Modernization of Swine Slaughter Inspection, 52300-52349 [2019-20245]
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Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations
employees but fewer than 500
employees, on January 29, 2020; and
(3) In very small establishments,
defined as all establishments with fewer
than 10 employees or annual sales of
less than $2.5 million, on March 30,
2020.
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 309, and 310
[Docket No. FSIS–2016–0017]
RIN 0583–AD62
FOR FURTHER INFORMATION CONTACT:
Roberta Wagner, Assistant
Administrator, Office of Policy and
Program Development; Telephone: (202)
205–0495.
SUPPLEMENTARY INFORMATION:
Modernization of Swine Slaughter
Inspection
Food Safety and Inspection
Service, USDA.
ACTION: Final rule.
AGENCY:
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Executive Summary
The Food Safety and
Inspection Service (FSIS) is amending
the Federal meat inspection regulations
to establish an optional new inspection
system for market hog slaughter
establishments that has been
demonstrated to provide public health
protection at least equivalent to the
existing inspection system. Market hog
slaughter establishments that do not
choose to operate under the new swine
inspection system may continue to
operate under their existing inspection
system. The Agency is also making
several changes to the regulations that
will affect all establishments that
slaughter swine, regardless of the
inspection system under which they
operate or the age, size, or class of
swine. These changes will allow all
swine slaughter establishments to
develop sampling plans that are more
tailored to their specific operations, and
thus more effective in monitoring their
specific process control, unlike the
current requirements in the regulations.
DATES:
Effective date: December 2, 2019.
Notification date: All market hog
establishments will initially have until
March 30, 2020 to notify their FSIS
District Office (DO) of their intent to
operate under the New Swine Slaughter
Inspection System (NSIS).
Establishments that do not notify their
DO of their intent by March 30, 2020
will be deemed to have chosen to
continue operating under their existing
inspection system. For additional
information, see section II.G.
Implementation.
Applicability dates: The regulations
that prescribe procedures for controlling
contamination throughout the slaughter
and dressing process in 9 CFR 310.18(c),
and the regulations that prescribe
recordkeeping requirements in 9 CFR
310.18(d), will be applicable as follows:
(1) In large establishments, defined as
all establishments with 500 or more
employees, on December 30, 2019;
(2) In small establishments, defined as
all establishments with 10 or more
SUMMARY:
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On February 1, 2018, FSIS published
a proposed rule to modernize swine
slaughter inspection (83 FR 4780). This
final rule adopts, with modifications,
the provisions in the proposed rule.
FSIS is establishing an optional new
inspection system for market hog
slaughter establishments, NSIS,
informed by the Agency’s experiences
under its Hazard Analysis and Critical
Control Point (HACCP)-Based
Inspection Models Project (HIMP). FSIS
is establishing NSIS to improve the
effectiveness of market hog slaughter
inspection; make better use of the
Agency’s resources; and remove
unnecessary regulatory obstacles to
industry innovation by revoking
maximum line speeds and allowing
establishments flexibility to reconfigure
evisceration lines. NSIS may also
facilitate pathogen reduction in pork
products and improve compliance with
the Humane Methods of Slaughter Act
(HMSA) (7 U.S.C. 1901 et seq.).
Because this final rule requires
establishment personnel in NSIS
establishments to sort and remove unfit
animals before ante-mortem inspection
by FSIS inspectors and trim and identify
defects on carcasses and parts before
post-mortem inspection by FSIS
inspectors, the Agency’s inspectors will
be presented with healthier animals and
carcasses that have fewer defects,
allowing them to conduct a more
efficient inspection of each animal and
each carcass. As a result, under NSIS,
FSIS can assign fewer inspectors to
online inspection, freeing up Agency
resources to conduct more offline
inspection activities that are more
effective in ensuring food safety, such as
verifying compliance with sanitation
and HACCP, as well as humane
handling requirements.
Key elements of the NSIS include: (1)
Requiring establishment personnel to
sort and remove unfit animals before
ante-mortem inspection by FSIS
inspectors and to trim and identify
defects on carcasses and parts before
post-mortem inspection by FSIS
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inspectors; (2) requiring establishment
personnel to identify animals or
carcasses, that they have sorted and
removed for disposal before FSIS
inspection, with a unique tag, tattoo, or
similar device, and to develop,
implement, and maintain written
procedures in their HACCP system to
ensure that animals and carcasses sorted
and removed for disposal do not enter
the human food supply and are properly
disposed of according to 9 CFR part 314;
(3) requiring establishments to maintain
records to document the total number of
animals and carcasses sorted and
removed per day and the reasons for
their removal; (4) requiring
establishment personnel to immediately
notify FSIS inspectors if they identify,
while conducting sorting activities, an
animal or carcass that they suspect has
a reportable or foreign animal disease
(e.g., African swine fever, classical
swine fever, or Nipah virus
encephalitis); (5) shifting Agency
resources to conduct more offline
inspection activities that are more
effective in ensuring food safety, which
allows for up to two offline verification
inspectors per line per shift and reduces
the number of online inspectors to a
maximum of three per line per shift; (6)
requiring establishments to maintain
records documenting that products
resulting from their slaughter operations
meet the new definition of ready-tocook (RTC) pork product, which is any
slaughtered pork product sufficiently
free from bile, hair, scurf, dirt, hooves,
toe nails, claws, bruises, edema, scabs,
skin lesions, icterus, foreign material,
and odor which is suitable for cooking
without need of further processing; and
(7) revoking maximum line speeds and
authorizing establishments to determine
their own line speeds based on their
ability to maintain process control for
preventing fecal contamination and
meeting microbial performance
measures for carcasses during the
slaughter operation. FSIS retains the
ability to slow or stop the line, as
needed (9 CFR 310.26(c)). Based on its
experience under HIMP, the NSIS is
unlikely to result in a higher prevalence
of Salmonella on market hog carcasses
and may result in a lower prevalence of
Salmonella on market hog carcasses,
which in turn may lead to fewer human
illnesses. In addition, FSIS expects that
the new inspection system will improve
animal welfare and compliance with the
HMSA because more FSIS resources
will be available to verify the humane
handling of animals.
Under the NSIS, establishment sorters
will be required to incise mandibular
lymph nodes and palpate the viscera to
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Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 / Rules and Regulations
detect the presence of animal diseases
(e.g., Mycobacterium (M.) Avium) as
part of their sorting activities before
FSIS post-mortem inspection (9 CFR
310.26(b)). The Agency determined that
it needs more information on the public
health impact of these sorting activities
before it can allow establishments to
decide, on a lot-by-lot basis, whether
establishment sorters need to incise
lymph nodes and palpate the viscera to
detect the presence of animal diseases.
To gather this information, FSIS has
decided to allow establishments that
operate under the NSIS to apply for
waivers to 9 CFR 310.26(b) under 9 CFR
303.1(h). As a condition of the waiver,
establishments operating under waivers
are required to submit data to FSIS.
FSIS then assesses that data to
determine whether changes to the
regulations are appropriate and
necessary. The Agency will announce
the criteria for these waivers in a future
Federal Register document.
Under this final rule, market hog
slaughter establishments that do not
choose to operate under the NSIS may
continue to operate under traditional
inspection (i.e., inspection described in
current regulations). Establishments that
slaughter swine other than market hogs
are not eligible to operate under the
NSIS unless they obtain a waiver under
the Salmonella Initiative Program (SIP)
(79 FR 633, January 6, 2014).
Under this final rule, FSIS is also
making several changes that will affect
all establishments that slaughter swine,
regardless of the inspection system
under which they operate. Specifically,
all official swine slaughter
establishments must develop,
implement, and maintain in their
HACCP plans, sanitation standard
operating procedures (sanitation SOPs),
or other prerequisite programs (hereafter
collectively referred to as their ‘‘HACCP
systems’’), written procedures to
prevent the contamination of carcasses
and parts by enteric pathogens, and
visible fecal material, ingesta, and milk
throughout the entire slaughter and
dressing operation. These procedures
must include sampling and analysis for
microbial organisms to monitor process
control for enteric pathogens, as well as
written procedures to prevent visible
fecal material, ingesta, and milk
contamination.
As part of their written procedures,
establishments will be required to
collect and test two carcass samples for
microbial organisms, one at pre-
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evisceration and one at post-chill (i.e.,
the point in the slaughter process after
the carcass has chilled in the cooler and
after all slaughter interventions are
completed), or, for very low-volume
establishments, a single post-chill
carcass sample. Establishments that
bone their products before chilling (i.e.,
hot-boned products) will be required to
collect the pre-evisceration sample and
a sample after the final wash instead of
at post-chill, because these products are
not chilled before further processing.
Under this final rule, establishments,
except for very low-volume
establishments, are required to collect
carcass samples and test for microbial
organisms pre-evisceration and postchill, or, for hot-boned products, preevisceration and after the final wash, at
a frequency of once per 1,000 carcasses.
Very low-volume establishments are
required to collect at least one carcass
sample during each week of operation
starting June 1 of each year. If, after
consecutively collecting and testing 13
weekly carcass samples, very lowvolume establishments can demonstrate
that they are not exceeding their upper
control limit for microbial organisms
and that they are effectively maintaining
process control, they can modify their
sampling plans to collect samples less
frequently. FSIS provides more
information on upper control limits in
its guideline titled Developing Effective
Microbiological Sampling Programs in
Swine Slaughter Establishments to
Assess Process Control and Sanitary
Conditions (hereafter referred to as the
sampling guideline). The sampling
guideline is available on FSIS’s website
at https://www.fsis.usda.gov/wps/
portal/fsis/topics/regulatorycompliance/compliance-guides-index.
This final rule rescinds the current
requirement that swine establishments
test carcasses for generic E. coli post
chill to monitor process control and
replaces this requirement with the new
testing requirements described above.
The new testing requirements will allow
establishments to develop sampling
plans that are more tailored to their
specific operation, and thus more
effective in monitoring their specific
process control than the current generic
E. coli criteria. This final rule also
removes the codified Salmonella
pathogen reduction performance
standard for hogs (carcasses) because
verifying the codified standard was not
a good use of Agency resources. As FSIS
explained in the proposed rule (83 FR
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4780, 4786), the Agency discontinued
its Salmonella verification sampling
program for market hogs in 2011
because the estimated prevalence of
Salmonella on hog carcasses was low,
and FSIS did not find enough pathogen
positives to justify the resources needed
(e.g., time and supplies) to conduct
carcass swabbing.
This final rule does not allow
establishments to collect samples for
microbial organisms at alternative
sampling locations or frequencies, as
was proposed. FSIS made this change
from the proposed rule in response to
comments that it may be too difficult for
inspection personnel to review and
verify sampling plans with alternative
sampling locations or frequencies.
Establishments that currently operate
under SIP waivers from the former
generic E. coli regulations may continue
to conduct process control sampling at
the alternative frequencies provided for
in their waivers. All other SIP waivers
(e.g., waivers for 9 CFR 310.1(b)(3)—line
speed; 9 CFR 310.25(b)—Salmonella
performance standards; 9 CFR
310.18(a)—contamination of organs; and
9 CFR 310.14—handling of bruised
parts) will end. FSIS will allow other
establishments that would like to
experiment with alternative sampling
locations and frequencies to submit
waiver requests under the SIP to FSIS.
FSIS will announce new waiver criteria
in a future Federal Register document.
This final rule also does not require
swine slaughter establishments to
develop, implement, and maintain in
their HACCP systems written
procedures to prevent contamination of
the pre-operational environment by
enteric pathogens, as was proposed.
FSIS has decided to withdraw this part
of the proposal until the Agency
considers its options and timing for
gathering more data on contamination
in the pre-operational environment. A
summary of changes to the proposed
rule is included below under section I.
Background.
In Table 1 below, FSIS presents the
estimated costs and benefits of the final
rule. The regulatory impact analysis
section below contains an explanation
of the assumptions, provides alternative
adoption scenarios, and includes a
discussion of the uncertainty
surrounding the net benefits associated
with how much of the industry will
choose to adopt NSIS.
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TABLE 1—NET COSTS AND (BENEFITS)
[M$]
Costs to Industry ..............................................................................................................
Voluntary * .................................................................................................................
Mandatory .................................................................................................................
Health Benefits *** ............................................................................................................
Industrial Efficiency ..........................................................................................................
Impacts to Agency’s Budget ............................................................................................
Number of
establishments
One-time
............................
** 40
612
............................
............................
............................
$3.14
0.84
2.30
............................
............................
2.80
Recurring
$22.72
22.15
0.58
(9.33)
(87.64)
(8.73)
Totals
One-Time Cost ................................................................................................................................................
Recurring Cost .................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................
$5.94
(82.98)
(62.56)
(60.00)
* Further explanation and details on the NSIS adoption rate are provided in section G. Potential Cost of the Final Rule, Table 6: NSIS Adoption
Rate and section J. Net Benefits, Table 26: Quantified Cost and (Benefits) of Various Adoption Rates
** Note, this includes 5 HIMP establishments, which are not expected to incur any costs or benefits associated with the NSIS.
*** Further explanation and details on the range of health benefits have been provided in section H. Potential Benefits of the Final Rule, Table
18: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from a $6.33 million decrease to a $24.62 million increase in health benefits, with a mean increase in benefits of $9.33 million, assuming a cost per illness of $3,682.
**** Note, some of the totals may not equal the sum due to rounding.
Table of Contents
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I. Background
II. Comments and Responses
III. Executive Orders 12866 and 13563
IV. Regulatory Flexibility Act Assessment
V. Executive Order 13771
VI. Congressional Review Act
VII. E-Government Act
VIII. Executive Order 12988, Civil Justice
Reform
IX. Executive Order 13175
X. USDA Nondiscrimination Statement
XI. Environmental Impact
XII. Paperwork Reduction Act
XIII. Additional Public Notification
Final Regulatory Amendments
I. Background
FSIS began experimenting with new
approaches to slaughter inspection
based on HACCP principles shortly after
publishing the Pathogen Reduction/
HACCP rule in 1996. In 1997, the
Agency developed the HIMP pilot study
to determine whether applying new
government slaughter inspection
procedures, with new establishment
responsibilities, could promote industry
innovation and provide at least the same
food safety and consumer protection as
the other available slaughter inspection
systems. FSIS initiated the HIMP pilot
study in 20 young chicken, five young
turkey, and five market hog
establishments on a waiver basis.
In 2014, the Agency amended the
poultry products inspection regulations
to establish an optional new inspection
system for young chicken and all turkey
slaughter establishments informed by
the Agency’s experiences under HIMP
(79 FR 49566, August 21, 2014). The
New Poultry Inspection System (NPIS)
was designed to facilitate pathogen
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reduction in poultry products, improve
the effectiveness of poultry slaughter
inspection, make better use of the
Agency’s resources, and remove
unnecessary regulatory obstacles to
innovation.
In addition to establishing the NPIS
for young chickens and turkeys, FSIS
also amended the poultry products
inspection regulations that apply to all
establishments that slaughter poultry
other than ratites. The new
requirements ensure that all poultry
slaughter establishments implement
appropriate measures in their HACCP
systems to prevent contamination of
carcasses and parts by enteric pathogens
and visible fecal material throughout the
entire slaughter operation and ensure
that both FSIS and establishments have
the documentation they need to verify
the effectiveness of these measures on
an ongoing basis.
Proposed Rule
On February 1, 2018, FSIS proposed
to amend the meat inspection
regulations to establish an optional new
slaughter inspection system for market
hog establishments (83 FR 4780). FSIS
also proposed several changes to the
regulations that would affect all
establishments that slaughter swine,
regardless of the inspection system
under which they operate or the age,
size, or class of swine.
The proposed rule’s comment period
closed on May 2, 2018, 90 days after its
publication. After reviewing comments
on the proposed rule, FSIS is finalizing,
with some changes, the provisions in
the February 2018 proposed rule. In this
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final rule, the Agency is modifying its
proposal to:
• Establish a phased approach to
implement the NSIS;
• Establish separate applicability
dates for large, small, and very small
establishments to comply with the
provisions in the rule that prescribe the
new recordkeeping and microbiological
sampling requirements that will apply
to all establishments that slaughter
swine. The applicability dates will
provide additional time for small and
very small establishments to comply
with these provisions;
• Revise the disposal requirements to
require establishments operating under
the NSIS to develop, implement, and
maintain written procedures in their
HACCP systems to ensure that animals
and carcasses that have been sorted and
removed for disposal do not enter the
human food supply and are properly
disposed of according to 9 CFR part 314;
• Require establishments operating
under the NSIS to maintain records to
document the total number of animals
and carcasses sorted and removed per
day and the reasons for their removal
and make these records available for
review and evaluation by FSIS;
• Clarify that all establishments
operating under the NSIS must provide
a mirror at the carcass inspection
station;
• Clarify that establishments that
bone their products before chilling (i.e.,
hot-boned products) must collect a
carcass sample pre-evisceration and
after the final wash instead of at postchill. These establishments must also
collect a sample at the pre-evisceration
point in the process;
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• Withdraw the proposal to allow
establishments to use alternative
sampling locations and sampling
frequencies;
• Revise the sampling regulations to
require very small establishments that
slaughter more than 20,000 swine, or a
combination of swine and other
livestock exceeding 6,000 cattle and
20,000 total of all livestock to collect
two carcass samples, one at preevisceration and one at post-chill, at a
frequency of 1 per 1,000 carcasses,
instead of a single post-chill sample;
• Require establishment sorters to
incise mandibular lymph nodes and
palpate the viscera to detect the
presence of animal diseases (e.g., M.
Avium) as part of their sorting activities
before FSIS post-mortem inspection;
• Revise the definition of ‘‘RTC pork
product’’ to clarify that the standard is
a performance standard for non-food
safety defects and not a zero-tolerance
standard; and
• Withdraw the proposed
requirement for swine slaughter
establishments to develop, implement,
and maintain in their HACCP systems
written procedures to prevent
contamination of the pre-operational
environment by enteric pathogens.
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Hog HIMP Report
The proposed rule was informed by
the Agency’s comprehensive analysis of
data collected from HIMP market hog
establishments. In 2014, the Agency
evaluated inspection findings in market
hog slaughter establishments
participating in HIMP to determine
whether the HIMP inspection system
performs as well as the existing
inspection system in terms of safety and
wholesomeness of the products
produced and of overall consumer
protection. FSIS summarized its
findings in its report titled ‘‘Evaluation
of HACCP Inspection Models Project
(HIMP) for Market Hogs’’ (hereafter the
‘‘Hog HIMP Report’’) 1 and in the
proposed rule (83 FR 4780, 4789). The
Hog HIMP Report concluded that
market hog slaughter establishments
participating in HIMP are performing as
well as comparable large non-HIMP
market hog establishments.
The Hog HIMP Report is based on two
time periods: The years CY2006–
CY2010 and the years CY2012–CY2013.
The evaluation compared 5 HIMP
market hog establishments with a
comparison set of 21 non-HIMP market
hog slaughter establishments selected to
1 The Hog HIMP Report is available on the FSIS
website at: https://www.fsis.usda.gov/wps/wcm/
connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/
Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES.
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be comparable with HIMP market hog
establishments with respect to
production volume, line speed, and
days of slaughter operation.
The Hog HIMP Report found that
HIMP market hog establishments
received more off-line food safety
related inspection verification checks
than the traditional non-HIMP market
hog establishments. HIMP market hog
establishments had higher compliance
with Sanitation SOP and HACCP
regulations, lower levels of non-food
safety defects, equivalent or better
Salmonella verification testing positive
rates than traditional non-HIMP market
hog establishments, and lower levels of
violative chemical residues. The Hog
HIMP Report also found that under
HIMP, market hog establishments
received an increased level of Sanitation
SOP and HACCP inspection. Based on
these findings, HIMP has been
demonstrated to provide public health
protection at least equivalent to the
traditional inspection system.
Risk Assessment
The proposed rule was also informed
by FSIS’s Assessment of the Potential
Change in Human Risk of Salmonella
Illnesses Associated with Modernizing
Inspection of Market Hog Slaughter
Establishments. The risk assessment 2
used available data from FSIS’s
microbiological baseline studies 3 and
the Agency’s Salmonella verification
results from swine slaughter
establishments. FSIS employed a
stochastic simulation model using
multi-variable logistic regressions to
identify correlations between (1) the
numbers of offline food-safety
inspection procedures, both scheduled
and unscheduled, along with the
numbers of non-compliances and
scheduled-but-not-completed
procedures,4 and (2) contamination of
hog carcasses with Salmonella. The
correlations were used to predict the
2 As FSIS explained in the proposed rule, the
Agency used a similar approach to estimate the
public health benefits associated with the final rule
titled Modernization of Poultry Slaughter
Inspection (79 FR 49565).
3 FSIS baseline data is available at: https://
www.fsis.usda.gov/wps/portal/fsis/topics/datacollection-and-reports/microbiology/baseline/
baseline.
4 Scheduled procedures are assigned to inspectors
at an establishment by the Public Health
Information System (PHIS). Before FSIS
implemented the PHIS, scheduled procedures were
assigned by the Performance-Based Inspection
System (PBIS). Unscheduled procedures are
performed according to inspector needs at an
establishment and may include verification checks
for fecal material, ingesta, and milk, or they may be
a response to unforeseen hazards or unsanitary
conditions arising from sanitation SOP failures, or
the need to verify corrective actions taken under the
establishment’s HACCP plan.
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potential effect that devoting more
resources to those offline procedures
might have on human illness
attributable to the consumption of pork
products. Stochastic simulations were
used to account for statistical
uncertainty in the estimates relating
inspection procedures in an
establishment to detection of
Salmonella in samples from hog
carcasses.5 Illness estimates were based
on data from the Centers for Disease
Control and Prevention (CDC), and
uncertainty distributions were used to
account for the variability in annual
Salmonella illnesses and statistical
uncertainty about the relationship
between the pathogen prevalence levels
at the establishments and the
corresponding annual number of
illnesses that could be attributed to the
pathogens.
As with any risk assessment, FSIS’s
risk assessment relies on a number of
assumptions. FSIS assumed that the
differences between the approach to
slaughtering hogs and slaughtering
poultry would not alter the relationship
between the presence of Salmonella
contamination on carcasses and the
likelihood of contamination of meat and
human illness. Furthermore, hog
slaughter establishment specialization
has been facilitated by vertical
integration within the industry, much
like the poultry industry.6 FSIS also
assumed, for the purpose of this risk
assessment, that the relationship
between Salmonella contamination of
hog carcasses and downstream products
such as pork parts (e.g., pork chops) and
ground pork closely mirrors that of the
established relationship between
Salmonella contamination of poultry
(e.g., chicken) carcasses and
downstream products such as chicken
parts and ground chicken. On the other
hand, the likelihood of positive
Salmonella findings on hog carcasses is
significantly lower than on chickens.
While FSIS did not conduct any specific
analyses to examine this assumption,
the Agency has conducted numerous
peer-reviewed analyses of the
relationship between Salmonella
contamination frequency on chicken
5 For the risk assessment, FSIS used data from
The Nationwide Microbiological Baseline Data
Collection Program: Market Hogs Survey August
2010–2011 available at https://www.fsis.usda.gov/
wps/wcm/connect/d5c7c1d6-09b5-4dcc-93aef3e67ff045bb/Baseline_Data_Market_Hogs_20102011.pdf?MOD=AJPERES).
6 Muth, M. (2007). Pork Slaughter and Processing
Sector Facility-Level Model. https://www.rti.org/
sites/default/files/resources/muth_pork-slaughter_
final.pdf.
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carcasses and chicken parts.7 These
analyses indicate that the prevalence of
Salmonella contamination on
downstream products (e.g., parts) often
exceeds the frequency of measurement
of Salmonella contamination in
upstream products (e.g., carcasses), and
the Agency expects this relationship
would apply to other amenable species
slaughtered in FSIS establishments. The
assumption of higher prevalence is
logical given that samples of
downstream products contain primals
from multiple carcasses, increasing the
likelihood of a single sample being
contaminated.
The regression analysis of the
historical data included in the market
hog risk assessment showed a
statistically significant correlation
between (1) increased scheduled and
unscheduled offline procedures and
decreased scheduled but not performed
procedures and (2) reduction in the
prevalence of Salmonella positive
samples from carcasses. Based on these
results, the redeployment of Agency
resources to scheduled and
unscheduled offline activities, along
with a reduction in scheduled but not
performed procedures, is likely to
contribute to food safety resulting from
a lower prevalence of carcasses
contaminated with Salmonella, which
in turn the Agency expects to lead to
fewer human illnesses. FSIS will
evaluate policy effectiveness by
routinely analyzing inspection task data
in PHIS (e.g., NRs for regulations on the
PHR list, including NRs for HACCP,
sanitation SOP, and Livestock Zero
Tolerance tasks).
In April 2018, the Agency conducted
an external peer review of the risk
assessment. On August 6, 2018, FSIS
posted a revised version of the risk
assessment on its website at https://
www.fsis.usda.gov/wps/portal/fsis/
topics/regulations/federal-register/
proposed-rules. The revised risk
assessment addressed reviewers’
comments that FSIS should have used
different modeling approaches. The
revised risk assessment also included an
in-depth power analysis,
multicollinearity diagnostics, model
parameters and estimates when more
complex crossover and mixed-effects
modeling approaches were applied, and
a summary of all alternative models
(Appendix H). The revisions made in
response to the reviewers’ comments
did not produce changes to the risk
assessment’s conclusions that would
7 Ebel, E.D., Williams, M.S., Tameru, B. (2019)
Relatedness of Salmonella contamination frequency
on chicken carcasses and parts when processed in
the same establishment. Food Control 100: 198–203.
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require modifications of the proposed
rule. However, the Agency gave
interested persons 30 days (until
September 5, 2018) to comment on the
changes made to the risk assessment. To
be transparent, FSIS has decided to add
text to the risk assessment to better
characterize the two different models
that were conducted (see Tables 13 and
14 in the risk assessment and
accompanying text). Specifically, FSIS
has added additional language to the
risk assessment—both in the summary
and in the discussion—to highlight the
results of the modeling without
simulated data. To that end, the results
of the modeling with simulated data—
which, as would be expected, had less
uncertainty around the estimated
change in illnesses—are not used in
support of this rule. The modeling
without simulated data is now carried
through in the Regulatory Impact
Analysis. The result of those additions
is that the uncertainty around estimated
illnesses avoided is greater; however,
the most likely estimated illnesses
avoided are not affected. Notably, FSIS
received a comment questioning FSIS’s
use of simulated data. FSIS believes that
this change addresses the commenter’s
questions.
Additionally, minor edits and
corrections for clarity and consistency
were made in the main body of the risk
assessment report. The most likely
estimates of illnesses avoided from
converting from traditional inspection
to the NSIS did not change with
incorporation of these additional
analyses and other minor changes to the
risk assessment.
The final risk assessment is available
on FSIS’s website at https://
www.fsis.usda.gov/wps/portal/fsis/
topics/science/risk-assessments. FSIS is
responding to comments received
regarding the risk assessment in Part C
of section II. ‘‘Comments and
Responses’’ below.
II. Comments and Responses
FSIS received over 83,000 comments
in response to the February 2018
proposed rule and five comments on the
revised risk assessment. Most of these
comments were form letters submitted
as part of various write-in campaigns
initiated by consumer advocacy
organizations, animal welfare
organizations, labor unions, and worker
advocacy organizations. FSIS also
received individual comments from
private citizens.
In addition to the form letters and
individual comments, the Agency also
received comments from trade
associations representing the meat
industry, companies that conduct swine
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slaughter operations, consumer
advocacy organizations, public health
organizations, animal welfare
organizations, labor unions, worker
advocacy organizations, foreign
countries, FSIS inspectors, an
environmental organization, and a State
Department of Agriculture. Below is a
summary of the comments and FSIS’s
responses.
A. Requests for Public Meetings,
Comment Extensions, and Documents
Comments: Several consumer
advocacy organizations, labor unions,
and worker advocacy organizations
stated that FSIS should have held public
meetings to discuss the proposed rule.
According to the comments, public
meetings focused on the proposed rule
may have helped to clarify the pros and
cons of important proposed changes. A
few consumer advocacy organizations
argued that FSIS should have submitted
the risk assessment for peer review
before publishing the proposed rule, or,
at least, extended the comment period
for the proposed rule until all
stakeholders had the opportunity to
read and respond to the peer reviewed
version of the risk assessment.
Response: Rather than hold a public
meeting on the proposed rule, the
Agency held two webinars in March and
April 2018, to provide an overview of
the proposed rule and provide the
public with an opportunity to ask
questions about the proposed rule.
(Transcripts of the webinars are
available on the FSIS website at https://
www.fsis.usda.gov/wps/portal/fsis/
newsroom/meetings/past-meetings.)
During the webinars, FSIS provided the
public with all the information that it
would have provided during a public
meeting.
The Agency explained during the
webinars and monthly consumer and
industry stakeholder meetings that it
would reopen the comment period for
the proposed rule if the Agency had to
make significant changes to the risk
assessment based on peer review
comments. And, even though FSIS did
not have to make significant changes to
the risk assessment, the Agency
reopened the comment period on the
risk assessment for an additional 30
days to give stakeholders an opportunity
to comment on the revised document.
In total, stakeholders had 90 days to
review and comment on the proposed
rule and 120 days to review and
comment on the risk assessment.
Executive Order (E.O.) 12866, as
supplemented by E.O. 13563, states that
agencies are to ‘‘afford the public . . .
with a comment period that should
generally consist of not less than 60
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days.’’ The Agency believes that the
public had ample time to consider the
issues raised in the proposed rule and
risk assessment to develop their
comments.
Comment: A few worker advocacy
groups argued that FSIS should have
reopened the comment period on the
proposed rule because, according to the
commenters, the Agency relied on an
unpublished data set of Occupational
Safety and Health Administration
(OSHA) logs to compare worker injury
rates between HIMP and non-HIMP
establishments.
Response: In the proposed rule, FSIS
explained that the Agency compared
injury rates between establishments
operating under traditional inspection
and HIMP (83 FR 4796). FSIS’s analysis
showed that HIMP establishments had
lower mean injury rates than non-HIMP
establishments. The analysis used injury
rate data available on OSHA’s website.
FSIS further explained that the survey
captured data from OSHA logs of
workplace injuries and illnesses,
maintained by employers as mandated
by regulations (see 29 CFR part 1904),
and that 56 FSIS inspected market hog
slaughter establishments submitted their
injury rate data to OSHA (83 FR 4796).
From these 56 establishments, FSIS
explained that it excluded 27 lowvolume establishments, leaving 29
establishments (5 HIMP and 24
Traditional). The low-volume
establishments were excluded to
provide a better comparison group of
traditional establishments because all
HIMP establishments are high-volume
establishments. The results showed
HIMP establishments had a lower mean
number of injuries using three OSHA
injury rate measures: Total Case Rate
(TCR); Days Away, Restricted or
Transferred (DART); and Days Away
from Work (DAFW). However, FSIS
noted that factors other than line speed
may affect injury rates (e.g., automation
and number of sorters per line) and
requested comments on worker safety
issues in the proposed rule as a result.
All the information that FSIS used in
its analysis is publicly available. FSIS
does acknowledge that it did not
provided the web address for OSHA’s
Establishment Specific Injury and
Illness Data, which is available at
https://www.osha.gov/pls/odi/
establishment_search.html. However, it
is easy to find on OSHA’s website under
the ‘‘Data’’ tab.
And, while FSIS did not post the
exact data that the Agency pulled from
its Public Health Information System
(PHIS) to select swine slaughter
establishments present in the OSHA
data set, the same information can be
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found in other formats on FSIS’s
website. Establishment level production
volume information is available at
https://www.fsis.usda.gov/wps/portal/
fsis/topics/data-collection-and-reports/
data. This data would allow interested
parties to identify the high-volume
establishments. Additionally, the list of
establishments participating in HIMP is
available at https://www.fsis.usda.gov/
wps/portal/fsis/topics/regulatorycompliance/haccp/haccp-basedinspection-models-project/HIMP-list-ofparticipating-plants.
Although FSIS conducted an analysis
of injury rates during the development
of the proposed rule, FSIS did not use
the analysis to draw conclusions on
worker safety in HIMP or non-HIMP
establishments or whether there is an
associated impact on food safety. As
discussed in more detail below, while
FSIS recognizes that working conditions
in swine slaughter establishments is an
important issue, the Agency does not
have the authority to regulate issues
related to establishment worker safety.
OSHA is the Federal agency with
statutory and regulatory authority to
promote workplace safety and health.
Comment: A few commenters argued
that FSIS violated the Administrative
Procedure Act (APA, 5 U.S.C. 551 et
seq.) because the Agency did not
identify the 21 non-HIMP
establishments that it used to conduct
its comparisons for the Hog HIMP
Report or post all the raw data that it
used to develop the Hog HIMP Report.
According to the commenters, the APA
requires reasoned decision-making
based on an examination of relevant
data articulated in a satisfactory
explanation. The commenters argued
that because FSIS did not provide all its
raw data, the Agency failed to provide
the public a meaningful opportunity to
participate in the rulemaking process.
Response: The APA does not require
Federal agencies to post all their raw
data. That said, FSIS is committed to
being transparent and responsive to
stakeholders. FSIS clearly explained in
the Hog HIMP Report that FSIS selected
the 21 non-HIMP establishments
because they were large, high-volume
market hog slaughter establishments
that had similar production volume,
line speed, and days of slaughter
operation to the five market hog
slaughter HIMP establishments. FSIS
also clearly explained in the Hog HIMP
Report and the proposed rule (83 FR
4780, 4789) the Agency’s analysis of its
inspection data and its conclusions
based on the data. Moreover, FSIS made
every effort to respond to FOIA requests
related to the proposed rule before the
close of the comment period. The
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Agency has added all the information
that it has recently released to its FOIA
Electronic Reading Room.8
B. HIMP
Comment: Several consumer
advocacy organizations, public health
organizations, animal welfare
organizations, worker advocacy
organizations, and private citizens
questioned whether data collected
under the HIMP pilot study should be
used to inform the NSIS. The
commenters argued that the USDA’s
Office of the Inspector General (OIG)
was critical of HIMP in its 2013 report.9
The commenters stated that OIG found
that FSIS: Did not adequately oversee
the HIMP program because it did not
evaluate whether the program resulted
in a measurable improvement of the
inspection process; allowed one HIMP
establishment to forgo the standard FSIS
policy to manually inspect viscera; and
did not have formal agreements with the
HIMP establishments.
According to the commenters, OIG’s
audit report also raised issues with the
Agency’s enforcement policies at all hog
slaughter operations, finding that FSIS’s
policies did not deter establishments
from becoming repeat violators of food
safety regulations and that FSIS could
not always ensure the humane handling
of animals.
In September 2013, the U.S.
Government Accountability Office
(GAO) followed the OIG with a report
entitled, More Disclosure and Data
Needed to Clarify Impact of Changes to
Poultry and Hog Inspections.10
According to the commenters, GAO
found that FSIS did not collect
comparable data from establishments
participating and not participating in
the HIMP pilot study. The commenters
also stated that GAO found that the use
of volunteer facilities raised questions
about self-selection bias and that
information collected from the five
market hog slaughter HIMP
establishments would not provide
reasonable assurance that any
conclusions could apply more broadly
to all swine slaughter establishments
because of the small sample size.
Response: FSIS addressed OIG’s
concerns in the Agency’s responses to
the audit. In response to the OIG audit,
8 FSIS’s FOIA Electronic Reading Room is
available at https://www.fsis.usda.gov/readingroom.
9 OIG, 2013. Food Safety and Inspection Service,
Inspection and Enforcement Activities at Swine
Slaughter Plants, https://www.usda.gov/oig/
webdocs/24601-0001-41.pdf.
10 GAO, 2013. More Disclosure and Data Needed
to Clarify Impact of Changes to Poultry and Hog
Inspections, https://www.gao.gov/assets/660/
657144.pdf.
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FSIS updated its SIP letters (i.e., formal
agreements), requiring all HIMP
establishments to conduct the same
viscera inspection procedures, and
implemented PHIS, enhancing the
Agency’s ability to better track trends in
NRs.
In addition, the Agency implemented
required supplemental training after the
release of the updated Directive 6900.2,
Humane Handling and Slaughter of
Livestock, to improve inspectors’
objective observation and assessment
skills. The Situation Based Humane
Handling training modules (Module I
and Module II) effectively teach
inspectors how to interpret an egregious
or non-egregious inhumane handling
event objectively, and to take
appropriate enforcement actions. The
training modules contain fictional
scenarios of inhumane and egregious
events and describe in detail how an
inspector is to proceed with regulatory
enforcement.
Furthermore, in October 2013, FSIS
announced that it hired a Humane
Handling Enforcement Coordinator,
who conducts ongoing reviews of
relevant NRs, suspensions and Notices
of Intended Enforcement (NOIEs).11 To
accomplish this, the Humane Handling
Enforcement Coordinator maintains a
database to track the review of NRs and
the review and tracking of suspensions
and NOIEs pertaining to violations of
the HMSA. The Humane Handling
Enforcement Coordinator also conducts
correlations with inspectors to help
them improve their objective analysis
when enforcing the HMSA and related
regulations, which serves to reduce
subjective interpretation of inhumane
events and their regulatory outcome.
To deter repeat violators, the Agency
changed the way that it schedules its indepth reviews of establishments’ food
safety systems, known as food safety
assessments (FSAs).12 13 In 2015, FSIS
implemented its Public Health Risk
Evaluation (PHRE) methodology, which
consists of a decision-making evaluation
that helps Enforcement, Investigations
and Analysis Officers (EIAOs) and DOs
determine if an FSA needs to be
scheduled and conducted or if
enforcement action is warranted for a
particular establishment. The decision
criteria used in the PHRE include
factors such as pathogen testing results,
recalls, outbreaks, regulatory findings,
and inspection results at an
establishment. The PHRE methodology
and the decision criteria are described
in detail in FSIS Directive 5100.4.14
Rather than schedule routine FSAs
every four years, FSIS’s Office of
Planning, Analysis and Risk
Management (OPARM) provides DOs
with a prioritized list of establishments
for PHREs once per month based on
public health risk triggers (e.g., if an
establishment has produced adulterated
product). EIAOs review historical data
on the listed establishments and
coordinate with inspection program
personnel assigned to the listed
establishments to determine if an FSA
or other enforcement action is needed.
DOs can still schedule for cause PHREs
at establishments not on the prioritized
list (i.e., if there is an illness or
outbreak, significant or repetitive
contamination or adulteration incidents,
or repetitive microbiological sampling
failures). The use of the PHRE
methodology allows FSIS to better target
establishments for FSAs based on risk
and to more effectively deploy its
investigational resources (EIAOs).
In addition, FSIS developed PHIS
alerts for inspection personnel that are
triggered when an establishment
receives a certain percentage of NRs for
regulations on the Public Health
Regulation (PHR) list.15 The PHR list,
which is updated annually and posted
on the Agency’s website, consists of
regulations and specific provisions of
regulations that historically have higher
rates of noncompliance three months
before a pathogen positive or
enforcement action. Each month
OPARM calculates a PHR NR rate for
each meat and poultry establishment
and determines if an establishment will
be issued a PHR alert or if they should
be considered by the DO for a PHRE,
which may lead to an FSA. PHIS alerts
have helped FSIS better identify trends
11 https://www.fsis.usda.gov/wps/portal/fsis/
newsroom/news-releases-statements-andtranscripts/news-release-archives-by-year/archive/
2013/nr-102313-01.
12 See FSIS Directive 5100.1, Enforcement,
Investigations and Analysis Officer (EIAO) Food
Safety Assessment (FS) Methodology available at
https://www.fsis.usda.gov/wps/wcm/connect/
31bb8000-fb33-4b51-964b-1db9dfb488dd/
5100.1.pdf?MOD=AJPERES.
13 See FSIS Directive 5100.4, Enforcement,
Investigations and Analysis Officer (EIAO) Public
Health Risk Evaluation (PHRE) Methodology
available at https://www.fsis.usda.gov/wps/wcm/
connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/
5100.4.pdf?MOD=AJPERES.
14 FSIS Directive 5100.4, Enforcement,
Investigations and Analysis Officer (EIAO) Public
Health Risk Evaluation (PHRE) Methodology
available at https://www.fsis.usda.gov/wps/wcm/
connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/
5100.4.pdf?MOD=AJPERES.
15 See FSIS Notice 15–18, Public Health
Regulations and Alerts for use in Determining
Inspection Program Personnel Actions and Public
Health Risk Evaluation Scheduling in Meat and
Poultry Establishments available at https://
www.fsis.usda.gov/wps/wcm/connect/8f218f5b197e-4813-bf92-be29be36ec08/1518.pdf?MOD=AJPERES&CONVERT_
TO=url&CACHEID=8f218f5b-197e-4813-bf92be29be36ec08.
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that may warrant an FSIS enforcement
action.
The GAO report identified what it
believed to be data gaps in the HIMP
pilot study and recommended that FSIS
collect and analyze information to
determine if the HIMP pilot study was
meeting its purpose. FSIS agreed with
the recommendation and began working
on the Hog HIMP Report. GAO also
identified strengths in the HIMP pilot
study, including that of giving
establishments responsibility and
flexibility for ensuring food safety and
quality and allowing FSIS inspectors to
focus more on food safety related
activities.
While it is true that the five market
hog slaughter HIMP establishments
represent a small sample size of
establishments, they collectively
represent diversity in geography,
corporate structure, management styles,
product distribution patterns, and other
variables. FSIS believes that the
volunteer market hog slaughter
establishments participating in the
HIMP pilot study, viewed collectively,
are typical of the broader industry.
Comment: Some consumer advocacy
groups questioned why the Agency did
not use a third-party contractor to
conduct its evaluation of the hog HIMP
pilot study.
Response: FSIS did not hire a thirdparty contractor to draft the Hog HIMP
Report because the model and the
resulting inspection data had already
been reviewed by third-party
contractors. As FSIS explained in the
proposed rule, the independent
consulting firm, Research Triangle
Institute (RTI), collected baseline
organoleptic and microbiological data in
the five market hog slaughter
establishments that volunteered to
participate in the HIMP pilot study
before they implemented HIMP (83 FR
4780, 4788). These baseline data reflect
the performance of these five
establishments under traditional
inspection before they implemented
HIMP and provided the basis to
establish HIMP performance standards
for food safety defects and non-food
safety ‘‘Other Consumer Protection’’
(OCP) defects.
FSIS also explained in the final rule
to modernize poultry slaughter
inspection (79 FR 49566, 49573) that in
2002, the Agency contracted with a
third-party technical review team
(review team, henceforth) selected by
the National Alliance for Food Safety to
review and evaluate the data collected
from young chicken establishments
operating under HIMP. The review team
focused on the validity of the HIMP
pilot study design and method to
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determine whether FSIS could use the
organoleptic and microbial data
collected under HIMP to compare the
performance of establishments operating
under HIMP to the performance of
establishments operating under nonHIMP inspection systems. Overall, the
review team found that the HIMP study
design and method were valid and
provided a useful and legitimate
comparison of the performance of
establishments operating under HIMP
and non-HIMP inspection systems. The
review team’s findings are described in
the report titled Review of the HACCPBased Inspection Models Project by the
National Alliance for Food Safety
Technical Team (The Hargis Report).16
While the review team did not review
data collected from the market hog
establishments operating under HIMP,
the poultry and market hog HIMP
models and the resulting inspection
data are very similar. Therefore, FSIS
determined there would be no benefit in
hiring another review team to evaluate
the HIMP market hog inspection data.
Comment: A few consumer advocacy
organizations stated that the data used
in the Hog HIMP Report is now stale as
the Agency analyzed data from CY2006
through CY2010 and then CY2012
through CY2013.
Response: FSIS disagrees. FSIS has
not made any significant changes to the
HIMP model since 2013, and FSIS
inspectors are still performing the same
inspection tasks. The Hog HIMP Report
findings from CY2006 through CY2010
and CY2012 through CY2013 were very
similar. This shows that not much
changed over a seven-year period, and
that the model is stable. No significant
changes in swine slaughter, FSIS
inspection, or related regulations have
occurred since CY 2013. Therefore, FSIS
has no reason to believe that the data in
the Hog HIMP Report is no longer useful
simply because of the passage of time.
Comment: One consumer advocacy
group noted that the Hog HIMP Report
shows that there was an increase in total
offline verification tasks in HIMP
establishments during CY2012 and
CY2013. However, according to the
same commenter, tables 3–2 and 3–3 in
the Hog HIMP Report show that
inspectors performed fewer verification
tasks in HIMP establishments than they
did in non-HIMP establishments for
more than half of the PHRs in CY2012
and CY2013. According to the
commenter, the Agency treats a total
pooled increase in inspection tasks
across all regulations as outweighing the
16 The Hargis Report is available at https://
www.fsis.usda.gov/OPPDE/nacmpi/Nov2002/
Papers/NAFS97.pdf.
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decreases in some inspection tasks. The
commenter argued that FSIS needs to
justify why a decrease in any inspection
task for any regulation will not be
detrimental to food safety. The
commenter further argued that FSIS did
not explain why the PHRs are relevant.
Another consumer advocacy group
complained that the Hog HIMP Report
did not indicate which inspection tasks
were scheduled or unscheduled. The
same commenter stated that FSIS did
not demonstrate that the increased
offline verification tasks in HIMP
establishments were statistically
significant, as opposed to a product of
chance.
Response: The Agency uses PHIS to
assign scheduled or ‘‘routine’’
inspection tasks. Inspectors in large,
high-volume market hog slaughter
establishments receive the same number
of routine inspection tasks in both HIMP
and traditional establishments.
Unscheduled or ‘‘directed’’ inspection
tasks are initiated by the inspector or
their supervisor.
The Hog HIMP Report was not
generated to evaluate the benefits of
performing more scheduled versus
unscheduled offline inspection
verification tasks. The risk assessment
discussed above evaluated, among other
things, the effect of increased offline
inspection verification tasks in swine
slaughter establishments. The objective
of the Hog HIMP Report was to
determine whether the HIMP inspection
system performs as well as the
traditional inspection system in terms of
product safety and wholesomeness, and
overall consumer protection. As FSIS
explained in the proposed rule (83 FR
4780, 4790), the Hog HIMP Report
found that inspectors at HIMP market
hog establishments are performing more
off-line food safety related inspection
verification tasks than inspectors at
traditional market hog establishments,
including an increased level of
Sanitation SOP and HACCP inspection
verification tasks. The Hog HIMP Report
also found that HIMP market hog
establishments have higher compliance
rates with Sanitation SOP and HACCP
regulations, lower levels of non-food
safety defects, equivalent or better
Salmonella verification testing positive
rates, and lower levels of violative
chemical residues, as compared to
traditional non-HIMP market hog
establishments.
FSIS disagrees that the Agency
needed to indicate which offline
inspection verification tasks were
scheduled and unscheduled or
demonstrate that the increased number
of offline verification tasks in HIMP
establishments were statistically
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significant and could therefore be used
to evaluate whether HIMP market hog
establishments performed as well as
traditional market hog establishments.
FSIS explained in the Hog HIMP Report
that inspectors conducted more offline
inspection tasks in HIMP establishments
largely due to the increased inspection
for visible fecal material, ingesta, and
milk contamination under 9 CFR
310.18. FSIS inspectors at hog HIMP
establishments inspect a sample of 24
carcasses when they perform a Zero
Tolerance verification task specifically
for 9 CFR 310.18, whereas FSIS
inspectors at traditional market hog
establishments inspect a sample of 11
carcasses. These Zero Tolerance
verification tasks are required every
shift.
Tables 3–2 and 3–3 in the Hog HIMP
Report show the number of times that
FSIS inspectors verified compliance
with a regulation. These tables do not
necessarily show the number of times a
task was performed. FSIS inspectors
verify whether establishments meet
requirements in 9 CFR part 417 when
they conduct HACCP tasks; whether
establishments meet requirements in 9
CFR 416.1–6 when they conduct
sanitation performance standards (SPS)
tasks; and whether establishments meet
requirements in 9 CFR 416.11–17 when
they conduct Sanitation SOP tasks. And,
while inspectors receive the same
routine tasks, not every regulation in
tables 3–2 and 3–3 needs to be verified
in every establishment. For example,
FSIS inspectors would only verify
whether establishments meet
requirements in 9 CFR 416.16(b) if the
establishment maintains records on a
computer. In addition, inspectors would
only check 9 CFR 417.3(a)–(c) in PHIS
if they were verifying whether
establishments met corrective action
requirements after a deviation. So, the
fact that table 3–2 and 3–3 show that
FSIS inspectors verified fewer 9 CFR
part 417 regulations in HIMP
establishments does not mean that FSIS
performed fewer HACCP inspection
verification tasks in CY2012 and
CY2013. Rather, it could mean that
inspectors found fewer deviations that
required the subsequent verification of
corrective actions. Therefore, tables 3–2
and 3–3 do not support the commenter’s
argument that FSIS conducted fewer
tasks in HIMP establishments, which
they claimed could be detrimental to
food safety.
As FSIS explained in the proposed
rule (83 FR 4789) and above, the PHR
list is relevant because it consists of
regulations that have higher rates of
noncompliance three months before a
pathogen positive or enforcement
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action. The PHR list allows FSIS to
focus on specific health related
provisions of regulations that may be
the most informative for prioritizing
PHREs and FSAs. FSIS compared the
number of verifications of PHR
regulations in HIMP and traditional
establishments because non-compliance
with these regulations was determined
by OPARM to be an important indicator
of subsequent food safety issues and
loss of process control.
Comment: One consumer advocacy
group argued that the increased offline
regulation verifications under HIMP are
probably the result of greater reporting,
rather than an actual increase in
verifications. The commenter stated that
they have received information that
inspectors find that entering data into
PHIS is cumbersome, so they do not
enter data for unscheduled tasks unless
they find problems. According to the
commenter, there has been a significant
drop in the number of verification tasks
performed since the implementation of
PHIS.
Response: FSIS inspectors in both
HIMP and non-HIMP establishments use
PHIS. FSIS provides instructions on
how to use PHIS in its directives and
notices. As FSIS explained above, an
inspector at a large, high-volume
slaughter establishment operating under
HIMP would receive the same tasks as
an inspector at a large, high-volume
slaughter establishment operating under
traditional inspection, except that the
inspector in the HIMP establishment is
instructed to schedule more carcass
verification tasks. The documentation
requirements for inspectors are also the
same for HIMP and non-HIMP
establishments. The key difference is
that FSIS inspectors in HIMP
establishments routinely document
fewer condemned animals, carcasses,
and parts because establishments
conduct sorting procedures before FSIS
inspection. Additionally, comments on
inspectors not wanting to document
completion of tasks in PHIS are outside
the scope of these regulations.
Comment: A few consumer advocacy
groups stated that they found 32
instances in which establishments were
cited for violating 9 CFR 311.16(a)—
Carcasses So Infected that Consumption
of the Meat May Cause Food Poisoning.
According to the commenters, these
instances occurred in HIMP
establishments rather than
establishments operating under
traditional inspection because
establishment sorters on the slaughter
line presented carcasses to FSIS that
were unfit for processing. The
commenters argued that the Hog HIMP
Report should have compared NRs for 9
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CFR 311.16(a) in HIMP and traditional
establishments.
One consumer advocacy group noted
that the Hog HIMP Report shows that
there were statistically significant
differences in the weighted, healthrelated Sanitation SOP and HACCP NRs
for the five Hog HIMP establishments as
compared to those establishments
operating under traditional inspection
for a combined four years. The
commenter noted that while the Agency
indicated in tables 3–9 and 3–10 that
the total NRs for Sanitation SOP and
HACCP PHRs were lower in CY2012
and CY2013 for the 5 HIMP
establishments, these establishments
had more NRs for non-compliance with
other regulations. The commenter
argued that for certain regulations like 9
CFR 417.3(a)(2), the five HIMP
establishments had higher and
statistically significant NRs compared to
the 21 comparable non-HIMP traditional
establishments. The commenter stated
that the five HIMP establishments had
an 11-fold and three-fold higher rate of
violating 9 CFR 417.3(a)(2) in CY2012
and CY2013, respectively. The
commenter noted that 9 CFR 417.3(a)(2)
is a measure of whether an
establishment is maintaining control
over a critical control point. The
commenter argued that because the five
HIMP establishments received more
NRs for this regulation, they were not
adhering to their HACCP plans, and
were out of control more frequently than
the 21 comparable non-HIMP traditional
establishments.
The same consumer advocacy group
stated that they conducted their own
analysis of NRs issued in the five HIMP
establishments and five comparablysized non-HIMP traditional
establishments from CY2012 to CY2016.
The commenter noted that, based on
their own analysis, the five HIMP
establishments had more NRs for noncompliance with 9 CFR 310.18, 416.3–
416.5, 416.13, and 417.2. The
commenter highlighted an NR that was
issued to a HIMP establishment in 2017
because an establishment sorter did not
identify a carcass with a food safety
defect. The commenter also noted that
OIG found that from FY 2008 to 2011,
three of the 10 swine slaughter
establishments cited with the most
noncompliance records (NRs) were
HIMP establishments. The commenter
argued that these NRs demonstrate that
the HIMP inspection system is not as
effective as the traditional inspection
system.
Response: FSIS disagrees that these
NRs prove that HIMP establishments
lose process control more often than
traditional establishments. In Table 3–9
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in the Hog HIMP Report,17 PHR
noncompliance rates in CY2012 at the
five HIMP market hog establishments
were statistically significantly higher for
four regulations, statistically
significantly lower for five regulations,
and not statistically significantly
different for eighteen regulations.
Overall, the CY2012 PHR
noncompliance rate for Sanitation SOP
and HACCP regulations (9 CFR parts
416 and 417) in the five HIMP market
hog establishments was statistically
significantly lower than that for the 21
comparison non-HIMP market hog
establishments. In Table 3–10 in the
Hog HIMP Report, PHR noncompliance
rates in CY2013 at HIMP market hog
establishments were statistically
significantly higher for three
regulations, statistically significantly
lower for five regulations, and not
statistically significantly different for
nineteen regulations. Overall, the PHR
noncompliance rate in CY2013 for
Sanitation SOP and HACCP regulations
in the five HIMP market hog
establishments was statistically
significantly lower than that for the 21
comparison non-HIMP market hog
establishments. The Sanitation SOP and
HACCP regulations are among the
regulations most strongly related to
public health.
Under HIMP, if an establishment does
not adequately sort for carcasses
showing signs of septicemia or pyemia,
FSIS issues an NR for 9 CFR 311.16(a).
FSIS does not issue NRs for this
regulation under traditional inspection
because FSIS inspectors are responsible
for identifying and removing food safety
and non-food safety defects.
As is explained above, under HIMP,
FSIS inspectors inspect a sample of 24
carcasses when they perform a Zero
Tolerance verification task as opposed
to inspecting a sample of 11 carcasses
under traditional inspection. In
addition, the Agency’s offline inspectors
in HIMP establishments perform more
offline inspection activities that FSIS
has concluded are more effective in
ensuring food safety than offline FSIS
inspectors perform in non-HIMP
establishments operating under the
traditional inspection system. Therefore,
FSIS inspectors in HIMP establishments
have more opportunities for detecting
noncompliance with regulatory
requirements that are directly related to
public health than inspectors do in nonHIMP traditional establishments.
Comment: Several commenters argued
that until FSIS can compare and
17 https://www.fsis.usda.gov/wps/wcm/connect/
f7be3e74-552f-4239-ac4c-59a024fd0ec2/EvaluationHIMP-Market-Hogs.pdf?MOD=AJPERES.
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evaluate HIMP and non-HIMP
establishment performance using
compatible data, the same data reporting
period, and an equal number of
establishments, and show a marked
superiority of HIMP establishment
performance, FSIS must not finalize the
proposed rule.
Response: FSIS maintains that the
data collected during the HIMP pilot
study was valuable for evaluating
whether the HIMP inspection system
performs as well as the traditional
inspection system. As stated above,
FSIS did compare data from the same
reporting periods and compared
establishments with similar HACCP size
and production volume. As stated in the
Hargis report, ‘‘[t]he review team noted
some issues related to optimal design
and interpretation, but finds that overall
the data collected were both meaningful
and useful and that the study was
designed and conducted under realworld conditions and limitations.’’ The
review team also concluded that ‘‘the
overall design and methodology . . .
were perhaps the best available options
to allow for comparison of organoleptic
data between the traditional and HIMP
systems.’’ FSIS disagrees that the
Agency needs to show that the HIMP
system is superior to the traditional
inspection system before it can finalize
the proposed rule.
C. Risk Assessment
Comment: The risk assessment used
FSIS microbiological testing and
inspection data from 2010–2011 and
data from the HIMP pilot study. A few
consumer advocacy organizations and
public health organizations argued that
the data has the following problems: (1)
The data is generated through regulatory
programs designed to verify process
control within a given establishment at
a specific point in time; (2) the data is
at least seven years old and may not be
representative of current industry
practices, and (3) there were only five
market hog slaughter establishments
that volunteered and agreed to meet the
additional requirements in the HIMP
pilot study, resulting in a biased sample
and results that are not generalizable to
all non-HIMP market hog slaughter
establishments.
Response: For purposes of the risk
assessment, data from HIMP
establishments were combined with
data from traditional establishments to
get a more complete picture of the
possible combinations of establishment
characteristics, inspection procedures,
and Salmonella prevalence. The
assessment produced estimates of
Salmonella illnesses under scenarios
where inspectors perform more offline
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food safety activities as compared to
traditional inspection. As FSIS
explained above, the data FSIS used in
the Hog HIMP Report and risk
assessment are still useful, despite the
passage of time, because the HIMP
inspection model has not changed since
2013 and FSIS is still conducting the
same inspection procedures. FSIS also
explained above that the Agency does
not believe that the results are biased
because there is evidence that the
volunteer establishments participating
in the HIMP pilot study are typical of
the broader industry.
Comment: One public health
organization stated that the model
predicts that maximum reduction in the
percentage of Salmonella positive
samples and market hog-attributable
salmonellosis cases occurs when the
average numbers of offline inspection
procedures performed (Scheduled and
Performed (SP) and Unscheduled (U))
increase 25 percent and the numbers of
Scheduled but Not Performed (SNP) and
NR inspection procedures decrease 50
percent and 46.67 percent, respectively.
The commenter also stated that FSIS
concluded that all establishments under
NSIS are expected to achieve greater
process control in response to increases
in FSIS offline inspection tasks in
addition to industry-wide commercial
and technological innovation that will
likely occur over time. According to the
commenter, these results assume that
resources will be re-allocated within an
establishment in such a way that the
FSIS offline inspection resources
increase by 25 percent and the number
of scheduled but not performed FSIS
tasks decreases by 50 percent. The
commenter questioned if this is
achievable given FSIS’s current
inspection resources. The commenter
stated that if inspection resources are
lost, through attrition or budget cuts,
these assumptions may not be realistic.
Response: The predicted increase in
offline inspection resources and
decrease in scheduled but not
performed activities are achievable with
FSIS’s current inspection resources. In
fact, NSIS will allow FSIS to better use
its inspection resources. FSIS discusses
the impact of attrition and budget in
more detail in section ‘‘I. Potential
Budgetary Impacts on the Agency.’’
Comment: One consumer advocacy
organization stated that the risk
assessment shows that the five HIMP
establishments had higher NRs (9.4times more, when weighted by volume)
than the non-HIMP traditional
establishments. According to the
commenter, the risk assessment also
shows that NRs are the strongest and a
statistically significant indicator of
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52309
human illnesses related to consuming
contaminated pork.
The same commenter stated that
decreasing NRs in all market hog
establishments would have the effect of
reducing illnesses by 3,893, or 4.7
percent. The commenter argued that this
reduction would be 1.5 times greater
than the reduction FSIS expects will be
possible (2,533) by increasing offline
verification tasks under NSIS.
According to this organization’s
analysis, FSIS would reduce more
illnesses by decreasing NRs, compared
to redeploying inspection resources
under NSIS.
Response: As FSIS explained in the
risk assessment, NRs were included in
this assessment for theoretical
evaluation only as a possible decision
variable because of inclusion in the
NPIS risk assessment. For this
assessment, the variables associated
with offline inspection tasks represent
the sum of each type of category across
the various inspection procedure codes
in an establishment on each day that a
Salmonella sample was collected.
Unlike SP, SNP, and U, NRs depend on
noncompliance by establishments and
are strictly not an FSIS decision
variable. Historic occurrences of
establishment non-compliance may help
explain variability in pathogen
performance that already has been
observed. However, because future NR
rates depend on the behavior of
establishments, it is not feasible to
assume that the NR rates can be varied
(like SP, SNP, and U) solely by
reallocating Agency inspection
resources. Therefore, FSIS considers
implementation scenarios that simulate
future changes in the NR variable
infeasible, but the theoretical
examination of NRs offers potential risk
management insights.
Comment: A consumer advocacy
organization asked, if conducting more
offline procedures at HIMP
establishments reduces Salmonella
contamination, why didn’t FSIS find a
statistically significant reduction in
Salmonella in HIMP establishments as
compared to non-HIMP traditional
establishments? The commenter noted
that from CY2006 through CY2009 the
Salmonella percent positive for market
hogs was lower in HIMP establishments
than in non-HIMP establishments, but it
was higher in the HIMP establishments
in CY2010. According to the
commenter, data from a baseline
Salmonella study from August 2010
through August 2011 found that the
Salmonella percent positive for
carcasses in the HIMP establishments
was almost one-half the value of the rate
in comparable non-HIMP
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establishments—0.69 percent and 1.35
percent, respectively—but the difference
was not statistically significant.
According to the commenter, FSIS did
not explain why the Salmonella percent
positive for carcasses are sometimes
higher in HIMP establishments and
sometimes lower as compared to nonHIMP establishments.
Response: The risk assessment was
not conducted as a comparison between
HIMP and non-HIMP establishments
operating under traditional inspection.
It was a regression analysis that looked
at the numbers of FSIS inspection
procedures conducted and Salmonella
prevalence at all swine slaughter
establishments together. The risk
assessment did show a statistically
significant relationship between
increased offline inspection procedures
and reduced Salmonella contamination
for carcasses. In contrast, the Hog HIMP
Report compared the average
Salmonella percent positive between
the five HIMP establishments and
twenty-one non-HIMP comparison
establishments. The latter analysis did
not detect statistically significant
differences between these two
establishment groups across years, and
this is likely attributable to the small
sample size (number of HIMP and nonHIMP establishments) relative to the
low number of Salmonella percent
positives at the post-chill carcass
sampling point.
Comment: A few consumer advocacy
organizations and public health
organizations noted that the risk
assessment that informed the
modernization of poultry slaughter
inspection final rule also predicted that
conducting more offline tasks would
likely result in food safety benefits.
According to the commenters, microbial
sampling conducted since NPIS’s
implementation has not supported this
prediction. A few commenters noted
that in a preliminary assessment of NPIS
provided to stakeholders last fall, FSIS
indicated that Salmonella and
Campylobacter percent positives were
similar between large establishments
that volunteered to operate under NPIS
and large establishments that decided
not to change their inspection systems.
One consumer advocacy organization
argued that recent data reveal that NPIS
establishments are more likely to fail
FSIS Salmonella performance standards
than establishments that have not
converted to NPIS. The commenters
argued that like NPIS, NSIS will not
have food safety benefits.
Response: As noted by the
commenters, in a preliminary
assessment of NPIS, FSIS found that
carcass Salmonella and Campylobacter
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percent positives for the group of
establishments that had converted to
NPIS were comparable to those for
similar establishments that had not
converted to NPIS.18 This assessment
included all establishments that had
converted to NPIS at that point in time,
including the former HIMP
establishments. The assessment also
found that the former HIMP
establishments had lower carcass
Salmonella percent positives than both
non-NPIS establishments and non-HIMP
NPIS establishments, suggesting that
carcass Salmonella percent positives are
lower in establishments with more
experience operating under HIMP and
NPIS inspection systems. The Agency
will continue to track FSIS carcass
Salmonella percent positives as more
establishments convert to NPIS.
The October 2017 preliminary
analysis mentioned by the commenters
compared 39 large NPIS establishments,
23 of which were former HIMP
establishments, to 126 large non-HIMP
and non-NPIS establishments. Poultry
establishments continue to convert to
NPIS, allowing for a more meaningful
comparison between NPIS and nonNPIS establishments. FSIS analyzed the
data and found no statistically
significant difference in the proportion
of establishments that fail to meet
carcass Salmonella performance
standards between those operating
under NPIS and those operating under
the traditional inspection system.
Considering uncertainty, the 95 percent
confidence interval for the difference in
proportions includes zero. This
provides supporting empirical evidence
independent of the risk assessment
model that in practice the NPIS
provides an equivalent level of food
safety protection compared to
traditional inspection. FSIS disagrees
that the current data shows that there
will be no food safety benefits related to
NPIS, and therefore, there will be no
food safety benefits related to NSIS.
Especially since the October 2017
preliminary analysis found that FSIS
inspectors are performing
approximately four times more offline
verification tasks for visible
contamination in NPIS establishments
than in non-NPIS establishments. FSIS
will continue to evaluate the public
health impact associated with NPIS as
more establishments convert and
experience is gained with operating
under NPIS.
18 Update on Preliminary Analysis of
Modernization of Poultry Slaughter, October 2017
available at: https://www.fsis.usda.gov/wps/portal/
fsis/topics/regulatory-compliance/haccp/haccpbased-inspection-models-project/himp-study-plansresources/poultry-slaughter-inspection.
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Comment: One consumer advocacy
organization noted that FSIS’s
uncertainty analysis indicated that there
is a 12.5 percent chance that there will
be increased illnesses simply by
increasing the number of scheduledperformed verification tasks. The
commenter argued that FSIS should not
finalize a rule that would not improve
public health.
Response: The risk assessment
analyzed data on specific types of
inspection activities and the prevalence
of Salmonella in market hog slaughter
establishments. The results suggest that,
because inspection personnel assigned
to NSIS will conduct more of the type
of inspection activities that were
correlated with lower Salmonella
prevalence, NSIS will potentially result
in fewer human illnesses than would be
expected if not implemented. Therefore,
FSIS needs to publish and implement
this rule to be able to shift resources and
realize the predicted benefits. In
addition to the estimated values, the
analysis provides the statistical
uncertainty of the estimated number of
averted illnesses by reporting the upper
and lower confidence bounds around
the estimates to acknowledge that
uncertainty always will exist in such
models.
Comment: One public health
organization stated that FSIS did not
assess the public health impact of
increasing establishments’ line speeds
in the proposed rule. The same
commenter stated that FSIS should
explore the public health impact of
increasing line speeds before finalizing
the proposed rule.
Response: While the relationship
between line speed and Salmonella
prevalence was not incorporated into
the risk assessment model, FSIS did
consider the impact of line speed on
HIMP establishment performance in the
Hog HIMP Report. The Hog HIMP
Report estimated that in CY2013, line
speeds at the 5 HIMP market hog
establishments varied from 885 to 1,295
head per hour (hph), with an estimated
average line speed of 1,099 hph. The 21
non-HIMP comparison establishments
had estimated line speeds of 571 to
1,149 hph, with an estimated average
line speed of 977 hph. The Hog HIMP
Report found that even with slightly
faster line speeds, HIMP market hog
establishments had higher compliance
with Sanitation SOP and HACCP
regulations, lower levels of non-food
safety defects, equivalent or better
Salmonella verification testing positive
rates than the 21 traditional non-HIMP
comparison market hog establishments,
and lower levels of violative chemical
residues.
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Comment: A few commenters urged
the Agency to redo the risk analysis
model using data from FSIS’s
Salmonella pork cuts and comminuted
pork exploratory testing after that
project has been finalized.
Response: Data from the Agency’s
pork cuts and comminuted pork
exploratory testing project would not
improve the risk assessment. While the
pork parts data may prove useful for
monitoring and evaluating process
control during further processing, it will
not be useful for measuring process
control during slaughter operations.
Processing establishments purchase
primals from multiple slaughter
establishments. Because establishments
comingle primals during processing,
they may become contaminated during
processing. As a result, the Salmonella
percent positives during processing
would not be reflective of Salmonella
percent positives or pathogen
contamination at the end of slaughter
operations.
Comment: One animal welfare group
argued that the risk assessment and peer
review were too narrow in scope. The
commenter argued that the risk
assessment should not have been
limited to Salmonella risk but should
have included every potential food
safety and public health risk. The
commenter was especially concerned
about the risk of Yersinia enterocolitica
and influenza.
Response: FSIS selected Salmonella
because it is the most common cause of
foodborne illness associated with pork
products and interventions targeted at
reducing Salmonella have been shown
to be effective at reducing
contamination by other enteric
pathogens, such as Yersinia
enterocolitica. FSIS did not include
swine influenza in the Agency’s risk
assessment because swine influenza has
not been shown to be transmissible to
people through eating pork products.
Comment: One consumer advocacy
organization commented that FSIS had
not adequately considered the peer
review comments and cited Reviewer
E’s comment about whether using
simulated data is ‘‘a statistically
legitimate approach.’’
Response: After additional internal
review, FSIS has decided to add
language to the risk assessment to
highlight the results of the modeling
without simulated data (see Table 13 in
the risk assessment). FSIS is confident
that it has addressed reviewers’
comments on the risk assessment.
D. NSIS
Comment: Comments from swine
slaughter establishments, trade
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associations representing the pork
industry, and a few private citizens
supported the proposed rule. These
comments stated that NSIS will enhance
FSIS inspection procedures and
increase industry efficiency while
ensuring safeguards are in place to
promote worker safety and animal
welfare.
However, comments from consumer
advocacy organizations, labor unions,
public health organizations, animal
welfare advocacy organizations, worker
rights advocacy organizations, and
private citizens objected to NSIS for
various reasons. Many of these
commenters objected to NSIS because
they view NSIS as a system that
‘‘privatizes’’ inspection by replacing
FSIS inspectors with establishment
employees.
Response: FSIS is not privatizing
swine slaughter inspection. The new
inspection system will not eliminate
FSIS inspection. NSIS simply requires
establishments to take additional steps
before FSIS inspection to ensure that
their products are safe and wholesome.
As FSIS explained in the proposed
rule, most market hog establishments
under traditional inspection already
voluntarily conduct sorting activities
before FSIS ante-mortem inspection (83
FR 4780, 4783). Under NSIS, because
establishment employees are
responsible for identifying and
removing market hogs that are not fit for
slaughter before FSIS ante-mortem
inspection, FSIS inspectors are
presented with healthier animals that
are more likely to pass inspection.
Under NSIS, FSIS will continue to
conduct ante-mortem inspection. The
key difference is that establishment
sorting activities will be mandatory.
Under traditional inspection,
establishments conduct no post-mortem
carcass sorting to identify which
carcasses and parts appear eligible to
bear the mark of inspection, which
carcasses and parts contain removable
defects correctable through trimming,
and which carcasses and parts should
be submitted to FSIS for condemnation
because of generalized diseases or
conditions. Rather, under traditional
inspection, establishments are required
to assign competent assistants to take
such actions as directed by FSIS online
inspectors after the inspectors have
conducted the initial inspection
activities (see 9 CFR 307.2(g)).
Therefore, under traditional inspection,
establishments rely on FSIS online
inspectors to effectively control and
direct their processing.
Under NSIS, FSIS inspectors will still
be stationed on the evisceration line and
these inspectors will continue to inspect
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every head, viscera, and carcass as
required by the FMIA. FSIS offline
inspectors will also continue to conduct
food safety related inspection activities
and evaluate establishment process
controls. However, FSIS will require
establishments operating under NSIS to
take a more proactive role in removing
contamination and identifying defects
before FSIS post-mortem inspection.
Comment: A few consumer advocacy
groups argued that the proposed rule’s
ante-mortem condemnation provisions
violate the FMIA. One consumer
advocacy group stated that 21 U.S.C.
603 and 9 CFR 301.9(a) require FSIS
inspectors to examine and inspect each
animal before it can be slaughtered for
human food. The consumer advocacy
group argued that FSIS completely
disregards this requirement by allowing
establishment employees to ‘‘bypass’’
antemortem inspection for 90 to 95
percent of all moving animals not
deemed suspect by the establishment.
Several commenters noted that a
former chief veterinarian for FSIS spoke
out against the ante-mortem portion of
the proposal, suggesting that it would
increase the risk that FSIS veterinarians
could miss the early signs of a largescale animal disease outbreak. The
commenters stated that an outbreak
could impact food safety while having
devastating economic consequences for
U.S. animal producers. According to the
commenters, a large outbreak of Foot
and Mouth Disease (FMD) has the
potential to shut off all foreign markets
to U.S. beef and pork, costing American
producers an estimated $128 billion
over a 10-year period.
Two foreign countries requested
clarification on the role of the FSIS
Public Health Veterinarian (PHV) and
inspectors in the context of ante-mortem
activities under the NSIS. The
commenters questioned if FSIS
inspectors or veterinarians will inspect
all animals or carcasses removed by the
establishment sorters.
Response: As FSIS explained in the
proposed rule, animal sorting
procedures under HIMP and NSIS are
virtually the same as animal segregation
procedures used voluntarily by most
market hog establishments under
traditional inspection. FSIS has allowed
establishments operating under
traditional inspection to voluntarily
implement animal segregation
procedures since at least the 1980s
without adverse economic
consequences.
Most establishments under traditional
inspection that slaughter only market
hogs voluntarily segregate animals that
show signs of diseases or conditions
from healthy animals before the Agency
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performs ante-mortem inspection.19
Therefore, market hog establishment
personnel segregate animals that appear
to be normal and healthy from abnormal
or unhealthy animals that appear to
have condemnable diseases or
conditions (e.g., animals exhibiting
signs of neurologic conditions, pyrexia,
or severe lameness) into ‘‘subject’’ pens,
where they undergo additional FSIS
inspection. FSIS requires these
establishments to document their
segregation procedures in their HACCP
plans or prerequisite programs.20 FSIS
inspectors examine all animals found by
the establishment to be normal at rest,
and five to ten percent of those animals
in motion.21
FSIS disagrees that this inspection
scheme violates the FMIA. FSIS
inspectors still conduct 100 percent
ante-mortem inspection.22 If any
animals exhibit signs of condemnable
conditions, FSIS inspectors direct
establishment employees to move the
animals to the ‘‘U.S. Suspect’’ pens for
final disposition by the FSIS PHV. The
FSIS PHV examines all animals in the
‘‘subject’’ and ‘‘U.S. Suspect’’ pens.
FSIS inspectors observe establishment
employees performing animal
segregation procedures at least once per
month.
As mentioned above, the key
difference, as compared to traditional
inspection, is that sorting procedures
are mandatory under NSIS. All
establishments operating under the
NSIS must address, as part of their
HACCP system, procedures for sorting
animals showing signs of diseases or
abnormalities from healthy animals.
These procedures must cover
establishment sorting activities for dead
and moribund swine and swine
suspected of having central nervous
system (CNS) conditions or pyrexia.
Establishments under NSIS that do not
adequately sort for these food safety
defects before FSIS ante-mortem
19 See FSIS Directive 6100.1, Ante-mortem
Livestock Inspection available at https://
www.fsis.usda.gov/wps/wcm/connect/2b2e7adc961e-4b1d-b593-7dc5a0263504/
6100.1.pdf?MOD=AJPERES.
20 See FSIS Directive 6100.1, Ante-mortem
Livestock Inspection available at https://
www.fsis.usda.gov/wps/wcm/connect/2b2e7adc961e-4b1d-b593-7dc5a0263504/
6100.1.pdf?MOD=AJPERES.
21 See FSIS Directive 6100.1, Ante-mortem
Livestock Inspection available at https://
www.fsis.usda.gov/wps/wcm/connect/2b2e7adc961e-4b1d-b593-7dc5a0263504/
6100.1.pdf?MOD=AJPERES.
22 See FSIS Directive 6100.1, Ante-mortem
Livestock Inspection available at https://
www.fsis.usda.gov/wps/wcm/connect/2b2e7adc961e-4b1d-b593-7dc5a0263504/
6100.1.pdf?MOD=AJPERES.
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inspection will receive an NR for
noncompliance with 9 CFR 309.19.
Regarding the questions from the
foreign countries, FSIS inspectors
inspect every market hog offered for
slaughter. However, an establishment
may decide to divert hogs that do not
meet its market specifications to another
slaughter facility, where they will
receive 100 percent ante-mortem
inspection by an FSIS inspector. This is
not a change in policy. Establishments
operating under traditional inspection
may also divert hogs to other
establishments operating under
traditional inspection. If establishments
decide to divert hogs, they are required
to follow the Animal and Plant Health
Inspection Service’s (APHIS’s)
regulations governing the movement of
live animals.
Under the NSIS, FSIS inspectors will
observe establishment employees
performing sorting procedures. During
this time, FSIS inspectors will verify
that animals that are intended to be
disposed of are humanely euthanized
and that animals that are intended to be
diverted to another official
establishment are eligible for transport.
Comment: Several comments asserted
that revoking maximum line speeds
conflicts with the purposes or
provisions of the FMIA because faster
line speeds will make it more difficult
for FSIS inspectors to effectively
conduct online inspection. A consumer
advocacy organization stated that the
FSIS inspectors must provide a ‘‘critical
appraisal’’ of all carcasses (AFGE v.
Glickman, 215 F.3d 7, 11 (D.C. Cir.
2000)). According to the comments,
revoking maximum line speeds will
make it extremely difficult, if not
impossible, for FSIS to conduct a
critical appraisal of each hog.
Comments from consumer advocacy
organizations and an animal welfare
organization further argued that FSIS
does not have the statutory authority to
conduct rulemaking to increase
efficiencies for the government and
industry.
Response: Based on FSIS’s
experiences under HIMP, online
inspectors in HIMP establishments can
conduct an effective online inspection
of the head, viscera, and carcass of each
hog when operating at faster line
speeds. To ensure that online inspectors
will be able to conduct effective online
inspections, FSIS PHVs in all NSIS
establishments are authorized to direct
establishments to operate at reduced
line speeds when, in the PHV’s
judgment, a carcass-by-carcass
inspection cannot be performed within
the time available due to the way that
the hogs are presented to online
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inspectors, or because the establishment
is not maintaining process control (9
CFR 310.26).
FSIS has the authority to change its
regulations to conduct more efficient
inspections and to reduce unnecessary
regulatory burdens on industry. As FSIS
explained in the proposed rule (83 FR
4780, 4782), 21 U.S.C. 621 provides that
the Secretary shall make such rules and
regulations as are necessary for the
efficient execution of the provisions of
the FMIA. In addition, this rulemaking
is consistent with E.O. 13563, which
directs Federal agencies to review
existing rules that may be burdensome,
unnecessary, and outdated and to
modify, streamline, expand, or repeal
them accordingly.
Comment: Several comments from
consumer advocacy organizations,
public health organizations, worker
advocacy organizations, labor unions,
and private citizens objected to FSIS’s
requirement that establishment
employees sort carcasses and parts
before they are presented for FSIS
inspection because the commenters
believe that establishment employees
will miss many food safety and OCP
defects. A few commenters referenced
affidavits from three FSIS inspectors
who worked in HIMP establishments
who stated that because of excessive
line speeds and lack of training,
establishment sorters routinely miss
many food safety and wholesomeness
defects. The commenters argued that
FSIS must more thoroughly evaluate the
proposal to allow establishment
employees to perform preliminary
sorting before the Agency implements
NSIS.
Response: The Hog HIMP Report
found that the overall performance of
HIMP establishments was as good as
non-HIMP establishments. Results from
offline inspections in HIMP
establishments, which are conducted
after establishment employees have
completed the initial sorting of
carcasses and parts, show that the rates
of carcasses with food safety defects
(e.g., septicemia, toxemia, pyemia, and
cysticercosis) and visible contamination
from visible fecal material, ingesta, and
milk in HIMP establishments were very
low, well below the levels set by the
HIMP performance standards. In
addition, as explained in the proposed
rule, OCP defect rates identified on
carcasses and parts in HIMP
establishments average about half the
corresponding OCP HIMP performance
standard. Therefore, the data from the
HIMP pilot study show that
establishment employees do effectively
sort carcasses, trim defects, and identify
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carcasses for disposal before FSIS post
mortem inspection.
Comment: Several consumer
advocacy groups and a public health
organization recommended that FSIS
establish training for establishment
employees performing sorting activities
and require sorters to prove proficiency
in performing their duties.
Members of industry stated that
establishments operating under HIMP
have been successful at training
employees to sort for food safety and
non-food safety defects. These
commenters commended the Agency for
creating its sorter guide. The
commenters stated that the sorter guide
is comprehensive and consistent with
current practices under HIMP. However,
the commenters stated that the sorter
guide could be improved by defining
several pathological conditions and
veterinary terms not well-known to
industry personnel, as well as updating
photos and diagrams.
Response: FSIS is not prescribing
specific sorter training or certification.
FSIS made some editorial changes to its
sorter guide to simplify the guideline.
The Agency did not make any
significant changes to its sorter guide in
response to comments. FSIS did not
think it was necessary to add the
pathological conditions, veterinary
terms, or pictures mentioned in the
comments because they are not
commonly found or used. However,
FSIS PHVs will be available to discuss
conditions and terms if an
establishment has any questions. The
guide is available on the FSIS website
at: https://www.fsis.usda.gov/wps/portal/
fsis/topics/regulatorycompliance/
compliance-guides-index. As FSIS
explained in the proposed rule, the
guide that the Agency has developed is
based on the training that FSIS provides
to its online inspection personnel that
are responsible for sorting carcasses
under the existing inspection systems.
Comment: Members of the pork
industry and a trade association
representing members of the pork
industry requested that FSIS clarify
when NRs will be issued by offline
inspectors for carcasses contaminated
with visible fecal material, ingesta and
milk. The commenters noted that the
proposed rule stated that FSIS will issue
NRs for every carcass contaminated
with fecal material, ingesta, and milk.
According to the commenters, this
policy is not consistent with FSIS
Directive 6420.2, which instructs
inspection personnel to issue NRs based
on a specific sampling procedure during
carcass verification checks.
Response: FSIS is clarifying that,
consistent with FSIS Directive 6420.2,
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only offline inspectors will issue NRs
for fecal material, ingesta, or milk
contamination if they observe the
contamination on sampled carcasses
when performing the Livestock Zero
Tolerance Verification task. FSIS online
inspectors will not issue NRs if they
observe fecal material, ingesta, or milk
contamination on the carcasses. Rather,
online inspectors will stop the slaughter
line to allow for trimming of the carcass
by establishment personnel and
reinspection of the carcass by the
inspector, unless the establishment has
provided a rail-out loop. FSIS did not
intend to change these inspection
procedures with the implementation of
this rule.
Comment: Members of the pork
industry and trade associations
representing the pork industry stated
that the proposed requirement to
immediately denature carcasses that
have been sorted and removed from
slaughter is overly burdensome and
unnecessary. One trade association
stated that imposing specific denaturing
requirements may discourage
establishments from adopting NSIS.
That commenter suggested that FSIS
amend the proposed 9 CFR 309.19(c) to
read ‘‘the establishment must dispose of
the carcass according to 9 CFR part
314.’’ A HIMP establishment
recommended FSIS require that
establishments maintain procedures to
control and isolate carcasses and parts
removed from slaughter and
demonstrate that they do not enter the
human food chain or immediately
denature in accordance with 9 CFR part
314.
Response: FSIS has considered these
comments and believes they have merit.
Therefore, FSIS has revised its proposed
disposal requirements and will instead
require establishments to develop,
implement, and maintain written
procedures to ensure that animals and
carcasses that have been sorted and
removed for disposal do not enter the
human food supply and are properly
disposed of according to 9 CFR part 314.
Comment: Members of the pork
industry and trade associations
representing members of the pork
industry noted that APHIS uses FSIS
animal disposition data, collected and
maintained through PHIS, to monitor
animal disease rates and identify trends.
These commenters all agreed that these
data are useful and should not be lost
in the transition to NSIS. According to
these commenters, it would not be
overly burdensome for establishments to
keep records of the specific reasons why
hogs are removed from slaughter
because they already produce similar
records. The commenters recommended
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52313
that FSIS work with establishments on
a procedure to transfer disposition
information to APHIS on a regular
schedule to ensure the ongoing utility of
APHIS’s swine health surveillance
programs.
Response: In response to these
comments, FSIS has amended its
proposed record keeping regulations to
require swine slaughter establishments
to maintain records to document the
total number of animals and carcasses
sorted and removed per day and the
reasons for their removal. FSIS has
created a form to collect disposition
data from establishments.
Establishments may provide the same
information as requested on the form
electronically if it is submitted in a
format approved by FSIS; FSIS will
provide further instructions on
submitting this data electronically via
PHIS later. FSIS will need
establishments to submit their
electronic data in a format that is
compatible with PHIS so that the
Agency can quickly analyze the data
and share it with APHIS. FSIS has
updated its Paperwork Reduction Act
analysis to account for this new
requirement.
Comment: Members of the pork
industry, trade associations representing
the pork industry, and a foreign country
urged the Agency to allow
establishments the discretion to incise
lymph nodes when conducting carcass
sorting activities based on their own
hazard analysis. One member of the
pork industry stated that they have
demonstrated through testing and a
supplier risk assessment that there is no
value in incising lymph nodes to
identify pathological conditions.
The foreign country noted that this
approach aligns with the visual-only
inspection methodology already
implemented by other World Trade
Organization (WTO) members.
According to the foreign country, onfarm practices (husbandry, biosecurity,
etc.) have evolved and improved to a
point that disease transmission risks can
be greatly reduced through effective onfarm controls. The foreign country
stated that palpating and incising the
mandibular lymph nodes has been
shown to contribute to cross
contamination of pork products by food
safety hazards such as Salmonella and
Yersinia. Therefore, the foreign country
argued that moving to a routine visualonly inspection, supported by supplychain information from primary
production facilities, would improve
food safety systems.
One trade association stated that the
administrative hassle involved in
collecting, organizing, and presenting
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supply-chain information to FSIS to
demonstrate that animal diseases like M.
avium are not reasonably likely to occur
would be unnecessarily arduous and not
worth the benefits related to not incising
lymph nodes.
Response: This final rule requires that
establishment sorters incise mandibular
lymph nodes and palpate viscera to
detect the presence of animal diseases
as part of their sorting activities, as was
proposed (9 CFR 310.26(b)). However,
establishments that operate under NSIS
may seek waivers (9 CFR 303.1(h))
under the SIP to 9 CFR 310.26(b).
Establishments would need to submit
documentation supporting that the
presence of animal diseases like M.
Avium is not reasonably likely to occur.
Should FSIS grant these waivers,
establishments would be permitted to
decide, on a lot-by-lot basis, whether to
incise mandibular lymph nodes and
palpate the viscera to detect the
presence of animal diseases. The
Agency has decided to grant waivers,
when appropriate, to gather more
information on the public health impact
of such sorting activities to support
potential future rulemaking.
Comment: A foreign country
requested clarification on the
requirement (9 CFR 310.26(a)) for
establishments with fewer than three
inspection stations to have a mirror at
the carcass inspection station. The
commenter questioned whether all NSIS
establishments will have to have mirrors
at the carcass inspection station. The
foreign country was concerned that this
requirement will be more burdensome
than necessary, particularly for small
establishments operating at slower line
speeds.
Response: FSIS is requiring all NSIS
establishments to provide a mirror so
that FSIS can adequately inspect
carcasses. Large, high-volume market
hog slaughter establishments under
traditional inspection are already
required to provide mirrors to assist
FSIS inspection (see 9 CFR 310.1(b)(3)
and 307.2(m)(6)).
As FSIS explained in the proposed
rule, the Agency does not expect very
small establishments to convert to NSIS
because of the costs of hiring and
training establishment sorters.
E. Line Speed
Comment: Members of the pork
industry and trade associations
representing members of the pork
industry supported FSIS’s proposal to
revoke maximum line speed limits for
establishments operating under NSIS.
Some of these commenters noted that
line speeds were originally established
to define the number of FSIS online
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inspectors required to inspect carcasses
based on the number of carcasses an
individual could reasonably evaluate in
a given period. According to the
commenters, when these limits were set,
animal disease prevalence was much
higher, so inspectors needed more time
to complete inspection. The
commenters agreed with FSIS’s
conclusions that innovations in animal
housing, genetics, and processing have
been implemented and have improved
livestock conditions at slaughter;
therefore, the current line speed limits
are outdated and unnecessary.
Members of the pork industry and
trade associations representing the pork
industry also stated that revoking
maximum line speeds will allow
establishments to better adapt their line
speeds to slaughter conditions. These
commenters argued that line speeds can
be adjusted to optimize efficiencies
without jeopardizing worker safety,
animal welfare, food safety, or quality.
These commenters noted that the Hog
HIMP Report found that HIMP
establishments do not operate at line
speeds that are significantly faster than
the current maximum line speed for
market hogs.
Response: This final rule revokes the
maximum line speeds for
establishments operating under NSIS.
The maximum line speed under the
existing regulations for market hogs is
1,106 head per hour (hph) with seven
online inspectors. Experience from the
HIMP pilot study shows that HIMP
establishments operate with an
estimated average line speed of 1,099
hph, and that the line speeds varied
from 885 hph to 1,295 hph (under a
waiver). Thus, although they are
authorized to do so, market hog HIMP
establishments do not operate at line
speeds that are significantly faster than
the current maximum line speeds for
market hog establishments operating
under traditional inspection.
NSIS is informed by the Agency’s
experiences under HIMP, and
establishments operating under HIMP
have demonstrated that they are capable
of consistently producing safe,
wholesome, and unadulterated pork
products while operating at line speeds
above the current maximum line speeds
(for market hogs under traditional
inspection). HIMP establishments also
have consistently met pathogen
reduction and other performance
standards when operating without
prescribed maximum line speeds.
Moreover, NSIS incorporates additional
measures that will apply to all swine
slaughter establishments. These
measures, which include carcass testing
for microbial organisms at pre-
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evisceration and post-chill (or for hotboned product, pre-evisceration and
after the final wash), are designed to
ensure that establishments maintain
process control. As a result, FSIS has
decided that line speed limits are not
necessary for establishments operating
under NSIS.
Comments: Members of the pork
industry and trade associations
representing the pork industry stated
that increased line speeds will not
present greater risks for worker safety.
One company that owns a HIMP
establishment commented that they
have not found a correlation between
line speeds and worker safety issues in
their establishment. According to this
commenter, their company’s Total
Recordable Incident Rate (an OSHA
reporting category) has shown a
significant decline in recordable injuries
since they started operating under their
line speed waiver. The commenter also
stated that their findings were
consistent with the proposed rule’s
comparative analysis of injuries, which
found that HIMP establishments had
lower mean injury rates than non-HIMP
establishments.
Members of the pork industry and
trade associations representing the pork
industry stated that establishments
continuously evaluate worker safety.
According to the commenters,
establishments actively work to reduce
injuries by implementing ergonomic
programs, modifying processes, and
creating additional job positions to
distribute manual tasks among workers.
However, comments from worker
advocacy organizations, labor unions,
consumer advocacy organizations, an
environmental advocacy organization,
and private citizens asserted that
revoking maximum line speeds will
increase risks to worker health and
safety in establishments that operate
under NSIS. The comments referenced
studies, reports, and other data on workrelated injuries in the meat processing
industry. The most commonly
referenced information sources
included:
• Documents published by OSHA
that state that musculoskeletal injuries
and disorders are prevalent in the
meatpacking industry. In the
documents, OSHA recommends that
establishments should reduce line
speeds and production rates to decrease
injury rates.
• 2016 BLS data showing that
employer reported injury rates for meat
establishment workers who were
injured or made ill at work are 2.4 times
the rate of workers in other privatesector industries.
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• Reports published by the GAO that
concluded, among other things, that
injury rates in the meat slaughter
industry continue to be higher than the
rates for others in the manufacturing
industry, that meat workers may underreport illnesses and injuries because
they fear losing their jobs, and that
employers may underreport worker
injuries because of concerns about
potential costs.
• Various reports from worker
advocacy organizations on worker safety
in meat processing establishments.
These reports include statements from
slaughter establishment workers that
have suffered illnesses and injury from
the fast-paced repetitive tasks associated
with the current line speeds.
The comments stated that the
available studies, reports, and data
contradict FSIS’s analysis of worker
illness and injury in the proposed rule.
Response: While FSIS agrees that safe
working conditions in swine slaughter
establishments are important, the
Agency has neither the authority nor the
expertise to regulate issues related to
establishment worker safety. FSIS has
been delegated the authority to exercise
the functions of the Secretary of
Agriculture under the FMIA, the Poultry
Products Inspection Act (PPIA; 21
U.S.C. 451 et seq.), and the Egg Products
Inspection Act (EPIA; 21 U.S.C 1301 et
seq.) (the Acts). Under these Acts, FSIS
protects the public by verifying that
meat, poultry, and egg products are safe,
wholesome, not adulterated, and
properly marked, labeled, and packaged.
The Acts authorize FSIS to administer
and enforce laws and regulations solely
to protect the health and welfare of
consumers.
The Department of Labor’s OSHA was
created by the Occupational Safety and
Health Act of 1970 (29 U.S.C. 651 et
seq.) to assure safe and healthful
working conditions for men and women
by setting and enforcing standards and
by providing training, outreach,
education, and assistance. OSHA is the
Federal agency with statutory and
regulatory authority to promote
workplace safety and health. FSIS’s
authority with respect to working
conditions in slaughter establishments
extends only to FSIS inspection
personnel.
FSIS has worked with OSHA to
develop a poster that establishments
must display providing information on
the signs and symptoms of occupational
injuries and illnesses experienced by
market hog slaughter workers, and about
workers’ rights to report these
conditions without fear of retaliation
(see 9 CFR 310.27). This final rule also
requires establishments operating under
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NSIS to submit on an annual basis an
attestation to the management member
of the local FSIS circuit safety
committee stating that the establishment
maintains a program to monitor and
document any work-related conditions
of establishment workers (9 CFR
310.27). Because OSHA is the Federal
agency with statutory and regulatory
authority to promote workplace safety
and health, FSIS will forward these
annual attestations to OSHA for use in
its own enforcement program. FSIS
employees, however, will not be
responsible for determining the merit of
the content of the attestation or for
enforcement of non-compliance with
the attestation provision. OSHA and
FSIS will continue to partner through a
Memorandum of Understanding,23 to
strengthen collaboration between FSIS
inspectors and OSHA enforcement staff
and ensure identification and reporting
of safety hazards impacting working
conditions of FSIS inspectors and those
of establishment employees.
Comments: Comments from animal
welfare advocacy organizations and
private citizens concerned about animal
welfare asserted that revoking maximum
line speeds for establishments that
operate under NSIS will have adverse
effects on the humane handling of
swine. The comments expressed
concern that faster line speeds would
increase the potential for workers to
force animals to move faster than
normal walking speeds and for
ineffective stunning. Most of these
comments referenced an undercover
video that was taken at a HIMP
establishment in 2015. According to the
commenters, the video showed hogs
that were beaten and electrically
prodded to move to keep up with the
slaughter line speed. The commenters
claimed that the video showed hogs that
were conscious when they entered the
scalding tank because they were
improperly stunned.
Several animal welfare groups also
claimed that establishment employees
are pressured by establishment
management to never slow the slaughter
line. A few commenters stated that they
found a Memorandum of Interview
(MOI) issued in 2017 to a HIMP
establishment that stated that an FSIS
inspector observed that hog handlers
were driving animals too fast and with
more excitement than necessary, in
violation of 9 CFR 313.2. According to
the commenters, the MOI also stated
that the inspector’s concerns had been
raised at least twice at weekly meetings
with establishment management. The
23 The MOU is available at: https://
www.osha.gov/laws-regs/mou/1994-02-04.
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52315
commenters argued that the MOI shows
that hogs are routinely forced to move
too fast in HIMP establishments.
One commenter supported FSIS’s
decision to add a second offline
inspector to conduct additional offline
activities such as monitoring
compliance with the HMSA. However,
the commenter opposed FSIS’s decision
to decrease the total number of FSIS inplant personnel.
Response: FSIS disagrees that
revoking line speeds will have a
negative effect on animal welfare. As the
Agency explained in the proposed rule,
FSIS was able to conduct more offline
humane handling verification tasks
under HIMP as compared to traditional
inspection. As is the case under HIMP,
more inspection resources will be
available to verify whether
establishments meet humane handling
requirements as an offline activity under
NSIS.
Regarding the undercover video,
multiple FSIS experts—including
trained veterinarians and humane
handling experts—reviewed the video
and determined that there was
unacceptable rough handling and
inappropriate use of a rattle paddle to
drive animals. FSIS took immediate
regulatory action against the
establishment and required it to respond
with acceptable corrective actions to
prevent a recurrence.
While a person in the video suggests
that animals were conscious after
stunning, FSIS found that the animals
appeared properly stunned and
insensible to pain, as required by
Federal law. The video was reviewed by
a professor of animal science, who
reached the same conclusion.
FSIS reviewed the 2017 MOI that
stated that an FSIS inspector observed
that hog handlers were driving animals
too fast and with more excitement than
necessary. FSIS has instructed its
inspection personnel to properly
document noncompliance in NRs and
not MOIs.
Comment: One animal welfare
organization noted that they submitted
a petition in 2014 requesting that the
Agency require all swine slaughter
establishments to immediately and
humanely euthanize non-ambulatory
disabled (NAD) pigs. According to the
petition, prohibiting the slaughter of
NAD pigs would improve inspection
efficiency and compliance with the
HMSA, as well as reduce Salmonella
risks. The animal welfare organization
argued that FSIS must respond to their
petition before finalizing the proposed
rule.
Response: After carefully considering
the issues raised in the petition, along
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with the referenced information and
other letters received in support of the
petition, FSIS has concluded that its
existing regulations and inspection
procedures are sufficient and effective
in ensuring that NAD pigs are handled
humanely at slaughter and in preventing
diseased animals from entering the
human food supply. Consequently, the
Agency is denying the petition. The
Agency’s final petition response is
available at https://www.fsis.usda.gov/
wps/portal/fsis/topics/regulations/
petitions. FSIS denied a similar petition
in 2013 requesting that the Agency
prohibit the slaughter of all NAD
livestock. That petition response is also
available at https://www.fsis.usda.gov/
wps/portal/fsis/topics/regulations/
petitions.
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F. Ready-to-Cook
Comment: Members of the pork
industry and trade associations
representing members of the pork
industry generally support the proposed
RTC pork product standard. However,
the commenters requested that FSIS
amend the definition to include
language such as ‘‘reasonably free,’’ or
‘‘sufficiently free,’’ to clarify that the
RTC standard is a standard for non-food
safety defects and not a zero-tolerance
standard.
These same commenters
recommended that the Agency allow
establishments to apply the RTC
standard at any appropriate location at
or before the point of packaging or to
clarify that the Agency intends this type
of flexibility if that is the case. One
trade association said that because an
establishment may apply processes
targeting RTC criteria and other quality
issues at various locations after the
cooler, FSIS should not inspect for RTC
criteria before the cooler. The
commenter argued that there is no food
safety concern associated with carcasses
and parts that may not yet meet the RTC
standard entering the cooler.
Members of the pork industry, trade
associations, and a foreign country
asked FSIS to clarify when FSIS
inspectors can slow or stop the
evisceration line because of non-food
safety defects in establishments
operating under NSIS. These
commenters also asked FSIS to clarify
how the Agency will document
noncompliance with RTC standards.
According to the commenters, online
inspectors should be instructed to stop
the line only to remove food safety
defects after the establishment’s final
control, and NRs should only be given
after offline personnel assess and
confirm a loss of process control.
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A trade association noted that several
processing defects covered in the RTC
definition are listed under 9 CFR
310.18(a), which applies to all swine
establishments and is typically enforced
as a zero-tolerance standard. The
commenter also noted that 310.18(a) is
regularly categorized as a PHR. The
commenter was concerned that if an
NSIS establishment receives an NR for
9 CFR 310.18(a) for failure to meet RTC
standards, it will unjustly influence the
establishment’s PHR rate. Rather than
cite 9 CFR 310.18(a), the commenter
suggested that inspectors should cite 9
CFR 310.26(d)(1) for products not
meeting RTC standards at NSIS
establishments to delineate NRs for nonfood safety issues from NRs for food
safety issues.
Response: Under NSIS,
establishments will have the flexibility
to design and implement measures to
address OCP defects that are best suited
to their operations. They will also be
responsible for determining the type of
records that will best document that
they are meeting the RTC pork product
definition. The records will be subject to
review and evaluation by FSIS offline
inspectors (9 CFR 310.26(d)(1)).
FSIS has decided to amend the
definition of RTC pork product to clarify
that it is not a zero-tolerance standard.
RTC pork product will now be defined
as ‘‘any slaughtered pork product
sufficiently free from bile, hair, scurf,
dirt, hooves, toe nails, claws, bruises,
edema, scabs, skin lesions, icterus,
foreign material, and odor, which is
suitable for cooking without need of
further processing.’’
FSIS also is clarifying that the RTC
definition applies to pork products at
the end of the slaughter process and
before carcasses and parts enter the
cooler. This is consistent with the
Agency’s requirements under HIMP and
NPIS.
FSIS will issue instructions to its
inspectors on how to verify the RTC
pork product requirements using the
routine and directed PHIS Swine RTC
task. When conducting the routine task,
FSIS offline inspectors will verify that
an establishment maintains records as
required by 9 CFR 310.26(d)(1). FSIS
will issue an NR for 9 CFR 310.26(d)(1)
if an establishment does not have
records to document that the products
resulting from its slaughter operation
meet the definition of RTC pork
product.
If FSIS online inspectors believe that
the presentation of persistent
unattended trim or processing defects
indicates a lack of process control, they
will notify the PHV. The PHV may then
tell an offline inspector to conduct a
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directed PHIS Swine RTC task. FSIS
offline inspectors will follow the same
method and apply the same criteria that
the establishment uses to check that
they are meeting the RTC standard. FSIS
will issue an NR for 9 CFR 310.26(d)(1)
if the results exceed the criteria set by
the establishment or if the establishment
did not take the necessary corrective
actions to restore process control when
the evaluation criteria was exceeded.
If the PHV determines that the
presentation of persistent unattended
trim or processing defects indicates a
loss of process control that affects the
online inspectors’ ability to adequately
conduct a carcass-by-carcass inspection,
the PHV will direct the establishment to
reduce its line speeds. The PHV will
then issue an NR citing 9 CFR
310.26(d)(1).
FSIS inspectors will use PHIS to link
all NRs that are issued for the failure to
meet the RTC pork product standard
and associated documentation
requirements. If establishment
management is unwilling or unable to
take the necessary steps to re-establish
control of its process to meet RTC
regulatory requirements, FSIS
inspectors will discuss the issue with
their supervisor and the DO. The DO
will notify the establishment in writing
that repeated NRs may lead the Agency
to take a regulatory control action (9
CFR 500.2).
In the rare case that FSIS online
inspectors identify a carcass so affected
with non-food safety defects (e.g.,
malignant lymphoma, icterus, or
uremia) that the entire carcass must be
condemned, they will stop the line for
carcass condemnation unless the
establishment provides a rail-out loop to
rail carcasses offline for reexamination
and condemnation.
G. Implementation
Comment: One member of the pork
industry supported the NSIS
implementation strategy suggested in
the proposed rule. However, the pork
producer requested more information on
whether two shift operations must
convert both shifts to NSIS at the same
time. The same commenter also
requested more information on what
would happen if an establishment that
converted to NSIS decided it wants to
move back to traditional inspection.
A trade association noted that FSIS’s
implementation plan for NPIS was
phased in with close coordination with
DOs and establishments. The
commenter stated that FSIS should
follow a similar implementation plan
for NSIS, with an initial notification
period for establishments that want to
adopt NSIS and an algorithm to
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determine transition order. This
commenter also suggested a phased-in
approach for the mandatory provisions
for all swine establishments based on
establishment size.
The same trade association stated that
establishments should submit for
approval unique transition plans to the
DO when providing notification that
they intend to adopt NSIS. The trade
association suggested that FSIS identify
and provide acceptable examples of
transition plan elements. According to
the commenter, pre-approved elements
should include transitioning single
inspection stations in succession, one
shift at a time, one inspection focus area
(i.e., head inspection) at a time, RTC
monitoring before transitioning
inspection activities, and others.
Consumer advocacy organizations
stated that only establishments that
have their HACCP plans approved by
FSIS should be allowed to implement
NSIS. The commenters suggested that
FSIS should review every
establishment’s HACCP plans to
determine if their tailored
microbiological testing programs are
valid before allowing them to convert to
NSIS.
Response: All market hog
establishments will initially have six
months to notify their DO of their intent
to operate under NSIS. Establishments
that do not notify their DO of their
intent to transition during this time will
be deemed to have chosen to continue
to operate under traditional inspection.
Market hog establishments that decide
that they would like to convert to NSIS
after the initial notification date may
notify their DO of their intent at any
time after that date. The Agency will
implement NSIS in the additional
establishments that intend to convert on
a schedule consistent with the
availability of Agency resources and
establishment readiness. The Agency
intends to implement NSIS in all market
hog establishments that choose to
operate under this new inspection
system, regardless of when the
establishment notifies FSIS of its intent
to transition to NSIS. However, the
initial implementation wave will only
include those establishments that
submit their intent to convert to NSIS
within the initial notification period.
Because there are fewer market hog
establishments than poultry
establishments, the Agency does not
think it will be necessary to use an
algorithm to determine transition order.
FSIS also does not think it is necessary
to require establishments to develop
formal transition plans. Establishments
will need to transition all shifts and
inspection stations to NSIS at one time.
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However, FSIS DOs will work with
establishments to ensure a smooth
transition from traditional inspection to
NSIS. And, if necessary, FSIS DOs will
work with establishments to ensure a
smooth transition from NSIS back to
traditional inspection.
FSIS does not think it is necessary to
review HACCP plans before
establishments convert to NSIS. FSIS
already has inspection tasks in place to
verify that establishments are properly
implementing their HACCP systems in
accordance with 9 CFR part 417.
The Agency is establishing separate
applicability dates for large, small, and
very small establishments to comply
with the regulations that prescribe
procedures for controlling
contamination throughout the slaughter
and dressing process in 9 CFR 310.18(c),
and the regulations that prescribe
recordkeeping requirements in 9 CFR
310.18(d). The applicability dates will
provide additional time for small and
very small establishments to comply
with these provisions.
H. Environmental Assessment
Comments: Comments from an animal
welfare advocacy organization and an
environmental advocacy organization
stated that before FSIS can finalize the
proposed rule, the Agency must prepare
an Environmental Impact Statement
(EIS), as required under the National
Environmental Policy Act (NEPA; 42
U.S.C. 4321 et seq.) because, according
to these commenters, allowing market
hog slaughter establishments to increase
line speeds will result in significant
environmental impacts. The
commenters stated that faster line
speeds would mean more hogs
slaughtered per shift. According to the
commenters, more hogs slaughtered
would mean more waste and more water
use. The commenters asserted that these
are all significant environmental
impacts, with both individual and
cumulative effects at the local, state, and
national levels. The commenters also
stated that FSIS cannot claim the
categorical exclusion from the
preparation of an Environmental
Assessment (EA) or an EIS under 7 CFR
part 1b of the USDA regulations.
Response: FSIS maintains that this
rulemaking is categorically excluded
from NEPA requirements. Federal
agencies may identify classes of actions
that normally do not require the
preparation of either an EA or EIS
because such actions do not have a
significant effect on the human
environment, either individually or
cumulatively (40 CFR 1507.3(b)(2)).
Such classes of actions are
‘‘categorically excluded’’ from NEPA
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requirements (40 CFR 1508.4). Under 7
CFR 1b.4, all FSIS actions, including
inspection functions, are categorically
excluded from preparation of an EA or
EIS unless the Agency head determines
that a particular action may have a
significant environmental effect.
Accordingly, FSIS is not required to
prepare an EA or EIS unless it
anticipates that this rule may have a
significant environmental effect.
The Agency does not anticipate that
its decision to revoke maximum line
speeds for establishments that operate
under NSIS will have individual or
cumulative effects on the environment.
As FSIS explained in the proposed rule,
expected sales of pork products to
consumers will determine the total
number of hogs that an establishment
slaughters, not the maximum line speed
under which it operates. The Agency
has no authority to determine an
establishment’s production levels. An
establishment may decide to increase
production hours to slaughter more hogs
in response to market demand,
regardless of its maximum line speed.
Revoking maximum line speeds allow
establishments to slaughter hogs more
efficiently but will not directly affect
consumer demand for the
establishment’s pork products. In some
instances, an establishment operating
under NSIS may be able to reduce its
hours of operation while maintaining
production at a rate necessary to meet
market demand for its meat products.
Thus, revoking line speeds is not
expected to determine the number of
hogs slaughtered or result in more waste
or more water use, as suggested by the
commenters.
In addition, all slaughter
establishments, regardless of line speed,
are required to meet all local, State, and
Federal environmental requirements.
Sampling
Comments: Comments from consumer
advocacy organizations and public
health organizations supported FSIS’s
decision to require establishments to
develop written procedures to prevent
and mitigate microbial contamination of
carcasses throughout the entire
slaughter and dressing operations and
incorporate the intervention strategies
into their HACCP systems. These same
commenters stated that sampling at preevisceration and post-chill will make it
easier for establishments to see if their
process control system is working.
According to the commenters, microbial
testing at the end of the process
encourages industry to focus primarily
on post-slaughter interventions, while
the new approach encourages them to
focus on prevention and mitigation of
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microbial contamination throughout the
slaughter process.
Response: FSIS agrees that requiring
establishments to keep written records
to document the implementation and
monitoring of their process control
procedures is a positive step forward for
public health. This ongoing
documentation will allow both the
establishment and FSIS to identify
specific points in the production
process where a lack of process control
may have resulted in product
contamination or insanitary conditions.
This will allow the establishment to
take the necessary corrective actions to
prevent further product contamination.
Comments: Comments from members
of industry stated that FSIS should
revise the proposed rule to remove
sampling schemes based on
establishment size. According to the
commenters, basing sampling frequency
on the size of the establishment is not
supportable from a statistical sampling
point of view. The commenters
suggested that FSIS propose a minimum
sampling frequency for all
establishments based on the number of
head slaughtered, over a certain time
period.
Response: FSIS changed its proposed
sampling frequency to remove the
exception for very small establishments.
Under this final rule, very small
establishments will need to sample
carcasses at pre-evisceration and postchill (for hot-boned product, carcasses
sampled at pre-evisceration and after
the final wash) at a frequency of one per
1,000 carcasses. However, FSIS has
decided to keep the exception for very
low-volume establishments. This
change makes the sampling
requirements for swine slaughter
establishments more consistent with the
sampling requirements for poultry
slaughter establishments. Additionally,
if FSIS adopted a sample frequency of
one per 1,000 carcasses for very lowvolume establishments, many of these
establishments would not have to
sample at all.
Comment: Several consumer
advocacy organizations and one public
health organization objected to FSIS’s
proposal to allow establishments to
develop their own sampling and testing
protocols and to use alternate sampling
locations and frequencies. These same
commenters argued that it would be too
difficult for FSIS inspectors to verify
sampling plans that use alternate
sampling locations and frequencies.
Two consumer advocacy organizations
argued that FSIS’s Salmonella
performance standards remain a core
element of HACCP and should not be
eliminated under the proposed rule.
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One consumer advocacy organization
argued that FSIS must not move forward
with proposed inspection changes
without maintaining a pathogen-specific
performance standard. The commenter
argued that modernized, HACCP-based
inspection cannot function adequately
without such a performance standard.
The commenter further stated that
uniform microbial testing is necessary to
evaluate the impact of FSIS’s planned
inspection changes, as the Agency will
not be able to verify trends in pathogen
rates caused by the inspection changes
without an effective national testing
program.
One consumer advocacy organization
argued that FSIS should maintain the
current generic E. coli testing standard.
Although the commenter did not oppose
substitution of another indicator
organism for generic E. coli, they argued
that FSIS must ensure that any newly
permitted testing program is evidencebased and equal or superior to the prior
generic E. coli standard for fecal
contamination detection. The
commenter recommended that FSIS
require establishments who seek to use
an alternative testing program to the
generic E. coli standard to apply for a
regulatory waiver, which would allow
for pre-implementation Agency review.
Response: The purpose of the new
sampling requirement is to ensure that
establishments monitor and evaluate the
effectiveness of their procedures to
prevent contamination of carcasses by
enteric pathogens, and visible fecal
material, ingesta, and milk on an
ongoing basis. It is not intended to
generate data to compare establishment
performance across the industry.
However, FSIS has determined that it
may be too difficult for inspectors to
review and verify sampling plans that
use alternate sampling frequencies and
locations. As a result, FSIS is
withdrawing the proposal to allow
establishments to use alternate sampling
frequencies and locations.
Establishments that still wish to use
alternate sampling frequencies and
locations may submit a SIP waiver
request to FSIS for review.24 As is noted
above, FSIS will provide information
about waiver criteria in a future Federal
Register document.
As FSIS explained in the proposed
rule, FSIS discontinued its Salmonella
verification sampling program for
market hogs (carcasses) in 2011 to make
better use of its resources. Because
24 See FSIS Compliance Guideline Procedures for
New Technology Notifications and Protocols
available at https://www.fsis.usda.gov/wps/wcm/
connect/c64d8f3b-56aa-49c9-91f3-daf0caaba6bd/
New-Technology-Protocols042015.pdf?MOD=AJPERES.
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verifying the codified performance
standards for market hogs was not a
good use of Agency resources, and the
standards have not been used since
2011, FSIS is removing the carcass
Salmonella performance standards for
market hogs. With that said, FSIS is
currently testing pork cuts and
comminuted pork products for
Salmonella and expects to decide in
2019 whether to develop new pathogen
performance standards for these
products or take other actions to address
Salmonella in these products.25 FSIS
pathogen test results for pork products
are posted quarterly on the FSIS
website: https://www.fsis.usda.gov/wps/
wcm/connect/df529ce7-575a-43e7-921948be29c80fa5/Sampling-Project-ResultsData.xlsx?MOD=AJPERES.
Establishments may continue to
sample for generic E. coli. FSIS
considers the requirements under the
former regulations for generic E. coli to
be a scientifically validated ‘‘safe
harbor’’ for monitoring process control,
specifically for fecal contamination.
FSIS previously granted waivers under
the SIP to the generic E. coli testing
regulations for establishments that want
to test for other indicator organisms.
Establishments operating under these
waivers have demonstrated that they are
able to effectively maintain process
control based on their SIP sampling
data.
Comments: Several members of
industry, trade associations, and a State
Department of Agriculture objected to
the proposed pre-operational
environmental sampling requirements.
One HIMP establishment stated that
environmental sampling would be an
expensive change with little value. The
commenter argued that current HIMP
establishments have not been required
to conduct environmental sampling
beyond those tests that may also meet
the Sanitation SOP requirements, and
these establishments have shown
consistent or better performance
controlling for Salmonella.
A few public health organizations
stated that requiring facilities to monitor
and assess food contact surfaces for
enteric pathogens is a reasonable
measure given that recent investigations
of Salmonella foodborne illness
outbreaks revealed food contact surfaces
to be contaminated with the outbreak
strain. The commenters stated that
requiring pre-operational environmental
sampling should help ensure that
25 See U.S. Govt. Accountability Office, GAO–18–
272, Food Safety: USDA Should Take Further
Action to Reduce Pathogens in Meat and Poultry
Products (March 2018). https://www.gao.gov/assets/
700/690709.pdf.
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surfaces are sanitary and free of enteric
pathogens.
Response: This final rule does not
require swine slaughter establishments
to develop, implement, and maintain in
their HACCP systems written
procedures to prevent contamination of
the pre-operational environment by
enteric pathogens. In response to
concerns about the regulatory burden,
FSIS has decided to withdraw this part
of the proposal until it considers
options and timing for gathering more
data on enteric pathogen contamination
in the pre-operational environment.
FSIS agrees that current HIMP
establishments have shown consistent
performance controlling for Salmonella.
Comments: Several members of
industry, industry trade associations,
and private individuals objected to
certain content in the sampling guide.
These commenters argued that the
language in the sampling guide is
prescriptive in both tone and language
and implies mandatory requirements.
The commenters stated that the
sampling guide includes unhelpful and
problematic sampling methods,
techniques, and analysis, as these
depend on individual establishments’
sampling programs. For example,
several commenters argued that, absent
codified standards, Table 4 in the
sampling guide would be a de facto
performance standard, contrary to the
objectives in the proposed rule. The
commenters stated that the sampling
guide should be revised to promote
sampling programs tailored to each
establishment. One industry commenter
further argued that the word
‘‘compliance’’ should be removed from
the document title to be consistent with
recent changes to other FSIS guidance
documents and because the document
provides best practice recommendations
and not regulatory requirements.
Response: FSIS guidance documents
are intended to provide best practices
and, in some cases, safe harbors based
on the most current science available to
Agency stakeholders to help them
comply with regulatory requirements,
and when applicable, meet performance
standards. The sampling guide explains
that FSIS considers the requirements
under the former regulations for generic
E. coli to be a scientifically validated
‘‘safe harbor’’ for monitoring process
control for very low-volume
establishments. The sampling guide also
includes recommendations to assist
small and very small establishments to
meet regulatory requirements, and
recommendations to develop a custom
approach that are not dependent on
establishments’ available resources. For
example, the sampling guide provides
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baseline information for those
establishments that may need a starting
place from which to calculate their own
control limits. However, control limits
change over time as establishmentspecific data is collected and analyzed.
FSIS has removed Table 4 and replaced
it with a new table (Table 2) to provide
better guidance for establishments that
may want to use data from the 2010–
2011 market hog baseline survey as an
initial starting point from which to set
their upper control limits. Therefore, the
information provided in the document
is not a performance standard.
In response to the comments, FSIS
has revised the sampling guide to, in
part, further clarify the purpose of the
document, which is to assist small and
very small establishments to comply
with the new microbial organism
sampling requirements that apply to all
swine slaughter establishments under
this final rule. The sampling guide has
also been revised to include additional
information on the intended use of
provided methods, techniques, and
analyses; and to remove the word
‘‘compliance’’ from the document title
and clarify that the document does not
constitute regulatory requirements.
Additionally, the Agency moved the
example control charts from the
sampling guide from the sampling guide
to Appendix 2 of the guideline and
clarified how establishments can use
control charts. The Agency did not
recommend a specific control chart
format. Finally, the Agency removed all
references to pre-operational
environmental sampling. The updated
sampling guide is available at https://
www.fsis.usda.gov/wps/portal/fsis/
topics/regulatory-compliance/
compliance-guides-index.
Comments: Several commenters
objected to certain information provided
in the sampling guide related to
indicator organism sampling and
testing. One industry commenter stated
that both the proposed rule and the
sampling guide, as written, could
mandate a shift from analyzing market
hog carcasses for enteric pathogens of
concern, such as Salmonella, to
monitoring a surrogate, such as Aerobic
Plate Count (APC). The commenter
argued that this process control
approach is too singular, and FSIS
should clarify in the sampling guide
that establishments will maintain the
flexibility to select for one or more
indicator organisms. In addition, several
commenters argued that FSIS should
revise the sampling guide to remove
sampling schemes based on
establishment size. They stated that,
from a statistical sampling viewpoint,
establishing sampling frequency based
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on the size of the establishment is not
supportable. These commenters also
stated that generic E. coli testing should
not remain a ‘‘safe harbor,’’ even for
small and very small establishments,
because no scientific correlation exists
between microorganism presence/
growth and facility size. Finally, one
industry commenter noted that the
sampling guide does not summarize all
known control points for Salmonella, as
the document claims it does.
Response: The sampling guide
provides flexibility and monitoring
options for establishments, and it makes
clear that establishments may select one
or more indicator organisms to monitor.
To address the comment about the
singular process control approach, the
sampling guide provides a link to the
December 2013 FSIS guideline for
controlling Salmonella in market hogs,
which describes potential control points
for Salmonella in the pre- and postharvest production process. The
potential control points described in
that 2013 guideline may or may not be
applicable to a specific establishment’s
process.
Comments: Several commenters
expressed concerns with information
provided in reference and example
charts throughout the sampling guide.
One member of the pork industry and
one trade association representing the
pork industry argued that
establishments should not compare
process control results to a nationwide
geometric mean displayed in one chart.
The commenters argued that market hog
data is an inappropriate basis for
developing upper control limits, as it is
not applicable to all swine
establishments. Further, they stated that
these data from 2011 are outdated. One
commenter stated that ‘‘under NSIS’’
should be removed from one table
column heading, as the information
would apply to all swine
establishments.
Response: FSIS revised the sampling
guide to remove the table that provided
averages that represented the 80th
percentile limits for each indicator
organism included in FSIS’s 2010–2011
market hog baseline survey. The Agency
also removed the ‘‘under NSIS’’
language from the table that provides
information for all swine establishments
In cases where an establishment does
not have the resources or capacity to
initially develop its own statistical
control limits or analytical procedures,
an establishment can utilize the
aggregated data from the FSIS
Nationwide Market Hog Microbiological
Baseline Survey. The 2010–2011
baseline survey provides a wealth of
microbiological data specific to swine
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carcass sampling; these data are meant
to provide a starting point for an
establishment to develop its own
control limit parameters over time.
During the survey, FSIS collected two
carcass samples at pre-evisceration and
post chill.
Comment: One member of the pork
industry and one trade association
representing the pork industry
recommended that FSIS remove from
the sampling guide information related
to finished product standard (FPS)
waivers, as the subject is unrelated to
the sampling guide.
Response: FSIS has removed the FPS
waiver information from the sampling
guideline.
I. Economic Assessment
Comment: One company that owns a
HIMP establishment said that the cost of
additional employees has been their
most significant cost from the HIMP
pilot study, and that they have had to
hire and train up to 11 employees per
shift to staff and maintain the inspection
process.
Response: FSIS incorporated
information from this comment into
section III.G.1.a by revising the upper
bound estimate from 10 employees to 11
in the description of additional
establishment workers likely to be
required by establishments that adopt
the NSIS.
Comment: One industry commenter
estimated that a full-time position, per
slaughter shift, would be required to
collect, record, and analyze data
required to verify that an
establishment’s products meet the
definition of RTC.
Response: While establishments are
free to design their own process control
monitoring systems, FSIS finds the
estimated time and labor requirement
provided in this comment to be
inconsistent with FSIS’s observations of
HIMP establishments verifying OCP
performance standards. FSIS explained
in the proposed rule that pork carcasses
that meet the HIMP OCP performance
standards would meet the RTC pork
product definition. Large swine
establishments can verify OCP
performance standards by taking 24
carcass samples per shift, requiring
roughly one hour to collect, record, and
analyze the data.
Comments: Several comments from
members of the pork industry stated that
they own establishments that operate
under SIP waivers and conduct process
control sampling at alternate
frequencies.
Response: FSIS incorporated the
information from these comments into
section III.G.2.b of the final rule and
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used it to revise the cost estimate
associated with changes to requirements
for microbial organism process control
sampling and analysis. This revision
caused a slight decrease in potential
industry savings. Under the SIP, 11
large swine establishments currently
sample at an alternative frequency and
the Agency assumes that these
establishments will continue to do so
when the applicability dates for this
final rule arrive. As such, these
establishments are not expected to
change their process control sampling
and will not experience a change in
associated costs.
Comment: One member of the pork
industry claimed that process control
sampling requirements would increase
cost.
Response: As is detailed in section
III.G.2.b of the final rule, overall, the
changes in process control sampling
requirements were estimated to reduce
industry wide sampling costs by about
$0.57 million annualized over 10 years,
applying a three percent discount rate.
Comment: One member of the pork
industry reported that all six of their
company’s facilities have written
sanitary dressing plans.
Response: FSIS incorporated
information from this comment into
section III.G.2.a of the final rule to
reduce the cost estimate associated with
developing, composing, training,
monitoring, recording, and verifying
written sanitary dressing plans to reflect
that six establishments already have
written sanitary dressing plans.
Comment: One company stated that
many small and very small
establishments are unlikely to adopt the
NSIS due to the program’s costs.
Response: FSIS agrees that many
small and very small establishments are
unlikely to adopt the NSIS. The
Agency’s cost benefit analysis assumes
that very small establishments that
exclusively slaughter market hogs do
not have a high enough production
volume to justify incurring the costs of
converting to the NSIS.
Comment: One company participating
in HIMP stated that it invested in capital
expenditure projects to add or relocate
inspection stations and reconfigure
lines.
Response: The NSIS may require a
minor capital improvement if the
establishment does not already provide
a mirror at the carcass inspection
station. All the large high-volume
establishments are already required to
provide mirrors under existing
regulations. Providing a mirror is a
minor potential cost for a limited
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number of establishments.26 If an
establishment believes that additional
capital expenditures will result in a
benefit, they may voluntarily
reconfigure or update their facilities to
fully capture all the potential
production efficiencies offered through
participation in NSIS. Examples of such
changes include line reconfiguration,
which can cost between $10,000 and
$250,000 and the creation of an
inspection station, which can cost
between $5,000 and $6,000.
Establishments may reduce these costs
by coordinating these facility updates
with previously planned establishment
renovations.
Comment: A few consumer advocacy
organizations claimed that the Agency’s
cost benefit analysis understated
training costs because the industry has
a high turnover rate, necessitating that
training take place more frequently than
once per year.
Response: FSIS used BLS’ industry
turnover rate for non-durable
manufactured goods to estimate annual
training costs. Section III.G.1.a of the
final rule provides additional details on
how the cost benefit analysis estimates
industry’s training costs, which
includes training new employees given
the industry’s turnover rate.
Comments: Several commenters
stated that the Agency’s guidance
documents will likely need to be
translated into additional languages.
One commenter claimed that industry
would be forced to hire translators to
translate the Agency’s guidance
documents, the cost of which was not
included in the cost benefit analysis.
Response: The Agency plans to make
translated guidance documents publicly
available as the need arises at no cost to
industry. The cost of translating these
documents is already within the
Agency’s budget. As such, the cost is
not expected to increase the Agency’s
budgetary needs and is therefore not
included in the rule’s cost analysis.
III. Executive Orders (E.O.s) 12866 and
13563
E.O.s 12866 and 13563 direct agencies
to assess all costs and benefits of
available regulatory alternatives and, if
regulation is necessary, to select
regulatory approaches that maximize
net benefits (including potential
economic, environmental, public health
and safety effects, distributive impacts,
26 The cost was estimated to be very small
because all 22 large high-volume establishments
and potentially several of the 13 small high-volume
establishments are already required to provide
mirrors. As such, any new expense would be
negligible compared to the industry costs included
in the cost-benefit analysis.
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and equity). E.O. 13563 emphasizes the
importance of quantifying both costs
and benefits, of reducing costs, of
harmonizing rules, and of promoting
flexibility. This final rule has been
designated a ‘‘significant’’ regulatory
action under section 3(f) of E.O. 12866.
Accordingly, the rule has been reviewed
by the OMB under E.O. 12866.
A. Updates to the Regulatory Impact
Analysis (RIA)
FSIS updated the proposed rule’s RIA
to reflect the changes made in the final
rule in response to public comments.
The changes to the costs and benefits
sections incorporate the following
factors:
• The Agency removed the
mandatory pre-operational
environmental sampling requirement.
• Establishments currently operating
under SIP waivers conduct process
control sampling at an alternative
frequency and the Agency assumes that
they will continue to do so when the
applicability dates for this final rule
arrive. Therefore, these establishments
have been removed from the cost
estimate associated with changes to
requirements for microbial organism
process control sampling and analysis.
• Additional information from the
risk assessment that more transparently
demonstrates the potential uncertainty,
is now reflected in the cost-benefit
analysis. However, the anticipated net
benefit did not change.
• One company reported that all 6 of
its establishments already have written
sanitary dressing plans. As such, the
annual cost estimate associated with
developing, composing, training,
monitoring, recording, and verifying
written sanitary dressing plans has been
revised down by approximately
$87,000.
• The highest number of
establishment employees to be hired to
meet the needs of NSIS has been revised
up to 11, based on an industry
comment.
• The per head margin has been
updated to rely on the North American
Meat Institute’s (NAMI’s) 2017 Meat and
Poultry Facts.27
establishments that exclusively
slaughter market hogs, the current
regulations that require FSIS to focus on
non-food safety issues prevent FSIS
from efficiently allocating resources,
which inhibits food safety
improvements and humane handling
hazard prevention. Therefore, while
traditional inspection is generally
sufficient for low-volume
establishments and for establishments
that slaughter classes of swine other
than market hogs, a modernized swine
slaughter inspection system is needed,
one that is less prescriptive, creates
incentives for establishments to develop
and invest in advancements in food
safety and quality controls and
procedures, and allows FSIS to improve
inspection methods.
B. Need for the Rule
Baseline
The swine slaughter industry in the
United States has evolved since
Congress enacted the Wholesome Meat
Act in 1967. Many of today’s producers
have invested in farm to table quality
and food safety controls that effectively
address health risks and consumer
quality issues.28 For these producers,
the prescriptive nature of some FSIS
regulations inhibits efficient production
and the adoption of improved
production methods and restricts their
ability to adopt new technologies.
Further, at large and high-volume
C. Overview of the Market
U.S. pork production has increased at
a moderate pace as seen in Table 2.
Much of the additional growth in
domestic production has been used to
satisfy increasing export demands,
which increased 43 percent between
2009 and 2018.29 According to the Food
and Agricultural Organization (FAO),
pork is consistently ranked as the top
meat in per-capita consumption
worldwide 30 and is ranked third in the
United States.31
TABLE 2—U.S. PORK SUPPLY AND DEMAND
[Carcass weight, million pounds]
2009
2010
2011
2012
2013
2014
2015
2016
2017
2018
Consumption
U.S.
production
Year
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
Imports
Exports
Domestic
22,999
22,437
22,758
23,253
23,187
22,843
24,501
24,941
25,584
26,315
834
859
803
802
880
1,011
1,116
1,091
1,116
1,042
4,094
4,223
5,196
5,379
4,986
5,092
5,010
5,239
5,632
5,870
19,869
19,077
18,382
18,607
19,104
18,836
20,592
20,892
21,034
21,497
Per capita *
65
62
59
59
60
59
64
65
65
66
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* Measured in carcass weight, pounds.
Source: Livestock and Meat Domestic Data, All supply and disappearance, Historical, WASDE Pork-Full. USDA ERS Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock-meat-domestic-data/livestock-meat-domestic-data/#All%20meat%20statistics>
accessed on 6/12/2019. Last updated on 5/29/19.
In 2016, there were approximately
612 swine slaughter establishments
under Federal inspection, Table 3.32
Combined, these establishments process
roughly 118 million hogs annually. FSIS
divides swine into the following
27 Nalivka, J.S., The 2017 Meat and Poultry Facts,
NAMI August 2018.
28 Key, Nigel and William McBride. 2007. The
Changing Economics of U.S. Hog Production. USDA
Economic Research Service (ERS.). Report No. 52.
29 Livestock and Meat Domestic Data, All supply
and disappearance, Historical, WASDE Pork-Full.
USDA ERS Livestock and Meat Domestic Data.
<https://www.ers.usda.gov/data-products/livestock-
meat-domestic-data/livestock-meat-domestic-data/
#All%20meat%20statistics> accessed on 6/12/2019.
Last updated on 5/29/19.
30 FAO Livestock commodities. <https://www.fao
.org/docrep/005/y4252e/y4252e05b.htm> Accessed
on 11/29/16.
31 Livestock and Meat Domestic Data, All supply
and disappearance, Historical. USDA ERS Livestock
and Meat Domestic Data. <https://www.ers.usda
.gov/data-products/livestock-meat-domestic-data/
livestock-meat-domestic-data/#All%20meat%20
statistics> accessed on 6/12/2019. Last updated on
5/29/19.
32 USDA, FSIS, Public Health Information System
(PHIS).
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production categories for data collection
purposes: Roaster swine, market hog,
sow, and boar/stag. Today, the majority
(97%) of the pork products available in
the market are derived from market
hogs.33
TABLE 3—NUMBER OF SWINE SLAUGHTER ESTABLISHMENTS BY SIZE, 2016
HACCP
processing size
Number of
establishments
Total swine
slaughter
(head count)
Total market
hog slaughter
(head count)
Percent
market
hog
Large ........................................................................................................
Small ........................................................................................................
Very Small * .............................................................................................
28
105
479
105,678,519
11,862,341
903,009
105,321,950
8,497,891
625,863
99.66
71.64
69.31
Total ..................................................................................................
612
118,443,869
114,445,704
96.62
Source: Public Health Information System (PHIS).
* Two establishments classified as N/A were included in the category total for Very Small establishments.
As shown below in Table 4, many
establishments now exclusively
slaughter market hogs, a species sub
class which, because of technological
and animal management improvements,
such as improved genetics, nutrition,
and medical services, generally presents
fewer food safety and quality issues.34
D. Overview of the Final Rule’s NSIS
Several of the final rule’s provisions
apply to only those establishments that
choose to participate in the optional
NSIS. Meeting these provisions will
likely increase an establishment’s labor
and training costs. Only market hog
slaughter establishments are eligible to
participate in the NSIS. Due to the
economic constraints, FSIS expects that
only large and small high-volume
establishments that exclusively
slaughter market hogs will choose to
participate in the optional NSIS. In
2016,35 there were 40 high-volume
establishments that exclusively
slaughtered market hogs: 27 36 large 37 (5
HIMP + 22 non-HIMP) 38 and 13 small
establishments, Table 4. These
establishments account for 93 percent of
total swine slaughter annually, Table 4.
Given their large share of the market
and the ability to slaughter a sufficient
number of market hogs to justify the
likely costs associated with the NSIS,
these 40 market hog establishments are
expected to choose to implement the
optional NSIS. Therefore, this analysis
calculates the costs and benefits
associated with the NSIS provisions for
these 40 market hog establishments.
However, because the 5 HIMP
establishments already meet NSIS
requirements, they are not expected to
incur any additional new costs nor
contribute to any increase in quantified
benefits associated with adopting the
NSIS.
TABLE 4—HEAD COUNT DISTRIBUTION ACROSS TYPES OF ESTABLISHMENTS, 2016
Number of
establishments
Total swine
slaughter
(head count)
Percent of
total head
count
Type of establishment
HACCP size
High-Volume Market Hog Only .....................
Large—HIMP ................................................
Large—Non-HIMP ........................................
Small .............................................................
Very Small ....................................................
Large/Small ..................................................
Very Small ....................................................
5
22
13
71
93
408
17,517,254
87,746,770
4,617,680
32,360
7,659,156
870,649
14.79
74.08
3.90
0.03
6.47
0.74
.......................................................................
612
118,443,869
........................
Low-Volume Market Hog Only .....................
Mix of Species and Swine Sub Classes ......
Grand Totals ..........................................
* HACCP sizes were combined so as to not reveal proprietary information.
Source: PHIS.
E. Overview of the Final Rule’s
Mandatory Components
All swine slaughter establishments
will need to comply with the two
mandatory provisions of the final rule
discussed below.
1. Written Sanitary Dressing Plans
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FSIS is amending 9 CFR 310.18 to
require swine slaughter establishments
to develop, implement, and maintain as
33 Source:
PHIS.
Nigel and William McBride. 2007. The
Changing Economics of U.S. Hog Production. USDA
ERS. Report No. 52.
35 Establishment level data from 2016 was used in
both the Preliminary Regulatory Impact Analysis
(RIA) and the Final RIA.
34 Key,
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part of their HACCP systems, written
procedures to ensure that no visible
fecal material, ingesta, or milk is present
by the point of FSIS post-mortem
inspection of swine carcasses. This
requirement will address a weakness of
the current traditional inspection
system, which is that verification checks
performed at the end of the slaughter
and chilling process encourage industry
to focus its activities on post-process
interventions to reduce contamination
rather than prevention throughout the
slaughter process. Prevention
throughout the slaughter process is
preferred because it promotes
containing contamination close to its
origin, which reduces cross
contamination of multiple carcasses.
The existing regulations require that
establishments prevent swine carcasses
contaminated with visible fecal material
36 In 2016 there was 1 large establishment that did
not exclusively slaughter market hogs. As such, this
analysis assumed they would not choose to
participate in the optional NSIS and were excluded
from the relevant sections in the analysis.
37 HACCP size: Very Small Establishment = Less
than 10 employees or less than $2.5 million in
annual sales; Small Establishment = 10–499
employees; Large Establishment = 500 or more
employees.
38 In 2016, there was 1 large establishment that
did not exclusively slaughter market hogs.
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from entering the cooler. While
preventing swine carcasses
contaminated with visible fecal material
from entering the cooler is an important
safeguard for reducing the prevalence of
pathogens on swine carcasses, this
result generally cannot be effectively
accomplished unless establishments
implement appropriate measures to
prevent contamination from occurring
throughout the slaughter and dressing
operation and implement process
control procedures for preventive
measures. Requiring establishments to
keep daily written records to document
the implementation and monitoring of
their process control procedures is a
positive step forward for public health.
This ongoing documentation allows
both the establishment and FSIS to
identify specific points in the
production process where a lack of
process control may have resulted in
product contamination or insanitary
conditions. In addition, it will allow the
establishment to implement corrective
actions that could include the addition
of preventive control measures to
prevent recurrence of similar product
contamination events or insanitary
conditions.
Based on public comment, the final
rule assumes all but six establishments
will need to develop written sanitary
dressing plans.
2. Process Control Sampling and
Analysis for Microbial Organisms
Under this final rule, instead of
following a prescribed microbiological
testing program, each establishment will
be responsible for developing and
implementing its own microbiological
sampling plan. Each establishment,
except very low-volume establishments,
is required to include carcass sampling
at pre-evisceration and post-chill (i.e.,
the point in the slaughter process after
the carcass has chilled in the cooler and
after all slaughter interventions are
completed) or for hot-boned products,
carcass sampling at pre-evisceration and
after the final wash.
The microbiological standards prior to
the final rule prescribed that all
establishments monitor process control
by sampling for generic E. coli. Highvolume establishments were required to
take one sample per 1,000 carcasses or
request an alternative frequency. Very
low-volume establishments were
required to take 1 sample per week of
operation up to 13 times a year. Several
commenters from industry reported that
39 Viator, C. et al. 2015. Meat Industry Survey in
Support of Public Health Risk-Based Inspection.
P5–42. Question 3.1.
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each of their establishments operating
under SIP conduct process control
sampling at an alternative frequency. In
addition, an industry survey found that
many establishments elect to perform
other microbiological tests in addition
to testing for generic E. coli.39
components. The 35 establishments that
the Agency assumes will adopt the NSIS
portion of the rule have similar
characteristics to the 5 HIMP
establishments, such as volume and sub
species slaughtered. Given the
successful participation of the 5 HIMP
establishments in the pilot program and
F. Overview of the Impact of the Final
industry’s continued interest in
Rule on the Agency
increasing the number of establishments
This analysis, in part, takes into
participating in the HIMP pilot study,
consideration potential impacts to the
the potential benefits from adopting
Agency’s budget. FSIS’s budget is
NSIS are expected to outweigh the
expected to be impacted by changes in
potential costs. This analysis assumes
staffing and training requirements for
that very small establishments that
those establishments that choose to
exclusively slaughter market hogs do
operate under the NSIS. Under
not have a high enough production
traditional inspection, each slaughter
volume to justify incurring the costs of
line requires up to 11 full-time
converting to the NSIS. While the 5
positions. Generally, these positions
HIMP establishments are expected to
include both a supervisory and nonsupervisory Public Health Veterinarian, adopt the NSIS, they have already
(PHV) (OPM Veterinary Medical Science implemented the changes associated
with the NSIS by their participation in
Series, 0701); a supervisory and nonthe HIMP pilot study and are not
supervisory consumer safety inspector,
(CSI) (OPM Consumer Safety Inspection expected to incur any new or additional
expenses. As such, they are not
Series, 1862); and up to 7 Food
included in the group of establishments
Inspectors, (FI) (OPM Food Inspection
expected to incur an increase in costs
Series, 1863). There are currently 418
associated with NSIS. The following
full-time equivalent units (FTE)
analysis also excludes further
assigned to slaughter inspection at the
consideration of the costs of submitting
22 large non-HIMP (27 large—5 HIMP)
and 13 small swine slaughter
an attestation of work-related conditions
establishments expected to convert to
due to its small estimated cost.40 Costs
the NSIS, Table 5. When these
examined generally fall under three
establishments convert to the NSIS,
categories: Labor, capital expenses, and
Agency personnel will require NSIS
developing written procedures.
training. Additionally, the number of
In the following sections, this analysis
Agency personnel required to inspect
presents the costs and benefits
the slaughter process will likely be
generated over a range of assumptions
reduced. See Agency Staffing section for
with respect to how much of the
details.
industry chooses to adopt the NSIS
TABLE 5—CURRENT FSIS SLAUGHTER within five years. As was done with the
LINE POSITIONS AT NON-HIMP ES- NPIS, this analysis assumes a 5-year
adoption period with roughly consistent
TABLISHMENTS THAT SLAUGHTER
annual adoption rates. These estimates
EXCLUSIVELY MARKET HOGS
are scaled for an illustrative calculation
and assume that 35 of the 40
Number
of
OPM job code
establishments that are likely to adopt
positions
the NSIS will incur additional costs
1862 (CSI) ............................
120 associated with adoption. Using this
1863 (FI) ...............................
245 illustrative calculation was supported
0701 (PHV) ...........................
53 by one public comment, which
Total ..................................
418 suggested that adoption timing and rate
are difficult to estimate without a final
Source: PHIS.
rule. As is stated above, the 5 HIMP
establishments are not expected to incur
G. Potential Costs of the Final Rule
any additional costs associated with
1. Costs Associated With the NSIS
adopting the NSIS and are therefore
Components of the Rule
excluded when calculating potential
This analysis estimates the costs
costs of the NSIS components of this
associated with the final rule’s NSIS
final rule.
40 It was estimated that submitting such an
attestation would require a Quality Control
Technician with a labor compensation rate of
$68.52 per hour, 2 minutes per year. Combined,
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submitting an annual attestation would cost all 27
large and 13 small establishments likely to adopt
the NSIS approximately $91.36 annually (2 minutes
* $68.52 per hour * 40).
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TABLE 6—NSIS ADOPTION RATE
Total number of establishments
adopted
Year
Large
1
2
3
4
5
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
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a. Costs of Additional Establishment
Workers
This analysis expects establishments
operating under the NSIS to experience
an increase in labor costs. Under the
NSIS, establishments will be required to
dedicate labor to sort and remove unfit
animals before ante-mortem inspection;
trim and identify defects, such as
dressing defects, contamination, and
pathology defects, on carcasses and
parts before post-mortem inspection;
identify animals or carcasses that they
have sorted and removed for disposal
before FSIS inspection with a unique
tag, tattoo, or similar device, and to
develop, implement, and maintain
written procedures to ensure that
animals and carcasses that have been
sorted and removed for disposal do not
enter the human food supply and are
properly disposed of; maintain records
to document the total number of
animals and carcasses sorted and
removed per day and the reasons for
their removal; while conducting sorting
activities, notify Agency inspectors if
they suspect that an animal or carcass
has a reportable or foreign animal
disease; and maintain records
documenting that products resulting
from their slaughter operations meet the
new definition of RTC pork product.
Based on observations 41 of HIMP
establishments and a comment from
industry,42 this increase in work is
expected to require an increase in labor
demand ranging from 6–11 additional
workers per line per shift at large
establishments. This analysis assumes
each large establishment that converts to
the NSIS will require 9 additional
workers per line per shift. Due to data
limitations, this analysis assumes small
establishments that convert to the NSIS
will require 1 additional worker per line
per shift. Costs associated with this
41 Observations were obtained through a survey
conducted, in February 2016, through the
Salmonella Initiative Program and conversations
with industry at a meeting, which took place in
February 2016, with the North American Meat
Institute.
42 One corporation reported in a comment to the
proposed rule that they hired and trained up to 11
employees per shift.
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Percent
adopted
Small
4
8
12
17
22
2
4
7
10
13
17
34
54
77
100
labor fall into 3 categories: Wages and
benefits, training, and continuing
education.
estimates take into consideration the
fact that some establishments operate
multiple lines and multiple shifts.
Establishment Labor Wage Increases
Many of the 22 large and 13 small
non-HIMP market hog establishments
that are assumed to adopt the NSIS
operate multiple lines and shifts. Taking
these multiple lines and shifts into
consideration, the number of industry
positions is estimated to increase by 383
if all high-volume establishments that
have a history of exclusively
slaughtering market hogs, adopt NSIS.
The majority of these, 369, are
attributable to the large establishments
(41 (number of lines) × 9),43 Table 7.
The remaining 14 positions are
attributable to the small establishments
(14 (number of lines) × 1),44 Table 7.
According to the BLS, the estimated
hourly wage for a Slaughterer and Meat
Packer occupation (‘‘production
employee’’) is $13.00.45 A benefits and
overhead factor of two was then used to
estimate the total labor costs. The total
hourly labor costs to industry for a
production employee including benefits
and overhead, is $26.00 per hour
($13.00 × 2 46). Based on data obtained
through PHIS, the average large
establishment slaughters swine 269 days
annually. Assuming workers work 8hour shifts, the total annual
remuneration cost to these 22 large
establishments is approximately $20.65
million, (369 × $26.00 × 269 × 8), Table
7. The average small establishment
slaughters 244 days annually. Again,
assuming workers work 8-hour shifts,
the total annual remuneration cost to
these 13 small establishments is
approximately $0.71 million, (14 ×
$26.00 × 244 × 8), Table 7. These cost
Costs for Training Online Sorters and
Carcass-Inspection Helpers
Establishments are expected to incur
costs associated with initially training
employees to fill online sorter and
carcass-inspection helper positions,
annual replacement training, and
continuing education training. This
analysis assumes the cost to train online
sorters and carcass-inspection helpers
are similar to the costs of training
production employees in HACCP,
which range from $274 to $823 with a
midpoint average of $549 per new
employee.47 To ensure a conservative
estimate and account for employee
rotation patterns as well as leave, FSIS
assumes that establishments will train 4
employees for each new position. Under
these assumptions, large establishments
will need to train approximately 1,476
(369 × 4) employees, while small
establishments will need to train
approximately 56 (14 × 4) employees.
The cost of this training ranges from
$419,768 to $1,260,836, with a midpoint
estimate of $0.84 million (1,532 × $549),
Table 7.
To account for estimated turnover of
establishment employees, FSIS projects
that establishments will have to train
approximately 452 (1,532 × 0.295)
replacement employees annually, 435 at
the large and 17 at the small
establishments.48 The additional annual
training cost for new employees was
estimated to also be similar to the costs
of HACCP training. Therefore, FSIS
estimates the combined annual training
costs due to turnover to be
approximately $0.25 million (452 ×
43 Source:
PHIS.
PHIS.
45 BLS Occupational Employment Statistics,
Occupational Employment and Wages, May 2016.
51–3023 Slaughterers and Meat Packers https://
www.bls.gov/news.release/archives/ocwage_
03312017.pdf Accessed on 12/04/18. Last modified
3/31/17.
46 To be consistent with analyses done by the
Department of Health and Human Services, this
analysis accounts for fringe benefits and overhead
by multiplying wages by a factor of 2.
44 Source:
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47 Viator, C. et al. 2015. Costs of Food Safety
Investments. Table 4–4. Training Costs for
Management and Production Employees.
48 This estimate was rounded up. This analysis
uses the industry turnover rate for non-durable
manufactured goods to estimate separations.
Source: BLS Economic News Release Table 16.
Annual total separations rates by industry and
region, not seasonally adjusted. https://
www.bls.gov/news.release/archives/jolts_
03162017.htm Accessed on 12/04/18. Last updated
on 3/16/17.
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$549), with large establishments
accounting for approximately $0.24
million (435 × $549) and small
establishments accounting for
approximately $9,333 (17 × $549), Table
7.
FSIS assumes that 1,080 (1,532 ×
0.705) retained employees, 1,041 at the
large and 39 at the small establishments,
will require annual continuing
education. This analysis assumes
annual continuing education costs to be
similar to annual HACCP refresher
training costs, which range from $12 to
$36 per employee, with a mid-point of
$24.49 Using the mid-point value, this
analysis estimates the combined average
recurring cost for continuing education
is $25,920 (1,080 × $24), with large
establishments accounting for
approximately $24,984 (1,041 × $24)
52325
and small establishments accounting for
approximately $936 (39 × 24).
Under the assumed adoption rate as
set forth in Table 6, annualized wages
and training cost to industry for staffing
additional online personnel is
approximately $16.61 million, applying
a 3 percent discount rate 50 over 10
years, Table 7. The majority of this cost
is attributed to wages and benefits,
Table 7.
TABLE 7—ESTABLISHMENT LABOR COSTS
[M$]
Number of
personnel
One-time
cost
Recurring
cost
369
1,476
435
1,041
........................
$0.81
........................
........................
$20.65
........................
0.24
0.02
14
56
17
39
........................
0.03
........................
........................
0.71
........................
0.009
0.001
One-Time .............................................................................................................................................................................................
0.84
Recurring Cost .....................................................................................................................................................................................
21.63
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
16.61
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
15.97
Type of establishment
Type of expense
Large ...............................................................
Wages ............................................................
Initial Training .................................................
Training Due to Labor Turnover ....................
Continuing Education .....................................
Small ...............................................................
Wages ............................................................
Initial Training .................................................
Training Due to Labor Turnover ....................
Continuing Education .....................................
Totals
b. Costs of Capital Improvements
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The NSIS may require a minor capital
improvement if the establishment does
not already provide a mirror at the
carcass inspection station. All the large
high-volume establishments are already
required to provide mirrors under
existing regulations. The following
analysis excludes further consideration
of the costs of requiring a mirror due to
its minor potential cost for a limited
number of establishments.51 If an
establishment believes that additional
capital expenditures will result in a
benefit, they may voluntarily
reconfigure or update their facilities to
fully capture all the potential
production efficiencies offered through
participation in the NSIS. Examples of
such changes include line
reconfiguration, which can cost between
$10,000 to $250,000 52 and the creation
49 Viator, C. et al. 2015. Costs of Food Safety
Investments. Table 4–4. Training Costs for
Management and Production Employees.
50 As is explained in Circular A–4, a discount
factor should be used to adjust the estimated
benefits and costs for differences in timing. For
regulatory analysis, net benefit estimates should be
provided using a 3 percent and 7 percent discount
rate. Source: Circular A–4, OMB, September 17,
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of an inspection station, which can cost
between $5,000 and $6,000.53
Establishments may reduce these costs
by coordinating these facility updates
with previously planned establishment
renovations.
c. Costs of Developing Ante-Mortem
Written Procedures
Under the final rule, establishments
operating under the NSIS are required to
develop and maintain in their HACCP
systems (HACCP plans, sanitation SOPs,
or other prerequisite programs) written
procedures for the segregation,
identification, and disposition of
animals suspected of having one of the
condemnable generalized diseases or
conditions listed in 9 CFR 309. This
analysis assumes establishments will
coordinate this work and costs with the
development of written procedures to
prevent the contamination of carcasses
2003, https://www.whitehouse.gov/sites/
whitehouse.gov/files/omb/circulars/A4/a-4.pdf.
51 The cost was estimated to be very small
because all 22 large high-volume establishments
and potentially several of the 13 small high-volume
establishments are already required to provide
mirrors. As such, any new expense would be
negligible compared to the industry costs included
in the analysis.
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and parts by enteric pathogens, and
visible fecal material, ingesta, and milk
throughout the entire slaughter and
dressing operation, a mandatory
component of the final rule. Details of
these costs can be found in the sanitary
dressing costs section III.G.2.a.
d. Costs Associated With Ready-to-Cook
Pork Standards
Under the final rule, establishments
operating under the NSIS are required to
collect, record, and analyze
documentation to demonstrate that the
products resulting from their slaughter
operation meet the definition of RTC
pork products. This analysis estimates
the labor costs to collect, record and
analyze such documentation under two
assumptions. First, FSIS assumes that
establishments will assign the task to a
quality control (QC) technician, with an
hourly compensation rate, which
52 In a May 2004 study, ERS estimated the cost
of compliance per establishment with the PR/
HACCP rule. Capital expenditures in Hog Slaughter
establishments were estimated to be $251,800.
Ollinger, Moore, Chandran (2004). Meat and
Poultry Establishments’ Food Safety Investments.
USDA, Economic Research Service.
53 Modernization of Poultry Slaughter Inspection;
Final Rule, 79 FR 49566 (2014).
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includes wages, benefits, and overhead,
of $68.52.54 55 Second, FSIS assumes
that this work will take 1 hour at a large
establishment and 1⁄2 hour at a small
establishment per day. As is explained
in the Draft Market Hogs HIMP paper, 56
large swine establishments can verify
they meet OCP performance standards
by taking 24 unit samples, requiring
roughly 1 hour to collect, record, and
analyze the data. Based on information
obtained through PHIS, the average
large swine establishment operates 269
days per year. This equates to an annual
cost of approximately $18,432 (269 × 1
× $68.52), or approximately $0.41
million for all 22 non-HIMP
establishments ($18,432 × 22).
Similarly, the cost to an average small
establishment, which based on data
obtained through PHIS operates 244
days a year, is approximately $8,359
(244 × 0.5 × $68.52), or approximately
$0.11 million for all 13 small
establishments ($8,359 × 13). Combined,
under the assumed adoption rate as set
forth in Table 6, these costs are expected
to increase NSIS establishments’ annual
labor costs by approximately $0.39
million, applying a 3 percent discount
rate over 10 years, Table 8.
TABLE 8—COST OF RTC REQUIREMENTS
[M$]
Number of
establishments
Type of market hog only establishment
Large ....................................................................................................................................................................
Small ....................................................................................................................................................................
Recurring
Labor
22
13
$0.41
0.11
Recurring Cost .....................................................................................................................................................................................
0.51
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
0.39
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
0.38
Totals *
* Note, some of the totals may not equal the sum due to rounding.
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2. Costs Associated With Requirements
for All Swine Slaughter Establishments
The mandatory costs of the final rule
will apply to all 612 swine slaughter
establishments and begin on the
effective date for these requirements.
These costs are associated with (a)
written procedures to prevent visible
fecal material, ingesta, and milk
contamination; and (b) sampling and
analysis for microbial organisms to
monitor process control for enteric
pathogens.
swine, FSIS is requiring that all official
swine slaughter establishments develop,
implement, and maintain in their
HACCP systems written procedures to
prevent the contamination of carcasses
and parts by enteric pathogens, and
visible fecal material, ingesta, and milk
throughout the entire slaughter and
dressing operation. This cost component
for establishments includes: (1)
Developing and incorporating these
procedures into their food safety system,
(2) training, and (3) monitoring,
recordkeeping, and verification. This
analysis assumes 606 swine
establishments will incur these costs.57
a. Costs of Developing, Composing,
Training, Monitoring, Recording, and
Verifying Written Sanitary Dressing
Plans
Under the mandatory portion of the
final rule affecting all Federally
inspected establishments that slaughter
Costs for Developing and Composing a
Written Sanitary Dressing Plan
54 BLS Occupational Employment Statistics,
Occupational Employment and Wages, May 2016.
19–1021 Food Scientist and Technologist. <https://
www.bls.gov/news.release/archives/ocwage_
03312017.pdf>. Accessed on 12/04/18. Last
Modified 3/31/2017.
55 To be consistent with analyses done by the
Department of Health and Human Services, this
analysis accounts for fringe benefits and overhead
by multiplying wages by a factor of 2.
56 Draft Market Hogs HIMP (HACCP-Bases
Inspection Models Project). Draft 6/21/05. <https://
www.fsis.usda.gov/wps/wcm/connect/d6ccbad759e0-43f5-bf54-1987152ccfe8/HIMP_Market_
Hog.pdf?MOD=AJPERES.>.
57 One corporation has informed FSIS, through
public comment, that all six of its swine harvest
facilities have written sanitary dressing plans. As
such, they were not included in this portion of the
cost analysis, which reduced annual costs by
roughly $87,000 as compared to the proposed rule.
58 Viator, C. et al. 2015. RTI International
collected data on the cost of food safety investments
for the production of meat and poultry products at
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FSIS assumes incorporating written
sanitary dressing plans into an
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establishment’s HACCP system will
result in a one-time HACCP plan
reassessment cost. According to RTI’s
Costs of Food Safety Investments
report,58 the mid-point costs of a
HACCP plan reassessment for large
establishments is $730, the mid-point
costs for small and very small
establishments is $365.59 The cost to
large establishments is approximately
$16,060 (22 × $730), small
establishments is approximately
$38,325 (105 × $365), and very small
establishments is approximately
$174,835 (479 × $365). The annualized
costs to industry with a 3 percent
discount rate for all 606 swine slaughter
establishments is approximately $0.03
million, Table 9.
the pre-harvest and slaughter and processing stages.
This data was provided to FSIS in a final report
titled ‘Costs of Food Safety Investments’ and was
prepared by Catherine L. Viator, Mary K. Muth, and
Jenna E. Brophy. The contract number is No. AG–
3A94–B–3–0003. The order number is AG–3A94–
K–14–0056.
59 Viator, C. et al. 2015. Table 4–1. Costs of
HACCP Plan Development, Validation and
Reassessment per HACCP.
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TABLE 9—WRITTEN SANITARY DRESSING PLAN DEVELOPMENT
[M$]
Number of
establishments
HACCP size
Large ....................................................................................................................................................................
Small ....................................................................................................................................................................
Very Small ...........................................................................................................................................................
One-time cost
22
105
479
$0.02
0.04
0.17
One-Time Cost ....................................................................................................................................................................................
0.23
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
0.03
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
0.03
Totals
Costs for Training Establishment
Personnel on Executing a Written
Sanitary Dressing Plan
FSIS assumes training programs will
be utilized to ensure that establishment
personnel understand and can execute
the sanitary dressing plan. This training
includes a one-time initial training cost
to the establishment, a recurring cost of
training new hires due to separations,
and the cost of conducting annual
refresher training. This portion of the
model is informed by the RTI Costs of
Food Safety Investments report.60 As is
noted in the RTI report, these costs are
based on the amount of time a panel of
experts recommends establishments
spend on training, which may exceed
the amount of time establishments
spend on training. Due to data
limitations, this analysis assumes the
number of establishment employees
conducting sanitary dressing tasks at
swine establishments is equal to the
number of employees conducting
sanitary dressing tasks at beef slaughter
establishments.61 This is likely an
overestimate because unlike beef, the
majority of swine are scalded, de-haired,
and polished prior to opening the
carcass, which decreases the need for
employees to conduct sanitary dressing
tasks.
As seen in Table 10, costs are shared
across HACCP sizes, with large
establishments incurring higher costs.
The rate of new hires, 29.5 percent, is
derived from the BLS, 2016 Turnover
Rate for Non-Durable Manufacturing
Goods.62 Likewise, the retention rate for
the refresher training is one minus the
turnover rate. The total one-time cost to
train the employees for all 606
establishments is roughly $1.00 million,
while the total recurring costs is roughly
$0.44 million, Table 10. The annualized
costs with a 3 percent discount rate over
10 years for Sanitary Dressing task
related training is $0.55 million, Table
10.
TABLE 10—SANITARY DRESSING TRAINING COSTS
[M$]
Training costs
Number of
establishments
HACCP size
Average
number
of employees
One-time
Initial
Large ................................................................................
Small ................................................................................
Very Small ........................................................................
22
105
479
179
25
3
Recurring
New hires
$0.48
0.32
0.20
Refresher
$0.14
0.09
0.06
$0.07
0.04
0.03
One-Time Cost ....................................................................................................................................................................................
1.00
Recurring Cost .....................................................................................................................................................................................
0.44
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
0.55
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
0.57
Totals *
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* Note, some of the totals may not equal the sum due to rounding.
60 Viator,
C. et al. 2015.
Survey is at: https://www.fsis.usda.gov/wps/
wcm/connect/184a3baa-2f73-4651-8aba68124580f4e0/Pathogen_Controls_in_Beef_
Operations_Survey.pdf?MOD=AJPERES. The survey
report is at: https://www.fsis.usda.gov/wps/wcm/
61 The
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connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/
STEC_Survey_Comments_
Summary.pdf?MOD=AJPERES.
62 Source: BLS Economic News Release Table 16.
Annual total separations rates by industry and
region, not seasonally adjusted. <https://
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03162017.htm> Accessed on 12/04/18. Last
updated on 3/16/17.
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Cost of Monitoring, Recordkeeping, and
Verification Associated With the
Written Sanitary Dressing Plan
This analysis also estimates the
annual monitoring, recordkeeping and
verification costs associated with
maintaining sanitary dressing
procedures. This analysis assumes it
will take a production employee 5
minutes to monitor and 5 minutes to
maintain records for the sanitary
dressing procedures, for a total of 10
minutes. Establishments are required to
verify the plan each day of production.
In addition, this analysis assumes it will
take a QC manager 15 minutes to
perform a verification task and that such
task will be completed each week that
slaughter takes place. Combined, these
tasks are estimated to cost the entire
industry roughly $0.84 million
annually, applying a 3 percent discount
rate over 10 years, Table 11.
TABLE 11—MONITORING, RECORDKEEPING AND VERIFICATION COSTS
[M$]
Recurring costs
HACCP size
Monitoring
Large ................................................................................................................
Small ................................................................................................................
Very Small .......................................................................................................
Recordkeeping
$0.01
0.04
0.07
$0.01
0.04
0.07
Verification
Combined
$0.03
0.12
0.44
$0.05
0.20
0.58
Recurring Cost .....................................................................................................................................................................................
0.84
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
0.84
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
0.84
Totals *
* Note, some of the totals may not equal the sum due to rounding.
Summary Costs of Written Sanitary
Dressing Procedures
Table 12 provides an overview of the
one-time and recurring costs associated
with requiring all establishments to
develop written sanitary dressing
procedures. Combined, these tasks are
expected to cost the industry $1.41
million annualized, assuming a 3
percent discount rate over 10 years,
Table 12.
TABLE 12—SUMMARY OF COSTS ASSOCIATED WITH REQUIRING WRITTEN SANITARY DRESSING PROCEDURES
[M$]
One-time costs
Number of
establishments
HACCP size
Large ....................................................................................
Small ....................................................................................
Very Small ............................................................................
Development
22
105
479
Recurring costs
Initial training
$0.02
0.04
0.17
$0.48
0.32
0.20
Training
Monitoring,
recording,
validating
$0.21
0.14
0.09
$0.05
0.20
0.58
One-Time Cost ....................................................................................................................................................................................
1.23
Recurring Cost .....................................................................................................................................................................................
1.27
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
1.41
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
1.44
Totals *
* Note, some of the totals may not equal the sum due to rounding.
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b. Cost of Carcass Sampling and
Analysis for Microbial Organisms
This section reviews the potential
changes in costs associated with the
alterations to microorganism testing.
These costs are limited to the changes
associated with removing the
requirement that swine establishments
test carcasses for generic E. coli and
replacing it with new testing
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requirements described above. While
the final rule also removes the codified
Salmonella pathogen reduction
performance standards for swine,
because the codified standards are
already no longer in use, there are no
potential costs or benefits to industry.
Such changes fall under four categories:
Sampling plan reassessment,
transferring from prescriptive to process
testing requirements, sampling rates,
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and sample recordkeeping. This
analysis uses results from the RTI
International Meat Industry Survey in
Support of Public Health Risk-Based
Inspection report 63 and Costs of Food
63 Viator, C. et al. 2015. (a) RTI International
designed and conducted surveys on industry
practices to control pathogens and promote food
safety. The sample design, administration
procedures, analysis and results were provided to
FSIS in a final report titled ‘Meat Industry Survey
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Safety Investments report.64 Each of
these categories is explained in detail
below. Based on industry comment on
the proposed rule, this analysis
excludes the 11 large swine
establishments that were participating
in the SIP program when data for this
analysis was collected. Under SIP, these
establishments currently sample at an
alternative frequency and we assume
that they will continue to do so. As
such, these 11 SIP swine slaughter
establishments are not expected to
change their process control sampling
and will not experience a change in
associated costs.
Cost of Process Control Sampling Plan
Reassessment
This analysis assumes establishments
will incur one-time costs of conducting
a process control sample plan
reassessment under the final 9 CFR
310.25(a)(2)(i). The RTI Costs of Food
Safety Investments report estimates the
costs of reassessing a microbiological
52329
sampling plan. For large establishments,
these costs include labor, consultant
fees, and travel expenses, which
combined range from $27,320 to
$81,960, with a midpoint of $54,640 per
establishment. Costs to small and very
small establishments are limited to labor
expenses and range from $122 to $365,
with a midpoint of $243 per
establishment.65 The annualized
reassessment cost to industry is roughly
$0.12 million, assuming a 3 percent
discount rate over 10 years, Table 13.
TABLE 13—COST OF PROCESS CONTROL SAMPLING PLAN REASSESSMENT
[M$]
Number of
establishments
HACCP size
Large ................................................................................................................................
Small ................................................................................................................................
Very Small .......................................................................................................................
Per
establishment
(mid-point
estimate) *
17
105
479
Total one-time
costs
$0.05
243
243
$0.93
0.03
0.12
One-Time Cost ................................................................................................................................................................................
1.07
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................................................
0.12
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................................................
0.14
Totals **
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* The values for Small and Very Small Establishments are in dollars.
** Note, some of the totals may not equal the sum due to rounding.
Cost of Transferring From Prescriptive
To Process Specific Microbiological
Testing Requirements
Prior to the final rule, regulations
prescribed that each slaughter
establishment test for generic E. coli.66
In addition to mandated generic E. coli
testing, many establishments voluntarily
conduct additional microbiological
testing to verify process control.
Common microbiologic tests include
APC, total plate count (TPC), and total
coliforms. Based on the meat slaughter
survey conducted by RTI, roughly 71
percent of very small, 80 percent of
small, and 100 percent of large
establishments conduct microbiological
testing in addition to testing for generic
E. coli.67 Establishments voluntarily
conducting additional testing are an
indication that the generic E. coli testing
is not the best means to verify process
control in their respective
establishments.
This analysis assumes that, if
permitted to choose a microbiological
test to ensure process control,
establishments will select the single best
test that demonstrates process control at
their establishment. Under these
assumptions, establishments that
currently test for generic E. coli and
conduct at least one other type of
microbiological test will stop testing for
generic E. coli. As a result, the 17 large
(17 × 1.00), 41 small high-volume (51 ×
.80), 43 small low-volume (54 × .80), 4
very small high-volume 68 (6 × .714),
and 338 very small (473 × .714)
establishments that currently test for
generic E. coli and at least one other
microbial or pathogen indicator 69 will
experience a cost reduction. Given the
similarity in laboratory testing costs and
costs associated with switching
sampling programs, this analysis
assumes the remaining 158
establishments that exclusively test for
generic E. coli will continue to do so.
Calculating the cost reductions is a
function of estimating the testing rate
and testing costs. This analysis assumes
all large, small, and very small highvolume,70 establishments conduct 1
test, every 1,000 carcasses, and all lowvolume establishments conduct 13 tests
annually.71 To calculate testing costs,
this analysis estimates the associated
labor expenses, laboratory fees, and
shipping costs. The mean cost to an
establishment to test a single generic E.
coli sample in house is $25.97.72 To
have the sample tested at a contracted
in Support of Public Health Risk-Based Inspection’
and was prepared by Catherine Viator, Sheri C.
Cates, Shawn A. Karns, Peter Siegel, Ariana Napier,
and Mary K. Muth. The contract number is No. AG–
3A94–B–13–0003. The order No. is AG–3A94–K–
13–0053.
64 Viator, C. et al. 2015. (b).
65 The report classifies establishments as either
large or small. Given this data limitation, this
analysis assumes very small and small
establishments have similar reassessment costs.
66 9 CFR 310.25 (2018).
67 Viator, C. et al. 2015. (a) P5–42. Question 3.1.
68 Very small high-volume establishments
slaughter more than 20,000 swine, or a combination
of swine and other livestock exceeding 6,000 cattle
and 20,000 total of all livestock.
69 Question 3.1 from the Meat Industry Survey in
Support of Public Health Risk-Based Inspection
Report asks ‘‘In addition to the generic E. coli
testing of carcasses and Listeria testing of ready-toeat (RTE) products required by FSIS regulation,
does this establishment conduct microbiological
testing? ’’; 28.6% of very small, 20% of small, and
0% of large establishments responded no, meaning
71.4% of very small, 80% of small and 100% of
large establishments conduct additional testing.
70 Note that the 11 large establishments
participating in SIP have been excluded from this
analysis because they have an alternative sampling
frequency.
71 9 CFR 310.25(a)(2)(iii)(B). The current
regulation (9 CFR 310.25(a)(2)(v)) defines very lowvolume swine slaughter establishments as
slaughtering 20,000 head annually or fewer. For the
purposes of this analysis, FSIS has labeled swine
establishments that annually slaughter more than
20,000 head per year as high volume.
72 Viator, C. et al. 2015. (b) Table 5–1.
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lab, the cost is $49.81.73 Based on
survey results, this analysis assumes 79
percent of large, 28 percent of small and
5 percent of very small establishments
test in house.74 For these 443
establishments, the combined reduction
in testing costs of no longer being
required to test for generic E. coli was
estimated to reduce annual testing costs
by approximately $2.69 million,
assuming a 3 percent discount rate over
10 years, Table 14.
TABLE 14—RECURRING COSTS (SAVINGS) FROM NO LONGER REQUIRING GENERIC E. coli TESTING
[M$]
Number of
establishments
HACCP size
Large ................................................................................................................................................................
Small High-Volume ..........................................................................................................................................
Small Low-Volume ...........................................................................................................................................
Very Small High-Volume .................................................................................................................................
Very Small Low-Volume ..................................................................................................................................
(Savings)
17
41
43
4
338
($2.04)
(0.40)
(0.02)
(0.01)
(0.21)
Recurring Cost .................................................................................................................................................................................
(2.69)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................................................
(2.69)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................................................
(2.69)
Totals
* Note, some of the totals may not equal the sum due to rounding.
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Process Control Sampling Rates
The final rule requires large, small,
and very small high-volume
establishments to take carcass samples
at pre-evisceration and post-chill (for
hot-boned products carcass samples
must be taken pre-evisceration and after
the final wash), which will increase the
number of samples taken from 1 sample
per 1,000 carcasses to 2 samples per
1,000 carcasses for large, small, and very
small high-volume establishments. The
final rule does not require low-volume
establishments to increase their
sampling rates. Under the final
regulations, large establishments’
annual process control sampling costs
were estimated to increase by roughly
$1.46 million, which is roughly $85,745
per establishment ($1.46 million/17), 75
Table 15. Small high-volume
establishments’ annual process control
sampling costs were estimated to
increase by roughly $0.30 million,
which is roughly $5,974 ($0.30 million/
51) per establishment, Table 15. Very
small high-volume establishments’
annual process control sampling costs
were estimated to increase by roughly
$8,890, which is roughly $1,482
($8,890/6) per establishment, Table 15.
Cost of Process Control Sample
Recordkeeping
This analysis takes into consideration
the increase in recordkeeping costs
associated with an increase in the
73 Viator,
C. et al. 2015. (b) Table 5–1.
C. et al. 2015. (b).
75 Values in text may differ because of rounding.
76 Values in text may differ because of rounding.
74 Viator,
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sampling rate from 1 to 2 samples per
1,000 head. According to PHIS data, the
average large non-SIP establishment
slaughters approximately 3.87 million
swine per year. As such, this analysis
estimates that a large non-SIP
establishment currently takes
approximately 3,869 samples annually
(3,869,276/1,000). The average small
high-volume swine establishment
slaughters 0.23 million swine per year
and requires approximately 229 samples
(228,784/1,000) annually. While the
average very small high-volume
establishment slaughters 51,925 swine
per year and requires approximately 52
samples (51,925/1,000) annually.
Assuming it takes 2.5 minutes to record
the results of each sample, the average
large establishment currently requires
9,673 minutes (2.5 × 3,869) per year; the
average small high-volume
establishment currently requires 573
minutes (2.5 × 229) per year; and the
average very small high-volume
establishment currently requires 130
minutes (2.5 × 52) per year. Requiring
establishments to increase their
sampling rates from 1 to 2 samples per
1,000 head will increase the average
large non-SIP establishment’s annual
number of samples to 7,738 samples
annually (3,869,276/1,000 × 2), which
will require approximately 19,346
minutes (2.5 × 7,738) 76 annually. The
same requirement will increase a small
high-volume establishment’s annual
77 BLS Occupational Employment Statistics,
Occupational Employment and Wages, May 2016.
19–1021 Food Scientist and Technologist. https://
www.bls.gov/news.release/archives/ocwage_
03312017.pdf Accessed on 12/04/18. Last Modified
3/31/2017.
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sampling to 458 (228,784/1,000 × 2),
which will require approximately 1,145
minutes (2.5 × 458) annually. Likewise,
a very small high-volume
establishment’s annual sampling will
increase to 104 (51,925/1,000 × 2),
which will require approximately 260
minutes (2.5 × 104) annually. As such,
the estimated additional time required
for recordkeeping is approximately
9,673 minutes (19,346¥9,673) for large
non-SIP establishments; 572 minutes
(1,145¥573) for small high-volume
establishments; and 130 minutes
(260¥130) for very small high-volume
establishments. Assuming a quality
control technician with a compensation
rate of $68.52 per hour 77 78 conducts
this work, the additional costs to the
average large non-SIP establishment is
approximately $11,046 (9,673/60 ×
$68.52). Similarly, the additional cost to
the average small high-volume and very
small high-volume establishment is
approximately $653 (572/60 × $68.52)
and $148 (130/60 × $68.52,
respectively). Scaling this up to all
impacted establishments, the total
increase in costs to all large non-SIP
establishments is approximately $0.19
million ($11,046 × 17); $0.03 million
($654 × 51) for small high-volume
establishments; and $888 ($148 × 6) for
very small high-volume establishments,
Table 15.
78 To be consistent with analyses done by the
Department of Health and Human Services, this
analysis accounts for benefits and overhead by
multiplying wages by a factor of 2.
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The combined annualized sampling
and recordkeeping cost to all large nonSIP, small, and very small high-volume
establishments is roughly $1.99 million,
applying a 3 percent discount rate over
10 years. Large establishments will
potentially incur the majority of this
cost, Table 15.
TABLE 15—COSTS CHANGES ASSOCIATED WITH INCREASE SAMPLING RATES
[M$]
Number of
establishments
Large non-SIP ..................................................................................
Small High-Volume ..........................................................................
Very Small High-Volume (Dollars) ...................................................
Costs
Sampling
17
51
6
Recordkeeping
$1.46
0.30
8,890
Combined *
$0.19
0.03
888
$1.65
0.34
9,778
Recurring Cost .................................................................................................................................................................................
1.99
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ................................................................................................
1.99
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ................................................................................................
1.99
Totals
* Note, some of the totals may not equal the sum due to rounding.
Summary of Process Control Sampling
Cost Changes
Overall, the changes in sampling
requirements under the final rule were
estimated to reduce industry wide
sampling costs by about $0.57 million
annualized over 10 years, applying a 3
percent discount rate, Table 16.
However, only the 443 establishments
that currently conduct multiple types of
microbiological tests will potentially
experience a reduction in cost. The
remaining establishments, roughly 158
small and very small establishments,
will potentially incur a portion of the
one-time costs associated with plan
reassessment, Table 16. Cost increases
associated with testing and
recordkeeping will be exclusively borne
by large, small, and very small highvolume establishments.
TABLE 16—SUMMARY OF CHANGES TO PROCESS CONTROL SAMPLING
[M$]
Cost
(savings)
Type of change
One-time
Recurring
$1.07
........................
........................
........................
........................
($2.69)
1.77
0.22
One-Time Cost ....................................................................................................................................................................................
1.07
Recurring Cost .....................................................................................................................................................................................
(0.70)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
(0.57)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
(0.55)
Plan Reassessment .................................................................................................................................................
Converting to Process Control Sampling ................................................................................................................
Testing Costs ...........................................................................................................................................................
Recordkeeping .........................................................................................................................................................
Totals *
* Note, some of the totals may not equal the sum due to rounding.
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Summary of Voluntary and Mandatory
Costs for Final Rule
The total annualized value of all costs
to industry, under the assumed five-year
adoption rate as shown in Table 6, is
roughly $17.83 million, assuming a 10year annualization and a 3 percent
discount rate, Table 17. Large
establishments that voluntarily switch
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to the NSIS incur the majority of costs.
For example, the recurring labor costs
associated with the NSIS is the single
largest recurring cost to industry and is
mostly incurred by large establishments.
It should be noted that the five HIMP
pilot study establishments have already
incurred these costs, suggesting for
those five establishments, the benefits of
the NSIS outweigh the costs. It also
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suggests that the benefits of adopting the
NSIS outweigh the costs for other
establishments as well. Training staff
accounts for the bulk of the costs
associated with written sanitary
dressing procedures. Sampling costs
will potentially decrease for those
establishments that currently conduct
microbiological tests in addition to
generic E. coli.
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TABLE 17—COMBINED COSTS TO INDUSTRY
[M$]
Total costs
Number of
establishments
Type of cost
Voluntary:
Establishment Labor .........................................................................................................
Ready to Cook ..................................................................................................................
Mandatory:
Written Sanitary Dressing Procedures .............................................................................
Process Control Sampling ................................................................................................
One-time
Recurring
35
35
$0.84
........................
$21.63
0.51
606
601
1.23
1.07
1.27
(0.70)
Number of Establishments ** ...............................................................................................................................................................
612
One Time Cost ....................................................................................................................................................................................
3.14
Recurring Cost .....................................................................................................................................................................................
22.72
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
17.83
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
17.23
Totals *
Totals Mandatory *
Number of Establishments ** ...............................................................................................................................................................
612
One-Time Cost ....................................................................................................................................................................................
2.30
Recurring Cost .....................................................................................................................................................................................
0.58
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
0.84
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
0.88
Totals Voluntary *
Number of Establishments ..................................................................................................................................................................
35
One-Time Cost ....................................................................................................................................................................................
0.84
Recurring Cost .....................................................................................................................................................................................
22.15
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
17.0
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
16.35
* Note, some of the totals may not equal the sum due to rounding.
** Note, 612 includes all swine slaughter establishments, including the 11 SIP establishments that were excluded from the process control
sampling costs and the 6 establishments that were excluded from the written sanitary dressing plans costs.
H. Potential Benefits of the Final Rule
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1. Potential Benefits Associated With
Public Health
Switching existing FSIS inspection
program personnel (IPP) activities
toward more offline verification
activities (e.g., sanitation performance
standards, sampling, fecal inspections,
and other inspection requirements) is
unlikely to result in a higher prevalence
of Salmonella on market hog carcasses
and is estimated to result in a lower
prevalence of Salmonella on market hog
carcasses, which in turn may lead to
fewer human illnesses. This conclusion
is supported by a two-part risk
assessment which compares typical
FSIS market swine inspection outcomes
with the outcomes observed in a small
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subset of establishments that
participated in the HIMP pilot study
(referred to in the risk assessment as
HIMP plants).
Stage 1 of the risk assessment consists
of a multiple regression analysis to
identify the relationships between
establishment characteristics (including
HIMP status) and carcass contamination
prevalence. FSIS presents two different
models for estimating the potential for
avoiding illnesses in the risk assessment
one using only empirical data and one
using additional simulated data, see
Tables 13 and 14 in the risk assessment
and accompanying text. The results of
the modeling with simulated data, had
less uncertainty around the estimated
change in illnesses—are not used in
support of the final rule. The modeling
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without simulated data is carried
through in this section. As a result, the
uncertainty around estimated illnesses
avoided is greater; however, the most
likely estimated illnesses avoided are
not affected. Stage 2 of the risk
assessment consists of multiple scenario
models in which combinations of
plausible changes to inspection
procedures are inserted into equations
created using the coefficients computed
in Stage 1. These scenarios produce
estimates of changes in carcass
contamination prevalence under the
inspection procedures of NSIS.
Changes in estimated numbers of
Salmonella illness are estimated based
on a proportional relationship between
carcass contamination prevalence and
illnesses that has been published in the
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peer-reviewed literature.79 80 This
relationship was also validated
internally in the risk assessment, with
an analysis of variance (ANOVA) test
indicating that carcasses slaughtered in
establishments with relatively low
prevalence of Salmonella did not show
significantly different contamination
load (measured by enumeration of
Salmonella colony-forming units per
gram) when compared with
establishments with relatively high
prevalence of Salmonella. In other
words, the proportion of contaminated
carcasses is more predictive of
Salmonella illnesses than the
contamination load of each
contaminated carcass; thus, if the
proportion of carcasses with no
detectable Salmonella contamination
increases with implementation of the
NSIS, illnesses caused by consumers’
exposure to these carcasses were
estimated to decrease proportionally.
As with any risk assessment, FSIS’s
risk assessment relies on a number of
assumptions. FSIS assumed that the
differences between the process of
slaughtering hogs and slaughtering
poultry do not alter the relationship
between the presence of Salmonella
contamination post-slaughter and
human illness.
FSIS also assumed, for the purpose of
this risk assessment, that the
relationship between Salmonella
contamination of hog carcasses and
downstream products such as pork parts
(e.g., pork chops) and ground pork
closely mirrors that of the established
relationship between Salmonella
contamination of poultry (e.g., chicken)
carcasses and downstream products
such as chicken parts and ground
chicken. While FSIS did not conduct
any specific analyses to examine this
assumption, the Agency has conducted
numerous peer-reviewed analyses of the
relationship between Salmonella
contamination frequency on chicken
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79 Williams M.S., Ebel, E.D., Vose, D. 2011.
Framework for Microbial Food-Safety Risk
Assessments Amenable to Bayesian Modeling. Risk
Analysis 31(4):548–565.
80 Ebel, E.E., et al. 2012. Simplified framework for
predicting changes in public health from
performance standards applied in slaughter
establishments. Food Control 28(2): pp. 250 257.
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carcasses and chicken parts.81 These
analyses indicate that the prevalence of
Salmonella contamination on
downstream products (e.g., parts) often
exceeds that for the prevalence of
Salmonella contamination in upstream
products (e.g., carcasses). The higher
prevalence is logical given that samples
of downstream products contain primals
from multiple carcasses, increasing the
likelihood of a single sample being
contaminated.
The market hog Salmonella illness
risk model estimates that the prevalence
of Salmonella detected in carcasses may
decline on average from an initial
prevalence of 0.9407% to a final
prevalence of 0.9066% if the 35
identified establishments adopt the new
inspection system. This decrease in
prevalence should correspond to an
average decrease in illnesses due to
market hog product consumption by an
average of 2,533 annual cases.82
More specifically, CDC applies 14
empirical, population-adjusted, and Pert
uncertainty distributions
multiplicatively modeled as Monte
Carlo distributions with repeated
sampling and Bayesian characteristics to
the data collected at their surveillance
sites. CDC states that the illness
estimates are robust but likely
underestimates due to extrapolation
from surveillance and outbreak data
with underreporting not captured in the
CDC uncertainty estimates based
ultimately on laboratory confirmed
cases. CDC’s modeling approach used to
estimate total uncertainty of illnesses is
designed to capture multiple sources of
uncertainty that were not explicitly
modeled, that is, the uncertainty in CDC
illness estimates captures components
of consumer behavior, cross
contamination and Salmonella
81 Ebel, E.D., Williams, M.S., Tameru, B. (2019)
Relatedness of Salmonella contamination frequency
on chicken carcasses and parts when processed in
the same establishment. Food Control 100: 198–203.
82 The relationship between carcass
contamination prevalence and human illnesses
modeled as in Williams et al., 2010, Estimating
changes in public health following implementation
of hazard analysis and critical control point in the
United States broiler slaughter industry, Foodborne
Pathogens and Disease, 9 and Ebel et al., 2012,
Simplified framework for predicting changes in
public health from performance standards applied
in slaughter establishments, Food Control, 28.
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52333
inactivation and growth between
production and consumption.83 The
uncertainty surrounding illness
estimates is the largest contributor to
overall uncertainty in the NSIS risk
model. The total uncertainty in the case
rate is estimated to be bounded at the
10th and 90th percentiles by a potential
increase of 1,719 and a potential
decrease of 6,685 cases, respectively.
The total case uncertainty distribution is
dependent on the uncertainty in the
change in Salmonella prevalence in
market hogs.
The prevalence estimates are modeled
with data variability and robust
uncertainty components taken from
sampling data and model parameter
estimates. Additional, unquantified
uncertainty includes the possibility that
differences between HIMP plants and
non-HIMP plants that adopt NSIS not
accounted for in the risk assessment
could affect Salmonella prevalence. A
number of potential differences,
however, are taken into account in the
risk assessment. The variability and
uncertainty in the market hog
proportion of illnesses is modeled from
FSIS market hog slaughter data and
Bayesian uncertainty. As demonstrated
in the 2010–2011 Market Hog Baseline
Study, the market hog slaughter process
resulted in 2,390,482 carcasses
produced per year and a weighted
Salmonella contamination prevalence
rate of 1.66%; the 10th percentile
estimate for this value is 2,218,169
carcasses and the 90th percentile
estimate is 2,561,973 carcasses. This
uncertainty in the carcass prevalence
rate in market hogs according to the
peer reviewed prevalence model
corresponds to the overall uncertainty
in consumer Salmonella cases of
illnesses from market hogs with an
average of 69,857 cases and 10th and
90th percentiles of 40,778 and 104,333
cases respectively, under traditional
inspection. With adoption of the new
inspection system, the average number
of cases is likely to decrease to 67,324.
83 CDC’s surveillance and outbreak attribution
data are available in Scallan, E., et al. 2011.
Foodborne Illness Acquired in the United States—
Major Pathogens. Emerging Infectious Diseases
17(1): 7–15.
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The market hog risk assessment
estimates that if the 35 establishments
expected to convert to the NSIS over 5
years do so, the number of human
illnesses attributed to products derived
from market hogs could reduce by an
average of 2,533 Salmonella illnesses.
The combined robust model estimate of
quantified uncertainty in the case rate
based on CDC Salmonella illness and
FSIS market hog contamination data is
estimated to be bounded at the 10th and
90th percentiles by an increase of 1,719
and a decrease of 6,685 cases,
respectively. It is worth noting,
however, that there is an approximately
80% likelihood of a decrease in
illnesses.84 The ERS estimates of the
annual per case cost of foodborne
illnesses for Salmonella range from
roughly $321 to $5,820, with a mean of
roughly $3,682.85 These estimates factor
in the costs of physician office,
emergency room, and outpatient clinic
visits, as well as hospitalizations,
productivity loss, and deaths. Assuming
approximately 2,533 averted cases of
Salmonella, potential savings range
from roughly $0.81 million to $14.74
million, with a midpoint of $9.33
million, Table 18. Health costs would
increase by roughly $6.33 million if
cases increased by 1,719, which
corresponds to the 10th percentile, and
each case cost $3,682, Table 18.
Alternatively, health costs would
decrease by roughly $24.62 million if
6,685 cases were averted, which
corresponds to the 90th percentile, and
each case cost $3,682, Table 18. Using
the midpoint estimate of $9.33 million
cost decrease and applying a five-year
adoption rate, the annualized value is
approximately $7.09 million, at a 3
percent discount rate, Table 18. These
estimated benefits may underestimate
total benefits because they do not
include pain and suffering costs. They
may also overestimate benefits and cost
savings given the uncertainty between
the number of illnesses and the number
of carcasses with detectable Salmonella.
TABLE 18—POTENTIAL BENEFITS FROM AVERTED CASES OF SALMONELLA
Cost per illness *
Change in
illnesses by
scenario
Percentile
Low
Mid
High
$321
$3,682
$5,820
Scenario Costs, $M
10th ..................................................................................................................
Mean ................................................................................................................
90th ..................................................................................................................
1,719
(2,533)
(6,685)
$0.55
(0.81)
(2.15)
$6.33
(9.33)
(24.62)
$10.01
(14.74)
(38.91)
Recurring Cost .....................................................................................................................................................................................
6.33
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
4.81
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
4.62
Comparison of Mean Recurring Costs (M$)
Low
Mid
Recurring Cost .....................................................................................................................................................................................
(9.33)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
(7.09)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
(6.81)
High
Recurring Cost .....................................................................................................................................................................................
(24.62)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
(18.71)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
($17.97)
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* Source: USDA ERS, 2014, Cost Estimates of foodborne illnesses. https://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446 Accessed on 9/9/2011. Last updated on 11/12/2014.
Note, some of the totals may not equal the sum due to rounding.
84 The primary conclusion for the purposes of this
regulatory change, however, is that the NSIS is
unlikely to result in a higher prevalence of
Salmonella on market hog carcasses and may result
in a lower prevalence of Salmonella on market hog
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carcasses, which in turn may lead to fewer human
illnesses. As such, public health benefits are
characterized as ‘‘potential’’ rather than ‘‘expected’’
benefits.
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85 USDA ERS, 2014, Cost Estimates of foodborne
illnesses. https://www.ers.usda.gov/data-products/
cost-estimates-of-foodborne-illnesses.aspx#48446
Accessed on 9/9/2011. Last Updated on 11/12/2014.
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2. Other Benefits Associated With
Modernizing Existing Regulations
The final rule will potentially reduce
the regulatory burden on establishments
by shifting from prescriptive to
performance-based regulation. Based on
the Evaluation of HACCP Inspection
Models Project (HIMP) for Market Hogs
Report, the five HIMP establishments’
average line speed was approximately
12.49 percent faster than comparable
establishments.86 This increase in line
speed is synonymous with an increase
in industrial efficiency. To quantify the
benefit associated with this efficiency
gain, this analysis used the North
American Meat Institutes’ (NAMI’s)
average pork packer margins for 2013–
2017, which was reported to be
$15.20 87 per head in NAMI’s 2017 Meat
and Poultry Facts.88 The pork packer
margin is the price the packer receives
less the cost of the hog and production
costs, making it an estimate for
accounting profits. However, economic
profit may be more precisely associated
with producer surplus. Economic profit
is equal to the establishment’s revenues
minus its implicit and explicit costs.
Implicit costs are costs establishments
do not spend money on, such as
opportunity costs, while explicit costs
are costs establishments spend money
on, such as labor or hogs. Accounting
profits can be larger than economic
profits because they exclude some
implicit costs. FSIS requested, but did
not receive, comment on refining this
estimate so as to distinguish between
accounting profit and economic profit.
By using accounting profits to
estimate producer surplus, this analysis
multiplied the change in quantity
produced by half the per head margin,
which is $7.60 ($15.20/2). This
approach assumes that marginal costs
increases as a function of quantity
produced and that the marginal cost
curve is linear, in which case the profit
margin reaches zero for the last unit
produced.
Assuming establishments increase
their production by 12.49 percent and
that this increased production has an
average packer margin of $7.60 per
head, an average large establishment’s
surplus could increase by
approximately $3.78 million, while an
average small high-volume
establishment’s surplus could increase
by $0.34 million, all else being equal.
Combined, such an increase in
efficiency at all 35 establishments will
increase producer surplus by roughly
$87.64 million 89 (22 × $3.78 million +
13 × $0.34 million), which has an
annualized benefit of roughly $66.93
million, assuming a 3 percent discount
rate over 10 years, Table 19. This
estimate takes into consideration the
assumed five-year adoption rate.
However, this increase in surplus may
be an overestimate given that an
increase in line speeds may change
market hog prices, establishment
production costs, retail prices, and
export volumes. Additionally, this
analysis does not account for a change
in consumer surplus, which will be
conditional on how an increase in line
speed affects retail prices. The Agency
sought, but did not receive, comment on
the extent to which such an increase in
line speeds will affect market hog
prices, establishment hours of
production, consumer prices, and
export volumes.
TABLE 19—INDUSTRIAL EFFICIENCY, (BENEFITS)
[M$]
Change in producer
surplus
Number of
establishments
Type of establishment
Per establishment
Large ..............................................................................................................................
Small ..............................................................................................................................
Combined * .....................................................................................................................
22
13
35
Combined
($3.78)
(0.34)
..................................
($83.26)
(4.38)
(87.64)
Recurring Cost .....................................................................................................................................................................................
(87.64)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
(66.93)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
(64.32)
Totals *
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* Note, some of the totals may not equal the sum due to rounding.
86 USDA FSIS Evaluations—HACCP Inspection
Models Project (HIMP) for Market Hogs https://
www.fsis.usda.gov/wps/portal/fsis/topics/
regulatory-compliance/haccp/haccp-basedinspection-models-project/evaluations+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
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87 Note that the increase in benefits as compared
to the proposed rule is due to updating the margin
used from NAMI’s 2015 Meat and Poultry Facts to
NAMI’s 2017 Meat and Poultry Facts. The proposed
rule used a five-year average of $4.10 (2010–2014)
per head, with a low of a $2.85 (2012) per head loss
to a $11.49 (2010) per head gain. While the Final
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Rule uses a five-year average of $15.20 (2013–2017)
per head, with a low of a $4.50 (2013) per head gain
to a $25.26 (2017) per head gain.
88 Nalivka, J.S., The 2017 Meat and Poultry Facts,
NAMI August 2018.
89 Note, some of the totals may not equal the sum
due to rounding.
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The five HIMP establishments have
demonstrated that establishments
operating under the NSIS are able to
increase their compliance with
sanitation SOPs and HACCP
regulations, lower their level of nonfood safety defects, achieve equivalent
or better Salmonella verification testing
rates, and lower the level of violative
chemical residues.90 The five
establishments that participated in the
HIMP pilot study account for 15 percent
of total swine production.
Additionally, the NSIS increases the
Agency’s ability to conduct more
process and product verification and to
increase monitoring of humane
handling procedures, which is expected
to improve animal welfare. FSIS
inspectors devoted approximately 5.33
hours per shift to verifying humane
handling activities for the Humane
Activity Tracking System, HATS,
categories in HIMP market hog
establishments compared to
approximately 4.29 hours per shift in
the 21 non-HIMP market hog
comparison establishments.91 Under the
NSIS, establishments sort, remove, and
identify swine unfit for slaughter before
FSIS ante-mortem inspection. More
FSIS resources can be devoted to offline
inspection activities because initial
sorting and tagging functions are
performed by establishment personnel.
This change will provide Agency
personnel with more time to conduct
offline inspection activities.
I. Potential Budgetary Impacts on the
Agency
Under the final rule, FSIS will shift
Agency resources from online to offline
activities. This analysis estimates how
such a shift will reduce labor expenses
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90 USDA FSIS Evaluations—HACCP Inspection
Models Project (HIMP) for Market Hogs https://
www.fsis.usda.gov/wps/portal/fsis/topics/
regulatory-compliance/haccp/haccp-basedinspection-models-project/evaluations+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
91 USDA FSIS Evaluations—HACCP Inspection
Models Project (HIMP) for Market Hogs https://
www.fsis.usda.gov/wps/portal/fsis/topics/
regulatory-compliance/haccp/haccp-basedinspection-models-project/evaluations+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
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by approximately $6.67 million
annually, Table 20. However, Agency
personnel at NSIS establishments will
require additional training, the
annualized cost of which is estimated to
be approximately $0.30 million. Both
annualized estimates apply a 3 percent
discount rate over 10 years and takes
into consideration the assumed five-year
adoption period. The Agency will also
update PHIS to allow establishments to
enter information on animals removed
from the slaughter process. This
modernization process will likely cost
FSIS approximately $300,000 but will
be paid for using existing Agency funds.
Details of these costs are provided
below.
1. Agency Staffing
The following section discusses the
impact on the Agency’s budget due to
reassignment of the inspection staff. As
discussed in section F of this document,
under traditional inspection, a single
slaughter line at a large establishment
requires up to 11 FTEs, while a small
market hog establishment requires up to
2 FTEs. Under NSIS, a single slaughter
line at a large establishment will
potentially require 6 FTEs, while a
small market hog establishment will
potentially to require 3 FTEs. Under
NSIS, large establishments with 2
slaughter lines will potentially require
10 FTEs,92 while a small market hog
establishment with 2 slaughter lines
will potentially require 4 FTEs.
This analysis considers likely staffing
changes at the 22 large and 13 small
establishments which will potentially
convert to NSIS over a course of five
years. Combined, these establishments
operate 46 shifts and 55 lines.93 This
analysis uses PHIS data provided by the
Office of Field Operations (OFO) to
calculate the number of FTEs assigned
to each slaughter line. The FSIS Office
of the Chief Financial Officer (OCFO)
provided the wage and benefit data for
92 The difference in staffing between large
establishments with 1 and 2 lines is because the
Agency does not anticipate duplicating offline FTEs
per line.
93 The 22 large establishments operate 41
slaughter lines during 32 shifts, while the 13 small
establishments operate 14 lines during 14 shifts,
source PHIS.
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each of these positions. This data was
used to model the staffing changes in
terms of both full- time positions and
monetary value. Based on this data, to
conduct traditional inspection, the
Agency requires a combined 365 (334 at
large and 31 at small establishments)
FTE food or consumer safety inspectors
at an annual cost of approximately
$30.43 million, Table 20. If all 22 large
non-HIMP and 13 small high-volume
market hog only establishments convert
to the NSIS, the Agency will require 218
(187 at large and 31 at small
establishments) FTE food or consumer
safety inspectors. This number was
arrived at by assuming that under NSIS
each of the 41 lines at the large
establishments will have up to 3 FTEs
assigned to them and each of the 32
shifts at the large establishments will
have up 2 FTEs assigned to them ((41
lines × 3 FTEs) + (32 shifts × 2 FTEs)
= 187 FTEs). Likewise, under NSIS, the
13 small establishments will each
require between 2–3 FTEs, based on
configuration, for a total of 31 FTEs.
These staffing levels are based on FSIS’s
experience at HIMP establishments. The
combined labor costs for NSIS is
approximately $21.70 million, Table 20.
This cost estimate includes estimated
grade increases associated with
converting to the NSIS. As is shown in
Table 20, if all 22 large establishments
convert to NSIS, this analysis estimates
a net decrease of 147 (334¥187) FTEs
required for slaughter line inspection.
The NSIS inspection program at these
large establishments has a remuneration
value of just over $18.58 million. A
similar analysis of the 13 small highvolume establishments reveals no net
change in the number of FTEs.
However, because the NSIS requires all
inspectors to be CSIs, many of the FTEs
will likely be promoted from a FI to a
CSI. Overall, if all 35 establishments
converted to NSIS, the Agency will
require 147 fewer FTEs for swine
slaughter inspection, with potential
annual decrease in costs of roughly
$8.73 million, which is equal to roughly
$6.67 million a year, assuming a 3
percent discount rate and the assumed
five-year adoption period, Table 20.
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52337
TABLE 20—POTENTIAL CHANGES IN AGENCY STAFFING
[M$]
Traditional
Type
Number
positions
NSIS
Labor
costs
Number
positions
Increases (reductions)
Labor
costs
Number
positions
Labor
costs
Large ........................................................
Small ........................................................
334
31
$27.56
$2.87
187
31
$18.58
$3.12
(147)
0
($8.98)
0.25
Total ..................................................
365
$30.43
218
$21.70
(147)
(8.73)
Recurring Cost .....................................................................................................................................................................................
(8.73)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
(6.67)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
(6.42)
Totals
Since 2008, the Agency has annually
lost, through attrition, 270 food
inspectors on average. See Table 21 for
details. The Agency plans to utilize all
personnel made available as a result of
conversion to NSIS to fill these vacant
positions.
TABLE 21—ANNUAL TURNOVER OF
FOOD INSPECTORS
Fiscal year
2008
2009
2010
2011
2012
2013
2014
2015
Number of
positions
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
307
264
231
268
266
246
273
305
small establishments, Table 22. The
associated one-time cost of such training
includes labor and travel expenses
associated with the employees receiving
Number
of
Fiscal year
positions
training, as well as temporary
replacement labor costs required to
Average ................................
270 fulfill the work that would have been
completed by the employees receiving
Source: OFO.
training. Based on the HIMP pilot study,
2. Agency Training
this analysis assumes NSIS methods
training will take 3 days and
a. Three Day NSIS Methods Course
replacement labor will be equivalent to
If all 22 large and 13 small market hog GS–13 step 5. Under these assumptions,
establishments convert to NSIS over the the total one-time cost of NSIS training
course of five years, as set forth in Table is approximately $0.64 million ($0.56
6, the Agency estimated training 266
million for all large establishments and
personnel (218 CSIs and 48 PHVs), with $0.08 million for all small
pay grades ranging from GS–8 to GS–13, establishments), Table 22. This one-time
on NSIS methods. The majority of these cost equals approximately $0.07 million
personnel, 228, are associated with 22
if it were annualized over 10 years
large establishments, while the
under a 3 percent discount rate, Table
remaining 38 are associated with 13
22.
TABLE 21—ANNUAL TURNOVER OF
FOOD INSPECTORS—Continued
TABLE 22—THREE DAY NSIS TRAINING COURSE
[M$]
Cost of trainee
Number of
inspectors
requiring
training
Type of establishment
Large ....................................................................................
Small ....................................................................................
Replacement labor
Costs of
wages and
benefits for
trainees
228
38
Number of
replacement
inspectors
required
$0.21
0.03
228
38
Costs of
wages and
benefits for
replacements
Combined
costs
$0.34
0.06
$0.56
0.08
One-Time Cost ....................................................................................................................................................................................
0.64
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
0.07
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
0.07
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Totals *
* Note, some of the totals may not equal the sum due to rounding.
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b. Fill an Increase Need for Consumer
Safety Inspectors
Under the final rule, slaughter line
inspectors at a NSIS establishment will
work both on and off the slaughter line.
As such, every inspection position will
fall under the CSI position
classification. To fill the increase in
demand for CSIs, the Agency plans to
train existing FIs. Training includes a
four-week meat inspector course titled
Inspection Methods (IM) and a one-day
computer familiarization course. If all
22 large establishments convert to NSIS,
the Agency will need an additional 82
CSIs. Likewise, if all 13 small market
hog establishments convert, the Agency
will need an additional 16 CSIs.
Converting a FI into a CSI may result in
a grade increase, the cost of which has
been included in the Agency Staffing
section above. The combined one-time
cost for converting FIs into CSIs is
roughly $2.16 million, Table 23. Nearly
half of this cost stems from the need for
replacement labor. Again, under the
projected five-year adoption rate, as set
forth in Table 6, and annualized over 10
years under a 3 percent discount rate,
the cost for converting FIs to CSIs is
approximately $0.23 million, Table 23.
TABLE 23—COST OF CONVERTING A FOOD INSPECTOR INTO A CONSUMER SAFETY INSPECTOR
[M$]
Labor
Travel,
M&IE, and
lodging
Training component
Trainee
Four Week IM Course .....................................................................................
One Day Computer Training ............................................................................
Replacement
$0.52
0.03
$0.98
0.05
Combined
costs
$0.59
........................
$2.09
0.07
One-Time Cost ....................................................................................................................................................................................
2.16
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
0.23
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
0.25
Totals *
* Note, some of the totals may not equal the sum due to rounding.
Combined Estimated Budgetary Impacts
The Agency’s budget will potentially
be impacted both by changes to
personnel and training requirements.
First, on average, there will be fewer
Agency inspection personnel per
slaughter line operating under NSIS. If
all 22 large and 13 small establishments
convert to NSIS over the course of five
years, the Agency will require
approximately 147 fewer FTEs to
inspect the 55 94 slaughter lines
operating at these establishments. The
annual remuneration value of these 147
positions is roughly $8.73 million, Table
24. Second, the Agency will need to
train approximately 266 personnel on
NSIS methods at a one-time cost of
approximately $0.64 million, Table 24.
Third, the Agency plans to meet the
increase in demand for CSIs by
converting existing FIs into CSIs. The
one-time cost of doing so is
approximately $2.16 million, Table 24.
The annualized value of the combined
changes to the Agency’s budget is a net
reduction of roughly $6.38 million, over
10 years assuming a 3 percent discount
rate, Table 24.
TABLE 24—COMBINED CHANGES TO FSIS’S BUDGET
[M$]
Total costs
One-time
Recurring
........................
$0.64
2.16
($8.73)
........................
........................
One-Time Cost ....................................................................................................................................................................................
2.80
Recurring Cost .....................................................................................................................................................................................
(8.73)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ....................................................................................................
(6.38)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ....................................................................................................
(6.09)
Changes to Agency Staffing ....................................................................................................................................
Three Day NSIS Training ........................................................................................................................................
Converting Food Inspectors into Consumer Safety Inspectors ..............................................................................
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Totals
J. Net Benefits
Assuming all high-volume large and
small exclusively market hog
establishments convert to NSIS (5
94 Source:
HIMP, 22 large, and 13 small highvolume), the rule is anticipated to have
a net benefit of approximately $62.56
million a year, annualized over 10 years
assuming a 3 percent discount rate,
Table 25. The majority of the costs will
be incurred by the 35 non-HIMP
establishments that will potentially
voluntarily switch to the NSIS in the
form of increased labor needs.
PHIS.
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52339
TABLE 25—NET COSTS AND (BENEFITS)
[M$]
Number of
establishments
Costs to Industry ......................................................................................................................
Voluntary * ................................................................................................................................
Mandatory ................................................................................................................................
One-time
Recurring
$3.14
0.84
2.30
** 40
612
$22.72
22.15
0.58
Health Benefits *** ....................................................................................................................................................
(9.33)
Industrial Efficiency ..................................................................................................................................................
(87.64)
Impacts to Agency’s Budget ....................................................................................................................................
2.80
(8.73)
Totals
One-Time Cost ........................................................................................................................................................
$5.94
Recurring Cost .........................................................................................................................................................
(82.98)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ........................................................................
(62.56)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ........................................................................
(60.00)
* Further explanation and details on the NSIS adoption rate are provided in section G. Potential Cost of the Final Rule, Table 6: NSIS Adoption
Rate and section J. Net Benefits, Table 26: Quantified Cost and (Benefits) of Various Adoption Rates
** Note, this includes 5 HIMP establishments, which were not estimated to incur any cost or benefits associated with the NSIS
*** Further explanation and details on the range of health benefits have been provided in section H. Potential Benefits of the Final Rule, Table
18: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from a $6.33 million decrease to a $24.62 million increase in health benefits, with a mean increase in benefits of $9.33 million, assuming a cost per illness of $3,682.
**** Note, some of the totals may not equal the sum due to rounding.
Given the lack of data with which to
make cost-benefit comparisons across
the industry, Table 26 provides a range
of possible adoption scenarios and their
corresponding costs and benefits. Under
scenario A, only the 5 HIMP
establishments adopt the NSIS. Because
these 5 establishments are already
operating under NSIS practices, there
will not be any additional voluntary
costs or benefits associated with these 5
establishments adopting the NSIS.
However, 606 establishments will incur
costs associated with the final rule’s
mandatory components. As such,
scenario A has a net cost. Scenario B
assesses the net cost and benefits of just
6 establishments adopting the NSIS (5
HIMP and 1 large). This scenario reveals
that the rule is net beneficial if just 1
large establishment adopts the NSIS in
addition to the 5 HIMP establishments.
Scenarios C, D, and E measure the net
costs and benefits of 50, 75, and 100
percent of the 35 non-HIMP
establishments converting to the NSIS,
respectively. Each of these scenarios are
net beneficial.
TABLE 26—QUANTIFIED COST AND (BENEFITS) OF VARIOUS ADOPTION RATES
[M$] ∧
Number to
adopt *
A
B
C
D
E
.................................
.................................
.................................
.................................
.................................
5
6
23
32
40
Costs
(Benefits)
Net
Mandatory @
$0.84
0.84
0.84
0.84
0.84
NSIS
Health
$0.0
0.86
8.34
13.08
17.0
$0.0
(0.27)
(3.59)
(5.52)
(7.09)
Line speeds
Agency budget
$0.0
(3.78)
(33.34)
(51.51)
(66.93)
$0.0
(0.38)
(3.14)
(4.88)
(6.38)
$0.84
(2.73)
(30.90)
(47.99)
(62.56)
* These numbers include the 5 HIMP establishments. However, because these establishments are already conducting NSIS practices, they did
not contribute to quantified NSIS costs, health benefits, or the impacts to the Agency’s budget.
@These costs are incurred by all 612 swine establishments.
∧ Annualized Assuming a 3% Discount Rate Over 10 Years
* Note, some of the totals may not equal the sum due to rounding.
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K. Alternatives
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Table 27: Alternative Policy Options
Benefits
Costs
1. In comparison
to the baseline,
potential $0.57M
in Process Control
Sampling cost
B. Mandatory
Portion of the
Final Rule Only
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1. Potentially
more than $7.09M
in averted
illnesses.
BILLING CODE 3410–DM–C
A—Taking No Action (Baseline)
FSIS considered maintaining the
current inspection system for all 612
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1. In comparison to
the baseline,
potential $1.41M in
Other Industry
Costs.
1. Potential $25.9M
Increase in Industry
Labor
swine slaughter establishments. The
Agency rejected this alternative because
it would forgo the benefits provided by
the NSIS. These benefits include the
establishment’s ability to innovate and
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Net
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Costs of
$0.84M
Benefits of
$47.59M
develop process controls which increase
foodborne hazard detection and more
efficiently use all their resources.
Taking no action would also forgo
potential industrial efficiency increases.
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Further, no action would result in the
Agency continuing to dedicate resources
to food quality issues, at the expense of
increasing offline activities benefitting
food safety. Last, taking no action would
also forgo potential health benefits
identified under the final rule.
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B—The Mandatory Portion of the Final
Rule
FSIS considered limiting the final rule
to only include new requirements that
affect all swine slaughter
establishments. Under such a scenario,
quantified benefits are limited to an
estimated $0.57 million reduction in
process control sampling costs. This
cost reduction will potentially be off-set
by a $1.41 million increase in other
industry costs associated with requiring
written sanitary dressing plans. In
comparison to the baseline, this
scenario has a net cost of roughly $0.84
million. Additionally, under such a
scenario, the Agency’s inspection staff
would not be reassigned, and the
Agency would continue to require the
same number of inspectors. As such, the
Agency’s labor costs would not decrease
by the estimated $6.67 million.
However, because FIs would not be
converted into CSIs nor will inspectors
require additional training, the Agency
would not incur the corresponding
$0.30 million in training costs ($0.07 for
NSIS training plus $0.23 in CSI
training). As mentioned earlier,
simultaneously increasing unscheduled
and scheduled inspection procedures
and decreasing scheduled but not
performed procedures accrues most of
the public health benefits. The
unscheduled and scheduled tasks are
currently not performed as a result of
lack of offline personnel. In comparison
to the final rule, this alternative would
eliminate most of the public health
benefits associated with the rule, which
are estimated at $7.09 million annually.
Additionally, line speed restrictions
would remain in place, leading to an
estimated loss of over $36.14 million in
industrial efficiency gains. FSIS has
rejected this alternative in light of its
estimated net cost as compared to the
baseline as well as the decrease in net
benefits as compared to the final rule.
C—The Final Rule
Applying a 3 percent discount rate
over 10 years the costs associated with
the final rule includes $16.61 million in
additional industry labor costs, $1.80
million in other industry costs
including costs associated with meeting
ready to cook standards and written
sanitary dressing plans, as well as $0.30
million in Agency training costs. The
quantified health benefits of the final
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rule are limited to reductions in
Salmonella illnesses and have an
estimated value of $7.09 million,
assuming a 3 percent discount rate.
Allowing establishments to set line
speeds so long as they maintain process
control will potentially increase their
efficiency by $66.93 million, assuming a
3 percent discount rate. The final rule
could potentially reduce industry costs
associated with process control
sampling by roughly $0.57 million,
assuming a 3 percent discount rate.
Additionally, the final rule could
potentially reduce the Agency’s labor
costs by roughly $6.67 million,
assuming a 3 percent discount rate. In
comparison to the baseline, the final
rule has an estimated net benefit of
$62.56 million, assuming a 3 percent
discount rate over 10 years, and as such,
the Agency recommends the final rule.
D—Requiring All Federally Inspected
Establishments Adopt the New Swine
Inspection System
FSIS considered requiring all
federally inspected swine slaughter
establishments to convert to NSIS. This
would expand NSIS from the 5 large
HIMP, 22 large and 13 small highvolume non-HIMP establishments
expected to convert under the final rule
to include 572 additional
establishments. This expansion would
include low-volume establishments that
slaughter all types of swine as well as
other establishments that slaughter a
mix of species.
In comparison to the baseline, the
benefits of this alternative potentially
include more than $7.09 million in
averted illnesses, a $66.93 million
increase in industrial efficiency, $0.57
million in industrial savings associated
with process control sampling
requirements, assuming a 3 percent
discount rate over 10 years. While
compared to the baseline, this
alternative reduces Agency labor costs
by $2.72 million, assuming a 3 percent
discount rate over 10 years. However,
this alternative’s Agency labor costs
savings are less than the final rule’s
Agency labor costs savings because this
alternative would result in additional
promotions and training in small and
very small establishments. The
production at these 572 additional
establishments represents less than 8
percent of total production and, as such,
is not expected to return substantial
reductions in contamination prevalence
or illnesses and falls outside of the
current risk assessment. In particular,
the uncertainty around measurement
and model parameters that is already
included in the health benefit
calculations for the final rule likely
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52341
produce wide enough estimates that the
impact of adopting the NSIS in all
establishments would have an effect
within the uncertainty bounds. The
increase in industrial efficiency remains
similar to that of the final rule because
these additional establishments are
generally less automated and maintain
slower line speeds to address higher
rates of quality defects associated with
non-market hogs.
In comparison to the baseline, the
potential costs associated with this
alternative include a $25.90 million
increase in industrial labor, a $3.14
million increase in other industry costs,
which include costs associated with
RTC standards and written sanitary
dressing plans, as well as roughly $0.68
million in Agency training costs. In
comparison to the final rule, the
additional increases in costs to industry
are substantially higher and
predominately fall on small and very
small business. While this alternative
has a net benefit of $47.59 million,
assuming a 3 percent discount rate over
10 years, the Agency rejects it because
its net benefit is less than the final rule.
IV. Regulatory Flexibility Act
Assessment
The FSIS Administrator has made a
determination that this final rule will
not have a significant economic impact
on a substantial number of small entities
in the United States, as defined by the
Regulatory Flexibility Act (5 U.S.C. 601
et seq.). FSIS used an establishment’s
HACCP processing size, which applies
to an individual establishment, as a
proxy for business size. HACCP
processing sizes are the following: large
establishments have 500 or more
employees; small establishments have
between 10 and 499 employees; very
small establishments have fewer than 10
employees or annual sales of less than
$2.5 million. Section III provides
additional details on costs incurred by
small businesses.
The final rule’s mandatory
requirements will affect approximately
584 small entities—105 small and 479
very small. First, the mandatory
requirements include that all small and
very small establishments create written
sanitary dressing plans with cost
components of development of the plan,
training of employees, and
recordkeeping, at an annualized cost of
$1,869 per establishment, applying a 3
percent discount rate over 10 years.
Second, the mandatory changes to
process control sampling requirements
could potentially decrease small
establishments’ sampling costs by
roughly $984 per establishment
annually, applying a 3 percent discount
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rate over 10 years. In addition to this
sampling cost reduction, the Agency
will allow small and very small lowvolume establishments to modify their
sampling plans to collect samples less
frequently once they have collected 13
consecutive weekly samples and can
demonstrate that they are not exceeding
their upper control limit and that they
are effectively maintaining process
control. FSIS is also allowing
establishments to develop sampling
plans that are more tailored to their
specific operation, and thus more
effective in monitoring their specific
process control as compared to the
current generic E. coli criteria.
Therefore, the final rule’s mandatory
requirements could potentially increase
small establishments’ costs by roughly
$885 ($1,869¥$984 = $885) per
establishment annually, an amount that
will potentially have little effect on
small entities. To put this in
perspective, the average small and very
small establishment slaughters over
21,000 swine annually. Using the
American Meat Institute’s average pork
packer dollars per head margins for
2013–2017, the average small and very
small establishment’s marginal revenue
is $332 thousand (21,858 (heads
slaughtered) × $15.20 (average margin
per head)). The final rule also provides
small and very small establishments
with additional time to comply with the
new requirements in 9 CFR 310.18(c)
and (d). Additionally, the optional NSIS
portion of the rule could potentially
provide an overall cost savings for the
13 small high-volume establishments of
roughly $288,731 per establishment that
adopts the NSIS. This estimate takes
into consideration the increase in labor
cost ($42,025 per establishment), cost
associated with meeting RTC standards
($6,300 per establishments) and cost
savings from increased industrial
efficiency ($337,056 per establishment).
See section III for additional details.
jbell on DSK3GLQ082PROD with RULES4
V. Executive Order 13771
Consistent with E.O. 13771 (82 FR
9339, February 3, 2017), FSIS estimates
that this final rule will yield cost
savings. Assuming a 7 percent discount
rate, a perpetual time horizon, and a
starting year of 2019, the final rule is
estimated to yield approximately $51.91
million (2016$) in annual cost savings,
not including potential health benefits.
Therefore, this rule is an E.O. 13771
deregulatory action.
VI. Congressional Review Act
Pursuant to the Congressional Review
Act (5 U.S.C. 801 et seq.), the Office of
Information and Regulatory Affairs
VerDate Sep<11>2014
19:06 Sep 30, 2019
Jkt 250001
designated this rule as not a ‘‘major
rule,’’ as defined by 5 U.S.C. 804(2).
How To File a Complaint of
Discrimination
VII. E-Government Act
To file a complaint of discrimination,
complete the USDA Program
Discrimination Complaint Form, which
may be accessed on-line 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: program.intake@usda.gov.
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).
FSIS and USDA are committed to
achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et
seq.) by, among other things, promoting
the use of the internet and other
information technologies and providing
increased opportunities for citizen
access to Government information and
services, and for other purposes.
VIII. Executive Order 12988, Civil
Justice Reform
This rule has been reviewed under
E.O. 12988, Civil Justice Reform. Under
this rule: (1) All State and local laws
and regulations that are inconsistent
with this rule will be preempted; (2) no
retroactive effect will be given to this
rule; and (3) no administrative
proceedings will be required before
parties may file suit in court challenging
this rule.
IX. Executive Order 13175
This rule has been reviewed in
accordance with the requirements of
E.O. 13175, Consultation and
Coordination with Indian Tribal
Governments. E.O. 13175 requires
Federal agencies to consult and
coordinate with Indian tribes on a
government-to-government basis on
policies that have tribal implications,
including regulations, legislative
comments or proposed legislation, and
other policy statements or actions that
have substantial direct effects on one or
more Indian tribes, on the relationship
between the Federal Government and
Indian tribes, or on the distribution of
power and responsibilities between the
Federal Government and Indian tribes.
The USDA’s Office of Tribal Relations
(OTR) has assessed the impact of this
rule on Indian tribes and determined
that this rule has minimal tribal
implications. If an Indian tribe requests
consultation, FSIS will work with the
OTR to ensure meaningful consultation
is provided.
X. USDA Nondiscrimination Statement
No agency, officer, or employee of the
USDA must, 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.
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XI. Environmental Impact
Each USDA agency is required to
comply with 7 CFR part 1b of the
Departmental regulations, which
supplements the National
Environmental Policy Act regulations
published by the Council on
Environmental Quality. Under these
regulations, actions of certain USDA
agencies and agency units are
categorically excluded from the
preparation of an EA or an EIS unless
the agency head determines that an
action may have a significant
environmental effect (7 CFR 1b.4 (b)).
FSIS is among the agencies categorically
excluded from the preparation of an EA
or EIS (7 CFR 1b.4 (b)(6)).
Establishments that operate under
NSIS will be able to slaughter and
process swine more efficiently than is
possible under current regulations,
leading to a reduction in production
costs. FSIS expects that consumer
demand for pork products will
determine the number of swine
slaughtered rather than production
costs. Because of the efficiencies in the
NSIS, the price of pork products may
decrease. The predicted price reduction
could lead to a slight increase in
demand for pork products. With the
slight increase in pork product sales,
some establishments may choose to
increase the number of swine
slaughtered, which could result in an
increase in the number of condemned
carcasses and parts that must be
disposed of. However, because the
anticipated change in price and sales is
very small, especially in comparison to
changes in price and sales in response
to other market forces, the Agency has
determined that the change in the
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number of swine slaughtered, as well as
the number of condemned carcasses and
parts to be disposed of, will be very
small and thus will not have a
significant individual or cumulative
effect on the human environment.
Therefore, this regulatory action is
appropriately subject to the categorical
exclusion from the preparation of an EA
or EIS provided under 7 CFR 1b.4(b)(6)
of the USDA regulations.
XII. Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995
(44 U.S.C. 3501 et seq.), the information
collection and recordkeeping
requirements included in this final rule
have been submitted by the Agency to
OMB for approval which has not yet
been received. FSIS will collect no
information associated with this rule
until the information collection is
approved by OMB.
Title: Swine Slaughter Inspection.
Type of Collection: New.
Abstract: FSIS updated the proposed
rule’s information collection assessment
to reflect the changes made in the final
rule in response to public comments
and to better align it with the final cost
estimates in section III. FSIS is also
requiring a new information collection
burden but has reduced the total annual
burden estimate by 52,729.04 hours.
The changes to the final burden
estimates incorporate the following
factors:
• FSIS is requiring a new information
collection burden; specifically, the
Agency is requiring market hog
slaughter establishments operating
under NSIS to maintain records to
document the total number of animals
and carcasses sorted and removed per
day and the reasons for their removal.
• The proposed mandatory preoperational environmental sampling
was removed from the final rule.
Therefore, these time estimates were
removed from the final burden
estimates.
• Establishments operating under SIP
conduct process control sampling at an
alternative frequency. Therefore, these
11 establishments have been removed
from the final burden estimates.
• The final burden estimates only
include the time to record the sample
results for the new process control
sampling requirements.
• The final burden estimates were
updated so that the establishment and
time estimates align with the final cost
analysis in section III.
New Information Collection in This
Final Rule
FSIS is requiring a new regulation
that will create a new information
collection burden, in that it will require
market hog slaughter establishments
operating under NSIS to maintain
Estimated
number of
respondents
Respondents
Large establishments ..........
Small high-volume establishments.
jbell on DSK3GLQ082PROD with RULES4
Total Recordkeeping
Burden for sorting
and removing.
records to document the total number of
animals and carcasses sorted and
removed per day and the reasons for
their removal. FSIS has created a form
to collect disposition data from
establishments. Establishments may
provide the same information as
requested on the form electronically if it
is submitted in a format approved by
FSIS. FSIS estimates this new
requirement will take establishments
operating under NSIS, 5 minutes per
shift regardless of whether
establishments complete the form or
submit the information electronically.
This is a new recordkeeping
requirement that FSIS has submitted to
OMB for approval.
Estimated Annual Recordkeeping
Burden for Maintaining Records to
Document the Total Number of Animals
and Carcasses Sorted and Removed per
Day and the Reasons for Their Removal
Respondents: Official market hog
slaughter establishments that operate
under NSIS.
Estimated maximum number of
respondents: 40.
Estimated Average Annual Number of
Responses per Respondent: Large
establishments 352; small high-volume
establishments 290.
Estimated Maximum Total Potential
Annual Responses: 13,282.
Estimated Total Annual
Recordkeeping Burden: 1,107 hours.
Total annual
responses
Time per
response
in minutes
Total annual
burden hours
Animals and carcasses
sorted and removed and
their reasons.
Animals and carcasses
sorted and removed and
their reasons.
27
352
9,504
5
792
13
290
3,770
5
314
.............................................
40
332
13,274
5
1,106
Under this final rule, establishments
also will have to maintain written
procedures to ensure that animals and
carcasses that have been sorted and
removed for disposal do not enter the
human food supply and are properly
disposed of under 9 CFR part 314. The
requirement that swine slaughter
establishments have written procedures
in their HACCP systems is already
covered under an approved information
collection system, Pathogen Reduction/
Hazard Analysis and Critical Control
Point Systems (OMB control number
VerDate Sep<11>2014
Average
annual number
of responses
per
respondent
52343
19:06 Sep 30, 2019
Jkt 250001
0583–0103). Therefore, this requirement
of this final rule will create no new
burden on establishments.
Copies of this information collection
assessment can be obtained from Gina
Kouba, Office of Policy and Program
Development, Food Safety and
Inspection Service, USDA, 1400
Independence Avenue SW, Room 6065,
South Building, Washington, DC 20250;
(202)720–5627.
Comments are invited on: (a) Whether
the proposed collection of information
is necessary for the proper performance
PO 00000
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Fmt 4701
Sfmt 4700
of FSIS’s functions, including whether
the information will have practical
utility; (b) the accuracy of FSIS’s
estimate of the burden of the proposed
collection of information, including the
validity of the method and assumptions
used; (c) ways to enhance the quality,
utility, and clarity of the information to
be collected; and (d) ways to minimize
the burden of the collection of
information, including through the use
of appropriate automated, electronic,
mechanical, or other technological
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collection techniques, or other forms of
information technology.
Comments on the proposed
information collection may be sent to
both FSIS, at the addresses provided
above, and the Desk Officer for
Agriculture, Office of Information and
Regulatory Affairs, Office of
Management and Budget, Washington,
DC 20253. To be most effective,
comments should be sent within 60
days of the publication date of this final
rule.
Information Collections That Were
Included in the Proposed Rule
Under this final rule, establishments
operating under NSIS are required to (1)
identify animals or carcasses that
establishment personnel have sorted
and removed for disposal before FSIS
inspection with a unique tag, tattoo, or
similar device, and to develop,
implement, (2) maintain records to
document the total number of animals
and carcasses sorted and removed per
day and the reasons for their removal,
and (3) maintain records documenting
that products resulting from their
slaughter operations meet the new
definition of RTC pork product.
Furthermore, each establishment
operating under the NSIS will also need
to submit, on an annual basis, an
attestation to the management member
of the local FSIS circuit safety
committee stating that it maintains a
program to monitor and document any
work-related conditions of
establishment workers.
In addition, each official swine
slaughter establishment, regardless of
the inspection system under which they
operate, will need to maintain, as part
of its HACCP system, written
procedures for preventing, throughout
the entire slaughter and dressing
operation, contamination of carcasses
and parts by enteric pathogens, and
visible fecal material, ingesta, and milk.
These procedures must include
sampling and analysis for microbial
organisms to monitor process control for
enteric pathogens, as well as written
procedures to prevent visible fecal
material, ingesta, and milk
contamination.
As mentioned above, the requirement
that swine slaughter establishments
have written procedures in their HACCP
systems is already covered under an
approved information collection system.
Therefore, this requirement of this final
rule will create no new burden on
establishments.
The requirement that swine slaughter
establishments monitor their systems
through microbial testing and
recordkeeping will create a new
information collection burden. For each
Respondents
jbell on DSK3GLQ082PROD with RULES4
Average annual
number of
responses per
respondent
Estimated
number of
respondents
sample on which a microbiological test
is conducted, there is a ‘‘response’’ for
the establishment to record the sample
result. Under the final rule, large, small
and very small high-volume
establishments will test and record
microbiological results for enteric
pathogens, for carcass samples taken at
both pre-evisceration and post-chill (for
hot-boned products, carcass samples
will be collected pre-evisceration and
after the final wash), at a frequency of
once per 1,000 carcasses; and small and
very small low-volume establishments,
13 times a year. The small and very
small low-volume establishments do not
experience an increase in sampling
under the final rule.
Estimated Annual Recordkeeping
Burden: Swine Slaughter Inspection.
Respondents: Official high-volume
swine establishments.
Estimated Number of Respondents: 74
(17 large, 51 small high-volume, and 6
very small high-volume).
Estimated Average Annual Number of
Responses (samples) per Respondent:
Large establishments 3,869; small highvolume establishments 229; and very
small high-volume establishments 52.
Estimated Total Annual Responses:
77,764.
Estimated Total Annual
Recordkeeping Burden: 3,240 hours.
Total annual
responses
Time per
response in
minutes
Total annual
burden hours
Large establishments.
Small high-volume establishments.
Very small highvolume establishments.
Microbial testing data recordkeeping ...
17
3,869
65,773
2.5
2,741
Microbial testing data recordkeeping ...
51
229
11,679
2.5
487
Microbial testing data recordkeeping ...
6
52
312
2.5
13
Total Recordkeeping Burden for process control.
...............................................................
74
1,051
77,764
2.5
3,240
FSIS is also requiring that market hog
slaughter establishments operating
under NSIS submit on an annual basis,
an attestation to the management
member of the local FSIS circuit safety
committee stating that it maintains a
program to monitor and document any
work-related conditions of
establishment workers.
VerDate Sep<11>2014
19:06 Sep 30, 2019
Jkt 250001
Estimated Annual Reporting Burden
for Submitting an Annual Attestation on
Work-Related Conditions to the FSIS
Circuit. Safety Committee: Swine
Slaughter Inspection.
Respondents: Official market hog
slaughter establishments that operate
under NSIS.
Estimated maximum number of
respondents: 40.
PO 00000
Frm 00046
Fmt 4701
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Estimated Average Annual Number of
Responses per Respondent: Large
establishments 1; small high-volume
establishments 1.
Estimated Maximum Total Potential
Annual Responses: 40.
Estimated Total Annual
Recordkeeping Burden: 1.33 hours.
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Estimated
number of
respondents
Respondents
Large establishments ..........
Small high-volume establishments.
Total Reporting Burden
Average
annual number
of
responses per
respondent
Total annual
burden hours
27
1
27
2
.90
13
1
13
2
.43
.............................................
40
1
40
2
1.33
information. This service is available at:
https://www.fsis.usda.gov/subscribe.
Options range from recalls, export
[With the recordkeeping burden for maintaining records to document the total number of information, regulations, directives, and
animals and carcasses sorted and removed notices. Customers can add or delete
per day and the reasons for their removal]
subscriptions themselves and have the
option to password protect their
Total Number Respondents
84 accounts.
Average Annual Number Responses per Respondent ..
Total Annual Responses ......
Average Hours per Response ...............................
Total Annual Burden Hours ..
1,084.33
91,084
0.05
Final Regulatory Amendments
List of Subjects
9 CFR Part 301
Meat inspection.
4,347.33
9 CFR Part 309
SUMMARY OF BURDEN SWINE
SLAUGHTER INSPECTION
[Without the recordkeeping burden for maintaining records to document the total number of animals and carcasses sorted and removed per day and the reasons for their removal]
jbell on DSK3GLQ082PROD with RULES4
Time per
response in
minutes
Attestation on Work-Related Conditions.
Attestation on Work-Related Conditions.
SUMMARY OF BURDEN SWINE
SLAUGHTER INSPECTION
Total Number Respondents
Average Annual Number Responses per Respondent ..
Total Annual Responses ......
Average Hours per Response ...............................
926.24
77,804
Total Annual Burden Hours ..
3,241.33
84
19:06 Sep 30, 2019
Animal diseases, Meat inspection,
Reporting and recordkeeping
requirements.
9 CFR Part 310
Animal diseases, Meat inspection.
For the reasons stated in the
preamble, FSIS is amending 9 CFR
chapter III as follows:
PART 301—TERMINOLOGY;
ADULTERATION AND MISBRANDING
0.04 STANDARDS
XIII. Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, FSIS will
announce this Federal Register
publication on-line through the FSIS
web page located at: https://
www.fsis.usda.gov/federal-register.
FSIS will also announce and provide
a link to it through the FSIS Constituent
Update, which is used to provide
information regarding FSIS policies,
procedures, regulations, Federal
Register notices, FSIS public meetings,
and other types of information that
could affect or would be of interest to
our constituents and stakeholders. The
Constituent Update is available on the
FSIS web page. Through the web page,
FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an email
subscription service which provides
automatic and customized access to
selected food safety news and
VerDate Sep<11>2014
Total annual
responses
52345
Jkt 250001
1. The authority citation for part 301
is revised to read as follows:
■
Authority: 7 U.S.C. 138–138i, 450, 1901–
1906; 21 U.S.C. 601–695; 7 CFR 2.7, 2.18,
2.53.
2. Amend § 301.2 by adding the
definition of ‘‘Ready-to-cook (RTC) pork
product’’ in alphabetical order to read as
follows:
■
§ 301.2
Definitions.
*
*
*
*
*
Ready-to-cook (RTC) pork product.
Any slaughtered pork product
sufficiently free from bile, hair, scurf,
dirt, hooves, toe nails, claws, bruises,
edema, scabs, skin lesions, icterus,
foreign material, and odor, which is
suitable for cooking without need of
further processing.
*
*
*
*
*
PART 309—ANTE–MORTEM
INSPECTION
3. The authority citation for part 309
continues to read as follows:
■
PO 00000
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Fmt 4701
Sfmt 4700
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
■
4. Add § 309.19 to read as follows:
§ 309.19 Market hog segregation under the
new swine slaughter inspection system.
(a) The establishment must conduct
market hog sorting activities before the
animals are presented for ante-mortem
inspection. Market hogs exhibiting signs
of moribundity, central nervous system
disorders, or pyrexia must be disposed
of according to paragraph (c) of this
section.
(b) The establishment must develop,
implement, and maintain written
procedures to ensure that market hogs
exhibiting signs of moribundity, central
nervous system disorders, or pyrexia do
not enter the official establishment to be
slaughtered. The establishment must
incorporate these procedures into its
HACCP plan, or sanitation SOPs, or
other prerequisite programs.
(c) The establishment must identify
livestock that establishment employees
have sorted and removed from slaughter
with a unique tag, tattoo, or similar
device. The establishment must
develop, implement, and maintain
written procedures to ensure that the
animals sorted and removed from
slaughter do not enter the human food
supply and are disposed of according to
9 CFR part 314.
(d) The establishment must maintain
records to document the number of
animals disposed of per day because
they were removed from slaughter by
establishment sorters before antemortem inspection by FSIS inspectors
and the reasons that the animals were
removed. These records are subject to
review and evaluation by FSIS
personnel.
(e) The establishment must
immediately notify FSIS inspectors if
the establishment has reason to believe
that market hogs may have a notifiable
animal disease. Notifiable animal
diseases are designated by World
Animal Health Organization.
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PART 310—POST-MORTEM
INSPECTION
5. The authority citation for part 310
continues to read as follows:
■
Authority: 21 U.S.C. 601–695; 7 CFR 2.18,
2.53.
6. Amend § 310.1 by revising
paragraph (b)(3) to read as follows:
■
§ 310.1 Extent and time of post-mortem
inspection; post-mortem inspection staffing
standards.
*
*
*
*
*
(b) * * *
(3) Swine inspection. There are two
systems of post-mortem inspection: The
New Swine Slaughter Inspection System
(NSIS), which may be used for market
hogs, and the traditional inspection
system, which may be used for all
swine.
(i) The NSIS may be used for market
hogs if the official establishment
requests to use it and meets or agrees to
meet the requirements in 9 CFR 309.19
and § 310.26. The Administrator may
permit establishments that slaughter
classes of swine other than market hogs
to use NSIS under a waiver from the
provisions in 9 CFR 309.19 and § 310.26
as provided by 9 CFR 303.1(h). The
Administrator also may permit
establishments that slaughter both
market hogs and other classes of swine
to slaughter the market hogs under NSIS
and slaughter the other classes of swine
under traditional inspection.
(ii) Traditional inspection shall be
used for swine when NSIS is not used.
The following inspection staffing
standards are applicable to swine
slaughter configurations operating
under traditional inspection when NSIS
is not used. The inspection standards
for all slaughter lines are based upon the
observation rather than palpation, at the
viscera inspection station, of the spleen,
liver, heart, lungs, and mediastinal
lymph nodes. In addition, for one- and
two-inspector lines under traditional
inspection, the standards are based
upon the distance walked (in feet) by
the inspector between work stations;
and for three or more inspector
slaughter lines, upon the use of a mirror,
as described in § 307.2(m)(6) of this
chapter, at the carcass inspection
station. Although not required in a oneor two-inspector slaughter
configuration, except in certain cases as
determined by the inspection service, if
a mirror is used, it must comply with
the requirements of § 307.2(m)(6).
TABLE 1 TO PARAGRAPH (B)(3)—ONE INSPECTOR—STAFFING STANDARDS FOR SWINE
Maximum inspection rates (head per hour)
Market hogs
(heads attached or detached)
Distance walked 1 in feet is—
Without mirror
0 to 5 ................................................................................................................
6 to 10 ..............................................................................................................
11 to 15 ............................................................................................................
16 to 20 ............................................................................................................
21 to 35 ............................................................................................................
26 to 30 ............................................................................................................
31 to 35 ............................................................................................................
36 to 40 ............................................................................................................
41 to 45 ............................................................................................................
46 to 50 ............................................................................................................
51 to 55 ............................................................................................................
56 to 60 ............................................................................................................
61 to 65 ............................................................................................................
66 to 70 ............................................................................................................
71 to 75 ............................................................................................................
76 to 80 ............................................................................................................
81 to 85 ............................................................................................................
86 to 90 ............................................................................................................
91 to 95 ............................................................................................................
96 to 100 ..........................................................................................................
Sows and boars
(heads detached)
With mirror
140
134
129
124
120
116
112
108
105
101
98
96
93
90
88
86
84
82
80
78
Without mirror
150
144
137
132
127
122
118
114
110
107
103
100
97
95
92
89
87
85
83
81
With mirror
131
126
122
117
113
110
106
103
100
97
94
91
89
87
85
82
80
79
77
75
143
137
132
127
122
118
114
110
106
103
100
97
94
92
89
87
85
83
81
79
1 Distance walked is the total distance that the inspector will have to walk between work stations during one inspection cycle (e.g., between
viscera, carcass, head, and wash-basin).
TABLE 2 TO PARAGRAPH (B)(3)—TWO INSPECTORS—STAFFING STANDARDS FOR MARKET HOGS
Maximum inspection rates
(head per hour with heads attached or detached)
Distance walked 1 in feet by inspector B is—
Line configuration
Carcass,2
head viscera 3
Viscera,2 head
carcass 3
Head,2 viscera
carcass 3
151–253
151–239
151–226
151–214
151–204
151–271
151–255
151–240
151–227
151–215
151–296
151–277
151–260
151–244
151–231
jbell on DSK3GLQ082PROD with RULES4
Without Mirror
0 to 5 ............................................................................................................................................
6 to 10 ..........................................................................................................................................
11 to 15 ........................................................................................................................................
16 to 20 ........................................................................................................................................
21 to 25 ........................................................................................................................................
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19:06 Sep 30, 2019
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TABLE 2 TO PARAGRAPH (B)(3)—TWO INSPECTORS—STAFFING STANDARDS FOR MARKET HOGS—Continued
Maximum inspection rates
(head per hour with heads attached or detached)
Distance walked 1 in feet by inspector B is—
Line configuration
Carcass,2
head viscera 3
Viscera,2 head
carcass 3
Head,2 viscera
carcass 3
151–253
151–239
151–226
151–214
151–204
151–303
151–283
151–265
151–249
151–235
151–318
151–304
151–289
151–270
151–254
With Mirror
0 to 5 ............................................................................................................................................
6 to 10 ..........................................................................................................................................
11 to 15 ........................................................................................................................................
16 to 20 ........................................................................................................................................
21 to 25 ........................................................................................................................................
1Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (e.g., between
viscera, carcass, and washbasin).
2Inspector A.
3Inspector B.
Note 1 to Table 2 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all inspection positions during each shift
to equalize the workload.
TABLE 3 TO PARAGRAPH (B)(3)—TWO INSPECTORS—STAFFING STANDARDS FOR SOWS AND BOARS
Maximum inspection rates
(head per hour)
Line Configuration
Distance walked 1 in feet by inspector B is—
Carcass,2
head viscera,3
heads detached
Viscera,2 head
carcass,3
heads detached
Head,2 viscera
carcass,3
heads detached
Head,2 viscera
carcass,3
heads attached
144–248
144–235
144–222
144–211
144–201
144–254
144–240
144–227
144–215
144–205
144–267
144–253
144–239
144–226
144–214
144–267
144–253
144–239
144–226
144–214
144–248
144–235
144–222
144–211
144–201
144–292
144–273
144–256
144–241
144–228
144–305
144–291
144–272
144–255
144–240
144–292
144–280
144–268
144–255
144–240
Without Mirror
0 to 5 ................................................................................................................
6 to 10 ..............................................................................................................
11 to 15 ............................................................................................................
16 to 20 ............................................................................................................
21 to 25 ............................................................................................................
With Mirror
0 to 5 ................................................................................................................
6 to 10 ..............................................................................................................
11 to 15 ............................................................................................................
16 to 20 ............................................................................................................
21 to 25 ............................................................................................................
1Distance walked is the total distance that Inspector B will have to walk between work stations during one inspection cycle (e.g., between
viscera, carcass, and washbasin).
2Inspector A.
3Inspector B.
Note 1 to table 3 to Paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all inspection positions during each
shift to equalize the workload.
TABLE 4 TO PARAGRAPH (B)(3)—THREE INSPECTORS OR MORE—STAFFING STANDARDS FOR SWINE
Number of inspectors by station
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Maximum inspection rates
(head per hour with heads attached)
Head
Market hogs:
319 to 506 ........................................................................................................
507 to 540 ........................................................................................................
541 to 859 ........................................................................................................
860 to 1,022 .....................................................................................................
1,023 to 1,106 ..................................................................................................
Sows and boars:
306 to 439 ........................................................................................................
306 to 462 1 ......................................................................................................
440 to 475 ........................................................................................................
476 to 752 ........................................................................................................
753 to 895 ........................................................................................................
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Viscera
Carcass
Total
1
1
2
2
3
1
2
2
3
3
1
1
1
1
1
3
4
5
6
7
1
1
2
2
3
1
1
1
2
2
1
1
1
1
1
3
3
4
5
6
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TABLE 4 TO PARAGRAPH (B)(3)—THREE INSPECTORS OR MORE—STAFFING STANDARDS FOR SWINE—Continued
Number of inspectors by station
Maximum inspection rates
(head per hour with heads attached)
Head
896 to 964 ........................................................................................................
Viscera
3
Carcass
3
Total
1
7
1This
rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection.
Note 1 to table 4 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all inspection positions during each
shift to equalize the workload.
7. Amend § 310.18 by adding
paragraphs (c) and (d) to read as follows:
■
§ 310.18 Contamination of carcasses,
organs, or other parts.
jbell on DSK3GLQ082PROD with RULES4
*
*
*
*
*
(c) Official swine slaughter
establishments must develop,
implement, and maintain written
procedures to prevent contamination of
carcasses and parts by enteric
pathogens, and visible fecal material,
ingesta, and milk contamination
throughout the entire slaughter and
dressing operation. Establishments must
incorporate these procedures into their
HACCP plans, or sanitation SOPs, or
other prerequisite programs. These
procedures must include sampling and
analysis for microbial organisms in
accordance with the sampling location
and frequency requirements in
paragraphs (c)(1) and (2) of this section
to monitor their ability to maintain
process control.
(1) Sampling locations. Official swine
slaughter establishments, except for
very low-volume establishments, must
collect and analyze carcass samples for
microbial organisms at the preevisceration and post-chill points in the
process. Establishments that slaughter
more than one type of livestock must
test the type of livestock slaughtered in
the greatest number. Establishments that
bone their products before chilling (i.e.,
hot-boned products) must collect and
analyze samples at the pre-evisceration
point in the process and after the final
wash instead of at post-chill. Very lowvolume establishments must collect and
analyze samples for microbial organisms
at the post-chill point in the process. All
swine establishments must sponge or
excise tissue from the ham, belly, and
jowl areas.
(i) Very low-volume establishments
annually slaughter no more than 20,000
swine, or a combination of swine and
other livestock not exceeding 6,000
cattle and 20,000 total of all livestock.
(ii) [Reserved]
(2) Sampling frequency.
Establishments, except for very lowvolume establishments as defined in
paragraph (c)(1)(i) of this section, must
collect and analyze samples at a
frequency proportional to the
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19:06 Sep 30, 2019
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establishment’s volume of production at
the following rates:
(i) Establishments, except for very
low-volume establishments as defined
in paragraph (c)(1)(i) of this section,
must collect and analyze samples at a
frequency of once per 1,000 carcasses,
but a minimum of once during each
week of operation.
(ii) Very low-volume establishments
as defined in paragraph (c)(1)(i) of this
section must collect and analyze
samples at least once during each week
of operation starting June 1 of every
year. If, after consecutively collecting 13
weekly samples, very low-volume
establishments can demonstrate that
they are effectively maintaining process
control, they may modify their sampling
plans.
(iii) Establishments must maintain
accurate records of all test results and
retain these records as provided in
paragraph (d) of this section.
(d) Official swine slaughter
establishments must maintain daily
records sufficient to document the
implementation and monitoring of the
procedures required under this section.
Records required by this section may be
maintained on computers if the
establishment implements appropriate
controls to ensure the integrity of the
electronic data. Records required by this
section must be maintained for at least
one year and must be accessible to FSIS.
§ 310.25
[Amended]
8. Amend § 310.25 as follows:
a. Remove paragraph (a)(2)(ii)(C);
b. Remove the undesignated sentence
following paragraph (a)(2)(iii)(A);
■ c. Remove ‘‘20,000 swine,’’ in
paragraph (a)(2)(v)(A);
■ d. In paragraph (a)(5):
■ i. Redesignate Table 1 as Table 1 to
paragraph (a)(5); and
■ ii. In newly redesignated Table 1 to
paragraph (a)(5), remove the entry for
‘‘swine’’;
■ e. In paragraph (b)(1):
■ i. Remove ‘‘in Table 2’’ and add ‘‘in
Table 1 to this paragraph’’ in its place;
■ ii. Redesignate Table 2 as Table 1 to
paragraph (b)(1); and
■ iii. In newly redesignated Table 1 to
paragraph (b)(1), remove the entries for
■
■
■
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‘‘Hogs’’ and ‘‘fresh pork sausages’’ and
footnote (b).
■ 9. Add § 310.26 to read as follows:
§ 310.26 Establishment responsibilities
under the new swine slaughter inspection
system.
(a) Facilities. The establishment must
comply with the facilities requirements
in 9 CFR part 307. The establishment
must provide a mirror at the carcass
inspection station in accordance with 9
CFR 307.2(m)(6).
(b) Carcass sorting and disposition.
The establishment must conduct carcass
sorting activities and identify any
condemnable conditions or defects
before carcasses are presented to online
inspectors. Establishment sorters must
incise mandibular lymph nodes and
palpate the viscera to detect the
presence of animal diseases as part of
their sorting activities. The
establishment must develop,
implement, and maintain written
procedures to ensure that market hog
carcasses adulterated with septicemia,
toxemia, pyemia, or cysticercosis are
properly removed before the point of
post-mortem inspection of carcasses.
The establishment must incorporate
these procedures into its HACCP plan,
or sanitation SOPs, or other prerequisite
program. These procedures must cover
the establishment sorting activities
required under this section.
(c) Line speed limits. The line speed
limits in § 310.1 do not apply to the
establishment, provided it is able to
maintain effective process control and
prevent contamination of carcasses and
parts by enteric pathogens and visible
fecal material, ingesta, and milk.
Establishments operating under the
NSIS must reduce their line speed as
directed by the Inspector-in-Charge
(IIC). The IIC is authorized to direct an
establishment to operate at a reduced
line speed when in their judgment a
carcass-by-carcass inspection cannot be
adequately performed within the time
available due to the manner in which
the carcasses are presented to the online
inspector, the health conditions of a
particular herd, or factors that may
indicate a loss of process control.
(d) Records. (1) The establishment
must maintain records to document that
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the products resulting from its slaughter
operation meet the definition of Readyto-cook pork product in § 301.2. These
records are subject to review and
evaluation by FSIS personnel.
(2) The establishment must maintain
records to document the number of
carcasses disposed of per day by
establishment sorters before FSIS postmortem inspection and the reasons that
the carcasses were disposed of. These
records are subject to review and
evaluation by FSIS personnel.
■ 10. Add § 310.27 to read as follows:
§ 310.27
Attestation requirements.
jbell on DSK3GLQ082PROD with RULES4
Each establishment that participates
in the NSIS must submit on an annual
basis an attestation to the management
member of the local FSIS circuit safety
committee stating that it maintains a
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19:06 Sep 30, 2019
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program to monitor and document any
work-related conditions of
establishment workers, and that the
program includes the following
elements:
(a) Policies to encourage early
reporting of symptoms of injuries and
illnesses, and assurance that it has no
policies or programs in place that would
discourage the reporting of injuries and
illnesses.
(b) Notification to employees of the
nature and early symptoms of
occupational illnesses and injuries, in a
manner and language that workers can
understand, including by posting in a
conspicuous place or places where
notices to employees are customarily
posted, a copy of the FSIS/OSHA poster
encouraging reporting and describing
reportable signs and symptoms.
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52349
(c) Monitoring, on a regular and
routine basis, injury and illness logs, as
well as nurse or medical office logs,
workers’ compensation data, and any
other injury or illness information
available.
■
11. Add § 310.28 to read as follows:
§ 310.28
Severability.
Should a court of competent
jurisdiction hold any provision of
§ 310.27 to be invalid, such action will
not affect any other provision of 9 CFR
part 309 or this part.
Done in Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019–20245 Filed 9–30–19; 8:45 am]
BILLING CODE 3410–DM–P
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]]>Agencies
[Federal Register Volume 84, Number 190 (Tuesday, October 1, 2019)]
[Rules and Regulations]
[Pages 52300-52349]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2019-20245]
[[Page 52299]]
Vol. 84
Tuesday,
No. 190
October 1, 2019
Part IV
Department of Agriculture
-----------------------------------------------------------------------
Food and Safety and Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 301, 309, and 31
Modernization of Swine Slaughter Inspection; Final Rule
Federal Register / Vol. 84, No. 190 / Tuesday, October 1, 2019 /
Rules and Regulations
[[Page 52300]]
-----------------------------------------------------------------------
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 309, and 310
[Docket No. FSIS-2016-0017]
RIN 0583-AD62
Modernization of Swine Slaughter Inspection
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Final rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
Federal meat inspection regulations to establish an optional new
inspection system for market hog slaughter establishments that has been
demonstrated to provide public health protection at least equivalent to
the existing inspection system. Market hog slaughter establishments
that do not choose to operate under the new swine inspection system may
continue to operate under their existing inspection system. The Agency
is also making several changes to the regulations that will affect all
establishments that slaughter swine, regardless of the inspection
system under which they operate or the age, size, or class of swine.
These changes will allow all swine slaughter establishments to develop
sampling plans that are more tailored to their specific operations, and
thus more effective in monitoring their specific process control,
unlike the current requirements in the regulations.
DATES:
Effective date: December 2, 2019.
Notification date: All market hog establishments will initially
have until March 30, 2020 to notify their FSIS District Office (DO) of
their intent to operate under the New Swine Slaughter Inspection System
(NSIS). Establishments that do not notify their DO of their intent by
March 30, 2020 will be deemed to have chosen to continue operating
under their existing inspection system. For additional information, see
section II.G. Implementation.
Applicability dates: The regulations that prescribe procedures for
controlling contamination throughout the slaughter and dressing process
in 9 CFR 310.18(c), and the regulations that prescribe recordkeeping
requirements in 9 CFR 310.18(d), will be applicable as follows:
(1) In large establishments, defined as all establishments with 500
or more employees, on December 30, 2019;
(2) In small establishments, defined as all establishments with 10
or more employees but fewer than 500 employees, on January 29, 2020;
and
(3) In very small establishments, defined as all establishments
with fewer than 10 employees or annual sales of less than $2.5 million,
on March 30, 2020.
FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Executive Summary
On February 1, 2018, FSIS published a proposed rule to modernize
swine slaughter inspection (83 FR 4780). This final rule adopts, with
modifications, the provisions in the proposed rule.
FSIS is establishing an optional new inspection system for market
hog slaughter establishments, NSIS, informed by the Agency's
experiences under its Hazard Analysis and Critical Control Point
(HACCP)-Based Inspection Models Project (HIMP). FSIS is establishing
NSIS to improve the effectiveness of market hog slaughter inspection;
make better use of the Agency's resources; and remove unnecessary
regulatory obstacles to industry innovation by revoking maximum line
speeds and allowing establishments flexibility to reconfigure
evisceration lines. NSIS may also facilitate pathogen reduction in pork
products and improve compliance with the Humane Methods of Slaughter
Act (HMSA) (7 U.S.C. 1901 et seq.).
Because this final rule requires establishment personnel in NSIS
establishments to sort and remove unfit animals before ante-mortem
inspection by FSIS inspectors and trim and identify defects on
carcasses and parts before post-mortem inspection by FSIS inspectors,
the Agency's inspectors will be presented with healthier animals and
carcasses that have fewer defects, allowing them to conduct a more
efficient inspection of each animal and each carcass. As a result,
under NSIS, FSIS can assign fewer inspectors to online inspection,
freeing up Agency resources to conduct more offline inspection
activities that are more effective in ensuring food safety, such as
verifying compliance with sanitation and HACCP, as well as humane
handling requirements.
Key elements of the NSIS include: (1) Requiring establishment
personnel to sort and remove unfit animals before ante-mortem
inspection by FSIS inspectors and to trim and identify defects on
carcasses and parts before post-mortem inspection by FSIS inspectors;
(2) requiring establishment personnel to identify animals or carcasses,
that they have sorted and removed for disposal before FSIS inspection,
with a unique tag, tattoo, or similar device, and to develop,
implement, and maintain written procedures in their HACCP system to
ensure that animals and carcasses sorted and removed for disposal do
not enter the human food supply and are properly disposed of according
to 9 CFR part 314; (3) requiring establishments to maintain records to
document the total number of animals and carcasses sorted and removed
per day and the reasons for their removal; (4) requiring establishment
personnel to immediately notify FSIS inspectors if they identify, while
conducting sorting activities, an animal or carcass that they suspect
has a reportable or foreign animal disease (e.g., African swine fever,
classical swine fever, or Nipah virus encephalitis); (5) shifting
Agency resources to conduct more offline inspection activities that are
more effective in ensuring food safety, which allows for up to two
offline verification inspectors per line per shift and reduces the
number of online inspectors to a maximum of three per line per shift;
(6) requiring establishments to maintain records documenting that
products resulting from their slaughter operations meet the new
definition of ready-to-cook (RTC) pork product, which is any
slaughtered pork product sufficiently free from bile, hair, scurf,
dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions,
icterus, foreign material, and odor which is suitable for cooking
without need of further processing; and (7) revoking maximum line
speeds and authorizing establishments to determine their own line
speeds based on their ability to maintain process control for
preventing fecal contamination and meeting microbial performance
measures for carcasses during the slaughter operation. FSIS retains the
ability to slow or stop the line, as needed (9 CFR 310.26(c)). Based on
its experience under HIMP, the NSIS is unlikely to result in a higher
prevalence of Salmonella on market hog carcasses and may result in a
lower prevalence of Salmonella on market hog carcasses, which in turn
may lead to fewer human illnesses. In addition, FSIS expects that the
new inspection system will improve animal welfare and compliance with
the HMSA because more FSIS resources will be available to verify the
humane handling of animals.
Under the NSIS, establishment sorters will be required to incise
mandibular lymph nodes and palpate the viscera to
[[Page 52301]]
detect the presence of animal diseases (e.g., Mycobacterium (M.) Avium)
as part of their sorting activities before FSIS post-mortem inspection
(9 CFR 310.26(b)). The Agency determined that it needs more information
on the public health impact of these sorting activities before it can
allow establishments to decide, on a lot-by-lot basis, whether
establishment sorters need to incise lymph nodes and palpate the
viscera to detect the presence of animal diseases. To gather this
information, FSIS has decided to allow establishments that operate
under the NSIS to apply for waivers to 9 CFR 310.26(b) under 9 CFR
303.1(h). As a condition of the waiver, establishments operating under
waivers are required to submit data to FSIS. FSIS then assesses that
data to determine whether changes to the regulations are appropriate
and necessary. The Agency will announce the criteria for these waivers
in a future Federal Register document.
Under this final rule, market hog slaughter establishments that do
not choose to operate under the NSIS may continue to operate under
traditional inspection (i.e., inspection described in current
regulations). Establishments that slaughter swine other than market
hogs are not eligible to operate under the NSIS unless they obtain a
waiver under the Salmonella Initiative Program (SIP) (79 FR 633,
January 6, 2014).
Under this final rule, FSIS is also making several changes that
will affect all establishments that slaughter swine, regardless of the
inspection system under which they operate. Specifically, all official
swine slaughter establishments must develop, implement, and maintain in
their HACCP plans, sanitation standard operating procedures (sanitation
SOPs), or other prerequisite programs (hereafter collectively referred
to as their ``HACCP systems''), written procedures to prevent the
contamination of carcasses and parts by enteric pathogens, and visible
fecal material, ingesta, and milk throughout the entire slaughter and
dressing operation. These procedures must include sampling and analysis
for microbial organisms to monitor process control for enteric
pathogens, as well as written procedures to prevent visible fecal
material, ingesta, and milk contamination.
As part of their written procedures, establishments will be
required to collect and test two carcass samples for microbial
organisms, one at pre-evisceration and one at post-chill (i.e., the
point in the slaughter process after the carcass has chilled in the
cooler and after all slaughter interventions are completed), or, for
very low-volume establishments, a single post-chill carcass sample.
Establishments that bone their products before chilling (i.e., hot-
boned products) will be required to collect the pre-evisceration sample
and a sample after the final wash instead of at post-chill, because
these products are not chilled before further processing.
Under this final rule, establishments, except for very low-volume
establishments, are required to collect carcass samples and test for
microbial organisms pre-evisceration and post-chill, or, for hot-boned
products, pre-evisceration and after the final wash, at a frequency of
once per 1,000 carcasses. Very low-volume establishments are required
to collect at least one carcass sample during each week of operation
starting June 1 of each year. If, after consecutively collecting and
testing 13 weekly carcass samples, very low-volume establishments can
demonstrate that they are not exceeding their upper control limit for
microbial organisms and that they are effectively maintaining process
control, they can modify their sampling plans to collect samples less
frequently. FSIS provides more information on upper control limits in
its guideline titled Developing Effective Microbiological Sampling
Programs in Swine Slaughter Establishments to Assess Process Control
and Sanitary Conditions (hereafter referred to as the sampling
guideline). The sampling guideline is available on FSIS's website at
https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
This final rule rescinds the current requirement that swine
establishments test carcasses for generic E. coli post chill to monitor
process control and replaces this requirement with the new testing
requirements described above. The new testing requirements will allow
establishments to develop sampling plans that are more tailored to
their specific operation, and thus more effective in monitoring their
specific process control than the current generic E. coli criteria.
This final rule also removes the codified Salmonella pathogen reduction
performance standard for hogs (carcasses) because verifying the
codified standard was not a good use of Agency resources. As FSIS
explained in the proposed rule (83 FR 4780, 4786), the Agency
discontinued its Salmonella verification sampling program for market
hogs in 2011 because the estimated prevalence of Salmonella on hog
carcasses was low, and FSIS did not find enough pathogen positives to
justify the resources needed (e.g., time and supplies) to conduct
carcass swabbing.
This final rule does not allow establishments to collect samples
for microbial organisms at alternative sampling locations or
frequencies, as was proposed. FSIS made this change from the proposed
rule in response to comments that it may be too difficult for
inspection personnel to review and verify sampling plans with
alternative sampling locations or frequencies. Establishments that
currently operate under SIP waivers from the former generic E. coli
regulations may continue to conduct process control sampling at the
alternative frequencies provided for in their waivers. All other SIP
waivers (e.g., waivers for 9 CFR 310.1(b)(3)--line speed; 9 CFR
310.25(b)--Salmonella performance standards; 9 CFR 310.18(a)--
contamination of organs; and 9 CFR 310.14--handling of bruised parts)
will end. FSIS will allow other establishments that would like to
experiment with alternative sampling locations and frequencies to
submit waiver requests under the SIP to FSIS. FSIS will announce new
waiver criteria in a future Federal Register document. This final rule
also does not require swine slaughter establishments to develop,
implement, and maintain in their HACCP systems written procedures to
prevent contamination of the pre-operational environment by enteric
pathogens, as was proposed. FSIS has decided to withdraw this part of
the proposal until the Agency considers its options and timing for
gathering more data on contamination in the pre-operational
environment. A summary of changes to the proposed rule is included
below under section I. Background.
In Table 1 below, FSIS presents the estimated costs and benefits of
the final rule. The regulatory impact analysis section below contains
an explanation of the assumptions, provides alternative adoption
scenarios, and includes a discussion of the uncertainty surrounding the
net benefits associated with how much of the industry will choose to
adopt NSIS.
[[Page 52302]]
Table 1--Net Costs and (Benefits)
[M$]
----------------------------------------------------------------------------------------------------------------
Number of
establishments One-time Recurring
----------------------------------------------------------------------------------------------------------------
Costs to Industry......................................... ................ $3.14 $22.72
Voluntary *........................................... ** 40 0.84 22.15
Mandatory............................................. 612 2.30 0.58
Health Benefits ***....................................... ................ ................ (9.33)
Industrial Efficiency..................................... ................ ................ (87.64)
Impacts to Agency's Budget................................ ................ 2.80 (8.73)
----------------------------------------------------------------------------------------------------------------
Totals
----------------------------------------------------------------------------------------------------------------
One-Time Cost..............................................................$5.94
Recurring Cost............................................................(82.98)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years...............(62.56)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years...............(60.00)
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* Further explanation and details on the NSIS adoption rate are provided in section G. Potential Cost of the
Final Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 26: Quantified Cost and (Benefits)
of Various Adoption Rates
** Note, this includes 5 HIMP establishments, which are not expected to incur any costs or benefits associated
with the NSIS.
*** Further explanation and details on the range of health benefits have been provided in section H. Potential
Benefits of the Final Rule, Table 18: Health Benefits from Averted Cases of Salmonella. The value of health
benefits ranges from a $6.33 million decrease to a $24.62 million increase in health benefits, with a mean
increase in benefits of $9.33 million, assuming a cost per illness of $3,682.
**** Note, some of the totals may not equal the sum due to rounding.
Table of Contents
I. Background
II. Comments and Responses
III. Executive Orders 12866 and 13563
IV. Regulatory Flexibility Act Assessment
V. Executive Order 13771
VI. Congressional Review Act
VII. E-Government Act
VIII. Executive Order 12988, Civil Justice Reform
IX. Executive Order 13175
X. USDA Nondiscrimination Statement
XI. Environmental Impact
XII. Paperwork Reduction Act
XIII. Additional Public Notification
Final Regulatory Amendments
I. Background
FSIS began experimenting with new approaches to slaughter
inspection based on HACCP principles shortly after publishing the
Pathogen Reduction/HACCP rule in 1996. In 1997, the Agency developed
the HIMP pilot study to determine whether applying new government
slaughter inspection procedures, with new establishment
responsibilities, could promote industry innovation and provide at
least the same food safety and consumer protection as the other
available slaughter inspection systems. FSIS initiated the HIMP pilot
study in 20 young chicken, five young turkey, and five market hog
establishments on a waiver basis.
In 2014, the Agency amended the poultry products inspection
regulations to establish an optional new inspection system for young
chicken and all turkey slaughter establishments informed by the
Agency's experiences under HIMP (79 FR 49566, August 21, 2014). The New
Poultry Inspection System (NPIS) was designed to facilitate pathogen
reduction in poultry products, improve the effectiveness of poultry
slaughter inspection, make better use of the Agency's resources, and
remove unnecessary regulatory obstacles to innovation.
In addition to establishing the NPIS for young chickens and
turkeys, FSIS also amended the poultry products inspection regulations
that apply to all establishments that slaughter poultry other than
ratites. The new requirements ensure that all poultry slaughter
establishments implement appropriate measures in their HACCP systems to
prevent contamination of carcasses and parts by enteric pathogens and
visible fecal material throughout the entire slaughter operation and
ensure that both FSIS and establishments have the documentation they
need to verify the effectiveness of these measures on an ongoing basis.
Proposed Rule
On February 1, 2018, FSIS proposed to amend the meat inspection
regulations to establish an optional new slaughter inspection system
for market hog establishments (83 FR 4780). FSIS also proposed several
changes to the regulations that would affect all establishments that
slaughter swine, regardless of the inspection system under which they
operate or the age, size, or class of swine.
The proposed rule's comment period closed on May 2, 2018, 90 days
after its publication. After reviewing comments on the proposed rule,
FSIS is finalizing, with some changes, the provisions in the February
2018 proposed rule. In this final rule, the Agency is modifying its
proposal to:
Establish a phased approach to implement the NSIS;
Establish separate applicability dates for large, small,
and very small establishments to comply with the provisions in the rule
that prescribe the new recordkeeping and microbiological sampling
requirements that will apply to all establishments that slaughter
swine. The applicability dates will provide additional time for small
and very small establishments to comply with these provisions;
Revise the disposal requirements to require establishments
operating under the NSIS to develop, implement, and maintain written
procedures in their HACCP systems to ensure that animals and carcasses
that have been sorted and removed for disposal do not enter the human
food supply and are properly disposed of according to 9 CFR part 314;
Require establishments operating under the NSIS to
maintain records to document the total number of animals and carcasses
sorted and removed per day and the reasons for their removal and make
these records available for review and evaluation by FSIS;
Clarify that all establishments operating under the NSIS
must provide a mirror at the carcass inspection station;
Clarify that establishments that bone their products
before chilling (i.e., hot-boned products) must collect a carcass
sample pre-evisceration and after the final wash instead of at post-
chill. These establishments must also collect a sample at the pre-
evisceration point in the process;
[[Page 52303]]
Withdraw the proposal to allow establishments to use
alternative sampling locations and sampling frequencies;
Revise the sampling regulations to require very small
establishments that slaughter more than 20,000 swine, or a combination
of swine and other livestock exceeding 6,000 cattle and 20,000 total of
all livestock to collect two carcass samples, one at pre-evisceration
and one at post-chill, at a frequency of 1 per 1,000 carcasses, instead
of a single post-chill sample;
Require establishment sorters to incise mandibular lymph
nodes and palpate the viscera to detect the presence of animal diseases
(e.g., M. Avium) as part of their sorting activities before FSIS post-
mortem inspection;
Revise the definition of ``RTC pork product'' to clarify
that the standard is a performance standard for non-food safety defects
and not a zero-tolerance standard; and
Withdraw the proposed requirement for swine slaughter
establishments to develop, implement, and maintain in their HACCP
systems written procedures to prevent contamination of the pre-
operational environment by enteric pathogens.
Hog HIMP Report
The proposed rule was informed by the Agency's comprehensive
analysis of data collected from HIMP market hog establishments. In
2014, the Agency evaluated inspection findings in market hog slaughter
establishments participating in HIMP to determine whether the HIMP
inspection system performs as well as the existing inspection system in
terms of safety and wholesomeness of the products produced and of
overall consumer protection. FSIS summarized its findings in its report
titled ``Evaluation of HACCP Inspection Models Project (HIMP) for
Market Hogs'' (hereafter the ``Hog HIMP Report'') \1\ and in the
proposed rule (83 FR 4780, 4789). The Hog HIMP Report concluded that
market hog slaughter establishments participating in HIMP are
performing as well as comparable large non-HIMP market hog
establishments.
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\1\ The Hog HIMP Report is available on the FSIS website at:
https://www.fsis.usda.gov/wps/wcm/connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES.
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The Hog HIMP Report is based on two time periods: The years CY2006-
CY2010 and the years CY2012-CY2013. The evaluation compared 5 HIMP
market hog establishments with a comparison set of 21 non-HIMP market
hog slaughter establishments selected to be comparable with HIMP market
hog establishments with respect to production volume, line speed, and
days of slaughter operation.
The Hog HIMP Report found that HIMP market hog establishments
received more off-line food safety related inspection verification
checks than the traditional non-HIMP market hog establishments. HIMP
market hog establishments had higher compliance with Sanitation SOP and
HACCP regulations, lower levels of non-food safety defects, equivalent
or better Salmonella verification testing positive rates than
traditional non-HIMP market hog establishments, and lower levels of
violative chemical residues. The Hog HIMP Report also found that under
HIMP, market hog establishments received an increased level of
Sanitation SOP and HACCP inspection. Based on these findings, HIMP has
been demonstrated to provide public health protection at least
equivalent to the traditional inspection system.
Risk Assessment
The proposed rule was also informed by FSIS's Assessment of the
Potential Change in Human Risk of Salmonella Illnesses Associated with
Modernizing Inspection of Market Hog Slaughter Establishments. The risk
assessment \2\ used available data from FSIS's microbiological baseline
studies \3\ and the Agency's Salmonella verification results from swine
slaughter establishments. FSIS employed a stochastic simulation model
using multi-variable logistic regressions to identify correlations
between (1) the numbers of offline food-safety inspection procedures,
both scheduled and unscheduled, along with the numbers of non-
compliances and scheduled-but-not-completed procedures,\4\ and (2)
contamination of hog carcasses with Salmonella. The correlations were
used to predict the potential effect that devoting more resources to
those offline procedures might have on human illness attributable to
the consumption of pork products. Stochastic simulations were used to
account for statistical uncertainty in the estimates relating
inspection procedures in an establishment to detection of Salmonella in
samples from hog carcasses.\5\ Illness estimates were based on data
from the Centers for Disease Control and Prevention (CDC), and
uncertainty distributions were used to account for the variability in
annual Salmonella illnesses and statistical uncertainty about the
relationship between the pathogen prevalence levels at the
establishments and the corresponding annual number of illnesses that
could be attributed to the pathogens.
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\2\ As FSIS explained in the proposed rule, the Agency used a
similar approach to estimate the public health benefits associated
with the final rule titled Modernization of Poultry Slaughter
Inspection (79 FR 49565).
\3\ FSIS baseline data is available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/microbiology/baseline/baseline.
\4\ Scheduled procedures are assigned to inspectors at an
establishment by the Public Health Information System (PHIS). Before
FSIS implemented the PHIS, scheduled procedures were assigned by the
Performance-Based Inspection System (PBIS). Unscheduled procedures
are performed according to inspector needs at an establishment and
may include verification checks for fecal material, ingesta, and
milk, or they may be a response to unforeseen hazards or unsanitary
conditions arising from sanitation SOP failures, or the need to
verify corrective actions taken under the establishment's HACCP
plan.
\5\ For the risk assessment, FSIS used data from The Nationwide
Microbiological Baseline Data Collection Program: Market Hogs Survey
August 2010-2011 available at https://www.fsis.usda.gov/wps/wcm/connect/d5c7c1d6-09b5-4dcc-93ae-f3e67ff045bb/Baseline_Data_Market_Hogs_2010-2011.pdf?MOD=AJPERES).
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As with any risk assessment, FSIS's risk assessment relies on a
number of assumptions. FSIS assumed that the differences between the
approach to slaughtering hogs and slaughtering poultry would not alter
the relationship between the presence of Salmonella contamination on
carcasses and the likelihood of contamination of meat and human
illness. Furthermore, hog slaughter establishment specialization has
been facilitated by vertical integration within the industry, much like
the poultry industry.\6\ FSIS also assumed, for the purpose of this
risk assessment, that the relationship between Salmonella contamination
of hog carcasses and downstream products such as pork parts (e.g., pork
chops) and ground pork closely mirrors that of the established
relationship between Salmonella contamination of poultry (e.g.,
chicken) carcasses and downstream products such as chicken parts and
ground chicken. On the other hand, the likelihood of positive
Salmonella findings on hog carcasses is significantly lower than on
chickens. While FSIS did not conduct any specific analyses to examine
this assumption, the Agency has conducted numerous peer-reviewed
analyses of the relationship between Salmonella contamination frequency
on chicken
[[Page 52304]]
carcasses and chicken parts.\7\ These analyses indicate that the
prevalence of Salmonella contamination on downstream products (e.g.,
parts) often exceeds the frequency of measurement of Salmonella
contamination in upstream products (e.g., carcasses), and the Agency
expects this relationship would apply to other amenable species
slaughtered in FSIS establishments. The assumption of higher prevalence
is logical given that samples of downstream products contain primals
from multiple carcasses, increasing the likelihood of a single sample
being contaminated.
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\6\ Muth, M. (2007). Pork Slaughter and Processing Sector
Facility-Level Model. https://www.rti.org/sites/default/files/resources/muth_pork-slaughter_final.pdf.
\7\ Ebel, E.D., Williams, M.S., Tameru, B. (2019) Relatedness of
Salmonella contamination frequency on chicken carcasses and parts
when processed in the same establishment. Food Control 100: 198-203.
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The regression analysis of the historical data included in the
market hog risk assessment showed a statistically significant
correlation between (1) increased scheduled and unscheduled offline
procedures and decreased scheduled but not performed procedures and (2)
reduction in the prevalence of Salmonella positive samples from
carcasses. Based on these results, the redeployment of Agency resources
to scheduled and unscheduled offline activities, along with a reduction
in scheduled but not performed procedures, is likely to contribute to
food safety resulting from a lower prevalence of carcasses contaminated
with Salmonella, which in turn the Agency expects to lead to fewer
human illnesses. FSIS will evaluate policy effectiveness by routinely
analyzing inspection task data in PHIS (e.g., NRs for regulations on
the PHR list, including NRs for HACCP, sanitation SOP, and Livestock
Zero Tolerance tasks).
In April 2018, the Agency conducted an external peer review of the
risk assessment. On August 6, 2018, FSIS posted a revised version of
the risk assessment on its website at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/proposed-rules. The
revised risk assessment addressed reviewers' comments that FSIS should
have used different modeling approaches. The revised risk assessment
also included an in-depth power analysis, multicollinearity
diagnostics, model parameters and estimates when more complex crossover
and mixed-effects modeling approaches were applied, and a summary of
all alternative models (Appendix H). The revisions made in response to
the reviewers' comments did not produce changes to the risk
assessment's conclusions that would require modifications of the
proposed rule. However, the Agency gave interested persons 30 days
(until September 5, 2018) to comment on the changes made to the risk
assessment. To be transparent, FSIS has decided to add text to the risk
assessment to better characterize the two different models that were
conducted (see Tables 13 and 14 in the risk assessment and accompanying
text). Specifically, FSIS has added additional language to the risk
assessment--both in the summary and in the discussion--to highlight the
results of the modeling without simulated data. To that end, the
results of the modeling with simulated data--which, as would be
expected, had less uncertainty around the estimated change in
illnesses--are not used in support of this rule. The modeling without
simulated data is now carried through in the Regulatory Impact
Analysis. The result of those additions is that the uncertainty around
estimated illnesses avoided is greater; however, the most likely
estimated illnesses avoided are not affected. Notably, FSIS received a
comment questioning FSIS's use of simulated data. FSIS believes that
this change addresses the commenter's questions.
Additionally, minor edits and corrections for clarity and
consistency were made in the main body of the risk assessment report.
The most likely estimates of illnesses avoided from converting from
traditional inspection to the NSIS did not change with incorporation of
these additional analyses and other minor changes to the risk
assessment.
The final risk assessment is available on FSIS's website at https://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-assessments.
FSIS is responding to comments received regarding the risk assessment
in Part C of section II. ``Comments and Responses'' below.
II. Comments and Responses
FSIS received over 83,000 comments in response to the February 2018
proposed rule and five comments on the revised risk assessment. Most of
these comments were form letters submitted as part of various write-in
campaigns initiated by consumer advocacy organizations, animal welfare
organizations, labor unions, and worker advocacy organizations. FSIS
also received individual comments from private citizens.
In addition to the form letters and individual comments, the Agency
also received comments from trade associations representing the meat
industry, companies that conduct swine slaughter operations, consumer
advocacy organizations, public health organizations, animal welfare
organizations, labor unions, worker advocacy organizations, foreign
countries, FSIS inspectors, an environmental organization, and a State
Department of Agriculture. Below is a summary of the comments and
FSIS's responses.
A. Requests for Public Meetings, Comment Extensions, and Documents
Comments: Several consumer advocacy organizations, labor unions,
and worker advocacy organizations stated that FSIS should have held
public meetings to discuss the proposed rule. According to the
comments, public meetings focused on the proposed rule may have helped
to clarify the pros and cons of important proposed changes. A few
consumer advocacy organizations argued that FSIS should have submitted
the risk assessment for peer review before publishing the proposed
rule, or, at least, extended the comment period for the proposed rule
until all stakeholders had the opportunity to read and respond to the
peer reviewed version of the risk assessment.
Response: Rather than hold a public meeting on the proposed rule,
the Agency held two webinars in March and April 2018, to provide an
overview of the proposed rule and provide the public with an
opportunity to ask questions about the proposed rule. (Transcripts of
the webinars are available on the FSIS website at https://www.fsis.usda.gov/wps/portal/fsis/newsroom/meetings/past-meetings.)
During the webinars, FSIS provided the public with all the information
that it would have provided during a public meeting.
The Agency explained during the webinars and monthly consumer and
industry stakeholder meetings that it would reopen the comment period
for the proposed rule if the Agency had to make significant changes to
the risk assessment based on peer review comments. And, even though
FSIS did not have to make significant changes to the risk assessment,
the Agency reopened the comment period on the risk assessment for an
additional 30 days to give stakeholders an opportunity to comment on
the revised document.
In total, stakeholders had 90 days to review and comment on the
proposed rule and 120 days to review and comment on the risk
assessment. Executive Order (E.O.) 12866, as supplemented by E.O.
13563, states that agencies are to ``afford the public . . . with a
comment period that should generally consist of not less than 60
[[Page 52305]]
days.'' The Agency believes that the public had ample time to consider
the issues raised in the proposed rule and risk assessment to develop
their comments.
Comment: A few worker advocacy groups argued that FSIS should have
reopened the comment period on the proposed rule because, according to
the commenters, the Agency relied on an unpublished data set of
Occupational Safety and Health Administration (OSHA) logs to compare
worker injury rates between HIMP and non-HIMP establishments.
Response: In the proposed rule, FSIS explained that the Agency
compared injury rates between establishments operating under
traditional inspection and HIMP (83 FR 4796). FSIS's analysis showed
that HIMP establishments had lower mean injury rates than non-HIMP
establishments. The analysis used injury rate data available on OSHA's
website.
FSIS further explained that the survey captured data from OSHA logs
of workplace injuries and illnesses, maintained by employers as
mandated by regulations (see 29 CFR part 1904), and that 56 FSIS
inspected market hog slaughter establishments submitted their injury
rate data to OSHA (83 FR 4796). From these 56 establishments, FSIS
explained that it excluded 27 low-volume establishments, leaving 29
establishments (5 HIMP and 24 Traditional). The low-volume
establishments were excluded to provide a better comparison group of
traditional establishments because all HIMP establishments are high-
volume establishments. The results showed HIMP establishments had a
lower mean number of injuries using three OSHA injury rate measures:
Total Case Rate (TCR); Days Away, Restricted or Transferred (DART); and
Days Away from Work (DAFW). However, FSIS noted that factors other than
line speed may affect injury rates (e.g., automation and number of
sorters per line) and requested comments on worker safety issues in the
proposed rule as a result.
All the information that FSIS used in its analysis is publicly
available. FSIS does acknowledge that it did not provided the web
address for OSHA's Establishment Specific Injury and Illness Data,
which is available at https://www.osha.gov/pls/odi/establishment_search.html. However, it is easy to find on OSHA's
website under the ``Data'' tab.
And, while FSIS did not post the exact data that the Agency pulled
from its Public Health Information System (PHIS) to select swine
slaughter establishments present in the OSHA data set, the same
information can be found in other formats on FSIS's website.
Establishment level production volume information is available at
https://www.fsis.usda.gov/wps/portal/fsis/topics/data-collection-and-reports/data. This data would allow interested parties to identify the
high-volume establishments. Additionally, the list of establishments
participating in HIMP is available at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/HIMP-list-of-participating-plants.
Although FSIS conducted an analysis of injury rates during the
development of the proposed rule, FSIS did not use the analysis to draw
conclusions on worker safety in HIMP or non-HIMP establishments or
whether there is an associated impact on food safety. As discussed in
more detail below, while FSIS recognizes that working conditions in
swine slaughter establishments is an important issue, the Agency does
not have the authority to regulate issues related to establishment
worker safety. OSHA is the Federal agency with statutory and regulatory
authority to promote workplace safety and health.
Comment: A few commenters argued that FSIS violated the
Administrative Procedure Act (APA, 5 U.S.C. 551 et seq.) because the
Agency did not identify the 21 non-HIMP establishments that it used to
conduct its comparisons for the Hog HIMP Report or post all the raw
data that it used to develop the Hog HIMP Report. According to the
commenters, the APA requires reasoned decision-making based on an
examination of relevant data articulated in a satisfactory explanation.
The commenters argued that because FSIS did not provide all its raw
data, the Agency failed to provide the public a meaningful opportunity
to participate in the rulemaking process.
Response: The APA does not require Federal agencies to post all
their raw data. That said, FSIS is committed to being transparent and
responsive to stakeholders. FSIS clearly explained in the Hog HIMP
Report that FSIS selected the 21 non-HIMP establishments because they
were large, high-volume market hog slaughter establishments that had
similar production volume, line speed, and days of slaughter operation
to the five market hog slaughter HIMP establishments. FSIS also clearly
explained in the Hog HIMP Report and the proposed rule (83 FR 4780,
4789) the Agency's analysis of its inspection data and its conclusions
based on the data. Moreover, FSIS made every effort to respond to FOIA
requests related to the proposed rule before the close of the comment
period. The Agency has added all the information that it has recently
released to its FOIA Electronic Reading Room.\8\
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\8\ FSIS's FOIA Electronic Reading Room is available at https://www.fsis.usda.gov/readingroom.
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B. HIMP
Comment: Several consumer advocacy organizations, public health
organizations, animal welfare organizations, worker advocacy
organizations, and private citizens questioned whether data collected
under the HIMP pilot study should be used to inform the NSIS. The
commenters argued that the USDA's Office of the Inspector General (OIG)
was critical of HIMP in its 2013 report.\9\ The commenters stated that
OIG found that FSIS: Did not adequately oversee the HIMP program
because it did not evaluate whether the program resulted in a
measurable improvement of the inspection process; allowed one HIMP
establishment to forgo the standard FSIS policy to manually inspect
viscera; and did not have formal agreements with the HIMP
establishments.
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\9\ OIG, 2013. Food Safety and Inspection Service, Inspection
and Enforcement Activities at Swine Slaughter Plants, https://www.usda.gov/oig/webdocs/24601-0001-41.pdf.
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According to the commenters, OIG's audit report also raised issues
with the Agency's enforcement policies at all hog slaughter operations,
finding that FSIS's policies did not deter establishments from becoming
repeat violators of food safety regulations and that FSIS could not
always ensure the humane handling of animals.
In September 2013, the U.S. Government Accountability Office (GAO)
followed the OIG with a report entitled, More Disclosure and Data
Needed to Clarify Impact of Changes to Poultry and Hog Inspections.\10\
According to the commenters, GAO found that FSIS did not collect
comparable data from establishments participating and not participating
in the HIMP pilot study. The commenters also stated that GAO found that
the use of volunteer facilities raised questions about self-selection
bias and that information collected from the five market hog slaughter
HIMP establishments would not provide reasonable assurance that any
conclusions could apply more broadly to all swine slaughter
establishments because of the small sample size.
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\10\ GAO, 2013. More Disclosure and Data Needed to Clarify
Impact of Changes to Poultry and Hog Inspections, https://www.gao.gov/assets/660/657144.pdf.
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Response: FSIS addressed OIG's concerns in the Agency's responses
to the audit. In response to the OIG audit,
[[Page 52306]]
FSIS updated its SIP letters (i.e., formal agreements), requiring all
HIMP establishments to conduct the same viscera inspection procedures,
and implemented PHIS, enhancing the Agency's ability to better track
trends in NRs.
In addition, the Agency implemented required supplemental training
after the release of the updated Directive 6900.2, Humane Handling and
Slaughter of Livestock, to improve inspectors' objective observation
and assessment skills. The Situation Based Humane Handling training
modules (Module I and Module II) effectively teach inspectors how to
interpret an egregious or non-egregious inhumane handling event
objectively, and to take appropriate enforcement actions. The training
modules contain fictional scenarios of inhumane and egregious events
and describe in detail how an inspector is to proceed with regulatory
enforcement.
Furthermore, in October 2013, FSIS announced that it hired a Humane
Handling Enforcement Coordinator, who conducts ongoing reviews of
relevant NRs, suspensions and Notices of Intended Enforcement
(NOIEs).\11\ To accomplish this, the Humane Handling Enforcement
Coordinator maintains a database to track the review of NRs and the
review and tracking of suspensions and NOIEs pertaining to violations
of the HMSA. The Humane Handling Enforcement Coordinator also conducts
correlations with inspectors to help them improve their objective
analysis when enforcing the HMSA and related regulations, which serves
to reduce subjective interpretation of inhumane events and their
regulatory outcome.
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\11\ https://www.fsis.usda.gov/wps/portal/fsis/newsroom/news-releases-statements-and-transcripts/news-release-archives-by-year/archive/2013/nr-102313-01.
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To deter repeat violators, the Agency changed the way that it
schedules its in-depth reviews of establishments' food safety systems,
known as food safety assessments (FSAs).12 13 In 2015, FSIS
implemented its Public Health Risk Evaluation (PHRE) methodology, which
consists of a decision-making evaluation that helps Enforcement,
Investigations and Analysis Officers (EIAOs) and DOs determine if an
FSA needs to be scheduled and conducted or if enforcement action is
warranted for a particular establishment. The decision criteria used in
the PHRE include factors such as pathogen testing results, recalls,
outbreaks, regulatory findings, and inspection results at an
establishment. The PHRE methodology and the decision criteria are
described in detail in FSIS Directive 5100.4.\14\
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\12\ See FSIS Directive 5100.1, Enforcement, Investigations and
Analysis Officer (EIAO) Food Safety Assessment (FS) Methodology
available at https://www.fsis.usda.gov/wps/wcm/connect/31bb8000-fb33-4b51-964b-1db9dfb488dd/5100.1.pdf?MOD=AJPERES.
\13\ See FSIS Directive 5100.4, Enforcement, Investigations and
Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE)
Methodology available at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.
\14\ FSIS Directive 5100.4, Enforcement, Investigations and
Analysis Officer (EIAO) Public Health Risk Evaluation (PHRE)
Methodology available at https://www.fsis.usda.gov/wps/wcm/connect/6c30c8b0-ab6a-4a3c-bd87-fbce9bd71001/5100.4.pdf?MOD=AJPERES.
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Rather than schedule routine FSAs every four years, FSIS's Office
of Planning, Analysis and Risk Management (OPARM) provides DOs with a
prioritized list of establishments for PHREs once per month based on
public health risk triggers (e.g., if an establishment has produced
adulterated product). EIAOs review historical data on the listed
establishments and coordinate with inspection program personnel
assigned to the listed establishments to determine if an FSA or other
enforcement action is needed. DOs can still schedule for cause PHREs at
establishments not on the prioritized list (i.e., if there is an
illness or outbreak, significant or repetitive contamination or
adulteration incidents, or repetitive microbiological sampling
failures). The use of the PHRE methodology allows FSIS to better target
establishments for FSAs based on risk and to more effectively deploy
its investigational resources (EIAOs).
In addition, FSIS developed PHIS alerts for inspection personnel
that are triggered when an establishment receives a certain percentage
of NRs for regulations on the Public Health Regulation (PHR) list.\15\
The PHR list, which is updated annually and posted on the Agency's
website, consists of regulations and specific provisions of regulations
that historically have higher rates of noncompliance three months
before a pathogen positive or enforcement action. Each month OPARM
calculates a PHR NR rate for each meat and poultry establishment and
determines if an establishment will be issued a PHR alert or if they
should be considered by the DO for a PHRE, which may lead to an FSA.
PHIS alerts have helped FSIS better identify trends that may warrant an
FSIS enforcement action.
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\15\ See FSIS Notice 15-18, Public Health Regulations and Alerts
for use in Determining Inspection Program Personnel Actions and
Public Health Risk Evaluation Scheduling in Meat and Poultry
Establishments available at https://www.fsis.usda.gov/wps/wcm/connect/8f218f5b-197e-4813-bf92-be29be36ec08/15-18.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=8f218f5b-197e-4813-bf92-be29be36ec08.
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The GAO report identified what it believed to be data gaps in the
HIMP pilot study and recommended that FSIS collect and analyze
information to determine if the HIMP pilot study was meeting its
purpose. FSIS agreed with the recommendation and began working on the
Hog HIMP Report. GAO also identified strengths in the HIMP pilot study,
including that of giving establishments responsibility and flexibility
for ensuring food safety and quality and allowing FSIS inspectors to
focus more on food safety related activities.
While it is true that the five market hog slaughter HIMP
establishments represent a small sample size of establishments, they
collectively represent diversity in geography, corporate structure,
management styles, product distribution patterns, and other variables.
FSIS believes that the volunteer market hog slaughter establishments
participating in the HIMP pilot study, viewed collectively, are typical
of the broader industry.
Comment: Some consumer advocacy groups questioned why the Agency
did not use a third-party contractor to conduct its evaluation of the
hog HIMP pilot study.
Response: FSIS did not hire a third-party contractor to draft the
Hog HIMP Report because the model and the resulting inspection data had
already been reviewed by third-party contractors. As FSIS explained in
the proposed rule, the independent consulting firm, Research Triangle
Institute (RTI), collected baseline organoleptic and microbiological
data in the five market hog slaughter establishments that volunteered
to participate in the HIMP pilot study before they implemented HIMP (83
FR 4780, 4788). These baseline data reflect the performance of these
five establishments under traditional inspection before they
implemented HIMP and provided the basis to establish HIMP performance
standards for food safety defects and non-food safety ``Other Consumer
Protection'' (OCP) defects.
FSIS also explained in the final rule to modernize poultry
slaughter inspection (79 FR 49566, 49573) that in 2002, the Agency
contracted with a third-party technical review team (review team,
henceforth) selected by the National Alliance for Food Safety to review
and evaluate the data collected from young chicken establishments
operating under HIMP. The review team focused on the validity of the
HIMP pilot study design and method to
[[Page 52307]]
determine whether FSIS could use the organoleptic and microbial data
collected under HIMP to compare the performance of establishments
operating under HIMP to the performance of establishments operating
under non-HIMP inspection systems. Overall, the review team found that
the HIMP study design and method were valid and provided a useful and
legitimate comparison of the performance of establishments operating
under HIMP and non-HIMP inspection systems. The review team's findings
are described in the report titled Review of the HACCP-Based Inspection
Models Project by the National Alliance for Food Safety Technical Team
(The Hargis Report).\16\ While the review team did not review data
collected from the market hog establishments operating under HIMP, the
poultry and market hog HIMP models and the resulting inspection data
are very similar. Therefore, FSIS determined there would be no benefit
in hiring another review team to evaluate the HIMP market hog
inspection data.
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\16\ The Hargis Report is available at https://www.fsis.usda.gov/OPPDE/nacmpi/Nov2002/Papers/NAFS97.pdf.
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Comment: A few consumer advocacy organizations stated that the data
used in the Hog HIMP Report is now stale as the Agency analyzed data
from CY2006 through CY2010 and then CY2012 through CY2013.
Response: FSIS disagrees. FSIS has not made any significant changes
to the HIMP model since 2013, and FSIS inspectors are still performing
the same inspection tasks. The Hog HIMP Report findings from CY2006
through CY2010 and CY2012 through CY2013 were very similar. This shows
that not much changed over a seven-year period, and that the model is
stable. No significant changes in swine slaughter, FSIS inspection, or
related regulations have occurred since CY 2013. Therefore, FSIS has no
reason to believe that the data in the Hog HIMP Report is no longer
useful simply because of the passage of time.
Comment: One consumer advocacy group noted that the Hog HIMP Report
shows that there was an increase in total offline verification tasks in
HIMP establishments during CY2012 and CY2013. However, according to the
same commenter, tables 3-2 and 3-3 in the Hog HIMP Report show that
inspectors performed fewer verification tasks in HIMP establishments
than they did in non-HIMP establishments for more than half of the PHRs
in CY2012 and CY2013. According to the commenter, the Agency treats a
total pooled increase in inspection tasks across all regulations as
outweighing the decreases in some inspection tasks. The commenter
argued that FSIS needs to justify why a decrease in any inspection task
for any regulation will not be detrimental to food safety. The
commenter further argued that FSIS did not explain why the PHRs are
relevant.
Another consumer advocacy group complained that the Hog HIMP Report
did not indicate which inspection tasks were scheduled or unscheduled.
The same commenter stated that FSIS did not demonstrate that the
increased offline verification tasks in HIMP establishments were
statistically significant, as opposed to a product of chance.
Response: The Agency uses PHIS to assign scheduled or ``routine''
inspection tasks. Inspectors in large, high-volume market hog slaughter
establishments receive the same number of routine inspection tasks in
both HIMP and traditional establishments. Unscheduled or ``directed''
inspection tasks are initiated by the inspector or their supervisor.
The Hog HIMP Report was not generated to evaluate the benefits of
performing more scheduled versus unscheduled offline inspection
verification tasks. The risk assessment discussed above evaluated,
among other things, the effect of increased offline inspection
verification tasks in swine slaughter establishments. The objective of
the Hog HIMP Report was to determine whether the HIMP inspection system
performs as well as the traditional inspection system in terms of
product safety and wholesomeness, and overall consumer protection. As
FSIS explained in the proposed rule (83 FR 4780, 4790), the Hog HIMP
Report found that inspectors at HIMP market hog establishments are
performing more off-line food safety related inspection verification
tasks than inspectors at traditional market hog establishments,
including an increased level of Sanitation SOP and HACCP inspection
verification tasks. The Hog HIMP Report also found that HIMP market hog
establishments have higher compliance rates with Sanitation SOP and
HACCP regulations, lower levels of non-food safety defects, equivalent
or better Salmonella verification testing positive rates, and lower
levels of violative chemical residues, as compared to traditional non-
HIMP market hog establishments.
FSIS disagrees that the Agency needed to indicate which offline
inspection verification tasks were scheduled and unscheduled or
demonstrate that the increased number of offline verification tasks in
HIMP establishments were statistically significant and could therefore
be used to evaluate whether HIMP market hog establishments performed as
well as traditional market hog establishments. FSIS explained in the
Hog HIMP Report that inspectors conducted more offline inspection tasks
in HIMP establishments largely due to the increased inspection for
visible fecal material, ingesta, and milk contamination under 9 CFR
310.18. FSIS inspectors at hog HIMP establishments inspect a sample of
24 carcasses when they perform a Zero Tolerance verification task
specifically for 9 CFR 310.18, whereas FSIS inspectors at traditional
market hog establishments inspect a sample of 11 carcasses. These Zero
Tolerance verification tasks are required every shift.
Tables 3-2 and 3-3 in the Hog HIMP Report show the number of times
that FSIS inspectors verified compliance with a regulation. These
tables do not necessarily show the number of times a task was
performed. FSIS inspectors verify whether establishments meet
requirements in 9 CFR part 417 when they conduct HACCP tasks; whether
establishments meet requirements in 9 CFR 416.1-6 when they conduct
sanitation performance standards (SPS) tasks; and whether
establishments meet requirements in 9 CFR 416.11-17 when they conduct
Sanitation SOP tasks. And, while inspectors receive the same routine
tasks, not every regulation in tables 3-2 and 3-3 needs to be verified
in every establishment. For example, FSIS inspectors would only verify
whether establishments meet requirements in 9 CFR 416.16(b) if the
establishment maintains records on a computer. In addition, inspectors
would only check 9 CFR 417.3(a)-(c) in PHIS if they were verifying
whether establishments met corrective action requirements after a
deviation. So, the fact that table 3-2 and 3-3 show that FSIS
inspectors verified fewer 9 CFR part 417 regulations in HIMP
establishments does not mean that FSIS performed fewer HACCP inspection
verification tasks in CY2012 and CY2013. Rather, it could mean that
inspectors found fewer deviations that required the subsequent
verification of corrective actions. Therefore, tables 3-2 and 3-3 do
not support the commenter's argument that FSIS conducted fewer tasks in
HIMP establishments, which they claimed could be detrimental to food
safety.
As FSIS explained in the proposed rule (83 FR 4789) and above, the
PHR list is relevant because it consists of regulations that have
higher rates of noncompliance three months before a pathogen positive
or enforcement
[[Page 52308]]
action. The PHR list allows FSIS to focus on specific health related
provisions of regulations that may be the most informative for
prioritizing PHREs and FSAs. FSIS compared the number of verifications
of PHR regulations in HIMP and traditional establishments because non-
compliance with these regulations was determined by OPARM to be an
important indicator of subsequent food safety issues and loss of
process control.
Comment: One consumer advocacy group argued that the increased
offline regulation verifications under HIMP are probably the result of
greater reporting, rather than an actual increase in verifications. The
commenter stated that they have received information that inspectors
find that entering data into PHIS is cumbersome, so they do not enter
data for unscheduled tasks unless they find problems. According to the
commenter, there has been a significant drop in the number of
verification tasks performed since the implementation of PHIS.
Response: FSIS inspectors in both HIMP and non-HIMP establishments
use PHIS. FSIS provides instructions on how to use PHIS in its
directives and notices. As FSIS explained above, an inspector at a
large, high-volume slaughter establishment operating under HIMP would
receive the same tasks as an inspector at a large, high-volume
slaughter establishment operating under traditional inspection, except
that the inspector in the HIMP establishment is instructed to schedule
more carcass verification tasks. The documentation requirements for
inspectors are also the same for HIMP and non-HIMP establishments. The
key difference is that FSIS inspectors in HIMP establishments routinely
document fewer condemned animals, carcasses, and parts because
establishments conduct sorting procedures before FSIS inspection.
Additionally, comments on inspectors not wanting to document completion
of tasks in PHIS are outside the scope of these regulations.
Comment: A few consumer advocacy groups stated that they found 32
instances in which establishments were cited for violating 9 CFR
311.16(a)--Carcasses So Infected that Consumption of the Meat May Cause
Food Poisoning. According to the commenters, these instances occurred
in HIMP establishments rather than establishments operating under
traditional inspection because establishment sorters on the slaughter
line presented carcasses to FSIS that were unfit for processing. The
commenters argued that the Hog HIMP Report should have compared NRs for
9 CFR 311.16(a) in HIMP and traditional establishments.
One consumer advocacy group noted that the Hog HIMP Report shows
that there were statistically significant differences in the weighted,
health-related Sanitation SOP and HACCP NRs for the five Hog HIMP
establishments as compared to those establishments operating under
traditional inspection for a combined four years. The commenter noted
that while the Agency indicated in tables 3-9 and 3-10 that the total
NRs for Sanitation SOP and HACCP PHRs were lower in CY2012 and CY2013
for the 5 HIMP establishments, these establishments had more NRs for
non-compliance with other regulations. The commenter argued that for
certain regulations like 9 CFR 417.3(a)(2), the five HIMP
establishments had higher and statistically significant NRs compared to
the 21 comparable non-HIMP traditional establishments. The commenter
stated that the five HIMP establishments had an 11-fold and three-fold
higher rate of violating 9 CFR 417.3(a)(2) in CY2012 and CY2013,
respectively. The commenter noted that 9 CFR 417.3(a)(2) is a measure
of whether an establishment is maintaining control over a critical
control point. The commenter argued that because the five HIMP
establishments received more NRs for this regulation, they were not
adhering to their HACCP plans, and were out of control more frequently
than the 21 comparable non-HIMP traditional establishments.
The same consumer advocacy group stated that they conducted their
own analysis of NRs issued in the five HIMP establishments and five
comparably-sized non-HIMP traditional establishments from CY2012 to
CY2016. The commenter noted that, based on their own analysis, the five
HIMP establishments had more NRs for non-compliance with 9 CFR 310.18,
416.3-416.5, 416.13, and 417.2. The commenter highlighted an NR that
was issued to a HIMP establishment in 2017 because an establishment
sorter did not identify a carcass with a food safety defect. The
commenter also noted that OIG found that from FY 2008 to 2011, three of
the 10 swine slaughter establishments cited with the most noncompliance
records (NRs) were HIMP establishments. The commenter argued that these
NRs demonstrate that the HIMP inspection system is not as effective as
the traditional inspection system.
Response: FSIS disagrees that these NRs prove that HIMP
establishments lose process control more often than traditional
establishments. In Table 3-9 in the Hog HIMP Report,\17\ PHR
noncompliance rates in CY2012 at the five HIMP market hog
establishments were statistically significantly higher for four
regulations, statistically significantly lower for five regulations,
and not statistically significantly different for eighteen regulations.
Overall, the CY2012 PHR noncompliance rate for Sanitation SOP and HACCP
regulations (9 CFR parts 416 and 417) in the five HIMP market hog
establishments was statistically significantly lower than that for the
21 comparison non-HIMP market hog establishments. In Table 3-10 in the
Hog HIMP Report, PHR noncompliance rates in CY2013 at HIMP market hog
establishments were statistically significantly higher for three
regulations, statistically significantly lower for five regulations,
and not statistically significantly different for nineteen regulations.
Overall, the PHR noncompliance rate in CY2013 for Sanitation SOP and
HACCP regulations in the five HIMP market hog establishments was
statistically significantly lower than that for the 21 comparison non-
HIMP market hog establishments. The Sanitation SOP and HACCP
regulations are among the regulations most strongly related to public
health.
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\17\ https://www.fsis.usda.gov/wps/wcm/connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES.
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Under HIMP, if an establishment does not adequately sort for
carcasses showing signs of septicemia or pyemia, FSIS issues an NR for
9 CFR 311.16(a). FSIS does not issue NRs for this regulation under
traditional inspection because FSIS inspectors are responsible for
identifying and removing food safety and non-food safety defects.
As is explained above, under HIMP, FSIS inspectors inspect a sample
of 24 carcasses when they perform a Zero Tolerance verification task as
opposed to inspecting a sample of 11 carcasses under traditional
inspection. In addition, the Agency's offline inspectors in HIMP
establishments perform more offline inspection activities that FSIS has
concluded are more effective in ensuring food safety than offline FSIS
inspectors perform in non-HIMP establishments operating under the
traditional inspection system. Therefore, FSIS inspectors in HIMP
establishments have more opportunities for detecting noncompliance with
regulatory requirements that are directly related to public health than
inspectors do in non-HIMP traditional establishments.
Comment: Several commenters argued that until FSIS can compare and
[[Page 52309]]
evaluate HIMP and non-HIMP establishment performance using compatible
data, the same data reporting period, and an equal number of
establishments, and show a marked superiority of HIMP establishment
performance, FSIS must not finalize the proposed rule.
Response: FSIS maintains that the data collected during the HIMP
pilot study was valuable for evaluating whether the HIMP inspection
system performs as well as the traditional inspection system. As stated
above, FSIS did compare data from the same reporting periods and
compared establishments with similar HACCP size and production volume.
As stated in the Hargis report, ``[t]he review team noted some issues
related to optimal design and interpretation, but finds that overall
the data collected were both meaningful and useful and that the study
was designed and conducted under real-world conditions and
limitations.'' The review team also concluded that ``the overall design
and methodology . . . were perhaps the best available options to allow
for comparison of organoleptic data between the traditional and HIMP
systems.'' FSIS disagrees that the Agency needs to show that the HIMP
system is superior to the traditional inspection system before it can
finalize the proposed rule.
C. Risk Assessment
Comment: The risk assessment used FSIS microbiological testing and
inspection data from 2010-2011 and data from the HIMP pilot study. A
few consumer advocacy organizations and public health organizations
argued that the data has the following problems: (1) The data is
generated through regulatory programs designed to verify process
control within a given establishment at a specific point in time; (2)
the data is at least seven years old and may not be representative of
current industry practices, and (3) there were only five market hog
slaughter establishments that volunteered and agreed to meet the
additional requirements in the HIMP pilot study, resulting in a biased
sample and results that are not generalizable to all non-HIMP market
hog slaughter establishments.
Response: For purposes of the risk assessment, data from HIMP
establishments were combined with data from traditional establishments
to get a more complete picture of the possible combinations of
establishment characteristics, inspection procedures, and Salmonella
prevalence. The assessment produced estimates of Salmonella illnesses
under scenarios where inspectors perform more offline food safety
activities as compared to traditional inspection. As FSIS explained
above, the data FSIS used in the Hog HIMP Report and risk assessment
are still useful, despite the passage of time, because the HIMP
inspection model has not changed since 2013 and FSIS is still
conducting the same inspection procedures. FSIS also explained above
that the Agency does not believe that the results are biased because
there is evidence that the volunteer establishments participating in
the HIMP pilot study are typical of the broader industry.
Comment: One public health organization stated that the model
predicts that maximum reduction in the percentage of Salmonella
positive samples and market hog-attributable salmonellosis cases occurs
when the average numbers of offline inspection procedures performed
(Scheduled and Performed (SP) and Unscheduled (U)) increase 25 percent
and the numbers of Scheduled but Not Performed (SNP) and NR inspection
procedures decrease 50 percent and 46.67 percent, respectively. The
commenter also stated that FSIS concluded that all establishments under
NSIS are expected to achieve greater process control in response to
increases in FSIS offline inspection tasks in addition to industry-wide
commercial and technological innovation that will likely occur over
time. According to the commenter, these results assume that resources
will be re-allocated within an establishment in such a way that the
FSIS offline inspection resources increase by 25 percent and the number
of scheduled but not performed FSIS tasks decreases by 50 percent. The
commenter questioned if this is achievable given FSIS's current
inspection resources. The commenter stated that if inspection resources
are lost, through attrition or budget cuts, these assumptions may not
be realistic.
Response: The predicted increase in offline inspection resources
and decrease in scheduled but not performed activities are achievable
with FSIS's current inspection resources. In fact, NSIS will allow FSIS
to better use its inspection resources. FSIS discusses the impact of
attrition and budget in more detail in section ``I. Potential Budgetary
Impacts on the Agency.''
Comment: One consumer advocacy organization stated that the risk
assessment shows that the five HIMP establishments had higher NRs (9.4-
times more, when weighted by volume) than the non-HIMP traditional
establishments. According to the commenter, the risk assessment also
shows that NRs are the strongest and a statistically significant
indicator of human illnesses related to consuming contaminated pork.
The same commenter stated that decreasing NRs in all market hog
establishments would have the effect of reducing illnesses by 3,893, or
4.7 percent. The commenter argued that this reduction would be 1.5
times greater than the reduction FSIS expects will be possible (2,533)
by increasing offline verification tasks under NSIS. According to this
organization's analysis, FSIS would reduce more illnesses by decreasing
NRs, compared to redeploying inspection resources under NSIS.
Response: As FSIS explained in the risk assessment, NRs were
included in this assessment for theoretical evaluation only as a
possible decision variable because of inclusion in the NPIS risk
assessment. For this assessment, the variables associated with offline
inspection tasks represent the sum of each type of category across the
various inspection procedure codes in an establishment on each day that
a Salmonella sample was collected. Unlike SP, SNP, and U, NRs depend on
noncompliance by establishments and are strictly not an FSIS decision
variable. Historic occurrences of establishment non-compliance may help
explain variability in pathogen performance that already has been
observed. However, because future NR rates depend on the behavior of
establishments, it is not feasible to assume that the NR rates can be
varied (like SP, SNP, and U) solely by reallocating Agency inspection
resources. Therefore, FSIS considers implementation scenarios that
simulate future changes in the NR variable infeasible, but the
theoretical examination of NRs offers potential risk management
insights.
Comment: A consumer advocacy organization asked, if conducting more
offline procedures at HIMP establishments reduces Salmonella
contamination, why didn't FSIS find a statistically significant
reduction in Salmonella in HIMP establishments as compared to non-HIMP
traditional establishments? The commenter noted that from CY2006
through CY2009 the Salmonella percent positive for market hogs was
lower in HIMP establishments than in non-HIMP establishments, but it
was higher in the HIMP establishments in CY2010. According to the
commenter, data from a baseline Salmonella study from August 2010
through August 2011 found that the Salmonella percent positive for
carcasses in the HIMP establishments was almost one-half the value of
the rate in comparable non-HIMP
[[Page 52310]]
establishments--0.69 percent and 1.35 percent, respectively--but the
difference was not statistically significant. According to the
commenter, FSIS did not explain why the Salmonella percent positive for
carcasses are sometimes higher in HIMP establishments and sometimes
lower as compared to non-HIMP establishments.
Response: The risk assessment was not conducted as a comparison
between HIMP and non-HIMP establishments operating under traditional
inspection. It was a regression analysis that looked at the numbers of
FSIS inspection procedures conducted and Salmonella prevalence at all
swine slaughter establishments together. The risk assessment did show a
statistically significant relationship between increased offline
inspection procedures and reduced Salmonella contamination for
carcasses. In contrast, the Hog HIMP Report compared the average
Salmonella percent positive between the five HIMP establishments and
twenty-one non-HIMP comparison establishments. The latter analysis did
not detect statistically significant differences between these two
establishment groups across years, and this is likely attributable to
the small sample size (number of HIMP and non-HIMP establishments)
relative to the low number of Salmonella percent positives at the post-
chill carcass sampling point.
Comment: A few consumer advocacy organizations and public health
organizations noted that the risk assessment that informed the
modernization of poultry slaughter inspection final rule also predicted
that conducting more offline tasks would likely result in food safety
benefits. According to the commenters, microbial sampling conducted
since NPIS's implementation has not supported this prediction. A few
commenters noted that in a preliminary assessment of NPIS provided to
stakeholders last fall, FSIS indicated that Salmonella and
Campylobacter percent positives were similar between large
establishments that volunteered to operate under NPIS and large
establishments that decided not to change their inspection systems. One
consumer advocacy organization argued that recent data reveal that NPIS
establishments are more likely to fail FSIS Salmonella performance
standards than establishments that have not converted to NPIS. The
commenters argued that like NPIS, NSIS will not have food safety
benefits.
Response: As noted by the commenters, in a preliminary assessment
of NPIS, FSIS found that carcass Salmonella and Campylobacter percent
positives for the group of establishments that had converted to NPIS
were comparable to those for similar establishments that had not
converted to NPIS.\18\ This assessment included all establishments that
had converted to NPIS at that point in time, including the former HIMP
establishments. The assessment also found that the former HIMP
establishments had lower carcass Salmonella percent positives than both
non-NPIS establishments and non-HIMP NPIS establishments, suggesting
that carcass Salmonella percent positives are lower in establishments
with more experience operating under HIMP and NPIS inspection systems.
The Agency will continue to track FSIS carcass Salmonella percent
positives as more establishments convert to NPIS.
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\18\ Update on Preliminary Analysis of Modernization of Poultry
Slaughter, October 2017 available at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/himp-study-plans-resources/poultry-slaughter-inspection.
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The October 2017 preliminary analysis mentioned by the commenters
compared 39 large NPIS establishments, 23 of which were former HIMP
establishments, to 126 large non-HIMP and non-NPIS establishments.
Poultry establishments continue to convert to NPIS, allowing for a more
meaningful comparison between NPIS and non-NPIS establishments. FSIS
analyzed the data and found no statistically significant difference in
the proportion of establishments that fail to meet carcass Salmonella
performance standards between those operating under NPIS and those
operating under the traditional inspection system. Considering
uncertainty, the 95 percent confidence interval for the difference in
proportions includes zero. This provides supporting empirical evidence
independent of the risk assessment model that in practice the NPIS
provides an equivalent level of food safety protection compared to
traditional inspection. FSIS disagrees that the current data shows that
there will be no food safety benefits related to NPIS, and therefore,
there will be no food safety benefits related to NSIS. Especially since
the October 2017 preliminary analysis found that FSIS inspectors are
performing approximately four times more offline verification tasks for
visible contamination in NPIS establishments than in non-NPIS
establishments. FSIS will continue to evaluate the public health impact
associated with NPIS as more establishments convert and experience is
gained with operating under NPIS.
Comment: One consumer advocacy organization noted that FSIS's
uncertainty analysis indicated that there is a 12.5 percent chance that
there will be increased illnesses simply by increasing the number of
scheduled-performed verification tasks. The commenter argued that FSIS
should not finalize a rule that would not improve public health.
Response: The risk assessment analyzed data on specific types of
inspection activities and the prevalence of Salmonella in market hog
slaughter establishments. The results suggest that, because inspection
personnel assigned to NSIS will conduct more of the type of inspection
activities that were correlated with lower Salmonella prevalence, NSIS
will potentially result in fewer human illnesses than would be expected
if not implemented. Therefore, FSIS needs to publish and implement this
rule to be able to shift resources and realize the predicted benefits.
In addition to the estimated values, the analysis provides the
statistical uncertainty of the estimated number of averted illnesses by
reporting the upper and lower confidence bounds around the estimates to
acknowledge that uncertainty always will exist in such models.
Comment: One public health organization stated that FSIS did not
assess the public health impact of increasing establishments' line
speeds in the proposed rule. The same commenter stated that FSIS should
explore the public health impact of increasing line speeds before
finalizing the proposed rule.
Response: While the relationship between line speed and Salmonella
prevalence was not incorporated into the risk assessment model, FSIS
did consider the impact of line speed on HIMP establishment performance
in the Hog HIMP Report. The Hog HIMP Report estimated that in CY2013,
line speeds at the 5 HIMP market hog establishments varied from 885 to
1,295 head per hour (hph), with an estimated average line speed of
1,099 hph. The 21 non-HIMP comparison establishments had estimated line
speeds of 571 to 1,149 hph, with an estimated average line speed of 977
hph. The Hog HIMP Report found that even with slightly faster line
speeds, HIMP market hog establishments had higher compliance with
Sanitation SOP and HACCP regulations, lower levels of non-food safety
defects, equivalent or better Salmonella verification testing positive
rates than the 21 traditional non-HIMP comparison market hog
establishments, and lower levels of violative chemical residues.
[[Page 52311]]
Comment: A few commenters urged the Agency to redo the risk
analysis model using data from FSIS's Salmonella pork cuts and
comminuted pork exploratory testing after that project has been
finalized.
Response: Data from the Agency's pork cuts and comminuted pork
exploratory testing project would not improve the risk assessment.
While the pork parts data may prove useful for monitoring and
evaluating process control during further processing, it will not be
useful for measuring process control during slaughter operations.
Processing establishments purchase primals from multiple slaughter
establishments. Because establishments comingle primals during
processing, they may become contaminated during processing. As a
result, the Salmonella percent positives during processing would not be
reflective of Salmonella percent positives or pathogen contamination at
the end of slaughter operations.
Comment: One animal welfare group argued that the risk assessment
and peer review were too narrow in scope. The commenter argued that the
risk assessment should not have been limited to Salmonella risk but
should have included every potential food safety and public health
risk. The commenter was especially concerned about the risk of Yersinia
enterocolitica and influenza.
Response: FSIS selected Salmonella because it is the most common
cause of foodborne illness associated with pork products and
interventions targeted at reducing Salmonella have been shown to be
effective at reducing contamination by other enteric pathogens, such as
Yersinia enterocolitica. FSIS did not include swine influenza in the
Agency's risk assessment because swine influenza has not been shown to
be transmissible to people through eating pork products.
Comment: One consumer advocacy organization commented that FSIS had
not adequately considered the peer review comments and cited Reviewer
E's comment about whether using simulated data is ``a statistically
legitimate approach.''
Response: After additional internal review, FSIS has decided to add
language to the risk assessment to highlight the results of the
modeling without simulated data (see Table 13 in the risk assessment).
FSIS is confident that it has addressed reviewers' comments on the risk
assessment.
D. NSIS
Comment: Comments from swine slaughter establishments, trade
associations representing the pork industry, and a few private citizens
supported the proposed rule. These comments stated that NSIS will
enhance FSIS inspection procedures and increase industry efficiency
while ensuring safeguards are in place to promote worker safety and
animal welfare.
However, comments from consumer advocacy organizations, labor
unions, public health organizations, animal welfare advocacy
organizations, worker rights advocacy organizations, and private
citizens objected to NSIS for various reasons. Many of these commenters
objected to NSIS because they view NSIS as a system that ``privatizes''
inspection by replacing FSIS inspectors with establishment employees.
Response: FSIS is not privatizing swine slaughter inspection. The
new inspection system will not eliminate FSIS inspection. NSIS simply
requires establishments to take additional steps before FSIS inspection
to ensure that their products are safe and wholesome.
As FSIS explained in the proposed rule, most market hog
establishments under traditional inspection already voluntarily conduct
sorting activities before FSIS ante-mortem inspection (83 FR 4780,
4783). Under NSIS, because establishment employees are responsible for
identifying and removing market hogs that are not fit for slaughter
before FSIS ante-mortem inspection, FSIS inspectors are presented with
healthier animals that are more likely to pass inspection. Under NSIS,
FSIS will continue to conduct ante-mortem inspection. The key
difference is that establishment sorting activities will be mandatory.
Under traditional inspection, establishments conduct no post-mortem
carcass sorting to identify which carcasses and parts appear eligible
to bear the mark of inspection, which carcasses and parts contain
removable defects correctable through trimming, and which carcasses and
parts should be submitted to FSIS for condemnation because of
generalized diseases or conditions. Rather, under traditional
inspection, establishments are required to assign competent assistants
to take such actions as directed by FSIS online inspectors after the
inspectors have conducted the initial inspection activities (see 9 CFR
307.2(g)). Therefore, under traditional inspection, establishments rely
on FSIS online inspectors to effectively control and direct their
processing.
Under NSIS, FSIS inspectors will still be stationed on the
evisceration line and these inspectors will continue to inspect every
head, viscera, and carcass as required by the FMIA. FSIS offline
inspectors will also continue to conduct food safety related inspection
activities and evaluate establishment process controls. However, FSIS
will require establishments operating under NSIS to take a more
proactive role in removing contamination and identifying defects before
FSIS post-mortem inspection.
Comment: A few consumer advocacy groups argued that the proposed
rule's ante-mortem condemnation provisions violate the FMIA. One
consumer advocacy group stated that 21 U.S.C. 603 and 9 CFR 301.9(a)
require FSIS inspectors to examine and inspect each animal before it
can be slaughtered for human food. The consumer advocacy group argued
that FSIS completely disregards this requirement by allowing
establishment employees to ``bypass'' antemortem inspection for 90 to
95 percent of all moving animals not deemed suspect by the
establishment.
Several commenters noted that a former chief veterinarian for FSIS
spoke out against the ante-mortem portion of the proposal, suggesting
that it would increase the risk that FSIS veterinarians could miss the
early signs of a large-scale animal disease outbreak. The commenters
stated that an outbreak could impact food safety while having
devastating economic consequences for U.S. animal producers. According
to the commenters, a large outbreak of Foot and Mouth Disease (FMD) has
the potential to shut off all foreign markets to U.S. beef and pork,
costing American producers an estimated $128 billion over a 10-year
period.
Two foreign countries requested clarification on the role of the
FSIS Public Health Veterinarian (PHV) and inspectors in the context of
ante-mortem activities under the NSIS. The commenters questioned if
FSIS inspectors or veterinarians will inspect all animals or carcasses
removed by the establishment sorters.
Response: As FSIS explained in the proposed rule, animal sorting
procedures under HIMP and NSIS are virtually the same as animal
segregation procedures used voluntarily by most market hog
establishments under traditional inspection. FSIS has allowed
establishments operating under traditional inspection to voluntarily
implement animal segregation procedures since at least the 1980s
without adverse economic consequences.
Most establishments under traditional inspection that slaughter
only market hogs voluntarily segregate animals that show signs of
diseases or conditions from healthy animals before the Agency
[[Page 52312]]
performs ante-mortem inspection.\19\ Therefore, market hog
establishment personnel segregate animals that appear to be normal and
healthy from abnormal or unhealthy animals that appear to have
condemnable diseases or conditions (e.g., animals exhibiting signs of
neurologic conditions, pyrexia, or severe lameness) into ``subject''
pens, where they undergo additional FSIS inspection. FSIS requires
these establishments to document their segregation procedures in their
HACCP plans or prerequisite programs.\20\ FSIS inspectors examine all
animals found by the establishment to be normal at rest, and five to
ten percent of those animals in motion.\21\
---------------------------------------------------------------------------
\19\ See FSIS Directive 6100.1, Ante-mortem Livestock Inspection
available at https://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES.
\20\ See FSIS Directive 6100.1, Ante-mortem Livestock Inspection
available at https://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES.
\21\ See FSIS Directive 6100.1, Ante-mortem Livestock Inspection
available at https://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES.
---------------------------------------------------------------------------
FSIS disagrees that this inspection scheme violates the FMIA. FSIS
inspectors still conduct 100 percent ante-mortem inspection.\22\ If any
animals exhibit signs of condemnable conditions, FSIS inspectors direct
establishment employees to move the animals to the ``U.S. Suspect''
pens for final disposition by the FSIS PHV. The FSIS PHV examines all
animals in the ``subject'' and ``U.S. Suspect'' pens. FSIS inspectors
observe establishment employees performing animal segregation
procedures at least once per month.
---------------------------------------------------------------------------
\22\ See FSIS Directive 6100.1, Ante-mortem Livestock Inspection
available at https://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES.
---------------------------------------------------------------------------
As mentioned above, the key difference, as compared to traditional
inspection, is that sorting procedures are mandatory under NSIS. All
establishments operating under the NSIS must address, as part of their
HACCP system, procedures for sorting animals showing signs of diseases
or abnormalities from healthy animals. These procedures must cover
establishment sorting activities for dead and moribund swine and swine
suspected of having central nervous system (CNS) conditions or pyrexia.
Establishments under NSIS that do not adequately sort for these food
safety defects before FSIS ante-mortem inspection will receive an NR
for noncompliance with 9 CFR 309.19.
Regarding the questions from the foreign countries, FSIS inspectors
inspect every market hog offered for slaughter. However, an
establishment may decide to divert hogs that do not meet its market
specifications to another slaughter facility, where they will receive
100 percent ante-mortem inspection by an FSIS inspector. This is not a
change in policy. Establishments operating under traditional inspection
may also divert hogs to other establishments operating under
traditional inspection. If establishments decide to divert hogs, they
are required to follow the Animal and Plant Health Inspection Service's
(APHIS's) regulations governing the movement of live animals.
Under the NSIS, FSIS inspectors will observe establishment
employees performing sorting procedures. During this time, FSIS
inspectors will verify that animals that are intended to be disposed of
are humanely euthanized and that animals that are intended to be
diverted to another official establishment are eligible for transport.
Comment: Several comments asserted that revoking maximum line
speeds conflicts with the purposes or provisions of the FMIA because
faster line speeds will make it more difficult for FSIS inspectors to
effectively conduct online inspection. A consumer advocacy organization
stated that the FSIS inspectors must provide a ``critical appraisal''
of all carcasses (AFGE v. Glickman, 215 F.3d 7, 11 (D.C. Cir. 2000)).
According to the comments, revoking maximum line speeds will make it
extremely difficult, if not impossible, for FSIS to conduct a critical
appraisal of each hog.
Comments from consumer advocacy organizations and an animal welfare
organization further argued that FSIS does not have the statutory
authority to conduct rulemaking to increase efficiencies for the
government and industry.
Response: Based on FSIS's experiences under HIMP, online inspectors
in HIMP establishments can conduct an effective online inspection of
the head, viscera, and carcass of each hog when operating at faster
line speeds. To ensure that online inspectors will be able to conduct
effective online inspections, FSIS PHVs in all NSIS establishments are
authorized to direct establishments to operate at reduced line speeds
when, in the PHV's judgment, a carcass-by-carcass inspection cannot be
performed within the time available due to the way that the hogs are
presented to online inspectors, or because the establishment is not
maintaining process control (9 CFR 310.26).
FSIS has the authority to change its regulations to conduct more
efficient inspections and to reduce unnecessary regulatory burdens on
industry. As FSIS explained in the proposed rule (83 FR 4780, 4782), 21
U.S.C. 621 provides that the Secretary shall make such rules and
regulations as are necessary for the efficient execution of the
provisions of the FMIA. In addition, this rulemaking is consistent with
E.O. 13563, which directs Federal agencies to review existing rules
that may be burdensome, unnecessary, and outdated and to modify,
streamline, expand, or repeal them accordingly.
Comment: Several comments from consumer advocacy organizations,
public health organizations, worker advocacy organizations, labor
unions, and private citizens objected to FSIS's requirement that
establishment employees sort carcasses and parts before they are
presented for FSIS inspection because the commenters believe that
establishment employees will miss many food safety and OCP defects. A
few commenters referenced affidavits from three FSIS inspectors who
worked in HIMP establishments who stated that because of excessive line
speeds and lack of training, establishment sorters routinely miss many
food safety and wholesomeness defects. The commenters argued that FSIS
must more thoroughly evaluate the proposal to allow establishment
employees to perform preliminary sorting before the Agency implements
NSIS.
Response: The Hog HIMP Report found that the overall performance of
HIMP establishments was as good as non-HIMP establishments. Results
from offline inspections in HIMP establishments, which are conducted
after establishment employees have completed the initial sorting of
carcasses and parts, show that the rates of carcasses with food safety
defects (e.g., septicemia, toxemia, pyemia, and cysticercosis) and
visible contamination from visible fecal material, ingesta, and milk in
HIMP establishments were very low, well below the levels set by the
HIMP performance standards. In addition, as explained in the proposed
rule, OCP defect rates identified on carcasses and parts in HIMP
establishments average about half the corresponding OCP HIMP
performance standard. Therefore, the data from the HIMP pilot study
show that establishment employees do effectively sort carcasses, trim
defects, and identify
[[Page 52313]]
carcasses for disposal before FSIS post mortem inspection.
Comment: Several consumer advocacy groups and a public health
organization recommended that FSIS establish training for establishment
employees performing sorting activities and require sorters to prove
proficiency in performing their duties.
Members of industry stated that establishments operating under HIMP
have been successful at training employees to sort for food safety and
non-food safety defects. These commenters commended the Agency for
creating its sorter guide. The commenters stated that the sorter guide
is comprehensive and consistent with current practices under HIMP.
However, the commenters stated that the sorter guide could be improved
by defining several pathological conditions and veterinary terms not
well-known to industry personnel, as well as updating photos and
diagrams.
Response: FSIS is not prescribing specific sorter training or
certification. FSIS made some editorial changes to its sorter guide to
simplify the guideline. The Agency did not make any significant changes
to its sorter guide in response to comments. FSIS did not think it was
necessary to add the pathological conditions, veterinary terms, or
pictures mentioned in the comments because they are not commonly found
or used. However, FSIS PHVs will be available to discuss conditions and
terms if an establishment has any questions. The guide is available on
the FSIS website at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatorycompliance/compliance-guides-index. As FSIS explained in the
proposed rule, the guide that the Agency has developed is based on the
training that FSIS provides to its online inspection personnel that are
responsible for sorting carcasses under the existing inspection
systems.
Comment: Members of the pork industry and a trade association
representing members of the pork industry requested that FSIS clarify
when NRs will be issued by offline inspectors for carcasses
contaminated with visible fecal material, ingesta and milk. The
commenters noted that the proposed rule stated that FSIS will issue NRs
for every carcass contaminated with fecal material, ingesta, and milk.
According to the commenters, this policy is not consistent with FSIS
Directive 6420.2, which instructs inspection personnel to issue NRs
based on a specific sampling procedure during carcass verification
checks.
Response: FSIS is clarifying that, consistent with FSIS Directive
6420.2, only offline inspectors will issue NRs for fecal material,
ingesta, or milk contamination if they observe the contamination on
sampled carcasses when performing the Livestock Zero Tolerance
Verification task. FSIS online inspectors will not issue NRs if they
observe fecal material, ingesta, or milk contamination on the
carcasses. Rather, online inspectors will stop the slaughter line to
allow for trimming of the carcass by establishment personnel and
reinspection of the carcass by the inspector, unless the establishment
has provided a rail-out loop. FSIS did not intend to change these
inspection procedures with the implementation of this rule.
Comment: Members of the pork industry and trade associations
representing the pork industry stated that the proposed requirement to
immediately denature carcasses that have been sorted and removed from
slaughter is overly burdensome and unnecessary. One trade association
stated that imposing specific denaturing requirements may discourage
establishments from adopting NSIS. That commenter suggested that FSIS
amend the proposed 9 CFR 309.19(c) to read ``the establishment must
dispose of the carcass according to 9 CFR part 314.'' A HIMP
establishment recommended FSIS require that establishments maintain
procedures to control and isolate carcasses and parts removed from
slaughter and demonstrate that they do not enter the human food chain
or immediately denature in accordance with 9 CFR part 314.
Response: FSIS has considered these comments and believes they have
merit. Therefore, FSIS has revised its proposed disposal requirements
and will instead require establishments to develop, implement, and
maintain written procedures to ensure that animals and carcasses that
have been sorted and removed for disposal do not enter the human food
supply and are properly disposed of according to 9 CFR part 314.
Comment: Members of the pork industry and trade associations
representing members of the pork industry noted that APHIS uses FSIS
animal disposition data, collected and maintained through PHIS, to
monitor animal disease rates and identify trends. These commenters all
agreed that these data are useful and should not be lost in the
transition to NSIS. According to these commenters, it would not be
overly burdensome for establishments to keep records of the specific
reasons why hogs are removed from slaughter because they already
produce similar records. The commenters recommended that FSIS work with
establishments on a procedure to transfer disposition information to
APHIS on a regular schedule to ensure the ongoing utility of APHIS's
swine health surveillance programs.
Response: In response to these comments, FSIS has amended its
proposed record keeping regulations to require swine slaughter
establishments to maintain records to document the total number of
animals and carcasses sorted and removed per day and the reasons for
their removal. FSIS has created a form to collect disposition data from
establishments. Establishments may provide the same information as
requested on the form electronically if it is submitted in a format
approved by FSIS; FSIS will provide further instructions on submitting
this data electronically via PHIS later. FSIS will need establishments
to submit their electronic data in a format that is compatible with
PHIS so that the Agency can quickly analyze the data and share it with
APHIS. FSIS has updated its Paperwork Reduction Act analysis to account
for this new requirement.
Comment: Members of the pork industry, trade associations
representing the pork industry, and a foreign country urged the Agency
to allow establishments the discretion to incise lymph nodes when
conducting carcass sorting activities based on their own hazard
analysis. One member of the pork industry stated that they have
demonstrated through testing and a supplier risk assessment that there
is no value in incising lymph nodes to identify pathological
conditions.
The foreign country noted that this approach aligns with the
visual-only inspection methodology already implemented by other World
Trade Organization (WTO) members. According to the foreign country, on-
farm practices (husbandry, biosecurity, etc.) have evolved and improved
to a point that disease transmission risks can be greatly reduced
through effective on-farm controls. The foreign country stated that
palpating and incising the mandibular lymph nodes has been shown to
contribute to cross contamination of pork products by food safety
hazards such as Salmonella and Yersinia. Therefore, the foreign country
argued that moving to a routine visual-only inspection, supported by
supply-chain information from primary production facilities, would
improve food safety systems.
One trade association stated that the administrative hassle
involved in collecting, organizing, and presenting
[[Page 52314]]
supply-chain information to FSIS to demonstrate that animal diseases
like M. avium are not reasonably likely to occur would be unnecessarily
arduous and not worth the benefits related to not incising lymph nodes.
Response: This final rule requires that establishment sorters
incise mandibular lymph nodes and palpate viscera to detect the
presence of animal diseases as part of their sorting activities, as was
proposed (9 CFR 310.26(b)). However, establishments that operate under
NSIS may seek waivers (9 CFR 303.1(h)) under the SIP to 9 CFR
310.26(b). Establishments would need to submit documentation supporting
that the presence of animal diseases like M. Avium is not reasonably
likely to occur. Should FSIS grant these waivers, establishments would
be permitted to decide, on a lot-by-lot basis, whether to incise
mandibular lymph nodes and palpate the viscera to detect the presence
of animal diseases. The Agency has decided to grant waivers, when
appropriate, to gather more information on the public health impact of
such sorting activities to support potential future rulemaking.
Comment: A foreign country requested clarification on the
requirement (9 CFR 310.26(a)) for establishments with fewer than three
inspection stations to have a mirror at the carcass inspection station.
The commenter questioned whether all NSIS establishments will have to
have mirrors at the carcass inspection station. The foreign country was
concerned that this requirement will be more burdensome than necessary,
particularly for small establishments operating at slower line speeds.
Response: FSIS is requiring all NSIS establishments to provide a
mirror so that FSIS can adequately inspect carcasses. Large, high-
volume market hog slaughter establishments under traditional inspection
are already required to provide mirrors to assist FSIS inspection (see
9 CFR 310.1(b)(3) and 307.2(m)(6)).
As FSIS explained in the proposed rule, the Agency does not expect
very small establishments to convert to NSIS because of the costs of
hiring and training establishment sorters.
E. Line Speed
Comment: Members of the pork industry and trade associations
representing members of the pork industry supported FSIS's proposal to
revoke maximum line speed limits for establishments operating under
NSIS. Some of these commenters noted that line speeds were originally
established to define the number of FSIS online inspectors required to
inspect carcasses based on the number of carcasses an individual could
reasonably evaluate in a given period. According to the commenters,
when these limits were set, animal disease prevalence was much higher,
so inspectors needed more time to complete inspection. The commenters
agreed with FSIS's conclusions that innovations in animal housing,
genetics, and processing have been implemented and have improved
livestock conditions at slaughter; therefore, the current line speed
limits are outdated and unnecessary.
Members of the pork industry and trade associations representing
the pork industry also stated that revoking maximum line speeds will
allow establishments to better adapt their line speeds to slaughter
conditions. These commenters argued that line speeds can be adjusted to
optimize efficiencies without jeopardizing worker safety, animal
welfare, food safety, or quality. These commenters noted that the Hog
HIMP Report found that HIMP establishments do not operate at line
speeds that are significantly faster than the current maximum line
speed for market hogs.
Response: This final rule revokes the maximum line speeds for
establishments operating under NSIS. The maximum line speed under the
existing regulations for market hogs is 1,106 head per hour (hph) with
seven online inspectors. Experience from the HIMP pilot study shows
that HIMP establishments operate with an estimated average line speed
of 1,099 hph, and that the line speeds varied from 885 hph to 1,295 hph
(under a waiver). Thus, although they are authorized to do so, market
hog HIMP establishments do not operate at line speeds that are
significantly faster than the current maximum line speeds for market
hog establishments operating under traditional inspection.
NSIS is informed by the Agency's experiences under HIMP, and
establishments operating under HIMP have demonstrated that they are
capable of consistently producing safe, wholesome, and unadulterated
pork products while operating at line speeds above the current maximum
line speeds (for market hogs under traditional inspection). HIMP
establishments also have consistently met pathogen reduction and other
performance standards when operating without prescribed maximum line
speeds. Moreover, NSIS incorporates additional measures that will apply
to all swine slaughter establishments. These measures, which include
carcass testing for microbial organisms at pre-evisceration and post-
chill (or for hot-boned product, pre-evisceration and after the final
wash), are designed to ensure that establishments maintain process
control. As a result, FSIS has decided that line speed limits are not
necessary for establishments operating under NSIS.
Comments: Members of the pork industry and trade associations
representing the pork industry stated that increased line speeds will
not present greater risks for worker safety. One company that owns a
HIMP establishment commented that they have not found a correlation
between line speeds and worker safety issues in their establishment.
According to this commenter, their company's Total Recordable Incident
Rate (an OSHA reporting category) has shown a significant decline in
recordable injuries since they started operating under their line speed
waiver. The commenter also stated that their findings were consistent
with the proposed rule's comparative analysis of injuries, which found
that HIMP establishments had lower mean injury rates than non-HIMP
establishments.
Members of the pork industry and trade associations representing
the pork industry stated that establishments continuously evaluate
worker safety. According to the commenters, establishments actively
work to reduce injuries by implementing ergonomic programs, modifying
processes, and creating additional job positions to distribute manual
tasks among workers.
However, comments from worker advocacy organizations, labor unions,
consumer advocacy organizations, an environmental advocacy
organization, and private citizens asserted that revoking maximum line
speeds will increase risks to worker health and safety in
establishments that operate under NSIS. The comments referenced
studies, reports, and other data on work-related injuries in the meat
processing industry. The most commonly referenced information sources
included:
Documents published by OSHA that state that
musculoskeletal injuries and disorders are prevalent in the meatpacking
industry. In the documents, OSHA recommends that establishments should
reduce line speeds and production rates to decrease injury rates.
2016 BLS data showing that employer reported injury rates
for meat establishment workers who were injured or made ill at work are
2.4 times the rate of workers in other private-sector industries.
[[Page 52315]]
Reports published by the GAO that concluded, among other
things, that injury rates in the meat slaughter industry continue to be
higher than the rates for others in the manufacturing industry, that
meat workers may under-report illnesses and injuries because they fear
losing their jobs, and that employers may underreport worker injuries
because of concerns about potential costs.
Various reports from worker advocacy organizations on
worker safety in meat processing establishments. These reports include
statements from slaughter establishment workers that have suffered
illnesses and injury from the fast-paced repetitive tasks associated
with the current line speeds.
The comments stated that the available studies, reports, and data
contradict FSIS's analysis of worker illness and injury in the proposed
rule.
Response: While FSIS agrees that safe working conditions in swine
slaughter establishments are important, the Agency has neither the
authority nor the expertise to regulate issues related to establishment
worker safety. FSIS has been delegated the authority to exercise the
functions of the Secretary of Agriculture under the FMIA, the Poultry
Products Inspection Act (PPIA; 21 U.S.C. 451 et seq.), and the Egg
Products Inspection Act (EPIA; 21 U.S.C 1301 et seq.) (the Acts). Under
these Acts, FSIS protects the public by verifying that meat, poultry,
and egg products are safe, wholesome, not adulterated, and properly
marked, labeled, and packaged. The Acts authorize FSIS to administer
and enforce laws and regulations solely to protect the health and
welfare of consumers.
The Department of Labor's OSHA was created by the Occupational
Safety and Health Act of 1970 (29 U.S.C. 651 et seq.) to assure safe
and healthful working conditions for men and women by setting and
enforcing standards and by providing training, outreach, education, and
assistance. OSHA is the Federal agency with statutory and regulatory
authority to promote workplace safety and health. FSIS's authority with
respect to working conditions in slaughter establishments extends only
to FSIS inspection personnel.
FSIS has worked with OSHA to develop a poster that establishments
must display providing information on the signs and symptoms of
occupational injuries and illnesses experienced by market hog slaughter
workers, and about workers' rights to report these conditions without
fear of retaliation (see 9 CFR 310.27). This final rule also requires
establishments operating under NSIS to submit on an annual basis an
attestation to the management member of the local FSIS circuit safety
committee stating that the establishment maintains a program to monitor
and document any work-related conditions of establishment workers (9
CFR 310.27). Because OSHA is the Federal agency with statutory and
regulatory authority to promote workplace safety and health, FSIS will
forward these annual attestations to OSHA for use in its own
enforcement program. FSIS employees, however, will not be responsible
for determining the merit of the content of the attestation or for
enforcement of non-compliance with the attestation provision. OSHA and
FSIS will continue to partner through a Memorandum of
Understanding,\23\ to strengthen collaboration between FSIS inspectors
and OSHA enforcement staff and ensure identification and reporting of
safety hazards impacting working conditions of FSIS inspectors and
those of establishment employees.
---------------------------------------------------------------------------
\23\ The MOU is available at: https://www.osha.gov/laws-regs/mou/1994-02-04.
---------------------------------------------------------------------------
Comments: Comments from animal welfare advocacy organizations and
private citizens concerned about animal welfare asserted that revoking
maximum line speeds for establishments that operate under NSIS will
have adverse effects on the humane handling of swine. The comments
expressed concern that faster line speeds would increase the potential
for workers to force animals to move faster than normal walking speeds
and for ineffective stunning. Most of these comments referenced an
undercover video that was taken at a HIMP establishment in 2015.
According to the commenters, the video showed hogs that were beaten and
electrically prodded to move to keep up with the slaughter line speed.
The commenters claimed that the video showed hogs that were conscious
when they entered the scalding tank because they were improperly
stunned.
Several animal welfare groups also claimed that establishment
employees are pressured by establishment management to never slow the
slaughter line. A few commenters stated that they found a Memorandum of
Interview (MOI) issued in 2017 to a HIMP establishment that stated that
an FSIS inspector observed that hog handlers were driving animals too
fast and with more excitement than necessary, in violation of 9 CFR
313.2. According to the commenters, the MOI also stated that the
inspector's concerns had been raised at least twice at weekly meetings
with establishment management. The commenters argued that the MOI shows
that hogs are routinely forced to move too fast in HIMP establishments.
One commenter supported FSIS's decision to add a second offline
inspector to conduct additional offline activities such as monitoring
compliance with the HMSA. However, the commenter opposed FSIS's
decision to decrease the total number of FSIS in-plant personnel.
Response: FSIS disagrees that revoking line speeds will have a
negative effect on animal welfare. As the Agency explained in the
proposed rule, FSIS was able to conduct more offline humane handling
verification tasks under HIMP as compared to traditional inspection. As
is the case under HIMP, more inspection resources will be available to
verify whether establishments meet humane handling requirements as an
offline activity under NSIS.
Regarding the undercover video, multiple FSIS experts--including
trained veterinarians and humane handling experts--reviewed the video
and determined that there was unacceptable rough handling and
inappropriate use of a rattle paddle to drive animals. FSIS took
immediate regulatory action against the establishment and required it
to respond with acceptable corrective actions to prevent a recurrence.
While a person in the video suggests that animals were conscious
after stunning, FSIS found that the animals appeared properly stunned
and insensible to pain, as required by Federal law. The video was
reviewed by a professor of animal science, who reached the same
conclusion.
FSIS reviewed the 2017 MOI that stated that an FSIS inspector
observed that hog handlers were driving animals too fast and with more
excitement than necessary. FSIS has instructed its inspection personnel
to properly document noncompliance in NRs and not MOIs.
Comment: One animal welfare organization noted that they submitted
a petition in 2014 requesting that the Agency require all swine
slaughter establishments to immediately and humanely euthanize non-
ambulatory disabled (NAD) pigs. According to the petition, prohibiting
the slaughter of NAD pigs would improve inspection efficiency and
compliance with the HMSA, as well as reduce Salmonella risks. The
animal welfare organization argued that FSIS must respond to their
petition before finalizing the proposed rule.
Response: After carefully considering the issues raised in the
petition, along
[[Page 52316]]
with the referenced information and other letters received in support
of the petition, FSIS has concluded that its existing regulations and
inspection procedures are sufficient and effective in ensuring that NAD
pigs are handled humanely at slaughter and in preventing diseased
animals from entering the human food supply. Consequently, the Agency
is denying the petition. The Agency's final petition response is
available at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/petitions. FSIS denied a similar petition in 2013
requesting that the Agency prohibit the slaughter of all NAD livestock.
That petition response is also available at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/petitions.
F. Ready-to-Cook
Comment: Members of the pork industry and trade associations
representing members of the pork industry generally support the
proposed RTC pork product standard. However, the commenters requested
that FSIS amend the definition to include language such as ``reasonably
free,'' or ``sufficiently free,'' to clarify that the RTC standard is a
standard for non-food safety defects and not a zero-tolerance standard.
These same commenters recommended that the Agency allow
establishments to apply the RTC standard at any appropriate location at
or before the point of packaging or to clarify that the Agency intends
this type of flexibility if that is the case. One trade association
said that because an establishment may apply processes targeting RTC
criteria and other quality issues at various locations after the
cooler, FSIS should not inspect for RTC criteria before the cooler. The
commenter argued that there is no food safety concern associated with
carcasses and parts that may not yet meet the RTC standard entering the
cooler.
Members of the pork industry, trade associations, and a foreign
country asked FSIS to clarify when FSIS inspectors can slow or stop the
evisceration line because of non-food safety defects in establishments
operating under NSIS. These commenters also asked FSIS to clarify how
the Agency will document noncompliance with RTC standards. According to
the commenters, online inspectors should be instructed to stop the line
only to remove food safety defects after the establishment's final
control, and NRs should only be given after offline personnel assess
and confirm a loss of process control.
A trade association noted that several processing defects covered
in the RTC definition are listed under 9 CFR 310.18(a), which applies
to all swine establishments and is typically enforced as a zero-
tolerance standard. The commenter also noted that 310.18(a) is
regularly categorized as a PHR. The commenter was concerned that if an
NSIS establishment receives an NR for 9 CFR 310.18(a) for failure to
meet RTC standards, it will unjustly influence the establishment's PHR
rate. Rather than cite 9 CFR 310.18(a), the commenter suggested that
inspectors should cite 9 CFR 310.26(d)(1) for products not meeting RTC
standards at NSIS establishments to delineate NRs for non-food safety
issues from NRs for food safety issues.
Response: Under NSIS, establishments will have the flexibility to
design and implement measures to address OCP defects that are best
suited to their operations. They will also be responsible for
determining the type of records that will best document that they are
meeting the RTC pork product definition. The records will be subject to
review and evaluation by FSIS offline inspectors (9 CFR 310.26(d)(1)).
FSIS has decided to amend the definition of RTC pork product to
clarify that it is not a zero-tolerance standard. RTC pork product will
now be defined as ``any slaughtered pork product sufficiently free from
bile, hair, scurf, dirt, hooves, toe nails, claws, bruises, edema,
scabs, skin lesions, icterus, foreign material, and odor, which is
suitable for cooking without need of further processing.''
FSIS also is clarifying that the RTC definition applies to pork
products at the end of the slaughter process and before carcasses and
parts enter the cooler. This is consistent with the Agency's
requirements under HIMP and NPIS.
FSIS will issue instructions to its inspectors on how to verify the
RTC pork product requirements using the routine and directed PHIS Swine
RTC task. When conducting the routine task, FSIS offline inspectors
will verify that an establishment maintains records as required by 9
CFR 310.26(d)(1). FSIS will issue an NR for 9 CFR 310.26(d)(1) if an
establishment does not have records to document that the products
resulting from its slaughter operation meet the definition of RTC pork
product.
If FSIS online inspectors believe that the presentation of
persistent unattended trim or processing defects indicates a lack of
process control, they will notify the PHV. The PHV may then tell an
offline inspector to conduct a directed PHIS Swine RTC task. FSIS
offline inspectors will follow the same method and apply the same
criteria that the establishment uses to check that they are meeting the
RTC standard. FSIS will issue an NR for 9 CFR 310.26(d)(1) if the
results exceed the criteria set by the establishment or if the
establishment did not take the necessary corrective actions to restore
process control when the evaluation criteria was exceeded.
If the PHV determines that the presentation of persistent
unattended trim or processing defects indicates a loss of process
control that affects the online inspectors' ability to adequately
conduct a carcass-by-carcass inspection, the PHV will direct the
establishment to reduce its line speeds. The PHV will then issue an NR
citing 9 CFR 310.26(d)(1).
FSIS inspectors will use PHIS to link all NRs that are issued for
the failure to meet the RTC pork product standard and associated
documentation requirements. If establishment management is unwilling or
unable to take the necessary steps to re-establish control of its
process to meet RTC regulatory requirements, FSIS inspectors will
discuss the issue with their supervisor and the DO. The DO will notify
the establishment in writing that repeated NRs may lead the Agency to
take a regulatory control action (9 CFR 500.2).
In the rare case that FSIS online inspectors identify a carcass so
affected with non-food safety defects (e.g., malignant lymphoma,
icterus, or uremia) that the entire carcass must be condemned, they
will stop the line for carcass condemnation unless the establishment
provides a rail-out loop to rail carcasses offline for reexamination
and condemnation.
G. Implementation
Comment: One member of the pork industry supported the NSIS
implementation strategy suggested in the proposed rule. However, the
pork producer requested more information on whether two shift
operations must convert both shifts to NSIS at the same time. The same
commenter also requested more information on what would happen if an
establishment that converted to NSIS decided it wants to move back to
traditional inspection.
A trade association noted that FSIS's implementation plan for NPIS
was phased in with close coordination with DOs and establishments. The
commenter stated that FSIS should follow a similar implementation plan
for NSIS, with an initial notification period for establishments that
want to adopt NSIS and an algorithm to
[[Page 52317]]
determine transition order. This commenter also suggested a phased-in
approach for the mandatory provisions for all swine establishments
based on establishment size.
The same trade association stated that establishments should submit
for approval unique transition plans to the DO when providing
notification that they intend to adopt NSIS. The trade association
suggested that FSIS identify and provide acceptable examples of
transition plan elements. According to the commenter, pre-approved
elements should include transitioning single inspection stations in
succession, one shift at a time, one inspection focus area (i.e., head
inspection) at a time, RTC monitoring before transitioning inspection
activities, and others.
Consumer advocacy organizations stated that only establishments
that have their HACCP plans approved by FSIS should be allowed to
implement NSIS. The commenters suggested that FSIS should review every
establishment's HACCP plans to determine if their tailored
microbiological testing programs are valid before allowing them to
convert to NSIS.
Response: All market hog establishments will initially have six
months to notify their DO of their intent to operate under NSIS.
Establishments that do not notify their DO of their intent to
transition during this time will be deemed to have chosen to continue
to operate under traditional inspection. Market hog establishments that
decide that they would like to convert to NSIS after the initial
notification date may notify their DO of their intent at any time after
that date. The Agency will implement NSIS in the additional
establishments that intend to convert on a schedule consistent with the
availability of Agency resources and establishment readiness. The
Agency intends to implement NSIS in all market hog establishments that
choose to operate under this new inspection system, regardless of when
the establishment notifies FSIS of its intent to transition to NSIS.
However, the initial implementation wave will only include those
establishments that submit their intent to convert to NSIS within the
initial notification period.
Because there are fewer market hog establishments than poultry
establishments, the Agency does not think it will be necessary to use
an algorithm to determine transition order. FSIS also does not think it
is necessary to require establishments to develop formal transition
plans. Establishments will need to transition all shifts and inspection
stations to NSIS at one time. However, FSIS DOs will work with
establishments to ensure a smooth transition from traditional
inspection to NSIS. And, if necessary, FSIS DOs will work with
establishments to ensure a smooth transition from NSIS back to
traditional inspection.
FSIS does not think it is necessary to review HACCP plans before
establishments convert to NSIS. FSIS already has inspection tasks in
place to verify that establishments are properly implementing their
HACCP systems in accordance with 9 CFR part 417.
The Agency is establishing separate applicability dates for large,
small, and very small establishments to comply with the regulations
that prescribe procedures for controlling contamination throughout the
slaughter and dressing process in 9 CFR 310.18(c), and the regulations
that prescribe recordkeeping requirements in 9 CFR 310.18(d). The
applicability dates will provide additional time for small and very
small establishments to comply with these provisions.
H. Environmental Assessment
Comments: Comments from an animal welfare advocacy organization and
an environmental advocacy organization stated that before FSIS can
finalize the proposed rule, the Agency must prepare an Environmental
Impact Statement (EIS), as required under the National Environmental
Policy Act (NEPA; 42 U.S.C. 4321 et seq.) because, according to these
commenters, allowing market hog slaughter establishments to increase
line speeds will result in significant environmental impacts. The
commenters stated that faster line speeds would mean more hogs
slaughtered per shift. According to the commenters, more hogs
slaughtered would mean more waste and more water use. The commenters
asserted that these are all significant environmental impacts, with
both individual and cumulative effects at the local, state, and
national levels. The commenters also stated that FSIS cannot claim the
categorical exclusion from the preparation of an Environmental
Assessment (EA) or an EIS under 7 CFR part 1b of the USDA regulations.
Response: FSIS maintains that this rulemaking is categorically
excluded from NEPA requirements. Federal agencies may identify classes
of actions that normally do not require the preparation of either an EA
or EIS because such actions do not have a significant effect on the
human environment, either individually or cumulatively (40 CFR
1507.3(b)(2)). Such classes of actions are ``categorically excluded''
from NEPA requirements (40 CFR 1508.4). Under 7 CFR 1b.4, all FSIS
actions, including inspection functions, are categorically excluded
from preparation of an EA or EIS unless the Agency head determines that
a particular action may have a significant environmental effect.
Accordingly, FSIS is not required to prepare an EA or EIS unless it
anticipates that this rule may have a significant environmental effect.
The Agency does not anticipate that its decision to revoke maximum
line speeds for establishments that operate under NSIS will have
individual or cumulative effects on the environment. As FSIS explained
in the proposed rule, expected sales of pork products to consumers will
determine the total number of hogs that an establishment slaughters,
not the maximum line speed under which it operates. The Agency has no
authority to determine an establishment's production levels. An
establishment may decide to increase production hours to slaughter more
hogs in response to market demand, regardless of its maximum line
speed. Revoking maximum line speeds allow establishments to slaughter
hogs more efficiently but will not directly affect consumer demand for
the establishment's pork products. In some instances, an establishment
operating under NSIS may be able to reduce its hours of operation while
maintaining production at a rate necessary to meet market demand for
its meat products. Thus, revoking line speeds is not expected to
determine the number of hogs slaughtered or result in more waste or
more water use, as suggested by the commenters.
In addition, all slaughter establishments, regardless of line
speed, are required to meet all local, State, and Federal environmental
requirements.
Sampling
Comments: Comments from consumer advocacy organizations and public
health organizations supported FSIS's decision to require
establishments to develop written procedures to prevent and mitigate
microbial contamination of carcasses throughout the entire slaughter
and dressing operations and incorporate the intervention strategies
into their HACCP systems. These same commenters stated that sampling at
pre-evisceration and post-chill will make it easier for establishments
to see if their process control system is working. According to the
commenters, microbial testing at the end of the process encourages
industry to focus primarily on post-slaughter interventions, while the
new approach encourages them to focus on prevention and mitigation of
[[Page 52318]]
microbial contamination throughout the slaughter process.
Response: FSIS agrees that requiring establishments to keep written
records to document the implementation and monitoring of their process
control procedures is a positive step forward for public health. This
ongoing documentation will allow both the establishment and FSIS to
identify specific points in the production process where a lack of
process control may have resulted in product contamination or
insanitary conditions. This will allow the establishment to take the
necessary corrective actions to prevent further product contamination.
Comments: Comments from members of industry stated that FSIS should
revise the proposed rule to remove sampling schemes based on
establishment size. According to the commenters, basing sampling
frequency on the size of the establishment is not supportable from a
statistical sampling point of view. The commenters suggested that FSIS
propose a minimum sampling frequency for all establishments based on
the number of head slaughtered, over a certain time period.
Response: FSIS changed its proposed sampling frequency to remove
the exception for very small establishments. Under this final rule,
very small establishments will need to sample carcasses at pre-
evisceration and post-chill (for hot-boned product, carcasses sampled
at pre-evisceration and after the final wash) at a frequency of one per
1,000 carcasses. However, FSIS has decided to keep the exception for
very low-volume establishments. This change makes the sampling
requirements for swine slaughter establishments more consistent with
the sampling requirements for poultry slaughter establishments.
Additionally, if FSIS adopted a sample frequency of one per 1,000
carcasses for very low-volume establishments, many of these
establishments would not have to sample at all.
Comment: Several consumer advocacy organizations and one public
health organization objected to FSIS's proposal to allow establishments
to develop their own sampling and testing protocols and to use
alternate sampling locations and frequencies. These same commenters
argued that it would be too difficult for FSIS inspectors to verify
sampling plans that use alternate sampling locations and frequencies.
Two consumer advocacy organizations argued that FSIS's Salmonella
performance standards remain a core element of HACCP and should not be
eliminated under the proposed rule. One consumer advocacy organization
argued that FSIS must not move forward with proposed inspection changes
without maintaining a pathogen-specific performance standard. The
commenter argued that modernized, HACCP-based inspection cannot
function adequately without such a performance standard. The commenter
further stated that uniform microbial testing is necessary to evaluate
the impact of FSIS's planned inspection changes, as the Agency will not
be able to verify trends in pathogen rates caused by the inspection
changes without an effective national testing program.
One consumer advocacy organization argued that FSIS should maintain
the current generic E. coli testing standard. Although the commenter
did not oppose substitution of another indicator organism for generic
E. coli, they argued that FSIS must ensure that any newly permitted
testing program is evidence-based and equal or superior to the prior
generic E. coli standard for fecal contamination detection. The
commenter recommended that FSIS require establishments who seek to use
an alternative testing program to the generic E. coli standard to apply
for a regulatory waiver, which would allow for pre-implementation
Agency review.
Response: The purpose of the new sampling requirement is to ensure
that establishments monitor and evaluate the effectiveness of their
procedures to prevent contamination of carcasses by enteric pathogens,
and visible fecal material, ingesta, and milk on an ongoing basis. It
is not intended to generate data to compare establishment performance
across the industry.
However, FSIS has determined that it may be too difficult for
inspectors to review and verify sampling plans that use alternate
sampling frequencies and locations. As a result, FSIS is withdrawing
the proposal to allow establishments to use alternate sampling
frequencies and locations. Establishments that still wish to use
alternate sampling frequencies and locations may submit a SIP waiver
request to FSIS for review.\24\ As is noted above, FSIS will provide
information about waiver criteria in a future Federal Register
document.
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\24\ See FSIS Compliance Guideline Procedures for New Technology
Notifications and Protocols available at https://www.fsis.usda.gov/wps/wcm/connect/c64d8f3b-56aa-49c9-91f3-daf0caaba6bd/New-Technology-Protocols-042015.pdf?MOD=AJPERES.
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As FSIS explained in the proposed rule, FSIS discontinued its
Salmonella verification sampling program for market hogs (carcasses) in
2011 to make better use of its resources. Because verifying the
codified performance standards for market hogs was not a good use of
Agency resources, and the standards have not been used since 2011, FSIS
is removing the carcass Salmonella performance standards for market
hogs. With that said, FSIS is currently testing pork cuts and
comminuted pork products for Salmonella and expects to decide in 2019
whether to develop new pathogen performance standards for these
products or take other actions to address Salmonella in these
products.\25\ FSIS pathogen test results for pork products are posted
quarterly on the FSIS website: https://www.fsis.usda.gov/wps/wcm/connect/df529ce7-575a-43e7-9219-48be29c80fa5/Sampling-Project-Results-Data.xlsx?MOD=AJPERES.
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\25\ See U.S. Govt. Accountability Office, GAO-18-272, Food
Safety: USDA Should Take Further Action to Reduce Pathogens in Meat
and Poultry Products (March 2018). https://www.gao.gov/assets/700/690709.pdf.
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Establishments may continue to sample for generic E. coli. FSIS
considers the requirements under the former regulations for generic E.
coli to be a scientifically validated ``safe harbor'' for monitoring
process control, specifically for fecal contamination. FSIS previously
granted waivers under the SIP to the generic E. coli testing
regulations for establishments that want to test for other indicator
organisms. Establishments operating under these waivers have
demonstrated that they are able to effectively maintain process control
based on their SIP sampling data.
Comments: Several members of industry, trade associations, and a
State Department of Agriculture objected to the proposed pre-
operational environmental sampling requirements. One HIMP establishment
stated that environmental sampling would be an expensive change with
little value. The commenter argued that current HIMP establishments
have not been required to conduct environmental sampling beyond those
tests that may also meet the Sanitation SOP requirements, and these
establishments have shown consistent or better performance controlling
for Salmonella.
A few public health organizations stated that requiring facilities
to monitor and assess food contact surfaces for enteric pathogens is a
reasonable measure given that recent investigations of Salmonella
foodborne illness outbreaks revealed food contact surfaces to be
contaminated with the outbreak strain. The commenters stated that
requiring pre-operational environmental sampling should help ensure
that
[[Page 52319]]
surfaces are sanitary and free of enteric pathogens.
Response: This final rule does not require swine slaughter
establishments to develop, implement, and maintain in their HACCP
systems written procedures to prevent contamination of the pre-
operational environment by enteric pathogens. In response to concerns
about the regulatory burden, FSIS has decided to withdraw this part of
the proposal until it considers options and timing for gathering more
data on enteric pathogen contamination in the pre-operational
environment. FSIS agrees that current HIMP establishments have shown
consistent performance controlling for Salmonella.
Comments: Several members of industry, industry trade associations,
and private individuals objected to certain content in the sampling
guide. These commenters argued that the language in the sampling guide
is prescriptive in both tone and language and implies mandatory
requirements. The commenters stated that the sampling guide includes
unhelpful and problematic sampling methods, techniques, and analysis,
as these depend on individual establishments' sampling programs. For
example, several commenters argued that, absent codified standards,
Table 4 in the sampling guide would be a de facto performance standard,
contrary to the objectives in the proposed rule. The commenters stated
that the sampling guide should be revised to promote sampling programs
tailored to each establishment. One industry commenter further argued
that the word ``compliance'' should be removed from the document title
to be consistent with recent changes to other FSIS guidance documents
and because the document provides best practice recommendations and not
regulatory requirements.
Response: FSIS guidance documents are intended to provide best
practices and, in some cases, safe harbors based on the most current
science available to Agency stakeholders to help them comply with
regulatory requirements, and when applicable, meet performance
standards. The sampling guide explains that FSIS considers the
requirements under the former regulations for generic E. coli to be a
scientifically validated ``safe harbor'' for monitoring process control
for very low-volume establishments. The sampling guide also includes
recommendations to assist small and very small establishments to meet
regulatory requirements, and recommendations to develop a custom
approach that are not dependent on establishments' available resources.
For example, the sampling guide provides baseline information for those
establishments that may need a starting place from which to calculate
their own control limits. However, control limits change over time as
establishment-specific data is collected and analyzed. FSIS has removed
Table 4 and replaced it with a new table (Table 2) to provide better
guidance for establishments that may want to use data from the 2010-
2011 market hog baseline survey as an initial starting point from which
to set their upper control limits. Therefore, the information provided
in the document is not a performance standard.
In response to the comments, FSIS has revised the sampling guide
to, in part, further clarify the purpose of the document, which is to
assist small and very small establishments to comply with the new
microbial organism sampling requirements that apply to all swine
slaughter establishments under this final rule. The sampling guide has
also been revised to include additional information on the intended use
of provided methods, techniques, and analyses; and to remove the word
``compliance'' from the document title and clarify that the document
does not constitute regulatory requirements. Additionally, the Agency
moved the example control charts from the sampling guide from the
sampling guide to Appendix 2 of the guideline and clarified how
establishments can use control charts. The Agency did not recommend a
specific control chart format. Finally, the Agency removed all
references to pre-operational environmental sampling. The updated
sampling guide is available at https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
Comments: Several commenters objected to certain information
provided in the sampling guide related to indicator organism sampling
and testing. One industry commenter stated that both the proposed rule
and the sampling guide, as written, could mandate a shift from
analyzing market hog carcasses for enteric pathogens of concern, such
as Salmonella, to monitoring a surrogate, such as Aerobic Plate Count
(APC). The commenter argued that this process control approach is too
singular, and FSIS should clarify in the sampling guide that
establishments will maintain the flexibility to select for one or more
indicator organisms. In addition, several commenters argued that FSIS
should revise the sampling guide to remove sampling schemes based on
establishment size. They stated that, from a statistical sampling
viewpoint, establishing sampling frequency based on the size of the
establishment is not supportable. These commenters also stated that
generic E. coli testing should not remain a ``safe harbor,'' even for
small and very small establishments, because no scientific correlation
exists between microorganism presence/growth and facility size.
Finally, one industry commenter noted that the sampling guide does not
summarize all known control points for Salmonella, as the document
claims it does.
Response: The sampling guide provides flexibility and monitoring
options for establishments, and it makes clear that establishments may
select one or more indicator organisms to monitor.
To address the comment about the singular process control approach,
the sampling guide provides a link to the December 2013 FSIS guideline
for controlling Salmonella in market hogs, which describes potential
control points for Salmonella in the pre- and post-harvest production
process. The potential control points described in that 2013 guideline
may or may not be applicable to a specific establishment's process.
Comments: Several commenters expressed concerns with information
provided in reference and example charts throughout the sampling guide.
One member of the pork industry and one trade association representing
the pork industry argued that establishments should not compare process
control results to a nationwide geometric mean displayed in one chart.
The commenters argued that market hog data is an inappropriate basis
for developing upper control limits, as it is not applicable to all
swine establishments. Further, they stated that these data from 2011
are outdated. One commenter stated that ``under NSIS'' should be
removed from one table column heading, as the information would apply
to all swine establishments.
Response: FSIS revised the sampling guide to remove the table that
provided averages that represented the 80th percentile limits for each
indicator organism included in FSIS's 2010-2011 market hog baseline
survey. The Agency also removed the ``under NSIS'' language from the
table that provides information for all swine establishments
In cases where an establishment does not have the resources or
capacity to initially develop its own statistical control limits or
analytical procedures, an establishment can utilize the aggregated data
from the FSIS Nationwide Market Hog Microbiological Baseline Survey.
The 2010-2011 baseline survey provides a wealth of microbiological data
specific to swine
[[Page 52320]]
carcass sampling; these data are meant to provide a starting point for
an establishment to develop its own control limit parameters over time.
During the survey, FSIS collected two carcass samples at pre-
evisceration and post chill.
Comment: One member of the pork industry and one trade association
representing the pork industry recommended that FSIS remove from the
sampling guide information related to finished product standard (FPS)
waivers, as the subject is unrelated to the sampling guide.
Response: FSIS has removed the FPS waiver information from the
sampling guideline.
I. Economic Assessment
Comment: One company that owns a HIMP establishment said that the
cost of additional employees has been their most significant cost from
the HIMP pilot study, and that they have had to hire and train up to 11
employees per shift to staff and maintain the inspection process.
Response: FSIS incorporated information from this comment into
section III.G.1.a by revising the upper bound estimate from 10
employees to 11 in the description of additional establishment workers
likely to be required by establishments that adopt the NSIS.
Comment: One industry commenter estimated that a full-time
position, per slaughter shift, would be required to collect, record,
and analyze data required to verify that an establishment's products
meet the definition of RTC.
Response: While establishments are free to design their own process
control monitoring systems, FSIS finds the estimated time and labor
requirement provided in this comment to be inconsistent with FSIS's
observations of HIMP establishments verifying OCP performance
standards. FSIS explained in the proposed rule that pork carcasses that
meet the HIMP OCP performance standards would meet the RTC pork product
definition. Large swine establishments can verify OCP performance
standards by taking 24 carcass samples per shift, requiring roughly one
hour to collect, record, and analyze the data.
Comments: Several comments from members of the pork industry stated
that they own establishments that operate under SIP waivers and conduct
process control sampling at alternate frequencies.
Response: FSIS incorporated the information from these comments
into section III.G.2.b of the final rule and used it to revise the cost
estimate associated with changes to requirements for microbial organism
process control sampling and analysis. This revision caused a slight
decrease in potential industry savings. Under the SIP, 11 large swine
establishments currently sample at an alternative frequency and the
Agency assumes that these establishments will continue to do so when
the applicability dates for this final rule arrive. As such, these
establishments are not expected to change their process control
sampling and will not experience a change in associated costs.
Comment: One member of the pork industry claimed that process
control sampling requirements would increase cost.
Response: As is detailed in section III.G.2.b of the final rule,
overall, the changes in process control sampling requirements were
estimated to reduce industry wide sampling costs by about $0.57 million
annualized over 10 years, applying a three percent discount rate.
Comment: One member of the pork industry reported that all six of
their company's facilities have written sanitary dressing plans.
Response: FSIS incorporated information from this comment into
section III.G.2.a of the final rule to reduce the cost estimate
associated with developing, composing, training, monitoring, recording,
and verifying written sanitary dressing plans to reflect that six
establishments already have written sanitary dressing plans.
Comment: One company stated that many small and very small
establishments are unlikely to adopt the NSIS due to the program's
costs.
Response: FSIS agrees that many small and very small establishments
are unlikely to adopt the NSIS. The Agency's cost benefit analysis
assumes that very small establishments that exclusively slaughter
market hogs do not have a high enough production volume to justify
incurring the costs of converting to the NSIS.
Comment: One company participating in HIMP stated that it invested
in capital expenditure projects to add or relocate inspection stations
and reconfigure lines.
Response: The NSIS may require a minor capital improvement if the
establishment does not already provide a mirror at the carcass
inspection station. All the large high-volume establishments are
already required to provide mirrors under existing regulations.
Providing a mirror is a minor potential cost for a limited number of
establishments.\26\ If an establishment believes that additional
capital expenditures will result in a benefit, they may voluntarily
reconfigure or update their facilities to fully capture all the
potential production efficiencies offered through participation in
NSIS. Examples of such changes include line reconfiguration, which can
cost between $10,000 and $250,000 and the creation of an inspection
station, which can cost between $5,000 and $6,000. Establishments may
reduce these costs by coordinating these facility updates with
previously planned establishment renovations.
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\26\ The cost was estimated to be very small because all 22
large high-volume establishments and potentially several of the 13
small high-volume establishments are already required to provide
mirrors. As such, any new expense would be negligible compared to
the industry costs included in the cost-benefit analysis.
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Comment: A few consumer advocacy organizations claimed that the
Agency's cost benefit analysis understated training costs because the
industry has a high turnover rate, necessitating that training take
place more frequently than once per year.
Response: FSIS used BLS' industry turnover rate for non-durable
manufactured goods to estimate annual training costs. Section III.G.1.a
of the final rule provides additional details on how the cost benefit
analysis estimates industry's training costs, which includes training
new employees given the industry's turnover rate.
Comments: Several commenters stated that the Agency's guidance
documents will likely need to be translated into additional languages.
One commenter claimed that industry would be forced to hire translators
to translate the Agency's guidance documents, the cost of which was not
included in the cost benefit analysis.
Response: The Agency plans to make translated guidance documents
publicly available as the need arises at no cost to industry. The cost
of translating these documents is already within the Agency's budget.
As such, the cost is not expected to increase the Agency's budgetary
needs and is therefore not included in the rule's cost analysis.
III. Executive Orders (E.O.s) 12866 and 13563
E.O.s 12866 and 13563 direct agencies to assess all costs and
benefits of available regulatory alternatives and, if regulation is
necessary, to select regulatory approaches that maximize net benefits
(including potential economic, environmental, public health and safety
effects, distributive impacts,
[[Page 52321]]
and equity). E.O. 13563 emphasizes the importance of quantifying both
costs and benefits, of reducing costs, of harmonizing rules, and of
promoting flexibility. This final rule has been designated a
``significant'' regulatory action under section 3(f) of E.O. 12866.
Accordingly, the rule has been reviewed by the OMB under E.O. 12866.
A. Updates to the Regulatory Impact Analysis (RIA)
FSIS updated the proposed rule's RIA to reflect the changes made in
the final rule in response to public comments. The changes to the costs
and benefits sections incorporate the following factors:
The Agency removed the mandatory pre-operational
environmental sampling requirement.
Establishments currently operating under SIP waivers
conduct process control sampling at an alternative frequency and the
Agency assumes that they will continue to do so when the applicability
dates for this final rule arrive. Therefore, these establishments have
been removed from the cost estimate associated with changes to
requirements for microbial organism process control sampling and
analysis.
Additional information from the risk assessment that more
transparently demonstrates the potential uncertainty, is now reflected
in the cost-benefit analysis. However, the anticipated net benefit did
not change.
One company reported that all 6 of its establishments
already have written sanitary dressing plans. As such, the annual cost
estimate associated with developing, composing, training, monitoring,
recording, and verifying written sanitary dressing plans has been
revised down by approximately $87,000.
The highest number of establishment employees to be hired
to meet the needs of NSIS has been revised up to 11, based on an
industry comment.
The per head margin has been updated to rely on the North
American Meat Institute's (NAMI's) 2017 Meat and Poultry Facts.\27\
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\27\ Nalivka, J.S., The 2017 Meat and Poultry Facts, NAMI August
2018.
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B. Need for the Rule
The swine slaughter industry in the United States has evolved since
Congress enacted the Wholesome Meat Act in 1967. Many of today's
producers have invested in farm to table quality and food safety
controls that effectively address health risks and consumer quality
issues.\28\ For these producers, the prescriptive nature of some FSIS
regulations inhibits efficient production and the adoption of improved
production methods and restricts their ability to adopt new
technologies. Further, at large and high-volume establishments that
exclusively slaughter market hogs, the current regulations that require
FSIS to focus on non-food safety issues prevent FSIS from efficiently
allocating resources, which inhibits food safety improvements and
humane handling hazard prevention. Therefore, while traditional
inspection is generally sufficient for low-volume establishments and
for establishments that slaughter classes of swine other than market
hogs, a modernized swine slaughter inspection system is needed, one
that is less prescriptive, creates incentives for establishments to
develop and invest in advancements in food safety and quality controls
and procedures, and allows FSIS to improve inspection methods.
---------------------------------------------------------------------------
\28\ Key, Nigel and William McBride. 2007. The Changing
Economics of U.S. Hog Production. USDA Economic Research Service
(ERS.). Report No. 52.
---------------------------------------------------------------------------
Baseline
C. Overview of the Market
U.S. pork production has increased at a moderate pace as seen in
Table 2. Much of the additional growth in domestic production has been
used to satisfy increasing export demands, which increased 43 percent
between 2009 and 2018.\29\ According to the Food and Agricultural
Organization (FAO), pork is consistently ranked as the top meat in per-
capita consumption worldwide \30\ and is ranked third in the United
States.\31\
---------------------------------------------------------------------------
\29\ Livestock and Meat Domestic Data, All supply and
disappearance, Historical, WASDE Pork-Full. USDA ERS Livestock and
Meat Domestic Data. <https://www.ers.usda.gov/data-products/
livestock-meat-domestic-data/livestock-meat-domestic-data/
#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/
29/19.
\30\ FAO Livestock commodities. <https://www.fao .org/docrep/005/
y4252e/y4252e05b.htm> Accessed on 11/29/16.
\31\ Livestock and Meat Domestic Data, All supply and
disappearance, Historical. USDA ERS Livestock and Meat Domestic
Data. <https://www.ers.usda .gov/data-products/livestock-meat-
domestic-data/livestock-meat-domestic-data/#All%20meat%20
statistics> accessed on 6/12/2019. Last updated on 5/29/19.
Table 2--U.S. Pork Supply and Demand
[Carcass weight, million pounds]
----------------------------------------------------------------------------------------------------------------
Consumption
Year U.S. Imports Exports -------------------------------
production Domestic Per capita *
----------------------------------------------------------------------------------------------------------------
2009............................ 22,999 834 4,094 19,869 65
2010............................ 22,437 859 4,223 19,077 62
2011............................ 22,758 803 5,196 18,382 59
2012............................ 23,253 802 5,379 18,607 59
2013............................ 23,187 880 4,986 19,104 60
2014............................ 22,843 1,011 5,092 18,836 59
2015............................ 24,501 1,116 5,010 20,592 64
2016............................ 24,941 1,091 5,239 20,892 65
2017............................ 25,584 1,116 5,632 21,034 65
2018............................ 26,315 1,042 5,870 21,497 66
----------------------------------------------------------------------------------------------------------------
* Measured in carcass weight, pounds.
Source: Livestock and Meat Domestic Data, All supply and disappearance, Historical, WASDE Pork-Full. USDA ERS
Livestock and Meat Domestic Data. <https://www.ers.usda.gov/data-products/livestock-meat-domestic-data/
livestock-meat-domestic-data/#All%20meat%20statistics> accessed on 6/12/2019. Last updated on 5/29/19.
In 2016, there were approximately 612 swine slaughter
establishments under Federal inspection, Table 3.\32\ Combined, these
establishments process roughly 118 million hogs annually. FSIS divides
swine into the following
[[Page 52322]]
production categories for data collection purposes: Roaster swine,
market hog, sow, and boar/stag. Today, the majority (97%) of the pork
products available in the market are derived from market hogs.\33\
---------------------------------------------------------------------------
\32\ USDA, FSIS, Public Health Information System (PHIS).
\33\ Source: PHIS.
Table 3--Number of Swine Slaughter Establishments by Size, 2016
----------------------------------------------------------------------------------------------------------------
Total swine Total market
HACCP processing size Number of slaughter hog slaughter Percent market
establishments (head count) (head count) hog
----------------------------------------------------------------------------------------------------------------
Large....................................... 28 105,678,519 105,321,950 99.66
Small....................................... 105 11,862,341 8,497,891 71.64
Very Small *................................ 479 903,009 625,863 69.31
-------------------------------------------------------------------
Total................................... 612 118,443,869 114,445,704 96.62
----------------------------------------------------------------------------------------------------------------
Source: Public Health Information System (PHIS).
* Two establishments classified as N/A were included in the category total for Very Small establishments.
As shown below in Table 4, many establishments now exclusively
slaughter market hogs, a species sub class which, because of
technological and animal management improvements, such as improved
genetics, nutrition, and medical services, generally presents fewer
food safety and quality issues.\34\
---------------------------------------------------------------------------
\34\ Key, Nigel and William McBride. 2007. The Changing
Economics of U.S. Hog Production. USDA ERS. Report No. 52.
---------------------------------------------------------------------------
D. Overview of the Final Rule's NSIS
Several of the final rule's provisions apply to only those
establishments that choose to participate in the optional NSIS. Meeting
these provisions will likely increase an establishment's labor and
training costs. Only market hog slaughter establishments are eligible
to participate in the NSIS. Due to the economic constraints, FSIS
expects that only large and small high-volume establishments that
exclusively slaughter market hogs will choose to participate in the
optional NSIS. In 2016,\35\ there were 40 high-volume establishments
that exclusively slaughtered market hogs: 27 \36\ large \37\ (5 HIMP +
22 non-HIMP) \38\ and 13 small establishments, Table 4. These
establishments account for 93 percent of total swine slaughter
annually, Table 4. Given their large share of the market and the
ability to slaughter a sufficient number of market hogs to justify the
likely costs associated with the NSIS, these 40 market hog
establishments are expected to choose to implement the optional NSIS.
Therefore, this analysis calculates the costs and benefits associated
with the NSIS provisions for these 40 market hog establishments.
However, because the 5 HIMP establishments already meet NSIS
requirements, they are not expected to incur any additional new costs
nor contribute to any increase in quantified benefits associated with
adopting the NSIS.
---------------------------------------------------------------------------
\35\ Establishment level data from 2016 was used in both the
Preliminary Regulatory Impact Analysis (RIA) and the Final RIA.
\36\ In 2016 there was 1 large establishment that did not
exclusively slaughter market hogs. As such, this analysis assumed
they would not choose to participate in the optional NSIS and were
excluded from the relevant sections in the analysis.
\37\ HACCP size: Very Small Establishment = Less than 10
employees or less than $2.5 million in annual sales; Small
Establishment = 10-499 employees; Large Establishment = 500 or more
employees.
\38\ In 2016, there was 1 large establishment that did not
exclusively slaughter market hogs.
Table 4--Head Count Distribution Across Types of Establishments, 2016
----------------------------------------------------------------------------------------------------------------
Total swine Percent of
Type of establishment HACCP size Number of slaughter total head
establishments (head count) count
----------------------------------------------------------------------------------------------------------------
High-Volume Market Hog Only.......... Large--HIMP............ 5 17,517,254 14.79
Large--Non-HIMP........ 22 87,746,770 74.08
Small.................. 13 4,617,680 3.90
Low-Volume Market Hog Only........... Very Small............. 71 32,360 0.03
Mix of Species and Swine Sub Classes. Large/Small............ 93 7,659,156 6.47
Very Small............. 408 870,649 0.74
-------------------------------------------------
Grand Totals..................... ....................... 612 118,443,869 ..............
----------------------------------------------------------------------------------------------------------------
* HACCP sizes were combined so as to not reveal proprietary information.
Source: PHIS.
E. Overview of the Final Rule's Mandatory Components
All swine slaughter establishments will need to comply with the two
mandatory provisions of the final rule discussed below.
1. Written Sanitary Dressing Plans
FSIS is amending 9 CFR 310.18 to require swine slaughter
establishments to develop, implement, and maintain as part of their
HACCP systems, written procedures to ensure that no visible fecal
material, ingesta, or milk is present by the point of FSIS post-mortem
inspection of swine carcasses. This requirement will address a weakness
of the current traditional inspection system, which is that
verification checks performed at the end of the slaughter and chilling
process encourage industry to focus its activities on post-process
interventions to reduce contamination rather than prevention throughout
the slaughter process. Prevention throughout the slaughter process is
preferred because it promotes containing contamination close to its
origin, which reduces cross contamination of multiple carcasses. The
existing regulations require that establishments prevent swine
carcasses contaminated with visible fecal material
[[Page 52323]]
from entering the cooler. While preventing swine carcasses contaminated
with visible fecal material from entering the cooler is an important
safeguard for reducing the prevalence of pathogens on swine carcasses,
this result generally cannot be effectively accomplished unless
establishments implement appropriate measures to prevent contamination
from occurring throughout the slaughter and dressing operation and
implement process control procedures for preventive measures. Requiring
establishments to keep daily written records to document the
implementation and monitoring of their process control procedures is a
positive step forward for public health. This ongoing documentation
allows both the establishment and FSIS to identify specific points in
the production process where a lack of process control may have
resulted in product contamination or insanitary conditions. In
addition, it will allow the establishment to implement corrective
actions that could include the addition of preventive control measures
to prevent recurrence of similar product contamination events or
insanitary conditions.
Based on public comment, the final rule assumes all but six
establishments will need to develop written sanitary dressing plans.
2. Process Control Sampling and Analysis for Microbial Organisms
Under this final rule, instead of following a prescribed
microbiological testing program, each establishment will be responsible
for developing and implementing its own microbiological sampling plan.
Each establishment, except very low-volume establishments, is required
to include carcass sampling at pre-evisceration and post-chill (i.e.,
the point in the slaughter process after the carcass has chilled in the
cooler and after all slaughter interventions are completed) or for hot-
boned products, carcass sampling at pre-evisceration and after the
final wash.
The microbiological standards prior to the final rule prescribed
that all establishments monitor process control by sampling for generic
E. coli. High-volume establishments were required to take one sample
per 1,000 carcasses or request an alternative frequency. Very low-
volume establishments were required to take 1 sample per week of
operation up to 13 times a year. Several commenters from industry
reported that each of their establishments operating under SIP conduct
process control sampling at an alternative frequency. In addition, an
industry survey found that many establishments elect to perform other
microbiological tests in addition to testing for generic E. coli.\39\
---------------------------------------------------------------------------
\39\ Viator, C. et al. 2015. Meat Industry Survey in Support of
Public Health Risk-Based Inspection. P5-42. Question 3.1.
---------------------------------------------------------------------------
F. Overview of the Impact of the Final Rule on the Agency
This analysis, in part, takes into consideration potential impacts
to the Agency's budget. FSIS's budget is expected to be impacted by
changes in staffing and training requirements for those establishments
that choose to operate under the NSIS. Under traditional inspection,
each slaughter line requires up to 11 full-time positions. Generally,
these positions include both a supervisory and non-supervisory Public
Health Veterinarian, (PHV) (OPM Veterinary Medical Science Series,
0701); a supervisory and non-supervisory consumer safety inspector,
(CSI) (OPM Consumer Safety Inspection Series, 1862); and up to 7 Food
Inspectors, (FI) (OPM Food Inspection Series, 1863). There are
currently 418 full-time equivalent units (FTE) assigned to slaughter
inspection at the 22 large non-HIMP (27 large--5 HIMP) and 13 small
swine slaughter establishments expected to convert to the NSIS, Table
5. When these establishments convert to the NSIS, Agency personnel will
require NSIS training. Additionally, the number of Agency personnel
required to inspect the slaughter process will likely be reduced. See
Agency Staffing section for details.
Table 5--Current FSIS Slaughter Line Positions at Non-HIMP
Establishments That Slaughter Exclusively Market Hogs
------------------------------------------------------------------------
Number of
OPM job code positions
------------------------------------------------------------------------
1862 (CSI).............................................. 120
1863 (FI)............................................... 245
0701 (PHV).............................................. 53
---------------
Total................................................. 418
------------------------------------------------------------------------
Source: PHIS.
G. Potential Costs of the Final Rule
1. Costs Associated With the NSIS Components of the Rule
This analysis estimates the costs associated with the final rule's
NSIS components. The 35 establishments that the Agency assumes will
adopt the NSIS portion of the rule have similar characteristics to the
5 HIMP establishments, such as volume and sub species slaughtered.
Given the successful participation of the 5 HIMP establishments in the
pilot program and industry's continued interest in increasing the
number of establishments participating in the HIMP pilot study, the
potential benefits from adopting NSIS are expected to outweigh the
potential costs. This analysis assumes that very small establishments
that exclusively slaughter market hogs do not have a high enough
production volume to justify incurring the costs of converting to the
NSIS. While the 5 HIMP establishments are expected to adopt the NSIS,
they have already implemented the changes associated with the NSIS by
their participation in the HIMP pilot study and are not expected to
incur any new or additional expenses. As such, they are not included in
the group of establishments expected to incur an increase in costs
associated with NSIS. The following analysis also excludes further
consideration of the costs of submitting an attestation of work-related
conditions due to its small estimated cost.\40\ Costs examined
generally fall under three categories: Labor, capital expenses, and
developing written procedures.
---------------------------------------------------------------------------
\40\ It was estimated that submitting such an attestation would
require a Quality Control Technician with a labor compensation rate
of $68.52 per hour, 2 minutes per year. Combined, submitting an
annual attestation would cost all 27 large and 13 small
establishments likely to adopt the NSIS approximately $91.36
annually (2 minutes * $68.52 per hour * 40).
---------------------------------------------------------------------------
In the following sections, this analysis presents the costs and
benefits generated over a range of assumptions with respect to how much
of the industry chooses to adopt the NSIS within five years. As was
done with the NPIS, this analysis assumes a 5-year adoption period with
roughly consistent annual adoption rates. These estimates are scaled
for an illustrative calculation and assume that 35 of the 40
establishments that are likely to adopt the NSIS will incur additional
costs associated with adoption. Using this illustrative calculation was
supported by one public comment, which suggested that adoption timing
and rate are difficult to estimate without a final rule. As is stated
above, the 5 HIMP establishments are not expected to incur any
additional costs associated with adopting the NSIS and are therefore
excluded when calculating potential costs of the NSIS components of
this final rule.
[[Page 52324]]
Table 6--NSIS Adoption Rate
----------------------------------------------------------------------------------------------------------------
Total number of establishments
adopted Percent
Year -------------------------------- adopted
Large Small
----------------------------------------------------------------------------------------------------------------
1............................................................... 4 2 17
2............................................................... 8 4 34
3............................................................... 12 7 54
4............................................................... 17 10 77
5............................................................... 22 13 100
----------------------------------------------------------------------------------------------------------------
a. Costs of Additional Establishment Workers
This analysis expects establishments operating under the NSIS to
experience an increase in labor costs. Under the NSIS, establishments
will be required to dedicate labor to sort and remove unfit animals
before ante-mortem inspection; trim and identify defects, such as
dressing defects, contamination, and pathology defects, on carcasses
and parts before post-mortem inspection; identify animals or carcasses
that they have sorted and removed for disposal before FSIS inspection
with a unique tag, tattoo, or similar device, and to develop,
implement, and maintain written procedures to ensure that animals and
carcasses that have been sorted and removed for disposal do not enter
the human food supply and are properly disposed of; maintain records to
document the total number of animals and carcasses sorted and removed
per day and the reasons for their removal; while conducting sorting
activities, notify Agency inspectors if they suspect that an animal or
carcass has a reportable or foreign animal disease; and maintain
records documenting that products resulting from their slaughter
operations meet the new definition of RTC pork product. Based on
observations \41\ of HIMP establishments and a comment from
industry,\42\ this increase in work is expected to require an increase
in labor demand ranging from 6-11 additional workers per line per shift
at large establishments. This analysis assumes each large establishment
that converts to the NSIS will require 9 additional workers per line
per shift. Due to data limitations, this analysis assumes small
establishments that convert to the NSIS will require 1 additional
worker per line per shift. Costs associated with this labor fall into 3
categories: Wages and benefits, training, and continuing education.
---------------------------------------------------------------------------
\41\ Observations were obtained through a survey conducted, in
February 2016, through the Salmonella Initiative Program and
conversations with industry at a meeting, which took place in
February 2016, with the North American Meat Institute.
\42\ One corporation reported in a comment to the proposed rule
that they hired and trained up to 11 employees per shift.
---------------------------------------------------------------------------
Establishment Labor Wage Increases
Many of the 22 large and 13 small non-HIMP market hog
establishments that are assumed to adopt the NSIS operate multiple
lines and shifts. Taking these multiple lines and shifts into
consideration, the number of industry positions is estimated to
increase by 383 if all high-volume establishments that have a history
of exclusively slaughtering market hogs, adopt NSIS. The majority of
these, 369, are attributable to the large establishments (41 (number of
lines) x 9),\43\ Table 7. The remaining 14 positions are attributable
to the small establishments (14 (number of lines) x 1),\44\ Table 7.
According to the BLS, the estimated hourly wage for a Slaughterer and
Meat Packer occupation (``production employee'') is $13.00.\45\ A
benefits and overhead factor of two was then used to estimate the total
labor costs. The total hourly labor costs to industry for a production
employee including benefits and overhead, is $26.00 per hour ($13.00 x
2 \46\). Based on data obtained through PHIS, the average large
establishment slaughters swine 269 days annually. Assuming workers work
8-hour shifts, the total annual remuneration cost to these 22 large
establishments is approximately $20.65 million, (369 x $26.00 x 269 x
8), Table 7. The average small establishment slaughters 244 days
annually. Again, assuming workers work 8-hour shifts, the total annual
remuneration cost to these 13 small establishments is approximately
$0.71 million, (14 x $26.00 x 244 x 8), Table 7. These cost estimates
take into consideration the fact that some establishments operate
multiple lines and multiple shifts.
---------------------------------------------------------------------------
\43\ Source: PHIS.
\44\ Source: PHIS.
\45\ BLS Occupational Employment Statistics, Occupational
Employment and Wages, May 2016. 51-3023 Slaughterers and Meat
Packers https://www.bls.gov/news.release/archives/ocwage_03312017.pdf Accessed on 12/04/18. Last modified 3/31/17.
\46\ To be consistent with analyses done by the Department of
Health and Human Services, this analysis accounts for fringe
benefits and overhead by multiplying wages by a factor of 2.
---------------------------------------------------------------------------
Costs for Training Online Sorters and Carcass-Inspection Helpers
Establishments are expected to incur costs associated with
initially training employees to fill online sorter and carcass-
inspection helper positions, annual replacement training, and
continuing education training. This analysis assumes the cost to train
online sorters and carcass-inspection helpers are similar to the costs
of training production employees in HACCP, which range from $274 to
$823 with a midpoint average of $549 per new employee.\47\ To ensure a
conservative estimate and account for employee rotation patterns as
well as leave, FSIS assumes that establishments will train 4 employees
for each new position. Under these assumptions, large establishments
will need to train approximately 1,476 (369 x 4) employees, while small
establishments will need to train approximately 56 (14 x 4) employees.
The cost of this training ranges from $419,768 to $1,260,836, with a
midpoint estimate of $0.84 million (1,532 x $549), Table 7.
---------------------------------------------------------------------------
\47\ Viator, C. et al. 2015. Costs of Food Safety Investments.
Table 4-4. Training Costs for Management and Production Employees.
---------------------------------------------------------------------------
To account for estimated turnover of establishment employees, FSIS
projects that establishments will have to train approximately 452
(1,532 x 0.295) replacement employees annually, 435 at the large and 17
at the small establishments.\48\ The additional annual training cost
for new employees was estimated to also be similar to the costs of
HACCP training. Therefore, FSIS estimates the combined annual training
costs due to turnover to be approximately $0.25 million (452 x
[[Page 52325]]
$549), with large establishments accounting for approximately $0.24
million (435 x $549) and small establishments accounting for
approximately $9,333 (17 x $549), Table 7.
---------------------------------------------------------------------------
\48\ This estimate was rounded up. This analysis uses the
industry turnover rate for non-durable manufactured goods to
estimate separations. Source: BLS Economic News Release Table 16.
Annual total separations rates by industry and region, not
seasonally adjusted. https://www.bls.gov/news.release/archives/jolts_03162017.htm Accessed on 12/04/18. Last updated on 3/16/17.
---------------------------------------------------------------------------
FSIS assumes that 1,080 (1,532 x 0.705) retained employees, 1,041
at the large and 39 at the small establishments, will require annual
continuing education. This analysis assumes annual continuing education
costs to be similar to annual HACCP refresher training costs, which
range from $12 to $36 per employee, with a mid-point of $24.\49\ Using
the mid-point value, this analysis estimates the combined average
recurring cost for continuing education is $25,920 (1,080 x $24), with
large establishments accounting for approximately $24,984 (1,041 x $24)
and small establishments accounting for approximately $936 (39 x 24).
---------------------------------------------------------------------------
\49\ Viator, C. et al. 2015. Costs of Food Safety Investments.
Table 4-4. Training Costs for Management and Production Employees.
---------------------------------------------------------------------------
Under the assumed adoption rate as set forth in Table 6, annualized
wages and training cost to industry for staffing additional online
personnel is approximately $16.61 million, applying a 3 percent
discount rate \50\ over 10 years, Table 7. The majority of this cost is
attributed to wages and benefits, Table 7.
---------------------------------------------------------------------------
\50\ As is explained in Circular A-4, a discount factor should
be used to adjust the estimated benefits and costs for differences
in timing. For regulatory analysis, net benefit estimates should be
provided using a 3 percent and 7 percent discount rate. Source:
Circular A-4, OMB, September 17, 2003, https://www.whitehouse.gov/sites/whitehouse.gov/files/omb/circulars/A4/a-4.pdf.
Table 7--Establishment Labor Costs
[M$]
----------------------------------------------------------------------------------------------------------------
Number of Recurring
Type of establishment Type of expense personnel One-time cost cost
----------------------------------------------------------------------------------------------------------------
Large.............................. Wages...................... 369 .............. $20.65
Initial Training........... 1,476 $0.81 ..............
Training Due to Labor 435 .............. 0.24
Turnover.
Continuing Education....... 1,041 .............. 0.02
----------------------------------------------------------------------------------------------------------------
Small.............................. Wages...................... 14 .............. 0.71
Initial Training........... 56 0.03 ..............
Training Due to Labor 17 .............. 0.009
Turnover.
Continuing Education....... 39 .............. 0.001
----------------------------------------------------------------------------------------------------------------
Totals
----------------------------------------------------------------------------------------------------------------
One-Time........................................................................................ 0.84
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 21.63
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 16.61
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 15.97
----------------------------------------------------------------------------------------------------------------
b. Costs of Capital Improvements
The NSIS may require a minor capital improvement if the
establishment does not already provide a mirror at the carcass
inspection station. All the large high-volume establishments are
already required to provide mirrors under existing regulations. The
following analysis excludes further consideration of the costs of
requiring a mirror due to its minor potential cost for a limited number
of establishments.\51\ If an establishment believes that additional
capital expenditures will result in a benefit, they may voluntarily
reconfigure or update their facilities to fully capture all the
potential production efficiencies offered through participation in the
NSIS. Examples of such changes include line reconfiguration, which can
cost between $10,000 to $250,000 \52\ and the creation of an inspection
station, which can cost between $5,000 and $6,000.\53\ Establishments
may reduce these costs by coordinating these facility updates with
previously planned establishment renovations.
---------------------------------------------------------------------------
\51\ The cost was estimated to be very small because all 22
large high-volume establishments and potentially several of the 13
small high-volume establishments are already required to provide
mirrors. As such, any new expense would be negligible compared to
the industry costs included in the analysis.
\52\ In a May 2004 study, ERS estimated the cost of compliance
per establishment with the PR/HACCP rule. Capital expenditures in
Hog Slaughter establishments were estimated to be $251,800.
Ollinger, Moore, Chandran (2004). Meat and Poultry
Establishments' Food Safety Investments. USDA, Economic Research
Service.
\53\ Modernization of Poultry Slaughter Inspection; Final Rule,
79 FR 49566 (2014).
---------------------------------------------------------------------------
c. Costs of Developing Ante-Mortem Written Procedures
Under the final rule, establishments operating under the NSIS are
required to develop and maintain in their HACCP systems (HACCP plans,
sanitation SOPs, or other prerequisite programs) written procedures for
the segregation, identification, and disposition of animals suspected
of having one of the condemnable generalized diseases or conditions
listed in 9 CFR 309. This analysis assumes establishments will
coordinate this work and costs with the development of written
procedures to prevent the contamination of carcasses and parts by
enteric pathogens, and visible fecal material, ingesta, and milk
throughout the entire slaughter and dressing operation, a mandatory
component of the final rule. Details of these costs can be found in the
sanitary dressing costs section III.G.2.a.
d. Costs Associated With Ready-to-Cook Pork Standards
Under the final rule, establishments operating under the NSIS are
required to collect, record, and analyze documentation to demonstrate
that the products resulting from their slaughter operation meet the
definition of RTC pork products. This analysis estimates the labor
costs to collect, record and analyze such documentation under two
assumptions. First, FSIS assumes that establishments will assign the
task to a quality control (QC) technician, with an hourly compensation
rate, which
[[Page 52326]]
includes wages, benefits, and overhead, of $68.52.54 55
Second, FSIS assumes that this work will take 1 hour at a large
establishment and \1/2\ hour at a small establishment per day. As is
explained in the Draft Market Hogs HIMP paper, \56\ large swine
establishments can verify they meet OCP performance standards by taking
24 unit samples, requiring roughly 1 hour to collect, record, and
analyze the data. Based on information obtained through PHIS, the
average large swine establishment operates 269 days per year. This
equates to an annual cost of approximately $18,432 (269 x 1 x $68.52),
or approximately $0.41 million for all 22 non-HIMP establishments
($18,432 x 22). Similarly, the cost to an average small establishment,
which based on data obtained through PHIS operates 244 days a year, is
approximately $8,359 (244 x 0.5 x $68.52), or approximately $0.11
million for all 13 small establishments ($8,359 x 13). Combined, under
the assumed adoption rate as set forth in Table 6, these costs are
expected to increase NSIS establishments' annual labor costs by
approximately $0.39 million, applying a 3 percent discount rate over 10
years, Table 8.
---------------------------------------------------------------------------
\54\ BLS Occupational Employment Statistics, Occupational
Employment and Wages, May 2016. 19-1021 Food Scientist and
Technologist. <https://www.bls.gov/news.release/archives/ocwage_03312017.pdf>. Accessed on 12/04/18. Last Modified 3/31/2017.
\55\ To be consistent with analyses done by the Department of
Health and Human Services, this analysis accounts for fringe
benefits and overhead by multiplying wages by a factor of 2.
\56\ Draft Market Hogs HIMP (HACCP-Bases Inspection Models
Project). Draft 6/21/05. <https://www.fsis.usda.gov/wps/wcm/connect/d6ccbad7-59e0-43f5-bf54-1987152ccfe8/HIMP_Market_Hog.pdf?MOD=AJPERES.>.
Table 8--Cost of RTC Requirements
[M$]
----------------------------------------------------------------------------------------------------------------
Recurring
Type of market hog only establishment Number of ---------------
establishments Labor
----------------------------------------------------------------------------------------------------------------
Large......................................................................... 22 $0.41
Small......................................................................... 13 0.11
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 0.51
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 0.39
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 0.38
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
2. Costs Associated With Requirements for All Swine Slaughter
Establishments
The mandatory costs of the final rule will apply to all 612 swine
slaughter establishments and begin on the effective date for these
requirements. These costs are associated with (a) written procedures to
prevent visible fecal material, ingesta, and milk contamination; and
(b) sampling and analysis for microbial organisms to monitor process
control for enteric pathogens.
a. Costs of Developing, Composing, Training, Monitoring, Recording, and
Verifying Written Sanitary Dressing Plans
Under the mandatory portion of the final rule affecting all
Federally inspected establishments that slaughter swine, FSIS is
requiring that all official swine slaughter establishments develop,
implement, and maintain in their HACCP systems written procedures to
prevent the contamination of carcasses and parts by enteric pathogens,
and visible fecal material, ingesta, and milk throughout the entire
slaughter and dressing operation. This cost component for
establishments includes: (1) Developing and incorporating these
procedures into their food safety system, (2) training, and (3)
monitoring, recordkeeping, and verification. This analysis assumes 606
swine establishments will incur these costs.\57\
---------------------------------------------------------------------------
\57\ One corporation has informed FSIS, through public comment,
that all six of its swine harvest facilities have written sanitary
dressing plans. As such, they were not included in this portion of
the cost analysis, which reduced annual costs by roughly $87,000 as
compared to the proposed rule.
---------------------------------------------------------------------------
Costs for Developing and Composing a Written Sanitary Dressing Plan
FSIS assumes incorporating written sanitary dressing plans into an
establishment's HACCP system will result in a one-time HACCP plan
reassessment cost. According to RTI's Costs of Food Safety Investments
report,\58\ the mid-point costs of a HACCP plan reassessment for large
establishments is $730, the mid-point costs for small and very small
establishments is $365.\59\ The cost to large establishments is
approximately $16,060 (22 x $730), small establishments is
approximately $38,325 (105 x $365), and very small establishments is
approximately $174,835 (479 x $365). The annualized costs to industry
with a 3 percent discount rate for all 606 swine slaughter
establishments is approximately $0.03 million, Table 9.
---------------------------------------------------------------------------
\58\ Viator, C. et al. 2015. RTI International collected data on
the cost of food safety investments for the production of meat and
poultry products at the pre-harvest and slaughter and processing
stages. This data was provided to FSIS in a final report titled
`Costs of Food Safety Investments' and was prepared by Catherine L.
Viator, Mary K. Muth, and Jenna E. Brophy. The contract number is
No. AG-3A94-B-3-0003. The order number is AG-3A94-K-14-0056.
\59\ Viator, C. et al. 2015. Table 4-1. Costs of HACCP Plan
Development, Validation and Reassessment per HACCP.
[[Page 52327]]
Table 9--Written Sanitary Dressing Plan Development
[M$]
------------------------------------------------------------------------
Number of
HACCP size establishments One-time cost
------------------------------------------------------------------------
Large................................. 22 $0.02
Small................................. 105 0.04
Very Small............................ 479 0.17
------------------------------------------------------------------------
Totals
------------------------------------------------------------------------
One-Time Cost........................................... 0.23
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 0.03
Years..................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 0.03
Years..................................................
------------------------------------------------------------------------
Costs for Training Establishment Personnel on Executing a Written
Sanitary Dressing Plan
FSIS assumes training programs will be utilized to ensure that
establishment personnel understand and can execute the sanitary
dressing plan. This training includes a one-time initial training cost
to the establishment, a recurring cost of training new hires due to
separations, and the cost of conducting annual refresher training. This
portion of the model is informed by the RTI Costs of Food Safety
Investments report.\60\ As is noted in the RTI report, these costs are
based on the amount of time a panel of experts recommends
establishments spend on training, which may exceed the amount of time
establishments spend on training. Due to data limitations, this
analysis assumes the number of establishment employees conducting
sanitary dressing tasks at swine establishments is equal to the number
of employees conducting sanitary dressing tasks at beef slaughter
establishments.\61\ This is likely an overestimate because unlike beef,
the majority of swine are scalded, de-haired, and polished prior to
opening the carcass, which decreases the need for employees to conduct
sanitary dressing tasks.
---------------------------------------------------------------------------
\60\ Viator, C. et al. 2015.
\61\ The Survey is at: https://www.fsis.usda.gov/wps/wcm/connect/184a3baa-2f73-4651-8aba-68124580f4e0/Pathogen_Controls_in_Beef_Operations_Survey.pdf?MOD=AJPERES. The
survey report is at: https://www.fsis.usda.gov/wps/wcm/connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/STEC_Survey_Comments_Summary.pdf?MOD=AJPERES.
---------------------------------------------------------------------------
As seen in Table 10, costs are shared across HACCP sizes, with
large establishments incurring higher costs. The rate of new hires,
29.5 percent, is derived from the BLS, 2016 Turnover Rate for Non-
Durable Manufacturing Goods.\62\ Likewise, the retention rate for the
refresher training is one minus the turnover rate. The total one-time
cost to train the employees for all 606 establishments is roughly $1.00
million, while the total recurring costs is roughly $0.44 million,
Table 10. The annualized costs with a 3 percent discount rate over 10
years for Sanitary Dressing task related training is $0.55 million,
Table 10.
---------------------------------------------------------------------------
\62\ Source: BLS Economic News Release Table 16. Annual total
separations rates by industry and region, not seasonally adjusted.
<https://www.bls.gov/news.release/archives/jolts_03162017.htm>
Accessed on 12/04/18. Last updated on 3/16/17.
Table 10--Sanitary Dressing Training Costs
[M$]
----------------------------------------------------------------------------------------------------------------
Training costs
Average -----------------------------------------------
HACCP size Number of number of One-time Recurring
establishments employees -----------------------------------------------
Initial New hires Refresher
----------------------------------------------------------------------------------------------------------------
Large......................... 22 179 $0.48 $0.14 $0.07
Small......................... 105 25 0.32 0.09 0.04
Very Small.................... 479 3 0.20 0.06 0.03
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost................................................................................... 1.00
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 0.44
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 0.55
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 0.57
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
[[Page 52328]]
Cost of Monitoring, Recordkeeping, and Verification Associated With the
Written Sanitary Dressing Plan
This analysis also estimates the annual monitoring, recordkeeping
and verification costs associated with maintaining sanitary dressing
procedures. This analysis assumes it will take a production employee 5
minutes to monitor and 5 minutes to maintain records for the sanitary
dressing procedures, for a total of 10 minutes. Establishments are
required to verify the plan each day of production. In addition, this
analysis assumes it will take a QC manager 15 minutes to perform a
verification task and that such task will be completed each week that
slaughter takes place. Combined, these tasks are estimated to cost the
entire industry roughly $0.84 million annually, applying a 3 percent
discount rate over 10 years, Table 11.
Table 11--Monitoring, Recordkeeping and Verification Costs
[M$]
----------------------------------------------------------------------------------------------------------------
Recurring costs
-----------------------------------------------------------------------------------------------------------------
HACCP size Monitoring Recordkeeping Verification Combined
----------------------------------------------------------------------------------------------------------------
Large........................................... $0.01 $0.01 $0.03 $0.05
Small........................................... 0.04 0.04 0.12 0.20
Very Small...................................... 0.07 0.07 0.44 0.58
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 0.84
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 0.84
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 0.84
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
Summary Costs of Written Sanitary Dressing Procedures
Table 12 provides an overview of the one-time and recurring costs
associated with requiring all establishments to develop written
sanitary dressing procedures. Combined, these tasks are expected to
cost the industry $1.41 million annualized, assuming a 3 percent
discount rate over 10 years, Table 12.
Table 12--Summary of Costs Associated With Requiring Written Sanitary Dressing Procedures
[M$]
----------------------------------------------------------------------------------------------------------------
One-time costs Recurring costs
---------------------------------------------------------------
HACCP size Number of Monitoring,
establishments Development Initial Training recording,
training validating
----------------------------------------------------------------------------------------------------------------
Large........................... 22 $0.02 $0.48 $0.21 $0.05
Small........................... 105 0.04 0.32 0.14 0.20
Very Small...................... 479 0.17 0.20 0.09 0.58
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost................................................................................... 1.23
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 1.27
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 1.41
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 1.44
----------------------------------------------------------------------------------------------------------------
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
b. Cost of Carcass Sampling and Analysis for Microbial Organisms
This section reviews the potential changes in costs associated with
the alterations to microorganism testing. These costs are limited to
the changes associated with removing the requirement that swine
establishments test carcasses for generic E. coli and replacing it with
new testing requirements described above. While the final rule also
removes the codified Salmonella pathogen reduction performance
standards for swine, because the codified standards are already no
longer in use, there are no potential costs or benefits to industry.
Such changes fall under four categories: Sampling plan reassessment,
transferring from prescriptive to process testing requirements,
sampling rates, and sample recordkeeping. This analysis uses results
from the RTI International Meat Industry Survey in Support of Public
Health Risk-Based Inspection report \63\ and Costs of Food
[[Page 52329]]
Safety Investments report.\64\ Each of these categories is explained in
detail below. Based on industry comment on the proposed rule, this
analysis excludes the 11 large swine establishments that were
participating in the SIP program when data for this analysis was
collected. Under SIP, these establishments currently sample at an
alternative frequency and we assume that they will continue to do so.
As such, these 11 SIP swine slaughter establishments are not expected
to change their process control sampling and will not experience a
change in associated costs.
---------------------------------------------------------------------------
\63\ Viator, C. et al. 2015. (a) RTI International designed and
conducted surveys on industry practices to control pathogens and
promote food safety. The sample design, administration procedures,
analysis and results were provided to FSIS in a final report titled
`Meat Industry Survey in Support of Public Health Risk-Based
Inspection' and was prepared by Catherine Viator, Sheri C. Cates,
Shawn A. Karns, Peter Siegel, Ariana Napier, and Mary K. Muth. The
contract number is No. AG-3A94-B-13-0003. The order No. is AG-3A94-
K-13-0053.
\64\ Viator, C. et al. 2015. (b).
---------------------------------------------------------------------------
Cost of Process Control Sampling Plan Reassessment
This analysis assumes establishments will incur one-time costs of
conducting a process control sample plan reassessment under the final 9
CFR 310.25(a)(2)(i). The RTI Costs of Food Safety Investments report
estimates the costs of reassessing a microbiological sampling plan. For
large establishments, these costs include labor, consultant fees, and
travel expenses, which combined range from $27,320 to $81,960, with a
midpoint of $54,640 per establishment. Costs to small and very small
establishments are limited to labor expenses and range from $122 to
$365, with a midpoint of $243 per establishment.\65\ The annualized
reassessment cost to industry is roughly $0.12 million, assuming a 3
percent discount rate over 10 years, Table 13.
---------------------------------------------------------------------------
\65\ The report classifies establishments as either large or
small. Given this data limitation, this analysis assumes very small
and small establishments have similar reassessment costs.
Table 13--Cost of Process Control Sampling Plan Reassessment
[M$]
----------------------------------------------------------------------------------------------------------------
Per
Number of establishment Total one-time
HACCP size establishments (mid-point costs
estimate) *
----------------------------------------------------------------------------------------------------------------
Large..................................................... 17 $0.05 $0.93
Small..................................................... 105 243 0.03
Very Small................................................ 479 243 0.12
----------------------------------------------------------------------------------------------------------------
Totals **
----------------------------------------------------------------------------------------------------------------
One-Time Cost................................................................................. 1.07
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years................................... 0.12
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years................................... 0.14
----------------------------------------------------------------------------------------------------------------
* The values for Small and Very Small Establishments are in dollars.
** Note, some of the totals may not equal the sum due to rounding.
Cost of Transferring From Prescriptive To Process Specific
Microbiological Testing Requirements
Prior to the final rule, regulations prescribed that each slaughter
establishment test for generic E. coli.\66\ In addition to mandated
generic E. coli testing, many establishments voluntarily conduct
additional microbiological testing to verify process control. Common
microbiologic tests include APC, total plate count (TPC), and total
coliforms. Based on the meat slaughter survey conducted by RTI, roughly
71 percent of very small, 80 percent of small, and 100 percent of large
establishments conduct microbiological testing in addition to testing
for generic E. coli.\67\ Establishments voluntarily conducting
additional testing are an indication that the generic E. coli testing
is not the best means to verify process control in their respective
establishments.
---------------------------------------------------------------------------
\66\ 9 CFR 310.25 (2018).
\67\ Viator, C. et al. 2015. (a) P5-42. Question 3.1.
---------------------------------------------------------------------------
This analysis assumes that, if permitted to choose a
microbiological test to ensure process control, establishments will
select the single best test that demonstrates process control at their
establishment. Under these assumptions, establishments that currently
test for generic E. coli and conduct at least one other type of
microbiological test will stop testing for generic E. coli. As a
result, the 17 large (17 x 1.00), 41 small high-volume (51 x .80), 43
small low-volume (54 x .80), 4 very small high-volume \68\ (6 x .714),
and 338 very small (473 x .714) establishments that currently test for
generic E. coli and at least one other microbial or pathogen indicator
\69\ will experience a cost reduction. Given the similarity in
laboratory testing costs and costs associated with switching sampling
programs, this analysis assumes the remaining 158 establishments that
exclusively test for generic E. coli will continue to do so.
---------------------------------------------------------------------------
\68\ Very small high-volume establishments slaughter more than
20,000 swine, or a combination of swine and other livestock
exceeding 6,000 cattle and 20,000 total of all livestock.
\69\ Question 3.1 from the Meat Industry Survey in Support of
Public Health Risk-Based Inspection Report asks ``In addition to the
generic E. coli testing of carcasses and Listeria testing of ready-
to-eat (RTE) products required by FSIS regulation, does this
establishment conduct microbiological testing? ''; 28.6% of very
small, 20% of small, and 0% of large establishments responded no,
meaning 71.4% of very small, 80% of small and 100% of large
establishments conduct additional testing.
---------------------------------------------------------------------------
Calculating the cost reductions is a function of estimating the
testing rate and testing costs. This analysis assumes all large, small,
and very small high-volume,\70\ establishments conduct 1 test, every
1,000 carcasses, and all low-volume establishments conduct 13 tests
annually.\71\ To calculate testing costs, this analysis estimates the
associated labor expenses, laboratory fees, and shipping costs. The
mean cost to an establishment to test a single generic E. coli sample
in house is $25.97.\72\ To have the sample tested at a contracted
[[Page 52330]]
lab, the cost is $49.81.\73\ Based on survey results, this analysis
assumes 79 percent of large, 28 percent of small and 5 percent of very
small establishments test in house.\74\ For these 443 establishments,
the combined reduction in testing costs of no longer being required to
test for generic E. coli was estimated to reduce annual testing costs
by approximately $2.69 million, assuming a 3 percent discount rate over
10 years, Table 14.
---------------------------------------------------------------------------
\70\ Note that the 11 large establishments participating in SIP
have been excluded from this analysis because they have an
alternative sampling frequency.
\71\ 9 CFR 310.25(a)(2)(iii)(B). The current regulation (9 CFR
310.25(a)(2)(v)) defines very low-volume swine slaughter
establishments as slaughtering 20,000 head annually or fewer. For
the purposes of this analysis, FSIS has labeled swine establishments
that annually slaughter more than 20,000 head per year as high
volume.
\72\ Viator, C. et al. 2015. (b) Table 5-1.
\73\ Viator, C. et al. 2015. (b) Table 5-1.
\74\ Viator, C. et al. 2015. (b).
\75\ Values in text may differ because of rounding.
\76\ Values in text may differ because of rounding.
\77\ BLS Occupational Employment Statistics, Occupational
Employment and Wages, May 2016. 19-1021 Food Scientist and
Technologist. https://www.bls.gov/news.release/archives/ocwage_03312017.pdf Accessed on 12/04/18. Last Modified 3/31/2017.
\78\ To be consistent with analyses done by the Department of
Health and Human Services, this analysis accounts for benefits and
overhead by multiplying wages by a factor of 2.
Table 14--Recurring Costs (Savings) From No Longer Requiring Generic E.
coli Testing
[M$]
------------------------------------------------------------------------
Number of
HACCP size establishments (Savings)
------------------------------------------------------------------------
Large............................... 17 ($2.04)
Small High-Volume................... 41 (0.40)
Small Low-Volume.................... 43 (0.02)
Very Small High-Volume.............. 4 (0.01)
Very Small Low-Volume............... 338 (0.21)
------------------------------------------------------------------------
Totals
------------------------------------------------------------------------
Recurring Cost........................................ (2.69)
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 (2.69)
Years................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 (2.69)
Years................................................
------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
Process Control Sampling Rates
The final rule requires large, small, and very small high-volume
establishments to take carcass samples at pre-evisceration and post-
chill (for hot-boned products carcass samples must be taken pre-
evisceration and after the final wash), which will increase the number
of samples taken from 1 sample per 1,000 carcasses to 2 samples per
1,000 carcasses for large, small, and very small high-volume
establishments. The final rule does not require low-volume
establishments to increase their sampling rates. Under the final
regulations, large establishments' annual process control sampling
costs were estimated to increase by roughly $1.46 million, which is
roughly $85,745 per establishment ($1.46 million/17), \75\ Table 15.
Small high-volume establishments' annual process control sampling costs
were estimated to increase by roughly $0.30 million, which is roughly
$5,974 ($0.30 million/51) per establishment, Table 15. Very small high-
volume establishments' annual process control sampling costs were
estimated to increase by roughly $8,890, which is roughly $1,482
($8,890/6) per establishment, Table 15.
Cost of Process Control Sample Recordkeeping
This analysis takes into consideration the increase in
recordkeeping costs associated with an increase in the sampling rate
from 1 to 2 samples per 1,000 head. According to PHIS data, the average
large non-SIP establishment slaughters approximately 3.87 million swine
per year. As such, this analysis estimates that a large non-SIP
establishment currently takes approximately 3,869 samples annually
(3,869,276/1,000). The average small high-volume swine establishment
slaughters 0.23 million swine per year and requires approximately 229
samples (228,784/1,000) annually. While the average very small high-
volume establishment slaughters 51,925 swine per year and requires
approximately 52 samples (51,925/1,000) annually. Assuming it takes 2.5
minutes to record the results of each sample, the average large
establishment currently requires 9,673 minutes (2.5 x 3,869) per year;
the average small high-volume establishment currently requires 573
minutes (2.5 x 229) per year; and the average very small high-volume
establishment currently requires 130 minutes (2.5 x 52) per year.
Requiring establishments to increase their sampling rates from 1 to 2
samples per 1,000 head will increase the average large non-SIP
establishment's annual number of samples to 7,738 samples annually
(3,869,276/1,000 x 2), which will require approximately 19,346 minutes
(2.5 x 7,738) \76\ annually. The same requirement will increase a small
high-volume establishment's annual sampling to 458 (228,784/1,000 x 2),
which will require approximately 1,145 minutes (2.5 x 458) annually.
Likewise, a very small high-volume establishment's annual sampling will
increase to 104 (51,925/1,000 x 2), which will require approximately
260 minutes (2.5 x 104) annually. As such, the estimated additional
time required for recordkeeping is approximately 9,673 minutes (19,346-
9,673) for large non-SIP establishments; 572 minutes (1,145-573) for
small high-volume establishments; and 130 minutes (260-130) for very
small high-volume establishments. Assuming a quality control technician
with a compensation rate of $68.52 per hour 77 78 conducts
this work, the additional costs to the average large non-SIP
establishment is approximately $11,046 (9,673/60 x $68.52). Similarly,
the additional cost to the average small high-volume and very small
high-volume establishment is approximately $653 (572/60 x $68.52) and
$148 (130/60 x $68.52, respectively). Scaling this up to all impacted
establishments, the total increase in costs to all large non-SIP
establishments is approximately $0.19 million ($11,046 x 17); $0.03
million ($654 x 51) for small high-volume establishments; and $888
($148 x 6) for very small high-volume establishments, Table 15.
[[Page 52331]]
The combined annualized sampling and recordkeeping cost to all
large non-SIP, small, and very small high-volume establishments is
roughly $1.99 million, applying a 3 percent discount rate over 10
years. Large establishments will potentially incur the majority of this
cost, Table 15.
Table 15--Costs Changes Associated With Increase Sampling Rates
[M$]
----------------------------------------------------------------------------------------------------------------
Costs
Number of -----------------------------------------------------
establishments Sampling Recordkeeping Combined *
----------------------------------------------------------------------------------------------------------------
Large non-SIP........................... 17 $1.46 $0.19 $1.65
Small High-Volume....................... 51 0.30 0.03 0.34
Very Small High-Volume (Dollars)........ 6 8,890 888 9,778
----------------------------------------------------------------------------------------------------------------
Totals
----------------------------------------------------------------------------------------------------------------
Recurring Cost................................................................................ 1.99
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years................................... 1.99
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years................................... 1.99
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
Summary of Process Control Sampling Cost Changes
Overall, the changes in sampling requirements under the final rule
were estimated to reduce industry wide sampling costs by about $0.57
million annualized over 10 years, applying a 3 percent discount rate,
Table 16. However, only the 443 establishments that currently conduct
multiple types of microbiological tests will potentially experience a
reduction in cost. The remaining establishments, roughly 158 small and
very small establishments, will potentially incur a portion of the one-
time costs associated with plan reassessment, Table 16. Cost increases
associated with testing and recordkeeping will be exclusively borne by
large, small, and very small high-volume establishments.
Table 16--Summary of Changes to Process Control Sampling
[M$]
------------------------------------------------------------------------
Cost (savings)
Type of change -------------------------------
One-time Recurring
------------------------------------------------------------------------
Plan Reassessment....................... $1.07 ..............
Converting to Process Control Sampling.. .............. ($2.69)
Testing Costs........................... .............. 1.77
Recordkeeping........................... .............. 0.22
------------------------------------------------------------------------
Totals *
------------------------------------------------------------------------
One-Time Cost........................................... 1.07
------------------------------------------------------------------------
Recurring Cost.......................................... (0.70)
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 (0.57)
Years..................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 (0.55)
Years..................................................
------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
Summary of Voluntary and Mandatory Costs for Final Rule
The total annualized value of all costs to industry, under the
assumed five-year adoption rate as shown in Table 6, is roughly $17.83
million, assuming a 10-year annualization and a 3 percent discount
rate, Table 17. Large establishments that voluntarily switch to the
NSIS incur the majority of costs. For example, the recurring labor
costs associated with the NSIS is the single largest recurring cost to
industry and is mostly incurred by large establishments. It should be
noted that the five HIMP pilot study establishments have already
incurred these costs, suggesting for those five establishments, the
benefits of the NSIS outweigh the costs. It also suggests that the
benefits of adopting the NSIS outweigh the costs for other
establishments as well. Training staff accounts for the bulk of the
costs associated with written sanitary dressing procedures. Sampling
costs will potentially decrease for those establishments that currently
conduct microbiological tests in addition to generic E. coli.
[[Page 52332]]
Table 17--Combined Costs to Industry
[M$]
----------------------------------------------------------------------------------------------------------------
Total costs
Type of cost Number of -------------------------------
establishments One-time Recurring
----------------------------------------------------------------------------------------------------------------
Voluntary:
Establishment Labor....................................... 35 $0.84 $21.63
Ready to Cook............................................. 35 .............. 0.51
Mandatory:
Written Sanitary Dressing Procedures...................... 606 1.23 1.27
Process Control Sampling.................................. 601 1.07 (0.70)
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
Number of Establishments **..................................................................... 612
----------------------------------------------------------------------------------------------------------------
One Time Cost................................................................................... 3.14
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 22.72
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 17.83
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 17.23
----------------------------------------------------------------------------------------------------------------
Totals Mandatory *
----------------------------------------------------------------------------------------------------------------
Number of Establishments **..................................................................... 612
----------------------------------------------------------------------------------------------------------------
One-Time Cost................................................................................... 2.30
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 0.58
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 0.84
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 0.88
----------------------------------------------------------------------------------------------------------------
Totals Voluntary *
----------------------------------------------------------------------------------------------------------------
Number of Establishments........................................................................ 35
----------------------------------------------------------------------------------------------------------------
One-Time Cost................................................................................... 0.84
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 22.15
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 17.0
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 16.35
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
** Note, 612 includes all swine slaughter establishments, including the 11 SIP establishments that were excluded
from the process control sampling costs and the 6 establishments that were excluded from the written sanitary
dressing plans costs.
H. Potential Benefits of the Final Rule
1. Potential Benefits Associated With Public Health
Switching existing FSIS inspection program personnel (IPP)
activities toward more offline verification activities (e.g.,
sanitation performance standards, sampling, fecal inspections, and
other inspection requirements) is unlikely to result in a higher
prevalence of Salmonella on market hog carcasses and is estimated to
result in a lower prevalence of Salmonella on market hog carcasses,
which in turn may lead to fewer human illnesses. This conclusion is
supported by a two-part risk assessment which compares typical FSIS
market swine inspection outcomes with the outcomes observed in a small
subset of establishments that participated in the HIMP pilot study
(referred to in the risk assessment as HIMP plants).
Stage 1 of the risk assessment consists of a multiple regression
analysis to identify the relationships between establishment
characteristics (including HIMP status) and carcass contamination
prevalence. FSIS presents two different models for estimating the
potential for avoiding illnesses in the risk assessment one using only
empirical data and one using additional simulated data, see Tables 13
and 14 in the risk assessment and accompanying text. The results of the
modeling with simulated data, had less uncertainty around the estimated
change in illnesses--are not used in support of the final rule. The
modeling without simulated data is carried through in this section. As
a result, the uncertainty around estimated illnesses avoided is
greater; however, the most likely estimated illnesses avoided are not
affected. Stage 2 of the risk assessment consists of multiple scenario
models in which combinations of plausible changes to inspection
procedures are inserted into equations created using the coefficients
computed in Stage 1. These scenarios produce estimates of changes in
carcass contamination prevalence under the inspection procedures of
NSIS.
Changes in estimated numbers of Salmonella illness are estimated
based on a proportional relationship between carcass contamination
prevalence and illnesses that has been published in the
[[Page 52333]]
peer-reviewed literature.79 80 This relationship was also
validated internally in the risk assessment, with an analysis of
variance (ANOVA) test indicating that carcasses slaughtered in
establishments with relatively low prevalence of Salmonella did not
show significantly different contamination load (measured by
enumeration of Salmonella colony-forming units per gram) when compared
with establishments with relatively high prevalence of Salmonella. In
other words, the proportion of contaminated carcasses is more
predictive of Salmonella illnesses than the contamination load of each
contaminated carcass; thus, if the proportion of carcasses with no
detectable Salmonella contamination increases with implementation of
the NSIS, illnesses caused by consumers' exposure to these carcasses
were estimated to decrease proportionally.
---------------------------------------------------------------------------
\79\ Williams M.S., Ebel, E.D., Vose, D. 2011. Framework for
Microbial Food-Safety Risk Assessments Amenable to Bayesian
Modeling. Risk Analysis 31(4):548-565.
\80\ Ebel, E.E., et al. 2012. Simplified framework for
predicting changes in public health from performance standards
applied in slaughter establishments. Food Control 28(2): pp. 250
257.
---------------------------------------------------------------------------
As with any risk assessment, FSIS's risk assessment relies on a
number of assumptions. FSIS assumed that the differences between the
process of slaughtering hogs and slaughtering poultry do not alter the
relationship between the presence of Salmonella contamination post-
slaughter and human illness.
FSIS also assumed, for the purpose of this risk assessment, that
the relationship between Salmonella contamination of hog carcasses and
downstream products such as pork parts (e.g., pork chops) and ground
pork closely mirrors that of the established relationship between
Salmonella contamination of poultry (e.g., chicken) carcasses and
downstream products such as chicken parts and ground chicken. While
FSIS did not conduct any specific analyses to examine this assumption,
the Agency has conducted numerous peer-reviewed analyses of the
relationship between Salmonella contamination frequency on chicken
carcasses and chicken parts.\81\ These analyses indicate that the
prevalence of Salmonella contamination on downstream products (e.g.,
parts) often exceeds that for the prevalence of Salmonella
contamination in upstream products (e.g., carcasses). The higher
prevalence is logical given that samples of downstream products contain
primals from multiple carcasses, increasing the likelihood of a single
sample being contaminated.
---------------------------------------------------------------------------
\81\ Ebel, E.D., Williams, M.S., Tameru, B. (2019) Relatedness
of Salmonella contamination frequency on chicken carcasses and parts
when processed in the same establishment. Food Control 100: 198-203.
---------------------------------------------------------------------------
The market hog Salmonella illness risk model estimates that the
prevalence of Salmonella detected in carcasses may decline on average
from an initial prevalence of 0.9407% to a final prevalence of 0.9066%
if the 35 identified establishments adopt the new inspection system.
This decrease in prevalence should correspond to an average decrease in
illnesses due to market hog product consumption by an average of 2,533
annual cases.\82\
---------------------------------------------------------------------------
\82\ The relationship between carcass contamination prevalence
and human illnesses modeled as in Williams et al., 2010, Estimating
changes in public health following implementation of hazard analysis
and critical control point in the United States broiler slaughter
industry, Foodborne Pathogens and Disease, 9 and Ebel et al., 2012,
Simplified framework for predicting changes in public health from
performance standards applied in slaughter establishments, Food
Control, 28.
---------------------------------------------------------------------------
More specifically, CDC applies 14 empirical, population-adjusted,
and Pert uncertainty distributions multiplicatively modeled as Monte
Carlo distributions with repeated sampling and Bayesian characteristics
to the data collected at their surveillance sites. CDC states that the
illness estimates are robust but likely underestimates due to
extrapolation from surveillance and outbreak data with underreporting
not captured in the CDC uncertainty estimates based ultimately on
laboratory confirmed cases. CDC's modeling approach used to estimate
total uncertainty of illnesses is designed to capture multiple sources
of uncertainty that were not explicitly modeled, that is, the
uncertainty in CDC illness estimates captures components of consumer
behavior, cross contamination and Salmonella inactivation and growth
between production and consumption.\83\ The uncertainty surrounding
illness estimates is the largest contributor to overall uncertainty in
the NSIS risk model. The total uncertainty in the case rate is
estimated to be bounded at the 10th and 90th percentiles by a potential
increase of 1,719 and a potential decrease of 6,685 cases,
respectively. The total case uncertainty distribution is dependent on
the uncertainty in the change in Salmonella prevalence in market hogs.
---------------------------------------------------------------------------
\83\ CDC's surveillance and outbreak attribution data are
available in Scallan, E., et al. 2011. Foodborne Illness Acquired in
the United States--Major Pathogens. Emerging Infectious Diseases
17(1): 7-15.
---------------------------------------------------------------------------
The prevalence estimates are modeled with data variability and
robust uncertainty components taken from sampling data and model
parameter estimates. Additional, unquantified uncertainty includes the
possibility that differences between HIMP plants and non-HIMP plants
that adopt NSIS not accounted for in the risk assessment could affect
Salmonella prevalence. A number of potential differences, however, are
taken into account in the risk assessment. The variability and
uncertainty in the market hog proportion of illnesses is modeled from
FSIS market hog slaughter data and Bayesian uncertainty. As
demonstrated in the 2010-2011 Market Hog Baseline Study, the market hog
slaughter process resulted in 2,390,482 carcasses produced per year and
a weighted Salmonella contamination prevalence rate of 1.66%; the 10th
percentile estimate for this value is 2,218,169 carcasses and the 90th
percentile estimate is 2,561,973 carcasses. This uncertainty in the
carcass prevalence rate in market hogs according to the peer reviewed
prevalence model corresponds to the overall uncertainty in consumer
Salmonella cases of illnesses from market hogs with an average of
69,857 cases and 10th and 90th percentiles of 40,778 and 104,333 cases
respectively, under traditional inspection. With adoption of the new
inspection system, the average number of cases is likely to decrease to
67,324.
[[Page 52334]]
The market hog risk assessment estimates that if the 35
establishments expected to convert to the NSIS over 5 years do so, the
number of human illnesses attributed to products derived from market
hogs could reduce by an average of 2,533 Salmonella illnesses. The
combined robust model estimate of quantified uncertainty in the case
rate based on CDC Salmonella illness and FSIS market hog contamination
data is estimated to be bounded at the 10th and 90th percentiles by an
increase of 1,719 and a decrease of 6,685 cases, respectively. It is
worth noting, however, that there is an approximately 80% likelihood of
a decrease in illnesses.\84\ The ERS estimates of the annual per case
cost of foodborne illnesses for Salmonella range from roughly $321 to
$5,820, with a mean of roughly $3,682.\85\ These estimates factor in
the costs of physician office, emergency room, and outpatient clinic
visits, as well as hospitalizations, productivity loss, and deaths.
Assuming approximately 2,533 averted cases of Salmonella, potential
savings range from roughly $0.81 million to $14.74 million, with a
midpoint of $9.33 million, Table 18. Health costs would increase by
roughly $6.33 million if cases increased by 1,719, which corresponds to
the 10th percentile, and each case cost $3,682, Table 18.
Alternatively, health costs would decrease by roughly $24.62 million if
6,685 cases were averted, which corresponds to the 90th percentile, and
each case cost $3,682, Table 18. Using the midpoint estimate of $9.33
million cost decrease and applying a five-year adoption rate, the
annualized value is approximately $7.09 million, at a 3 percent
discount rate, Table 18. These estimated benefits may underestimate
total benefits because they do not include pain and suffering costs.
They may also overestimate benefits and cost savings given the
uncertainty between the number of illnesses and the number of carcasses
with detectable Salmonella.
---------------------------------------------------------------------------
\84\ The primary conclusion for the purposes of this regulatory
change, however, is that the NSIS is unlikely to result in a higher
prevalence of Salmonella on market hog carcasses and may result in a
lower prevalence of Salmonella on market hog carcasses, which in
turn may lead to fewer human illnesses. As such, public health
benefits are characterized as ``potential'' rather than ``expected''
benefits.
\85\ USDA ERS, 2014, Cost Estimates of foodborne illnesses.
https://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446 Accessed on 9/9/2011. Last Updated on 11/12/
2014.
Table 18--Potential Benefits From Averted Cases of Salmonella
----------------------------------------------------------------------------------------------------------------
Cost per illness *
Change in -----------------------------------------------
Percentile illnesses by Low Mid High
scenario -----------------------------------------------
$321 $3,682 $5,820
----------------------------------------------------------------------------------------------------------------
Scenario Costs, $M
----------------------------------------------------------------------------------------------------------------
10th............................................ 1,719 $0.55 $6.33 $10.01
Mean............................................ (2,533) (0.81) (9.33) (14.74)
90th............................................ (6,685) (2.15) (24.62) (38.91)
----------------------------------------------------------------------------------------------------------------
Comparison of Mean Recurring Costs (M$)
----------------------------------------------------------------------------------------------------------------
Low
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. 6.33
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 4.81
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 4.62
----------------------------------------------------------------------------------------------------------------
Mid
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. (9.33)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... (7.09)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... (6.81)
----------------------------------------------------------------------------------------------------------------
High
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. (24.62)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... (18.71)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... ($17.97)
----------------------------------------------------------------------------------------------------------------
* Source: USDA ERS, 2014, Cost Estimates of foodborne illnesses. https://www.ers.usda.gov/data-products/cost-estimates-of-foodborne-illnesses.aspx#48446 Accessed on 9/9/2011. Last updated on 11/12/2014.
Note, some of the totals may not equal the sum due to rounding.
[[Page 52335]]
2. Other Benefits Associated With Modernizing Existing Regulations
The final rule will potentially reduce the regulatory burden on
establishments by shifting from prescriptive to performance-based
regulation. Based on the Evaluation of HACCP Inspection Models Project
(HIMP) for Market Hogs Report, the five HIMP establishments' average
line speed was approximately 12.49 percent faster than comparable
establishments.\86\ This increase in line speed is synonymous with an
increase in industrial efficiency. To quantify the benefit associated
with this efficiency gain, this analysis used the North American Meat
Institutes' (NAMI's) average pork packer margins for 2013-2017, which
was reported to be $15.20 \87\ per head in NAMI's 2017 Meat and Poultry
Facts.\88\ The pork packer margin is the price the packer receives less
the cost of the hog and production costs, making it an estimate for
accounting profits. However, economic profit may be more precisely
associated with producer surplus. Economic profit is equal to the
establishment's revenues minus its implicit and explicit costs.
Implicit costs are costs establishments do not spend money on, such as
opportunity costs, while explicit costs are costs establishments spend
money on, such as labor or hogs. Accounting profits can be larger than
economic profits because they exclude some implicit costs. FSIS
requested, but did not receive, comment on refining this estimate so as
to distinguish between accounting profit and economic profit.
---------------------------------------------------------------------------
\86\ USDA FSIS Evaluations--HACCP Inspection Models Project
(HIMP) for Market Hogs https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/evaluations-+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
\87\ Note that the increase in benefits as compared to the
proposed rule is due to updating the margin used from NAMI's 2015
Meat and Poultry Facts to NAMI's 2017 Meat and Poultry Facts. The
proposed rule used a five-year average of $4.10 (2010-2014) per
head, with a low of a $2.85 (2012) per head loss to a $11.49 (2010)
per head gain. While the Final Rule uses a five-year average of
$15.20 (2013-2017) per head, with a low of a $4.50 (2013) per head
gain to a $25.26 (2017) per head gain.
\88\ Nalivka, J.S., The 2017 Meat and Poultry Facts, NAMI August
2018.
---------------------------------------------------------------------------
By using accounting profits to estimate producer surplus, this
analysis multiplied the change in quantity produced by half the per
head margin, which is $7.60 ($15.20/2). This approach assumes that
marginal costs increases as a function of quantity produced and that
the marginal cost curve is linear, in which case the profit margin
reaches zero for the last unit produced.
Assuming establishments increase their production by 12.49 percent
and that this increased production has an average packer margin of
$7.60 per head, an average large establishment's surplus could increase
by approximately $3.78 million, while an average small high-volume
establishment's surplus could increase by $0.34 million, all else being
equal. Combined, such an increase in efficiency at all 35
establishments will increase producer surplus by roughly $87.64 million
\89\ (22 x $3.78 million + 13 x $0.34 million), which has an annualized
benefit of roughly $66.93 million, assuming a 3 percent discount rate
over 10 years, Table 19. This estimate takes into consideration the
assumed five-year adoption rate. However, this increase in surplus may
be an overestimate given that an increase in line speeds may change
market hog prices, establishment production costs, retail prices, and
export volumes. Additionally, this analysis does not account for a
change in consumer surplus, which will be conditional on how an
increase in line speed affects retail prices. The Agency sought, but
did not receive, comment on the extent to which such an increase in
line speeds will affect market hog prices, establishment hours of
production, consumer prices, and export volumes.
---------------------------------------------------------------------------
\89\ Note, some of the totals may not equal the sum due to
rounding.
Table 19--Industrial Efficiency, (Benefits)
[M$]
----------------------------------------------------------------------------------------------------------------
Change in producer surplus
Type of establishment Number of ------------------------------------
establishments Per establishment Combined
----------------------------------------------------------------------------------------------------------------
Large.................................................... 22 ($3.78) ($83.26)
Small.................................................... 13 (0.34) (4.38)
Combined *............................................... 35 ................... (87.64)
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
Recurring Cost.................................................................................. (87.64)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... (66.93)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... (64.32)
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
[[Page 52336]]
The five HIMP establishments have demonstrated that establishments
operating under the NSIS are able to increase their compliance with
sanitation SOPs and HACCP regulations, lower their level of non-food
safety defects, achieve equivalent or better Salmonella verification
testing rates, and lower the level of violative chemical residues.\90\
The five establishments that participated in the HIMP pilot study
account for 15 percent of total swine production.
---------------------------------------------------------------------------
\90\ USDA FSIS Evaluations--HACCP Inspection Models Project
(HIMP) for Market Hogs https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/evaluations-+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
---------------------------------------------------------------------------
Additionally, the NSIS increases the Agency's ability to conduct
more process and product verification and to increase monitoring of
humane handling procedures, which is expected to improve animal
welfare. FSIS inspectors devoted approximately 5.33 hours per shift to
verifying humane handling activities for the Humane Activity Tracking
System, HATS, categories in HIMP market hog establishments compared to
approximately 4.29 hours per shift in the 21 non-HIMP market hog
comparison establishments.\91\ Under the NSIS, establishments sort,
remove, and identify swine unfit for slaughter before FSIS ante-mortem
inspection. More FSIS resources can be devoted to offline inspection
activities because initial sorting and tagging functions are performed
by establishment personnel. This change will provide Agency personnel
with more time to conduct offline inspection activities.
---------------------------------------------------------------------------
\91\ USDA FSIS Evaluations--HACCP Inspection Models Project
(HIMP) for Market Hogs https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/evaluations-+himpAccessedon1/6/2017. Last updated on 11/14/
2014.
---------------------------------------------------------------------------
I. Potential Budgetary Impacts on the Agency
Under the final rule, FSIS will shift Agency resources from online
to offline activities. This analysis estimates how such a shift will
reduce labor expenses by approximately $6.67 million annually, Table
20. However, Agency personnel at NSIS establishments will require
additional training, the annualized cost of which is estimated to be
approximately $0.30 million. Both annualized estimates apply a 3
percent discount rate over 10 years and takes into consideration the
assumed five-year adoption period. The Agency will also update PHIS to
allow establishments to enter information on animals removed from the
slaughter process. This modernization process will likely cost FSIS
approximately $300,000 but will be paid for using existing Agency
funds. Details of these costs are provided below.
1. Agency Staffing
The following section discusses the impact on the Agency's budget
due to reassignment of the inspection staff. As discussed in section F
of this document, under traditional inspection, a single slaughter line
at a large establishment requires up to 11 FTEs, while a small market
hog establishment requires up to 2 FTEs. Under NSIS, a single slaughter
line at a large establishment will potentially require 6 FTEs, while a
small market hog establishment will potentially to require 3 FTEs.
Under NSIS, large establishments with 2 slaughter lines will
potentially require 10 FTEs,\92\ while a small market hog establishment
with 2 slaughter lines will potentially require 4 FTEs.
---------------------------------------------------------------------------
\92\ The difference in staffing between large establishments
with 1 and 2 lines is because the Agency does not anticipate
duplicating offline FTEs per line.
---------------------------------------------------------------------------
This analysis considers likely staffing changes at the 22 large and
13 small establishments which will potentially convert to NSIS over a
course of five years. Combined, these establishments operate 46 shifts
and 55 lines.\93\ This analysis uses PHIS data provided by the Office
of Field Operations (OFO) to calculate the number of FTEs assigned to
each slaughter line. The FSIS Office of the Chief Financial Officer
(OCFO) provided the wage and benefit data for each of these positions.
This data was used to model the staffing changes in terms of both full-
time positions and monetary value. Based on this data, to conduct
traditional inspection, the Agency requires a combined 365 (334 at
large and 31 at small establishments) FTE food or consumer safety
inspectors at an annual cost of approximately $30.43 million, Table 20.
If all 22 large non-HIMP and 13 small high-volume market hog only
establishments convert to the NSIS, the Agency will require 218 (187 at
large and 31 at small establishments) FTE food or consumer safety
inspectors. This number was arrived at by assuming that under NSIS each
of the 41 lines at the large establishments will have up to 3 FTEs
assigned to them and each of the 32 shifts at the large establishments
will have up 2 FTEs assigned to them ((41 lines x 3 FTEs) + (32 shifts
x 2 FTEs) = 187 FTEs). Likewise, under NSIS, the 13 small
establishments will each require between 2-3 FTEs, based on
configuration, for a total of 31 FTEs. These staffing levels are based
on FSIS's experience at HIMP establishments. The combined labor costs
for NSIS is approximately $21.70 million, Table 20. This cost estimate
includes estimated grade increases associated with converting to the
NSIS. As is shown in Table 20, if all 22 large establishments convert
to NSIS, this analysis estimates a net decrease of 147 (334-187) FTEs
required for slaughter line inspection. The NSIS inspection program at
these large establishments has a remuneration value of just over $18.58
million. A similar analysis of the 13 small high-volume establishments
reveals no net change in the number of FTEs. However, because the NSIS
requires all inspectors to be CSIs, many of the FTEs will likely be
promoted from a FI to a CSI. Overall, if all 35 establishments
converted to NSIS, the Agency will require 147 fewer FTEs for swine
slaughter inspection, with potential annual decrease in costs of
roughly $8.73 million, which is equal to roughly $6.67 million a year,
assuming a 3 percent discount rate and the assumed five-year adoption
period, Table 20.
---------------------------------------------------------------------------
\93\ The 22 large establishments operate 41 slaughter lines
during 32 shifts, while the 13 small establishments operate 14 lines
during 14 shifts, source PHIS.
[[Page 52337]]
Table 20--Potential Changes in Agency Staffing
[M$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Traditional NSIS Increases (reductions)
-----------------------------------------------------------------------------------------------
Type Number Number Number
positions Labor costs positions Labor costs positions Labor costs
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large................................................... 334 $27.56 187 $18.58 (147) ($8.98)
Small................................................... 31 $2.87 31 $3.12 0 0.25
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total............................................... 365 $30.43 218 $21.70 (147) (8.73)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Totals
--------------------------------------------------------------------------------------------------------------------------------------------------------
Recurring Cost.......................................................................................................................... (8.73)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................................................................. (6.67)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................................................................. (6.42)
--------------------------------------------------------------------------------------------------------------------------------------------------------
Since 2008, the Agency has annually lost, through attrition, 270
food inspectors on average. See Table 21 for details. The Agency plans
to utilize all personnel made available as a result of conversion to
NSIS to fill these vacant positions.
Table 21--Annual Turnover of Food Inspectors
------------------------------------------------------------------------
Number of
Fiscal year positions
------------------------------------------------------------------------
2008.................................................... 307
2009.................................................... 264
2010.................................................... 231
2011.................................................... 268
2012.................................................... 266
2013.................................................... 246
2014.................................................... 273
2015.................................................... 305
Average................................................. 270
------------------------------------------------------------------------
Source: OFO.
2. Agency Training
a. Three Day NSIS Methods Course
If all 22 large and 13 small market hog establishments convert to
NSIS over the course of five years, as set forth in Table 6, the Agency
estimated training 266 personnel (218 CSIs and 48 PHVs), with pay
grades ranging from GS-8 to GS-13, on NSIS methods. The majority of
these personnel, 228, are associated with 22 large establishments,
while the remaining 38 are associated with 13 small establishments,
Table 22. The associated one-time cost of such training includes labor
and travel expenses associated with the employees receiving training,
as well as temporary replacement labor costs required to fulfill the
work that would have been completed by the employees receiving
training. Based on the HIMP pilot study, this analysis assumes NSIS
methods training will take 3 days and replacement labor will be
equivalent to GS-13 step 5. Under these assumptions, the total one-time
cost of NSIS training is approximately $0.64 million ($0.56 million for
all large establishments and $0.08 million for all small
establishments), Table 22. This one-time cost equals approximately
$0.07 million if it were annualized over 10 years under a 3 percent
discount rate, Table 22.
Table 22--Three Day NSIS Training Course
[M$]
----------------------------------------------------------------------------------------------------------------
Cost of trainee Replacement labor
----------------------------------------------------------------
Number of Costs of Number of Costs of
Type of establishment inspectors wages and replacement wages and Combined costs
requiring benefits for inspectors benefits for
training trainees required replacements
----------------------------------------------------------------------------------------------------------------
Large........................... 228 $0.21 228 $0.34 $0.56
Small........................... 38 0.03 38 0.06 0.08
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost................................................................................... 0.64
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 0.07
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 0.07
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
[[Page 52338]]
b. Fill an Increase Need for Consumer Safety Inspectors
Under the final rule, slaughter line inspectors at a NSIS
establishment will work both on and off the slaughter line. As such,
every inspection position will fall under the CSI position
classification. To fill the increase in demand for CSIs, the Agency
plans to train existing FIs. Training includes a four-week meat
inspector course titled Inspection Methods (IM) and a one-day computer
familiarization course. If all 22 large establishments convert to NSIS,
the Agency will need an additional 82 CSIs. Likewise, if all 13 small
market hog establishments convert, the Agency will need an additional
16 CSIs. Converting a FI into a CSI may result in a grade increase, the
cost of which has been included in the Agency Staffing section above.
The combined one-time cost for converting FIs into CSIs is roughly
$2.16 million, Table 23. Nearly half of this cost stems from the need
for replacement labor. Again, under the projected five-year adoption
rate, as set forth in Table 6, and annualized over 10 years under a 3
percent discount rate, the cost for converting FIs to CSIs is
approximately $0.23 million, Table 23.
Table 23--Cost of Converting a Food Inspector Into a Consumer Safety Inspector
[M$]
----------------------------------------------------------------------------------------------------------------
Labor
Training component -------------------------------- Travel, M&IE, Combined
Trainee Replacement and lodging costs
----------------------------------------------------------------------------------------------------------------
Four Week IM Course............................. $0.52 $0.98 $0.59 $2.09
One Day Computer Training....................... 0.03 0.05 .............. 0.07
----------------------------------------------------------------------------------------------------------------
Totals *
----------------------------------------------------------------------------------------------------------------
One-Time Cost................................................................................... 2.16
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................................... 0.23
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................................... 0.25
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
Combined Estimated Budgetary Impacts
The Agency's budget will potentially be impacted both by changes to
personnel and training requirements. First, on average, there will be
fewer Agency inspection personnel per slaughter line operating under
NSIS. If all 22 large and 13 small establishments convert to NSIS over
the course of five years, the Agency will require approximately 147
fewer FTEs to inspect the 55 \94\ slaughter lines operating at these
establishments. The annual remuneration value of these 147 positions is
roughly $8.73 million, Table 24. Second, the Agency will need to train
approximately 266 personnel on NSIS methods at a one-time cost of
approximately $0.64 million, Table 24. Third, the Agency plans to meet
the increase in demand for CSIs by converting existing FIs into CSIs.
The one-time cost of doing so is approximately $2.16 million, Table 24.
The annualized value of the combined changes to the Agency's budget is
a net reduction of roughly $6.38 million, over 10 years assuming a 3
percent discount rate, Table 24.
---------------------------------------------------------------------------
\94\ Source: PHIS.
Table 24--Combined Changes to FSIS's Budget
[M$]
------------------------------------------------------------------------
Total costs
-------------------------------
One-time Recurring
------------------------------------------------------------------------
Changes to Agency Staffing.............. .............. ($8.73)
Three Day NSIS Training................. $0.64 ..............
Converting Food Inspectors into Consumer 2.16 ..............
Safety Inspectors......................
------------------------------------------------------------------------
Totals
------------------------------------------------------------------------
One-Time Cost........................................... 2.80
------------------------------------------------------------------------
Recurring Cost.......................................... (8.73)
------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 (6.38)
Years..................................................
------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 (6.09)
Years..................................................
------------------------------------------------------------------------
J. Net Benefits
Assuming all high-volume large and small exclusively market hog
establishments convert to NSIS (5 HIMP, 22 large, and 13 small high-
volume), the rule is anticipated to have a net benefit of approximately
$62.56 million a year, annualized over 10 years assuming a 3 percent
discount rate, Table 25. The majority of the costs will be incurred by
the 35 non-HIMP establishments that will potentially voluntarily switch
to the NSIS in the form of increased labor needs.
[[Page 52339]]
Table 25--Net Costs and (Benefits)
[M$]
----------------------------------------------------------------------------------------------------------------
Number of
establishments One-time Recurring
----------------------------------------------------------------------------------------------------------------
Costs to Industry............................................. ................ $3.14 $22.72
Voluntary *................................................... ** 40 0.84 22.15
Mandatory..................................................... 612 2.30 0.58
----------------------------------------------------------------------------------------------------------------
Health Benefits ***............................................................. .............. (9.33)
----------------------------------------------------------------------------------------------------------------
Industrial Efficiency........................................................... .............. (87.64)
----------------------------------------------------------------------------------------------------------------
Impacts to Agency's Budget...................................................... 2.80 (8.73)
----------------------------------------------------------------------------------------------------------------
Totals
----------------------------------------------------------------------------------------------------------------
One-Time Cost.................................................................$5.94
----------------------------------------------------------------------------------------------------------------
Recurring Cost...............................................................(82.98)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years..................(62.56)
----------------------------------------------------------------------------------------------------------------
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years..................(60.00)
----------------------------------------------------------------------------------------------------------------
* Further explanation and details on the NSIS adoption rate are provided in section G. Potential Cost of the
Final Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 26: Quantified Cost and (Benefits)
of Various Adoption Rates
** Note, this includes 5 HIMP establishments, which were not estimated to incur any cost or benefits associated
with the NSIS
*** Further explanation and details on the range of health benefits have been provided in section H. Potential
Benefits of the Final Rule, Table 18: Health Benefits from Averted Cases of Salmonella. The value of health
benefits ranges from a $6.33 million decrease to a $24.62 million increase in health benefits, with a mean
increase in benefits of $9.33 million, assuming a cost per illness of $3,682.
**** Note, some of the totals may not equal the sum due to rounding.
Given the lack of data with which to make cost-benefit comparisons
across the industry, Table 26 provides a range of possible adoption
scenarios and their corresponding costs and benefits. Under scenario A,
only the 5 HIMP establishments adopt the NSIS. Because these 5
establishments are already operating under NSIS practices, there will
not be any additional voluntary costs or benefits associated with these
5 establishments adopting the NSIS. However, 606 establishments will
incur costs associated with the final rule's mandatory components. As
such, scenario A has a net cost. Scenario B assesses the net cost and
benefits of just 6 establishments adopting the NSIS (5 HIMP and 1
large). This scenario reveals that the rule is net beneficial if just 1
large establishment adopts the NSIS in addition to the 5 HIMP
establishments. Scenarios C, D, and E measure the net costs and
benefits of 50, 75, and 100 percent of the 35 non-HIMP establishments
converting to the NSIS, respectively. Each of these scenarios are net
beneficial.
Table 26--Quantified Cost and (Benefits) of Various Adoption Rates
[M$] [supcaret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs (Benefits)
Number to ---------------------------------------------------------------------------------
adopt * Mandatory @ Net
NSIS Health Line speeds Agency budget
--------------------------------------------------------------------------------------------------------------------------------------------------------
A...................................... 5 $0.84 $0.0 $0.0 $0.0 $0.0 $0.84
B...................................... 6 0.84 0.86 (0.27) (3.78) (0.38) (2.73)
C...................................... 23 0.84 8.34 (3.59) (33.34) (3.14) (30.90)
D...................................... 32 0.84 13.08 (5.52) (51.51) (4.88) (47.99)
E...................................... 40 0.84 17.0 (7.09) (66.93) (6.38) (62.56)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* These numbers include the 5 HIMP establishments. However, because these establishments are already conducting NSIS practices, they did not contribute
to quantified NSIS costs, health benefits, or the impacts to the Agency's budget.
@These costs are incurred by all 612 swine establishments.
[supcaret] Annualized Assuming a 3% Discount Rate Over 10 Years
* Note, some of the totals may not equal the sum due to rounding.
K. Alternatives
[[Page 52340]]
[GRAPHIC] [TIFF OMITTED] TR01OC19.000
BILLING CODE 3410-DM-C
A--Taking No Action (Baseline)
FSIS considered maintaining the current inspection system for all
612 swine slaughter establishments. The Agency rejected this
alternative because it would forgo the benefits provided by the NSIS.
These benefits include the establishment's ability to innovate and
develop process controls which increase foodborne hazard detection and
more efficiently use all their resources. Taking no action would also
forgo potential industrial efficiency increases.
[[Page 52341]]
Further, no action would result in the Agency continuing to dedicate
resources to food quality issues, at the expense of increasing offline
activities benefitting food safety. Last, taking no action would also
forgo potential health benefits identified under the final rule.
B--The Mandatory Portion of the Final Rule
FSIS considered limiting the final rule to only include new
requirements that affect all swine slaughter establishments. Under such
a scenario, quantified benefits are limited to an estimated $0.57
million reduction in process control sampling costs. This cost
reduction will potentially be off-set by a $1.41 million increase in
other industry costs associated with requiring written sanitary
dressing plans. In comparison to the baseline, this scenario has a net
cost of roughly $0.84 million. Additionally, under such a scenario, the
Agency's inspection staff would not be reassigned, and the Agency would
continue to require the same number of inspectors. As such, the
Agency's labor costs would not decrease by the estimated $6.67 million.
However, because FIs would not be converted into CSIs nor will
inspectors require additional training, the Agency would not incur the
corresponding $0.30 million in training costs ($0.07 for NSIS training
plus $0.23 in CSI training). As mentioned earlier, simultaneously
increasing unscheduled and scheduled inspection procedures and
decreasing scheduled but not performed procedures accrues most of the
public health benefits. The unscheduled and scheduled tasks are
currently not performed as a result of lack of offline personnel. In
comparison to the final rule, this alternative would eliminate most of
the public health benefits associated with the rule, which are
estimated at $7.09 million annually. Additionally, line speed
restrictions would remain in place, leading to an estimated loss of
over $36.14 million in industrial efficiency gains. FSIS has rejected
this alternative in light of its estimated net cost as compared to the
baseline as well as the decrease in net benefits as compared to the
final rule.
C--The Final Rule
Applying a 3 percent discount rate over 10 years the costs
associated with the final rule includes $16.61 million in additional
industry labor costs, $1.80 million in other industry costs including
costs associated with meeting ready to cook standards and written
sanitary dressing plans, as well as $0.30 million in Agency training
costs. The quantified health benefits of the final rule are limited to
reductions in Salmonella illnesses and have an estimated value of $7.09
million, assuming a 3 percent discount rate. Allowing establishments to
set line speeds so long as they maintain process control will
potentially increase their efficiency by $66.93 million, assuming a 3
percent discount rate. The final rule could potentially reduce industry
costs associated with process control sampling by roughly $0.57
million, assuming a 3 percent discount rate. Additionally, the final
rule could potentially reduce the Agency's labor costs by roughly $6.67
million, assuming a 3 percent discount rate. In comparison to the
baseline, the final rule has an estimated net benefit of $62.56
million, assuming a 3 percent discount rate over 10 years, and as such,
the Agency recommends the final rule.
D--Requiring All Federally Inspected Establishments Adopt the New Swine
Inspection System
FSIS considered requiring all federally inspected swine slaughter
establishments to convert to NSIS. This would expand NSIS from the 5
large HIMP, 22 large and 13 small high-volume non-HIMP establishments
expected to convert under the final rule to include 572 additional
establishments. This expansion would include low-volume establishments
that slaughter all types of swine as well as other establishments that
slaughter a mix of species.
In comparison to the baseline, the benefits of this alternative
potentially include more than $7.09 million in averted illnesses, a
$66.93 million increase in industrial efficiency, $0.57 million in
industrial savings associated with process control sampling
requirements, assuming a 3 percent discount rate over 10 years. While
compared to the baseline, this alternative reduces Agency labor costs
by $2.72 million, assuming a 3 percent discount rate over 10 years.
However, this alternative's Agency labor costs savings are less than
the final rule's Agency labor costs savings because this alternative
would result in additional promotions and training in small and very
small establishments. The production at these 572 additional
establishments represents less than 8 percent of total production and,
as such, is not expected to return substantial reductions in
contamination prevalence or illnesses and falls outside of the current
risk assessment. In particular, the uncertainty around measurement and
model parameters that is already included in the health benefit
calculations for the final rule likely produce wide enough estimates
that the impact of adopting the NSIS in all establishments would have
an effect within the uncertainty bounds. The increase in industrial
efficiency remains similar to that of the final rule because these
additional establishments are generally less automated and maintain
slower line speeds to address higher rates of quality defects
associated with non-market hogs.
In comparison to the baseline, the potential costs associated with
this alternative include a $25.90 million increase in industrial labor,
a $3.14 million increase in other industry costs, which include costs
associated with RTC standards and written sanitary dressing plans, as
well as roughly $0.68 million in Agency training costs. In comparison
to the final rule, the additional increases in costs to industry are
substantially higher and predominately fall on small and very small
business. While this alternative has a net benefit of $47.59 million,
assuming a 3 percent discount rate over 10 years, the Agency rejects it
because its net benefit is less than the final rule.
IV. Regulatory Flexibility Act Assessment
The FSIS Administrator has made a determination that this final
rule will not have a significant economic impact on a substantial
number of small entities in the United States, as defined by the
Regulatory Flexibility Act (5 U.S.C. 601 et seq.). FSIS used an
establishment's HACCP processing size, which applies to an individual
establishment, as a proxy for business size. HACCP processing sizes are
the following: large establishments have 500 or more employees; small
establishments have between 10 and 499 employees; very small
establishments have fewer than 10 employees or annual sales of less
than $2.5 million. Section III provides additional details on costs
incurred by small businesses.
The final rule's mandatory requirements will affect approximately
584 small entities--105 small and 479 very small. First, the mandatory
requirements include that all small and very small establishments
create written sanitary dressing plans with cost components of
development of the plan, training of employees, and recordkeeping, at
an annualized cost of $1,869 per establishment, applying a 3 percent
discount rate over 10 years. Second, the mandatory changes to process
control sampling requirements could potentially decrease small
establishments' sampling costs by roughly $984 per establishment
annually, applying a 3 percent discount
[[Page 52342]]
rate over 10 years. In addition to this sampling cost reduction, the
Agency will allow small and very small low-volume establishments to
modify their sampling plans to collect samples less frequently once
they have collected 13 consecutive weekly samples and can demonstrate
that they are not exceeding their upper control limit and that they are
effectively maintaining process control. FSIS is also allowing
establishments to develop sampling plans that are more tailored to
their specific operation, and thus more effective in monitoring their
specific process control as compared to the current generic E. coli
criteria. Therefore, the final rule's mandatory requirements could
potentially increase small establishments' costs by roughly $885
($1,869-$984 = $885) per establishment annually, an amount that will
potentially have little effect on small entities. To put this in
perspective, the average small and very small establishment slaughters
over 21,000 swine annually. Using the American Meat Institute's average
pork packer dollars per head margins for 2013-2017, the average small
and very small establishment's marginal revenue is $332 thousand
(21,858 (heads slaughtered) x $15.20 (average margin per head)). The
final rule also provides small and very small establishments with
additional time to comply with the new requirements in 9 CFR 310.18(c)
and (d). Additionally, the optional NSIS portion of the rule could
potentially provide an overall cost savings for the 13 small high-
volume establishments of roughly $288,731 per establishment that adopts
the NSIS. This estimate takes into consideration the increase in labor
cost ($42,025 per establishment), cost associated with meeting RTC
standards ($6,300 per establishments) and cost savings from increased
industrial efficiency ($337,056 per establishment). See section III for
additional details.
V. Executive Order 13771
Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), FSIS
estimates that this final rule will yield cost savings. Assuming a 7
percent discount rate, a perpetual time horizon, and a starting year of
2019, the final rule is estimated to yield approximately $51.91 million
(2016$) in annual cost savings, not including potential health
benefits. Therefore, this rule is an E.O. 13771 deregulatory action.
VI. Congressional Review Act
Pursuant to the Congressional Review Act (5 U.S.C. 801 et seq.),
the Office of Information and Regulatory Affairs designated this rule
as not a ``major rule,'' as defined by 5 U.S.C. 804(2).
VII. E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the internet and other information technologies
and providing increased opportunities for citizen access to Government
information and services, and for other purposes.
VIII. Executive Order 12988, Civil Justice Reform
This rule has been reviewed under E.O. 12988, Civil Justice Reform.
Under this rule: (1) All State and local laws and regulations that are
inconsistent with this rule will be preempted; (2) no retroactive
effect will be given to this rule; and (3) no administrative
proceedings will be required before parties may file suit in court
challenging this rule.
IX. Executive Order 13175
This rule has been reviewed in accordance with the requirements of
E.O. 13175, Consultation and Coordination with Indian Tribal
Governments. E.O. 13175 requires Federal agencies to consult and
coordinate with Indian tribes on a government-to-government basis on
policies that have tribal implications, including regulations,
legislative comments or proposed legislation, and other policy
statements or actions that have substantial direct effects on one or
more Indian tribes, on the relationship between the Federal Government
and Indian tribes, or on the distribution of power and responsibilities
between the Federal Government and Indian tribes.
The USDA's Office of Tribal Relations (OTR) has assessed the impact
of this rule on Indian tribes and determined that this rule has minimal
tribal implications. If an Indian tribe requests consultation, FSIS
will work with the OTR to ensure meaningful consultation is provided.
X. USDA Nondiscrimination Statement
No agency, officer, or employee of the USDA must, 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 on-line 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].
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).
XI. Environmental Impact
Each USDA agency is required to comply with 7 CFR part 1b of the
Departmental regulations, which supplements the National Environmental
Policy Act regulations published by the Council on Environmental
Quality. Under these regulations, actions of certain USDA agencies and
agency units are categorically excluded from the preparation of an EA
or an EIS unless the agency head determines that an action may have a
significant environmental effect (7 CFR 1b.4 (b)). FSIS is among the
agencies categorically excluded from the preparation of an EA or EIS (7
CFR 1b.4 (b)(6)).
Establishments that operate under NSIS will be able to slaughter
and process swine more efficiently than is possible under current
regulations, leading to a reduction in production costs. FSIS expects
that consumer demand for pork products will determine the number of
swine slaughtered rather than production costs. Because of the
efficiencies in the NSIS, the price of pork products may decrease. The
predicted price reduction could lead to a slight increase in demand for
pork products. With the slight increase in pork product sales, some
establishments may choose to increase the number of swine slaughtered,
which could result in an increase in the number of condemned carcasses
and parts that must be disposed of. However, because the anticipated
change in price and sales is very small, especially in comparison to
changes in price and sales in response to other market forces, the
Agency has determined that the change in the
[[Page 52343]]
number of swine slaughtered, as well as the number of condemned
carcasses and parts to be disposed of, will be very small and thus will
not have a significant individual or cumulative effect on the human
environment. Therefore, this regulatory action is appropriately subject
to the categorical exclusion from the preparation of an EA or EIS
provided under 7 CFR 1b.4(b)(6) of the USDA regulations.
XII. Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the information collection and
recordkeeping requirements included in this final rule have been
submitted by the Agency to OMB for approval which has not yet been
received. FSIS will collect no information associated with this rule
until the information collection is approved by OMB.
Title: Swine Slaughter Inspection.
Type of Collection: New.
Abstract: FSIS updated the proposed rule's information collection
assessment to reflect the changes made in the final rule in response to
public comments and to better align it with the final cost estimates in
section III. FSIS is also requiring a new information collection burden
but has reduced the total annual burden estimate by 52,729.04 hours.
The changes to the final burden estimates incorporate the following
factors:
FSIS is requiring a new information collection burden;
specifically, the Agency is requiring market hog slaughter
establishments operating under NSIS to maintain records to document the
total number of animals and carcasses sorted and removed per day and
the reasons for their removal.
The proposed mandatory pre-operational environmental
sampling was removed from the final rule. Therefore, these time
estimates were removed from the final burden estimates.
Establishments operating under SIP conduct process control
sampling at an alternative frequency. Therefore, these 11
establishments have been removed from the final burden estimates.
The final burden estimates only include the time to record
the sample results for the new process control sampling requirements.
The final burden estimates were updated so that the
establishment and time estimates align with the final cost analysis in
section III.
New Information Collection in This Final Rule
FSIS is requiring a new regulation that will create a new
information collection burden, in that it will require market hog
slaughter establishments operating under NSIS to maintain records to
document the total number of animals and carcasses sorted and removed
per day and the reasons for their removal. FSIS has created a form to
collect disposition data from establishments. Establishments may
provide the same information as requested on the form electronically if
it is submitted in a format approved by FSIS. FSIS estimates this new
requirement will take establishments operating under NSIS, 5 minutes
per shift regardless of whether establishments complete the form or
submit the information electronically. This is a new recordkeeping
requirement that FSIS has submitted to OMB for approval.
Estimated Annual Recordkeeping Burden for Maintaining Records to
Document the Total Number of Animals and Carcasses Sorted and Removed
per Day and the Reasons for Their Removal
Respondents: Official market hog slaughter establishments that
operate under NSIS.
Estimated maximum number of respondents: 40.
Estimated Average Annual Number of Responses per Respondent: Large
establishments 352; small high-volume establishments 290.
Estimated Maximum Total Potential Annual Responses: 13,282.
Estimated Total Annual Recordkeeping Burden: 1,107 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Estimated annual number Time per
Respondents number of of responses Total annual response in Total annual
respondents per responses minutes burden hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments...................... Animals and carcasses sorted 27 352 9,504 5 792
and removed and their
reasons.
Small high-volume establishments.......... Animals and carcasses sorted 13 290 3,770 5 314
and removed and their
reasons.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Recordkeeping Burden for sorting ............................ 40 332 13,274 5 1,106
and removing.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Under this final rule, establishments also will have to maintain
written procedures to ensure that animals and carcasses that have been
sorted and removed for disposal do not enter the human food supply and
are properly disposed of under 9 CFR part 314. The requirement that
swine slaughter establishments have written procedures in their HACCP
systems is already covered under an approved information collection
system, Pathogen Reduction/Hazard Analysis and Critical Control Point
Systems (OMB control number 0583-0103). Therefore, this requirement of
this final rule will create no new burden on establishments.
Copies of this information collection assessment can be obtained
from Gina Kouba, Office of Policy and Program Development, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue SW, Room 6065,
South Building, Washington, DC 20250; (202)720-5627.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
method and assumptions used; (c) ways to enhance the quality, utility,
and clarity of the information to be collected; and (d) ways to
minimize the burden of the collection of information, including through
the use of appropriate automated, electronic, mechanical, or other
technological
[[Page 52344]]
collection techniques, or other forms of information technology.
Comments on the proposed information collection may be sent to both
FSIS, at the addresses provided above, and the Desk Officer for
Agriculture, Office of Information and Regulatory Affairs, Office of
Management and Budget, Washington, DC 20253. To be most effective,
comments should be sent within 60 days of the publication date of this
final rule.
Information Collections That Were Included in the Proposed Rule
Under this final rule, establishments operating under NSIS are
required to (1) identify animals or carcasses that establishment
personnel have sorted and removed for disposal before FSIS inspection
with a unique tag, tattoo, or similar device, and to develop,
implement, (2) maintain records to document the total number of animals
and carcasses sorted and removed per day and the reasons for their
removal, and (3) maintain records documenting that products resulting
from their slaughter operations meet the new definition of RTC pork
product. Furthermore, each establishment operating under the NSIS will
also need to submit, on an annual basis, an attestation to the
management member of the local FSIS circuit safety committee stating
that it maintains a program to monitor and document any work-related
conditions of establishment workers.
In addition, each official swine slaughter establishment,
regardless of the inspection system under which they operate, will need
to maintain, as part of its HACCP system, written procedures for
preventing, throughout the entire slaughter and dressing operation,
contamination of carcasses and parts by enteric pathogens, and visible
fecal material, ingesta, and milk. These procedures must include
sampling and analysis for microbial organisms to monitor process
control for enteric pathogens, as well as written procedures to prevent
visible fecal material, ingesta, and milk contamination.
As mentioned above, the requirement that swine slaughter
establishments have written procedures in their HACCP systems is
already covered under an approved information collection system.
Therefore, this requirement of this final rule will create no new
burden on establishments.
The requirement that swine slaughter establishments monitor their
systems through microbial testing and recordkeeping will create a new
information collection burden. For each sample on which a
microbiological test is conducted, there is a ``response'' for the
establishment to record the sample result. Under the final rule, large,
small and very small high-volume establishments will test and record
microbiological results for enteric pathogens, for carcass samples
taken at both pre-evisceration and post-chill (for hot-boned products,
carcass samples will be collected pre-evisceration and after the final
wash), at a frequency of once per 1,000 carcasses; and small and very
small low-volume establishments, 13 times a year. The small and very
small low-volume establishments do not experience an increase in
sampling under the final rule.
Estimated Annual Recordkeeping Burden: Swine Slaughter Inspection.
Respondents: Official high-volume swine establishments.
Estimated Number of Respondents: 74 (17 large, 51 small high-
volume, and 6 very small high-volume).
Estimated Average Annual Number of Responses (samples) per
Respondent: Large establishments 3,869; small high-volume
establishments 229; and very small high-volume establishments 52.
Estimated Total Annual Responses: 77,764.
Estimated Total Annual Recordkeeping Burden: 3,240 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average annual
Estimated number of Total annual Time per Total annual
Respondents number of responses per responses response in burden hours
respondents respondent minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments...................... Microbial testing data 17 3,869 65,773 2.5 2,741
recordkeeping.
Small high-volume establishments.......... Microbial testing data 51 229 11,679 2.5 487
recordkeeping.
Very small high-volume establishments..... Microbial testing data 6 52 312 2.5 13
recordkeeping.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Recordkeeping Burden for process ............................ 74 1,051 77,764 2.5 3,240
control.
--------------------------------------------------------------------------------------------------------------------------------------------------------
FSIS is also requiring that market hog slaughter establishments
operating under NSIS submit on an annual basis, an attestation to the
management member of the local FSIS circuit safety committee stating
that it maintains a program to monitor and document any work-related
conditions of establishment workers.
Estimated Annual Reporting Burden for Submitting an Annual
Attestation on Work-Related Conditions to the FSIS Circuit. Safety
Committee: Swine Slaughter Inspection.
Respondents: Official market hog slaughter establishments that
operate under NSIS.
Estimated maximum number of respondents: 40.
Estimated Average Annual Number of Responses per Respondent: Large
establishments 1; small high-volume establishments 1.
Estimated Maximum Total Potential Annual Responses: 40.
Estimated Total Annual Recordkeeping Burden: 1.33 hours.
[[Page 52345]]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average
Estimated annual number Time per
Respondents number of of responses Total annual response in Total annual
respondents per responses minutes burden hours
respondent
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments...................... Attestation on Work-Related 27 1 27 2 .90
Conditions.
Small high-volume establishments.......... Attestation on Work-Related 13 1 13 2 .43
Conditions.
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Reporting Burden................ ............................ 40 1 40 2 1.33
--------------------------------------------------------------------------------------------------------------------------------------------------------
SUMMARY OF BURDEN Swine Slaughter Inspection
[With the recordkeeping burden for maintaining records to document the
total number of animals and carcasses sorted and removed per day and the
reasons for their removal]
------------------------------------------------------------------------
------------------------------------------------------------------------
Total Number Respondents................................ 84
Average Annual Number Responses per Respondent.......... 1,084.33
Total Annual Responses.................................. 91,084
Average Hours per Response.............................. 0.05
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Annual Burden Hours............................... 4,347.33
------------------------------------------------------------------------
SUMMARY OF BURDEN Swine Slaughter Inspection
[Without the recordkeeping burden for maintaining records to document
the total number of animals and carcasses sorted and removed per day and
the reasons for their removal]
------------------------------------------------------------------------
------------------------------------------------------------------------
Total Number Respondents................................ 84
Average Annual Number Responses per Respondent.......... 926.24
Total Annual Responses.................................. 77,804
Average Hours per Response.............................. 0.04
rrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrrr
Total Annual Burden Hours............................... 3,241.33
------------------------------------------------------------------------
XIII. Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, FSIS will announce this Federal
Register publication on-line through the FSIS web page located at:
https://www.fsis.usda.gov/federal-register.
FSIS will also announce and provide a link to it through the FSIS
Constituent Update, which is used to provide information regarding FSIS
policies, procedures, regulations, Federal Register notices, FSIS
public meetings, and other types of information that could affect or
would be of interest to our constituents and stakeholders. The
Constituent Update is available on the FSIS web page. Through the web
page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls, export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves and have the option to password protect
their accounts.
Final Regulatory Amendments
List of Subjects
9 CFR Part 301
Meat inspection.
9 CFR Part 309
Animal diseases, Meat inspection, Reporting and recordkeeping
requirements.
9 CFR Part 310
Animal diseases, Meat inspection.
For the reasons stated in the preamble, FSIS is amending 9 CFR
chapter III as follows:
PART 301--TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS
0
1. The authority citation for part 301 is revised to read as follows:
Authority: 7 U.S.C. 138-138i, 450, 1901-1906; 21 U.S.C. 601-
695; 7 CFR 2.7, 2.18, 2.53.
0
2. Amend Sec. 301.2 by adding the definition of ``Ready-to-cook (RTC)
pork product'' in alphabetical order to read as follows:
Sec. 301.2 Definitions.
* * * * *
Ready-to-cook (RTC) pork product. Any slaughtered pork product
sufficiently free from bile, hair, scurf, dirt, hooves, toe nails,
claws, bruises, edema, scabs, skin lesions, icterus, foreign material,
and odor, which is suitable for cooking without need of further
processing.
* * * * *
PART 309--ANTE-MORTEM INSPECTION
0
3. The authority citation for part 309 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
4. Add Sec. 309.19 to read as follows:
Sec. 309.19 Market hog segregation under the new swine slaughter
inspection system.
(a) The establishment must conduct market hog sorting activities
before the animals are presented for ante-mortem inspection. Market
hogs exhibiting signs of moribundity, central nervous system disorders,
or pyrexia must be disposed of according to paragraph (c) of this
section.
(b) The establishment must develop, implement, and maintain written
procedures to ensure that market hogs exhibiting signs of moribundity,
central nervous system disorders, or pyrexia do not enter the official
establishment to be slaughtered. The establishment must incorporate
these procedures into its HACCP plan, or sanitation SOPs, or other
prerequisite programs.
(c) The establishment must identify livestock that establishment
employees have sorted and removed from slaughter with a unique tag,
tattoo, or similar device. The establishment must develop, implement,
and maintain written procedures to ensure that the animals sorted and
removed from slaughter do not enter the human food supply and are
disposed of according to 9 CFR part 314.
(d) The establishment must maintain records to document the number
of animals disposed of per day because they were removed from slaughter
by establishment sorters before ante-mortem inspection by FSIS
inspectors and the reasons that the animals were removed. These records
are subject to review and evaluation by FSIS personnel.
(e) The establishment must immediately notify FSIS inspectors if
the establishment has reason to believe that market hogs may have a
notifiable animal disease. Notifiable animal diseases are designated by
World Animal Health Organization.
[[Page 52346]]
PART 310--POST-MORTEM INSPECTION
0
5. The authority citation for part 310 continues to read as follows:
Authority: 21 U.S.C. 601-695; 7 CFR 2.18, 2.53.
0
6. Amend Sec. 310.1 by revising paragraph (b)(3) to read as follows:
Sec. 310.1 Extent and time of post-mortem inspection; post-mortem
inspection staffing standards.
* * * * *
(b) * * *
(3) Swine inspection. There are two systems of post-mortem
inspection: The New Swine Slaughter Inspection System (NSIS), which may
be used for market hogs, and the traditional inspection system, which
may be used for all swine.
(i) The NSIS may be used for market hogs if the official
establishment requests to use it and meets or agrees to meet the
requirements in 9 CFR 309.19 and Sec. 310.26. The Administrator may
permit establishments that slaughter classes of swine other than market
hogs to use NSIS under a waiver from the provisions in 9 CFR 309.19 and
Sec. 310.26 as provided by 9 CFR 303.1(h). The Administrator also may
permit establishments that slaughter both market hogs and other classes
of swine to slaughter the market hogs under NSIS and slaughter the
other classes of swine under traditional inspection.
(ii) Traditional inspection shall be used for swine when NSIS is
not used. The following inspection staffing standards are applicable to
swine slaughter configurations operating under traditional inspection
when NSIS is not used. The inspection standards for all slaughter lines
are based upon the observation rather than palpation, at the viscera
inspection station, of the spleen, liver, heart, lungs, and mediastinal
lymph nodes. In addition, for one- and two-inspector lines under
traditional inspection, the standards are based upon the distance
walked (in feet) by the inspector between work stations; and for three
or more inspector slaughter lines, upon the use of a mirror, as
described in Sec. 307.2(m)(6) of this chapter, at the carcass
inspection station. Although not required in a one- or two-inspector
slaughter configuration, except in certain cases as determined by the
inspection service, if a mirror is used, it must comply with the
requirements of Sec. 307.2(m)(6).
Table 1 to Paragraph (b)(3)--One Inspector--Staffing Standards for Swine
----------------------------------------------------------------------------------------------------------------
Maximum inspection rates (head per hour)
---------------------------------------------------------------
Market hogs (heads attached Sows and boars (heads
Distance walked \1\ in feet is-- or detached) detached)
---------------------------------------------------------------
Without mirror With mirror Without mirror With mirror
----------------------------------------------------------------------------------------------------------------
0 to 5.......................................... 140 150 131 143
6 to 10......................................... 134 144 126 137
11 to 15........................................ 129 137 122 132
16 to 20........................................ 124 132 117 127
21 to 35........................................ 120 127 113 122
26 to 30........................................ 116 122 110 118
31 to 35........................................ 112 118 106 114
36 to 40........................................ 108 114 103 110
41 to 45........................................ 105 110 100 106
46 to 50........................................ 101 107 97 103
51 to 55........................................ 98 103 94 100
56 to 60........................................ 96 100 91 97
61 to 65........................................ 93 97 89 94
66 to 70........................................ 90 95 87 92
71 to 75........................................ 88 92 85 89
76 to 80........................................ 86 89 82 87
81 to 85........................................ 84 87 80 85
86 to 90........................................ 82 85 79 83
91 to 95........................................ 80 83 77 81
96 to 100....................................... 78 81 75 79
----------------------------------------------------------------------------------------------------------------
\1\ Distance walked is the total distance that the inspector will have to walk between work stations during one
inspection cycle (e.g., between viscera, carcass, head, and wash-basin).
Table 2 to Paragraph (b)(3)--Two Inspectors--Staffing Standards for Market Hogs
----------------------------------------------------------------------------------------------------------------
Maximum inspection rates (head per hour with
heads attached or detached)
-----------------------------------------------
Line configuration
Distance walked \1\ in feet by inspector B is-- -----------------------------------------------
Carcass,\2\ Viscera,\2\ Head,\2\
head viscera head carcass viscera
\3\ \3\ carcass \3\
----------------------------------------------------------------------------------------------------------------
Without Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5.......................................................... 151-253 151-271 151-296
6 to 10......................................................... 151-239 151-255 151-277
11 to 15........................................................ 151-226 151-240 151-260
16 to 20........................................................ 151-214 151-227 151-244
21 to 25........................................................ 151-204 151-215 151-231
----------------------------------------------------------------------------------------------------------------
[[Page 52347]]
With Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5.......................................................... 151-253 151-303 151-318
6 to 10......................................................... 151-239 151-283 151-304
11 to 15........................................................ 151-226 151-265 151-289
16 to 20........................................................ 151-214 151-249 151-270
21 to 25........................................................ 151-204 151-235 151-254
----------------------------------------------------------------------------------------------------------------
\1\Distance walked is the total distance that Inspector B will have to walk between work stations during one
inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\Inspector A.
\3\Inspector B.
Note 1 to Table 2 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all
inspection positions during each shift to equalize the workload.
Table 3 to Paragraph (b)(3)--Two Inspectors--Staffing Standards for Sows and Boars
----------------------------------------------------------------------------------------------------------------
Maximum inspection rates (head per hour)
---------------------------------------------------------------
Line Configuration
---------------------------------------------------------------
Distance walked \1\ in feet by inspector B is-- Carcass,\2\ Viscera,\2\ Head,\2\ Head,\2\
head head viscera viscera
viscera,\3\ carcass,\3\ carcass,\3\ carcass,\3\
heads detached heads detached heads detached heads attached
----------------------------------------------------------------------------------------------------------------
Without Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5.......................................... 144-248 144-254 144-267 144-267
6 to 10......................................... 144-235 144-240 144-253 144-253
11 to 15........................................ 144-222 144-227 144-239 144-239
16 to 20........................................ 144-211 144-215 144-226 144-226
21 to 25........................................ 144-201 144-205 144-214 144-214
----------------------------------------------------------------------------------------------------------------
With Mirror
----------------------------------------------------------------------------------------------------------------
0 to 5.......................................... 144-248 144-292 144-305 144-292
6 to 10......................................... 144-235 144-273 144-291 144-280
11 to 15........................................ 144-222 144-256 144-272 144-268
16 to 20........................................ 144-211 144-241 144-255 144-255
21 to 25........................................ 144-201 144-228 144-240 144-240
----------------------------------------------------------------------------------------------------------------
\1\Distance walked is the total distance that Inspector B will have to walk between work stations during one
inspection cycle (e.g., between viscera, carcass, and washbasin).
\2\Inspector A.
\3\Inspector B.
Note 1 to table 3 to Paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all
inspection positions during each shift to equalize the workload.
Table 4 to paragraph (b)(3)--Three Inspectors or More--Staffing Standards for Swine
----------------------------------------------------------------------------------------------------------------
Number of inspectors by station
Maximum inspection rates (head per hour with ---------------------------------------------------------------
heads attached) Head Viscera Carcass Total
----------------------------------------------------------------------------------------------------------------
Market hogs:
319 to 506...................................... 1 1 1 3
507 to 540...................................... 1 2 1 4
541 to 859...................................... 2 2 1 5
860 to 1,022.................................... 2 3 1 6
1,023 to 1,106.................................. 3 3 1 7
Sows and boars:
306 to 439...................................... 1 1 1 3
306 to 462 \1\.................................. 1 1 1 3
440 to 475...................................... 2 1 1 4
476 to 752...................................... 2 2 1 5
753 to 895...................................... 3 2 1 6
[[Page 52348]]
896 to 964...................................... 3 3 1 7
----------------------------------------------------------------------------------------------------------------
\1\This rate applies if the heads of sows and boars are detached from the carcasses at the time of inspection.
Note 1 to table 4 to paragraph (b)(3): In multiple-inspector plants, the inspectors must rotate between all
inspection positions during each shift to equalize the workload.
0
7. Amend Sec. 310.18 by adding paragraphs (c) and (d) to read as
follows:
Sec. 310.18 Contamination of carcasses, organs, or other parts.
* * * * *
(c) Official swine slaughter establishments must develop,
implement, and maintain written procedures to prevent contamination of
carcasses and parts by enteric pathogens, and visible fecal material,
ingesta, and milk contamination throughout the entire slaughter and
dressing operation. Establishments must incorporate these procedures
into their HACCP plans, or sanitation SOPs, or other prerequisite
programs. These procedures must include sampling and analysis for
microbial organisms in accordance with the sampling location and
frequency requirements in paragraphs (c)(1) and (2) of this section to
monitor their ability to maintain process control.
(1) Sampling locations. Official swine slaughter establishments,
except for very low-volume establishments, must collect and analyze
carcass samples for microbial organisms at the pre-evisceration and
post-chill points in the process. Establishments that slaughter more
than one type of livestock must test the type of livestock slaughtered
in the greatest number. Establishments that bone their products before
chilling (i.e., hot-boned products) must collect and analyze samples at
the pre-evisceration point in the process and after the final wash
instead of at post-chill. Very low-volume establishments must collect
and analyze samples for microbial organisms at the post-chill point in
the process. All swine establishments must sponge or excise tissue from
the ham, belly, and jowl areas.
(i) Very low-volume establishments annually slaughter no more than
20,000 swine, or a combination of swine and other livestock not
exceeding 6,000 cattle and 20,000 total of all livestock.
(ii) [Reserved]
(2) Sampling frequency. Establishments, except for very low-volume
establishments as defined in paragraph (c)(1)(i) of this section, must
collect and analyze samples at a frequency proportional to the
establishment's volume of production at the following rates:
(i) Establishments, except for very low-volume establishments as
defined in paragraph (c)(1)(i) of this section, must collect and
analyze samples at a frequency of once per 1,000 carcasses, but a
minimum of once during each week of operation.
(ii) Very low-volume establishments as defined in paragraph
(c)(1)(i) of this section must collect and analyze samples at least
once during each week of operation starting June 1 of every year. If,
after consecutively collecting 13 weekly samples, very low-volume
establishments can demonstrate that they are effectively maintaining
process control, they may modify their sampling plans.
(iii) Establishments must maintain accurate records of all test
results and retain these records as provided in paragraph (d) of this
section.
(d) Official swine slaughter establishments must maintain daily
records sufficient to document the implementation and monitoring of the
procedures required under this section. Records required by this
section may be maintained on computers if the establishment implements
appropriate controls to ensure the integrity of the electronic data.
Records required by this section must be maintained for at least one
year and must be accessible to FSIS.
Sec. 310.25 [Amended]
0
8. Amend Sec. 310.25 as follows:
0
a. Remove paragraph (a)(2)(ii)(C);
0
b. Remove the undesignated sentence following paragraph (a)(2)(iii)(A);
0
c. Remove ``20,000 swine,'' in paragraph (a)(2)(v)(A);
0
d. In paragraph (a)(5):
0
i. Redesignate Table 1 as Table 1 to paragraph (a)(5); and
0
ii. In newly redesignated Table 1 to paragraph (a)(5), remove the entry
for ``swine'';
0
e. In paragraph (b)(1):
0
i. Remove ``in Table 2'' and add ``in Table 1 to this paragraph'' in
its place;
0
ii. Redesignate Table 2 as Table 1 to paragraph (b)(1); and
0
iii. In newly redesignated Table 1 to paragraph (b)(1), remove the
entries for ``Hogs'' and ``fresh pork sausages'' and footnote (b).
0
9. Add Sec. 310.26 to read as follows:
Sec. 310.26 Establishment responsibilities under the new swine
slaughter inspection system.
(a) Facilities. The establishment must comply with the facilities
requirements in 9 CFR part 307. The establishment must provide a mirror
at the carcass inspection station in accordance with 9 CFR 307.2(m)(6).
(b) Carcass sorting and disposition. The establishment must conduct
carcass sorting activities and identify any condemnable conditions or
defects before carcasses are presented to online inspectors.
Establishment sorters must incise mandibular lymph nodes and palpate
the viscera to detect the presence of animal diseases as part of their
sorting activities. The establishment must develop, implement, and
maintain written procedures to ensure that market hog carcasses
adulterated with septicemia, toxemia, pyemia, or cysticercosis are
properly removed before the point of post-mortem inspection of
carcasses. The establishment must incorporate these procedures into its
HACCP plan, or sanitation SOPs, or other prerequisite program. These
procedures must cover the establishment sorting activities required
under this section.
(c) Line speed limits. The line speed limits in Sec. 310.1 do not
apply to the establishment, provided it is able to maintain effective
process control and prevent contamination of carcasses and parts by
enteric pathogens and visible fecal material, ingesta, and milk.
Establishments operating under the NSIS must reduce their line speed as
directed by the Inspector-in-Charge (IIC). The IIC is authorized to
direct an establishment to operate at a reduced line speed when in
their judgment a carcass-by-carcass inspection cannot be adequately
performed within the time available due to the manner in which the
carcasses are presented to the online inspector, the health conditions
of a particular herd, or factors that may indicate a loss of process
control.
(d) Records. (1) The establishment must maintain records to
document that
[[Page 52349]]
the products resulting from its slaughter operation meet the definition
of Ready-to-cook pork product in Sec. 301.2. These records are subject
to review and evaluation by FSIS personnel.
(2) The establishment must maintain records to document the number
of carcasses disposed of per day by establishment sorters before FSIS
post-mortem inspection and the reasons that the carcasses were disposed
of. These records are subject to review and evaluation by FSIS
personnel.
0
10. Add Sec. 310.27 to read as follows:
Sec. 310.27 Attestation requirements.
Each establishment that participates in the NSIS must submit on an
annual basis an attestation to the management member of the local FSIS
circuit safety committee stating that it maintains a program to monitor
and document any work-related conditions of establishment workers, and
that the program includes the following elements:
(a) Policies to encourage early reporting of symptoms of injuries
and illnesses, and assurance that it has no policies or programs in
place that would discourage the reporting of injuries and illnesses.
(b) Notification to employees of the nature and early symptoms of
occupational illnesses and injuries, in a manner and language that
workers can understand, including by posting in a conspicuous place or
places where notices to employees are customarily posted, a copy of the
FSIS/OSHA poster encouraging reporting and describing reportable signs
and symptoms.
(c) Monitoring, on a regular and routine basis, injury and illness
logs, as well as nurse or medical office logs, workers' compensation
data, and any other injury or illness information available.
0
11. Add Sec. 310.28 to read as follows:
Sec. 310.28 Severability.
Should a court of competent jurisdiction hold any provision of
Sec. 310.27 to be invalid, such action will not affect any other
provision of 9 CFR part 309 or this part.
Done in Washington, DC.
Carmen M. Rottenberg,
Administrator.
[FR Doc. 2019-20245 Filed 9-30-19; 8:45 am]
BILLING CODE 3410-DM-P
