of Health) for clinical
isolates 27 that match (via WGS) food
isolates obtained by FSIS in its sampling
of products produced by official
establishments. This monitoring gives
FSIS early warning that an outbreak
involving an establishment’s product
could be developing. FSIS may alert its
public health partners if it appears there
are human illness (clinical isolates) and
food isolate matches indicating a
potential emerging outbreak. In such
situations, FSIS may also collect
distribution information (e.g., the
consignee list) for product produced to
be able to focus attention on the
geographic area in which the affected
product was distributed.
Cost-Benefit Analysis
FSIS has considered the economic
effects of the proposed pathogen
reduction performance standards for
Salmonella in raw ground beef and beef
manufacturing trimmings. The full
analysis is published on the FSIS
website as supporting documentation to
this notice. FSIS is seeking comment on
the information and assumptions used
in the cost-benefit analysis. A summary
of the analysis follows.
Industry Costs
Establishments would incur costs as
they make changes to their processes to
meet the new performance standards.
FSIS predicts that approximately 18
percent of the higher-volume raw
ground beef establishments (about 14
establishments) and 20 percent of the
higher-volume beef manufacturing
trimmings establishments (about 10
establishments) would not initially meet
the standards. As discussed above,
higher-volume establishments produce
more than 50,000 pounds of that
particular product per day.
Some establishments that initially do
not meet the performance standards but
aspire to do so would need to make
changes to their production processes to
lower the prevalence of Salmonella in
their products. For example, affected
establishments may conduct Salmonella
sampling, apply antimicrobial
interventions (including purchasing
necessary capital equipment), reassess
their HACCP plans and/or conduct
training. FSIS expects that highervolume raw ground beef and beef
manufacturing trimmings
establishments would be most likely to
begin collecting samples for Salmonella
testing in an effort to assure they would
57693
meet the updated or new performance
standards. As an example, if the
establishment currently collects samples
to test for other pathogens, the
establishment may begin including
testing for Salmonella in its current
sampling programs. Or, if the
establishment does not currently collect
any samples for pathogen testing, the
establishment may begin collecting
samples for Salmonella testing.
Based on available information, FSIS
expects that beef manufacturing
trimmings establishments subject to the
performance standard would be most
likely to add antimicrobial interventions
and equipment to their production
process to meet the performance
standard.
FSIS estimates that not all
establishments would make changes
after not meeting the performance
standards. For those establishments
initially not meeting the performance
standards, FSIS assumes approximately
50 percent would start making changes
after one year and eventually would
meet the standards in two years by
making changes to their production
process. To ensure a conservative cost
estimate, FSIS assumes that those
establishments making changes to their
production processes would validate
those changes and conduct employee
training. For HACCP re-assessment,
FSIS assumes that all establishments
(100 percent) that do not meet the
standard will re-assess their HACCP
plan. These costs are summarized and
annualized over 10 years at a discount
rate of 7 percent in Table 2.
TABLE 2—INDUSTRY COSTS ANNUALIZED
Low
estimate
Cost component
High
estimate
Capital Equipment .......................................................................................................................
Antimicrobial Intervention ............................................................................................................
Sampling ......................................................................................................................................
HACCP Reassessment ...............................................................................................................
Employee Training .......................................................................................................................
$1,002
147,998
3,393,114
10,781
2,701
$1,002
147,998
3,393,114
21,562
2,701
$1,002
147,998
3,393,114
32,344
2,701
Total Costs * .........................................................................................................................
3,555,596
3,556,377
3,577,159
Agency Costs
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Primary
estimate
FSIS does not expect the Agency to
incur any budgetary impacts as a result
of implementing the new or updated
performance standards. FSIS intends to
implement the two major components of
the performance standards, product
sampling/testing and follow-up actions,
in such a way that they are resource
neutral. At this time, FSIS is not
expanding the overall number of
samples it would analyze or collect.
Instead, it would reallocate samples
from lower-volume beef establishments.
Moreover, since FSIS has already
transitioned to continuous sampling for
Salmonella in beef manufacturing
trimmings and in raw ground beef, the
number of samples FSIS would collect
and analyze after the performance
standard is implemented would remain
the same. FSIS would not need to invest
in additional laboratory equipment or
additional personnel.
The resources required for follow-up
actions, namely PHREs, which may lead
to FSAs, would also remain unchanged
because very few establishments are
expected to continue to not meet the
27 In microbiology, the term ‘‘isolates’’ refers to
strains of microorganisms isolated for study.
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16:58 Oct 25, 2019
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Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices
performance standards. In addition, in
2015, the FSA methodology was
updated to include a PHRE. The PHRE
is a remote evaluation performed by
FSIS personnel to determine if an
establishment’s food safety system is
effective. Information learned during the
PHRE would be used to determine if an
onsite FSA is warranted. FSIS personnel
have been able to evaluate a greater
number of establishments under the
updated FSA methodology. FSIS
intends to maintain its current FSA
scheduling protocol, which combines
risk-based and routine PHREs.
Benefits
As beef establishments subject to the
proposed performance standards make
changes to their production processes
and reduce the prevalence of
Salmonella in raw ground beef and beef
manufacturing trimmings, public health
benefits would be realized in the form
of averted illnesses. As discussed in the
2019 Risk Assessment, FSIS estimated
the annual Salmonella foodborne
illnesses associated with beef products.
FSIS then estimated the number of
annual illnesses attributed to products
under the updated or new performance
standards. Finally, FSIS estimated the
number of illnesses averted if 50 percent
of the establishments that do not meet
the standards, meet the standards over
the course of two years. Additionally,
FSIS estimated the cost savings
associated with the percentage
reduction in human illnesses as
calculated in the 2019 Risk Assessment.
The estimated public health benefits
from the illnesses averted as a result of
the proposed Salmonella beef
performance standards are summarized
and annualized over 10 years at a
discount rate of 7 percent in Table 3.
TABLE 3—PUBLIC HEALTH BENEFITS ANNUALIZED
Percentage of
establishments
initially not
meeting the
standards, but
then meet the
standards over
2 years
Product
Raw Ground Beef and Beef Manufacturing
Trimmings.
Averted illnesses due to salmonella
50
Cost of illness *
8,900 ..............................................................
$29,265,796.
(2,000–20,000) (5th–95th percentile) .............
($6,576,583–$65,765,834).
* Cost of Illness annualized at a discount rate of 7% over 10 years, occurring one year after establishments would begin making changes.
Industry Benefits
FSIS expects that industry would
benefit from reduced Salmonella
outbreak-related recalls. The negative
impacts of recalls on industry include
the loss of sales revenue, the cost to
dispose of recalled products, and the
loss of consumer confidence and
business reputation. Recalls negatively
impact consumers by creating anxiety
and time-consuming inconveniences
(e.g., looking for recall information,
checking products purchased to
determine if they are part of the recall,
returning or disposing of products
identified by the recalls, and so on).
FSIS expects the raw ground beef and
beef manufacturing trimmings
performance standards would lead to
less contaminated products, because of
industry actions taken to reduce
Salmonella in products to meet the
performance standards. The reduction
in Salmonella would result in less
exposure to the consumers that eat beef
products and fewer illnesses, outbreaks
and recalls.
Summary of Net Benefits
Table 4 displays the total costs and
benefits expected from the
implementation of the performance
standards for beef manufacturing
trimmings and raw ground beef. FSIS
annualized all values over 10 years at a
7 percent discount rate.
TABLE 4—SUMMARY OF ESTIMATED NET BENEFITS
Compliance rate
for
establishments
initially not
meeting the
standard
50% ..................................
Industry Costs ...............................................................................
Public Health Benefits ...................................................................
Net Benefits ...................................................................................
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USDA Non-Discrimination Statement
No agency, officer, or employee of the
USDA shall, on the grounds of race,
color, national origin, religion, sex,
gender identity, sexual orientation,
disability, age, marital status, family/
parental status, income derived from a
public assistance program, or political
beliefs, exclude from participation in,
deny the benefits of, or subject to
VerDate Sep<11>2014
Low
estimate
($mil)
Cost/benefit component
16:58 Oct 25, 2019
Jkt 250001
discrimination any person in the United
States under any program or activity
conducted by the USDA.
How To File a Complaint of
Discrimination
To file a complaint of discrimination,
complete the USDA Program
Discrimination Complaint Form, which
may be accessed online at https://
www.ocio.usda.gov/sites/default/files/
PO 00000
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Fmt 4703
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3.56
6.58
3.02
Primary
estimate
($mil)
3.57
29.27
25.70
High
estimate
($mil)
3.58
65.77
62.19
docs/2012/Complain_combined_6_8_
12.pdf, or write a letter signed by you
or your authorized representative.
Send your completed complaint form
or letter to USDA by mail, fax, or email:
Mail: U.S. Department of Agriculture,
Director, Office of Adjudication, 1400
Independence Avenue SW, Washington,
DC 20250–9410.
Fax: (202) 690–7442.
Email: program.intake@usda.gov.
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Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 / Notices
Persons with disabilities who require
alternative means for communication
(Braille, large print, audiotape, etc.)
should contact USDA’s TARGET Center
at (202) 720–2600 (voice and TDD).
Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, FSIS will
announce this Federal Register
publication online through the FSIS
web page located at: 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.
Done at Washington, DC.
Carmen M. Rottenberg,
Administrator.
BILLING CODE 3410–DM–P
CHEMICAL SAFETY AND HAZARD
INVESTIGATION BOARD
Sunshine Act Meeting
October 30, 2019, 11:00
a.m. EDT.
PLACE: U.S. Chemical Safety and
Hazard Investigation Board, 1750
Pennsylvania Ave. NW, Suite 910,
Washington, DC 20006.
STATUS: Open to the public.
MATTERS TO BE CONSIDERED: The
Chemical Safety and Hazard
Investigation Board (CSB) will convene
a public meeting on Wednesday,
October 30, 2019, at 11:00 a.m. EDT in
Washington, DC, at the CSB offices
located at 1750 Pennsylvania Avenue
NW, Suite 910. The Board will discuss
open investigations, the status of audits
from the Office of the Inspector General,
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TIME AND DATE:
16:58 Oct 25, 2019
COMMISSION ON CIVIL RIGHTS
Additional Information
SUMMARY:
The meeting is free and open to the
public. If you require a translator or
interpreter, please notify the individual
listed below as the CONTACT PERSON FOR
FURTHER INFORMATION, at least three
business days prior to the meeting.
A conference call line will be
provided for those who cannot attend in
person. Please use the following dial-in
number to join the conference:
1 (888) 424–8151—Audience US Toll
Free
1 (847) 585–4422—Audience US Toll
Audience Passcode: 9387 018
The CSB is an independent federal
agency charged with investigating
incidents and hazards that result, or
may result, in the catastrophic release of
extremely hazardous substances. The
agency’s Board Members are appointed
by the President and confirmed by the
Senate. CSB investigations look into all
aspects of chemical accidents and
hazards, including physical causes,
such as equipment failure, as well as
inadequacies in regulations, industry
standards, and safety management
systems.
Public Comment
[FR Doc. 2019–23473 Filed 10–25–19; 8:45 am]
VerDate Sep<11>2014
and financial and organizational
updates. There will also be a
presentation on the ongoing CSB
investigation into the March 17, 2019,
Intercontinental Terminal Company
(ITC) Tank Fire which occurred in Deer
Park, TX.
Jkt 250001
The time provided for public
statements will depend upon the
number of people who wish to speak.
Speakers should assume that their
presentations will be limited to three
minutes or less, but commenters may
submit written statements for the
record.
CONTACT PERSON FOR FURTHER
INFORMATION: Hillary Cohen,
Communications Manager, at public@
csb.gov or (202) 446–8094. Further
information about this public meeting
can be found on the CSB website at:
www.csb.gov.
(Authority: 5 U.S.C. 552b)
Dated: October 1, 2019.
Raymond C. Porfiri,
Deputy General Counsel, Chemical Safety and
Hazard Investigation Board.
[FR Doc. 2019–23545 Filed 10–24–19; 11:15 am]
BILLING CODE 6350–01–P
PO 00000
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57695
Notice of Public Meeting of the
Minnesota Advisory Committee
U.S. Commission on Civil
Rights.
ACTION: Announcement of meeting.
AGENCY:
Notice is hereby given,
pursuant to the provisions of the rules
and regulations of the U.S. Commission
on Civil Rights (Commission) and the
Federal Advisory Committee Act
(FACA) that a meeting of the Minnesota
Advisory Committee (Committee) to the
Commission will be held at 6:00 p.m.
CDT Tuesday November 12, 2019 to
conduct a community forum in St. Paul,
Minnesota for the topic of Racial
Trauma.
DATES: The meeting will be held on
Tuesday November 12, 2019, at 6:00
p.m. CDT.
ADDRESSES: Comunidades Latinas
Unidas en Servicio (CLUES), 797 East
7th Street, St. Paul, MN 55106. Public
Call Information: Dial: 800–367–2403;
Conference ID: 2628752.
FOR FURTHER INFORMATION CONTACT:
David Barreras at dbarreras@usccr.gov
or (312) 353–8311.
SUPPLEMENTARY INFORMATION: This
meeting is available to the public at the
above address and through the above
toll-free call-in number. Any interested
member of the public may attend the
meeting or call the number and listen to
the meeting. Callers can expect to incur
charges for calls they initiate over
wireless lines, and the Commission will
not refund any incurred charges. Callers
will incur no charge for calls they
initiate over land-line connections to
the toll-free telephone number. Persons
with hearing impairments may also
follow the proceedings by first calling
the Federal Relay Service at 1–800–877–
8339 and providing the Service with the
conference call number and conference
ID number.
Members of the public are entitled to
make comments during the open period
at the end of the meeting. Members of
the public may also submit written
comments; the comments must be
received in the Regional Programs Unit
within 30 days following the meeting.
Written comments may be mailed to the
U.S. Commission on Civil Rights,
Regional Programs Unit, 230 S
Dearborn, Suite 2120, Chicago, IL
60604. They may be faxed to the
Commission at (312) 353–8324 or
emailed to David Barreras at dbarreras@
usccr.gov. Persons who desire
additional information may contact the
Regional Programs Unit at (312) 353–
8311.
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]]>Agencies
[Federal Register Volume 84, Number 208 (Monday, October 28, 2019)]
[Notices]
[Pages 57688-57695]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-23473]
========================================================================
Notices
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.
========================================================================
Federal Register / Vol. 84, No. 208 / Monday, October 28, 2019 /
Notices
[[Page 57688]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
[Docket No. FSIS-2018-0045]
Changes to the Salmonella Verification Testing Program: Proposed
Performance Standards for Salmonella in Raw Ground Beef and Beef
Manufacturing Trimmings and Related Agency Verification Procedures
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Notice and request for comments.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is announcing
and requesting comment on new pathogen reduction performance standards
for Salmonella in raw ground beef and beef manufacturing trimmings.
The Agency is also announcing how it plans to assess whether
establishments producing raw ground beef and/or beef manufacturing
trimmings are effectively addressing Salmonella, using a 52-week moving
window of FSIS sampling results and other related verification
activities. Approximately one year (52 weeks) after the new standards
are made final, the Agency plans to post individual establishment
performance as either ``meeting'' or ``not meeting'' the pathogen
reduction performance standard on the FSIS website, based on the most
recent 48 Salmonella sample results.
Finally, FSIS is also announcing that it intends to increase
Salmonella sampling to once per week in beef establishments that
produce greater than 50,000 pounds of raw ground beef and beef
manufacturing trimmings per day, so that a sufficient number of
Salmonella samples (i.e., 48) are collected to assess these
establishments' performance against the new Salmonella performance
standards. Note that FSIS will continue to analyze these beef
manufacturing trimmings samples for Escherichia coli O517:H7 and
applicable non-O157 Shiga-toxin producing E. coli (STEC); FSIS will
continue to analyze these ground beef samples for E. coli O157:H7.
Although unlikely with this change, if fewer than 48 samples are
collected or analyzed in a 52-week window at an establishment, its
status would be reported as ``N/A,'' provided the establishment has two
or fewer Salmonella positives in that window.
FSIS will consider comments received on this notice before
announcing the final performance standards in the Federal Register and
assessing whether establishments meet them.
DATES: Submit comments on or before December 27, 2019.
ADDRESSES: FSIS invites interested persons to submit comments on this
notice. Comments may be submitted by one of the following methods:
Federal eRulemaking Portal: This website provides
commenters the ability to type short comments directly into the comment
field on the web page or to attach a file for lengthier comments. Go to
https://www.regulations.gov. Follow the on-line instructions at that
site for submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, 1400
Independence Avenue SW, Mailstop 3758, Room 6065, Washington, DC 20250-
3700.
Hand- or courier-delivered submittals: Deliver to 1400
Independence Avenue SW, Room 6065, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2018-0045. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to 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, Room 6065, Washington, DC 20250-3700.
FOR FURTHER INFORMATION CONTACT: Terri Nintemann, Assistant
Administrator, Office of Policy and Program Development by telephone at
(202) 205-0495.
SUPPLEMENTARY INFORMATION: FSIS is responsible for verifying that the
nation's commercial supply of meat, poultry, and egg products is safe,
wholesome, and properly labeled and packaged.
Salmonella bacteria are among the most frequent causes of foodborne
illness. These bacteria reside in the gastrointestinal tract and other
organs of food animals; therefore, they also are good indicators for
food product contamination with enteric pathogens. Salmonella are often
introduced during the rearing of live animals, e.g., Salmonella may
contaminate the exterior of an animal on the farm, remain attached to
the animal's hide or carcass, and can contaminate raw beef products
during slaughter and subsequent fabrication and further processing.
Currently, events that cause contamination of beef carcasses cannot be
completely eliminated from commercial slaughter, fabrication, or
further processing operations. Contamination can be minimized, however,
with the use of proper sanitary dressing procedures and through the
application of antimicrobial interventions during the slaughter,
fabrication, and further processing of carcasses into beef products,
including ground beef.
FSIS began its Salmonella verification testing program with the
final rule entitled ``Pathogen Reduction; Hazard Analysis and Critical
Control Point Systems'' (PR/HACCP Rule), published on July 25, 1996 (61
FR 38805). Among other things, the PR/HACCP Rule established Salmonella
pathogen reduction performance standards for establishments that
slaughter selected classes of food animals \1\ and/or that produce
selected classes of raw ground products. FSIS continues to use pathogen
reduction performance standards as a measure of process control and to
ensure that establishments are consistently controlling or reducing
harmful bacteria not ordinarily considered adulterants in raw meat and
poultry products.\2\
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\1\ In 2011, FSIS stopped sampling and testing for Salmonella in
beef carcasses (steers and heifers and cows and bulls) because
percent positive findings were very low; less than one percent. FSIS
sampling and testing for Salmonella in raw ground beef continued,
however.
\2\ The Agency's ability to directly enforce the pathogen
reduction performance standards in 9 CFR 310.25 has been limited
since 2001, after a ruling by the U.S. Court of Appeals for the
Fifth Circuit in Supreme Beef Processors, Inc. v. USDA. In that
case, the court enjoined FSIS from suspending inspection services
against a meat grinding operation for failure to meet the Salmonella
performance standards. Since that time, FSIS has used Salmonella
failures as a basis to conduct an in-depth evaluation of the
establishment's Hazard Analysis and Critical Control Point systems,
including its HACCP plan and Sanitation Standard Operating
Procedures.
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[[Page 57689]]
Because of continued outbreaks of Salmonella illness associated
with the consumption of ground beef products, FSIS is proposing to
update its Salmonella performance standard for raw ground beef and
establish a new performance standard for beef manufacturing
trimmings,\3\ the primary component of raw ground beef. These updated
and new performance standards would address the market failure from
information asymmetry between producers and buyers. Absent these
standards, buyers could not readily identify the difference in
Salmonella levels across producers. A summary of the most recent
Salmonella outbreaks linked to ground beef and FSIS's responses to
these outbreaks that ultimately led to the development of the new
performance standards follows.
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\3\ FSIS defines ``beef manufacturing trimmings'' as trim
produced from cattle (including veal) that are slaughtered at the
establishment where the FSIS sampling is occurring. Beef
manufacturing trimmings include trim of any size and primal or
subprimal cuts, such as chucks, rounds, or shanks, or boneless beef
of any size used at the slaughter establishment for non-intact use,
or that is intended for raw non-intact use by other establishments.
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In 2011, FSIS investigated a multi-State outbreak of 20 Salmonella
Typhimurium infections linked to the consumption of ground beef.\4\
Eight people were hospitalized, and the outbreak strain was resistant
to at least seven antibiotics. In 2012, an establishment recalled
approximately 30,000 pounds of raw ground beef linked to a multi-state
outbreak of Salmonella Enteritidis with 46 persons infected.\5\ Twelve
people were hospitalized. Also, in 2012, the Centers for Disease
Control and Prevention (CDC) confirmed a single-State outbreak from
ground beef contaminated with Salmonella Enteritidis that resulted in
24 illnesses. Two people were hospitalized. In 2013, 22 persons from
six States were infected with Salmonella Typhimurium linked to ground
beef.\6\ Seven people were hospitalized.
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\4\ https://www.cdc.gov/salmonella/2011/ground-beef-2-1-2012.html.
\5\ https://www.cdc.gov/salmonella/enteritidis-07-12/;
FSIS Recall 045-2012.
\6\ https://www.cdc.gov/salmonella/typhimurium-01-13/;
FSIS Recalls 008-2013 and 009-2013.
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In response to these outbreaks, on August 28, 2013, FSIS published
in the Federal Register a notice announcing changes it was making to
its Salmonella verification testing program for raw beef products
intended for non-intact use (78 FR 53017). Specifically, FSIS announced
that it would begin analyzing for Salmonella all samples of raw ground
beef, beef manufacturing trimmings, bench trim, and other raw ground
beef components that it already collects for STEC testing, including
raw ground beef products that FSIS samples at retail stores, and
imported shipments of raw ground beef, trim, and other raw ground beef
components that FSIS samples at official import inspection
establishments. In addition, FSIS announced that it was increasing the
raw ground beef analytical sample portion from 25 grams to 325
grams.\7\ FSIS explained that the likelihood of detecting positive
samples increases with the analytical portion size. FSIS also described
how it intended to use the results generated from its raw ground beef
(``MT43'') and beef manufacturing trimmings (``MT60'') verification
testing programs to estimate the Salmonella prevalence in those
products and to develop updated or new pathogen reduction performance
standards.
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\7\ After the Agency increased the analytical sample portion
from 25 grams to 325 grams, FSIS stopped using the Salmonella
performance standard for ground beef Table 2 in 9 CFR 310.25(b)
because it was established on the basis of prevalence as measured by
a 25-gram sample.
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Finally, FSIS stated in this notice that it was considering
alternatives to set-based sampling for Salmonella, including routine
sampling throughout the year used in conjunction with a ``moving
window'' approach to assess process control in establishments subject
to performance standards. FSIS explained that this approach would allow
for on-going scheduled Salmonella sampling, similar to the approach
FSIS has used for STEC sampling and would provide FSIS with more
flexibility for scheduling sample collections at different
establishments.
After reviewing the comments received on the August 2013 notice,
FSIS announced in the Federal Register that it was implementing the
plans in that notice on June 5, 2014 (79 FR 32436). Thus, on June 29,
2014, FSIS discontinued Salmonella sampling set procedures for raw
ground beef products (the ``HC01'' sampling program) and stopped
assessing whether establishments met the codified pathogen reduction
performance standards for ground product, except in those
establishments in Category 3.8 9 At the same time, FSIS
began co-analyzing for Salmonella all samples of raw beef products it
collects for STEC analysis (including imported raw beef products) using
the larger analytical sample portion. FSIS collects raw beef products
for STEC analysis and Salmonella analysis regardless of production
volume; FSIS did not establish a low volume exemption for beef
establishments for FSIS STEC or Salmonella verification testing. FSIS
has posted the aggregate results of this testing as part of its
quarterly sampling project results reporting.\10\
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\8\ An establishment in Category 3 is exceeding the Salmonella
performance standard. FSIS Notice 28-14 instructed FSIS inspectors
to continue set testing at establishments in Category 3 until the
establishment is in Category 1 or 2.
\9\ FSIS discontinued all sampling sets for ground beef products
in establishments in Category 3 in June 2015.
\10\ https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/sampling-project-results.
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Notably, in 2015, the CDC published an analysis of beef-related
outbreaks from 1973-2011 and reported that ground beef is now a
significant source of Salmonella outbreaks and that stronger measures
are needed to decrease contamination of raw ground beef with
Salmonella.\11\
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\11\ Laufer, A., Grass, J., Holt, K., Whichard, J., Griffin, P.,
Gould, L., 2015. Outbreaks of Salmonella infections attributed to
beef--United States, 1973-2011. Epidemiology and Infection 143,
2003-2013.
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Beginning in 2016 and ending in 2017, the CDC reported 106
illnesses in 21 States associated with Salmonella Newport from ground
beef.\12\ One person died, and 42 people were hospitalized. Notably,
the CDC is currently investigating a multi-State illness outbreak from
beef products contaminated with Salmonella Newport.\13\ To date, this
outbreak has resulted in 403 illnesses from 30 States, with 117 people
hospitalized. On October 4, 2018, approximately 6.5 million pounds of
beef products, including ground beef, were recalled due to this
outbreak and an expansion of the recall with an additional 5.2 million
pounds of beef products occurred on December 4, 2018.\14\
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\12\ https://www.cdc.gov/mmwr/volumes/67/wr/mm6715a2.htm.
\13\ https://www.cdc.gov/salmonella/newport-10-18/.
\14\ FSIS Recall 085-2018.
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Moving Window Approach
On February 11, 2016, the Agency explained how it would assess
performance using a moving window of FSIS sampling results in poultry
establishments subject to Salmonella and Campylobacter pathogen
reduction performance standards (81 FR 7285). FSIS stated that the
moving window would be 52 weeks and that the Agency
[[Page 57690]]
would collect samples more frequently in higher-volume establishments
and less frequently in lower-volume establishments. The 52-week window
obviates the need to account directly for seasonal fluctuations in
contamination frequency.\15\ FSIS intends to use a similar approach for
beef establishments that produce raw ground beef and/or beef
manufacturing trimmings that will be subject to the updated or new
Salmonella performance standards. As further explained below, the
category reported for each establishment would be based on the last 48
FSIS Salmonella sample results during the most recent 52-week window.
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\15\ FSIS (2015). Public health effects of raw chicken parts and
comminuted chicken and poultry performance standards. Washington,
DC, United States Department of Agriculture; Williams, M.S., Ebel,
E.D., Golden, N.J., Schlosser, W.D. (2014). Temporal patterns in the
occurrence of Salmonella in raw meat and poultry products and their
relationship to human illnesses in the United States. Food Control
35(1): 267-273.
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Healthy People 2020 (HP2020) Goals
Food safety is a key component of the Healthy People (HP)
initiative, with an entire focus area dedicated to joint FSIS, Food and
Drug Administration (FDA), and CDC efforts to reduce foodborne illness,
including salmonellosis, in the population. Under the HP2020 goals,
FSIS committed, with its public health partners, to a 25-percent
reduction in annual cases of salmonellosis.\16\ Using published results
from the CDC,\17\ FSIS estimates a median of about 80,000 annual cases
of salmonellosis associated with the consumption of cuts of intact beef
and ground beef contaminated with Salmonella. FSIS estimates that
approximately 53 percent of these illnesses are associated with ground
beef. Thus, to meet the 25-percent reduction goal, there would need to
be 10,600 fewer annual illnesses caused by raw ground beef contaminated
with Salmonella.\18\
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\16\ Once the Healthy People 2030 objectives have been
finalized, FSIS intends to assess whether changes to its performance
standards are warranted.
\17\ Scallan et al., 2011; Painter et al., 2013
\18\ Moving forward, FSIS plans to utilize more recent estimates
of foodborne illness source attribution to estimate cases of
foodborne illness attributed to FSIS-regulated products. These
estimates, produced by the Interagency Food Safety Analytics
Collaboration (IFSAC), a tri-agency group with representatives from
the CDC, FDA, and FSIS, uses foodborne outbreak data to produce
harmonized, annual attribution estimates for Salmonella, Escherichia
coli O157, Listeria monocytogenes, and Campylobacter.
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Pathogen Reduction Performance Standards
With the goal of reducing Salmonella in raw ground beef products,
the Agency is proposing an updated and a new pathogen reduction
performance standard for Salmonella in raw ground beef and in beef
manufacturing trimmings (the primary component of ground beef),
respectively. Because the ground beef industry is highly concentrated
by production volume, FSIS developed pathogen reduction performance
standards for each product class based on a daily production volume
threshold. Both proposed performance standards would be applicable to
higher-volume establishments (i.e., those producing greater than 50,000
pounds of these products per day). This approach would account for
approximately 91 percent of the total raw ground beef and 96 percent of
the total beef manufacturing trimmings production volume annually. And
as further explained in FSIS's Public Health Effects of Performance
Standards for Ground Beef and Beef Manufacturing Trimmings (2019 Risk
Assessment),\19\ the approach would also focus Agency resources on raw
ground beef establishments shown to have the highest Salmonella
prevalence. FSIS predicts that most higher-volume beef establishments
would meet the proposed performance standards.
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\19\ Available at https://www.fsis.usda.gov/wps/wcm/connect/8a38566a-6d6c-4c96-85ce-41fd02050358/beef-ps-aug-2019.pdf?MOD=AJPERES.
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FSIS's goal is to collect and analyze at least 48 samples per year
for each establishment producing greater than 50,000 pounds of ground
beef or beef manufacturing trimmings per day. Analyzing this number of
samples would provide strong evidence that an establishment is either
meeting or not meeting the performance standards. To achieve this goal,
FSIS plans to change how it currently assigns STEC sampling and thus
Salmonella sampling in higher-volume beef establishments producing
ground beef and/or beef manufacturing trimmings by increasing the
sample collection frequency from a maximum of four times per month to
once per week for these product classes. FSIS intends to implement this
change in a resource neutral manner by reallocating resources from
lower-volume beef establishments (i.e., those producing 50,000 pounds
or less per day). As noted above, FSIS samples less frequently in the
lower-volume establishments. The Agency requests comments on the
proposed changes.
The methods for developing the proposed pathogen reduction
performance standards and predictions for the public health effect of
those standards are described in the 2019 Risk Assessment. FSIS used
the same methodology to estimate the public health effects for the
young chicken and turkey carcass Salmonella and Campylobacter
performance standards in 2011 \20\ and to develop pathogen reduction
performance standards for Salmonella and Campylobacter in raw chicken
parts and not-ready-to-eat (NRTE) comminuted chicken and turkey
products in 2015.\21\
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\20\ 76 FR 15282; Mar. 14, 2011.
\21\ 80 FR at 3940; Jan. 26, 2015.
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FSIS has opted not to propose pathogen reduction performance
standards for raw ground beef and/or beef manufacturing trimmings in
lower-volume establishments (i.e., those producing 50,000 pounds or
less per day of these products) at this time. FSIS will, however,
continue co-analyzing for Salmonella in all samples it collects for
STEC analysis from these establishments to monitor ongoing pathogen
prevalence. A summary of the updated or new performance standards is
provided in Table 1.
Since there are not enough data (i.e., samples collected and
tested) for components of ground beef other than beef manufacturing
trimmings, e.g., esophagus (weasand) meat, head meat, and cheek meat to
estimate a national prevalence, FSIS is not proposing a pathogen
reduction performance standard for such products at this time. With
that said, FSIS will continue to analyze its testing data to better
understand the potential for contamination in these products. Such
information could be used by the Agency to decide whether a pathogen
reduction performance standard for one or more of these components is
also necessary. FSIS is seeking comment on the merits of developing a
pathogen reduction performance standard for components of raw ground
beef other than beef manufacturing trimmings.
[[Page 57691]]
Table 1--Updated or New Performance Standards for Salmonella in Raw
Ground Beef and Beef Manufacturing Trimmings
------------------------------------------------------------------------
Minimum number of
Maximum number of samples needed to
Product (establishment volume allowable positive assess
(lbs./day)) samples establishment
performance *
------------------------------------------------------------------------
Raw Ground Beef (>50,000)....... 2 of 48........... 48
Beef Manufacturing Trimmings 2 of 48........... 48
(>50,000).
------------------------------------------------------------------------
* Any establishment with three or more Salmonella positives in a 52-week
window would be categorized as not meeting the performance standard
even when less than the minimum number of samples (48) are collected/
analyzed.
Raw Ground Beef
For raw ground beef, FSIS is proposing a pathogen reduction
performance standard for Salmonella of two allowable positives out of
48 samples. This standard would be applied to all higher-volume
establishments, which includes those producing more than 50,000 pounds
of raw ground beef product per day (approximately 75 establishments).
As mentioned above, FSIS intends to assign samples weekly in all
establishments producing more than 50,000 pounds of eligible product
per day with the goal of collecting and analyzing 48 samples in a 52-
week window.
FSIS predicts that approximately 18 percent of establishments
(about 14 establishments) would initially not meet this performance
standard. Once implemented, if about half of the establishments
producing more than 50,000 pounds of raw ground beef per day that are
not meeting the proposed performance standard subsequently begin to
meet this standard, this should result in about a 25-percent reduction
in Salmonella illnesses from that product. The median expected number
of illnesses avoided per year would be about 8,900 (90% Uncertainty
Interval: 2,000-20,000).
Specifics of the 52-Week Window Approach and Categorizing
Establishments
As stated, the performance standard is intended to apply to 48
samples in a 52-week window. If FSIS collects and analyzes more than 48
samples in a 52-week window, the most recent 48 sample results in that
52-week window would be used to categorize the establishment. Although
unlikely with the proposed reallocation of sampling resources, there
may be rare occasions when fewer than 48 samples are collected and
analyzed in these establishments within a 52-week window. If fewer than
48 samples are collected or analyzed, the establishment's status would
be reported as ``N/A,'' provided the establishment has two or fewer
Salmonella positives in that window. Any establishment with three or
more Salmonella positives in a 52-week window would be categorized as
not meeting the performance standard regardless of the number of
samples collected/analyzed in that window.
Beef Manufacturing Trimmings
For beef manufacturing trimmings, FSIS is also proposing a pathogen
reduction performance standard for Salmonella of two allowable
positives out of 48 samples in a 52-week window that would be applied
to eligible establishments producing more than 50,000 pounds of this
product per day (approximately 49 establishments). Approximately 20
percent of establishments (about 10 establishments) are predicted to
initially not meet this performance standard.
The specifics of the 52-week window and categorizing establishments
are the same as above. Each establishment's category status (i.e.,
meeting, not meeting, or N/A) for beef manufacturing trimmings would be
reported as described above for raw ground beef.
FSIS has chosen not to attribute any averted illnesses resulting
from the proposed performance standard for beef manufacturing trimmings
because this product is not consumed directly. FSIS believes, however,
that a performance standard is needed for beef manufacturing trimmings
to assist grinding establishments that purchase this product for
further processing in managing Salmonella contamination in their ground
beef. For example, a grinding operation may opt to change beef
manufacturing trimmings suppliers if its current supplier is
categorized as not meeting the beef manufacturing trimmings Salmonella
performance standard and has not taken actions to reduce Salmonella
contamination in its product; this is especially true if the grinding
operation is concerned about not meeting the raw ground beef Salmonella
performance standard and wants to mitigate the chances of that outcome.
Although reductions in Salmonella surface contamination on beef
manufacturing trimmings should reduce contamination of raw ground beef,
the specific magnitude of this reduction is uncertain.
Web-Posting Establishment Performance
FSIS announced that it intended to post the category status for all
establishments subject to pathogen reduction performance standards
because web posting delivers greater transparency, thereby providing
the public with the tools and information it needs to make informed
food safety decisions (80 FR at 3948; Jan. 26, 2015). FSIS intends to
post the category status for all beef establishments subject to the
pathogen reduction performance standards announced in this notice upon
implementation.
FSIS currently assesses poultry establishment performance weekly
based on the most recent 52-week window of FSIS sample results (83 FR
56046; Nov. 9, 2018). As explained in the November 2018 Federal
Register notice, FSIS no longer includes follow-up sampling results
when calculating an establishment's category. On or about the 20th of
the month, FSIS posts the category of individual establishments
producing an eligible product on the FSIS website.\22\
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\22\ Individual establishment category information is posted on
FSIS's website at https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/salmonella-verification-testing-program/salmonella-verification-testing-program.
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Should FSIS move forward with finalizing the proposed pathogen
reduction performance standards for Salmonella in raw ground beef and
beef manufacturing trimmings, FSIS would announce the final standards
and an effective date in a subsequent Federal Register notice. About
one year after the final standards go into effect, FSIS would determine
individual establishment performance based on the last 48 FSIS
Salmonella sample results and then report on the FSIS website the
status of each establishment subject to the performance standards as
either
[[Page 57692]]
meeting or not meeting the particular standard using the following
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criteria:
Meeting. Establishments with no more than the allowable number
of positive Salmonella sample results for that product class during
the 52-week window ending the last Saturday of the previous month,
based on the last 48 FSIS Salmonella sample results.
Not Meeting. Establishments with more than the allowable number
of positive Salmonella sample results for that product class during
the 52-week window ending the last Saturday of the previous month,
based on the last 48 FSIS Salmonella sample results.
In the interim between the final standards becoming effective and
when the status of individual establishments is posted, FSIS intends to
make available monthly aggregate information relative to status (i.e.,
meeting or not meeting the performance standard) for all establishments
subject to sampling under the final performance standards, using the
most recent FSIS Salmonella sample results. This information will be
aggregated and will not identify any specific establishment. FSIS would
make this information available to give industry and other stakeholders
timely information about progress being made to reduce Salmonella
contamination in raw ground beef and beef manufacturing trimmings.
Related Agency Verification Actions
An establishment that does not meet a pathogen reduction
performance standard or produces product that has been associated with
an outbreak may not have adequately addressed the food safety hazard,
Salmonella, in its HACCP system. If the establishment considers
Salmonella reasonably likely to occur and addresses Salmonella in its
HACCP plan, it must take corrective actions as required in 9 CFR
417.3(a). If the establishment considers Salmonella not reasonably
likely to occur, it must take corrective actions and reassess its HACCP
plan for that product to determine whether the plan needs to be
modified to address Salmonella as a hazard (9 CFR 417.3(b)). To
maintain an adequate HACCP system, the establishment may need to
address the pathogen Salmonella in its HACCP plan, rather than through
Sanitation Standard Operating Procedures (Sanitation SOPs) or another
prerequisite program. Corrective actions taken in response to exceeding
a pathogen reduction performance standard would need to be documented
in records subject to verification by FSIS as required in 9 CFR
417.3(c)).
Consistent with FSIS inspection program personnel instructions for
poultry establishments currently subject to performance standards, when
a beef establishment does not meet a Salmonella performance standard
(i.e., when the number of positive samples within a specified timeframe
exceeds the number of allowable positives for that product class), FSIS
may initiate follow-up sampling after the establishment is first
categorized as not meeting the performance standard to verify the
adequacy of corrective actions taken by the establishment. FSIS would
likely co-analyze any follow-up samples for STEC, as applicable to that
product class. The follow-up samples would not count towards the
samples collected as part of the moving window procedure for assessing
whether the establishment meets the standards, which is consistent with
FSIS procedures for poultry performance standards (83 FR at 56048).
Follow-up sampling for establishments that do not meet the raw ground
beef and/or beef manufacturing performance standard for an extended
period of time, or that fluctuate between meeting or not meeting one or
both of these performance standards, would occur at a frequency
determined by FSIS.\23\
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\23\ See FSIS Notice 17-19 for additional information on follow-
up sampling in poultry establishments, available at https://www.fsis.usda.gov/wps/wcm/connect/e16cfd59-8f8a-48a5-a607-999c9eecfec2/17-19.pdf?MOD=AJPERES.
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In addition, FSIS would schedule a Public Health Risk Evaluation
(PHRE) for any beef establishment that (a) does not meet a Salmonella
pathogen reduction performance standard; (b) has produced products with
repetitive Salmonella serotypes of public health concern \24\ or
repetitive antibiotic-resistant Salmonella; and/or (c) has Salmonella
whole-genome sequencing (WGS) and/or pulsed-field gel electrophoresis
patterns matching those found in recent outbreaks or epidemiologically
linked to illnesses (see FSIS Directive 5100.1 at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES). FSIS would use the results of the PHRE to
determine whether to schedule a Food Safety Assessment (FSA) \25\ at
the establishment.
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\24\ Information about the 20 most frequently reported
Salmonella serotypes reported to the CDC's Laboratory-based Enteric
Disease Surveillance system is available at https://www.cdc.gov/nationalsurveillance/pdfs/2016-Salmonella-report-508.pdf.
\25\ The purpose of an FSA is to assess and analyze an
establishment's food safety system to verify that the establishment
is able to produce safe and wholesome meat or poultry products in
accordance with FSIS statutory and regulatory requirements.
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As explained above, and also consistent with existing FSIS
practices,\26\ after notifying a beef establishment that it has not met
a pathogen reduction performance standard, FSIS would conduct an
assessment of the establishment's HACCP plan and SSOPs, through a PHRE
and possible subsequent FSA, focusing on the establishment's corrective
actions, HACCP plan reassessment (if applicable), and the effectiveness
of the establishment's system for controlling Salmonella in raw beef
products. In addition, when necessary, FSIS would develop a plan to
verify whether the establishment implemented corrective actions. If,
after 120 days from not meeting the standard, the establishment has not
been able to demonstrate reduced variability of process control, as
determined from FSIS's follow-up and routine sampling and from the
results of the PHRE and in some cases an FSA, and the establishment has
not taken corrective actions, FSIS would likely take an enforcement
action, such as issuing a Notice of Intended Enforcement (NOIE) or
suspending inspection, under the conditions and according to the
procedures described in 9 CFR part 500. FSIS would not issue an NOIE or
suspend inspection based solely on the fact that an establishment did
not meet a pathogen reduction performance standard for Salmonella.
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\26\ FSIS stated in a Federal Register notice published April
16, 2003 (68 FR 18593), that it was using Salmonella sample-set
failures ``as an indication that there is something wrong in the
establishment's HACCP system, and that the system needs to be
carefully evaluated by the Agency.'' More recently, FSIS announced
the same course of action for poultry products subject to pathogen
reduction performance standards on February 11, 2016 (81 FR at
7288).
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Although establishments producing 50,000 pounds or less of raw
ground beef or beef manufacturing trimmings per day would not be
subject to the proposed performance standards, FSIS would initiate
follow-up sampling and/or conduct a PHRE or a FSA in these
establishments when there is evidence of high levels of Salmonella
contamination, e.g., three or more positive Salmonella sample results
within a 52-week time period, and for any of the other reasons listed
above. Recognizing that these lower-volume establishments are sampled
much less frequently than the higher-volume establishments, FSIS
requests comments on this approach.
As previously announced, if any beef establishment produces product
associated with a Salmonella illness outbreak identified minimally
through epidemiological and/or traceback investigations, FSIS likely
will consider the product to be adulterated under 21
[[Page 57693]]
U.S.C. 601(m)(3) because the product is ``* * * unsound, unhealthful,
unwholesome, or otherwise unfit for human food'' (77 FR at 72689; Dec.
6, 2012). In such cases, the Agency would request that the
establishment recall the product if it is still in commerce.
Additionally, in such situations, even if the establishment is meeting
a Salmonella performance standard, FSIS will scrutinize its corrective
actions closely and may conduct an Incident Investigation Team review
(see FSIS Directive 5500.3 at https://www.fsis.usda.gov/wps/wcm/connect/bf3095f8-c6aa-4ed7-b819-45668c05c44b/5500.3.pdf?MOD=AJPERES).
FSIS monitors relevant databases (e.g., those maintained by the CDC
and the National Institutes of Health) for clinical isolates \27\ that
match (via WGS) food isolates obtained by FSIS in its sampling of
products produced by official establishments. This monitoring gives
FSIS early warning that an outbreak involving an establishment's
product could be developing. FSIS may alert its public health partners
if it appears there are human illness (clinical isolates) and food
isolate matches indicating a potential emerging outbreak. In such
situations, FSIS may also collect distribution information (e.g., the
consignee list) for product produced to be able to focus attention on
the geographic area in which the affected product was distributed.
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\27\ 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 ground beef and
beef manufacturing trimmings. The full analysis is published on the
FSIS website as supporting documentation to this notice. FSIS is
seeking comment on the information and assumptions used in the cost-
benefit analysis. A summary of the analysis follows.
Industry Costs
Establishments would incur costs as they make changes to their
processes to meet the new performance standards. FSIS predicts that
approximately 18 percent of the higher-volume raw ground beef
establishments (about 14 establishments) and 20 percent of the higher-
volume beef manufacturing trimmings establishments (about 10
establishments) would not initially meet the standards. As discussed
above, higher-volume establishments produce more than 50,000 pounds of
that particular product per day.
Some establishments that initially do not meet the performance
standards but aspire to do so would need to make changes to their
production processes to lower the prevalence of Salmonella in their
products. For example, affected establishments may conduct Salmonella
sampling, apply antimicrobial interventions (including purchasing
necessary capital equipment), reassess their HACCP plans and/or conduct
training. FSIS expects that higher-volume raw ground beef and beef
manufacturing trimmings establishments would be most likely to begin
collecting samples for Salmonella testing in an effort to assure they
would meet the updated or new performance standards. As an example, if
the establishment currently collects samples to test for other
pathogens, the establishment may begin including testing for Salmonella
in its current sampling programs. Or, if the establishment does not
currently collect any samples for pathogen testing, the establishment
may begin collecting samples for Salmonella testing.
Based on available information, FSIS expects that beef
manufacturing trimmings establishments subject to the performance
standard would be most likely to add antimicrobial interventions and
equipment to their production process to meet the performance standard.
FSIS estimates that not all establishments would make changes after
not meeting the performance standards. For those establishments
initially not meeting the performance standards, FSIS assumes
approximately 50 percent would start making changes after one year and
eventually would meet the standards in two years by making changes to
their production process. To ensure a conservative cost estimate, FSIS
assumes that those establishments making changes to their production
processes would validate those changes and conduct employee training.
For HACCP re-assessment, FSIS assumes that all establishments (100
percent) that do not meet the standard will re-assess their HACCP plan.
These costs are summarized and annualized over 10 years at a discount
rate of 7 percent in Table 2.
Table 2--Industry Costs Annualized
----------------------------------------------------------------------------------------------------------------
Primary
Cost component Low estimate estimate High estimate
----------------------------------------------------------------------------------------------------------------
Capital Equipment............................................... $1,002 $1,002 $1,002
Antimicrobial Intervention...................................... 147,998 147,998 147,998
Sampling........................................................ 3,393,114 3,393,114 3,393,114
HACCP Reassessment.............................................. 10,781 21,562 32,344
Employee Training............................................... 2,701 2,701 2,701
-----------------------------------------------
Total Costs *............................................... 3,555,596 3,556,377 3,577,159
----------------------------------------------------------------------------------------------------------------
Agency Costs
FSIS does not expect the Agency to incur any budgetary impacts as a
result of implementing the new or updated performance standards. FSIS
intends to implement the two major components of the performance
standards, product sampling/testing and follow-up actions, in such a
way that they are resource neutral. At this time, FSIS is not expanding
the overall number of samples it would analyze or collect. Instead, it
would reallocate samples from lower-volume beef establishments.
Moreover, since FSIS has already transitioned to continuous sampling
for Salmonella in beef manufacturing trimmings and in raw ground beef,
the number of samples FSIS would collect and analyze after the
performance standard is implemented would remain the same. FSIS would
not need to invest in additional laboratory equipment or additional
personnel.
The resources required for follow-up actions, namely PHREs, which
may lead to FSAs, would also remain unchanged because very few
establishments are expected to continue to not meet the
[[Page 57694]]
performance standards. In addition, in 2015, the FSA methodology was
updated to include a PHRE. The PHRE is a remote evaluation performed by
FSIS personnel to determine if an establishment's food safety system is
effective. Information learned during the PHRE would be used to
determine if an onsite FSA is warranted. FSIS personnel have been able
to evaluate a greater number of establishments under the updated FSA
methodology. FSIS intends to maintain its current FSA scheduling
protocol, which combines risk-based and routine PHREs.
Benefits
As beef establishments subject to the proposed performance
standards make changes to their production processes and reduce the
prevalence of Salmonella in raw ground beef and beef manufacturing
trimmings, public health benefits would be realized in the form of
averted illnesses. As discussed in the 2019 Risk Assessment, FSIS
estimated the annual Salmonella foodborne illnesses associated with
beef products. FSIS then estimated the number of annual illnesses
attributed to products under the updated or new performance standards.
Finally, FSIS estimated the number of illnesses averted if 50 percent
of the establishments that do not meet the standards, meet the
standards over the course of two years. Additionally, FSIS estimated
the cost savings associated with the percentage reduction in human
illnesses as calculated in the 2019 Risk Assessment. The estimated
public health benefits from the illnesses averted as a result of the
proposed Salmonella beef performance standards are summarized and
annualized over 10 years at a discount rate of 7 percent in Table 3.
Table 3--Public Health Benefits Annualized
----------------------------------------------------------------------------------------------------------------
Percentage of
establishments
initially not
meeting the Averted illnesses
Product standards, but due to salmonella Cost of illness \*\
then meet the
standards over 2
years
----------------------------------------------------------------------------------------------------------------
Raw Ground Beef and Beef 50 8,900.............. $29,265,796.
Manufacturing Trimmings.
(2,000-20,000) (5th- ($6,576,583-$65,765,834).
95th percentile).
----------------------------------------------------------------------------------------------------------------
* Cost of Illness annualized at a discount rate of 7% over 10 years, occurring one year after establishments
would begin making changes.
Industry Benefits
FSIS expects that industry would benefit from reduced Salmonella
outbreak-related recalls. The negative impacts of recalls on industry
include the loss of sales revenue, the cost to dispose of recalled
products, and the loss of consumer confidence and business reputation.
Recalls negatively impact consumers by creating anxiety and time-
consuming inconveniences (e.g., looking for recall information,
checking products purchased to determine if they are part of the
recall, returning or disposing of products identified by the recalls,
and so on).
FSIS expects the raw ground beef and beef manufacturing trimmings
performance standards would lead to less contaminated products, because
of industry actions taken to reduce Salmonella in products to meet the
performance standards. The reduction in Salmonella would result in less
exposure to the consumers that eat beef products and fewer illnesses,
outbreaks and recalls.
Summary of Net Benefits
Table 4 displays the total costs and benefits expected from the
implementation of the performance standards for beef manufacturing
trimmings and raw ground beef. FSIS annualized all values over 10 years
at a 7 percent discount rate.
Table 4--Summary of Estimated Net Benefits
----------------------------------------------------------------------------------------------------------------
Primary
Compliance rate for establishments Cost/benefit component Low estimate estimate High estimate
initially not meeting the standard ($mil) ($mil) ($mil)
----------------------------------------------------------------------------------------------------------------
50%................................... Industry Costs.......... 3.56 3.57 3.58
Public Health Benefits.. 6.58 29.27 65.77
Net Benefits............ 3.02 25.70 62.19
----------------------------------------------------------------------------------------------------------------
USDA Non-Discrimination Statement
No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.
How To File a Complaint of Discrimination
To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at https://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your
authorized representative.
Send your completed complaint form or letter to USDA by mail, fax,
or email:
Mail: U.S. Department of Agriculture, Director, Office of
Adjudication, 1400 Independence Avenue SW, Washington, DC 20250-9410.
Fax: (202) 690-7442.
Email: [email protected].
[[Page 57695]]
Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.) should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).
Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication online through the FSIS web page located at:
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.
Done at Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-23473 Filed 10-25-19; 8:45 am]
BILLING CODE 3410-DM-P
