[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Proposed Rules]
[Pages 4408-4456]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2012-1516]
[[Page 4407]]
Vol. 77
Friday,
No. 18
January 27, 2012
Part II
Department of Agriculture
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Food Safety and Inspection Service
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9 CFR Parts 381 and 500
Modernization of Poultry Slaughter Inspection; Proposed Rule
Federal Register / Vol. 77, No. 18 / Friday, January 27, 2012 /
Proposed Rules
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DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 381 and 500
[Docket No. FSIS-2011-0012]
RIN 0583-AD32
Modernization of Poultry Slaughter Inspection
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule.
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SUMMARY: The Food Safety and Inspection Service (FSIS) is proposing a
new inspection system for young chicken and turkey slaughter
establishments that would replace the current Streamlined Inspection
System (SIS), the New Line Speed Inspection System (NELS), and the New
Turkey Inspection System (NTIS). The Agency is also proposing several
changes that would affect all establishments that slaughter poultry
other than ratites, regardless of the inspection system under which
they operate. This proposed rule is a result of the Agency's 2011
regulatory review efforts conducted under Executive Order 13563 on
Improving Regulation and Regulatory Review.
DATES: Comments must be received by April 26, 2012.
ADDRESSES: FSIS invites interested persons to submit relevant comments
on the implementation of this proposed rule. The Agency specifically
requests comment on whether it should phase-in the implementation of
this proposed rule to provide additional time for small and very small
establishments to adjust their operations to comply with the new
requirements. If commenters believe that a phased implementation would
mitigate the impact of this rule on small and very small
establishments, FSIS requests comments on how the Agency can make the
phased implementation most effective.
Comments may be submitted by either of the following methods:
Federal eRulemaking Portal: This Web site 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 http://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including floppy disks or CD-ROMs, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 355 E. Street
SW., 8-163A, Mailstop 3782, Washington, DC 20250-3700.
Instructions: All items submitted by mail or electronic mail must
include the Agency name and docket number FSIS-2011-0012. Comments
received in response to this docket will be made available for public
inspection and posted without change, including any personal
information, to http://www.regulations.gov.
Docket: For access to background documents or comments received, go
to the FSIS Docket Room at the address listed above between 8 a.m. and
4:30 p.m., Monday through Friday.
All background documents referenced in this proposed rule are
available for viewing by the public on the FSIS Web site at: http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp or
in the FSIS docket room.
FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant
Administrator, Office of Policy and Program Development, FSIS, U.S.
Department of Agriculture, 1400 Independence Avenue SW., Washington, DC
20250-3700, (202) 720-2709.
SUPPLEMENTARY INFORMATION:
Executive Summary
In January 2011, President Obama issued Executive Order (E.O.)
13563 on Improving Regulation and Regulatory Review. As part of this
E.O., agencies were asked to review existing rules that may be
outmoded, ineffective, insufficient, or excessively burdensome, and to
modify, streamline, expand, or repeal them accordingly. FSIS is
proposing to modernize poultry slaughter inspection as a result of its
2011 regulatory review efforts conducted under E.O. 13563. The Agency
is taking this action to improve food safety and the effectiveness of
poultry slaughter inspection systems, remove unnecessary regulatory
obstacles to innovation, and make better use of the Agency's resources.
FSIS is proposing a new inspection system for young chicken and
turkey slaughter establishments. The new inspection system would
replace the current Streamlined Inspection System (SIS), the New Line
Speed Inspection System (NELS), and the New Turkey Inspection System
(NTIS). Under this proposed rule, establishments that slaughter young
chickens or turkeys would have to choose whether to operate under the
traditional inspection system or under the proposed new inspection
system. FSIS is proposing to limit the number of online inspectors in
the traditional inspection system to two.
Key elements of the new inspection system include: (1) Requiring
establishment personnel to conduct carcass sorting activities before
FSIS conducts online carcass inspection so that only carcasses that the
establishment deems likely to pass inspection are presented to the
carcass inspector; (2) reducing the number of online FSIS carcass
inspectors to one per line; (3) permitting faster line speeds than are
permitted under the current inspection systems it replaces; and (4)
removing the existing Finished Product Standards (FPS) and replacing
them with a requirement that establishments that operate under the new
system maintain records to document that the products resulting from
their slaughter operations meet the regulatory definition of ready-to-
cook poultry.
The proposed new inspection system may facilitate the reduction of
pathogen levels in poultry products by permitting FSIS to conduct more
food safety related offline inspection activities, will allow for
better use of FSIS inspection resources, and will lead to industry
innovations in operations and processing.
In addition to the New Poultry Slaughter Inspection System, FSIS is
proposing changes to its regulations that will apply to all
establishments that slaughter poultry other than ratites, regardless of
the inspection system under which they operate. Because contamination
by enteric pathogens and fecal material are hazards reasonably likely
to occur in poultry slaughter operations unless they are addressed in a
sanitation standard operating procedure (SOP) or other prerequisite
program, the Agency is proposing that all poultry slaughter
establishments develop, implement, and maintain, as part of their HACCP
plans, or sanitation SOPs, or other prerequisite programs written
procedures to ensure that carcasses contaminated with visible fecal
material do not enter the chiller. FSIS is also proposing to require
that all poultry slaughter establishments develop, implement, and
maintain, as part of their HACCP plans, or sanitation SOPs, or other
prerequisite programs written procedures to prevent contamination of
carcasses and parts by enteric pathogens (e.g., Salmonella and
Campylobacter) and fecal material throughout the entire slaughter and
dressing operation. FSIS is proposing that, at a minimum, these
procedures must include sampling and analysis for microbial organisms
at the pre-chill and post-chill points in the process to monitor
process control for enteric pathogens. FSIS is proposing to remove the
current requirement that poultry
[[Page 4409]]
establishments test for generic E. coli and to remove the codified
Salmonella pathogen reduction performance standards for poultry.
Finally, FSIS is proposing to amend its regulations to provide for
the use of certain poultry slaughter technologies that have been
demonstrated to be successful through waivers of the existing
regulations, thus ending most current waivers. FSIS is proposing to
remove the chilling requirements for ready-to-cook poultry, which now
provide specific time and temperature parameters, and to require that
establishments incorporate procedures for chilling poultry into their
HACCP plans, or sanitation SOPs, or other prerequisite programs. This
will give establishments greater flexibility to determine what chilling
process is best suited to prevent outgrowth of pathogens on carcasses
immediately after slaughter operations. The Agency is also proposing to
permit poultry slaughter establishments to use (1) approved online
reprocessing antimicrobial systems or (2) offline reprocessing
antimicrobial agents including chlorinated water containing 20 ppm to
50 ppm available chlorine or other antimicrobial substances that have
been approved as safe and suitable for reprocessing poultry.
Establishments would be required to address the use of online or
offline reprocessing of poultry in their HACCP plans, or sanitation
SOPs, or other prerequisite programs.
Statutory Authorities
FSIS inspects and regulates the production of poultry prepared for
distribution in interstate commerce under the authority of the Poultry
Products Inspection Act (PPIA) (21 U.S.C. 451 et seq.). 21 U.S.C.
455(b) provides that the Secretary shall cause to be made by inspectors
post-mortem inspection of the carcass of each bird processed, and at
any time reinspection as he deems necessary of poultry and poultry
products capable of use as human food. 21 U.S.C. 455(c) requires that
all poultry carcasses and other poultry products found to be
adulterated be condemned. Carcasses and parts that may be reprocessed
to be made not adulterated are not required to be condemned if they are
reprocessed under the supervision of an inspector and thereafter found
to be not adulterated (21 U.S.C. 455(c)). Under the PPIA, a poultry
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. 453(g)(1), (3), (4), and (8)). Finally, 21 U.S.C. 463(b)
provides that the Secretary shall promulgate such other rules and
regulations as are necessary to carry out the provisions of the PPIA.
FSIS regulations and inspection programs are designed to verify that
poultry products are unadulterated, wholesome, and properly marked,
labeled, and packaged.
Table of Contents of Proposed Rule Discussion
I. Background
A. Poultry Slaughter Inspection Systems Under Existing
Regulations
1. Description of Inspection Systems Under Existing Regulations
2. Limitations of Current Inspection Systems Under Existing
Regulations and Need for Improvement
B. Regulations for Microbiological Testing Under the Existing
Inspection Systems
1. Generic E. coli Criteria for Measuring Process Control
2. Salmonella Pathogen Reduction/HACCP Performance Standards
C. Waivers of Regulatory Requirements
1. Regulations Providing for the Administrator To Waive
Provisions of Inspection Regulations
2. The FSIS Salmonella Initiative Program
II. Consideration of Need for a New Poultry Slaughter Inspection
System
A. Early Development of the Inspection Models Program
B. Existing HACCP-Based Inspection Models Program
C. Analysis of HIMP
1. FSIS Evaluation of HIMP
a. Overview of HIMP Report
b. Inspection of Each Carcass by Online FSIS Inspectors To
Determine Whether the Carcass Is Not Adulterated and Therefore
Eligible To Bear the Mark of Inspection
c. Verification by Offline Inspectors of the Establishment
Executing Its HIMP Process Control Plan Under Which Establishment
Employees Sort Acceptable and Unacceptable Carcasses and Parts
d. Verification of the Establishment Executing Its Sanitation
SOPs and Its HACCP System Under 9 CFR Parts 416 and 417
e. Verification of the Outcomes of the Establishment Process
Control Plan, Both Organoleptic and Microbiologic
f. Conclusion
2. 2001 Government Accountability Office Report on HIMP
D. Public Health Benefits Projected From Allocating More
Inspection Resources to Food Safety-Related Inspection Activities
1. Risk Assessment
2. Model
3. Conclusions of the Risk Assessment
III. Proposed New Poultry Inspection System for Young Chickens and
Turkeys
A. Replacement of SIS, NELS, and NTIS With the New Poultry
Inspection System
B. Carcass Sorting and Online Carcass Inspection
C. Offline Verification Inspection
D. Finished Product Standards To Be Replaced With Requirement
That Establishments Operating Under the New Poultry Inspection
System Maintain Records To Document That the Products Resulting From
Their Slaughter Operations Meet the Definition of Ready-to-Cook
Poultry
1. Establishment Requirements
2. FSIS Verification
E. Maximum Line Speeds Under the New Poultry Inspection System
F. Facilities Requirements for Establishments Operating Under
the New Poultry Inspection System
1. General
2. Online Carcass Inspection Stations
3. Offline Verification Inspection Stations
4. Location To Inspect the Viscera of the First 300 Carcasses of
Each Flock
5. Drainage From Processing Line
G. Eligibility To Operate Under the New Poultry Inspection
System
IV. Other Proposed Changes to Poultry Slaughter Regulations
A. Proposed Changes to Traditional Inspection System
B. Proposed Changes Affecting All Poultry Slaughter
Establishments
1. Procedures To Address Enteric Pathogens and Fecal
Contamination as Hazards Reasonably Likely To Occur
a. Contamination of Poultry Carcasses and Parts by Fecal
Material and Enteric Pathogens Are Hazards Reasonably Likely To
Occur in Poultry Slaughter Establishments
b. Procedures Addressing Zero Tolerance for Visible Fecal
Material Before Chilling
c. Procedures To Prevent Contamination of Carcasses and Parts by
Enteric Pathogens and Fecal Material Throughout the Entire Slaughter
and Dressing Operation
2. Impact Considerations for Small/Very Small Low Volume
Establishments
3. Proposed Changes to Time and Temperature Requirements for
Chilling
a. Background
b. Proposed Rule
c. Air Chilling
4. Proposed Changes to Online and Offline Reprocessing
Regulations
a. Background
b. Proposed Rule
V. Executive Order 12866 and Executive Order 13563
VI. Initial Regulatory Flexibility Analysis
VII. E-Government Act
VIII. Executive Order 13175
IX. USDA Nondiscrimination Statement
X. Environmental Impact
XI. Paperwork Reduction Act
XII. Additional Public Notification
XIII. Proposed Regulatory Amendments
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I. Background
A. Poultry Slaughter Inspection Systems Under Existing Regulations
1. Description of Inspection Systems Under Existing Regulations
Under current regulations, FSIS employs four inspection systems for
poultry other than ratites: \1\ The Streamline Inspection System (SIS),
the New Line Speed Inspection System (NELS), the New Turkey Inspection
System (NTIS), and traditional inspection.\2\ SIS, NELS, and NTIS are
employed in official poultry slaughter establishments that utilize
automated evisceration systems. Traditional inspection is typically
employed at smaller, lower product volume establishments that
eviscerate carcasses by hand. Automated evisceration allows
establishments to run at faster line speeds than is possible when the
carcasses are eviscerated by hand. Under all of the current inspection
systems, the inspection process consists of online post-mortem
inspection and offline reinspection.
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\1\ Ratites, including ostriches, can grow to exceed 600 lbs and
typically weigh as much as 350 lbs when slaughtered. They are
slaughtered and inspected under a system that is more similar to red
meat than other poultry species. This rule would not affect ratite
inspection.
\2\ SIS, NELS, and NTIS are codified at 9 CFR 381.76;
traditional inspection is codified at 9 CFR 381.67 and 381.76(a).
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In all four of the existing inspection systems, one or more FSIS
online inspectors inspect every carcass, with its viscera, at a fixed
point along the slaughter and evisceration line immediately following
the separation of the viscera from the interior of the carcass (9 CFR
381.76(b)). They examine each eviscerated carcass for visual defects
and direct establishment employees to take appropriate corrective
actions if the defects can be corrected through trimming or
reprocessing. The online inspectors also identify and condemn carcasses
with septicemic and toxemic animal diseases, which cannot be corrected
through trimming or reprocessing. Establishment personnel then dispose
of the condemned carcasses under FSIS supervision.
Under each of the existing inspection systems, establishments
conduct no carcass sorting to determine which eviscerated carcasses
appear eligible to bear the mark of inspection, which carcasses contain
removable defects correctable through trimming or reprocessing, and
which carcasses must be condemned because of septicemic and toxemic
animal diseases. Rather, the existing regulations require
establishments to assign a helper to take such actions as directed by
the online post-mortem inspector after the inspector has conducted the
initial sorting activities (9 CFR 381.76(b)). Thus, under the existing
inspection systems, establishments rely on FSIS online inspection
personnel 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 appraisal than would be necessary if
establishments sorted and trimmed carcasses before they were inspected.
In addition to post-mortem inspection conducted by the online
inspector, the existing inspection systems consist of reinspection
activities conducted by offline inspectors (9 CFR 381.76(b)). During
reinspection, FSIS inspectors apply various trim and processing
standards, referred to as Finished Product Standards (FPS), designed to
verify that the slaughter and evisceration process is under control (9
CFR 381.76(b)(3)(iv)(c). This is done by examining ten bird sample sets
to determine compliance with the FPS. Under traditional inspection, all
trim defects (e.g., breast blisters, bruises, fractures, and scabs)
identified by the online carcass inspector must be removed at the
online inspection station. Processing defects (e.g. ingesta, cloaca,
and feathers) may be corrected further down the line, subject to
reinspection. Under SIS, NELS, and NTIS, all reinspection is conducted
at separate reinspection stations located either before and after the
chiller (SIS; 9 CFR 381.76(b)(3)(iv)(a)), or before the chiller only
(NELS and NTIS; 9 CFR 381.76(b)(4)(i)(b) and 381.76(b)(5)(i)(b)).
In addition to applying the trim and dressing standards under FPS,
offline inspection also consists of such food safety related activities
as verifying Hazard Analysis Critical Control Point (HACCP) critical
limits, verifying the effectiveness of sanitation SOPs, and collecting
samples for pathogen testing.
2. Limitations of Current Inspection Systems Under Existing Regulations
and Need for Improvement
Traditional inspection is generally sufficient for low product
volume establishments that operate at relatively slower line speeds;
however, SIS, NELS, and NTIS are lacking in two important respects.
First, they obscure the proper roles of industry and inspection
personnel by assigning to FSIS online inspectors responsibility for
sorting acceptable product from unacceptable product, finding defects,
identifying corrective actions, and solving production control
problems. Second, they require FSIS to allocate significant inspection
personnel resources towards inspection activities to detect defects and
conditions that present minimal food safety risks, thus limiting the
resources available for more important food safety-related inspection
activities.
One limitation of the existing inspection systems is that they
require online inspectors to conduct sorting activities. This
necessitates a time-intensive online process that requires FSIS to
allocate significant personnel resources to conduct activities that are
more appropriately the responsibility of the establishment. The current
systems thus limit line speeds, even if establishments can demonstrate
that they are able to produce safe, unadulterated, wholesome products
at more efficient rates. It also limits establishments' incentive to
improve their processing methods and to develop more efficient
slaughter and dressing technologies.
For example, under SIS, an establishment operating under optimal
processing conditions is limited to line speeds of 35 carcasses per
minute with one online inspector per line and 70 carcasses per minute
with two online inspectors per line. Although NELS allows for a
slightly faster maximum line speed--91 birds per minute under optimal
processing conditions--it requires three online inspectors per line.
And under NTIS, an establishment operating under optimal processing
conditions is limited to processing 32 light birds per minute with one
online inspector per line and 51 light birds per minute with two online
inspectors per line. For heavy birds, those speeds decrease to 25 birds
per minute and 45 birds per minute, respectively.
FSIS is proposing a new inspection system 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.
If establishment personnel sorted the carcasses and took necessary
corrective actions before the carcasses were presented for inspection,
the online inspectors could be stationed later in the process and would
be presented with carcasses that have fewer defects. Such a system
would allow the online inspector to conduct a more efficient
inspection, a carcass-by-carcass critical appraisal, to determine
whether each carcass is not adulterated and therefore eligible to bear
the mark of inspection. As a result, FSIS could assign fewer inspectors
to online inspection, freeing up Agency resources
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to conduct offline inspection activities that are more important for
food safety, such as verifying compliance with sanitation and HAACP
requirements, or conducting Food Safety Assessments.
Moreover, the existing poultry slaughter inspection systems were
designed before FSIS issued its HACCP regulations and began targeting
its resources to address public health risks associated with foodborne
pathogens. The existing systems were developed when visually detectable
animal diseases were more prevalent and considered to be more of a
concern than they are today. The line speed limits prescribed in SIS,
NELS, and NTIS reflect the Agency's previous focus on the detection of
visible defects and animal diseases and do not give establishments the
flexibility to develop new technologies that would allow for a more
efficient approach to address these conditions. For example, while FSIS
inspectors are required to inspect and condemn carcasses for visual
defects at one point in the slaughter process, poultry slaughter
establishments could be given more flexibility to develop procedures to
identify and condemn unacceptable carcasses and parts earlier and at
various points in the slaughter and production process. An inspection
system that provides flexibility for establishments to detect and
remove visible defects and animal at point in the process before the
carcasses are presented to the FSIS inspector would permit
establishments to operate at faster line speeds if they are able to
maintain process control.
Another limitation with SIS, NELS, and NTIS is that they focus
substantial FSIS inspection resources on detecting visible trim and
dressing defects that are less important to food safety, particularly
in light of what is now known about the role microbial contamination
plays in causing foodborne human illness. These inspection models need
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 young chickens.
Moreover, the analysis in the risk assessment conducted by FSIS
suggests a significant correlation between increased unscheduled
offline inspection services and lower levels of Salmonella and
Campylobacter in young chicken and turkey slaughter establishments.
This analysis indicates that reallocating inspection resources
currently dedicated to online inspection under the existing inspection
systems to offline, food safety related inspection activities, such as
increased HACCP verification, sanitation SOP verification, pathogen
sampling, and Food Safety Assessments, could potentially reduce
pathogen levels. Additionally, FSIS could devote more resources to
inspection activities that focus on the areas of greatest risk in the
poultry production system if establishments were required to assume
greater responsibility for monitoring compliance with trim and dressing
performance standards.
B. Regulations for Microbiological Testing Under the Existing
Inspection Systems
1. Generic E. coli Criteria for Measuring Process Control
The current regulations require that official poultry slaughter
establishments conduct regular testing for generic Escherichia coli (E.
coli) at the end of the chilling process or at the end of the slaughter
line as a means to verify process control (9 CFR 381.94(a)). These
regulations prescribe requirements for collecting the samples,
obtaining analytical results, and maintaining records of such results
(9 CFR 381.94(a)(2), (3), and (4)). They also include criteria for
evaluating an establishment's generic E. coli testing results (9 CFR
381.94(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 381.94(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
381.94(6)).
In the preamble to the HACCP final rule (61 FR 38806, July 25,
1996), FSIS stated that microbial testing is an essential element for
verifying process control of raw meat and poultry. Escherichia coli
Biotype 1 (generic E. coli) was selected as the target organism for
verifying process control for a variety of reasons, including: A strong
association of E. coli with the presence of enteric pathogens and, in
the case of slaughtering, the presence of fecal contamination; E. coli
occurs at a higher frequency than Salmonella, and quantitative E. coli
testing permits more rapid and more frequent adjustment of process
control; and there is wide acceptance in the international scientific
community of its use as an indicator of the potential presence of
enteric pathogens. However, since the implementation of the HACCP final
rule, and with respect to young chicken carcasses, the reliability of
E. coli as an indicator of process control has been called into
question. In its final report adopted February 13, 2004, ``Response to
the Questions Posed by FSIS Regarding Performance Standards with
Particular Reference to Broilers (Young Chickens),'' the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF)
stated that E. coli may no longer be as useful in broiler operations as
originally thought. NACMCF recognized that FSIS viewed E. coli as a
direct measure of control of fecal contamination and, by implication,
Salmonella or other enteric pathogens. However, NACMCF stated that
recent published information indicates that this assumption may not be
valid for E. coli in young chickens. For example, in young chickens,
its presence may also be a result of infectious process and air
sacculitis, in addition to fecal contamination.\3\
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\3\ Gomis, S.M., Riddell, C., Potter, A.A., and Allan, B.J.,
Phenotypic and genotypic characterization of virulence factors
Escherichia coli isolated from broiler chickens with simultaneous
occurrence of cellulites and other colibacillosis lesions. Can J Vet
Res. 2001 Jan; 65(1):1-6.
Russell, S. M., The effect of airsacculitis on bird weights,
uniformity, fecal contamination, processing errors, and populations
of Campylobacter spp. and Escherichia coli. Poult. Sci. 2003;
82:1326-1331.
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Thus, FSIS has tentatively decided to remove the requirement that
poultry slaughter establishments test for generic E. coli at post-chill
and to allow establishments to use other, more relevant indicators of
process control. FSIS is proposing that all poultry slaughter
establishments collect and analyze carcass samples for microbiological
analysis at the pre-chill and post-chill points in the process. The
basis for this decision and a discussion of the proposed testing
requirements are 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 certain
poultry slaughter establishments and establishments that produce
certain raw ground poultry products (9 CFR 381.94(b)). The codified
performance standards are based on the prevalence of Salmonella found
by the Agency's nationwide microbiological baseline studies, which were
conducted before the PR/HACCP rule was adopted. The
[[Page 4412]]
regulations provide for FSIS to collect and analyze unannounced
Salmonella samples sets in poultry slaughter establishments to detect
whether these establishments are meeting the pathogen reduction
performance standards (9 CFR 381.94(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 381.94(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 381.94(b)(3)(iii)). The regulations
provide that such failure will cause FSIS to suspend inspection
services (9 CFR 381.94(b)(3)(iii)). However, the Agency's ability to
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 food
safety systems, including its HACCP plan and sanitation SOPs.
In 2006, after an intensive review of the results of several years
of Salmonella testing that showed a trend of increasing prevalence of
Salmonella in young chicken establishments, FSIS established three
establishment performance categories for Salmonella based on the
codified performance standards (``Salmonella Verification Sample Result
Reporting: Agency Policy and Use in Public Health Protection,'' 71 FR
9772-9777, February 27, 2006). The new performance Category 1
represented the best performing establishments and was defined as no
more than half of the regulatory standard. Category 2 was set at more
than half but not exceeding the regulatory standard. Category 3
establishments were exceeding the regulatory standard and represent the
worst performing establishments.
When FSIS announced the new performance categories, the Agency
explained that it intended to track the performance of the different
product classes it samples for Salmonella and publish on the FSIS Web
site the names of establishments in Categories 2 and 3 for any product
class that did not have 90 percent of its establishments in Category 1.
FSIS began publishing the names of young chicken establishments in
Category 2 and 3 in March 2008. FSIS has continued to publish the names
of these establishments on or about the 15th of each month since then.
Since it established the new Salmonella performance categories,
FSIS has updated the year-long Nationwide Microbiological Baseline Data
Collection Programs to better measure improvements in pathogen
reduction in all classes of raw product. Young chicken and young turkey
microbiological baselines were completed in 2008 and 2009,
respectively. On May 14, 2010, in response to a charge from the
President's Food Safety Working Group, the Agency announced that it had
developed new performance standards for Salmonella and Campylobacter
for chilled carcasses in young chicken and turkey slaughter
establishments based on the new baseline results (``New Performance
Standards for Salmonella and Campylobacter in Young Chicken and Turkey
Slaughter Establishments,'' 75 FR 27288).
On March 21, 2011, FSIS published a Federal Register notice to
announce the forthcoming implementation of the new performance
standards for Salmonella and Campylobacter (``New Performance Standards
for Salmonella and Campylobacter in Young Chicken and Turkey Slaughter
Establishments: Response to Comments and Announcement of Implementation
Schedule,'' 76 FR 15282). In the Federal Register notice, FSIS
announced, among other actions, that Web-posting of young chicken and
turkey establishments that fail the new Salmonella standards
(``Category 3'') for their last set will begin as sample sets scheduled
for July 2011 are completed. In that notice, the Agency also explained
that ``[t]hese new Salmonella standards are to be applied to sample
sets from establishments included in the Agency's Salmonella
Verification Program in the place of the performance standards for
young chickens (as broilers) codified at 9 CFR 381.94 and the standards
for young turkeys announced in a Federal Register Notice of 1995.''
FSIS also stated that ``[t]he Agency intends to issue a proposed rule
that would formally rescind the codified standards that are no longer
in effect'' (76 FR 15282).
Therefore, FSIS is proposing to eliminate the pathogen performance
standard regulations in 9 CFR 381.94(b). FSIS can effectively address
Salmonella through the actions discussed above and through the
Salmonella Initiative Program described below.
C. Waivers of Regulatory Requirements
1. Regulations Providing for the Administrator To Waive Provisions of
Inspection Regulations
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.\4\ 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.
---------------------------------------------------------------------------
\4\ For Agency New Technology waiver procedures, see http://www.fsis.usda.gov/Regulations_&_Policies/New_Technologies/index.asp.
---------------------------------------------------------------------------
Several poultry slaughter establishments are operating under
waivers that allow them to use technologies that are not provided for
in the regulations. As of April 2011, for example, FSIS had granted
waivers to 144 poultry slaughter establishments to allow these
establishments to conduct online re-processing of poultry carcasses and
parts accidentally contaminated with digestive tract contents. As
discussed in detail later in this document, the current regulations
only provide for reprocessing of accidentally contaminated poultry at a
designated
[[Page 4413]]
offline reprocessing station (9 CFR 381.91). Under the Salmonella
Initiative Program (SIP) (76 FR 41186, July 13, 2011), the Agency has
also granted six poultry slaughter establishments waivers from the
specific time and temperature chilling requirements prescribed in 9 CFR
381.66. Any establishment that has been granted a waiver for on-line
reprocessing, or any other slaughter process, and is continuing to
operate under that waiver, must now participate in SIP and conduct
testing as discussed in greater detail below.
The data generated from the in-plant trials conducted under the
online reprocessing waivers and the waivers from the time and
temperature chilling requirements have demonstrated that the
technologies used in these studies have been successful and yielded
definite improvements.(See ``FSIS Analysis of On-line and Off-line
Reprocessing Systems,'' available for viewing by the public in the FSIS
docket room and on the FSIS Web site at: http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.) Therefore, FSIS is
proposing to amend the regulations to provide for the use of these
technologies, which would end the need for these waivers. The proposed
amendments are described under the headings ``Proposed Changes to Time
and Temperature Requirements for Chilling'' and ``Proposed Changes to
Online and Offline Reprocessing Regulations,'' below.
All establishments operating under waivers from any regulatory
requirements, not just waivers for OLR and time and temperature
regulations, will be participating in the Salmonella Initiative Program
(SIP), described below. Thus, the SIP would continue after any final
rule resulting from this proposal becomes effective.
2. The FSIS Salmonella Initiative Program (SIP)
Under SIP, meat and poultry slaughter establishments receive
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 currently operating under
regulatory waivers must participate in SIP or forfeit their waivers.
All establishments operating under waivers will continue to operate
under a SIP waiver and will continue to conduct testing under SIP if
their waivers are not addressed in the final rule resulting from this
proposal.
II. Consideration of Need for a New Poultry Slaughter Inspection System
A. Early Development of the Inspection Models Program
In 1996, FSIS published its 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).
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.
The existing poultry slaughter inspection systems were developed
before HACCP was implemented and require that FSIS inspectors sort
carcasses and direct establishments' corrective actions, rather than
requiring establishments to sort, trim, and reprocess carcasses before
they are inspected by FSIS. 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 HACCP-based inspection models project (62 FR 31553).
During the HACCP-based inspection models project, FSIS would design and
test various new inspection models in a series of trials in volunteer
meat and poultry slaughter establishments.
Under the initial inspection models approach, establishment
personnel were responsible for identifying and removing normal from
abnormal carcasses and parts, and FSIS inspection personnel performed
inspection activities that focused on the areas of greatest risk in the
poultry products inspection system in each establishment.
In 1998, the American Federation of Government Employees, several
FSIS inspectors, and a public interest organization filed a suit to
enjoin FSIS from implementing the HACCP-based inspection model project
(``HIMP''). The plaintiffs alleged that HIMP violated the requirement
in the PPIA that government inspectors conduct a post-mortem inspection
of each poultry carcass. Specifically, the PPIA provides that the
Secretary, whenever processing operations are being conducted, shall
cause to be made by inspectors post-mortem inspection of the carcass of
each bird processed (21 U.S.C. 455(b)). 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 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
found that the PPIA requires Federal inspectors--rather than plant
employees--to make the decision about whether each carcass is
adulterated within the meaning of the statute. The case was remanded to
the district court for further proceedings.
In response to the Court of Appeals' opinion, FSIS modified HIMP to
position one inspector at a fixed location near the end of the
slaughter line in each poultry slaughter establishment. This inspector
was responsible for examining each poultry carcass for adulteration
after the carcasses had been eviscerated, sorted, washed, and trimmed
by establishment employees, but before the carcasses entered the
chiller. The modified models project also included FSIS off-line
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 birds 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 DC
Circuit.
[[Page 4414]]
Plaintiffs argued that the modified inspection procedures were not in
compliance with the Court of Appeals' 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 rejected this argument,
finding that the PPIA does not prohibit plant employees from paring
down the overall number of carcasses by sorting and removing carcasses
before they reach the Federal inspector. The Court held that because
the modified inspection model program required Federal inspectors to
personally examine each poultry carcass leaving the slaughter line,
FSIS was in compliance with the PPIA's requirement that ``the carcass
of each bird processed'' be inspected for adulteration.
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 defective carcasses prior
to Federal inspection, resulting in fewer adulterated poultry carcasses
being presented for Federal inspection. The Court also noted that
although the PPIA delineates what must be inspected and by whom, it
does not tell the reader exactly what an inspection is. The court
concluded that HIMP, as modified, reflected a reasonable design of an
inspection system by the agency charged with responsibility for
administering the PPIA 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 \5\
---------------------------------------------------------------------------
\5\ For a description of the performance standards used during
the HIMP pilot, see Appendix A.
---------------------------------------------------------------------------
The revised HACCP-Based Inspection Models Project (HIMP) was
initiated in 20 young chicken slaughter establishments and 5 turkey
slaughter establishments on a waiver basis.
Under HIMP, post-mortem inspection, referred to simply as ``carcass
inspection,'' is conducted by a single online carcass inspector who
visually inspects every carcass at a fixed location on the evisceration
line immediately prior to the chiller. Carcass inspection takes place
after establishment personnel have already sorted the eviscerated
carcasses, disposed of carcasses that they have identified as having
condemnable conditions, and conducted any trim and reprocessing they
believe necessary to correct removable defects. Carcass inspection is
conducted much more efficiently and effectively under HIMP than under
the existing inspection systems because establishment personnel have
already sorted, trimmed, and reprocessed the carcasses, thereby
removing most visible defects, before the online carcass inspector
appraises them.
Under HIMP, offline inspection is referred to as ``verification
inspection.'' Verification 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 the
existing inspection systems. Some examples of verification inspection
activities include: HACCP, sanitation SOP, and other prerequisite
program verification procedures, including verification checks
specifically for septicemia and toxemia and for fecal contamination;
verifying sanitary dressing requirements at multiple points in the
inspection system; and sample collection for pathogen testing.
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 poultry production system and providing an incentive to
establishments to improve and innovate, while ensuring effective online
inspection at line speeds of 175 birds per minute.
C. Analysis of HIMP
1. FSIS Evaluation of HIMP
FSIS has conducted a comprehensive analysis of data collected from
the operation of HIMP in young chicken slaughter establishments and has
prepared a written report (the ``HIMP Report'') that presents a
thorough evaluation of the models tested. Based on this evaluation,
FSIS has concluded that compared to inspection at non-HIMP
establishments, HIMP has improved the safety of poultry products and
increased overall consumer protection while still ensuring carcass-by-
carcass inspection of each eviscerated carcass.
A detailed summary of the HIMP Report is provided below. The full
HIMP Report is available for viewing by the public in the FSIS docket
room and on the FSIS Web site at: http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
Prior to beginning HIMP, an independent consulting firm, Research
Triangle Institute (RTI) conducted baseline organoleptic and
microbiological data collection in 16 young chicken slaughter
establishments that volunteered to participate in the HIMP program.
These baseline collection results reflect the performance of pre-HIMP
poultry slaughter inspection systems and provided the basis to
establish HIMP performance standards for septicemia and toxemia, for
fecal contamination, and for five other consumer protection (OCP)
concerns (see Appendix A for information about these performance
standards). Prior to finalizing the standards, RTI conducted the same
data collection after HIMP was implemented in 16 establishments and
found improvement in various aspects of establishment performance after
implementation of the HIMP system. The HIMP performance standards were
finalized in November 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 new HIMP inspection system with performance when operating under
the current non-HIMP inspection systems.
Following entry of a total of 20 young chicken slaughter
establishments into the HIMP program, in 2002, FSIS collected FSIS
verification data that show that HIMP establishments exceeded the
performance standards for food safety and all but one of the OCP
standards. The HIMP Report contains the most recent data showing that
the HIMP establishments continue to meet the HIMP performance
standards. The HIMP Report also evaluates other measures to compare
HIMP establishment performance with non-HIMP establishment performance.
Therefore, based on these results, HIMP establishments have
consistently performed better under HIMP than they did under non-HIMP
inspection systems.
a. Overview of HIMP Report
The HIMP Report describes FSIS's microbiological and inspection
findings in young chicken slaughter establishments participating in
HIMP and compares them with the HIMP performance standards or with
comparison sets of non-HIMP
[[Page 4415]]
establishments. The first comparison set of establishments was a subset
of 64 non-HIMP establishments selected to be comparable to HIMP
establishments with respect to total slaughter volume, line speeds, and
geographic distribution. The second comparison set was all 176 non-HIMP
establishments that slaughtered young chickens in all 5 years
considered in the study. The evaluation is based on data for the
calendar years CY2006 through CY2010, with exceptions where only more
recent data are available.
Across HIMP and non-HIMP establishments, analyses compared the
number of offline inspection procedures, the rates of health-related
regulatory noncompliances, fecal contamination noncompliances, and
Salmonella positive rates. FSIS evaluated offline inspection procedures
to determine whether comparable levels of inspection are being
performed in HIMP establishments compared to non-HIMP establishments.
FSIS looked at the other data to evaluate whether the HIMP system
resulted in public health benefits and continued to ensure that FSIS
inspected each carcass presented for inspection.
b. Inspection of Each Carcass by FSIS Inspectors To Determine Whether
the Carcass Is Not Adulterated and Therefore Eligible To Bear the Mark
of Inspection
The HIMP Report evaluates the ability of the FSIS online carcass
inspector (CI) to detect carcasses affected with septicemia/toxemia and
visible fecal contamination after the establishment has sorted the
carcasses but before the carcasses enter the chiller. The purpose of
this analysis is to demonstrate that even though CI's in HIMP plants
are presented with an extremely low number of carcasses affected with
septecimia/toxemia and visible fecal contamination, they are still able
to detect carcasses with these visible food safety defects.
Data collected from April 1, 2009, to March 31, 2011, show that the
CI in HIMP establishments found 125 carcasses affected with septicmia/
toxemia and 26,815 carcasses with visible fecal contamination. The HIMP
Report calculates the CI detection rates for both of these food safety
defects by dividing the number of carcasses affected with them by the
total number of carcasses presented to the CI inspector. For
septicemia/toxemia, the CI detected affected carcasses at a rate of
0.000004 percent or 4 per 100 million carcasses slaughtered. For
visible fecal contamination, the CI detected affected carcasses at a
rate of 0.0009 percent or 9 per million carcasses slaughtered. The
levels of these diseases and fecal contamination that are presented to
the CI can be measured by the results of the FSIS off-line verification
of the HIMP performance standards. Verification checks are conducted by
the FSIS verification inspector (VI) before the CI and after the
establishments has sorted the carcasses. The findings of those
verification checks show that fewer than 8 per 1 million carcasses
(0.0008 percent) processed in HIMP establishments were found to have
septicemia/toxemia and that fewer than 0.8 per thousand carcasses (0.08
percent) processed in HIMP establishments were found to have visible
fecal contamination. These rates were lower than the HIMP performance
standards of 0.1% carcasses for septicemia/toxemia and 0.8% carcasses
for visible fecal contamination.
Therefore, levels of these diseases and fecal contamination
presented to the CI are very low in HIMP establishments. Nevertheless,
the CI in HIMP establishments further reduces the number of carcasses
with septicemia, toxemia, or visible fecal contamination, thereby
reducing food safety defects to levels lower than found in non-HIMP
establishments. In conclusion, the most recent data demonstrates that
the CI in HIMP establishments is able to identify carcasses affected
with septicemia, toxemia, and visible fecal contamination.
c. Verification by Offline Inspectors of the Establishment Executing
Its HIMP Process Control Plan Under Which Establishment Employees Sort
Acceptable and Unacceptable Carcasses and Parts
Because fewer inspectors are required to conduct online carcass
inspection in HIMP establishments, FSIS inspection personnel are able
to perform more offline food safety inspection activities. The HIMP
study focuses on 11 offline inspection procedures identified by codes
that apply to all poultry slaughter establishments. FSIS chose to focus
on these procedures because they are all related to food safety or
production of wholesome product (with minimal defects). These
inspection procedures determine the type of inspection activities that
FSIS personnel perform to verify compliance with specific regulatory
requirements. The 11 inspection procedure codes considered in the HIMP
study are associated with procedures that FSIS inspection personnel
perform to:
Verify an establishment's compliance with the sanitation
SOP regulations in 9 CFR 416.11-416.16 (procedure codes 01A01, 01B01,
01B02, 01C01, 01C02);
Verify compliance the HACCP regulations in 9 CFR part 417
(procedure codes 03A01, 03J01, 03J02);
Verify compliance with relevant regulations for finished
product standards (FPS) and good commercial practices (procedure code
04C04);
Verify compliance with generic E. coli testing
requirements under 9 CFR 381.91 (procedure code 05A01); and
Verify compliance with the Sanitation Performance
Standards regulations in 9 CFR 416.1-416.6 (procedure code 06D01).
The HIMP Report compares the ratio of each inspection procedure
performed per young chicken slaughter establishment for HIMP and non-
HIMP establishments. The comparison shows that in CY2010, FSIS offline
inspection personnel performed 1.6 times more offline inspection
procedures in HIMP establishments than in non-HIMP establishments.
These procedures include verifying compliance with both OCP- and food
safety-related regulations. This increased level of offline inspection
activities ensures that HIMP establishments are maintaining OCP and
food safety defects at levels that are less than in non-HIMP
establishments and thereby producing a safer product.
Table 1 below presents the findings for each inspection procedure
code.
[[Page 4416]]
Table 1--CY2010 Ratios of Inspection Procedures per Establishment in HIMP to Non-HIMP
----------------------------------------------------------------------------------------------------------------
20 HIMP 64 Non-HIMP
establishments comparison
Procedure code (procedures/ establishments HIMP/Non-HIMP
establishment) (procedures/ ratio
\6\ establishment)
----------------------------------------------------------------------------------------------------------------
Total..................................................... 14135.9 8723.7 1.6
----------------------------------------------------------------------------------------------------------------
Sanitation SOP verification procedures
----------------------------------------------------------------------------------------------------------------
01A01..................................................... 3.4 3.7 0.9
01B01..................................................... 140.3 148.7 0.9
01B02..................................................... 98.0 110.9 0.9
01C01..................................................... 259.2 272.5 1.0
01C02..................................................... 294.8 299.0 1.0
----------------------------------------------------------------------------------------------------------------
HACCP verification procedures
----------------------------------------------------------------------------------------------------------------
03A01..................................................... 2.5 1.9 1.3
03J01..................................................... 10296.1 3027.5 3.4
03J02..................................................... 287.0 259.4 1.1
----------------------------------------------------------------------------------------------------------------
FPS and good commercial practices verification procedures
----------------------------------------------------------------------------------------------------------------
04C04..................................................... 2612.3 4447.4 0.6
----------------------------------------------------------------------------------------------------------------
Generic E. Coli testing verification procedures
----------------------------------------------------------------------------------------------------------------
05A01..................................................... 0.2 1.3 0.2
----------------------------------------------------------------------------------------------------------------
Sanitation Performance Standards verification procedures
----------------------------------------------------------------------------------------------------------------
06D01..................................................... 142.2 151.5 0.9
----------------------------------------------------------------------------------------------------------------
The number of 04C04 inspections in HIMP establishments appears to
be less than in non-HIMP establishments. However, the number of 04C04
inspection procedures in HIMP and non-HIMP establishments is not
directly comparable since they are counted differently. In HIMP
establishments, during this procedure, a minimum of 2 OCP 10 bird
sample sets are conducted in a single shift and are counted as a single
04C04 inspection procedure. In non-HIMP plants, each 10 bird sample set
is counted as a separate 04C04 inspection procedure.
d. Verification of the Establishment Executing Its Sanitation SOPs and
Its HACCP System Under 9 CFR Parts 416 and 417
(1) Offline Inspection Procedures Performed
The Sanitation SOP regulations in 9 CFR 416 and the HACCP
regulation in 9 CFR 417 are among the regulations most strongly related
to public health. There are eight inspection procedures associated with
activities that FSIS inspectors perform to verify compliance with the
Sanitation SOP and HACCP regulations. These are the inspection
procedures with codes in the 01 series and 03 series presented in Table
1 above. The HIMP Report found that in CY2010, FSIS inspectors
performed approximately 2.8 more offline procedures to verify
compliance with Sanitation SOP and HACCP regulatory requirements than
inspectors did in non-HIMP establishments.
The HIMP Report also compares the rate at which inspectors in HIMP
establishments performed the HACCP 3J01 procedure in HIMP
establishments to the rate performed in non-HIMP establishments. The
inspection activities under the 03J01 procedure include random
verification of all HACCP requirements, and over 90 percent of these
activities involve verifying an establishment's compliance with FSIS's
zero tolerance for visible fecal contamination. The HIMP Report found
that in CY2010, inspectors in HIMP establishments performed 3.4 more
03J01 procedures overall than inspectors in non-HIMP establishments
(see Table 3 above). These data show that under HIMP, compared to non-
HIMP inspection systems, inspectors are able to spend more time in
prevention-oriented inspections, which better protects the public from
foodborne disease. This increased level of inspection ensures that HIMP
establishments continuously satisfy food safety performance standards
and HACCP regulations and are maintaining OCP- and food safety defects
at levels that are less than in non-HIMP establishments and thereby
producing a safer product.
(2) Public Health Related Non-Compliances
For purposes of data analysis and for targeting FSIS resources,
FSIS categorizes each of its regulatory requirements based on how
strongly non-compliance with that regulation could adversely affect
public health. The categories are ranked from zero to three, and the
FSIS regulations that are most strongly related to public health are
classified as category 3 regulations. Category 3 regulations are those
that if in non-compliance are most likely to endanger public health. A
non-compliance record or ``NR'' associated with a category 3 regulation
is classified as a ``W3 Non-compliance Record'' or ``W3NR.'' These are
also referred to as ``health-related'' NRs.
The HIMP Report summarizes and compares the health-related NR rates
by inspection procedure for HIMP and the control set of non-HIMP
establishments for the 5 years of combined CY2006 to CY2010 data. The
health-related NR rate for an inspection procedure is calculated by
dividing the total number of health-related NRs associated with that
inspection procedure by the total number of inspection procedures
performed under that inspection
[[Page 4417]]
procedure. The comparison shows that health-related NR rates at HIMP
establishments are not statistically different or are statistically
lower for all inspection procedures considered. This information is
presented in Table 2 below. These data demonstrate that HIMP
establishments are satisfying all food safety, HACCP, and sanitation
regulations designed to insure that establishments are producing safe
product and wholesome products.
Table 2--Five Year Average Health-Related NR Rates for HIMP and Non-HIMP
Broiler Establishments
------------------------------------------------------------------------
Non-HIMP
HIMP broiler comparison
Proc Code establishments broiler
(percent) establishments
(percent)
------------------------------------------------------------------------
01A01............................... 0.00 0.09
01B01............................... 0.21 0.28
01B02............................... 1.33 1.33
01C01............................... 0.38 0.39
01C02............................... 1.27 1.27
03A01............................... 0.00 0.39
03J01............................... 0.90 \*\ 1.41
03J02............................... 0.67 0.75
05A01............................... 0.00 0.00
06D01............................... 0.02 0.03
------------------------------------------------------------------------
* indicates a statistically significant difference at the 0.05 level.
(3) Fecal Contamination: NRs Associated With Fecal Contamination
The HIMP Report analyzes NR rates for visible fecal contamination
in HIMP and non-HIMP comparison establishments for CY2006 to CY2010.
Because visible fecal contamination is a hazard reasonably likely to
occur, poultry slaughter establishments address visible fecal
contamination in their HACCP plans. The visible fecal NR rate was
computed as the total number of fecal contamination NRs divided by the
sum of the number of the HACCP verification 03J01 and 03J02 procedures
performed. This comparison found that fecal NR rates in HIMP
establishments are statistically lower than those in both the control
set of non-HIMP establishments and the all non-HIMP comparison set for
all the years considered (see Table 3 below). This means that the rate
of visible fecal material contamination in HIMP establishments is about
half that of non-HIMP establishments. Thus, establishments operating
under the HIMP inspection system had lower rates of visible fecal
contamination than establishments operating under non-HIMP inspection
systems. In slaughter establishments, fecal contamination of carcasses
is the primary avenue for contamination by pathogens. Based on these
data, HIMP establishments likely have lower levels of pathogens than
non-HIMP establishments. The fecal NR rates are presented in Table 3
below.
Table 3--Fecal NR Rates at HIMP and Non-HIMP Comparison Establishments
----------------------------------------------------------------------------------------------------------------
Non-HIMP
comparison All Non-HIMP
HIMP (percent) establishments establishments
(percent) (percent)
----------------------------------------------------------------------------------------------------------------
2006...................................................... 0.70 1.10 1.07
2007...................................................... 0.59 1.21 1.17
2008...................................................... 0.67 1.25 1.26
2009...................................................... 0.65 1.25 1.20
2010...................................................... 0.73 1.49 1.40
----------------------------------------------------------------------------------------------------------------
Additional analysis conducted on the fecal NR rates in HIMP and non-
HIMP establishments shows that that fecal NR rates in HIMP
establishments are independent of production volume.
The HIMP Report also evaluates the effect of line speeds on fecal
NR rates and found no statistical difference in either total fecal NR
counts or fecal NR rates between establishments with different line
speeds.
e. Verification of the Outcomes of the Establishment Process Control
Plan, Both Organoleptic and Microbiologic
(1) Food Safety Performance Standards
As discussed above, for the HIMP study, FSIS developed food safety
performance standards for septicemic/toxemic animal conditions and
visible fecal contamination. These performance standards allow the
Agency to compare performance between HIMP and non-HIMP establishments
in meeting the zero tolerance standard for these conditions. The HIMP
Report compares the findings of the offline FSIS verification
inspectors (VIs) for the 2-year period April 1, 2009, to March 31,
2011, with the HIMP performance standards. The HIMP Report calculates
the FSIS offline VI detection rates for carcasses affected with
septicemia/toxemia or contaminated with visible fecal material by
dividing the number affected carcasses identified by the VIs by the
total number of carcasses examined by the VI. The total number of
carcasses examined by VIs in HIMP establishments is 4 times greater
than the number examined by offline inspectors in non-HIMP
establishments.
The findings of the VIs verification checks show that fewer than 8
per 1 million carcasses (0.0008 percent) processed in HIMP
establishments were found to have septicemia/toxemia. This rate is 125
times lower than the HIMP performance standard of 0.1% of the carcasses
processed. The data also show that fewer than 0.8 per thousand
carcasses (0.08 percent) processed in HIMP establishments were found to
have visible fecal contamination, which
[[Page 4418]]
is about 19 times lower than the HIMP performance standard. These
findings are presented in Table 4 below.
Table 4--HIMP Achievement of Food Safety Performance Standards at Young Chicken Establishments
----------------------------------------------------------------------------------------------------------------
HIMP performance HIMP establishment performance based on
Defect categories standards (% of FSIS offline inspector verification checks
carcasses) (% of carcasses)
----------------------------------------------------------------------------------------------------------------
Septicemia/Toxemia............................. * 0.1% 0.0008% (0.002%)
Range 0.0-0.008%
Visible fecal contamination.................... * 1.5% 0.08% (0.05%)
Range 0.008-0.17%
----------------------------------------------------------------------------------------------------------------
* FSIS has a zero tolerance policy for Septicemia/Toxemia and Visible Fecal Contamination.
Period of data collection: April 1, 2009 through March 31, 2011.
(2) OCP Performance Standards
As discussed in the appendix to this proposal, FSIS developed OCP
performance standards based on a tightening of the existing FPS for
removable animal diseases and trim and dressing defects. The OCP
performance standards allow the Agency to compare the performance of
HIMP and non-HIMP establishments in addressing these non-food safety
defects. The Agency collected data on the number and type of OCP
defects identified by the FSIS offline VIs from January 1, 2009,
through December 31, 2010, and compared them with the corresponding OCP
HIMP performance standard. A comparison of young chicken HIMP
establishment performance with OCP HIMP performance standards is
presented in Table 5 below.
Table 5--HIMP Achievement of OCP Performance Standards at Young Chicken Establishments
----------------------------------------------------------------------------------------------------------------
Performance
standards based on HIMP establishment performance based on
non-HIMP FSIS inspector verification checks (% of
inspection (% of carcasses)
carcasses)
----------------------------------------------------------------------------------------------------------------
OCP 1.......................................... 1.7% 0.38% (0.36%)
Condition--Animal Diseases (e.g., .................. Range 0.0-1.25%
airsacculitis).
OCP 2.......................................... 52.5% 34.1% 9.3%
Condition--Miscellaneous (e.g., bruises, .................. Range 18.2-49.9%
sores, and other processing defects).
OCP 3.......................................... 18.6% 6.3% 4.3%
Contamination--Digestive Content (non- .................. Range 0.25-15.2%
fecal) (e.g., ingesta).
OCP 4.......................................... 80.0% 66.4% 10.4%
Dressing Defects--Other (e.g., feathers)... .................. Range 41.2-80.2%
OCP 5.......................................... 20.8% 9.8% 4.0%
Dressing Defects--Digestive Tract Tissue .................. Range 3.2--15.8%
(e.g., bursa, cloaca).
----------------------------------------------------------------------------------------------------------------
Period of data collection: CY2009 through CY2010.
The data show that OCP defects identified on carcasses processed in
HIMP establishments average about half the corresponding OCP HIMP
performance standard. The analysis found no statistically significant
difference in OCP2-OCP5 rates between HIMP establishments with
different line speeds. This shows that these establishments are
effectively addressing OCP standards.
(3) Salmonella Positive Rates
The HIMP Report compares the Salmonella percent positive rates for
HIMP young chicken slaughter establishments and the control set of 64
non-HIMP establishments for the years CY2006 to CY2010. This comparison
is presented in Table 6.
Table 6--Salmonella Percent Positive Rates for HIMP and Non-HIMP Broiler Establishments
--------------------------------------------------------------------------------------------------------------------------------------------------------
2006 2007 2008 2009 2010
--------------------------------------------------------------------------------------------------------------------------------------------------------
20 HIMP Broiler Establishments................................ 9.0% 5.8% 4.2% 4.9% 4.7%
64 Non-HIMP Comparison Broiler Establishments................. 10.8% 8.5% 7.3% 4.3% 4.0%
176 All Non-HIMP Broiler Establishments....................... 11.1% 8.1% 7.6% 6.8% 4.7%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Analysis of these rates found that in CY2006-CY2008 the Salmonella
positive rate in HIMP establishments was statistically significantly
lower than in the non-HIMP comparison set and that the difference in
CY2009 and CY2010 was not statistically significant. The Salmonella
positive rate in HIMP establishments was statistically
[[Page 4419]]
significantly lower than in the all non-HIMP comparison set for CY2006
to CY2009. There was no statistically significant difference in CY2010,
which most likely reflects the effects of the Salmonella initiatives
that FSIS implemented in 2006 to reverse the multi-year trend of
persistently higher percent positive rates for Salmonella detected
through FSIS's HACCP verification testing each year. As a result of
these initiatives, the entire industry was forced to reduce the
incidence of positive Salmonella results, particularly those
establishments with the highest Salmonella positive rates.
The analysis in the HIMP Report also found that, after adjusting
for production volume, the difference in the Salmonella positive rate
between establishments with different line speeds is not statistically
significant. This analysis is based on the 10 HIMP establishments with
Salmonella testing during CY2010. The line speeds for these 10
establishments ranged from annual average of 98 to 162 birds per
minute.
f. Conclusion
Based on its evaluation of the HIMP study, FSIS has concluded that
establishments operating under the HIMP inspection system performed
better than establishments operating under non-HIMP inspection systems
with respect to rates of food safety and OCP defects. Also, fecal
contamination rates and Salmonella positive rates are lower in HIMP
than in non-HIMP establishments. HIMP establishments have higher
compliance with sanitation SOP and HACCP prevention regulations. Based
on the data discussed in the HIMP Report, FSIS has concluded that more
offline food safety inspections results in greater compliance with
sanitation and HACCP regulations and birds with lower levels of fecal
and Salmonella contamination. In aggregate, the findings support that
the HIMP inspection system results in public health benefits, allows
FSIS to conduct inspection more efficiently, and ensures that HIMP
inspectors perform in a manner that properly enables them to inspect
each carcass.
2. 2001 Government Accountability Office Report on HIMP
On December 17, 2001, the Government Accountability Office
(``GAO'') issued a report on HIMP entitled ``Food Safety: Weaknesses in
Meat and Poultry Inspection Pilot Should Be Addressed Before
Implementation.'' \7\ The following describes FSIS's current thinking
regarding the GAO's 2001 recommendations for executive action that that
specifically pertain to elements of this proposed rule. FSIS requests
comment on these aspects of the proposed rule.
---------------------------------------------------------------------------
\7\ GAO, 2001. Food Safety: Weaknesses in Meat and Poultry
Inspection Pilot Should Be Addressed Before Implementation, http://www.gao.gov/new.items/d0259.pdf.
---------------------------------------------------------------------------
1. GAO recommended that only establishments with a good history of
regulatory compliance be eligible to participate in the inspection
program.
Response: The GAO recommendation was made in the context of HIMP as
a pilot program. The pilot program is now completed and FSIS has
conducted a comprehensive evaluation of the HIMP inspection system,
which is described in the HIMP Report. Thus, FSIS believes that this
gradation among establishments recommended by GAO is no longer relevant
to the implementation of the New Poultry Inspection System.
2. GAO recommended that establishments operating under the new
inspection system be required to implement statistical process controls
to manage and control production and that FSIS monitor and verify the
efficacy of these systems.
Response: FSIS believes that statistical process control (``SPC'')
systems, which help to determine whether an establishment's production
processes are performing within established performance standards with
regard to non-food-safety related defects, are effective tools for
establishments to use to manage and control their production. However,
instead of specifically mandating the use of SPC in this proposal, FSIS
is proposing to allow establishments operating under the new inspection
system to implement the process controls that they have determined will
best allow them to produce ready-to-cook poultry that is wholesome and
not adulterated. FSIS is proposing that the establishments document
that they are meeting the standard for ready-to-cook poultry.
Establishments could, but would not be required to, use SPC systems to
meet this requirement. FSIS expects that most establishments will
choose to use SPC systems as part of their effort to meet this
requirement, but the Agency believes that it is more appropriate and
more in keeping with HACCP requirements to provide each establishment
the flexibility to determine how best to meet the requirement within
the context of its unique production environment.
3. GAO recommended that FSIS, in conjunction with industry, develop
a training and certification program for establishment sorting
activities, and that only trained and certified establishment personnel
be permitted to perform these duties.
Response: FSIS agrees that proper training is important to
establishment sorters' ability to make accurate decisions on how to
address animal disease conditions and trim and dressing defects. If
sorters do not make these decisions correctly, inspection personnel
will be required to take actions such as stopping the production line
to remove contaminated carcasses, issuing non-compliance records, and
directing the establishment to reduce the line speed to ensure that the
establishment is able to maintain process control, and that inspectors
are able to conduct a proper inspection. Training of sorters is vitally
important to ensure that sorting procedures are properly performed.
Lack of effective sorter training would cause FSIS to initiate action
to ensure that plant employees are properly trained.
FSIS is not proposing to require specific, formalized sorter
training. However, FSIS will develop guidance documents to assist
establishments in the training of their sorters. The Agency intends to
post draft guidance materials on the FSIS Web site and announce the
availability of such materials in the Federal Register and through the
FSIS Constituent Update. The Agency will seek public comment on these
draft materials to inform the development of the final guidance
documents to ensure they are as useful as possible. The Agency will
make the final guidance documents available to the public on the FSIS
Web site before the final rule resulting from this proposal becomes
effective. The guidance that the Agency is planning to develop would be
based on the training that FSIS provides to on-line inspection
personnel that are responsible for sorting carcasses under the existing
inspection system. Under this proposed rule, establishments would have
the flexibility to select the training program that best assist them to
meet the requirements of this proposed rule.
D. Public Health Benefits Projected From Allocating More Inspection
Resources to Food Safety-Related Inspection Activities
1. Risk Assessment
In June 2011, FSIS completed a quantitative risk assessment to
[[Page 4420]]
determine how performing a greater number of sanitation, sampling, and
other offline inspection procedures in young chicken and turkey
slaughter establishments might affect the number of human illnesses
from Salmonella and Campylobacter. These offline inspection procedures
primarily involve activities that FSIS inspection personnel perform to
verify the effectiveness of establishment sanitary operations and other
health and safety-related activities. The 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 in non-HIMP establishments. The risk
assessment is available for viewing by the public in the FSIS docket
room and on the FSIS Web site at: http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
FSIS developed the risk assessment to help the Agency determine how
it could help reduce risks to public health associated with processed
poultry by improving its approach to inspection. To give the Agency the
information it needed, the risk assessment focused on four risk
management questions: (1) Can FSIS redeploy its inspection activities
within official establishments without causing an increased prevalence
of microbial pathogens in the establishments? (2) Will redeploying
inspectors to offline duties have an effect on the prevalence of
microbial pathogens, and hence on human illness? (3) Where in a poultry
establishment will redeployed inspection activities have the greatest
effect in reducing the prevalence of microbial pathogens and thus, in
reducing human illness? (4) What is the quantitative uncertainty of the
pathogen prevalence and illness reductions?
2. Model
FSIS developed a risk assessment model for examining relationships
between current variations in inspection personnel assignments and
prevalence of Salmonella and Campylobacter on young chicken and turkey
carcasses and subsequent human illnesses attributable to those
pathogens. FSIS paired inspection data with Salmonella and
Campylobacter prevalence data for the same establishments and
timeframes.\8\
---------------------------------------------------------------------------
\8\ The prevalence of Salmonella on young chickens came from the
USDA/FSIS Salmonella PR/HACCP verification testing program from July
2007 to September 2010 and the most recent young chicken baseline
study (2007-2008). Data for prevalence of Campylobacter on young
chickens came from the young chicken baseline study (2007-2008).
Data for inspection procedures performed in an establishment came
from the FSIS performance-based inspection system (PBIS) data base
(July 2007-September 2010). Data for turkey establishments comprise
results of the FSIS ``Young Turkey Baseline'' (August 2008 through
July 2009, 9) and PR/HACCP Salmonella verification program (July
2007 through September 2010).
---------------------------------------------------------------------------
FSIS employed a stochastic simulation model using multi-variable
logistic regressions to identify correlations between the numbers of
offline food-safety inspection procedures, both scheduled and
unscheduled, along with numbers of non-compliances and scheduled-but-
not-completed procedures, and contamination of poultry with Salmonella
or Campylobacter. (Scheduled procedures are assigned to inspectors at
an establishment by the Agency's automated management system.
Unscheduled procedures are performed according to inspector needs at an
establishment and may include fecal checks for compliance with the
zero-tolerance requirement, 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.) The correlations were used to predict the
effect that devoting more resources to these procedures would have on
human illness attributable to the consumption of young chicken.
Stochastic simulations were used to account for uncertainty in the
estimates relating inspection procedures in an establishment to
detection of Salmonella and Campylobacter in poultry. Illness estimates
were based on CDC data, and uncertainty distributions were used to
account for the variability in annual Salmonella and Campylobacter
illnesses and 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 Risk Assessment
The results of the risk assessment show that redeployment of Agency
resources from on-line inspection activities to unscheduled off-line
activities to verify compliance with Sanitation SOPs, HACCP
requirements, and other requirements that are important to food safety,
is correlated with lower prevalence of carcasses contaminated with
Salmonella and Campylobacter and may result in a reduction in the
number of human illnesses.
Regarding the first risk-management question, the risk assessment
showed that establishments with more unscheduled offline inspection
activities have lower Salmonella and Campylobacter prevalence than
establishments with fewer unscheduled offline activities. The
assessment also suggested that there may be fewer illnesses
attributable to both Salmonella and Campylobacter when additional
unscheduled offline inspection procedures are performed.
In answer to the second risk-management question, the lower
prevalence of Salmonella and Campylobacter on poultry at establishments
where additional unscheduled offline procedures were performed could
lead to as many as 4286 fewer Salmonella-related illnesses and 986
fewer Campylobacter-related illnesses per year. FSIS has estimated that
174,686 expected annual Salmonella illnesses could be attributed to
both young chicken and turkey consumption, and an estimated 169,005
expected annual Campylobacter illnesses attributable to young chicken
or turkey consumption. Thus, a reduction of 4,286 expected Salmonella
illnesses annually, reflects a 2.5% reduction in attributable
illnesses. A reduction of 986 expected Campylobacter illnesses annually
reflects a 0.6% reduction in attributable illnesses.
Responding to the third question, the risk assessment showed that
the greatest effect on Salmonella and Campylobacter prevalence and
related illness would occur when inspection activities were
concentrated on increased unscheduled off-line procedures. These could
include additional unscheduled sanitation procedures, additional
unscheduled sampling procedures, or additional unscheduled HACCP
procedures.
In answer to the fourth risk-management question, on the
uncertainty of the results for pathogen prevalence and illness
reductions, FSIS analysts reflected the uncertainty of illness
estimates by reporting not only expected values but also the upper and
lower bounds of an 80-percent confidence band around the estimates.
Thus, for example, they calculated the annual averted Salmonella
illnesses to be as few as 1514 and as many as 7682, and the averted
Campylobacter illnesses as few as 26 and as many as 2865. Table 7
presents total estimated reductions in human illnesses relating to
increased offline inspection procedures.
[[Page 4421]]
Table 7--Total Potential Reductions in Annual Human Illnesses Relating to Better Offline Inspection Procedure
Performance in Young Chicken and Turkey Slaughter Establishments
----------------------------------------------------------------------------------------------------------------
What happens if unscheduled offline inspection
procedures increase in young chicken and turkey
establishments? \1\
-----------------------------------------------------
Confidence interval
Expected value -----------------------------------
10th% 90th%
----------------------------------------------------------------------------------------------------------------
Annual Salmonella illnesses prevented..................... 4286 1514 7682
Annual Campylobacter illnesses prevented.................. 986 26 2865
----------------------------------------------------------------------------------------------------------------
\1\ Risk assessment scenario assumes that all unscheduled inspection activities could change by as little as no
increase to as much as a 60% increase.
III. Proposed New Poultry Inspection System for Young Chickens and
Turkeys
A. Replacement of SIS, NELS, and NTIS With the New Poultry Inspection
System
Based on the Agency's experience under HIMP and the improved
performance related to food safety and non-food-safety standards and
especially in reducing pathogen levels, FSIS is proposing to eliminate
SIS, NELS, and NTIS and to replace them with the New Poultry Inspection
System. All young chicken and turkey slaughter establishments would be
required to operate under either the new inspection system or the
traditional inspection system.
Establishments that slaughter classes of poultry other than young
chickens and turkeys would be permitted to operate under the New
Poultry Inspection System under a waiver through the SIP. FSIS would
consider the data collected in poultry slaughter establishments
operating under a SIP waiver to determine whether to expand the New
Poultry Inspection System to other classes of poultry.
B. Carcass Sorting and Online Carcass Inspection
Under the new inspection system, establishments will be required to
sort carcasses, to dispose of carcasses that must be condemned, and to
conduct any necessary trimming or reprocessing activities before
carcasses are presented to the online FSIS carcass inspector. After
these sorting activities have been completed, the online carcass
inspector will conduct a carcass-by-carcass inspection before the
carcasses enter the chiller. If the online carcass inspector observes
any food safety defects on any of the carcasses, such as the presence
of septicemic or toxemic animal disease or fecal material, he or she
will stop the line to prevent the contaminated carcass from entering
the chiller. Under this new inspection system, the inspector will not
restart the line until establishment personnel have removed the
contaminated carcass from the line. The online carcass inspector will
notify the inspector-in-charge if the presence of excessive food safety
related or non-food-safety related conditions, poor presentation of
carcass for inspection by the carcass inspector, or other indications
that there may be a loss of process control. Under such conditions, the
inspector-in-charge will take appropriate remedial action and will be
authorized to require that the establishment slow the line speed.
Establishments' responsibility for carcass sorting under the
proposed new inspection system would include removing carcasses that
exhibit septicemic and toxemic conditions from the processing line.
Carcasses that exhibit septicemic and toxemic conditions 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 chiller.
Because establishments operating under the proposed new inspection
system would be required to identify and remove carcasses affected by
septicemic and toxemic conditions before FSIS carcass inspection, FSIS
is proposing that establishments under the new system address, as part
of their HACCP plan, or sanitation SOP, or other prerequisite program,
procedures for ensuring that septicemic and toxemic carcasses are
prevented from entering the chiller. These procedures must cover, at a
minimum, establishment sorting activities for these conditions.
Under this proposal, FSIS would maintain its zero tolerance for
septicemic and toxemic carcasses. Carcasses exhibiting septicemic and
toxemic conditions would be condemned, if not removed by the
establishment, by the online carcass inspector, as under the existing
regulations (9 CFR 381.83). A noncompliance record (NR) would be issued
for every carcass affected by septicemia and toxemia that reaches the
online carcass inspection station. Moreover, because establishments
would be required to address this food safety hazard in their HACCP
plan, or sanitation SOP, or other prerequisite programs, the Agency
continuously would assess the effectiveness of an establishment's HACCP
system if FSIS inspection personnel observed septicemic or toxemic
carcasses.
Under the proposed new inspection system, because the online
carcass inspector will be positioned immediately before the chiller and
will not conduct a carcass inspection until after sorting, trimming,
and reprocessing has been completed by establishment employees, viscera
will not be presented together with the carcasses as in the current
inspection systems. FSIS has determined that not presenting the viscera
will not prevent the online carcass inspector from ensuring that all
carcasses are unadulterated and wholesome. With the exception of one
condition, i.e., visceral leukosis, observing the outside of the
carcass is sufficient to determine whether the carcass should be
condemned. Systemically affected carcasses are darker in color from
dehydration and hemorrhaging and may be smaller or have less body fat
because of inappetence or increased metabolic rate. There may be an
obvious cause of the systemic involvement such as a large tumor,
bruise, or infected joint. Although observing the viscera provides
additional assurance that the decision to condemn is correct and may
help determine the specific category for recording the reason for
condemnation, observing the viscera is not required to identify the
presence of a condemnable condition, with the exception of visceral
leukosis.
Avian visceral leukosis can only be detected by observing the
viscera. Avian visceral leukosis, a rare manifestation of the viral
disease leukosis, is not transmissible to humans and does not
[[Page 4422]]
present a human health concern. However, it may render poultry
unwholesome or otherwise unfit for human food.
Avian leukosis can be identified by observing the viscera of the
first 300 birds of each flock because if avian visceral leukosis is
present, it will be present throughout the entire flock. In general, a
flock constitutes birds raised under similar circumstances on the same
premises. It is common commercial practice to vaccinate each flock of
chickens for viral leukosis. Nationwide data from 1984 revealed that
all forms of leukosis (skin, visceral, other viral leukoses) resulted
in the condemnation of 0.017 percent of the approximately 7.4 billion
young chickens slaughtered. On rare occasions, the vaccine is not
effective. If it is not, visceral leukosis is present on a flock basis.
Accordingly, FSIS is proposing that an offline inspector will observe
the viscera of the first 300 birds slaughtered of each young chicken
flock under the New Poultry Inspection System to determine whether the
disease is present in the flock. FSIS has followed this practice in
young chicken HIMP establishments, and it has been shown to be
effective. (See HIMP Report, available for viewing by the public in the
FSIS docket room and on the FSIS Web site at: http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp). Turkeys do not
typically display liver lesions associate with leukosis, therefore, the
300 bird viscera check is not performed on turkeys.
To allow FSIS to properly inspect viscera for avian leukosis, FSIS
is proposing to require that establishments that slaughter young
chickens notify the FSIS IIC prior to the slaughter of each new flock.
Under this proposed rule, if the inspector identifies a carcass
affected with visceral leukosis, he or she may expand the sample beyond
300 birds. The decision to designate a flock as leukosis positive would
be made by the FSIS inspector-in-charge (IIC). In case of a positive
flock, the IIC would position an inspector to inspect each viscera for
visceral leukosis only, at a location where viscera and carcass can be
identified together. This activity would be for the duration of the
slaughter of the flock.
C. Offline Verification Inspection
In addition to the online carcass inspector, FSIS is proposing that
one offline verification inspector be assigned for each evisceration
line in establishments operating under the New Poultry Inspection
System. As in HIMP, verification inspectors under the new inspection
system will conduct food safety related inspection activities and will
continuously monitor and evaluate establishment process control.
Verification inspectors will conduct inspection activities including
HACCP, sanitation SOP, and other prerequisite program verification
procedures; verification checks for septicemia and toxemia, and fecal
contamination; checks to verify and ensure that sanitary dressing
requirements are being met; ante-mortem inspection; and sample
collection for pathogen testing. The offline verification inspector
will work with the inspector-in-charge to ensure that food safety
related or non-food-safety related conditions do not impair the online
carcass inspector's ability to conduct the inspection of each carcass
or will notify the inspector-in-charge whenever circumstances indicate
a loss of process control. Under such conditions, the inspector-in-
charge will take appropriate remedial action and will be authorized to
require that the establishment slow the line speed.
D. Finished Product Standards To Be Replaced With Requirement That
Establishments Maintain Records To Document That the Products Resulting
From Their Slaughter Operations Meet the Definition of Ready-to-Cook
Poultry
1. Establishment Requirements
FSIS is proposing to eliminate SIS, NELS, and NTIS, which would
include eliminating the current ``Finished Product Standards'' (FPS)
under 9 CFR 381.76 that address trim and dressing defects. FSIS is
proposing to replace these FPS with a requirement that establishments
operating under the New Poultry Inspection System document that the
products resulting from their slaughter operations meet the definition
of ready-to-cook poultry.
FPS are criteria applied to processed birds before and after chill
to ensure that the product being produced is consistently wholesome and
unadulterated. The FPS address defects that are less important to food
safety than conditions such as septicemia/toxemia or visible fecal
contamination. However, the conditions addressed in the FPS may render
a carcass unwholesome or adulterated.
Ready-to-cook poultry is ``* * * any slaughtered poultry free from
protruding pinfeathers and vestigial feathers (hair or down) from which
the head, feed crop, oil gland, trachea, esophagus, entrails, and lungs
have been removed, and from which the mature reproductive organs and
kidneys may have been removed, and with or without giblets, and which
is suitable for cooking without need for further processing'' (9 CFR
381.1). All poultry slaughter establishments are required to prepare
all eviscerated carcasses as ``ready-to-cook poultry'' (9 CFR
381.76(a)). Carcasses affected with removable animal diseases or that
contain numerous trim and dressing defects are not ``suitable for
cooking without the need for further processing,'' and thus do not meet
the definition for ready-to-cook poultry.
Examples of removable animal diseases include airsacculitis,
arthritis, ascites, avian leukosis complex, avian tuberculosis,
cadaver, enteritis, erysipelas, generalized inflammatory process,
generalized keratoacanthomas, neoplasms, nephritis, osteomyelitis,
pericarditis, salpingitis, tenosynovitis, and tumors (e.g., carcinoma
or sarcoma). Although these conditions are less important to food
safety than conditions such as septicemic/toxemic carcasses or visible
fecal contamination do, they do render carcasses unwholesome and unfit
for human food at levels above those provided for in the regulations.
Moreover, under 9 CFR 381.81-90, carcasses and parts affected with
these conditions must be condemned unless the condition can be removed.
Examples of trim and dressing defects include extraneous material,
such as, feathers, lung, oil gland, trachea, and bile; digestive tract
tissue defects, such as bursa of fabricius, cloaca, crop, esophagus,
and intestine; non-fecal digestive content contamination, such as
ingesta; and other miscellaneous defects, such as breast blisters,
bruises, external mutilation, fractures, overscald, scabs, trimable
keratoacanthomas, and localized inflammatory process. Like removable
animal diseases, poultry carcasses or parts that contain a large number
of trim or dressing defects would not be ``suitable for cooking without
the need for further processing'' and therefore would not meet the
definition of ready-to-cook poultry.
As discussed above, under HIMP, removable animal diseases and trim
and dressing defects addressed in the FPS are referred to as ``OCPs.''
There are five categories of OCPs addressing removable animal diseases
and various types of trim and dressing defects that account for 29
specific defects addressed under the existing FPS.
To develop the OCP categories FSIS first determined baseline
performance levels for establishments operating under the FPS. To do
this, a private consulting firm, Research Triangle Institute, collected
thousands of samples from 16 young chicken slaughter establishments
operating under the existing inspection systems. The sampled carcasses
had passed FSIS
[[Page 4423]]
online inspection, undergone trimming by establishment personnel to
remove visible defects, and been determined by FSIS offline inspectors
to be in compliance with the FPS. As such, these carcasses were
suitable for cooking without the need for further processing, and thus
met the definition of ready-to-cook poultry.
FSIS ranked the 16 establishments based on their performance under
each of the five OCP categories. The performance standard for each OCP
category was then established based on the performance level of the
establishment representing the 75th percentile for that category (i.e.,
the performance level of the fourth-best performing establishment of
each category). Thus, the OCP performance standards represent a
reduction from the highest prevalence of defects found in ready-to-cook
poultry that had passed the FPS.
Data collected from young chicken and turkey establishments
operating under HIMP show that for the two year period CY2009 through
CY2010, 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 both HIMP and non-HIMP inspection
systems perform well in controlling for OCP defects, but that
establishments operating under the HIMP system do exceptionally well.
Accordingly, FSIS has concluded that it is not necessary to adopt
prescriptive OCP requirements as a condition for establishments to
participate in the New Poultry Inspection System. Under this proposal,
establishments operating under the New Poultry Inspection System will
be allowed to implement the process controls that they have determined
will best allow them to produce ready-to-cook poultry that is wholesome
and not adulterated.
Under this proposed rule, establishments will have the flexibility
to design and implement measures to address OCP defects that are best
suited to their operations. They will also be responsible for
determining the type of records that will best document that they are
meeting the ready-to-cook poultry definition. FSIS expects that most
establishments will implement some type of statistical process control
to address removable animal diseases and trim and dressing defects and
use the statistical control charts associated with such procedures to
document that the resulting products are ready-to-cook poultry.
If they choose to do so, establishments operating under the New
Poultry Inspection System could incorporate procedures to address
removable animal diseases and trim and dressing defects into their
HACCP plans, or sanitation SOPs, or other prerequisite programs, and
rely on the records generated under these programs to document that the
resulting products are ready-to-cook poultry. Establishments would most
likely address these defects in their sanitation SOPs or other
prerequisite programs. However, an establishment could address these
defects in its HACCP plan if its hazard analysis determined that one or
more of these removable diseases presented a food safety hazard.
Establishments could also address removable animal diseases and trim
and dressing defects as part of a quality control program and rely on
the records generated under that program to document that they are
meeting the ready-to-cook poultry definition.
2. FSIS Verification
Under this proposed rule, FSIS would verify that an establishment's
poultry products comply with the ready-to-cook poultry definition by
reviewing the records maintained by the establishment to document that
its products are ready-to-cook poultry. In addition to inspecting for
food safety defects, the FSIS on-line carcass inspector will also
inspect carcasses for trim and dressing defects and removable animal
diseases. The presence of persistent, unattended trim and dressing
defects or removable animal diseases would indicate that the plant is
not producing ready-to-cook poultry. Furthermore, an establishment's
inability to consistently produce product that meets the ready-to-cook
poultry definitions may indicate a general lack of control in an
establishment's overall slaughter and dressing process. Thus, if the
establishment or FSIS inspection personnel observe the presence of
persistent, unattended removable animal diseases or trim and dressing
defects on poultry carcasses or parts, FSIS would require the
establishment to take appropriate actions to ensure that it is
operating under conditions needed to produce safe, wholesome, and
unadulterated products. Under this proposal, if inspection personnel
see evidence that an establishment is not producing products that meet
the definition of ready-to-cook poultry, then inspector-in-charge would
be authorized to require that the establishment reduce its line speed
and remedy the defects.
E. Maximum Line Speeds Under the New Poultry Inspection System
Based on FSIS's experience under HIMP, the Agency is proposing that
the maximum line speed for young chicken slaughter establishments be
175 birds per minute, and that the maximum line speed for turkey
slaughter establishments be 55 birds per minute.
Establishments operating under HIMP have demonstrated that they are
capable of consistently producing safe, wholesome, and unadulterated
poultry products while operating at these line speeds. Moreover, they
have consistently met pathogen reduction and other performance
standards operating at these line speeds. The new inspection system is
modeled on HIMP and, as discussed later in this document, also
incorporates additional measures that will apply to all poultry
establishments. These measures, which include testing for microbial
organisms at pre-chill and post-chill, are designed to ensure that
establishments maintain process control.
To gather additional data on the effects of line speeds on the
worker safety and the ability of establishments to maintain process
control, the Agency will select a maximum of five non-HIMP
establishments that applied through the SIP to receive waivers of
existing regulations restricting line speeds. The Agency limited the
number of non-HIMP establishments that would receive SIP waivers for
line speed requirements to five because FSIS inspectors rather than
establishment personnel would continue to be responsible for conducting
carcass sorting. Thus, these non-HIMP plants would need additional
inspectors to ensure that faster line speeds do not affect product
safety.
FSIS recognizes that evaluation of the effects of line speed on
food safety should include the effects of line speed on establishment
employee safety. To obtain preliminary data on this matter, FSIS asked
the National Institute for Occupational Safety and Health (NIOSH) to
evaluate the effects of increased line speed by collecting data from
the five non-HIMP plants that have been granted waivers from line speed
restrictions under the SIP. NIOSH has expressed its willingness to
evaluate the effects of increased production volume on employee health,
with a focus on musculoskeletal disorders and acute traumatic injuries
(76 FR 41186, 41189). NIOSH will prepare a report based on its findings
of short-, intermediate-, and long-term effects from the process
modifications. NIOSH will make recommendations as needed. FSIS has made
cooperation with NIOSH a
[[Page 4424]]
condition for the five non-HIMP plants to operate at faster line speeds
under the SIP waiver. FSIS will consider the available data on employee
effects collected from NIOSH activities when implementing any final
rule resulting from this proposal.
F. Facilities Requirements for Establishments Operating Under the New
Poultry Inspection System
1. General
As discussed above, the new inspection system would replace SIS,
NELS, and NTIS. FSIS anticipates that most, if not all, of the
establishments that will choose to use the proposed inspection system
are establishments that operate under one of those inspection systems.
Accordingly, the following discussion of the facilities requirements
associated with the proposed new inspection system highlights the
differences between the proposed system and the existing inspection
systems.
The proposed regulatory text describing the facilities requirements
under the new inspection system is organized differently than the
existing regulatory text. Whereas the existing regulations describe
facilities requirements under Sections 9 CFR 381.36 and 381.76, the
proposed regulatory text incorporates all facilities requirements
relating to the new inspection system under proposed 9 CFR 381.36(c).
The requirements are subdivided into four paragraphs: Paragraph (1)
describes facilities requirements for the online carcass inspection
station; Paragraph (2) describes facilities requirements for the
offline verification inspection stations; Paragraph (3) describes
facilities requirements pertaining to inspection of the viscera of the
first 300 carcasses of each flock; and Paragraph (4) describes a
facilities requirement for a trough extending beneath the processing
line from the point of evisceration to the point where trimming is
performed.
2. Online Carcass Inspection Stations
Under the proposed inspection system, one online carcass inspection
station will be provided on each processing line. If this proposal is
adopted, it will be located at the end of the processing line,
immediately before the chiller and after the establishments has
conducted sorting, trimming, and reprocessing activities and has
applied all pre-chill interventions. This location for the online
inspection station differs from the existing inspection systems, which
require several online inspection stations to be located after
evisceration has occurred but before any trimming or pre-chill
interventions have been applied. Based on its experience under HIMP,
FSIS expects that when establishments operating under SIS, NELS, or
NTIS convert to the new inspection system, they will use their existing
online inspection stations to conduct required establishment sorting
activities.
Under the proposed inspection system, as under the existing
inspection systems, the conveyor line will be level for the entire
length of the online carcass inspection station, and the vertical
distance from the bottom of the shackles to the top of the platform
will be at least 60 inches. Other requirements for the proposed online
inspection station that are the same as those under the existing
inspection systems include requirements for a conveyor line start/stop
switch, for proper lighting, for a clipboard holder, for receptacles to
be used for condemned carcasses and parts, and for hangback racks.
FSIS is proposing that the platform for the online carcass
inspection station be of the same dimensions and include the same
safety features as under the existing inspection systems except that
under the proposed system, the platform need only be four feet long
instead of eight feet long. The inspection platform can be shorter
under the proposed inspection system because, unlike the existing
inspection systems, the new inspection system does not require an
establishment helper to flank each online carcass inspector. Also
unlike the existing inspection systems, the platform need not be
height-adjustable under the proposed inspection system because the
inspection procedure under the proposed system does not require the
online carcass inspector to handle every carcass.
As under the existing inspection systems, FSIS is proposing that
establishments equip each online carcass inspection station with hand
rinsing facilities to prevent cross-contamination from occurring when
the online carcass inspector is required to touch carcasses with his or
her hands. However, the carcass inspection method under the proposed
inspection system does not require the carcass inspector to touch every
carcass; such hand contact will be infrequent. Therefore, the Agency is
not proposing to require that establishments equip the online
inspection station with continuous flow hand rinse facilities as under
the existing regulations. Instead, the Agency is proposing that
establishments provide either continuous flow hand rinse facilities or
hand rinse facilities capable of being activated in a hands-free manner
(e.g., by placing the hands in front of a motion sensor or by stepping
on a foot pedal). This flexibility will allow establishments to
conserve water. As is the case now, under this proposal, all online
hand rinse facilities must operate in a sanitary manner that minimizes
splashing and the risk of cross-contamination, and the hand rinse
facilities must provide water that is at least 65 degrees Fahrenheit to
ensure effective sanitation.
FSIS is proposing that the water provided by the hand rinse
facilities at online carcass inspection stations may not exceed 120
degrees Fahrenheit. The current regulations do not provide a maximum
temperature. FSIS is proposing this change to prevent the risk of
scalding. According to the U.S. Consumer Product Safety Commission
(CPSC), most adults will suffer third-degree burns if exposed to 150
degree Fahrenheit water for two seconds, to 140 degree water for six
seconds, to 130 degree water for 30 seconds, and 120 degree water for
five minutes.\9\ Carcass inspectors wear latex gloves, and it is
possible for water to become trapped underneath the gloves and remain
in contact with inspectors' hands even after their hands are removed
from the water source. FSIS has granted some establishments waivers to
install non-continuous flow online hand rinsing facilities in order to
conserve water. These facilities are referred to as ``water savers.''
However, inspection personnel have identified that water provided by
water savers is oftentimes too hot due to build-up of water in the
pipes, causing burning of forearms while contacting the water and/or
metal railings at the inspection station. Inspection personnel have
also identified that water pressure from water savers is uneven, causes
splattering, and does not provide water in a manner that allows
inspectors to wash their hands quickly between birds presented for
inspection. Inspection personnel have filed grievances against FSIS
management for not stopping the use of these hand rinsing facilities or
for not getting establishments to correct these problems. Therefore, to
ensure that inspectors are protected from scalding and to encourage
maximum use of hand rinsing facilities as needed to prevent cross
contamination from occurring, FSIS is proposing that hand rinsing
facilities provide water at a minimum temperature of 65 degrees
Fahrenheit and a maximum temperature of 120 degrees Fahrenheit. The
Agency
[[Page 4425]]
requests comment on the efficacy and safety of this proposed
temperature range and on the hand rinsing facilities requirement in
general.
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\9\ US Consumer Product Safety Commission Document
5098, ``Tap Water Scalds.'' Available at: http://www.cpsc.gov/cpscpub/pubs/5098.html.
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The online inspection station under the proposed inspection system
must also be equipped with a buzzer within reach of the on-line
inspector that the inspector can use when necessary to alert the
inspector-in-charge, offline inspectors, or establishment management of
the need to correct a deficiency that require their attention.
3. Offline Verification Inspection Stations
FSIS is proposing to require that establishments operating under
the proposed inspection system provide offline verification inspection
stations that are similar to the offline inspection stations required
under the existing inspection systems. As under the existing inspection
systems, FSIS is proposing that at least one offline verification
inspection station be located at a pre-chill location and at least one
be located at a post-chill location. For establishments having more
than one processing line or more than one chiller, the Agency will
determine how many offline verification inspection stations are
required under the specific processing conditions of the establishment
concerned.
FSIS is proposing to require that the offline verification
inspection stations under the new system consist of the same dimensions
as the offline stations under the existing inspection systems. The
dimensions and features of the offline inspection tables would also be
the same. The requirements for lighting, hangback racks, and
accessibility to hand washing facilities would also be the same as
under the existing inspection systems. The requirement for a clipboard
holder is the same except FSIS is also proposing to allow
establishments to elect to provide offline verification inspectors with
electronic means of recording inspection results.
4. Location To Inspect the Viscera of the First 300 Carcasses of Each
Flock
Under the proposed inspection system, an offline inspector in young
chicken slaughter establishments will inspect the viscera of each of
the first 300 birds slaughtered in each flock. Accordingly, FSIS is
proposing to require that young chicken establishments operating under
the proposed inspection system provide a location along the processing
line after the carcasses are eviscerated at which the viscera
inspection can safely and properly be conducted. The viscera must be
presented at this location either uniformly trailing or leading. Based
on FSIS's experience under HIMP, most establishments choosing to
operate under the new inspection system will provide this location
where establishment sorting activities take place.
5. Drainage From Processing Line
FSIS is proposing no change to the existing requirement that a
trough or other drainage and collection facilities must extend beneath
the conveyor at all places where processing operations are conducted
from the point where the carcass is opened to the point where trimming
has been performed.
G. Eligibility To Operate Under the New Poultry Inspection System
FSIS is proposing that young chicken and turkey slaughter
establishments may use the new inspection system if they apply to do
so, and if the Administrator determines that they are eligible. To be
eligible, the establishment must agree to meet all facilities
requirements and to maintain records to document that the products
resulting from their slaughter operations meet the definition of ready-
to-cook poultry.
Because FSIS is proposing to eliminate SIS, NELS, and NTIS, and to
end HIMP, the Agency is also proposing to require that all young
chicken and turkey slaughter establishments that do not operate under
the new inspection system operate under traditional inspection.
In addition, FSIS is proposing to allow establishments that
slaughter poultry classes other than young chicken and turkey to
operate under the New Poultry Inspection System if they request and are
granted a waiver through the SIP.
IV. Other Proposed Changes to Poultry Slaughter Regulations
A. Proposed Changes to Traditional Inspection System
FSIS is proposing to limit to two the number of online inspectors
per line in all poultry slaughter establishments operating under
traditional inspection, with an exception for existing establishments
other than young chicken and turkey that are currently operating with
more than two online inspectors. Under traditional inspection, online
carcass inspectors would continue to use the current traditional
inspection methods. The Agency anticipates that it will assign
approximately one offline inspector for every six online inspectors
under traditional inspection. Additionally, the Agency would continue
to provide oversight of workforce through veterinarians.
Most poultry slaughter establishments operating under traditional
inspection are currently staffed with two online inspectors. As of
September 2011, all of the very small establishments that slaughter
young chickens or turkeys under the traditional inspection were staffed
with two or fewer on-line inspectors. However, there is a small number
of poultry slaughter establishments that slaughter species other than
young chickens and turkeys that have more than two online inspectors.
FSIS will continue to staff these establishments with the number of
online inspectors they currently have. FSIS has tentatively concluded
that doing so will ensure that this rule change does not have an
adverse impact on these establishments. FSIS is proposing that this
exception will not apply to new establishments after a final rule is
published because the Agency anticipates that new establishments would
be aware of the requirements of the rule and would factor this into
their decisions to operate. Also, this exception would not apply to
young chicken and turkey slaughter establishments because doing so
would undercut the efficiencies that are presented by this proposal.
B. Proposed Changes Affecting All Poultry Slaughter Establishments
1. Procedures To Address Contamination by Fecal Material and Enteric
Pathogens as Hazards Reasonably Likely To Occur
a. Contamination of Poultry Carcasses and Parts by Fecal Material and
Enteric Pathogens Are Hazards Reasonably Likely To Occur in Poultry
Slaughter Establishments
The Centers for Disease Control and Prevention collects data on
laboratory-confirmed human foodborne illness cases through the
Foodborne Diseases Active Surveillance Network (FoodNet), an active,
population-based, sentinel surveillance system for the United
States.\10\ Several FoodNet case-control studies have examined the link
between chicken and human infection with Salmonella or Campylobacter
and have found that poultry products are an important vehicle for human
Salmonella and Campylobacter infections in the United States (CDC memo:
Foodborne illness from Salmonella and Campylobacter
[[Page 4426]]
associated with poultry, United States, available at: http://www.fsis.usda.gov/PDF/Salmonella_Campylobacter_011811.pdf).
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\10\ For more information on FoodNet see http://www.cdc.gov/foodnet/.
---------------------------------------------------------------------------
In addition to FoodNet case-control studies, CDC collects outbreak
data reported by State and local health departments through the
Foodbome Disease Outbreak Surveillance System (FDOSS). Outbreak data
collected through FDOSS provides important evidence linking sources of
Salmonella and Campylobacter to human illness.\11\
---------------------------------------------------------------------------
\11\ For more information on CDC's FDOSS see: http://www.cdc.gov/outbreaknet/surveillance_data.html.
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Fecal contamination is a major vehicle for spreading enteric
pathogenic microorganisms, such as Salmonella, to raw poultry.
Accordingly, contamination of poultry carcasses and parts by fecal
material and enteric pathogens (e.g., Salmonella and Campylobacter) are
hazards reasonably likely to occur in poultry slaughter establishments
unless addressed in a sanitation SOP or other prerequisite program.
In order to ensure that establishments properly address the food
safety hazards associated with contamination of poultry carcasses by
fecal material and enteric pathogens, FSIS is proposing to amend the
poultry slaughter inspection regulations as described in the following
two sections.
b. Procedures Addressing Zero Tolerance for Visible Fecal Material
Before Chilling
In 1997, FSIS codified its zero tolerance policy for poultry
carcasses contaminated with visible fecal material entering the chiller
(62 FR 5139, February 4, 1997). At that time, the Agency published a
final rule that removed ``feces'' from the list of nonconformance
elements under the FPS and provided that ``Poultry carcasses
contaminated with visible fecal material shall be prevented from
entering the chilling tank'' (9 CFR 381.65(e)). The preamble to that
final rule emphasized that the ``zero tolerance policy for visible
fecal contamination is an important food safety standard because fecal
contamination is a major vehicle for spreading pathogenic
microorganisms, such as Salmonella, to raw poultry.''
Later the same year, FSIS published a second Federal Register
document entitled ``Notice on complying with food safety standards
under the HACCP system regulations'' (62 FR 63254, November 28, 1997).
The purpose of the second document was to ensure that establishments
understood the Agency's zero tolerance policy for visible fecal
material as a food safety hazard as establishments prepared to comply
with the then newly enacted HACCP system regulations. The notice first
cited the zero tolerance policy for visible fecal contamination before
the chiller that had recently been codified at 9 CFR 381.65(e). Then,
the notice 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 * * *
before poultry carcasses enter the chilling tank'' (citing 9 CFR
417.2(c)). Finally, the notice 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.''
Thus, in February 1997, FSIS codified the requirement that all
poultry slaughter establishments must prevent carcasses contaminated
with visible fecal material from entering the chiller (9 CFR
381.65(e)); and in November 1997, FSIS specified in a Federal Register
notice that procedures for doing so must be incorporated in
establishments' HACCP systems. As a result, all poultry slaughter
establishments' HACCP plans currently include critical control points
for preventing carcasses contaminated with visible fecal material from
entering the chiller. Accordingly, FSIS is proposing to amend 9 CFR
381.65 to require poultry slaughter establishments to develop,
implement, and maintain as part of their HACCP plans, or sanitation
SOPs, or other prerequisite programs, written procedures to ensure that
poultry carcasses contaminated with visible fecal material do not enter
the chilling tank. Such a requirement will ensure that establishments
maintain the records to verify that that they have implemented the
necessary measures and, when necessary, have taken appropriate
corrective actions to prevent carcasses contaminated with visible fecal
material from entering the chiller.
c. Procedures To Prevent Contamination of Carcasses and Parts by
Enteric Pathogens and Fecal Material Throughout the Entire Slaughter
and Dressing Operation
Background
Although the existing requirement for establishments to prevent
visible fecal material from entering the chiller, and the proposed
clarification described above that establishments must have procedures
addressing how they do so, are important safeguards, those safeguards
will 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 and Campylobacter, to raw
poultry, 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. However, FSIS's experience with HACCP shows that instead of
implementing controls to prevent contamination from occurring early in
the production process, some poultry slaughter establishments rely on
interventions applied at the end of the process to remove contamination
after it occurs. This may be due in part to the fact that FSIS
inspectors perform verification checks for zero visible fecal
contamination and Salmonella and Campylobacter testing at the end of
the slaughter and chilling processes. 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 and fecal material. 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.
Information that FSIS has collected from comprehensive Food Safety
Assessments (FSA's) it has conducted in establishments that have failed
to meet the Agency's Salmonella performance standards 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 on-going basis.
For example, FSIS conducted an FSA at a young chicken slaughter
establishment that failed its Salmonella set in 2007. For the FSA, FSIS
reviewed the establishment's Salmonella testing data, controls, and
records associated
[[Page 4427]]
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 high levels of Salmonella on incoming birds. The high
levels of Salmonella sustained throughout the process appeared to have
overwhelmed any subsequent in-process interventions. As a result of the
FSA findings, FSIS notified the establishment in writing that the
Agency would withhold or suspend inspection unless the establishments
provided a written response within 72 hours on the actions it would
take to achieve compliance. In response, the establishment gave a
written description of immediate corrective actions it would take,
including removing debris and repositioning equipment, retraining of
employees in the HACCP and Sanitation SOP methodology prescribed in the
establishments control programs, and reassessing the establishments
HACCP plan to incorporate a new antimicrobial treatment for the chill
tank and similar antimicrobial interventions applied during the
dressing operation. FSIS then put in place a verification plan in which
inspectors in that establishment were expected to routinely verify the
corrective actions proffered by the establishment. Since implementation
of these corrective actions, the establishment has passed all of its
Salmonella performance sets.
In another example, FSIS conducted an FSA in an establishment that
had failed a Salmonella set in 2005. From the FSA, the Agency found
that the establishment failed to: (i) Identify Salmonella as a
significant hazard, (ii) control hazards it did identify, (iii),
identify corrective actions in its sanitation SOPs, (iv) perform
verification, (v) perform all corrective actions, and (vi) monitor pre-
shipment records sufficiently. As a result, FSIS notified the
establishment in writing that the Agency would withhold or suspend
inspection unless the establishment provided a timely response on how
it would achieve compliance. Consequently, the establishment reassessed
and redesigned its HACCP plan for slaughter; revised its preoperational
plan; and conducted remedial training of personnel in HACCP and
sanitation SOPs. Because the establishment did not previously have
defined verification activities for its employees to perform and
document, the establishment instituted hourly checks for sanitary
dressing at evisceration. FSIS issued a Notice of Deferral on August 8,
2005, and a Closeout Letter of Warning on March 3, 2006. FSIS then put
in place a verification plan in which inspectors in that establishment
were expected to routinely verify the corrective actions proffered by
the establishment. Since implementation of these corrective actions,
the establishment has passed all of its Salmonella performance sets.
Proposed Regulatory Requirements
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 poultry slaughter
establishments develop, implement, and maintain written procedures to
prevent contamination of carcasses and parts by enteric pathogens and
fecal material throughout the entire slaughter and dressing operation.
FSIS is proposing that establishments incorporate these procedures into
their HACCP plans, or sanitation SOPs, or other prerequisite programs,
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.
Many establishments have in place process control measures to
address the prevention of contamination by enteric pathogens and fecal
material, but are not maintaining documentation to verify the
effectiveness of these procedures on an on-going basis. If this rule
becomes final, establishments may choose to incorporate those measures
into their procedures addressing how they prevent contamination from
occurring during slaughter and dressing operations. Examples of such
measures include: monitoring of evisceration equipment to ensure it is
properly adjusted to the size of birds within a particular flock;
purchase specification agreements requiring feed withdrawal; and
employee hygiene and hand washing policies. Under this proposed rule,
establishments will be required to incorporate these procedures into
their HACCP plans, or Sanitation SOPs, or other prerequisite programs,
and to maintain on-going documentation to demonstrate that the
procedures are effective. This on-going 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, which will allow the
establishment to take the necessary corrective actions to prevent
further product contamination.
FSIS is not proposing to prescribe the specific procedures that
establishments must follow to prevent carcasses from becoming
contaminated by enteric pathogens or fecal material 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 HACCP
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 chiller.
As discussed in detail earlier in this document, the current
regulations require that official poultry slaughter establishments
conduct regular testing for generic E. coli at the end of the chilling
process as a means of verifying process control (9 CFR 381.94(a)). The
regulations include performance criteria that are intended to represent
the highest expected microbial loads on carcasses when the slaughter
process is in control (9 CFR 381.94(a)(5)(1)). However, FSIS's
experience with using post-chill testing for generic E. coli to monitor
process control for fecal contamination and sanitary dressing has led
the Agency to conclude that such testing is not the most effective way
to prevent contamination from occurring throughout the slaughter and
dressing operation. As noted above, recent studies indicate that E.
coli levels may not be a valid measure of fecal contamination. This
finding was also supported by a 2004 report issued by the National
Advisory Committee on Microbiological Criteria for Foods (NACMCF).
Additionally, while post-chill testing may be useful for identifying
microbial levels on carcasses after they have been subjected to
antimicrobial chemicals in the chiller, it does not necessarily reflect
the effectiveness of the preventive measures implemented earlier in the
process to address contamination at points in the process before the
chiller.
[[Page 4428]]
Given these limitations, FSIS is proposing to rescind the generic
E. coli testing requirements in 9 CFR 381.94 and to replace them with a
new testing requirement that will 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-chill position in order to ensure
establishments will be able to monitor the effectiveness of process
control for enteric pathogens throughout the slaughter and dressing
operation.
Although FSIS has tentatively concluded that verification testing
conducted at two proposed points, i.e., pre-chill and post-chill, will
provide the evidence establishments need to verify that their process
control measures are effective in preventing carcasses from becoming
contaminated with pathogens, the Agency also considered two
alternatives approaches. FSIS considered requiring a third verification
test at the re-hang position to monitor the incoming load of pathogens
but does not believe it is necessary to impose the additional costs
that would be associated with testing at this point. FSIS also
considered requiring only one verification test at any position along
the production line to provide maximum flexibility but concluded this
approach may not be sufficient to monitor the effectiveness of an
establishment's procedures to prevent contamination throughout the
slaughter and dressing operation. The Agency requests comments on these
alternatives.
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-chill and post-chill. The establishment would be responsible for
determining which microbiological organisms will best help it to
monitor the effectiveness of its process control procedures. Because
FSIS is proposing that an establishment's microbiological sampling plan
be part of its HACCP plan, sanitation SOP, or other prerequisite
program, each establishment would be required to provide scientific or
technical documentation to support the judgments made in designing its
sampling plan (see 9 CFR 417.4(a)). Under this proposal, establishments
could develop sampling plans to test carcasses for enteric pathogens,
such as Salmonella and Campylobacter, at pre-chill and post chill, or
they could test for an appropriate indicator organism. FSIS intends to
provide sampling guidance to assist small and very small establishments
develop sampling plans that meet the Agency's expectations for testing
designs and sampling frequency.
This proposed rule does not prescribe how frequently establishments
must sample and test poultry carcasses for microbiological organisms at
pre-chill and post-chill. Instead, FSIS is proposing to require that an
establishment's sampling frequency be adequate to monitor the
effectiveness of the establishment's process control for enteric
pathogens. The frequency with which establishments would need to
conduct such testing will depend on a number of factors, including
their production volume, the source of their flocks, their slaughter
and dressing process, and the consistency of their microbial test
results over time. Because the testing frequency would be an integral
part of an establishment's HACCP system verification procedures,
establishments would need to collect and maintain data to demonstrate
that their testing frequency is adequate to verify the effectiveness of
their process control procedures.
This proposed rule does not mandate that establishments meet
specific performance standards for microbial testing. Rather, because
establishments would be required to incorporate their procedures for
preventing contamination by enteric pathogens and fecal contamination
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.
Small and very small, low-volume establishment \12\ that choose to
operate under the revised traditional inspection system rather than the
New Poultry Inspection System may not need to conduct testing at two
points in the slaughter process to adequately monitor process control.
Therefore, FSIS is considering permitting these establishments to
conduct testing for microbial pathogens at one point in the process if
they can demonstrate that they are maintaining adequate process
control. Under this proposal, if the Agency had evidence to indicate
that an establishment conducting testing at a single point in the
process was having difficulty maintaining process control, such as not
meeting FSIS's pathogen performance standards, the establishment would
need to conduct additional testing or implement additional measures to
ensure that its process remains in control. The Agency request comments
on this aspect of the proposed rule.
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\12\ Low-volume establishments would include those classified as
very low volume establishments under the existing generic E. coli
testing regulations, e.g., establishments that slaughter no more
than 440,000 young chicken or no more than 60,000 young turkeys on
an annual basis (9 CFR 381.94(a)(2)(v)).
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If this proposal is finalized, FSIS will issue guidance to assist
establishments in developing procedures for controlling contamination
throughout the slaughter and processing operation and for developing
appropriate sampling plans to verify the effectiveness of their
procedures. This guidance will include a default sampling frequency for
small and very small establishments.
Under this proposed rule, FSIS would verify the effectiveness of an
establishment's process control procedures in preventing carcasses from
becoming contaminated with enteric pathogens and fecal material by
reviewing the establishment's monitoring records, including the
establishment's microbial testing results, observing an establishment
implementing its procedures, and inspecting carcasses and parts for
visible fecal contamination when conducting both online carcass
inspection and offline verification inspection procedures. FSIS
personnel would consider both the establishment's testing results, as
well as the results of the Agency's testing for Salmonella and
Campylobacter to determine young chicken and turkey establishment's
compliance with the Agency's Salmonella and Campylobacter performance
standards, to help assess how well the establishment is controlling its
slaughter and dressing processes.
If inspection personnel determine that an establishment's process
control procedures are not effective in preventing contamination by
enteric pathogens or fecal contamination, 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
[[Page 4429]]
and facilities, increasing offline verification inspections, initiating
Food Safety Assessments (FSAs), conducting hazard analysis verification
procedures, conducting intensified product sampling for Salmonella and
Campylobacter under the Agency's performance standard sampling program,
and retaining or condemning product.
2. Impact Considerations for Small/Very Small Low Volume Establishments
As noted in the Preliminary Impact Analysis (PRIA) for this
proposed rule, FSIS projects that all 51 of the very small
establishments that operate under the existing traditional inspection
system will chose to operate under the proposed revised traditional
inspection system. However, this proposed rule will impose certain
costs on establishments regardless of the proposed inspection system
under which they chose to operate. Therefore, because FSIS is
interested in implementing this proposed rule in a manner that will
minimize the impact on small and very small establishments, the Agency
requests comments on the following measures to help mitigate the impact
on to small and very small establishments.
Phase-in for small businesses: FSIS requests comments on
whether a phased implementation would help to mitigate the impact of
this proposed rule on small and very small establishments. The Agency
also requests comments on the type of phased implementation that would
be most effective in mitigating the impact on very small
establishments. For example, would a phased implementation that
establishes separate effective dates for large, small, and very small
establishments be effective in mitigating the impact of this proposed
rule on small and very small establishments?
Allow small and very small plants that operate under the
modified traditional inspection system to test for microbial pathogens
at one point in the slaughter process instead of two. As noted above,
this proposed rule requires that all young chicken and turkey slaughter
establishments conduct testing for microbial pathogens at two points in
the slaughter process regardless of the inspection system that they
operate under. However, FSIS believes that it may not be necessary for
very small, low-volume establishments that operate under the revised
traditional inspection system to conduct testing at two points in the
process to effectively monitor process control. Therefore, FSIS
requests comments on whether it should revise this provision in the
proposed rule to permit very small, low volume establishments to
conduct testing for microbial pathogens at one point in the process if
these establishments can demonstrate that they are maintaining adequate
process control through other means.
Number of on-line inspectors permitted for revised
traditional inspection: As discussed earlier in this document, this
proposed rule would limit the number of on-line inspectors for the
revised traditions inspection system to two, with an exception for
existing establishments other than young chicken and turkey that are
currently operating with more than two online inspectors. FSIS is
proposing to continue to staff establishments that slaughter poultry
other than young chickens and turkeys with the number of online
inspectors that they currently have to mitigate the impact of this
proposed rule on these establishments. FSIS has tentatively decided
that this exception would not apply to young chicken and turkey
slaughter establishments because doing so would undercut the
efficiencies that are presented by this proposal. However, because the
young chicken and turkey slaughter establishments that operate under
the existing traditional inspection system are classified as either
small or very small, FSIS requests comments on it should permit these
establishments to retain more than two inspectors if they are currently
operating with more than two inspectors under the existing traditional
inspection system.
In addition to the proposed mitigations discussed above, FSIS
intends to adopt the following measures to assist small and very small
establishments meet the requirements of this proposed rule.
Provide FSIS outreach training programs to small and very
small establishments to help them comply with the proposed requirements
to address enteric pathogens and fecal contamination. FSIS intends to
provide training to small and very small establishments to assist them
to develop, implement, and maintain written procedures for the
prevention of contamination by enteric pathogens and fecal material and
for preventing carcasses contaminated with fecal material from entering
the chill tank. To ensure that very small plant operators have access
to such training, FSIS is considering providing computer-based training
or using a webinar format.
Provide guidance on measures small establishments can take
to control for enteric pathogens. As discussed above, under both the
New Poultry Inspection System and the revised traditional inspection
system, establishments will be required to conduct testing for
microbial pathogens at pre-chill and post-chill to verify process
control. The frequency with which establishments conduct testing under
this proposed rule will depend on, among other things, the production
volume, source of flock, and the plants slaughter and dressing process.
FSIS believes that very small, low volume establishments that have
slower line speeds and that do not use automated evisceration equipment
will likely not need to conduct frequent testing to demonstrate that
their process is in control. Therefore, FSIS intends to develop
guidance to assist small plants implement measures other than testing
to demonstrate that their process is in control. FSIS believes that
this will help to minimize the amount of testing (and the associated
costs) that small plants will need to conduct to comply with the
proposed rule. The guidance would provide for an increase in testing
frequency if an establishment is having difficulty maintaining process
control, such as not meeting FSIS's pathogen performance standards.
FSIS requests comments on these and other possible measures that
that the Agency can implement to minimize this proposed rule's impact
on small and very small, low volume establishments.
3. Proposed Changes to Time and Temperature Requirements for Chilling
a. Background
As discussed earlier in this document, FSIS has granted SIP waivers
from the time and temperature chilling regulations to six poultry
slaughter establishments. The current poultry chilling regulations (9
CFR 381.66) require ready-to-cook poultry, except for ratites, to be
chilled immediately after evisceration unless the poultry is to be
frozen or cooked immediately at the establishment. The purpose of these
regulations is to ensure prompt removal of body heat and to prevent the
incubation and rapid growth of bacterial populations on or within the
carcasses, thereby preserving the conditions and wholesomeness of the
poultry and preventing adulteration (9 CFR 381.66(a); 35 FR 15739,
October 7, 1970).
Under the current regulations, poultry slaughtering establishments
must ensure that the internal temperature of poultry carcasses weighing
4 to 8 pounds is reduced to 40 [deg]F or below within 4 hours;
carcasses weighing 4 to 8 pounds, within 6 hours; and those weighing
over 8 pounds, within 8 hours (9 CFR 381.66(b)). Once chilled, poultry
[[Page 4430]]
to be packaged and shipped must be stored at 40 [deg]F or less. FSIS
believes that a chilling process satisfying the present requirement
results in no outgrowth of bacteria.
During further processing and packaging operations, the internal
temperature of the poultry carcass may be allowed to rise to 55 [deg]F,
provided that immediately after packaging, the poultry is chilled to 40
[deg]F or placed in a freezer. The regulation requires that any poultry
that is to be held at the establishment in packaged form longer than 24
hours must be held in a room at a temperature of 36 [deg]F or lower (9
CFR 381.66(c)(3)). This requirement provides assurance that no
bacterial outgrowth occurs before the package leaves the establishment.
9 CFR 381.66(c)(4) requires the chilling of giblets to 40 [deg]F or
lower within two hours of the time that they are removed from the
inedible viscera. But when the giblets are cooled with the carcass from
which they are drawn, the giblets are subject to the same chilling time
as the carcass. 9 CFR 381.66(e) requires that the temperature of air-
chilled, ready-to-cook poultry be reduced to 40 [deg]F or lower within
16 hours.
The temperature limits in these regulations were based on the fact
that most relevant foodborne bacteria have not been reported as being
capable of multiplying at temperatures below 40 [deg]F (35 FR 15739).
Thus, any bacteria would be in a suspended state, if not actually
killed. Chilling ready-to-cook poultry and keeping it at sufficiently
low temperatures inhibits the multiplication of spoilage organisms as
well as foodborne pathogens on the poultry and permits the poultry to
be sold in markets at great distances from the processing
establishment.
Most poultry slaughtering establishments in the United States chill
eviscerated poultry by immersion in vats of water and ice. Where the
chilling operation has been identified as a CCP in an official
establishment's HACCP plan, FSIS inspectors verify that the
establishment is monitoring at that CCP, and that the establishment's
process is meeting the critical limits for the CCP. For raw poultry
products, the chilling operation must meet the 40 [deg]F temperature
and time requirement, no matter what other limits the establishment may
have identified in its hazard analysis. FSIS inspectors may determine
whether products are compliant with the regulatory requirements by
taking the temperatures of fresh and frozen poultry products--including
carcasses, parts, and giblets--or by observing establishment employees
conducting monitoring, by verification procedures, or by reviewing
establishment records.
The regulation limiting chilling operations to specific time-and-
temperature combinations is at odds with the PR/HACCP regulations.
Additionally, FSIS has two long pending petitions requesting that the
Agency repeal the prescriptive time and temperature chilling
requirements. The American Meat Institute (AMI) petitioned the
Department to amend the regulations governing moisture absorption and
retention in certain raw meat and poultry products. AMI also requested
other changes, including repeal of the regulations requiring poultry
carcasses to be chilled below 40 [deg]F within a specified time. The
National Turkey Federation (NTF) has requested that FSIS waive the time
and temperature requirements for poultry carcass cooling. FSIS has
carefully considered the AMI and NTF requests in developing this
proposal.
FSIS has concluded that alternative approaches to chilling are
effective and safe. As discussed above, under SIP, the Agency has
granted six poultry slaughter establishments waivers from the specific
time and temperature chilling requirements prescribed in 9 CFR 381.66.
FSIS will review the data provided through these waivers to ensure that
these alternative approaches to chilling poultry are effective at
controlling levels of bacteria and ensuring food safety. The Agency
will take this data into consideration before issuing a final rule in
this proceeding.
Based on the foregoing, FSIS is proposing to eliminate the time and
temperature requirements for chilling ready-to-cook poultry carcasses
and giblets. The existing requirements prescribe both the time and
temperature parameters to be used in the chilling process and do not
allow for alternative approaches that the establishment can use to
control levels of bacteria. The regulation gives an establishment
producing ready-to-cook poultry no flexibility to use procedures other
than those in the regulations, even if alternative procedures achieve
the same results. Because the objective of the current chilling
regulations is to prevent microbial multiplication, establishments
should have the option of choosing the means to do so, instead of being
required to use a prescribed method of chilling that achieves a
specific temperature limit, 40 [deg]F, that applies to ready-to-cook
poultry products.
In addition, the time and temperature regulations are inconsistent
with the Agency's regulations on retained water (9 CFR 441.10) in that
they tend to prevent poultry establishments from making full use of
available options for reducing retained water in their products, such
as the option of reducing the dwell time of products in immersion
chillers.
b. Proposed Rule
FSIS is proposing to replace these prescriptive time and
temperature requirements with a requirement that poultry slaughter
establishments develop and maintain procedures that control the levels
and prevent the multiplication of spoilage organisms and pathogenic
bacteria in the product after evisceration. Establishments would have
to include these procedures in their HACCP plans, or sanitation SOPs,
or other prerequisite programs. Establishments would be required to
maintain a chilling process so that at the end of slaughter operations,
no pathogen outgrowth occurs.
Additionally, establishments would be required to keep previously
chilled poultry carcasses and major portions chilled so that there
would be no outgrowth of the pathogens, unless such poultry is to be
packed and frozen immediately at the official establishment. And
establishments would be required to chill giblets after processing so
that there is no outgrowth of pathogens. Giblets could either be
chilled with the carcass or separately.
Under this proposed rule, unless poultry are to be frozen or cooked
immediately at the establishment after evisceration, poultry
establishments would be required to identify those conditions at the
establishment affecting carcass chilling and pathogen outgrowth
afterwards. These conditions could include the amount of agitation of
the chiller medium, the concentration of anti-microbial substances in
the chiller medium, the temperature of the chiller medium, the rate of
temperature reduction of the carcasses, and the internal temperature or
microbial condition of the carcasses exiting the chiller.
Establishments would have to incorporate procedures for chilling
into their HACCP plans, or Sanitation SOPs, or other prerequisite
programs. These written procedures would include the conditions of use
affecting carcass chilling and microbial multiplication identified by
the establishment.
FSIS would consider the present chilling requirements as safe
harbors. If an establishment uses a chilling and subsequent storage
process different from the present requirements, the establishment
would be required to specify the point where chilling has been
completed and to validate that at
[[Page 4431]]
that point any residual microbial population is inhibited from growing.
The establishment would also be required to validate that the bacterial
population does not increase during storage at the establishment.
To ensure that the bacterial population does not multiply during
storage (after chilling), the establishment could take into account any
of several effects of temperature on microbial growth. For example, at
temperatures of 48 [deg]F (10 [deg]C) or below, the multiplication of
microorganisms of concern is very slow and has no significant effect on
the microbiological quality of the carcass. At temperatures below 50
[deg]F, spoilage bacteria generally multiply faster than pathogens, and
meat or poultry kept below 50 [deg]F will tend to spoil before
excessive pathogen multiplication could occur. Gram negative pathogens,
such as salmonellae, tend not to multiply below 45 [deg]F (7[deg] C).
Removal of the time and temperature chilling requirements is
unlikely to lead to a significant change in carcass chilling methods or
long-established packaging and shipping practices that the poultry
products industry considers necessary to meet both regulatory and
market requirements to maintain raw products in a sanitary condition.
It would, however, eliminate a prescriptive requirement and give
establishments greater flexibility to manage how they chill poultry.
Processors must ensure good temperature controls at the establishment
and during shipment to maintain product quality during transport and
ensure a usable shelf life for the products after delivery to retail
establishments.
More than half of the raw poultry products destined for the retail
market are shipped using the chill-pack method of refrigeration, under
which the products are quickly chilled after packaging and held at
temperatures of from 28 [deg]F to 32 [deg]F. The rapid chilling limits
the growth of pathogenic and spoilage bacteria on the carcass. Almost a
third of the products are packed in containers filled with shaved or
crushed ice (the ice-pack method) or dry ice (dry-ice pack) and held at
temperatures between 30 [deg]F and 35 [deg]F and shipped to
distributors, grocers, and fast-food chains. Other raw poultry products
are shipped either in the frozen state or under other forms of
refrigeration. This proposal would not affect these practices and the
resulting consumer protections. The Agency has, therefore, concluded
that consumers would be fully protected without the very prescriptive
requirements that this proposed rule would eliminate.
Time and temperature requirements are intended to remove animal
heat and inhibit the multiplication of bacteria, including food-
poisoning organisms, on ready-to-cook poultry products. But time and
temperature combinations other than those in the current regulations
and technologies other than chilling are available to reduce bacterial
levels and control bacterial multiplication on products at the
processing establishment.
FSIS would verify that establishments are controlling levels of
bacteria through verifying an establishment's chilling procedures in
its HACCP plan or Sanitation SOP or other prerequisite programs.
Consistent with current regulations, once the product is chilled, the
establishment would be required to continue to inhibit the outgrowth of
such organisms as long as the product remains at the establishment.
c. Air Chilling
Under this proposal, air-chilled poultry would be required to meet
the same regulatory requirements for pathogen control as poultry
chilled by immersion. FSIS is proposing to amend the regulations to
clarify what constitutes the air chilling of poultry carcasses and
parts. Air chilling is a production method that rapidly cools poultry
carcasses and parts by moving them through cold air chambers. In
immersion chilling, by contrast, the carcasses are dipped into ice cold
water containing one or more antimicrobial agents. Regardless of the
method used, establishments would need to define when the chilling
process is complete.
The Agency is taking this step because industry is using ``air
chilling'' and ``air chilled'' as label claims on packages of ready-to-
cook poultry and parts. Moreover, many consumers apparently believe
that air-chilled poultry is superior in taste and in wholesomeness to
poultry that is chilled by conventional methods.
Because of the perceived marketing advantage in air chilling
poultry, the industry has asked FSIS exactly what constitutes air
chilling. Consequently, the Agency has decided to propose a definition
of air chilling. Based on FSIS' knowledge of industry practices and
consumer expectations, the Agency is proposing to define ``air
chilling'' as the method of chilling raw poultry carcasses and parts
exclusively with air. Under this proposed definition, an anti-microbial
intervention that is applied with water may be used for a short
duration if its use does not result in any pick-up of water or
moisture, and if it does not assist the chilling process by lowering
the product temperature (cooling effect).
By contrast, so-called evaporation chilling does not qualify as air
chilling. Evaporation chilling consists of using a mist to chill
poultry carcasses and parts and then using air to further chill the
poultry.
FSIS is also proposing that ready-to-cook poultry may bear an ``air
chilled'' or ``air chilling'' claim on the label if the chilling
process used with the poultry carcasses and parts meets the definition
of air chilling.
FSIS would verify that establishments that use air chilling and
include ``air chilled'' or ``air chilling'' on their product labels use
procedures that meet all the regulatory requirements, i.e., no water is
used to aid the chilling process, and, if water is used to apply an
anti-microbial, the product retains no water.
4. Proposed Changes to Online and Offline Reprocessing Regulations
a. Background
As noted earlier in this document, 144 poultry slaughter
establishments are operating under waivers that allow them to use
online antimicrobial systems to reprocess carcasses accidentally
contaminated with digestive tract contents. On December 1, 2000, FSIS
issued a proposed rule to permit the use of online reprocessing in
poultry slaughter establishment (``Performance Standards for On-line
Antimicrobial Reprocessing of Pre-chill Poultry Carcasses'' (65 FR
75187)). FSIS initiated this rulemaking in response to petitions
submitted by two companies that have developed online reprocessing
systems, Rhodia, Inc. and Alcide Corporation. Rhodia's online
reprocessing system uses trisodium phosphate (TSP) rinse in combination
with a chlorinated water system to treat carcasses pre-chill. Alcide's
system uses acidified sodium chlorite as pre-chill antimicrobial
treatment. Both systems are among those used in establishments
operating under online reprocessing waivers.
The Agency proposed to amend its regulations to allow
establishments to reprocess contaminated carcasses online by applying a
pre-chill antimicrobial intervention if such carcasses met pre-chill
performance standards for Salmonella and generic E. coli that would be
significantly lower than the current generic E. coli regulatory
criteria for verifying process control and the codified pathogen
reduction Salmonella performance standards (65 FR 75192). At that time,
FSIS had determined that it was necessary to hold poultry
[[Page 4432]]
contaminated with digestive tract contents to a more rigid pathogen
reduction standard than product that is not visibly contaminated
because digestive tract contents are a source of pathogens and other
microorganisms. The available data evidenced that physical removal of
visible contamination does not necessarily remove significant levels of
pathogens and other microorganisms. However, although both the Rhodia
and Alcide petition included data from in-plant trials that
demonstrated that each company's pre-chill online reprocessing system
is effective in reducing pathogens and other microorganisms on visibly
contaminated poultry carcasses, Rhodia's data were quantitative and
focused on absolute levels of reduction (e.g., less than 0.5 percent of
the treated samples were positive for Salmonella), while Alcide's data
documented degrees of reduction (e.g., there was an average reduction
by 27.27 percent of the prevalence of Salmonella on the treated
samples).
Therefore, because the various antimicrobial treatments used in the
in-plant online reprocessing trials had differing effects with respect
to pathogen reduction, FSIS did not include specific pre-chill
standards in the proposed rule. Instead, the December 2000 proposed
rule requested comments, especially in the form of additional data, on
the specific performance standards that establishments that use pre-
chill online antimicrobial reprocessing systems should be required to
meet.
Most of the comments submitted in response to the proposed rule
supported the use of online reprocessing. Some commenters recommended
different kinds of performance standards that could be associated with
online reprocessing but did not include microbiological data to support
the suggested standards. There was also a general lack of consensus on
the type of performance standard the Agency should adopt. Other
commenters said that FSIS should not require a performance standard
specifically for the use of online reprocessing.
As discussed above, FSIS enforces a zero tolerance standard for
contamination by visible fecal material on poultry carcasses and parts
pre-chill. Under the current regulations, the Agency permits the
reprocessing of carcasses contaminated on their inner surfaces with
visible digestive tract material before they enter the chilling tank.
The regulations require that all reprocessing of poultry occur at an
approved reprocessing station away from the processing line.
Contaminated surfaces that are cut must be reprocessed only by
trimming. Contaminated inner surfaces that are not cut may be
reprocessed by trimming alone or in combination with other methods,
such as washing and vacuuming. If the inner surfaces of carcasses are
reprocessed other than solely by trimming, all surfaces of the carcass
must be treated with chlorinated water containing 20 ppm available
chlorine (9 CFR 381.91 (b)). The Agency estimates that approximately 2
to 3 percent of inspected poultry carcasses is reprocessed offline.
There are concerns that offline reprocessing of poultry carcasses
may spread pathogenic organisms because the technique involves a
significant amount of product handling and provides ample opportunity
for cross contamination. As mentioned earlier in this document, FSIS
has experience with industry use of online reprocessing in poultry
slaughter establishments through approved experimentation conducted
under waivers from the current regulations. Although the data generated
from these in-plant trials demonstrated that various online
antimicrobial treatments have differing effects with respect to
pathogen reduction, the results indicate that online reprocessing, when
properly employed, is safe and effective. The results of 11 online
reprocessing system waivers show that on the aggregate, online
reprocessing reduces APC, E. coli, Coliforms, and Salmonella on treated
carcass.
The Agency also has experience with industry use of offline
reprocessing using antimicrobial agents other than chlorinated water
containing 20 ppm available chlorine through approved experimentation
conducted under waivers. The results from four offline reprocessing
system waivers show that on the aggregate, offline reprocessing using
antimicrobial agents other than chlorine reduces APC, E. coli, and
Salmonella at a level equal to or better than chlorine. These waivers
have also demonstrated that the use of chlorinated water containing
between 20 and 50 ppm available chlorine is safe and effective when
properly employed.
b. Proposed Rule
FSIS is re-proposing to amend its regulations to permit the use of
online reprocessing of poultry carcasses. However, the Agency has
decided not to propose performance standards specifically associated
with the use of online reprocessing. As noted above, data generated
from in-plant trials show that various online antimicrobial treatments
have differing but equally effective results with respect to pathogen
reduction. The comments submitted on this issue did not provide any new
data on the type of performance standard that the Agency should adopt.
Therefore, instead of proposing performance standards, FSIS has decided
to permit establishments to use online reprocessing antimicrobial
interventions if the parameters for use of the antimicrobial
intervention system have been approved by the FSIS, and the
establishment incorporates procedures for online reprocessing into its
HACCP plan, or sanitation SOP, or other prerequisite programs.
Establishments choosing to use online reprocessing would be
required to comply with the same standards and regulations addressing
digestive tract contents that are applicable to all poultry slaughter
establishments. Establishments using online reprocessing would still be
required to ensure that poultry carcasses contaminated with visible
fecal material do not enter the chilling tank.
Permitting establishments the option of online reprocessing would
allow visibly contaminated poultry carcasses to remain online for
treatment by a system of automatic bird washers and antimicrobial
spraying or drenching equipment, rather than have to be moved off the
line to an offline reprocessing station. All carcasses would remain on
the line to be treated with the on-line anti-microbial agent, whether
they are contaminated or not. However, carcasses that are mutilated or
entirely contaminated are adulterated and would not be permitted to be
reprocessed online or offline.
Online reprocessing of pre-chill young poultry carcasses offers
substantial benefits--it will reduce the potential of cross-
contamination, reduce digestive tract contamination for all carcasses
because all carcasses would pass through the same system of automatic
bird washers and antimicrobial spraying or drenching equipment, and
will maintain a continuous flow of carcasses down the processing line.
This proposed rule would not require establishments to use online
reprocessing. Establishments that elect to use online reprocessing
would have to incorporate procedures into their HACCP plans, or
sanitation SOPs, or other prerequisite programs for applying an online
antimicrobial intervention to all carcasses after evisceration and
before the carcasses enter the chiller.
FSIS will list all antimicrobial agents that have been approved for
use in online reprocessing, together with the specific parameters of
use under which
[[Page 4433]]
the antimicrobial agents have been approved, in FSIS Directive 7120.1:
``Safe and Suitable Ingredients Used in the Production of Meat,
Poultry, and Egg Products.'' As under current regulations, the safety
of antimicrobial substances will be determined by the FDA. The
suitability of those substances as reprocessing agents will be
determined by FSIS. Establishments opting to use online reprocessing
would be permitted to use online reprocessing systems and antimicrobial
agents that have been approved by FSIS under the specific conditions of
use for which they have been approved. Establishments would not need to
request a waiver to use these approved online reprocessing systems. If
deficiencies occur with the use of online reprocessing, an
establishment would be required to take corrective actions.
FSIS would verify that establishments were properly using online
reprocessing by verifying an establishment's online reprocessing
procedures as detailed in its HACCP plan, sanitation SOP, or other
prerequisite programs.
FSIS is also proposing to amend the current regulations pertaining
to offline reprocessing to allow establishments that reprocess inner
surfaces other than solely by trimming to use chlorinated water
containing 20 ppm to 50 ppm available chlorine or another approved
antimicrobial substance in accordance with the parameters approved by
the Agency. As with the methods of online reprocessing described above,
approved methods of offline reprocessing will be listed in FSIS
Directive 7120.1, ``Safe And Suitable Ingredients Used in the
Production of Meat, Poultry, And Egg Products,'' and establishments
would be required to incorporate their procedures for offline
reprocessing into their HACCP plans, or sanitation SOPs, or other
prerequisite programs.
FSIS is proposing to revise the offline reprocessing regulations to
remove the provisions that provide for the Agency to withdraw approval
for an establishment to conduct offline reprocessing. As noted above,
under this proposal, FSIS would ensure the effectiveness of an
establishment's procedures for online or offline reprocessing through
its HACCP verification activities.
Finally, even though a poultry product has been subjected to anti-
microbial treatments as part of online reprocessing, it may still
qualify for a certified organic claim, depending on the anti-microbial
agent that was used. The use of ``organic'' labeling for such poultry
products is determined on a case-by-case basis. Two treatments
permitted for use in poultry products labeled as ``organic'' are
Hydrogen Peroxide and Peracetic Acid. In addition, Orange Pulp and
Acidified Sodium Chlorite have been formally recommended for use in
organic handling in an Agricultural Marketing Service (AMS) National
Organic Program (NOP) proposed rule.
V. Executive Order 12866 and Executive Order 13563
Executive Orders 13563 and 12866 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 rule has been designated an ``economically
significant regulatory action,'' under section 3(f) of Executive Order
12866. Accordingly, the rule has been reviewed by the Office of
Management and Budget.
Introduction
The Food Safety and Inspection Service (FSIS) is proposing to
implement a new system for inspecting the slaughter of young chickens
and turkeys. Furthermore, other proposed actions include a revised
traditional inspection system for inspecting the slaughter of all
poultry; and proposed requirements that would apply to all
establishments that slaughter poultry, other than ratites (e.g.,
ostriches, emu, and rhea).
Need for the Rule
Given technological advances in the production of poultry, the
current inspection system's line speed restrictions result in higher-
than-necessary costs per bird. The new system described in this
document makes available a new voluntary inspection system that would
enable producers to decrease production costs by increasing line speeds
in a manner that does not compromise the safety of the production
process. Based on our experience with the HIMP program, FSIS expects
the new inspection system to improve food safety and the effectiveness
of inspection systems, remove unnecessary regulatory obstacles to
innovation, and make better use of the Agency's resources.
Furthermore, FSIS has determined that contamination of poultry
carcasses and parts by fecal material and enteric pathogens (e.g.,
Salmonella and Campylobacter) are hazards reasonably likely to occur in
poultry slaughter establishments unless addressed in a sanitation SOP
or other prerequisite program.
Therefore, to ensure that all establishments that slaughter poultry
properly address the food safety hazards associated with contamination
of poultry carcasses by fecal material and enteric pathogens, FSIS is
proposing that all poultry establishments develop, implement and
maintain written procedures to (1) prevent poultry carcasses
contaminated with visible fecal material from entering the chiller and
(2) prevent contamination of carcasses and parts by enteric pathogens
and fecal contamination throughout the entire slaughter and dressing
operation. FSIS is proposing that establishments incorporate these
procedures into their HACCP plan, or sanitation SOP, or other
prerequisite program.
Proposed Actions
Table 8 compares the components or requirements of the actions of
the proposed rule with a comparison to the current regulatory
environment for the approximately 289 federally inspected
establishments that slaughtered all poultry other than ratites in 2010
(FSIS Animal Disposition Reporting System (ADRS)). Actions include
requirements for young chicken and turkey establishments and
requirements for all poultry slaughter establishments excluding
ratites. Table 8 includes information for SIS and NELS inspection
systems and SIS Automated Evisceration Equipment Systems, referred to
as MAESTRO, which is an acronym for ``Meyn's Automatic Evisceration
System Total Removal of Organs'', and Nu-Tech Nuova. These automated
poultry evisceration systems were introduced in the late 1990s. For
young chicken establishments, four inspectors are stationed on the same
side of a processing line that runs at a maximum of 140 bpm or 35 bpm
per inspector--the same per-inspector line speed as under SIS. The
evisceration equipment used in SIS or NELS must be supported by
establishment employees who manually complete carcass and viscera
presentation. In contrast, the automated evisceration systems do not
require that support.
[[Page 4434]]
Table 8--Comparison of Key Components of the Baseline Regulatory Environment and Proposed Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Very small and small establishments, Small and large, non-traditional
Key features or provisions of traditional -----------------------------------------------------------------------
the proposal -------------------------------------------------
Baseline Proposed Non-HIMP baseline HIMP baseline Proposed
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Establishments....... 70..................... ...................... 194................... 25.................... ......................
Carcass Sorting Activities..... FSIS................... FSIS.................. FSIS.................. Establishment......... Establishment.
Online Inspector per Line...... 1-4.................... 1-2 \a\............... 2-4................... 1..................... 1.
Online Inspector Limit......... No..................... Yes................... No.................... Yes................... Yes.
Addition of Online No..................... Yes................... No.................... Yes................... Yes.
Establishment Workers because
of Relocation of Online IPP.
Line Speed Maximum Birds per 16-25.................. 16-25................. 70-140................ 175................... 175.
minute for Young Chickens.
Line Speed Maximum Birds per 16-25.................. 16-25................. 70.................... ...................... SIP Waiver determined.
minute for Mature Chickens.
Line Speed Maximum Birds per 21-51.................. 21-51................. 45.................... 55.................... 55.
minute for Turkeys.
Line Speed Maximum Birds per 16-25.................. 16-25................. Na.................... Na.................... SIP Waiver determined.
minute for Other Poultry.
Records to document that No..................... No.................... No.................... No.................... Yes.
products meet the definition
of ready-to-cook poultry.
New Facilities Requirements.... No..................... No.................... No.................... Yes................... Yes.
New carcass inspection station No..................... No.................... No.................... Yes................... Yes.
online for each evisceration
line.
New carcass inspection station No..................... No.................... No.................... Yes................... Yes.
offline for each evisceration
line.
New carcass inspection area No..................... No.................... No.................... No.................... Yes.
online for avian leukosis for
each evisceration line.
Underline Trough for each No..................... No.................... No.................... Yes................... Yes.
evisceration line.
HACCP System--written to No..................... Yes................... No.................... No.................... Yes.
prevent contamination by
enteric pathogens and fecal
material & testing.
HACCP System--written to No..................... Yes................... No.................... No.................... Yes.
prevent carcasses contaminated
with fecal material from
entering the chill tank.
Replace Requirement to Test for No..................... Yes................... No.................... No.................... Yes.
Generic E. coli and Salmonella
performance standards with 2-
point testing.
End Waivers for: Chilling No..................... Yes................... No.................... No.................... Yes.
Requirements for RTC Time and
Temp Eliminated.
End Waivers for: Use Online No..................... Yes................... No.................... No.................... Yes.
Reprocessing (OLR)
Antimicrobial Systems or
Offline Antimicrobial Agents.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Na Does not apply.
\a\ Establishments that already have more than two Inspection Program Personnel (IPP) per evisceration line will get to keep all of them.
As shown in Table 8, online inspectors in the Very Small and Small
establishments currently range from 1 to 4 per line. Under the revised
traditional inspection system, this range will decrease to 1 to 2
(except that establishments that already have more than two IPP per
evisceration line will be allowed to keep them). The Small and Large
Establishments, all of which FSIS expects to adopt the proposed new
inspection system, will have 1 online inspector per line, down from the
current 2 to 4 online inspectors per line under the current non-
traditional systems (SIS, NELS, and NTIS) and equal to the number of
online inspectors per line under HIMP.
Summary of the Proposed Rule's Provisions
A. Elements of the new system for the slaughter of young chickens
and turkeys:
(1) Requirements by establishment personnel to conduct carcass
sorting activities before FSIS inspection program personnel (IPP)
conduct online carcass inspection so that only carcasses that the
establishment deems likely to pass inspection are presented to the FSIS
carcass IPP, expected to impact 194 establishments;
(2) A limit of one FSIS online carcass inspector per evisceration
line, expected to impact 194 establishments;
(3) Faster slaughter and evisceration line speeds than are
permitted under the current inspection systems. Existing evisceration
line speeds in the non-traditional inspection systems are currently
operating below capacity, expected to impact 194 establishments;
(4) Development, implementation, and maintenance of written
procedures to ensure that young chicken and turkey carcasses
contaminated with septicemic and toxemic conditions do not enter the
chilling tank. Establishments must incorporate these procedures into
their HACCP plans, or sanitation SOPs, or other prerequisite programs,
expected to impact 219 establishments;
(5) Removal of the existing Finished Product Standards (FPS) and
subsequent replacement with a requirement to maintain records that
document finished products meet the definition of ready-to-cook
poultry. Establishments will have the flexibility to design and
implement measures for producing ready-to-cook poultry that are best
suited to their operations. In addition to inspecting for food safety
defects, the FSIS on-line carcass inspector will also conduct a carcass
inspection for defects that are less important to food safety. The
presence of persistent, unattended defects would indicate that the
plant is not producing ready-to-cook poultry, expected to impact 219
establishments; and
[[Page 4435]]
(6) Requirement that facilities in the establishment include: (a)
an online carcass inspection station for each evisceration line; (b)
one or more offline carcass inspection stations for each evisceration
line; (c) an online area for the online inspection of carcasses for
avian leukosis; and (d) an underline trough for each evisceration line
in order to prevent the contamination of online carcasses by removed
poultry waste or inedible products of the evisceration process. FSIS
projects that this action would affect about 219 establishments of
about 270 official federally inspected establishments that slaughter
young chickens and turkeys and that would adopt this proposed new
inspection system. This 219 total includes HIMP establishments, though
they will have already installed this equipment, meaning that 194
establishments are affected.
B. Elements that would affect all 289 poultry, non-ratite slaughter
establishments:
(1) Development, implementation, and maintenance of written
procedures to prevent contamination of carcasses and parts by fecal
material and enteric pathogens (e.g., Salmonella spp. and Campylobacter
spp.) as part of an establishment's HACCP plans, sanitation SOP, or
other prerequisite programs. FSIS is proposing that, at a minimum,
these written procedures include sampling and analysis for microbial
organisms at the pre-chill and post-chill points in the process to
verify process control.
(2) Development, implementation, and maintenance of written
procedures to ensure that carcasses and parts with visible fecal
contamination do not enter the chiller as part of an establishment's
HACCP plans, sanitation SOP, or other prerequisite programs.
(3) Removal of current requirement to test for generic E. coli and
the codified Salmonella pathogen reduction performance standards for
poultry.
(4) Removal of the chilling requirements for ready-to-cook (RTC)
poultry, which now provide specific time and temperature parameters.
(5) Requirements regarding the use of approved online reprocessing
antimicrobial systems or offline reprocessing approved antimicrobial
agents, if these procedures for reprocessing are incorporated into
their HACCP plans, sanitation SOPs, or other prerequisite programs.
Among the 70 establishments that are expected to use the revised
traditional inspection system, the maximum number of FSIS IPP per
poultry evisceration line will be set to two unless the establishment
is already operating with more than two online IPP per line under the
current traditional poultry inspection system.\13\ FSIS projects that
this action would affect about 51 establishments of about 270 official
federally inspected establishments that slaughter young chickens and
turkeys; and all 19 official federally inspected establishments that
slaughter other chicken and other poultry and that would choose to
switch to the proposed revised traditional inspection system.
---------------------------------------------------------------------------
\13\ Under the revised traditional inspection system, only
establishments that currently have more than two inspectors per line
will be allowed to retain more than two inspectors per line.
---------------------------------------------------------------------------
Analysis of the Benefits and Expenditures (Costs) of the Proposed
Action
Baseline
Table 9 shows the baseline characterization of the U.S. poultry
market other than ratites in 2010. Domestic federally inspected
establishments slaughtered and dressed about 9.0 billion birds other
than ratites in 2010, including about 8.4 billion young chickens; about
140 million other chickens (e.g., fowl and capon); about 252 million
turkeys; and about 27 million other poultry (e.g., ducks, geese, quail,
pheasants, and squab).
Table 9--Baseline Characterization of the U.S. Poultry Market
----------------------------------------------------------------------------------------------------------------
Young
chickens Other chickens Turkey Other poultry
----------------------------------------------------------------------------------------------------------------
Market price ($/bird) \a\....................... $3.38 $1.34 $22.74 $9.02
Market quantity \b\ (thousand birds/year)
Domestic production......................... 8,386,671.6 139,499.2 251,787. 8 26,781.1
Exports..................................... 1,314,710.8 14,675.8 18,428.9 903.4
Imports..................................... 9,314.1 0 229.8 243.2
----------------------------------------------------------------------------------------------------------------
A summary of the types of young chicken and turkey operations and
the sizes of these official establishments is in Table 10 (FSIS ADRS
2010). Table 10 summarizes the 270 federally inspected establishments
that slaughtered young chickens (231 establishments) and turkeys (39
establishments) and excludes the 19 other establishments that
slaughtered only other chickens (such as fowl and capon) (6
establishments) and only other poultry (such as squabs, pheasants,
quail, ducks or geese) (13 establishments) in 2010 along with the 19
that slaughtered other chicken and other poultry.
Table 10--Summary of HACCP Establishment Size of the 289 Official Establishments that Slaughtered All Poultry
Under Federal Inspection in 2010 (FSIS ADRS, 2010)
----------------------------------------------------------------------------------------------------------------
Percent of all
Type of operation Very small Small Large Total establishments
----------------------------------------------------------------------------------------------------------------
Young Chicken:*
Young Only.................. 7 (4%) 33 (20%) 124 (76%) 164 (57%)
Young and Mature............ 11 (42%) 14 (54%) 1 (4%) 26 (9%)
Young Chicken and Other 26 (63%) 13 (32%) 2 (5%) 41 (14%)
Poultry....................
Turkey:
Young Only.................. 7 (23%) 6 (20%) 17 (57%) 30 (10%)
Young and Mature............ 0 4 (44%) 5 (56%) 9 (3%)
-------------------------------------------------------------------------------
[[Page 4436]]
Total Young Chicken and 51 (19%) 70 (26%) 149 (55%) 270 (100%) (93%)
Turkeys................
-------------------------------------------------------------------------------
Other Chicken................... 0 4 (67%) 2 (33%) 6 (2%)
Other Poultry................... 3 (23%) 10 (77%) 0 13 (4%)
-------------------------------------------------------------------------------
Total Poultry............... 54 (19%) 84 (29%) 151 (52%) 289 (100%) (100%)
----------------------------------------------------------------------------------------------------------------
* Establishments that slaughter primarily young chickens.
Projected Number of Establishments That Will Opt for the Revised
Traditional System
FSIS is proposing that all establishments that slaughter poultry
other than ratites and are not participating in the new inspection
system must switch to the proposed revised traditional inspection
system.
FSIS projects that about 70 federally inspected establishments will
switch from their current traditional inspection system to the proposed
revised traditional system for the slaughter of poultry, other than
ratites.
The basis for this projection is that these 70 establishments
consist of 51 HACCP Very Small establishments, or about 19 percent, of
the 270 official federally inspected establishments that slaughter
young chickens and turkeys and 19 establishments that slaughter poultry
other than young chicken or turkey (or ratites). The Very Small young
chicken and turkey establishments do not have sufficient output volume
over which to spread the initial set-up costs of the proposed new
system or the training and maintenance costs resulting from this
system.
These 70 establishments represent about 24 percent of the 289
official federally inspected establishments that slaughtered one or
more classes of poultry other than ratites,\14\ under all poultry
inspection systems in 2010. In addition, based on FSIS's ADRS records,
the 70 establishments slaughtered less than 1 percent of all poultry
(other than ratites) of the domestic poultry industry, in 2010.
Furthermore, based on FSIS's Animal Disposition Reporting System (ADRS)
records of 2010, the approximately 219 official federally inspected
establishments slaughtered about 99.9 percent of the young chickens and
turkeys of the domestic poultry industry in 2010.
---------------------------------------------------------------------------
\14\ Based on FSIS's Animal Disposition Reporting System (ADRS)
of 2010, 289 establishments slaughtered all classes of poultry,
under all poultry inspection systems in 2010, other than ratites. Of
the 289 establishments, about 270 establishments slaughtered young
chicken and young turkey in 2010.
---------------------------------------------------------------------------
Projected Changes in the Number of Lines and Shifts Under the Revised
Inspection System
FSIS ADRS 2010 records indicated that there were 663 line shifts in
270 establishments that slaughter young chickens and turkeys, as shown
in Table 11.\15\ In these establishments, one shift is defined as about
8 hours per day and two shifts as about 16 hours per day. Approximately
55 percent of the 270 establishments operated two slaughter shifts per
day in 2010. For this analysis, the 663 line-shifts of production
results from multiplying the number of lines by the number of shifts.
Table 11 shows the details of the FSIS ADRS 2010 information on the 270
young chicken and turkey establishments, classified by current
inspection system. FSIS maintains this type of information because
staffing patterns in current inspection are determined based on the
number and type of slaughter lines. These 663 lines operate daily in
the 270 young chicken and turkey establishments with one or two 8-hour-
shift(s), on about 5 or 6 days of the week.
---------------------------------------------------------------------------
\15\ The very small establishments that slaughter annually a
relatively small number of young chickens and turkeys by methods
that do not use a high-speed line are included.
---------------------------------------------------------------------------
Table 11 also summarizes the transition of the young chicken and
turkey industry to the proposed new inspection system. This table shows
distribution of the 270 establishments that slaughtered young chickens
and turkeys in 2010.
Of the 187 young chicken establishments (not under the traditional
inspection system) with 542 high-speed lines, there were 117
establishments under SIS inspection, 50 under NELS inspection, and 20
under the HIMP inspection. Of the 32 turkey establishments (not under
the traditional inspection system) with 56 high-speed lines, there were
27 establishments under NITS inspection, and 5 under the HIMP
inspection. Therefore, 219 of the 270 young chicken and turkey
establishments, or 81 percent, have about 598 lines that are high
speed.
[[Page 4437]]
Table 11--Transition of 270 Official Establishments and Line-Shifts That Slaughtered Young Chickens and Turkeys Under Federal Inspection Systems to the
New Inspection Systems and the Revised Traditional Inspection System
[Source: FSIS ADRS, 2010]
--------------------------------------------------------------------------------------------------------------------------------------------------------
--------------------------------------------------------------------------------------------------------------------------------------------------------
Inspection Systems Before the Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Slaughter Processing--With Lines in 2010
270 Establishments
663 Line-shifts
--------------------------------------------------------------------------------------------------------------------------------------------------------
High-Speed Lines Low-Speed Lines
219 Establishments 51 Establishments
598 Line-shifts 65 Line-shifts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Young Chickens Turkeys Young Chickens
and Turkeys
187 Establishment32 Establishments 51 Establishments
542 Line-shifts 56 Line-shifts 65 Line-shifts
--------------------------------------------------------------------------------------------------------------------------------------------------------
SIS........................... NELS............. HIMP............. NTIS............. HIMP............. Traditional.
117 Estab..................... 50 Estab......... 20 Estab......... 27 Estab......... 5 Estab.......... 51 Establishments.
346 Line-shifts............... 153 Line-shifts.. 43 line-shifts... 42 line-shifts... 14 line-shifts... 65 Line-shifts.
--------------------------------------------------------------------------------------------------------------------------------------------------------
Expected Inspection Systems After the Proposed Rule Is Implemented
--------------------------------------------------------------------------------------------------------------------------------------------------------
New Inspection System (Young Chickens and Turkeys) Revised Traditional
219 Establishments 51 Establishments
598 Line-shifts 65 Line-shifts
--------------------------------------------------------------------------------------------------------------------------------------------------------
Notes: The number of line shifts is the number of slaughter lines in establishments that operate one shift plus two times the number of lines in
establishments that operate two shifts.
Each shift is about 8 hours of operation per day.
Table 12 shows that of the 187 young chicken establishments (not
under the traditional inspection system) with 542 high-speed lines, 127
were HACCP large establishments and 60 were HACCP small establishments.
Of the 32 turkey establishments (not under the traditional inspection
system) with 56 high-speed lines, 22 were HACCP large establishments
and 10 were HACCP small establishments. None of the HACCP very small
establishments is known to have high-speed line systems.
Table 12--Number of Lines of 289 Establishments That Slaughtered Young Chickens, Other Chickens, Turkeys, and
Other Poultry Under Federal Inspection Systems
[FSIS ADRS, 2010]
----------------------------------------------------------------------------------------------------------------
Number of Number of Number of
Establishment HACCP Size Number of evisceration establishments-- establishments--
establishments line-shifts 1-shift 2-shifts
----------------------------------------------------------------------------------------------------------------
Numbers of Evisceration Lines in Active Federally Inspected Establishments That Slaughter All Classes of Poultry
Other Than Ratites
----------------------------------------------------------------------------------------------------------------
Very Small.......................... 54 68 54 0
Small............................... 84 99 82 2
Large............................... 151 531 0 151
---------------------------------------------------------------------------
Total........................... 289 698 136 153
----------------------------------------------------------------------------------------------------------------
Numbers of Evisceration Lines in Active Federally Inspected Establishments That Slaughter Primarily Young
Chickens
----------------------------------------------------------------------------------------------------------------
Very Small.......................... 44 58 44 0
Small............................... 60 60 60 0
Large............................... 127 482 0 127
---------------------------------------------------------------------------
Total........................... 231 600 104 127
----------------------------------------------------------------------------------------------------------------
Numbers of Evisceration Lines in Active Federally Inspected Establishments That Slaughter Primarily Turkeys
----------------------------------------------------------------------------------------------------------------
Very Small.......................... 7 7 7 0
Small............................... 10 15 10 0
Large............................... 22 41 0 22
---------------------------------------------------------------------------
Total........................... 39 63 17 22
----------------------------------------------------------------------------------------------------------------
Numbers of Evisceration Lines in Active Federally Inspected Establishments That Slaughter Only Other Chickens
(e.g., Fowl)
----------------------------------------------------------------------------------------------------------------
Very Small.......................... 0 0 0 0
[[Page 4438]]
Small............................... 4 4 4 0
Large............................... 2 8 0 2
---------------------------------------------------------------------------
Total........................... 6 12 4 2
----------------------------------------------------------------------------------------------------------------
Numbers of Evisceration Lines in Active Federally Inspected Establishments That Slaughter Primarily Other
Poultry (e.g., Ducks)
----------------------------------------------------------------------------------------------------------------
Very Small.......................... 3 3 3 0
Small............................... 10 20 8 2
Large............................... 0 0 0 0
---------------------------------------------------------------------------
Total........................... 13 23 11 2
----------------------------------------------------------------------------------------------------------------
Notes:
(1) Source: FSIS PBIS, March 2011. These federally inspected establishments have 03J HACCP codes for slaughter
operations
(2) Source: FSIS ADRS, March 2011. These federally inspected establishments slaughtered poultry in 2010.
(3) 1-shift is about 8 hours of slaughter operation; 2-shifts are about 16 hours of slaughter operation, each
workday.
Expected Benefits associated with the voluntary portion of the
proposed action--Consumer and producer benefits from increased line
speed:
Reducing current restrictions on line speeds will result in more
birds being processed per minute. For this analysis, we used a
conservative increase of an average of 6 percent for the line speed and
measured as increased birds per minute (BPM), for young chickens.\16\
FSIS requests comments on the precision of this estimate for increased
line speed. At this relatively low marginal increase in line speed or
BPM, we expect that the affected establishments would process an
average of 6 percent more BPM with no additional online labor cost on
the evisceration line. This is because we expect that the
establishments would do some of their sorting and removal of defective
birds before rehang. Then there should be few if any empty shackles as
can happen when FSIS inspection program personnel remove defective
birds after the rehang process. Furthermore, the additional adoption of
online reprocessing under these actions would keep additional birds in
the evisceration shackles instead of being sent to the rework area.
These changes with the new inspection system would increase the number
of birds populating the evisceration shackles and thus increase the
throughput or BPM under the new inspection system. For the private
sector (e.g., industry and consumer groups) of the economy, FSIS
projects that the proposed rule will result in lower costs of
production, which will lead to more industry profits and lower consumer
prices. The lower production costs may also lead to increased sales of
domestic and exported products in the long run. We estimate these
economic benefits to be at least $258.9 million (3 cents per bird for
99.9 percent of 8.64 billion birds) annually. This is the expected
annual net increase in consumer and producer surplus and does not take
into account either the increased long-term production or expanded
exports. This increase in well-being from the lower cost will benefit
both consumers and producers. Given the estimates of own price
elasticity of demand and elasticity of supply for both chicken and
turkey,\17\ the expectation is that, with the relatively high (in
absolute terms) estimate for own price elasticity of demand, 2 to 2.4
cents of the 3 cents per bird will go to producer surplus and the
remaining 0.6 to 1 cent will go to consumer surplus. Assuming an
increase of 6 percent in line speed allows for an estimate of the
decrease in processing cost per bird. This means that, for a given unit
of a worker's time, 6 percent more birds will be processed. Assuming
that labor is 15 percent of the total cost of processing a bird,\18\
then this increase of 6 percent in the number of birds per period of
time means a decrease of 0.85% in the processing cost of a bird. Using
a wholesale price of ready-to-cook poultry of $1.35 per kilogram and a
ready-to-cook poultry wholesale cost of $1.23 per kilogram,\19\ then
the mark-up from wholesale is 10 percent ((1.35-1.23)/1.23 = 9.8%).
With a weighted average wholesale price per bird for young chicken and
turkey of $3.94,\20\ the wholesale cost, using the mark-up margin of
10.0%, is $3.58. With the 0.85% reduction in cost, the wholesale cost
will decline by 3 cents ($3.58 x 0.0085). This reduction of 3 cents
will be divided between producers and consumers, based on the relative
absolute values of the elasticities of demand and supply.
---------------------------------------------------------------------------
\16\ This estimate is very conservative because the current
maximum speed allowed is 140 BPM for young chickens (45 for
turkeys), while the proposed rule increases this maximum speed to
175 BPM for young chickens (55 for turkeys), which represents a 25
percent increase in line speed for young chickens (22 percent for
turkey).
\17\ The 3 cents per bird cost reduction will be divided between
producers and consumers. The own price elasticity of demand
estimates are -0.43 for chicken and -0.58 for turkey and estimates
of elasticity of supply are 0.22 and 0.26 for chicken and turkey,
respectively. Muth, M.K., R.H. Beach, C.L. Viator, S.A. Karns, and
J.L. Taylor. 2006. ``Poultry Slaughter and Processing Sector
Facility-Level Model.'' Prepared for U.S. Department of Agriculture,
Food Safety and Inspection Service. Research Triangle Park, NC: RTI
International. ERS has estimates of own price elasticity of demand
for chicken ranging from -0.602 (1985) to -0.841 (1975-80) (see USDA
Economic Research Service at http://www.ers.usda.gov/Data/Elasticities/Query.aspx). The greater value, in absolute terms, for
elasticity of demand suggests that the division of the cost
reduction between producers and consumers will be weighted toward
producers.
\18\ Structural Change in U.S. Chicken and Turkey Slaughter. By
Michael Ollinger, James MacDonald, Economic Research Service, U.S.
Department of Agriculture. Agricultural Economic Report No. 787.
\19\ See p. 269 of Watkins, B, YC Lu, and YR Chen. Economic
feasibility analysis for an automated on-line poultry inspection
technology. Poultry Science 2000 79: 265-274.
\20\ Muth, M.K., R.H. Beach, C.L. Viator, S.A. Karns, and J.L.
Taylor. 2006. ``Poultry Slaughter and Processing Sector Facility-
Level Model.'' Prepared for U.S. Department of Agriculture, Food
Safety and Inspection Service. Research Triangle Park, NC: RTI
International.
---------------------------------------------------------------------------
Expected Benefits associated with the voluntary portion of the
proposed action--Public health benefits from reallocating FSIS
inspection activities:
[[Page 4439]]
FSIS hypothesizes that switching existing FSIS IPP activities
towards more off-line verification activities (such as sanitation
performance standards, sampling, other inspection requirements, and
fecal inspections) may reduce pathogen levels in poultry slaughter
establishments. This is supported in the findings from the FSIS Risk
Assessment (October, 2011), which found a significant correlation
between more off-line inspection activities and lower levels of
Salmonella and Campylobacter in certain poultry products. It is
possible that these reductions may lead to a corresponding reduction in
illnesses.
Using results from this risk assessment (Table 7), FSIS estimates
that the proposed rule is expected to reduce the number of human
illness attributed to young chicken and turkey products by an average
of about 4,286 (with a range of 1,514 to 7,682) Salmonella spp.
illnesses and about 986 (with a range of 26 to 2,865) Campylobacter
spp. illnesses. Annual Salmonella spp. cost savings from an averted
case is $18,000 (74 FR 33030); \21\ and the annual Campylobacter spp.
cost savings from an averted case is $2,067.\22\ Thus, FSIS projects
that the monetized value of the human illness reductions is an expected
annual average of about $79.19 million (with a range of $27.3 million
to $144.2 million).
---------------------------------------------------------------------------
\21\ Food and Drug Administration, Prevention of Salmonella
Enteritidis in Shell Eggs During Production, Storage, and
Transportation, July 2009. Batz et. al estimate an averted
Salmonella illnesses is $3,220. This would reduce the estimated cost
savings from 4,286 averted cases from Salmonella, from $77.15
million to $13.8 million. The final economic analysis will provide
estimates for Salmonella and Campylobacter based on consistent
methodology.
\22\ Batz, Michael B., Sandra Hoffman, and J. Glenn Morris, Jr.
2011. Ranking the Risks: The 10 Pathogen-Food Combinations with the
Greatest Burden on Public Health. University of Florida Emerging
Pathogens Institute.
Table 13--Expected Total Potential Reductions in Human Illnesses or Illnesses Averted and Projected Cost Savings
due to Better Inspection Procedure Performance in Young Chicken and Turkey Slaughter Establishments
----------------------------------------------------------------------------------------------------------------
What happens if all young chicken and turkey establishments have
increased unscheduled offline inspection procedures? 1 2 3
--------------------------------------------------------------------------
Range
Expected value -------------------------------------------------
10th percentile 90th percentile
----------------------------------------------------------------------------------------------------------------
Annual Salmonella spp. cost savings $77.15 million......... $27.25 million......... $138.28 million.
\a\ and averted illnesses: (4,286 illnesses (1,514 illnesses (7,682 illnesses
averted). averted). averted).
Annual Campylobacter spp. cost $2.04 million.......... $0.05 million.......... $5.92 million
savings \b\ and averted illnesses: (986 illnesses averted) (26 illnesses averted). ( 2,865 illnesses
averted).
--------------------------------------------------------------------------
Annual Total Cost savings........ $79.19 million......... $27.30 million......... $144.20 million.
----------------------------------------------------------------------------------------------------------------
\1\ The number of establishments in each size category throughout the economic analysis is different from the
number used in the risk assessment. The risk assessment uses the most recent data for the correlation between
baseline and inspection data (2008) and participating establishments, while the economic analysis uses 2010
size categories to reflect the most up-to-date size distribution.
\2\ The reported expected reductions in illnesses represent the unscheduled inspection procedures scenario from
the risk assessment.
\3\ Totals may not add up due to rounding.
\a\ Average cost savings from an averted Salmonella spp. cost case is $18,000. This estimate is based on the FDA
estimate (74 FR 33030).
\b\ Average cost savings from an averted Campylobacter spp. is $2,067. This estimate is based on Batz, Michael
B., Sandra Hoffman, and J. Glenn Morris, Jr. 2011.
Thus, FSIS estimates that the total annual average private sector
benefit from this proposed rule is approximately $338.1 million ($258.9
+ $79.19).
Unquantifiable Benefits Associated With the Mandatory Portion of the
Proposed Action--Public Health Benefits Resulting From Preventing
Contamination of Carcasses and Parts by Enteric Pathogens and Fecal
Material Throughout the Entire Slaughter and Dressing Operation
In addition to the benefits listed in the previous section, FSIS
expects public health benefits from the mandatory component of the
proposed rule, which is proposed to apply to all poultry slaughter
establishments. FSIS is proposing to require that all poultry slaughter
establishments develop, implement, and maintain, as part of their HACCP
plans, sanitation SOPs, or other prerequisite programs, written
procedures to prevent contamination of carcasses and parts by enteric
pathogens and fecal contamination throughout the entire slaughter and
dressing operation. FSIS is proposing that, at a minimum, these
procedures must include sampling and analysis for microbial organisms
at the pre-chill and post-chill points in the process to monitor
process control for enteric pathogens.
Effective sanitary dressing and process control procedures are
crucial to an establishment's ability to produce a clean, safe, and
wholesome product. The existing regulations require that establishments
prevent poultry carcasses contaminated with visible fecal contamination
from entering the chiller (9 CFR 381.65(a)). To clarify the existing
requirements, FSIS is proposing to require that that establishments
develop, implement, and maintain written procedures to ensure that
poultry carcasses contaminated with visible fecal material do not enter
the chilling tank. However, because this proposed requirement reflects
existing practices, it is unlikely to have a significant effect on the
poultry industry.
While preventing poultry carcasses contaminated with visible fecal
material from entering the chiller is an important safeguard for
reducing the prevalence of pathogens on poultry carcasses, it cannot be
fully effective unless establishments implement appropriate measures to
prevent contamination from occurring throughout the slaughter and
dressing operation. Although many establishments do have in place
process control measures to prevent contamination of carcasses by
enteric pathogens and fecal material throughout the slaughter and
dressing process, they are not required to maintain written procedures
that describe their process control measures or to maintain records to
verify the effectiveness of their process controls. In addition, under
the existing regulations, official poultry slaughter establishments are
required to comply with prescriptive requirements
[[Page 4440]]
for testing for generic E. coli at the end of the chilling process as a
means of verifying process control.
As discussed earlier in this document, FSIS's experience with using
post-chill testing for generic E. coli to monitor process control for
fecal contamination and sanitary dressing has led the Agency to
conclude that such testing is not the most effective way to prevent
contamination from occurring throughout the slaughter and dressing
operation. Therefore, FSIS is proposing to remove the prescriptive
generic E. coli testing and replacing it with a more flexible
microbiological testing scheme that provides for testing at the points
in the process where contamination is most likely to occur, i.e., pre-
chill and post-chill. Such a testing scheme has the benefit of allowing
poultry slaughter to have the flexibility they need to determine which
microbiological organisms will best help them to monitor the
effectiveness of their process control procedures. It will also allow
establishments to identify the points in their production process where
microbial levels are the highest and to implement controls at the
points where contamination is most likely to occur.
FSIS is proposing to require that establishments incorporate their
procedures for preventing contamination of carcasses with enteric
pathogens and fecal material into their HACCP systems, and that they
maintain records sufficient to document the implementation and
monitoring of their procedures. These records will improve the
establishment's overall HACCP system by providing additional
documentation that the establishment and FSIS can use to verify the
effectiveness of the establishment's process control procedures. The
records that would be required under this proposed rule, including the
records of the establishment's testing results, will provide
establishments and FSIS with on-going information on the effectiveness
of the establishment's process controls, and allow establishments to
identify situations associated with in an increase in microbial levels
so that they can take the necessary corrective actions to prevent
further potential contamination. The documentation that would result
from this proposed rule could also limit the scope of a product recall
if the establishment maintains records sufficient to allow it to
identify the point when a lack of process control could have resulted
in product contamination.
Summary of Estimated Costs and Cost Savings of the Proposed Rule
Items 1-7 are costs and cost savings associated with the voluntary
component of the proposed new rule:
1. Addition of Online Establishment Workers Because of the Relocation
of Online Inspection Program Personnel and Online Sorters--Annual Cost
Associated With the Voluntary Component
FSIS expects, based on information provided by establishments
participating in the HIMP pilot program, that young chicken and turkey
establishments initially would expand their labor resources by
employing about 0.8 staff-years of online sorters and carcass-
inspection helpers that substitute for every 1.0 staff-year of FSIS
online inspection program personnel. For example, in one shift, an
establishment that had ten FSIS online inspection program personnel
would add eight online sorters and carcass-inspection helpers in
response to the proposal. This substitution rate is based on survey
results of young chicken and turkey establishments that are in the HIMP
pilot program. As the line speed is increased, however, the
substitution rate is expected to increase to 1.0 FTE or even higher.
In the 219 establishments that will slaughter young chickens and
turkeys under the new inspection system, FSIS expects between 663 and
750 FSIS online inspection program personnel will be shifted from
online inspection to verification inspection activities and online
inspection of carcasses (carcass inspection, after the final wash and
before the chiller). FSIS estimates that this shifted number of 750
FSIS online inspection program personnel is the upper bound of the
expected range for the 219 establishments that would transition to the
new inspection system, if the proposed rule is put into effect.
Using the expected substitution rate of 0.8 (8 for 10), the 219
establishments would initially need about 600 (750 x .8) additional
trained personnel to do the online sorting of young chickens and
turkeys, and helping carcass inspection program personnel for all
shifts. This implies that about 750 inspection program personnel would
be reassigned to other inspection activities within the establishment
(e.g. carcass inspection, verification inspection, and relief
coverage). The 750 inspection program personnel, however, may be an
over estimate, because of attrition.
The Bureau of Labor Statistics indicated that the expected standard
rate for establishment labor is about $13.95 per hour,\23\ and
including benefits and related costs, the wage cost is taken for this
analysis to be about $27,900 per staff-year (for about 2000 hours \24\
per staff-year). Therefore, the average cost to 219 establishments for
the initial additional 600 staff-years of online sorter labor is about
$16.7 million annually (600 x $27,900). The cost is expected to
decrease on a per-bird basis, because of the expected labor
productivity increase associated with increased line speed and more
cost-effective evisceration equipment.
---------------------------------------------------------------------------
\23\ Based on the 2008 Bureau of Labor Statistics employment
cost index.
\24\ This is a simplifying assumption.
---------------------------------------------------------------------------
2. Training Online Sorters, Under the New Inspection System--One-Time
Cost Associated With the Voluntary Component
Initial training costs are expected, based on information provided
by establishments participating in the HIMP pilot program, to be about
$200 to $600 per employee (sorter), or an average cost of about $400
per employee. Additional training costs accrue for the extra
establishment employees (sorters) needed to cover for task rotation
patterns and scheduled and unscheduled leave of trained establishment
employees. FSIS projects, based on information provided by
establishments participating in the HIMP pilot program, that rotation
schedules would be about three times per shift. FSIS did not report
costs in the official HIMP Report. FSIS, however, obtained information
on establishment costs and practices from site visits to the HIMP
project establishments and non-HIMP establishments that slaughter
poultry. The HIMP establishments (20 young chickens and 5 turkeys, as
shown in Table 11) reported a range of costs for their implementation
of the FSIS's requirements of the HIMP inspection system. Based on this
information, FSIS made assumptions on costs and practices of the
poultry establishments that would be affected by this proposed rule. We
are requesting information on the expected costs to the plants that
will be affected by the proposal.
FSIS assumes that the 219 establishments will need about 3.5 to 4
times the replacement staff-hours, or about 2,100 (600 x 3.5) to 2,400
(600 x 4) establishment employees who are trained to perform online
sorting and CI helper activities. Therefore, initially, an average of
about 2,250 establishment employees will need to be trained at a one-
time average cost of about $400 each, or a total for 219
establishments,
[[Page 4441]]
of about $0.9 million (2,250 x $400). FSIS is requesting comments on
these assumptions for staff turnover in the official establishments.
3. Training, Annually--for Replacement Sorters Due to Labor Turnover--
Annual Cost Associated With the Voluntary Component
Annual labor costs are estimated based on information provided by
establishments participating in the HIMP pilot program, in order to
account for the expected labor turnover rates in young chicken and
turkey establishments and the need to train and educate replacement
establishment personnel for sorting young chickens and turkeys.
FSIS projects that if the annual turnover rate of trained sorters
is taken to be between 5 and 20 percent, or an average of 12.5 percent
over a five-year period, then about 281 (.125 x 2250) new establishment
sorters will need to be trained annually. FSIS projects that the
initial training costs are expected to be about $200 to $600, or an
average of about $400 per employee (sorter), then the additional
training costs will average about $0.11 million (281 x $400), annually.
4. Continuing Education & Training, Annually--for Existing Sorter
Labor--Annual Cost Associated With the Voluntary Component
After the initial training, the establishments will have additional
costs to provide ongoing annual education and training (formalized).
This education and training is for the knowledgeable establishment
staff (sorters) of an average of about 2,250 persons who need to
maintain a sufficiently high correlation of agreement with FSIS on
regulatory compliance for dressing performance standards. The annual
training cost, based on information provided by establishments
participating in the HIMP pilot program, was about $150 to $200 per
sorter, or an average of $175 per sorter, then the total average cost
would be about $0.39 million (2250 x $175), annually.
5. Additional Facilities: Online Carcass and Offline Inspection
Stations, Avian Leukosis Inspection Area, and Underline Troughs
Associated With the Voluntary Component
Under the proposal, all of the poultry establishments participating
in the new poultry slaughter inspection system will need to add capital
investments to install a carcass inspection station except for the
establishments participating in the HIMP pilot.
Establishments operating under SIS, NELS, and NTIS are currently
required to have an underline trough but they will need an additional
new trough at the end of the evisceration line. The 25 establishments
(20 young chicken and 5 turkey) that operate under HIMP will not need
new trough installations under the proposed new rule. This means that
of the 219 establishments projected to adopt the proposed new system,
194 will need installations that will require inspection stations that
will cost about $5,000 to $6,000, or an average of about $5,500, for
most establishments, based on information provided by establishments
participating in the HIMP pilot program. FSIS assumes installations
will require a stainless steel underline trough (or equivalent) that
will cost about $8,000 to $12,000, or an average of about $10,000, for
most establishments, based on information provided by commercial
construction guidelines of costs for purchasing (or constructing) and
installing such systems.
For the carcass inspection station, this cost is for the
construction of a stainless steel elevated stand that has stairs and a
surrounding guardrail. This carcass inspection stand must have a floor
area large enough to allow sufficient space to accommodate the carcass
inspection program person and an establishment employee, that is, a
helper for removal of defective or rejected birds from the line. This
inspection station would contain plumbing for hot and cold water, and a
stainless steel hand-washing basin.
Furthermore, electrical service must be installed for powering
bright lights (200 foot-candles of illumination at the level of the
bird) required for inspection, and control switches must be installed
to allow the starting and stopping of the eviscerating line. The
verification inspection station typically is already in place in most
young chicken and turkey, and other poultry slaughter establishments.
Therefore, in most cases, there would be no additional cost for a
verification inspection station near the end of the eviscerating line.
The verification inspection station is typically a stainless steel
table illuminated with bright lights (200 foot-candles).
These capital investments for the carcass inspection stations are
necessary for each of the about 566 eviscerating lines now installed in
the 194 non-HIMP establishments that will implement the new inspection
system. Therefore, the calculated cost for adding carcass and
verification inspection stations for the 194 establishments is about
$8.8 million (566 x $15,500).
6. Carcass Dressing for Meeting the Definition of Ready-to-Cook (RTC)
Poultry and the Removal of the Finished Product Standards (FPS) Under
the New Inspection System Associated With the Voluntary Component
FSIS is proposing to remove the existing Finished Product Standards
(FPS) and replacing them with a requirement that establishments
maintain documentation to demonstrate that the products resulting from
their slaughter operations meet the definition of ready-to-cook
poultry. Establishments will have the flexibility to design and
implement measures for producing ready-to-cook poultry that are best
suited to their operations. FSIS on-line carcass inspectors will
inspect each carcass for defects that are important for food safety,
such as septicemia and toxemia, as well as for defects that are less
important to food safety but that may render carcasses or parts
unwholesome or adulterated, such as persistent, unattended removable
animal diseases and trim and dressing defects.
FSIS seeks comments on these carcass dressing issues--products
resulting from their slaughter operations would meet the definition of
ready-to-cook poultry. Based on meeting the definition of ready-to-cook
poultry, how many additional birds would go to the salvage and
reprocessing area? How many additional establishment employees would be
added to the eviscerating line to do online trimming and reprocessing?
What are the relationships between salvage and reprocessing activities
(online and offline) and eviscerating line speeds? For example, for
every 20 to 25 percent increase in line speed, would the establishment
require a five percent increase in labor time for extra trimming and
cleaning activities (online and offline)? FSIS also seeks comments on
the requirement that establishments maintain documentation to
demonstrate that the products resulting from their slaughter operations
meet the definition of ready-to-cook poultry.
7. Elimination of Some Line Speed Restrictions--Annual Cost Savings
Associated With the Voluntary Component
Based on information provided by establishments participating in
the HIMP pilot program, establishments will marginally increase their
line speeds given the opportunity to take advantage of the flexibility
provided by the proposal and relocation of inspection program
personnel. This will reduce their dressing costs, as discussed in the
benefits section above. To
[[Page 4442]]
gradually increase line speeds, some establishments will not need to
purchase additional equipment, until they reach their slaughter and
eviscerating-line system capacity limit (i.e., re-hang, chilling, or
cold (chilled and frozen) storage capacity). Some establishments will
need to purchase more automated evisceration and dressing equipment, or
eliminate bottlenecks. Eliminating bottlenecks of production could
include the establishment's additional capital investments (facilities
or equipment) of upgrading the capacity of transfer and re-hang
stations; straightening the run of slaughter and eviscerating lines;
increasing cut-up or deboning capacity; adding chillers or increasing
chilling capacity; or increasing cold (chilled and frozen) storage
capacity.
FSIS solicits information on how the elimination of some line speed
restriction in the proposed rule would affect cost saving per dressed
carcass, such with greater throughput of dressed carcasses and a lower
unit cost per dressed carcass or per pound of product for labor,
materials, water, and energy per bird or per pound of dressed poultry
carcass. FSIS also solicits information on planned investments in the
domestic poultry industry in order to increase evisceration line speed
within the next few years.
The estimated costs and costs savings to establishments from the
voluntary portion of the proposed regulation are summarized in Table
14a. Annualized costs are calculated using a discount rate of 7% over a
ten year planning period.
Table 14a--Estimated Annual Cost (Cost Savings) of the Proposed Rule to
Establishments: Elements Associated With the Voluntary Component of the
Proposed New Rule (Millions of Dollars)
------------------------------------------------------------------------
Recurring
One-time annual
costs costs
------------------------------------------------------------------------
Additional annual sorting labor............... ........... 16.7
Additional knowledge costs (human capital):
Initial one-time training of sorting 0.9 ...........
workers..................................
Training annual sorting labor-turnover ........... 0.11
rate of 12.5%............................
Continuing annual education and training.. ........... 0.39
Additional one-time capital expenditure for 8.8 ...........
inspection stations and underline troughs....
-------------------------
Total costs to establishments from 9.7 17.2
voluntary component..................
-------------------------
Average cost to establishments from voluntary
component.................................... 18.49
------------------------------------------------------------------------
Items 8-13 are costs and cost savings associated with the mandatory
component of the proposed new rule:
8. Sampling and Analysis for Microbial Organisms Pre-Chill and Post-
Chill to monitor Process Control for Enteric Pathogens--One-Time and
Annual Cost Associated With the Mandatory Component
New sampling is required for a one-time baseline and for recurring
microbial testing to monitor process control for enteric pathogens.
Such testing is required as part of the written procedures to prevent
contamination of carcasses and parts by enteric pathogens and fecal
contamination throughout the entire slaughter and dressing operation.
FSIS is proposing that establishments incorporate these procedures into
their HACCP plan, or sanitation SOP, or other prerequisite program, and
that they maintain records sufficient to document the implementation
and monitoring of these procedures.
The baseline sampling would be done in a relatively short period of
time and only sample a few events. Thus it would require less labor for
collection compared to the ongoing sampling that would extend over a
year with multiple sampling events. Therefore, the estimated cost per
sample for the one-time baseline is lower than for the ongoing
sampling. The baseline was calculated by multiplying 150 samples
collected for the baseline by the prorated hourly pay of $29.03 for a
QC technician for 25 minutes needed to collect the samples and a cost
of $33.75 for analytical cost of the samples. This was done for all 289
firms.
For annual costs, the same salary and analytical costs were applied
and multiplied by the estimated number of samples, which was calculated
by assuming 319,332 chicken samples (8.526 billion chickens divided by
26,700 chickens for the number of sampling events) plus 83,929 turkey
samples (251.787 million turkeys divided by 3,000 for sampling events
number) multiplied by a wage rate of $29.03 times 5/60.\25\
---------------------------------------------------------------------------
\25\ Samples are assumed to be collected for every 26,700
chickens and every 3,000 turkeys. The sampling event refers to
sampling at pre-chill and post-chill. This ensures that sampling is
based on volume of output and does not impose unnecessary burdens on
small businesses.
---------------------------------------------------------------------------
FSIS projects this cost for testing samples and collection of the
samples to be about $2.0 million one-time for the baseline and about
$12.6 million annually for the poultry industry.\26\
---------------------------------------------------------------------------
\26\ The baseline sampling has less labor for collection because
it is done in a relatively short period of time (a few sampling
events) versus ongoing sampling that extends over a year with
multiple sampling events. Therefore, the cost per sample for the
one-time baseline is lower than for the ongoing sampling. The
baseline was calculated by multiplying 150 samples collected for the
baseline by the prorated hourly pay of $29.03 for a QC technician
for 25 minutes needed to collect the samples and a cost of $33.75
for analytical cost of the samples. This was done for all 289 firms.
For annual costs, the same salary and analytical costs applied and
were multiplied by the estimated number of samples assuming 1 for
each 26,700 chickens and 3,000 turkeys.
---------------------------------------------------------------------------
Furthermore, FSIS expects costs for the ``ready-to-cook'' proposed
requirements would be offset by the present costs to industry for the
Finished Product Standards, and that additional cost, if any, to
industry would be minimal. Thus FSIS did not include costs associated
with the requirement.
9. Additional Labor Due to Increased Line Speed Associated With the
Mandatory Component
Young chicken and turkey, and other poultry slaughter
establishments that can increase line speed with their existing
eviscerating line equipment, would probably also need to add additional
labor to the line in order to handle the additional birds per minute
that need to be sorted and trimmed, salvaged, or reprocessed, online
and offline. In this scenario, the establishment does not replace its
existing eviscerating line equipment with newer technology. More labor
is applied to the line but the labor per bird would decrease due to the
increase in
[[Page 4443]]
throughput from the increase in the line speed.
FSIS solicits information on the additional labor that might be
needed.
10. Additional Recordkeeping, Monitoring, and Record Storage Associated
With the Mandatory Component
Establishments are required to maintain written documentation of
sample results for verifying their process controls. The proposal that
all poultry slaughter establishments monitor their systems through
microbial testing and recordkeeping implies more information than
presently required to be monitored. Thus, FSIS includes only recurring
costs associated with record keeping. FSIS assumed that the time spent
for a QC technician salaried at $29.03 per hour for recording results
keeping (including review) for each sample event is 5 minutes. FSIS
estimates the time spent presently is about 2.5 minutes. From these,
FSIS estimated recordkeeping costs for this proposed requirement to be
$975,600 per year, based on an assumption of 5 minutes to record each
of the over 403,300 samples \27\ under the new system. This replaces
$568,500 for recordkeeping for the generic E. coli testing, based on an
estimate of 2.5 minutes per sample for recording. Since FSIS does not
specify required testing frequencies, establishments may test with
lower frequency than the one assumed and would therefore have lower
costs. FSIS does not dictate the frequency of testing that is assumed
in the cost estimates. A lower frequency would result in lower costs.
---------------------------------------------------------------------------
\27\ Calculated by assuming 319,332 chicken samples (8.526
billion chickens divided by 26,700 chickens for the number of
sampling events) plus 83,929 turkey samples (251.787 million turkeys
divided by 3,000 for sampling events number) multiplied by a wage
rate of $29.03 times 5/60. For eliminated E. coli recordkeeping,
470,000 samples were recorded in 2.5 minutes at $29.03 per hour.
---------------------------------------------------------------------------
11. a. Modification of the HACCP Plans and Process Control Plans--One-
Time Cost Associated With the Mandatory Component
The establishments would need to modify their HACCP plans,
Sanitation SOPs, or other Pre-requisite programs so as to address
septicemic and toxemic carcasses and food safety hazards that are
reasonably likely to occur. Establishments would also be required to
maintain records to document that their product meet the definition for
ready-to-cook poultry. Under the proposed rule, establishments will
have the flexibility to design and implement measures to address OCP
defects that are best suited to their operations. They will also be
responsible for determining the type of records that will best document
that they are meeting the ready-to-cook poultry definition. The FSIS
estimates based on information provided by establishments participating
in the HIMP pilot program, that these initial costs (for developing and
verifying the plan) would average about $5,000 for a HACCP small and
about $9,000 for a HACCP large establishment; and FSIS projected about
$2,000 for a HACCP very small establishment for process control
implementation costs in response to the requirements for the new
inspection system in the first year; or a one-time average cost of
about $1.9 million ((83 x $5000) + (151 x $9000) + (55 x $2000)) in
total for 289 establishments.
11. b. Written Procedures To Ensure That Carcasses and Parts With
Visible Fecal Contamination Do Not Enter the Chiller, After
Evisceration Operations Associated With the Mandatory Component
FSIS is proposing that all of the 289 federally inspected
establishments that slaughtered poultry other than ratites in 2010
develop, implement, and maintain, as part of their HACCP plans, or
sanitation SOPs, or other prerequisite programs, written procedures to
ensure that carcasses and parts with visible fecal contamination do not
enter the chiller, after evisceration operations. The one-time cost to
develop the plan and ongoing cost of implementation and maintenance of
the plan are included in the costs of changing the HACCP system as
discussed in cost item number 5 above. FSIS solicits information on
added costs that are associated with the proposed requirement for
written procedures, and then the implementation and maintenance costs
of the procedures to ensure that carcasses and parts with visible fecal
contamination do not enter the chiller, after evisceration operations.
11. c. Written Procedures To Ensure That Young Chicken and Turkey
Carcasses Contaminated With Septicemic and Toxemic Conditions Do Not
Enter the Chilling Tank, for the New Inspection System Associated With
the Mandatory Component
FSIS is proposing that the 219 federally inspected establishments
that would slaughter young chickens and turkeys under the new
inspection system develop, implement, and maintain written procedures
to ensure that poultry carcasses contaminated with septicemic and
toxemic conditions do not enter the chilling tank. Establishments must
incorporate these procedures into their HACCP plans, or sanitation
SOPs, or other prerequisite programs. The one-time cost to develop the
plan and ongoing cost of implementation and maintenance of the plan are
included in the costs of changing the HACCP system as discussed in cost
item number 5 above. FSIS solicits information on added costs that are
associated with this proposed requirement.
12. Elimination of Generic E. Coli Standards--Annual Cost Savings
Associated With the Mandatory Component
FSIS proposes the removal of the current requirement that poultry
establishments test for generic E. coli and to remove the codified
Salmonella pathogen reduction performance standards for poultry. For
the poultry industry, this would mean about 77,000 fewer samples
collected and tested for generic E. coli. FSIS projects that this
action would affect about 289 official federally inspected
establishments that slaughter all poultry other than ratites. FSIS
projects that this would have a cost savings of approximately $11.71
million per year for the 289 official federally inspected
establishments that slaughter all poultry other than ratites. This is
the cost saving of labor for sampling event collection; materials;
shipping; and laboratory testing from eliminating about 470,000 E. coli
samples and testing. The estimated cost per sampling avoided is about
$57.10 per sampling event. For 470,000 sampling events at $30, the
annual total would be about $11.71 million.
13. Elimination of Carcass Cooling Standards--Possible Cost Savings
Associated With the Mandatory Component
FSIS projects that the proposed elimination of carcass cooling
standards will remove some of the ``bottleneck'' restrictions of the
chilling system. FSIS projects that the birds may take less time to
cool to meet this new requirement of no microbial growth. FSIS projects
that the establishments will be able to increase the output from the
chiller in order to accommodate increased line speed. FSIS solicits
information on any added costs and any cost saving associated with the
proposed elimination of carcass cooling standards.
Table 14b shows the considered additional one-time, first-year, and
annual average expenditures for the proposed rule for the 289 affected
poultry establishments of complying with the mandatory actions of the
[[Page 4444]]
proposal. Again, annualized costs are calculated using a discount rate
of 7% over a ten year planning period.
Table 14b--Estimated Annual Cost (Cost Savings) of the Proposed Rule to
Establishments: Elements Associated With the Mandatory Component of the
Proposed New Rule (Millions of Dollars)
------------------------------------------------------------------------
Recurring
One-time annual
costs costs
------------------------------------------------------------------------
Additional PC microbial testing--plate counts, ........... ...........
collection, packaging, shipping
One-time baseline......................... 2 ...........
Annual recurring testing.................. ........... 12.6
Additional annual recordkeeping, monitoring, ........... 0.98
and record storage...........................
Eliminated generic E. coli testing ........... -0.57
recordkeeping................................
Additional one-time HACCP system plans 1.9 ...........
(additions and modifications) and
ProcessControl (PC) plan development.........
Reduced annual microbial testing--generic E. ........... -11.7
coli plate counts, collection, packaging, and
shipping.....................................
-------------------------
Total costs to establishments from 3.9 1.3
mandatory component..................
-------------------------
Average costs to establishments from mandatory
component.................................... 1.82
------------------------------------------------------------------------
For the poultry industry, as shown in Tables 14a and 14b, the one-
time costs are about $13.6 million, consisting of $9.7 million in one-
time costs incurred by the establishments that adopt the proposed new
inspection system and $3.9 million in one-time costs for all firms in
the industry with the requirements of the proposed new rule. The on-
going annual average net expenditure to the poultry industry would be
about $18.5 million, with $17.2 million from adopting the proposed new
rule and $1.3 million in costs for all firms with this proposed rule.
These cost figures annualize to $20.3 million over 10 years at 7%. In
addition, however, FSIS projects a cost savings for the poultry
industry. FSIS projects that the dressing costs per bird will be
lowered for about 99.9 percent of the RTC young chicken and turkey
production of the poultry industry. FSIS projects a net cost savings
with the proposed regulation of about $258.9 million annually for
companies that slaughter poultry (see Table 16 below). The initial one-
time expenditure and on-going annual expenditures are more than offset
by these savings due to the increased line speed. These net savings are
included in the expected benefits.
The proposed new rule will have mandatory costs for all firms,
whether they adopt the proposed new rule or go to the revised
traditional inspection system. FSIS expects the 51 very small
establishments that slaughter young chicken and turkey to adopt the
revised traditional inspection system instead of the proposed rule yet
still incur the mandatory costs listed in Table 14b. To assess the
impact on these very small establishments, Table 14c lists these
estimated mandatory costs.
As mentioned, the baseline was calculated by multiplying 150
samples collected for the baseline by the prorated hourly pay of $29.03
for a QC technician for 25 minutes needed to collect the samples and a
cost of $33.75 for analytical cost of the samples for all 289
establishments. This comes to about $6,900 per firm and $351,000 for
the 51 very small establishments. For annual recurring costs, the same
salary and analytical costs applied and were multiplied by the
estimated number of samples, as before, and adjusted for volume so that
the cost of annual recurring testing for very small establishments is
0.1 percent of the cost for recurring testing in Table 14b. For annual
recording and storage, the samples are based on volume and this is
adjusted to 0.1 percent of the costs in Table 14b, or about $1,000
annually, to be balanced by the savings from eliminated generic E. coli
testing recordkeeping of 0.1 percent of the estimated $568,500
annually. The cost of the additions and modifications to the HACCP
plans and the process control (PC) plan development are estimated at
$2,000 per very small establishment, for a total cost of $102,000 for
the 51 very small establishments. The cost savings for very small
establishments from reduced annual microbial testing is volume-based
and is 0.1 percent of the $11.7 million in annual savings to the
industry.
Table 14c--Estimated Annual Cost (Cost Savings) of the Proposed Rule to
Very Small Establishments: Elements Associated With the Mandatory
Component of the Proposed New Rule (Millions)
------------------------------------------------------------------------
Recurring
One-time annual
costs costs
------------------------------------------------------------------------
Additional PC microbial testing--plate counts,
collection, packaging, shipping:
One-time baseline......................... 0.351
Annual recurring testing.................. ........... 0.013
Additional annual recordkeeping, monitoring, ........... 0.001
and record storage...........................
Eliminated generic E. coli testing ........... -0.001
recordkeeping................................
Additional one-time HACCP system plans 0.102
(additions and modifications) and
ProcessControl (PC) plan development.........
Reduced annual microbial testing--generic E. ........... -0.012
coli plate counts, collection, packaging, and
shipping.....................................
-------------------------
Total costs to establishments from 0.453 0.001
mandatory component..................
-------------------------
Average costs to very small establishments
from mandatory component..................... 0.061
------------------------------------------------------------------------
[[Page 4445]]
These costs are estimated at about $0.453 million in one-time costs
and about $0.001 million for annual costs. This is over $8900 per very
small establishment in one-time costs, primarily for establishing the
baseline testing required for all firms under the proposed rule, and
very low costs per very small establishment in annual costs. These
costs are based on the mandatory elements of the proposed new rule that
apply to all establishments that slaughter young chicken and turkey,
whether they adopt the proposed new rule or move to the revised
traditional system of inspection. These estimates include the reduction
in costs from the elimination of the generic E. coli testing. The
annualized costs of these requirements for very small establishments
are $0.061 million, or about $1,200 per establishment for the 51 very
small establishments. This represents an average annual cost per bird
of less than 0.9 cents (and less than 0.25 cents per pound), based on
the assumption that very small establishments slaughter one-tenth of
one percent of the nearly 9 billion birds slaughtered annually.
These costs are estimated at about $0.45 million in one-time costs
and about $0.02 million for annual costs. This is over $8800 per very
small establishment in one-time costs, primarily for establishing the
baseline testing required for all firms under the proposed rule, and
about $400 per very small establishment in annual costs. These costs
are based on the mandatory elements of the proposed new rule that apply
to all establishments that slaughter young chicken and turkey, whether
they adopt the proposed new rule or move to the revised traditional
system of inspection. These estimates include the reduction in costs
from the elimination of the generic E. coli testing. The annualized
costs of these requirements for very small establishments are $0.08
million, or about $1,600 per establishment for the 51 very small
establishments. This represents an average annual cost per bird of less
than 0.9 cents (and less than 0.25 cents per pound), based on the
assumption that very small establishments slaughter one-tenth of one
percent of the nearly 9 billion birds slaughtered annually.
Expected FSIS Budgetary Effects:
Table 15 shows the expected FSIS budgetary net savings effects from
the proposed rule for the slaughter of all poultry other than ratites
and including the new inspection system for the slaughter of young
chickens and turkeys.
FSIS used the following scenario assumptions in its financial cost
model to project the FSIS budgetary effects of the proposed rule:
175 establishments (150 young chicken establishments and
25 turkey establishments)
1,498 food inspector grade increases (from GS7 to GS8)
(1,436 inspectors in young chicken establishments and 62 inspectors in
turkey establishments)
375 CSI (Consumer Safety Inspector) upgrades (from GS8 to
GS9) (354 in young chicken establishments and 21 in turkey
establishments)
A reduction in the number of inspector positions (between
approximately 500 and 800) through managing vacancy or refill rates, a
reduction of approximately 190 positions will be affected in the
following way:
[cir] Of the 190 positions, 100 will be relocated to livestock
slaughter establishments
[cir] 90 inspectors will be relocated to jobs in the Agency for
which their skills and experience qualify them.
A reduction of approximately 140 SCSI (Slaughter Consumer
Safety Inspector) positions--potentially all of the personnel involved
to be relocated
150 fewer OTP staff years required for relief--no
severance or relocation impact
Training costs for approximately 3,300 employees
Relocation costs for approximately 350 CSI employees
Travel savings with fewer number of relief inspectors
FSIS projects that the 25 young chicken and turkey establishments
currently under HIMP inspections would switch to the new inspection
system. The equipment used in the HIMP, as well as in the other current
non-traditional inspection systems, can be used in the proposed new
inspection system. Furthermore, FSIS projects that about 19 other
poultry establishments may enter the program under the SIP waiver. FSIS
projects that these establishments will choose to make the capital and
labor investment, when they see that their economic competitiveness may
diminish. FSIS did not include the impact from these additional
establishments in the financial cost model of Table 15 that projects
the FSIS budgetary effects of the proposed rule because we expect it to
be very small. Establishments that change operations but continue to
produce will continue to have FSIS inspectors.
---------------------------------------------------------------------------
\28\ First year cost savings are lower than for the following
years because the rule will not be in effect for the full first
year.
Table 15--Estimated Annual Cost (Cost Savings) of the Proposed Rule to
FSIS: Elements Associated With the Voluntary Component of the Proposed
New Rule (Millions of Dollars)
------------------------------------------------------------------------
Recurring
First year costs (cost
costs (cost savings)
savings) 28 after first
year
------------------------------------------------------------------------
Cost from Grade Increases (Salary & Benefits). $5.1 $8.26
Training Costs................................ 4.78 0
Relocation Costs.............................. 3.79 0
Savings From Position Elimination............. (26.4) (47.62)
Savings from reduced Relief Inspector Travel.. (.14) (.22)
-------------------------
Total Costs (Savings)..................... (12.9) (39.58)
------------------------------------------------------------------------
The expected FSIS budgetary savings effects are cost savings to the
FSIS related to position elimination of about $47.6 million, after the
first year of implementation. Furthermore, FSIS projects cost savings
annually from
[[Page 4446]]
expected reduction in travel expenses for relief IPP. FSIS projected
total Relief Inspector travel savings of about $223,000, after the
first year of implementation. FSIS, however, projects an annual cost
increase for the FSIS IPP upgrade increases from GS-7 to GS-8 and GS-8
to GS-9 that would total about $8.3 million, after the first year of
implementation. In addition, FSIS projects a one-time training cost for
the FSIS IPP that would total about $4.8 million, and a one-time
relocation cost for the FSIS IPP that would total about $3.8 million,
in the first year of implementation.
Furthermore, possible IPP health improvement effects are expected
to be associated with lower recruitment costs, lower medical and worker
compensation costs, and fewer unscheduled leaves.
In summary, budgetary benefits in cost savings will accrue to FSIS
from the more effective utilization of its inspection program personnel
(IPP) to focus on activities that affect food safety. Based on FSIS
projections of its budget cost-savings analysis, the expected benefit
to FSIS would be the net savings of about $14.6 million, in the first
full year of implementation in FY 2013. Then, in subsequent years, the
projected net savings would average about $39.6 million.
Summary of Net Social Benefits
Considering the social benefits and costs discussed, FSIS expects
the average net benefits to the public health, the poultry industry and
consumers is about $377.7 million annually. The costs outlined in Table
16 below are annualized over 10 years at 7% to $20.3 million. Annual
net benefits, therefore are $357.4 million.
Table 16--Expected Net Social Benefits From the Proposed Rule (Millions
of Dollars) Starting With the First Full Year of Implementation
------------------------------------------------------------------------
Primary Minimum Maximum
estimate estimate estimate
------------------------------------------------------------------------
Benefits:
Annual public health benefits 79.2 27.3 144.2
Annual FSIS net savings...... 39.6 ........... ...........
Annual cost savings for 258.9 ........... ...........
establishments *............
--------------------------------------
Annual total benefits.... 377.7 325.8 442.7
--------------------------------------
Unquantified benefits............ Additional public health benefits
from documentation and testing
--------------------------------------
Costs:
Annual cost to establishments 20.3 ........... ...........
--------------------------------------
Annual net benefits.......... 357.4 305.5 422.4
------------------------------------------------------------------------
Note: These cost savings will not all be enjoyed by the establishments.
A portion of these savings will be passed on to consumers in the form
of lower prices.
Analysis of Considered Alternatives
FSIS considered several alternatives to the proposed rule. Table 17
summarizes these alternatives and presents the annual net benefits
associated with each alternative.
A. Taking No Action
FSIS considered maintaining the current inspection system and
finished product standards requirements for the 289 establishments that
slaughtered young chickens and turkeys, and other poultry in 2010. That
is, FSIS considered taking no action. Consequently, poultry
establishments slaughtering young chickens and turkeys, and other
poultry would not benefit from increased flexibility, productivity, or
opportunity for innovation. FSIS would not be able to focus its
inspection activities on verification of process controls for product
safety and OCPs or on additional offline activities (such as
unscheduled sanitary procedures, for example). Under this alternative,
establishments would be restricted to the current regulated
eviscerating line speeds that in most cases are operated below the
capability of their currently installed eviscerating equipment. This
action will have zero net benefits.
Table 17--Comparisons of the Considered Alternatives to the Proposed Poultry Slaughter Rule
----------------------------------------------------------------------------------------------------------------
Considered alternatives Benefits Costs Net benefits
----------------------------------------------------------------------------------------------------------------
A. Take No Action.................... No change in the Establishments would be Zero Net Benefits.
existing inspection restricted to the
systems for poultry. current regulated
FSIS does not need eviscerating line
significantly more speeds that in most
resources. cases are operated
below the capability
of their currently
installed eviscerating
equipment.
B. Intensifying the Present Annual benefits of $32.76 million per year Annual net benefits of
Inspection Systems by Allocating about $258.9 million for FSIS to add extra $225.0 million.
Additional FSIS Resources to from reducing dressing inspectors. FSIS
Eliminate FSIS Inspection Personnel costs. resources are limited
(IPP) Vacancies. for expansion of its
workforce and these
costs may be
prohibitive.
[[Page 4447]]
C. Mandatory Use of Dressing About $259.2 million Annualized costs of This alternative would
Performance Standards and the New from reducing dressing $20.4 million, of have net benefits
Poultry Inspection System for All costs added to public which about $0.06 equal to $357.6
Establishments that Slaughter Young health benefits and million annually borne million.
Chickens and Turkeys. reduced FSIS costs for by very small
total benefits of establishments under
$378.0 million this alternative.
annually.
D. The Proposed Rule: the Requirement Public health benefits Annualized costs equal Selected Alternative
of a New Inspection System for Young from reduced $20.3 million. See Annual net benefits
Chickens and Turkeys; a Revised illnesses, reduced Tables 14a and 14b equal $357.4 million,
Traditional Inspection System for dressing costs, and below for explanation from $377.7 million in
All Poultry other than Ratites; FSIS savings add to of these costs. benefits less the
Requirement of Three Locations for total benefits of costs to industry of
Sampling to monitor process control $377.7 million $20.3 million.
for enteric pathogens; and other annually. Additional
Actions (see Table 8 above).. unquantified public
health benefits from
the mandatory
component of the
proposed rule.
E. Voluntary component only.......... $377.7 million in Annualized costs of $359.2 million
benefits. No $18.5 million. annually.
additional
unquantified benefits,
as detailed in section
titled ``other public
health benefits
resulting from the
mandatory component of
the proposed rule.''
----------------------------------------------------------------------------------------------------------------
B. Intensifying the Present Inspection Systems by Allocating Additional
FSIS Resources To Allow Establishments To Increase the Line Speed and
Maintain the Same Level of Food Safety
FSIS considered intensifying the present inspection system by
allocating additional FSIS resources to accommodate the demand of the
industry for additional IPP on high-speed evisceration systems that the
poultry industry is adopting in order to produce safe poultry products
and reduce dressing costs per bird. Annual benefits of this alternative
equal approximately $258.9 million from reducing dressing costs by 3
cents per bird for 99.9 percent of 8.64 billion birds slaughtered
annually. No additional public health benefits result from this
alternative because FSIS staff will not be doing additional offline
inspection activities.
This alternative does not change the existing inspection system, no
additional training is needed for FSIS or establishment staff. This
alternative, however, requires an extra FSIS inspector at each of the
573 high-speed non-HIMP chicken and turkey line shifts at $57,153 year
for $32.76 million in annual costs. Resource constraints would not
allow for this option. These additional costs (to FSIS) will not be
offset by increased safety as the newly hired inspectors will not be
performing additional offline tasks. This alternative has net benefits
of $225.0 million.
C. Requiring Mandatory Use of Dressing Performance Standards and the
New Poultry Inspection System for All Establishments That Slaughter
Young Chickens and Turkeys
FSIS considered proposing the mandatory use of dressing performance
standards and a New Poultry Inspection System in all federally
inspected establishments that slaughter young chickens and turkeys.
This alternative is the same as the proposed regulation except that
this alternative would be mandatory for the young chicken and turkey
industry, while the proposed regulation s a choice between the new
inspection system and the revised traditional inspection system. This
alternative would result in a replacement of existing choices among
other (traditional, SIS, NELS, and NTIS) types of inspection systems
within the RTC young chicken and turkey industry. For the projected 270
federally inspected establishments that would slaughter young chickens
and turkeys under the new inspection system, this alternative has the
costs to the poultry industry of replacing online FSIS IPP with trained
establishment personnel for sorting birds. As a result, the poultry
industry annual labor costs and labor training costs would be higher
due to the extra labor and training necessary to take over the sorting
and to maintain personnel proficiency in the sorting of young chickens
and turkeys, in the establishments that would not voluntarily choose
the new inspection system. These establishments are the very small
establishments that do not have large enough volume to make up for the
additional costs imposed by this proposed rule.
This alternative has total annual benefits of 378.0 million. This
includes benefits of $259.2 million from reducing costs by 3 cents per
bird for 100 percent of the 8.64 billion birds slaughtered annually,
and public health benefits of about $79.19 million, and FSIS budget
savings, which may exceed the estimate of $39.6 million as
establishment personnel replace FSIS inspectors. These benefits are
slightly higher than those of the proposed alternative because this
alternative covers 100 percent of plants and production. Costs to very
small establishments are $0.453 million in initial one-time costs and
$0.001 million in annual costs, primarily for underline troughs for
one-time costs and additional sorter labor and training for ongoing
costs. Annualizing the one-time costs for 10 years at 7 percent brings
the annualized cost to $0.061 million. These costs for very small
establishments are in addition to the $20.3 million annually calculated
for the other establishments, bringing the annual cost of the
alternative to $20.4 million. The net benefits of this alternative
equal $357.6 million annually.
[[Page 4448]]
D. The Proposed Rule: the Requirement of a New Inspection System for
Young Chickens and Turkeys; a Revised Traditional Inspection System for
All Poultry Other Than Ratites; Requirement That All Poultry Slaughter
Establishments Develop, Implement, and Maintain Written Procedures To
Prevent Contamination of Carcasses and Parts by Enteric Pathogens and
Fecal Material Throughout the Entire Slaughter and Dressing Process;
Requirement That Procedures To Prevent Contamination Include Three
Locations for Sampling To Monitor Process Control for Enteric
Pathogens; and Other Actions (See Table 8 Above)
FSIS's preferred alternative is the proposed rule as discussed
above. The Proposed Rule has the requirement of a new inspection system
for young chickens and turkeys; a revised traditional inspection system
for all poultry other than ratites; requirement that establishments
develop, implement, and maintain written procedures to prevent
contamination of carcasses with enteric pathogens and fecal material
contamination, and that these procedures include, at a minimum, three
locations for sampling for microbial organisms to monitor process
control for enteric pathogens; and other actions (see Table 8).
The proposed rule gives the individual establishment the choice
between the new inspection system and the revised tradition inspected
system. An establishment will choose the new inspection system if the
benefits, primarily from the expected increased flexibility of
operations and lower dressing costs per RTC bird, exceeds the costs of
implementation of this proposed new inspection system. While this would
probably be true for the HACCP large and HACCP small establishments
that slaughtered young chickens and turkeys in 2010, the HACCP very
small establishments would find that the initial capital investment in
additional facilities and equipment, additional labor for sorting and
training sorters costs, and other additional annual costs for
maintaining the additional facilities and equipment would not lower
their average cost of dressing a RTC bird. FSIS rejected this
alternative (alternative C above) in order to minimize the impact on
small businesses and to allow them the flexibility to choose the
proposed revised traditional inspection system, if they stand to lose
from the proposed new slaughter inspection system.
Public health benefits (discussed in detail in the next section) of
the proposed rule include a reduction in illnesses attributed to young
chicken and turkey. The monetized value of this reduction is $79.19
million annually. Industry cost reductions from the proposed rule are
about $258.9 million annually from reducing dressing costs by 3 cents
per bird for 99.9 percent of 8.64 billion birds. FSIS savings under the
proposed rule are expected to equal $39.58 million annually, bringing
total benefits to $377.7 million annually.
Costs of the proposed rule include a one-time expenditure of about
$13.6 million and net variable expenditures of $18.5 million annually
(see Tables 14a and b). Annualizing the costs at 7 percent for 10 years
brings the annual cost total to $20.3 million. Net benefits of the
proposed rule are $357.4 million annually.
While Alternative C, mandating uniform standards for all
establishments, provides net benefits greater in value to the net
benefits of the proposed rule, in the interest of regulatory
flexibility requirements for small businesses, FSIS proposes in the
preferred alternative to make compliance with the proposed new system
voluntary. Not adopting the system under the proposed rule will not
disadvantage very small establishments that have niche markets and
local markets because the expected market price reduction from the
proposed rule is 0.6 to 1 cent per bird which, for an average bird
weight of 3.94 lbs., means a price reduction of around 0.15 to 0.25
cents per pound. Evidence of a willingness of consumers to pay a
premium for the local food products exists,\29\ suggesting that this
reduction in price for the output of the firms that adopt the proposed
new rule is not expected to disadvantage these establishments that
slaughter for local, niche markets.
---------------------------------------------------------------------------
\29\ Martinez, Steve et al., Local Food Systems: Concepts,
Impacts, and Issues, ERR 97, U.S. Department of Agriculture,
Economic Research Service, May 2010, discusses consumers'
willingness to pay a price premium (p. 29) for such characteristics
as traceabililty (p. 26) offered by local producers.
---------------------------------------------------------------------------
E. Requiring Only the Voluntary Component of the Proposed Rule
The benefits from this alternative include, as under the proposed
rule, the budgetary savings to FSIS from reallocation of personnel and
the lower costs per bird from the increased line speeds and public
health benefits of $79.19 million annually from reduced illnesses.
As shown in Table 14a, the costs to firms that adopt the proposed
new rule are $9.7 million in one-time costs and $17.2 million in annual
costs. These costs annualize to $18.5 million over 10 years at 7%.
This alternative eliminates the mandatory costs to all firms,
whether they adopt the proposed new inspection system or not, under the
proposed rule. Under the proposed rule, all firms, including the very
small firms that FSIS expects will not adopt the proposed rule, must
adopt some measures, as listed in Table 14b. These costs are from plan
development, recordkeeping, and testing. The benefits \30\ of these
activities include the conduct of business in a manner more accountable
to the public; the support and document of production safety decision-
making; and the facilitation of oversight and transparency activities
like audits and inspections. The proposed recordkeeping requirements
are designed to help operators of facilities and the Agency to identify
potential sources of contamination and contain and mitigate the adverse
health effects of contaminated food. While many of these benefits are
social and not captured by the firms, the lower probability of recall,
the lower costs of indentifying contaminated product if a recall
occurs, and enhanced product reputation when a product is not subject
to recall, all benefit the implementing firms. Table 14c lists the
mandatory costs that FSIS expects for the 51 very small establishments
that FSIS projects will not adopt the proposed new inspection system.
---------------------------------------------------------------------------
\30\ Please see the FDA's preliminary regulatory impact analysis
of the Preventive Controls rule for a similar discussion of
recordkeeping benefits.
---------------------------------------------------------------------------
With annual benefits estimated at $377.7 million and costs at $18.5
million, the annual net benefits of this alternative are $359.2
million. FSIS did not select this alternative even though it has higher
quantified net benefits (compared to the proposed rule) because the net
benefits of the proposed rule are expected to be higher due to
additional benefits (disc used in section titled ``Other public health
benefits resulting from the mandatory component of the proposed
rule''). from the voluntary component of the proposed rule.
VI. Initial Regulatory Flexibility Analysis
In accordance with the Regulatory Flexibility Act, FSIS reviewed
the proposed rule for its effects on small businesses. The
Administrator has determined that, for the purposes of the Regulatory
Flexibility Act (5 U.S.C. 601-612); this proposed rule would not have a
significant economic impact on a substantial number of small companies
or small entities.
[[Page 4449]]
FSIS considered proposing the mandatory use of dressing performance
standards and the New Poultry Inspection System in all federally
inspected establishments that slaughter young chickens and turkeys.
(See Table 17 for a list of all alternatives considered.) This
alternative is the same as the proposed rule except that this
alternative would make the new inspection system mandatory for the
young chicken and turkey industry, while the proposed rule is a choice
between the new inspection system and the revised traditional
inspection system.
This alternative would result in a replacement of existing choices
among other (traditional, SIS, NELS, and NTIS) types of inspection
systems within the RTC young chicken and turkey industry. The poultry
industry would not have a choice between the proposed new inspection
system and the revised traditional inspection system for establishments
that slaughter the young chickens and turkeys.
The preferred alternative (the proposed rule) has the choice that
is given to the individual establishment to determine if it is
beneficial for the establishment to choose the new inspection system
(if the expected increased flexibility of operations and lower dressing
costs per RTC bird results in benefits that would exceed the costs of
implementation of this inspection system).
While this would probably be true for the HACCP large and HACCP
small establishments that slaughtered young chickens and turkeys in
2010, and the HACCP very small establishments could find that the
initial capital investment in additional facilities and equipment,
additional labor for sorting and training sorters costs, and other
additional annual costs for maintaining the additional facilities and
equipment a burdensome change. FSIS expects dressing costs to decrease
by about $2.6 million for very small establishments with the proposed
new inspection system while expenditures would increase by an
annualized amount of $0.28 million for 10 years at 7% to comply with
the system. These costs are already in addition to those outlined in
Table 14c, which annualize to $0.13 million at 7% over 10 years.
This alternative of mandatory adoption by all establishments was
not selected because of its expected economic burden on small
businesses and to allow small producers the flexibility to choose the
proposed revised traditional inspection system, if they stand to lose
from the proposed new slaughter inspection system.
Expected Effects on Small Entities or Small Companies
There are economies of size and scale with the evisceration and
dressing of young chickens and turkeys.\31\ A possible result of these
economies of size and scale is that there are only about 54 HACCP very
small establishments owned by 54 small companies under Federal
Inspection that slaughter poultry. These very small companies
slaughtered only about one-tenth of one percent of the young chickens,
turkeys, and other poultry slaughtered, in 2010 (ADRS, 2010). Further,
about 34, or about 63 percent, of these 54 very small companies
slaughtered other livestock such as cattle, calves, swine, sheep, and
goats, in 2010, according to FSIS's ADRS. These 34 companies often
operate seasonally for slaughtering poultry, yet slaughter livestock
during the entire year.
---------------------------------------------------------------------------
\31\ Ollinger, M., J. MacDonald & M. Madison, Structural Change
in U.S. Chicken and Turkey Slaughter. USDA Economic Research
Service, Agricultural Economics Report 787. 2000.
---------------------------------------------------------------------------
The proposed rule is expected to result in a cost reduction of
about 3 cents per bird and a reduction of the price of poultry of about
0.6 to 1 cent per bird (or about 0.15 to 0.25 cents per pound) for
those establishments that choose to operate under the new poultry
inspections system. All of the very small establishments that slaughter
poultry are expected to choose to operate under the revised traditional
inspection system rather than the New Poultry Inspection System.
However, the reduction in price per bird for establishments operating
under the proposed new rule is not expected to impose a burden on very
small establishments because they generally slaughter birds that are
sold in local, niche markets, where consumers have shown a willingness
to pay more for a food product that is of local origin.\32\ An ability
to charge a higher price for product differentiation based on origin
enables the very small establishments to compete in the market even
with the cost advantage that other producers will have with the
proposed new rule.
---------------------------------------------------------------------------
\32\ Please see Martinez, Steve et al., Local Food Systems:
Concepts, Impacts, and Issues, ERR 97, U.S. Department of
Agriculture, Economic Research Service, May 2010 for a discussion of
consumers' willingness to pay a price premium (p. 29) for such
characteristics as traceability (p. 26, p. 70) offered by local
producers.
---------------------------------------------------------------------------
Under the proposed rule, the mandatory costs on very small
establishments (shown in Table 14c) annualize at 7% over 10 years to
$0.130 million, or about $2,500 per establishment. With the assumption
that very small establishments account for one-tenth of one percent of
the total number of the nearly 9 billion birds slaughtered annually,
the annualized costs of the mandatory portion of the proposed rule
amount to less than 1.5 cents per bird or less than 0.4 cents per
pound.
There are about 109 small companies that slaughter small quantities
of federally inspected poultry. FSIS expects that none of the very
small companies would choose to participate in the new inspection
system for the slaughter of young chickens and turkeys because of the
one-time set-up costs associated with the new system, but would
slaughter young chickens, turkeys, and other poultry under the revised
traditional inspection system. The revised traditional inspection
system is designed to minimize costs on these small entities while
preserving the social benefits from testing and recordkeeping. Using
the estimated cost per very small establishment from the Table 14c
figures, the annual burden to small entities that do not adopt the rule
because the additional fixed costs required by the rule is $1,500. With
an estimated cost of establishment labor of $13.95 per hours, this
represents about 100 staff hours annually. The return for this
expenditure is the benefits from better testing and recordkeeping, such
as greater ability to fulfill mandatory oversight requirements, which
cost an unspecified number of staff-hours under the current inspection
system, and lower insurance premiums. FSIS believes that a Regulatory
Flexibility analysis would not be necessary to evaluate the effects of
the proposal on small companies. In making this determination, the
Agency considered alternatives (see table 17) to the proposed rule,
including one alternative rejected for its small business impact:
Taking no action, intensifying the current system, mandatory standards
for all firms that slaughter young chickens and turkeys, and the
voluntary component only. Taking no action would prevent the increased
utilization of capacity by firms that FSIS expects to voluntarily
choose the proposed new system. For this reason, FSIS rejected this
alternative. The second alternative was to intensify the present system
but this would require more FSIS resources and was therefore not
feasible. FSIS rejected the third option of mandatory requirements for
all firms that slaughter young chickens and turkeys because of the
burden that this alternative would place on small establishments. The
last option of the voluntary component of the proposed new rule only
(as shown
[[Page 4450]]
in Table 14a) would eliminate the public health benefits of the
mandatory requirements.
Public health safeguards are a cost of entering commerce and FSIS
believes that product differentiation, based on the growing preference
for local produce, will enable very small establishments to effectively
compete for market share against the larger firms that will enjoy the
cost reduction from the proposed new rule.
FSIS assumes that some of the small companies may choose the new
inspection system under the proposed rule. With this choice, these
small businesses will incur the costs associated with the rule,
including the documentation requirements for HACCP systems and
sanitation SOPs. These documentation requirements represent fixed costs
that small establishments will allocate to fewer sales units when
compared to the number of sales units available for the same purpose
for large establishments. With the choice of the revised traditional
system, however, FSIS believes that small firms that adopt the new
system under the proposed rule will do so only when estimates of the
benefits exceed the costs, meaning that small companies that adopt the
new system will expect net benefits.
The proposed PSR limits the number of on-line inspectors for the
revised traditions inspection system to two. However, plants that are
currently operating with more than two on-line inspectors per line will
be permitted to continue to do so after the rule goes into effect.
Thus, small and very small plants that currently operate with more than
two inspectors will not need to modify their operations based on a
reduction in inspectors.
Table 18 shows the capacity comparisons for SBA small and large
companies. FSIS shows in this table that SBA small companies have a
relatively small share of the capacity, 4.7 percent, to slaughter
poultry.
Table 18--Capacity Comparisons for Small and Large Companies
----------------------------------------------------------------------------------------------------------------
Share of
Company size (SBA definition) Number of Number of facilities (in
companies facilities percent)
----------------------------------------------------------------------------------------------------------------
Small..................................................... 109 110 38.10
Large..................................................... 49 179 61.90
-----------------------------------------------------
Total................................................. 158 289 100.00
----------------------------------------------------------------------------------------------------------------
Source: ADRS.
Table 19 shows the capacity comparisons for HACCP very small,
small, and large establishments.
Table 19--Capacity Comparisons for Very Small, Small, and Large
Establishments
------------------------------------------------------------------------
Establishment size (HACCP Number of Share of
definition) facilities facilities
------------------------------------------------------------------------
Very Small.......................... 54 18.70
Small............................... 84 29.00
Large............................... 151 52.30
Total........................... 289 100.00
------------------------------------------------------------------------
Source: ADRS.
Table 20--Accounting Summary for Proposed Rule
----------------------------------------------------------------------------------------------------------------
Category Primary estimate Minimum estimate Maximum estimate Source citation
----------------------------------------------------------------------------------------------------------------
BENEFITS:
Annualized monetized $377.7 million.... $325.8 million.... $442.7 million.... RA, PRIA.
benefits.
-------------------------------------------------------------------------------
Unquantified benefits....... Public health benefits from documentation and revised testing.
-------------------------------------------------------------------------------
COSTS:
Annualized monetized costs.. $20.3 million..... .................. .................. PRIA.
----------------------------------------------------------------------------------------------------------------
VII. E-Government Act
FSIS and USDA are committed to achieving the purposes of the E-
Government Act (44 U.S.C. 3601, et seq.) by, among other things,
promoting the use of the Internet and other information technologies
and providing increased opportunities for citizen access to government
information and services, and for other purposes.
VIII. Executive Order 13175
This proposed rule has been reviewed in accordance with the
requirements of Executive Order 13175, Consultation and Coordination
with Indian Tribal Governments. The review reveals that this regulation
will not have substantial and direct effects on Tribal governments and
will not have significant Tribal implications.
IX. USDA Nondiscrimination Statement
The U.S. Department of Agriculture (USDA) prohibits discrimination
in all its programs and activities on the basis
[[Page 4451]]
of race, color, national origin, gender, religion, age, disability,
political beliefs, sexual orientation, and marital or family status.
(Not all prohibited bases apply to all programs.)
Persons with disabilities who require alternative means for
communication of program information (Braille, large print, audiotape,
etc.) should contact USDA's Target Center at 202-720-2600 (voice and
TTY).
To file a written complaint of discrimination, write USDA, Office
of the Assistant Secretary for Civil Rights, 1400 Independence Avenue
SW., Washington, DC 20250-9410 or call 202-720-5964 (voice and TTY).
USDA is an equal opportunity provider and employer.
X. Environmental Impact
Summary: 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)).
Evaluation: Under this proposed rule, young chicken and turkey
slaughter establishments that operate under the proposed New Poultry
Inspection System will be able to slaughter and process birds more
efficiently because they will be permitted to operate faster line
speeds. In the Preliminary Regulatory Impact Analysis (PRIA) of this
proposed rule, FSIS predicted that, because of the efficiencies in the
proposed new poultry inspections system, the price of chicken products
would decrease by two cents per bird. FSIS projected that the predicted
price reduction could lead to an increase in sales of poultry products
of about a quarter of one percent or less. With the slight increase in
sales of poultry products, some establishments may choose to increase
the number of birds that they slaughter, which could result in an
increase in the number of condemned carcasses and parts that must be
disposed of. However, because the predicted increase in sales is very
small, FSIS has determined that the increase in the number of birds
slaughtered, as well as the number of condemned carcasses and parts
that will need to be disposed of, will also be very small and thus will
not have a significant individual or cumulative effect on the human
environment.
Expected sales of poultry products will determine the number of
birds that poultry establishments slaughter. Allowing establishments to
operate at faster lines speeds will allow them to slaughter the birds
more efficiently. It will also allow them to reduce their hours of
operation while maintaining production at a rate necessary to meet
market demands. Thus, by allowing establishments to reduce their hours
of operations, the faster line speeds permitted under this proposed
rule will result in a small, if any, increase in water use or runoff by
establishments that operate under the New Poultry Inspection System. In
addition, poultry slaughter establishments are required to meet all
local, State, and Federal environmental requirements. Thus, FSIS has
determined that allowing establishments to operate under faster line
speeds provided in the proposed PSR will not have a not have a
significant individual or cumulative effect on the human environment.
FSIS also considered the potential environmental effects of the
provision in the proposed rule that would permit poultry slaughter
establishments to use approved online reprocessing (OLR) antimicrobial
systems. One antimicrobial agent used in OLR systems, trisodium
phosphate (TSP), can result in high levels of phosphorus as a
byproduct, which, if untreated, could overcome local municipal water
systems. FSIS estimates that approximately 5-7 of the 144
establishments operating under regulatory waivers for OLR are using TSP
as an antimicrobial agent. As noted above, regardless of the substance
that an establishment chooses to use for its OLR system, it is required
to meet all local, State, and Federal environmental requirements. The
waste water from the few poultry establishments that use TSP is handled
routinely by existing water treatment systems or recycled as by-
products without entering the plant's systems, municipal water systems,
or the ground water. Thus, FSIS has determined that allowing
establishment to use approved OLR antimicrobial systems will not have a
significant individual or cumulative effect on the human environment.
Conclusion: For the reasons discussed above, FSIS has determined
that the proposed PSR will not have individual or cumulative effect on
the human health 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. 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 the
Office of Management and Budget (OMB).
Title: Poultry Slaughter Inspection.
Type of Collection: New.
Abstract: Under this proposed rule, each official poultry slaughter
establishment would need to maintain as part of its HACCP plan, or
sanitation SOP, or other prerequisite program, written procedures
addressing (1)the prevention, throughout the entire slaughter and
dressing operation, of contamination of carcasses and parts by enteric
pathogens (e.g. Salmonella and Campylobacter) and by fecal material,
and (2) the prevention of carcasses and parts contaminated by visible
fecal material from entering the chiller. Each establishment operating
under the proposed new inspection system would also have to maintain
written procedures to prevent caracasses affected with septicemia and
toxemia from entering the chiller. The procedures addressing prevention
of contamination by enteric pathogens would need to include, at a
minimum, microbial testing at pre-chill and at post-chill. In addition,
each establishment operating under the proposed inspection system would
need to maintain records that document that the products resulting from
its slaughter operations meet the definition of ready-to-cook poultry.
The proposed regulations that would require poultry slaughter
establishments to have written procedures in their HACCP plans, or
sanitation SOPs, or prerequisite programs is already covered under an
approved information collection, Pathogen Reduction/Hazard Analysis and
Critical Control Point Systems (OMB control number 0583-0103).
The proposal that poultry slaughter establishments monitor their
systems through microbial testing and recordkeeping creates a new
information collection burden. FSIS estimates that large establishments
will test and record microbial results at the 2 prescribed locations
(pre-chill and post-chill) 15 times a day, small establishments 7 times
a day, and very small establishments 3 times a day.
Estimate of Burden: FSIS estimates that it will take 5 minutes per
response.
[[Page 4452]]
Respondents: Poultry Slaughter Establishments.
Estimated Number of Respondents: 289.
Estimated Number of Responses per Respondent: Large establishments
15,300; small establishments 7,140; very small establishments 1,800.
Estimated Total Annual Burden on Respondents: 250,160 hours.
Copies of this information collection assessment can be obtained
from John O'Connell, Paperwork Reduction Act Coordinator, Food Safety
and Inspection Service, USDA, 1400 Independence Avenue SW., Room 6083,
South Building, Washington, DC 20250.
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 collection of information 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 John O'Connell, Paperwork Reduction
Act Coordinator, 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 to OMB within 60 days of the publication date
of this proposed rule.
XII. Additional Public Notification
Public awareness of all segments of rulemaking and policy
development is important. Consequently, in an effort to ensure that the
public and in particular minorities, women, and persons with
disabilities, are aware of this proposed rule, FSIS will announce it
on-line through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp. FSIS also will make
copies of this Federal Register 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 communicated via Listserv, a free email subscription service
consisting of industry, trade, and farm groups, consumer interest
groups, allied health professionals, scientific professionals, and
other individuals who have requested to be included. The Update also is
available on the FSIS Web page. Through Listserv and 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 http://www.fsis.usda.gov/news_&_events/email_subscription/. Options range from recalls to
export information to regulations, directives and notices. Customers
can add or delete subscriptions themselves, and have the option to
password protect their accounts.
XIII. Proposed Regulatory Amendments
List of Subjects
9 CFR Part 381
Poultry inspection, Poultry products, Recordkeeping requirements.
9 CFR Part 500
Administrative practice and procedure, Meat inspection, Poultry and
poultry products.
For the reasons stated in the preamble, FSIS is proposing to amend
9 CFR Chapter III as follows:
PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS
1. The authority citation for part 381 continues to read as
follows:
Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 451-470; 7 CFR 2.7,
2.18, 2.53.
2. Section 381.36 is amended as follows:
a. Paragraph (c) is revised.
b. Paragraphs (d) and (e) are removed.
The revisions read as follows:
Sec. 381.36 Facilities required.
* * * * *
(c) Facilities for post-mortem inspection under the New Poultry
Inspection System. The following facilities requirements apply to
establishments operating under the New Poultry Inspection System and
are in addition to the requirements for obtaining a grant of
inspection.
(1) The following provisions apply to the online carcass inspection
station:
(i) On each production line, at a point before the chiller and
after the establishment has completed all sorting, trimming, and
reprocessing activities necessary to comply with Sec. 381.76(d)(2) of
this part, at least 4 feet of floor space along the conveyor line must
be provided for one online carcass inspection station.
(ii) The conveyor line must be level for the entire length of the
online carcass inspection station. The vertical distance from the
bottom of the shackles to the top of the platform (paragraph
(c)(1)(iii) of this section) must not be less than 60 inches.
(iii) Each online carcass inspection station must have a platform
that is slip-resistant and can be safely accessed by the inspector. The
platform must be a minimum length of 4 feet and have a minimum width of
2 feet. The platform must be designed with a 42-inch high rail on the
back side and with \1/2\-inch foot bumpers on both sides and front to
allow safe working conditions. The platform must be large enough for
the inspector to sit on a stool and to change stations during breaks or
station rotation.
(iv) Conveyor line stop/start switches must be located within easy
reach of the online carcass inspector.
(v) A minimum of 200-foot candles of shadow-free lighting with a
minimum color rendering index value of 85 must be provided where the
birds are inspected to facilitate online carcass inspection.
(vi) Hand rinsing facilities must be provided for use by and within
easy reach of the online carcass inspector. The hand rinsing facilities
must have a continuous flow of water or be capable of being immediately
activated and deactivated in a hands-free manner, must minimize any
splash affect, and must otherwise operate in a sanitary manner that
prevents contamination of carcasses and inspector clothing. The hand
rinsing facilities must provide water at a temperature between 65 and
120 degrees Fahrenheit.
(vii) A separate clipboard holder for holding recording sheets must
be provided for and within easy reach of the online carcass inspector.
(viii) Receptacles for condemned carcasses and parts that comply
with the performance standards in Sec. 416.3(c) of this chapter must
be provided at each online carcass inspection station.
(ix) Hangback racks designed to hold at least 10 carcasses must be
provided and positioned within easy reach of the online carcass
inspector.
(x) A buzzer switch shall be located within easy reach of the
online carcass inspector to be used by the carcass inspector to alert
the inspector-in-charge, offline inspectors, or
[[Page 4453]]
establishment management of conditions that require their attention.
(2) The following provisions apply to pre-chill and post-chill
offline verification inspection stations:
(i) One or more offline verification inspection stations must be
located at the end of the line or lines prior to the chiller; one or
more offline verification inspection stations must also be located
after the chiller or chillers. The Agency will determine the number of
stations needed in establishments having more than one processing line
or more than one chiller.
(ii) Floor space for all offline verification inspection stations
must consist of a minimum of 3 feet along each conveyor line and after
each chiller, as applicable, to allow carcasses to be removed for
evaluation by the verification inspector. The space must be level and
protected from all traffic and overhead obstructions.
(iii) At the pre-chill location, the vertical distance from the
bottom of the shackles to the floor must not be less than 48 inches.
(iv) At each offline verification inspection station, a table
designed to be readily cleanable and drainable must be provided for
offline verification inspectors to conduct offline verification
activities. At turkey slaughter establishments, the table must be at
least 3 feet wide, 2 feet deep, and 3 feet high. At all other poultry
slaughter establishments, the table must be at least 2 feet wide, 2
feet deep, and 3 feet high.
(v) A minimum of 200-footcandles of shadow-free lighting with a
minimum color rendering index of 85 on the table surface must be
provided.
(vi) The establishment must provide a separate clipboard holder for
holding recording sheets; or alternatively, the establishment may
provide electronic means for the offline verification inspector to
record inspection results.
(vii) Hangback racks designed to hold at least 10 carcasses must be
provided and positioned within easy reach of the offline verification
inspector.
(viii) Hand washing facilities must be provided within easy access
of all offline verification inspection stations.
(3) Each establishment operating under the New Poultry Inspection
System must provide a location at a point along the production line
after the carcasses are eviscerated at which an inspector may safely
and properly inspect for leukosis the first 300 carcasses of each flock
together with associated viscera either uniformly trailing or leading,
or otherwise identified with the corresponding carcass. The leukosis
inspection area must provide a minimum of 200-footcandles of shadow-
free lighting on the surface where the viscera are inspected.
(4) A trough or other similar drainage facility must extend beneath
the conveyor at all places where processing operations are conducted
from the point where the carcass is opened to the point where trimming
has been performed. The trough must be of sufficient width to preclude
trimmings, drippage, and debris from accumulating on the floor or
platforms. The clearance between suspended carcasses and the trough
must be sufficient to preclude contamination of carcasses by splashing.
3. Section 381.65 is amended as follows:
a. Paragraphs (e) and (f) are redesignated as paragraphs (f) and
(e) respectively.
b. Newly redesignated as paragraph (f) is revised.
c. A new paragraph (g) is added.
d. A new paragraph (h) is added.
The revisions and additions read as follows:
Sec. 381.65 Operations and procedures, generally.
* * * * *
(f) Procedures for controlling visible fecal contamination.
Official poultry slaughter establishments must develop, implement, and
maintain written procedures to ensure that poultry carcasses
contaminated with visible fecal material do not enter the chilling
tank. Establishments must incorporate these procedures into their HACCP
plans, or sanitation SOPs, or other prerequisite programs.
(g) Procedures for controlling contamination throughout the
slaughter and dressing process. Official poultry slaughter
establishments must develop, implement, and maintain written procedures
to prevent contamination of carcasses and parts by enteric pathogens
(e.g., Salmonella and Campylobacter) and fecal contamination throughout
the entire slaughter and dressing operation. Establishments must
incorporate these procedures into their HACCP plans, or sanitation
SOPs, or other prerequisite programs. At a minimum, these procedures
must include sampling and analysis for microbial organisms at the pre-
chill and post-chill points in the process. The sampling frequency must
be adequate to monitor the establishment's 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 (h) of this section.
(h) Recordkeeping requirements. Official poultry slaughter
establishment must maintain daily records sufficient to document the
implementation and monitoring of the procedures required under
paragraph (g) of this section. Records required by this section may be
maintained on computers provided that the establishment implements
appropriate controls to ensure the integrity of the electronic data.
Records require by this section must be maintained for at least one
year and must be accessible to FSIS.
4. Section 381.66 is amended as follows:
a. Paragraph (b) is revised.
b. Paragraphs (c)(3) and (c)(4) are removed.
c. Paragraph (e) is revised.
The revisions read as follows:
Sec. 381.66 Temperatures and chilling and freezing procedures.
* * * * *
(b) Chilling performance standards, except for ratites.
(1)(i) Each official poultry slaughter establishment must ensure
that all poultry carcasses, parts, and giblets are chilled immediately
after slaughter operations so that there is no outgrowth of pathogens,
unless such poultry is to be frozen or cooked immediately at the
official establishment.
(ii) Previously chilled poultry carcasses and major portions must
be kept chilled so that there is no outgrowth of the pathogens, unless
such poultry is to be packed and frozen immediately at the official
establishment.
(2) After product has been chilled, the establishment must prevent
the outgrowth of pathogens on the product as long as the product
remains at the establishment.
(3) The establishment must develop, implement, and maintain written
procedures for chilling that address, at a minimum, the potential for
pathogen outgrowth, the conditions affecting carcass chilling, and when
its chilling process is completed. The establishment must incorporate
these procedures into its HACCP plan, or sanitation SOP, or other
prerequisite program.
* * * * *
(e) Air chilling. Air chilling is the method of chilling raw
poultry carcasses and parts exclusively with air. No water, including
mists or sprays, may be used to help chill the product. However, an
anti-microbial intervention that is applied with water may be used for
a short duration if its use does not result in any pick-up of water or
moisture and
[[Page 4454]]
if it does not assist the chilling process by lowering the product
temperature.
* * * * *
5. Section 381.67 is amended as follows:
a. The section heading is revised.
b. The first sentence of the introductory text is amended by
removing the words ``young chicken and squab'' and adding in their
place the word ``poultry.''
c. The second to the last sentence of the introductory text is
removed.
d. The last sentence of the introductory text is revised.
e. The table is revised.
f. A new table is added after the first table.
The revisions read as follows:
Sec. 381.67 Poultry slaughter inspection rate maximums under
traditional inspection procedure.
* * * Section 381.76(b) specifies when the traditional inspection
procedure can or must be used.
Maximum Production Line Rates--Poultry Other Than Turkeys and Ratites--
Traditional Inspection Procedures
------------------------------------------------------------------------
Number of Birds per
Line configuration \1\ inspection inspector per
stations minute
------------------------------------------------------------------------
6-1................................. 1 25
12-1................................ 2 23
12-2................................ 2 21
------------------------------------------------------------------------
\1\ Birds are suspended on the slaughter line at 6-inch intervals. The
first number indicates the interval in inches between the birds that
each inspector examines, i.e., 6 or 12 inches. The second number
indicates how many of the birds presented, the inspector is to
inspect, i.e., ``1'' means inspect every bird and ``2'' means inspect
every second bird.
Maximum Production Line Rates--Turkeys--Traditional Inspection Procedures
----------------------------------------------------------------------------------------------------------------
Birds per Birds per
Number of inspector per inspector per
Line configuration\1\ inspection minute for light minute for heavy
stations birds (<16 lbs) birds (>16 lbs)
----------------------------------------------------------------------------------------------------------------
12-1...................................................... 1 20 16
24-2...................................................... 2 34 26
----------------------------------------------------------------------------------------------------------------
\1\ Birds are suspended on the slaughter line at 12-inch intervals. The first number indicates the interval in
inches between the birds that each inspector examines, i.e., 12 or 24 inches. The second number indicates how
many of the birds presented, the inspector is to inspect, i.e., ``1'' means inspect every bird and ``2'' means
inspect every second bird.
6. Section 381.68 is revised to read as follows:
Sec. 381.68 Maximum line speed rates under the New Poultry Inspection
System.
(a) The maximum line speed for young chicken slaughter
establishments that operate under the New Poultry Inspection System is
175 birds per minute.
(b) The maximum line speed for turkey slaughter establishments that
operate under the New Poultry Inspection System is 55 birds per minute.
(c) Notwithstanding paragraphs (a) and (b) of this Section,
establishments that operate under the New Poultry Inspection System
must reduce their line speed as directed by inspectors-in-charge.
Inspectors-in-charge are authorized to direct establishments to operate
at a reduced line speed when in his or her judgment a carcass-by-
carcass inspection cannot be adequately performed within the time
available due to the manner in which the birds are presented to the
online carcass inspector, the health conditions of a particular flock,
or factors that may indicate a loss of process control.
7. Section 381.76 is revised to read as follows:
Sec. 381.76 Post-mortem inspection under Traditional Inspection, the
New Poultry Inspection System, and Ratite Inspection.
(a) A post-mortem inspection shall be made on a bird-by-bird basis
on all poultry eviscerated in every official establishment. Each
carcass, or all parts comprising such carcass, must be examined by an
inspector, except for parts that are not needed for inspection purposes
and are not intended for human food and are condemned. Each carcass
eviscerated shall be prepared as ready-to-cook poultry.
(b) There are three systems of post-mortem inspection: New Poultry
Inspection System, which may be used for young chickens and turkeys;
Traditional Inspection, which may be used for all poultry, except for
ratites; and ratite inspection. Traditional Inspection must be used for
young chickens and turkeys if the New Poultry Inspection System is not
used.
(c) Official establishments that operate under traditional
inspection must meet the following requirements:
(1) No viscera or any part thereof may be removed from any poultry
processed in any official establishment, except at the time of post-
mortem inspection, unless its identity with the rest of the carcass is
maintained in a manner satisfactory to the inspector until such
inspection is made;
(2) Each carcass to be eviscerated must be opened so as to expose
the organs and the body cavity for proper examination by the inspector.
(3) If a carcass is frozen, it must be thoroughly thawed before
being opened for examination by an inspector.
(d) The New Poultry Inspection System may be used for young
chickens and turkeys if the official establishment requests to use it
and meets or agrees to meet the requirements of this paragraph (d) and
the Administrator approves the establishment's request. The
Administrator may permit establishments that slaughter classes of
poultry other then young chickens and turkeys to operate under the New
Poultry Inspection System under a waiver from the provisions of the
regulations as provided in Sec. 381.3(b) of this part.
(1) Facilities: The establishment must comply with the facilities
requirements in Sec. 381.36(c) of this part.
(2) Carcass Sorting and Disposition:
(i) The establishment must conduct carcass with associated viscera
sorting activities, dispose of carcasses and parts exhibiting
condemnable conditions, and conduct appropriate trimming and
[[Page 4455]]
reprocessing activities before carcasses are presented to the online
carcass inspector.
(ii) Any carcasses removed from the line for reprocessing
activities or salvage must be returned to the line before the online
carcass inspection station. The establishment must include in its
written HACCP plan, or sanitation standard operating procedure, or
other prerequisite program a process by which parts, other than parts
identified as ``major portions'' as defined in 9 CFR 381.170(b)(22),
are available for inspection offline after reprocessing or salvage.
(iii) The establishment must develop, implement, and maintain
written procedures to ensure that poultry carcasses contaminated with
septicemic and toxemic conditions do not enter the chilling tank.
Establishments must incorporate these procedures into their HACCP
plans, or sanitation SOPs, or other prerequisite programs. These
procedures must cover, at a minimum, establishment sorting activities
required under paragraph (d)(2)(i) of this section.
(iv) The establishment must maintain records to document that the
products resulting from their slaughter operations meet the definition
of ready-to-cook poultry in Sec. 381.1 of this part.
(v) If there is evidence that a flock may be affected by avian
visceral leukosis, the inspector-in-charge is authorized to adjust
inspection procedures as needed to ensure adequate inspection of each
carcass and viscera for that condition. The inspector-in-charge is also
authorized to require the establishment to adjust its processing
operations as needed to accommodate the adjusted inspection procedures.
(3) Presentation for Online Carcass Inspection: To ensure the
online carcass inspector may properly inspect every carcass, the
establishment must present carcasses as follows:
(i) Each carcass, except carcasses and parts identified as ``major
portions'' under 9 CFR 381.179(b)(22), must be held by a single
shackle;
(ii) Both hocks of each carcass must be held by the shackle;
(iii) The back side of the carcass must be faced toward the
inspector;
(iv) There must be minimal carcass swinging motion; and
(v) Establishments that slaughter young chickens must notify the
inspector-in-charge prior to the slaughter of each new flock to allow
the inspection of viscera as provided in Sec. 381.36(c)(3) of this
part. The establishment must ensure that it can sufficiently identify
viscera and parts corresponding with each carcass inspected by the
online carcass inspector so that if the carcass inspector condemns a
carcass all corresponding viscera and parts are also condemned.
8. Section 381.91 is amended by revising paragraph (b) to read as
follows:
Sec. 381.91 Contamination.
* * * * *
(b) Any carcass of poultry accidentally contaminated during
slaughter with digestive tract contents need not be condemned if
promptly under the supervision of an inspector and thereafter found not
to be adulterated. Contaminated surfaces that are cut must be removed
only by trimming. Contaminated inner surfaces that are not cut may be
cleaned by trimming alone or may be re-processed as provided in
subparagraph (b)(1) or (b)(2) of this section.
(1) Online. Poultry carcasses accidentally contaminated with
digestive tract contents may be cleaned by applying an online
antimicrobial intervention to all carcasses after evisceration and
before the carcasses enter the chiller if the parameters for use of the
antimicrobial intervention system have been approved by the
Administrator. Establishments must incorporate procedures for the use
of any online reprocessing antimicrobial intervention system into their
HACCP plans, Sanitation Standard Operating Procedures, or other
prerequisite programs.
(2) Offline reprocessing. Contaminated inner surfaces that are not
cut may be cleaned at an approved reprocessing station away from the
main processing line by any method that will remove the contamination,
such as vacuuming, washing, and trimming, singly or in combination. All
visible specks of contamination must be removed, and if the inner
surfaces are reprocessed other than solely by trimming, all surfaces of
the carcass must be treated with chlorinated water containing 20 ppm to
50 ppm available chlorine or another approved antimicrobial substance
in accordance with the parameters approved by Administrator .
Establishments must incorporate procedures for the use of any offline
reprocessing into their HACCP plans, Sanitation Standard Operating
Procedures, or other prerequisite programs.
9. Section 381.94 is removed.
10. Section 381.129 is amended by adding a new paragraph (b)(6)(v)
to read as follows:
Sec. 381.129 False or misleading labeling or containers.
* * * * *
(b) * * *
(6) * * *
(v) Ready-to-cook chicken may bear the claim ``air chilled'' or
``air chilling'' on its label only if the product was chilled under a
process that meets the definition of air chilling in Sec. 381.66(e) of
this part.
* * * * *
PART 500--RULES OF PRACTICE
11. The authority citation for part 500 continues to read as
follows:
Authority: 21 U.S.C. 451-470, 601-695; 7 U.S.C. 450, 1901-1906;
7 CFR 2.18, 2.53.
Sec. 500.6 [Amended]
12. Section 500.6 is amended to remove and reserve paragraph (f).
Done in Washington, DC, on January 20, 2012.
Alfred V. Almanza,
Administrator.
Note: The following Appendix will not appear in the Code of
Federal Regulations.
APPENDIX A--HIMP PERFORMANCE STANDARDS
Establishments operating under HIMP are required to meet
performance standards for food safety and non-food-safety related
defects and to maintain process control plans to meet those
performance standards. The following is a description of the HIMP
performance standards.
FSIS has a zero tolerance for visible fecal contamination and
septicemic and toxemic animal diseases (see 9 CFR 381.83 and
381.65(e)). Notwithstanding this zero tolerance policy, there are
two categories of food safety related performance standards under
HIMP for these conditions: ``FS-1'' addresses septicemic and toxemic
animal diseases and ``FS-2'' addresses visible fecal material. The
Agency developed performance standards for FS-1 and FS-2 conditions
to compare the performance of HIMP and non-HIMP establishments in
meeting the zero tolerance for septicemic and toxemic animal
diseases and visible fecal contamination.
To develop the performance standards, a private contractor, the
Research Triangle Institute (RTI), conducted a study of 16 young
chicken establishments operating under the existing poultry
inspection systems to establish baseline organoleptic and microbial
levels at young chicken slaughter establishments operating under the
inspection systems provided for under the current regulations. The
baseline studies were conducted between 1998 and 2000, prior to
young chicken slaughter establishments beginning to operate under
HIMP. The performance standards for the FS-1 and FS-2 conditions
were set at the 75th percentile of what was achieved under the RTI
baseline study. The young chicken performance standards for each
food safety defect category are presented in Table 1.
[[Page 4456]]
Table A-1--Food Safety Performance Standards for Young Chicken Slaughter
Establishments *
------------------------------------------------------------------------
Performance standards
based on existing
Defect categories inspection systems (%
of carcasses)
------------------------------------------------------------------------
Food Safety 1:
Condition--Infectious (e.g., Septicemia, 0.1 *
toxemia)..................................
Food Safety 2:
Contamination--Digestive Content (e.g., 1.5 *
fecal material)...........................
------------------------------------------------------------------------
* FSIS has a zero tolerance for Food Safety 1 and 2 defects.
As noted above, the FS-1 and FS-2 HIMP performance standards
were developed for purposes of comparison. Therefore, FSIS
inspection personnel in HIMP establishments are responsible for
enforcing the zero tolerance for visible fecal contamination and
septicemic and toxemic animal diseases. If the online carcass
inspector in a HIMP establishment identifies a carcass with FS-1 or
FS-2 conditions, he or she stops the evisceration line and notifies
the establishment to hang the affected carcass back for condemnation
or reprocessing. The carcass inspector does not restart the line
until the contaminated carcass is removed.
Non-food-safety related performance standards are referred to as
``Other Consumer Protection'' standards, or ``OCPs,'' under HIMP.
There are five categories of OCPs various types of trim and dressing
defects that mainly affect the quality of products. Examples include
removable non-septicemic and non-toxemic animal diseases, breast
blisters, bruises, fractures, and feathers. Together, the five OCP
categories account for 29 specific defects addressed under the
current regulations by the FPS, codified at 9 CFR 381.76. The OCP
categories are logically grouped and simpler to apply than the FPS.
Under the FPS, defects are weighted and a complex numerical system
is applied to each sample group of carcasses. In contrast, to
determine compliance with the OCP categories, an individually
sampled carcass with any defect in one of the five categories is
counted as ``defective.'' A carcass with more than one category of
defects is counted in both (or more) categories. The performance
standard for each category is expressed as the maximum percentage of
sampled carcasses that may contain one or more defects from that
category. The young chicken performance standards for each OCP
category are presented in Table A-2.
Table A-2--OCP Performance Standards for Young Chicken Slaughter
Establishments
------------------------------------------------------------------------
Performance standard (%
Nonconformance category carcasses)
------------------------------------------------------------------------
OCP-1:
Condition--Animal Diseases--non-septicemic 1.7
or non-toxemic (e.g., airsacculitis,
arthritis, ascites, skin leukosis, avian
tuberculosis, cadaver, enteritis,
erysipelas, inflammatory process,
nephritis, osteomyelitis, other tumors--
carcinoma, sarcoma, etc., pericarditis,
pneumonia, reportable disease,
salpingitis, tenosynovitis................
OCP-2:
Condition--Miscellaneous (e.g., breast 52.5
blister, bruises, external mutilation,
fractures, overscald, sores, scabs, and
localized inflammatory process)...........
------------------------------------------------------------------------
[FR Doc. 2012-1516 Filed 1-20-12; 4:15 pm]
BILLING CODE 3410-DM-P