Modernization of Poultry Slaughter Inspection, 4408-4456 [2012-1516]

Agencies

• DEPARTMENT OF AGRICULTURE
• Food Safety and Inspection Service

[Federal Register Volume 77, Number 18 (Friday, January 27, 2012)]
[Proposed Rules]
[Pages 4408-4456]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-1516]



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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 https://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 https://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: https://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

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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 https://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: https://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: https://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 requireme