[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.
---------------------------------------------------------------------------

    \9\ US Consumer Product Safety Commission Document 
5098, ``Tap Water Scalds.'' Available at: http://www.cpsc.gov/cpscpub/pubs/5098.html.
---------------------------------------------------------------------------

    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).
---------------------------------------------------------------------------

    \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.
---------------------------------------------------------------------------

    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.
---------------------------------------------------------------------------

    \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)).
---------------------------------------------------------------------------

    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