Modernization of Swine Slaughter Inspection, 4780-4823 [2018-01256]
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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules
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
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is proposing
to amend the Federal meat inspection
regulations to establish a 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 proposing
several changes to the regulations that
would affect all establishments that
slaughter any swine, regardless of the
inspection system under which they
operate or the age, size, or class of
swine. These proposed changes would
allow all swine slaughter establishments
to develop sampling plans that are more
tailored to their specific operations, and
thus be more effective in monitoring
their specific process control. These
proposed changes also would ensure
that before the start of slaughter
operations, food-contact surfaces are
sanitary and free of enteric pathogens.
DATES: Comments must be received on
or before April 2, 2018.
ADDRESSES: FSIS invites interested
persons to submit comments on this
rule. Comments may be submitted by
one of the following methods:
• Federal eRulemaking Portal: This
website provides the ability to type
short comments directly into the
comment field on this web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov. Follow
the on-line instructions at that site for
submitting comments.
• Mail, including CD–ROMs, etc.:
Send to Docket Clerk, U.S. Department
of Agriculture, Food Safety and
Inspection Service, Patriots Plaza 3,
1400 Independence Avenue SW,
Mailstop 3782, Room 8–163A,
Washington, DC 20250–3700.
• Hand- or courier-delivered
submittals: Deliver to Patriots Plaza 3,
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SUMMARY:
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355 E Street SW, Room 8–163A,
Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2016–0017. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov.
Docket: For access to background
documents or comments received, go to
the FSIS Docket Room at Patriots Plaza
3, 355 E Street SW, Room 8–164,
Washington, DC 20250–3700, between
8:00 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT:
Roberta Wagner, Assistant
Administrator, Office of Policy and
Program Development; Telephone: (202)
205–0495.
SUPPLEMENTARY INFORMATION:
Executive Summary
FSIS began experimenting with new
approaches to slaughter inspection
based on Hazard Analysis and Critical
Control Point Systems (HACCP)
principles shortly after publishing the
Pathogen Reduction/HACCP rule in
1996. In 1997, the Agency developed
the HACCP-Based Inspection Models
Project (HIMP) study to determine
whether applying new Government
slaughter inspection procedures, along
with new plant responsibilities, could
promote innovation and provide at least
the same food safety and consumer
protection. FSIS initiated the HIMP
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 a new optional 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. The risk model employed to
assess the potential impact of the NPIS
modeled scenarios involving an increase
in targeted inspection activities
(specifically unscheduled offline
inspection activities). The results of this
model, constructed on the assumption
that the number of offline procedures
performed in poultry establishments
under the NPIS would increase
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proportionally to the number observed
in HIMP establishments, suggested that
implementing the NPIS would likely
result in public health benefits, in the
form of fewer poultry-associated
foodborne Salmonella illnesses per year.
Consistent with the underlying
assumptions of the model, it is
reasonable to conclude that inspection
systems in which Agency resources are
used to continue core online inspection
activities while enhancing the frequency
and focus of unscheduled offline
activities directly related to food safety,
such as HIMP and the NPIS, would
likely result in a lower prevalence of
carcasses contaminated with
Salmonella, which in turn would likely
lead to fewer human illnesses.
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
plans, sanitation standard operating
procedures (sanitation SOPs), or other
prerequisite programs (hereafter referred
to as 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.
FSIS is now proposing to amend the
Federal meat inspection regulations to
establish a new optional inspection
system for market hog slaughter
establishments, the New Swine
Slaughter Inspection System (NSIS),
informed by the Agency’s experiences
under HIMP. FSIS is proposing this new
inspection system to facilitate pathogen
reduction in pork products; improve
compliance with the HMSA; improve
the effectiveness of market hog slaughter
inspection; make better use of the
Agency’s resources; and remove
unnecessary regulatory obstacles to
innovation by revoking maximum line
speeds and allowing establishments
flexibility to reconfigure evisceration
lines. If establishment personnel sorted
and removed unfit animals before antemortem inspection and trimmed and
identified defects on carcasses and parts
before post-mortem inspection by FSIS
inspectors, FSIS inspectors would be
presented with healthier animals and
carcasses that have fewer defects to
inspect, which would allow inspectors
to conduct a more efficient and effective
inspection of each animal and each
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carcass. Such a system would allow
FSIS inspectors to conduct a more
efficient inspection. As a result, FSIS
could assign fewer inspectors to online
inspection, freeing up Agency resources
to conduct more offline inspection
activities that FSIS has determined are
more effective in ensuring food safety,
such as verifying compliance with
sanitation, HACCP, and humane
handling requirements.
Key elements of the proposed NSIS
include: (1) Requiring establishment
personnel to sort and remove unfit
animals before ante-mortem inspection
by FSIS and to trim and identify defects
on carcasses and parts before postmortem inspection by FSIS; (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
immediately denature all major portions
of the carcass on-site, and maintain
records to document the total number of
animals and carcasses sorted and
removed per day; (3) requiring
establishment personnel to immediately
notify FSIS inspectors if they suspect an
animal or carcass with a reportable or
foreign animal disease (e.g., African
swine fever, classical swine fever, or
Nipah virus encephalitis) while
conducting sorting activities; (4) shifting
Agency resources to conduct more
offline inspection activities that are
more effective in ensuring food safety,
which would allow for up to two offline
verification inspectors per line per shift
and would reduce the number of online
inspectors to a maximum of three per
line per shift; (5) requiring
establishments to maintain records
documenting that products resulting
from their slaughter operations meet the
new proposed definition of Ready-tocook (RTC) pork product, which would
be defined as any slaughtered pork
product 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 (6) 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 during
the slaughter operation. FSIS projects
that the new system is unlikely to result
in a higher prevalence of Salmonella on
market hog carcasses and may even
result in a lower prevalence of
Salmonella on market hog carcasses,
which in turn may lead to fewer human
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illnesses. In addition, the new system
should improve animal welfare and
compliance with the Humane Methods
of Slaughter Act (HMSA) because more
FSIS resources will be available to
verify humane handling as an offline
activity.
Under the proposed rule, market hog
slaughter establishments that do not
choose to operate under the NSIS may
continue to operate under their existing
inspection system (hereafter referred to
as ‘‘traditional inspection’’). As
mentioned above, NSIS provides public
health protection at least equivalent to
traditional inspection. FSIS recognizes
that some establishments may not be
prepared to make the investment in
facilities and labor needed to convert to
NSIS. In addition, many small, very low
volume establishments slaughter more
than one type of livestock species and
the facilities updates need to convert to
the proposed NSIS may not
accommodate the slaughter of livestock
other than market hogs. Therefore, FSIS
is proposing to give establishments the
flexibility to operate under the system
that is best suited to their operations.
FSIS is also proposing several changes
that would affect all establishments that
slaughter swine, regardless of the
inspection system under which they
operate. FSIS is proposing to require
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, 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.
FSIS is proposing to prescribe a
minimum frequency with which
establishments would be required to
collect two samples, one at preevisceration 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 small and very
low volume establishments, a single
post-chill sample. FSIS considers the
microbial load of hog carcasses at preevisceration to be a valuable source of
data about how well an establishment is
taking into account the sanitary
condition of live hogs coming to
slaughter and the processing steps (i.e.,
washing, dehairing) they implement to
reduce the external contamination of the
carcass prior to evisceration. FSIS also
considers the microbial characteristics
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of hog carcasses post-chill (after all
processing steps have taken place) to be
a valuable source of data about how
well an establishment is minimizing
contamination during chilling as well as
the overall effectiveness of all process
control interventions the establishment
has chosen to apply throughout its
production process. Because most
establishments apply one or more
interventions between the preevisceration and post-chill sampling
points to help control microbiological
hazards, FSIS would expect that a
reduction in microbiological
contamination between these two
sampling points to be an indication of
the effectiveness of those controls.
Under the proposed rule,
establishments, except for very small
and very low volume establishments,
would be required to collect preevisceration and post chill samples at a
frequency of once per 1,000 carcasses.
Very small and very low volume
establishments would be required to
collect at least one sample during each
week of operation each year. If, after
consecutively collecting 13 weekly
samples, very small and very low
volume establishments can demonstrate
that they are effectively maintaining
process control, they can modify their
sampling plans to collect samples less
frequently. FSIS is proposing to allow
very small and very low volume
establishments to collect and analyze
samples for microbial organisms at the
post-chill point in the process only
because these establishments typically
are less automated and run at slower
line speeds than larger establishments.
The lower level of automation and the
slower line speeds require less
complicated measures for maintaining
and monitoring process control on an
ongoing basis. These proposed
frequencies reflect the frequencies
prescribed under the existing
regulations for generic Escherichia coli
(E. coli) testing. FSIS is proposing to
remove the current requirement that
swine establishments test carcasses for
generic E. coli to monitor process
control and to remove the codified
Salmonella pathogen reduction
performance standards for swine and
replace them with the new testing
requirements described above. The new
testing requirements would allow
establishments to develop sampling
plans that are more tailored to the
specific establishment, and thus more
effective in monitoring their specific
process control than the current generic
E. coli criteria.
FSIS is proposing to allow
establishments to substitute alternative
sampling locations if they are able to
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demonstrate that the alternative
sampling locations are able to provide a
definite improvement in monitoring
process control than at pre-evisceration
and post-chill. FSIS interprets ‘‘definite
improvement’’ to mean any
improvement of equipment, substances,
methods, processes, or procedures
affecting the slaughter of livestock and
poultry or processing of meat, poultry,
or egg products. FSIS is also proposing
to allow establishments to substitute
alternative sampling frequencies if they
are able to demonstrate that the
alternative is an integral part of the
establishments’ verification procedures
for their HACCP plans and are able to
provide a definite improvement in
monitoring process control than at the
prescribed frequency. FSIS is requesting
comments on the proposed sampling
requirements, particularly the
incremental value (from both a processimprovement and public health
standpoint) of pre-evisceration sampling
over what is provided by post-chill
sampling.
Finally, FSIS is proposing to require
that all official swine slaughter
establishments develop, implement, and
maintain in their HACCP systems
written procedures to prevent
contamination of the pre-operational
environment by enteric pathogens. The
pre-operational environment comprises
food contact surfaces, reuse water, and
equipment, including knives, in edible
food production departments before
slaughter operations begin. These
procedures would need to include
sampling and analysis of food-contact
surfaces in the pre-operational
environment for microbial organisms to
ensure that the surfaces are sanitary and
free of enteric pathogens. The sampling
frequency would need to be adequate to
monitor the establishment’s ability to
maintain sanitary conditions in the pre-
operational environment. Please see the
draft compliance guide for additional
information about implementation of
this provision. FSIS is proposing this
requirement as a direct result of a recent
outbreak of foodborne illness associated
with a hog slaughter establishment
where food contact surfaces were found
to be contaminated with the outbreak
strain. FSIS is requesting comments on
this proposed sampling requirement and
the extent to which interventions in the
pre-operational environment are needed
to ensure food safety.
In Table 1 below, FSIS presents the
estimated costs and benefits of the
proposed rule. Later portions of the
regulatory impact analysis section
contain explanation of the assumptions,
alternative adoption scenarios, and a
discussion of the uncertainty
surrounding the net benefits associated
with how much of the industry would
choose to adopt NSIS.
TABLE 1—NET COSTS AND (BENEFITS)
[M$]
Number of
establishments
One-time
........................
** 40
612
........................
........................
........................
$3.88
0.84
3.03
........................
........................
2.80
$22.65
22.17
0.48
(9.33)
(47.33)
(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 ......................................................................................
$6.68
(42.75)
(31.77)
(30.40)
Costs To Industry ........................................................................................................................
Voluntary * .............................................................................................................................
Mandatory .............................................................................................................................
Potential Health Benefits *** ........................................................................................................
Industrial Efficiency ......................................................................................................................
Impacts to Agency’s Budget ........................................................................................................
Recurring
* Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the Proposed Rule, Table 6: NSIS
Adoption Rate and section J. Net Benefits, Table 28: 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. Expected Benefits Associated With Public
Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from $0.19 million to $18.97 million,
with a mean of $9.33 million.
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Statutory Authority
FSIS inspects and regulates the
production of meat and meat food
products prepared for distribution in
commerce under the authority of the
Federal Meat Inspection Act (FMIA) (21
U.S.C. 601 et seq.). The FMIA provides
that the Secretary shall cause to be made
by inspectors an examination and
inspection of all amenable species
before they enter into any establishment
in which they are to be slaughtered and
the meat and meat food products thereof
are to be used in commerce (21 U.S.C.
603(a)). All amenable species found to
show symptoms of disease are to be set
apart and slaughtered separately; the
carcasses of such animals are to be
subject to a careful inspection (21 U.S.C.
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603(a)). The FMIA requires that the
livestock be slaughtered and handled in
connection with slaughter in a manner
that is consistent with the HMSA (21
U.S.C. 603(b)). Under the HMSA, the
handling of livestock in connection with
slaughter must be carried out only by
humane methods (7 U.S.C. 1902).
The FMIA also requires inspectors to
conduct a post-mortem examination and
inspection, and any necessary
reinspection, of carcasses and parts of
amenable species prepared for human
food (21 U.S.C. 604). The FMIA requires
that all carcasses and parts found to be
adulterated be condemned (21 U.S.C.
604). Under the FMIA, a meat or meat
food product is adulterated, among
other circumstances, if it bears or
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contains any poisonous or deleterious
substance that may render it injurious to
health; it is unhealthful, unwholesome,
or otherwise unfit for human
consumption; it was prepared,
packaged, or held under insanitary
conditions whereby it may have been
rendered injurious to health; or if
damage or inferiority has been
concealed in any manner (21 U.S.C.
601(m)(1), (3), (4), and (8)). Finally, 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. FSIS
regulations and inspection programs are
designed to verify that livestock are
handled and slaughtered humanely, and
that meat and meat food products are
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unadulterated, wholesome, and
properly marked, labeled, and packaged.
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Table of Contents of Proposed Rule
Discussion
I. Background
A. Traditional Market Hog Slaughter
Inspection Under Existing Regulations
1. Description of the Inspection System
Under Existing Regulations
2. Need for Modernization
B. Regulations for Microbiological Testing
Under Traditional Inspection
1. Generic E. Coli Criteria for Measuring
Process Control
2. Salmonella Pathogen Reduction/HACCP
Performance Standards
C. Waivers of Regulatory Requirements
1. Waivers to Test New Technology
2. Salmonella Initiative Program Waivers
II. Consideration of Need for a New Swine
Slaughter Inspection System
A. Early Development of the Inspection
Models Program
B. Existing HACCP-Based Inspection
Models Program
C. U.S. General Accountability Office
(GAO) and the USDA’s Office of the
Inspector General (OIG) Reports on
HIMP
D. Analysis of HIMP
1. FSIS Evaluation of HIMP
a. Overview of the HIMP Report
b. Verification by Offline Inspectors of the
Establishment Executing Its HIMP
Process Control Plan Under Which
Establishment Employees Sort
Acceptable and Unacceptable Carcasses
and Parts
c. Verification of the Establishment
Executing Its HACCP System Under 9
CFR Parts 416 and 417
d. Verification of the Outcomes of the
Establishment Process Control Plan, Both
Organoleptic and Microbiologic
e. Conclusion of HIMP Report
f. Verification of Humane Handling
E. Public Health Benefits Projected From
Allocating More Inspection Resources to
Food Safety-Related Inspection
Activities
1. Market Hog Risk Assessment
2. Model
3. Conclusions of the Market Hog Risk
Assessment
III. Proposed NSIS
A. Live Market Hog Sorting by
Establishment Personnel
B. Post-Mortem Carcass Sorting by
Establishment Employees and Online
Carcass Inspection
C. Offline Verification Inspection
D. RTC Pork Product
E. Line Speeds Under NSIS
IV. Other Proposed Changes That Affect All
Swine Slaughter Establishments
A. Procedures To Address Enteric
Pathogens, Fecal Material, Ingesta, and
Milk Contamination as Hazards
Reasonably Likely to Occur
V. Implementation
VI. Executive Orders 12866 and 13563
A. Request for Comments Summary
B. Need for the Rule
C. Overview of the Market
D. Overview of the Proposed Rule’s NSIS
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E. Overview of the Proposed Rule’s
Mandatory Components
F. Overview of the Proposed Rule’s Agency
Impact
G. Expected Cost of the Proposed Rule
1. Costs Associated With the NSIS
Components of the Rule
a. Costs of Additional Establishment
Workers
b. Costs of Capital Improvements: Line
Configuration and Inspection Stations
c. Costs of Developing Ante-Mortem
Written Procedures
d. Ready-to-Cook Standards
2. Costs Associated With the Mandatory
Components of the Rule
a. Costs of Developing, Composing,
Training, Monitoring, Recording, and
Verifying Written Sanitary Dressing
Plans
b. Process Control Sampling and Analysis
for Microbial Organisms
c. Environmental Sampling
H. Expected Benefits of the Proposed Rule
1. Expected Benefits Associated With
Public Health
2. Other Benefits Associated With
Modernizing Existing Regulations
I. Expected Budgetary Impacts
1. Agency Staffing
2. Agency Training
J. Net Benefits
K. Alternatives
VII. Regulatory Flexibility Act Assessment
VIII. E-Government Act
IX. Executive Order 12988, Civil Justice
Reform
X. Executive Order 13175
XI. USDA Nondiscrimination Statement
XII. Environmental Impact
XIII. Paperwork Reduction Act
XIV. Additional Public Notification
XV. Proposed Regulatory Amendments
I. Background
A. Traditional Market Hog Slaughter
Inspection Under Existing Regulations
1. Description of the Inspection System
Under Existing Regulations
Under the existing regulations for
traditional inspection, FSIS antemortem inspectors examine all market
hogs for visible signs of condemnable
diseases or conditions while they are at
rest and in motion (see 9 CFR part 309).
FSIS ante-mortem inspectors direct
establishment personnel to set apart
animals showing signs of condemnable
diseases or conditions into separate
‘‘U.S. Suspect’’ pens for further
examination by the FSIS Public Health
Veterinarian (PHV). The FSIS PHV
determines whether the animals shall be
identified as ‘‘U.S. Condemned’’ and
disposed of in accordance with 9 CFR
309.13 (9 CFR 309.2).
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
performs ante-mortem inspection (see
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FSIS Directive 6100.1, Ante-mortem
Livestock Inspection available at https://
www.fsis.usda.gov/wps/wcm/connect/
2b2e7adc-961e-4b1d-b5937dc5a0263504/6100.1.pdf
?MOD=AJPERES). 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 are subject to additional
FSIS inspection. FSIS requires these
establishments to document their
segregation procedures in their HACCP
plans or prerequisite programs. FSIS
inspectors examine all animals found by
the establishment to be normal at rest,
and five to ten percent of those animals
in motion. 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’’ pens, and directs
establishment employees to move
animals to ‘‘U.S. Suspect’’ pens for final
disposition. FSIS inspectors observe
establishment employees performing
segregation procedures at least once per
month. 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.
Therefore, under the voluntary
segregation procedures, FSIS inspectors
are able to conduct a more efficient and
effective ante-mortem inspection to
determine whether each animal is fit for
slaughter.
During post-mortem inspection at all
market hog slaughter establishments,
FSIS online inspectors inspect the head,
viscera, and carcass of each animal for
localized defects and direct
establishment employees to remove the
defects through trimming (9 CFR
310.1(b)(3)). FSIS online inspectors
perform manual incisions, palpations,
and other organoleptic inspections (i.e.,
using sight, smell, and touch) to detect
signs of disease or contamination. In
large establishments, up to seven online
inspectors are assigned per line per shift
to cover inspection stations for the head,
viscera, and carcass at fixed points
along the slaughter and evisceration
line. In small or very small
establishments, one inspector may
perform all of the post-mortem
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inspection procedures on each animal.
FSIS online inspectors identify and
retain carcasses and parts with visible
animal diseases and conditions. The
FSIS PHV thoroughly examines retained
carcasses and parts to determine
whether they should be condemned;
establishment personnel then dispose of
condemned carcasses under FSIS
supervision in accordance with 9 CFR
part 314.
Under the existing regulations for
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.
These sorting functions are conducted
by establishment personnel under
HIMP. Rather, the existing regulations
for traditional inspection require
establishments to assign competent
assistants to take such actions as
directed by FSIS online inspectors after
the inspectors have conducted the
initial sorting activities (see 9 CFR
307.2(g)). Therefore, under the existing
regulations for traditional inspection,
establishments rely on FSIS online
inspectors to effectively control and
direct their processing. Moreover,
because FSIS online inspectors are
responsible for identifying unacceptable
carcasses and parts, it takes online
inspectors more time to conduct a
carcass-by-carcass inspection than
would be necessary if establishments
sorted carcasses and parts, trimmed
dressing defects and contamination that
do not impact the FSIS inspectors’
ability to assess the fitness of the carcass
or part, and identified pathology
defects, before the carcasses and parts
were inspected.
More FSIS resources also could be
devoted to offline inspection activities if
initial sorting and tagging functions
were performed by establishment
personnel. Under the existing
regulations, only FSIS inspectors may
direct the application and removal of
‘‘U.S. Condemned’’ tags from animals
and carcasses condemned by FSIS
inspectors on ante-mortem and postmortem inspection (9 CFR 309.13 and
310.5). The tag must remain on the
carcass until it goes into the tank, or the
carcass is otherwise disposed of in
accordance with 9 CFR part 314.
Establishments are required to denature
condemned carcasses and parts if they
do not have tanking facilities and the
carcasses and parts are to be rendered or
otherwise disposed of off-site (see 9 CFR
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314.3). FSIS inspectors enter the
number on each ‘‘U.S. Condemned’’ tag
into the Public Health Information
System (PHIS). Under the existing
regulations, most ‘‘U.S. Condemned’’
tags are applied during ante-mortem
inspection to animals that arrive dead.
Because FSIS inspectors are responsible
for removing all of the ‘‘U.S.
Condemned’’ tags and documenting
each ‘‘U.S. Condemned’’ tag number
into PHIS, it takes inspectors more time
to complete ante-mortem and postmortem inspections than it would if
establishments sorted and removed
these animals before FSIS inspection
and maintained records that could be
verified by FSIS, as appropriate, and
reported their daily totals to FSIS
inspectors.
In addition to the post-mortem
inspection activities conducted by
online inspectors, offline inspectors
conduct additional food safety related
activities such as verifying that
establishments’ processing meets their
HACCP critical limits and verifying
whether sanitation SOPs are effective.
2. Need for Modernization
Modernization of market hog
slaughter inspection is necessary
because traditional inspection was
developed before FSIS issued its
HACCP regulations, and before the
Agency began targeting its resources to
address public health risks associated
with foodborne pathogens. Traditional
inspection obscures the proper roles of
industry and inspection personnel by
assigning to FSIS inspectors
responsibility for sorting acceptable
animals from unacceptable animals,
finding carcass defects, identifying
production control problems for the
establishment, and verifying corrective
actions in addition to determining
whether the carcasses meet regulatory
requirements. Additionally, traditional
inspection requires FSIS to allocate
significant inspection personnel
resources towards online inspection
activities in large and high volume
market hog establishments to detect
quality defects and conditions that
present minimal food safety risks, thus
limiting the resources available for
offline inspection activities such as
verifying the effectiveness of HACCP
plans and sanitation SOPs. FSIS has
concluded, based on the Agency’s
analysis of the market hog HIMP pilot
(discussed in more detail below),
conducting more offline activities will
be more effective in ensuring food safety
and humane handling verification tasks.
Traditional inspection requires
inspectors to conduct time-intensive
ante-mortem and post-mortem sorting
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activities. This necessitates FSIS to
allocate significant personnel resources
to conduct activities that are more
appropriately the responsibility of the
establishment. As a result, traditional
inspection limits line speeds, even if
establishments can demonstrate that
they are able to produce safe,
unadulterated, wholesome products at
more efficient rates. It also limits large
and high volume market hog slaughter
establishments’ incentive to improve
their processing methods and to develop
more efficient slaughter and dressing
technologies.
For example, under traditional
inspection, the maximum line speed
authorized for slaughter lines with one
or two inspectors is partially based
upon the distance walked (in feet) by
the inspector between work stations to
conduct the sorting activities mentioned
above (see 9 CFR 310.1(b)(3)). For
slaughter lines with three or more
inspectors, line speeds may also depend
on whether FSIS online inspectors
observe the back of the carcasses by
looking in a mirror or whether they
must turn the carcass to observe the
back of the carcass (see 9 CFR
310.1(b)(3)). The maximum line speed
under the existing regulations for
market hogs is 1,106 head per hour
(hph) with seven online inspectors.
Establishments determine their line
speeds based on their equipment, size
and condition of the animals, and their
ability to maintain process control when
operating at a given line speed.
Additionally, traditional inspection
restricts establishments’ ability to
reconfigure and consolidate lines if they
determine that they need more space to
conduct other activities in their
facilities. For example, establishments
slaughtering 1,025 market hogs per hour
must configure their evisceration lines
to accommodate three online head
inspectors, three online viscera
inspectors, and one online carcass
inspector. The regulations require that
establishments provide an inspection
station consisting of five feet of
unobstructed line space for each head or
carcass inspector and, for viscera table
kills, eight feet for each viscera
inspector on the inspector’s side of the
table (9 CFR 307.2 (m)(1)). As a result,
the current regulations for traditional
inspection prevent large and high
volume market hog slaughter
establishments from consolidating
inspection stations or otherwise
reconfiguring their evisceration lines in
order to make room for more innovative,
automated equipment such as head
dropping equipment, bung equipment
(which separates digestive and urinary
organs from pelvic attachments),
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eviscerating equipment, and back saws.
Traditional inspection is generally
sufficient for low volume
establishments and for establishments
that slaughter classes of swine other
than market hogs because these
establishments typically are less
automated and run at slower line speeds
than larger establishments.
Additionally, traditional inspection
was developed when visually detectable
animal diseases such as pneumonias,
erysipelas, hog cholera, cystercercosis,
parasites, and arthritis were more
prevalent and considered to be more of
a concern than they are today. The line
speed limits prescribed under
traditional inspection reflect the
Agency’s previous focus on the
detection of visible defects and animal
diseases and do not give establishments
the flexibility to address these
conditions before presenting the
carcasses and parts to FSIS inspectors.
Traditional inspection focuses
substantial FSIS resources on detecting
visible trim and dressing defects that are
not directly related to food safety,
particularly in light of what is now
known about the role microbial
contamination plays in causing
foodborne human illness. The
traditional inspection model needs to be
updated in light of the significant
advances that have been made in the
control or eradication of many animal
diseases that were more prevalent and
were considered to present a greater
concern when the existing inspection
systems were designed, particularly in
generally healthy classes of animals
such as market hogs.
Moreover, the analysis in FSIS’s
‘‘Assessment of the Potential Change in
Human Health Risk Associated with
Modernizing Inspection of Market Hog
Slaughter Establishments’’ (hereafter
referred to as the market hog risk
assessment) conducted by FSIS suggests
a statistically significant correlation
between increased scheduled and
unscheduled offline inspection
procedures and a reduction in the
prevalence of Salmonella in market hog
establishments. Projecting out illness
reductions based on reduction in
Salmonella prevalence in 35 plants
results in wide uncertainty, but the
model confidently estimates that the
level of protection from Salmonella
illnesses would be at least as good as the
current system. Based on these results,
the redeployment of Agency resources
dedicated to online inspection under
the traditional inspection system to
unscheduled offline activities, such as
increased HACCP and sanitation SOP
verification, has the potential to
contribute to improved food safety
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resulting from a lower prevalence of
carcasses contaminated with
Salmonella, which may in turn lead to
fewer human illnesses. While
prevalence of Salmonella measured in
FSIS’s market hog baseline study is low,
Salmonella is a pathogen of public
health concern for pork products, and
the data available are adequate to
estimate the potential changes in
prevalence with changes in FSIS’s
swine inspection system.
B. Regulations for Microbiological
Testing Under Traditional Inspection
1. Generic E. Coli Criteria for Measuring
Process Control
The existing regulations require that
official swine slaughter establishments
conduct regular testing for generic E.
coli at the end of the chilling process or
after the final wash as a means to verify
process control (9 CFR 310.25(a)(1)).
These regulations prescribe
requirements for collecting the samples,
obtaining analytical results, and
maintaining records of such results (9
CFR 310.25(a)(2), (3), and (4)). They also
include criteria for evaluating an
establishment’s generic E. coli testing
results (9 CFR 310.25(a)(5)). The
regulations provide that generic E. coli
testing results that do not meet the
criteria described in the regulations
indicate that the establishment may not
be maintaining process controls
sufficient to prevent fecal contamination
(9 CFR 310.25(a)(6)). If an establishment
is not meeting the E. coli test results
criteria, the regulations state that FSIS
will take further action as appropriate to
ensure that all applicable provisions of
the law are being met (9 CFR
310.25(a)(6)).
In 2014, FSIS rescinded the
regulations that required that poultry
establishments test carcasses for generic
E. coli to monitor for process control (79
FR 49565, August 21, 2014). The final
regulations replaced the generic E. coli
regulations with new testing
requirements that allow establishments
to develop sampling plans that are more
tailored to the specific establishment,
and thus are more effective in
monitoring their specific process control
than the former generic E. coli criteria.
The Agency concluded that the use of
generic E. coli as an indicator for
process control may not be as useful in
certain poultry slaughter operations as
originally thought. Therefore, FSIS
made the change to allow poultry
establishments to use other more
relevant indicators of process control.
The Agency is aware that most swine
slaughter establishments currently
conduct additional sampling for micro-
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4785
organisms other than generic E. coli
(e.g., Salmonella spp. and aerobic plate
count bacteria (APC)) because they have
found these organisms to be more
relevant indicators of their process
control. Therefore, FSIS is proposing to
remove the generic E. coli sampling
requirements for swine slaughter
establishments to give establishments
more flexibility in monitoring their
process control and to make the Federal
meat inspection regulations more
consistent with the Federal poultry
products inspection regulations. FSIS is
proposing that all swine slaughter
establishments collect and analyze
carcass samples for microbiological
analysis at the pre-evisceration and
post-chill points in the process. The
discussion of the proposed testing
requirements is set out later in this
document.
2. Salmonella Pathogen Reduction/
HACCP Performance Standards
In addition to generic E. coli criteria,
the existing regulations contain
Salmonella pathogen reduction
performance standards for market hogs
(9 CFR 310.25(b)). The codified
performance standards are based on the
prevalence of Salmonella found by two
nationwide microbiological baseline
surveys conducted from April 1995 to
March 1996 and from June 1997 to May
1998. The regulations provide for FSIS
to collect and analyze unannounced
Salmonella samples sets in swine
slaughter establishments to detect
whether these establishments are
meeting the pathogen reduction
performance standards (9 CFR
310.25(b)(2)). The performance
standards set a maximum number of
Salmonella-positive samples allowable
per sample set and are defined on a
product class basis so that an
establishment operating at the baseline
level would have an 80 percent chance
of meeting the standard. Establishments
are required to take corrective actions
when FSIS determines that they are not
meeting the performance standards (9
CFR 310.25(b)(3)(i) and (ii)).
Under the regulations, an
establishment’s failure to take the
corrective actions necessary to comply
with the Salmonella performance
standards, or an establishment’s failure
to meet the standards on the third
consecutive series of FSIS-conducted
tests for that product, constitutes a
failure to maintain sanitary conditions
and to maintain an adequate HACCP
plan (9 CFR 310.25(b)(3)(iii)). The
regulations provide that such failure
will cause FSIS to suspend inspection
services (9 CFR 310.25(b)(3)(iii)).
However, the Agency’s ability to
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directly enforce the pathogen reduction
performance standards has been limited
since 2001, after a ruling by the U.S.
Court of Appeals for the Fifth Circuit in
Supreme Beef Processors, Inc. v. USDA.
In that case, the court enjoined FSIS
from suspending inspection services
against a meat grinding operation for
failure to meet the Salmonella
performance standards. Since that time,
FSIS has used Salmonella failures as a
basis to conduct an in-depth evaluation
of the establishment’s HACCP systems,
including its HACCP plan and
sanitation SOPs.
From August 2010 to August 2011,
FSIS conducted a third market hog
baseline survey to estimate the national
prevalence of Salmonella in market
hogs (The Nationwide Microbiological
Baseline Data Collection Program:
Market Hogs Survey August 2010–2011
available at https://www.fsis.usda.gov/
wps/wcm/connect/d5c7c1d6-09b5-4dcc93ae-f3e67ff045bb/Baseline_Data_
Market_Hogs_2010-2011.pdf?MOD=
AJPERES). The third market hog
baseline survey included 253
establishments that produce
approximately 99.9 percent of market
hogs slaughtered in the United States.
For the third baseline survey, FSIS
collected samples in 152 random
establishments from market hog
carcasses at two points in the slaughter
process: Pre-evisceration and post-chill.
The Salmonella percent positive rate at
pre-evisceration was 69.64 percent, but
at post-chill it was reduced to 2.70
percent. The third baseline survey’s
percent positive rate at post-chill was
significantly lower than the rates found
in the two earlier surveys mentioned
above, which reported Salmonella
percent positive rates of 8.7 percent and
6.9 percent, respectively. Based on the
data from the third baseline survey,
FSIS estimated prevalence of
Salmonella in market hogs was 1.66
percent with a 95 percent confidence
interval between 0.82 percent and 2.51
percent. Because the estimated
prevalence of Salmonella was low, and
FSIS did not find enough pathogen
positives to justify the resources needed
(e.g., time and supplies) to conduct
carcass swabbing, the Agency
determined that this type of sampling
was not an effective use of resources for
verifying process control. As a result,
FSIS did not develop new Salmonella
performance standards for market hogs.
Rather, in September 2011, FSIS
discontinued its Salmonella verification
sampling program for market hogs to
make better use of its resources.
Therefore, FSIS is proposing to
eliminate the pathogen performance
standards for market hogs in 9 CFR
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310.25(b) because verifying the codified
standards was not a good use of Agency
resources and the standards have not
been used since 2011. Instead, FSIS has
decided to focus on its resources on
sampling raw pork parts for pathogens
of public health concern, as well as for
indicator organisms.
FSIS is currently addressing
Salmonella through the Salmonella
Initiative Program (SIP) described
below. In addition, FSIS has published
a compliance guideline to help official
establishments control and reduce the
spread of Salmonella in hog slaughter
facilities (79 FR 633, January 6, 2014).
The guidance is available on the FSIS
web page at: https://www.fsis.usda.gov/
wps/portal/fsis/topics/regulatorycompliance/compliance-guides-index.
The guidance provides information on
best practices that may be applied at a
hog slaughter facility to prevent,
eliminate, or reduce levels of
Salmonella on hogs at all stages of
slaughter and dressing. Importantly,
FSIS has identified microbial
performance measures, as guidance, at
the pre-evisceration and post chill
points.
Moreover, FSIS is currently
conducting exploratory sampling of raw
pork products for pathogens of public
health concern, as well as for indicator
organisms (80 FR 12618). A summary of
the Phase I positive sampling results
collected from May 2015 to November
2015 are as follows: 16.7 percent
Salmonella, 1 percent Campylobacter,
4.5 percent Methicillin-Resistant
Staphylococcus aureus (MRSA), 1
percent Toxoplasma gondii, 1.5 percent
Yersinia enterocolitica, 0 percent E. coli
O157:H7, and 5 percent non-O157 shiga
toxin-producing E. coli (non-O157
STEC). FSIS has posted more detailed
sampling results on its website at
https://www.fsis.usda.gov/wps/wcm/
connect/68f5f6f2-9863-41a5-a5c425cc6470c09f/Sampling-Project-ResultsData.pdf?MOD=AJPERES. The Agency
may develop pathogen reduction
performance standards for pork parts at
a later date. In 2019, the Agency will
use this data to determine whether
standards or additional policies (e.g.,
training, guidance to industry, or
instructions to field personnel) are
needed to address Salmonella in pork
products.
C. Waivers of Regulatory Requirements
1. Waivers To Test New Technology
The regulations in 9 CFR 303.2(h) and
381.3(b) provide for the Administrator
to waive for limited periods any
provisions of the regulations to permit
experimentation so that new
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procedures, equipment, or processing
techniques may be tested to facilitate
definite improvements. Under these
regulations, FSIS may only grant
waivers from the provisions in the
regulations that are not in conflict with
the purposes or provisions of the FMIA
or PPIA (9 CFR 303.1(h) and 381.3(b)).
FSIS decides whether to grant
requests for waivers based on proposals
and documentation submitted by
establishments to demonstrate that the
use of a new technology is scientifically
sound; that it will facilitate definite
improvements; and that issuing the
waiver will not conflict with the
provisions of the FMIA or PPIA.1 If FSIS
determines that the information
submitted by an establishment supports
the requested waiver, the Agency will
waive the appropriate provisions in the
regulation for a limited period of time
to allow the establishment to conduct an
in-plant trial. The purpose of the inplant trial is to gather data on the effects
of the use of the new technology. FSIS
reviews the data that is developed in the
trial to determine whether they establish
that the purpose of the waiver is being
met.
2. Salmonella Initiative Program
Waivers
Under SIP, the Agency grants meat
and poultry slaughter establishments
waivers of regulatory requirements on
condition that they will conduct regular
microbial testing and share the resulting
data with FSIS. The Agency described
preliminary details of SIP in a January
28, 2008, Federal Register notice (73 FR
4767–4774) and announced its final
terms and conditions in the July 13,
2011, Federal Register notice (76 FR
41186). SIP benefits public health in
that it encourages slaughter
establishments to conduct testing for
microbial pathogens, which is a key
feature of effective process control, and
to respond to testing results by taking
steps when necessary to regain process
control. In addition, SIP enables FSIS to
use establishment data to inform
Agency policy aimed at enhancing
public health protection.
SIP establishments test for
Salmonella, Campylobacter (if
applicable), and generic E. coli or other
indicator organisms and share all
sample results with FSIS.
Establishments that had been operating
under regulatory waivers before FSIS
implemented the SIP were required to
participate in SIP or forfeit their
waivers. The list of establishments
1 For Agency New Technology waiver procedures,
see https://www.fsis.usda.gov/wps/portal/fsis/topics/
regulatory-compliance/New-Technologies.
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participating in SIP is available on
FSIS’s website at https://www.fsis.
usda.gov/wps/wcm/connect/188bf58345c9-4837-9205-37e0eb1ba243/Waiver_
Table.pdf?MOD=AJPERES. To date the
regulations waived for swine slaughter
establishments under SIP include: 9
CFR 310.1(b)(3)— line speed; 9 CFR
310.25(a)— generic E. coli testing 2; 9
CFR 310.25(b)—Salmonella
performance standards; 9 CFR
310.18(a)— contamination of organs; 9
CFR 310.11—cleaning and hair removal;
and 9 CFR 310.14—handling of bruised
parts. All swine slaughter
establishments operating under SIP
waivers will continue to operate under
waivers and will continue to conduct
testing under SIP if their waivers are not
addressed in the final rule resulting
from this proposal. If their waivers are
addressed in the final rule resulting
from this proposal, their waivers will
end.
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II. Consideration of Need for a New
Swine Slaughter Inspection System
A. Early Development of the Inspection
Models Program
In 1996, FSIS published its Pathogen
Reduction/HACCP (PR/HACCP) final
rule as the first step of a comprehensive
initiative to target the Agency’s
resources to address the public health
risks associated with foodborne
pathogens, which cannot be detected by
organoleptic inspection (61 FR 38868,
July 25, 1996). Under FSIS’s PR/HACCP
regulations, establishments are required
to develop and implement a system of
preventive controls to ensure that their
products are safe. This approach gives
establishments more flexibility to
determine how they can best meet the
Agency’s regulatory requirements. FSIS
verifies the adequacy and effectiveness
of establishments’ HACCP systems.
In 1997, in order to improve food
safety and the effectiveness of
inspection systems, reduce the risk of
foodborne illness in the United States,
remove unnecessary regulatory
obstacles to innovation, and make better
use of the Agency’s resources, FSIS
announced, in a Federal Register notice,
that the Agency would be developing a
new HIMP study (62 FR 31553, June 10,
1997). During the HIMP study, FSIS
would design and test various new
inspection models in a series of trials in
volunteer meat and poultry slaughter
establishments.
Under the initial HIMP inspection
models approach, establishment
2 Some establishments continue to sample for
generic e. coli to monitor their process control. The
SIP waivers allow these establishments to use
alternative sampling locations and frequencies.
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personnel were responsible for sorting
and removing animals unfit for
slaughter and identifying and removing
abnormal carcasses and parts, and FSIS
inspection personnel performed
inspection activities that focused on the
areas of greatest risk in the hog slaughter
inspection system in each
establishment.
In 1998, the American Federation of
Government Employees, several FSIS
inspectors, and a public interest
organization filed suit to enjoin FSIS
from implementing the HIMP model.
The plaintiffs alleged that HIMP
violated the requirement in the FMIA
that government inspectors conduct a
post-mortem inspection of each carcass.
Specifically, the FMIA provides that the
Secretary shall cause to be made by
inspectors a post-mortem inspection of
the carcasses and parts thereof of all
amenable species to be prepared at any
slaughtering, meat-canning, salting,
packing, rendering, or similar
establishment (21 U.S.C. 604). The
district court upheld HIMP, finding that
the word ‘‘inspection’’, as used in the
statute, does not necessarily mandate a
direct, physical examination of each
carcass by an FSIS inspector, and that
the model program was a rational policy
judgment within the discretion afforded
to the Secretary.
The plaintiffs appealed, and the Court
of Appeals for the District of Columbia
Circuit reversed the district court’s
decision. The Court of Appeals found
that the FMIA requires Federal
inspectors—rather than plant
employees—to make the decision
whether each carcass is adulterated
within the meaning of the statute (AFGE
v. Glickman, 215 F.3d 7, 11 (D.C. Circ.
2000)). The case was remanded to the
district court for further proceedings.
In response to the Court of Appeals’
opinion, FSIS modified HIMP to
position up to three 3 online inspectors
at fixed locations along the slaughter
lines: In the area where the carcass and
head were separated; where the carcass
and viscera were separated; and at the
pre-wash carcass verification location.
These inspectors were responsible for
examining the head, viscera, and carcass
of each hog. The modified models
project also included FSIS offline
inspectors who were responsible for
conducting HACCP and sanitation
system verification activities and for
3 FSIS is able to assign fewer than three online
inspectors if the physical configuration of the
slaughter line allows one inspector to inspect both
the head and viscera or the viscera and carcass. For
example, in one establishment, the chain that
carries the carcass is adjacent to the viscera pans,
which enables one inspector to examine both the
carcass and viscera.
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4787
closely examining a sample of carcasses
for food safety defects to ensure that the
establishment’s process was under
control and that adulterated carcasses
and parts were not getting past the
establishment sorters. On remand, the
district court found that HIMP, as
modified, complied with both the
applicable statutory provisions and the
opinion issued by the Court of Appeals.
The plaintiffs again appealed to the
Court of Appeals for the D.C. Circuit.
The plaintiffs argued that the modified
inspection procedures were not in
compliance with the Court of Appeals’
prior opinion because FSIS had
delegated some inspection duties to
plant employees who were responsible
for sorting defective carcasses and
making preliminary decisions regarding
adulteration. The Court of Appeals
rejected this argument, finding that the
FMIA does not prohibit plant employees
from paring down the overall number of
carcasses by sorting and removing
carcasses before they reach the Federal
inspector (AFGE v. Veneman, 284 F.3d
125, 131 (D.C. Cir. 2002)). The Court
held that the modified inspection model
program satisfied the FMIA because it
required Federal inspectors to
personally examine all hog carcasses,
heads, and viscera, as required by 21
U.S.C. 604.
The plaintiffs also argued that the line
speeds allowed in the HIMP plants were
too fast to allow Federal inspectors to
make a critical appraisal of each carcass.
The Court found that FSIS’s decision to
allow higher line speeds was reasonable
in light of the fact that establishment
employees are required to sort carcasses
and parts and identify defects prior to
Federal inspection, resulting in fewer
adulterated carcasses and parts being
presented for Federal inspection. The
Court also noted that although the FMIA
delineates what must be inspected and
by whom, it does not define exactly
what constitutes an inspection. The
court concluded that HIMP, as
modified, reflected a reasonable design
of an inspection system by the agency
charged with responsibility for
administering the FMIA and that it
would rely on the Agency’s experience
and informed judgment in evaluating
the validity of the system under the law.
Under these circumstances, the Court of
Appeals upheld HIMP, as modified.
B. Existing HACCP-Based Inspection
Models Program
The revised HIMP study was initiated
in five market hog slaughter
establishments on a waiver basis.
Similar to the voluntary segregation
procedures described above in
establishments that slaughter only
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market hogs under traditional
inspection, establishment personnel sort
animals before they are presented to
FSIS ante-mortem inspectors under
HIMP. Establishment personnel sort
animals that appear to be healthy into
‘‘Normal’’ pens and animals that appear
to have condemnable diseases or
conditions into ‘‘Subject’’ pens.
Establishment personnel remove and
dispose of dead and moribund animals
and animals suspected of having central
nervous system disorders (CNS) or
pyrexia. Under HIMP, FSIS inspectors
examine all animals found by the
establishment to be normal at rest, and
five to ten percent of those animals in
motion. 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. FSIS PHVs
examine all animals in the
establishment’s ‘‘Subject’’ pens, and
direct establishment employees to move
animals to ‘‘U.S. Suspect’’ pens for final
disposition by the FSIS PHV. The FSIS
PHV determines if any animals must be
identified as ‘‘U.S. Condemned’’ and
disposed of in accordance with 9 CFR
309.13 (9 CFR 309.2). While
establishment personnel sort and
remove animals unfit for slaughter, only
FSIS inspectors have the authority to
condemn an animal. FSIS inspectors
observe establishment employees
performing sorting procedures at least
twice per shift under HIMP compared to
at least once per month under the
voluntary segregation procedures
permitted under traditional inspection
of market hogs.
Under HIMP, post-mortem inspection
is conducted by up to three online
inspectors who visually inspect the
head, viscera, and carcass of each hog at
fixed locations on the evisceration line.
Before FSIS online inspection,
establishment personnel sort carcasses
and parts and trim dressing defects and
contamination (e.g., hair, bruises, feces,
ingesta, and milk). Establishment
employees also mark with ink localized
pathology defects intended for removal
under FSIS supervision (e.g. localized
nephritis and localized arthritis) and
carcasses and parts intended for
disposal under FSIS supervision (e.g.,
carcasses and parts with malignant
lymphoma). Online inspection is
conducted much more efficiently and
effectively under HIMP than under
traditional inspection because
establishment personnel have already
sorted carcasses and parts, trimmed
dressing defects and contamination, and
identified pathology defects on the
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carcasses, thereby correcting most
removable defects, before the FSIS
online inspectors perform their carcassby-carcass inspection.
Under HIMP, offline inspection
consists of system verification activities
through which FSIS continuously
monitors and evaluates establishment
process control. FSIS conducts more
offline, food safety related verification
inspection activities under HIMP than
under traditional inspection. Some
examples of food safety related
verification inspection activities
include: HACCP, sanitation SOP, and
other prerequisite program verification
procedures, including 24 carcass
verification checks per shift specifically
for generalized diseases and conditions
and for contamination (compared to 11
carcass verification checks per shift
under traditional inspection). FSIS also
conducts more offline humane handling
verification tasks under HIMP than
under traditional inspection.
FSIS has concluded that the HIMP
model has a number of benefits, such as
focusing FSIS inspection personnel on
the areas of greatest risk in the hog
slaughter system and providing an
incentive to establishments to improve
and innovate, while ensuring effective
online inspection.
C. U.S. General Accountability Office
(GAO) and the USDA’s Office of the
Inspector General (OIG) Reports on
HIMP
In 2013, the U.S. General
Accountability Office (GAO) and the
USDA’s Office of the Inspector General
(OIG) evaluated FSIS’s HIMP pilot study
and issued findings and
recommendations.4 5 GAO identified
strengths in the pilot study, including
that of giving plants responsibility and
flexibility for ensuring food safety and
quality and allowing FSIS inspectors to
focus more on food safety activities.
However, GAO also identified what it
believed to be data gaps in the HIMP
pilot study. GAO recommended that
FSIS collect and analyze information to
determine if the HIMP pilot study is
meeting its purpose, and FSIS agreed
with the recommendation.
The OIG report also included
recommendations related to HIMP
procedures. According to the OIG, FSIS
did not adequately oversee the HIMP
program because the Agency did not
4 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.
5 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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evaluate whether the program resulted
in a measurable improvement of the
inspection process; allowed one HIMP
plant to forgo the standard FSIS policy
to manually inspect viscera; and did not
have formal agreements with the HIMP
plants. In response to OIG, FSIS agreed
to complete an evaluation of HIMP
market hog establishments.
D. Analysis of HIMP
1. FSIS Evaluation of HIMP
In 2014, in response to the GAO and
OIG reports, FSIS conducted a
comprehensive analysis of data
collected from the operation of HIMP in
market hog establishments and prepared
a written report (the ‘‘Hog HIMP
Report’’) that presents a thorough
evaluation of the models tested. Based
on this evaluation, FSIS concluded that
market hog slaughter establishments
participating in HIMP were performing
as well as comparable large non-HIMP
market hog establishments and meeting
FSIS requirements for operating under
waivers through the HIMP project.
A summary of the Hog HIMP Report
is provided below. The full Hog HIMP
Report is available on the FSIS website
at: https://www.fsis.usda.gov/wps/wcm/
connect/f7be3e74-552f-4239-ac4c59a024fd0ec2/Evaluation-HIMP-MarketHogs.pdf?MOD=AJPERES. Before
implementation of the HIMP project, an
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
program. These data reflect the
performance of the establishments
under traditional inspection and
provided the basis to establish HIMP
performance standards for food safety
defects and non-food safety ‘‘Other
Consumer Protection’’ (OCP) defects.
FSIS established three categories of
food safety related performance
standards under HIMP for these
conditions: ‘‘FS–1’’ addresses infectious
conditions (e.g., septicemia, toxemia,
pyemia, and cysticercosis); ‘‘FS–2’’
addresses contamination from fecal
material, ingesta, and milk; and ‘‘FS–3’’
addresses certain conditions identified
at ante-mortem (e.g. moribund, pyretic,
and neurologic conditions). FSIS has a
zero tolerance policy for food safety
conditions identified as FS–1, FS–2, and
FS–3 to protect consumers from
conditions that may be harmful.
Therefore, the HIMP performance
standard for food safety defects was set
at zero.
FSIS established the performance
standard for non-food safety OCP
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defects based on the performance level
of the establishment representing the
75th percentile for each category of OCP
defects (i.e., slightly below the fourth of
the five baseline results for each
category). FSIS established three
categories of OCP performance
standards for various types of trim and
dressing defects that primarily affect the
quality of products: ‘‘OCP–1’’ addresses
carcass pathology defects (e.g., arthritis,
emaciation, and erysipelas) and was set
at 4.1 percent of carcasses, ‘‘OCP–2’’
addresses visceral pathology defects
(e.g., cystic kidneys, enteritis, and
nephritis) and was set at 7.2 percent of
carcasses, and ‘‘OCP–3’’ addresses
miscellaneous defects such as bile,
bruises, and skin lesions and was set at
20.5 percent of carcasses. The HIMP
performance standards were finalized in
November 2000 (see 65 FR 65828,
November 2, 2000). To participate in the
program, establishments operating
under HIMP are required to maintain
process control plans to meet the
performance standards for food safety
and non-food safety OCP defects. The
HIMP performance standards are a
measure for comparing the performance
of establishments operating under the
HIMP inspection system with
performance when operating under the
current non-HIMP, traditional
inspection system.
a. Overview of the HIMP Report
The Hog HIMP Report describes
FSIS’s microbiological and inspection
findings in the five market hog slaughter
establishments participating in HIMP
and compares them with 21 non-HIMP
establishments of comparable
production volume, line speed, and
days of operation. The evaluation is
based on establishment performance
results for calendar years CY2006
through CY2010, and CY2012 through
CY2013. Establishment performance
results from CY2006 to CY2010 are
based on data from the previously used
Performance Based Inspection System
(PBIS) database and results from
CY2012 to CY2013 are based on data
from the new Public Health Information
System (PHIS) database. FSIS began
transitioning establishments from PBIS
to the PHIS in April 2011. The period
April 2011 to December 2011 was a
transitional period during which the
inspection results for some
establishments were recorded under
PBIS, while others were recorded under
PHIS. The data under the two systems
are not completely compatible because
inspection task codes and
noncompliance records (NRs) were
recorded differently in PHIS than in
PBIS. For this reason, the transitional
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period CY2011 is not included in the
Hog HIMP Report, and the analysis of
CY2006 through CY2010 data is
separate from the CY2012 through
CY2013 data.
Across HIMP and non-HIMP
establishments, analyses compared the
number of offline inspection
procedures, the rates of health-related
regulatory non-compliances, Salmonella
positive rates, and violative chemical
residue rates. FSIS evaluated offline
inspection procedures to determine
whether comparable levels of inspection
are being performed in HIMP
establishments compared to non-HIMP
establishments. The Hog HIMP Report
found that establishments participating
in HIMP performed as well as
comparable large non-HIMP
establishments and met the Agency’s
requirements for participating in the
HIMP project.
b. Verification by Offline Inspectors of
the Establishment Executing Its HIMP
Process Control Plan Under Which
Establishment Employees Sort
Acceptable and Unacceptable Carcasses
and Parts
The Hog HIMP Report found that the
rate of ante- and post-mortem sorting by
HIMP establishment personnel was
comparable to the rate of ante- and postmortem condemnation by FSIS
inspectors at non-HIMP market hog
establishments (3.0 per 1,000 hogs
compared to 2.7 per 1,000 hogs,
respectively). The Hog HIMP Report
also found that FSIS inspectors in HIMP
establishments performed more offline
inspection activities than in non-HIMP
establishments to verify that the
establishments are executing their HIMP
slaughter process control plans. In
CY2010, FSIS inspectors performed an
average of 2,061 offline verification
inspections per HIMP market hog
establishment compared to an average of
1,482 offline verification inspection
procedures per non-HIMP
establishment. Accordingly, FSIS
inspectors performed 1.4 times more
offline verification inspection
procedures in HIMP market hog
establishments than in non-HIMP
market hog establishments. In CY2013,
FSIS inspectors performed an average of
19,180 Public Health Regulation (PHR) 6
verification tasks per HIMP market hog
6 PHRs consists of regulations and specific
provisions of regulations that have higher rates of
noncompliance three months before a pathogen
positive or enforcement action. The inclusion of
provisions of regulations in the PHR list allows
FSIS to focus on specific health related provisions
of regulations that may be most informative for
prioritizing Food Safety Assessments (FSAs). FSAs
are in-depth evaluations of an establishment’s food
safety system. FSAs can be routine or for cause.
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4789
establishment compared to an average of
14,099 PHR verification tasks per nonHIMP establishment. Thus, FSIS
inspectors performed 1.4 times more of
the offline inspection verifications of
mandatory regulations in HIMP market
hog establishments than in non-HIMP
market hog establishments. The HIMP
Report concluded that this increased
level of offline inspection activities
provides increased assurance that HIMP
establishments are maintaining OCP and
food safety defects at levels that are to
or less than the levels in non-HIMP
establishments.
c. Verification of the Establishment
Executing Its HACCP System Under 9
CFR Parts 416 and 417
The sanitation SOP regulations in 9
CFR 416 and the HACCP regulations in
9 CFR 417 are among the regulations
most strongly related to public health.
The Hog HIMP Report found that in
CY2010, FSIS inspectors performed 1.5
times more offline sanitation SOP and
HACCP inspection verifications of
public health-related regulations in
HIMP than non-HIMP market hog
comparison establishments. In CY2012
and CY2013, FSIS inspectors performed
1.1 times more offline sanitation SOP
and HACCP inspection verifications of
public health-related regulations in
HIMP than non-HIMP market hog
comparison establishments.
The regression analysis of historical
data that was included in FSIS’s ‘‘Risk
Assessment for Guiding Public HealthBased Poultry Slaughter Inspection,’’
which was used to inform the final rule
‘‘Modernization of Poultry Slaughter
Inspection’’ (79 FR 49565), showed a
statistically significant correlation
between unscheduled offline inspection
procedures and reduction in the
prevalence of Salmonella and
Campylobacter positive samples. Based
on these modeling results, FSIS thought
it was reasonable to conclude that the
redeployment of Agency resources to
unscheduled offline activities was likely
to contribute to improved food safety
resulting from a lower prevalence of
carcasses contaminated with Salmonella
and Campylobacter, which in turn could
lead to fewer human illnesses.
Depending on how reallocation of
inspection activities was implemented,
it was likely that changes in off-line
inspection could have resulted in a
decrease in the numbers of positive
microbial samples in FSIS-regulated
young chicken and young turkey
establishments. Specifically, the
scenario that only increased
unscheduled inspection procedures
performed much better than the
scenario that did not target specific
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types of procedures, and the results
suggest a reasonable degree of
confidence that the discriminate
scenario would do no harm. That
poultry slaughter risk assessment is
available on FSIS’s website at https://
www.fsis.usda.gov/wps/portal/fsis/
topics/regulatory-compliance/haccp/
haccp-based-inspection-models-project/
himp-study-plans-resources/poultryslaughter-inspection. The risk model
and model results are also posted online as a technical support document for
the risk assessment on the FSIS website.
The market hog risk assessment uses a
similar approach and model as the
poultry slaughter risk assessment and
estimates the reduction in illnesses
likely to result from the reallocation of
inspectors contemplated by this
proposed rule. The market hog risk
assessment is discussed in more detail
below.
d. Verification of the Outcomes of the
Establishment Process Control Plan,
Both Organoleptic and Microbiologic
To assess the microbiological
outcomes of HIMP establishments’
process control plans, the Hog HIMP
Report analyzed data from FSIS’s
Salmonella verification program. For
the years CY2006–CY2009, the
differences in Salmonella positive rates
between HIMP market hog
establishments and non-HIMP
comparison establishments were not
statistically significant for any of the
years. The Hog HIMP Report also
analyzed data from FSIS’s Salmonella
baseline study on market hog slaughter
establishments, conducted from August
2010 to August 2011. The Salmonella
positive rates in HIMP market hog
establishments were not statistically
significantly different from those in the
subset of 21 non-HIMP comparison
establishments. This is probably the
result of the small sample size relative
to the low Salmonella positive rate.
However, in the August 2010 to August
2011 baseline study the Salmonella
positive rates in HIMP market hog
establishments were statistically
significantly lower than those in all 147
non-HIMP market hog establishments
(which included the subset of 21 nonHIMP comparison establishments, as
well as all other non-HIMP market hog
establishments) (0.65 percent versus
3.05 percent).
The Hog HIMP Report also analyzed
data from FSIS’s residue sampling
program for chemical contaminants
including approved and unapproved
veterinary drugs, pesticides, and
environmental compounds. FSIS
conducts directed sampling scheduled
by FSIS Headquarters and inspector-
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generated sampling when the FSIS PHV
suspects that an animal may have a
violative level of chemical residue. The
Hog HIMP Report found no differences
in the number of scheduled directed
samples collected in the HIMP market
hog establishments and those in the
non-HIMP market hog comparison
establishments. However, the Hog HIMP
Report found that FSIS offline
inspectors at the HIMP market hog
establishments were able to collect 2.7
times more inspector-generated residue
samples than inspectors at the nonHIMP market hog comparison
establishments for CY2009–2010, and
1.7 times more for CY2012–2013
because the inspectors had more time to
conduct offline activities. Data from
FSIS’s residue sampling program
showed that from CY2006 to CY2010,
the number of samples that tested
positive for violative levels of chemical
residues in HIMP market hog
establishments were not statistically
significantly different from those in the
non-HIMP market hog comparison
establishments (zero versus six (0.057
percent of samples)). However, from
CY2012 to CY2013, the amount of
samples that tested positive for violative
levels of chemical residues in HIMP
market hog establishments was
statistically significantly lower than
non-HIMP market hog comparison
establishments (nine violative levels
(0.15 percent of samples) versus 115
(0.76 percent of samples). The Hog
HIMP Report explained that this
difference could suggest that the HIMP
market hog establishments are
exercising active control of potential
chemical hazards in their products, and
that this approach may result from
better control over contract grower
relationships by the five HIMP market
hog establishments.
e. Conclusion of HIMP Report
The Hog HIMP Report concluded that
HIMP market hog establishments are
receiving more offline food safety
related inspection verification checks
than the non-HIMP market hog
comparison establishments, and that the
HIMP inspection system, which
provides for increased offline inspection
activities that are directly related to food
safety, results in greater compliance
with sanitation and HACCP regulations
(9 CFR parts 416 and 417); carcasses
with equivalent or lower levels of
Salmonella contamination; and
carcasses with lower levels of violative
chemical residues.
f. Verification of Humane Handling
FSIS inspectors verify that
establishments comply with the HMSA
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by performing Humane Activities
Tracking System (HATS) tasks that are
divided into nine categories. The HATS
tasks provide FSIS with data on the time
that FSIS inspectors spend verifying
whether (1) establishments adapt their
facilities to inclement weather; (2)
humanely handle livestock during truck
unloading; (3) provide water and feed to
livestock in holding pens; (4) humanely
handle livestock during ante-mortem
inspection; (5) humanely handle ‘‘U.S.
Suspect’’ and disabled livestock; (6)
move livestock without excessive
prodding or the use of sharp objects
after ante-mortem inspection; (7)
prevent livestock from slipping and
falling; (8) effectively administer
stunning methods that produce
unconsciousness in the animals; and (9)
ensure that animals do not regain
consciousness throughout the shackling,
sticking, and bleeding process. FSIS
inspectors enter the hours devoted to
verifying humane handling activities for
the HATS categories. The data is
entered into PHIS in one-quarter hour
increments (e.g., .25, .5, .75, 1.0).
The Hog HIMP Report did not address
compliance with the HMSA, but FSIS
reviewed HATS task data in PHIS from
January 2013 through September 2015
and compared the number of offline
humane handling activities performed
in five HIMP market hog establishments
and the same 21 comparable large nonHIMP market hog establishments that
FSIS used in the Hog HIMP Report. The
Agency found that FSIS inspectors
spent more time verifying that specific
humane handling and slaughter
requirements were met in HIMP market
hog establishments than in non-HIMP
market hog establishments. FSIS
inspectors devoted approximately 5.33
hours per shift to verifying humane
handling activities for the HATS
categories in HIMP market hog
establishments compared to
approximately 4.29 hours per shift in
the 21 non-HIMP market hog
comparison establishments. FSIS also
compared the rate of humane handling
NRs issued in HIMP market hog
establishments and non-HIMP market
hog establishments. FSIS inspectors
documented fewer humane handling
NRs in HIMP market hog establishments
than in non-HIMP market hog
establishments. From January 2013
through September 2015, FSIS recorded
11 humane handling NRs in five HIMP
market hog establishments and 117 NRs
in the 21 non-HIMP market hog
comparison establishments. It should be
noted that none of the 11 NRs recorded
in the HIMP establishments
documented market hogs being forced to
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move faster than normal walking speeds
to keep up with faster evisceration line
speeds. The data demonstrate that HIMP
establishments have higher compliance
with humane handling regulations than
non-HIMP establishments, and that
increased offline inspection may
improve compliance with the HMSA.
E. Public Health Benefits Projected From
Allocating More Inspection Resources to
Food Safety-Related Inspection
Activities
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1. Market Hog Risk Assessment
FSIS completed a quantitative risk
assessment to determine how
performing a greater number of offline
inspection procedures in market hog
slaughter establishments might affect
the number of human illnesses from
Salmonella. These offline inspection
procedures primarily involve activities
that FSIS inspection personnel perform
to verify the effectiveness of
establishment sanitary operations and
other food safety-related activities. The
Hog HIMP Report, discussed above,
found that FSIS inspectors performed
more offline inspections to verify
compliance with sanitation SOP and
HACCP regulations in HIMP
establishments than they do in nonHIMP establishments. The risk
assessment is available for viewing by
the public in the FSIS docket room and
on the FSIS website at: https://
www.fsis.usda.gov/regulations_&_
policies/Proposed_Rules/index.asp.
FSIS developed the market hog risk
assessment to help the Agency inform
its judgement about the potential impact
of changes to FSIS’s swine inspection
system on risks to public health
associated with pork products. To give
the Agency the information it needed,
the market hog risk assessment focused
on three risk management questions:
(1) What predicted effects will various
models for increasing the number of
offline inspection tasks in non-HIMP
establishments have on human
salmonellosis rates?
(2) Where can inspectors be relocated
to have the most impact toward
reducing Salmonella prevalence and
corresponding human illness?
(3) What is the magnitude of
uncertainty about the predicted
prevalence of pathogens and
corresponding illness effects?
2. Model
FSIS developed a risk assessment
model for exploring the potential
relationships between current variations
in inspection personnel assignments
and prevalence of Salmonella on hog
carcasses, and estimating the
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subsequent possible reductions in
human illnesses attributable to that
pathogen. FSIS paired inspection data
with Salmonella prevalence data for the
same establishments and timeframes. As
explained above, FSIS based this risk
assessment model on the model for the
risk assessment that FSIS used to inform
the final rule ‘‘Modernization of Poultry
Slaughter Inspection’’ (79 FR 49565).
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-butnot-completed procedures, and (2)
contamination of hog carcasses with
Salmonella.7 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. 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.
3. Conclusions of the Market Hog Risk
Assessment
The regression analysis of 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. Based on these results, the
redeployment of Agency resources to
scheduled and unscheduled offline
activities, along with a reduction in
scheduled but not performed
7 Scheduled procedures are assigned to inspectors
at an establishment by PBIS or PHIS. Unscheduled
procedures are performed according to inspector
needs at an establishment and may include
verification checks for fecal, 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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4791
procedures, is likely to contribute to
food safety resulting from a lower
prevalence of carcasses contaminated
with Salmonella, which in turn we
expect to lead to fewer human illnesses.
In answer to the first risk-management
question, the market hog risk
assessment results suggest that,
depending on how reallocation of
inspection activities is implemented, it
is likely that changes in offline
inspection would not result in an
increase in the prevalence of Salmonella
in hog carcasses, and could even result
in a decrease in the prevalence of
Salmonella in hog carcasses.
Specifically, the scenario that
simultaneously increases unscheduled
and scheduled inspection procedures
and decreases scheduled but not
performed procedures performs better
than scenarios that target the three
specific types of procedures one at a
time. Under the scenario where all types
of procedures are targeted for increase,
with resulting decrease in scheduled but
not performed procedures and decrease
in instances of observed and reported
establishment non-compliance, the
model estimates an average decrease of
2,533 Salmonella-related illnesses per
year attributable to pork products. FSIS
assumes that 65,869 expected annual
Salmonella illnesses are attributed to
consumption of pork products. Thus, a
reduction of 2,533 expected Salmonella
illnesses annually, would reflect a 3.8
percent reduction in Salmonella
illnesses attributable to pork products.
Responding to the second question,
modeling and scenario analysis results
suggest that increasing scheduled and
unscheduled procedures and decreasing
scheduled but not performed
procedures would be most effective in
reducing pathogen occurrence on
carcasses because of consistency in the
decision variable parameter’s effect
across all models. However, each
category of offline procedures relates to
an individual decrease in Salmonella
contaminated carcasses which if any
one of the three categories or a
combination of categories of offline
procedures were implemented still
would result in decreased
contamination, but less than if the
scenario combining all three decision
variables was adopted.
In answer to the third riskmanagement question, on the
uncertainty of the results for pathogen
prevalence and illness reductions,
FSIS’s modeling approach includes the
inherent uncertainty about the
relationship between the frequency of
inspection activities and pathogen
prevalence, about the actual change in
future inspection activities that would
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likely be observed, and about the
representativeness of the rates of human
Salmonella illnesses attributable to pork
products.
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III. Proposed NSIS
FSIS is proposing to create a new
swine slaughter inspection system, the
NSIS, informed by the Agency’s
experiences under HIMP and NPIS. All
establishments that slaughter market
hogs would be permitted to operate
under the proposed NSIS.
Establishments that slaughter classes of
swine other than market hogs would be
permitted to operate under NSIS under
a waiver through the SIP. FSIS would
consider the data collected in swine
slaughter establishments operating
under a SIP waiver to determine
whether to expand NSIS to other classes
of swine. Establishments that slaughter
market hogs and other classes of swine,
and that do not want to slaughter other
classes of swine under NSIS under a
waiver through the SIP, would be
permitted to slaughter market hogs
under NSIS and to slaughter the other
classes of swine under traditional
inspection. FSIS would staff such
establishments to NSIS and would not
add additional staff for traditional
inspection; therefore, establishments
would need to operate traditional
inspection under slower line speeds
than they are currently operating to
accommodate for the reduced number of
inspectors. FSIS seeks comment on the
impact of staffing at establishments that
slaughter market hogs and other classes
of swine and how it will impact their
decision to participate in NSIS.
A. Live Market Hog Sorting by
Establishment Personnel
Under the proposed NSIS,
establishment personnel would be
required to sort market hogs and remove
for disposal animals unfit for slaughter
before they are presented to FSIS PHVs
for inspection and final disposition.
Establishment personnel would sort
animals that appear to be healthy into
‘‘Normal’’ pens and animals that appear
to have diseases or abnormal conditions
into ‘‘Subject’’ pens. Establishment
personnel may also sort and remove
animals with localized conditions (e.g.,
animals with arthritis or abscesses) or
animals that do not meet establishment
specifications (e.g., hogs that are the
wrong size or underweight) to be
diverted to another official
establishment for slaughter.
Establishment personnel would remove
and properly dispose of dead and
moribund animals and animals
suspected of having CNS conditions or
pyrexia. Under the proposed NSIS, FSIS
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inspectors would inspect all animals
found by the establishment to be normal
at rest, and five to ten percent of those
animals in motion. If any animals
exhibit signs of condemnable
conditions, FSIS inspectors would
direct establishment employees to move
the animals to the ‘‘U.S. Suspect’’ pens
for final disposition by the FSIS PHV.
The FSIS PHV would inspect all
animals in the ‘‘Subject’’ and ‘‘U.S.
Suspect’’ pens and render a final
disposition decision. FSIS inspectors
would observe establishment employees
performing sorting procedures at least
twice per shift. During this time, FSIS
inspectors would 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. FSIS inspectors
also would conduct HACCP verification
tasks in PHIS at least twice per shift to
verify that establishments meet the
regulatory requirements found in 9 CFR
417 for implementation, monitoring,
recordkeeping, prerequisite programs
(when applicable), and corrective
actions. Under the proposed rule, if any
market hogs become non-ambulatory
disabled after ante-mortem inspection,
establishments would be required to
move them to the ‘‘Subject’’ pens for reinspection by FSIS PHVs. All sorting
would be a function of the
establishment’s HACCP plan or prerequisite program. Because
establishments operating under the
proposed NSIS would be required to
sort and remove market hogs that are
unfit for slaughter before FSIS antemortem inspection, FSIS is proposing
that establishments under the proposed
NSIS 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 CNS conditions or
pyrexia.
FSIS also is proposing to require that
establishments immediately notify FSIS
inspectors in the rare circumstance that
they suspect animals of having
notifiable or foreign animal diseases
during sorting activities. For example,
establishments may suspect that market
hogs have notifiable or foreign animal
diseases if they observe animals with
abnormal lesions or behavior, or an
abnormal change in the amount of
animals that arrive to the establishment
dead. Notifiable diseases are those that
are designated by the World Animal
Health Organization (Office
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International des Epizooties or OIE).
The list of notifiable diseases includes
anthrax, cysticercosis, scabies, bovine
tuberculosis, myiasis (screwworm), and
vesicular diseases. Of these diseases,
anthrax, cysticercosis, and bovine
tuberculosis are transmissible to
humans. The complete list is available
on OIE’s website at https://www.oie.int/
en/animal-health-in-the-world/oielisted-diseases-2016/. FSIS would report
any animal disease issues to the USDA
Animal and Plant Health Inspection
Service (APHIS).
Under the proposed NSIS, FSIS
would maintain its zero tolerance for
market hogs exhibiting signs of
moribundity, CNS conditions, and
pyrexia. Market hogs exhibiting signs of
these generalized diseases or conditions,
if not sorted and removed by the
establishment before ante-mortem
inspection, would be condemned by
FSIS PHVs, as under the existing
regulations (9 CFR 309.3). FSIS PHVs
would issue an NR for every animal
exhibiting signs of moribundity, CNS
conditions, or pyrexia found by the FSIS
inspector after the establishment sorting
step is completed.
Additionally, under the proposed
NSIS, FSIS would maintain its zero
tolerance for violative levels of chemical
residues. Establishments would be
required to address chemical hazards
through their HACCP program including
preventing animals with violative levels
of chemical residues from being
presented for slaughter. FSIS inspectors
would continue to select animals at
post-mortem and perform chemical
residue sample collection and testing
procedures in accordance with FSIS
Directive 10,800.1, Residue Sampling,
Testing and Other Verification
Procedures under the National Residue
Program for Meat and Poultry Products
(available on FSIS’s website at https://
www.fsis.usda.gov/wps/wcm/connect/
147066f0-564c-4590-b36f-97ffc5ab9797/
10800.1.pdf?MOD=AJPERES).
Under the proposed NSIS,
establishment personnel would be
required to identify carcasses of market
hogs sorted and removed by
establishment employees before FSIS
inspection and intended for disposal
and destruction with a unique tag,
tattoo, or similar device. Establishment
personnel also would be required to
immediately denature all carcasses and
parts removed as unacceptable by plant
sorters on-site, even if establishments
have tanking facilities, to ensure that the
carcasses and parts are properly
disposed of and never enter commerce.
Under the proposed NSIS,
establishment personnel would be
required to maintain records to
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document the number of animals and
carcasses and parts sorted and removed
by establishment personnel per day.
These records and procedures would be
subject to daily review by FSIS
inspectors. Under NSIS, FSIS inspectors
would document in PHIS the total
number of animals that the
establishment employees have sorted
and removed per day. Under the
proposed rule, FSIS would still direct
the application and removal of ‘‘U.S.
Condemned’’ tags to animals
condemned during ante-mortem
inspection. FSIS would also continue to
enter each and every ‘‘U.S. Condemned’’
tag into PHIS. However, FSIS inspectors
should be able to complete these tasks
faster because they would be presented
animals that have been sorted by
establishment employees and are thus
more likely to pass ante-mortem
inspection and not have condemnable
conditions.
In addition to the total number of
animals sorted and removed by
establishment personnel per day before
FSIS ante-mortem and post-mortem
inspection, FSIS is requesting comments
on whether or not the Agency should
require establishments under NSIS to
specify in their records the reason that
the animals were removed from
slaughter, including animals sorted and
removed because they were dead on
arrival or suspected of having CNS
conditions, pneumonia, pyrexia,
septicemia, erysipelas, or tuberculosis
(e.g., 20 sorted and removed; 10
pneumonia, 10 dead on arrival) and
how this information should be
collected. Under traditional inspection,
FSIS inspectors record similar
condemnation information into PHIS for
APHIS’ swine slaughter condemnation
monitoring system; however, this
information is not being collected under
HIMP. APHIS Veterinary Services (VS)
uses this type of data to monitor
changes in the rate or count of swine
condemnations by swine type (market,
roaster, sow, and boar) and by selected
condemnation categories (e.g., central
nervous system disorders, dead on
arrival, pneumonia, pyrexia, septicemia,
erysipelas, and tuberculosis). APHIS
conducts weekly monitoring to compare
baseline (expected) condemnation
counts by condemnation category to
current weekly counts to identify
noteworthy increases (signals) in
condemnations in near-real time. APHIS
produces a weekly report, and shares it
with the National Pork Board to identify
any noteworthy increases in
condemnations which could indicate
the emergence of disease and may
warrant further investigation. FSIS and
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APHIS recognize that ‘‘presumptive
diagnoses’’ by establishment personnel
under the NSIS may not be as accurate
as condemnation information entered by
an FSIS PHV under traditional
inspection. However, FSIS and APHIS
believe that the self-reported
information may still be useful and
significant in monitoring disease
conditions in the United States.
B. Post-Mortem Carcass Sorting by
Establishment Employees and Online
Carcass Inspection
Under the proposed NSIS,
establishment personnel would be
required to sort carcasses and parts and
trim dressing defects and contamination
(e.g., hair, bruises, feces, ingesta, and
milk) before the carcasses and parts are
presented to an FSIS online inspector
for post-mortem inspection.
Establishment personnel also would be
required to mark with ink, or otherwise
identify, localized pathological defects
intended for removal under FSIS
supervision (e.g. localized nephritis and
localized arthritis) and carcasses and
parts intended for disposal under FSIS
supervision (e.g., carcasses and parts
with malignant lymphoma). Under the
proposed NSIS, the head, and viscera of
each hog must be handled in a way as
to identify them with the rest of the
carcass and as being derived from the
particular animal involved, until FSIS’s
post-mortem inspection of the carcass
and parts thereof have been complete.
FSIS would not complete an inspection
of the carcass if the head or viscera were
missing before the final rail, unless the
head or viscera were properly disposed
of under FSIS supervision. Consistent
with traditional inspection, only FSIS
inspectors would be authorized to
condemn carcasses and parts.
Carcasses and parts contaminated
with fecal material, ingesta, or milk or
that exhibit signs of septicemia,
toxemia, pyemia, or cysticercosis during
post-mortem examination are likely to
contain infectious agents, such as
bacteria, virus, richettsia, fungus,
protozoa, or helminth organisms, which
can be transmitted to humans. For this
reason, they present a food safety risk if
they are permitted to enter the cooler.
Therefore, FSIS is proposing that
establishments under the new system
address, as part of their HACCP systems,
procedures for ensuring that carcasses
and parts contaminated with fecal
material, ingesta, or milk or affected by
septicemia, toxemia, pyemia, or
cysticercosis are trimmed or identified
by the establishment before they are
presented to the FSIS carcass inspector
and disposed of under FSIS supervision.
These procedures must cover
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establishment sorting activities for these
conditions.
Under this proposal, FSIS would
maintain its zero tolerance for carcasses
and parts contaminated by fecal
material, ingesta, or milk, or affected by
septicemia, toxemia, pyemia, or
cysticercosis. If FSIS online inspectors
discover a carcass contaminated by fecal
material, ingesta, or milk, they would
stop the line for carcass reexamination
and trimming by the establishment
unless the establishment elected to
provide a rail-out loop to rail
contaminated carcasses offline for
reexamination, trimming, and
positioning back on the line for
reinspection, consistent with the
existing regulations (9 CFR 310.17 and
310.18) and FSIS Directive 6420.2,
Verification of Procedures for
Controlling Fecal Material, Ingesta, and
Milk in Slaughter Operations (available
on FSIS’s website at https://www.fsis.
usda.gov/wps/wcm/connect/478aca7637c5-4dc3-9925-1556402d8daf/PHIS_
6420.2.pdf?MOD=AJPERES). An NR
would be issued by the FSIS offline
inspector at or after the final rail for
every carcass contaminated by fecal
material, ingesta, or milk. FSIS online
inspectors would also stop the line if
they discover carcasses exhibiting
septicemia, toxemia, pyemia, or
cysticercosis, as under the existing
regulations (9 CFR 311.16 and 311.17).
The carcasses would be retained for
FSIS PHV disposition. An NR would be
issued by the PHV for every carcass
affected by septicemia, toxemia, pyemia,
or cysticercosis that reaches the online
carcass inspection station. Moreover,
because establishments would be
required to address these food safety
hazards in their HACCP systems, the
Agency continuously would assess the
effectiveness of an establishment’s
procedures for ensuring that carcasses
are prevented from becoming
contaminated with fecal material,
ingesta, or milk, and that carcasses
affected by septicemia, toxemia, pyemia,
or cysticercosis do not reach the final
FSIS inspection station.
FSIS is not proposing to prescribe
specific sorter training or certification to
give establishments operating under the
NSIS the flexibility to select the training
program that would best assist them to
meet the requirements of this proposed
rule. However, the Agency has
developed a draft guidance document to
assist establishments in training their
sorters should this rule become final.
The draft guidance is based on the
training that FSIS provides to online
inspection personnel that are
responsible for identifying these nonfood safety defects on carcasses and
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parts under traditional inspection. FSIS
has posted this draft compliance guide
on its web page (https://www.fsis.usda.
gov/wps/portal/fsis/topics/regulatorycompliance/compliance-guides-index)
and is requesting comments on the
guidance.
FSIS believes that training of sorters
is important to ensure that they are able
to properly perform their duties. Proper
training is necessary if sorters are to
make accurate decisions on how to
address animal disease conditions and
trim and dressing defects. Under the
proposed NSIS, if sorters do not make
these decisions correctly, FSIS
inspection personnel would take
appropriate action such as stopping the
line, issuing NRs, and directing the
establishment to reduce the line speed.
FSIS would thereby ensure that the
establishment is able to maintain
process control as evidenced by
preventing fecal contamination and
meeting microbial performance
measures, that the establishment sorters
are able to successfully perform their
duties, and that the FSIS online
inspectors are able to conduct a proper
food safety inspection.
Establishments that operate under the
proposed NSIS would have greater
flexibility over their production process.
For example, establishments operating
under the proposed NSIS would have
the flexibility to reconfigure lines if they
decided to change the way that the
head, viscera, and carcasses are
presented to FSIS inspectors to improve
ergonomics and process control and to
maintain optimum line speed. FSIS
would still inspect the head, viscera,
and carcass of each animal. However,
under the proposed NSIS,
establishments may reconfigure their
lines so that they present a ready-toinspect head, viscera, and carcass for
FSIS post-mortem inspection in one
location or separately in two or three
locations. FSIS would assign one to
three inspectors to conduct online
inspection activities, depending on need
and line configuration. These inspectors
would also rotate to conduct offline
inspection activities. FSIS would assign
one online inspector only if the Agency
had the data and experience (including
processes and procedures) to ensure that
one inspector is able to conduct all
online post-mortem inspection
activities. Under the proposed NSIS, all
establishments with fewer than three
inspection stations would be required to
provide a mirror at the carcass
inspection station in accordance with 9
CFR 307.2 (m)(6) so that the inspector
standing at the inspection station can
readily view the back of the carcass for
evidence that could impact food safety.
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Under NSIS, as under HIMP,
establishment sorters would be required
to incise mandibular lymph nodes and
palpate the viscera to detect the
presence of animal diseases (e.g.,
Mycobacterium Avium) as part of their
sorting activities before FSIS postmortem inspection. FSIS is requesting
comments on whether or not the Agency
should allow establishments that
operate under the proposed NSIS to use
discretion when deciding, on a lot-bylot basis, whether or not to incise
mandibular lymph nodes and palpate
the viscera to detect the presence of
animal diseases (e.g., M. Avium) if they
submit documentation to FSIS
supporting that the presence of M.
Avium is not likely to occur, such as
records documenting their on-farm
controls. In the last 10–15 years,
industry led initiatives like the Pork
Quality Assurance Plus certification
program (https://www.pork.org/pqa-pluscertification) and the Common Industry
Audit (https://www.pork.org/commonindustry-audit) have improved
biosecurity practices which not only
reduce disease spread but also address
risk factors for M. Avium such as
exposure to birds.8 9 Because on-farm
practices have improved, the prevalence
of M. Avium in U.S. swine is very low.
After reviewing PHIS condemnation
data from 21 large market hog
establishments from 2012 through 2015,
FSIS found that only 0.9 percent of all
condemnations are due to M. Avium.
The animal disease M. Avium does not
present a food safety concern, and can
be detected visually by inspectors.
Moreover, Denmark and the
Netherlands already conduct alternative
post-mortem visual inspections and
allow establishments to use discretion
when determining, on a lot-by-lot basis,
whether or not to incise lymph nodes
and palpate the viscera. Under the
FMIA and the regulations that
implement it, meat and meat products
imported into the United States must be
produced under standards for safety,
wholesomeness, and labeling accuracy
that are equivalent to those of the
United States (21 U.S.C. 620). FSIS has
8 United States Department of Agriculture,
Animal and Plant Health Inspection Service. (2008).
National Animal Health Monitoring System Swine
2006, Part IV: Changes in the U.S. Pork Industry,
1990–2006. Retrieved from https://
www.aphis.usda.gov/animal_health/nahms/swine/
downloads/swine2006/Swine2006_dr_PartIV.pdf.
9 United States Department of Agriculture,
Animal and Plant Health Inspection Service. (2015).
National Animal Health Monitoring System Swine
2012, Part 1: Baseline Reference of Swine Health
and Management in the United States, 2012.
Retrieved from https://www.aphis.usda.gov/
animal_health/nahms/swine/downloads/
swine2012/Swine2012_dr_PartI.pdf.
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reviewed Denmark’s and the
Netherlands’ market hog slaughter
inspection systems and found them to
be equivalent to the United States’
market hog slaughter inspection system.
FSIS determined that visual postmortem inspection will still allow
veterinary inspectors to palpate and
incise lymph nodes and organs (as
occurs in traditional inspection) at their
discretion. Each herd of hogs that
arrives at establishments to be
slaughtered is accompanied by
historical ‘‘Supply-Chain Information,’’
which consists of paperwork that
documents the health status and history
of each herd, complete traceback
information, as well as details about the
originating farm (e.g., history of disease,
use of medications, and on-farm
practices that contribute to maintenance
of the herd’s health.) FSIS concluded
that this documentation, as well as any
ante-mortem inspection observances,
will be sufficient to inform the
veterinary inspector’s decision whether
or not to perform visual inspection or
traditional inspection. Importantly,
because lymphatic tissue may be
contaminated with pathogens, not
incising the lymphatic tissue may
reduce contamination of food contact
surfaces and other carcasses.
FSIS also is proposing to require
establishment personnel to maintain
records to document the number of
carcasses and parts disposed of by
establishment personnel per day as part
of their sorting activities. The records
would not need to include the number
of carcasses condemned by FSIS. These
records would be subject to review by
FSIS inspectors. Under NSIS, FSIS
inspectors would document in PHIS the
total number of carcasses and parts
sorted and disposed of by plant
employees per day. FSIS inspectors
would continue to enter dispositions for
each and every carcass condemned by
FSIS into PHIS.
C. Offline Verification Inspection
In addition to the online inspectors
performing carcass inspection, FSIS is
proposing that up to two inspectors be
assigned for each evisceration line per
shift to conduct offline verification
activities in establishments operating
under the proposed NSIS. Inspectors
conducting offline inspection activities
would rotate with the inspectors
conducting online inspection activities.
FSIS is also proposing to assign one
PHV to make carcass and parts
dispositions.
As in HIMP, offline inspectors under
the new inspection system would
conduct food safety related inspection
activities and would continuously
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monitor and evaluate establishment
process control. Offline inspectors
would conduct inspection activities
including HACCP, sanitation SOP, and
other prerequisite program verification
procedures; verification checks for
septicemia, toxemia, pyemia,
cysticercosis, fecal material, ingesta, or
milk contamination; checks to verify
and ensure that sanitary dressing
requirements are being met; and antemortem inspection. Under this proposed
rule, offline inspectors would also
conduct more humane handling
verification tasks than are conducted
under traditional inspection. The offline
verification inspectors would work with
the Inspector-In-Charge (IIC) to ensure
that food safety related or non-foodsafety related conditions do not impair
the online carcass inspectors’ ability to
conduct the inspection of each head,
viscera, and carcass or would notify the
IIC whenever circumstances indicate a
loss of process control. When
circumstances indicate a loss of process
control, the IIC will be authorized to
require that the establishment slow the
evisceration line speed.
D. RTC Pork Product
As discussed above, under HIMP,
OCP standards are non-food safety
standards concerned primarily with
diseases of no public health significance
and carcass processing defects. Data
collected from market hog
establishments operating under HIMP
show that from CY 2012 through 2013,
HIMP establishments maintained OCP
defect levels that average about half the
corresponding OCP performance
standards derived from the performance
of non-HIMP establishments. Thus, the
data show that establishments operating
under the HIMP system do
exceptionally well in controlling OCP
defects.
Accordingly, FSIS is not proposing
OCP requirements as a condition for
establishments to participate in the
proposed NSIS. Under this proposal,
establishments operating under NSIS
would be allowed to implement the
process controls that they have
determined will best allow them to
produce an RTC pork product that is
wholesome and not adulterated. The
new proposed definition of RTC pork
product is any slaughtered pork product
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.
Under the proposed NSIS,
establishments would have the
flexibility to design and implement
measures to address OCP defects that
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are best suited to their operations. They
would also be responsible for
determining the type of records that will
best document that they are meeting the
RTC pork product definition. The
records would be subject to review and
evaluation by FSIS inspectors.
For their record reviews, FSIS
inspectors would verify that
establishments operating under the
proposed NSIS have written criteria for
determining whether carcasses meet the
RTC definition and that they are
documenting that the pork products
resulting from their slaughter operations
meet these criteria before packaging or
further processing that would conceal a
defect. Records that would meet the
proposed requirements include:
• The records system that the
establishment uses to document that it
is producing RTC pork. For example, an
establishment may use statistical
process control charts, HACCP records,
or other documentation.
• The points in the operation where
the establishment monitors carcasses to
determine whether they meet the RTC
definition and records the results of its
monitoring activities. For example, an
establishment may conduct monitoring
and record the results at a preevisceration and a post-chill station.
• The frequency with which the
establishment conducts monitoring
activities. The records should specify
how often the establishment monitors
carcasses per line per shift. For
example, an establishment may conduct
and document its monitoring activities
at least every two hours per line per
shift at the pre-evisceration location and
at least twice per shift per line for postchill location.
• The definitions of the OCP nonconformances or processing and trim
defects for which the establishment is
monitoring. For example, the
establishment may be monitoring
carcasses for processing and trim nonconformances as specified for trim and
processing OCP defects specified under
the HIMP OCP performance standards,
or defects as defined in a published
study or a study that the establishment
conducted itself. If the establishment
references a study, it should give a brief
description of the study and have the
supporting information on file.
• The criteria that the establishment
would use to determine that the
products resulting from its slaughter
operation meet the RTC definition. For
example, an establishment may follow
the subgroup limits for nonconformances and defects in the trim
and processing defect levels for the
HIMP OCP performance standards, or it
may determine the upper limits for non-
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conformances using a statistical process
control program.
• The corrective actions that the
establishment would take if the levels of
defects and non-conformances exceed
its evaluation criteria for RTC pork.
Under this proposed rule, pork
carcasses that meet the OCP
performance standards under HIMP
would be considered ‘‘suitable for
cooking without the need for further
processing,’’ and as such, meet the RTC
pork product definition. Therefore,
establishments operating under the
NSIS that adopt the OCP HIMP
performance standards as their criteria
for determining whether they are
producing RTC pork product would
meet the regulatory requirements if: (1)
They can document that the products
resulting from their slaughter operations
consistently meet these standards, and
(2) FSIS inspectors do not observe
persistent, unattended defects on the
products resulting from the
establishment’s slaughter operations.
Establishments that adopt criteria other
than the HIMP OCP standards would be
required to have documentation to
demonstrate how they will use these
criteria to demonstrate that the products
resulting from their slaughter operations
meet the RTC pork product definition.
In addition to record reviews, FSIS
inspectors would verify that
establishments operating under the
NSIS are producing RTC pork product
by visually observing carcasses as part
of their inspection activities. The
presence of persistent, unattended trim
and dressing defects on carcasses at the
end of the process would indicate that
the establishment is not producing RTC
pork product. It may also indicate a
general lack of control in an
establishment’s overall slaughter and
dressing process. Thus, if inspectors
observe persistent, unattended defects,
FSIS would require that the
establishment take appropriate actions
to ensure that its process is under
control and that it is operating under
conditions necessary to produce safe,
wholesome, and unadulterated RTC
products. If inspection personnel
through their record review or direct
observation of carcasses find evidence
that an establishment is producing pork
that does not meet the RTC definition,
the IIC would be authorized to take
appropriate action to ensure that the
establishment remedies the defects,
including requiring that the
establishment slow the evisceration line
speed.
E. Line Speeds Under NSIS
Based on FSIS’s experience under
HIMP, the Agency is proposing to allow
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establishments operating under NSIS to
determine their own evisceration line
speeds if Agency personnel verify that
process control is maintained. 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 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 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 hogs. Establishments
determine their line speeds based on
their equipment, animal size and herd
condition, and their ability to maintain
process control when operating at a
given line speed. In addition, line
speeds under HIMP depend on the
number of employees the
establishments hire and train to perform
sorting activities. If FSIS finalizes the
proposed NSIS, establishments choosing
to operate under the NSIS will likely
determine their line speeds based on the
same factors that establishments
considered when setting line speeds
under HIMP for the past 16 years.
Establishments operating under HIMP
have demonstrated that they are capable
of consistently producing safe,
wholesome, and unadulterated pork
products while operating at these line
speeds. Moreover, they have
consistently met pathogen reduction
and other performance standards when
operating at the line speeds they
established under HIMP. The proposed
new inspection system was informed by
the Agency’s experience under HIMP
and, as discussed later in this
document, also incorporates additional
measures that will apply to all swine
slaughter establishments. These
measures, which include testing for
microbial organisms at pre-evisceration
and post-chill, are designed to ensure
that establishments maintain process
control.
FSIS recognizes that evaluation of the
effects of line speed on food safety
should include the effects of line speed
on establishment employee safety. FSIS
compared in-establishment injury rates
between HIMP and traditional
establishments from 2002 to 2010. The
preliminary analysis shows that HIMP
establishments had lower mean injury
rates than non-HIMP establishments.
The analysis uses injury rate data by
occupational injury estimates that are
derived from the BLS annual Survey of
Occupational Injuries and Illnesses
(SOII) https://www.bls.gov/iif/data.htm).
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The survey captures data from
Occupational Safety and Health
Administration (OSHA) logs of
workplace injuries and illnesses
maintained by employers. Fifty-six FSIS
inspected market hog slaughter
establishments voluntarily submitted
injury rate data to OSHA (approximately
nine percent of all market hog slaughter
establishments). From these 56
establishments, 27 low volume
establishments were excluded, leaving
29 plants (5 HIMP and 24 Traditional).
The low volume plants were excluded
to provide a better comparison group of
traditional plants because all HIMP
plants are high volume plants. The
results showed HIMP plants had a lower
mean number of injuries using three
OSHA injury rate measures: Total Case
Rate (TCR), Days Away Transferred
Restricted (DART), and Days Away
From Work (DAFW). However, FSIS
realizes that factors other than line
speed may affect injury rates (e.g.,
automation and number of sorters per
line).
FSIS is requesting comments on the
effects of faster line speeds on worker
safety. Specifically, FSIS is requesting
comments on whether line speeds for
the NSIS should be set at the current
regulatory limit of 1,106 hph or some
other number. The Agency is also
interested in comments on the
availability of records or studies that
contain data that OSHA or the National
Institute for Occupational Safety and
Health (NIOSH) may be able to use in
analyzing the effects of increased line
speed on the safety and health of
employees throughout the
establishment, including effects prior to
and following the evisceration line.
FSIS is also requesting comments on
whether the Agency should maintain
the 1,106 hph maximum line speed for
establishments operating under NSIS
but grant waivers from the maximum
line speed to establishments that agree
to work with the National Institute for
Occupational Safety and Health NIOSH
to evaluate the effects of waivers of line
speed restrictions on employee health.
FSIS is requesting comments on best
practices and other measures that
establishments can take to protect
workers throughout the plant, including
possible protective factors such as
increasing the size of the workforce,
rotating assignments, increased
automation, or improved tools and
techniques.
FSIS is proposing to require each
establishment that operates under the
NSIS to provide an annual attestation to
the management member of the local
FSIS circuit safety committee stating
that the establishment maintains a
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program to monitor and document any
work-related conditions that arise
among establishment workers. The
elements of this program would include:
(1) Policies to encourage early
reporting of symptoms of work-related
injuries and illnesses, and assurance
that the establishment has no policies or
programs intended to discourage the
reporting of injuries and illnesses.
(2) 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.
(3) Monitoring on a regular and
routine basis of injury and illness logs,
as well as nurse or medical office logs,
workers’ compensation data, and any
other injury or illness information
available.
FSIS is also proposing to create a new
severability clause (proposed 9 CFR
310.28), which would state that should
a court of competent jurisdiction hold
any provision of the proposed worker
safety attestation requirement (proposed
9 CFR 310.27) to be invalid, such action
would not affect any other provision of
9 CFR parts 309 and 310.
As OSHA is the Federal agency with
statutory and regulatory authority to
promote workplace safety and health,
FSIS would forward the annual
attestations to OSHA for further review.
OSHA, in turn, may use the information
in the attestations in its own
enforcement program. FSIS employees
would not be responsible for
determining the merit of the content of
each establishment’s monitoring
program or enforcement of
noncompliance with this section. FSIS
would work with OSHA to develop the
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.
IV. Other Proposed Changes That Affect
All Swine Slaughter Establishments
A. Procedures To Address Enteric
Pathogens, Fecal Material, Ingesta, and
Milk Contamination as Hazards
Reasonably Likely to Occur
In 1997, FSIS published a Federal
Register document entitled ‘‘Notice on
complying with food safety standards
under the HACCP system regulations’’
(62 FR 63254, November 28, 1997). The
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purpose of the document was to ensure
that establishments understood the
Agency’s zero tolerance policy for
visible fecal material as food safety
hazards, as establishments prepared to
comply with the then newly enacted
HACCP system regulations. The
document explained that under 9 CFR
310.18, establishments must handle
livestock carcasses and carcass parts to
prevent contamination with fecal
material and promptly remove
contamination if it occurs. Based on this
regulation, FSIS enforces a zero
tolerance policy for visible fecal
contamination. Then, the document
explained that ‘‘to meet the zero
tolerance standard, an establishment’s
[HACCP] controls must (among other
things) include limits that ensure that
no visible fecal material is present by
the point of post-mortem inspection of
livestock carcasses’’ (citing 9 CFR
417.2(c)). Finally, the document
explained that ‘‘Under the HACCP
system regulations, critical control
points to eliminate contamination with
visible fecal material are predictable and
essential components of all slaughter
establishments’ HACCP plans.’’ As a
result, all swine slaughter
establishments’ HACCP plans currently
include critical control points (CCPs) for
preventing carcasses contaminated with
visible fecal material at or after the final
rail.
FSIS also enforces a zero tolerance
policy for contamination by ingesta and
milk because the microbial pathogens
associated with ingesta and milk
contamination are likely sources of
potential food safety hazards in
slaughter establishments. As mentioned
above, the regulations require
establishments to handle livestock
carcasses and carcass parts to prevent
contamination and promptly remove
contamination if it occurs (9 CFR
310.18) The regulations also require that
lactating mammary glands and diseased
mammary glands of swine be removed
without opening the milk ducts or
sinuses because if pus or other
objectionable material is permitted to
come in contact with the carcass, the
parts of the carcass are contaminated
and must be removed and condemned
(9 CFR 310.17). Because such
contamination is largely preventable,
most slaughter establishments already
have in place procedures designed to
prevent and remove ingesta and milk.
FSIS is now proposing to amend 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 post-
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mortem inspection of swine carcasses.
Such a requirement would ensure that
establishments maintain the records to
verify that they have implemented the
necessary measures and, when
necessary, have taken appropriate
corrective actions to prevent carcasses
contaminated with visible fecal
material, ingesta, or milk at or after the
final rail.
Although the existing requirements
for establishments to prevent visible
fecal material, ingesta, or milk at or after
the final rail, and the proposed
requirement described above that
establishments must have procedures
addressing how they do so, are
important safeguards, those safeguards
would not be fully effective if an
appropriate effort is not made to prevent
contamination from occurring
throughout the slaughter and dressing
operation. Fecal material is a major
vehicle for spreading pathogenic
microorganisms, such as Salmonella, to
raw pork products, and therefore, it is
vital for establishments to maintain
sanitary conditions and to prevent, to
the maximum extent possible,
contamination from occurring before
slaughter and throughout the slaughter
and dressing process.
Under HACCP, establishments are
responsible for identifying food safety
hazards that are reasonably likely to
occur in the production process and for
implementing preventive measures to
control those hazards. Failure to
implement preventive measures
throughout the slaughter and dressing
process can lead to the creation of
insanitary conditions in the
establishment and increases the
potential for carcasses and parts to
become contaminated with enteric
pathogens, fecal material, ingesta, and
milk. Interventions with chemical
antimicrobials applied at the end of the
process are less likely to be fully
effective on carcasses that contain high
levels of pathogens, and these chemical
treatments are not effective in
preventing insanitary conditions
throughout the slaughter establishment.
To ensure that establishments
implement appropriate measures to
prevent carcasses from becoming
contaminated with pathogens, and to
ensure that both FSIS and
establishments have the documentation
they need to verify the effectiveness of
these measures on an on-going basis,
FSIS is proposing to require that all
swine slaughter establishments develop,
implement, and maintain written
procedures to prevent contamination of
carcasses and parts by enteric
pathogens, fecal material, ingesta, and
milk throughout the entire slaughter and
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dressing operation. FSIS is proposing
that establishments incorporate these
procedures into their HACCP systems
and that they maintain records
sufficient to document the
implementation and monitoring of these
procedures. These proposed
requirements are necessary to fully
implement the existing HACCP
regulations.
Information that FSIS has collected
from investigations it has conducted in
establishments that have received a
Notice of Intended Enforcement due to
Salmonella serotypes linked to human
illness demonstrate the need for
establishments to adopt preventive
measures to control contamination
throughout the entire production
process, as well as the need to maintain
documentation to verify the
effectiveness of those measures on an
ongoing basis.
For example, FSIS conducted an
investigation at a swine slaughter
establishment that resulted in a Notice
of Intended Enforcement after a State
department of health conducted
sampling and found the presence of
Salmonella serotypes linked to human
illness, and after FSIS requested a
voluntary recall in 2015. FSIS reviewed
the establishment’s controls, and
records associated with the
establishment’s sanitary dressing
procedures and microbial interventions,
and observed the establishment’s
implementation of these controls and
procedures. The Agency’s review found
that the establishment had
contamination of Salmonella
throughout the slaughter process,
including carcasses, environmental
samples and pre-operational swabs. The
cross contamination and failure to
maintain sanitary procedures appeared
to have overwhelmed any subsequent
in-process interventions. FSIS
determined that the establishment’s
HACCP system was inadequate due to
multiple or recurring noncompliance
(see 9 CFR 500.4(a)). If this rule becomes
final, establishments may choose to
incorporate measures to address the
prevention of contamination by enteric
pathogens and contaminants (e.g., fecal,
ingesta, and milk) into their procedures
addressing how they prevent
contamination from occurring during
slaughter and dressing operations.
Examples of such measures include:
Sanitary dressing protocols, statistical
process control programs, and sampling.
Under this proposed rule,
establishments will be required to
incorporate these procedures into
HACCP systems, and to maintain ongoing documentation to demonstrate
that the procedures are effective. FSIS is
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not proposing to prescribe the specific
procedures that establishments must
follow to prevent carcasses from
becoming contaminated by enteric
pathogens, fecal material, ingesta, or
milk because the Agency believes that
establishments should have the
flexibility to implement the most
appropriate measures that will best
achieve the requirements of this
proposed rule. However, on-going
verification and documentation to
demonstrate that an establishment’s
process controls are effective in
preventing food safety hazards are
critical components of the food safety
system. FSIS believes that
microbiological test results that
represent levels of microbial
contamination at key steps in the
slaughter process are necessary for
establishments to provide
comprehensive, objective evidence to
demonstrate that they are effectively
preventing carcasses from becoming
contaminated with pathogens before
and after they enter the cooler.
In light of these changes, FSIS is
proposing to rescind the generic E. coli
testing requirements in 9 CFR 310.25
and to replace them with a new testing
requirement that would provide
establishments the flexibility to sample
for other, potentially more useful
indicator organisms. Under this
proposal, establishments would
continue to conduct sampling and
analysis of carcasses for microbial
organisms at the post-chill location, but
in addition the Agency is proposing a
second testing location at the preevisceration position in order to ensure
establishments would be able to monitor
the effectiveness of process control for
enteric pathogens throughout the
slaughter and dressing operation.
Under this proposed rule, instead of
following a prescribed microbiological
testing program, each establishment
would be responsible for developing
and implementing its own
microbiological sampling plan, which
would be required to include carcass
sampling at pre-evisceration and postchill. FSIS considers the microbial load
of hog carcasses at pre-evisceration to be
a valuable source of data about how
well an establishment is taking into
account the sanitary condition of live
hogs coming to slaughter and the
processing steps (i.e., washing,
dehairing) they implement to reduce the
external contamination of the carcass
prior to evisceration. Following a
similar logic, FSIS considers the
microbial characteristics of hog
carcasses post-chill (after all processing
steps have taken place) to be a valuable
source of data about how well an
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establishment is minimizing
contamination during chilling as well as
the overall effectiveness of all process
control interventions the establishment
has chosen to apply throughout its
production process. Because most
establishments apply one or more
interventions between the preevisceration and post-chill sampling
points to help control microbiological
hazards, FSIS would expect that a
reduction in microbiological
contamination between these two
sampling points to be an indication of
the effectiveness of those controls. The
establishment would be responsible for
determining which microbiological
organisms would best help it to monitor
the effectiveness of its process control
procedures.
Because FSIS is proposing that
establishments’ microbiological
sampling plans be part of their HACCP
systems, all swine slaughter
establishments would be required to
provide scientific or technical
documentation to support the
judgments made in designing their
sampling plans (see 9 CFR 417.4(a)).
Under this proposal, establishments
could develop sampling plans to test
carcasses for enteric pathogens, such as
Salmonella, at pre-evisceration and post
chill, or they could test for an
appropriate indicator organism. FSIS
has developed draft sampling guidance
to assist small and very small
establishments in developing sampling
plans that meet the Agency’s
expectations for testing designs and
sampling frequency should this rule
become final. FSIS has posted this draft
compliance guide on its web page
(https://www.fsis.usda.gov/wps/portal/
fsis/topics/regulatory-compliance/
compliance-guides-index) and is
requesting comments on the guidance.
FSIS is proposing to prescribe a
minimum frequency with which
establishments would be required to
collect two samples, one at preevisceration and one at post-chill, or, for
very small and very low volume
establishments, a single post-chill
sample. Under the proposed rule,
establishments, except for very small
and very low volume establishments 10,
would be required to collect samples at
a frequency of once per 1,000 carcasses.
Very small and very low volume
establishments would be required to
collect at least one sample during each
10 Very small establishments are establishments
with fewer than 10 employees or annual sales of
less than $2.5 million. 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.
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week of operation each year. FSIS is
proposing to allow very small and very
low volume establishments to collect
and analyze samples for microbial
organisms at the post-chill point in the
process only because these
establishments typically are less
automated and run at slower line speeds
than larger establishments. The lower
level of automation and the slower line
speeds require less complicated
measures for maintaining and
monitoring process control on an
ongoing basis. If, after consecutively
collecting 13 weekly samples, very
small and very low volume
establishments can demonstrate that
they are effectively maintaining process
control, they can modify their sampling
plans to collect samples less frequently.
These proposed frequencies reflect the
frequencies prescribed under the
existing regulations for generic E. coli
testing. In light of these changes, FSIS
is proposing to remove the current
requirement that swine establishments
test carcasses for generic E. coli to
monitor process control. FSIS is also
proposing to eliminate the pathogen
performance standards for market hogs
in 9 CFR 310.25(b) because, as
explained above, the codified standards
are no longer in use.
FSIS is proposing to allow
establishments to substitute alternative
sampling locations if they are able to
demonstrate that the alternative
sampling locations provide a definite
improvement in monitoring process
control than at pre-evisceration and
post-chill. FSIS is also proposing to
allow establishments to substitute
alternative sampling frequencies if they
are able to demonstrate that the
alternative is an integral part of the
establishments’ verification procedures
for their HACCP plans.
This proposed rule does not mandate
that establishments meet specific
performance standards for microbial
testing. Because establishments would
be required to incorporate their
procedures for preventing
contamination by enteric pathogens and
other contamination (e.g., fecal material,
ingesta, and milk) into their HACCP
plans, or sanitation SOPs, or other
prerequisite programs, establishments
would be required to take appropriate
corrective action when either the
establishment or FSIS determines that
the establishment’s procedures are not
effective in preventing carcass
contamination throughout the entire
slaughter and dressing process.
Establishments would also need to
routinely evaluate the effectiveness of
their procedures in preventing carcass
contamination.
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Under this proposed rule, FSIS would
verify the effectiveness of
establishments’ process control
procedures in preventing carcasses from
becoming contaminated with enteric
pathogens, fecal material, ingesta, and
milk by reviewing the establishments’
monitoring records, including the
establishments’ microbial testing
results, observing establishments
implementing their procedures, and
inspecting carcasses and parts for
visible fecal, ingesta, and milk
contamination when conducting both
online carcass inspection and offline
verification inspection procedures.
If inspection personnel determine that
an establishment’s process control
procedures are not effective in
preventing contamination by enteric
pathogens, fecal material, ingesta, and
milk, the Agency would take
appropriate regulatory action to ensure
that the establishment’s production
process is in control, and that product
is not being adulterated. Such action
could include performing additional
visual inspections of products or
equipment and facilities, increasing
offline verification inspections,
initiating Food Safety Assessments
(FSAs), conducting hazard analysis
verification procedures, and retaining or
condemning product.
Finally, FSIS is proposing to require
that all official swine slaughter
establishments develop, implement, and
maintain in their HACCP systems
written procedures to prevent
contamination of the pre-operational
environment by enteric pathogens.
These procedures must include
sampling and analysis of food-contact
surfaces, reuse water, and equipment,
including knives, in edible food
production departments in the preoperational environment for microbial
organisms to ensure that the surfaces are
sanitary and free of enteric pathogens.
The sampling frequency must be
adequate to monitor the establishment’s
ability to maintain sanitary conditions
in the pre-operational environment.
FSIS is proposing this environmental
sampling requirement because in 2015,
152 people became ill after
consumption of product produced at an
establishment where FSIS found
evidence during an investigation of
insanitary conditions, including, but not
limited to, tables and knives in the preoperational environment that were
contaminated with Salmonella. The
proposed environmental sampling
requirement would reduce the risk of
cross-contamination from insanitary
conditions in the pre-operational
environment. FSIS is requesting
comments on this proposed
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environmental sampling requirement.
The proposed environmental sampling
does not specifically include lairage
(e.g., holding pens for live swine)
although scientific literature
conclusively shows that contamination
occurs in this area of the establishment.
FSIS is also asking for comments on
how to ensure that lairage does not
contribute to insanitary conditions.
V. Implementation
If this proposed rule becomes final,
establishments interested in NSIS
would need to notify FSIS in writing of
their intent to operate under the new
inspection system. The Agency is also
considering establishing separate
applicability dates for large, small, and
very small establishments to comply
with the proposed regulations that
prescribe procedures for controlling
visible fecal, ingesta, and milk
contamination; the regulations that
prescribe procedures for controlling
contamination throughout the slaughter
and dressing process; and the
regulations that prescribe recordkeeping
requirements. The applicability dates
would provide additional time for small
and very small establishments to
comply with these provisions. The
Agency is requesting comments on its
proposed implementation plan,
especially the phased in applicability
dates for the proposed provisions in the
rule that prescribe requirements for all
swine slaughter establishments.
VI. Executive Orders 12866 and 13563
Executive Orders 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, and
equity). Executive Order 13563
emphasizes the importance of
quantifying both costs and benefits, of
reducing costs, of harmonizing rules,
and of promoting flexibility. This
proposed rule has been designated a
‘‘significant’’ regulatory action under
section 3(f) of Executive Order 12866.
Accordingly, the rule has been reviewed
by the Office of Management and
Budget under Executive Order (E.O.)
12866.
A. Request for Comments Summary
FSIS is requesting comments on:
1. Whether or not the Agency should
require establishments under NSIS to
specify in their records the reason that
the animals were removed from
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slaughter and how this information
should be collected.
2. The draft compliance guides.
3. Whether or not the Agency should
allow establishments that operate under
the proposed NSIS to use discretion
when deciding, on a lot-by-lot basis,
whether or not to incise mandibular
lymph nodes and palpate the viscera to
detect the presence of animal diseases
(e.g., M. Avium) if they submit
documentation to FSIS supporting that
the presence of M. Avium is not likely
to occur, such as records documenting
their on-farm controls.
4. The effects of faster line speeds on
worker safety.
a. Whether line speeds for the NSIS
should be set at the current regulatory
limit of 1,106 hph or some other
number.
b. The availability of records or
studies that contain data that FSIS may
be able to use in analyzing the effects of
increased line speed on the safety and
health of employees throughout the
establishment, including effects prior to
and following the evisceration line.
c. Whether the Agency should
maintain the 1,106 hph maximum line
speed for establishments operating
under NSIS but grant waivers from the
maximum line speed to establishments
that agree to work with the National
Institute for Occupational Safety and
Health to evaluate the effects of waivers
of line speed restrictions on employee
health.
5. The proposed sampling
requirements, especially the
environmental sampling requirement.
6. The proposed implementation plan,
especially the phased in applicability
dates for the proposed provisions in the
rule that prescribe requirements for all
swine slaughter establishments.
In addition, FSIS is requesting the
following data to further inform its
consideration of the proposed rule.
Further discussions of these requests are
provided in their corresponding
sections.
1. Are very small establishments that
exclusively slaughter market hogs likely
to convert to the NSIS?
2. How soon do establishments plan
on adopting the NSIS?
3. Depending on establishment size,
how many additional establishment
employees would the NSIS system
require?
4. What are the capital costs for
establishments associated with the
NSIS?
5. How long will it take establishment
personnel such as a quality technician
to collect, record, and analyze data
required to verify that an
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establishment’s products meet the
definition of RTC?
6. How many swine establishments
have written sanitary dressing plans?
7. How many establishment
employees perform sanitary dressing
tasks in a swine slaughter
establishment?
8. How many establishments conduct
generic E. coli sampling at an alternative
frequency?
9. What are the alternative frequencies
at which establishments are conducting
process control sampling?
10. How will changes in line speeds
affect market hog prices, establishment
hours of production, consumer prices,
and export volumes?
B. Need for the Rule
The swine slaughter industry in the
U.S. has evolved since the advent of the
current swine inspection regulations
used by the FSIS. 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.11 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, adherence to
current regulations at large and high
volume establishments that exclusively
slaughter market hogs prevents 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, one that is
less prescriptive, creates incentives for
establishments to develop and invest in
food quality controls and safety
procedures, and allows FSIS to improve
inspection methods, is needed.
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 88 percent between
2005 and 2015.12 According to the Food
and Agricultural Organization, pork is
consistently ranked as the top meat in
per-capita consumption worldwide 13
and is ranked third in the United
States.14
TABLE 2—U.S. PORK SUPPLY AND DEMAND
U.S.
production *
Year
2005
2006
2007
2008
2009
2010
2011
2012
2013
2014
2015
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
.....................................................................................
Imports *
20,705
21,074
21,962
23,367
23,020
22,456
22,775
23,268
23,204
22,858
24,517
Exports *
1,024
990
968
832
834
859
803
802
880
1,011
1,116
Domestic
consumption *
Per capita
consumption **
19,093
19,055
19,763
19,431
19,869
19,077
18,382
18,607
19,105
18,836
20,593
65
64
66
64
65
62
59
59
60
59
64
2,666
2,995
3,141
4,651
4,094
4,223
5,196
5,379
4,986
5,092
5,009
* Measured in carcass weight, million pounds.
** Measured in carcass weight, pounds.
Source: USDA ERS Livestock and Meat Domestic Data. https://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105
accessed on 11/29/16. Last updated on 10/27/16.
In 2016, there were approximately
612 swine slaughter establishments
under Federal Inspection, Table 3.15
Combined, these establishments process
roughly 118 million hogs annually. FSIS
divides these swine into the following
production categories for data
collection: Roaster swine, market hog,
sow, and boar/stag. Today, the majority
(96%) of the pork products available in
the market are derived from market
hogs.16
TABLE 3—NUMBER OF SWINE SLAUGHTER ESTABLISHMENTS BY SIZE, 2016
Number of
establishments
HACCP processing size
Total swine
slaughter
(head count)
Total market
hog slaughter
(head count)
Percent
market hog
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 ..........................................................................................................
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Large ................................................................................................................
Small ................................................................................................................
Very Small * .....................................................................................................
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.
11 Key, Nigel and William McBride. 2007. The
Changing Economics of U.S. Hog Production. USDA
ERS. Report No. 52.
12 USDA ERS Livestock and Meat Domestic Data.
https://www.ers.usda.gov/data-products/livestockmeat-domestic-data.aspx#26105. Accessed on 12/2/
15. Last updated on 11/30/15.
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13 FAO Livestock commodities. https://
www.fao.org/docrep/005/y4252e/y4252e05b.htm.
Accessed on 11/29/16.
14 USDA ERS Livestock and Meat Domestic Data.
https://www.ers.usda.gov/data-products/livestockmeat-domestic-data.aspx#26105. Accessed on 11/
29/16. Last updated on 10/27/16.
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15 USDA, FSIS, Public Health Information System
(PHIS).
16 Source: PHIS.
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As shown below in Table 4, many
establishments now exclusively
slaughter market hog, a species sub class
which due to technological and
managerial improvements, such as
improved genetics, nutrition, and
medical services, generally presents
fewer food safety and quality issues.17
D. Overview of the Proposed Rule’s
NSIS
Eight of the proposed rule’s
provisions apply to only those
establishments that voluntarily
participate in the NSIS. Meeting these
provisions will likely increase an
establishment’s labor and training costs.
Additionally, only market hogs are
eligible to participate in the NSIS. Due
to these economic constraints discussed
above, we expect that only large and
small high volume establishments that
exclusively slaughter market hogs
would voluntarily participate in the
NSIS. In 2016 there were 40 high
volume establishments that exclusively
slaughter market hogs, 27 large 18 (5
HIMP + 22 non-HIMP) 19 and 13 small
establishments, Table 4. These
establishments account for 92 percent of
total swine slaughter, Table 4. Given
their large share of the market and the
4801
ability to slaughter a sufficient amount
of market hogs to justify the likely costs
associated with NSIS, these
establishments are expected to
voluntarily implement the proposed
NSIS. Therefore, this analysis calculates
the costs and benefits associated with
the voluntary provisions for these 40
market hog establishments. However,
because the 5 HIMP establishments are
already practicing the proposed NSIS
methods, 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.
FSIS is proposing to amend 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 postmortem inspection of swine carcasses.
This requirement would address a
weakness of the current 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
contamination from entering the cooler.
While preventing swine carcasses
contaminated with visible fecal material
from entering the chiller 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
controls for them. 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 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 action to
prevent further product contamination.
FSIS seeks comment on the extent to
which written sanitary dressing plans
are necessary for ensuring that existing
process controls are effective.
While many establishments may
already have written sanitary dressing
plans, due to data limitations, this
analysis assumes that every
establishment will need to develop a
written sanitary dressing plan. This
assumption will help ensure a
conservative estimate. Ongoing sanitary
dressing 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.
17 Key, Nigel and William McBride. 2007. The
Changing Economics of U.S. Hog Production. USDA
ERS. Report No. 52.
18 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.
19 In 2016 there was 1 large establishment that did
not exclusively slaughter market hogs.
E. Overview of the Proposed Rule’s
Mandatory Components
All swine slaughter establishments
would need to comply with the three
mandatory provisions of the proposed
rule, which are described in more detail
in section IV. A.
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1. Written Sanitary Dressing Plans
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2. Process Control Sampling and
Analysis for Microbial Organisms
Under this proposed rule, instead of
following a prescribed microbiological
testing program, each establishment
would be responsible for developing
and implementing its own
microbiological sampling plan, which
would be required to include carcass
sampling at pre-evisceration and postchill. Current microbiological standards
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prescribe that all establishments
monitor process control by sampling for
generic E. coli. High volume
establishments are required to take one
sample per 1,000 carcasses, or request
an alternative rate. The Agency is
seeking comment on both the number of
establishments conducting alternative
sampling rates and approved alternative
sampling rates. Very low volume
establishments are required to take 1
sample per week of operation up to 13
times a year. An industry survey found
that many establishments elect to
perform other microbiological tests in
addition to testing for generic E. coli.20
3. Environmental Sampling
FSIS is proposing to require that all
official swine slaughter establishments
develop, implement, and maintain in
their HACCP systems written
procedures to prevent contamination of
the pre-operational environment by
enteric pathogens.
Such procedures must be
incorporated into an establishment’s
HACCP, sanitation SOP, or other
prerequisite program. This analysis
assumes an establishment will
incorporate its procedures for
controlling contamination in the preoperational environment into its
sanitation SOP. These procedures must
include sampling and analysis of food
contact surfaces in the pre-operational
environment at a frequency adequate to
monitor the establishment’s ability to
maintain sanitary conditions in the preoperational environment.
F. Overview of the Proposed Rule’s
Agency Impact
This analysis also takes into
consideration potential impacts to the
Agency’s budget, which is expected to
be impacted by changes in staffing and
training requirements. 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 nonsupervisory 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 establishments expected to
convert to NSIS, Table 5. When these
establishments convert to NSIS, Agency
personnel will require NSIS training.
Additionally, the number of Agency
personnel required to inspect the
slaughter process will likely change, see
Agency Staffing section for details.
TABLE 5—CURRENT FSIS SLAUGHTER
LINE POSITIONS AT NON-HIMP FACILITIES THAT SLAUGHTER EXCLUSIVELY MARKET HOGS
Number of
positions
OPM job code
1862 ......................................
1863 ......................................
701 ........................................
120
245
53
Total ..................................
418
Source: PHIS.
G. Expected Cost of the Proposed Rule
1. Associated With the NSIS
Components of the Rule
This analysis estimates the cost
associated with the proposed rule’s
NSIS components. The Agency assumes
that 22 large high volume and 13 small
high volume establishments, that have a
history of exclusively slaughtering
market hogs, will adopt the NSIS
portions of the rule. These 35
establishments have similar
characteristics as 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, the
benefits from adopting NSIS are
expected to outweigh the 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. The Agency is seeking
comment on this assumption. While the
5 HIMP establishments are expected to
adopt the NSIS, they have already
implemented the proposed changes
associated with the NSIS by their
participation in the HIMP program 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.
This analysis excludes further
consideration in the Preliminary
Regulatory Impact Analysis of the costs
of submitting an attestation of work
related conditions due to its small
expected cost.21 Costs examined
generally fall under three categories:
Labor, capital expenses, and developing
written procedures.
In the following sections, this analysis
presents the costs and benefits that
would be 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 which are likely to adopt
the NSIS will incur additional costs
associated with adoption. The Agency is
seeking comment on this assumption.
Note, the 5 HIMP establishments are not
expected to incur any additional costs
associated with adopting the NSIS and
are therefore excluded from this portion.
Also, based on actual NPIS adoption
rates thus far, the assumptions
presented in this analysis may be an
overestimate of adoption of NSIS.
TABLE 6—NSIS ADOPTION RATE
Total number of
establishments
adopted
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Year
Large
1
2
3
4
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
...................................................................................................................................................
20 Viator C. et al. 2015. (a) Meat Industry Survey
in Support of Public Health Risk-Based Inspection.
P5–42. Question 3.1.
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21 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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Percent
adopted
Small
4
8
12
17
2
4
7
10
17
34
54
77
submitting an annual attestation would cost all 28
large and 13 small establishments approximately
$93.64 annually (2 minutes * $68.52 per hour * 41).
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TABLE 6—NSIS ADOPTION RATE—Continued
Total number of
establishments
adopted
Year
Large
5 ...................................................................................................................................................
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a. Costs of Additional Establishment
Workers
This analysis expects establishments
operating under NSIS to experience an
increase in labor costs. Under NSIS,
establishments will be required to
dedicate labor to sort and remove unfit
animals before ante-mortem inspection
and trim; identify defects, such as
dressing defects, contamination, and
pathology defects, on carcasses and
parts before post-mortem inspection;
ensure product is presented to Agency
inspectors in an appropriate manner;
identify carcasses condemned on antemortem inspection; denature all major
portions of condemned carcasses onsite; maintain records to document the
number of animals condemned on antemortem inspection; and notify Agency
inspectors if they suspect that an animal
or carcass has a reportable or foreign
animal disease, while conducting
sorting activities. Based on
observations 22 of HIMP establishments,
this increase in work is expected to
require an increase in labor demand
ranging from 6–10 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. The Agency seeks comment on
the number of additional employees
each establishment will require due to
the NSIS. Costs associated with this
labor fall into 3 categories: Wages and
benefits, training, and continuing
education.
Establishment Labor Wage Increases
Many of the 22 large and 13 small
non-HIMP market hog establishments
that are assumed will adopt NSIS
operate multiple lines and shifts. Taking
these multiple lines and shifts into
consideration, the number of industry
positions is expected to increase by 383.
22 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.
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The majority of these, 369, are
attributable to the large establishments
(41 (number of lines) × 9),23 Table 7.
The remaining 14 positions are
attributable to the small establishments
(14 (number of lines) × 1),24 Table 7.
According to the Bureau of Labor
Statistics (BLS) the expected hourly
wage for a Slaughter and Meat Packer
occupation (‘‘production employee’’) is
$13.00.25 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).26 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 ×
$26.00 × 269 × 8), Table 7. The average
small establishment slaughters on 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 estimates take into
consideration the fact that some
establishments operate multiple lines
and multiple shifts.
Training Online Sorters and CarcassInspection Helpers
Establishments are expected to incur
costs associated with initially training
employees to fill these 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
23 Source:
PHIS.
24 Source: PHIS.
25 BLS Occupational Employment Statistics,
Occupational Employment and Wages, May 2016.
51–3023 Slaughters and Meat Packers https://
www.bls.gov/oes/current/oes513023.htm accessed
on 7/24/17. Last modified 3/31/17.
26 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.
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Percent
adopted
Small
22
13
100
employee.27 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 expected 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.28 The additional annual
training cost for new employees is
expected 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 ×
$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, with a mid-point of $24.29 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
27 Viator. C. et al. 2015. (b) Costs of Food Safety
Investments. Table 4–4. Training Costs for
Management and Production Employees.
28 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/jolts.t16.htm. Accessed on 7/21/17.
Last updated on 3/16/17.
29 Viator. C. et al. 2015. (b) Table 4–4. Training
Costs for Management and Production Employees.
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approximately $24,984 (1,041 × $24)
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 $16.45 million, applying
a 3 percent discount rate over 10 years,
Table 7. The majority of this cost is
attributed to wages and benefits, Table
7.
TABLE 7—ESTABLISHMENT LABOR COSTS
[M$]
Number of
personnel
One-Time
cost
Recurring
cost
........................
0.81
........................
........................
........................
0.03
........................
........................
$20.65
........................
0.24
0.02
0.71
........................
0.009
0.03
Totals:
One-Time ...............................................................................................................................................................................
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
0.84
21.66
16.62
15.99
Type of establishment
Type of expense
Large ...............................................................
Wages ............................................................
Initial Training .................................................
Training Due to Labor Turnover ....................
Continuing Education .....................................
Wages ............................................................
Initial Training .................................................
Training Due to Labor Turnover ....................
Continuing Education .....................................
Small ...............................................................
b. Costs of Capital Improvements: Line
Configuration and Inspection Stations
As proposed, participating in NSIS
does not necessitate capital
improvements. As such, this analysis
does not include capital expenditures.
However, if establishments believe that
capital expenditures would result in a
benefit they may voluntarily reconfigure
or update their facilities so as 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 to
$250,000,30 and the creation of an
inspection station, which can cost
between $5,000 and $6,000.31
Establishments may reduce these costs
by coordinating these facility updates
with previously planned establishment
renovations. The Agency is seeking
comment on both the required and
voluntary capital costs associated with
the NSIS.
srobinson on DSK9F5VC42PROD with PROPOSALS2
c. Costs of Developing Ante-Mortem
Written Procedures
Under the proposed rule,
establishments operating under NSIS
are required to develop and maintain in
30 In a May 2004 study, ERS estimated the cost
of compliance per establishment with PR/HACCP
rule. Capital expenditures in Hog Slaughter
establishments were estimated to be $251,800.
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their HACCP systems (HACCP plans,
Sanitation Standard Operating
Procedures, 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, fecal
material, ingesta, and milk throughout
the entire slaughter and dressing
operation, a mandatory component of
the proposed rule. Details of these costs
can be found in the sanitary dressing
costs section VI.2.a.
d. Ready-To-Cook Pork Standards
As proposed, establishments
operating under NSIS are required to
collect, record, and analyze
documentation to demonstrate that the
products resulting from their slaughter
operation meet the proposed definition
of RTC pork products. While the Agency
is seeking comment on this requirement,
this analysis estimates the labor costs to
Ollinger, Michael, Danna Moore, Ram Chandran
(2004). Meat and Poultry Establishments’ Food
Safety Investments. USDA, Economic Research.
31 Modernization of Poultry Slaughter Inspection;
Final Rule, 79 FR. 49566 (2014).
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369
1,476
435
1,041
14
56
17
39
conduct such documentation under two
assumptions. First, FSIS assumes that
establishments would assign the task to
a quality control technician, QC, with
an hourly compensation rate, which
included wages, benefits, and overhead,
of $68.52.32 Second, FSIS assumes that
this work would take 1 hour at a large
establishment and 1⁄2 hour at a small
establishment. The Agency is seeking
comment on this assumption. Based on
information obtained through PHIS, the
average large establishment operates 269
days per year. This equates to an annual
cost of approximately $18,432 (268 * 1
* $68.52), or approximately $0.41
million for all 22 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 $0.39 million,
applying a 3 percent discount rate over
10 years, Table 8.
32 To be consistent with analyses done by the
Department of Health and Human Services, this
analysis accounts for fringe benefits and overhead
by multiplying wages by a factor of 2.
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TABLE 8—COST OF RTC REQUIREMENTS
[M$]
Number of
establishments
Type of market hog only establishment
Large ........................................................................................................................................................................
Small ........................................................................................................................................................................
Recurring
Labor
22
13
$0.41
0.11
Totals:
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
0.51
0.39
0.38
2. Costs Associated With the Mandatory
Components of the Rule
The mandatory costs of the proposed
rule are expected to apply to all 612
swine slaughter establishments and
begin within the first year after the rule
is finalized. These costs are associated
with (a) establishing and implementing
written sanitary dressing plans to
prevent contamination of carcasses and
parts by enteric pathogens, fecal
material, ingesta, and milk, throughout
the entire slaughter and dressing
operation; (b) modernizing process
control sampling programs for microbial
organisms; and (c) sampling the
slaughter environment for
microbiological contamination.
a. Costs of Developing, Composing,
Training, Monitoring, Recording, and
Verifying Written Sanitary Dressing
Plans
Under the mandatory portion of the
proposed rule affecting all federally
inspected establishments that slaughter
swine, FSIS is proposing to require 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, fecal material,
ingesta, and milk throughout the entire
slaughter and dressing operation. This
cost component includes: (1)
Developing these procedures into their
food safety system, (2) training, and (3)
monitoring, recordkeeping, and
verification.
Developing and Composing
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 the
Research Triangle Institute’s (RTI) Costs
of Food Safety Investments report,33 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 $365.34 To
ensure a conservative cost estimate, this
analysis assumes all 612 swine
establishments will incur this cost. The
Agency is seeking comment on this
assumption. The cost to all large
establishments is approximately
$20,440 (28 * $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 612 swine slaughter
establishments is approximately $0.03
million, Table 9.
TABLE 9—WRITTEN SANITARY DRESSING PLAN DEVELOPMENT
[M$]
Number of
plants
HACCP size
Large ........................................................................................................................................................................
Small ........................................................................................................................................................................
Very Small ...............................................................................................................................................................
One-time
cost
28
105
479
$0.02
0.04
0.17
Totals:
One-Time Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
0.23
0.03
0.03
srobinson on DSK9F5VC42PROD with PROPOSALS2
Training
Training programs should 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.35 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
actually spend on training. Due to data
limitations, this analysis assumes the
number of establishment employees
33 Viator. C. et al. 2015. (b) 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.
34 Viator. C. et al. 2015. (b) Table 4–2. Costs of
Sanitation SOP Plan Development, Validation and
Reassessment.
35 Viator, C. et al. 2015. (b).
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conducting sanitary dressing tasks at
swine establishments is equal to the
number of employees conducting
sanitary dressing tasks at beef slaughter
establishments.36 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. The Agency is seeking comment
on this assumption.
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 Bureau of Labor
Statistics’, BLS, 2016 turnover rate for
non-durable manufacturing goods.37
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 612
establishments is roughly $1.13 million,
while the total recurring costs is roughly
$0.49 million, Table 10. The annualized
costs with a 3 percent discount rate over
10 years for Sanitary Dressing task
related training is $0.62 million, Table
10.
TABLE 10—SANITARY DRESSING TRAINING COSTS
[M$]
Training costs
Number of
establishments
HACCP size
Average
number of
employees
One-time
Initial
Large ....................................................................................
Small ....................................................................................
Very Small ............................................................................
179
25
3
Refresher
$0.09
0.04
0.03
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 ......................................................................................
1.13
0.49
0.62
0.64
Inspection Final Rule,38 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
expected to verify the plan each day of
production. In addition, this analysis
$0.61
0.32
0.20
New hires
$0.18
0.09
0.06
Monitoring, Recordkeeping, and
Verification
This analysis also measures the
annual monitoring, recordkeeping and
verification costs associated with
maintaining sanitary dressing
procedures. Similar to the
Modernization of Poultry Slaughter
28
105
479
Recurring
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 $0.85
million annually, applying a 3 percent
discount rate over 10 years, Table 11.
TABLE 11—MONITORING, RECORD KEEPING AND VERIFICATION COSTS
[M$]
Recurring costs
HACCP Size
Monitoring
Large ................................................................................................................
Small ................................................................................................................
Very Small .......................................................................................................
Record
keeping
$0.07
0.20
0.58
Totals:
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
0.85
0.85
0.85
srobinson on DSK9F5VC42PROD with PROPOSALS2
Table 12 provides an overview of the
one-time and recurring costs associated
36 The 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/
connect/6d37a1fc-a3e1-40b6-90cc-719bdb391522/
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$0.02
0.04
0.07
Combined
$0.04
0.12
0.44
Summary Cost of Written Sanitary
Dressing Procedures
$0.016
0.038
0.070
Verification
with requiring all establishments to
develop written sanitary dressing
procedures. Combined, these tasks are
expected to cost the industry $1.50
million annualized, assuming a 3
percent discount rate over 10 years,
Table 12.
STEC_Survey_Comments_Summary.pdf
?MOD=AJPERES].
37 This analysis uses the industry turnover rate for
non-durable manufactured goods to estimate.
Source: BLS Economic News Release Table 16.
Annual total separations rates by industry and
region, not seasonally adjusted. <https://
www.bls.gov/news.release/jolts.t16.htm> Accessed
on 7/21/17. Last updated on 3/16/17.
38 79 FR 49566–49637, August 21, 2014.
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TABLE 12—SUMMARY OF COSTS ASSOCIATED WITH REQUIRING WRITTEN SANITARY DRESSING PROCEDURES
[M$]
One-time costs
Number of
establishments
HACCP size
Large ....................................................................................
Small ....................................................................................
Very Small ............................................................................
Development
Recurring costs
Initial training
Training
Monitoring,
recording,
validating
28
105
479
$0.02
0.04
0.17
$0.61
0.32
0.20
$0.27
0.14
0.09
$0.07
0.20
0.58
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 ..
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
........................
1.36
1.34
1.50
1.53
b. Process Control Sampling and
Analysis for Microbial Organisms
This section reviews the expected
changes in costs associated with the
proposed alterations to microorganism
process control verification. These costs
are limited to the changes associated
with removing the requirement that
swine establishments test carcasses for
generic E. coli and replacing them with
new testing requirements described
above. While the proposed 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 expected 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 39 and Costs of Food Safety
Investments report.40 Each of these
categories is explained in detail below.
reassessment under the proposed 9 CFR
310.25(a)(2)(i). The RTI Costs of Food
Safety Investment 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.41 The annualized
reassessment cost to industry is roughly
$0.19 million, assuming a 3 percent
discount rate over 10 years, Table 13.
Process Control Sampling Plan
Reassessment
This analysis assumes establishments
will incur one-time costs of conducting
a process control sample plan
TABLE 13—COSTS OF PROCESS CONTROL SAMPLING PLAN REASSESSMENT
[M$]
Number of
establishments
Per
establishment
(mid-point
estimate) *
28
105
479
$0.05
243
243
$1.53
0.03
0.12
Totals:
One-Time Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
1.67
0.19
0.22
HACCP size
Large ............................................................................................................................................
Small ............................................................................................................................................
Very Small ...................................................................................................................................
Total onetime costs
* The values for Small and Very Small Establishments are in dollars.
srobinson on DSK9F5VC42PROD with PROPOSALS2
Transferring From Prescriptive To
Process Testing Requirements
Current regulation prescribes that
each slaughter facility will test for
generic E. coli.42 In addition to
mandated generic E. coli testing, many
39 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’
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establishments voluntarily conduct
additional microbiological testing to
verify process control. Common
microbiologic tests include aerobic plate
count (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.43
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.
40 Viator C. et al. 2015. (b).
41 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.
42 9 CFR 310.25.
43 Viator C. et al. 2015. (a) P5–42. Question 3.1.
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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 would 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 28 large
(28 * 1.00), 41 small high volume (51 *
.80), 43 small low volume (54 * .80) and
342 very small (479 * .714)
establishments that currently test for
generic E. coli and at least one other
microbial or pathogen indicator 44
would 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 and small high volume
establishments conduct 1 test, every
1,000 carcasses, and all small low
volume and very small establishments
conduct 13 tests annually.45 The
Agency is seeking comment on this
assumption. 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 $24.92.46 To
have the sample tested at a contracted
lab, the cost is $48.76.47 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.48 For these 454
establishments, the combined reduction
in testing costs of no longer being
required to test for generic E. coli is
expected to reduce annual testing costs
by approximately $3.92 million,
assuming a 3 percent discount rate over
10 years, Table 14.
TABLE 14—RECURRING COSTS (SAVINGS) FROM NO LONGER REQUIRING GENERIC E. coli TESTING
[M$]
Number of
establishments
HACCP size
Large ........................................................................................................................................................................
Small High Volume ..................................................................................................................................................
Small Low Volume ...................................................................................................................................................
Very Small ...............................................................................................................................................................
(Savings)
28
41
43
342
($3.28)
(0.40)
(0.02)
(0.22)
Totals:
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
(3.92)
(3.92)
(3.92)
srobinson on DSK9F5VC42PROD with PROPOSALS2
Process Control Sampling Rates
The proposed rule would require
large and small high volume
establishments to take samples at preevisceration and post-chill, which
would increase the number of samples
taken from 1 sample per 1,000 carcasses
to 2 samples per 1,000 carcasses for
large and small high volume
establishments. The proposed rule does
not require small low volume and very
small establishments to increase their
sampling rates. Under the proposed
regulations, large establishments annual
process control sampling costs are
expected to increase by roughly $2.34
million, which is roughly $83,639 per
establishment ($2.34 million/28), Table
15. Small high volume establishments
annual process control sampling costs
are expected to increase by roughly
$0.29 million, which is roughly $5,740
44 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
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($0.29 million/51) per establishment,
Table 15.
Process Control Sample Recordkeeping
This analysis takes into consideration
the increase in record keeping 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 establishment slaughters
approximately 3.77 million swine per
year. As such, this analysis estimates
that a large establishment currently
takes approximately 3,774 samples
annually (3,774,223/1,000). The average
small high volume swine establishment
slaughters 0.23 million swine per year
and requires approximately 229 samples
(228,784/1,000) annually. Assuming it
takes 2.5 minutes to record the results
of each sample, the average large
establishment currently requires 9,435
minutes (2.5 * 3,774) per year and the
average small high volume
71.4% of very small, 80% of small and 100% of
large establishments conduct additional testing.
45 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.
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establishment currently requires 573
minutes (2.5 * 229) per year. Requiring
establishments to increase their
sampling rates from 1 to 2 samples per
1,000 head would increase the average
large establishment’s annual number of
samples to 7,548 samples annually
(3,774,223/1,000 *2), which would
require approximately 18,870 minutes
(2.5 * 7,548) annually. The same
requirement would increase a small
high volume establishment’s annual
sampling to 458 (228,784/1,000 * 2),
which would require approximately
1,145 minutes (2.5 * 458) annually. As
such, the expected additional time
required for recordkeeping is
approximately 9,435 minutes (18,870–
9,435) for large establishments and 572
minutes (1,145–573) for small high
volume establishments. Assuming a
quality control technician with a
compensation rate of $68.52 per hour 49
conducts this work, the additional costs
46 Viator
C. et al. 2015. (b) Table 5–1.
C. et al. 2015. (b) Table 5–1.
48 Viator, C. et al. 2015. (b).
49 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.
47 Viator
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to the average large establishment is
approximately $10,775 (9,435/60 *
$68.52). Similarly, the additional cost to
the average small high volume
establishment is approximately $653
(572/60 * 68.52). Scaling this up to all
establishments, the total increase in
costs to all large establishments is
approximately $0.30 million ($10,775 *
28) and $0.03 million ($653 * 51) for
small high volume establishments,
Table 15.
The combined annualized sampling
and recordkeeping cost to all large and
small high volume establishments is
roughly $2.97 million, applying a 3
percent discount rate over 10 years.
Large establishments are expected to
incur the majority of this cost.
TABLE 15—COSTS CHANGES ASSOCIATED WITH INCREASE SAMPLING RATES
[M$]
Number of
establishments
Large ..............................................................................................................
Small–High Volume .......................................................................................
Costs
Sampling
$2.64
0.33
Totals:
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
2.97
2.97
2.97
percent discount rate, Table 16.
However, only the 454 establishments
that currently conduct multiple types of
microbiological tests are expected to
experience a reduction in cost. The
remaining establishments, roughly 158
small and very small establishments, are
$2.34
0.29
Combined
$0.30
0.03
Summary of Process Control Sampling
Costs Changes
Overall, the changes in sampling
requirements under the proposed rule
are expected to reduce industry wide
sampling costs by about $0.76 million
annualized over 10 years, applying a 3
28
51
Recordkeeping
expected to incur a portion of the onetime costs associated with plan
reassessment, Table 16. Cost increases
associated with testing and
recordkeeping will be exclusively borne
by large and small high volume
establishments.
TABLE 16—SUMMARY OF CHANGES TO PROCESS CONTROL SAMPLING
[M$]
Cost (savings)
Type of change
One-time
Recurring
$1.67
........................
........................
........................
........................
($3.92)
2.63
0.33
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 ......................................................................................
1.67
(0.95)
(0.76)
(0.72)
Plan Reassessment .................................................................................................................................................
Converting to Process Control Sampling ................................................................................................................
Testing Costs ...........................................................................................................................................................
Recordkeeping .........................................................................................................................................................
srobinson on DSK9F5VC42PROD with PROPOSALS2
c. Environmental Sampling
As proposed, all swine slaughter
establishments will be required to
control for enteric pathogen
contamination in the pre-operational
environment. Such controls will have to
be included in an establishment’s
HACCP system, requiring a plan
reassessment. This analysis assumes
establishments will coordinate this
work with the HACCP plan
reassessment required by the
development of written sanitary
dressing procedures. As such the cost of
incorporating pre-operational
environment sampling plans into an
establishment’s HACCP system is
included in the reassessment costs
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associated with written sanitary
dressing procedures.
While establishments will set
sampling frequency so as to ensure
effective control, this analysis assumes
each large establishment will take 4
samples per 30 days of operation per
line, while each small high volume
establishment will take 2 samples per 30
days of operation per line, and small
low volume and very small
establishments will take 1 sample per 30
days of operation per line.50 Under this
50 In absence of other data we assumed
establishments would conduct environmental
sampling similar to the recommended frequencies
described on Page 91 in: FSIS Compliance
Guidelines: Controlling Listeria monocytogenes in
Post-lethality Exposed Ready-to-Eat Meat and
Poultry Products. January 2014. Accessed on 12/3/
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assumption, the annual number of tests
required by the entire industry is
approximately 3,266. The Agency is
seeking comment on this assumption.
Establishments are permitted to conduct
a variety of tests, including testing for
Aerobic Plate Count, APC, Coliforms,
Generic E. coli, Total Plate Count, TPC,
and Salmonella. The laboratory testing
15. Available at https://www.fsis.usda.gov/wps/wcm/
connect/d3373299-50e6-47d6-a577-e74a1e549fde/
Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES.
Industry is familiar with this methodology for
sampling food-contact-surfaces in the post-lethality
environment to ensure that the surfaces are sanitary
and free of Listeria monocytogenes or an indicator
organism. We assumed industry would take a
similar approach in sampling food-contact-surfaces
in market hog establishments to meet the proposed
environmental sampling requirements.
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costs for these test range from $15 to
$32, with an average mean testing cost
of $19, Table 17.51
$32, with an average mean testing cost
of $19, Table 17.51
TABLE 17—LABORATORY TESTING COSTS
Test
Minimum
APC ..............................................................................................................................................
Coliforms ......................................................................................................................................
E. coli ...........................................................................................................................................
Salmonella ...................................................................................................................................
TPC ..............................................................................................................................................
Average ........................................................................................................................................
Mean
$16
15
15
17
16
16
Maximum
$18
18
18
25
16
19
$20
22
22
32
17
23
Source: Viator. C. et al. 2015. Costs of Food Safety Investments. Table 5–1. Laboratory Testing Costs.
To ensure a conservative estimate this
analysis assumes establishments will
test for Salmonella, which is the most
expensive option, Table 17. Under these
assumptions, the combined total annual
environmental sampling cost is
approximately $0.08 million (3,266 ×
$25). The annualized cost of these
combined expenditures is roughly $0.08
million, assuming a 3 percent discount
rate over 10 years, Table 18.
TABLE 18—COSTS OF ENVIRONMENTAL SAMPLING
[M$]
Number of
establishments
HACCP size
Large ........................................................................................................................................................................
Small High Volume ..................................................................................................................................................
Small Low Volume ...................................................................................................................................................
Very Small ...............................................................................................................................................................
Sampling
costs
28
51
54
479
0.03
0.02
0.004
0.03
Totals:
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
0.08
0.08
0.08
Summary of Voluntary and Mandatory
Costs
The total annualized value of all costs
to industry, under the assumed five year
adoption rate as shown in Table 6, is
roughly $17.84 million, assuming a 10
year annualization and a 3 percent
discount rate, Table 19. Large
establishments that voluntarily switch
to the NSIS incur the majority of costs.
For example, the recurring labor costs
associated with the NSIS is the single
largest recurring cost to industry and is
mostly incurred by large establishments.
It should be noted that the five HIMP
pilot establishments have already
incurred these costs, suggesting for
those five establishments, the benefits of
NSIS outweigh the costs. It also suggests
that the benefits of adopting NSIS
outweigh the costs for other
establishments as well. Training staff
accounts for the bulk of the costs
associated with written sanitary
dressing procedures. Sampling costs are
expected to decrease for those
establishments that currently conduct
microbiological tests in addition to
generic E. coli.
TABLE 19—COMBINED COSTS TO INDUSTRY
[M$]
Number of
establishments
srobinson on DSK9F5VC42PROD with PROPOSALS2
Type of cost
Voluntary:
Establishment Labor .............................................................................................................
Ready to Cook ......................................................................................................................
Mandatory:
Written Sanitary Dressing Plan ............................................................................................
Process Control Sampling ....................................................................................................
Environmental Sampling .......................................................................................................
Total costs
One-time
Recurring
35
35
$0.84
........................
$21.66
0.51
612
612
612
1.36
1.67
0.0
1.34
(0.95)
0.08
Totals *:
Number of Establishments ....................................................................................................................................................
One-Time Cost ......................................................................................................................................................................
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
612
3.88
22.65
17.84
51 Viator. C. et al. 2015. (b) Table 5–1. Laboratory
Testing Costs.
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TABLE 19—COMBINED COSTS TO INDUSTRY—Continued
[M$]
Number of
establishments
Type of cost
Total costs
One-time
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
Totals Mandatory *:
Number of Establishments ....................................................................................................................................................
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 ......................................................................................
Totals Voluntary *:
Number of Establishments ....................................................................................................................................................
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 ......................................................................................
Recurring
17.24
612
$3.03
$0.48
$0.82
$0.88
35
$0.84
$22.17
$17.02
$16.36
* Note, some of the totals may not equal the sum due to rounding.
H. Expected Benefits of the Proposed
Rule
srobinson on DSK9F5VC42PROD with PROPOSALS2
1. Expected 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
expected to reduce pathogen levels in
swine slaughter establishments. 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 HACCP-based
Inspection Models Project (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. 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 change in carcass
contamination prevalence under the
inspection procedures of NSIS.
Changes in expected numbers of
Salmonella illness are estimated based
on a proportional relationship between
carcass contamination prevalence and
illnesses that has been published in the
peer-reviewed literature.52 53 This
52 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.
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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, if the proportion of carcasses
with no detectable Salmonella
contamination increases with
implementation of the NSIS, illnesses
caused by consumers’ exposure to these
carcasses are expected to decrease
proportionally.
The market hog Salmonella illness
risk model estimates that the prevalence
of Salmonella detected in carcasses will
decline on average from an initial
prevalence of 0.9407% to a final
prevalence of 0.9066% if the 35
establishments identified adopt the new
inspection system. The uncertainty of
the final prevalence ranges from
0.8982% to 0.915%, at the 10th and
90th percentiles, respectively. 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.54
53 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.
54 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
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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.55 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 768 and
4,287 decreased cases, respectively. The
total case uncertainty distribution is
dependent on the uncertainty in the
change in Salmonella prevalence in
market hogs which has an average
percent uncertainty of a 3.626%
decrease and is bounded at the 10th and
90th percentiles by a decrease of
1.0989% and 6.1362%, respectively.
public health from performance standards applied
in slaughter establishments, Food Control,28.
55 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 prevalence estimates are modeled
with data variability and robust
uncertainty components taken from
sampling data and model parameter
estimates. 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, without intervention.
With adoption of the new inspection
system, the average number of cases is
likely to decrease to 67,324 with 10th
and 90th percentiles of 38,653 and
101,417 cases, respectively.
The market hog risk assessment
estimates that if the 35 establishments
expected to covert to the NSIS over 5
years do so, the number of human
illness attributed to products derived
from market hogs could reduce by an
average of 2,533 Salmonella illnesses.
The combined robust model estimate of
total 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 768 and 4,287
decreased cases, respectively. 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 $3,682.56 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 20. The cost savings
assuming the lowest cost per illness and
only 768 cases avoided, which
corresponds to the 10th percentile, is
$0.25 million, Table 20. Alternatively,
the cost savings assuming the highest
cost per illness and 4,287 averted
illnesses, which corresponds to the 90th
percentile, is $24.95 million, Table 20.
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 20.
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
detectable with Salmonella.
TABLE 20—HEALTH BENEFITS FROM AVERTED CASES OF SALMONELLA
Cost per illness *
Illnesses
averted by
scenario
Percentile
Low
Mid
High
$321
$3,682
$5,820
Scenario costs, $M
10th ..................................................................................................................
Mean ................................................................................................................
90th ..................................................................................................................
768
2,533
4,287
($0.25)
(0.81)
(1.38)
($2.83)
(9.33)
(15.79)
Totals (Low)(M$):
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
Totals (Mid)(M$):
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
Totals (High)(M$):
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
($4.47)
(14.74)
(24.95)
($0.25)
($0.19)
($0.18)
($9.33)
($7.09)
($6.81)
($24.95)
($18.97)
($18.22)
* 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.
The proposed regulation is expected
to reduce the regulatory burden on
establishments by shifting from
prescriptive to performance based
regulation. Specifically, the proposed
rule amends requirements related to
slaughter line speeds,57 microbiological
testing, and sorting activities. Based on
the Evaluation of HACCP Inspection
Models Project (HIMP) for Market Hogs
report, the five HIMP establishments’
average line speed were approximately
12.49 percent faster than comparable
establishments.58 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
56 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.
57 According to the Evaluation of HACCP
Inspection Models Project (HIMP) for Market Hogs
Final Report, November 2014, ‘‘In CY 2013, the
estimated line speeds at the 5 HIMP market hog
establishments varied from 885 to 1,285 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’’.
58 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-+himp
Accessed on 1/6/2017. Last updated on 11/14/2014.
srobinson on DSK9F5VC42PROD with PROPOSALS2
2. Other Benefits Associated With
Modernizing Existing Regulations
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American Meat Institutes’ average pork
packer margins for 2010–2014, which
was reported to be $4.10 per head in
NAMI’s 2015 Meat and Poultry Facts.59
The pork packer margin is the price the
packer receives less the cost of the hog
and production costs, making the packer
margin an approximation for producer
surplus. FSIS requests comment on
refining this estimate so as to
distinguish between accounting profit
and economic profit—the latter being
more precisely associated with producer
surplus.
Assuming establishments increase
their line speeds by 12.49 percent and
have a packer margin of $4.10 per head,
an average large establishment’s surplus
could increase by approximately $2.04
million, while an average small high
volume establishment’s surplus could
increase by $0.18 million, all else being
equal. Combined, such an increase in
efficiency at all 35 establishments
would increase producer surplus by
roughly $47.33 million 60 (22 × $2.04
million + 13 × $0.18 million), which has
an annualized benefit of roughly $47.33
million, assuming a 3 percent discount
rate over 10 years, Table 21. This
estimate takes into consideration the
4813
assumed five year adoption rate.
However, this increase in surplus may
be an overestimate given that an
increase in line speeds may change
market hog prices, establishment
production costs, retail prices, and
export volumes. Additionally, consumer
benefits would be conditional on how
an increase in line speed affects retail
prices. As such, the Agency is seeking
comment on the extent to which such
an increase in line speeds would affect
market hog prices, establishment hours
of production, consumer prices, and
export volumes.61
TABLE 21—INDUSTRIAL EFFICIENCY, (BENEFITS) M$
Change in efficiency
Number of
establishments
Type of establishment
Large ............................................................................................................................................
Small ............................................................................................................................................
Combined * ...................................................................................................................................
22
13
35
Per
establishment
Combined
($2.04)
(0.18)
........................
($44.97)
(2.37)
(47.33)
Totals:
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
(47.33)
(36.14)
(34.74)
* Note, some of the totals may not equal the sum due to rounding.
estimated to be approximately $0.30
million. Both of these annualized
estimates apply a 3 percent discount
rate over 10 years. Details of these costs
are provided below.
srobinson on DSK9F5VC42PROD with PROPOSALS2
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.62 The five
establishments that participated in the
pilot project account for 15 percent of
total swine production.
Additionally, NSIS inspection
increases the Agency’s ability to
conduct more process and product
verification and 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 HATS
categories in HIMP market hog
establishments compared to
approximately 4.29 hours per shift in
the 21 non-HIMP market hog
comparison establishments.63 Under
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.
Under the proposed rule, the Agency
would shift Agency resources from
online to offline activities. This analysis
estimates such a shift will reduce labor
expenses by approximately $6.67
million annually, Table 22. However,
Agency personnel at NSIS
establishments will require additional
training, the annualized cost of which is
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 and up to 2 FTEs
at a small market hog establishment.
Under NSIS, a single slaughter line at a
large establishment is expected to
require 6 FTEs, while a small market
hog establishment is expected to require
3 FTEs. Large establishments with two
slaughter lines are expected to require
10 FTEs, while a small market hog
establishment with 2 slaughter lines is
expected to require 4 FTEs.
59 Nalivka, J.S., The 2015 Meat and Poultry Facts,
NAMI December 2015.
60 Note, some of the totals may not equal the sum
due to rounding.
61 The Agency further notes that marginal costs
typically increase as a function of production
quantity, in which case profit margins reach zero
for the last unit of production; indeed, the
phenomenon of rising marginal costs is consistent
with the observation of HIMP line speed increases
that are less than the maximum increase that is
theoretically permissible. Assuming linearity of the
relevant marginal cost curve would yield a margin
of $2.05 per head, thus making producer surplus
half the amount estimated here as the change in
industrial efficiency. Meanwhile, if demand and
supply elasticities for pork products are similar—
which may or may not be plausible—then consumer
surplus would increase by half the industrial
efficiency amount estimated here, thus making the
overall efficiency change estimate a reasonable
approximation for the total (consumer plus
producer) surplus gain.
62 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-+himp
Accessed on 1/6/2017. Last updated on 11/14/2014.
63 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-+himp
Accessed on 1/6/2017. Last updated on 11/14/2014.
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This analysis considers likely staffing
changes at the 22 large and 13 small
establishments which are expected to
convert to NSIS over a course of five
years. Combined, these establishments
operate 46 shifts and 55 lines.64 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 22. If all 22 large
non-HIMP and 13 small high volume
market hog only establishments convert
to the NSIS, the Agency would 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 would have up to 3 FTEs
assigned to them and each of the 32
shifts at the large establishments would
have up 2 FTEs assigned to them ((41
lines × 3 FTEs) + (32 shifts × 2 FTEs)
= 187 FTEs). Likewise, under NSIS, the
13 small establishments would 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 22.
This cost estimate includes expected
grade increases associated with
converting to the NSIS. As is shown in
Table 22, 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 would
require 147 fewer FTEs for swine
slaughter inspection, with an expected
annual decrease in costs of roughly
$8.73 million, which is equal to roughly
$6.67 million a year, assuming a 3
percent discount rate, Table 22.
TABLE 22—EXPECTED CHANGES IN AGENCY STAFFING
[M$]
Traditional
Type
Number
positions
Proposed 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)
Totals:
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
(8.73)
(6.67)
(6.42)
Since 2008, the Agency has annually
lost, through attrition, 270 food
inspectors on average. See Table 23 for
details. The Agency plans to utilize all
personnel made available as a result of
conversion to NSIS to fill these vacant
positions.
TABLE 23—ANNUAL TURNOVER OF
FOOD INSPECTORS
srobinson on DSK9F5VC42PROD with PROPOSALS2
Fiscal year
2008
2009
2010
2011
2012
2013
2014
2015
Number of
positions
......................................
......................................
......................................
......................................
......................................
......................................
......................................
......................................
307
264
231
268
266
246
273
305
64 The 22 large establishments operate 41
slaughter lines during 32 shifts, while the 13 small
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small establishments, Table 24. 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 program,
2. Agency Training
this analysis assumes NSIS methods
training will take 3 days and
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
6, the Agency expects to train 266
($550,942 for all large establishments
personnel (218 CSIs and 48 PHVs), with and $81,697 for all small
pay grades ranging from GS–8 to GS–13, establishments), Table 24. This one-time
on NSIS methods. The majority of these cost equals approximately $0.07 million
personnel, 228, are associated with 22
if it were annualized over 10 years
large establishments, while the
under a 3 percent discount rate, Table
remaining 38 are associated with 13
24.
TABLE 23—ANNUAL TURNOVER OF
FOOD INSPECTORS—Continued
establishments operate 14 lines during 14 shifts,
source PHIS.
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TABLE 24—THREE DAY NSIS TRAINING COURSE
[M$]
Cost of trainee
Number of
inspectors
requiring
training
Type of establishment
Large ....................................................................................
Small ....................................................................................
Replacement labor
Costs of
wages and
benefits for
trainees
228
38
Combined
costs
$0.56
0.08
Totals:
One-Time Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
0.64
0.07
0.07
As proposed, 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.
$0.21
0.03
Costs of
wages and
benefits for
replacements
$0.34
0.06
Fill an Increase Need for Consumer
Safety Inspectors
228
38
Number of
replacement
inspectors
required
been included in the Agency Staffing
section above. The combined one-time
cost for converting FIs into CSIs is
roughly $2.16 million, Table 25. Nearly
half of this cost stems from the need for
replacement labor. Again, under the
proposed five year adoption rate, as set
forth in Table 6, and under a 3 percent
discount rate the annualized costs is
approximately $0.23 million, Table 25.
Training includes a four-week meat
inspector course and a one-day
computer familiarization course. If all
22 large establishments convert to NSIS,
the Agency will need an additional 82
CSIs. Likewise, if all 13 small market
hog establishments convert, the Agency
will need an additional 16 CSIs.
Converting a FI into a CSI may result in
a grade increase, the cost of which has
TABLE 25—COST OF CONVERTING A FOOD INSPECTOR INTO A CONSUMER SAFETY INSPECTOR
[M$]
Labor
Training component
Trainee
Four Week MI Course .....................................................................................
One Day Computer Training ............................................................................
Replacement
$2.09
0.07
Totals:
One-Time Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
2.16
0.23
0.25
The Agency’s budget is expected to be
impacted both by changes to personnel
and training requirements. First, there
will be a reduced need for Agency
personnel to inspect a slaughter line
operating under NSIS. If all 22 large and
13 small establishments convert to NSIS
over the course of five years, the Agency
would require approximately 147 fewer
FTEs to inspect the 55 65 slaughter lines
operating at these establishments. The
annual remuneration value of these 147
positions is roughly $8.73 million, Table
26. Second, the Agency will need to
train approximately 266 personnel on
NSIS methods at a one-time cost of
approximately $0.64 million, Table 26.
Third, the Agency plans to meet the
$0.98
0.05
Combined
costs
$0.59
........................
Combined Expected Budgetary Impacts
$0.52
0.03
Travel, M&IE,
and lodging
increase in demand for CSIs by
converting existing FIs into CSIs. The
one-time cost of doing so is
approximately $2.16 million, Table 26.
The annualized value of the combined
changes to the Agency’s budget is a net
reduction of roughly $6.38 million, over
10 years assuming a 3 percent discount
rate, Table 26.
TABLE 26—COMBINED CHANGES TO FSIS’S BUDGET
[M$]
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Total costs
One-time
Recurring
........................
$0.64
2.16
($8.73)
........................
........................
Totals:
One-Time Cost ......................................................................................................................................................................
2.80
Changes to Agency Staffing ....................................................................................................................................
Three Day NSIS Training ........................................................................................................................................
Converting Food Inspectors into Consumer Safety Inspectors ..............................................................................
65 Source:
PHIS.
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TABLE 26—COMBINED CHANGES TO FSIS’S BUDGET—Continued
[M$]
Total costs
One-time
Recurring Cost ......................................................................................................................................................................
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years ......................................................................................
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years ......................................................................................
J. Net Benefits
With the expected impact on the
Agency’s budget and industry’s revenue
included, and assuming all large and
small exclusively market hog
Recurring
(8.73)
(6.38)
(6.09)
Table 27. The majority of the costs are
experienced by the 35 non-HIMP
establishments expected to voluntarily
switch to the NSIS in the form of
increased labor needs.
establishments convert to NSIS (5
HIMP, 22 large, and 13 Small high
volume), the rule is anticipated to have
a net benefit of approximately $31.77
million a year, annualized over 10 years
assuming a 3 percent discount rate,
TABLE 27—NET COSTS AND (BENEFITS)
[M$]
Number of
establishments
One-time
........................
** 40
612
........................
........................
........................
$3.88
0.84
3.03
........................
........................
2.80
$22.65
22.17
0.48
(9.33)
(47.33)
(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 ......................................................................................
6.68
(42.75)
(31.77)
(30.40)
Costs To Industry ........................................................................................................................
Voluntary * .............................................................................................................................
Mandatory .............................................................................................................................
Health Benefits *** ........................................................................................................................
Industrial Efficiency ......................................................................................................................
Impacts to Agency’s Budget ........................................................................................................
Recurring
* Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the Proposed Rule, Table 6: NSIS
Adoption Rate and section J. Net Benefits, Table 28: Quantified Cost and (Benefits) of Various Adoption Rates.
** Note, this includes 5 HIMP establishments, which are not expected 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. Expected Benefits Associated With Public
Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value of health benefits ranges from $0.19 million to $18.97 million,
with a mean of $9.33 million.
Given the lack of data with which to
make cost-benefit comparisons across
the industry, Table 28 provides a range
of possible adoption scenarios and their
corresponding costs and benefits. Under
scenario A, only the 5 HIMP
establishments adopt the NSIS. Because
these 5 establishments are already
operating under NSIS practices, there
would not be any additional voluntary
costs or benefits associated with these 5
establishments adopting the NSIS.
However, all 612 establishments would
incur costs associated with the proposed
rule’s mandatory components. As such,
scenario A has a net cost. Scenario B
assesses the net cost and benefits of just
6 establishments adopting the NSIS (5
HIMP and 1 large). This scenario reveals
that the rule is net beneficial if just 1
large establishment adopts the NSIS in
addition to the 5 HIMP establishments.
Scenarios C, D, and E measure the net
costs and benefits of 50, 75, and 100
percent of the 40 establishments
converting to the NSIS, respectively.
Each of these scenarios are net
beneficial.
TABLE 28—QUANTIFIED COST AND (BENEFITS) OF VARIOUS ADOPTION RATES
[M$] ∧
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Number to
Adopt *
A
B
C
D
E
...................................
...................................
...................................
...................................
...................................
Costs
(Benefits)
Net
Mandatory @
5
6
23
32
40
$0.82
0.82
0.82
0.82
0.82
NSIS
Health
$0.0
0.86
8.35
13.09
17.02
Line speeds
$0.0
(0.27)
(3.59)
(5.52)
(7.09)
$0.0
(2.04)
(18.01)
(27.82)
(36.14)
Agency budget
$0.0
(0.38)
(3.14)
(4.88)
(6.38)
$0.82
(1.00)
(15.57)
(24.30)
(31.77)
* 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.
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K. Alternatives
TABLE 29—ALTERNATIVE POLICY OPTIONS
Alternatives
Benefits
Costs
A. No action (Baseline) ........................
1. No additional costs to industry ........
B. Mandatory Portion of the Proposed
Rule Only.
1. In comparison to the baseline, potential $0.76M in Process Control
Sampling cost savings.
1. Potential $7.09M in averted illnesses.
2. Potential $36.14M in Industrial Efficiency.
3. Potential $0.76M in Process Control Sampling cost savings.
4. Roughly $6.67M in Agency Labor
Savings.
1. Potentially more than $7.09M in
averted illnesses.
2. Potential $36.14M in Industrial Efficiency.
3. Potential $0.76M in Process Control Sampling cost savings.
4. Roughly $2.72M in Agency Labor
Savings.
1. Potential for inefficient use of agency resources.
2. No potential increase in industrial
efficiency.
3. Lack of incentive for establishments
to innovate and improve their process controls.
4. No potential health benefits.
1. In comparison to the baseline, potential $1.58M in Other Industry
Costs.
1. Potential $16.62M Increase in Industry Labor Costs.
C. Proposed Rule (40 Establishments
Adopt NSIS).
D. Require All 612 Establishments
Adopt NSIS.
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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
NSIS. These benefits include the
establishment’s ability to innovate and
develop process controls which increase
foodborne hazard detection and more
efficiently use all of their resources.
Taking no action would also forgo
potential industrial efficiency increases.
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 proposed rule.
B—The Mandatory Portion of the
Proposed Rule
FSIS considered limiting the
proposed rule to only include the
mandatory sections. Under such a
scenario quantified benefits are limited
to an estimated $0.76 million reduction
in process control sampling costs. This
cost reduction is expected to be off-set
by a $1.58 million increase in other
industry costs associated with requiring
written sanitary dressing plans and
environmental sampling. In comparison
to the baseline, this scenario has a net
cost of roughly $0.82 million.
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2. Potential $1.97M in Other Industry
Costs.
3. Roughly $0.30M in Agency Training
Costs.
1. Potential $25.9M Increase in Industry Labor.
2. Potential $3.3M in Other Industry
Costs.
3. Roughly $0.68M in Agency Training
Costs.
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
expected $6.67 million. However,
because FIs will 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
proposed 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
expected net cost as compared to the
baseline as well as the decrease in net
benefits as compared to the proposed
rule.
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Net
Costs of $0.82M.
Benefits of $31.77M.
Benefits of $16.83M.
C—The Proposed Rule
Applying a 3 percent discount rate
over 10 years the costs associated with
the proposed rule include $16.62
million in additional industry labor
costs, $1.97 million in other industry
costs including costs associated with
meeting ready to cook standards,
written sanitary dressing plans, and
environmental sampling, and $0.3
million in Agency training costs. The
quantified health benefits of the
proposed 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 is expected to increase their
efficiency by $36.14 million, assuming a
3 percent discount rate. The proposed
rule is also expected to reduce industry
costs associated with process control
sampling by roughly $0.76 million,
assuming a 3 percent discount rate.
Additionally, the proposed rule is
expected to reduce the Agency’s labor
costs by roughly $6.67 million,
assuming a 3 percent discount rate. In
comparison to the baseline, the
proposed rule has an estimated net
benefit of $31.77 million, assuming a 3
percent discount rate over 10 years and
as such the Agency recommends the
proposed rule.
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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 HIMP,
27 large, and 13 small high volume
establishments expected to convert
under the proposed rule to include 572
additional establishments. This
expansion would include low volume
establishments that slaughter all types
of swine as well as 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 $36.14 million
increase in industrial efficiency, $0.76
million in industrial savings associated
with process control sampling
requirements, and $2.72 million in
Agency labor cost savings, assuming a 3
percent discount rate over 10 years. 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 proposed 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 proposed 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. While compared
to the baseline, this alternative reduces
Agency labor costs; it would result in
additional promotions reducing the
benefit in comparison to the proposed
rule.
In comparison to the baseline, the
potential costs associated with this
alternative include a $25.90 million
increase in industrial labor, a $3.30
million increase in other industry costs
which include costs associated with
ready to cook standards, written
sanitary dressing plans, and
environmental sampling, and roughly
$0.68 million in Agency training costs.
In comparison to the proposed rule, the
additional increases in costs to industry
predominately fall on small and very
small business. While this alternative
has a net benefit of $16.83 million,
assuming a 3 percent discount rate over
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10 years, the Agency rejects it because
its net benefit is less than the proposed
rule.
VII. Regulatory Flexibility Act
Assessment
The FSIS Administrator has made a
preliminary determination that this
proposed rule would 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. At the beginning of section
VI is a list of specific economic issues
that the Agency is seeking comment on.
Section VI also provides additional
details on costs incurred by small
businesses.
The proposed rule’s mandatory
requirements would 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 plant, applying a 3 percent
discount rate over 10 years. Second, the
mandatory proposed changes to process
control sampling requirements are
expected to decrease small
establishments’ sampling costs by
roughly $1,296 per establishment
annually, applying a 3 percent discount
rate over 10 years. In addition to this
sampling cost reduction, the Agency
would allow small and very small
establishments to modify their sampling
plans to collect samples less frequently
once they have collected 13 consecutive
weekly samples and have demonstrated
that they are effectively maintaining
process control. FSIS is also proposing
to allow establishments to develop
sampling plans that are more tailored to
their specific establishment, and thus
more effective in monitoring their
specific process control than the current
generic E. coli criteria. Third, the
mandatory environmental sampling
program is expected to increase the
average small and very small
establishments’ costs by $87 per
establishment annually, assuming a 3
percent discount rate over ten years.
Therefore, the proposed rule’s
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mandatory requirements are expected to
increase small establishments’ costs by
roughly $660 ($1,869¥$1,296 + $87 =
$660) per establishment annually, an
amount that is expected to have little
effect on small entities. To put this in
perspective, the average small and very
small establishment slaughters over 21
thousand swine annually. Using the
American Meat Institute’s average pork
packer dollars per head margins for
2010–2014, the average small and very
small establishment’s marginal revenue
is $0.09 million (21,858 (heads
slaughtered) x $4.10 (average margin per
head)). Additionally, the voluntary NSIS
portion of the rule is expected to
provide an overall cost savings for the
13 small high volume establishments or
roughly $87,449 per establishment that
adopt the NSIS. This estimate takes into
consideration the increase in labor cost
($43,439 per establishment), cost
associated with meeting ready-to-cook
standards ($6,300 per establishments)
and cost savings from increased
industrial efficiency ($137,189 per
establishment). See section VI for
additional details.
Executive Order 13771
Consistent with E.O. 13771 (82 FR
9339, February 3, 2017), we have
estimated that this proposed rule would
yield cost savings. Assuming a 7 percent
discount rate and a perpetual time
horizon and a starting year of 2018, the
proposed rule would yield
approximately $24.97 million (2016$) in
cost savings, not including health
benefits. Therefore, if finalized as
proposed, this rule is expected to be an
E.O. 13771 deregulatory action.
VIII. E-Government Act
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.
IX. Executive Order 12988, Civil Justice
Reform
This proposed rule has been reviewed
under Executive Order 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.
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X. Executive Order 13175
XII. Environmental Impact
This rule has been reviewed in
accordance with the requirements of
Executive Order 13175, ‘‘Consultation
and Coordination with Indian Tribal
Governments.’’ E.O. 13175 requires
Federal agencies to consult and
coordinate with tribes on a governmentto-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.
FSIS has assessed the impact of this
rule on Indian tribes and determined
that this rule does not, to our
knowledge, have tribal implications that
require tribal consultation under E.O.
13175. If a Tribe requests consultation,
FSIS will work with the Office of Tribal
Relations to ensure meaningful
consultation is provided where changes,
additions and modifications identified
herein are not expressly mandated by
Congress.
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 Environmental
Assessment (EA) or an Environmental
Impact Statement (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 the
proposed NSIS are expected to 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 sales is very
small, the Agency has determined that
the change in the 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.
XI. 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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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: 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).
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XIII. Paperwork Reduction Act
In accordance with section 3507(d) of
the Paperwork Reduction Act of 1995,
the information collection or
recordkeeping requirements included in
this proposed rule have been submitted
for approval to OMB.
Title: Swine Slaughter Inspection.
Type of Collection: New.
Abstract: Under this proposed rule,
establishments operating under NSIS
would have to develop, implement, and
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maintain in their HACCP systems
written procedures for the segregation,
identification, and disposition of
animals exhibiting signs of moribundity,
central nervous system disorders, or
pyrexia. In addition, each official swine
slaughter establishment would need to
maintain, as part of its HACCP system,
written procedures for (1) preventing
throughout the entire slaughter and
dressing operation, contamination of
carcasses and parts by enteric
pathogens, fecal material, ingesta, and
milk and (2) preventing contamination
of the pre-operational environment by
enteric pathogens. The procedures
addressing prevention of contamination
by enteric pathogens would need to
include microbial testing. Furthermore,
all swine slaughter establishments
operating would have to maintain
records that document that the products
resulting from its slaughter operations
meet the definition of RTC pork
products. Each establishment operating
under the NSIS would 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.
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 proposed rule would create no
new burden on establishments.
The proposed requirement that swine
slaughter establishments monitor their
systems through microbial testing and
recordkeeping would create a new
information collection burden. For each
sample on which a microbiological test
is conducted, there are two ‘‘responses’’
for the establishment: One response for
the actual collecting of the sample and
sending it to the laboratory for analysis,
and the other for recording the sample
result. Under the proposed rule, large
establishments would test and record
microbiological results for enteric
pathogens, at both pre-evisceration and
post-chill, 13 times a day; small highvolume establishments, one-time a day;
and small low-volume and very small
establishments, 13 times a year. FSIS
estimates that large establishments
would test and record microbial results
for the pre-operational environment
weekly; small establishments, biweekly;
small low-volume and very small
establishments, monthly.
Estimated Annual Recordkeeping
Burden: Swine Slaughter Inspection.
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Respondents: Official swine
establishments.
Estimated Number of Respondents:
612 (28 large, 51 small high volume, 54
small low volume, and 479 very small).
Estimated Average Annual Number of
Responses (samples) per Respondent:
Large establishments 6,846; small high
volume establishments 430; and small
low volume and very small
establishments 25.
Estimated
number of
respondents
Respondents
Large establishments ..........
Small high volume establishments.
Small low volume establishments.
Very small establishments ..
Microbial testing
ordkeeping.
Microbial testing
ordkeeping.
Microbial testing
ordkeeping.
Microbial testing
ordkeeping.
Total Recordkeeping
Burden for process
control.
Small high volume establishments.
Small low volume establishments.
Very small establishments ..
191,688
2.5
7,987
data rec-
49
430
21,070
2.5
878
data rec-
54
25
1,350
2.5
56
data rec-
479
25
11,975
2.5
499
612
7,326
226,083
........................
9,420
Estimated Average Annual Number of
Responses per Respondent: Large
establishments 6,846; small high
volume establishments 430; and small
low volume and very small
establishments 25.
srobinson on DSK9F5VC42PROD with PROPOSALS2
Average
annual
number of
responses per
respondent
Estimated Total Annual Responses:
226,083.
Estimated Total Annual
Recordkeeping Burden: 47,655 hours.
Total
annual
responses
Time per
respone
in minutes
Total
annual
burden hours
Microbial testing data recordkeeping.
Microbial testing .................
28
6,846
191,688
12.5
39,702
49
430
21,070
12.5
4,389
Microbial testing .................
54
25
1,350
15
338
Microbial testing .................
479
25
11,975
15
2,993
.............................................
612
7,326
226,083
........................
47,655
FSIS is also proposing a new
regulation that would create a new
information collection burden, in that it
would require 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.
This is a new recordkeeping
requirement that FSIS has submitted to
OMB for approval.
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
number of
respondents
Respondents
VerDate Sep<11>2014
Total
annual
burden hours
6,846
Estimated
number of
respondents
Total Reporting Burden .......
Large establishments ..........
Time per
respone
in minutes
28
Respondents
Large establishments ..........
Total
annual
responses
data rec-
.............................................
Estimated Annual Reporting Burden:
Swine Slaughter Inspection.
Respondents: Official swine
establishments.
Estimated Number of Respondents:
612 (28 large, 51 small high volume, 54
small low volume, and 479 very small).
Average
annual
number of
responses per
respondent
Estimated Total Annual Responses:
226,558.
Estimated Total Annual
Recordkeeping Burden: 9,440 hours.
Attestation on Work-Related Conditions.
20:42 Jan 31, 2018
Jkt 244001
PO 00000
Frm 00042
Average
annual
number of
responses per
respondent
28
Fmt 4701
Sfmt 4702
Estimated Maximum Number of
Respondents: 41.
Estimated Average Annual Number of
Responses per Respondent: Large
establishments 1; small high volume
establishments 1.
Estimated Maximum Total Potential
Annual Responses: 41.
Estimated Total Annual
Recordkeeping Burden: 1.37 hours.
Total
annual
responses
1
E:\FR\FM\01FEP2.SGM
28
01FEP2
Time per
respone
in minutes
Total
annual
burden hours
2
.93
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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules
Estimated
number of
respondents
Respondents
Small high volume establishments.
Average
annual
number of
responses per
respondent
Total
annual
burden hours
13
1
49
2
.43
.............................................
41
1
41
........................
1.37
publication on-line through the FSIS
web page located at: https://www.fsis.
usda.gov/federal-register.
FSIS also will make copies of this
Total No. Respondents .........
612
publication available through the FSIS
Average Annual No. Responses per Respondent ..
14,693 Constituent Update, which is used to
Total Annual Responses ......
453,157 provide information regarding FSIS
Average Hours per Repolicies, procedures, regulations,
sponse ...............................
.125 Federal Register notices, FSIS public
Total Annual Burden Hours ..
57,216.37 meetings, and other types of information
that could affect or would be of interest
Copies of this information collection
to our constituents and stakeholders.
assessment can be obtained from Gina
The Update is available on the FSIS web
Kouba, Office of Policy and Program
page. Through the web page, FSIS is
Development, Food Safety and
able to provide information to a much
Inspection Service, USDA, 1400
broader, more diverse audience. In
Independence Avenue SW, Room 6065, addition, FSIS offers an email
South Building, Washington, DC 20250; subscription service which provides
(202) 720–5627.
automatic and customized access to
Comments are invited on: (a) Whether selected food safety news and
the proposed collection of information
information. This service is available at:
is necessary for the proper performance
https://www.fsis.usda.gov/subscribe.
of FSIS’s functions, including whether
Options range from recalls to export
the information will have practical
information, regulations, directives, and
utility; (b) the accuracy of FSIS’s
notices. Customers can add or delete
estimate of the burden of the proposed
subscriptions themselves, and have the
collection of information, including the
option to password protect their
validity of the methodology and
accounts.
assumptions used; (c) ways to enhance
XV. Proposed Regulatory Amendments
the quality, utility, and clarity of the
information to be collected; and (d)
List of Subjects
ways to minimize the burden of the
information collection on those who are 9 CFR Part 301
to respond, including through the use of
Meat inspection.
appropriate automated, electronic,
9 CFR Part 309
mechanical, or other technological
Animal diseases, meat inspection,
collection techniques or other forms of
reporting and recordkeeping
information technology.
Comments may be sent to both Gina
requirements.
Kouba, Office of Policy and Program
9 CFR Part 310
Development, at the address provided
Animal diseases, meat inspection.
above, and the Desk Officer for
For the reasons stated in the
Agriculture, Office of Information and
preamble, FSIS is proposing to amend 9
Regulatory Affairs, Office of
CFR Chapter III as follows:
Management and Budget, Washington,
DC 20253. To be most effective,
PART 301—TERMINOLOGY;
comments should be sent within 60
ADULTERATION AND MISBRANDING
days of the publication date of this
STANDARDS
proposed rule. All responses to this
notice will be summarized and included
■ 1. The authority citation for part 301
in the request for OMB approval. All
continues to read as follows:
comments will also become a matter of
Authority: 7 U.S.C. 138–138i, 450, 1901–
public record.
SUMMARY OF BURDEN SWINE
SLAUGHTER INSPECTION
srobinson on DSK9F5VC42PROD with PROPOSALS2
Time per
respone
in minutes
Attestation on Work-Related Conditions.
Total Reporting Burden
XIV. Additional Public Notification
Public awareness of all segments of
rulemaking and policy development is
important. Consequently, FSIS will
announce this Federal Register
VerDate Sep<11>2014
Total
annual
responses
20:42 Jan 31, 2018
Jkt 244001
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:
■
PO 00000
Frm 00043
Fmt 4701
Sfmt 4702
§ 301.2
Definitions.
*
*
*
*
*
Ready-to-cook (RTC) pork product.
Any slaughtered pork product 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:
■
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 SOP, or other
prerequisite program.
(c) The establishment must identify
carcasses of livestock that establishment
employees have sorted and removed
from slaughter or that FSIS inspectors
have condemned on ante-mortem
inspection with a unique tag, tattoo, or
similar device. The establishment must
immediately denature all major portions
of the carcass on-site and dispose of the
carcass according to 9 CFR part 314.3.
(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.
These records are subject to review and
evaluation by FSIS personnel.
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(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.
determined by the inspection service, if
a mirror is used, it must comply with
the requirements of § 307.2(m)(6).
*
*
*
*
*
■ 7. Amend § 310.18 by adding
paragraphs (c) through (e) to read as
follows:
PART 310—POST-MORTEM
INSPECTION
§ 310.18 Contamination of carcasses,
organs, or other parts.
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.
srobinson on DSK9F5VC42PROD with PROPOSALS2
*
*
*
*
*
(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 9 CFR 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 of the regulations as
provided by 9 CFR 303.1(h). The
Administrator also may permit
establishments that slaughter market
hogs and other classes of swine to
slaughter market hogs under NSIS and
slaughter 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
VerDate Sep<11>2014
20:42 Jan 31, 2018
Jkt 244001
*
*
*
*
(c) Procedures for controlling
contamination throughout the slaughter
and dressing operation. Official swine
slaughter establishments must develop,
implement, and maintain written
procedures to prevent contamination of
carcasses and parts by enteric
pathogens, fecal, 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 small establishments or very low
volume establishments, must collect
and analyze samples for microbial
organisms at the pre-evisceration and
post-chill points in the process. Very
small establishments and 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, or
jowl areas.
(i) Very small establishments are
establishments with fewer than 10
employees or annual sales of less than
$2.5 million.
(ii) 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.
(iii) An establishment may substitute
alternative sampling locations if:
(A) The establishment has support to
demonstrate the alternative sampling
locations are able to provide a definite
improvement in monitoring process
control than at pre-evisceration and
post-chill; and
(B) FSIS does not determine, and
notify the establishment in writing, that
the alternative sampling locations are
inadequate to verify the effectiveness of
the establishment’s process controls for
enteric pathogens.
PO 00000
Frm 00044
Fmt 4701
Sfmt 4702
(2) Sampling frequency.
Establishments, except for very small
and very low volume establishments as
defined in paragraphs (c)(1)(i) and (ii) 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
small and very low volume
establishments as defined in paragraphs
(c)(1)(i) and (ii) 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 small and very low volume
establishments as defined in paragraph
(c)(1)(i) and (ii) 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 small and very low
volume establishments can demonstrate
that they are effectively maintaining
process control, they may modify their
sampling plans.
(iii) An establishment may substitute
an alternative frequency if:
(A) The alternative is an integral part
of the establishment’s verification
procedures for its HACCP plan; and
(B) FSIS does not determine, and
notify the establishment in writing, that
the alternative frequency is inadequate
to verify the effectiveness of the
establishment’s process controls for
enteric pathogens.
(iv) Establishments must sample at a
frequency that is adequate to monitor
their ability to maintain process control
for enteric pathogens. Establishments
must maintain accurate records of all
test results and retain these records as
provided in paragraph (e) of this
section.
(d) Procedures for controlling
contamination in the pre-operational
environment. Official swine slaughter
establishments must develop,
implement, and maintain written
procedures to prevent contamination of
the pre-operational environment by
enteric pathogens. Establishments must
incorporate these procedures into their
HACCP plans, sanitation SOPs, or other
prerequisite programs. These
procedures must include sampling and
analysis of food contact surfaces in the
pre-operational environment for
microbial organisms to ensure that the
surfaces are sanitary and free of enteric
pathogens and that water used to clean
food contact surfaces is free of enteric
pathogens. The sampling frequency
must be adequate to monitor the
establishment’s ability to maintain
sanitary conditions in the pre-
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Federal Register / Vol. 83, No. 22 / Thursday, February 1, 2018 / Proposed Rules
operational environment.
Establishments must maintain accurate
records of all test results and retain
these records as provided in paragraph
(e) of this section.
(e) Recordkeeping requirements.
Official swine slaughter establishments
must maintain daily records sufficient
to document the implementation and
monitoring of the procedures required
under paragraphs (c), (d) and (e) of 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.
■ 8. Amend § 310.25 as follows:
■ a. Remove paragraph (a)(2)(ii)(C);
■ b. Remove the second sentence in
paragraph (a)(2)(iii)(A);
■ c. Remove ‘‘20,000 swine,’’ in
paragraph (a)(2)(v)(A);
■ d. Remove the ‘‘swine’’ row in Table
1—Evaluation of E. Coli Test Results;
■ e. Remove the ‘‘Hogs’’ and ‘‘fresh pork
sausages’’ rows and footnote (b) from
Table 2—Salmonella Performance
Standards.
■ 9. Add § 310.26 to read as follows:
§ 310.26 Establishment responsibilities
under the new swine slaughter inspection
system.
srobinson on DSK9F5VC42PROD with PROPOSALS2
(a) Facilities. The establishment must
comply with the facilities requirements
in 9 CFR part 307. If the establishment
has less than three inspection stations,
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. The establishment must
develop, implement, and maintain
VerDate Sep<11>2014
20:42 Jan 31, 2018
Jkt 244001
written procedures to ensure that
market hog carcasses contaminated 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 SOP, or other prerequisite
program. These procedures must cover
establishment sorting activities required
under this section.
(c) Line speed limits. The line speed
limits in 9 CFR 310.1 do not apply to
the establishment, provided that they
are able to maintain effective process
control and prevent contamination of
carcasses and parts by fecal material and
enteric pathogens. Establishments
operating under NSIS must reduce their
line speed as directed by the Inspectorin-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
the products resulting from its slaughter
operation meet the definition of readyto-cook pork product in 9 CFR 301.2.
These records are subject to review and
evaluation by FSIS personnel.
(2) The establishment must maintain
records to document the number of
animals disposed of per day by plant
sorters or condemned per day by FSIS
inspectors upon post-mortem
inspection. These records are subject to
review and evaluation by FSIS
personnel.
■ 10. Add § 310.27 to read as follows:
PO 00000
Frm 00045
Fmt 4701
Sfmt 9990
§ 310.27
4823
Attestation requirements.
Each establishment that participates
in the New Swine Slaughter Inspection
System (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.
■ 11. Add § 310.28 to read as follows:
§ 310.28
Severability.
Should a court of competent
jurisdiction hold any provision of 9 CFR
310.27 to be invalid, such action will
not affect any other provision of 9 CFR
parts 309 or 310.
Done in Washington, DC, on January 19,
2018.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2018–01256 Filed 1–31–18; 8:45 am]
BILLING CODE 3410–DM–P
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]]>Agencies
[Federal Register Volume 83, Number 22 (Thursday, February 1, 2018)]
[Proposed Rules]
[Pages 4780-4823]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-01256]
[[Page 4779]]
Vol. 83
Thursday,
No. 22
February 1, 2018
Part II
Department of Agriculture
-----------------------------------------------------------------------
Food Safety and Inspection Service
-----------------------------------------------------------------------
9 CFR Parts 301, 309, and 310
Modernization of Swine Slaughter Inspection; Proposed Rule
Federal Register / Vol. 83 , No. 22 / Thursday, February 1, 2018 /
Proposed Rules
[[Page 4780]]
-----------------------------------------------------------------------
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: Proposed rule.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing to
amend the Federal meat inspection regulations to establish a 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 proposing several changes to the regulations that would affect
all establishments that slaughter any swine, regardless of the
inspection system under which they operate or the age, size, or class
of swine. These proposed changes would allow all swine slaughter
establishments to develop sampling plans that are more tailored to
their specific operations, and thus be more effective in monitoring
their specific process control. These proposed changes also would
ensure that before the start of slaughter operations, food-contact
surfaces are sanitary and free of enteric pathogens.
DATES: Comments must be received on or before April 2, 2018.
ADDRESSES: FSIS invites interested persons to submit comments on this
rule. Comments may be submitted by one of the following methods:
Federal eRulemaking Portal: This website provides the
ability to type short comments directly into the comment field on this
web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the on-line instructions at that site for
submitting comments.
Mail, including CD-ROMs, etc.: Send to Docket Clerk, U.S.
Department of Agriculture, Food Safety and Inspection Service, Patriots
Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, Room 8-163A,
Washington, DC 20250-3700.
Hand- or courier-delivered submittals: Deliver to Patriots
Plaza 3, 355 E Street SW, Room 8-163A, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2016-0017. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to https://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW, Room 8-
164, Washington, DC 20250-3700, between 8:00 a.m. and 4:30 p.m., Monday
through Friday.
FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant
Administrator, Office of Policy and Program Development; Telephone:
(202) 205-0495.
SUPPLEMENTARY INFORMATION:
Executive Summary
FSIS began experimenting with new approaches to slaughter
inspection based on Hazard Analysis and Critical Control Point Systems
(HACCP) principles shortly after publishing the Pathogen Reduction/
HACCP rule in 1996. In 1997, the Agency developed the HACCP-Based
Inspection Models Project (HIMP) study to determine whether applying
new Government slaughter inspection procedures, along with new plant
responsibilities, could promote innovation and provide at least the
same food safety and consumer protection. FSIS initiated the HIMP 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 a new optional 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. The risk model
employed to assess the potential impact of the NPIS modeled scenarios
involving an increase in targeted inspection activities (specifically
unscheduled offline inspection activities). The results of this model,
constructed on the assumption that the number of offline procedures
performed in poultry establishments under the NPIS would increase
proportionally to the number observed in HIMP establishments, suggested
that implementing the NPIS would likely result in public health
benefits, in the form of fewer poultry-associated foodborne Salmonella
illnesses per year. Consistent with the underlying assumptions of the
model, it is reasonable to conclude that inspection systems in which
Agency resources are used to continue core online inspection activities
while enhancing the frequency and focus of unscheduled offline
activities directly related to food safety, such as HIMP and the NPIS,
would likely result in a lower prevalence of carcasses contaminated
with Salmonella, which in turn would likely lead to fewer human
illnesses.
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 plans,
sanitation standard operating procedures (sanitation SOPs), or other
prerequisite programs (hereafter referred to as 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.
FSIS is now proposing to amend the Federal meat inspection
regulations to establish a new optional inspection system for market
hog slaughter establishments, the New Swine Slaughter Inspection System
(NSIS), informed by the Agency's experiences under HIMP. FSIS is
proposing this new inspection system to facilitate pathogen reduction
in pork products; improve compliance with the HMSA; improve the
effectiveness of market hog slaughter inspection; make better use of
the Agency's resources; and remove unnecessary regulatory obstacles to
innovation by revoking maximum line speeds and allowing establishments
flexibility to reconfigure evisceration lines. If establishment
personnel sorted and removed unfit animals before ante-mortem
inspection and trimmed and identified defects on carcasses and parts
before post-mortem inspection by FSIS inspectors, FSIS inspectors would
be presented with healthier animals and carcasses that have fewer
defects to inspect, which would allow inspectors to conduct a more
efficient and effective inspection of each animal and each
[[Page 4781]]
carcass. Such a system would allow FSIS inspectors to conduct a more
efficient inspection. As a result, FSIS could assign fewer inspectors
to online inspection, freeing up Agency resources to conduct more
offline inspection activities that FSIS has determined are more
effective in ensuring food safety, such as verifying compliance with
sanitation, HACCP, and humane handling requirements.
Key elements of the proposed NSIS include: (1) Requiring
establishment personnel to sort and remove unfit animals before ante-
mortem inspection by FSIS and to trim and identify defects on carcasses
and parts before post-mortem inspection by FSIS; (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 immediately denature all major
portions of the carcass on-site, and maintain records to document the
total number of animals and carcasses sorted and removed per day; (3)
requiring establishment personnel to immediately notify FSIS inspectors
if they suspect an animal or carcass with a reportable or foreign
animal disease (e.g., African swine fever, classical swine fever, or
Nipah virus encephalitis) while conducting sorting activities; (4)
shifting Agency resources to conduct more offline inspection activities
that are more effective in ensuring food safety, which would allow for
up to two offline verification inspectors per line per shift and would
reduce the number of online inspectors to a maximum of three per line
per shift; (5) requiring establishments to maintain records documenting
that products resulting from their slaughter operations meet the new
proposed definition of Ready-to-cook (RTC) pork product, which would be
defined as any slaughtered pork product 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 (6) 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 during the slaughter operation. FSIS projects that the new
system is unlikely to result in a higher prevalence of Salmonella on
market hog carcasses and may even result in a lower prevalence of
Salmonella on market hog carcasses, which in turn may lead to fewer
human illnesses. In addition, the new system should improve animal
welfare and compliance with the Humane Methods of Slaughter Act (HMSA)
because more FSIS resources will be available to verify humane handling
as an offline activity.
Under the proposed rule, market hog slaughter establishments that
do not choose to operate under the NSIS may continue to operate under
their existing inspection system (hereafter referred to as
``traditional inspection''). As mentioned above, NSIS provides public
health protection at least equivalent to traditional inspection. FSIS
recognizes that some establishments may not be prepared to make the
investment in facilities and labor needed to convert to NSIS. In
addition, many small, very low volume establishments slaughter more
than one type of livestock species and the facilities updates need to
convert to the proposed NSIS may not accommodate the slaughter of
livestock other than market hogs. Therefore, FSIS is proposing to give
establishments the flexibility to operate under the system that is best
suited to their operations.
FSIS is also proposing several changes that would affect all
establishments that slaughter swine, regardless of the inspection
system under which they operate. FSIS is proposing to require 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, 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.
FSIS is proposing to prescribe a minimum frequency with which
establishments would be required to collect two samples, 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 small and very low
volume establishments, a single post-chill sample. FSIS considers the
microbial load of hog carcasses at pre-evisceration to be a valuable
source of data about how well an establishment is taking into account
the sanitary condition of live hogs coming to slaughter and the
processing steps (i.e., washing, dehairing) they implement to reduce
the external contamination of the carcass prior to evisceration. FSIS
also considers the microbial characteristics of hog carcasses post-
chill (after all processing steps have taken place) to be a valuable
source of data about how well an establishment is minimizing
contamination during chilling as well as the overall effectiveness of
all process control interventions the establishment has chosen to apply
throughout its production process. Because most establishments apply
one or more interventions between the pre-evisceration and post-chill
sampling points to help control microbiological hazards, FSIS would
expect that a reduction in microbiological contamination between these
two sampling points to be an indication of the effectiveness of those
controls.
Under the proposed rule, establishments, except for very small and
very low volume establishments, would be required to collect pre-
evisceration and post chill samples at a frequency of once per 1,000
carcasses. Very small and very low volume establishments would be
required to collect at least one sample during each week of operation
each year. If, after consecutively collecting 13 weekly samples, very
small and very low volume establishments can demonstrate that they are
effectively maintaining process control, they can modify their sampling
plans to collect samples less frequently. FSIS is proposing to allow
very small and very low volume establishments to collect and analyze
samples for microbial organisms at the post-chill point in the process
only because these establishments typically are less automated and run
at slower line speeds than larger establishments. The lower level of
automation and the slower line speeds require less complicated measures
for maintaining and monitoring process control on an ongoing basis.
These proposed frequencies reflect the frequencies prescribed under the
existing regulations for generic Escherichia coli (E. coli) testing.
FSIS is proposing to remove the current requirement that swine
establishments test carcasses for generic E. coli to monitor process
control and to remove the codified Salmonella pathogen reduction
performance standards for swine and replace them with the new testing
requirements described above. The new testing requirements would allow
establishments to develop sampling plans that are more tailored to the
specific establishment, and thus more effective in monitoring their
specific process control than the current generic E. coli criteria.
FSIS is proposing to allow establishments to substitute alternative
sampling locations if they are able to
[[Page 4782]]
demonstrate that the alternative sampling locations are able to provide
a definite improvement in monitoring process control than at pre-
evisceration and post-chill. FSIS interprets ``definite improvement''
to mean any improvement of equipment, substances, methods, processes,
or procedures affecting the slaughter of livestock and poultry or
processing of meat, poultry, or egg products. FSIS is also proposing to
allow establishments to substitute alternative sampling frequencies if
they are able to demonstrate that the alternative is an integral part
of the establishments' verification procedures for their HACCP plans
and are able to provide a definite improvement in monitoring process
control than at the prescribed frequency. FSIS is requesting comments
on the proposed sampling requirements, particularly the incremental
value (from both a process-improvement and public health standpoint) of
pre-evisceration sampling over what is provided by post-chill sampling.
Finally, FSIS is proposing to require that all official swine
slaughter establishments develop, implement, and maintain in their
HACCP systems written procedures to prevent contamination of the pre-
operational environment by enteric pathogens. The pre-operational
environment comprises food contact surfaces, reuse water, and
equipment, including knives, in edible food production departments
before slaughter operations begin. These procedures would need to
include sampling and analysis of food-contact surfaces in the pre-
operational environment for microbial organisms to ensure that the
surfaces are sanitary and free of enteric pathogens. The sampling
frequency would need to be adequate to monitor the establishment's
ability to maintain sanitary conditions in the pre-operational
environment. Please see the draft compliance guide for additional
information about implementation of this provision. FSIS is proposing
this requirement as a direct result of a recent outbreak of foodborne
illness associated with a hog slaughter establishment where food
contact surfaces were found to be contaminated with the outbreak
strain. FSIS is requesting comments on this proposed sampling
requirement and the extent to which interventions in the pre-
operational environment are needed to ensure food safety.
In Table 1 below, FSIS presents the estimated costs and benefits of
the proposed rule. Later portions of the regulatory impact analysis
section contain explanation of the assumptions, alternative adoption
scenarios, and a discussion of the uncertainty surrounding the net
benefits associated with how much of the industry would choose to adopt
NSIS.
Table 1--Net Costs and (Benefits)
[M$]
----------------------------------------------------------------------------------------------------------------
Number of
establishments One-time Recurring
----------------------------------------------------------------------------------------------------------------
Costs To Industry............................................... .............. $3.88 $22.65
Voluntary *................................................. ** 40 0.84 22.17
Mandatory................................................... 612 3.03 0.48
Potential Health Benefits ***................................... .............. .............. (9.33)
Industrial Efficiency........................................... .............. .............. (47.33)
Impacts to Agency's Budget...................................... .............. 2.80 (8.73)
----------------------------------------------------------------------------------------------------------------
Totals:
One-Time Cost........................................................................... $6.68
Recurring Cost.......................................................................... (42.75)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. (31.77)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. (30.40)
----------------------------------------------------------------------------------------------------------------
* Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the
Proposed Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 28: 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. Expected
Benefits Associated With Public Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value
of health benefits ranges from $0.19 million to $18.97 million, with a mean of $9.33 million.
Statutory Authority
FSIS inspects and regulates the production of meat and meat food
products prepared for distribution in commerce under the authority of
the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.). The
FMIA provides that the Secretary shall cause to be made by inspectors
an examination and inspection of all amenable species before they enter
into any establishment in which they are to be slaughtered and the meat
and meat food products thereof are to be used in commerce (21 U.S.C.
603(a)). All amenable species found to show symptoms of disease are to
be set apart and slaughtered separately; the carcasses of such animals
are to be subject to a careful inspection (21 U.S.C. 603(a)). The FMIA
requires that the livestock be slaughtered and handled in connection
with slaughter in a manner that is consistent with the HMSA (21 U.S.C.
603(b)). Under the HMSA, the handling of livestock in connection with
slaughter must be carried out only by humane methods (7 U.S.C. 1902).
The FMIA also requires inspectors to conduct a post-mortem
examination and inspection, and any necessary reinspection, of
carcasses and parts of amenable species prepared for human food (21
U.S.C. 604). The FMIA requires that all carcasses and parts found to be
adulterated be condemned (21 U.S.C. 604). Under the FMIA, a meat or
meat food product is adulterated, among other circumstances, if it
bears or contains any poisonous or deleterious substance that may
render it injurious to health; it is unhealthful, unwholesome, or
otherwise unfit for human consumption; it was prepared, packaged, or
held under insanitary conditions whereby it may have been rendered
injurious to health; or if damage or inferiority has been concealed in
any manner (21 U.S.C. 601(m)(1), (3), (4), and (8)). Finally, 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. FSIS regulations and inspection programs are designed to verify
that livestock are handled and slaughtered humanely, and that meat and
meat food products are
[[Page 4783]]
unadulterated, wholesome, and properly marked, labeled, and packaged.
Table of Contents of Proposed Rule Discussion
I. Background
A. Traditional Market Hog Slaughter Inspection Under Existing
Regulations
1. Description of the Inspection System Under Existing
Regulations
2. Need for Modernization
B. Regulations for Microbiological Testing Under Traditional
Inspection
1. Generic E. Coli Criteria for Measuring Process Control
2. Salmonella Pathogen Reduction/HACCP Performance Standards
C. Waivers of Regulatory Requirements
1. Waivers to Test New Technology
2. Salmonella Initiative Program Waivers
II. Consideration of Need for a New Swine Slaughter Inspection
System
A. Early Development of the Inspection Models Program
B. Existing HACCP-Based Inspection Models Program
C. U.S. General Accountability Office (GAO) and the USDA's
Office of the Inspector General (OIG) Reports on HIMP
D. Analysis of HIMP
1. FSIS Evaluation of HIMP
a. Overview of the HIMP Report
b. Verification by Offline Inspectors of the Establishment
Executing Its HIMP Process Control Plan Under Which Establishment
Employees Sort Acceptable and Unacceptable Carcasses and Parts
c. Verification of the Establishment Executing Its HACCP System
Under 9 CFR Parts 416 and 417
d. Verification of the Outcomes of the Establishment Process
Control Plan, Both Organoleptic and Microbiologic
e. Conclusion of HIMP Report
f. Verification of Humane Handling
E. Public Health Benefits Projected From Allocating More
Inspection Resources to Food Safety-Related Inspection Activities
1. Market Hog Risk Assessment
2. Model
3. Conclusions of the Market Hog Risk Assessment
III. Proposed NSIS
A. Live Market Hog Sorting by Establishment Personnel
B. Post-Mortem Carcass Sorting by Establishment Employees and
Online Carcass Inspection
C. Offline Verification Inspection
D. RTC Pork Product
E. Line Speeds Under NSIS
IV. Other Proposed Changes That Affect All Swine Slaughter
Establishments
A. Procedures To Address Enteric Pathogens, Fecal Material,
Ingesta, and Milk Contamination as Hazards Reasonably Likely to
Occur
V. Implementation
VI. Executive Orders 12866 and 13563
A. Request for Comments Summary
B. Need for the Rule
C. Overview of the Market
D. Overview of the Proposed Rule's NSIS
E. Overview of the Proposed Rule's Mandatory Components
F. Overview of the Proposed Rule's Agency Impact
G. Expected Cost of the Proposed Rule
1. Costs Associated With the NSIS Components of the Rule
a. Costs of Additional Establishment Workers
b. Costs of Capital Improvements: Line Configuration and
Inspection Stations
c. Costs of Developing Ante-Mortem Written Procedures
d. Ready-to-Cook Standards
2. Costs Associated With the Mandatory Components of the Rule
a. Costs of Developing, Composing, Training, Monitoring,
Recording, and Verifying Written Sanitary Dressing Plans
b. Process Control Sampling and Analysis for Microbial Organisms
c. Environmental Sampling
H. Expected Benefits of the Proposed Rule
1. Expected Benefits Associated With Public Health
2. Other Benefits Associated With Modernizing Existing
Regulations
I. Expected Budgetary Impacts
1. Agency Staffing
2. Agency Training
J. Net Benefits
K. Alternatives
VII. Regulatory Flexibility Act Assessment
VIII. E-Government Act
IX. Executive Order 12988, Civil Justice Reform
X. Executive Order 13175
XI. USDA Nondiscrimination Statement
XII. Environmental Impact
XIII. Paperwork Reduction Act
XIV. Additional Public Notification
XV. Proposed Regulatory Amendments
I. Background
A. Traditional Market Hog Slaughter Inspection Under Existing
Regulations
1. Description of the Inspection System Under Existing Regulations
Under the existing regulations for traditional inspection, FSIS
ante-mortem inspectors examine all market hogs for visible signs of
condemnable diseases or conditions while they are at rest and in motion
(see 9 CFR part 309). FSIS ante-mortem inspectors direct establishment
personnel to set apart animals showing signs of condemnable diseases or
conditions into separate ``U.S. Suspect'' pens for further examination
by the FSIS Public Health Veterinarian (PHV). The FSIS PHV determines
whether the animals shall be identified as ``U.S. Condemned'' and
disposed of in accordance with 9 CFR 309.13 (9 CFR 309.2).
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 performs
ante-mortem inspection (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).
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 are subject to additional FSIS inspection. FSIS
requires these establishments to document their segregation procedures
in their HACCP plans or prerequisite programs. FSIS inspectors examine
all animals found by the establishment to be normal at rest, and five
to ten percent of those animals in motion. 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'' pens, and directs establishment employees to move animals
to ``U.S. Suspect'' pens for final disposition. FSIS inspectors observe
establishment employees performing segregation procedures at least once
per month. 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. Therefore,
under the voluntary segregation procedures, FSIS inspectors are able to
conduct a more efficient and effective ante-mortem inspection to
determine whether each animal is fit for slaughter.
During post-mortem inspection at all market hog slaughter
establishments, FSIS online inspectors inspect the head, viscera, and
carcass of each animal for localized defects and direct establishment
employees to remove the defects through trimming (9 CFR 310.1(b)(3)).
FSIS online inspectors perform manual incisions, palpations, and other
organoleptic inspections (i.e., using sight, smell, and touch) to
detect signs of disease or contamination. In large establishments, up
to seven online inspectors are assigned per line per shift to cover
inspection stations for the head, viscera, and carcass at fixed points
along the slaughter and evisceration line. In small or very small
establishments, one inspector may perform all of the post-mortem
[[Page 4784]]
inspection procedures on each animal. FSIS online inspectors identify
and retain carcasses and parts with visible animal diseases and
conditions. The FSIS PHV thoroughly examines retained carcasses and
parts to determine whether they should be condemned; establishment
personnel then dispose of condemned carcasses under FSIS supervision in
accordance with 9 CFR part 314.
Under the existing regulations for 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. These
sorting functions are conducted by establishment personnel under HIMP.
Rather, the existing regulations for traditional inspection require
establishments to assign competent assistants to take such actions as
directed by FSIS online inspectors after the inspectors have conducted
the initial sorting activities (see 9 CFR 307.2(g)). Therefore, under
the existing regulations for traditional inspection, establishments
rely on FSIS online inspectors to effectively control and direct their
processing. Moreover, because FSIS online inspectors are responsible
for identifying unacceptable carcasses and parts, it takes online
inspectors more time to conduct a carcass-by-carcass inspection than
would be necessary if establishments sorted carcasses and parts,
trimmed dressing defects and contamination that do not impact the FSIS
inspectors' ability to assess the fitness of the carcass or part, and
identified pathology defects, before the carcasses and parts were
inspected.
More FSIS resources also could be devoted to offline inspection
activities if initial sorting and tagging functions were performed by
establishment personnel. Under the existing regulations, only FSIS
inspectors may direct the application and removal of ``U.S. Condemned''
tags from animals and carcasses condemned by FSIS inspectors on ante-
mortem and post-mortem inspection (9 CFR 309.13 and 310.5). The tag
must remain on the carcass until it goes into the tank, or the carcass
is otherwise disposed of in accordance with 9 CFR part 314.
Establishments are required to denature condemned carcasses and parts
if they do not have tanking facilities and the carcasses and parts are
to be rendered or otherwise disposed of off-site (see 9 CFR 314.3).
FSIS inspectors enter the number on each ``U.S. Condemned'' tag into
the Public Health Information System (PHIS). Under the existing
regulations, most ``U.S. Condemned'' tags are applied during ante-
mortem inspection to animals that arrive dead. Because FSIS inspectors
are responsible for removing all of the ``U.S. Condemned'' tags and
documenting each ``U.S. Condemned'' tag number into PHIS, it takes
inspectors more time to complete ante-mortem and post-mortem
inspections than it would if establishments sorted and removed these
animals before FSIS inspection and maintained records that could be
verified by FSIS, as appropriate, and reported their daily totals to
FSIS inspectors.
In addition to the post-mortem inspection activities conducted by
online inspectors, offline inspectors conduct additional food safety
related activities such as verifying that establishments' processing
meets their HACCP critical limits and verifying whether sanitation SOPs
are effective.
2. Need for Modernization
Modernization of market hog slaughter inspection is necessary
because traditional inspection was developed before FSIS issued its
HACCP regulations, and before the Agency began targeting its resources
to address public health risks associated with foodborne pathogens.
Traditional inspection obscures the proper roles of industry and
inspection personnel by assigning to FSIS inspectors responsibility for
sorting acceptable animals from unacceptable animals, finding carcass
defects, identifying production control problems for the establishment,
and verifying corrective actions in addition to determining whether the
carcasses meet regulatory requirements. Additionally, traditional
inspection requires FSIS to allocate significant inspection personnel
resources towards online inspection activities in large and high volume
market hog establishments to detect quality defects and conditions that
present minimal food safety risks, thus limiting the resources
available for offline inspection activities such as verifying the
effectiveness of HACCP plans and sanitation SOPs. FSIS has concluded,
based on the Agency's analysis of the market hog HIMP pilot (discussed
in more detail below), conducting more offline activities will be more
effective in ensuring food safety and humane handling verification
tasks.
Traditional inspection requires inspectors to conduct time-
intensive ante-mortem and post-mortem sorting activities. This
necessitates FSIS to allocate significant personnel resources to
conduct activities that are more appropriately the responsibility of
the establishment. As a result, traditional inspection limits line
speeds, even if establishments can demonstrate that they are able to
produce safe, unadulterated, wholesome products at more efficient
rates. It also limits large and high volume market hog slaughter
establishments' incentive to improve their processing methods and to
develop more efficient slaughter and dressing technologies.
For example, under traditional inspection, the maximum line speed
authorized for slaughter lines with one or two inspectors is partially
based upon the distance walked (in feet) by the inspector between work
stations to conduct the sorting activities mentioned above (see 9 CFR
310.1(b)(3)). For slaughter lines with three or more inspectors, line
speeds may also depend on whether FSIS online inspectors observe the
back of the carcasses by looking in a mirror or whether they must turn
the carcass to observe the back of the carcass (see 9 CFR 310.1(b)(3)).
The maximum line speed under the existing regulations for market hogs
is 1,106 head per hour (hph) with seven online inspectors.
Establishments determine their line speeds based on their equipment,
size and condition of the animals, and their ability to maintain
process control when operating at a given line speed.
Additionally, traditional inspection restricts establishments'
ability to reconfigure and consolidate lines if they determine that
they need more space to conduct other activities in their facilities.
For example, establishments slaughtering 1,025 market hogs per hour
must configure their evisceration lines to accommodate three online
head inspectors, three online viscera inspectors, and one online
carcass inspector. The regulations require that establishments provide
an inspection station consisting of five feet of unobstructed line
space for each head or carcass inspector and, for viscera table kills,
eight feet for each viscera inspector on the inspector's side of the
table (9 CFR 307.2 (m)(1)). As a result, the current regulations for
traditional inspection prevent large and high volume market hog
slaughter establishments from consolidating inspection stations or
otherwise reconfiguring their evisceration lines in order to make room
for more innovative, automated equipment such as head dropping
equipment, bung equipment (which separates digestive and urinary organs
from pelvic attachments),
[[Page 4785]]
eviscerating equipment, and back saws. Traditional inspection is
generally sufficient for low volume establishments and for
establishments that slaughter classes of swine other than market hogs
because these establishments typically are less automated and run at
slower line speeds than larger establishments.
Additionally, traditional inspection was developed when visually
detectable animal diseases such as pneumonias, erysipelas, hog cholera,
cystercercosis, parasites, and arthritis were more prevalent and
considered to be more of a concern than they are today. The line speed
limits prescribed under traditional inspection reflect the Agency's
previous focus on the detection of visible defects and animal diseases
and do not give establishments the flexibility to address these
conditions before presenting the carcasses and parts to FSIS
inspectors.
Traditional inspection focuses substantial FSIS resources on
detecting visible trim and dressing defects that are not directly
related to food safety, particularly in light of what is now known
about the role microbial contamination plays in causing foodborne human
illness. The traditional inspection model needs to be updated in light
of the significant advances that have been made in the control or
eradication of many animal diseases that were more prevalent and were
considered to present a greater concern when the existing inspection
systems were designed, particularly in generally healthy classes of
animals such as market hogs.
Moreover, the analysis in FSIS's ``Assessment of the Potential
Change in Human Health Risk Associated with Modernizing Inspection of
Market Hog Slaughter Establishments'' (hereafter referred to as the
market hog risk assessment) conducted by FSIS suggests a statistically
significant correlation between increased scheduled and unscheduled
offline inspection procedures and a reduction in the prevalence of
Salmonella in market hog establishments. Projecting out illness
reductions based on reduction in Salmonella prevalence in 35 plants
results in wide uncertainty, but the model confidently estimates that
the level of protection from Salmonella illnesses would be at least as
good as the current system. Based on these results, the redeployment of
Agency resources dedicated to online inspection under the traditional
inspection system to unscheduled offline activities, such as increased
HACCP and sanitation SOP verification, has the potential to contribute
to improved food safety resulting from a lower prevalence of carcasses
contaminated with Salmonella, which may in turn lead to fewer human
illnesses. While prevalence of Salmonella measured in FSIS's market hog
baseline study is low, Salmonella is a pathogen of public health
concern for pork products, and the data available are adequate to
estimate the potential changes in prevalence with changes in FSIS's
swine inspection system.
B. Regulations for Microbiological Testing Under Traditional Inspection
1. Generic E. Coli Criteria for Measuring Process Control
The existing regulations require that official swine slaughter
establishments conduct regular testing for generic E. coli at the end
of the chilling process or after the final wash as a means to verify
process control (9 CFR 310.25(a)(1)). These regulations prescribe
requirements for collecting the samples, obtaining analytical results,
and maintaining records of such results (9 CFR 310.25(a)(2), (3), and
(4)). They also include criteria for evaluating an establishment's
generic E. coli testing results (9 CFR 310.25(a)(5)). The regulations
provide that generic E. coli testing results that do not meet the
criteria described in the regulations indicate that the establishment
may not be maintaining process controls sufficient to prevent fecal
contamination (9 CFR 310.25(a)(6)). If an establishment is not meeting
the E. coli test results criteria, the regulations state that FSIS will
take further action as appropriate to ensure that all applicable
provisions of the law are being met (9 CFR 310.25(a)(6)).
In 2014, FSIS rescinded the regulations that required that poultry
establishments test carcasses for generic E. coli to monitor for
process control (79 FR 49565, August 21, 2014). The final regulations
replaced the generic E. coli regulations with new testing requirements
that allow establishments to develop sampling plans that are more
tailored to the specific establishment, and thus are more effective in
monitoring their specific process control than the former generic E.
coli criteria. The Agency concluded that the use of generic E. coli as
an indicator for process control may not be as useful in certain
poultry slaughter operations as originally thought. Therefore, FSIS
made the change to allow poultry establishments to use other more
relevant indicators of process control.
The Agency is aware that most swine slaughter establishments
currently conduct additional sampling for micro-organisms other than
generic E. coli (e.g., Salmonella spp. and aerobic plate count bacteria
(APC)) because they have found these organisms to be more relevant
indicators of their process control. Therefore, FSIS is proposing to
remove the generic E. coli sampling requirements for swine slaughter
establishments to give establishments more flexibility in monitoring
their process control and to make the Federal meat inspection
regulations more consistent with the Federal poultry products
inspection regulations. FSIS is proposing that all swine slaughter
establishments collect and analyze carcass samples for microbiological
analysis at the pre-evisceration and post-chill points in the process.
The discussion of the proposed testing requirements is set out later in
this document.
2. Salmonella Pathogen Reduction/HACCP Performance Standards
In addition to generic E. coli criteria, the existing regulations
contain Salmonella pathogen reduction performance standards for market
hogs (9 CFR 310.25(b)). The codified performance standards are based on
the prevalence of Salmonella found by two nationwide microbiological
baseline surveys conducted from April 1995 to March 1996 and from June
1997 to May 1998. The regulations provide for FSIS to collect and
analyze unannounced Salmonella samples sets in swine slaughter
establishments to detect whether these establishments are meeting the
pathogen reduction performance standards (9 CFR 310.25(b)(2)). The
performance standards set a maximum number of Salmonella-positive
samples allowable per sample set and are defined on a product class
basis so that an establishment operating at the baseline level would
have an 80 percent chance of meeting the standard. Establishments are
required to take corrective actions when FSIS determines that they are
not meeting the performance standards (9 CFR 310.25(b)(3)(i) and (ii)).
Under the regulations, an establishment's failure to take the
corrective actions necessary to comply with the Salmonella performance
standards, or an establishment's failure to meet the standards on the
third consecutive series of FSIS-conducted tests for that product,
constitutes a failure to maintain sanitary conditions and to maintain
an adequate HACCP plan (9 CFR 310.25(b)(3)(iii)). The regulations
provide that such failure will cause FSIS to suspend inspection
services (9 CFR 310.25(b)(3)(iii)). However, the Agency's ability to
[[Page 4786]]
directly enforce the pathogen reduction performance standards has been
limited since 2001, after a ruling by the U.S. Court of Appeals for the
Fifth Circuit in Supreme Beef Processors, Inc. v. USDA. In that case,
the court enjoined FSIS from suspending inspection services against a
meat grinding operation for failure to meet the Salmonella performance
standards. Since that time, FSIS has used Salmonella failures as a
basis to conduct an in-depth evaluation of the establishment's HACCP
systems, including its HACCP plan and sanitation SOPs.
From August 2010 to August 2011, FSIS conducted a third market hog
baseline survey to estimate the national prevalence of Salmonella in
market hogs (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). The third market
hog baseline survey included 253 establishments that produce
approximately 99.9 percent of market hogs slaughtered in the United
States. For the third baseline survey, FSIS collected samples in 152
random establishments from market hog carcasses at two points in the
slaughter process: Pre-evisceration and post-chill. The Salmonella
percent positive rate at pre-evisceration was 69.64 percent, but at
post-chill it was reduced to 2.70 percent. The third baseline survey's
percent positive rate at post-chill was significantly lower than the
rates found in the two earlier surveys mentioned above, which reported
Salmonella percent positive rates of 8.7 percent and 6.9 percent,
respectively. Based on the data from the third baseline survey, FSIS
estimated prevalence of Salmonella in market hogs was 1.66 percent with
a 95 percent confidence interval between 0.82 percent and 2.51 percent.
Because the estimated prevalence of Salmonella was low, and FSIS did
not find enough pathogen positives to justify the resources needed
(e.g., time and supplies) to conduct carcass swabbing, the Agency
determined that this type of sampling was not an effective use of
resources for verifying process control. As a result, FSIS did not
develop new Salmonella performance standards for market hogs. Rather,
in September 2011, FSIS discontinued its Salmonella verification
sampling program for market hogs to make better use of its resources.
Therefore, FSIS is proposing to eliminate the pathogen performance
standards for market hogs in 9 CFR 310.25(b) because verifying the
codified standards was not a good use of Agency resources and the
standards have not been used since 2011. Instead, FSIS has decided to
focus on its resources on sampling raw pork parts for pathogens of
public health concern, as well as for indicator organisms.
FSIS is currently addressing Salmonella through the Salmonella
Initiative Program (SIP) described below. In addition, FSIS has
published a compliance guideline to help official establishments
control and reduce the spread of Salmonella in hog slaughter facilities
(79 FR 633, January 6, 2014). The guidance is available on the FSIS web
page at: https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. The guidance provides information
on best practices that may be applied at a hog slaughter facility to
prevent, eliminate, or reduce levels of Salmonella on hogs at all
stages of slaughter and dressing. Importantly, FSIS has identified
microbial performance measures, as guidance, at the pre-evisceration
and post chill points.
Moreover, FSIS is currently conducting exploratory sampling of raw
pork products for pathogens of public health concern, as well as for
indicator organisms (80 FR 12618). A summary of the Phase I positive
sampling results collected from May 2015 to November 2015 are as
follows: 16.7 percent Salmonella, 1 percent Campylobacter, 4.5 percent
Methicillin-Resistant Staphylococcus aureus (MRSA), 1 percent
Toxoplasma gondii, 1.5 percent Yersinia enterocolitica, 0 percent E.
coli O157:H7, and 5 percent non-O157 shiga toxin-producing E. coli
(non-O157 STEC). FSIS has posted more detailed sampling results on its
website at https://www.fsis.usda.gov/wps/wcm/connect/68f5f6f2-9863-41a5-a5c4-25cc6470c09f/Sampling-Project-Results-Data.pdf?MOD=AJPERES.
The Agency may develop pathogen reduction performance standards for
pork parts at a later date. In 2019, the Agency will use this data to
determine whether standards or additional policies (e.g., training,
guidance to industry, or instructions to field personnel) are needed to
address Salmonella in pork products.
C. Waivers of Regulatory Requirements
1. Waivers To Test New Technology
The regulations in 9 CFR 303.2(h) and 381.3(b) provide for the
Administrator to waive for limited periods any provisions of the
regulations to permit experimentation so that new procedures,
equipment, or processing techniques may be tested to facilitate
definite improvements. Under these regulations, FSIS may only grant
waivers from the provisions in the regulations that are not in conflict
with the purposes or provisions of the FMIA or PPIA (9 CFR 303.1(h) and
381.3(b)).
FSIS decides whether to grant requests for waivers based on
proposals and documentation submitted by establishments to demonstrate
that the use of a new technology is scientifically sound; that it will
facilitate definite improvements; and that issuing the waiver will not
conflict with the provisions of the FMIA or PPIA.\1\ If FSIS determines
that the information submitted by an establishment supports the
requested waiver, the Agency will waive the appropriate provisions in
the regulation for a limited period of time to allow the establishment
to conduct an in-plant trial. The purpose of the in-plant trial is to
gather data on the effects of the use of the new technology. FSIS
reviews the data that is developed in the trial to determine whether
they establish that the purpose of the waiver is being met.
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\1\ For Agency New Technology waiver procedures, see https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/New-Technologies.
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2. Salmonella Initiative Program Waivers
Under SIP, the Agency grants meat and poultry slaughter
establishments waivers of regulatory requirements on condition that
they will conduct regular microbial testing and share the resulting
data with FSIS. The Agency described preliminary details of SIP in a
January 28, 2008, Federal Register notice (73 FR 4767-4774) and
announced its final terms and conditions in the July 13, 2011, Federal
Register notice (76 FR 41186). SIP benefits public health in that it
encourages slaughter establishments to conduct testing for microbial
pathogens, which is a key feature of effective process control, and to
respond to testing results by taking steps when necessary to regain
process control. In addition, SIP enables FSIS to use establishment
data to inform Agency policy aimed at enhancing public health
protection.
SIP establishments test for Salmonella, Campylobacter (if
applicable), and generic E. coli or other indicator organisms and share
all sample results with FSIS. Establishments that had been operating
under regulatory waivers before FSIS implemented the SIP were required
to participate in SIP or forfeit their waivers. The list of
establishments
[[Page 4787]]
participating in SIP is available on FSIS's website at https://www.fsis.usda.gov/wps/wcm/connect/188bf583-45c9-4837-9205-37e0eb1ba243/Waiver_Table.pdf?MOD=AJPERES. To date the regulations waived for swine
slaughter establishments under SIP include: 9 CFR 310.1(b)(3)-- line
speed; 9 CFR 310.25(a)-- generic E. coli testing \2\; 9 CFR 310.25(b)--
Salmonella performance standards; 9 CFR 310.18(a)-- contamination of
organs; 9 CFR 310.11--cleaning and hair removal; and 9 CFR 310.14--
handling of bruised parts. All swine slaughter establishments operating
under SIP waivers will continue to operate under waivers and will
continue to conduct testing under SIP if their waivers are not
addressed in the final rule resulting from this proposal. If their
waivers are addressed in the final rule resulting from this proposal,
their waivers will end.
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\2\ Some establishments continue to sample for generic e. coli
to monitor their process control. The SIP waivers allow these
establishments to use alternative sampling locations and
frequencies.
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II. Consideration of Need for a New Swine Slaughter Inspection System
A. Early Development of the Inspection Models Program
In 1996, FSIS published its Pathogen Reduction/HACCP (PR/HACCP)
final rule as the first step of a comprehensive initiative to target
the Agency's resources to address the public health risks associated
with foodborne pathogens, which cannot be detected by organoleptic
inspection (61 FR 38868, July 25, 1996). Under FSIS's PR/HACCP
regulations, establishments are required to develop and implement a
system of preventive controls to ensure that their products are safe.
This approach gives establishments more flexibility to determine how
they can best meet the Agency's regulatory requirements. FSIS verifies
the adequacy and effectiveness of establishments' HACCP systems.
In 1997, in order to improve food safety and the effectiveness of
inspection systems, reduce the risk of foodborne illness in the United
States, remove unnecessary regulatory obstacles to innovation, and make
better use of the Agency's resources, FSIS announced, in a Federal
Register notice, that the Agency would be developing a new HIMP study
(62 FR 31553, June 10, 1997). During the HIMP study, FSIS would design
and test various new inspection models in a series of trials in
volunteer meat and poultry slaughter establishments.
Under the initial HIMP inspection models approach, establishment
personnel were responsible for sorting and removing animals unfit for
slaughter and identifying and removing abnormal carcasses and parts,
and FSIS inspection personnel performed inspection activities that
focused on the areas of greatest risk in the hog slaughter inspection
system in each establishment.
In 1998, the American Federation of Government Employees, several
FSIS inspectors, and a public interest organization filed suit to
enjoin FSIS from implementing the HIMP model. The plaintiffs alleged
that HIMP violated the requirement in the FMIA that government
inspectors conduct a post-mortem inspection of each carcass.
Specifically, the FMIA provides that the Secretary shall cause to be
made by inspectors a post-mortem inspection of the carcasses and parts
thereof of all amenable species to be prepared at any slaughtering,
meat-canning, salting, packing, rendering, or similar establishment (21
U.S.C. 604). The district court upheld HIMP, finding that the word
``inspection'', as used in the statute, does not necessarily mandate a
direct, physical examination of each carcass by an FSIS inspector, and
that the model program was a rational policy judgment within the
discretion afforded to the Secretary.
The plaintiffs appealed, and the Court of Appeals for the District
of Columbia Circuit reversed the district court's decision. The Court
of Appeals found that the FMIA requires Federal inspectors--rather than
plant employees--to make the decision whether each carcass is
adulterated within the meaning of the statute (AFGE v. Glickman, 215
F.3d 7, 11 (D.C. Circ. 2000)). The case was remanded to the district
court for further proceedings.
In response to the Court of Appeals' opinion, FSIS modified HIMP to
position up to three \3\ online inspectors at fixed locations along the
slaughter lines: In the area where the carcass and head were separated;
where the carcass and viscera were separated; and at the pre-wash
carcass verification location. These inspectors were responsible for
examining the head, viscera, and carcass of each hog. The modified
models project also included FSIS offline inspectors who were
responsible for conducting HACCP and sanitation system verification
activities and for closely examining a sample of carcasses for food
safety defects to ensure that the establishment's process was under
control and that adulterated carcasses and parts were not getting past
the establishment sorters. On remand, the district court found that
HIMP, as modified, complied with both the applicable statutory
provisions and the opinion issued by the Court of Appeals.
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\3\ FSIS is able to assign fewer than three online inspectors if
the physical configuration of the slaughter line allows one
inspector to inspect both the head and viscera or the viscera and
carcass. For example, in one establishment, the chain that carries
the carcass is adjacent to the viscera pans, which enables one
inspector to examine both the carcass and viscera.
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The plaintiffs again appealed to the Court of Appeals for the D.C.
Circuit. The plaintiffs argued that the modified inspection procedures
were not in compliance with the Court of Appeals' prior opinion because
FSIS had delegated some inspection duties to plant employees who were
responsible for sorting defective carcasses and making preliminary
decisions regarding adulteration. The Court of Appeals rejected this
argument, finding that the FMIA does not prohibit plant employees from
paring down the overall number of carcasses by sorting and removing
carcasses before they reach the Federal inspector (AFGE v. Veneman, 284
F.3d 125, 131 (D.C. Cir. 2002)). The Court held that the modified
inspection model program satisfied the FMIA because it required Federal
inspectors to personally examine all hog carcasses, heads, and viscera,
as required by 21 U.S.C. 604.
The plaintiffs also argued that the line speeds allowed in the HIMP
plants were too fast to allow Federal inspectors to make a critical
appraisal of each carcass. The Court found that FSIS's decision to
allow higher line speeds was reasonable in light of the fact that
establishment employees are required to sort carcasses and parts and
identify defects prior to Federal inspection, resulting in fewer
adulterated carcasses and parts being presented for Federal inspection.
The Court also noted that although the FMIA delineates what must be
inspected and by whom, it does not define exactly what constitutes an
inspection. The court concluded that HIMP, as modified, reflected a
reasonable design of an inspection system by the agency charged with
responsibility for administering the FMIA and that it would rely on the
Agency's experience and informed judgment in evaluating the validity of
the system under the law. Under these circumstances, the Court of
Appeals upheld HIMP, as modified.
B. Existing HACCP-Based Inspection Models Program
The revised HIMP study was initiated in five market hog slaughter
establishments on a waiver basis.
Similar to the voluntary segregation procedures described above in
establishments that slaughter only
[[Page 4788]]
market hogs under traditional inspection, establishment personnel sort
animals before they are presented to FSIS ante-mortem inspectors under
HIMP. Establishment personnel sort animals that appear to be healthy
into ``Normal'' pens and animals that appear to have condemnable
diseases or conditions into ``Subject'' pens. Establishment personnel
remove and dispose of dead and moribund animals and animals suspected
of having central nervous system disorders (CNS) or pyrexia. Under
HIMP, FSIS inspectors examine all animals found by the establishment to
be normal at rest, and five to ten percent of those animals in motion.
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. FSIS PHVs examine
all animals in the establishment's ``Subject'' pens, and direct
establishment employees to move animals to ``U.S. Suspect'' pens for
final disposition by the FSIS PHV. The FSIS PHV determines if any
animals must be identified as ``U.S. Condemned'' and disposed of in
accordance with 9 CFR 309.13 (9 CFR 309.2). While establishment
personnel sort and remove animals unfit for slaughter, only FSIS
inspectors have the authority to condemn an animal. FSIS inspectors
observe establishment employees performing sorting procedures at least
twice per shift under HIMP compared to at least once per month under
the voluntary segregation procedures permitted under traditional
inspection of market hogs.
Under HIMP, post-mortem inspection is conducted by up to three
online inspectors who visually inspect the head, viscera, and carcass
of each hog at fixed locations on the evisceration line. Before FSIS
online inspection, establishment personnel sort carcasses and parts and
trim dressing defects and contamination (e.g., hair, bruises, feces,
ingesta, and milk). Establishment employees also mark with ink
localized pathology defects intended for removal under FSIS supervision
(e.g. localized nephritis and localized arthritis) and carcasses and
parts intended for disposal under FSIS supervision (e.g., carcasses and
parts with malignant lymphoma). Online inspection is conducted much
more efficiently and effectively under HIMP than under traditional
inspection because establishment personnel have already sorted
carcasses and parts, trimmed dressing defects and contamination, and
identified pathology defects on the carcasses, thereby correcting most
removable defects, before the FSIS online inspectors perform their
carcass-by-carcass inspection.
Under HIMP, offline inspection consists of system verification
activities through which FSIS continuously monitors and evaluates
establishment process control. FSIS conducts more offline, food safety
related verification inspection activities under HIMP than under
traditional inspection. Some examples of food safety related
verification inspection activities include: HACCP, sanitation SOP, and
other prerequisite program verification procedures, including 24
carcass verification checks per shift specifically for generalized
diseases and conditions and for contamination (compared to 11 carcass
verification checks per shift under traditional inspection). FSIS also
conducts more offline humane handling verification tasks under HIMP
than under traditional inspection.
FSIS has concluded that the HIMP model has a number of benefits,
such as focusing FSIS inspection personnel on the areas of greatest
risk in the hog slaughter system and providing an incentive to
establishments to improve and innovate, while ensuring effective online
inspection.
C. U.S. General Accountability Office (GAO) and the USDA's Office of
the Inspector General (OIG) Reports on HIMP
In 2013, the U.S. General Accountability Office (GAO) and the
USDA's Office of the Inspector General (OIG) evaluated FSIS's HIMP
pilot study and issued findings and recommendations.4 5 GAO
identified strengths in the pilot study, including that of giving
plants responsibility and flexibility for ensuring food safety and
quality and allowing FSIS inspectors to focus more on food safety
activities. However, GAO also identified what it believed to be data
gaps in the HIMP pilot study. GAO recommended that FSIS collect and
analyze information to determine if the HIMP pilot study is meeting its
purpose, and FSIS agreed with the recommendation.
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\4\ 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.
\5\ 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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The OIG report also included recommendations related to HIMP
procedures. According to the OIG, FSIS did not adequately oversee the
HIMP program because the Agency did not evaluate whether the program
resulted in a measurable improvement of the inspection process; allowed
one HIMP plant to forgo the standard FSIS policy to manually inspect
viscera; and did not have formal agreements with the HIMP plants. In
response to OIG, FSIS agreed to complete an evaluation of HIMP market
hog establishments.
D. Analysis of HIMP
1. FSIS Evaluation of HIMP
In 2014, in response to the GAO and OIG reports, FSIS conducted a
comprehensive analysis of data collected from the operation of HIMP in
market hog establishments and prepared a written report (the ``Hog HIMP
Report'') that presents a thorough evaluation of the models tested.
Based on this evaluation, FSIS concluded that market hog slaughter
establishments participating in HIMP were performing as well as
comparable large non-HIMP market hog establishments and meeting FSIS
requirements for operating under waivers through the HIMP project.
A summary of the Hog HIMP Report is provided below. The full 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. Before implementation of
the HIMP project, an 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 program. These data reflect the performance
of the establishments under traditional inspection and provided the
basis to establish HIMP performance standards for food safety defects
and non-food safety ``Other Consumer Protection'' (OCP) defects.
FSIS established three categories of food safety related
performance standards under HIMP for these conditions: ``FS-1''
addresses infectious conditions (e.g., septicemia, toxemia, pyemia, and
cysticercosis); ``FS-2'' addresses contamination from fecal material,
ingesta, and milk; and ``FS-3'' addresses certain conditions identified
at ante-mortem (e.g. moribund, pyretic, and neurologic conditions).
FSIS has a zero tolerance policy for food safety conditions identified
as FS-1, FS-2, and FS-3 to protect consumers from conditions that may
be harmful. Therefore, the HIMP performance standard for food safety
defects was set at zero.
FSIS established the performance standard for non-food safety OCP
[[Page 4789]]
defects based on the performance level of the establishment
representing the 75th percentile for each category of OCP defects
(i.e., slightly below the fourth of the five baseline results for each
category). FSIS established three categories of OCP performance
standards for various types of trim and dressing defects that primarily
affect the quality of products: ``OCP-1'' addresses carcass pathology
defects (e.g., arthritis, emaciation, and erysipelas) and was set at
4.1 percent of carcasses, ``OCP-2'' addresses visceral pathology
defects (e.g., cystic kidneys, enteritis, and nephritis) and was set at
7.2 percent of carcasses, and ``OCP-3'' addresses miscellaneous defects
such as bile, bruises, and skin lesions and was set at 20.5 percent of
carcasses. The HIMP performance standards were finalized in November
2000 (see 65 FR 65828, November 2, 2000). To participate in the
program, establishments operating under HIMP are required to maintain
process control plans to meet the performance standards for food safety
and non-food safety OCP defects. The HIMP performance standards are a
measure for comparing the performance of establishments operating under
the HIMP inspection system with performance when operating under the
current non-HIMP, traditional inspection system.
a. Overview of the HIMP Report
The Hog HIMP Report describes FSIS's microbiological and inspection
findings in the five market hog slaughter establishments participating
in HIMP and compares them with 21 non-HIMP establishments of comparable
production volume, line speed, and days of operation. The evaluation is
based on establishment performance results for calendar years CY2006
through CY2010, and CY2012 through CY2013. Establishment performance
results from CY2006 to CY2010 are based on data from the previously
used Performance Based Inspection System (PBIS) database and results
from CY2012 to CY2013 are based on data from the new Public Health
Information System (PHIS) database. FSIS began transitioning
establishments from PBIS to the PHIS in April 2011. The period April
2011 to December 2011 was a transitional period during which the
inspection results for some establishments were recorded under PBIS,
while others were recorded under PHIS. The data under the two systems
are not completely compatible because inspection task codes and
noncompliance records (NRs) were recorded differently in PHIS than in
PBIS. For this reason, the transitional period CY2011 is not included
in the Hog HIMP Report, and the analysis of CY2006 through CY2010 data
is separate from the CY2012 through CY2013 data.
Across HIMP and non-HIMP establishments, analyses compared the
number of offline inspection procedures, the rates of health-related
regulatory non-compliances, Salmonella positive rates, and violative
chemical residue rates. FSIS evaluated offline inspection procedures to
determine whether comparable levels of inspection are being performed
in HIMP establishments compared to non-HIMP establishments. The Hog
HIMP Report found that establishments participating in HIMP performed
as well as comparable large non-HIMP establishments and met the
Agency's requirements for participating in the HIMP project.
b. Verification by Offline Inspectors of the Establishment Executing
Its HIMP Process Control Plan Under Which Establishment Employees Sort
Acceptable and Unacceptable Carcasses and Parts
The Hog HIMP Report found that the rate of ante- and post-mortem
sorting by HIMP establishment personnel was comparable to the rate of
ante- and post-mortem condemnation by FSIS inspectors at non-HIMP
market hog establishments (3.0 per 1,000 hogs compared to 2.7 per 1,000
hogs, respectively). The Hog HIMP Report also found that FSIS
inspectors in HIMP establishments performed more offline inspection
activities than in non-HIMP establishments to verify that the
establishments are executing their HIMP slaughter process control
plans. In CY2010, FSIS inspectors performed an average of 2,061 offline
verification inspections per HIMP market hog establishment compared to
an average of 1,482 offline verification inspection procedures per non-
HIMP establishment. Accordingly, FSIS inspectors performed 1.4 times
more offline verification inspection procedures in HIMP market hog
establishments than in non-HIMP market hog establishments. In CY2013,
FSIS inspectors performed an average of 19,180 Public Health Regulation
(PHR) \6\ verification tasks per HIMP market hog establishment compared
to an average of 14,099 PHR verification tasks per non-HIMP
establishment. Thus, FSIS inspectors performed 1.4 times more of the
offline inspection verifications of mandatory regulations in HIMP
market hog establishments than in non-HIMP market hog establishments.
The HIMP Report concluded that this increased level of offline
inspection activities provides increased assurance that HIMP
establishments are maintaining OCP and food safety defects at levels
that are to or less than the levels in non-HIMP establishments.
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\6\ PHRs consists of regulations and specific provisions of
regulations that have higher rates of noncompliance three months
before a pathogen positive or enforcement action. The inclusion of
provisions of regulations in the PHR list allows FSIS to focus on
specific health related provisions of regulations that may be most
informative for prioritizing Food Safety Assessments (FSAs). FSAs
are in-depth evaluations of an establishment's food safety system.
FSAs can be routine or for cause.
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c. Verification of the Establishment Executing Its HACCP System Under 9
CFR Parts 416 and 417
The sanitation SOP regulations in 9 CFR 416 and the HACCP
regulations in 9 CFR 417 are among the regulations most strongly
related to public health. The Hog HIMP Report found that in CY2010,
FSIS inspectors performed 1.5 times more offline sanitation SOP and
HACCP inspection verifications of public health-related regulations in
HIMP than non-HIMP market hog comparison establishments. In CY2012 and
CY2013, FSIS inspectors performed 1.1 times more offline sanitation SOP
and HACCP inspection verifications of public health-related regulations
in HIMP than non-HIMP market hog comparison establishments.
The regression analysis of historical data that was included in
FSIS's ``Risk Assessment for Guiding Public Health-Based Poultry
Slaughter Inspection,'' which was used to inform the final rule
``Modernization of Poultry Slaughter Inspection'' (79 FR 49565), showed
a statistically significant correlation between unscheduled offline
inspection procedures and reduction in the prevalence of Salmonella and
Campylobacter positive samples. Based on these modeling results, FSIS
thought it was reasonable to conclude that the redeployment of Agency
resources to unscheduled offline activities was likely to contribute to
improved food safety resulting from a lower prevalence of carcasses
contaminated with Salmonella and Campylobacter, which in turn could
lead to fewer human illnesses. Depending on how reallocation of
inspection activities was implemented, it was likely that changes in
off-line inspection could have resulted in a decrease in the numbers of
positive microbial samples in FSIS-regulated young chicken and young
turkey establishments. Specifically, the scenario that only increased
unscheduled inspection procedures performed much better than the
scenario that did not target specific
[[Page 4790]]
types of procedures, and the results suggest a reasonable degree of
confidence that the discriminate scenario would do no harm. That
poultry slaughter risk assessment is available on FSIS's website 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. The risk model and model results are also
posted on-line as a technical support document for the risk assessment
on the FSIS website. The market hog risk assessment uses a similar
approach and model as the poultry slaughter risk assessment and
estimates the reduction in illnesses likely to result from the
reallocation of inspectors contemplated by this proposed rule. The
market hog risk assessment is discussed in more detail below.
d. Verification of the Outcomes of the Establishment Process Control
Plan, Both Organoleptic and Microbiologic
To assess the microbiological outcomes of HIMP establishments'
process control plans, the Hog HIMP Report analyzed data from FSIS's
Salmonella verification program. For the years CY2006-CY2009, the
differences in Salmonella positive rates between HIMP market hog
establishments and non-HIMP comparison establishments were not
statistically significant for any of the years. The Hog HIMP Report
also analyzed data from FSIS's Salmonella baseline study on market hog
slaughter establishments, conducted from August 2010 to August 2011.
The Salmonella positive rates in HIMP market hog establishments were
not statistically significantly different from those in the subset of
21 non-HIMP comparison establishments. This is probably the result of
the small sample size relative to the low Salmonella positive rate.
However, in the August 2010 to August 2011 baseline study the
Salmonella positive rates in HIMP market hog establishments were
statistically significantly lower than those in all 147 non-HIMP market
hog establishments (which included the subset of 21 non-HIMP comparison
establishments, as well as all other non-HIMP market hog
establishments) (0.65 percent versus 3.05 percent).
The Hog HIMP Report also analyzed data from FSIS's residue sampling
program for chemical contaminants including approved and unapproved
veterinary drugs, pesticides, and environmental compounds. FSIS
conducts directed sampling scheduled by FSIS Headquarters and
inspector-generated sampling when the FSIS PHV suspects that an animal
may have a violative level of chemical residue. The Hog HIMP Report
found no differences in the number of scheduled directed samples
collected in the HIMP market hog establishments and those in the non-
HIMP market hog comparison establishments. However, the Hog HIMP Report
found that FSIS offline inspectors at the HIMP market hog
establishments were able to collect 2.7 times more inspector-generated
residue samples than inspectors at the non-HIMP market hog comparison
establishments for CY2009-2010, and 1.7 times more for CY2012-2013
because the inspectors had more time to conduct offline activities.
Data from FSIS's residue sampling program showed that from CY2006 to
CY2010, the number of samples that tested positive for violative levels
of chemical residues in HIMP market hog establishments were not
statistically significantly different from those in the non-HIMP market
hog comparison establishments (zero versus six (0.057 percent of
samples)). However, from CY2012 to CY2013, the amount of samples that
tested positive for violative levels of chemical residues in HIMP
market hog establishments was statistically significantly lower than
non-HIMP market hog comparison establishments (nine violative levels
(0.15 percent of samples) versus 115 (0.76 percent of samples). The Hog
HIMP Report explained that this difference could suggest that the HIMP
market hog establishments are exercising active control of potential
chemical hazards in their products, and that this approach may result
from better control over contract grower relationships by the five HIMP
market hog establishments.
e. Conclusion of HIMP Report
The Hog HIMP Report concluded that HIMP market hog establishments
are receiving more offline food safety related inspection verification
checks than the non-HIMP market hog comparison establishments, and that
the HIMP inspection system, which provides for increased offline
inspection activities that are directly related to food safety, results
in greater compliance with sanitation and HACCP regulations (9 CFR
parts 416 and 417); carcasses with equivalent or lower levels of
Salmonella contamination; and carcasses with lower levels of violative
chemical residues.
f. Verification of Humane Handling
FSIS inspectors verify that establishments comply with the HMSA by
performing Humane Activities Tracking System (HATS) tasks that are
divided into nine categories. The HATS tasks provide FSIS with data on
the time that FSIS inspectors spend verifying whether (1)
establishments adapt their facilities to inclement weather; (2)
humanely handle livestock during truck unloading; (3) provide water and
feed to livestock in holding pens; (4) humanely handle livestock during
ante-mortem inspection; (5) humanely handle ``U.S. Suspect'' and
disabled livestock; (6) move livestock without excessive prodding or
the use of sharp objects after ante-mortem inspection; (7) prevent
livestock from slipping and falling; (8) effectively administer
stunning methods that produce unconsciousness in the animals; and (9)
ensure that animals do not regain consciousness throughout the
shackling, sticking, and bleeding process. FSIS inspectors enter the
hours devoted to verifying humane handling activities for the HATS
categories. The data is entered into PHIS in one-quarter hour
increments (e.g., .25, .5, .75, 1.0).
The Hog HIMP Report did not address compliance with the HMSA, but
FSIS reviewed HATS task data in PHIS from January 2013 through
September 2015 and compared the number of offline humane handling
activities performed in five HIMP market hog establishments and the
same 21 comparable large non-HIMP market hog establishments that FSIS
used in the Hog HIMP Report. The Agency found that FSIS inspectors
spent more time verifying that specific humane handling and slaughter
requirements were met in HIMP market hog establishments than in non-
HIMP market hog establishments. FSIS inspectors devoted approximately
5.33 hours per shift to verifying humane handling activities for the
HATS categories in HIMP market hog establishments compared to
approximately 4.29 hours per shift in the 21 non-HIMP market hog
comparison establishments. FSIS also compared the rate of humane
handling NRs issued in HIMP market hog establishments and non-HIMP
market hog establishments. FSIS inspectors documented fewer humane
handling NRs in HIMP market hog establishments than in non-HIMP market
hog establishments. From January 2013 through September 2015, FSIS
recorded 11 humane handling NRs in five HIMP market hog establishments
and 117 NRs in the 21 non-HIMP market hog comparison establishments. It
should be noted that none of the 11 NRs recorded in the HIMP
establishments documented market hogs being forced to
[[Page 4791]]
move faster than normal walking speeds to keep up with faster
evisceration line speeds. The data demonstrate that HIMP establishments
have higher compliance with humane handling regulations than non-HIMP
establishments, and that increased offline inspection may improve
compliance with the HMSA.
E. Public Health Benefits Projected From Allocating More Inspection
Resources to Food Safety-Related Inspection Activities
1. Market Hog Risk Assessment
FSIS completed a quantitative risk assessment to determine how
performing a greater number of offline inspection procedures in market
hog slaughter establishments might affect the number of human illnesses
from Salmonella. These offline inspection procedures primarily involve
activities that FSIS inspection personnel perform to verify the
effectiveness of establishment sanitary operations and other food
safety-related activities. The Hog HIMP Report, discussed above, found
that FSIS inspectors performed more offline inspections to verify
compliance with sanitation SOP and HACCP regulations in HIMP
establishments than they do in non-HIMP establishments. The risk
assessment is available for viewing by the public in the FSIS docket
room and on the FSIS website at: https://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
FSIS developed the market hog risk assessment to help the Agency
inform its judgement about the potential impact of changes to FSIS's
swine inspection system on risks to public health associated with pork
products. To give the Agency the information it needed, the market hog
risk assessment focused on three risk management questions:
(1) What predicted effects will various models for increasing the
number of offline inspection tasks in non-HIMP establishments have on
human salmonellosis rates?
(2) Where can inspectors be relocated to have the most impact
toward reducing Salmonella prevalence and corresponding human illness?
(3) What is the magnitude of uncertainty about the predicted
prevalence of pathogens and corresponding illness effects?
2. Model
FSIS developed a risk assessment model for exploring the potential
relationships between current variations in inspection personnel
assignments and prevalence of Salmonella on hog carcasses, and
estimating the subsequent possible reductions in human illnesses
attributable to that pathogen. FSIS paired inspection data with
Salmonella prevalence data for the same establishments and timeframes.
As explained above, FSIS based this risk assessment model on the model
for the risk assessment that FSIS used to inform the final rule
``Modernization of Poultry Slaughter Inspection'' (79 FR 49565).
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, and (2) contamination of hog carcasses
with Salmonella.\7\ 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. 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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\7\ Scheduled procedures are assigned to inspectors at an
establishment by PBIS or PHIS. Unscheduled procedures are performed
according to inspector needs at an establishment and may include
verification checks for fecal, 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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3. Conclusions of the Market Hog Risk Assessment
The regression analysis of 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. 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 we expect to lead to fewer human illnesses.
In answer to the first risk-management question, the market hog
risk assessment results suggest that, depending on how reallocation of
inspection activities is implemented, it is likely that changes in
offline inspection would not result in an increase in the prevalence of
Salmonella in hog carcasses, and could even result in a decrease in the
prevalence of Salmonella in hog carcasses. Specifically, the scenario
that simultaneously increases unscheduled and scheduled inspection
procedures and decreases scheduled but not performed procedures
performs better than scenarios that target the three specific types of
procedures one at a time. Under the scenario where all types of
procedures are targeted for increase, with resulting decrease in
scheduled but not performed procedures and decrease in instances of
observed and reported establishment non-compliance, the model estimates
an average decrease of 2,533 Salmonella-related illnesses per year
attributable to pork products. FSIS assumes that 65,869 expected annual
Salmonella illnesses are attributed to consumption of pork products.
Thus, a reduction of 2,533 expected Salmonella illnesses annually,
would reflect a 3.8 percent reduction in Salmonella illnesses
attributable to pork products.
Responding to the second question, modeling and scenario analysis
results suggest that increasing scheduled and unscheduled procedures
and decreasing scheduled but not performed procedures would be most
effective in reducing pathogen occurrence on carcasses because of
consistency in the decision variable parameter's effect across all
models. However, each category of offline procedures relates to an
individual decrease in Salmonella contaminated carcasses which if any
one of the three categories or a combination of categories of offline
procedures were implemented still would result in decreased
contamination, but less than if the scenario combining all three
decision variables was adopted.
In answer to the third risk-management question, on the uncertainty
of the results for pathogen prevalence and illness reductions, FSIS's
modeling approach includes the inherent uncertainty about the
relationship between the frequency of inspection activities and
pathogen prevalence, about the actual change in future inspection
activities that would
[[Page 4792]]
likely be observed, and about the representativeness of the rates of
human Salmonella illnesses attributable to pork products.
III. Proposed NSIS
FSIS is proposing to create a new swine slaughter inspection
system, the NSIS, informed by the Agency's experiences under HIMP and
NPIS. All establishments that slaughter market hogs would be permitted
to operate under the proposed NSIS. Establishments that slaughter
classes of swine other than market hogs would be permitted to operate
under NSIS under a waiver through the SIP. FSIS would consider the data
collected in swine slaughter establishments operating under a SIP
waiver to determine whether to expand NSIS to other classes of swine.
Establishments that slaughter market hogs and other classes of swine,
and that do not want to slaughter other classes of swine under NSIS
under a waiver through the SIP, would be permitted to slaughter market
hogs under NSIS and to slaughter the other classes of swine under
traditional inspection. FSIS would staff such establishments to NSIS
and would not add additional staff for traditional inspection;
therefore, establishments would need to operate traditional inspection
under slower line speeds than they are currently operating to
accommodate for the reduced number of inspectors. FSIS seeks comment on
the impact of staffing at establishments that slaughter market hogs and
other classes of swine and how it will impact their decision to
participate in NSIS.
A. Live Market Hog Sorting by Establishment Personnel
Under the proposed NSIS, establishment personnel would be required
to sort market hogs and remove for disposal animals unfit for slaughter
before they are presented to FSIS PHVs for inspection and final
disposition. Establishment personnel would sort animals that appear to
be healthy into ``Normal'' pens and animals that appear to have
diseases or abnormal conditions into ``Subject'' pens. Establishment
personnel may also sort and remove animals with localized conditions
(e.g., animals with arthritis or abscesses) or animals that do not meet
establishment specifications (e.g., hogs that are the wrong size or
underweight) to be diverted to another official establishment for
slaughter. Establishment personnel would remove and properly dispose of
dead and moribund animals and animals suspected of having CNS
conditions or pyrexia. Under the proposed NSIS, FSIS inspectors would
inspect all animals found by the establishment to be normal at rest,
and five to ten percent of those animals in motion. If any animals
exhibit signs of condemnable conditions, FSIS inspectors would direct
establishment employees to move the animals to the ``U.S. Suspect''
pens for final disposition by the FSIS PHV. The FSIS PHV would inspect
all animals in the ``Subject'' and ``U.S. Suspect'' pens and render a
final disposition decision. FSIS inspectors would observe establishment
employees performing sorting procedures at least twice per shift.
During this time, FSIS inspectors would 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. FSIS inspectors also would conduct HACCP
verification tasks in PHIS at least twice per shift to verify that
establishments meet the regulatory requirements found in 9 CFR 417 for
implementation, monitoring, recordkeeping, prerequisite programs (when
applicable), and corrective actions. Under the proposed rule, if any
market hogs become non-ambulatory disabled after ante-mortem
inspection, establishments would be required to move them to the
``Subject'' pens for re-inspection by FSIS PHVs. All sorting would be a
function of the establishment's HACCP plan or pre-requisite program.
Because establishments operating under the proposed NSIS would be
required to sort and remove market hogs that are unfit for slaughter
before FSIS ante-mortem inspection, FSIS is proposing that
establishments under the proposed NSIS 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 CNS conditions or pyrexia.
FSIS also is proposing to require that establishments immediately
notify FSIS inspectors in the rare circumstance that they suspect
animals of having notifiable or foreign animal diseases during sorting
activities. For example, establishments may suspect that market hogs
have notifiable or foreign animal diseases if they observe animals with
abnormal lesions or behavior, or an abnormal change in the amount of
animals that arrive to the establishment dead. Notifiable diseases are
those that are designated by the World Animal Health Organization
(Office International des Epizooties or OIE). The list of notifiable
diseases includes anthrax, cysticercosis, scabies, bovine tuberculosis,
myiasis (screwworm), and vesicular diseases. Of these diseases,
anthrax, cysticercosis, and bovine tuberculosis are transmissible to
humans. The complete list is available on OIE's website at https://www.oie.int/en/animal-health-in-the-world/oie-listed-diseases-2016/.
FSIS would report any animal disease issues to the USDA Animal and
Plant Health Inspection Service (APHIS).
Under the proposed NSIS, FSIS would maintain its zero tolerance for
market hogs exhibiting signs of moribundity, CNS conditions, and
pyrexia. Market hogs exhibiting signs of these generalized diseases or
conditions, if not sorted and removed by the establishment before ante-
mortem inspection, would be condemned by FSIS PHVs, as under the
existing regulations (9 CFR 309.3). FSIS PHVs would issue an NR for
every animal exhibiting signs of moribundity, CNS conditions, or
pyrexia found by the FSIS inspector after the establishment sorting
step is completed.
Additionally, under the proposed NSIS, FSIS would maintain its zero
tolerance for violative levels of chemical residues. Establishments
would be required to address chemical hazards through their HACCP
program including preventing animals with violative levels of chemical
residues from being presented for slaughter. FSIS inspectors would
continue to select animals at post-mortem and perform chemical residue
sample collection and testing procedures in accordance with FSIS
Directive 10,800.1, Residue Sampling, Testing and Other Verification
Procedures under the National Residue Program for Meat and Poultry
Products (available on FSIS's website at https://www.fsis.usda.gov/wps/wcm/connect/147066f0-564c-4590-b36f-97ffc5ab9797/10800.1.pdf?MOD=AJPERES).
Under the proposed NSIS, establishment personnel would be required
to identify carcasses of market hogs sorted and removed by
establishment employees before FSIS inspection and intended for
disposal and destruction with a unique tag, tattoo, or similar device.
Establishment personnel also would be required to immediately denature
all carcasses and parts removed as unacceptable by plant sorters on-
site, even if establishments have tanking facilities, to ensure that
the carcasses and parts are properly disposed of and never enter
commerce. Under the proposed NSIS, establishment personnel would be
required to maintain records to
[[Page 4793]]
document the number of animals and carcasses and parts sorted and
removed by establishment personnel per day. These records and
procedures would be subject to daily review by FSIS inspectors. Under
NSIS, FSIS inspectors would document in PHIS the total number of
animals that the establishment employees have sorted and removed per
day. Under the proposed rule, FSIS would still direct the application
and removal of ``U.S. Condemned'' tags to animals condemned during
ante-mortem inspection. FSIS would also continue to enter each and
every ``U.S. Condemned'' tag into PHIS. However, FSIS inspectors should
be able to complete these tasks faster because they would be presented
animals that have been sorted by establishment employees and are thus
more likely to pass ante-mortem inspection and not have condemnable
conditions.
In addition to the total number of animals sorted and removed by
establishment personnel per day before FSIS ante-mortem and post-mortem
inspection, FSIS is requesting comments on whether or not the Agency
should require establishments under NSIS to specify in their records
the reason that the animals were removed from slaughter, including
animals sorted and removed because they were dead on arrival or
suspected of having CNS conditions, pneumonia, pyrexia, septicemia,
erysipelas, or tuberculosis (e.g., 20 sorted and removed; 10 pneumonia,
10 dead on arrival) and how this information should be collected. Under
traditional inspection, FSIS inspectors record similar condemnation
information into PHIS for APHIS' swine slaughter condemnation
monitoring system; however, this information is not being collected
under HIMP. APHIS Veterinary Services (VS) uses this type of data to
monitor changes in the rate or count of swine condemnations by swine
type (market, roaster, sow, and boar) and by selected condemnation
categories (e.g., central nervous system disorders, dead on arrival,
pneumonia, pyrexia, septicemia, erysipelas, and tuberculosis). APHIS
conducts weekly monitoring to compare baseline (expected) condemnation
counts by condemnation category to current weekly counts to identify
noteworthy increases (signals) in condemnations in near-real time.
APHIS produces a weekly report, and shares it with the National Pork
Board to identify any noteworthy increases in condemnations which could
indicate the emergence of disease and may warrant further
investigation. FSIS and APHIS recognize that ``presumptive diagnoses''
by establishment personnel under the NSIS may not be as accurate as
condemnation information entered by an FSIS PHV under traditional
inspection. However, FSIS and APHIS believe that the self-reported
information may still be useful and significant in monitoring disease
conditions in the United States.
B. Post-Mortem Carcass Sorting by Establishment Employees and Online
Carcass Inspection
Under the proposed NSIS, establishment personnel would be required
to sort carcasses and parts and trim dressing defects and contamination
(e.g., hair, bruises, feces, ingesta, and milk) before the carcasses
and parts are presented to an FSIS online inspector for post-mortem
inspection. Establishment personnel also would be required to mark with
ink, or otherwise identify, localized pathological defects intended for
removal under FSIS supervision (e.g. localized nephritis and localized
arthritis) and carcasses and parts intended for disposal under FSIS
supervision (e.g., carcasses and parts with malignant lymphoma). Under
the proposed NSIS, the head, and viscera of each hog must be handled in
a way as to identify them with the rest of the carcass and as being
derived from the particular animal involved, until FSIS's post-mortem
inspection of the carcass and parts thereof have been complete. FSIS
would not complete an inspection of the carcass if the head or viscera
were missing before the final rail, unless the head or viscera were
properly disposed of under FSIS supervision. Consistent with
traditional inspection, only FSIS inspectors would be authorized to
condemn carcasses and parts.
Carcasses and parts contaminated with fecal material, ingesta, or
milk or that exhibit signs of septicemia, toxemia, pyemia, or
cysticercosis during post-mortem examination are likely to contain
infectious agents, such as bacteria, virus, richettsia, fungus,
protozoa, or helminth organisms, which can be transmitted to humans.
For this reason, they present a food safety risk if they are permitted
to enter the cooler. Therefore, FSIS is proposing that establishments
under the new system address, as part of their HACCP systems,
procedures for ensuring that carcasses and parts contaminated with
fecal material, ingesta, or milk or affected by septicemia, toxemia,
pyemia, or cysticercosis are trimmed or identified by the establishment
before they are presented to the FSIS carcass inspector and disposed of
under FSIS supervision. These procedures must cover establishment
sorting activities for these conditions.
Under this proposal, FSIS would maintain its zero tolerance for
carcasses and parts contaminated by fecal material, ingesta, or milk,
or affected by septicemia, toxemia, pyemia, or cysticercosis. If FSIS
online inspectors discover a carcass contaminated by fecal material,
ingesta, or milk, they would stop the line for carcass reexamination
and trimming by the establishment unless the establishment elected to
provide a rail-out loop to rail contaminated carcasses offline for
reexamination, trimming, and positioning back on the line for
reinspection, consistent with the existing regulations (9 CFR 310.17
and 310.18) and FSIS Directive 6420.2, Verification of Procedures for
Controlling Fecal Material, Ingesta, and Milk in Slaughter Operations
(available on FSIS's website at https://www.fsis.usda.gov/wps/wcm/connect/478aca76-37c5-4dc3-9925-1556402d8daf/PHIS_6420.2.pdf?MOD=AJPERES). An NR would be issued by the FSIS offline
inspector at or after the final rail for every carcass contaminated by
fecal material, ingesta, or milk. FSIS online inspectors would also
stop the line if they discover carcasses exhibiting septicemia,
toxemia, pyemia, or cysticercosis, as under the existing regulations (9
CFR 311.16 and 311.17). The carcasses would be retained for FSIS PHV
disposition. An NR would be issued by the PHV for every carcass
affected by septicemia, toxemia, pyemia, or cysticercosis that reaches
the online carcass inspection station. Moreover, because establishments
would be required to address these food safety hazards in their HACCP
systems, the Agency continuously would assess the effectiveness of an
establishment's procedures for ensuring that carcasses are prevented
from becoming contaminated with fecal material, ingesta, or milk, and
that carcasses affected by septicemia, toxemia, pyemia, or
cysticercosis do not reach the final FSIS inspection station.
FSIS is not proposing to prescribe specific sorter training or
certification to give establishments operating under the NSIS the
flexibility to select the training program that would best assist them
to meet the requirements of this proposed rule. However, the Agency has
developed a draft guidance document to assist establishments in
training their sorters should this rule become final. The draft
guidance is based on the training that FSIS provides to online
inspection personnel that are responsible for identifying these non-
food safety defects on carcasses and
[[Page 4794]]
parts under traditional inspection. FSIS has posted this draft
compliance guide on its web page (https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index) and is
requesting comments on the guidance.
FSIS believes that training of sorters is important to ensure that
they are able to properly perform their duties. Proper training is
necessary if sorters are to make accurate decisions on how to address
animal disease conditions and trim and dressing defects. Under the
proposed NSIS, if sorters do not make these decisions correctly, FSIS
inspection personnel would take appropriate action such as stopping the
line, issuing NRs, and directing the establishment to reduce the line
speed. FSIS would thereby ensure that the establishment is able to
maintain process control as evidenced by preventing fecal contamination
and meeting microbial performance measures, that the establishment
sorters are able to successfully perform their duties, and that the
FSIS online inspectors are able to conduct a proper food safety
inspection.
Establishments that operate under the proposed NSIS would have
greater flexibility over their production process. For example,
establishments operating under the proposed NSIS would have the
flexibility to reconfigure lines if they decided to change the way that
the head, viscera, and carcasses are presented to FSIS inspectors to
improve ergonomics and process control and to maintain optimum line
speed. FSIS would still inspect the head, viscera, and carcass of each
animal. However, under the proposed NSIS, establishments may
reconfigure their lines so that they present a ready-to-inspect head,
viscera, and carcass for FSIS post-mortem inspection in one location or
separately in two or three locations. FSIS would assign one to three
inspectors to conduct online inspection activities, depending on need
and line configuration. These inspectors would also rotate to conduct
offline inspection activities. FSIS would assign one online inspector
only if the Agency had the data and experience (including processes and
procedures) to ensure that one inspector is able to conduct all online
post-mortem inspection activities. Under the proposed NSIS, all
establishments with fewer than three inspection stations would be
required to provide a mirror at the carcass inspection station in
accordance with 9 CFR 307.2 (m)(6) so that the inspector standing at
the inspection station can readily view the back of the carcass for
evidence that could impact food safety.
Under NSIS, as under HIMP, establishment sorters would be required
to incise mandibular lymph nodes and palpate the viscera to detect the
presence of animal diseases (e.g., Mycobacterium Avium) as part of
their sorting activities before FSIS post-mortem inspection. FSIS is
requesting comments on whether or not the Agency should allow
establishments that operate under the proposed NSIS to use discretion
when deciding, on a lot-by-lot basis, whether or not to incise
mandibular lymph nodes and palpate the viscera to detect the presence
of animal diseases (e.g., M. Avium) if they submit documentation to
FSIS supporting that the presence of M. Avium is not likely to occur,
such as records documenting their on-farm controls. In the last 10-15
years, industry led initiatives like the Pork Quality Assurance Plus
certification program (https://www.pork.org/pqa-plus-certification) and
the Common Industry Audit (https://www.pork.org/common-industry-audit)
have improved biosecurity practices which not only reduce disease
spread but also address risk factors for M. Avium such as exposure to
birds.8 9 Because on-farm practices have improved, the
prevalence of M. Avium in U.S. swine is very low. After reviewing PHIS
condemnation data from 21 large market hog establishments from 2012
through 2015, FSIS found that only 0.9 percent of all condemnations are
due to M. Avium. The animal disease M. Avium does not present a food
safety concern, and can be detected visually by inspectors.
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\8\ United States Department of Agriculture, Animal and Plant
Health Inspection Service. (2008). National Animal Health Monitoring
System Swine 2006, Part IV: Changes in the U.S. Pork Industry, 1990-
2006. Retrieved from https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2006/Swine2006_dr_PartIV.pdf.
\9\ United States Department of Agriculture, Animal and Plant
Health Inspection Service. (2015). National Animal Health Monitoring
System Swine 2012, Part 1: Baseline Reference of Swine Health and
Management in the United States, 2012. Retrieved from https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2012/Swine2012_dr_PartI.pdf.
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Moreover, Denmark and the Netherlands already conduct alternative
post-mortem visual inspections and allow establishments to use
discretion when determining, on a lot-by-lot basis, whether or not to
incise lymph nodes and palpate the viscera. Under the FMIA and the
regulations that implement it, meat and meat products imported into the
United States must be produced under standards for safety,
wholesomeness, and labeling accuracy that are equivalent to those of
the United States (21 U.S.C. 620). FSIS has reviewed Denmark's and the
Netherlands' market hog slaughter inspection systems and found them to
be equivalent to the United States' market hog slaughter inspection
system. FSIS determined that visual post-mortem inspection will still
allow veterinary inspectors to palpate and incise lymph nodes and
organs (as occurs in traditional inspection) at their discretion. Each
herd of hogs that arrives at establishments to be slaughtered is
accompanied by historical ``Supply-Chain Information,'' which consists
of paperwork that documents the health status and history of each herd,
complete traceback information, as well as details about the
originating farm (e.g., history of disease, use of medications, and on-
farm practices that contribute to maintenance of the herd's health.)
FSIS concluded that this documentation, as well as any ante-mortem
inspection observances, will be sufficient to inform the veterinary
inspector's decision whether or not to perform visual inspection or
traditional inspection. Importantly, because lymphatic tissue may be
contaminated with pathogens, not incising the lymphatic tissue may
reduce contamination of food contact surfaces and other carcasses.
FSIS also is proposing to require establishment personnel to
maintain records to document the number of carcasses and parts disposed
of by establishment personnel per day as part of their sorting
activities. The records would not need to include the number of
carcasses condemned by FSIS. These records would be subject to review
by FSIS inspectors. Under NSIS, FSIS inspectors would document in PHIS
the total number of carcasses and parts sorted and disposed of by plant
employees per day. FSIS inspectors would continue to enter dispositions
for each and every carcass condemned by FSIS into PHIS.
C. Offline Verification Inspection
In addition to the online inspectors performing carcass inspection,
FSIS is proposing that up to two inspectors be assigned for each
evisceration line per shift to conduct offline verification activities
in establishments operating under the proposed NSIS. Inspectors
conducting offline inspection activities would rotate with the
inspectors conducting online inspection activities. FSIS is also
proposing to assign one PHV to make carcass and parts dispositions.
As in HIMP, offline inspectors under the new inspection system
would conduct food safety related inspection activities and would
continuously
[[Page 4795]]
monitor and evaluate establishment process control. Offline inspectors
would conduct inspection activities including HACCP, sanitation SOP,
and other prerequisite program verification procedures; verification
checks for septicemia, toxemia, pyemia, cysticercosis, fecal material,
ingesta, or milk contamination; checks to verify and ensure that
sanitary dressing requirements are being met; and ante-mortem
inspection. Under this proposed rule, offline inspectors would also
conduct more humane handling verification tasks than are conducted
under traditional inspection. The offline verification inspectors would
work with the Inspector-In-Charge (IIC) to ensure that food safety
related or non-food-safety related conditions do not impair the online
carcass inspectors' ability to conduct the inspection of each head,
viscera, and carcass or would notify the IIC whenever circumstances
indicate a loss of process control. When circumstances indicate a loss
of process control, the IIC will be authorized to require that the
establishment slow the evisceration line speed.
D. RTC Pork Product
As discussed above, under HIMP, OCP standards are non-food safety
standards concerned primarily with diseases of no public health
significance and carcass processing defects. Data collected from market
hog establishments operating under HIMP show that from CY 2012 through
2013, HIMP establishments maintained OCP defect levels that average
about half the corresponding OCP performance standards derived from the
performance of non-HIMP establishments. Thus, the data show that
establishments operating under the HIMP system do exceptionally well in
controlling OCP defects.
Accordingly, FSIS is not proposing OCP requirements as a condition
for establishments to participate in the proposed NSIS. Under this
proposal, establishments operating under NSIS would be allowed to
implement the process controls that they have determined will best
allow them to produce an RTC pork product that is wholesome and not
adulterated. The new proposed definition of RTC pork product is any
slaughtered pork product 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.
Under the proposed NSIS, establishments would have the flexibility
to design and implement measures to address OCP defects that are best
suited to their operations. They would also be responsible for
determining the type of records that will best document that they are
meeting the RTC pork product definition. The records would be subject
to review and evaluation by FSIS inspectors.
For their record reviews, FSIS inspectors would verify that
establishments operating under the proposed NSIS have written criteria
for determining whether carcasses meet the RTC definition and that they
are documenting that the pork products resulting from their slaughter
operations meet these criteria before packaging or further processing
that would conceal a defect. Records that would meet the proposed
requirements include:
The records system that the establishment uses to document
that it is producing RTC pork. For example, an establishment may use
statistical process control charts, HACCP records, or other
documentation.
The points in the operation where the establishment
monitors carcasses to determine whether they meet the RTC definition
and records the results of its monitoring activities. For example, an
establishment may conduct monitoring and record the results at a pre-
evisceration and a post-chill station.
The frequency with which the establishment conducts
monitoring activities. The records should specify how often the
establishment monitors carcasses per line per shift. For example, an
establishment may conduct and document its monitoring activities at
least every two hours per line per shift at the pre-evisceration
location and at least twice per shift per line for post-chill location.
The definitions of the OCP non-conformances or processing
and trim defects for which the establishment is monitoring. For
example, the establishment may be monitoring carcasses for processing
and trim non-conformances as specified for trim and processing OCP
defects specified under the HIMP OCP performance standards, or defects
as defined in a published study or a study that the establishment
conducted itself. If the establishment references a study, it should
give a brief description of the study and have the supporting
information on file.
The criteria that the establishment would use to determine
that the products resulting from its slaughter operation meet the RTC
definition. For example, an establishment may follow the subgroup
limits for non-conformances and defects in the trim and processing
defect levels for the HIMP OCP performance standards, or it may
determine the upper limits for non-conformances using a statistical
process control program.
The corrective actions that the establishment would take
if the levels of defects and non-conformances exceed its evaluation
criteria for RTC pork.
Under this proposed rule, pork carcasses that meet the OCP
performance standards under HIMP would be considered ``suitable for
cooking without the need for further processing,'' and as such, meet
the RTC pork product definition. Therefore, establishments operating
under the NSIS that adopt the OCP HIMP performance standards as their
criteria for determining whether they are producing RTC pork product
would meet the regulatory requirements if: (1) They can document that
the products resulting from their slaughter operations consistently
meet these standards, and (2) FSIS inspectors do not observe
persistent, unattended defects on the products resulting from the
establishment's slaughter operations. Establishments that adopt
criteria other than the HIMP OCP standards would be required to have
documentation to demonstrate how they will use these criteria to
demonstrate that the products resulting from their slaughter operations
meet the RTC pork product definition.
In addition to record reviews, FSIS inspectors would verify that
establishments operating under the NSIS are producing RTC pork product
by visually observing carcasses as part of their inspection activities.
The presence of persistent, unattended trim and dressing defects on
carcasses at the end of the process would indicate that the
establishment is not producing RTC pork product. It may also indicate a
general lack of control in an establishment's overall slaughter and
dressing process. Thus, if inspectors observe persistent, unattended
defects, FSIS would require that the establishment take appropriate
actions to ensure that its process is under control and that it is
operating under conditions necessary to produce safe, wholesome, and
unadulterated RTC products. If inspection personnel through their
record review or direct observation of carcasses find evidence that an
establishment is producing pork that does not meet the RTC definition,
the IIC would be authorized to take appropriate action to ensure that
the establishment remedies the defects, including requiring that the
establishment slow the evisceration line speed.
E. Line Speeds Under NSIS
Based on FSIS's experience under HIMP, the Agency is proposing to
allow
[[Page 4796]]
establishments operating under NSIS to determine their own evisceration
line speeds if Agency personnel verify that process control is
maintained. 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 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 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 hogs. Establishments determine their
line speeds based on their equipment, animal size and herd condition,
and their ability to maintain process control when operating at a given
line speed. In addition, line speeds under HIMP depend on the number of
employees the establishments hire and train to perform sorting
activities. If FSIS finalizes the proposed NSIS, establishments
choosing to operate under the NSIS will likely determine their line
speeds based on the same factors that establishments considered when
setting line speeds under HIMP for the past 16 years.
Establishments operating under HIMP have demonstrated that they are
capable of consistently producing safe, wholesome, and unadulterated
pork products while operating at these line speeds. Moreover, they have
consistently met pathogen reduction and other performance standards
when operating at the line speeds they established under HIMP. The
proposed new inspection system was informed by the Agency's experience
under HIMP and, as discussed later in this document, also incorporates
additional measures that will apply to all swine slaughter
establishments. These measures, which include testing for microbial
organisms at pre-evisceration and post-chill, are designed to ensure
that establishments maintain process control.
FSIS recognizes that evaluation of the effects of line speed on
food safety should include the effects of line speed on establishment
employee safety. FSIS compared in-establishment injury rates between
HIMP and traditional establishments from 2002 to 2010. The preliminary
analysis shows that HIMP establishments had lower mean injury rates
than non-HIMP establishments. The analysis uses injury rate data by
occupational injury estimates that are derived from the BLS annual
Survey of Occupational Injuries and Illnesses (SOII) https://www.bls.gov/iif/data.htm). The survey captures data from Occupational
Safety and Health Administration (OSHA) logs of workplace injuries and
illnesses maintained by employers. Fifty-six FSIS inspected market hog
slaughter establishments voluntarily submitted injury rate data to OSHA
(approximately nine percent of all market hog slaughter
establishments). From these 56 establishments, 27 low volume
establishments were excluded, leaving 29 plants (5 HIMP and 24
Traditional). The low volume plants were excluded to provide a better
comparison group of traditional plants because all HIMP plants are high
volume plants. The results showed HIMP plants had a lower mean number
of injuries using three OSHA injury rate measures: Total Case Rate
(TCR), Days Away Transferred Restricted (DART), and Days Away From Work
(DAFW). However, FSIS realizes that factors other than line speed may
affect injury rates (e.g., automation and number of sorters per line).
FSIS is requesting comments on the effects of faster line speeds on
worker safety. Specifically, FSIS is requesting comments on whether
line speeds for the NSIS should be set at the current regulatory limit
of 1,106 hph or some other number. The Agency is also interested in
comments on the availability of records or studies that contain data
that OSHA or the National Institute for Occupational Safety and Health
(NIOSH) may be able to use in analyzing the effects of increased line
speed on the safety and health of employees throughout the
establishment, including effects prior to and following the
evisceration line. FSIS is also requesting comments on whether the
Agency should maintain the 1,106 hph maximum line speed for
establishments operating under NSIS but grant waivers from the maximum
line speed to establishments that agree to work with the National
Institute for Occupational Safety and Health NIOSH to evaluate the
effects of waivers of line speed restrictions on employee health. FSIS
is requesting comments on best practices and other measures that
establishments can take to protect workers throughout the plant,
including possible protective factors such as increasing the size of
the workforce, rotating assignments, increased automation, or improved
tools and techniques.
FSIS is proposing to require each establishment that operates under
the NSIS to provide an annual 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
that arise among establishment workers. The elements of this program
would include:
(1) Policies to encourage early reporting of symptoms of work-
related injuries and illnesses, and assurance that the establishment
has no policies or programs intended to discourage the reporting of
injuries and illnesses.
(2) 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.
(3) Monitoring on a regular and routine basis of injury and illness
logs, as well as nurse or medical office logs, workers' compensation
data, and any other injury or illness information available.
FSIS is also proposing to create a new severability clause
(proposed 9 CFR 310.28), which would state that should a court of
competent jurisdiction hold any provision of the proposed worker safety
attestation requirement (proposed 9 CFR 310.27) to be invalid, such
action would not affect any other provision of 9 CFR parts 309 and 310.
As OSHA is the Federal agency with statutory and regulatory
authority to promote workplace safety and health, FSIS would forward
the annual attestations to OSHA for further review. OSHA, in turn, may
use the information in the attestations in its own enforcement program.
FSIS employees would not be responsible for determining the merit of
the content of each establishment's monitoring program or enforcement
of noncompliance with this section. FSIS would work with OSHA to
develop the 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.
IV. Other Proposed Changes That Affect All Swine Slaughter
Establishments
A. Procedures To Address Enteric Pathogens, Fecal Material, Ingesta,
and Milk Contamination as Hazards Reasonably Likely to Occur
In 1997, FSIS published a Federal Register document entitled
``Notice on complying with food safety standards under the HACCP system
regulations'' (62 FR 63254, November 28, 1997). The
[[Page 4797]]
purpose of the document was to ensure that establishments understood
the Agency's zero tolerance policy for visible fecal material as food
safety hazards, as establishments prepared to comply with the then
newly enacted HACCP system regulations. The document explained that
under 9 CFR 310.18, establishments must handle livestock carcasses and
carcass parts to prevent contamination with fecal material and promptly
remove contamination if it occurs. Based on this regulation, FSIS
enforces a zero tolerance policy for visible fecal contamination. Then,
the document explained that ``to meet the zero tolerance standard, an
establishment's [HACCP] controls must (among other things) include
limits that ensure that no visible fecal material is present by the
point of post-mortem inspection of livestock carcasses'' (citing 9 CFR
417.2(c)). Finally, the document explained that ``Under the HACCP
system regulations, critical control points to eliminate contamination
with visible fecal material are predictable and essential components of
all slaughter establishments' HACCP plans.'' As a result, all swine
slaughter establishments' HACCP plans currently include critical
control points (CCPs) for preventing carcasses contaminated with
visible fecal material at or after the final rail.
FSIS also enforces a zero tolerance policy for contamination by
ingesta and milk because the microbial pathogens associated with
ingesta and milk contamination are likely sources of potential food
safety hazards in slaughter establishments. As mentioned above, the
regulations require establishments to handle livestock carcasses and
carcass parts to prevent contamination and promptly remove
contamination if it occurs (9 CFR 310.18) The regulations also require
that lactating mammary glands and diseased mammary glands of swine be
removed without opening the milk ducts or sinuses because if pus or
other objectionable material is permitted to come in contact with the
carcass, the parts of the carcass are contaminated and must be removed
and condemned (9 CFR 310.17). Because such contamination is largely
preventable, most slaughter establishments already have in place
procedures designed to prevent and remove ingesta and milk.
FSIS is now proposing to amend 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 post-mortem
inspection of swine carcasses. Such a requirement would ensure that
establishments maintain the records to verify that they have
implemented the necessary measures and, when necessary, have taken
appropriate corrective actions to prevent carcasses contaminated with
visible fecal material, ingesta, or milk at or after the final rail.
Although the existing requirements for establishments to prevent
visible fecal material, ingesta, or milk at or after the final rail,
and the proposed requirement described above that establishments must
have procedures addressing how they do so, are important safeguards,
those safeguards would not be fully effective if an appropriate effort
is not made to prevent contamination from occurring throughout the
slaughter and dressing operation. Fecal material is a major vehicle for
spreading pathogenic microorganisms, such as Salmonella, to raw pork
products, and therefore, it is vital for establishments to maintain
sanitary conditions and to prevent, to the maximum extent possible,
contamination from occurring before slaughter and throughout the
slaughter and dressing process.
Under HACCP, establishments are responsible for identifying food
safety hazards that are reasonably likely to occur in the production
process and for implementing preventive measures to control those
hazards. Failure to implement preventive measures throughout the
slaughter and dressing process can lead to the creation of insanitary
conditions in the establishment and increases the potential for
carcasses and parts to become contaminated with enteric pathogens,
fecal material, ingesta, and milk. Interventions with chemical
antimicrobials applied at the end of the process are less likely to be
fully effective on carcasses that contain high levels of pathogens, and
these chemical treatments are not effective in preventing insanitary
conditions throughout the slaughter establishment.
To ensure that establishments implement appropriate measures to
prevent carcasses from becoming contaminated with pathogens, and to
ensure that both FSIS and establishments have the documentation they
need to verify the effectiveness of these measures on an on-going
basis, FSIS is proposing to require that all swine slaughter
establishments develop, implement, and maintain written procedures to
prevent contamination of carcasses and parts by enteric pathogens,
fecal material, ingesta, and milk throughout the entire slaughter and
dressing operation. FSIS is proposing that establishments incorporate
these procedures into their HACCP systems and that they maintain
records sufficient to document the implementation and monitoring of
these procedures. These proposed requirements are necessary to fully
implement the existing HACCP regulations.
Information that FSIS has collected from investigations it has
conducted in establishments that have received a Notice of Intended
Enforcement due to Salmonella serotypes linked to human illness
demonstrate the need for establishments to adopt preventive measures to
control contamination throughout the entire production process, as well
as the need to maintain documentation to verify the effectiveness of
those measures on an ongoing basis.
For example, FSIS conducted an investigation at a swine slaughter
establishment that resulted in a Notice of Intended Enforcement after a
State department of health conducted sampling and found the presence of
Salmonella serotypes linked to human illness, and after FSIS requested
a voluntary recall in 2015. FSIS reviewed the establishment's controls,
and records associated with the establishment's sanitary dressing
procedures and microbial interventions, and observed the
establishment's implementation of these controls and procedures. The
Agency's review found that the establishment had contamination of
Salmonella throughout the slaughter process, including carcasses,
environmental samples and pre-operational swabs. The cross
contamination and failure to maintain sanitary procedures appeared to
have overwhelmed any subsequent in-process interventions. FSIS
determined that the establishment's HACCP system was inadequate due to
multiple or recurring noncompliance (see 9 CFR 500.4(a)). If this rule
becomes final, establishments may choose to incorporate measures to
address the prevention of contamination by enteric pathogens and
contaminants (e.g., fecal, ingesta, and milk) into their procedures
addressing how they prevent contamination from occurring during
slaughter and dressing operations. Examples of such measures include:
Sanitary dressing protocols, statistical process control programs, and
sampling.
Under this proposed rule, establishments will be required to
incorporate these procedures into HACCP systems, and to maintain on-
going documentation to demonstrate that the procedures are effective.
FSIS is
[[Page 4798]]
not proposing to prescribe the specific procedures that establishments
must follow to prevent carcasses from becoming contaminated by enteric
pathogens, fecal material, ingesta, or milk because the Agency believes
that establishments should have the flexibility to implement the most
appropriate measures that will best achieve the requirements of this
proposed rule. However, on-going verification and documentation to
demonstrate that an establishment's process controls are effective in
preventing food safety hazards are critical components of the food
safety system. FSIS believes that microbiological test results that
represent levels of microbial contamination at key steps in the
slaughter process are necessary for establishments to provide
comprehensive, objective evidence to demonstrate that they are
effectively preventing carcasses from becoming contaminated with
pathogens before and after they enter the cooler.
In light of these changes, FSIS is proposing to rescind the generic
E. coli testing requirements in 9 CFR 310.25 and to replace them with a
new testing requirement that would provide establishments the
flexibility to sample for other, potentially more useful indicator
organisms. Under this proposal, establishments would continue to
conduct sampling and analysis of carcasses for microbial organisms at
the post-chill location, but in addition the Agency is proposing a
second testing location at the pre-evisceration position in order to
ensure establishments would be able to monitor the effectiveness of
process control for enteric pathogens throughout the slaughter and
dressing operation.
Under this proposed rule, instead of following a prescribed
microbiological testing program, each establishment would be
responsible for developing and implementing its own microbiological
sampling plan, which would be required to include carcass sampling at
pre-evisceration and post-chill. FSIS considers the microbial load of
hog carcasses at pre-evisceration to be a valuable source of data about
how well an establishment is taking into account the sanitary condition
of live hogs coming to slaughter and the processing steps (i.e.,
washing, dehairing) they implement to reduce the external contamination
of the carcass prior to evisceration. Following a similar logic, FSIS
considers the microbial characteristics of hog carcasses post-chill
(after all processing steps have taken place) to be a valuable source
of data about how well an establishment is minimizing contamination
during chilling as well as the overall effectiveness of all process
control interventions the establishment has chosen to apply throughout
its production process. Because most establishments apply one or more
interventions between the pre-evisceration and post-chill sampling
points to help control microbiological hazards, FSIS would expect that
a reduction in microbiological contamination between these two sampling
points to be an indication of the effectiveness of those controls. The
establishment would be responsible for determining which
microbiological organisms would best help it to monitor the
effectiveness of its process control procedures.
Because FSIS is proposing that establishments' microbiological
sampling plans be part of their HACCP systems, all swine slaughter
establishments would be required to provide scientific or technical
documentation to support the judgments made in designing their sampling
plans (see 9 CFR 417.4(a)). Under this proposal, establishments could
develop sampling plans to test carcasses for enteric pathogens, such as
Salmonella, at pre-evisceration and post chill, or they could test for
an appropriate indicator organism. FSIS has developed draft sampling
guidance to assist small and very small establishments in developing
sampling plans that meet the Agency's expectations for testing designs
and sampling frequency should this rule become final. FSIS has posted
this draft compliance guide on its web page (https://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index)
and is requesting comments on the guidance.
FSIS is proposing to prescribe a minimum frequency with which
establishments would be required to collect two samples, one at pre-
evisceration and one at post-chill, or, for very small and very low
volume establishments, a single post-chill sample. Under the proposed
rule, establishments, except for very small and very low volume
establishments \10\, would be required to collect samples at a
frequency of once per 1,000 carcasses. Very small and very low volume
establishments would be required to collect at least one sample during
each week of operation each year. FSIS is proposing to allow very small
and very low volume establishments to collect and analyze samples for
microbial organisms at the post-chill point in the process only because
these establishments typically are less automated and run at slower
line speeds than larger establishments. The lower level of automation
and the slower line speeds require less complicated measures for
maintaining and monitoring process control on an ongoing basis. If,
after consecutively collecting 13 weekly samples, very small and very
low volume establishments can demonstrate that they are effectively
maintaining process control, they can modify their sampling plans to
collect samples less frequently. These proposed frequencies reflect the
frequencies prescribed under the existing regulations for generic E.
coli testing. In light of these changes, FSIS is proposing to remove
the current requirement that swine establishments test carcasses for
generic E. coli to monitor process control. FSIS is also proposing to
eliminate the pathogen performance standards for market hogs in 9 CFR
310.25(b) because, as explained above, the codified standards are no
longer in use.
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\10\ Very small establishments are establishments with fewer
than 10 employees or annual sales of less than $2.5 million. 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.
---------------------------------------------------------------------------
FSIS is proposing to allow establishments to substitute alternative
sampling locations if they are able to demonstrate that the alternative
sampling locations provide a definite improvement in monitoring process
control than at pre-evisceration and post-chill. FSIS is also proposing
to allow establishments to substitute alternative sampling frequencies
if they are able to demonstrate that the alternative is an integral
part of the establishments' verification procedures for their HACCP
plans.
This proposed rule does not mandate that establishments meet
specific performance standards for microbial testing. Because
establishments would be required to incorporate their procedures for
preventing contamination by enteric pathogens and other contamination
(e.g., fecal material, ingesta, and milk) into their HACCP plans, or
sanitation SOPs, or other prerequisite programs, establishments would
be required to take appropriate corrective action when either the
establishment or FSIS determines that the establishment's procedures
are not effective in preventing carcass contamination throughout the
entire slaughter and dressing process. Establishments would also need
to routinely evaluate the effectiveness of their procedures in
preventing carcass contamination.
[[Page 4799]]
Under this proposed rule, FSIS would verify the effectiveness of
establishments' process control procedures in preventing carcasses from
becoming contaminated with enteric pathogens, fecal material, ingesta,
and milk by reviewing the establishments' monitoring records, including
the establishments' microbial testing results, observing establishments
implementing their procedures, and inspecting carcasses and parts for
visible fecal, ingesta, and milk contamination when conducting both
online carcass inspection and offline verification inspection
procedures.
If inspection personnel determine that an establishment's process
control procedures are not effective in preventing contamination by
enteric pathogens, fecal material, ingesta, and milk, the Agency would
take appropriate regulatory action to ensure that the establishment's
production process is in control, and that product is not being
adulterated. Such action could include performing additional visual
inspections of products or equipment and facilities, increasing offline
verification inspections, initiating Food Safety Assessments (FSAs),
conducting hazard analysis verification procedures, and retaining or
condemning product.
Finally, FSIS is proposing to require that all official swine
slaughter establishments develop, implement, and maintain in their
HACCP systems written procedures to prevent contamination of the pre-
operational environment by enteric pathogens. These procedures must
include sampling and analysis of food-contact surfaces, reuse water,
and equipment, including knives, in edible food production departments
in the pre-operational environment for microbial organisms to ensure
that the surfaces are sanitary and free of enteric pathogens. The
sampling frequency must be adequate to monitor the establishment's
ability to maintain sanitary conditions in the pre-operational
environment. FSIS is proposing this environmental sampling requirement
because in 2015, 152 people became ill after consumption of product
produced at an establishment where FSIS found evidence during an
investigation of insanitary conditions, including, but not limited to,
tables and knives in the pre-operational environment that were
contaminated with Salmonella. The proposed environmental sampling
requirement would reduce the risk of cross-contamination from
insanitary conditions in the pre-operational environment. FSIS is
requesting comments on this proposed environmental sampling
requirement. The proposed environmental sampling does not specifically
include lairage (e.g., holding pens for live swine) although scientific
literature conclusively shows that contamination occurs in this area of
the establishment. FSIS is also asking for comments on how to ensure
that lairage does not contribute to insanitary conditions.
V. Implementation
If this proposed rule becomes final, establishments interested in
NSIS would need to notify FSIS in writing of their intent to operate
under the new inspection system. The Agency is also considering
establishing separate applicability dates for large, small, and very
small establishments to comply with the proposed regulations that
prescribe procedures for controlling visible fecal, ingesta, and milk
contamination; the regulations that prescribe procedures for
controlling contamination throughout the slaughter and dressing
process; and the regulations that prescribe recordkeeping requirements.
The applicability dates would provide additional time for small and
very small establishments to comply with these provisions. The Agency
is requesting comments on its proposed implementation plan, especially
the phased in applicability dates for the proposed provisions in the
rule that prescribe requirements for all swine slaughter
establishments.
VI. Executive Orders 12866 and 13563
Executive Orders 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, and equity). Executive
Order 13563 emphasizes the importance of quantifying both costs and
benefits, of reducing costs, of harmonizing rules, and of promoting
flexibility. This proposed rule has been designated a ``significant''
regulatory action under section 3(f) of Executive Order 12866.
Accordingly, the rule has been reviewed by the Office of Management and
Budget under Executive Order (E.O.) 12866.
A. Request for Comments Summary
FSIS is requesting comments on:
1. Whether or not the Agency should require establishments under
NSIS to specify in their records the reason that the animals were
removed from slaughter and how this information should be collected.
2. The draft compliance guides.
3. Whether or not the Agency should allow establishments that
operate under the proposed NSIS to use discretion when deciding, on a
lot-by-lot basis, whether or not to incise mandibular lymph nodes and
palpate the viscera to detect the presence of animal diseases (e.g., M.
Avium) if they submit documentation to FSIS supporting that the
presence of M. Avium is not likely to occur, such as records
documenting their on-farm controls.
4. The effects of faster line speeds on worker safety.
a. Whether line speeds for the NSIS should be set at the current
regulatory limit of 1,106 hph or some other number.
b. The availability of records or studies that contain data that
FSIS may be able to use in analyzing the effects of increased line
speed on the safety and health of employees throughout the
establishment, including effects prior to and following the
evisceration line.
c. Whether the Agency should maintain the 1,106 hph maximum line
speed for establishments operating under NSIS but grant waivers from
the maximum line speed to establishments that agree to work with the
National Institute for Occupational Safety and Health to evaluate the
effects of waivers of line speed restrictions on employee health.
5. The proposed sampling requirements, especially the environmental
sampling requirement.
6. The proposed implementation plan, especially the phased in
applicability dates for the proposed provisions in the rule that
prescribe requirements for all swine slaughter establishments.
In addition, FSIS is requesting the following data to further
inform its consideration of the proposed rule. Further discussions of
these requests are provided in their corresponding sections.
1. Are very small establishments that exclusively slaughter market
hogs likely to convert to the NSIS?
2. How soon do establishments plan on adopting the NSIS?
3. Depending on establishment size, how many additional
establishment employees would the NSIS system require?
4. What are the capital costs for establishments associated with
the NSIS?
5. How long will it take establishment personnel such as a quality
technician to collect, record, and analyze data required to verify that
an
[[Page 4800]]
establishment's products meet the definition of RTC?
6. How many swine establishments have written sanitary dressing
plans?
7. How many establishment employees perform sanitary dressing tasks
in a swine slaughter establishment?
8. How many establishments conduct generic E. coli sampling at an
alternative frequency?
9. What are the alternative frequencies at which establishments are
conducting process control sampling?
10. How will changes in line speeds affect market hog prices,
establishment hours of production, consumer prices, and export volumes?
B. Need for the Rule
The swine slaughter industry in the U.S. has evolved since the
advent of the current swine inspection regulations used by the FSIS.
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.\11\ 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, adherence to current regulations at large
and high volume establishments that exclusively slaughter market hogs
prevents 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, one that is less prescriptive, creates incentives for
establishments to develop and invest in food quality controls and
safety procedures, and allows FSIS to improve inspection methods, is
needed.
---------------------------------------------------------------------------
\11\ Key, Nigel and William McBride. 2007. The Changing
Economics of U.S. Hog Production. USDA 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 88 percent
between 2005 and 2015.\12\ According to the Food and Agricultural
Organization, pork is consistently ranked as the top meat in per-capita
consumption worldwide \13\ and is ranked third in the United
States.\14\
---------------------------------------------------------------------------
\12\ USDA ERS Livestock and Meat Domestic Data. https://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105. Accessed on 12/2/15. Last updated on 11/30/15.
\13\ FAO Livestock commodities. https://www.fao.org/docrep/005/y4252e/y4252e05b.htm. Accessed on 11/29/16.
\14\ USDA ERS Livestock and Meat Domestic Data. https://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105. Accessed on 11/29/16. Last updated on 10/27/16.
Table 2--U.S. Pork Supply and Demand
----------------------------------------------------------------------------------------------------------------
U.S. Domestic Per capita
Year production * Imports * Exports * consumption * consumption **
----------------------------------------------------------------------------------------------------------------
2005............................ 20,705 1,024 2,666 19,093 65
2006............................ 21,074 990 2,995 19,055 64
2007............................ 21,962 968 3,141 19,763 66
2008............................ 23,367 832 4,651 19,431 64
2009............................ 23,020 834 4,094 19,869 65
2010............................ 22,456 859 4,223 19,077 62
2011............................ 22,775 803 5,196 18,382 59
2012............................ 23,268 802 5,379 18,607 59
2013............................ 23,204 880 4,986 19,105 60
2014............................ 22,858 1,011 5,092 18,836 59
2015............................ 24,517 1,116 5,009 20,593 64
----------------------------------------------------------------------------------------------------------------
* Measured in carcass weight, million pounds.
** Measured in carcass weight, pounds.
Source: USDA ERS Livestock and Meat Domestic Data. https://www.ers.usda.gov/data-products/livestock-meat-domestic-data.aspx#26105 accessed on 11/29/16. Last updated on 10/27/16.
In 2016, there were approximately 612 swine slaughter
establishments under Federal Inspection, Table 3.\15\ Combined, these
establishments process roughly 118 million hogs annually. FSIS divides
these swine into the following production categories for data
collection: Roaster swine, market hog, sow, and boar/stag. Today, the
majority (96%) of the pork products available in the market are derived
from market hogs.\16\
---------------------------------------------------------------------------
\15\ USDA, FSIS, Public Health Information System (PHIS).
\16\ 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.
[[Page 4801]]
As shown below in Table 4, many establishments now exclusively
slaughter market hog, a species sub class which due to technological
and managerial improvements, such as improved genetics, nutrition, and
medical services, generally presents fewer food safety and quality
issues.\17\
---------------------------------------------------------------------------
\17\ Key, Nigel and William McBride. 2007. The Changing
Economics of U.S. Hog Production. USDA ERS. Report No. 52.
---------------------------------------------------------------------------
D. Overview of the Proposed Rule's NSIS
Eight of the proposed rule's provisions apply to only those
establishments that voluntarily participate in the NSIS. Meeting these
provisions will likely increase an establishment's labor and training
costs. Additionally, only market hogs are eligible to participate in
the NSIS. Due to these economic constraints discussed above, we expect
that only large and small high volume establishments that exclusively
slaughter market hogs would voluntarily participate in the NSIS. In
2016 there were 40 high volume establishments that exclusively
slaughter market hogs, 27 large \18\ (5 HIMP + 22 non-HIMP) \19\ and 13
small establishments, Table 4. These establishments account for 92
percent of total swine slaughter, Table 4. Given their large share of
the market and the ability to slaughter a sufficient amount of market
hogs to justify the likely costs associated with NSIS, these
establishments are expected to voluntarily implement the proposed NSIS.
Therefore, this analysis calculates the costs and benefits associated
with the voluntary provisions for these 40 market hog establishments.
However, because the 5 HIMP establishments are already practicing the
proposed NSIS methods, they are not expected to incur any additional
new costs nor contribute to any increase in quantified benefits
associated with adopting the NSIS.
---------------------------------------------------------------------------
\18\ 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.
\19\ 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 Proposed Rule's Mandatory Components
All swine slaughter establishments would need to comply with the
three mandatory provisions of the proposed rule, which are described in
more detail in section IV. A.
1. Written Sanitary Dressing Plans
FSIS is proposing to amend 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 post-mortem
inspection of swine carcasses. This requirement would address a
weakness of the current 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 contamination from entering
the cooler. While preventing swine carcasses contaminated with visible
fecal material from entering the chiller 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
controls for them. 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 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 action to prevent further product contamination.
FSIS seeks comment on the extent to which written sanitary dressing
plans are necessary for ensuring that existing process controls are
effective.
While many establishments may already have written sanitary
dressing plans, due to data limitations, this analysis assumes that
every establishment will need to develop a written sanitary dressing
plan. This assumption will help ensure a conservative estimate. Ongoing
sanitary dressing 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.
2. Process Control Sampling and Analysis for Microbial Organisms
Under this proposed rule, instead of following a prescribed
microbiological testing program, each establishment would be
responsible for developing and implementing its own microbiological
sampling plan, which would be required to include carcass sampling at
pre-evisceration and post-chill. Current microbiological standards
[[Page 4802]]
prescribe that all establishments monitor process control by sampling
for generic E. coli. High volume establishments are required to take
one sample per 1,000 carcasses, or request an alternative rate. The
Agency is seeking comment on both the number of establishments
conducting alternative sampling rates and approved alternative sampling
rates. Very low volume establishments are required to take 1 sample per
week of operation up to 13 times a year. An industry survey found that
many establishments elect to perform other microbiological tests in
addition to testing for generic E. coli.\20\
---------------------------------------------------------------------------
\20\ Viator C. et al. 2015. (a) Meat Industry Survey in Support
of Public Health Risk-Based Inspection. P5-42. Question 3.1.
---------------------------------------------------------------------------
3. Environmental Sampling
FSIS is proposing to require that all official swine slaughter
establishments develop, implement, and maintain in their HACCP systems
written procedures to prevent contamination of the pre-operational
environment by enteric pathogens.
Such procedures must be incorporated into an establishment's HACCP,
sanitation SOP, or other prerequisite program. This analysis assumes an
establishment will incorporate its procedures for controlling
contamination in the pre-operational environment into its sanitation
SOP. These procedures must include sampling and analysis of food
contact surfaces in the pre-operational environment at a frequency
adequate to monitor the establishment's ability to maintain sanitary
conditions in the pre-operational environment.
F. Overview of the Proposed Rule's Agency Impact
This analysis also takes into consideration potential impacts to
the Agency's budget, which is expected to be impacted by changes in
staffing and training requirements. 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 establishments expected
to convert to NSIS, Table 5. When these establishments convert to NSIS,
Agency personnel will require NSIS training. Additionally, the number
of Agency personnel required to inspect the slaughter process will
likely change, see Agency Staffing section for details.
Table 5--Current FSIS Slaughter Line Positions at Non-HIMP Facilities
That Slaughter Exclusively Market Hogs
------------------------------------------------------------------------
Number of
OPM job code positions
------------------------------------------------------------------------
1862.................................................... 120
1863.................................................... 245
701..................................................... 53
---------------
Total................................................. 418
------------------------------------------------------------------------
Source: PHIS.
G. Expected Cost of the Proposed Rule
1. Associated With the NSIS Components of the Rule
This analysis estimates the cost associated with the proposed
rule's NSIS components. The Agency assumes that 22 large high volume
and 13 small high volume establishments, that have a history of
exclusively slaughtering market hogs, will adopt the NSIS portions of
the rule. These 35 establishments have similar characteristics as 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, the benefits from
adopting NSIS are expected to outweigh the 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. The Agency is seeking comment on this
assumption. While the 5 HIMP establishments are expected to adopt the
NSIS, they have already implemented the proposed changes associated
with the NSIS by their participation in the HIMP program 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. This analysis excludes further
consideration in the Preliminary Regulatory Impact Analysis of the
costs of submitting an attestation of work related conditions due to
its small expected cost.\21\ Costs examined generally fall under three
categories: Labor, capital expenses, and developing written procedures.
---------------------------------------------------------------------------
\21\ 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 28 large and 13 small
establishments approximately $93.64 annually (2 minutes * $68.52 per
hour * 41).
---------------------------------------------------------------------------
In the following sections, this analysis presents the costs and
benefits that would be 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 which are likely to adopt the NSIS will incur
additional costs associated with adoption. The Agency is seeking
comment on this assumption. Note, the 5 HIMP establishments are not
expected to incur any additional costs associated with adopting the
NSIS and are therefore excluded from this portion. Also, based on
actual NPIS adoption rates thus far, the assumptions presented in this
analysis may be an overestimate of adoption of NSIS.
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
[[Page 4803]]
5............................................................... 22 13 100
----------------------------------------------------------------------------------------------------------------
a. Costs of Additional Establishment Workers
This analysis expects establishments operating under NSIS to
experience an increase in labor costs. Under NSIS, establishments will
be required to dedicate labor to sort and remove unfit animals before
ante-mortem inspection and trim; identify defects, such as dressing
defects, contamination, and pathology defects, on carcasses and parts
before post-mortem inspection; ensure product is presented to Agency
inspectors in an appropriate manner; identify carcasses condemned on
ante-mortem inspection; denature all major portions of condemned
carcasses on-site; maintain records to document the number of animals
condemned on ante-mortem inspection; and notify Agency inspectors if
they suspect that an animal or carcass has a reportable or foreign
animal disease, while conducting sorting activities. Based on
observations \22\ of HIMP establishments, this increase in work is
expected to require an increase in labor demand ranging from 6-10
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. The
Agency seeks comment on the number of additional employees each
establishment will require due to the NSIS. Costs associated with this
labor fall into 3 categories: Wages and benefits, training, and
continuing education.
---------------------------------------------------------------------------
\22\ 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.
---------------------------------------------------------------------------
Establishment Labor Wage Increases
Many of the 22 large and 13 small non-HIMP market hog
establishments that are assumed will adopt NSIS operate multiple lines
and shifts. Taking these multiple lines and shifts into consideration,
the number of industry positions is expected to increase by 383. The
majority of these, 369, are attributable to the large establishments
(41 (number of lines) x 9),\23\ Table 7. The remaining 14 positions are
attributable to the small establishments (14 (number of lines) x
1),\24\ Table 7. According to the Bureau of Labor Statistics (BLS) the
expected hourly wage for a Slaughter and Meat Packer occupation
(``production employee'') is $13.00.\25\ 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).\26\ 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 on 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.
---------------------------------------------------------------------------
\23\ Source: PHIS.
\24\ Source: PHIS.
\25\ BLS Occupational Employment Statistics, Occupational
Employment and Wages, May 2016. 51-3023 Slaughters and Meat Packers
https://www.bls.gov/oes/current/oes513023.htm accessed on 7/24/17.
Last modified 3/31/17.
\26\ 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.
---------------------------------------------------------------------------
Training Online Sorters and Carcass-Inspection Helpers
Establishments are expected to incur costs associated with
initially training employees to fill these 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.\27\ 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 * $549), Table 7.
---------------------------------------------------------------------------
\27\ Viator. C. et al. 2015. (b) Costs of Food Safety
Investments. Table 4-4. Training Costs for Management and Production
Employees.
---------------------------------------------------------------------------
To account for expected 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.\28\ The additional annual training cost
for new employees is expected 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 $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.
---------------------------------------------------------------------------
\28\ 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/jolts.t16.htm.
Accessed on 7/21/17. 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, with a mid-point of $24.\29\ 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
[[Page 4804]]
approximately $24,984 (1,041 x $24) and small establishments accounting
for approximately $936 (39 x 24).
---------------------------------------------------------------------------
\29\ Viator. C. et al. 2015. (b) 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 $16.45 million, applying a 3 percent
discount rate over 10 years, Table 7. The majority of this cost is
attributed to wages and benefits, Table 7.
Table 7--Establishment Labor Costs
[M$]
----------------------------------------------------------------------------------------------------------------
Number of
Type of establishment Type of expense personnel One-Time cost Recurring 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 .............. 0.03
----------------------------------------------------------------------------------------------------------------
Totals:
One-Time................................................................................ 0.84
Recurring Cost.......................................................................... 21.66
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. 16.62
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. 15.99
----------------------------------------------------------------------------------------------------------------
b. Costs of Capital Improvements: Line Configuration and Inspection
Stations
As proposed, participating in NSIS does not necessitate capital
improvements. As such, this analysis does not include capital
expenditures. However, if establishments believe that capital
expenditures would result in a benefit they may voluntarily reconfigure
or update their facilities so as 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 to $250,000,\30\ and the creation of an inspection station,
which can cost between $5,000 and $6,000.\31\ Establishments may reduce
these costs by coordinating these facility updates with previously
planned establishment renovations. The Agency is seeking comment on
both the required and voluntary capital costs associated with the NSIS.
---------------------------------------------------------------------------
\30\ In a May 2004 study, ERS estimated the cost of compliance
per establishment with PR/HACCP rule. Capital expenditures in Hog
Slaughter establishments were estimated to be $251,800.
Ollinger, Michael, Danna Moore, Ram Chandran (2004). Meat and
Poultry Establishments' Food Safety Investments. USDA, Economic
Research.
\31\ Modernization of Poultry Slaughter Inspection; Final Rule,
79 FR. 49566 (2014).
---------------------------------------------------------------------------
c. Costs of Developing Ante-Mortem Written Procedures
Under the proposed rule, establishments operating under NSIS are
required to develop and maintain in their HACCP systems (HACCP plans,
Sanitation Standard Operating Procedures, 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, fecal
material, ingesta, and milk throughout the entire slaughter and
dressing operation, a mandatory component of the proposed rule. Details
of these costs can be found in the sanitary dressing costs section
VI.2.a.
d. Ready-To-Cook Pork Standards
As proposed, establishments operating under NSIS are required to
collect, record, and analyze documentation to demonstrate that the
products resulting from their slaughter operation meet the proposed
definition of RTC pork products. While the Agency is seeking comment on
this requirement, this analysis estimates the labor costs to conduct
such documentation under two assumptions. First, FSIS assumes that
establishments would assign the task to a quality control technician,
QC, with an hourly compensation rate, which included wages, benefits,
and overhead, of $68.52.\32\ Second, FSIS assumes that this work would
take 1 hour at a large establishment and \1/2\ hour at a small
establishment. The Agency is seeking comment on this assumption. Based
on information obtained through PHIS, the average large establishment
operates 269 days per year. This equates to an annual cost of
approximately $18,432 (268 * 1 * $68.52), or approximately $0.41
million for all 22 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 $0.39 million, applying a 3 percent
discount rate over 10 years, Table 8.
---------------------------------------------------------------------------
\32\ To be consistent with analyses done by the Department of
Health and Human Services, this analysis accounts for fringe
benefits and overhead by multiplying wages by a factor of 2.
[[Page 4805]]
Table 8--Cost of RTC Requirements
[M$]
------------------------------------------------------------------------
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 0.39
Over 10 Years..................................
Annualized Costs, Assuming a 7% Discount Rate 0.38
Over 10 Years..................................
------------------------------------------------------------------------
2. Costs Associated With the Mandatory Components of the Rule
The mandatory costs of the proposed rule are expected to apply to
all 612 swine slaughter establishments and begin within the first year
after the rule is finalized. These costs are associated with (a)
establishing and implementing written sanitary dressing plans to
prevent contamination of carcasses and parts by enteric pathogens,
fecal material, ingesta, and milk, throughout the entire slaughter and
dressing operation; (b) modernizing process control sampling programs
for microbial organisms; and (c) sampling the slaughter environment for
microbiological contamination.
a. Costs of Developing, Composing, Training, Monitoring, Recording, and
Verifying Written Sanitary Dressing Plans
Under the mandatory portion of the proposed rule affecting all
federally inspected establishments that slaughter swine, FSIS is
proposing to require 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, fecal material, ingesta, and milk throughout the
entire slaughter and dressing operation. This cost component includes:
(1) Developing these procedures into their food safety system, (2)
training, and (3) monitoring, recordkeeping, and verification.
Developing and Composing
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 the Research Triangle Institute's (RTI)
Costs of Food Safety Investments report,\33\ 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.\34\ To ensure a
conservative cost estimate, this analysis assumes all 612 swine
establishments will incur this cost. The Agency is seeking comment on
this assumption. The cost to all large establishments is approximately
$20,440 (28 * $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 612 swine slaughter establishments is approximately $0.03
million, Table 9.
---------------------------------------------------------------------------
\33\ Viator. C. et al. 2015. (b) RTI International collected
data on the cost of food safety investments for the production of
meat and poultry products at the pre-harvest and slaughter and
processing stages. This data was provided to FSIS in a final report
titled `Costs of Food Safety Investments' and was prepared by
Catherine L. Viator, Mary K. Muth, and Jenna E. Brophy. The contract
number is No. AG-3A94-B-3-0003. The order number is AG-3A94-K-14-
0056.
\34\ Viator. C. et al. 2015. (b) Table 4-2. Costs of Sanitation
SOP Plan Development, Validation and Reassessment.
Table 9--Written Sanitary Dressing Plan Development
[M$]
------------------------------------------------------------------------
Number of
HACCP size plants One-time cost
------------------------------------------------------------------------
Large................................... 28 $0.02
Small................................... 105 0.04
Very Small.............................. 479 0.17
------------------------------------------------------------------------
Totals:
One-Time Cost................................... 0.23
Annualized Costs, Assuming a 3% Discount Rate 0.03
Over 10 Years..................................
Annualized Costs, Assuming a 7% Discount Rate 0.03
Over 10 Years..................................
------------------------------------------------------------------------
Training
Training programs should 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.\35\ 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 actually spend on training. Due to data limitations,
this analysis assumes the number of establishment employees
[[Page 4806]]
conducting sanitary dressing tasks at swine establishments is equal to
the number of employees conducting sanitary dressing tasks at beef
slaughter establishments.\36\ 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. The Agency is seeking comment on this
assumption.
---------------------------------------------------------------------------
\35\ Viator, C. et al. 2015. (b).
\36\ 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 Bureau of Labor Statistics', BLS,
2016 turnover rate for non-durable manufacturing goods.\37\ 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 612
establishments is roughly $1.13 million, while the total recurring
costs is roughly $0.49 million, Table 10. The annualized costs with a 3
percent discount rate over 10 years for Sanitary Dressing task related
training is $0.62 million, Table 10.
---------------------------------------------------------------------------
\37\ This analysis uses the industry turnover rate for non-
durable manufactured goods to estimate. Source: BLS Economic News
Release Table 16. Annual total separations rates by industry and
region, not seasonally adjusted. <https://www.bls.gov/news.release/jolts.t16.htm Accessed on 7/21/17. Last updated on 3/16/
17.
Table 10--Sanitary Dressing Training Costs
[M$]
----------------------------------------------------------------------------------------------------------------
Training costs
-----------------------------------------------
HACCP size Number of Average number One-time Recurring
establishments of employees -----------------------------------------------
Initial New hires Refresher
----------------------------------------------------------------------------------------------------------------
Large........................... 28 179 $0.61 $0.18 $0.09
Small........................... 105 25 0.32 0.09 0.04
Very Small...................... 479 3 0.20 0.06 0.03
----------------------------------------------------------------------------------------------------------------
Totals:
One-Time Cost........................................................................... 1.13
Recurring Cost.......................................................................... 0.49
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. 0.62
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. 0.64
----------------------------------------------------------------------------------------------------------------
Monitoring, Recordkeeping, and Verification
This analysis also measures the annual monitoring, recordkeeping
and verification costs associated with maintaining sanitary dressing
procedures. Similar to the Modernization of Poultry Slaughter
Inspection Final Rule,\38\ 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 expected 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 $0.85 million
annually, applying a 3 percent discount rate over 10 years, Table 11.
---------------------------------------------------------------------------
\38\ 79 FR 49566-49637, August 21, 2014.
Table 11--Monitoring, Record Keeping and Verification Costs
[M$]
----------------------------------------------------------------------------------------------------------------
Recurring costs
-----------------------------------------------------------------------------------------------------------------
HACCP Size Monitoring Record keeping Verification Combined
----------------------------------------------------------------------------------------------------------------
Large........................................... $0.016 $0.02 $0.04 $0.07
Small........................................... 0.038 0.04 0.12 0.20
Very Small...................................... 0.070 0.07 0.44 0.58
----------------------------------------------------------------------------------------------------------------
Totals:
Recurring Cost.......................................................................... 0.85
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. 0.85
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. 0.85
----------------------------------------------------------------------------------------------------------------
Summary Cost 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 $1.50 million annualized, assuming a 3 percent
discount rate over 10 years, Table 12.
[[Page 4807]]
Table 12--Summary of Costs Associated With Requiring Written Sanitary Dressing Procedures
[M$]
----------------------------------------------------------------------------------------------------------------
One-time costs Recurring costs
---------------------------------------------------------------
HACCP size Number of Monitoring,
establishments Development Initial Training recording,
training validating
----------------------------------------------------------------------------------------------------------------
Large........................... 28 $0.02 $0.61 $0.27 $0.07
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........................... .............. .............. .............. 1.36
Recurring Cost.......................... .............. .............. .............. 1.34
Annualized Costs, Assuming a 3% Discount .............. .............. .............. 1.50
Rate Over 10 Years.....................
Annualized Costs, Assuming a 7% Discount .............. .............. .............. 1.53
Rate Over 10 Years.....................
----------------------------------------------------------------------------------------------------------------
b. Process Control Sampling and Analysis for Microbial Organisms
This section reviews the expected changes in costs associated with
the proposed alterations to microorganism process control verification.
These costs are limited to the changes associated with removing the
requirement that swine establishments test carcasses for generic E.
coli and replacing them with new testing requirements described above.
While the proposed 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 expected 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 \39\ and Costs of Food
Safety Investments report.\40\ Each of these categories is explained in
detail below.
---------------------------------------------------------------------------
\39\ 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.
\40\ Viator C. et al. 2015. (b).
---------------------------------------------------------------------------
Process Control Sampling Plan Reassessment
This analysis assumes establishments will incur one-time costs of
conducting a process control sample plan reassessment under the
proposed 9 CFR 310.25(a)(2)(i). The RTI Costs of Food Safety Investment
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.\41\ The
annualized reassessment cost to industry is roughly $0.19 million,
assuming a 3 percent discount rate over 10 years, Table 13.
---------------------------------------------------------------------------
\41\ The report classifies establishments as either large or
small. Given this data limitation, this analysis assumes very small
and small establishments have similar reassessment costs.
Table 13--Costs of Process Control Sampling Plan Reassessment
[M$]
----------------------------------------------------------------------------------------------------------------
Per
Number of establishment Total one-
HACCP size establishments (mid-point time costs
estimate) *
----------------------------------------------------------------------------------------------------------------
Large........................................................... 28 $0.05 $1.53
Small........................................................... 105 243 0.03
Very Small...................................................... 479 243 0.12
----------------------------------------------------------------------------------------------------------------
Totals:
One-Time Cost........................................................................... 1.67
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. 0.19
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. 0.22
----------------------------------------------------------------------------------------------------------------
* The values for Small and Very Small Establishments are in dollars.
Transferring From Prescriptive To Process Testing Requirements
Current regulation prescribes that each slaughter facility will
test for generic E. coli.\42\ In addition to mandated generic E. coli
testing, many establishments voluntarily conduct additional
microbiological testing to verify process control. Common microbiologic
tests include aerobic plate count (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.\43\
[[Page 4808]]
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.
---------------------------------------------------------------------------
\42\ 9 CFR 310.25.
\43\ 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 would
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 28 large (28 * 1.00), 41 small high volume (51 * .80), 43
small low volume (54 * .80) and 342 very small (479 * .714)
establishments that currently test for generic E. coli and at least one
other microbial or pathogen indicator \44\ would 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.
---------------------------------------------------------------------------
\44\ 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 and
small high volume establishments conduct 1 test, every 1,000 carcasses,
and all small low volume and very small establishments conduct 13 tests
annually.\45\ The Agency is seeking comment on this assumption. 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
$24.92.\46\ To have the sample tested at a contracted lab, the cost is
$48.76.\47\ 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.\48\ For these 454 establishments, the
combined reduction in testing costs of no longer being required to test
for generic E. coli is expected to reduce annual testing costs by
approximately $3.92 million, assuming a 3 percent discount rate over 10
years, Table 14.
---------------------------------------------------------------------------
\45\ 9 CFR 310.25(a)(2)(iii) (B). The current regulation (9 CFR
310.25(a)(2)(v)) defines very low volume swine slaughter
establishments as slaughtering 20,000 head annually or fewer. For
the purposes of this analysis, FSIS has labeled swine establishments
that annually slaughter more than 20,000 head per year as high
volume.
\46\ Viator C. et al. 2015. (b) Table 5-1.
\47\ Viator C. et al. 2015. (b) Table 5-1.
\48\ Viator, C. et al. 2015. (b).
Table 14--Recurring Costs (Savings) From No Longer Requiring Generic E.
coli Testing
[M$]
------------------------------------------------------------------------
Number of
HACCP size establishments (Savings)
------------------------------------------------------------------------
Large................................... 28 ($3.28)
Small High Volume....................... 41 (0.40)
Small Low Volume........................ 43 (0.02)
Very Small.............................. 342 (0.22)
------------------------------------------------------------------------
Totals:
Recurring Cost.................................. (3.92)
Annualized Costs, Assuming a 3% Discount Rate (3.92)
Over 10 Years..................................
Annualized Costs, Assuming a 7% Discount Rate (3.92)
Over 10 Years..................................
------------------------------------------------------------------------
Process Control Sampling Rates
The proposed rule would require large and small high volume
establishments to take samples at pre-evisceration and post-chill,
which would increase the number of samples taken from 1 sample per
1,000 carcasses to 2 samples per 1,000 carcasses for large and small
high volume establishments. The proposed rule does not require small
low volume and very small establishments to increase their sampling
rates. Under the proposed regulations, large establishments annual
process control sampling costs are expected to increase by roughly
$2.34 million, which is roughly $83,639 per establishment ($2.34
million/28), Table 15. Small high volume establishments annual process
control sampling costs are expected to increase by roughly $0.29
million, which is roughly $5,740 ($0.29 million/51) per establishment,
Table 15.
Process Control Sample Recordkeeping
This analysis takes into consideration the increase in record
keeping 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
establishment slaughters approximately 3.77 million swine per year. As
such, this analysis estimates that a large establishment currently
takes approximately 3,774 samples annually (3,774,223/1,000). The
average small high volume swine establishment slaughters 0.23 million
swine per year and requires approximately 229 samples (228,784/1,000)
annually. Assuming it takes 2.5 minutes to record the results of each
sample, the average large establishment currently requires 9,435
minutes (2.5 * 3,774) per year and the average small high volume
establishment currently requires 573 minutes (2.5 * 229) per year.
Requiring establishments to increase their sampling rates from 1 to 2
samples per 1,000 head would increase the average large establishment's
annual number of samples to 7,548 samples annually (3,774,223/1,000
*2), which would require approximately 18,870 minutes (2.5 * 7,548)
annually. The same requirement would increase a small high volume
establishment's annual sampling to 458 (228,784/1,000 * 2), which would
require approximately 1,145 minutes (2.5 * 458) annually. As such, the
expected additional time required for recordkeeping is approximately
9,435 minutes (18,870-9,435) for large establishments and 572 minutes
(1,145-573) for small high volume establishments. Assuming a quality
control technician with a compensation rate of $68.52 per hour \49\
conducts this work, the additional costs
[[Page 4809]]
to the average large establishment is approximately $10,775 (9,435/60 *
$68.52). Similarly, the additional cost to the average small high
volume establishment is approximately $653 (572/60 * 68.52). Scaling
this up to all establishments, the total increase in costs to all large
establishments is approximately $0.30 million ($10,775 * 28) and $0.03
million ($653 * 51) for small high volume establishments, Table 15.
---------------------------------------------------------------------------
\49\ 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.
---------------------------------------------------------------------------
The combined annualized sampling and recordkeeping cost to all
large and small high volume establishments is roughly $2.97 million,
applying a 3 percent discount rate over 10 years. Large establishments
are expected to incur the majority of this cost.
Table 15--Costs Changes Associated With Increase Sampling Rates
[M$]
----------------------------------------------------------------------------------------------------------------
Costs
Number of ------------------------------------------------
establishments Sampling Recordkeeping Combined
----------------------------------------------------------------------------------------------------------------
Large.......................................... 28 $2.34 $0.30 $2.64
Small-High Volume.............................. 51 0.29 0.03 0.33
----------------------------------------------------------------------------------------------------------------
Totals:
Recurring Cost.......................................................................... 2.97
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. 2.97
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. 2.97
----------------------------------------------------------------------------------------------------------------
Summary of Process Control Sampling Costs Changes
Overall, the changes in sampling requirements under the proposed
rule are expected to reduce industry wide sampling costs by about $0.76
million annualized over 10 years, applying a 3 percent discount rate,
Table 16. However, only the 454 establishments that currently conduct
multiple types of microbiological tests are expected to experience a
reduction in cost. The remaining establishments, roughly 158 small and
very small establishments, are expected to incur a portion of the one-
time costs associated with plan reassessment, Table 16. Cost increases
associated with testing and recordkeeping will be exclusively borne by
large and small high volume establishments.
Table 16--Summary of Changes to Process Control Sampling
[M$]
------------------------------------------------------------------------
Cost (savings)
Type of change -------------------------------
One-time Recurring
------------------------------------------------------------------------
Plan Reassessment....................... $1.67 ..............
Converting to Process Control Sampling.. .............. ($3.92)
Testing Costs........................... .............. 2.63
Recordkeeping........................... .............. 0.33
------------------------------------------------------------------------
Totals:
One-Time Cost................................... 1.67
Recurring Cost.................................. (0.95)
Annualized Costs, Assuming a 3% Discount Rate (0.76)
Over 10 Years..................................
Annualized Costs, Assuming a 7% Discount Rate (0.72)
Over 10 Years..................................
------------------------------------------------------------------------
c. Environmental Sampling
As proposed, all swine slaughter establishments will be required to
control for enteric pathogen contamination in the pre-operational
environment. Such controls will have to be included in an
establishment's HACCP system, requiring a plan reassessment. This
analysis assumes establishments will coordinate this work with the
HACCP plan reassessment required by the development of written sanitary
dressing procedures. As such the cost of incorporating pre-operational
environment sampling plans into an establishment's HACCP system is
included in the reassessment costs associated with written sanitary
dressing procedures.
While establishments will set sampling frequency so as to ensure
effective control, this analysis assumes each large establishment will
take 4 samples per 30 days of operation per line, while each small high
volume establishment will take 2 samples per 30 days of operation per
line, and small low volume and very small establishments will take 1
sample per 30 days of operation per line.\50\ Under this assumption,
the annual number of tests required by the entire industry is
approximately 3,266. The Agency is seeking comment on this assumption.
Establishments are permitted to conduct a variety of tests, including
testing for Aerobic Plate Count, APC, Coliforms, Generic E. coli, Total
Plate Count, TPC, and Salmonella. The laboratory testing
[[Page 4810]]
costs for these test range from $15 to $32, with an average mean
testing cost of $19, Table 17.\51\
---------------------------------------------------------------------------
\50\ In absence of other data we assumed establishments would
conduct environmental sampling similar to the recommended
frequencies described on Page 91 in: FSIS Compliance Guidelines:
Controlling Listeria monocytogenes in Post-lethality Exposed Ready-
to-Eat Meat and Poultry Products. January 2014. Accessed on 12/3/15.
Available at https://www.fsis.usda.gov/wps/wcm/connect/d3373299-50e6-47d6-a577-e74a1e549fde/Controlling-Lm-RTE-Guideline.pdf?MOD=AJPERES.
Industry is familiar with this methodology for sampling food-
contact-surfaces in the post-lethality environment to ensure that
the surfaces are sanitary and free of Listeria monocytogenes or an
indicator organism. We assumed industry would take a similar
approach in sampling food-contact-surfaces in market hog
establishments to meet the proposed environmental sampling
requirements.
\51\ Viator. C. et al. 2015. (b) Table 5-1. Laboratory Testing
Costs.
Table 17--Laboratory Testing Costs
----------------------------------------------------------------------------------------------------------------
Test Minimum Mean Maximum
----------------------------------------------------------------------------------------------------------------
APC............................................................. $16 $18 $20
Coliforms....................................................... 15 18 22
E. coli......................................................... 15 18 22
Salmonella...................................................... 17 25 32
TPC............................................................. 16 16 17
Average......................................................... 16 19 23
----------------------------------------------------------------------------------------------------------------
Source: Viator. C. et al. 2015. Costs of Food Safety Investments. Table 5-1. Laboratory Testing Costs.
To ensure a conservative estimate this analysis assumes
establishments will test for Salmonella, which is the most expensive
option, Table 17. Under these assumptions, the combined total annual
environmental sampling cost is approximately $0.08 million (3,266 x
$25). The annualized cost of these combined expenditures is roughly
$0.08 million, assuming a 3 percent discount rate over 10 years, Table
18.
Table 18--Costs of Environmental Sampling
[M$]
------------------------------------------------------------------------
Number of
HACCP size establishments Sampling costs
------------------------------------------------------------------------
Large................................... 28 0.03
Small High Volume....................... 51 0.02
Small Low Volume........................ 54 0.004
Very Small.............................. 479 0.03
------------------------------------------------------------------------
Totals:
Recurring Cost.................................. 0.08
Annualized Costs, Assuming a 3% Discount Rate 0.08
Over 10 Years..................................
Annualized Costs, Assuming a 7% Discount Rate 0.08
Over 10 Years..................................
------------------------------------------------------------------------
Summary of Voluntary and Mandatory Costs
The total annualized value of all costs to industry, under the
assumed five year adoption rate as shown in Table 6, is roughly $17.84
million, assuming a 10 year annualization and a 3 percent discount
rate, Table 19. Large establishments that voluntarily switch to the
NSIS incur the majority of costs. For example, the recurring labor
costs associated with the NSIS is the single largest recurring cost to
industry and is mostly incurred by large establishments. It should be
noted that the five HIMP pilot establishments have already incurred
these costs, suggesting for those five establishments, the benefits of
NSIS outweigh the costs. It also suggests that the benefits of adopting
NSIS outweigh the costs for other establishments as well. Training
staff accounts for the bulk of the costs associated with written
sanitary dressing procedures. Sampling costs are expected to decrease
for those establishments that currently conduct microbiological tests
in addition to generic E. coli.
Table 19--Combined Costs to Industry
[M$]
----------------------------------------------------------------------------------------------------------------
Total costs
Type of cost Number of -------------------------------
establishments One-time Recurring
----------------------------------------------------------------------------------------------------------------
Voluntary:
Establishment Labor......................................... 35 $0.84 $21.66
Ready to Cook............................................... 35 .............. 0.51
Mandatory:
Written Sanitary Dressing Plan.............................. 612 1.36 1.34
Process Control Sampling.................................... 612 1.67 (0.95)
Environmental Sampling...................................... 612 0.0 0.08
----------------------------------------------------------------------------------------------------------------
Totals *:
Number of Establishments................................................................ 612
One-Time Cost........................................................................... 3.88
Recurring Cost.......................................................................... 22.65
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. 17.84
[[Page 4811]]
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. 17.24
Totals Mandatory *:
Number of Establishments................................................................ 612
One-Time Cost........................................................................... $3.03
Recurring Cost.......................................................................... $0.48
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. $0.82
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.......................................................................... $22.17
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. $17.02
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. $16.36
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
H. Expected Benefits of the Proposed Rule
1. Expected 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 expected to reduce pathogen levels in
swine slaughter establishments. 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 HACCP-based Inspection Models
Project (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. 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
change in carcass contamination prevalence under the inspection
procedures of NSIS.
Changes in expected numbers of Salmonella illness are estimated
based on a proportional relationship between carcass contamination
prevalence and illnesses that has been published in the peer-reviewed
literature.52 53 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, if the
proportion of carcasses with no detectable Salmonella contamination
increases with implementation of the NSIS, illnesses caused by
consumers' exposure to these carcasses are expected to decrease
proportionally.
---------------------------------------------------------------------------
\52\ 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.
\53\ 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.
---------------------------------------------------------------------------
The market hog Salmonella illness risk model estimates that the
prevalence of Salmonella detected in carcasses will decline on average
from an initial prevalence of 0.9407% to a final prevalence of 0.9066%
if the 35 establishments identified adopt the new inspection system.
The uncertainty of the final prevalence ranges from 0.8982% to 0.915%,
at the 10th and 90th percentiles, respectively. 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.\54\
---------------------------------------------------------------------------
\54\ 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.\55\ 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 768 and
4,287 decreased cases, respectively. The total case uncertainty
distribution is dependent on the uncertainty in the change in
Salmonella prevalence in market hogs which has an average percent
uncertainty of a 3.626% decrease and is bounded at the 10th and 90th
percentiles by a decrease of 1.0989% and 6.1362%, respectively.
---------------------------------------------------------------------------
\55\ 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.
---------------------------------------------------------------------------
[[Page 4812]]
The prevalence estimates are modeled with data variability and
robust uncertainty components taken from sampling data and model
parameter estimates. 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, without
intervention. With adoption of the new inspection system, the average
number of cases is likely to decrease to 67,324 with 10th and 90th
percentiles of 38,653 and 101,417 cases, respectively.
The market hog risk assessment estimates that if the 35
establishments expected to covert to the NSIS over 5 years do so, the
number of human illness attributed to products derived from market hogs
could reduce by an average of 2,533 Salmonella illnesses. The combined
robust model estimate of total 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 768 and
4,287 decreased cases, respectively. 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.\56\ 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 20. The cost savings assuming
the lowest cost per illness and only 768 cases avoided, which
corresponds to the 10th percentile, is $0.25 million, Table 20.
Alternatively, the cost savings assuming the highest cost per illness
and 4,287 averted illnesses, which corresponds to the 90th percentile,
is $24.95 million, Table 20. 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 20. 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
detectable with Salmonella.
---------------------------------------------------------------------------
\56\ 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 20--Health Benefits From Averted Cases of Salmonella
----------------------------------------------------------------------------------------------------------------
Cost per illness *
Illnesses -----------------------------------------------
Percentile averted by Low Mid High
scenario -----------------------------------------------
$321 $3,682 $5,820
----------------------------------------------------------------------------------------------------------------
Scenario costs, $M
---------------------------------------------------------------
10th............................................ 768 ($0.25) ($2.83) ($4.47)
Mean............................................ 2,533 (0.81) (9.33) (14.74)
90th............................................ 4,287 (1.38) (15.79) (24.95)
----------------------------------------------------------------------------------------------------------------
Totals (Low)(M$):
Recurring Cost.......................................................................... ($0.25)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. ($0.19)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. ($0.18)
Totals (Mid)(M$):
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............................. ($6.81)
Totals (High)(M$):
Recurring Cost.......................................................................... ($24.95)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. ($18.97)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. ($18.22)
----------------------------------------------------------------------------------------------------------------
* 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.
2. Other Benefits Associated With Modernizing Existing Regulations
The proposed regulation is expected to reduce the regulatory burden
on establishments by shifting from prescriptive to performance based
regulation. Specifically, the proposed rule amends requirements related
to slaughter line speeds,\57\ microbiological testing, and sorting
activities. Based on the Evaluation of HACCP Inspection Models Project
(HIMP) for Market Hogs report, the five HIMP establishments' average
line speed were approximately 12.49 percent faster than comparable
establishments.\58\ 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
[[Page 4813]]
American Meat Institutes' average pork packer margins for 2010-2014,
which was reported to be $4.10 per head in NAMI's 2015 Meat and Poultry
Facts.\59\ The pork packer margin is the price the packer receives less
the cost of the hog and production costs, making the packer margin an
approximation for producer surplus. FSIS requests comment on refining
this estimate so as to distinguish between accounting profit and
economic profit--the latter being more precisely associated with
producer surplus.
---------------------------------------------------------------------------
\57\ According to the Evaluation of HACCP Inspection Models
Project (HIMP) for Market Hogs Final Report, November 2014, ``In CY
2013, the estimated line speeds at the 5 HIMP market hog
establishments varied from 885 to 1,285 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''.
\58\ 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-+himp Accessed on 1/6/2017. Last updated on 11/
14/2014.
\59\ Nalivka, J.S., The 2015 Meat and Poultry Facts, NAMI
December 2015.
---------------------------------------------------------------------------
Assuming establishments increase their line speeds by 12.49 percent
and have a packer margin of $4.10 per head, an average large
establishment's surplus could increase by approximately $2.04 million,
while an average small high volume establishment's surplus could
increase by $0.18 million, all else being equal. Combined, such an
increase in efficiency at all 35 establishments would increase producer
surplus by roughly $47.33 million \60\ (22 x $2.04 million + 13 x $0.18
million), which has an annualized benefit of roughly $47.33 million,
assuming a 3 percent discount rate over 10 years, Table 21. 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,
consumer benefits would be conditional on how an increase in line speed
affects retail prices. As such, the Agency is seeking comment on the
extent to which such an increase in line speeds would affect market hog
prices, establishment hours of production, consumer prices, and export
volumes.\61\
---------------------------------------------------------------------------
\60\ Note, some of the totals may not equal the sum due to
rounding.
\61\ The Agency further notes that marginal costs typically
increase as a function of production quantity, in which case profit
margins reach zero for the last unit of production; indeed, the
phenomenon of rising marginal costs is consistent with the
observation of HIMP line speed increases that are less than the
maximum increase that is theoretically permissible. Assuming
linearity of the relevant marginal cost curve would yield a margin
of $2.05 per head, thus making producer surplus half the amount
estimated here as the change in industrial efficiency. Meanwhile, if
demand and supply elasticities for pork products are similar--which
may or may not be plausible--then consumer surplus would increase by
half the industrial efficiency amount estimated here, thus making
the overall efficiency change estimate a reasonable approximation
for the total (consumer plus producer) surplus gain.
Table 21--Industrial Efficiency, (Benefits) M$
----------------------------------------------------------------------------------------------------------------
Change in efficiency
Number of -------------------------------
Type of establishment establishments Per
establishment Combined
----------------------------------------------------------------------------------------------------------------
Large........................................................... 22 ($2.04) ($44.97)
Small........................................................... 13 (0.18) (2.37)
Combined *...................................................... 35 .............. (47.33)
----------------------------------------------------------------------------------------------------------------
Totals:
Recurring Cost.......................................................................... (47.33)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. (36.14)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. (34.74)
----------------------------------------------------------------------------------------------------------------
* Note, some of the totals may not equal the sum due to rounding.
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.\62\
The five establishments that participated in the pilot project account
for 15 percent of total swine production.
---------------------------------------------------------------------------
\62\ 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-+himp Accessed on 1/6/2017. Last updated on 11/
14/2014.
---------------------------------------------------------------------------
Additionally, NSIS inspection increases the Agency's ability to
conduct more process and product verification and 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 HATS categories in HIMP
market hog establishments compared to approximately 4.29 hours per
shift in the 21 non-HIMP market hog comparison establishments.\63\
Under 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.
---------------------------------------------------------------------------
\63\ 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-+himp Accessed on 1/6/2017. Last updated on 11/
14/2014.
---------------------------------------------------------------------------
I. Expected Budgetary Impacts
Under the proposed rule, the Agency would shift Agency resources
from online to offline activities. This analysis estimates such a shift
will reduce labor expenses by approximately $6.67 million annually,
Table 22. However, Agency personnel at NSIS establishments will require
additional training, the annualized cost of which is estimated to be
approximately $0.30 million. Both of these annualized estimates apply a
3 percent discount rate over 10 years. 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 and up to 2 FTEs at a
small market hog establishment. Under NSIS, a single slaughter line at
a large establishment is expected to require 6 FTEs, while a small
market hog establishment is expected to require 3 FTEs. Large
establishments with two slaughter lines are expected to require 10
FTEs, while a small market hog establishment with 2 slaughter lines is
expected to require 4 FTEs.
[[Page 4814]]
This analysis considers likely staffing changes at the 22 large and
13 small establishments which are expected to convert to NSIS over a
course of five years. Combined, these establishments operate 46 shifts
and 55 lines.\64\ 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 22.
If all 22 large non-HIMP and 13 small high volume market hog only
establishments convert to the NSIS, the Agency would 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 would have up to 3 FTEs
assigned to them and each of the 32 shifts at the large establishments
would 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 would 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 22. This cost estimate
includes expected grade increases associated with converting to the
NSIS. As is shown in Table 22, 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 would require 147 fewer FTEs for swine
slaughter inspection, with an expected annual decrease in costs of
roughly $8.73 million, which is equal to roughly $6.67 million a year,
assuming a 3 percent discount rate, Table 22.
---------------------------------------------------------------------------
\64\ The 22 large establishments operate 41 slaughter lines
during 32 shifts, while the 13 small establishments operate 14 lines
during 14 shifts, source PHIS.
Table 22--Expected Changes in Agency Staffing
[M$]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Traditional Proposed 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
-----------------------------------------------------------------------------------------------
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 23 for details. The Agency plans
to utilize all personnel made available as a result of conversion to
NSIS to fill these vacant positions.
Table 23--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
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
expects to train 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 24. 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 program, 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 ($550,942 for all large establishments and
$81,697 for all small establishments), Table 24. This one-time cost
equals approximately $0.07 million if it were annualized over 10 years
under a 3 percent discount rate, Table 24.
[[Page 4815]]
Table 24--Three Day NSIS Training Course
[M$]
----------------------------------------------------------------------------------------------------------------
Cost of trainee Replacement labor
----------------------------------------------------------------
Number of Number of Costs of wages
Type of establishment inspectors Costs of wages replacement and benefits Combined costs
requiring and benefits inspectors for
training for 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
----------------------------------------------------------------------------------------------------------------
Fill an Increase Need for Consumer Safety Inspectors
As proposed, 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 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 25. Nearly half of this cost stems from
the need for replacement labor. Again, under the proposed five year
adoption rate, as set forth in Table 6, and under a 3 percent discount
rate the annualized costs is approximately $0.23 million, Table 25.
Table 25--Cost of Converting a Food Inspector Into a Consumer Safety Inspector
[M$]
----------------------------------------------------------------------------------------------------------------
Labor
Training component -------------------------------- Travel, M&IE, Combined costs
Trainee Replacement and lodging
----------------------------------------------------------------------------------------------------------------
Four Week MI 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
----------------------------------------------------------------------------------------------------------------
Combined Expected Budgetary Impacts
The Agency's budget is expected to be impacted both by changes to
personnel and training requirements. First, there will be a reduced
need for Agency personnel to inspect a slaughter line operating under
NSIS. If all 22 large and 13 small establishments convert to NSIS over
the course of five years, the Agency would require approximately 147
fewer FTEs to inspect the 55 \65\ slaughter lines operating at these
establishments. The annual remuneration value of these 147 positions is
roughly $8.73 million, Table 26. Second, the Agency will need to train
approximately 266 personnel on NSIS methods at a one-time cost of
approximately $0.64 million, Table 26. 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 26.
The annualized value of the combined changes to the Agency's budget is
a net reduction of roughly $6.38 million, over 10 years assuming a 3
percent discount rate, Table 26.
---------------------------------------------------------------------------
\65\ Source: PHIS.
Table 26--Combined Changes to FSIS's Budget
[M$]
------------------------------------------------------------------------
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
[[Page 4816]]
Recurring Cost.................................. (8.73)
Annualized Costs, Assuming a 3% Discount Rate (6.38)
Over 10 Years..................................
Annualized Costs, Assuming a 7% Discount Rate (6.09)
Over 10 Years..................................
------------------------------------------------------------------------
J. Net Benefits
With the expected impact on the Agency's budget and industry's
revenue included, and assuming all 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
$31.77 million a year, annualized over 10 years assuming a 3 percent
discount rate, Table 27. The majority of the costs are experienced by
the 35 non-HIMP establishments expected to voluntarily switch to the
NSIS in the form of increased labor needs.
Table 27--Net Costs and (Benefits)
[M$]
----------------------------------------------------------------------------------------------------------------
Number of
establishments One-time Recurring
----------------------------------------------------------------------------------------------------------------
Costs To Industry............................................... .............. $3.88 $22.65
Voluntary *................................................. ** 40 0.84 22.17
Mandatory................................................... 612 3.03 0.48
Health Benefits ***............................................. .............. .............. (9.33)
Industrial Efficiency........................................... .............. .............. (47.33)
Impacts to Agency's Budget...................................... .............. 2.80 (8.73)
----------------------------------------------------------------------------------------------------------------
Totals:
One-Time Cost........................................................................... 6.68
Recurring Cost.......................................................................... (42.75)
Annualized Costs, Assuming a 3% Discount Rate Over 10 Years............................. (31.77)
Annualized Costs, Assuming a 7% Discount Rate Over 10 Years............................. (30.40)
----------------------------------------------------------------------------------------------------------------
* Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the
Proposed Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 28: Quantified Cost and
(Benefits) of Various Adoption Rates.
** Note, this includes 5 HIMP establishments, which are not expected 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. Expected
Benefits Associated With Public Health, Table 20: Health Benefits from Averted Cases of Salmonella. The value
of health benefits ranges from $0.19 million to $18.97 million, with a mean of $9.33 million.
Given the lack of data with which to make cost-benefit comparisons
across the industry, Table 28 provides a range of possible adoption
scenarios and their corresponding costs and benefits. Under scenario A,
only the 5 HIMP establishments adopt the NSIS. Because these 5
establishments are already operating under NSIS practices, there would
not be any additional voluntary costs or benefits associated with these
5 establishments adopting the NSIS. However, all 612 establishments
would incur costs associated with the proposed rule's mandatory
components. As such, scenario A has a net cost. Scenario B assesses the
net cost and benefits of just 6 establishments adopting the NSIS (5
HIMP and 1 large). This scenario reveals that the rule is net
beneficial if just 1 large establishment adopts the NSIS in addition to
the 5 HIMP establishments. Scenarios C, D, and E measure the net costs
and benefits of 50, 75, and 100 percent of the 40 establishments
converting to the NSIS, respectively. Each of these scenarios are net
beneficial.
Table 28--Quantified Cost and (Benefits) of Various Adoption Rates
[M$] [caret]
--------------------------------------------------------------------------------------------------------------------------------------------------------
Costs (Benefits)
Number to -------------------------------------------------------------------------------- Net
Adopt * Mandatory @ NSIS Health Line speeds Agency budget
--------------------------------------------------------------------------------------------------------------------------------------------------------
A....................................... 5 $0.82 $0.0 $0.0 $0.0 $0.0 $0.82
B....................................... 6 0.82 0.86 (0.27) (2.04) (0.38) (1.00)
C....................................... 23 0.82 8.35 (3.59) (18.01) (3.14) (15.57)
D....................................... 32 0.82 13.09 (5.52) (27.82) (4.88) (24.30)
E....................................... 40 0.82 17.02 (7.09) (36.14) (6.38) (31.77)
--------------------------------------------------------------------------------------------------------------------------------------------------------
* 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.
[caret] Annualized Assuming a 3% Discount Rate Over 10 Years.
[[Page 4817]]
K. Alternatives
Table 29--Alternative Policy Options
----------------------------------------------------------------------------------------------------------------
Alternatives Benefits Costs Net
----------------------------------------------------------------------------------------------------------------
A. No action (Baseline)........ 1. No additional costs 1. Potential for
to industry. inefficient use of
agency resources.
2. No potential
increase in industrial
efficiency.
3. Lack of incentive
for establishments to
innovate and improve
their process controls.
4. No potential health
benefits.
B. Mandatory Portion of the 1. In comparison to the 1. In comparison to the Costs of $0.82M.
Proposed Rule Only. baseline, potential baseline, potential
$0.76M in Process $1.58M in Other
Control Sampling cost Industry Costs.
savings.
C. Proposed Rule (40 1. Potential $7.09M in 1. Potential $16.62M Benefits of $31.77M.
Establishments Adopt NSIS). averted illnesses. Increase in Industry
Labor Costs.
2. Potential $36.14M in
Industrial Efficiency.
3. Potential $0.76M in 2. Potential $1.97M in
Process Control Other Industry Costs.
Sampling cost savings.
4. Roughly $6.67M in 3. Roughly $0.30M in
Agency Labor Savings. Agency Training Costs.
D. Require All 612 1. Potentially more 1. Potential $25.9M Benefits of $16.83M.
Establishments Adopt NSIS. than $7.09M in averted Increase in Industry
illnesses. Labor.
2. Potential $36.14M in 2. Potential $3.3M in
Industrial Efficiency. Other Industry Costs.
3. Potential $0.76M in 3. Roughly $0.68M in
Process Control Agency Training Costs.
Sampling cost savings.
4. Roughly $2.72M in
Agency Labor Savings.
----------------------------------------------------------------------------------------------------------------
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 NSIS. These
benefits include the establishment's ability to innovate and develop
process controls which increase foodborne hazard detection and more
efficiently use all of their resources. Taking no action would also
forgo potential industrial efficiency increases. 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 proposed rule.
B--The Mandatory Portion of the Proposed Rule
FSIS considered limiting the proposed rule to only include the
mandatory sections. Under such a scenario quantified benefits are
limited to an estimated $0.76 million reduction in process control
sampling costs. This cost reduction is expected to be off-set by a
$1.58 million increase in other industry costs associated with
requiring written sanitary dressing plans and environmental sampling.
In comparison to the baseline, this scenario has a net cost of roughly
$0.82 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 expected $6.67 million. However,
because FIs will 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 proposed 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
expected net cost as compared to the baseline as well as the decrease
in net benefits as compared to the proposed rule.
C--The Proposed Rule
Applying a 3 percent discount rate over 10 years the costs
associated with the proposed rule include $16.62 million in additional
industry labor costs, $1.97 million in other industry costs including
costs associated with meeting ready to cook standards, written sanitary
dressing plans, and environmental sampling, and $0.3 million in Agency
training costs. The quantified health benefits of the proposed 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 is expected to increase their efficiency by $36.14 million,
assuming a 3 percent discount rate. The proposed rule is also expected
to reduce industry costs associated with process control sampling by
roughly $0.76 million, assuming a 3 percent discount rate.
Additionally, the proposed rule is expected to reduce the Agency's
labor costs by roughly $6.67 million, assuming a 3 percent discount
rate. In comparison to the baseline, the proposed rule has an estimated
net benefit of $31.77 million, assuming a 3 percent discount rate over
10 years and as such the Agency recommends the proposed rule.
[[Page 4818]]
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
HIMP, 27 large, and 13 small high volume establishments expected to
convert under the proposed rule to include 572 additional
establishments. This expansion would include low volume establishments
that slaughter all types of swine as well as 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
$36.14 million increase in industrial efficiency, $0.76 million in
industrial savings associated with process control sampling
requirements, and $2.72 million in Agency labor cost savings, assuming
a 3 percent discount rate over 10 years. 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 proposed 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 proposed 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. While compared to the
baseline, this alternative reduces Agency labor costs; it would result
in additional promotions reducing the benefit in comparison to the
proposed rule.
In comparison to the baseline, the potential costs associated with
this alternative include a $25.90 million increase in industrial labor,
a $3.30 million increase in other industry costs which include costs
associated with ready to cook standards, written sanitary dressing
plans, and environmental sampling, and roughly $0.68 million in Agency
training costs. In comparison to the proposed rule, the additional
increases in costs to industry predominately fall on small and very
small business. While this alternative has a net benefit of $16.83
million, assuming a 3 percent discount rate over 10 years, the Agency
rejects it because its net benefit is less than the proposed rule.
VII. Regulatory Flexibility Act Assessment
The FSIS Administrator has made a preliminary determination that
this proposed rule would 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. At the beginning of section VI is a list of specific
economic issues that the Agency is seeking comment on. Section VI also
provides additional details on costs incurred by small businesses.
The proposed rule's mandatory requirements would 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 plant, applying a 3
percent discount rate over 10 years. Second, the mandatory proposed
changes to process control sampling requirements are expected to
decrease small establishments' sampling costs by roughly $1,296 per
establishment annually, applying a 3 percent discount rate over 10
years. In addition to this sampling cost reduction, the Agency would
allow small and very small establishments to modify their sampling
plans to collect samples less frequently once they have collected 13
consecutive weekly samples and have demonstrated that they are
effectively maintaining process control. FSIS is also proposing to
allow establishments to develop sampling plans that are more tailored
to their specific establishment, and thus more effective in monitoring
their specific process control than the current generic E. coli
criteria. Third, the mandatory environmental sampling program is
expected to increase the average small and very small establishments'
costs by $87 per establishment annually, assuming a 3 percent discount
rate over ten years. Therefore, the proposed rule's mandatory
requirements are expected to increase small establishments' costs by
roughly $660 ($1,869-$1,296 + $87 = $660) per establishment annually,
an amount that is expected to have little effect on small entities. To
put this in perspective, the average small and very small establishment
slaughters over 21 thousand swine annually. Using the American Meat
Institute's average pork packer dollars per head margins for 2010-2014,
the average small and very small establishment's marginal revenue is
$0.09 million (21,858 (heads slaughtered) x $4.10 (average margin per
head)). Additionally, the voluntary NSIS portion of the rule is
expected to provide an overall cost savings for the 13 small high
volume establishments or roughly $87,449 per establishment that adopt
the NSIS. This estimate takes into consideration the increase in labor
cost ($43,439 per establishment), cost associated with meeting ready-
to-cook standards ($6,300 per establishments) and cost savings from
increased industrial efficiency ($137,189 per establishment). See
section VI for additional details.
Executive Order 13771
Consistent with E.O. 13771 (82 FR 9339, February 3, 2017), we have
estimated that this proposed rule would yield cost savings. Assuming a
7 percent discount rate and a perpetual time horizon and a starting
year of 2018, the proposed rule would yield approximately $24.97
million (2016$) in cost savings, not including health benefits.
Therefore, if finalized as proposed, this rule is expected to be an
E.O. 13771 deregulatory action.
VIII. 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.
IX. Executive Order 12988, Civil Justice Reform
This proposed rule has been reviewed under Executive Order 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.
[[Page 4819]]
X. Executive Order 13175
This rule has been reviewed in accordance with the requirements of
Executive Order 13175, ``Consultation and Coordination with Indian
Tribal Governments.'' E.O. 13175 requires Federal agencies to consult
and coordinate with 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.
FSIS has assessed the impact of this rule on Indian tribes and
determined that this rule does not, to our knowledge, have tribal
implications that require tribal consultation under E.O. 13175. If a
Tribe requests consultation, FSIS will work with the Office of Tribal
Relations to ensure meaningful consultation is provided where changes,
additions and modifications identified herein are not expressly
mandated by Congress.
XI. 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).
XII. 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
Environmental Assessment (EA) or an Environmental Impact Statement
(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 the proposed NSIS are expected to
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 sales is very small, the
Agency has determined that the change in the 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.
XIII. Paperwork Reduction Act
In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995, the information collection or recordkeeping requirements
included in this proposed rule have been submitted for approval to OMB.
Title: Swine Slaughter Inspection.
Type of Collection: New.
Abstract: Under this proposed rule, establishments operating under
NSIS would have to develop, implement, and maintain in their HACCP
systems written procedures for the segregation, identification, and
disposition of animals exhibiting signs of moribundity, central nervous
system disorders, or pyrexia. In addition, each official swine
slaughter establishment would need to maintain, as part of its HACCP
system, written procedures for (1) preventing throughout the entire
slaughter and dressing operation, contamination of carcasses and parts
by enteric pathogens, fecal material, ingesta, and milk and (2)
preventing contamination of the pre-operational environment by enteric
pathogens. The procedures addressing prevention of contamination by
enteric pathogens would need to include microbial testing. Furthermore,
all swine slaughter establishments operating would have to maintain
records that document that the products resulting from its slaughter
operations meet the definition of RTC pork products. Each establishment
operating under the NSIS would 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.
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 proposed rule would create no new
burden on establishments.
The proposed requirement that swine slaughter establishments
monitor their systems through microbial testing and recordkeeping would
create a new information collection burden. For each sample on which a
microbiological test is conducted, there are two ``responses'' for the
establishment: One response for the actual collecting of the sample and
sending it to the laboratory for analysis, and the other for recording
the sample result. Under the proposed rule, large establishments would
test and record microbiological results for enteric pathogens, at both
pre-evisceration and post-chill, 13 times a day; small high-volume
establishments, one-time a day; and small low-volume and very small
establishments, 13 times a year. FSIS estimates that large
establishments would test and record microbial results for the pre-
operational environment weekly; small establishments, biweekly; small
low-volume and very small establishments, monthly.
Estimated Annual Recordkeeping Burden: Swine Slaughter Inspection.
[[Page 4820]]
Respondents: Official swine establishments.
Estimated Number of Respondents: 612 (28 large, 51 small high
volume, 54 small low volume, and 479 very small).
Estimated Average Annual Number of Responses (samples) per
Respondent: Large establishments 6,846; small high volume
establishments 430; and small low volume and very small establishments
25.
Estimated Total Annual Responses: 226,558.
Estimated Total Annual Recordkeeping Burden: 9,440 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average annual
Estimated number of Total annual Time per Total annual
Respondents number of responses per responses respone in burden hours
respondents respondent minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments...................... Microbial testing data 28 6,846 191,688 2.5 7,987
recordkeeping.
Small high volume establishments.......... Microbial testing data 49 430 21,070 2.5 878
recordkeeping.
Small low volume establishments........... Microbial testing data 54 25 1,350 2.5 56
recordkeeping.
Very small establishments................. Microbial testing data 479 25 11,975 2.5 499
recordkeeping.
-------------------------------------------------------------------------------
Total Recordkeeping Burden for process ............................ 612 7,326 226,083 .............. 9,420
control.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Estimated Annual Reporting Burden: Swine Slaughter Inspection.
Respondents: Official swine establishments.
Estimated Number of Respondents: 612 (28 large, 51 small high
volume, 54 small low volume, and 479 very small).
Estimated Average Annual Number of Responses per Respondent: Large
establishments 6,846; small high volume establishments 430; and small
low volume and very small establishments 25.
Estimated Total Annual Responses: 226,083.
Estimated Total Annual Recordkeeping Burden: 47,655 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average annual
Estimated number of Total annual Time per Total annual
Respondents number of responses per responses respone in burden hours
respondents respondent minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments...................... Microbial testing data 28 6,846 191,688 12.5 39,702
recordkeeping.
Small high volume establishments.......... Microbial testing........... 49 430 21,070 12.5 4,389
Small low volume establishments........... Microbial testing........... 54 25 1,350 15 338
Very small establishments................. Microbial testing........... 479 25 11,975 15 2,993
-------------------------------------------------------------------------------
Total Reporting Burden.................... ............................ 612 7,326 226,083 .............. 47,655
--------------------------------------------------------------------------------------------------------------------------------------------------------
FSIS is also proposing a new regulation that would create a new
information collection burden, in that it would require 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. This is
a new recordkeeping requirement that FSIS has submitted to OMB for
approval.
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: 41.
Estimated Average Annual Number of Responses per Respondent: Large
establishments 1; small high volume establishments 1.
Estimated Maximum Total Potential Annual Responses: 41.
Estimated Total Annual Recordkeeping Burden: 1.37 hours.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Average annual
Estimated number of Total annual Time per Total annual
Respondents number of responses per responses respone in burden hours
respondents respondent minutes
--------------------------------------------------------------------------------------------------------------------------------------------------------
Large establishments...................... Attestation on Work-Related 28 1 28 2 .93
Conditions.
[[Page 4821]]
Small high volume establishments.......... Attestation on Work-Related 13 1 49 2 .43
Conditions.
-------------------------------------------------------------------------------
Total Reporting Burden................ ............................ 41 1 41 .............. 1.37
--------------------------------------------------------------------------------------------------------------------------------------------------------
Summary of Burden Swine Slaughter Inspection
------------------------------------------------------------------------
------------------------------------------------------------------------
Total No. Respondents................................... 612
Average Annual No. Responses per Respondent............. 14,693
Total Annual Responses.................................. 453,157
Average Hours per Response.............................. .125
Total Annual Burden Hours............................... 57,216.37
------------------------------------------------------------------------
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
methodology 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 information collection on those who are
to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments may be sent to both Gina Kouba, Office of Policy and
Program Development, at the address 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 proposed rule. All responses to this notice will be
summarized and included in the request for OMB approval. All comments
will also become a matter of public record.
XIV. 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 also will make copies of this publication available 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 Update is available on the FSIS web page. Through the
web page, FSIS is able to provide information to a much broader, more
diverse audience. In addition, FSIS offers an email subscription
service which provides automatic and customized access to selected food
safety news and information. This service is available at: https://www.fsis.usda.gov/subscribe. Options range from recalls to export
information, regulations, directives, and notices. Customers can add or
delete subscriptions themselves, and have the option to password
protect their accounts.
XV. Proposed 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 proposing to amend
9 CFR Chapter III as follows:
PART 301--TERMINOLOGY; ADULTERATION AND MISBRANDING STANDARDS
0
1. The authority citation for part 301 continues 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 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 SOP, or other
prerequisite program.
(c) The establishment must identify carcasses of livestock that
establishment employees have sorted and removed from slaughter or that
FSIS inspectors have condemned on ante-mortem inspection with a unique
tag, tattoo, or similar device. The establishment must immediately
denature all major portions of the carcass on-site and dispose of the
carcass according to 9 CFR part 314.3.
(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. These records are subject to review and evaluation by FSIS
personnel.
[[Page 4822]]
(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.
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 9 CFR 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 of the regulations
as provided by 9 CFR 303.1(h). The Administrator also may permit
establishments that slaughter market hogs and other classes of swine to
slaughter market hogs under NSIS and slaughter 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).
* * * * *
0
7. Amend Sec. 310.18 by adding paragraphs (c) through (e) to read as
follows:
Sec. 310.18 Contamination of carcasses, organs, or other parts.
* * * * *
(c) Procedures for controlling contamination throughout the
slaughter and dressing operation. Official swine slaughter
establishments must develop, implement, and maintain written procedures
to prevent contamination of carcasses and parts by enteric pathogens,
fecal, 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 small establishments or very low volume establishments,
must collect and analyze samples for microbial organisms at the pre-
evisceration and post-chill points in the process. Very small
establishments and 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, or jowl areas.
(i) Very small establishments are establishments with fewer than 10
employees or annual sales of less than $2.5 million.
(ii) 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.
(iii) An establishment may substitute alternative sampling
locations if:
(A) The establishment has support to demonstrate the alternative
sampling locations are able to provide a definite improvement in
monitoring process control than at pre-evisceration and post-chill; and
(B) FSIS does not determine, and notify the establishment in
writing, that the alternative sampling locations are inadequate to
verify the effectiveness of the establishment's process controls for
enteric pathogens.
(2) Sampling frequency. Establishments, except for very small and
very low volume establishments as defined in paragraphs (c)(1)(i) and
(ii) 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 small and very low volume
establishments as defined in paragraphs (c)(1)(i) and (ii) 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 small and very low volume establishments as defined in
paragraph (c)(1)(i) and (ii) 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
small and very low volume establishments can demonstrate that they are
effectively maintaining process control, they may modify their sampling
plans.
(iii) An establishment may substitute an alternative frequency if:
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan; and
(B) FSIS does not determine, and notify the establishment in
writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's process controls for enteric
pathogens.
(iv) Establishments must sample at a frequency that is adequate to
monitor their ability to maintain process control for enteric
pathogens. Establishments must maintain accurate records of all test
results and retain these records as provided in paragraph (e) of this
section.
(d) Procedures for controlling contamination in the pre-operational
environment. Official swine slaughter establishments must develop,
implement, and maintain written procedures to prevent contamination of
the pre-operational environment by enteric pathogens. Establishments
must incorporate these procedures into their HACCP plans, sanitation
SOPs, or other prerequisite programs. These procedures must include
sampling and analysis of food contact surfaces in the pre-operational
environment for microbial organisms to ensure that the surfaces are
sanitary and free of enteric pathogens and that water used to clean
food contact surfaces is free of enteric pathogens. The sampling
frequency must be adequate to monitor the establishment's ability to
maintain sanitary conditions in the pre-
[[Page 4823]]
operational environment. Establishments must maintain accurate records
of all test results and retain these records as provided in paragraph
(e) of this section.
(e) Recordkeeping requirements. Official swine slaughter
establishments must maintain daily records sufficient to document the
implementation and monitoring of the procedures required under
paragraphs (c), (d) and (e) of 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.
0
8. Amend Sec. 310.25 as follows:
0
a. Remove paragraph (a)(2)(ii)(C);
0
b. Remove the second sentence in paragraph (a)(2)(iii)(A);
0
c. Remove ``20,000 swine,'' in paragraph (a)(2)(v)(A);
0
d. Remove the ``swine'' row in Table 1--Evaluation of E. Coli Test
Results;
0
e. Remove the ``Hogs'' and ``fresh pork sausages'' rows and footnote
(b) from Table 2--Salmonella Performance Standards.
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. If the establishment has less than
three inspection stations, 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. The
establishment must develop, implement, and maintain written procedures
to ensure that market hog carcasses contaminated 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 SOP, or
other prerequisite program. These procedures must cover establishment
sorting activities required under this section.
(c) Line speed limits. The line speed limits in 9 CFR 310.1 do not
apply to the establishment, provided that they are able to maintain
effective process control and prevent contamination of carcasses and
parts by fecal material and enteric pathogens. Establishments operating
under 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 the products resulting from its slaughter operation meet
the definition of ready-to-cook pork product in 9 CFR 301.2. These
records are subject to review and evaluation by FSIS personnel.
(2) The establishment must maintain records to document the number
of animals disposed of per day by plant sorters or condemned per day by
FSIS inspectors upon post-mortem inspection. 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 New Swine Slaughter
Inspection System (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 9
CFR 310.27 to be invalid, such action will not affect any other
provision of 9 CFR parts 309 or 310.
Done in Washington, DC, on January 19, 2018.
Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-01256 Filed 1-31-18; 8:45 am]
BILLING CODE 3410-DM-P
