Federal Register, Volume 79 Issue 162 (Thursday, August 21, 2014)

[Federal Register Volume 79, Number 162 (Thursday, August 21, 2014)]
[Rules and Regulations]
[Pages 49566-49637]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2014-18526]

[[Page 49565]]

Vol. 79

Thursday,

No. 162

August 21, 2014

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; Final Rule

Federal Register / Vol. 79 , No. 162 / Thursday, August 21, 2014 /
Rules and Regulations

[[Page 49566]]

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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: Final rule.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is amending the
poultry products inspection regulations to establish a new inspection
system for young chicken and all turkey slaughter establishments. Young
chicken and turkey slaughter establishments that do not choose to
operate under the new poultry inspection system may continue to operate
under their current inspection system. The Agency is also making
several changes to the regulations that will affect all establishments
that slaughter poultry other than ratites. This final rule is a result
of the Agency's 2011 regulatory review efforts conducted under
Executive Order 13563 on Improving Regulation and Regulatory Review.

DATES:
Effective Date: October 20, 2014.
Notification Date: All young chicken and turkey slaughter
establishments will initially have until February 23, 2015, to notify
their District Office in writing of their intent to operate under the
New Poultry Inspection System (NPIS). Establishments that do not notify
their District Office of their intent by February 23, 2015, will be
deemed to have chosen the inspection system that they are currently
operating under. Young chicken and turkey slaughter establishments that
decide that they would like to convert to NPIS after the initial
notification date may notify FSIS of their intent at any time after
that date. The Agency will implement the NPIS in the additional
establishments that intend to convert on a schedule consistent with
Agency resources and readiness. The Agency intends to implement the
NPIS in all young chicken and turkey establishments that choose to
operate under the NPIS, regardless of when the establishment notifies
FSIS of its intent to transition to the NPIS. However, the initial
implementation wave will only include those establishments that
submitted their notifications within the initial notification period.
After October 20, 2014, FSIS will begin selecting from those
establishments that have notified FSIS of their intent to switch to the
NPIS. The Agency will use a computerized ranking system to determine
the schedule of establishments for implementation of the NPIS. This
ranking system will take into consideration several factors, such as
FSIS staffing needs, past performance of the establishment, the
location of the establishment with respect to other federally-inspected
establishments, and establishment readiness to transition to the NPIS.
FSIS will implement the NPIS in phases by clusters of establishments in
close geographic proximity to one another. The initial implementation
wave will only include those establishments that notified FSIS of their
intent to switch to the NPIS during the initial six-month notification
period. FSIS expects that in subsequent years many more establishments
will choose to transition to the new system. The Agency's
implementation strategy for the NPIS is described in more detail in the
preamble to this final rule.
Applicability Dates: The regulations that prescribe procedures for
controlling visible fecal contamination in 9 CFR 381.65(f), the
regulations that prescribe procedures for controlling contamination
throughout the slaughter and dressing process in 9 CFR 381.65(g), and
the regulations that prescribe recordkeeping requirements in 9 CFR
381.65(h) will be applicable as follows:
In large establishments, defined as all establishments
with 500 or more employees, on November 19, 2014;
In small establishments, defined as all establishments
with 10 or more employees but fewer than 500, on December 19, 2014;
In very small establishments, defined as all
establishments with fewer than 10 employees or annual sales of less
than $2.5 million February 17, 2015.

FOR FURTHER INFORMATION CONTACT: 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) 205-0495.

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. As a result of
FSIS's regulatory review efforts conducted under E.O. 13563, on January
27, 2012, the Agency published a proposed rule to modernize poultry
slaughter inspection (``Modernization of Poultry Slaughter
Inspection,'' 77 FR 13512). This final rule adopts, with modifications,
the provisions in the January 2012 proposal. FSIS is issuing this rule
to facilitate pathogen reduction in poultry products, improve the
effectiveness of poultry slaughter inspection, make better use of the
Agency's resources, and remove unnecessary regulatory obstacles to
innovation.
This final rule will establish a New Poultry Inspection System
(NPIS) for young chicken and all turkey slaughter establishments. The
NPIS will not replace, as was proposed, the current Streamlined
Inspection System (SIS), the New Line Speed Inspection System (NELS),
or the New Turkey Inspection System (NTIS). As such, young chicken and
turkey slaughter establishments may choose to operate under the NPIS or
may continue to operate under their current inspection system, i.e.,
SIS, NELS, NTIS, or Traditional Inspection, as modified by this final
rule. Establishments that slaughter poultry other than young chickens
or turkeys are not eligible to operate under the NPIS unless they
obtain a waiver under the Salmonella Initiative Program. The Agency is
not limiting the number of online inspectors in Traditional Inspection
to two, as was proposed. FSIS will continue to staff all establishments
that do not choose to operate under the NPIS with their current number
of online inspectors.
The NPIS is designed to facilitate pathogen reduction in poultry
products by shifting Agency resources to allow FSIS inspectors to
perform more offline inspection activities that are more effective in
ensuring food safety, while providing for a more efficient and
effective online carcass-by-carcass inspection. Data from the Agency's
Hazard Analysis and Critical Control Point Systems (HACCP)-Based
Inspection Models Project (HIMP) pilot study,\1\ which was used to
inform the NPIS, show that an inspection system that provides for
increased offline inspection activities that are more directly related
to food safety results in greater compliance with sanitation and HACCP
regulations, carcasses with

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lower levels of visible fecal contamination, and carcasses with
equivalent or lower levels of Salmonella contamination.
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\1\ See ``Evaluation of HACCP Inspection Models Project (HIMP),
August 2011 (available on the FSIS Web site at: http://www.fsis.usda.gov/wps/wcm/connect/fcd9ca3e-3f08-421f-84a7-936bc410627c/Evaluation_HACCP_HIMP.pdf?MOD=AJPERES).
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Key elements of the NPIS include: (1) Requiring that establishment
personnel sort carcasses and remove unacceptable carcasses and parts
before the birds are presented to the FSIS carcass inspector; (2)
shifting Agency resources to conduct more offline inspection activities
that are more effective in ensuring food safety, which will allow for
one offline verification inspector per line per shift and will reduce
the number of online inspectors to one; (3) replacing the Finished
Product Standards (FPS), which will apply to establishments that
continue operating under SIS, NELS, and NTIS, with a requirement that
establishments that operate under the NPIS maintain records to document
that the products resulting from their slaughter operations meet the
definition of ready-to-cook (RTC) poultry; and (4) authorizing young
chicken slaughter establishments to operate at a maximum line speed of
140 birds per minute (bpm), provided that they maintain process
control.
Under all of the current inspection systems, online inspectors
visually inspect every carcass, with its corresponding viscera, at
fixed locations on the evisceration line immediately after separation
of the viscera from the interior of the carcasses. The online
inspectors are responsible for identifying unacceptable carcasses and
parts, examining carcasses for visual defects, and directing
establishment employees to take appropriate corrective actions if the
defects can be corrected through trimming or reprocessing. The maximum
line speeds authorized under the existing inspection systems reflect
the time it takes for an inspector to effectively perform the online
carcass inspection procedures required under these systems.
Under the NPIS, there will be one online carcass inspector (CI) and
one offline verification inspector (VI) assigned to each evisceration
line. As under the HIMP inspection system, VIs and CIs under the NPIS
will have different but complementary roles in ensuring that poultry
products leaving the slaughter line are safe and wholesome. Under the
NPIS, CIs will conduct a continuous online inspection of each carcass
at a fixed location immediately before the chiller to determine whether
each carcass is not adulterated. CIs under the NPIS will be able to
conduct a more efficient and effective online carcass inspection than
online inspectors do under the current inspection systems because the
CIs are presented with carcasses that have been sorted, washed, and
trimmed by establishment employees, and are thus much more likely to
pass inspection.
The VIs under the NPIS will conduct offline food safety-related
inspection activities and will monitor and evaluate establishment
process controls. The VIs will conduct carcass verification checks on
carcass samples collected before the CI station to ensure that the
establishment is effectively sorting carcasses and that it is producing
products that comply with the Agency's zero visible fecal tolerance and
other performance standards. The VI and CI will work with the
inspector-in-charge (IIC) to ensure that the carcasses presented to the
CI are not affected with food safety defects or other conditions at
levels that may impair the CI's ability to effectively inspect each
carcass. VIs will also perform offline activities in addition to
carcass verification checks, such as verifying compliance with
sanitation standard operating procedures (SOPs), sanitation performance
standards (SPS), and HACCP regulatory requirements, and ensuring that
the establishment is meeting all regulatory requirements and is
effectively preventing contamination by enteric pathogens and fecal
material throughout the entire slaughter and dressing process.
The fastest maximum line speed authorized under the current
inspection systems is 140 bpm under the SIS for young chickens. To
determine line speeds for SIS, FSIS conducted field and work
measurement studies of online inspectors to determine the time needed
for an inspector to perform the SIS inspection procedure. The studies
showed that online inspectors can perform the SIS inspection procedure
at line speeds of up to 140 bpm if each inspector is presented with up
to 35 bpm. Thus, under SIS, establishments with automated evisceration
equipment may operate at 140 bpm with four FSIS online inspectors
assigned to the line. The maximum line speeds authorized under the
other inspection systems are 91 bpm with three online inspectors for
NELS, and 51 bpm for light turkeys with two online inspectors and 45
bpm for heavy turkeys with two online inspectors for NTIS. As noted in
the proposed rule, Traditional Inspection is typically employed at
smaller lower production volume establishments that eviscerate
carcasses by hand (77 FR 4410). Thus, the maximum line speeds
authorized under Traditional Inspection are slower than those under
SIS, NELS, and NTIS. The maximum line speed for young chickens under
Traditional Inspection is 64 bpm with four online inspectors. The
maximum line speed for turkeys under Traditional Inspection is 39 bpm
with three online inspectors.
As discussed in more detail later in this document, since 2007,
HIMP young chicken establishments have been authorized to operate at
line speeds of up to 175 bpm, depending on their ability to demonstrate
consistent process control. Experience from the HIMP pilot shows that
HIMP establishments operate with an average line speed of 131 bpm, and,
although they are authorized to do so, most of the young chicken HIMP
establishments do not operate line speeds at 175 bpm. Establishments
determine their line speeds based on their equipment and facilities,
bird size and flock conditions, and their ability to maintain process
control when operating at a given line speed. In addition, line speeds
under HIMP depend on the number of employees that the establishments
hire and train to perform sorting activities. Although the maximum line
speed under the NPIS is 140 bpm and not 175 bpm as authorized under
HIMP, FSIS believes that establishments choosing to operate under the
NPIS will determine their line speeds based on the same factors that
establishments considered when setting line speeds under HIMP for the
past 15 years.
Regardless of line speed, because HIMP and NPIS do not require that
establishments configure their evisceration lines to accommodate more
than one online carcass inspector, establishments operating under the
NPIS will have greater control over their lines and greater flexibility
over their production process. For example, as under HIMP,
establishments operating under the NPIS will have the flexibility to
reconfigure and consolidate lines if they determine that they need more
space to conduct other activities in their facilities. In addition,
because only one online inspector is required at the end of the line,
establishments operating under the NPIS will not need to adjust their
production based on the availability of FSIS inspection personnel to be
stationed online. Establishment employees will staff the lines to
perform the online sorting activities. Establishments that operate
under NPIS will also have greater flexibility to increase production to
respond to customer demands.
As under HIMP, in addition to having more control over their
production process, establishments operating under the NPIS will also
have more opportunities for innovation and greater flexibility to
develop and implement certain types of new technologies. Currently, if
an establishment operating

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under the existing inspection systems wants to use new technologies for
evisceration or for sorting, the establishment must work directly with
the Agency to accommodate FSIS`s online slaughter inspection
methodologies. Doing so takes time and can become an obstacle to
innovation. Under the NPIS, establishments will have direct control of
the sorting process within their facilities and therefore will have the
flexibility to implement and assess the technologies they think are
beneficial to their operations.
In addition to the NPIS for young chickens and turkeys, this final
rule includes changes to the regulations that will apply to all
establishments that slaughter poultry other than ratites. Under this
final rule, all poultry slaughter establishments must develop,
implement, and maintain written procedures to ensure that carcasses
contaminated with visible fecal material do not enter the chiller, and
they must incorporate these procedures into their HACCP plans, or
sanitation SOPs, or other prerequisite programs (also referred to
collectively as ``the HACCP system'' in this document). This final rule
also requires 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, and that they incorporate
their procedures into their HACCP systems. At a minimum, these
procedures must include sampling and analysis for microbial organisms
at the pre- and post-chill points in the process to monitor process
control for enteric pathogens, with some exceptions for very small and
very low volume establishments. Establishments will be required to
maintain daily records sufficient to document the implementation and
monitoring of these procedures. These new requirements will ensure that
all poultry slaughter establishments implement appropriate measures to
prevent contamination of carcasses by enteric pathogens and visible
fecal material and that both FSIS and establishments have the
documentation they need to verify the effectiveness of these measures
on an ongoing basis.
FSIS is also rescinding the regulation that requires that poultry
establishments test carcasses for generic E. coli to monitor for
process control. The generic E. coli regulations will be replaced by
the new testing requirements described above. The new testing
requirements will allow establishments to develop sampling plans that
are more tailored, thus more effective in monitoring their specific
process control than the current generic E. coli criteria. The Agency
has concluded that the use of generic E. coli as an indicator for
process control may not be as useful in broiler operations as
originally thought. The Agency is taking this action to allow
establishments to use other more relevant indicators of process
control. The Agency established new performance standards for
Salmonella and Campylobacter in 2011 to more effectively manage these
pathogens (76 FR 15282). Therefore, FSIS is removing the codified
Salmonella pathogen reduction performance standards for poultry.
Finally, FSIS is removing the prescriptive time and temperature
parameters from the chilling requirements for RTC poultry and instead
is requiring that poultry establishments incorporate procedures for
chilling poultry into their HACCP systems. The Agency is also amending
the regulations 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 will be required to address the
use of online or offline reprocessing in their HACCP systems.

Table 1--Estimated Net Social Benefits From the Rule (Millions of Dollars), Annualized Over 10 Years With a 7% Discount Rate, for Varying Percent
Changes That Switch to NPIS
[Percentage of Industry that Switches to NPIS]
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0% 10% 25% 50% 75% 90% 100%
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NPIS:
Benefits:
Public health benefits 0.0 1.0 (0.3 to 1.7) 2.4 (0.8 to 4.3) 4.8 (1.6 to 8.7) 7.2 (2.4 to 13.0) 8.6 (2.9 to 15.7) 9.6 (3.3 to 17.4)
(10%, 90%).............
FSIS net savings........ 0.0 2.3 5.7 11.4 17.1 20.5 22.8
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Unquantified benefits... Increased flexibility for establishments to design and implement production measures tailored to their operations, in some
cases possibly including increased line speed up to 140 chickens or 55 turkeys per minute
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Costs:
Costs to establishments. 0.0 1.6 4.0 8.0 12.0 14.4 16.0
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Unquantified costs...... Industry cost of responding to new NPIS inspections in a manner that may lead to public health benefits (e.g., discarding
contaminated food or cooking it longer)
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Mandatory Component:
Costs to establishments. 9.1 9.1 9.1 9.1 9.1 9.1 9.1
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Unquantified benefits... Potential additional public health benefits from documentation and testing
Unquantified costs...... Industry cost of responding to information generated by documentation and testing in a manner that may lead to public
health benefits (e.g., discarding contaminated food or cooking it longer)
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Total benefits (10%, 0.0 3.3 (2.6 to 4.0) 8.1 (6.5 to 10.0) 16.2 (13.0 to 24.3 (19.5 to 29.1 (23.4 to 32.4 (26.0 to
90%)................... 20.1) 30.1) 36.2) 40.2)
Total costs............. 9.1 10.7 13.1 17.1 21.1 23.5 25.1
Net benefits (10%, 90%). -9.1 -7.4 (-8.1 to - -5 (-6.6 to -3.1) -0.9 (-4.1 to 3.2 (-1.6 to 9.0) 5.6 (-0.1 to 7.3 (0.9 to 15.1)
6.7) 3.0) 12.7)
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FSIS presents the costs and cost savings that would be generated
over a range of assumptions with respect to how much of the industry
will choose to adopt NPIS within five years. These estimates are scaled
from an illustrative calculation that assumes that all 219 small and
large non-Traditional establishments adopt NPIS, which, while used to
calculate potential maximum effect, is not necessarily FSIS's
assumption of the most likely outcome. Later portions of the regulatory
impact analysis section contain discussion of the uncertainty
surrounding the net benefits associated with how much of the industry
will choose to adopt NPIS.

Table of Contents

I. Background
II. Summary of Modifications Made to the Proposed Rule
III. Comments and Responses
A. NACMPI and Public Process
B. The HIMP Report
1. Data and Methods Used in the HIMP Report
2. HIMP as the Basis for the NPIS
3. Carcass Inspection Under HIMP
4. Public Health-Related Non-Compliances
5. OCP Standards Under HIMP
6. Salmonella Positive Rates in HIMP Establishments
C. The Risk Assessment
D. The New Poultry Inspection System (NPIS)
1. General Comments on the NPIS
2. Scope of the NPIS
3. Carcass Sorting and Inspection Under the NPIS
a. Carcass Sorting by Establishment Employees
b. Online Carcass Inspection
c. Inspection for Avian Visceral Leukosis
d. Verification Inspection
e. RTC Poultry Definition Under the NPIS
4. Facilities Requirements and Staffing for NPIS
a. Facilities Requirements
b. Staffing
5. Line Speeds Under the NPIS
a. Line Speeds and Process Control
b. Line Speeds and Online Carcass Inspection
E. Implementation of the NPIS
1. Background
2. Implementation Strategy
3. Comments on Proposed Implementation Plan
F. Line Speeds and Worker Safety
1. Collaboration With the National Institute for Occupational
Safety and Health
2. Collaboration With OSHA
3. General Comments on Line Speed and Worker Safety
4. Inspection Line Speed, Processing Line Speed, and Production
Volume
5. Factors Influencing Inspection Line Speed
6. Inspection Line Speed and Inspector Safety Under the NPIS
7. Industry Efforts To Address Worker Safety
8. Reporting of Work-Related Injuries
9. Attestation to FSIS on Work-Related Conditions
G. Changes That Affect All Establishments That Slaughter Poultry
Other Than Ratites
1. Procedures and Recordkeeping Requirements for Preventing
Contamination by Enteric Pathogens and Visible Fecal Contamination
2. Sampling and Testing Requirements To Monitor Process Control
a. Sampling Plan and Sampling Sites
b. Very Small and Very Low Volume Establishment Sampling
c. Sampling Frequency
d. Indicator Organisms and Baseline
3. Rescind Testing for Generic E. coli for Establishments That
Slaughter Poultry Other Than Ratites
4. Rescind Codified Salmonella Performance Standards
H. Elimination of Time/Temperature Chilling Requirements
I. Online Reprocessing
J. Animal Welfare Considerations
1. Welfare of Live Birds
2. Line Speeds and Animal Welfare
3. Animal Welfare and the Reduction in Number of Online
Inspectors
K. Environmental Impact
L. Economic Impact
1. General
2. Environmental Justice
3. Small Business Considerations
4. Implementation Costs
IV. Executive Order 12866 and 13563
V. Final Regulatory Flexibility Act
VI. Executive Order 12988
VII. E-Government Act
VIII. Executive Order 13175
IX. USDA Non-Discrimination Statement
X. Paperwork Reduction Act
XI. Additional Public Notification
XII. Final Regulatory Amendments

I. Background

On January 27, 2012, FSIS published the proposed rule,
``Modernization of Poultry Slaughter Inspection,'' to establish a new
inspection system for young chickens and turkeys. Under the proposal,
the new poultry inspection system (NPIS) would have replaced the
current Streamlined Inspection System (SIS), the New Line Speed
Inspection System (NELS), and the New Turkey Inspection System (NTIS).
The NPIS that FSIS is adopting in this final rule is consistent with
the inspection system that FSIS proposed in January 2012, with
modifications, which are described below. However, in this final rule,
FSIS is not eliminating SIS, NELS, or the NTIS, as was proposed. This
final rule will leave all existing inspection systems in place to give
establishments the flexibility to operate under the system that is best
suited to their operations.
In the proposed rule, FSIS also proposed changes to the regulations
that would apply to all establishments that slaughter poultry other
than ratites. FSIS is adopting these proposed changes, with some
modifications, which are also described below.
When FSIS issued the proposed rule, it initially gave the public
until April 26, 2012, to submit comments. The Agency later extended the
comment period until May 29, 2012. The public meeting and the Agency's
decision to extend the comment period are discussed below.

Comment Period and Public Meeting

On March 21, 2012, FSIS held a public meeting with its National
Advisory Committee on Meat and Poultry Inspection (NACMPI) via Web
conference to discuss the January 2012 proposed rule to modernize
poultry slaughter inspection. FSIS held the meeting in response to a
request from certain members of the committee. At the meeting, FSIS
provided an overview of the proposed rule and then held an open
discussion with the committee members. A transcript of the public
meeting is available on the FSIS Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/advisory-committees/nacmpi.
When the Agency held the public meeting, the comment period for the
proposed rule was scheduled to close on April 26, 2012. At the public
meeting, some of the committee members representing consumer advocacy
organizations requested that FSIS extend the comment period. A
coalition of consumer advocacy organizations also submitted a written
request for the Agency to extend the comment period. On April 26, 2012,
FSIS announced that it was extending the comment period until May 29,
2012 (77 FR 24873).
In the Federal Register document that announced the comment period
extension, FSIS explained that during the comment period, the Agency
had met with a coalition of consumer advocacy organizations and two
trade associations representing the poultry industry to clarify certain
aspects of the proposed rule to help inform their comments (77 FR
24873). Because the issues addressed in these meetings may have been
relevant to the development of other stakeholders' comments, the
Federal Register document summarized the issues raised at the meetings
and the Agency's responses. In the Federal Register document, FSIS also
requested additional comments on how it should implement the final rule
resulting from the January 2012 proposal. The Agency also requested
available data on potential worker safety issues associated with
increased line speeds. In addition, the Agency explained that it had

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received a request to hold a public technical meeting on the proposed
rule, but that the Agency did not believe that such a meeting would be
useful.
In developing this final rule, FSIS considered all comments
submitted in response to the January 2012 proposed rule, as well as
those provided at the NACMPI public meeting held in March 2012. Based
on its analysis of the issues and of the information provided by the
comments, FSIS made certain changes to, and clarified certain aspects
of, the proposed regulations. Those revisions are summarized below and
are discussed in detail in the Agency's responses to comments.

II. Summary of Modifications Made to the Proposed Rule

In this document, FSIS is finalizing, with some changes, the
provisions in the January 27, 2012, proposed rule ``Modernization of
Poultry Slaughter Inspection'' (77 FR 4408). The Agency is modifying
the proposal to:
Change the maximum line speed permitted under the NPIS to
140 bpm for young chickens, for entities that chose to operate under
NPIS. The maximum line speed for turkeys will be 55 bpm, as was
proposed;
Leave all existing poultry inspection systems in place and
allow young chicken and turkey slaughter establishments that do not
choose to operate under the NPIS to continue to operate under their
current inspection system;
Continue to staff all establishments that do not choose to
operate under the NPIS with the number of online inspectors that they
currently have;
Allow young chicken establishments that currently operate
under HIMP through a Salmonella Initiative Program (SIP) waiver to
continue to operate under a waiver to run at a maximum line speed of up
to 175 bpm;
Update the SIP waivers for young chicken establishments
currently operating under HIMP to remove aspects of HIMP that are
inconsistent with the NPIS;
Establish a phased approach to implement the NPIS in
geographic clusters;
Establish separate applicability dates for large, small,
and very small establishments to comply with the provisions in the rule
that prescribe the new recordkeeping and microbiological sampling
requirements that will apply to all establishments that slaughter
poultry other than ratites. The applicability dates will provide
additional time for small and very small establishments to comply with
these provisions;
Revise the facilities requirements for the NPIS to require
that the online carcass inspection platform be height adjustable;
Clarify that the records that establishments operating
under the NPIS are required to maintain to document that the products
resulting from their slaughter operations meet the definition of RTC
poultry are subject to review and evaluation by FSIS personnel;
Revise the proposed regulation that prescribes maximum
line speed rates under the NPIS to emphasize establishments' existing
legal obligation to comply with the Occupational Safety and Health
Administration's regulations;
Establish a new subpart in the regulations that requires
each establishment that participates in the NPIS to submit on an annual
basis an attestation to the management member of the local FSIS circuit
safety committee stating that it maintains a program to monitor and
document any work-related conditions of establishment workers. Current
young chicken HIMP establishments that will be operating under the
updated SIP waivers described above will be required to submit the
annual attestation as a condition of their updated waivers;
Permit very small and very low volume establishments to
conduct sampling for microbial pathogens only at the post-chill point
in the slaughter and dressing process to monitor their process control
procedures instead of requiring sampling at pre- and post-chill, as was
proposed;
Prescribe a minimum frequency with which all
establishments that slaughter poultry other than ratites will need to
conduct testing for microbial organisms to monitor the effectiveness of
their process control procedures; and
Revise the definition for ``air chill'' to allow an
antimicrobial intervention to be applied with water at the beginning of
the chilling process if its use does not result in any net pick-up of
water or moisture during the chilling process. The initial
antimicrobial intervention may result in some temperature reduction of
the product if the majority of temperature removal is accomplished
exclusively by chilled air.
In addition, because the proposed pre-and post-chill sampling
requirements will not apply to ratite slaughter establishments, FSIS is
retaining the generic E. coli testing regulations as they apply to
ratites only, but is rescinding the provisions in these regulations
that apply to all other poultry classes. Poultry establishments other
than establishments that slaughter ratites will be required to comply
with the new sampling requirements prescribed in this final rule.

III. Comments and Responses

FSIS received over 250,000 comment letters in response to the
January 2012 proposed rule. Most comments were submitted as part of
organized write-in campaigns. The Agency also received a petition that
included approximately 150,000 signatures and form letters before the
comment period closed. The Agency received two petitions in November
2012, after the comment period had closed. One of these petitions
included approximately 180,000 signatures and 13,000 comments, and the
other included over 3,500 signatures. FSIS received an additional
petition in September 2013 with approximately 43,000 signatures. All of
the petitions requested that the Agency withdraw the proposed rule. The
issues raised in the petitions and comments submitted in November 2012
and September 2013 are similar to the issues raised by the petition and
comments submitted during the comment period. Therefore, the Agency
will address the issues raised in all of the petitions and associated
comments in this document.
Most of the individual comments were submitted as part of various
write-in campaigns initiated by consumer advocacy organizations, labor
unions, animal welfare organizations, and worker and human rights
advocacy organizations. FSIS also received individual comments from
private citizens, inspection personnel, and members of labor unions.
In addition to the individual comments, form letters, and
petitions, the Agency also received approximately 120 separate comment
letters from trade associations representing the poultry industry,
companies that conduct poultry slaughter operations, consumer advocacy
organizations, public health organizations, labor unions, animal
welfare advocacy organizations, members of academia, a State Department
of Agriculture, and worker/immigrant/human rights advocacy
organizations. Following is a summary of the comments and FSIS's
responses.

A. NACMPI Meeting and Public Process

Comments: Several consumer advocacy organizations expressed their
concern that FSIS published the proposed rule in the Federal Register
before it consulted with the NACMPI. According to the comments, the
Agency

[[Page 49571]]

is required to consult with members of the NACMPI before proposing
changes to its meat and poultry inspection program, and that the Agency
should have consulted with the NACMPI before publishing the proposed
rule to modernize poultry slaughter inspection.
Response: FSIS held the March 21, 2012, NACMPI public meeting in
response to a request from certain committee members representing
consumer advocacy organizations that the Agency convene the committee
to discuss the proposed rule. At the meeting, FSIS made clear that it
was interested in the committee's comments and suggestions, but that
the Agency was not seeking consensus from the committee.
FSIS disagrees that the Agency was required to consult with the
NACMPI before proposing changes to its poultry inspection program.
Under the Federal Meat Inspection Act (FMIA) and Poultry Products
Inspection Act (PPIA), the Secretary is authorized to ``appoint
advisory committees consisting of such representatives of appropriate
State agencies . . . to consult with him concerning State and Federal
programs with respect to [meat and poultry] inspection and other
matters within the scope of this chapter . . .'' (21 U.S.C. 661(a)(4)
and 21 U.S.C. 454(a)(4)). The Secretary of Agriculture established the
NACMPI to provide advice concerning State and Federal programs with
respect to meat and poultry inspection, food safety, and other matters
that fall within the scope of the FMIA and PPIA. Under the NACMPI
Charter, FSIS consults with the committee in carrying out its specific
responsibilities under 21 U.S.C. 607(c), 624, 645, 661(a)(3), and
661(c) of the FMIA and 21 U.S.C. 454(a)(3), 454(a)(4), 454(c), 457(b),
and 460(e) of the PPIA. These sections address: Type styles and sizes
of labeling; definitions and standards of identity or composition;
standards of fill of container; consistency of Federal and Federal-
State standards; storage and handling regulations; exemption of
establishments subject to non-Federal jurisdiction; Federal provisions
applicable to State or Territorial business transactions of a local
nature and not subject to local authority; scope of cooperation; and
State meat inspection requirements. Thus, the NACMPI charter does not
require that FSIS consult with the NACMPI before proposing changes to
its poultry inspection program, although the Agency conducted a public
meeting after the proposed rule was issued to seek feedback on the
proposal.
Comment: Some consumer advocacy organizations noted that FSIS
decided not to hold a technical public meeting as requested by a
coalition of consumer advocacy organizations.
Response: As stated in the Federal Register comment period
extension document, FSIS decided not to hold a public technical meeting
on the proposed rule because the Agency did not believe that such a
meeting would be useful (77 FR 24873). In April 2012, in response to a
request from a group of consumer advocacy organizations, FSIS extended
the comment period for the proposed rule. In the Federal Register
document that announced the comment period extension, FSIS summarized
issues that were raised in separate meetings with consumer and industry
stakeholders and clarified certain aspects of the proposed rule to help
inform stakeholder comments. In that document, the Agency also provided
additional information on worker safety issues and its tentative
strategy to implement the NPIS, and it solicited comments and data on
both issues. As such, FSIS provided the public with all of the
information it might have during a technical meeting, but through the
public comment process. Thus, the process for developing this final
rule was open and transparent and provided several opportunities for
stakeholder input.
Comment: One public health association said that FSIS failed to
comply with E.O. 12866 and E.O. 13563 requirements with respect to
public participation. The comment said E.O. 13563 requires that
agencies make all of the documents they rely on to justify rules
available to the public, and FSIS did not do so. According to the
comment, as of May 19, 2012, more than 80 days after the proposal was
published, there were only two documents in the public record posted by
USDA at Regulations.gov, the January 27, 2012, and April 26, 2012,
Federal Register document. The comment said that only 12 records are
posted on the FSIS Web site. According to the comment, the public is
unable to provide informed comments when the underlying records used to
develop the proposed rule are not available for review.
A labor union criticized the Agency for publishing a complex
statistical analysis while providing little raw data in the supporting
documents. The comment also questioned whether the comment period for
the proposed rule provided sufficient time for stakeholders to
adequately consider the supporting data.
Response: The Agency plans to post supporting documentation for
this final rule and future Agency rulemakings on Regulations.gov.
Although FSIS acknowledges that the underlying records used to develop
the proposed rule were not posted on Regulations.gov, the proposed rule
and all related documents, including supporting materials, were posted
on the FSIS Web site when the proposed rule published in the Federal
Register. The supporting materials included the Evaluation of the
HACCP-Based Inspection Models Project; the draft 2011 FSIS Risk
Assessment for Guiding Public Health-Based Poultry Slaughter
Inspection; the Agency's response to Peer Review Comments on its draft
2008 Risk Assessment for Guiding Public Health Risk-Based Poultry
Slaughter Inspection; and the On-Line and Off-Line Reprocessing In-
Plant Trial Analysis. The supporting data for the analyses in the
Evaluation of the HACCP-Based Inspection Models Project are presented
in tables in the report and in the appendices. The data and modeling
methods used in the 2011 FSIS Risk Assessment for Guiding Public
Health-Based Poultry Slaughter Inspection are also fully described in
the Appendix to that document.
The proposed rule and the Federal Register document extending the
comment period for the proposed rule were posted on both the FSIS Web
site and Regulations.gov when those documents published in the Federal
Register. The preamble to the proposed rule includes the FSIS Web site
link to the related materials and supporting documents, and it explains
that these documents are also available in the FSIS docket room. These
materials have been available on the Agency's Web site during the
entire comment period and remain available at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/proposed-rules/proposed-rules-2012/!ut/p/a1/jZDBCoJAEIafpQeQnVURPdqCpaUikdleYsHVFsxdVuvQ06d0UpKcOf3w_XzMIIoKRFv2EjXrhWxZM2bq3CADB3sEojTwAwgTK8jdZIfBxgNwnQAeHoE8Sw-EgJtYK_sL48O_frRCYOqYxDWiivV3Q7SVREXFS65ZY2hei67nGhVKSyU7Xhr62fBung0TsIkuiE51gIcddCd7HyUWpPYc-PGPL7B8sHqci_dx64XC33wAFla5ew!!/?1dmy¤t=true&urile=wcm%3apath%3a%2Ffsis-content%2Finternet%2Fmain%2Ftopics%2Fregulatory-compliance%2Fhaccp%2Fhaccp-based-inspection-models-project%2Fhimp-study-plans-resources%2Fpoultry-slaughter-inspection.
With respect to the comment that said that FSIS did not provide
sufficient time for public comment, E.O. 12866, as supplemented by E.O.
13563, states that agencies are to ``afford the public . . .

[[Page 49572]]

with a comment period that should generally consist of not less than 60
days.'' FSIS provided a 90-day comment period for the proposed rule and
then extended it for an additional 30 days. The Agency believes that
the public had ample time to consider the issues raised in the proposed
rule and supporting documentation in order to develop their comments.
Comment: A consumer advocacy organization criticized the Agency for
including the anticipated cost savings from the proposal in the
Agency's 2013 proposed budget to Congress before the public comment
period for the proposal closed.
Response: The Agency concluded that an open, transparent, and
effective budgetary process requires that the Agency report on the rule
and the associated estimated budget. In addition, the Appropriations
Committee Report that accompanied the FY 2013 appropriations bill
directs the Agency to notify the Committee of the status of the rule
not later than September 15, 2012.\2\
---------------------------------------------------------------------------

\2\ House Appropriations Committee report, p. 23 (http://appropriations.house.gov/uploadedfiles/hrpt-112-ap-fy13-agriculture.pdf).
---------------------------------------------------------------------------

B. The HIMP Report

In the proposed rule, FSIS explained that it was proposing to
establish a new system of inspection for young chickens and turkeys
based on its experience under the HACCP-based Inspection Models Project
(HIMP) pilot study (77 FR 4421). As discussed in the proposal, FSIS
initiated the HIMP pilot study in 20 young chicken and 5 turkey
slaughter establishments on a waiver basis after the Agency implemented
the 1996 HACCP regulations. Similar to the NPIS, under HIMP,
establishment personnel are responsible for sorting carcasses,
disposing of carcasses affected with conditions that would require that
they be condemned, and conducting any trim and reprocessing that they
believe necessary to correct removable defects.
In the HIMP inspection system, a single FSIS online carcass
inspector (CI) visually inspects every carcass at a fixed point on the
evisceration line immediately before the chiller. Under HIMP, an
offline verification inspector (VI) is responsible for conducting
system verification activities that the Agency has concluded will be
more effective in ensuring food safety, such as conducting offline
carcass verification checks for septicemia/toxemia and visible fecal
contamination, collecting samples for pathogen testing, and verifying
the effectiveness of an establishment's HACCP system by, among other
activities, reviewing the establishment's HACCP plan and HACCP
monitoring records, observing establishment employees performing tasks
specified in the HACCP plan, reviewing and determining the adequacy of
the corrective actions taken by the establishment when a deviation
occurs, and conducting measurements of critical control points (CCPs).
The Agency analyzed the data collected from the HIMP study and prepared
a written report that presents an evaluation of the model tested (see
the ``HIMP Report,'' available on the Agency's Web site at: http://www.fsis.usda.gov/wps/wcm/connect/fcd9ca3e-3f08-421f-84a7-936bc410627c/Evaluation_HACCP_HIMP.pdf?MOD=AJPERES).
The HIMP Report assesses FSIS inspection findings across four
interrelated inspection activities:
1. Inspection of each carcass by the CI to determine whether the
carcass is not adulterated and thus eligible to bear the mark of
inspection.
2. Verification by VIs of the establishment's execution of its HIMP
process control plan, under which establishment employees sort
acceptable and unacceptable carcasses and parts.
3. Verification of the establishment executing its sanitation SOPs
and HACCP system.
4. Verification of the outcomes of the establishment's HIMP process
control plan, both organoleptic and microbiological.
Inspection of each carcass by the CI to determine whether the
carcass is not adulterated. Based on an analysis of data collected from
April 1, 2009, through March 31, 2011, the HIMP Report found that fewer
than 0.0008 percent of the carcasses presented to the CI were affected
with septicemia/toxemia, and fewer than 0.08 percent had visible fecal
contamination. Despite these low rates, the CIs in HIMP establishments
detected carcasses affected with septicemia/toxemia at a rate of
0.000004 percent or 4 per 100 million carcasses slaughtered and
carcasses with visible fecal contamination at a rate of 0.0009 percent
or 9 per 1 million carcasses slaughtered.
Verification by VIs of the establishment's execution of its HIMP
process control plan. The HIMP Report compares the ratio of all offline
inspection procedures conducted in HIMP and non-HIMP establishments in
calendar year (CY) 2010. FSIS inspectors in HIMP establishments perform
offline inspection procedures to verify that the establishments are
properly executing their HIMP process control plans. This comparison
shows that overall in CY 2010, FSIS offline inspection personnel
performed 1.6 times more offline inspection procedures in HIMP
establishments than in non-HIMP establishments.
Verification of the establishment executing its sanitation SOPs and
HACCP system. The sanitation SOP and HACCP regulations are among the
regulations most strongly related to public health. The HIMP Report's
comparison of the ratio of offline inspection procedures performed in
HIMP and non-HIMP establishments in CY 2010 shows that FSIS offline
inspectors in HIMP establishments performed about 3.0 times more
sanitation SOP and HACCP inspection procedures than offline inspectors
performed in non-HIMP establishments. It also shows that offline
inspectors in HIMP establishments performed 3.4 more HACCP procedures
that include random verification of all HACCP requirements than
inspectors in non-HIMP establishments.
The HIMP Report also compares health-related non-compliances in
HIMP and non-HIMP establishments from CY 2006 through CY 2010. These
data show that health-related non-compliance record (NR) rates at HIMP
establishments are not statistically different from or are
statistically lower for all inspection procedures considered. The HIMP
Report also found that the rate of health-related non-compliances for
visible fecal contamination from CY 2006 through CY 2010 is about 1.6
times lower in HIMP establishments than in non-HIMP establishments.
Verification of the outcomes of the establishment's HIMP process
control plan, both organoleptic and microbiological. To assess the
outcomes of establishment's process control plans in addressing visible
food safety defects and defects related to the wholesomeness or quality
of the product, referred to as ``other consumer protection'' (OCP)
defects, FSIS developed performances standards for these defects based
on the performance of non-HIMP establishments. The performance
standards allow the Agency to compare the performance of establishments
operating under HIMP and non-HIMP inspection systems in controlling
visible food safety and OCP defects.
A comparison of the findings of the offline VIs in HIMP
establishments for the two-year period April 1, 2009, to March 31,
2011, with the HIMP food safety defect performance standards show that
the rate of septicemia/toxemia in carcasses processed in HIMP
establishments (8 per 1 million or 0.0008 percent) is 125 times lower
than

[[Page 49573]]

the HIMP performance standard (0.1 percent). The HIMP Report also found
that the rate of visible fecal material on carcasses processed in HIMP
establishments (fewer than 0.8 per thousand or 0.08 percent) is 19
times lower than the HIMP performance standards (1.5 percent). A
comparison of the findings of the offline VIs in HIMP establishments
for the two-year period January 1, 2009 through December 31, 2010, with
the HIMP OCP performance standards show that OCP defects identified on
carcasses processed in HIMP establishments averaged about half the
corresponding OCP HIMP performance standard.
To assess the microbiological outcomes of HIMP establishments'
process control plans, the HIMP Report analyzed data from FSIS's
Salmonella verification testing program collected from CY 2006 through
CY 2010. The HIMP Report compares the Salmonella percent positive rates
in 20 HIMP broiler establishments, 64 non-HIMP comparison
establishments, and all 176 non-HIMP broiler establishments. The
analysis shows that Salmonella positive rates in HIMP establishments
average about 80 percent of those in non-HIMP establishments.
In the preamble to the proposed rule, FSIS explained that the
Agency had concluded, based on analysis of the two-year data sets of
food safety and OCP defects, 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
defects and OCP defects that may affect the wholesomeness or quality of
the product (77 FR 4419). Data on health-related NRs collected from CY
2006 through CY 2010 show that non-compliances for fecal contamination
are lower in HIMP than in non-HIMP establishments and that HIMP
establishments have a higher compliance with sanitation SOP and HACCP
regulations. HIMP establishments also had equivalent or lower
Salmonella positive rates than non-HIMP establishments. The Agency
explained that it was proposing to establish a new poultry inspection
system informed by HIMP that would replace the SIS, NELS, and NTIS
inspection systems for young chickens and turkeys (77 FR 4421).
FSIS received several comments on the HIMP Report and the Agency's
analysis of the data collected under the HIMP study. Comments from the
poultry industry and trade associations representing the poultry
industry generally agreed with the findings of the HIMP Report and
supported the Agency's decision to establish a new poultry inspection
system. Comments from private citizens, consumer advocacy
organizations, labor unions, and members of academia raised issues and
concerns regarding the data collected under HIMP and the Agency's
conclusions based on the HIMP study results.
1. Data and Methods Used in the HIMP Report
Comment: Several comments from consumer advocacy organizations and
private citizens questioned whether data collected under that HIMP
study should be used to inform the NPIS. The comments said that the
HIMP pilot has never been independently evaluated to determine whether
the establishments operating under the HIMP inspection system are
producing food that is as safe as product produced in establishments
operating under non-HIMP inspection systems.
Response: FSIS disagrees with the comment. In 2002, after the
Government Accountability Office (GAO) issued its December 17, 2001,
report on HIMP \3\ (referred to as the ``2001 GAO report''), FSIS
contracted with a technical review team selected by the National
Alliance for Food Safety to review and evaluate the data collected from
young chicken establishments operating under HIMP. The review team
focused on the validity of the HIMP study design and methodology to
determine whether FSIS could use the organoleptic and microbial data
collected under HIMP to compare the performance of establishments
operating under HIMP and non-HIMP inspection systems. Overall, the
review team found that the HIMP study design and methodology were valid
and provided a useful and legitimate comparison of the HIMP and non-
HIMP inspection systems. The review team's findings are described in
the report: ``Review of the HACCP-Based Inspection Models Project by
the National Alliance for Food Safety Technical Team'' \4\ (also
referred to as ``The Hargis Report'').
---------------------------------------------------------------------------

\3\ GAO, 2001. Food Safety: Weaknesses in Meat and Poultry
Inspection Pilot Should Be Addressed Before Implementation: http://www.gao.gov/new.items/d0259.pdf.
\4\ The Hargis 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/OPPDE/nacmpi/Nov2002/Papers/NAFS97.pdf.
---------------------------------------------------------------------------

As stated in the report, ``[t]he review team noted some issues
related to optimal design and interpretation, but finds that overall
the data collected were both meaningful and useful and that the study
was designed and conducted under real-world conditions and
limitations.'' The review team also concluded that ``the overall design
and methodology . . . were perhaps the best available options to allow
for comparison of organoleptic data between the traditional and HIMP
systems.''
Comment: One consumer advocacy organization noted that the HIMP
Report said that the Agency's evaluations of microbiological and
inspection findings are based on data for calendar years (CY) 2006
through 2010, with certain exceptions where only more recent data are
available. According to the comment, the HIMP Report does not explain
why certain data are missing or why time periods for comparisons are
not uniform. The comment noted that the Agency only analyzed data from
CY 2010 when comparing the ratio of offline inspection procedures
performed in HIMP and non-HIMP establishments.
Response: The time periods for the data that were analyzed for the
HIMP Report vary because not all data were available as computerized
data sets. Data on the number of carcasses affected with food safety
and OCP defects were not available as computerized data sets. FSIS
field personnel manually collected these data and recorded the results
on paper forms. To reduce the burden on its field personnel, FSIS
decided that an analysis of two years' worth of these non-computerized
data sets would be sufficient. The HIMP report data for the number of
carcasses affected with food safety defects is from April 1, 2009,
through March 31, 2011, and data for carcasses affected with OCP
defects is from January 1, 2009, through December 31, 2010.
In the body of the HIMP Report, the Agency used computerized data
collected from CY 2010 to compare the ratio of offline inspection
procedures performed in HIMP and non-HIMP establishments. The Agency
used data from 2010 for this analysis because it was the most recent
data available. Tables C-2 and C-3 in the Appendix of the HIMP Report
contain summary information on non-compliances with sanitation SOP and
HACCP regulations and on the number of inspection procedures in HIMP
and non-HIMP establishments from CY 2006 through 2010. The data for
these years are similar to the data from CY 2010.
Comment: One comment noted that in the preamble to the proposed
rule, the Agency compares findings (1) by VIs of OCP defects between
January 1, 2009 and December 31, 2010; (2) by VIs of food safety
defects between April 1, 2009 and March 31, 2011; and (3) by CIs of
food safety defects between April 1, 2009 and March 31, 2011. The
comment

[[Page 49574]]

said that while these time periods are not very different, it is
possible that the slight shifts were made to conceal results that would
be less supportive, or that would even contradict Agency claims.
Response: The two-year period January 1, 2009 to December 31, 2010
was used to evaluate OCP defects, while the two-year period April 1,
2009, to March 31, 2011 was used to evaluate compliance with the HIMP
food safety standards. Both of these comparisons used the most recent
data available at the time. This is the reason for the different time
periods.
2. HIMP as the Basis for the NPIS
Comment: A trade association representing the poultry industry
stated that the HIMP pilot program has been successfully carried out
for the last 13 years. The comment said that during that time, food
safety records in establishments operating under the HIMP inspection
system have been as good as those in non-HIMP establishments. The
comment stated that the equivalent or lower pathogen rates in HIMP
establishments compared to non-HIMP establishments, as documented in
the HIMP Report, are evidence that the program has been successful. The
comment noted that this success is especially significant given that
the review team selected by the National Alliance for Food Safety
determined that food safety performance standards provide a
scientifically valid measure by which performance of HIMP
establishments can be evaluated (Hargis et al. 2002). The comment
stated that, based on the data, the trade association agreed with the
Agency's conclusion that the NPIS is a positive step toward enhancing
food safety.
On the other hand, several consumer advocacy organizations
questioned whether it is appropriate for FSIS to use the HIMP study
results to predict how establishments will perform when operating under
the NPIS. The comments noted that the 2001 GAO report criticized FSIS
for not randomly selecting establishments for the HIMP pilot study and
questioned whether the data generated by the pilot could be used to
predict how all of the young chicken establishments would perform if
FSIS were to adopt the HIMP inspection system nationwide.
Several comments stated that because participation in the HIMP
study was voluntary and required that poultry establishments meet
additional food safety and OCP performance standards, participating
establishments could be viewed as high performers with respect to food
safety. The comments asserted that for this reason, data from the HIMP
pilot may not represent what FSIS is likely to see when the majority of
young chicken and turkey slaughter establishments begin to operate
under the NPIS.
Response: The trade association comments support the agency
proposal. With regard to concerns raised by the consumer advocacy
organizations, FSIS addressed these issues in its comments on and
response to the 2001 GAO Report. In that document, FSIS stated that
although not randomly selected, there is evidence that volunteer
establishments participating in the HIMP study are typical of the
industry. The volunteer establishments represent diversity in
geography, corporate structure, management styles, number of
evisceration lines, product distribution patterns, inspection system in
use prior to the pilot, and other variables. In addition, the Hargis
Report, discussed above, noted that the establishments selected for the
HIMP pilot represent the States supplying the majority of domestic
chicken production and the size range of establishments included in the
study are representative of almost 90 percent of chickens slaughtered
in federally-inspected facilities in the United States. The Hargis
Report noted that establishment design, equipment, and procedures
within poultry establishments are relatively uniform. The report
concluded that ``[i]t is very difficult to hypothesize a geographic or
plant-selection bias in this study.''
Comment: Two consumer advocacy organizations stated that the NPIS
is not an exact replica of the HIMP pilot, which raises further
concerns about whether results from the HIMP pilot accurately reflect
how establishments will perform under the NPIS.
Response: Although the NPIS is not an exact replica of HIMP, the
NPIS was informed by the data collected under HIMP. These data
demonstrate that an inspection system that combines the features
described in this document, which include carcass sorting by
establishment employees, a CI that conducts an inspection of each
carcass before the chiller, and, most important, a VI that conducts
more offline inspection activities that specifically focus on food
safety, does not reduce the effectiveness and may, in fact, lead to
better compliance with sanitation and HACCP regulations and in
carcasses with lower levels of fecal contamination and equivalent or
lower levels of Salmonella contamination.
In addition, as discussed in detail below, in the 2014 risk
assessment, analysis of historical data shows a statistically
significant correlation between specifically targeted unscheduled
offline inspection procedures and reductions in Salmonella positive
samples in young chicken slaughter establishments and Campylobacter
positive samples in young turkey slaughter establishments. Modeled
scenarios involving an increase in targeted inspection activities
(specifically unscheduled offline inspection activities, rather than a
randomly selected set of activities) suggest that implementing the NPIS
would likely result in public health benefits. Assuming that the number
of offline inspection procedures performed in all poultry slaughter
establishments increase proportionately to the number of such
procedures currently performed in HIMP establishments, FSIS's risk
model predicts a likely public health benefit. Consistent with the
underlying assumptions of the model, it is reasonable to conclude that
inspection systems in which Agency resources continue the core online
inspection activities while enhancing the frequency and focus of
unscheduled offline activities directly related to food safety, such as
HIMP and the NPIS, would likely result in a lower prevalence of
carcasses contaminated with Salmonella and Campylobacter, which in turn
would likely lead to fewer human illnesses.
Comment: One consumer advocacy organization criticized the Agency's
evaluation of HIMP. The comment stated that the HIMP Report compares
the current performance of HIMP establishments with performance levels
observed from 1998-2000 when FSIS collected baseline data from
establishments that later joined the HIMP pilot.
The comment also stated that the Agency failed to explain how the
performance level of the bottom four establishments that entered the
HIMP pilot is representative of approximately 200 other establishments
more than a decade later.
Response: The Hargis Report, described above, concluded that the
design of the HIMP pilot ``is generally appropriate for a field study
of this nature, and the methodologies employed generally allow for
interpretation and comparison of [HIMP versus non-HIMP inspection
systems.]'' The Hargis Report also concluded that comparison of HIMP
food safety and OCP performance levels with performance standards does
provide a scientifically valid measure by which changes in food safety
and OCP performance under HIMP can be assessed.

[[Page 49575]]

With respect to the comment that suggests that the HIMP OCP
performance standards represent the performance level of the bottom
four establishments that entered the HIMP pilot, the HIMP OCP
performance standards are set at the 75th percentile of what was
achieved under the Research Triangle Institute (RTI) baseline study of
16 young chicken establishments under non-HIMP inspection systems
before they entered the HIMP study. Thus, the performance standards
were set so that 25 percent of the establishments that entered HIMP
would have to improve upon their baseline results in order to meet the
more stringent standards.
3. Carcass Inspection Under HIMP
In the preamble to the proposed rule, FSIS explained that the
Agency 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 (77 FR 4419). With respect to food safety-related defects,
the Agency noted that data collected from the HIMP study show that the
levels of carcasses affected with septicemic or toxemic conditions
(also referred to as ``septicemia/toxemia'') or visible fecal
contamination in HIMP establishments is very low (77 FR 4415). The HIMP
Report concluded that notwithstanding these very low levels, the data
demonstrate that CIs in HIMP establishments effectively identify
carcasses affected with septicemia/toxemia and visible fecal
contamination. Several consumer advocacy organizations commented on
this conclusion.
Comment: Some consumer advocacy organizations stated that the CI
detection rate for visible fecal contamination and septicemia/toxemia
is based on the assumption that the rates at which VIs detect these
food safety-related conditions represents the level at which these
conditions occur in the establishment. The comments questioned this
assumption. The comments noted that in HIMP establishments, the VI
collects eight 10-bird verification samples per line per shift. The
comment asserted that there is no evidence to indicate that this sample
size is sufficient to represent the true level of food safety defects
on carcasses throughout the shift.
Response: FSIS disagrees that the CI detection rate is based on the
assumption that the rate at which VIs detect carcasses affected with
septicemia/toxemia or visible fecal contamination represents the level
at which these conditions occur in the establishment. The CI detection
rate is the rate at which CIs in HIMP establishments detected carcasses
with these food safety-related conditions before the carcasses entered
the chiller. It is not based on the VI detection rate.
FSIS believes that its sampling for food safety defects under HIMP
is sufficient to reflect the level of food safety defects on carcasses
processed in HIMP establishments. Statistically, given the sample
design, the precision of an estimate of an establishment's level of
food safety defects depends primarily on the total number of samples
for an establishment collected over time.
The food safety performance standards, which are based on thousands
of samples collected by a 3rd party contractor and reflect the level of
food safety defects on carcasses processed in establishments before
they entered the HIMP pilot, vary by defect category. The performance
standard for septicemia/toxemia is 0.1 percent, and the performance
standard for visible fecal contamination is 1.5 percent. When deciding
the number of samples that FSIS should take to reflect an
establishment's level of food safety defects over time, FSIS determined
that collecting 80 birds per line per shift would provide an estimated
defect rate that was close to the true defect rate.
For example, if the true defect rate for visible fecal
contamination was 0.1 percent at an establishment that operated one
line for two shifts, 300 days per year, taking an 80 bird sample per
line per shift would give a total of 48,000 samples a year, per line.
This number of samples, assuming a random distribution of defects
throughout the year, would give FSIS an estimated defect rate between
0.72 and .128 percent with about 95 percent probability. Thus, FSIS
believes that the specified sample size is sufficient to make general
comparisons of average defect rates among establishments or lines.
Comment: One consumer advocacy organization stated that another
reason that the VI detection rate may not represent the actual level of
food safety-related defects in HIMP establishments is that statements
it obtained from HIMP inspectors indicate that establishment employees
take greater care to prevent and remove visible fecal contamination and
to identify and remove septicemic/toxemic carcasses when they know that
the VI inspector is getting ready to take a sample.
Response: The comments seem to suggest that establishment employees
are able to manipulate the results of the VI's verification checks.
FSIS disagrees.
As noted above, VIs in HIMP establishments collect scheduled
verification samples that consist of eight 10-bird samples per line per
shift. VIs also collect targeted, unscheduled 10-bird samples in
response to VI or CI findings of excessive food safety or OCP carcass
defects.
VIs in HIMP establishments collect scheduled and unscheduled
verification samples for septicemia/toxemia and visible fecal
contamination using the same offline verification methodology that
offline inspectors in non-HIMP establishments use to collect samples
for visible fecal contamination checks. In both HIMP and non-HIMP
establishments, offline inspectors do not inform establishment
employees when they collect verification samples and, equally
important, take care to ensure that the samples represent the operating
conditions in the establishment. Thus, there is no reason to believe
that employees in HIMP establishments have any significant opportunity,
and certainly no additional opportunity, to affect the results of the
verification checks.
Comment: Some consumer advocacy organizations said that the data in
the HIMP Report do not support the Agency's conclusion that CIs are
able to identify carcasses affected with visible fecal contamination
and septicemia/toxemia.
With respect to visible fecal contamination, one consumer advocacy
organization stated that the data presented in the HIMP Report indicate
that CIs did not detect 88 out of 89 birds with fecal contamination
going down the line. The comment stated that the inspectors in the VI
position who were able to examine both the inside and the outside of
the bird detected visible fecal contamination on the carcass at
approximately 90 times the rate that the CIs detected it. Another said
that based on the data, it is reasonable to calculate that CIs failed
to detect over a quarter of a million carcasses with fecal
contamination in the 20 HIMP establishments within the two-year period
of data collection.
With respect to septicemia/toxemia, one comment said that data
presented in the HIMP Report indicate that CIs detect approximately 1
of every 200 carcasses affected by septicemia/toxemia. The comment said
that this means that the CI does not detect 199 of every 200 carcasses
affected with septicemia/toxemia.
Response: FSIS disagrees with the commenters' conclusions. The
commenters' assessments are based on a

[[Page 49576]]

comparison of the results of the CI's carcass inspection and the VI's
carcass verification checks and do not take into account the difference
between the role of the CI and VI under HIMP. Under HIMP, the
inspections performed by the VI and CI serve different purposes and are
not done in the same way. Thus, the rate at which VIs identify food
safety defects when conducting offline verification checks is not an
appropriate basis for assessing whether the CI is conducting an
effective inspection of each carcass leaving the slaughter line.
Under the HIMP inspection system, the VI and CI have different but
complementary roles in ensuring that poultry products leaving the
slaughter line are safe and wholesome. CIs are responsible for
conducting a continuous online inspection of each carcass to determine
whether it is not adulterated. The VI's role is very different. VIs
collect carcass samples before the CI inspection station after the
establishment has conducted sorting, trimming, and reprocessing
activities to monitor and evaluate the establishment's process
controls. The samples collected by VIs may be either ``scheduled'' or
``unscheduled.''
On the one hand, VIs collect eight randomly selected 10-bird
samples per line per shift. These are referred to as the ``scheduled''
samples because the IIC schedules the collection of the eight sample
sets before each shift. On the other hand, VIs also collect targeted,
unscheduled 10-bird samples as directed by the IIC in response to VI or
CI findings of excessive food safety or OCP carcass defects. These
samples are in addition to the 80-bird scheduled samples. Because the
VI's unscheduled samples are collected when excessive carcass defects
have been identified, the results typically show higher rates of
carcass defects than the VI's scheduled sampling results.
The VI detection rates in the HIMP report reflect the combined
results of the VI's scheduled and unscheduled sampling and are thus are
much higher than the rates that would have resulted had the VI only
performed scheduled carcass sampling. Because CIs under HIMP perform an
online inspection of each carcass, the CI detection rates are not
subject to the same sampling bias introduced by the unscheduled
sampling that VIs perform during high defect periods. Significantly,
FSIS has not captured what percent of the defects found by VIs were
found in scheduled as opposed to unscheduled sampling. Thus, the VI and
CI detection rates are not comparable. Therefore, as stated above, the
comparisons of the VI and CI detection rates cited by the comments do
not provide a valid assessment of the CI's ability to conduct an
effective online carcass inspection.
4. Public Health-Related Non-Compliances
In the proposed rule, the Agency noted that the HIMP Report shows
that HIMP establishments have public health-related non-compliance
record(NR) rates that are not statistically different from or that are
statistically lower than the rates for non-HIMP establishments (77 FR
4416-4417). The Agency also noted that HIMP establishments had fewer
NRs for visible fecal contamination than non-HIMP establishments.
Several consumer advocacy organizations, FSIS inspectors, and a labor
union commented on these conclusions.
Comment: Comments from inspectors, labor unions, and consumer
advocacy organizations stated that the location of the establishment's
critical control point (``CCP'') for food safety defects may prevent a
CI from issuing an NR even if the CI detects such a defect. The
comments noted that at the start of the HIMP pilot, the CCPs for
visible fecal contamination and septicemia/toxemia were located before
the FSIS carcass inspection station. The comments stated that before
FSIS began collecting data to support the proposed rule, the Agency
allowed the HIMP establishments to move their CCPs for fecal
contamination and septicemia/toxemia to points after the CI. One
comment said that the timing for allowing establishments to move CCPs
to a point after the CI suggests that the primary purpose was to reduce
the number of NRs issued to HIMP establishments for these conditions.
Another comment said that the fact that CIs cannot issue an NR if they
observe food safety defects before the CCP, affects the HIMP Report's
CI detection rate statistics.
Response: FSIS disagrees with the suggestion that the location of
the CCP with respect to the CI affects the comparison of NR rates
between HIMP and non-HIMP establishments. The HIMP Report's analysis of
NRs for visible fecal contamination in HIMP and non-HIMP establishments
is based on a comparison of visible fecal NRs detected through offline
verification activities, not on the CI detection rate, as suggested by
one of the comments.
As noted above, the VI under HIMP collects carcass samples after
establishment employees have sorted and trimmed the carcasses, but
before the carcasses are presented to the CI. If the VI detects visible
fecal contamination offline, the VI issues an NR because the
establishment violated the Agency's zero tolerance for visible fecal
contamination. If a CI observes a carcass with visible fecal
contamination the CI stops the line to prevent the carcass from
entering the chiller. The location of the establishment's CCP for food
safety defects does not affect the CI's or VI's duties under HIMP.
Thus, because the NR rate for visible fecal contamination under HIMP is
based on the VI detection rate, the location of the CCP with respect to
the CI inspection station does not affect the HIMP Report's analysis of
visible fecal NRs.
With respect to the comment that suggested that the location of the
CCP affects the CI detection rate statistics, the CI detection rate
reflects the rate at which CIs stop the line to prevent carcasses with
food safety defects from entering the chiller. Thus, contrary to the
commenter's suggestion, the location of the CCP after the CI inspection
station does not affect the CI detection rate.
Comment: One comment stated that the Agency provided no information
to demonstrate that documentation policies and opportunities for
documenting public health-related NRs were the same in HIMP and non-
HIMP establishments. The comment stated that the 2001 GAO report on
HIMP noted that after the switch to HIMP, a substantial number of
establishments saw increased fecal NR rates. The comment said that the
GAO report cited increased line speeds under HIMP as a potential factor
for the increased rate of fecal NRs. The comment said that these
findings suggest that the transition to HIMP may result in increased
rates of fecal contamination.
Response: As noted in the Agency's comments on the 2001 GAO report,
under HIMP, the Agency performs verification checks on approximately 80
carcasses per line per shift as opposed to verification on
approximately 20 carcasses per line for fecal contamination under non-
HIMP broiler inspection. In addition, VIs under HIMP perform more
offline inspection activities that FSIS has concluded are more
effective in ensuring food safety than inspectors perform in non-HIMP
establishments. Thus, FSIS inspectors in HIMP establishments have more
opportunities for detecting non-compliances with regulatory
requirements that are directly related to public health than inspectors
do in non-HIMP establishments. The procedures for documenting public-
health related NRs are the same for both HIMP and non-HIMP
establishments.
Although the GAO report cited increased line speeds in HIMP
establishments as a potential factor for

[[Page 49577]]

the increased rate of fecal NRs, the Agency is not aware of any data to
support this hypothesis. The increased rates of fecal NRs that occurred
at the beginning of the HIMP pilot could just as easily be the result
of increased monitoring under the HIMP inspection system rather than an
increase in fecal contamination. Further, the final rule includes a
maximum line speed of 140 bpm under the NPIS rather than the 175 bpm
allowed in the HIMP pilot.
Comment: A consumer advocacy organization stated that it had
recently acquired records of NRs written for visible fecal
contamination within the last year from two HIMP establishments and two
non-HIMP establishments. The comment stated that to the best of the
commenter's knowledge, all of the establishments are large
establishments with two production lines and two production shifts. The
comment said that the non-HIMP establishments had 19 and 23 NRs for
visible fecal contamination, respectively, and the HIMP establishments
had 93 and 173 visible fecal NRs, respectively. The comment stated that
these comparisons add to the concerns that the lower NR rates for HIMP
establishments described in the HIMP Report may not be good indicators
of the actual level of food safety defects on carcasses.
Response: Because the consumer advocacy organization did not
indicate where it obtained the data or which establishments the data
are from, FSIS is unable to respond to the comment in detail.
The HIMP Report's comparison of visible fecal NRs issued from
offline verification checks in HIMP and non-HIMP establishments
compares `rates,' which adjust for the number of samples taken. The
report shows that fecal NR rates at HIMP establishments are
statistically lower than those in both the control set of 64 non-HIMP
establishments and the 176 all non-HIMP comparison set. In addition,
the rate of visible fecal material contamination on carcasses in HIMP
establishments is about half that in non-HIMP establishments. Thus,
when the sample is viewed as a whole and rates are the unit of
comparison, the data show that HIMP establishments have both slightly
lower visible fecal NR rates and slightly lower rates of visible fecal
contamination than non-HIMP establishments.
The comparison included in the comment is based on NR rates from
two HIMP establishment and two non-HIMP establishments and does not
necessarily reflect the average NR rates for all HIMP establishments.
Comment: Another consumer advocacy organization stated that it had
received records for the first shift of production for 11 young chicken
and 3 young turkey HIMP establishments from FSIS through a Freedom of
Information (FOIA) request. The organization analyzed documents that
covered the period of January 2011 through August 2011. According to
the comment, the overwhelming number of NRs filed for the 14
establishments was for visible fecal contamination found on the
carcasses. The comment stated that out of 229 NRs filed from March to
August 2011, 208 (90 percent) were for visible fecal contamination.
Other comments referenced this finding.
Response: The analysis conducted by the consumer advocacy
organization is not inconsistent with the conclusions in the HIMP
Report. While it is true that a large percentage of public health-
related NRs in poultry slaughter establishments are for visible fecal
contamination, the occurrence of fecal contamination on carcasses in
HIMP establishments is fewer than 8 per ten thousand carcasses, which
is about 19 times lower than the HIMP performance standards. In
addition, the rate of visible fecal material contamination on carcasses
in HIMP establishments averages about half that in non-HIMP
establishments (Table 3-7 in HIMP Report).
5. OCP Standards Under HIMP
In the preamble to the proposed rule, FSIS noted that data from the
HIMP Report show that OCP defects identified on carcasses processed in
HIMP establishments averaged about half the corresponding OCP HIMP
performance standards (77 FR 4418). Based on the HIMP data, the Agency
concluded that establishments operating under the HIMP inspection
system performed better than establishments operating under non-HIMP
inspection systems with respect to OCP defects. Several consumer
advocacy organizations and some private citizens commented on this
conclusion.
Comment: Some consumer advocacy organizations asserted that the OCP
standards under HIMP were not stringent. The comments said that even
with these less than rigorous OCP defect levels, HIMP establishments
were still just meeting the standards.
Response: While there is likely to be some variation in performance
among establishments, for the two year period from CY 2009 through
2010, FSIS verification data show that OCP defect levels in HIMP
establishments averaged about half the corresponding OCP performance
standards.
In addition, the HIMP OCP performance standards are set at the 75th
percentile of what was achieved under the RTI's baseline study of the
performance of 16 establishments before they entered the HIMP study.
Thus, 25 percent of the establishments that entered HIMP have had to
improve upon their baseline results to meet the more stringent
standards.
Comment: One comment noted that the HIMP study's statistics on
compliance with OCP performance standards are based on a sampling of up
to 80 carcasses per slaughter line per shift of production. The comment
asserted that when each slaughter line is processing upwards of 100,000
chickens per eight hour shift, this sample size is likely to be too
small to accurately reflect the level of OCP defects on RTC carcasses
produced by the establishment.
Response: FSIS disagrees with the comment. FSIS believes that its
sampling for OCP defects under HIMP is sufficient to reflect an
establishment's level of OCP defects. Statistically, given the sample
design, the precision of an estimate of an establishment's level of OCP
defects depends primarily on the total number of samples for an
establishment collected over time.
The OCP performance standards, which are based on a tightening of
the FPS for removable animal diseases and trim and dressing defects for
establishments before they entered the HIMP pilot, vary by OCP defect
category. For example the performance standard for OCP-1, Condition-
Animal Diseases, is 1.7 percent, and the performance standard for OCP-
3, Digestive Content (Ingesta), is 18.6 percent. When deciding the
number of samples that FSIS should take to reflect an establishment's
level of OCP defects over time, FSIS determined that collecting at most
80 birds per line per shift would provide an estimated defect rate that
was close to the true defect rate. For example, if the true defect rate
for OCP-1 defects was 1 percent at an establishment that operated one
line for two shifts, 300 days per year, taking an 80 bird sample per
line per shift would give a total of 48,000 samples a year, per line.
Eighty samples are not always collected; but in general, close to this
number were collected daily. It is reasonable to assume that the total
number of samples would not be less than 90 percent, or 43,200 samples.
This number of samples, assuming a random distribution of defects
throughout the year, would give FSIS an estimated defect rate between
0.905-1.095 percent with about 95 percent probability. Thus, FSIS
believes that the specified sample

[[Page 49578]]

size is sufficient to make general comparisons of average defect rates
among establishments or lines.
6. Salmonella Positive Rates in HIMP Establishments
The HIMP Report compares Salmonella positive rates for HIMP young
chicken slaughter establishments with a control set of 64 non-HIMP
establishments and all 176 non-HIMP broiler establishments (77 FR 4418-
4419). The data show that Salmonella positive rates are equivalent or
lower in HIMP establishments than they are in non-HIMP establishments.
The Agency concluded that the increase in offline inspection activities
provided for under HIMP resulted in the initial lower levels of
Salmonella contamination in HIMP establishments. Several consumer
advocacy organizations and private citizens commented on the HIMP
Report's analysis of Salmonella positive rates in HIMP and non-HIMP
establishments and on the Agency's conclusions with respect to this
analysis.
Comment: A consumer advocacy organization stated that the HIMP
Report's analysis of the Salmonella positive rates for HIMP
establishments may not reflect the rates for all establishments
operating under HIMP. The comment noted that data from the Agency's
Salmonella testing program show that the Agency collected data on
Salmonella positive rates from only 14 HIMP establishments in 2006, 17
HIMP establishments in 2007, and 15 HIMP establishments in 2008. The
comment noted that the Agency collected Salmonella data from only 10 of
the 20 HIMP broiler establishments in 2010. The comment also said that
the Agency provided no comparison on Salmonella results in the turkey
establishments. One member of academia said that the Agency's microbial
sampling and analysis under the HIMP pilot were not performed with
adequate frequency or power to detect sporadic low-level contamination
of carcasses.
Response: FSIS uses the same methodology to schedule and conduct
verification sampling for Salmonella in both HIMP and non-HIMP
establishments. Under the FSIS risk-based methodology for scheduling
Salmonella verification sample sets, not all establishments are sampled
every year. FSIS schedules up to 75 new sample sets each month. The
establishments and products selected for sample sets are chosen
according to a risk-based algorithm that involves sorting the list of
eligible establishments and their respective products by certain
criteria and selecting the top 75 from this list. Depending on the
frequency of production, product type, and availability of resources,
the time to complete a sample set ranges from less than two months to
over a year. In establishments that produce more than one product
subject to Salmonella verification testing, only one product is tested
at a time. However, since the same method is used in both HIMP and non-
HIMP establishments, Salmonella positive levels represent a valid means
of comparing the performance of HIMP and non-HIMP establishments.
With respect to the comment that said that the Agency's microbial
sampling and analysis under the HIMP pilot were not performed with
adequate frequency or power to detect sporadic low-level contamination
of carcasses, the sampling and analysis for Salmonella under the HIMP
pilot was used to compare performance of both HIMP and non-HIMP
establishments, not to detect sporadic, low-levels of contamination in
HIMP establishments.
Comment: One consumer advocacy organization said that the Agency's
conclusion that HIMP establishments have lower Salmonella positive
rates than non-HIMP establishments is misleading because the HIMP
Report compared Salmonella positive rates for HIMP establishments with
all establishments operating under non-HIMP inspection systems.
According to the comment, the Agency should have compared rates for
HIMP establishments with the rates for comparably sized non-HIMP
establishments.
Response: The HIMP Report compared Salmonella positive rates in
HIMP establishments with both comparable non-HIMP establishments and
all young chicken slaughter 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 chicken
in all 5 years considered in the study. The analysis shows that with
respect to Salmonella positive rates, the HIMP establishments performed
better than or as well as both the comparison set of 64 non-HIMP
establishments and the set of all 176 non-HIMP establishments from CY
2006 through 2010.
Comment: A consumer advocacy organization asserted that the
Salmonella positive rates in HIMP establishments do not support the
Agency's claim that HIMP establishments have consistently performed
better under HIMP than they did under non-HIMP inspection systems. The
comment stated that the Agency's own Salmonella data from 1998-2007
demonstrate that 14 of the 20 HIMP establishments had lower Salmonella
positive rates under the non-HIMP inspection systems than they did
under the HIMP, and that the average Salmonella positive rate for all
20 of the HIMP establishments was better when the establishments were
operating under non-HIMP inspection systems. The organization conducted
its own analysis of the Agency's Salmonella data from January 1, 2006
through September 20, 2007 and said that its analysis shows that the
HIMP establishments had an average Salmonella positive rate of 8.9
percent, while the non-HIMP establishments had an average rate of 6.5
percent.
Response: In CY 2006 through 2008, the Salmonella positive rate in
HIMP establishments was statistically significantly lower than in the
64 non-HIMP comparison set, and there was no statistically significant
difference in CY 2009 and CY 2010. A comparison of HIMP establishments
with all non-HIMP broiler establishments shows that the Salmonella
positive rate in HIMP establishments was statistically significantly
lower in CY 2006 through 2009 and not statistically significantly
different in CY 2010. This analysis demonstrates that with respect to
Salmonella positives rates, HIMP establishments are performing at least
as well as current non-HIMP establishments.
With respect to Salmonella data from January 1, 2006, through
September 20, 2007, referenced by the comment, FSIS has analyzed the
most recent data from that time period and found Salmonella positive
rates of 7.55 percent and 9.61 percent for HIMP and non-HIMP
establishments, respectively.
Comment: A consumer advocacy organization stated that in CY 2009
and CY 2010, HIMP establishments had higher Salmonella positive rates
than the 64 non-HIMP comparison establishments. The comment noted that
the HIMP Report shows that the rates for the HIMP establishment were
4.9 percent and 4.7 percent in CY 2009 and CY 2010, respectively, and
the rates for the non-HIMP establishments for these years were 4.3
percent and 4.0 percent, respectively. The comment suggested that
before moving forward with the NPIS, FSIS should first try to
understand why this happened.
Response: FSIS disagrees with the comment's suggestion that HIMP
establishments had higher Salmonella rates than non-HIMP establishment
in CY 2009 and CY 2010. The differences

[[Page 49579]]

in Salmonella positive rates in CY 2009 and CY 2010 noted by the
comment are not statistically significant. On the other hand, in CY
2006 through 2008, the Salmonella positive rate in HIMP establishments
was statistically significantly lower than in the 64 non-HIMP
comparison set.
Comment: Some consumer advocacy organizations stated that
reductions in Salmonella positive rates may be the result of factors
other than increased offline inspection procedures performed under the
HIMP inspection system. The comments noted that from CY 2006 through
2008, Salmonella positive carcass rates in HIMP establishments were
statistically significantly lower than in the non-HIMP comparison
establishments, but that in CY 2009 and CY 2010, there was no
statistically significant difference. The comments also noted that both
HIMP and non-HIMP establishments lowered their Salmonella positive
rates considerably between CY 2006 and CY 2010.
The comments asserted that because the Agency did not report any
changes to the HIMP or non-HIMP inspection systems during that time, it
is reasonable to assume that factors other than increased offline
inspection activities in HIMP establishments may have caused such a
significant decrease in Salmonella positive rates. One comment noted
that in 2008 FSIS began publishing the names of establishments in
Categories 2 and 3 under the Agency's new Salmonella performance
standards. The comment stated that the data for CY 2009 and CY 2010 may
indicate that the industry as a whole reduced its Salmonella positive
rates as a result of this initiative. Another comment stated that the
decline in Salmonella positive rates may have been caused by an
increase in the use of online reprocessing technology throughout the
industry.
Response: In the preamble to the proposed rule, the Agency
explained that results in CY 2010 most likely reflect the effects of
the Salmonella initiatives that FSIS began implementing in 2006 to
reverse the multi-year trend of persistently higher percent positive
rates for Salmonella detected through the Agency's HACCP verification
testing each year (77 FR 4419). As a result of these initiatives, the
industry reduced the incidence of positive Salmonella results,
particularly those establishments with the highest Salmonella positive
rates. Nonetheless, before these initiatives were fully implemented,
the HIMP report shows that HIMP establishments performed better than
non-HIMP establishments with respect to Salmonella positive rates. The
reduction in Salmonella positive rates in both HIMP and non-HIMP
establishments reflects the effectiveness of FSIS's initiatives to
reduce Salmonella industry-wide.
Comment: One member of academia said that the Agency needs to
conduct more frequent sampling for a broader range of pathogens to
assess the impact of the HIMP inspection system.
Response: Salmonella is a key pathogen of concern in poultry
products. FSIS conducts Salmonella verification sampling in both HIMP
and non-HIMP establishments. Thus, Salmonella positive rates are a
valid means of comparing the performance of both HIMP and non-HIMP
establishments.

C. The Risk Assessment

The preamble to the proposed rule explained that in June 2011, FSIS
completed a quantitative risk assessment to model 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
(77 FR 4420). FSIS updated the 2011 Risk Assessment in response to
public comments received on the January 2012 proposed rule; that
version of the risk assessment was subsequently posted to the FSIS Web
site in August 2012 (referred to as the August 2012 version). In
addition, the 2011 risk assessment was subjected to independent
external peer review; the risk assessment was further updated in
response to the peer review comments. It has also benefited from
editing consistent with the Office and Management memorandum, Final
Guidance on Implementing the Plain Writing Act of 2010 (M-11-15),
striving to make the risk assessment report language ``clear, concise,
well-organized. The most recent version of the risk assessment, which
reflects the revisions made in response to public and peer review
comments, is referred to as the July 2014 version. Both the August 2012
version and the July 2014 versions have been posted to the FSIS Risk
Assessment Web page at: http://www.fsis.usda.gov/wps/portal/fsis/topics/science/risk-assessments.
The HIMP Report explained that FSIS inspectors performed more
offline inspections to verify compliance with sanitation SOP and HACCP
regulations in HIMP establishment than they do in non-HIMP
establishments. The regression analysis of historical data that was
included in the risk assessment showed a statistically significant
correlation between unscheduled offline inspection procedures and
reduction in the prevalence of Salmonella and Campylobacter positive
samples. Based on these results, FSIS thinks it is reasonable to
conclude that the redeployment of Agency resources to unscheduled
offline activities is likely to contribute to improved food safety
resulting from a lower prevalence of carcasses contaminated with
Salmonella and Campylobacter, which in turn we expect to lead to fewer
human illnesses.
Comment: Several comments requested that the Agency clarify the
status of the 2011 risk assessment's peer review. The comments noted
that the Agency had prepared a risk assessment in 2005 that was peer
reviewed. The comments said as a result of the peer review, the Agency
prepared a revised risk assessment in 2008 but, according to the
comments, the docket for the proposed rule contains neither the 2008
risk assessment nor a peer review of that risk assessment.
Response: The FSIS ``Risk Assessment for Guiding Public Health-
Based Poultry Slaughter Inspection'' has been available to the public
on the FSIS Risk Assessment Web site since 2008 at: http://www.fsis.usda.gov/wps/wcm/connect/07c57a64-932f-4ebb-977b-2b10e45a1830/Poultry_Slaughter_Risk_Assess_Jan2008.pdf?MOD=AJPERES. The analysis
was originally peer reviewed in 2006 by an independent group of
mathematical modeling specialists. The risk assessment was modified and
improved based on the initial peer review. Because the model and
analysis has continued to evolve, the 2011 version of both the model
and analysis have undergone a peer review. The 2011 risk assessment has
been updated based on the peer review comments. The 2011 risk
assessment, the peer review comments, FSIS's response to those
comments, and the current version of the risk assessment are available
on the FSIS Web site at: http://www.fsis.usda.gov/wps/wcm/connect/8f374626-ee06-49d3-9d41-6eb65ad32cbb/Poultry_Slaughter_Risk_Assess_Aug2012.pdf?MOD=AJPERES.
Comment: A consumer advocacy organization said that the risk
assessment provides little raw data, little explanation of how it was
analyzed, and is largely silent on the assumptions upon which it was
based. A comment from a labor union was also critical of the FSIS risk
assessment.
Response: FSIS generally disagrees with the comments. The risk
assessment uses all relevant data taken from FSIS's inspection database
paired with Salmonella and Campylobacter regulatory and baseline
sampling data for young chickens and turkeys. Overall,

[[Page 49580]]

substantial amounts of empirical data were used in this risk
assessment. It uses the Young Chicken Baseline and PR/HACCP Salmonella
verification data from July 2007-September 2010 and the Young Chicken
Baseline Campylobacter data from July 2008-September 2009. It also uses
the Young Turkey Baseline and PR/HACCP Salmonella verification data
from July 2007-September 2010 and the Young Turkey Baseline
Campylobacter data from August 2008-July 2009. There are about 40,900
raw data samples collected on 94 inspection procedures taken from the
computerized Performance-Based Inspection System (PBIS).
Although FSIS thinks that the 2011 version of the risk assessment
is fully documented, the July 2014 version has benefited from the
addition of language that more clearly describes how the model works
and articulates more it clearly the underlying assumptions. As noted
above, this version also was updated in response to peer review
comments. As discussed above, the 2011 version of the risk assessment,
the peer review comments on that version, FSIS's response to the peer
review comments, and the updated 2014 version of the risk assessment
are posted on the FSIS Web site.
Comment: A commenter said that one of the major assumptions in the
risk assessment is that if performing more unscheduled offline
inspection procedures ``either reduces (or does not change) the
occurrence of foodborne pathogens such as Salmonella and Campylobacter
on finished poultry products, then a net public health benefit may
result.'' The comment questioned how there could be a ``net public
health benefit'' if there is no change to the incidence of pathogens on
poultry carcasses. The comment said that FSIS should not predicate a
significant restructuring of the poultry slaughter inspection program
based on a finding that there will be no change to the incidence of
contamination of poultry products. According to the comment, any
substantial change to meat or poultry inspection should result in
significant improvements to public health.
Response: The Agency agrees that the statement in the risk
assessment may not fully articulate how a net public health benefit may
result if performing more unscheduled offline inspection procedures
reduces (or does not change) the occurrence of foodborne pathogens. To
clarify, the risk assessment estimates that if more unscheduled offline
inspection procedures reduces the occurrence of a specific foodborne
pathogen, such as Salmonella, but does not change the occurrence of a
different pathogen, such as Campylobacter, there will be an overall
reduction in pathogens on finished poultry products. This aggregate
reduction of pathogens and the subsequent reduction in human illnesses
is what was hypothesized to result in a net public health benefit.
The risk assessment characterizes a negative correlation between
the frequency of unscheduled offline inspection activities and the
prevalence of both Salmonella and Campylobacter positive samples. Based
on these modeling results, FSIS thinks it is reasonable to conclude
that redeployment of Agency resources from online inspection activities
to targeted unscheduled offline activities is likely to produce an
improvement in the food safety system resulting from a lower prevalence
of carcasses contaminated with Salmonella and Campylobacter, which
could in turn result in a net reduction in the number of human
illnesses.
Comment: Several comments noted that the Agency conceded that
``substantial uncertainty about forecasted changes in illness rates''
results from uncertainty about the change in future inspection
activities and the rates of human illnesses attributable to poultry.
Response: The risk assessment analyzed data on specific types of
inspection activities and the prevalence of Salmonella and
Campylobacter in young chicken and turkey slaughter establishments. The
results suggest that, because inspection personnel assigned to the NPIS
will conduct more of the type of inspection activities that were
correlated with lower Salmonella and Campylobacter prevalence, the NPIS
will likely result in fewer human illnesses than would be expected if
not implemented. In addition to the expected values, the analysis
provides the statistical uncertainty of the estimated number of averted
illnesses by reporting the upper and lower 80 percent confidence bounds
around the estimates to acknowledge that uncertainty always will exist
in such models.
Comment: Several consumer advocacy organizations noted that the
2011 version of the risk assessment predicts that additional
unscheduled offline procedures could lead to as many as 986 fewer
Campylobacter-related illnesses per year. The comment noted that the
risk assessment states that ``this analysis suggests ambiguous effects
of the proposed rule with respect to Campylobacter occurrence on
chicken carcasses'' and thus does not show a clear public health
benefit.
Some comments noted that the Agency recently established a
performance standard for Campylobacter. The comment said that the
Agency does not have enough experience with the Campylobacter
performance standards to assess industry efforts to reduce
Campylobacter in poultry to make any reasonable predicted public health
benefits. The comments said that if the Agency's proposed changes to
poultry slaughter inspection are truly intended to improve public
health, the Agency needs a much better understanding of Campylobacter
rates in poultry establishments and of how the Agency's proposal will
impact those rates.
One comment added that the risk assessment suggests that ``the
positive Salmonella implications of HIMP'' could be applied to
Campylobacter, but the Agency provides no justification for this
statement. The comment said that several studies point to the
difficulty of making correlations between controlling for Salmonella
and controlling for Campylobacter.
The comments asserted that FSIS should postpone implementation of
the proposed rule until it has collected additional data on
Campylobacter and is better able to estimate the impacts of the
proposed rule on reducing this pathogen.
Response: The Risk Assessment presented the results of two
scenarios--one that was based on only increasing unscheduled offline
procedures (referred to as the ``discriminate scenario'') and one that
did not specify the particular activities to be increased (referred to
as the ``indiscriminate scenario''). The former (discriminate
scenario), which was based on the type inspection procedures performed
more often in the HIMP establishments, suggested larger improvements to
public health than the indiscriminate model. FSIS peer-reviewed risk
assessment (July 2014), results suggest that the discriminate scenario
of increased off-line inspection could decrease the number of positive
Salmonella and Campylobacter samples in young chicken and young turkey
establishments with high probability. This is the scenario upon which
this rule is based.
As noted by the comments, the Agency recently established
performance standards for Campylobacter for young chicken and turkey
slaughter establishments. Because the Agency has not been collecting
and analyzing samples for Campylobacter as long as it has been
collecting and analyzing samples for Salmonella, there are fewer

[[Page 49581]]

Campylobacter sampling results available for analysis. Thus, although
the trends for the Salmonella and Campylobacter results are the same,
the Campylobacter results are less robust because of the smaller sample
size. The updated risk assessment estimates that there would be a
reduction of 3,980 Salmonella illnesses attributable to young chicken
and turkey establishments combined. This in itself would be a positive
public health outcome. Because an increase in unscheduled offline
inspection activities is expected to result in fewer Salmonella
illnesses, FSIS believes that there is no reason to delay
implementation of the rule until the Agency collects and analyzes more
samples for Campylobacter. Additionally, Agency responses to
Campylobacter sample set failures will continue to follow procedures
for Salmonella set failures, i.e. immediate follow-up testing for both
organisms and, in most instances, Food Safety Assessments, regardless
of whether an establishment adopts the NPIS or not.
Comment: A consumer advocacy organization said that the risk
assessment relies heavily on the data collected through the HIMP pilot
and the microbiological verification testing programs. The comment
asserted that, because these programs are not representative of all
poultry establishments, data collected through these programs cannot be
generalized to the entire poultry industry. The comment said that the
microbiological verification testing programs were not designed to
estimate the incidence of foodborne pathogens in meat and poultry
products, nor were they designed to evaluate trends over time. The
comment said that despite these limitations, the risk assessment has
used these data to evaluate the public health impact of reassigning
online inspectors to offline activities and has concluded that there is
a public health benefit to doing so. The comment suggested that FSIS
conduct a pilot study in a representative sample of poultry
establishments to ensure that there is a public health benefit before
implementing the proposed rule in all poultry establishments.
Response: The assertion that the risk assessment relies on data
that are not representative of all poultry establishments is not
accurate. The risk assessment uses a volume-weighted model to account
for the fact that the microbiological sampling is not proportional to
volume. The risk assessment relies on Salmonella data collected from
189 young chicken and 25 turkey slaughter establishments and on
Campylobacter data collected from 181 young chicken and 65 young turkey
slaughter establishments from July 2007 to September 2010. There are 20
young chicken establishments and 5 turkey establishments operating
under the HIMP inspection system.
The risk assessment does not use the results of microbiological
verification testing programs to estimate the prevalence of foodborne
pathogens in poultry products or to evaluate trends over time, as
suggested by the comment. The risk assessment uses FSIS microbiological
verification testing results to analyze correlations between observed
positive samples and offline inspection activities in young chicken and
turkey slaughter establishments. These correlations are then used as
one input to the model that characterizes changes in attributable human
illness. The risk assessment showed that the greatest effect on
Salmonella and Campylobacter prevalence and related illness would occur
when inspection activities are concentrated on increased unscheduled
offline procedures. Thus, FSIS disagrees with the comment's suggestion
that the Agency should not implement the proposed rule until it
conducts a pilot study in a representative sample of poultry
establishments to ensure that there is a public health benefit. The
Agency has ample evidence to support its conclusions that there is a
solid basis to allow for the NPIS.
Comment: Comments from a consumer advocacy group and a labor union
said that the risk assessment is based on the assumption that the
Agency's Salmonella verification data accurately reflect the
performance of the establishments. The comments questioned whether the
Agency's Salmonella verification results reflect the typical operating
conditions in establishments. According to the comments, establishments
know when FSIS is about to collect Salmonella verification samples
because the test kit is mailed to the establishment right before the
inspectors are to collect the samples. According to the comments, on
days when inspectors collect samples for Salmonella testing, it is not
unusual for the establishments to increase the concentration of
available chlorine in the chiller. The comments asserted that the
results of the risk assessment are not reliable because the predictions
are not based on typical operating conditions in establishments. As a
result, the comments said that FSIS's claims that the proposed rule may
reduce the number of Salmonella and Campylobacter related illnesses are
highly speculative and unlikely to be realized.
Response: FSIS disagrees with the comments. The available data from
FSIS's microbiological baseline studies and the Agency's Salmonella
verification results indicate that FSIS's Salmonella verification
sampling results do reflect typical operating conditions in the
establishment.
The Agency compared its most recent baseline data for Salmonella
prevalence in young chicken and turkey slaughter establishments
collected under its National Microbiological Data Collection Programs
completed in 2008 and 2009, respectively, with the results of the
Salmonella samples that it collected and analyzed under its HACCP
Salmonella verification program for similar time periods. The estimated
Salmonella prevalence associated with the two sets of data, when volume
weighted and adjusted for other establishment characteristics, were not
significantly different. FSIS has documented this conclusion in a
series of Agency reports \5\ and written material associated with the
Federal Register notice, ``New Performance Standards for Salmonella and
Campylobacter in Young Chickens and Turkey Slaughter Establishments,
Response to Comments and Announcement of Implementation Schedule,''
which announced the new Salmonella and Campylobacter performance
standards (76 FR 15282).
---------------------------------------------------------------------------

\5\ http://www.fsis.usda.gov/wps/portal/fsis/topics/regulations/federal-register/federal-register-notices/notices-2011; Salmonella
and Campylobacter Notice and comparisons of HACCP and baseline
report.
---------------------------------------------------------------------------

In addition, under both HIMP and non-HIMP inspection systems, the
protocol is for inspectors to randomly collect scheduled Salmonella
verification samples and do not inform establishments when they collect
the samples. FSIS uses the best available data and has taken steps to
enhance data quality going forward. For example, FSIS authorizes its
inspectors to request that the Agency schedule additional Salmonella
verification sampling if they have evidence to demonstrate that an
establishment altered its food safety system to coincide with the FSIS
Salmonella verification sample set.\6\ Since FSIS implemented this
policy, there have been 10 requests, from which 3 were found to be
process changes during Salmonella sampling that justified an additional
verification set. As of July 21, 2014, there have been no requests
since December 2013. Thus,

[[Page 49582]]

FSIS has no basis to think that establishments are regularly making
changes to their processes that would substantially affect the Agency's
Salmonella verification results or, in turn, affect the conclusions of
the risk assessment or the HIMP report.
---------------------------------------------------------------------------

\6\ See FSIS Notice 66-12, which reissued the policy in former
FSIS Notice 42-11 at: http://www.fsis.usda.gov/OPPDE/rdad/FSISNotices/66-12.pdf.
---------------------------------------------------------------------------

Comment: A consumer advocacy organization said that the risk
assessment's assumptions regarding unscheduled inspection procedures
were based on procedures assigned under the PBIS. The comment said that
now that FSIS has implemented the Public Health Inspection System
(PHIS), the number of pre-operational sanitation procedures that
inspectors conduct on a monthly basis was reduced to accommodate other
inspection procedures under PHIS. According to the comment, the risk
assessment is flawed in that it is not based on the inspection tasks
that FSIS inspectors will actually be performing under PHIS.
Response: The risk assessment is based on the data that were
available at the time that FSIS conducted the analysis. At that time,
the available data on offline inspection procedures reflected the
number of such procedures scheduled under PBIS. The analysis of
historical data that is presented in the risk assessment showed a
relationship between lower Salmonella in young chicken and
Campylobacter in turkey prevalence and the type of inspection
activities that will be conducted more frequently under the NPIS. FSIS
inspectors will continue to conduct both unscheduled and scheduled
offline inspection activities under PHIS. Thus, the Agency thinks that
the risk assessment's results are valid under PHIS.
Comment: Two consumer advocacy organizations said that while the
risk assessment details the uncertainty about the change in human
illness rates when offline inspection activities are intensified, there
is no comparable examination of the human illness changes from reducing
online Federal inspection activities. One of the comments asserted that
the risk assessment also did not fully consider the other changes to
the inspection system that the Agency was proposing. This comment
specifically noted that the risk assessment did not consider the
increase in line speeds that had been proposed under the NPIS. Both
comments asserted that the Agency should withdraw the rule until an
analysis of all of the modifications and variables provides certainty
that the inspection changes will not increase the risk to human health.
Response: FSIS disagrees with the suggestion that the Agency
withdraw the rule until it conducts an additional analysis. The
modifications noted by the comments were addressed in the HIMP pilot
study. FSIS thinks that the performance of establishments under HIMP,
as documented in the HIMP report, represents what would be achieved
under the NPIS. These results support moving forward with this final
rule.
As under HIMP, under the NPIS, establishment employees will be
responsible for conducting online sorting activities that are currently
conducted by FSIS online inspectors. Based on the results of the HIMP
pilot, FSIS thinks that establishment employees can perform these
activities as effectively as FSIS inspectors do. To ensure that they
do, FSIS inspectors in establishments operating under the NPIS will
verify that establishment employees are effectively sorting carcasses
on an ongoing basis. As they do under HIMP, VIs under the NPIS will
collect samples and conduct verification checks and CIs will perform a
visual inspection of each carcass at the end of the line before the
chiller. If inspection personnel find food safety-related defects or
the presence of persistent, unattended trim and dressing defects or
removable animal diseases on carcasses and parts, FSIS will require
that the establishment take appropriate action to ensure that
establishment employees are effectively sorting carcasses and that the
establishment is operating under conditions needed to produce safe,
wholesome, and unadulterated product. Therefore, the Agency believes
that establishment employees operating under FSIS inspection can
effectively perform the sorting activities that they will be
responsible for under the NPIS.
FSIS also disagrees with the comment that suggested that the Agency
conduct an additional risk assessment to estimate the effects of line
speeds on food safety and public health. The focus of the risk
assessment is to determine how performing a greater number of
sanitation, sampling, and other offline activities in young chicken and
turkey slaughter establishments might affect the number of human
illnesses from Salmonella and Campylobacter. Although the regression
analysis used in the risk assessment did include a categorical variable
representing line speed as a structural (fixed effect) variable in the
regression model that predicts prevalence, the results do not reflect
measures that establishments typically implement in response to a given
line speed in order to maintain process control.\7\ The Agency believes
that the performance of establishments under HIMP, as documented in the
HIMP report, represent what would be achieved under the NPIS at similar
line speeds.
---------------------------------------------------------------------------

\7\ See Appendix Tables 6-9 in the July 2014 Risk Assessment.
---------------------------------------------------------------------------

Comment: One comment said that the risk assessment concludes that
more unscheduled offline procedures are the key to lowering Salmonella
levels. The comment noted that the risk assessment did not consider
whether this would be the case if inspectors also did not perform all
of the scheduled food safety verifications, which were the only
inspection tasks that inspectors performed more in HIMP establishments
than in non-HIMP establishments. According to the comment, this is
important because there are no scheduled offline food safety checks in
the NPIS. The comment questioned the Agency's ``assum[ption] that
offline inspection activities after the voluntary implementation of the
new inspection system will parallel offline inspection activities in
current HIMP establishments.''
Response: Inspection procedures that will be performed in
establishments operating under the NPIS will be determined by protocols
currently required under PHIS. Under PHIS, inspectors perform both
routine (scheduled) procedures and directed (unscheduled) procedures.
Thus, inspectors assigned to establishments operating under the NPIS
will perform both scheduled and unscheduled offline procedures, just as
they currently do in both HIMP and non-HIMP establishments. These
offline procedures include, verifying compliance with HACCP and
Sanitation SOP requirements, performing carcass verification checks for
septicemia/toxemia and visible fecal contamination, verifying sanitary
dressing requirements, and collecting samples. The offline inspection
activities conducted under the NPIS are intended to be the same rather
than parallel the procedures of the existing inspection systems,
yielding the same or better public health outcomes.

D. The New Poultry Inspection System (NPIS)

In the preamble to the proposed rule, the Agency explained that,
based on its experience under HIMP, it was proposing to establish the
NPIS for young chickens and turkeys (77 FR 4421). The proposed rule
would have eliminated SIS, NELS, NTIS, and the HIMP pilot and would
have required

[[Page 49583]]

that all young chicken and turkey slaughter establishments operate
either under the NPIS or the Traditional Inspection System, as modified
in the proposed rule. The proposed rule would also have limited the
number of online inspectors under Traditional Inspection to two for
each evisceration line, with an exception for existing establishments
that slaughter poultry other than young chickens and turkeys that are
currently operating with more than two online inspectors.
As discussed below, after considering the comments, FSIS has
decided to modify the proposed rule to leave in place all of the
existing poultry inspection systems. FSIS has also decided to allow the
20 young chicken establishments that have been granted SIP waivers to
operate under HIMP to continue to operate under a SIP waiver to run at
line speeds of up to 175 bpm. However, FSIS will update these SIP
waivers to remove aspects of HIMP that are inconsistent with the NPIS,
such as the OCP performance standards. If an establishment operating
under a SIP waiver described above goes out of business or decides to
give up its waiver, FSIS will select another establishment to take its
place. Thus, as under the current HIMP protocol, FSIS will continue to
provide SIP waivers for up to 20 young chicken establishments to
operate at 175 bpm. Under this final rule, the maximum line speed under
the NPIS for turkeys will be 55 bpm, as was proposed. Thus, there is no
need for the five HIMP turkey establishments to continue to operate
under an updated SIP waiver because they will be able to achieve the
same results by operating under the NPIS. FSIS has also decided that it
will not limit the number of online inspectors under Traditional
Inspection to two. Under this final rule, FSIS will continue to staff
all establishments that do not choose to operate under the NPIS with
the number of online inspectors currently assigned to the
establishment.
The preamble also explained that FSIS would allow establishments
that slaughter classes of poultry other than young chickens and turkeys
to operate under the NPIS under a waiver through the Salmonella
Initiative Program (SIP). Under the 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.
1. General Comments on the NPIS
Comment: Comments from producers of poultry products and trade
associations representing the poultry industry expressed general
support for the NPIS. Comments from some FSIS inspection personnel and
some private citizens also expressed support for the NPIS. Some
comments noted that the existing inspection systems were designed
before FSIS implemented HACCP and were developed to identify visual
defects that affect the quality of the product. The comments agreed
that Agency resources are better spent performing activities that are
more effective in ensuring food safety rather than performing functions
that establishments can effectively accomplish under FSIS inspection by
both VIs and CIs. Another comment said that the NPIS will give
establishments the flexibility to investigate and develop new and more
efficient technologies. The comment agreed with the Agency's conclusion
that the new inspection system will improve the effectiveness of
poultry slaughter inspection and overall food safety, remove
unnecessary regulatory obstacles to innovation, and make better use of
the Agency's resources. Another comment said that the NPIS is the next
logical step in protecting public health through modern, science-based
food safety technology.
One comment that supported the NPIS proposal stated that it should
be considered as part of a comprehensive food safety program that
includes the recently implemented PHIS and performance standards for
Salmonella and Campylobacter in broilers and turkeys. The comment said
that the proposal should not be considered separate and apart from
other regulatory food safety programs.
Response: The Agency agrees with the thrust of these comments and
concurs. Certainly the NPIS is part of the initiatives that contribute
to the Agency's comprehensive food safety program. As noted by one
comment, among these initiatives are the Salmonella and Campylobacter
performance standards, the SIP, PHIS, as well as the NPIS.
Comment: Comments from consumer advocacy organizations, labor
unions, FSIS inspectors, public health organizations, animal welfare
advocacy organizations, members of academia, human and worker rights
advocacy organizations, and some private citizens objected to the NPIS
for various reasons. Many of these comments objected to the NPIS
because the commenters view the NPIS as a system that ``privatizes''
inspection by replacing USDA online inspectors in part with
establishment employees. The petitions submitted in response to the
proposed rule express these same views.
Response: The NPIS will not privatize poultry inspection; this
system makes Federal inspection of poultry more effective and carcass
inspection by FSIS inspectors more efficient.
Under the existing poultry slaughter inspection systems, FSIS
inspectors check each carcass for defects and disease and direct
establishment employees to take corrective actions. Under the NPIS, a
well-trained FSIS CI will conduct a carcass-by-carcass inspection after
establishment employees have sorted, trimmed, and conducted any
necessary reprocessing. Thus, under the NPIS the CI will be able to
conduct a more effective and efficient carcass-by-carcass inspection
because carcasses will only be presented for inspection by the CI if
they have been sorted by the establishment and are likely to pass
inspection.
As discussed earlier in this document, the VIs under the NPIS will
conduct offline food safety-related inspection activities and will
monitor and evaluate establishment process controls. The VIs will
conduct carcass verification checks on carcass samples collected before
the CI station to ensure that the establishment is effectively sorting
carcasses and that it is producing products that comply with the
Agency's zero visible fecal tolerance and other performance standards.
VIs will also perform offline activities in addition to carcass
verification checks, such as verifying compliance with sanitation SOPs,
SPS, and HACCP regulatory requirements, and ensuring that the
establishment is meeting all regulatory requirements and is effectively
preventing contamination by enteric pathogens and fecal material
throughout the entire slaughter and dressing process.
2. Scope of the NPIS
Comment: One comment said that it interprets the proposed rule to
limit establishments that slaughter mature fowl to operate under the
NPIS only if they participate in the SIP. The comment noted that the
only other alternative for establishments that slaughter mature fowl
would be to operate under Traditional Inspection. The comment stated
that FSIS should expand the scope of the NPIS to include classes of
poultry other than young chickens and turkeys without additional
qualifications. According to the comment, requiring that establishments
that slaughter poultry classes other than young chickens and turkeys
operate under a SIP waiver places them at a competitive disadvantage
because they must incur costs associated with the

[[Page 49584]]

additional testing and data collection required under the SIP.
Response: The NPIS was informed by the Agency's experience under
the HIMP pilot, which, for poultry, was limited to young chicken and
turkey slaughter establishments. Thus, the Agency would need additional
data to support an expansion of the NPIS to classes of poultry other
than young chickens and turkeys. As noted by the comment, FSIS would
permit establishments that slaughter classes of poultry other than
young chickens and turkeys to operate under the NPIS under a waiver
through the SIP. At a later time, the Agency would consider the data
collected in such poultry slaughter establishments operating under a
SIP waiver to determine whether to expand the NPIS to other classes of
poultry.
Comment: Comments from two labor unions and a worker rights
advocacy organization stated that although the proposed rule allows
young chicken and turkey slaughter establishments to choose whether
they will operate under the NPIS or under Traditional Inspection, there
is no real choice because the Agency proposed to limit the number of
online inspectors in establishments operating under Traditional
Inspection to two. The comments noted that because most of the
establishments that slaughter young chickens and turkeys are large
automated operations, it is unlikely that these establishments will
choose the traditional method of inspection with slower line speed and
two inspectors per line. A comment from an individual questioned why
establishments cannot choose to continue to operate under their current
inspection systems. The comment stated that FSIS did not require that
establishments operate under SIS, NELS, or NTIS when the Agency
established those inspection systems. The comment said that allowing
establishments to choose to keep their current inspection system gives
them a true choice and maintains competition in the marketplace.
A comment from a member of academia said that the proposed rule
gives establishments that slaughter young chickens and turkeys the
flexibility to decide whether the benefits of switching to the NPIS
exceed their estimated costs to operate under such a system. The
comment said that many very small establishments are likely to choose
to remain under Traditional Inspection because, unlike larger
establishments, the benefits of operating under the NPIS may not exceed
their costs.
Response: After careful consideration of these comments, FSIS has
decided to revise the proposed rule to allow establishments that do not
choose to operate under the NPIS to continue to operate under their
current inspection system, i.e., SIS, NELS, NTIS, or Traditional
Inspection. FSIS has also decided to allow the 20 young chicken
establishments that have been granted SIP waivers to operate under HIMP
to continue to operate under a SIP waiver to run at line speeds of up
to 175 bpm. However, FSIS will update these SIP waivers to remove
aspects of HIMP that are inconsistent with the NPIS, such as the OCP
performance standards. If an establishment operating under a SIP waiver
described above goes out of business or decides to give up its waiver,
FSIS will select another establishment to take its place. Thus, as
under the current HIMP protocol, FSIS will continue to provide SIP
waivers for up to 20 young chicken establishments to operate at 175
bpm. Under this final rule, the maximum line speed under the NPIS for
turkeys will be 55 bpm, as was proposed. Thus, there is no need for the
five HIMP turkey establishments to continue to operate under an updated
SIP waiver.
This final rule will give establishments the flexibility to operate
under the system that is best suited to their operations. FSIS has also
determined that allowing establishments to continue to operate under
their current inspection system instead of converting to the modified
Traditional Inspection with two online inspectors will create less
disruption to the industry when FSIS begins to implement the NPIS. As
noted by the comments, large establishments will likely choose to
operate under the NPIS, while very small establishments are likely to
choose to operate under the modified Traditional Inspection System.
Some establishments may be interested in operating under the NPIS but
are not prepared to make the capital investments needed to convert
right away. Under this final rule, these establishments will have the
option to switch to the NPIS at a later date without having to convert
to a modified Traditional Inspection first.
3. Carcass Sorting and Inspection Under the NPIS
a. Carcass Sorting by Establishment Employees
Comment: Several comments from consumer advocacy organizations,
FSIS inspectors, labor unions, and private citizens objected to the
NPIS's requirement that establishment employees properly sort carcasses
before they are presented to the CI for inspection because the comments
believe that establishment employees will miss many food safety and OCP
defects. Many of the comments referenced the analysis conducted by the
consumer advocacy organization that obtained FSIS inspection records
from 14 establishments participating in the HIMP pilot presented in an
earlier comment. According to the comments, the analysis shows that
establishment employees missed food safety and wholesomeness defects at
high rates.
Another comment stated that it had secured affidavits from three
USDA inspectors who have worked in HIMP establishments who report that
because of excessive line speeds and lack of training, company
employees routinely miss many food safety and wholesomeness defects.
The comments stated that FSIS must more thoroughly evaluate the
proposal to allow establishment employees to perform preliminary
carcass sorting before it implements the NPIS.
Response: The overall performance of HIMP establishments measured
by the findings of offline inspections by VIs was as good as or better
than non-HIMP establishments. Results from the VI inspections in HIMP
establishments, which are conducted after establishment employees have
completed the initial carcass sorting, show that the rates of carcasses
with septicemia/toxemia and visible fecal contamination in HIMP
establishments were very low, well below the levels set by the HIMP
performance standards. These results were discussed in detail above. In
addition, as discussed above, OCP defect rates identified on carcasses
in HIMP establishments average about half the corresponding OCP HIMP
performance standard. Thus, the data from the HIMP pilot show that
establishment employees do effectively sort carcasses, dispose of
carcasses that must be condemned, and conduct necessary trimming and
re-processing activities before the carcasses are presented to the CI
for online carcass inspection.
Comment: Several comments from consumer advocacy organizations and
private citizens noted that the NPIS does not require that
establishment employees performing the sorting function receive
training or prove proficiency in performing their duties. The comments
noted that the 2001 GAO report on the HIMP pilot program criticized
FSIS for not requiring that establishment employees complete training
before assuming carcass sorting activities. The comments said that FSIS
should accept the GAO recommendation for FSIS to develop a

[[Page 49585]]

training and certification program in conjunction with industry.
Response: FSIS is not prescribing specific sorter training or
certification. However, the Agency has developed guidance documents to
assist establishments in training their sorters. This guidance is
available on the FSIS Web site at: http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index. The guidance
that the Agency has developed is based on the training that FSIS
provides to online inspection personnel that are responsible for
sorting carcasses under the existing inspection systems.
FSIS agrees with the comment that training of sorters is important
to ensure that they are able to properly perform their duties. Proper
training is necessary if sorters are to make accurate decisions on how
to address animal disease conditions and trim and dressing defects.
Under the NPIS, if sorters do not make these decisions correctly, FSIS
inspection personnel will take appropriate action such as stopping the
production line, issuing NRs, and directing the establishment to reduce
the line speed to ensure that the establishment is able to maintain
process control, that establishment sorters are able to successfully
perform their duties, and that FSIS CIs are able to conduct a proper
inspection.
Comment: A comment from an animal welfare advocacy organization
said that by requiring establishment employees to sort out damaged
carcasses before FSIS conducts online inspection, employees remove the
evidence, i.e., the carcasses themselves, that birds may have died from
causes other than slaughter. The comment asserted that this eliminates
one means by which FSIS can verify that establishments are employing
good commercial practices.
Response: Inspectors in both HIMP and non-HIMP establishments
verify that poultry is being slaughtered in accordance with good
commercial practices. Compliance with these requirements ensures that
poultry are handled humanely prior to FSIS online inspection. On a
daily basis, FSIS offline inspectors observe operations in the
receiving, hanging, stunning, bleeding, and pre-scalding areas in both
HIMP and non-HIMP establishments. Compliance and enforcement actions
are taken as warranted and necessary.
b. Online Carcass Inspection
Comment: Several consumer advocacy organizations expressed concern
that online inspectors will only look at the back of the bird under the
NPIS. The petitions submitted in response to proposed rule also raised
this issue. The comments stated that it is necessary to inspect the
front and inside of the carcass in order to detect food safety defects.
According the comments, under the NPIS, most inspectors will only look
at the back of the bird as it quickly moves down the line and are
therefore less likely to identify food safety defects in each carcass.
Response: FSIS disagrees with the comments. The CI carcass
presentation under the NPIS allows the CIs to focus their inspection on
the same condemnable diseases and conditions that online inspectors
focus on under the current inspection systems. Therefore, the Agency
believes that the CI carcass presentation under the NPIS will allow the
CI to conduct an effective online inspection to detect food safety
defects.
Under all four existing inspection systems, i.e., SIS, NELS, NTIS,
and Traditional Inspection, FSIS online inspectors focus their
inspection on identifying and condemning carcasses with septicemic and
toxemic animal diseases and other condemnable conditions that cannot be
corrected through trimming or reprocessing. Unlike septemia/toxemia,
visible fecal material on the surfaces of a carcass is a food safety
defect that can be corrected through reprocessing. Therefore, all
poultry slaughter establishments have an online or offline reprocessing
system for carcasses accidentally contaminated with fecal material.
Under the current inspection systems, FSIS online inspectors do not
issue NRs or condemn carcasses if they observe visible fecal
contamination on the interior or exterior carcass surfaces. The Agency
ensures that the establishment reprocesses the carcasses after online
inspection to remove any fecal contamination before the carcasses enter
the chiller. Unlike the NPIS, after such reprocessing, none of the
current inspection systems provide for an additional online carcass
inspection before the reprocessed birds enter the chiller.
FSIS online CIs under the NPIS will continue to focus on
identifying and condemning carcasses with septicemic and toxemic animal
diseases and other condemnable conditions that cannot be corrected
through trimming or reprocessing. In addition, while the Agency will
continue to ensure that the establishments operating under the NPIS
reprocess carcasses to remove any visible fecal contamination before
the carcasses enter the chiller, the FSIS online CI will also inspect
all of the carcasses after they have been sorted, washed, trimmed, and
reprocessed, before the carcasses enter the chiller. If there is
evidence of fecal material on a carcass, or that the carcass is
affected with septicemia or toxemia, the CI will stop the line to
prevent the affected carcass from entering the chiller. In addition,
the CI will issue an NR because the establishment's procedures for
preventing visible fecal contamination and for addressing carcasses
with septicemia/toxemia were not effective.
Poultry diseases and conditions, except for avian visceral
leukosis, are readily identified by observing the carcass alone;
pathogens require testing. Inspection of the outside of the carcass for
signs of septicemia/toxemia is sufficient to determine whether the
carcass and corresponding viscera must be condemned. Carcasses affected
with systemic septicemic or toxemic conditions are darker in color due
to dehydration or hemorrhaging and may be smaller or have less body fat
due to inappetence or increased metabolic rate. Accordingly, inspection
of the exterior of the carcass in accordance with the presentation
required under the NPIS is sufficient for CIs to effectively identify
and condemn carcasses affected with septicemia/toxemia, along with
their corresponding viscera. As discussed elsewhere in this document,
an FSIS offline inspector will determine the leukosis status of each
flock slaughtered. Viscera in leukosis positive flocks will be
inspected by FSIS inspectors.
Thus, online inspection under the NPIS is at least as good, if not
better, than online inspection under the current inspection systems.
CIs under the NPIS will focus their inspection not only on detecting
septicemic and toxemic animal diseases, but on detecting visible fecal
contamination as well. In addition, as discussed throughout this
document, the VI under the NPIS will conduct carcass verification
checks on carcass samples collected before the CI station to ensure
that the establishment is effectively sorting carcasses and that it is
producing products that comply with the Agency's zero visible fecal
tolerance and other performance standards. The VI and CI will work with
the IIC to ensure that food safety defects or other conditions do not
impair the CI's ability to effectively inspect each carcass.
Comment: Several labor unions and consumer advocacy organizations
expressed concern that the NPIS does not require that an inspector
examine the viscera of each bird or be able to identify each bird's
viscera for inspection. These comments asserted

[[Page 49586]]

that an examination of the viscera is important in determining whether
or not a bird is diseased, contaminated, or otherwise adulterated.
Response: All poultry diseases and conditions, except for avian
visceral leukosis, are readily identified by observing the carcass
alone. If the CI identifies a carcass with a condemnable condition, the
viscera associated with that carcass must also be condemned. When a
carcass is condemned, establishments that have maintained the identity
of the corresponding viscera must dispose of that viscera as inedible
or, where the identity has not been maintained, must dispose of all
viscera harvested within the time period related to the condemned
carcass. In either case, the CI's visual examination of each carcass
also determines the disposition of the corresponding viscera. The CI's
online carcass inspection serves as an inspection of the viscera.
Additionally, FSIS inspectors conduct verification checks on all
harvested giblets and necks and will apply the RTC standards under the
NPIS. These inspection activities ensure that carcasses and parts,
including viscera, have been inspected and are determined by FSIS
inspectors to be not adulterated. Inspection procedures for avian
visceral leukosis are discussed below.
Comment: A few labor unions expressed concern that under the
Traditional Inspection System retained by the proposed changes to part
381, there is no guarantee that an inspector will be able to inspect a
carcass along with its viscera. The unions stated that under the
current inspection regulations, the carcass and its viscera are
inspected together, as the viscera is required to be ``uniformly
trailing or leading.'' One union was of the view that while proposed 9
CFR 381.76(c) requires that the identity of each bird's viscera be
``maintained in a manner satisfactory to the inspector until such
inspection is made,'' this seems to depart from the current
requirements in 9 CFR 381.76 because the ``new'' Traditional Inspection
System does not ensure that the viscera and the corresponding carcasses
can be inspected by a government inspector.
Response: As discussed above, under this final rule, the
regulations that prescribe requirements for the existing inspection
systems will remain in place, with some modifications. Thus, the
regulations for all inspection systems except the NPIS and HIMP will
continue to require that carcasses and viscera be inspected together.
c. Inspection for Avian Visceral Leukosis
As discussed in the preamble to the proposed rule, avian visceral
leukosis is a rare manifestation of the viral disease leukosis that is
not transmissible to humans (77 FR 4421-2). Avian visceral leukosis can
only be detected by observing the viscera. Avian leukosis does not
present a human health concern, but it may render poultry unwholesome
or otherwise unfit for human food.
As explained in the preamble to the proposed rule, it is common
commercial practice to vaccinate each chicken flock for viral leukosis.
On rare occasions, the vaccine is not effective. If it is not, visceral
leukosis is present on a flock basis. Thus, under the NPIS, an offline
inspector will observe the viscera of the first 300 birds slaughtered
from each young chicken flock to determine whether the disease is
present in the flock. FSIS has followed this practice in young chicken
HIMP establishments, and it has been effective. In the HIMP report,
FSIS explained that ``[i]t is FSIS's experience that when a flock has
avian visceral leukosis, 10 to 15 percent of the birds in the flock
have detectable leukosis lesions. For a flock in which 10% of the birds
have detectable avian leukosis, a 300 bird sample provides a greater
than 95% probability of detecting 22 or greater more birds with visible
leukosis lesions'' (HIMP Report, p. 26). From these calculations, the
Agency concluded that a 300-bird sample is adequate to detect avian
leukosis in a flock.
FSIS received several comments on the proposed avian visceral
leukosis inspection procedures.
Comment: A trade association and a poultry producer argued that
FSIS should eliminate the proposed avian visceral leukosis check.
According to the trade association, the check serves no meaningful
public health purpose, is not scientifically sound, and is an outdated
inspection approach. The trade association stated that when avian
leukosis inspection procedures were originally designed, scientists did
not know that the condition is caused by Marek's Disease and the Avian
Leukosis Complex. According to the trade association, modern treatment
and flock handling practices have effectively eliminated these diseases
in commercial poultry operations. The comment stated that comprehensive
literature reviews of these conditions, including a statement by the
National Institutes of Health, have concluded that neither disease
presents an apparent risk to public health. Additionally, the trade
association stated that as early as 1984, Agency data has shown that
avian visceral leukosis was present in only .017 percent of young
chickens slaughtered, and that number is lower today.
Response: As noted by the comment, avian visceral leukosis is not
transmissible to humans and does not present a human health concern.
However, it may render poultry unwholesome or otherwise unfit for human
food. Thus, carcasses affected with the condition need to be condemned.
Because avian visceral leukosis, if present, will be present throughout
an entire flock, inspecting the first 300 birds of each flock is an
appropriate and effective procedure for identifying the disease.
Under the NPIS, an establishment must ensure that it can identify
viscera and parts corresponding with each carcass. This final rule also
requires that establishments operating under the NPIS provide a
location along the production line at which an inspector can inspect
for avian leukosis ``the first 300 carcasses of each flock together
with associated viscera either uniformly trailing or leading, or
otherwise identified with the corresponding carcass.''
Comment: One labor union stated that FSIS is going to require that
establishments notify the IIC when they intend to slaughter a new flock
so that FSIS may inspect the viscera, but ``flock'' is not defined
anywhere in the regulations. The union stated that FSIS's clarification
of flock, ``In general, a flock constitutes birds raised under similar
circumstances on the same premises'' in the preamble to the proposed
rule is imprecise and the clarification is not included in the PPIA or
Federal regulations. The union asserted that this lack of a definition
of ``flock'' makes the process for detecting avian leukosis
problematic.
Response: Establishments are able to identify which birds belong to
the same flock because birds from the same flock, i.e., birds that have
been raised under similar circumstances on the same premises, arrive at
slaughter together. Establishments operating under the NPIS will
identify when a new flock arrives and are required to notify the IIC
when they intend to slaughter a new flock.
d. Verification Inspection
Comment: A consumer advocacy organization and a trade association
requested that FSIS clarify the role of the VI under the NPIS. The
consumer advocacy organization requested that FSIS explain how the NPIS
will enable

[[Page 49587]]

inspectors to conduct more food safety checks; whether more VIs will be
assigned to each slaughter line; whether VIs will have to cover more
than one slaughter line in an establishment; and whether VIs will have
more than one establishment to cover on a given shift, similar to
processing assignments.
Response: There will be one CI and one VI assigned to each
evisceration line per shift in establishments that chose to operate
under the NPIS. As stated throughout this document, because the
establishment's employees will be responsible for sorting carcasses,
disposing of carcasses that must be condemned, and conducting any
trimming or reprocessing activities before carcasses are presented to
the online CI, the CI will be better able to focus on detecting
carcasses with visible defects that impact food safety, such as visible
fecal contamination and septicemia/toxemia.
In addition to online inspection performed by CIs, VIs under the
NPIS will conduct offline food safety-related inspection activities and
will monitor and evaluate establishment process controls. The VIs will
conduct carcass verification checks on carcass samples collected before
the CI station to ensure that the establishment is effectively sorting
carcasses and that it is producing products that comply with the
Agency's zero visible fecal tolerance and other performance standards.
As in HIMP, VIs under the NPIS will also conduct an array of other
inspection activities that are important to ensure food safety, such as
performing ante-mortem inspection; collecting samples for pathogen
testing; verifying the effectiveness of the establishment's HACCP
system; and verifying that the establishment is meeting sanitary
dressing requirements. As noted throughout this document, the VI and CI
will work with the IIC to ensure that food safety defects or other
conditions do not impair the CI's ability to effectively inspect each
carcass.
Comment: A consumer advocacy organization argued that the NPIS
decreases the protections that are part of the HIMP pilot program. The
comment stated that under HIMP, VIs collect and examine 10-bird samples
for food safety defects every hour, and examine at least two of the 10-
bird samples for wholesomeness defects. Because of the decreased role
of online FSIS inspectors, the consumer advocacy organization stated
that these 10 bird samples are the only hands-on verification of
poultry carcasses under HIMP. This comment expressed concern that the
NPIS does not provide for scheduled verification checks, i.e., food
safety or wholesomeness checks, and the Agency has been unwilling to
commit to any specific number of scheduled checks.
Response: FSIS agrees with the consumer advocacy organization's
assertion that the verification checks that VIs conduct for food safety
defects under HIMP are necessary to ensure that establishment employees
are effectively sorting carcasses and disposing of carcasses that must
be condemned before the carcasses are presented to the CI. Effective
carcass sorting by establishment employees is essential for the CI to
conduct an efficient and effective online carcass-by-carcass
inspection. Therefore, under the NPIS, VIs will continue to conduct
carcass verification checks for food safety defects at a point in the
slaughter process before the CI's online fixed position. VIs will also
verify that establishments are effectively addressing OCP defects
through review of establishment records documenting that the
establishment is producing RTC poultry and through observation of
carcasses when conducting verification checks.
Because HIMP was a pilot study, the activities for offline VIs
needed to be more controlled and prescriptive to ensure that the data
collected from each establishment participating in the study were
consistent. Under the NPIS, the carcass verification checks will be
more risk-based to reflect the performance of the establishment. Thus,
for some establishments, VIs may conduct more carcasses verification
checks under the NPIS than they do under HIMP.
Under the NPIS, the Agency will follow the same procedure used
under HIMP to schedule VI carcass checks for food safety defects to
ensure that VIs collect an appropriate number of verification samples
to assess each establishment's performance under the NPIS. The Agency
will monitor and analyze the ongoing results of its verification
activities to assess the effectiveness of the establishment's carcass
sorting and other process control procedures. The Agency will modify
carcass verification checks and other verification activities as needed
to respond to findings through the same data-driven process that FSIS
uses for all in-plant verification.
The inspection results recorded in PHIS provide FSIS with the
information it needs to ensure that verification activities are
targeted at identified public health risks. Under PHIS, FSIS is able to
modify verification activities to respond to specific situations in
individual establishments, to findings in a particular type of
establishment, or across the entire regulated industry. In-plant
inspection personnel use PHIS to initiate additional verification tasks
if their inspection findings raise concerns about an establishment's
compliance with regulatory requirements. FSIS managers use PHIS to
initiate additional verification and sampling tasks in individual
establishments in response to certain criteria, such as not meeting the
Salmonella performance standard. They are also able to adjust the
frequencies and priorities of verification tasks on a national level to
quickly shift inspectors' focus to verify requirements where findings
indicate problems may be occurring.
Comment: One trade association requested that the Agency clarify
where in the process a finding of fecal contamination would result in a
regulatory noncompliance.
Response: Similar to HIMP, under the NPIS, the VI will issue an NR
for visible fecal contamination if the VI detects such contamination
when performing carcass verification checks.
In addition, this final rule requires that all poultry slaughter
establishments develop, implement, and maintain written procedures to
ensure that carcasses with visible fecal contamination do not enter the
chiller and to incorporate these procedures into their HACCP systems.
It also requires that all poultry slaughter establishments develop,
implement, and maintain written procedures to prevent fecal
contamination and contamination by enteric pathogens throughout the
entire slaughter and dressing process and to incorporate these
procedures into their HACCP systems. These requirements are intended to
ensure that establishments are taking the necessary steps to prevent
contamination throughout the process and not just cleaning up the birds
at the end of the process.
Accordingly, if the CI in an establishment operating under the NPIS
observes a carcass with visible fecal contamination, in addition to
stopping the line to prevent the carcass from entering the chiller, the
CI will also issue an NR because the establishment's procedures for
preventing visible fecal contamination were not effective. Because
establishments are required to prevent visible fecal contamination
throughout the entire process, the CI will issue the NR regardless of
where the establishment's CCP for visible fecal contamination is
located.
In addition, under this final rule, FSIS inspectors under all
poultry inspection systems will not just be inspecting at the end of
the line to verify that the establishment's procedures for preventing
visible fecal contamination

[[Page 49588]]

are effective. Inspection personnel will be conducting verification
activities throughout the entire process to ensure that the
establishment's procedures for preventing contamination by enteric
pathogens and visible fecal material are effective.
e. RTC Poultry Definition Under the NPIS
As noted in the preamble to the proposed rule, removing the SIS,
NELS, and NTIS would have included removing the FPS prescribed under
these inspection systems (77 FR 4422). As discussed above, FSIS has
modified the proposed rule to leave all existing inspection systems in
place. Therefore, under this final rule, establishments that continue
to operate under SIS, NELS, and NTIS will continue to be subject to the
FPS.
However, as was proposed, under the NPIS, the FPS will be replaced
with a requirement that establishments document that the products
resulting from their slaughter operations meet the definition of ready-
to-cook (RTC) poultry. As explained in the preamble to the proposed
rule, establishments operating under the NPIS would (like HIMP
establishments) have the flexibility to design and implement measures
to address OCP defects that are suited to their operations (77 FR
4423). FSIS received several comments from trade associations, consumer
advocacy organizations, and industry members on the RTC poultry
standard. Comments from members of the poultry industry and a trade
association expressed support for the RTC poultry standard and agreed
that establishments should have the flexibility to design and implement
measures to address OCP defects that will be most effective in their
operations. Other comments raised various issues that are discussed
below.
Comment: Comments from consumer advocacy organizations suggested
that the RTC standard is not stringent enough and that the lack of
enforceable OCP goals will make it difficult for FSIS to enforce the
RTC standard. The comments said that in contrast to the HIMP inspection
system, the Agency is not committing to any specific level of scheduled
VI verifications for OCP defects under the NPIS. One comment said that
the Agency should have a robust sampling scheme to deal with OCP
defects. Another comment maintained that without specific standards for
ensuring that OCP defects are promptly identified and addressed, it
will be difficult to compare establishments across the industry and
trace the causes of systematic defects.
Response: FSIS disagrees with the comments that said that the RTC
standards are not stringent. The Agency believes that it can
effectively address OCP defects by requiring that establishments
operating under the NPIS maintain records to document that the products
resulting from their slaughter operations meet the RTC definition.
However, to address concerns expressed by the consumer advocacy
organizations, the Agency is making clear in this final rule that these
records are subject to review and evaluation by FSIS inspectors.
As noted above, the HIMP Report found that for the two-year period
from CY 2009 through 2010, HIMP establishments maintained OCP defect
levels that average about half the OCP performance standards derived
from the performance of non-HIMP establishments. Because the data show
that establishments operating under the HIMP inspection system
performed well in controlling OCP defects, FSIS tentatively concluded
that it was not necessary to adopt prescriptive OCP requirements under
the NPIS (77 FR 4423). Instead the Agency proposed to require that
establishments operating under the NPIS document that the products
resulting from their slaughter operations meet the definition of RTC
poultry. Although the NPIS will give establishments the flexibility to
design and implement effective measures for addressing OCP defects,
establishments will still be responsible for ensuring that the poultry
products resulting from their slaughter operations meet the RTC
definition.
As was proposed, under this final rule, FSIS will verify that an
establishment operating under the NPIS is producing RTC poultry by
reviewing the establishment's records and observing carcasses as part
of their inspection activities. This approach is consistent with the
Agency's view that the verification activities performed by FSIS
inspectors should be predominantly focused on activities that are more
important in ensuring food safety, but that it is also necessary to
verify compliance with requirements that provide non-food safety
protections to consumers.\8\
---------------------------------------------------------------------------

\8\ See FSIS Directive 7000.1, ``Verification of Non-Food Safety
Consumer Protection Regulatory Requirements,'' December 11, 2006
(http://www.fsis.usda.gov/wps/wcm/connect/aa15d83f-cd09-4553-a705-2e3a0eb94e5d/7000.1.pdf?MOD=AJPERES).
---------------------------------------------------------------------------

For their record reviews, FSIS inspectors will verify that
establishments operating under the NPIS have written criteria for
determining whether carcasses meet the RTC definition and that they are
documenting that the poultry products resulting from their slaughter
operations meet these criteria before packaging or further processing
that will conceal the defect. FSIS expects that the establishment will
maintain records that, at a minimum, include the following information:
The records system that the establishment uses to document
that it is producing RTC poultry. For example, an establishment may use
statistical process control charts, HACCP records, or other
documentation.
The points in the operation where the establishment
monitors carcasses to determine whether they meet the RTC definition
and records the results of its monitoring activities. For example, an
establishment may conduct monitoring and recording the results at a
pre-chill and a post-chill station.
The frequency with which the establishment conducts
monitoring activities. The records should specify how often the
establishment monitors carcasses per line per shift. For example, an
establishment may conduct and document its monitoring activities at
least every two hours per line per shift at the pre-chill location and
at least twice per shift per line for post-chill location.
The definitions of the OCP non-conformances or processing
and trim defects that for which the establishment is monitoring. For
example, the establishment may be monitoring carcasses for processing
and trim non-conformances as specified in the current FPS regulations,
for trim and processing OCP defects specified under the HIMP OCP
performance standards, or defects as defined in a published study or a
study that the establishment conducted itself. If the establishment
references a study, it should give a brief description of the study and
have the supporting information on file.
The criteria that the establishment uses to determine that
the products resulting from its slaughter operation meet the RTC
definition. For example, an establishment may follow the subgroup
limits for non-conformances and defects in the current FPS regulations,
the trim and processing defect levels for the HIMP OCP performance
standards, or it may determine the upper limits for non-conformances
using a statistical process control program.
The corrective actions that the establishment will take if
the levels of defects and non-conformances exceed its evaluation
criteria for RTC poultry.
As noted in the preamble to the proposed rule, poultry carcasses
that

[[Page 49589]]

meet the FPS under SIS and NELS, or that meet the OCP performance
standards under HIMP, are ``suitable for cooking without the need for
further processing,'' and as such, meet the RTC poultry definition.
Therefore, establishments operating under the NPIS that adopt the FPS
or the OCP HIMP performance standards as their criteria for determining
whether they are producing RTC poultry will meet the regulatory
requirements if: (1) They can document that the products resulting from
their slaughter operations consistently meet these standards and (2)
FSIS inspectors do not observe persistent, unattended defects on the
products resulting from the establishment's slaughter operations.
Establishments that adopt criteria other than the FPS or the HIMP OCP
standards must have documentation to demonstrate how they will use
these criteria to demonstrate that the products resulting from their
slaughter operations meet the RTC poultry definition.
In addition to record reviews, FSIS inspectors will verify that
establishments operating under the NPIS are producing RTC poultry by
visually observing carcasses as part of their inspection activities.
The presence of persistent, unattended trim and dressing defects on
carcasses at the end of the process would indicate that the
establishment is not producing RTC poultry. It may also indicate a
general lack of control in an establishment's overall slaughter and
dressing process. Thus, if inspectors observe persistent, unattended
defects, FSIS will require that the establishment take appropriate
actions to ensure that its process is under control and that it is
operating under conditions necessary to produce safe, wholesome, and
unadulterated RTC products. If inspection personnel through their
record review or direct observation of carcasses find evidence that an
establishment is producing poultry that does not meets the RTC
definition, the IIC will be authorized to take appropriate action to
ensure that the establishment remedies the defects, including requiring
that the establishment slow the line speed.
Comment: Some consumer advocacy organizations said that if FSIS
does not establish specific OCP standards for the NPIS, consumers will
have no assurances that poultry establishments operating under the NPIS
are producing poultry in a uniform manner and adequately removing
carcasses defects. One comment noted that there is an increasing market
for chicken parts and processed chicken, which enables companies to
profit from unwholesome product because consumers have no way to
determine that the product has defects. As an example, the comment
noted that consumers cannot recognize unwholesome tissue in breaded,
battered, or marinated products.
Response: Under the NPIS, establishments will be required to
document that the products resulting from their slaughter operations
meet the RTC poultry definition. Thus, because the RTC standard applies
to carcasses and parts at the end of the slaughter process,
establishments will be required to ensure and document that all
carcasses and parts meet the RTC definition before the establishment
conducts any additional processing to produce battered, marinated, or
other processed products.
Comment: Some consumer advocacy organizations noted that the 2001
GAO report on HIMP recommended that FSIS require establishments to
implement statistical process controls (SPC), and that FSIS should
monitor the efficacy of these systems. The comments noted that while
FSIS encourages establishments to implement SPC, the proposed rule does
not require it.
Response: FSIS agrees that SPC systems are effective tools for
establishments to use to manage and control their production. Some HIMP
establishments currently use SPC systems to monitor their compliance
with the HIMP OCP performance standards. The Agency believes that most
establishments operating under the NPIS will choose to use SPC systems
to allow them to document that their poultry products meet the RTC
definition. However, instead of mandating the use of SPC, the Agency
has decided to allow establishments operating under the NPIS to
implement the process controls that they have determined will best
produce RTC poultry that is wholesome and not adulterated. The Agency
believes that it will be more effective and more consistent with HACCP
requirements to provide each establishment operating under the NPIS the
flexibility to determine how best to meet the RTC requirement within
the context of its production environment while holding the
establishment to the Salmonella and Campylobacter performance
standards.
Comment: Comments from poultry producers and trade associations
recommended that the Agency allow establishments to apply the RTC
standard at any appropriate location at or before the point of
packaging or clarify that the Agency intended this flexibility if that
is the case. One comment from a trade association said that because an
establishment may apply processes targeting RTC criteria and other
quality issues at various locations after the chiller, it is not
appropriate for the CI to inspect for RTC criteria before the chiller.
The comment noted that the RTC standard addresses quality not food
safety issues, so there is no food safety concern associated with birds
that may not yet meet the RTC standard entering the chiller. The
comment said that a bird with bruising, for example, will not
``contaminate'' other birds in the chiller. The comment said that the
CI should not be distracted from inspecting for food safety issues with
the additional task of checking for RTC criteria.
Response: This final rule maintains the current requirements that
all poultry slaughter establishments prepare all eviscerated carcasses
as RTC poultry.\9\ This final rule also requires that establishments
operating under the NPIS maintain records to document that the products
resulting from their slaughter operations meet the definition of RTC
poultry. Thus, like the FPS, the RTC definition applies to the products
at the end of the slaughter process. However, if the CI or the VI
observe the presence of persistent unattended defects before the
chiller when performing online inspection or conducting offline
verification checks, FSIS will address the effectiveness of an
establishment's sorting process and its ability to maintain process
control. The Agency will require that the establishment operating under
the NPIS take appropriate actions to ensure that it is producing safe,
wholesome products that meet the definition of RTC poultry.
---------------------------------------------------------------------------

\9\ See 9 CFR 381.76(a) under the current regulation and this
final rule.
---------------------------------------------------------------------------

Comment: One consumer advocacy organization agreed that requiring
that establishments operating under the NPIS maintain documentation to
demonstrate that they are meeting the RTC standard is beneficial but
stated that it did not have enough information on the difference
between the FPS and the RTC standard to make a specific comment.
Another comment requested that FSIS retain the existing FPS as a safe-
harbor for establishments that choose to continue assessing compliance
with the RTC standard prior to chilling.
Response: RTC 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

[[Page 49590]]

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 RTC 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 do not meet the
RTC poultry definition.
As discussed above, establishments operating under the NPIS will
have the flexibility to design and implement measures to address OCP
defects that are best suited to their operations, and certainly
establishments may adopt procedures to address OCP defects based on the
existing FPS in order to meet the RTC poultry standard.
4. Facilities Requirements and Staffing for the NPIS
a. Facilities Requirements
Comment: One industry member suggested that establishments
operating under that NPIS be permitted to place the carcass inspection
station at any location before the chiller. The comment stated that
establishments have many reasons for placing carcass inspection
stations at locations other than immediately before the chiller. The
industry member believed that a facility-specific approach would be
more successful in ensuring food safety.
An industry member expressed concern that because of space or line-
layout constraints, establishments may not be able to place a carcass
inspection station meeting FSIS requirements immediately before the
chiller. According to this industry member, some equipment cannot be
moved, or if it can be moved, it will result in higher costs and will
be less effective elsewhere on the line.
Response: The CI inspection station needs to be located at the end
of the processing line immediately before the chiller to allow the CI
to ensure that carcasses affected with food safety defects do not enter
the chiller and to ensure that the establishment's procedures for
preventing visible fecal contamination are effective. Thus, FSIS
disagrees and concludes that a prescribed location for the CI station
best ensures effective inspection and food safety.
Comment: Two comments from inspectors recommended that FSIS modify
the proposed rule to require that the online CI's platform be height-
adjustable. The comments stated that, while handling of every carcass
is not required under the NPIS, online inspectors will still be
required to visually inspect each carcass and that the ideal platform
height for one inspector may not be ideal for another significantly
taller or shorter inspector. One comment believed that an adjustable
platform will benefit inspectors that wear corrective lenses.
Response: FSIS has considered the comments and agrees that the CI
inspection platform should be height-adjustable to ensure that CIs are
able to conduct an effective visual inspection of each carcass. The
Agency is amending the proposed facilities requirements to require that
the CI inspection platform under the NPIS be height-adjustable. Most
establishments that choose to operate under the NPIS will likely move
their present adjustable inspector platform to the new CI location when
they convert to the NPIS. Other establishments may consolidate lines
and therefore will have extra adjustable inspector platforms when they
convert to the NPIS.
Comment: One trade association stated, to be consistent with HACCP,
FSIS should remove the requirement in proposed 9 CFR 381.36(c)(4) for a
``trough or other similar drainage facility'' extending beneath the
conveyor at all places where processing occurs. According to the trade
association, drainage issues are covered by the general requirement for
establishments' to maintain sanitary conditions.
Response: FSIS believes that requiring that establishments provide
a trough or other drainage and collection facility beneath the conveyor
at all places is necessary to maintain sanitary conditions in the
establishment. The existing regulations that prescribe facilities
requirements for the SIS, NELS and NTIS provide for a trough or other
drainage facility under the conveyor.
b. Staffing
Comment: A consumer advocacy organization expressed concern that
there will be fewer FSIS inspectors in establishments operating under
the NPIS than there are in establishments operating under the HIMP
pilot because, according to the comment, FSIS has refused to commit to
maintaining similar, specific levels of food safety activities under
the NPIS. The comment asserted that the Agency has already allowed
staffing levels to decrease in some HIMP establishments.
Another consumer advocacy organization stated that the proposed
rule should include language regarding the number of full-time VIs and
CIs needed in establishments operating under the NPIS. The comment said
that FSIS should use production volume, along with other risk factors
to determine the number of inspectors needed at each facility, and that
the number of inspectors assigned to a facility be reviewed routinely
based on the establishment's performance.
Response: The staffing for each evisceration line under the NPIS
will remain the same as the staffing for each line under HIMP. As in
HIMP, each establishment operating under the NPIS will have one VI and
one CI per line per shift, as well as an IIC. While the verification
activities of the VI under the NPIS may not necessarily be identical to
those under HIMP, a VI will continue to be assigned to each line so
there will be no net reduction in the level of verification inspection.
FSIS District Managers and staff conduct periodic reviews of in-plant
staffing requirements to ensure appropriate coverage of frontline
inspection activities. This is already a standard practice and will not
change under the NPIS.
5. Line Speeds Under the NPIS
Based on FSIS's experience under HIMP, the Agency proposed that the
maximum line speeds for young chicken establishments operating under
the NPIS be 175 bpm and that maximum line speeds for turkey slaughter
establishments be 55 bpm (77 FR 4423). However, the Agency's experience
from the HIMP pilot has shown that HIMP establishments operate with an
average line speed of 131 bpm, and that, although they are authorized
to do so, most of the young chicken HIMP establishments do not operate
line speeds at 175 bpm. As noted above, the maximum line speed
permitted under the current poultry inspection systems is 140 bpm under
the SIS for young chickens, and there are many young chicken
establishments that do not operate at the maximum line speeds
authorized under the current inspection systems. Establishments
determine their line speeds based on their equipment and facilities,
bird size and flock conditions, and their ability to maintain process
control when operating at a given line speed.
Regardless of line speed, HIMP and NPIS do not require that
establishments configure their evisceration lines to accommodate more
than one online carcass inspector. Establishments operating under the
NPIS will have greater control over their lines and greater flexibility
over their production process. For example, consistent with HIMP,
establishments operating under the NPIS will have the flexibility to
reconfigure and consolidate lines if they determine that they need more
space to

[[Page 49591]]

conduct other activities in their facilities. In addition, because only
one online inspector is required at the end of the line, establishments
operating under the NPIS will not need to adjust their production based
on the availability of FSIS inspection personnel to be stationed
online. Establishment employees will staff the lines to perform the
online sorting activities. These establishments will also have greater
flexibility to vary their line speeds within the limits established by
this rule or increase production to respond to customer demands.
In addition to having more control over their production process,
establishments operating under the NPIS will also have more
opportunities for innovation and greater flexibility to develop and
implement new technologies. Currently, if an establishment operating
under the existing inspection systems wants to use new technologies for
evisceration or for sorting, the establishment must work directly with
the Agency to accommodate FSIS's online slaughter inspection
methodologies. Doing so takes time and can become an obstacle to
innovation. Under the NPIS, establishments will have direct control of
the sorting process within their facilities and therefore will have the
flexibility to implement and assess the technologies they think are
beneficial to their operations and food safety.
As will be mentioned in the section on ``Implementation of the
NPIS,'' some comments from consumer advocacy organizations suggested
that instead of allowing establishments to adopt all of the changes in
the proposed NPIS at once, FSIS should implement the NPIS in phases to
ensure that establishments maintain process control as each change is
adopted. However, because establishments operating under the NPIS will
have greater flexibility to adopt new technologies, it would be
difficult to develop an implementation strategy to assess each change
that establishments make to convert to the NPIS that could be applied
consistently across the industry.
After considering the comments, FSIS agrees that it is important to
assess establishments' ability to maintain process control as they
implement changes to operate under the NPIS. Data from the HIMP pilot
demonstrate that establishments operating under HIMP are able to
maintain process control at line speeds of up to 175 bpm. However, as
noted above, although they are authorized to do so, most HIMP
establishments do not operate at 175 bpm. The average line speed under
HIMP is 131 bpm. It is also the case that non-HIMP establishments have
been operating successfully at line speeds of 140 bpm or less.
Therefore, under this final rule, the maximum line speed for young
chickens will be 140 bpm for establishments operating under the NPIS
instead of 175 bpm, as was proposed. Limiting the maximum line speed
for young chickens under the NPIS to 140 bpm also addresses the concern
raised in some of the industry comments that establishments permitted
to implement the NPIS first during a staggered implementation will be
able to increase their line speeds while other establishments will be
economically harmed as they wait for their implementation date.
After the NPIS has been fully implemented on a wide scale, and the
Agency has gained at least a year of experience under the new system,
FSIS intends to assess the impact of changes adopted by establishments
operating under the NPIS by evaluating the results of the Agency's
Salmonella and Campylobacter verification sampling, reviewing
documentation on establishments' OCP performance, and other relevant
factors. FSIS will consider these results in assessing whether
establishments operating under the NPIS have implemented measures that
are effective in maintaining process control.
The maximum line speed for turkey establishments will remain at 55
bpm, as was proposed, because this is similar to the current maximum
line speed of 51 bpm authorized under the NTIS. The comments on line
speeds under the NPIS were also directed at the proposed 175 bpm line
speeds for young chickens.
FSIS has decided to allow the 20 young chicken establishments that
have been granted a SIP waiver to operate under HIMP to continue to
operate line speeds at a maximum of 175 bpm. As discussed above, FSIS
will update these SIP waivers to remove aspects of HIMP that are
inconsistent with the NPIS, such as the OCP performance standards. Data
from the HIMP pilot demonstrate that HIMP establishments operating at
the line speeds authorized under HIMP were capable of consistently
producing safe, wholesome, and unadulterated product, and that they
consistently met pathogen reduction and other performance standards.
Additionally, once the NPIS is fully implemented at most
establishments, data from these establishments can be used to compare
against data from the young chicken establishments operating under the
updated SIP waivers.
The comments on the NPIS maximum line speeds that would have been
permitted under the proposed rule raised a number of issues. The issue
that FSIS received the most comments on was the potential effects that
increased line speeds may have on the health and safety of workers in
poultry slaughter establishments. Because the issues raised by these
comments do not involve the technical aspects of the NPIS, FSIS will
address them in a separate section of this document.
a. Line Speed and Process Control
Comment: Comments from members of the poultry industry and trade
associations representing members of the poultry industry supported
faster line speeds under the NPIS. One comment stated that the industry
has made technological advancements and has produced scientific data to
demonstrate that establishments can operate at faster line speeds and
still maintain food safety. According to the comment, since HIMP's
inception, establishments operating under HIMP have demonstrated that
safe product could be produced at faster line speeds, as evidenced by
pathogen testing data for these establishments.
Some trade associations went further and suggested that the Agency
remove the maximum line speed limits and allow establishments to
determine their line speeds based on their ability to maintain process
control while ensuring inspection of each carcass. The comments said
that this would provide options for future changes as both Agency and
industry technology evolve and food safety challenges change. According
to one comment, limits on maximum line speeds could limit an
establishment's future investment decisions and affect hiring
practices.
Response: As discussed above, under this final rule the maximum
line speed for young chickens will be 140 bpm instead of 175 bpm, as
was proposed. FSIS has determined that maintaining a maximum line speed
of 140 bpm under the NPIS will allow the Agency to assess the impact of
the various changes and new technologies adopted by establishments
operating under the NPIS. As noted above, establishments operating
under the HIMP pilot may continue to operate under the line speeds
authorized under HIMP.
b. Line Speeds and Online Carcass Inspection
Comment: Several labor unions, consumer advocacy organizations, and
members of academia stated the maximum allowable line speeds that had
been proposed under the NPIS

[[Page 49592]]

would be too fast to allow the CI to conduct an adequate online
inspection. The petitions submitted in response to the proposed rule
also raised this issue.
Comments from a labor union, members of academia, and a private
citizen stated that while the most significant food safety concern is
microbiological contamination that is not visible to the naked eye, the
visual inspection of birds for signs of disease, remaining feathers,
and fecal matter remains critical to ensure that product is safe and
wholesome. The comments stated that the faster line speeds that would
have been permitted under the proposed NPIS would make it difficult for
the CI to perform this task.
Response: FSIS disagrees with the comments. Although the maximum
line speeds allowed under the NPIS will be 140 bpm for young chickens,
the Agency's experience under HIMP shows that CIs in HIMP
establishments are able to conduct an effective online inspection of
each carcass when operating under the line speeds authorized under
HIMP, i.e., up to 175 bpm for young chickens and 55 bpm for turkeys.
Since 2007, HIMP young chicken establishments have been authorized
to operate at line speeds of up to 175 bpm depending on their ability
to demonstrate consistent process control. Experience during the HIMP
pilot has shown that HIMP establishments operate with an average line
speed of 131 bpm, and, although they are authorized to do so, most of
the young chicken HIMP establishments do not operate line speeds at 175
bpm. As stated throughout this document, establishments determine their
line speeds based on their equipment and facilities, bird size and
flock conditions, and their ability to maintain process control when
operating at a given line speed. In addition, similar to HIMP, line
speeds under the NPIS will depend on the number of employees that the
establishments hire and train to perform sorting activities. Although
the maximum line speed for young chickens under the NPIS will be 140
bpm instead of 175, as was proposed, FSIS believes that establishments
choosing to operate under the NPIS will determine their line speeds
based on the same factors that establishments considered when setting
line speeds under HIMP for the past 15 years.
Furthermore, as noted throughout this document, under the NPIS, the
VI and the CI will work with the IIC to ensure that the food safety
defects or other conditions do not impair the CI's ability to conduct
an inspection of each carcass. The VI and CI will notify the IIC
whenever circumstances indicate a loss of process control, e.g., if the
VI observes the presence of persistent unattended defects or has
evidence to indicate that the establishment is having difficulty
maintaining sanitary conditions, or if the CI finds multiple carcasses
with defects. The IIC will take appropriate remedial actions and will
be authorized to and may require that the establishment slow the line
speed. Under all of the poultry inspection systems, the IIC is
authorized to direct establishments to operate at a reduced line speed
when in his or her judgment the online inspector cannot perform an
adequate carcass-by-carcass inspection because of the health conditions
of a particular flock, or because of factors that may indicate a loss
of process control.\10\
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\10\ See FSIS Notice 64-13, ``Inspection Responsibilities and
Authorities for Reducing Slaughter or Evisceration Line Speed'' at:
http://www.fsis.usda.gov/wps/wcm/connect/8612aba6-8f99-47c0-b024-1e33b3627a84/64-13.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=8612aba6-8f99-47c0-b024-1e33b3627a84.
---------------------------------------------------------------------------

Comment: A comment from members of academia said that between
routine cleanings of equipment, pathogens introduced by infected and
colonized birds can spread throughout a processing facility,
contaminating surfaces, equipment and workers' personal protective
equipment. The comment noted that studies have shown that Salmonella
species, along with other human pathogens, may survive the various
process controls and decontamination methods used in U.S. processing
facilities. The comment stated that because of the faster line speeds
that FSIS had proposed for the NPIS, more carcasses would be processed
in each facility per shift. According to the comment, this may increase
the likelihood that human pathogens will be introduced into the
processing environment and that a greater number of carcasses will
become cross-contaminated following the introduction of an infected and
colonized bird. The comment did not submit studies or other evidence to
support this view.
Response: As explained above, the maximum line speed for the NPIS
established in this final rule will be 140 bpm, which is also the
maximum line speeds permitted under the current SIS inspection system.
Thus, the comment that faster line speeds under the NPIS may contribute
to the introduction and spread of pathogens in the processing
environment is no longer applicable to this final rule.
Regardless of line speed, as discussed in more detail under the
section of this document on ``Changes that Affect All Establishments
that Slaughter Poultry Other than Ratites,'' in addition to proposing
the NPIS for young chickens and turkeys, FSIS also proposed to require
that all poultry slaughter establishments develop, implement, and
maintain, as part of their HACCP systems, written procedures to prevent
contamination of carcasses and parts by enteric pathogens and fecal
material throughout the entire slaughter and dressing process. At a
minimum, these procedures must include sampling and analysis for
microbial organisms pre- and post-chill to monitor process control for
enteric pathogens. FSIS also proposed to require that establishments
maintain daily records sufficient to document the implementation and
monitoring of their process control procedures.
The records that will be required under this rule, including the
records of the establishment's testing results, will provide
establishments and FSIS with ongoing information on the effectiveness
of the establishment's process controls. These records will also enable
establishments to identify situations associated with an increase in
microbial levels so that they can take the necessary corrective actions
to prevent further potential contamination. Additionally, the new
testing requirements will ensure that establishments are able 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.

E. Implementation of the NPIS

1. Background
In the Federal Register document that extended the comment period
for the proposed rule, the Agency provided additional information on
proposed implementation of the NPIS to solicit more focused comments on
the issue (77 FR 24876). In that document, FSIS explained that it
proposed to provide a time period in which all young chicken and turkey
slaughter establishments would have an opportunity to contact the
Agency to indicate whether they were interested in operating under the
NPIS. The Agency explained that those establishments that choose to
operate under the NPIS would inform the Agency when they would wish to
begin implementing the NPIS in their establishment. When it issued the
document, FSIS had tentatively decided that establishments would have
six

[[Page 49593]]

months to decide whether they would operate under the NPIS and up to
three years to switch to the new system.
FSIS received comments on its proposed implementation plan from
members of the poultry slaughter industry, trade associations
representing the industry, and consumer advocacy organizations. The
Agency considered these comments in developing the implementation
strategy discussed below.
2. Implementation Strategy
Under FSIS's final implementation strategy for the NPIS, all young
chicken and turkey slaughter establishments will initially have six
months from the date of publication of this final rule to notify their
District Office in writing if they intend to operate under the NPIS. If
an establishment does not give its District Office written notification
of its intent before the end of the initial 6-month period, the
establishment will be deemed to have selected to continue to operate
under its current inspection system for purposes of the initial
implementation. FSIS encourages establishments to notify their District
Office as soon as possible after publication of this final rule of
whether they intend transition to the NPIS during the initial
implementation period and, if so, when they will be ready to transition
to the NPIS. Implementation will not take place at all eligible
establishments at the same time. It will be phased in over time to
ensure proper FSIS inspection force readiness to successfully implement
the NPIS.
As soon as this final rule publishes in the Federal Register, and
establishments have started to notify FSIS of their intent regarding
the NPIS, FSIS will begin selecting establishments to switch to the
NPIS. FSIS is using a computerized ranking system to determine the
schedule of establishments for NPIS implementation. This ranking system
is based on a number of factors, such as FSIS staffing needs, past
performance of the establishment, and the location of the establishment
in relation to other FSIS-regulated establishments. Scores for each
establishment will be tabulated, and the establishments will be ordered
from highest score to lowest. The highest scoring establishments will
be placed first in the transition schedule. Many establishments will
likely receive the same score so a random number will be added to their
scores to separate these establishments and order them. A description
of the ranking algorithm and the rational for the ranking process is
available on the FSIS Web page at: http://www.fsis.usda.gov/wps/portal/fsis/home.
Once the ordered list of establishments is created, it will be
divided into blocks based on the expected number of establishments that
can be transitioned each month (expected to be approximately 12). A
computer program then examines the list by looking at the corporate
ownership (Dunn and Bradstreet corporate parent) of each establishment.
If a disproportionate number of one corporation's establishments
appears in the transition schedule for any month, another random number
will be added to the establishments' scores to separate them.
Because switching to the NPIS is voluntary, the implementation
schedule will also need to be adjusted based on establishment
readiness. Establishments that want to transition to the NPIS must
notify FSIS and provide a date at which they can be ready to
transition. Some establishments that are placed near the beginning of
the transition schedule based on the computerized ranking system may
need to be moved to a later month in the schedule because they are not
ready. In addition, FSIS is aware that several large parent
corporations are establishing roving teams to prepare their
establishments for the transition. The work of these teams may also
cause some establishments not to be ready to transition at the earliest
opportunity and require rescheduling them into later months.
FSIS will be implementing the NPIS by clusters of establishments in
close geographic proximity to one another. Once the NPIS is fully
implemented at all of the establishments in a cluster, FSIS will then
begin implementing the NPIS in the next selected cluster. Young chicken
and turkey slaughter establishments that decide that they would like to
convert to NPIS after the initial notification date may notify FSIS of
their intent at any time after that date. The Agency will implement the
NPIS in the additional establishments that intend to convert to the
NPIS on a schedule consistent with Agency resources and readiness. The
Agency intends to implement the NPIS in all young chicken and turkey
establishment that choose to operate under the NPIS, regardless of when
the establishment notifies FSIS of its intent to transition to the
NPIS. However, the initial implementation wave will only include those
establishments that submitted their notification within the initial
notification period.
3. Comments on Proposed Implementation Plan
Comment: A few trade associations and a poultry producer stated
that the implementation process needs to be structured in a way that is
fair and ensures that FSIS is not allowing one company a competitive
advantage over another. One poultry producer was concerned that the
establishments permitted to implement the NPIS first will be able to
increase their line speeds, efficiency, and slaughter capacity, while
other establishments will be economically harmed as they wait for their
implementation date. Industry members and trade associations did not
agree on what they believed to be the best implementation strategy.
Response: The system that FSIS will be using to determine the
schedule of establishments for implementation of the NPIS does take
into consideration corporate ownership of the establishments.
As discussed above, FSIS is using a computerized ranking scoring
system based on various factors, such as FSIS staffing needs,
establishment performance, and establishment location, to generate an
ordered list of establishments for NPIS implementation. After the
Agency establishes the initial establishment list, the list will be
divided into blocks based on the expected number of establishments that
can be transitioned each month. A computer program then examines the
list by looking at the corporate ownership of each establishment. If a
disproportionate number of one corporation's establishments appear in
the transition schedule for any month, another random number will be
added to the establishments' scores to separate them. FSIS believes
that this process will provide for a fair and objective NPIS
implementation schedule.
With respect to the comment that expressed concern that the
establishments permitted to implement the NPIS first will be able to
increase their line speeds while other establishments wait for their
implementation date, as discussed above, the maximum line speed for
young chickens under the NPIS will be 140 bpm. Thus, although
establishments that convert to the NPIS will have greater control over
their line and production process, the maximum line speeds for all
young chicken establishments will be 140 bpm regardless of when they
convert to the NPIS.

[[Page 49594]]

Comment: A State Department of Agriculture and a trade association
supported the idea of staggered implementation. One trade association
stated that establishments should be given a greater amount of time to
determine whether they want to convert to a new inspection system or
operate under Traditional Inspection, as was proposed. Another trade
association expressed concern that a turkey establishment may not know
by the end of the 6-month period, as proposed by FSIS, if it will want
to convert to the NPIS because of the long grow-out cycle for turkeys
compared to chickens (18-22 weeks for toms, broilers can be as short as
5 weeks). This trade association also stated that there needs to be a
process for those establishments that want to adopt the NPIS at a date
beyond the proposed 3-year implementation period.
Response: FSIS agrees that staggered implementation is the best
approach. The 6-month time period also works well for Agency planning
and staffing needs. The Agency has concluded that an initial 6-month
notification period is a reasonable amount of time. Therefore, all
young chicken and turkey slaughter establishments will have 6 months to
determine whether they want to convert to the NPIS during the initial
transition period or continue to operate under their current inspection
system. Additionally, there will be a process for those establishments
that want to adopt the NPIS at a date beyond the initial implementation
period. Those establishments may notify FSIS of their intent to operate
under the NPIS at any time after the initial 6-month notification
period. FSIS will implement the NPIS in the additional establishments
as Agency resources and readiness allow.
Comment: A consumer advocacy organization recommended that FSIS
implement one new provision in the rule at a time and assess the
potential food safety impact of each change before implementing the
next provision. The comment said that the Agency must ensure that
microbial contamination rates on carcasses continue to improve as
incremental changes are implemented. For example, before implementing
other changes for the NPIS, this consumer advocacy organization
suggested that FSIS implement the proposed new mandatory testing
provisions that would apply to all poultry slaughter establishments.
According to the comment, all poultry establishments should be required
to operate under the new testing program for at least 90 days to
generate a baseline that FSIS could use to assess the effects that the
additional proposed measures may have on contamination rates. This
comment stated that after establishments have generated the necessary
baseline data, FSIS could implement additional program changes while
assessing the effects on microbial contamination rates against the
existing baseline data to ensure that individual changes do not
negatively impact process controls. The comment said that if
establishments demonstrate that they are maintaining process control as
each change is implemented, FSIS could consider additional individual
changes.
Response: As discussed above, because establishments operating
under the NPIS will have more control over their lines and greater
flexibility to implement new technologies, it is difficult to predict
how establishments will implement the NPIS when this rule becomes
effective. Thus, it would be difficult to develop an NPIS
implementation strategy to assess individual changes adopted by each
establishment that could be applied consistently across the industry.
However, as discussed earlier in this document, after considering
the comments, FSIS agrees that it is important to assess
establishments' ability to maintain process control as they implement
changes to operate under the NPIS. Therefore, to allow the Agency to
assess the impact of the various changes implemented by establishments
to operate under the NPIS, the maximum line speed under the NPIS will
be 140 bpm for young chickens. This is the maximum line speed permitted
under the existing poultry inspection systems under SIS.
After the NPIS has been fully implemented on a wide scale, and the
Agency has gained at least a year of experience under the new system,
FSIS intends to assess the impact of changes adopted by establishments
operating under the NPIS by evaluating the results of the Agency's
Salmonella and Campylobacter verification sampling, reviewing
documentation on establishments' OCP performance, and considering other
relevant factors. FSIS will consider this information in assessing
whether establishments operating under the NPIS have implemented
measures that are effective in maintaining process control.
Furthermore, under this final rule, large establishments, small
establishments, and very small establishments will be required to
implement the new microbiological sampling requirements 90 days, 120
days, and 180 days, respectively, after the publication of this final
rule. Therefore, depending on when each establishment converts to NPIS,
they will likely have already implemented the new sampling requirements
when they transition to NPIS. When establishments transition to the
NPIS, they will be expected to maintain records, including records of
their test results, to demonstrate that they are maintaining process
control. Therefore, FSIS has concluded that it is not necessary to
require that establishments generate a baseline for at least 90 days
before implementing the NPIS.
Comment: A State Department of Agriculture stated that the smallest
volume establishments should have the longest time to comply because
they will find it difficult to implement certain sections of the
proposed rule because of limitations in personnel, budget, time, and
expertise in microbiology. As an example, the comment said that very
small establishments may need additional time to implement their
revised sampling programs.
Response: FSIS agrees that small businesses should have more time
to implement the new sampling requirements. Small establishments will
have 120 days and very small establishments will have 180 days to
implement the regulations that prescribe procedures for controlling
visible fecal contamination in 9 CFR 381.65(f), the regulations that
prescribe procedures for controlling contamination throughout the
slaughter and dressing process in 9 CFR 381.65(g), and the
recordkeeping requirements in 9 CFR 381.65(h).
Comment: A poultry producer and a trade association stated that
FSIS should consider allowing industry the option of staggering
implementation by line and shift as coordinated between establishment
management and the District Office. This poultry producer argued that
this will allow the industry to conduct on-the-job training with staff
and help the Agency reallocate inspection resources over a period of
time instead of having to reassign an entire establishment of
inspection program personnel all at once.
Response: FSIS has decided not to give establishments the option to
stagger implementation by line and shift. It would be too difficult for
FSIS to perform its inspection activities at establishments that are
operating different lines or shifts under the NPIS and one of the other
inspection systems at the same time. For Agency planning and resource
purposes, if an establishment wants to convert to the NPIS, all of the
establishment's lines and shifts will be required to switch to the NPIS
during the transition.

[[Page 49595]]

Comment: A few trade associations stated that implementation plans
should be establishment specific. One trade association stated that
these establishment specific plans should be based on the systems,
methods of processing, and supply considerations of that establishment.
Another trade association argued that establishments should be allowed
to develop individualized implementation plans in coordination with
their District Offices to facilitate Agency planning and resource
allocation.
One trade association stated that there should be a significant
transition period where establishments may continue to operate under
their current inspection system while developing their implementation
plans and making them available to the Agency. Under the trade
association's plan, the Agency would have a set period of time to
comment on the plans, after which establishments would begin making the
necessary financial, facility, and personnel changes to implement the
NPIS. The trade association also recommended that the Agency publish a
list of pre-approved implementation strategies in an FSIS notice and
encourage establishments to use strategies from the list to develop
their individualized implementation plans.
Response: FSIS expects that establishments will work closely with
their District Offices to implement the NPIS. As stated above, all
young chicken and turkey slaughter establishments will have 6 months
from the date of publication of this final rule to notify their
District Office in writing whether they intend to operate under the
NPIS during the initial transition period. FSIS will attempt to
accommodate establishments' requests to transition to the NPIS at the
times stated in their notification to the District Office. However,
FSIS will be implementing the NPIS by clusters of establishments in
close geographic proximity to one another. The system that FSIS will be
using to determine the schedule of establishments for implementation of
the NPIS is described above. Once an establishment is selected to
convert to the NPIS, the District Office will work with the
establishment to successfully transition its operations.
FSIS does not plan to publish a list of pre-approved implementation
strategies. However, if an establishment wants to make changes to its
operation to prepare for conversion to the NPIS, FSIS will try and
accommodate those changes as long as they do not affect FSIS inspection
activities or procedures. For example, if an establishment operating
under the current system wants to have employees practice sorting by
removing carcasses with septicemic or toxemic conditions from the line
before inspection and include these condemned birds in the official Lot
Tally totals, the FSIS District Office will work with the establishment
to try to accommodate such a request. FSIS will consider these requests
on a case-by-case basis. FSIS has concluded that allowing this type of
flexibility will help establishments successfully transition to the
NPIS.
Comment: A consumer advocacy organization stated that before FSIS
allows an establishment to transition to the NPIS, the Agency should
require that the establishment demonstrate that it is financially
capable of meeting the new requirements and assuming its new role under
the new inspection system. The comment stated that the theory behind
the consideration is that a firm under financial duress might cut
corners in its processes that could compromise food safety.
Response: Before an establishment is allowed to transition to the
NPIS, the establishment will need to develop a plan to meet the new
requirements. FSIS will not be imposing any financial requirements on
establishments before they are allowed to transition to the NPIS. Once
an establishment transitions to NPIS, it will have to demonstrate that
it is maintaining process control.
In addition, as discussed above, rather than eliminate SIS, NELS,
and NTIS, as was proposed, this final rule will leave in place all
existing inspection systems. Thus, establishments that do not have the
resources to convert to the NPIS during the first implementation phase
will have the flexibility to operate under the inspection system that
is best suited to their operations. These establishments will also have
the option to convert to the NPIS at a later date without having to
convert to a modified Traditional Inspection first.
Comment: Several industry members and trade associations stated
that the proposed rule lacks detail regarding implementation and that
implementation plans need to be clearly communicated to industry
through listening sessions or roundtables like HACCP or PHIS
implementation to help successful transition to the NPIS. One poultry
producer believed that FSIS may benefit from hosting a public meeting
to receive feedback on how best to implement the NPIS. One trade
association stated that the Agency needs to work closely with
stakeholders on implementation. One trade association also stated that
communication with inspection program personnel needs to happen well
before implementation and that communication materials need to be
shared with industry in an open and transparent manner.
Response: This final rule provides more detail regarding
implementation if an establishment chooses the NPIS. FSIS intends to
communicate its plans to industry, inspection program personnel, other
stakeholders, and the public through additional means as necessary.
Before implementation, FSIS will communicate with its inspection
program personnel about the NPIS and provide them with materials
regarding the NPIS. FSIS issues instructions to inspection program
personnel through FSIS Notices and Directives, which are published on
the FSIS Web site and are accessible to the public.
Comment: Several industry members and trade associations stated
that FSIS needs to provide clear and consistent guidance to FSIS
personnel and industry. One poultry producer argued that FSIS should
provide industry with the training tools utilized for inspection
program personnel under the existing slaughter systems to facilitate
the transition to the NPIS. Additionally, one trade association stated
that a compliance guide (e.g., describing training related to quality
defects and disease conditions) that is at least equivalent to FSIS's
expectations of its inspection program personnel should be created. A
State Department of Agriculture and a trade association stated that
FSIS needs to provide scale-appropriate guidance and training materials
(e.g., guidance on developing anti-contamination procedures and
sampling programs) to small and very small establishments to assist in
compliance with the rule.
Response: As stated previously, FSIS has converted the current
instructions that it provides Agency inspectors into guidance for
industry to use to train establishment sorters. This guidance is
available on the FSIS Web site at: http:[sol][sol]www.fsis.usda.gov/
wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
FSIS intends to provide guidance to industry on the new sections of
this final rule, including the new sampling plans. Guidance and
training materials will be scale-appropriate and will focus on guidance
that is appropriate for small and very small establishments.
Comment: Several trade associations advocated that the Agency
should create an experienced group of experts to coordinate
implementation of the NPIS, address key issues that arise during
implementation, and focus on facility and inspector concerns. According
to one of the trade associations, this approach would minimize cost and

[[Page 49596]]

disruption to the industry and inspection, provide mutually beneficial
training opportunities, and ensure a consistent approach to
implementing the NPIS across the nation. Several trade associations
stated that the group of experts should function as an operational
hotline (similar to the Agency's Small Plant Hotline) to quickly
address questions from establishments and inspectors about the NPIS and
how it is supposed to work in specific situations.
Response: The Agency will continue to provide technical support to
its workforce and industry through its standard channels. For example,
FSIS will continue to encourage referring questions to its Policy
Development Staff through askFSIS at http://askfsis.custhelp.com or by
telephone at 1-800-233-3935. Members of the Policy Development Staff
were involved in the development of this final rule and will have the
expertise to address issues that arise during implementation of this
final rule. FSIS believes that its existing Agency resources are
sufficient to address issues that arise with respect to this final
rule. Additionally, the Agency will be providing appropriate
instructions, guidance, and training to its inspectors on the NPIS. The
Agency will also provide guidance to industry that will help
establishments with regard to this final rule.

F. Line Speeds and Worker Safety

1. Collaboration With the National Institute for Occupational Safety
and Health
The National Institute for Occupational Safety and Health (NIOSH)
is part of the Centers for Disease Control and Prevention (CDC) in the
Department of Health and Human Services. NIOSH's mission is to generate
new scientific knowledge and provide practical solutions vital to
reducing risks of illness, injury, and death in the field of
occupational safety and health, and transfer that knowledge into
practice. In the proposed rule, FSIS acknowledged the potential for an
increase in inspection line speed to affect establishment employee
safety (77 FR 4423-4425). The Agency explained that to obtain
preliminary data on the matter, it had asked NIOSH to evaluate the
effects of increased inspection line speeds on establishment worker
safety by evaluating the inspection lines and workers from
establishments that had been granted waivers from line speed
restrictions under the SIP. As noted in both the proposed rule and the
Federal Register document to extend the comment period, NIOSH initiated
such an evaluation in one non-HIMP establishment that is operating
under a waiver from line speed restrictions under SIP (77 FR 4423 and
77 FR 2487).
The current NIOSH evaluation assessed this establishment prior to
any changes allowed under the SIP line speed waiver, and also after
changes were implemented. NIOSH completed its evaluation and made its
final report available to the public in March 2014 (Evaluation of
Musculoskeletal Disorders and Traumatic Injuries Among Employees at a
Poultry Processing Plant; Report No. 2012-0125-3204, March 2014.
Available on the Internet at: http://www.cdc.gov/niosh/hhe/reports/pdfs/2012-0125-3204.pdf). The report describes NIOSH's findings and
recommendations from an evaluation conducted before and after the
establishment combined two evisceration lines into one and increased
the evisceration line speed. The NIOSH evaluation provides valuable
information to FSIS, the Department of Labor's Occupational Safety and
Health Administration (OSHA), and other stakeholders.
FSIS considers the NIOSH evaluation to be an important first step
in measuring any impact of evisceration (or inspection) line speeds on
workers in poultry slaughter and processing establishments. Without the
NIOSH evaluation and access that FSIS was able to ensure, such
information likely would not be developed. As stated previously, FSIS
will consider the available data on employee effects collected from
NIOSH activities when implementing the final rule. FSIS has committed
to working with NIOSH and OSHA on disseminating the guidance resulting
from the current NIOSH study, and ensuring greater awareness by FSIS
and the industry about worker safety and health.
2. Collaboration With OSHA
OSHA is an agency of the United States Department of Labor, and was
created to assure safe and healthful working conditions for working men
and women by setting and enforcing standards and by providing training,
outreach, education, and assistance. OSHA is helping FSIS address the
health and safety of FSIS inspectors when they are performing their
duties in federally-regulated establishments. FSIS has an Occupational
Safety and Health Division, comprised of professional Occupational
Safety and Health Specialists, a Certified Professional Ergonomist,
Certified Industrial Hygienists, and Certified Safety Professionals
dedicated to ensuring a safe and healthful work environment for FSIS
employees. FSIS is in the process of establishing a Safety and Health
Committee made up of program representatives as well as members of the
National Joint Council of Food Inspection Locals to ensure continual
improvement of FSIS's safety and health programs. FSIS has recently
placed an increased emphasis on occupational safety and health for its
employees, and has identified a reduction of the injuries and illnesses
for FSIS employees as a key measure in the FSIS Strategic Plan for FY
2011-2016.\11\ FSIS Directive 4791.12, ``Reporting and Correcting
Occupational Hazards,'' and FSIS Directive 4791.13, ``Workplace
Inspections, and Injury, Illness and Motor Vehicle Incident
Reporting,'' provide FSIS inspection personnel with procedures for
reporting and correcting workplace safety and health hazards that
affect FSIS employees. FSIS AgLearn Course 8500, ``Recognizing and
Reporting Occupational Safety and Health Hazards,'' is available to
improve FSIS employees' ability to recognize and report workplace
safety and health hazards in accordance with the FSIS worker safety
directives.
---------------------------------------------------------------------------

\11\ http://www.fsis.usda.gov/wps/portal/informational/aboutfsis/strategic-planning/strategic+planning/.
---------------------------------------------------------------------------

FSIS also recognizes the importance of establishment worker safety
and will work with OSHA to heighten FSIS employees' awareness of
serious occupational safety hazards in FSIS-regulated establishments.
FSIS has begun working with OSHA to continually update and improve the
training of FSIS inspectors in recognition of serious workplace hazards
and will provide a referral system to report such hazards to OSHA. The
Agency will issue an FSIS Notice, ``Procedures for Notifying the
Occupational Safety and Health Administration (OSHA).'' The notice
establishes a procedure for FSIS inspection personnel to notify OSHA
directly of serious workplace hazards that may affect non-federal
establishment personnel in meat and poultry products establishments and
in egg product plants. The notice provides inspection personnel with
OSHA's confidential 1-800 number to refer an occupational safety or
health concern for a plant employee directly to OSHA.
FSIS has also taken action to encourage establishments to comply
with OSHA requirements. In May 2011, the Agency published an article on
``Reporting Work Related Injuries'' in its ``Small Plant News''
publication.\12\ The

[[Page 49597]]

article discussed the importance of OSHA's requirements for recording
and reporting work-related injuries, illnesses and fatalities, and
provided guidance to small establishments on how to comply with these
requirements. The article encouraged small establishments to contact
OSHA with any questions on OSHA's requirements and included contact
information for OSHA's regional recordkeeping coordinators.
---------------------------------------------------------------------------

\12\ ``Small Plant News, Vol. 4, No. 2. Available on the
Internet at: http://www.fsis.usda.gov/wps/wcm/connect/d277c886-f942-447b-baec-3247b405ae8a/Small_Plant_News_Vol4_No2.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

The Agency published another worker safety article in the December
2012 ``Small Plant News'' titled ``Know OSHA's Safety and Health
Standards.'' \13\ The article provides an overview of the OSHA
regulations that affect federally-inspected meat and poultry
establishments and processed egg products plants. It also provides an
excerpt of the standards described in OSHA's Small Business Handbook
and provides a link that allows interested parties to access the
document on the Internet.
---------------------------------------------------------------------------

\13\ ``Small Plant News, Vol. 6, No. 3. Available on the
Internet at: http://www.fsis.usda.gov/wps/wcm/connect/1b75a216-fa3c-43fb-a5eb-7cc27ed942fa/Small_Plant_News_Vol6_No3.pdf?MOD=AJPERES.
---------------------------------------------------------------------------

As part of FSIS's ongoing collaboration with OSHA, FSIS had
numerous discussions with OSHA during the development of this final
rule on how best to address potential issues related to line speeds and
worker safety. As discussed above, to allow FSIS to assess the impacts
of changes implemented by establishments that convert to the NPIS, the
maximum line speeds under the NPIS established in this final rule will
be 140 bpm for young chickens instead of 175 bpm, as was proposed. The
highest maximum line speed under the current inspection systems is 140
bpm under SIS. Thus, under this final rule, any increase in line speed
that establishments implement under the NPIS will not exceed the
maximum line speeds authorized under the existing inspection systems.
OSHA has provided FSIS with a set of recommended actions that
poultry establishments can take to address the health and safety of
establishment employees. These recommendations are as follows:
Develop and implement policies to encourage prompt
reporting of injuries and illnesses;
Evaluate existing programs to ensure that they do not
discourage employees from reporting injuries and illnesses;
Implement a training program for employees on job hazards,
early symptoms of illnesses and injuries, and how to prevent them.
Ensure that training is offered in a manner and language that workers
can understand;
Conduct routine surveillance of injury and illness logs as
well as the workplace to identify potential job hazards;
Establish an employee complaint or suggestion procedure
designed to allow employees to raise job hazard issues without fear of
reprisal;
Request employee feedback on workplace modifications; and
When job hazards are identified, implement mitigating
measures.
FSIS and OSHA agree that surveillance for injuries and illnesses is
particularly important to identify whether workers are experiencing
adverse health or safety effects when performing their duties and to
trigger appropriate intervention if they are.
Although FSIS does not have the authority to require that
establishments adopt these recommendations, the Agency believes that
prudent establishments will consider them carefully. FSIS recommends
that establishments develop plans to implement OSHA's recommendations.
FSIS expects establishments to adopt the OSHA recommendations discussed
in this preamble and any other reasonable measures to minimize the risk
of adverse health and safety effects to establishment employees.
Establishments are reminded that Federal and State OSHA retain
authority over assuring worker safety, and that OSHA will be paying
close attention to poultry slaughter establishments, including those
that elect to operate under the NPIS. FSIS recommends that
establishments review OSHA's recordkeeping regulations at 29 CFR 1904,
OSHA's General Industry Standards at 29 CFR 1910, and OSHA's Prevention
of Musculoskeletal Injuries in Poultry Processing (https://www.osha.gov/Publications/OSHA3213.pdf).
In addition to the recommended actions to enhance surveillance for
work-related injuries and illnesses, OSHA also recommended that
establishments implement an employee injury and illness prevention
program. FSIS and OSHA agree that injury and illness prevention
programs may substantially reduce the number and severity of workplace
injuries and alleviate the associated financial burdens on U.S.
workplaces. Most successful injury and illness prevention programs are
based on a common set of key elements, including management leadership,
worker participation, hazard identification and assessment, hazard
prevention and control, education and training, and program evaluation
and improvement.\14\ The Agency expects that a prudent establishment
would have such a program in place. FSIS recommends that establishments
that do not have existing employee illness and injury prevention
programs adopt OSHA's recommendation and take the necessary actions to
begin to implement such a program.
---------------------------------------------------------------------------

\14\ OSHA [2013]. Prevention of Musculoskeletal Injuries in
Poultry Processing. U.S. Department of Labor, Occupational Safety
and Health Administration, OSHA 3213-09N; available at: https://www.osha.gov/Publications/OSHA3213.pdf.
OSHA [2012]. Injury and Illness Prevention Programs--White
Paper. U.S. Department of Labor, Occupational Safety and Health
Administration; available at: http://www.osha.gov/dsg/InjuryIllnessPreventionProgramsWhitePaper.html.
---------------------------------------------------------------------------

All poultry establishments are required to comply with applicable
laws administered by other agencies, including the occupational safety
statutes administered by OSHA. To stress the importance of
establishment worker safety, FSIS has modified the proposed regulation
that prescribes maximum line speed rates under the NPIS to emphasize
establishments' existing legal obligation to comply with OSHA statutes.
Thus, 9 CFR 381.69 now includes a new paragraph (d) that states that
establishments operating under the line speed limits authorized in this
section shall comply with all other applicable requirements of the law,
including, but not limited to, 29 U.S.C. 654(a). Although this new
paragraph is included in the regulation that prescribes line speeds for
establishments operating under the NPIS, establishments operating under
any inspection system also must continue to comply with all other
applicable requirements of the law.
FSIS supports collaboration among industry, academia, and
governmental bodies such as OSHA, NIOSH, and FSIS to identify causal
relationships between workplace factors and musculoskeletal disorders
(MSDs), and develop mitigation strategies that are technically and
economically feasible. The NIOSH evaluation is a strong starting point
for this effort, but additional work may be needed.
3. General Comments on Line Speed and Worker Safety
In the Federal Register document to extend the comment period on
the proposed rule, FSIS requested comments on the effects of increased
line speeds and production volume on worker safety (77 FR 24877). FSIS
received many comments on this issue from worker and human rights
advocacy organizations, poultry establishment employees, consumer
advocacy

[[Page 49598]]

organizations, labor unions, public health associations, members of
academia, companies that own poultry slaughter establishments, trade
associations that represent the poultry industry, and private citizens.
The vast majority of comments that the Agency received in response to
the proposed rule were on this issue.
Many of the comments stated that FSIS should consult with NIOSH and
OSHA on the final rule. Additionally, many of the comments submitted by
workers and human rights advocacy organizations, immigrant advocacy
organizations, consumer advocacy organizations, labor unions, public
health associations, and members of academia said that FSIS should
withdraw the proposed rule because of risks that the proposed increased
maximum line speeds could potentially pose to the health and safety of
thousands of poultry slaughter and processing workers. These comments
said that if FSIS does not withdraw the rule, the Agency should at
least withhold implementation until NIOSH completes a comprehensive
study of the effect of production line speed on the health and safety
of workers, and OSHA considers any implications for potential
rulemaking.
Most of these comments referred to governmental reports, or
research studies published in the occupational and public health
literature. The most commonly cited sources included:
The 2005 GAO report, which linked production line speed to
occupational injury and illness rates in the slaughter industry and
called for independent research to better understand this relationship;
2010 Bureau of Labor Statistics (BLS) data showing that
injury rates were higher among poultry processing workers than the
overall private industry average, and that more lost time, job
transfers and restricted duty were incurred in the poultry industry
than the overall private industry average;
A study by the Wake Forest School of Medicine Center for
Worker Health, which reported a 59% prevalence of carpal tunnel
syndrome (CTS) symptoms among Latino workers at selected poultry plants
in North Carolina operating under the existing inspection systems; and
A 2007 study by researchers from the Duke University
Medical Center's Division of Occupational and Environmental Medicine,
which found that among low-income African-American women in rural North
Carolina the prevalence of musculoskeletal symptoms of the upper
extremities and neck was 2.4 times higher in those working at poultry
plants compared to workers in other local industries.
Most commenters were concerned that an increase in production line
speed would lead to increased rates of musculoskeletal disorders, other
traumatic injuries, and potentially adverse health effects of
psychological and emotional stress among industry workers, particularly
in processing jobs involving highly repetitive knife use. These will be
discussed below.
4. Inspection Line Speed, Processing Line Speed, and Production Volume
The 2005 GAO report recognized that the speed of the production
line may be ``an important factor influencing (worker) safety and
health.'' FSIS acknowledges NIOSH's finding of a strong relationship
between risk factors, such as prolonged or repetitive hand activity,
gripping force and exposure to cold, and MSDs including carpal tunnel
syndrome (CTS) in the processing environment. Increasing line speed in
processing, without changing other factors, could result in an increase
of work pace for establishment employees, and increasing work pace
among establishment employees, without taking appropriate mitigation
actions, could increase risk of injuries and illnesses among
establishment employees.
FSIS believes a key distinction should be made between processing
line speed, inspection line speed, and daily production volume. The
regulations require that establishments operate processing lines in a
manner that maintains sanitary conditions and that will result in the
production of poultry and poultry products that are not adulterated (9
CFR 381.65(a)). As the GAO report and many comments have pointed out,
the poultry regulations limit the speed of poultry inspection lines to
enable FSIS inspectors to effectively inspect each carcass presented to
them. The current poultry regulations and this final rule do not
prevent industry from running a processing line faster or slower than
the inspection line. Slaughter establishments have always had the
ability, at their discretion, to balance operating hours, staffing
levels, and production line speed in processing departments to match
the output of the inspection line. For example, an establishment could
choose to operate its processing department at twice the speed of the
inspection line, for half of the operating hours. Likewise, it could
increase staffing in a processing department and slow the line speed
proportionally to handle the volume of birds coming from the inspection
line. These are operational and economic decisions made by each
establishment, rather than a matter of FSIS regulations.
Slaughter establishments must make operational and economic
decisions balancing staffing levels, production line speeds, and
operating hours to accommodate daily production volume. While
inspection line speed does influence daily production volume,
establishments determine their own maximum production volume through
the number of inspection lines they choose to operate.
We also note the difference between line speed and work pace. While
work pace in processing departments is influenced by inspection line
speed, factors such as staffing levels, plant layout, and product flow
are more important predictors of work pace, as described in the
following examples. FSIS does not directly regulate these factors.
For example, if a single inspection line feeds a single processing
line (e.g., manual deboning), the work pace of processing workers will
depend on the number of workers assigned to that line. If the birds
from a single processing line are exiting the chiller at a maximum of
140 bpm, and if ten workers are assigned to that processing line, each
worker will have an average work pace of 14 bpm. Adding an eleventh
worker would reduce the work pace to an average of 12.7 bpm per worker.
Additional staffing would reduce the workload proportionally.
If, under this same scenario, the establishment changes its layout
to add a second identical processing line staffed with 10 additional
workers, the work pace for each worker would decrease from 14 bpm to 7
bpm. These are just some examples of how factors other than line speed
are more likely to affect work pace.
Industry employees' actual exposure to MSD risk factors, such as
repetitive or prolonged hand activity, will be affected by the number
of birds presented to each worker during a shift and the amount of time
each bird is in position to be worked on. In the simplest model of an
equal number of inspection and processing lines, it may be that
inspection line speed will influence the maximum processing line speed.
The Agency does not believe, however, that this model adequately
represents the industry as a whole, where a single inspection line may
feed multiple processing lines or different end products. Although the
inspection line speed is a potential factor, economic factors (e.g.,
consumer

[[Page 49599]]

demand and staffing/equipment capacity) will ultimately determine the
number of birds presented to each worker for processing during a shift.
These economic factors are addressed by industry and not regulated by
FSIS.
5. Factors Influencing Inspection Line Speed
Many comments seem to assume that the faster line speeds for
poultry inspection included in the proposed rule (but not included in
the final rule) that would necessarily have been authorized under the
NPIS would result in a very large increase in the volume of poultry
products being processed by workers. However, as discussed earlier,
line speed is not directly equivalent to production work pace;
inspection line speed does not directly impact plant employees in
further stages of an establishment (e.g., on the processing line).
The proposed faster line speeds for inspection--not included in
this final rule--would have allowed establishments to slaughter the
birds more efficiently but would not necessarily have led to a
substantial increase in processed output; consumer demand for poultry
products determine the number of birds slaughtered rather than line
speeds.
FSIS thinks that establishments choosing to operate under the NPIS
will determine their line speeds based on the same factors that
establishments considered when setting line speeds under HIMP.
6. Inspection Line Speed and Inspector Safety Under the NPIS
Comment: A labor union expressed concern about the potential
effects to the online CI if the proposed faster maximum line speed that
would have been authorized under the NPIS. The comment said that the
purpose of the NIOSH study described in the proposed rule is to assess
the effects of line speeds on establishment personnel. The comment
stated that the faster line speeds that would have been permitted under
the NPIS would also likely affect inspection personnel.
The comment noted that the NIOSH will study ``a maximum of five
non-HIMP establishments that applied through the SIP to receive waivers
of existing regulations restricting line speeds.'' The comment
expressed concern that the NIOSH study is only intended to gather
additional data of the effects of line speeds on the worker safety
without saying how increased line speeds have the potential to cause
unintended or foreseeable safety issues. The comment questioned how
this plan to gather additional data will relate to ensuring FSIS online
CIs are adequately protected, or how actual safety issues will be
remedied. The comment said that before FSIS decides to implement the
NPIS, it should make a serious, scientific inquiry into the potential
dangers related to the online inspector's new position.
Response: Under the NPIS, establishment employees rather than
online inspectors will be responsible for conducting sorting
activities. Therefore, the online inspection procedures under the NPIS
do not require that the CI touch or handle each carcass. Thus, because
CIs will have infrequent contact with the carcasses, their inspection
activities will involve less frequent head and hand motions than are
conducted under the existing non-HIMP inspection systems. In addition,
as discussed above, FSIS has revised the proposed facilities
requirements for the online carcass inspection platform to require that
the platform be height-adjustable to accommodate the individual CI.
Based on recent studies published in the occupational health
literature, FSIS believes the reduction in hand activity under the new
inspection system will lead to a reduction in the risk of
musculoskeletal disorders for inspection personnel.
7. Industry Efforts To Address Worker Safety
Comment: Some comments from trade associations agreed that worker
safety must be considered when establishing line speeds, and stated
that establishments do take worker safety into account. However, the
comments maintained that worker safety should be addressed separately
from food safety. The comments said the poultry industry has a strong
record of working with OSHA to help in OSHA's efforts to protect the
safety and health of employees, most recently with a formal OSHA
Alliance from 2007-2009. The comments expressed support for working
with the government and industry to maintain a strong safety record.
Response: FSIS will support effective industry efforts to protect
the health and safety of employees. FSIS also supports industry
collaboration with OSHA and NIOSH, and encourages the industry to work
with OSHA to further protect the health and safety of employees. FSIS
is willing to work with industry when it is appropriate and useful to
do so to move collaborative efforts forward with OSHA.
Comment: Two trade associations representing the poultry industry
stated that after 13 years of the HIMP pilot program, the data indicate
that the rate of worker injuries in HIMP establishments has been on
average at or below industry average rates. One comment said that, in
many instances, turkey HIMP establishments have reported worker injury
rates well below the already low industry average.
One comment stated that a recent survey of broiler establishments
participating in the Agency's HIMP pilot shows that, for both Total
Recordable Injury Rates and Days Away, Restricted, or Transferred
(DART) Rates, HIMP establishments are as safe for workers as
establishments that operate under non-HIMP inspection systems.
According to the comment, there is no statistical difference between
establishments involved in the HIMP pilot project and establishments
that operate under non-HIMP inspection systems with respect to Total
Recordable Injury Rates and DART Rates.
Response: The information provided in the comment suggests that
worker injury rates in HIMP establishments may be at or below the
worker injury rates in non-HIMP establishments. However, because the
comment did not discuss the details on how the survey was conducted,
the Agency is unable to assess the findings. As noted above, FSIS
encourages the trade association and its members to work with OSHA on
worker safety issues. It may be useful for the trade association to
submit its survey and findings to OSHA, since OSHA has the expertise in
evaluating this type of information regarding worker health and safety.
8. Reporting of Work-Related Injuries
Comment: Several comments said that although the data show that
workers in the poultry slaughter and processing industry suffer adverse
health and safety effects under the existing line speeds, studies
indicate, and statements by poultry workers confirm, that the official
injury statistics fail to accurately represent the extent to which
worker injuries and musculoskeletal diseases and disorders affect
workers in the poultry slaughter and processing industry.
The comments said that workers in the poultry industry are
regularly discouraged by their employers from reporting work-related
health conditions or seeking relief under the workers' compensation
system. The comments also stated that workers do not report injuries
for a variety of reasons, including concern about work hours, job
security, and residency status in the United States. The comments added
that injuries sustained by workers who are dismissed or resign during
their initial

[[Page 49600]]

three month probationary period are also not reported. The comments
noted that OSHA has recognized that there are problems related to the
under reporting of work-related injuries and established a Special
Emphasis Program on underreporting in 2009. According to the comments,
OSHA identified poultry processing as a targeted industry under this
program.
Response: OSHA is the appropriate agency to address issues
associated with the reporting of worker injuries. As discussed above,
OSHA has provided several recommendations that poultry slaughter
establishments can implement to improve surveillance for worker
injuries. FSIS strongly encourages establishments to adopt these
recommendations.
FSIS recognizes that systematic underreporting of work-related
injuries and illnesses could make it difficult to accurately assess the
extent to which poultry workers suffer from work-related injuries and
musculoskeletal diseases and disorders.
9. Attestation to FSIS on Work-Related Conditions
As discussed above, in both the proposed rule and the Federal
Register document extending the comment period, FSIS acknowledged the
potential for increased inspection line speed to affect the safety of
establishment workers (77 FR 4423-4424 and 77 FR 2487). FSIS also
``recognize[d] that the evaluation of the effects of line speed on food
safety should include the effects of line speed on establishment
employee safety'' (77 FR at 4423). And as noted above, commenters
raised concerns about the effects that increased line speeds might have
on the health and safety of workers in poultry slaughter
establishments.
Most of these comments expressed concern that workers subject to
faster line speeds could suffer increased numbers of occupational
injuries and illnesses, particularly musculoskeletal disorders (MSDs)
such as carpal tunnel syndrome, and that potential negative effects on
workers could also have an adverse effect on poultry safety. The
comments specifically noted that MSDs could affect workers to the
extent that they could not do their jobs properly, and also addressed
the possibility of bacterial contamination between workers and poultry,
exposure to other pathogens, and risk of laceration. Moreover, comments
also expressed concern that poultry processors' injury and illness logs
may not reflect the full extent of work-related conditions experienced
by poultry workers. A number of commenters requested that FSIS either
withdraw the proposal because of the increased risk of injury to
workers, or at least delay implementation of a final rule until NIOSH,
a part of the Centers for Disease Control and Prevention in the
Department of Health and Human Services, completed a comprehensive
study of the effect of line speed on worker safety and health.
As discussed above, in the proposed rule FSIS explained that it
asked NIOSH to evaluate the effects of increased inspection line speeds
on establishment worker safety by collecting data from establishments
that had been granted waivers from line speed restrictions under the
SIP (77 FR 4423-4425). NIOSH initiated such a study in one non-HIMP
establishment that is operating under a waiver from line speed
restrictions under SIP (77 FR 4423 and 77 FR 2487). NIOSH has completed
its evaluation and made its final report available to the public in
March 2014 (Evaluation of Musculoskeletal Disorders and Traumatic
Injuries Among Employees at a Poultry Processing Plant; Report No.
2012-0125-3204, March 2014; available on the Internet at: http://www.cdc.gov/niosh/hhe/reports/pdfs/2012-0125-3204.pdf). The results
from this study lend support to the concerns noted in the comments that
poultry processors' injury and illness logs often do not reflect the
full extent of work-related conditions experienced by poultry workers.
To address these concerns, FSIS is establishing a new subpart H
``Attestation on Work-Related Conditions.'' Subpart H includes an
annual attestation requirement (9 CFR 381.45) and a severability clause
(9 CFR 381.46). The attestation provision requires that each
establishment that operates under the NPIS provide an annual
attestation to the management member of the local FSIS circuit safety
committee stating that the establishment maintains a program to monitor
and document any work-related conditions that arise among establishment
workers. The elements of this program include:
(1) Policies to encourage early reporting of symptoms of work-
related injuries and illnesses, and assurance that the establishment
has no policies or programs intended to discourage the reporting of
injuries and illnesses.
(2) Notification to employees of the nature and early symptoms of
occupational illnesses and injuries, in a manner and language that
workers can understand, including by posting in a conspicuous place or
places where notices to employees are customarily posted, a copy of the
FSIS/OSHA poster encouraging reporting and describing reportable signs
and symptoms.
(3) Monitoring on a regular and routine basis of injury and illness
logs, as well as nurse or medical office logs, workers' compensation
data, and any other injury or illness information available.
As discussed earlier in this document FSIS has decided to allow the
20 young chicken establishments that have been granted SIP waivers to
operate under the HIMP inspection system to continue to operate under a
SIP waiver to run at line speeds of up to 175 bpm. FSIS will also
update these SIP waivers to remove aspects of HIMP that are
inconsistent with the NPIS, such as the OCP performance standards. To
ensure that the updated SIP waivers are consistent with the NPIS, the
Agency will also require that establishments operating under the
updated waivers submit the annual attestation discussed above as a
condition of their waivers.
The severability clause states that should a court of competent
jurisdiction hold any provision of part 381 to be invalid, such action
shall not affect any other provision of part 381 (9 CFR 381.46).
As OSHA is the Federal agency with statutory and regulatory
authority to promote workplace safety and health, FSIS will forward the
annual attestations to OSHA for further review. OSHA, in turn, may use
the information in the attestations in its own enforcement program.
FSIS employees will not be responsible for determining the merit of the
content of each establishment's monitoring program or enforcement of
noncompliance with this section. FSIS will work with OSHA to develop
the poster that establishments must display providing information on
the signs and symptoms of occupational injuries and illnesses
experienced by poultry workers, and about workers' rights to report
these conditions without fear of retaliation.
Consistent with the mandate of E.O. 12866, OSHA has advised FSIS
that the development and implementation of such a monitoring program
will enable establishments both to protect their workers and to
identify illnesses and injuries. Prompt intervention will also reduce
the costs associated with worker injury by enabling establishments to
adjust their processes or implement other appropriate measures before
additional employees are affected.

G. Changes That Affect All Establishments That Slaughter Poultry Other
Than Ratites

In addition to proposing to establish the NPIS, FSIS also proposed
changes to

[[Page 49601]]

the regulations that would apply to all establishments that slaughter
poultry other than ratites. The Agency proposed that all poultry
slaughter establishments develop, implement, and maintain written
procedures to ensure that carcasses contaminated with visible fecal
material do not enter the chiller and that they incorporate these
procedures into their HACCP plans, or sanitation SOPs, or other
prerequisite programs (77 FR 4426). The Agency also proposed to require
that all poultry slaughter establishments develop, implement, and
maintain, as part of their HACCP systems, 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 process, and that they maintain daily records
sufficient to document the implementation and monitoring of those
procedures (77 FR 4427). The Agency proposed that at a minimum, these
procedures must include sampling and analysis for microbial organisms
at the pre- and post-chill points in the process to monitor process
control for enteric pathogens.
The proposed new requirements are designed to ensure that
establishments incorporate process control measures to prevent
contamination into their HACCP systems, and that they develop and
maintain documentation to verify the effectiveness of their procedures
on an ongoing basis. In the preamble to the proposed rule, the Agency
explained that it would verify that establishments' procedures are
effective by reviewing the establishment's monitoring records,
including the establishment's microbiological testing results,
observing the establishment implementing its procedures, and inspecting
carcasses and parts for visible fecal contamination when performing
both online carcass inspection and offline verification inspection (77
FR 4427).
Under the proposed rule, each establishment would be responsible
for developing and implementing a microbiological sampling plan, which
would be required to include carcass sampling at pre-chill and post-
chill (77 FR 4428). The Agency also proposed to rescind the regulations
that require that poultry establishments test for generic E. coli and
to remove the codified Salmonella pathogen reduction standard for
poultry. The proposed new microbiological sampling requirements would
replace the generic E. coli testing regulations and would allow
establishments to develop sampling plans that are more tailored, and
thus more effective for monitoring their process control. FSIS would
consider both the establishment's testing results, as well as the
results of the Agency's testing Salmonella and Campylobacter
performance standards, to assess how well the establishment is
maintaining process control.
FSIS received several comments on these proposed new requirements.
1. Procedures and Recordkeeping Requirements for Preventing
Contamination by Enteric Pathogens and Visible Fecal Contamination
Comment: A consumer advocacy organization and an individual
expressed support for the proposed new requirement that all
establishments that slaughter poultry develop, implement, and maintain,
as part of their HACCP systems, written procedures to prevent carcass
contamination throughout the entire slaughter and dressing process. The
consumer advocacy organization also supported the proposal to require
that all poultry slaughter establishments develop, implement, and
maintain written procedures to ensure that carcasses contaminated with
visible fecal material do not enter the chiller, and incorporate these
procedures into their HACCP systems. According to the comments, the
proposed new requirements address a weakness of the current poultry
inspection system, which is that verification checks performed at the
end of the slaughter and chilling process encourage the industry to
focus its activities on post-process interventions to reduce
contamination rather than prevention throughout the slaughter process.
The comments also expressed support for the proposed requirement
that establishments maintain daily records sufficient to document the
implementation and monitoring of their procedures for preventing
contamination by enteric pathogens and fecal material. The comments
noted that many establishments may have in place process control
measures that attempt to address contamination by enteric pathogens and
fecal material, but nothing currently requires that the establishments
develop and maintain documentation to verify on an ongoing basis that
these procedures are effective. The comments said that without this
documentation, establishments can quickly lose process control or rely
on procedures that contribute to an ongoing risk of contamination. The
comments stated that the documentation proposed by the Agency will
allow both the establishment and the Agency to identify points of weak
process control, and can provide a roadmap for corrective action.
Response: FSIS agrees that requiring establishments to keep daily
written records to document the implementation and monitoring of their
process control procedures is a positive step forward for public
health. This ongoing documentation will allow both the establishment
and FSIS to identify specific points in the production process where a
lack of process control may have resulted in product contamination or
insanitary conditions. This will allow the establishment to take the
necessary corrective action to prevent further product contamination.
Comment: One trade association stated that it is unclear what
additional steps will be required in regard to sanitary dressing.
According to this trade association, all of its members already have
significant sanitary procedures in place.
Response: As noted above, in the preamble to the proposed rule,
FSIS acknowledged that many establishments have in place process
control measures to address the prevention of contamination by enteric
pathogens and fecal material, but that they are not maintaining
documentation to verify the effectiveness of these procedures on an
ongoing basis (77 FR 4427). Under this final rule, establishments will
be required to incorporate these procedures into their HACCP systems,
and to maintain ongoing documentation to demonstrate that the
procedures are effective. As noted above, this ongoing documentation
will allow both the establishment and FSIS to identify specific points
in the production process where a lack of process control may have
resulted in product contamination or insanitary conditions.
2. Sampling and Testing Requirements To Monitor Process Control
a. Sampling Plan and Sampling Sites
Comment: Several consumer advocacy organizations and a member of
academia disagreed with the Agency's proposal to allow each
establishment to develop its own sampling plan. These comments argued
that the sampling program needs to be standardized. According to one
comment, in other countries, such as New Zealand, the government sets
the testing frequencies and indicator pathogens for the industry.
One consumer advocacy organization argued that requiring all
establishments to conduct testing for the same organisms, at the same
frequency, and at the same locations along the production line will
provide the Agency and

[[Page 49602]]

stakeholders with valuable data on the impacts of incremental changes
in production on contamination levels both within a specific
establishment and industry-wide. According to this comment, under the
proposed rule, data analysis will be difficult for anyone (e.g., the
Agency, inspectors, and establishment management) trying to study the
data because of the variations in sampling at each establishment.
Another consumer advocacy organization stated that a uniform sampling
program can help identify additional steps that should be taken to
address hazards, modernize the system, and ensure facilities are
operating at line speeds that do not cause poultry contamination to
rise.
Response: The purpose of the proposed new sampling requirement is
to ensure that establishments monitor and evaluate the effectiveness of
their procedures to prevent contamination of carcasses by enteric
pathogens and visible fecal material on an ongoing basis. It is not
intended to generate data to compare establishment performance across
the industry. The data that FSIS collects from its Salmonella and
Campylobacter sampling programs serves that purpose. Because
establishments have differences in their operations, FSIS believes that
each establishment should have the flexibility to develop a sampling
plan that will accurately monitor the effectiveness of its process
control procedures while holding the establishment accountable through
the Salmonella and Campylobacter performance standards. As discussed
below, the Agency is prescribing a minimum frequency with which all
poultry establishments will need to collect samples.
FSIS will scrutinize an establishment's monitoring records,
including its microbial testing results, to verify the effectiveness of
the establishment's process control procedures. The Agency will
continue to assess and compare establishment performance across the
industry through the Agency's sampling program for Salmonella and
Campylobacter. Under this program, the samples are collected by FSIS
inspectors and analyzed by FSIS laboratories, ensuring that the
sampling and testing program is consistent, and that the Agency is able
to compare establishment performance and industry trends over time.
Comment: Several trade associations and an industry member stated
that, instead of requiring sampling at pre- and post-chill, FSIS should
allow establishments the flexibility to select the number and sampling
sites for their individual operations to demonstrate process control.
These comments argued that each establishment is different and that
sampling programs must be scientifically based and statistically valid
and are most effective when they are establishment specific. According
to these comments, sampling in one location could demonstrate process
control in one establishment because of certain interventions, but
sampling in two locations may be more appropriate to demonstrate
process control in another establishment. One trade association
believed that providing flexibility in sampling is consistent with
HACCP principles, encourages industry innovations in operations and
processing, and enables processors to develop new methods for
demonstrating process control through sampling.
Response: As stated in the preamble to the proposed rule, FSIS
believes that microbiological test results that represent levels of
microbiological contamination at key steps in the slaughter process are
necessary for establishments to provide comprehensive, objective
evidence to demonstrate that they are effectively maintaining process
control to prevent carcasses from becoming contaminated before and
after they enter the chiller (77 FR 4427). Process control in the
context of poultry slaughter consists of the programs and procedures an
establishment implements to ensure its processes are operating as
intended in preventing contamination (including contamination with
microbial pathogens and fecal material) of poultry carcasses and parts
throughout the slaughter and dressing process and to ensure that the
resulting products meet applicable regulatory standards or definitions.
Establishments must demonstrate that their process is in control by
implementing verification procedures, collecting data, and developing
and maintaining accurate records to demonstrate that their processes
and procedures are performing as intended and as required.
An effective process control system entails an establishment
responding effectively to re-establish control when its ongoing
verification activities show that its processes or procedures are not
producing the expected results. Effective process control procedures
should lead to lower rates of pathogen contamination because
establishments will discover deficiencies in processing sooner and more
reliably than would be the case without effective process control
procedures.
FSIS considers the microbial characteristics of poultry carcasses
at pre-chill to be a valuable source of data about how well an
establishment is minimizing contamination with fecal material and
enteric pathogens on live birds coming to slaughter and on carcasses
throughout the evisceration and dressing process. FSIS considers the
microbial characteristics of poultry carcasses post-chill to be a
valuable source of data about how well an establishment is minimizing
contamination during chilling and the overall effectiveness of any
antimicrobial interventions the establishment has chosen to apply
throughout its process. Because most establishments apply one or more
antimicrobial interventions between the pre- and post-chill sampling
points to help control microbiological hazards, FSIS would expect that
a reduction in microbiological contamination between these two points
to be an indication of the effectiveness of those controls.
Therefore, FSIS is finalizing the proposed requirements that
establishments collect samples for microbial analysis at the pre- and
post-chill locations to monitor for process control, with an exception
for very small and very low volume establishments operating under the
Traditional Inspection System. This exception is described below.
Comment: One trade association noted that if the Agency requires
sampling pre- and post-chill, the Agency needs to clarify that
establishments have the flexibility to select the sampling locations
where testing would occur before and after chilling. This comment also
argued that the Agency should not require a third sampling location at
re-hang because it would be overly prescriptive, burdensome, and would
not further food safety.
Response: Under this final rule, establishments will need to
collect pre-chill samples before the chiller at the end of the
evisceration process. The pre-chill testing is intended to monitor the
effectiveness of all process controls up to the point of the chiller.
An establishment will need to collect post-chill testing after it has
completed all interventions, which is the same point in the process
that FSIS collects samples for Salmonella and Campylobacter
verification testing.
As stated in the preamble to the proposed rule, FSIS had considered
requiring a third verification test at the re-hang position to monitor
the incoming load of pathogens but the Agency concluded that it was not
necessary to impose the additional costs that would be associated with
testing at this point (77 FR 4428).

[[Page 49603]]

Comment: A consumer advocacy organization argued that allowing each
establishment to use different tests with different indicator organisms
and standards for verifying that their process controls are effective
will create problems for inspectors. According to the comment, FSIS
inspectors will have to determine on a case-by-case basis whether each
test chosen is validated for that purpose and whether the standard used
by the establishment is adequate. This comment stated that determining
whether a HACCP plan is effective would be more complex for inspectors,
whereas the current generic E. coli testing program that FSIS proposed
to rescind provides an objective test and standard which are familiar
to FSIS and industry.
Response: As stated in the preamble to the proposed rule, because
an establishment's microbiological sampling plan will be part of its
HACCP system, each establishment will be required to provide scientific
or technical documentation to support the judgments made in designing
its sampling plan (77 FR 4428). FSIS inspection personnel will verify
the effectiveness of the establishment's sampling plan by reviewing the
supporting documentation and verifying that the establishment is
implementing its sampling plan as designed. These procedures are
consistent with the methodology that inspectors use to verify the
effectiveness of other measures incorporated into an establishment's
HACCP system. In addition, FSIS intends to provide training to its
inspectors and guidance to industry on all of the new requirements
under this final rule, including the new sampling plans. The Agency's
inspection personnel will be prepared to carry out their
responsibilities to ensure the effectiveness of establishments HACCP
systems, including the new sampling requirements, when this final rule
becomes effective.
b. Very Small and Very Low Volume Establishment Sampling
Comment: A State Department of Agriculture said that there should
be two sampling locations for all establishments, but that the sampling
frequency should be scale-dependent, e.g., the frequency should be
decreased for very small establishments. The comment noted that it is
just as important in a very small establishment as a large one to
maintain and document process control, but very small establishments
will have proportionally more difficulty than large establishments in
absorbing the costs for a second sampling location.
One industry member stated that sampling at small and very small
establishments should be the same as at all other establishments. This
industry member believed that the specific processes and programs in
place, not the size of the establishment or the volume of production,
should determine how process control is demonstrated.
Response: In the preamble to the proposed rule, FSIS noted that
small and very small low volume establishments that choose to operate
under the revised Traditional Inspection System may not need to conduct
testing for microbial organisms at two points in the slaughter process
to adequately monitor process control (77 FR 4428). These
establishments typically are less automated and run at slower line
speeds than larger establishments operating under SIS, NELS, and NTIS.
The lower level of automation and the slower line speeds require less
complicated measures for maintaining and monitoring process control on
an ongoing basis. Therefore, after considering this issue, FSIS has
decided to revise the proposed rule to allow very small and very low
volume establishments that operate under the modified Traditional
Inspection System to collect and analyze samples for microbial
organisms at the post-chill point in the process only. As stated in the
preamble to the proposed rule, very low volume establishments would
include those classified as very low volume establishments under the
existing generic E. coli testing regulations (77 FR 4428). To make this
clear, the Agency is establishing a codified definition for very low
volume establishments that is based on the existing very low volume
establishments definition under 9 CFR 381.94(2)(v), i.e.,
establishments that annually slaughter no more than 440,000 chickens,
60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000 guineas, or 60,000
squabs.
Under this rule, if FSIS has evidence to indicate that a very small
or very low volume establishment conducting sampling at a single point
in the process is not maintaining process control, such as not meeting
FSIS's pathogen performance standards, the establishment will need to
conduct additional testing or implement additional measures to ensure
that its process remains in control.
c. Sampling Frequency
Comment: Several consumer advocacy organizations requested that
FSIS explain how it developed the estimates on how frequently
establishments will conduct testing to monitor their process control
procedures. The comments noted that FSIS estimated that large
establishments will perform the prescribed tests 15 times a day, small
establishments 7 times a day, and very small establishments 3 times a
day. One of the consumer advocacy organizations asked that the Agency
explain the justification for the presumed sample size. The comment
stated that by providing clarification on the source of these
estimates, stakeholders can better ascertain whether they represent a
reasonable estimate of testing frequency.
Response: The estimates on how frequently establishments will
conduct sampling under the proposed rule are from the proposed rule's
Paperwork Reduction Act paperwork burden estimates. These estimates
were based on the frequency with which establishments operating under a
SIP waiver conduct sampling. Under SIP, FSIS grants establishments a
waiver of regulations under the condition that the establishment
collects and analyzes samples for microbial organisms and shares the
results with FSIS. As discussed below, FSIS is revising the proposed
rule to prescribe a minimum frequency with which all establishments
that slaughter poultry will need to conduct testing for microbial
organism to monitor their process control procedures. Thus, FSIS has
updated its paperwork burden estimates to reflect these changes.
Comment: Several consumer advocacy organizations and a member of
academia asserted that FSIS needs to prescribe the frequency with which
establishments must conduct sampling. One consumer advocacy
organization stated that establishments need to collect samples at a
specified frequency to evaluate whether any changes implemented by the
establishment as a result of the proposed rule have positive or
negative effects on rates of contamination. A consumer advocacy
organization argued that FSIS needs to require a specific testing
frequency per line and per shift to ensure that establishments achieve
sufficient testing for pathogens. Another consumer advocacy
organization suggested that FSIS require testing frequency per
production day based on production volume. One comment expressed
concern that poultry establishments have little incentive to incur
costs to test beyond a very minimum frequency that may not be
sufficient to monitor process control.
One trade association stated that FSIS should not remove the
generic E. coli

[[Page 49604]]

testing regulation because it includes 9 CFR 381.94(a)(2)(v), which
establishes definitions for very low volume establishments and provides
sampling frequencies for very low volume establishments. This trade
association asserted that specific testing frequencies for very low
volume establishments should remain in the regulations.
Several trade associations stated that FSIS should not prescribe
how often establishments must collect samples for testing. These trade
associations supported the flexibility in sampling frequency because
they believed sampling should be specific to an individual
establishment's programs and processes.
Response: After considering the comments from the consumer advocacy
organizations, FSIS believes that there is merit to requiring a minimum
frequency of testing to ensure that establishments will be able to
detect changes in processing or inconsistencies that may occur. FSIS
expects that for their sampling plans, most establishments will adopt
sampling frequencies that are similar to what is required under the
existing generic E. coli testing regulations because sampling less
frequently may affect the establishment's ability to detect problems
with their process controls in a timely manner. However, as indicated
by some of the comments, there is some concern that some establishments
may attempt to reduce sampling to a very low frequency. While a very
low testing frequency may be sufficient if the establishment is able to
consistently maintain process control, it could also decrease the
establishment's ability to detect changes or inconsistencies in
processing that may occur.
Therefore, to address concerns about minimal sampling frequencies
expressed by the consumer advocacy organizations, FSIS is revising the
proposed sampling requirements to prescribe a minimum frequency with
which establishments will be required to collect a pair of samples, one
at pre-chill and one at post-chill, or, for very small and very low
volume establishments that operate under Traditional Inspection, a
single post-chill sample. Under this final rule, establishments will be
required to collect samples at a frequency of once per 22,000 processed
carcasses for chickens and once per 3,000 processed carcasses for
turkeys, ducks, geese, guineas, and squabs. These frequencies reflect
the frequencies prescribed under the existing regulations for generic
E. coli testing.
Under the existing generic E. coli testing regulations, very low
volume establishments that slaughter turkeys, ducks, geese, guineas,
squabs, or ratites in the largest number must collect at least one
sample during each week of operation each year but may stop sampling
after 13 samples have been collected (9 CFR 381.94(a)(2)(v)). This
final rule includes a similar provision that will apply to very low
volume establishments to minimize the additional sampling costs to
these establishments, many of which are also small or very small
establishments. Thus, under this rule, if, after consecutively
collecting 13 weekly samples, a very low volume establishment
demonstrates that it is effectively maintaining process control, FSIS
will allow it to modify its sampling plan. For example, after
collecting 13 weekly samples, a very low volume establishment could
collect samples less frequently, such as once a month, and use visual
observation and documentation at control points to monitor process
control. FSIS will provide guidance to very low volume establishments
in developing alternative sampling plans and establish criteria, e.g.,
lower limit (m) and upper limit (M) values for test results, that will
allow them to effectively monitor process control.
Because ratites were not subject to the proposed rule,
establishments that slaughter ratites will continue to follow the
generic E. coli testing regulations in 9 CFR 381.94(a). These
regulations have been revised to remove all other poultry classes.
As noted in the preamble to the proposed rule, the frequency with
which establishments will need to conduct testing to monitor for
process control will depend on a number of factors, including their
production volume, the source of their flocks, their slaughter and
dressing processes, and the consistency of their microbial test results
(77 FR 4428). Therefore, the prescribed minimum sampling frequencies
may not necessarily be appropriate for every establishment to monitor
process control. Some establishment may need to sample more frequently
to effectively monitor process control. Because the testing frequency
will be an integral part of an establishment's HACCP system
verification procedures, establishments will need to collect and
maintain data to demonstrate that their testing frequency is adequate
to verify the effectiveness of their process control procedures.
Comment: Several trade associations stated that the source of
flocks should not be a factor in determining the frequency of
establishment testing. According to some of the comments, interventions
at establishments ensure that only unadulterated product leaves the
establishment, no matter where poultry is raised. One trade association
added that the best methods of controlling Salmonella occur in the
establishments, not on the farm. This trade association stated that the
decontamination process during slaughter has allowed the industry to
reduce its carcass swab incidence of Salmonella to less than 1.75
percent. Additionally, this comment noted that during a September 23,
2011, meeting, USDA's NACMPI rejected efforts to tie flock source to
process control because adequate science doesn't currently exist to
support such a relationship.
Additionally, one trade association believed that production volume
and slaughter and dressing processes should not be factors in
determining sampling frequencies. This comment argued that the manner
with which establishments demonstrate process control does not vary
with the operations being conducted. Several trade associations stated
that sampling frequency depends on an establishment's total food safety
system, not variables like volume or flock source that are already
accounted for.
Response: The proposed rule did not prescribe specific factors that
establishments would need to consider when developing their
microbiological sampling plans. However, because establishments are
required to incorporate their sampling plans into their HACCP systems,
they will be required to provide scientific or technical documentation
to support the judgments made in designing their sampling plans. In the
preamble to the proposed rule, the Agency stated that the frequency
with which establishments will need to collect samples for analysis
will depend on a number of factors, including, among other factors,
their production volume, and source of their flocks. As noted above,
even though the Agency is establishing a minimum testing frequency for
establishments to monitor process control, establishments will be
required to consider any factors that are relevant to their production
process to determine the sampling frequency that will be effective for
their operation to meet regulatory requirements.
FSIS is not requiring that establishments address specific factors,
such as flock source, to determine sampling frequency. However, because
establishments are required to incorporate their sampling programs into
their HACCP systems, they will need to provide scientific support for

[[Page 49605]]

the decisions made in determining the sampling frequency.
d. Indicator Organisms and Baseline
Comment: Several consumer advocacy organizations argued that
instead of allowing establishments to choose which organism to test
for, FSIS should require that establishments test for Salmonella and
Campylobacter. The comments said that these are the two pathogens of
greatest public health concern in the products affected by the proposed
rule and together account for nearly half of all poultry-related
outbreaks in the United States. One comment added that establishments
could still test for additional pathogens or indicator organisms as
warranted. One member of academia suggested that rapid testing be used
for Salmonella at pre- and post-chill testing locations, rather than an
indicator organism such as generic E. coli, because Salmonella is the
leading cause of bacterial foodborne disease.
Response: As discussed above, the purpose of the proposed new
testing requirements is to ensure that establishments are effectively
monitoring process control on an ongoing basis. FSIS has determined
that this can be achieved by sampling pre- and post-chill for enteric
pathogens, such as Salmonella and Campylobacter, or for an appropriate
indicator organism. The comments did not include any data to cause FSIS
to question this conclusion.
As discussed above, to effectively monitor their process control
procedures, establishments will need to conduct testing at a frequency
that is sufficient to detect a loss of process control soon after it
occurs so that they can take the necessary corrective actions to
prevent further product contamination. Because the percentage of
carcasses that are expected to show positive test results for
Salmonella and Campylobacter is small when compared with the percentage
of carcasses that are expected to show positive results for indicator
organisms, establishments would need to analyze a large number of
samples for Salmonella or Campylobacter to detect a loss of control,
much larger than when using an appropriate indicator organism,
everything else being equal. The cost to analyze samples for Salmonella
and Campylobacter is much greater than that to analyze for indicator
organisms.\15\ Thus, the costs to effectively monitor a process using
Salmonella and Campylobacter measurements would likely be considerably
more expensive than the costs to monitor the process using measurements
of levels of indicator organisms. FSIS has concluded that such costs
would not be justifiable when measurements of indicator organisms are
as effective for monitoring process control as measurements of
pathogens.\16\ \17\ \18\
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\15\ Laboratory cost for analyzing for Salmonella and
Campylobacter could exceed $300 per sample though we expect costs
would vary, and could be less, depending upon number of tests and
laboratory availability. The costs of analyzing these pathogens we
expect to be more than 10-fold greater than the costs for analyzing
for indicator organisms.
\16\ Altekruse, S.F., Berrang, M.E., Marks, H., Patel, B., Shaw,
W.K., Sani, P., Bennett, P.A., and Baily, J.S., 2009, Enumeration of
Escherichia coli Cells on Chicken Carcasses as a Potential Measure
of Microbial Process Control in a Random Selection of Slaughter
Establishments in the United States, Applied and Environmental
Microbiology, 75(9): 3522-3527.
\17\ Berrang, M.E., Bailey, J.S., Altekruse, S.F., and Shaw,
W.K., 2008, J. Appl. Poultry Res 17: 354-360.
\18\ Habib, I., De Zutter, L, Van Huffel, X., Geeraerd, A.H.,
and Uyttendaele, M., 2012, Potential of Escherichia coli as a
Surrogate Indicator for Postchill Broilers with High Campylobacter
Counts, Food Control 25: 96-100.
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Comment: Several consumer advocacy organizations and a member of
academia recommended that FSIS require that establishments conduct
testing for a specific period of time that can be statistically
justified to provide baseline testing data before the Agency moves
forward with any changes to its poultry slaughter inspection program.
One of the comments added that the baseline testing data will allow
FSIS and the establishment to determine how changes to the poultry
slaughter system impact pathogen rates at the establishment. Another
comment stated that FSIS should require the continuous generation of
baseline data for a period of at least 90 days prior to implementing
other substantive changes to the poultry inspection system.
Response: FSIS is requiring that establishments collect and analyze
samples for microbial organisms to monitor the effectiveness of their
process control procedures. As noted above, establishments will be
responsible for determining which microbiological organisms will best
help them to monitor the effectiveness of their process controls. The
establishment's baseline for its sampling plan will depend on the
organism that it selects. Establishments that choose to collect and
analyze samples for indicator microbial organisms rather than
pathogens, such as Salmonella and Campylobacter, will be responsible
for developing their own baseline for these organisms because the
Agency is not establishing performance standards for indicator
organisms. Of course, some establishments may already have data that
they can use to develop a baseline. For those that do not, the length
of time an establishment will need to develop a baseline will depend on
several factors, including the volume of birds it slaughters, the
number of lines, and the number of sources from which the establishment
receives birds.
Establishments must have developed their sampling plans before the
effective dates established in this final rule. The sampling plan must
be made part of the establishment's HACCP system, and as such, the
establishment is required to provide scientific or technical
documentation to support the effectiveness of its sampling plan, which
may include the development of an appropriate baseline to allow them to
detect changes or inconsistencies in microbial levels that may occur
during the slaughter and evisceration process.
3. Rescind Testing for Generic E. coli for Establishments That
Slaughter Poultry Other Than Ratites
In the proposed rule, FSIS explained that it was proposing to
rescind the generic E. coli testing requirements in 9 CFR 381.94 and
replace them with a new testing requirement that allow establishments
to sample for other, potentially more useful indicator organisms. The
new testing requirements were discussed above. FSIS received some
comments on this aspect of the proposed rule (77 FR 4428).
Comment: Comments from a consumer advocacy organization and a
member of academia said FSIS should not rescind the existing
regulations that prescribe testing for generic E. coli. A consumer
advocacy organization said that rescinding this regulation will remove
performance standards as a regulatory matter, expose consumers to
greater risks from contaminated poultry, and reduce options for
enforcement. One member of academia also stated that given that USDA
studies have shown that E. coli can serve as a reservoir or source of
transferable genetic determinants for antimicrobial resistance in
foodborne pathogens, testing for generic E. coli should not be
rescinded.
A consumer advocacy organization presented various arguments that,
according to the organization, show that FSIS did not adequately
support its decision to rescind the generic E. coli sampling
requirements. First the comment asserted that FSIS inappropriately
relied on a 2004 report of the National Advisory Committee on
Microbiological Criteria for Foods (NACMCF) as a basis for rescinding
the rule. Second, the comment argued that

[[Page 49606]]

the studies that FSIS referenced that indicate that the presence of
generic E. coli on young chicken carcasses may be a result of
infectious process or air saculitis, and do not provide a basis for
rescinding the generic E. coli testing regulations. According to the
comment, regardless of whether the source of contamination is fecal or
an infected carcass, testing and performance standards are still
relevant because detecting generic E. coli would be evidence of
problems in the establishment's process controls.
Response: As discussed in the preamble to the proposed rule, the
Agency's experience with the generic E. coli testing regulations has
led the Agency to conclude that such testing may not be the most
effective way for establishments to monitor the effectiveness of their
process control procedures.
The existing generic E. coli performance criteria represent the
distribution of measured generic E. coli results observed in FSIS's
1994 baseline survey of young chicken slaughter establishments. Since
FSIS implemented the generic E. coli testing requirements,
establishments have made changes to their processes that have led to
further reductions in the detectable levels of generic E. coli on
carcasses post-chill. The most recent young chicken baseline conducted
from 2007-2008 shows that the levels of detectable generic E. coli on
post-chill carcasses are well below the performance criteria in the
existing regulations and that over 60 percent of the sample
measurements had non-detectable levels of generic E. coli.
Data from FSIS's 2007-2008 Young Chicken Baseline survey show that
there were 12 establishments from which 10 or more samples were
analyzed during the survey and none with detectable levels of generic
E. coli. FSIS analyzed 22 samples each in 2 of these establishments.
All 44 samples had detectable Aerobic Plate Count (APC) measurements
even though none had detectable generic E. coli measurements. Thus, for
these establishments, it might be more efficient to use APC counts
instead of generic E. coli counts to monitor for process control
because a higher percentage of samples would be expected to have
measurable APC levels even when generic E. coli levels are not
detected.
In addition, FSIS used the most recent baseline survey of young
chicken establishments to perform correlation analyses of pathogen
presence and measured levels of indicator organisms on carcasses. The
results indicate that measured APC levels at re-hang were more highly
correlated with Salmonella presence at re-hang than were measured E.
coli levels. Such results suggest that APC measurements might provide a
better measure of process control.
Although the Agency has determined that the existing post-chill
testing for generic E. coli may not be the most effective means for
monitoring process control, establishments may sample for generic E.
coli or any other indicator organism pre- and post-chill, or for very
small and very low volume establishments operating under Traditional
Inspection, post-chill only, if the establishment provides scientific
or technical documentation to demonstrate that the use of a specific
indicator organism is appropriate for monitoring the establishment's
process control procedures.
4. Rescind Codified Salmonella Performance Standards
In the preamble to the proposed rule, FSIS explained that because
it can effectively address pathogen reduction in poultry establishments
through its new Salmonella and Campylobacter performance standards and
the SIP, the Agency was proposing to rescind the codified Salmonella
pathogen reduction performance standards in 9 CFR 381.94(b). The Agency
also explained that, since 2001, after a ruling by the U.S. Court of
Appeals for the Fifth Circuit in Supreme Beef Processors, Inc. v. USDA,
the Agency's ability to directly enforce the codified Salmonella
pathogen reduction performance standards has been limited. FSIS
received several comments from consumer advocacy organizations on its
decision to rescind the codified standards.
Comment: A consumer advocacy organization said that in developing
the proposed rule, FSIS should have considered the alternative of
retaining both the generic E. coli testing requirements and the
codified Salmonella performance standards as a way to ensure that an
establishment's processes are under control and its products meet a
minimum level of sanitation. The comment said that FSIS should retain
its ability to monitor end-products for fecal and microbial
contamination through mandated testing and performance standards. The
comment asserted that in rescinding the E. coli and Salmonella testing
provisions and their associated performance standards, FSIS is removing
a useful verification check.
Response: FSIS disagrees with the comments. The Agency does not
believe that it needs to retain the existing codified generic E. coli
performance criteria and the existing codified Salmonella performance
standards to verify that establishments' processes are in control and
that the products meet a minimum level of sanitation. The reasons the
Agency is rescinding the generic E. coli testing requirements were
discussed above. The new testing requirements will give establishments
the flexibility to sample for other potentially more useful indicator
organisms to monitor for process control.
As noted above, the Agency is rescinding the codified Salmonella
performance standards because it can effectively address pathogen
reduction in poultry establishments through its new Salmonella and
Campylobacter performance standards and the SIP. FSIS will continue to
collect verification samples and analyze them for Salmonella and
Campylobacter and compare the results to the Agency's most recent
performance standards for these pathogens. The Agency will also
continue to post the names of establishments that fail to meet the new
performance standards on the Agency's Web site and will continue to use
an establishment's failures to meet the standard as a basis for
conducting an in-depth evaluation of the establishment's food safety
system.
Comment: Some comments disagreed with the Agency's proposal to
rescind the codified Salmonella performance standards. The comments
said that under the existing regulations, an establishment's consistent
failure to comply with the Salmonella performance standards or take the
corrective actions necessary to comply with the standards constitutes a
failure to maintain sanitary conditions and to maintain an adequate
HACCP plan. The comments said that the codified Salmonella performance
standard is important because it informs poultry establishments of
their responsibilities to control their processes and the consequences
of repeated failures to do so.
The comments stated that rather than removing the codified
performance standards, the Agency should instead focus on updating
them. The comments noted that the Agency has developed new performance
standards for Salmonella and Campylobacter in young chicken and turkey
slaughter establishments. The comments suggested that the Agency
replace the existing codified Salmonella performance standards with the
new Salmonella and Campylobacter performance standards.
Response: One difficulty with establishing codified pathogen

[[Page 49607]]

reduction performance standards, as suggested by the comments, is that,
although these standards may represent an appropriate level of pathogen
reduction at the time they were established, over time, as
establishments make adjustments to their processes to meet these
standards, the standards may no longer be an effective means for
accomplishing pathogen reduction. The Agency's codified Salmonella
performance standards demonstrate the need for flexibility to update
performance standards based on changes in baseline levels for the
pathogens of concern.
As discussed in the preamble to the proposed rule, since 2001,
after the ruling in Supreme Beef Processors, Inc. v. USDA, the Agency's
ability to directly enforce the codified Salmonella pathogen reduction
performance standards has been limited (77 FR 4412). Therefore, after
the Supreme Beef ruling, the Agency began using Salmonella failures as
a basis to conduct an in-depth evaluation of an establishment's food
safety system. 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 chickens, FSIS initiated policies to
reduce Salmonella. One of those initiatives was to create three
establishment performance categories for Salmonella based on the
codified performance standards. The new performance Category 1
represented the best performing establishments and was defined as not
more than half the regulatory standard. Category 2 was set at more than
half, but, did not exceeding the regulatory standard. Category 3
establishments exceeded the standard, and represented the worse
performing establishments. FSIS began publishing the names of young
chicken establishments in Category 2 and 3 in March 2008, and has
continued to publish the names of establishments in Category 3 on or
about the 15th of each month.
After it established the new Salmonella performance categories,
FSIS completed new young chicken and turkey baselines in 2008 and 2009
respectively. In May 2010, the Agency announced that it had developed
tightened performance standards for Salmonella and a new performance
standard for Campylobacter for chilled carcasses in young chicken and
turkey slaughter establishments based on the new baseline results. In
March 2011, the Agency announced that it would implement the new
standards starting in July 2011 and that when two sets per
establishment are completed, the Agency will post the names of young
chicken and turkey establishments that fail the new Salmonella
standards, i.e., Category 3, on the Agency's Web site. The new, more
stringent standards are used in place of the codified Salmonella
performance standards.

H. Elimination of Time/Temperature Chilling Requirements

In the January 2012 proposed rule, FSIS proposed to replace the
regulations that prescribe the specific time and temperature parameters
needed to chill RTC poultry with a requirement that poultry slaughter
establishments develop written procedures, and implement and maintain
these procedures to control the levels and prevent the multiplication
of spoilage organisms and pathogenic bacteria in the product after
evisceration (77 FR 4430). Establishments would be required to
incorporate these procedures into their HACCP plans, or sanitation
SOPs, or other prerequisite programs. The Agency also proposed to
define ``air chilling'' as the method of chilling raw poultry carcasses
and parts exclusively with air. In the preamble to the proposal, the
Agency explained that under the proposed definition, an antimicrobial
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. FSIS received comments on the proposed
revision to its poultry chilling requirements as well as on the
proposed definition of air chilling.
Comment: One comment supported the Agency's decision to permit
establishments to develop and validate their own chilling processes
while still retaining the current chilling processes as a validated
safe harbor. The comment said that this approach was consistent with
the Agency's policies favoring a scientifically based approach to food
safety. The comment suggested that FSIS provide guidance on how
establishments should validate new chilling processes to facilitate
compliance and encourage innovative chilling processes. The comment
also said that the Agency should also reiterate the safe harbor
provisions in the final rule.
Response: As discussed in the proposed rule, establishments will be
required to incorporate their procedures for chilling into their HACCP
systems. Thus, establishments will need to validate their chilling
procedures as prescribed in the HACCP validation regulations (9 CFR
417.4(a)). Under these regulations, establishments are required to: (1)
Document the scientific or technical support for the judgments made in
their chilling process and (2) repeatedly test the adequacy of their
chilling process controls to demonstrate that their chilling process
will perform as expected. As stated in the preamble to the proposed
rule, FSIS will consider the existing time and temperature chilling
regulations as safe harbors and will incorporate these requirements
into compliance guidance on meeting the new chilling requirements.
Comment: Two labor unions commented that it is unsound for the
Agency to eliminate time and temperature chilling requirements and
replace them with a performance-based approach that permits
establishments to develop their own validated chilling procedures. One
of the labor unions said that because the proposed rule will allow
poultry slaughter establishments to select any chilling technique they
please, small and medium establishments may eviscerate 175 bpm now and
worry about adequate chilling later. According to the comment, the
proposal to eliminate the time and temperature requirements is an
attempt by the Agency to accommodate those small and medium-sized
slaughter establishments that cannot safely increase production to 175
bpm under the NPIS but that have no choice but to adopt the new system.
Response: The comments that suggest that the prescribed new
chilling requirements will allow poultry slaughter establishments to
increase line speeds before they have developed effective chilling
procedures is incorrect. Under this final rule, establishments are
required to develop, implement, and maintain validated chilling
procedures that will effectively control the levels and prevent the
multiplication of spoilage organisms and pathogenic bacteria before
they may operate at any given line speed. In addition, the maximum line
speed under the NPIS is 140 bpm and not 175 bpm, as was proposed.
FSIS also disagrees with the comment that the decision to amend the
poultry chilling requirements is not a sound proposal. To the contrary,
and as noted in the preamble to the proposal, FSIS has granted SIP
waivers from the time and temperature regulations to six poultry
slaughter establishments. The data collected from these establishments
demonstrate that alternative chilling procedures can be as effective as
the prescribed time and temperature requirements in controlling the
levels and preventing the multiplication of spoilage organisms and
pathogenic bacteria in the product after

[[Page 49608]]

evisceration. Under this rule, establishments will be required to
incorporate procedures for chilling into their validated HACCP systems.
These written procedures will include the conditions of use affecting
carcass chilling and microbial multiplication identified by the
establishment.
Comment: A trade association recommended that FSIS clarify the
definition of air chilled poultry to accommodate reasonable
applications of antimicrobials using small amounts of water. The
comment said that these applications are not designed to affect cooling
or moisture pick-up, but that a strict technical reading of the
proposed rule might be interpreted to prohibit their use. The comment
suggested that the Agency revise the air chilling definition to permit
antimicrobial applications applied with water if the water is used for
a short duration and does not materially contribute to the chilling
process or result in a material amount of water pick-up. According to
the comment, this change would align the proposal with industry
practice currently permitted by the Agency.
A company that has created a combination air chilling system that
begins with antimicrobial dips of birds at the end of the slaughter
process requested that the Agency revise the proposed definitions of
air chilling to make clear that poultry chilled using this process
qualify as ``air chilled.''
The comment explained that under its chilling system, poultry
carcasses are subject to an antimicrobial dip that lasts for 20-90
seconds at the end of the slaughter process and then are air chilled
without any water or sprays. According to the company, the combination
system results in no moisture pick-up when the entire process is viewed
from start to finish, but there is an unavoidable reduction of product
temperature because of the antimicrobial dip tanks prior to the start
of air chilling. The company requested that FSIS permit the use of an
``air chilled'' claim for a process that begins with antimicrobial dips
of limited duration immediately prior to air chilling, regardless of a
reduction in product temperature because of the antimicrobial
treatment, provided there is no pick-up of moisture for the entire
process.
According to the company, antimicrobials are generally more
effective if applied when the carcasses are warm, i.e., directly after
evisceration and before chilling, and its combination system has been
shown to reduce Salmonella and Campylobacter. The company argued that
allowing products chilled with this combination system to bear an ``air
chilled'' label will provide marketing benefits and encourage
establishments to adopt this food safety innovation.
The company also stated that its combination system has been
recognized as an air chill system by the European Union. According to
the comment, if FSIS were to adopt the proposed ``air chilled''
definition, poultry chilled using the combination system would be
allowed to be labeled as ``air chilled'' in the European Union but not
in the United States because the system reduces the product
temperature. The company stated the FSIS should allow establishments to
choose when chilling begins, so that establishments could treat the
antimicrobial dip tanks in a combination system as an intervention in
the slaughter process, so that the chilling would begin after the
intervention.
Alternatively, the company requested that FSIS revise proposed 9
CFR 381.66(e) to read ``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 antimicrobial intervention with water may be used
provided its use does not result in any pick-up of water or moisture
and the majority of the chilling time consists of chilling exclusively
with air.''
Response: After carefully considering these comments, FSIS believes
they have merit. Therefore, FSIS is revising the proposed definition of
air chilling to read as follows:
``Air chilling is the method of chilling raw poultry carcasses and
parts predominantly with air. An antimicrobial intervention may be
applied with water at the beginning of the chilling process if its use
does not result in any net pick-up of water or moisture during the
chilling process. The initial antimicrobial intervention may result in
some temperature reduction of the product only if the majority of
temperature removal is accomplished exclusively by chilled air.''
FSIS believes the revised definition will allow change and
innovation by industry, while still meeting the essential criteria for
approval of the ``air-chilled'' labeling claim, i.e., that the majority
of chilling is accomplished with air and the process does not result in
any pick-up of water or moisture. By allowing an antimicrobial
intervention to reduce to a non-material extent the product
temperature, FSIS will provide more opportunities for industry to apply
antimicrobial interventions without delaying the start of the chilling
process. This may well provide industry with more options to develop
and apply innovative antimicrobial interventions to improve the
microbiological characteristics of poultry products by reducing the
numbers of foodborne pathogens and spoilage organisms. By applying
antimicrobial interventions at a temperature that results in partial
chilling of the poultry products, industry may be able to make those
interventions more effective, while also decreasing the overall time to
chill the product.
FSIS has determined that this change in the definition of ``air
chilling'' will not result in mislabeling or the misleading of
consumers because it preserves the two essential characteristics that
FSIS considers when reviewing ``air chilled'' labeling claims: (1) That
the product does not gain moisture from the chilling process and (2)
that the majority of the temperature reduction is done by chilled air.

I. Online Reprocessing

In the January 2012 proposed rule, FSIS proposed to permit poultry
slaughter establishments to use approved online reprocessing
antimicrobial systems and offline reprocessing antimicrobial agents
including chlorinated water containing 20 ppm to 50 ppm available
chlorine or other antimicrobial agents that have been approved as safe
and suitable for reprocessing poultry (77 FR 4432). The Agency proposed
to require that establishments address the use of online or offline
reprocessing in their HACCP plans, or sanitation SOPs, or other
prerequisite programs. FSIS received a few comments on these proposed
new requirements.
Comment: Two trade associations expressed support for amending the
regulations to permit the use of safe and suitable substances for both
online and offline reprocessing, thereby eliminating the need for
individualized waivers for the use of these technologies.
One trade association recommended that the Agency eliminate the
distinction between online and offline reprocessing and instead require
that establishments justify the appropriate use of safe and suitable
antimicrobials in their HACCP plans. According to the comment,
establishments already must validate their processes, including the
antimicrobials used in reprocessing. The comment asserted that a
formalistic FSIS distinction serves no meaningful purpose and may
confuse issues and deter innovation. The comment said that limiting
uses of certain antimicrobials to online or offline

[[Page 49609]]

reprocessing overlooks the fact that all poultry must meet the same
standards. The comment said that relying on individual establishment
validations would reflect a more scientifically sound approach. The
comment said if FSIS has concerns about the appropriateness of
particular antimicrobials for certain applications, the Agency can
limit the conditions of use for the antimicrobial when listing the
antimicrobial as safe and suitable for use in poultry products.
Response: FSIS is maintaining the distinction between online and
offline reprocessing in this final rule because there are differences
between the two processes that require separate regulatory
requirements.
Establishments that use offline reprocessing remove the carcasses
accidentally contaminated with digestive tract contents from the main
slaughter line and reprocess them at a designated offline station in
any manner that will remove the contamination, such as vacuuming,
washing, and trimming, singly or in combination. Establishments that
reprocess carcasses online are permitted to leave the contaminated
carcasses on the main slaughter line. The carcasses then proceed to an
online reprocessing station where the contamination is removed by an
approved antimicrobial agent that is applied to all carcasses on the
line. The provisions in this final rule that permit poultry slaughter
establishment to use approved online reprocessing antimicrobial systems
and offline reprocessing antimicrobial agents do not affect the
separate procedures used for offline or online reprocessing. Thus, this
final rule maintains the distinction between the two processes.
Comment: A member of academia commented that issues related to
online reprocessing are complex and suggested that instead of
addressing online reprocessing provisions in this rulemaking, FSIS
should provide for online reprocessing in a separate rulemaking.
According to the comment, two problems arise from online reprocessing.
The comment said that first, carcasses will be allowed to remain on the
line despite visible fecal contamination, and second, that the use of
online reprocessing antimicrobial agents requires that all carcasses be
treated with unspecified antimicrobial agents whether contaminated or
not. The comment asserted that the data on online reprocessing that
FSIS described in the preamble to the proposed rule do not provide
sufficient information to determine whether the process can meet
sanitary standards. The comment said that, before FSIS finalizes the
rule, it needs to ensure that establishments conduct more pilot testing
under the supervision of disinterested parties.
Response: FSIS disagrees with the commenter. With respect to the
comment that all carcasses will be treated with ``unspecified
antimicrobial agents,'' as noted in the preamble to the proposed rule,
before a new substance can be used as an online reprocessing agent, the
Food and Drug Administration (FDA) will determine the safety of the
substance for use in online reprocessing and FSIS will determine its
suitability (77 FR 4433). Establishments opting to use online
reprocessing will 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. FSIS will list all
antimicrobial agents that have been approved for use in online
reprocessing, together with the specific parameters of use under which
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.''
FSIS also disagrees with the comment that the data on online
reprocessing do not provide sufficient information to determine whether
the process can meet sanitary standards. As discussed in the preamble
to the proposed rule, when FSIS published the proposed rule, 144
poultry slaughter establishments were operating under waivers that
allowed them to use online systems to reprocess carcasses accidentally
contaminated with digestive tract contents (77 FR 4432). The data
generated from the in-plant trials conducted under these waivers show
that various online antimicrobial treatments have differing but equally
effective results with respect to pathogen reduction. Thus, FSIS
disagrees that it needs to ensure that establishments conduct more
pilot testing on online reprocessing before the Agency finalizes the
proposed rule. There are extensive data available to show that the use
online reprocessing systems is an effective method for removing
digestive tract contents from accidentally contaminated carcasses and
that the process meets sanitary standards.

J. Animal Welfare Considerations

FSIS received thousands of comments from private citizens and
comment letters from animal welfare advocacy organizations that
expressed concerns about the potential impact that the NPIS may have on
the welfare of the live birds at slaughter. These comments raised
several issues related to the handling of live birds under the NPIS.
1. Welfare of Live Birds
Comment: Several animal welfare organizations stated that FSIS did
not adequately consider the impact that the NPIS will have on animal
welfare. The comments expressed concern that the NPIS would negatively
impact the welfare of birds. Numerous individuals and several animal
welfare organizations expressed their view that the NPIS is
inconsistent with FSIS's policy that ``considers humane methods of
handling animals and humane slaughter operations a high priority,'' and
it would undermine the Agency's food safety and humane slaughter
policies.
Response: FSIS regulations require that establishments slaughter
poultry in accordance with good commercial practices in a manner that
results in thorough bleeding of the poultry carcasses and that ensures
that breathing has stopped before scalding so that the birds do not
drown (9 CFR 381.65(b)). In September 2005, the Agency published a
Federal Register notice to explain that poultry products are more
likely to be adulterated if, among other circumstances, they are
produced from birds that have not been treated humanely because such
birds are more likely to be bruised or to die other than by slaughter
(70 FR 56624). The PPIA (21 U.S.C. 453(g)(5)), as well as the
regulations (9 CFR 381.90), provide that carcasses of poultry showing
evidence of having died from causes other than slaughter are considered
adulterated and condemned. The Agency did not propose changes to these
regulations and this final rule maintains these requirements without
change. Establishments operating under the NPIS will absolutely be
required to comply with these requirements. FSIS does not have a basis
to believe the NPIS will negatively impact bird welfare and does not
expect the new system to do so. Nonetheless, FSIS does consider humane
handling and good commercial practices to be a high priority and will
continue to be diligent in enforcing these requirements.
2. Line Speed and Animal Welfare
Comment: Approximately 1,000 individuals and several animal welfare
organizations said that the proposed increase in maximum slaughter line
speeds under the proposed rule would adversely impact humane handling
of poultry. Many examples were suggested by individuals and animal
welfare organizations of ways in which these adverse impacts could
potentially occur.

[[Page 49610]]

These encompass concerns about potential workers frustrations over
faster line speed and taking these frustrations out on the birds,
potential increased injuries that may occur from shackling birds at
faster line speeds, potential injuries from birds vigorously flapping
their wings while in shackles, and the potential for ineffective
stunning and throat cutting at faster line speeds.
Response: As discussed above, under this final rule, the maximum
line speed permitted under the NPIS will be 140 bpm for young chickens
rather than 175 bpm, as was proposed. Thus, the maximum line speed for
the NPIS will be no faster than the maximum line speed permitted under
the existing inspection systems under SIS.
As the Agency explained in the previous response, under the NPIS,
establishments are now and will continue to be required to slaughter
poultry in accordance with good commercial practices, in a manner that
results in thorough bleeding of the poultry carcasses and ensures that
breathing has stopped before scalding (9 CFR 381.65(b)). FSIS also
considers poultry carcasses showing evidence of having died from causes
other than slaughter to be adulterated and as such must be condemned
(21 U.S.C. 453(g)(5) and 9 CFR 381.90). For example, poultry that are
still breathing on entering the scalder die from drowning not from
slaughter and are, therefore, considered adulterated and unfit for
human food. Establishments operating under the NPIS will be subject to
these requirements regardless of an establishment's specific line
speed. If an establishment fails to meet these requirements, it will
have to adjust its operations to ensure that is does meet these
requirements. For example, some establishments may reduce line speeds,
others may station additional employees in the receiving-to-pre-scald
areas to ensure compliance.
Further, FSIS believes that employing humane methods of handling
and slaughtering that are consistent with good commercial practices
increases the likelihood of producing unadulterated product. In
addition, if an establishment chooses the NPIS, FSIS inspection
resources will be allocated to more offline food safety-related
inspection activities, including verification tasks to systematically
observe the conditions in the receiving to pre-scald area. When
verifying good commercial practices in this area, offline inspection
personnel observe whether establishment employees are mistreating birds
or handling them in a way that will cause death, injury, prevent
thorough bleeding, or result in excessive bruising. Offline inspection
personnel also verify that the birds are stunned before being bled and
determine whether there is other evidence that birds died other than by
slaughter. If offline inspection personnel observe that the
establishment is not following good commercial practices, they will
take appropriate enforcement action and require corrective and remedial
measures.
3. Animal Welfare and the Reduction in Number of Online FSIS Inspectors
Comment: Many individuals, several animal welfare organizations,
and a consumer advocacy organization commented that a reduction in the
number of online FSIS inspectors will harm animal welfare because FSIS
inspectors will have less of an opportunity to observe and address
inhumane handling. The comments expressed concern that current duties
regarding handling and treatment of birds will not be adequately
performed under the NPIS because there will be fewer FSIS inspectors.
One consumer advocacy organization asserted that industry may also have
less incentive to prevent injury to animals because of the Agency's new
approach to OCP defects.
Response: Under this final rule, the NPIS will become one of the
poultry inspection systems. FSIS disagrees that decreasing the number
of online FSIS inspectors under the NPIS will harm animal welfare or
impair its ability to carry out its human handling work effectively. As
with HIMP, VIs under the NPIS will conduct food safety related
inspection activities, including verification tasks to systematically
observe the conditions in the receiving to pre-scald area, and will
continuously monitor and evaluate establishment process control. For
example, FSIS offline VIs will be verifying that establishments are
following good commercial practices and will be checking for
mistreatment or improper handling of birds. If inspection personnel
observe that the establishment is not following good commercial
practices, they will take appropriate enforcement action. If an
establishment's line speed is seen as a cause of failure to follow good
commercial practices, or if food safety related or non-food safety
related conditions impair the online CI's ability to conduct the
inspection of each carcass, the IIC will take appropriate remedial
action and will be authorized to require that the establishment slow
the line speed.

K. Environmental Impact

In the preamble to the proposed rule, FSIS explained that each USDA
agency is required to comply with 7 CFR part 1b of the USDA
regulations, which supplement the National Environmental Policy Act
(NEPA) regulations (77 FR 4451). Under 7 CFR part 1b, actions of
certain USDA agencies and agency units are categorically excluded from
the preparation of an Environmental Assessment (EA) or Environmental
Impact Statement (EIS) unless the agency head determines that an action
may have a significant environmental effect. FSIS is among the agencies
categorically excluded from the preparation of an EA or EIS. In the
preamble to the proposed rule, FSIS explained that the Agency
determined that the proposed rule was subject to the categorical
exclusion from the preparation of an EA or EIS because the proposed
rule will not have individual or cumulative effects on the human
environment. FSIS received a few comments on the categorical exclusion.
Comment: Comments from an animal welfare advocacy organization and
a consumer advocacy organization asserted that FSIS did not adequately
analyze the environmental impacts of the proposed rule and therefore,
did not meet the burden to show that the proposed rule is appropriately
subject to the NEPA categorical exclusion. According to the comments,
the proposed increase in line speeds that would have been permitted
under the NPIS would allow establishments to slaughter more birds,
thereby increasing demand on water supplies, truck traffic and carbon
emissions from the transportation for each facility, and consumption of
electricity to run each facility. The comments also asserted that an
increase in birds slaughtered will result in an increase in condemned
and inedible carcasses and parts that will need to be disposed of.
Response: As discussed above, under this final rule the maximum
line speed permitted under the NPIS will be 140 bpm for young chickens
rather than 175 bpm, as was proposed. Thus, the maximum line speed for
the NPIS will be no faster than the maximum line speed permitted under
the existing inspection systems under SIS. While the NPIS may give
establishments the flexibility to slaughter and process birds more
efficiently, consumer demand for poultry products will determine the
number of birds slaughtered rather than line speeds. Thus, this final
rule will not have a significant individual or cumulative effect on the
human environment.

[[Page 49611]]

Comment: Some comments said that the provision in the proposed rule
that permits establishments to use online and offline antimicrobial
systems to reprocess contaminated carcasses will increase the discharge
of antimicrobial chemicals into the water supply. The comments stated
that one such substance, trisodium phosphate (TSP), can cause high
levels of phosphorus in water and cause algae blooms. The comment noted
that in the proposed rule, FSIS stated that only 5 to 7 of the 144
facilities with online reprocessing systems use TSP, and that the water
is recycled and does not enter public water supplies. The comment said
that the proposed rule did not account for whether there will be a
foreseeable increase in facilities using online reprocessing systems
that use TSP as a result of the proposed rule and what they will do
with their TSP-laden water.
A comment from a member of academia agreed with FSIS's conclusion
that the proposed rule was appropriately subject to a categorical
exclusion from the preparation of an EA or EIS. The comment noted that
although TSP may affect the aquatic environment, establishments that
use this substance for online reprocessing are required to meet all
local, State, and Federal environmental requirements. The comment said
that water from slaughter facilities is treated appropriately and
should continue to be treated appropriate within waste water treatment
facilities.
Response: FSIS considered the potential environmental effects of
the provision in this rule that will permit poultry slaughter
establishments to use approved online reprocessing antimicrobial
systems. As noted by the comment, TSP is used in a few online
reprocessing antimicrobial systems. However, regardless of the
substances that an establishment uses in its online reprocessing
system, it is required to meet all local, State, and Federal
environmental requirements. The waste water from all poultry
establishments is handled routinely by existing water treatment systems
or recycled as by-product without entering the establishment's water
system, municipal water system, or ground water.

L. Economic Impact

1. General
Comment: One consumer advocacy organization stated that under the
NPIS, FSIS would have authorized establishments operating under the
NPIS to increase their maximum line speeds to allow establishments to
operate more efficiently. The comment stated that this would allow
large corporations that own multiple establishments to close some and
still produce the same volume of product. The comment said that
establishment closures will result in worker layoffs and community
disruption, especially in locations where the establishment is the
largest employer.
Response: As discussed above, under this final rule the maximum
line speed permitted under the NPIS will be 140 bpm for young chickens
rather than 175 bpm, as was proposed. Thus, the maximum line speed for
the NPIS will be no faster than the maximum line speed permitted under
the existing inspection systems under SIS.
Regardless of line speed, establishments may choose to implement
the NPIS by adjusting shifts, reducing overtime, increasing output,
reducing the number of lines, or consolidating establishments.
Comment: One trade association stated that the NPIS will create new
jobs. According to the comment, even in the current economy, members of
the trade association that participate in the HIMP pilot have hired
additional in-plant personnel. The comment said that slaughter and
processing establishments are only able to increase line speeds as
staff levels permit, otherwise quality control could be adversely
affected. The comment said that some establishments that have joined
the HIMP pilot have expanded their facilities, hired new workers, and
purchased additional equipment and technology, further fueling rural
economies.
Response: While it is difficult to predict, FSIS agrees that
establishments adopting the NPIS will likely initially 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 (refer to number 1 under
Summary of Estimated Costs and Cost Savings of the Rule).
Comment: A consumer advocacy organization questioned the incentive
structures that would be in place with the NPIS. The comment questioned
whether the NPIS would result in pathogen reduction and would lead to a
reduction in health benefits. The comment questioned how the NPIS would
limit the number of recalls.
Response: It is within the establishment's economic interest to
take whatever actions are necessary to produce products that are safe,
wholesome, and free from excessive trim and dressing defects. FSIS is
responsible for ensuring that the establishment's process control
procedures for preventing contamination by enteric pathogens and fecal
material and for controlling OCP defects are effective. The NPIS gives
establishments the flexibility to more efficiently utilize their
resources to design systems that ensure their process control. As a
result, the NPIS is expected to improve food safety and the
effectiveness of inspection systems. FSIS estimates that this rule
could reduce the number of human illnesses attributed to young chicken
and turkey products by an average of about 3,980 Salmonella illnesses
and about 840 Campylobacter illnesses.
The records that all establishments that slaughter poultry other
than ratites would be required to keep under this rule, including the
records of the establishment's testing results, will provide
establishments and FSIS with ongoing information on the effectiveness
of the establishment's process controls. This will allow FSIS and
establishments to identify situations associated with 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 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.
2. Environmental Justice
Comment: Several comments from human and worker rights advocacy
organizations and a public health professional trade association said
that the Preliminary Regulatory Impact Analysis (PRIA) for the proposed
rule failed to consider costs to workers' health and safety. The
comments noted that FSIS estimated that the benefits of the proposed
rule would amount to at least $258.9 million, but that the Agency did
not present any data or estimates of the cost of injury, illness and
disability of the proposed increased in maximum line speed that would
have been permitted on the affected poultry plant workers. One comment
stated that PRIA must also consider costs associated with increased
worker's compensation, increased social service costs for State and
local government, and reduced tax and Social Security payments.
Response: Under this final rule the maximum line speed permitted
under the NPIS will be 140 bpm for young chickens rather than 175 bpm,
as was proposed. Thus, the maximum line speed for the NPIS will be no
faster than the maximum line speed permitted under the existing
inspection systems

[[Page 49612]]

under SIS. The FRIA for this final rule has been updated to reflect
this change from the proposal.
The effect of line speed on establishment employee safety is an
important issue. As discussed above, the 2005 GAO Report, which linked
production line speed to occupational injury and illness rates in the
slaughter industry, called for independent research to better
understand this relationship. As discussed earlier in this document, to
obtain at least preliminary data on the matter, FSIS has asked NIOSH to
evaluate the effects of increased line speeds on worker safety by
collecting data from establishments that had been granted waivers from
line speed restrictions under the SIP. NIOSH has completed such a study
in one non-HIMP establishment. FSIS considers the NIOSH study to be an
important first step in better assessing the impact of line speeds on
the health and safety of workers in poultry slaughter and processing
establishments.
3. Small Business Considerations
Comment: Some consumer advocacy organizations stated that the NPIS
will lead to further consolidation in the poultry industry and that
large producers will benefit at the expense of smaller processors. The
comments said that the proposed increase in line speeds that would have
been authorized under the proposed rule would cause small processors
that typically do not run at line speeds of up to 175 birds to go out
of business because the market will be flooded with poultry products
from the larger processors. One trade association and a member of
academia believed that the proposed rule adequately addressed
considerations for small and very small establishments. According to
the comments, the option to remain under Traditional Inspection will
benefit establishments that do not have the resources to absorb the
costs associated with facility and personnel changes. One comment
stated that because establishments will have an opportunity to opt-in
or opt-out of the NPIS, smaller businesses that have ``niche'' markets
will not be adversely affected. The comments said that poultry sold in
smaller markets has the appeal of being locally harvested and
slaughtered under less commercial conditions. According to the comment,
smaller establishments that have ``niche'' markets for their poultry
product may see an increase in consumer purchase as a result of larger
slaughter facilities choosing the new system.
Response: Under this final rule, establishments that do not choose
to operate under the NPIS may continue to operate under their current
inspection system, i.e., SIS, NELS, NTIS, or Traditional Inspection.
FSIS expects little to no impact on small producers. Very small
establishments that operate under Traditional Inspection 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.\19\ An ability to charge a higher price based on product
differentiation enables the very small establishments to continue to
compete in the market. The same pricing power based on product
differentiation holds for establishments that slaughter birds other
than young chickens and turkeys. Moreover, FSIS has revised the rule to
reduce the sampling requirements for very low volume and very small
establishments, which further reduces their cost to operate under the
Traditional Inspection System, as modified by this final rule.
---------------------------------------------------------------------------

\19\ 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.
---------------------------------------------------------------------------

4. Implementation Costs
Comment: One trade association stated that the proposed rule did
not address the significant costs of implementation, such as developing
training materials and training employees, developing new recordkeeping
based on the new system, and retraining or hiring new personnel to
manage those recordkeeping systems. This trade association also noted
that implementation of the NPIS will require significant capital
investments. This trade association argued that the potential costs of
implementation are exacerbated because it is unclear how the Agency
plans to implement the NPIS and establishments cannot yet begin to make
financial plans.
Response: FSIS carefully considered the costs associated with the
final rule and included establishment costs associated with
implementing the NPIS and complying with the mandatory recordkeeping
and testing requirements of the rule in its FRIA. Annualized costs
associated with the hiring of additional labor of sorters, both one-
time and ongoing training as well as capital expenditures for the NPIS
total $16.0 million (Table 7a). Annualized costs and cost savings
associated with both additional microbial testing, the elimination of
E. coli testing, recordkeeping and updating HACCP plans total $9.1
million (Table 7b).
Comment: One trade association questioned the Agency's estimated
industry savings in the PRIA. This trade association believed that some
of the assumptions that the estimate are based on are unrealistic, such
as, how many establishments will choose to or are capable of operating
at higher line speeds. Additionally, this trade association stated that
FSIS failed to take into account overall consumer demand when
estimating industry-wide output. However, this trade association
asserted that the benefits to food safety and the overall efficiencies
to be gained are worth the cost and investment.
Response: Under this final rule the maximum line speed permitted
under the NPIS will be 140 bpm for young chickens rather than 175 bpm,
as was proposed. Thus, the maximum line speed for the NPIS will be no
faster than the maximum line speed permitted under the existing
inspection systems under SIS. The FRIA for this final rule has been
updated to reflect this change from the proposal. In the proposed rule,
FSIS took into account overall consumer demand by using demand
elasticity to predict the increase in young chicken and turkey products
produced as a result of an increase in line speed. However, because the
maximum line speed under the NPIS will now be no faster than the
maximum line speed authorized under the existing inspection systems,
the impact of consumer demand on consumer and producer benefits has
been removed.

IV. Executive Orders 12866 and 13563

Executive Orders 12866 and 13563 direct agencies to assess 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 final rule has been designated a ``significant'' regulatory
action, under section 3(f) of Executive Order 12866. Accordingly, the
rule has been reviewed by the Office of Management and Budget, under
Executive Order 12866.

Introduction

FSIS updated the PRIA to take into account recently published data
and to reflect changes in the final rule in response to public
comments. The changes to the costs and benefits

[[Page 49613]]

sections incorporate the following factors:
Maximum line speeds permitted under the NPIS will be 140
bpm for young chickens.
Very small HACCP size establishments are required to only
test at one location instead of two and the sampling frequency for very
low volume establishments remains unchanged from the existing
regulation.
Additional Labor Cost Due to Attestation of Work-Related
Conditions is added to total cost.
Changes to the rule's implementation plan, which are
reflected in the Expected FSIS budgetary effects, establishment costs,
and public health benefits.
Changes to the costs of illness estimate, including
changes to the average cost per illness and to the averted number of
illnesses estimated in FSIS's risk assessment as a result of the latest
peer review.
Establishments are also now required to have a height-
adjustable CI stand (the proposed rule did not have the height-
adjustable requirement). FSIS has not included the price difference
between height-adjustable and non height-adjustable inspection stands
in the Final Regulatory Impact Analysis (FRIA) since the difference in
cost is expected to be minimal.

Need for the Rule

The current systems of poultry inspection are rooted in principles
of command and control regulation, where broad, rigid standards are
applied across finished products and establishments. As food processing
and food safety technology becomes more diverse, FSIS has worked to
reform its regulations with a focus on HACCP-based process control,
enabling establishments to have more flexibility in tailoring their
food safety plans to their products and processes. The new system of
poultry slaughter will help to further this effort. 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 spp. and Campylobacter spp.) are hazards reasonably likely
to occur in poultry slaughter establishments unless addressed in a
sanitation SOP or other prerequisite program.

Summary of the 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. FSIS expects this action to impact 194 establishments (70
small establishments plus 149 large establishments minus 25 HIMP
establishments);
(2) A limit of one FSIS online carcass inspector per evisceration
line. FSIS expects this action to impact 194 establishments;
(3) Removal of the existing Finished Product Standards (FPS) and
subsequent replacement with a requirement to maintain records that
document that the 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 online 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. FSIS expects this action
to may impact up to 219 establishments;
(4) 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 expects that this action would affect, at a
maximum, about 219 establishments that may choose to adopt this new
inspection system out of 270 official federally inspected
establishments that slaughter young chickens and turkeys (refer to
Table 4 for further explanation of the number of establishments
affected). This 219 total includes HIMP establishments, though they
will have already installed this equipment, meaning that 194
establishments are affected; and
(5) a requirement that each establishment that participates in the
New Poultry Inspection System (NPIS) shall submit on an annual basis an
attestation to the management member of the local FSIS circuit safety
committee stating that it maintains a program to monitor and document
any work-related conditions of establishment workers, and that the
program includes the elements listed in the preamble.
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 and Campylobacter) as
part of an establishment's HACCP plans, sanitation SOPs, or other
prerequisite programs. FSIS is requiring 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 (except for very small HACCP size establishments
and very low volume establishments, which are required to sample only
at post-chill);
(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 SOPs, or other prerequisite programs;
(3) Removal of the 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;
and
(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.

Baseline

Table 2 compares the components or requirements of the actions of
the final rule to the current regulatory regime for all federally
inspected establishments that slaughtered all poultry other than
ratites. From the FSIS Animal Disposition Reporting System (ADRS), we
identified 289 establishments in 2010 slaughtering poultry (excluding
ratites). Actions include requirements for young chicken and turkey
establishments and requirements for all poultry slaughter
establishments

[[Page 49614]]

excluding ratites. Table 2 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, up to four FSIS inspectors are
stationed on the same side of a processing line that runs at a maximum
of 140 birds per minute (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.

Table 2--Comparison of Key Components of the Baseline Regulatory Environment and the Rule
--------------------------------------------------------------------------------------------------------------------------------------------------------
Very small and small HACCP size establishments Small and large non-traditional
Key features or provisions of the traditional --------------------------------------------------------------------
rule ------------------------------------------------ Current inspection
Baseline Rule systems HIMP NPIS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Number of Establishments........... 70.................... ...................... 194.................. 25. .....................
Carcass Sorting Activities......... FSIS.................. FSIS.................. FSIS................. Establishment........ Establishment.
Online Inspector per Line.......... 1-4................... 1-4................... 2-4.................. 1.................... 1.
Online Inspector Limit............. No.................... No.................... No................... Yes.................. Yes.
Addition of Online Establishment No.................... No.................... No................... Yes.................. Yes.
Workers because of Relocation of
Online IPP.
Line Speed Maximum Birds per minute 25-46................. 25-46................. 70-140............... 175.................. 140.
for Young Chickens.
Line Speed Maximum Birds per minute <=66.................. <=66.................. N/A \1\.............. N/A.................. SIP Waiver
for Mature Chickens. determined.
Line Speed Maximum Birds per minute 16-25................. 16-25................. 21-51................ 55................... 55.
for Turkeys.
Line Speed Maximum Birds per minute <=66.................. <=66.................. N/A.................. N/A.................. SIP Waiver
for Other Poultry. determined.
Records to document that products No.................... No.................... No................... No................... Yes.
meet the definition of RTC poultry.
New Facilities Requirements........ No.................... No.................... No................... Yes.................. Yes.
New carcass inspection station for No.................... No.................... No................... Yes.................. Yes.
each evisceration line.
New carcass inspection area online No.................... No.................... No................... No................... Yes.
for avian leukosis for each
evisceration line.
Underline Trough for each No.................... No.................... No................... Yes.................. Yes.
evisceration line.
HACCP System--written to prevent No.................... No.................... No................... No................... Yes.
Sep/Tox carcasses from entering
chiller.
HACCP System--written to prevent No.................... Yes................... No................... No................... Yes.
contamination by enteric pathogens
and fecal material & testing.
HACCP System--written to prevent No.................... Yes................... No................... No................... Yes.
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.\2\
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.
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ N/A--does not apply.
\2\ Very small HACCP size establishments and very low volume establishments are required to test in one location.

Under the final rule, any of the young chicken and turkey
establishments (assumed to be limited to the 219 large and small non-
Traditional establishments) that adopt the new inspection system (some
while operating under updated SIP waivers), will have one online
inspector per line. Currently, there are two to four online inspectors
per line under the current non-traditional systems (SIS, NELS, and
NTIS); however, there is one online inspector per line under HIMP. Even
though FSIS, in the analysis that follows, only quantifies costs,
rather than benefits, of switching to NPIS, FSIS predicts that some
small and large non-traditional establishments alike will choose to
adopt the NPIS because it will give them greater control over their
production process and more flexibility to design, develop, and
implement new technologies. Comments received from industry indicate
that the benefits to food safety and the overall efficiencies to be
gained by the NPIS would be worth the cost and investment to

[[Page 49615]]

industry. These comments were submitted in response to the proposed
rule that would have allowed a maximum line speed of 175 bpm under
NPIS. Thus, the change in policy between the proposed and final rule
may change the appropriate interpretation of some of these comments.
However, one industry trade association commented that the proposed
rule's Preliminary Regulatory Impact Analysis contained unrealistic
assumptions of how many establishments would have chosen to, or would
have been capable of, operating at the faster line speeds that would
have been permitted under the proposed NPIS. Nevertheless, regardless
of line speed, this trade association believed that the benefits to
food safety and the overall efficiencies to be gained by the NPIS would
be worth the cost and investment to industry as noted throughout this
document. Establishments will have the flexibility to design and
implement measures for producing ready-to-cook poultry tailored to
their operations. The NPIS would also give establishments the ability
to investigate and develop new and more efficient technologies.
The Agency's experience under HIMP demonstrates that young chicken
establishments have incentives to participate and remain in the HIMP
pilot for reasons other than the ability to operate faster line speeds.
Experience from the HIMP pilot shows that HIMP establishments operate
with an average line speed of 131 bpm, and that although they are
authorized to do so, most of the young chicken HIMP establishments do
not operate line speeds at 175 bpm. Thus, the faster line speeds
authorized under HIMP do not appear to be the primary incentive for
establishments to participate in the pilot because the average line
speed of establishments operating under the HIMP inspection is slower
than the 140 bpm maximum line speed authorized under the existing
inspection systems.
The Agency's experience under HIMP also shows that once
establishments are selected to participate in the HIMP pilot, they
choose to remain under the HIMP inspection system. In 2002, after FSIS
had selected 20 young chicken establishments to participate in the HIMP
pilot, the Agency informed the industry that it would limit the pilot
to 20 establishments. At that time, over 40 establishments were placed
on a waiting list to participate in the HIMP pilot. Since then, two
establishments left the pilot because they closed. These establishments
were replaced by establishments on the waiting list, and more than 40
establishments remain on the list. Thus, the Agency's experience under
HIMP shows that young chicken establishments continue to be interested
in participating in the HIMP pilot, and those that are selected for the
pilot choose to remain under the HIMP inspection system even though
many are not operating at the maximum line speeds authorized under
HIMP.
Table 3 shows the baseline characterization of the U.S. poultry
market for birds other than ratites in 2010. Domestic federally
inspected establishments slaughtered and dressed about 8.8 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). Establishments slaughtered
about 8.64 billion young chickens and turkeys.

Table 3--Baseline Characterization of the U.S. Poultry Market
----------------------------------------------------------------------------------------------------------------
Young chickens Other chickens Turkey Other poultry
----------------------------------------------------------------------------------------------------------------
Market price ($/bird) \1\....................... $3.38 $1.34 $22.74 $9.02
Market quantity \2\ (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
----------------------------------------------------------------------------------------------------------------
\1\ Market price is calculated by multiplying the wholesale price per pound by the average dressed weight.
\2\ Market quantities in thousands of birds (dressed carcasses), or animal (dressed carcass) equivalence, other
than ratites. Source: Muth, M.K., Beach, R.H., Viator, C.L., Karns, S.A., & Taylor, J.L. (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.

A summary of the types of young chicken and turkey operations and
the sizes of these official establishments is in Table 4 (FSIS ADRS
2010). Table 4 summarizes the 270 federally inspected establishments
that slaughtered young chickens (231 establishments) and turkeys (39
establishments) along with the 19 that slaughtered other chicken (such
as fowl and capon) (6 establishments) and only other poultry (such as
squabs, pheasants, quail, ducks or geese) (13 establishments) in 2010.

[[Page 49616]]

[GRAPHIC] [TIFF OMITTED] TR21AU14.000

FSIS ADRS 2010 records indicated that there were 663 line-shifts in
270 establishments that slaughter young chickens and turkeys, as shown
in Table 5.\20\ 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 5 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 systems 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.
---------------------------------------------------------------------------

\20\ Included in this number are the very small establishments
that annually slaughter a relatively small number of young chickens
and turkeys by methods that do not use a high-speed line.
---------------------------------------------------------------------------

Table 5 also summarizes the maximum potential transition over five
years, assuming available resources and institutional readiness, of the
young chicken and turkey industry to the new inspection system. This
table shows the 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 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 lines, there were 27 establishments under
NTIS inspection, and 5 under the HIMP inspection. Altogether, this
suggests a maximum of 219 of the 270 young chicken and turkey
establishments, or 81 percent, which have about 598 lines, have the
opportunity to convert to NPIS.

[[Page 49617]]

[GRAPHIC] [TIFF OMITTED] TR21AU14.001

Table 6 shows that of the 187 young chicken establishments (not
under the Traditional Inspection System) with 542 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 lines, 22 were HACCP large establishments and 10 were HACCP
small establishments.

[[Page 49618]]

[GRAPHIC] [TIFF OMITTED] TR21AU14.002

Estimated Number of Establishments Predicted To Opt for the Modified
Traditional Inspection System

FSIS estimates that about 70 federally inspected establishments
will switch from their current Traditional Inspection System to the
modified Traditional Inspection System for the slaughter of poultry,
other than ratites. The 70 establishments consist of 51 very small
HACCP size establishments, or about 19 percent of the 270 official
federally inspected establishments that slaughter young chickens and
turkeys, and 19 establishments that slaughter poultry but not young
chicken or turkey (or ratites). The very small HACCP size young chicken
and turkey establishments, in general, do not have sufficient output
volume over which to spread the initial set-up costs of any of the more
automated systems 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,\21\ under all poultry
inspection systems in 2010. Based on FSIS's ADRS records, these 70
establishments slaughtered about 1 percent of all poultry (other than
ratites) of the domestic poultry industry in 2010. Furthermore, 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.
---------------------------------------------------------------------------

\21\ Based on FSIS's Animal Disposition Reporting System (ADRS)
of 2010, 289 establishments slaughtered all classes of poultry,
other than ratites, under all poultry inspection systems in 2010. Of
the 289 establishments, about 270 establishments slaughtered young
chicken and young turkey in 2010.

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[[Page 49619]]

Summary of Estimated Costs and Cost Savings of the Rule

In the following sub-sections, FSIS presents the costs and cost
savings that would be generated over a range of assumptions with
respect to how much of the industry will choose to adopt NPIS within
five years. These estimates are scaled from an illustrative calculation
that assumes that all 219 small and large non-Traditional
establishments adopt NPIS, which, while used to calculate potential
maximum effect, is not necessarily FSIS's assumption of the most likely
outcome. Later portions of the regulatory impact analysis contain
discussion of the uncertainty surrounding the net benefits associated
with how much of the industry will choose to adopt NPIS.

Items 1-7 are Costs and Cost Savings Associated With the New Poultry
Inspection System

1. Addition of Online Establishment Workers Because of the Relocation
of Online Inspection Program Personnel and Online Sorters--Annual Cost
Associated With the New Poultry Inspection System
FSIS estimates that young chicken and turkey establishments that
transition to NPIS will initially expand their labor resources by
employing about an average of 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 rule. This substitution rate is based on information
provided by 12 young chicken establishments in 2001 who participated in
the HIMP pilot program.\22\ If all of the 219 establishments eventually
slaughtered young chickens and turkeys under the NPIS, this would
translate to between 663 and 770 FSIS online inspection program
personnel shifted from online inspection to verification inspection
activities and online inspection of carcasses (carcass inspection,
after the final wash and before the chiller). However, as noted above,
there is not a way to predict how many of the establishments will
transition to NPIS, or over what time frame FSIS would have the
resources to accommodate requests after the initial 6 month period. As
such, table 8b suggests that the range of personnel under assumptions
that span 0 and 100 percent range from 0 to 770 online inspectors. FSIS
estimates that the 770 shifted FSIS online inspection program personnel
is the upper bound if indeed all the 219 establishments estimated
earlier opt to transition to NPIS during the first five years.
---------------------------------------------------------------------------

\22\ Most of the cost estimates in this section are also based
on the data collected from these 12 establishments.
---------------------------------------------------------------------------

Using the expected substitution rate of 0.8 (8 for 10), under the
100 percent adoption assumption for analytic purposes, the estimated
219 establishments would initially need about 616 (770 x 0.8)
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 the range of reassignments by FSIS would be
between 0 and about 770 inspection program personnel to other
inspection activities within the establishments (e.g. carcass
inspection, verification inspection, and relief coverage). The upper
bound of this range, or 770 inspection program personnel, however, may
be an over-estimate, because of attrition. The Bureau of Labor
Statistics (BLS) indicated that the expected standard rate for
establishment labor is about $13.96 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 2,000 hours \24\ per staff-
year). Therefore, the average cost if 219 establishments were to adopt
NPIS within five years, would be for the initial additional 616 staff-
years of online sorter labor is about $17.2 million annually (616 x
$27,900).
---------------------------------------------------------------------------

\23\ According to the 2011 Bureau of Labor Statistics employment
cost index, hourly wages for slaughtering and meatpacking workers is
$11.63. Estimates of benefits as a percent of total wages range from
20 to 39 percent according to the American Meat Institute. Since the
poultry industry is at the low end of the wage scale, we are
estimating benefits to be 20 percent of total wages.
\24\ This is a simplifying assumption.
---------------------------------------------------------------------------

2. Training Online Sorters, Under the New Inspection System--One-time
Cost Associated With the New Poultry Inspection System
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 5) 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 rule.
FSIS assumes that the, using the maximum potential upper bound of
establishments, 219 establishments will need about 3.5 to 4 times the
replacement staff-years, or about 2,310 (3.75 x 616) establishment
employees who are trained to perform online sorting and CI helper
activities. Therefore, initially, an average of about 2,310
establishment employees would need to be trained at a one-time average
cost of about $400 each, or a total for estimated 219 establishments,
of about $0.92 million (2,310 x $400).
3. Training, Annually--for Replacement Sorters Due to Labor Turnover--
Annual Cost Associated With the New Poultry Inspection System
Annual training 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
establishment sorters is, on average, 40 percent, establishments will
need to train about 924 (0.4 x 2,310) new establishment sorters
annually.\25\ FSIS projects that the initial training costs are
expected to be about $200 to $600, or an average of about $400 per
employee (sorter). Using the $400 per employee values, additional
training costs will average about $0.37 million (924 x $400), annually.
---------------------------------------------------------------------------

\25\ BLS reported that the overall private industry turnover
rate was approximately 41 percent in 2011. FSIS is rounding to 40
percent. U.S. Department of Labor. Bureau of Labor Statistics.
(2011). Job Openings and Labor Turnover Survey. Washington, DC: U.S.
Department of Labor.

---------------------------------------------------------------------------

[[Page 49620]]

4. Continuing Education & Training, Annually--for Existing Sorter
Labor--Annual Cost Associated With the New Poultry Inspection System
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 2,310 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. Using this average value, the
total average cost would be about $0.40 million (2,310 x $175),
annually.
5. Additions to Facilities: Carcass Inspection Stations, Avian Leukosis
Inspection Area, and Underline Troughs One Time Costs Associated With
the New Poultry Inspection System
Under the rule, all of the poultry establishments participating in
the NPIS will need to add capital investments to install a carcass
inspection height-adjustable station.
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 (Table 5) will
not need new trough installations under the new rule. 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. FSIS estimates that as many
as 194 establishments (Table 5, based on a projection that up to 219
establishments may adopt the NPIS, minus the 25 HIMP establishments)
will need 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.
For the carcass inspection station, this cost is for the
construction of a stainless steel height-adjustable 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 541 eviscerating lines now installed in
the 194 non-HIMP establishments (Table 5) that may implement the NPIS.
Therefore, the calculated cost for adding carcass and verification
inspection stations for the 194 establishments is about $8.39 million
(541 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)
Associated With the New Poultry Inspection System
FSIS is removing 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 and may have minimal savings. These savings are not
included in the benefits estimate.
FSIS online 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.
7. Additional Annual Labor Cost Due to Attestation of Work-Related
Conditions
Each establishment operating under the NPIS will need to submit on
an annual basis an attestation to the management member of the local
FSIS circuit safety committee stating that it maintains a program to
monitor and document any work-related conditions of establishment
workers. The cost of this attestation is estimated to take 2 minutes at
a wage rate of $13.96 per hour for a total of $102 annually.
Total Costs and Cost Savings Associated With the New Poultry Inspection
System
FSIS assumes that the projected adoption of NPIS will take place
over a five year time period.\26\ FSIS expects that HACCP size large
establishments will be the first to convert to the new inspection
system because they have greater resources available to them to make
the necessary changes. For the purposes of estimating costs, FSIS
assumed that 68% of all establishments that convert to NPIS will have
implemented NPIS by the third year, with approximately 1/3 of these
establishments converting each of the first three years. For the small
establishments that implement NPIS, FSIS assumed that half would
convert in year four, and half would convert in year five. If all large
and small establishments adopt NPIS, this pattern would result in the
complete conversion of establishments to the new inspection system
within the five year period used for this analysis. FSIS is uncertain
about how many and how fast establishments might opt into NPIS, as
such, FSIS presents the data in table 8b to reflect that uncertainty.
---------------------------------------------------------------------------

\26\ Please refer to the ``Baseline'' section for further
explanation on the projected adoption rate of NPIS.
---------------------------------------------------------------------------

As such, the costs to industry associated with making the necessary
changes to implement NPIS will fluctuate over the initial five years.
FSIS used establishment information including HACCP size, line-shift
data (see Table 5), and approximate volume contributions \27\ to
estimate how one-time industry costs will be spread across

[[Page 49621]]

the first five years. FSIS also used this information to approximate
the recurring costs to industry over time. These estimated costs are
summarized in Table 7a. Annualized costs were calculated using a
discount rate of 7 percent over a ten-year period.\28\
---------------------------------------------------------------------------

\27\ The USDA, GIPSA 2012 Packers and Stockyards Annual Report
states that the four largest broiler slaughterers posted a 52
percent market share in 2011. The share of the four largest turkey
slaughterers was 55 percent in 2011. The U.S. Census Bureau 2007
Economic Census of the United States reports that the 50 largest
Poultry Processing Companies (2007 NAICS 311615) post a 91.5% share
of the total value of shipments. For the purposes of this analysis,
FSIS assumed that large establishments accounted for 90% of the
production volume and small establishments accounted for the
remaining 9.9%. According to our analysis, very small establishments
account for the remaining 0.1%.
\28\ FSIS assumes first-year costs are incurred at the end of
the year.

Table 7a--Estimated Year-by-Year Cost of the Rule if All Large and Small Non-Traditional Establishments Select
the New Poultry Inspection System
[Millions of dollars]
----------------------------------------------------------------------------------------------------------------
Year 1 Year 2 Year 3 Year 4 Year 5 Recurring
----------------------------------------------------------------------------------------------------------------
Annual sorting labor.............. 5.01 10.03 15.04 16.12 17.20 17.20
Knowledge costs (human capital):
Initial one-time training of 0.27 0.27 0.27 0.06 0.06 ...........
sorting workers..............
Training annual sorting labor- ........... 0.11 0.22 0.32 0.35 0.37
turnover rate of 40%.........
Continuing annual education ........... 0.12 0.24 0.35 0.38 0.40
and training.................
One-time capital expenditure...... 2.44 2.44 2.44 0.53 0.53 ...........
Paperwork cost due to attestation ** ** ** ** ** **
of work-related conditions.......
-----------------------------------------------------------------------------
Total costs to 7.73 12.97 18.21 17.38 18.51 17.97
establishments from NPIS.
-----------------------------------------------------------------------------
Annualized (7%, 10 year)
total cost to
establishments from NPIS. 16.00
Annualized (3%, 10 year)
total cost to
establishments from NPIS. 16.27
----------------------------------------------------------------------------------------------------------------
** less than $1000, which rounds to zero.

Items 8-12 Are Costs and Cost Savings Associated With the Mandatory
Component of the 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
FSIS is requiring microbial testing to demonstrate process control
regarding the prevention of contamination of carcasses and parts by
enteric pathogens and fecal contamination throughout the entire
slaughter and dressing operation. FSIS is requiring establishments to
incorporate these procedures into their HACCP plans, or sanitation
SOPs, or other prerequisite programs, and to maintain records
sufficient to document the implementation and monitoring of these
procedures.
The regulation requires most establishments for each poultry type
to sample at two locations: pre-chill and post-chill. The exceptions
are for very small HACCP size establishments that choose to operate
under the modified Traditional Inspection System, which FSIS will
permit to conduct sampling only at post-chill. For two samples per
sampling event, FSIS assumes that it would take about 25 minutes for a
QC technician to collect these samples; for one sample, FSIS assumes it
would take 15 minutes to collect the sample. FSIS assumes costs of
$3.75 for material and time needed to provide sampling record
identification at the laboratory for two samples, and one-half that
amount of time for one sample. For two locations, the cost per sampling
event is $45.85; for one location, the cost per sampling event is
$24.13.\29\ FSIS assumes a cost of sending material and samples between
the establishment and laboratory of about $15 per sampling event, if
the laboratory is not on-site. Most large establishments have
laboratories on premises; FSIS assumes that 90 percent of large HACCP
size establishments have laboratories on the premises, and thus would
not incur a cost for sending samples to the laboratory. FSIS assumes
that 25 percent of small and very small HACCP size establishments have
laboratories onsite. Accounting for our assumed percentages of samples
that would need to be sent to laboratories, FSIS assumes a cost of
$47.35 per sampling event for large HACCP size establishments, $57.10
per sampling event for small HACCP size establishments, and $35.38 per
sampling event for very small HACCP size establishments (at one
location).\30\ For record keeping (discussed in a later section), FSIS
assumes 5 minutes for a sampling event for 2 locations, and 2.5 minutes
for 1 location, at the same $29.03 per hour wage.
---------------------------------------------------------------------------

\29\ FSIS assumes that establishments would not necessarily use
generic E coli because the cost per analysis of this organism is
greater than that for other indicator organisms. While costs per
sample can vary greatly depending on many factors, we assumed an
average cost of $15 per sample, plus a modest laboratory labor cost
($3.75) for handling paper. Therefore, the cost per sampling event
collecting two samples, excluding sending cost, is $30 + $3.75 +
$29.03(25/60) = $45.85. The cost per sampling event collecting one
sample is $15 + $1.87 + $29.03(15/60) = $24.13.
\30\ For example, for large HACCP size establishments, the cost
per sampling event is: [(0.9) ($45.85) + (0.1) (45.85 + 15)] =
$47.35, because we assumed that 90 percent of the samples would not
need to be sent by mail.
---------------------------------------------------------------------------

To establish a baseline, for other than very low volume
establishments, FSIS assumes that large HACCP size establishments would
collect 150 pairs of samples, on average; small HACCP size
establishments, 75 pairs; and very small HACCP size establishments, 30
samples. For very low volume establishments,\31\ FSIS assumes that
sampling would be minimal, and that for these establishments there
would be no baseline. The number of samples that establishments would
collect for each poultry type is proportional to the number of
slaughtered birds for the different poultry types.
---------------------------------------------------------------------------

\31\ FSIS assumes these establishments would remain under
Traditional Inspection.
---------------------------------------------------------------------------

To estimate the recurring annual cost for sampling, FSIS assumes
sampling at a rate of 1 sampling event per 22,000 carcasses for
sampling chicken, and 1 per 3,000 carcasses for sampling other species.
For very low volume establishments, FSIS assumes at least one sample
per week to a maximum of 16 samples per year, because some low volume
establishments might need to take more than 13 samples to demonstrate
process control.\32\ Based on

[[Page 49622]]

these assumptions, we calculated an expected number of sampling events
that establishments would take, and multiplied these numbers by the
appropriate costs per sampling event (weighted sum with weights equal
to the appropriate cost for the sampling event). We provide cost
estimates in Table 7b.
---------------------------------------------------------------------------

\32\ For the original HACCP rule, FSIS required 13 samples
provided that statistical criteria that FSIS used were satisfied.
The expected number of samples for this to occur is about 16.
---------------------------------------------------------------------------

FSIS expects industry to incur a savings by reducing present costs
associated with sampling for satisfying the present Finished Product
Standards (FPS), and that additional cost to industry due to our Other
Consumer Protection (OCP) requirements, if any, would be minimal. Thus,
FSIS did not include costs associated with the replacement of the
present FPS requirements with the and new OCP requirements.
9. Additional Annual 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. FSIS assumes that
the time spent for a QC technician salaried at $29.03 per hour for
recording results (including review) for each sample is 2.5 minutes. If
two samples are collected (pre-chill and post-chill), FSIS assumes 5
minutes are needed. For the present required generic E. coli testing,
FSIS assumes 2.5 minutes per sample.
10. (a.) Modification of the HACCP Plans and Process Control Plans--
One-time Cost Associated With the Mandatory Component of the Rule
Establishments will need to modify their HACCP plans, sanitation
SOPs, or other pre-requisite programs to address septicemic and toxemic
carcasses and food safety hazards that are reasonably likely to occur.
Establishments will also be required to maintain records to document
that their product meets the definition for ready-to-cook poultry.
Under the 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 based its estimates on information provided by
establishments participating in the HIMP pilot program regarding
initial costs for modifications to their HACCP plans. FSIS estimates
that, on average, the initial costs will be about $5,000 for small
HACCP size establishments and about $9,000 for large HACCP size
establishments. For the very small HACCP size establishments, FSIS
projected a cost of about $2,000, on average. Therefore, we estimate
the one-time cost to be equal to about $1.89 million ((84 x $5,000) +
(151 x $9,000) + (54 x $2,000)) for the 289 establishments.\33\
Moreover, once establishments design and implement these modifications,
they will incorporate them in their present HACCP plans, and thus we
assume no additional recurring cost associated with these
modifications. FSIS does not expect these costs to vary by the type or
species of bird that the establishments slaughter.
---------------------------------------------------------------------------

\33\ FSIS did not exclude HIMP establishments from this
calculation, though FSIS believes that the cost for these
establishments on average will be less. To the extent that this is
true, the above estimate is high, given everything else being true.
---------------------------------------------------------------------------

10. (b.) Written Procedures To Ensure That Carcasses and Parts With
Visible Fecal Contamination Do Not Enter the Chiller, After
Evisceration Operations--One-time Cost Associated With the Mandatory
Component of the Rule
FSIS is requiring that all federally inspected establishments that
slaughtered poultry (other than ratites) develop, implement, and
maintain, as part of their HACCP plans, 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 is
included in the costs of changing the HACCP system as discussed above
in item 10.a.
10. (c.) Written Procedures To Ensure That Young Chicken and Turkey
Carcasses Contaminated With Septicemic and Toxemic Conditions Do Not
Enter the Chiller, for the New Poultry Inspection System Associated
With the Mandatory Component of the Rule
FSIS is requiring that the 219 federally inspected establishments
that may decide to slaughter young chickens and turkeys under the NPIS
develop, implement, and maintain written procedures to ensure that
poultry carcasses contaminated with septicemic and toxemic conditions
do not enter the chiller. Establishments must incorporate these
procedures into their HACCP plans, sanitation SOPs, or other
prerequisite programs. The cost for developing these written procedures
is accounted for in the costs given in section 10.a.
11. Elimination of Generic E. coli and Salmonella Standards--Annual
Cost Savings Associated With the Mandatory Component of the Rule
FSIS is removing the current requirement that poultry
establishments that slaughter more poultry than other species test for
generic E. coli. Additionally, the agency is removing the codified
Salmonella pathogen reduction performance standards for poultry because
our existing Salmonella and Campylobacter performance standards are
better able to contribute to food safety. We used the same assumptions
for the cost of sampling as described above in section 9, with the
exception of assuming the analytical cost for generic E. coli is $20
instead of $15.\34\
---------------------------------------------------------------------------

\34\ The cost of analyzing generic E. coli is greater than that
of analyzing for Aerobic Plate Count (APC) because the former
involves extra steps for identifying E. coli cells. Based on its
experience with contracting, FSIS estimates that the analytical cost
per sample for E. coli is about $5 more.
---------------------------------------------------------------------------

FSIS assumes the cost savings associated with eliminating the
Salmonella performance standards are minimal, because typically
establishments are sampled, on average, roughly once every two years;
more than 95 percent of the sample sets' results satisfy FSIS's
criteria; \35\ and establishment-recording costs for FSIS sampling are
minimal. Therefore, FSIS did not account for savings due to eliminating
this requirement.
---------------------------------------------------------------------------

\35\ U.S. Department of Agriculture. Food Safety and Inspection
Service. (2011). Progress Report on Salmonella and Campylobacter
Testing of Raw Meat and Poultry Products, 1998-2011. Washington, DC:
U.S. Department of Agriculture. Retrieved from http://www.fsis.usda.gov/PDF/Progress_Report_Salmonella_Testing_1998-2011.pdf#page=14.
In the years 2009-2011, FSIS sent a yearly average of about 125
sample sets to establishments that slaughter young chicken and about
26 to establishments that slaughter turkey. Thus, per year, roughly
50 percent of the establishments received sample sets. Over 95
percent of the sets show results that are in compliance with the
performance standard.
---------------------------------------------------------------------------

12. Elimination of Carcass Cooling Standards--Possible Cost Savings
Associated With the Mandatory Component of the Rule
FSIS projects that the 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.

[[Page 49623]]

Total Costs and Cost Savings Associated With the Mandatory Component of
the Rule
Table 7b shows the implementation costs of complying with the
mandatory actions of the rule, over time, for the 289 affected poultry
establishments. For the 70 establishments expected to transition to the
modified Traditional Inspection System, FSIS assumed that half would
convert in year four, and the remaining half would convert in year
five, mirroring the implementation of the small young chicken and
turkey plants converting to NPIS. Again, annualized costs are
calculated using a discount rate of 7 percent over a ten year planning
period.

Table 7b--Estimated Annual Cost (Cost Savings) of the Rule to All
Establishments for Elements Associated With the Mandatory Component of
the Rule
[Millions of dollars]
------------------------------------------------------------------------
Year 1 Recurring
------------------------------------------------------------------------
Additional PC microbial testing:*
One-time baseline............. 1.34 .................
Annual recurring testing...... 23.59 23.59
Annual recordkeeping, monitoring, 1.17 1.17
and record storage...............
Eliminated generic E. coli testing (0.59) (0.59)
recordkeeping....................
One-time HACCP system and Process 1.89 .................
Control (PC) plan development....
Reduced annual microbial testing-- (15.51) (15.51)
generic E. coli..................
Total costs to establishments from 11.90 8.67
mandatory component..............
-------------------------------------
Annualized (10 year, 7% discount)
total mandatory costs............ 9.10
Annualized (10 year, 3% discount)
total mandatory costs............ 9.04
------------------------------------------------------------------------

For the poultry industry, as shown in Table 7a, the annualized
costs incurred if all establishments convert to NPIS are about $16.0
million over 10 years at a 7 percent discount rate. To comply with the
mandatory component, the rule will cost establishments about $9.1
million over 10 years at a 7 percent discount rate. Net total costs to
industry annualize to $25.1 million ($16.0 + $9.1).\36\
---------------------------------------------------------------------------

\36\ These costs annualized to about $25.3 million over 10 years
using a 3 percent discount rate.
---------------------------------------------------------------------------

FSIS expects the 51 very small HACCP size establishments that
slaughter young chicken and turkey and the three very small
establishments that slaughter other poultry to adopt the modified
Traditional Inspection System instead of NPIS. These establishments
will only incur mandatory costs associated with items discussed above
and listed in Table 7b. FSIS assumes a smaller analytical cost per
sample for these establishments, and in some cases for establishments
with large production volume, fewer numbers of samples.\37\
---------------------------------------------------------------------------

\37\ In the final rule, FSIS is permitting very small HACCP size
establishments to sample at one location, post-chill. Moreover, FSIS
is permitting very low volume establishments to sample at a
frequency similar to what is required presently. FSIS expects cost
per sample to decrease because FSIS is no longer requiring
establishments to sample for generic E. coli, but is permitting
establishments to sample for other indicator organisms that are less
expensive to analyze and expected to be more predictive of food
safety concerns.
---------------------------------------------------------------------------

Table 7c lists estimated mandatory costs for the 54 very small
HACCP size establishments. Estimated annualized costs to very small
establishments are approximately $11,760, which is about $218 per
establishment. This represents an average annual cost per bird of
approximately 0.098 cents, or 0.025 cents per pound, based on the
assumption that very small establishments slaughter about 12 million
birds annually, at an average weight of about 4 pounds per bird.

Table 7c--Estimated Annual Cost (Cost Savings) of the Rule to Very Small
HACCP Size Establishments (54) for Elements Associated With the
Mandatory Component of the New Rule
[Thousands of dollars]
------------------------------------------------------------------------
Year 1 Recurring
------------------------------------------------------------------------
Additional PC microbial testing--
plate counts, collection,
packaging, shipping
One-time baseline (including 4.25 .................
recordkeeping)...............
Annual recurring testing...... 22.47 22.47
Annual recordkeeping, monitoring, 0.77 0.77
and record storage...............
Eliminated generic E. coli testing (0.77) (0.77)
recordkeeping....................
One-time HACCP system plans and 108.00 .................
Process Control (PC) plan
development (item 11.a)..........
Reduced annual microbial testing-- (25.64) (25.64)
generic E. coli plate counts.....
Total costs to establishments from 109.07 (3.18)
mandatory component..............
-------------------------------------
Annualized total costs (7% for 10
years)........................... 11.76
Annualized total costs (3% for 10
years)........................... 9.60
------------------------------------------------------------------------

Expected FSIS Budgetary Effects

Table 8 shows the potential FSIS budgetary net savings from the
rule for the slaughter of all poultry other than ratites and including
the NPIS for the slaughter of young chickens and turkeys.
FSIS used the following scenario assumptions to project the
potential FSIS budgetary effects of the rule:
Of the 219 establishments that may adopt the NPIS, an
estimated 175 establishments (150 young chicken establishments and 25
turkey establishments) may be affected by FSIS

[[Page 49624]]

personnel changes. The estimated 175 establishments do not include the
25 young chicken and turkey establishments currently operating under
the HIMP program. FSIS also excluded approximately 19 other poultry
establishments currently operating under the SIP waivers, even though
FSIS expects them to choose to participate in the NPIS because FSIS
expects the impact on these 19 establishments to be relatively small.
Establishments that change operations but continue to produce will
continue to have FSIS inspectors.
1,498 food inspector grade increases (from GS-7 to GS-8)
(1,284 inspectors in young chicken establishments and 214 inspectors in
turkey establishments)
241 relief inspector grade increases (GS-7 to GS-8) \38\
---------------------------------------------------------------------------

\38\ Some inspection personnel will be promoted from GS-7 to GS-
8 due to assuming higher graded duties. These new Carcass/
Verification Inspector positions will perform routine and directed
inspection verification tasks to evaluate the establishment's
regulatory compliance and process control. The inspector collects
samples for pathogen testing, performs certain sample analysis, and
conducts post-mortem and ante-mortem inspection. The inspector also
performs verifications of good commercial practices, zero tolerance
for fecal and septicemia/toxemia, establishment microbiological
testing for preventing contamination throughout operations, food
safety systems, and sanitary dressing requirements.
---------------------------------------------------------------------------

FSIS is uncertain of the size of any reduction of food
inspector positions through managing vacancy or refill rates. Some
personnel are also expected to voluntarily retire. The range of
potential reductions is 0 to 630 (see table 8b). For purpose of this
analysis, FSIS includes the maximum potential change to calculate the
maximum potential effect. Approximately 190 of the 630 inspector
positions will be relocated to existing vacancies within the agency.
FSIS is uncertain of the size of any reduction of
approximately 140 Supervisory Consumer Safety Inspector (SCSI)
positions. The range of potential reductions is 0 to 140 (see table
8b). For purpose of this analysis, FSIS includes the maximum potential
change to calculate the maximum potential effect. Of those 140 SCSI
personnel, approximately 112 will be relocated to existing vacancies
within the agency with the remaining number expected to retire.
Training costs to include training of promoted personnel
and training for all personnel on the NPIS implementation processes.

Table 8--Estimated Potential Annual Cost (Cost Savings) of the Rule to FSIS: Elements Associated With the New
Poultry Inspection System
[Millions of dollars]
----------------------------------------------------------------------------------------------------------------
Category Year 1 Year 2 Year 3 Year 4 Year 5 Recurring
----------------------------------------------------------------------------------------------------------------
Cost from Grade Increases (Salary & $1.2 $3.5 $5.8 $7.0 $7.4 $7.6
Benefits)..............................
Savings From Positions Eliminated....... ($5.2) ($16.9) ($28.6) ($36.1) ($38.1) ($39.0)
Training Costs.......................... $2.0 $2.0 $2.0 $0.3 $0.3 $0.0
Relocation Costs........................ $1.4 $1.4 $1.4 $0.2 $0.2 $0.0
Total Cost (Savings).................... ($0.6) ($10.0) ($19.4) ($28.5) ($30.1) ($31.4)
----------------------------------------------------------------------------------------------------------------
Source: FSIS, Office of the Chief Financial Officer.

Table 8b--Estimated Potential Budgetary Effects to FSIS by Adoption Rate: Elements Associated With the New
Poultry Inspection System
----------------------------------------------------------------------------------------------------------------
Adoption Rate
Category --------------------------------------------------------------
0% 10% 25% 50% 75% 90% 100%
----------------------------------------------------------------------------------------------------------------
Food Inspector Grade Increases................... ....... 150 375 749 1,124 1,348 1,498
Relief Inspector Grade Increases................. ....... 24 60 121 181 217 241
Reduction in Food Inspector Positions............ ....... 63 158 315 473 567 630
Reduction in Supervisory Consumer Safety ....... 14 35 70 105 126 140
Inspectors......................................
----------------------------------------------------------------------------------------------------------------

FSIS expects a potential net cost savings of $0.6 million in the
first year of implementation. FSIS expects potential net cost savings
to total $10.0 million the second year of implementation. Cost savings
from position elimination (potentially totaling $16.9 million) scale
with the number of establishments that opt into NPIS and will therefore
more than offset the increase in one-time costs the agency will incur
the second year. Potential annual cost savings are expected to total
$31.4 million after the fifth year. The Agency's potential annual costs
for FSIS food and relief inspectors upgrades from GS-7 to GS-8 will
increase to $7.6 million after the fifth year of adoption. These
additional costs will be more than offset by the Agency's annual cost
savings from position elimination, potentially totaling $39.0 million.

Expected Benefits Associated With the New Poultry Inspection System--
Public Health Benefits From Reallocating FSIS Inspection Activities

FSIS hypothesizes that switching existing FSIS IPP activities
towards more offline verification activities (such as sanitation
performance standards, sampling, other inspection requirements, and
fecal inspections) will reduce pathogen levels in poultry slaughter
establishments. This is supported by the regression analysis of
historical data presented in the FSIS Risk Assessment (July 2014),
which found a significant correlation between more offline 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.
In Table 5 of FSIS' Risk Assessment (July 2014), FSIS presents
estimates that industry-wide adoption of NPIS would reduce the number
of human illness attributed to young chicken and turkey products by an
average of about 3,980 (with a range of 1,510 to 6,960) Salmonella
illnesses and about 840 (with a range of 100 to 1,860) Campylobacter
illnesses. Annual Salmonella cost savings from an averted

[[Page 49625]]

case is estimated to be $2,423 \39\ and the annual Campylobacter cost
savings from an averted case is estimated to be $2,067.\40\ Thus, FSIS
estimates that the potential monetized value of the human illness
reductions is an annual average of about $11.38 million (with a range
of $3.87 million to $20.71 million). These estimates may underestimate
the average cost of illness because they include medical costs and
loss-of-productivity costs. They do not include pain and suffering
costs or, in the case of Salmonella, the cost of accelerated mortality.
---------------------------------------------------------------------------

\39\ The FSIS estimate for the average cost of Salmonella
illnesses ($2,423 per case--2010 dollars) was developed using the
USDA, ERS Foodborne Illness Costs Calculator: Salmonella (June-
2011). FSIS updated the ERS calculator to include Scallan case
distribution for Salmonella. Scallan, E., Hoekstra, R., Angulo, F.,
et.al. (2011). Foodborne Illness Acquired in the United States--
Major Pathogens. Emerging Infectious Diseases, 17 (1), 7-15.
\40\ The FSIS estimate for the average cost of Campylobacter
illnesses ($2,067 per case--2010 dollars) is based on Hoffman
(2012). Annual Cost of Illness and QALY-Adjusted Life Year Losses in
the United States Due to Fourteen Foodborne Pathogens. Journal of
Food Protection, 75(7), 1292-1302. The ERS Cost calculator does not
include an estimate for Campylobacter illnesses.

Table 9--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 young chicken and turkey establishments have the
anticipated increase in unscheduled offline inspection procedures?1 2 3 4
5
--------------------------------------------------------------------------
Range
--------------------------------------------------------------------------
Expected Value 10th Percentile 90th Percentile
----------------------------------------------------------------------------------------------------------------
Annual Salmonella Cost Savings 6 and $9.64 million.......... $3.66 million.......... $16.86 million.
Averted Illnesses: (3,980 illnesses (1,510 illnesses (6,960 illnesses
averted). averted). averted).
Annual Campylobacter Cost Savings 7 $1.74 million.......... $0.21 million.......... $3.84 million.
and Averted Illnesses: (840 illnesses averted) (100 illnesses averted) (1,860 illnesses
averted).
--------------------------------------------------------------------------
Annual Total Cost Savings.......... $11.38 million......... $3.87 million.......... $20.71 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. FSIS selected this scenario to represent expected reduction in illnesses because it
involved an increase in targeted off-line inspection activities and not a random increase in all off-line
inspection activities, as represented in the indiscriminate scenario.
\3\ Totals may not add up due to rounding.
\4\ These estimates represent a lower bound for an average cost of illness because they only include medical
costs, loss-of-productivity costs (Salmonella and Campylobacter), and the value of reduced mortality
(Campylobacter only). They do not include pain and suffering costs.
\5\ FSIS explored--using a modified database--the effect of the very small plants on the output of the risk
assessment. Specifically, it used additional regression modeling post-analysis to look at what impact the
removal of very small establishments would have on the risk assessment results (see the risk assessment for
further details). That post-analysis showed no discernible difference from inclusion of very small
establishments in the changes in attributable human illnesses due to the poultry slaughter rule.
\6\ The FSIS estimate for the average cost of Salmonella illnesses ($2,423 per case--2010 dollars) was developed
using the USDA, ERS Foodborne Illness Costs Calculator: Salmonella (June-2011). FSIS updated the ERS
calculator to include Scallan case distribution for Salmonella. Scallan, E., Hoekstra, R., Angulo, F., et.al.
(2011). Foodborne Illness Acquired in the United States--Major Pathogens. Emerging Infectious Diseases, 17
(1), 7-15.
\7\ The FSIS estimate for the average cost of Campylobacter illnesses ($2,067 per case--2009 dollars, the latest
cost per illness data available) is based on Hoffman (2012). Annual Cost of Illness and QALY-Adjusted Life
Year Losses in the United States Due to Fourteen Foodborne Pathogens. Journal of Food Protection, 75(7), 1292-
1302. The ERS Cost calculator does not include an estimate for Campylobacter illnesses.

Potential annual benefits as shown in Table 9 would not be realized
fully unless and until all establishments convert to NPIS. Since the
adoption of NPIS may occur over a five year period, FSIS estimated the
incremental public health benefits that would be achieved under this
scenario as establishments make the transition to the new system. FSIS
used approximate volume distributions \41\ along with the assumed
implementation timeline to calculate these estimates, displayed in
Table 10.
---------------------------------------------------------------------------

\41\ See footnote 27.

Table 10--Estimated Incremental Public Health Benefits if All Large and Small Non-Traditional Establishments
Adopt NPIS Within 5 Years
----------------------------------------------------------------------------------------------------------------
Year 1 Year 2 Year 3 Year 4 Recurring
----------------------------------------------------------------------------------------------------------------
Salmonella Cost Savings......... 2.89 5.78 8.68 9.16 9.64
Campylobacter Cost Savings and 0.52 1.04 1.57 1.65 1.74
Incremental Longevity Value....
Total Cost Savings and 3.41 6.83 10.24 10.81 11.38
Incremental Longevity Value....
10th Percentile................. 1.16 2.32 3.48 3.68 3.87
90th Percentile................. 6.21 12.42 18.63 19.67 20.70
----------------------------------------------------------------------------------------------------------------

Expected value 10th Percentile 90th Percentile
----------------------------------------------------------------------------------------------------------------
Annualized total cost savings and Incremental 9.56 3.25 17.39
Longevity Value (7% for 10 years)..................
Annualized total cost savings and Incremental 9.79 3.33 17.81
Longevity Value (3% for 10 years)..................
----------------------------------------------------------------------------------------------------------------

[[Page 49626]]

Unquantifiable Benefits and Costs Associated With NPIS and the
Mandatory Portion of the Rule--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 benefits associated with an increase in line speed for turkey
establishments. Turkey establishments will have the option of
increasing their line speed from a maximum of 51 to 55 birds per
minute. Establishments will determine their line speeds based on their
equipment and facilities, bird size and flock conditions, and their
ability to maintain process control when operating at a given line
speed.
FSIS also expects public health benefits from the mandatory
component of the rule, which will apply to all poultry slaughter
establishments. FSIS is requiring 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 requiring 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. The exceptions are for very
small HACCP size establishments and very low volume establishments that
choose to operate under the modified Traditional Inspection System for
which FSIS will permit sampling at post-chill only if they show that
testing at one location is sufficient. 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 enhance compliance with this requirement, FSIS is
requiring that establishments develop, implement, and maintain written
procedures that ensure that poultry carcasses contaminated with visible
fecal material do not enter the chiller.
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, this result
generally cannot be effectively accomplished unless establishments
implement appropriate measures to prevent contamination from occurring
throughout the slaughter and dressing operation and implement process
controls for them.
Although many establishments do have process control measures in
place 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
measures and process controls or to maintain records to verify the
effectiveness of their process controls in preventing contaminated
carcasses from entering the chiller. Written plans that describe an
establishment's procedures and controls, including monitoring and
evaluation criteria, will greatly aid establishments in consistently
ensuring compliance with preventing fecal material on carcasses from
entering the chiller. The written plans and record keeping requirement
of this rule will also aid FSIS's inspectors in evaluations of an
establishment's procedures that are designed to ensure compliance with
the regulations.
In addition, under the existing regulations, official poultry
slaughter establishments are required to comply with requirements 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 might not be
the most effective way to prevent contamination from occurring
throughout the slaughter and dressing operation. Therefore, FSIS is
removing the generic E. coli testing requirements and replacing them
with a more microbiological-focused testing scheme that provides for
testing at the pre-chill and post-chill locations. Such a testing
scheme has the benefit of allowing poultry slaughter establishments to
have the flexibility they need to determine which microbiological
organisms and measurement procedures will best help them to monitor the
effectiveness of their process control procedures. This will lead to
more tailored, and thus more effective process monitoring and quicker
response to out of control processing, thereby reducing contamination
of pathogens on carcasses.
The information and procedural enhancements described above may be
followed by the disposal of contaminated product, cooking the product
longer, or other cost-generating actions by the establishment. Thus,
any unquantified public health benefits of the rule may be accompanied
by unquantified industry costs.
In summary, FSIS is requiring 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 rule, including the records
of the establishment's testing results, will provide an establishment
with ongoing information on the effectiveness of its process controls,
and allow it to identify situations associated with an increase in
microbial levels so that it can take the necessary corrective actions
to prevent further potential contamination. The documentation could
result in the lower probability of recall, resulting in enhanced
product reputation when a product is not subject to recall, which would
benefit the implementing establishment. The rule's documentation
requirements could also lower the costs of identifying contaminated
product of a recall as well as limit the scope of a product recall
should a recall occur, since the establishment records would allow it
to identify the point when a lack of process control could have
resulted in product contamination.

Summary of Net Benefits

Considering the benefits and costs discussed, if we were to assume
for purposes of analysis that all small and large non-Traditional
establishments were to switch to NPIS, FSIS expects average benefits to
the public health and FSIS of about $32.4 million (annualized, 10-years
at 7 percent). In this case, annualized (10-years, at 7 percent)
industry costs are an estimated $25.1 million. Annual net benefits,
therefore, would be an estimated $7.3 million. Table 11 provides the
summary of estimated annualized net benefits for various possible
percentages of the industry that switch to NPIS. As noted above, NPIS
may provide an incentive for establishments to switch from their
current inspection systems to NPIS; however, it is possible that the
costs associated with NPIS adoption will be

[[Page 49627]]

greater than the potential benefits for some establishments. Given the
lack of data with which to make cost-benefit comparisons across the
industry, Table 11 presents a wide range of possibilities for the
percentage of large and small non-Traditional establishments that will
choose to adopt NPIS.

Table 11--Estimated Net Social Benefits From the Rule (Millions of Dollars), Annualized Over 10 Years With a 7% Discount Rate, for Varying Percent
Changes That Switch to NPIS
--------------------------------------------------------------------------------------------------------------------------------------------------------
Percentage of Industry that Switches to NPIS \1\
------------------------------------------------------------------------------------------------------------------------
0% 10% 25% 50% 75% 90% 100%
--------------------------------------------------------------------------------------------------------------------------------------------------------
NPIS: \2\
Benefits:
Public health benefits 0.0 1.0 (0.3 to 1.7) 2.4 (0.8 to 4.3) 4.8 (1.6 to 8.7) 7.2 (2.4 to 8.6 (2.9 to 9.6 (3.3 to
(10%, 90%)................ 13.0) 15.7) 17.4)
FSIS net savings............... 0.0 2.3 5.7 11.4 17.1 20.5 22.8
------------------------------------------------------------------------------------------------------------------------
Unquantified benefits \3\.. Increased flexibility for establishments to design and implement production measures tailored to their operations, in
some cases possibly including increased line speed up to 140 chickens or 55 turkeys per minute
------------------------------------------------------------------------------------------------------------------------
Costs:
Costs to establishments.... 0.0 1.6 4.0 8.0 12.0 14.4 16.0
------------------------------------------------------------------------------------------------------------------------
Unquantified costs \3\..... Industry costs of responding to new NPIS inspections in a manner that may lead to public health benefits (e.g.,
discarding contaminated food or cooking it longer)
------------------------------------------------------------------------------------------------------------------------
Mandatory Component:
Costs to establishments.... 9.1 9.1 9.1 9.1 9.1 9.1 9.1
------------------------------------------------------------------------------------------------------------------------
Unquantified benefits...... Potential additional public health benefits from documentation and testing
------------------------------------------------------------------------------------------------------------------------
Unquantified costs......... Industry costs of responding to information generated by documentation and testing in a manner that may lead to public
health benefits (e.g., discarding contaminated food or cooking it longer)
------------------------------------------------------------------------------------------------------------------------
Total benefits (10%, 90%).. 0.0 3.3 (2.6 to 4.0) 8.1 (6.5 to 16.2 (13.0 to 24.3 (19.5 to 29.1 (23.4 to 32.4 (26.0 to
10.0) 20.1) 30.1) 36.2) 40.2)
Total costs................ 9.1 10.7 13.1 17.1 21.1 23.5 25.1
Net benefits (10%, 90%).... -9.1 -7.4 (-8.1 to - -5 (-6.6 to - -0.9 (-4.1 to 3.2 (-1.6 to 5.6 (-0.1 to 7.3 (0.9 to
6.7) 3.1) 3.0) 9.0) 12.7) 15.1)
--------------------------------------------------------------------------------------------------------------------------------------------------------
\1\ For costs and FSIS net savings, the relevant industry measure is the percentage of large and small establishments that switch to NPIS, whereas for
public health benefits, the relevant industry measure is percentage of product volume that is slaughtered in establishments that switch to NPIS.
\2\ The switch to NPIS includes two sets of policy changes: (1) the removal of some online FSIS inspectors, which generates labor cost savings for NPIS,
costs to industry of training and attestation, and the unquantified benefit to establishments of increased flexibility, and (2) the increase in
offline inspection activities by FSIS, which generates the estimated public health improvements, the associated unquantified costs, the quantified
costs to industry of installing new inspection stations, and the quantified costs to FSIS of grade increases, training and relocation.
\3\ As with quantified costs and benefits, unquantified NPIS-related cost and benefit estimates would be scaled proportionately to reflect the
percentage of the industry that switches to NPIS.
4 Annualized Over 10 Years with a 3% discount rate at 100% adoption rate, total benefits (10%, 90%) equal $33.6 million (27.1 to 41.6), total costs
equal $25.3 million. Net benefits equal $8.3 million (1.8 to 16.3).

Analysis of Considered Alternatives

Table 13--Comparisons of the Considered Alternatives to the Final Poultry Slaughter Rule
----------------------------------------------------------------------------------------------------------------
Considered alternatives Benefits Costs \1\ Net benefits
----------------------------------------------------------------------------------------------------------------
A. Taking No Action.................. No change in the Establishments would Zero Net Benefits.
existing inspection maintain existing
systems for poultry. practices.
FSIS does not need
significantly more
resources.
B. The Rule.......................... Public health benefits Annualized costs equal Selected Alternative
from reduced illnesses $25.1 million. See with annualized net
and FSIS savings add Tables 7a and 7b above benefits equal $7.3
to total benefits of for explanation of million.
$26.0 million to $40.2 these costs.
million annually.
Additional
unquantified public
health benefits from
NPIS and mandatory
components of the rule.
C. The Final Rule Without Offline Additional FSIS cost Annualized costs equal Net benefits will be
Inspection Activity. savings associated to Alternative B. lower than Alternative
with a reduction in B due to loss of
offline inspector public health
positions. benefits.

[[Page 49628]]

D. Requiring Only the New Poultry Public health benefits Annualized costs The net benefits will
Inspection System. from reduced illnesses greater than $20.5 be lower than
and FSIS savings add million. All Alternative B due to
to total benefits of establishments not the increased burden
$26.1 million to $40.2 included in on very small
million annually No Alternative B will establishments.
additional accrue additional
unquantified benefits, costs.
as detailed in section
titled
``Unquantifiable
Benefits Associated
with the Mandatory
Portion of the Rule.''.
----------------------------------------------------------------------------------------------------------------

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. FSIS
rejected this alternative because the NPIS will allow poultry
establishments slaughtering young chickens, turkeys and other poultry
to benefit and to enhance their food safety efforts through increased
flexibility and 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). Therefore this
alternative would not result in any public health benefits. This action
will have zero net benefits.
B. The Rule
FSIS's preferred alternative is the final rule as discussed above.
The final rule has an elective NPIS for young chickens and turkeys; a
modified Traditional Inspection System for all poultry other than
ratites; requirements 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, two locations for sampling for
microbial organisms to monitor process control for enteric pathogens
(except HACCP very small and very low volume establishments); and other
actions (see Table 2).
The rule gives the individual establishment the choice between the
NPIS (with or without the HIMP SIP waiver), the modified Traditional
Inspection System, and their current inspection system (SIS, NELS, or
NTIS). An establishment will choose the NPIS if the benefits, primarily
from the expected increased flexibility of operations, exceed the costs
of implementation. While this would probably be true for the HACCP
large and HACCP small establishments that slaughter young chickens and
turkeys, it may not be true for the HACCP very small establishments.
FSIS selected this alternative to minimize the impact on very small
establishments and to allow them the flexibility to choose the modified
Traditional Inspection System or their current inspection system if
they stand to lose from the NPIS.
Public health benefits (as discussed in section titled ``Expected
Benefits Associated with the NPIS--Public Health Benefits from
Reallocating FSIS Inspection Activities'') of the rule include a
reduction in illnesses attributed to young chicken and turkey. The
monetized annualized value of this reduction is $3.3 million to $17.4
million. FSIS annualized savings under the rule are expected to equal
$22.8 million.
Costs of the rule include $16.0 million annualized for the
conversion of establishments to NPIS, and $9.1 million annualized (10
years, 7 percent) for the mandatory component of the rule (see Tables
7a and 7b). This corresponds to total costs of about $25.1 million
annualized. Net benefits of the rule are estimated at $7.3 million.
C. The Rule Without Offline Inspection Activities
Removing the offline inspectors would eliminate the health benefits
of the rule which is the main purpose of the rule. While removing
offline inspectors might affect the savings for FSIS, the Agency could
not estimate any additional savings at this time because the offline
inspectors were part of an integrated inspections plan so the offline
inspectors could not be pulled out of the plan or the estimate. More
importantly, any changes to FSIS savings would be insignificant
compared to the loss of public health benefits.
D. Requiring the New Poultry Inspection System
FSIS considered requiring that all establishments convert to the
NPIS. The benefits from this alternative include, as under the rule,
the budgetary savings to FSIS from reallocation of personnel and public
health benefits of $9.6 million annually from reduced illnesses.
As shown in Table 7a, costs to firms that adopt the new rule are
about $16.0 million annualized over 10 years at 7 percent.
Under this alternative, all firms, including the very small firms
that FSIS expects will not adopt the rule, must adopt some measures, as
listed in Table 7b. These costs are from plan development,
recordkeeping and testing. The benefits \42\ of these activities
include the conduct of business in a manner more accountable to the
public; the support and documentation of production safety decision-
making; and the facilitation of oversight and transparency activities
like audits and inspections. The recordkeeping requirements are
designed to help operators of facilities and the Agency to identify
potential sources of contamination as well as contain and mitigate the
adverse health effects of contaminated food. Many of these benefits are
unquantifiable: the lower probability of recall, the lower costs of
identifying contaminated product if a recall occurs, and enhanced
product reputation when a product is not subject to recall, all benefit
the implementing firms. Table 7c lists the mandatory costs that FSIS
expects for the 54 very small establishments that FSIS projects will
not adopt the new inspection system.
---------------------------------------------------------------------------

\42\ Please see the FDA's preliminary regulatory impact analysis
of the Preventive Controls rule for a similar discussion of
recordkeeping benefits.
---------------------------------------------------------------------------

This alternative would result in higher costs for the industry,
specifically for very small establishments that would have difficulty
absorbing such costs. The annual benefits would be the same as
alternative B, the rule. FSIS rejected this

[[Page 49629]]

alternative because it would result in lower net benefits.

V. Final Regulatory Flexibility Act

In accordance with the Regulatory Flexibility Act, FSIS reviewed
the rule for its effects on small businesses. In response to public
comments received on the impact on small business, FSIS relaxed the
proposed requirement for small businesses to sample and test at pre-
chill and post-chill to allow very small HACCP size establishments to
sample and test only at post-chill. In addition, FSIS is maintaining
its present sampling frequency requirement for very low volume
establishments. This change reduces the costs imposed on small
establishments. The FSIS Administrator certifies that, for the purposes
of the Regulatory Flexibility Act (5 U.S.C. 601-602), this rule will
not have a significant economic impact on a substantial number of small
entities in the United States.
In this final regulatory flexibility analysis, FSIS first analyzes
the impact on the Agency-assigned HACCP small and very small size
categories. Then, FSIS highlights the minimal impact of the regulation
on very small and small companies.
FSIS will modernize and streamline poultry slaughter inspection
because of its 2011 regulatory review. 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.
In this final regulatory flexibility analysis, FSIS uses a
definition of small entities that is similar, but not identical, to
that used by the Small Business Administration \43\ and is more
appropriate with respect to estimating possible adverse economic
effects. The Small Business Administration defines a small business in
terms of ownership, while the HACCP production size definition \44\
applies to individual establishments and not companies that might own
more than one establishment. FSIS considers establishments to be the
economic entity of interest in this rule and thus uses the HACCP size
definition to characterize establishments that this rule might affect
adversely.
---------------------------------------------------------------------------

\43\ The Small Business Administration defines a small business
in poultry processing as an entity that is independently owned and
operated, is organized for profit, is not dominant, and has 500 or
fewer employees.
\44\ HAACP production size classes: large establishments, with
500 or more employees; small establishments, with 10-499 employees;
and very small establishments, with fewer than 10 employees or
annual sales of less than $2.5 million.
---------------------------------------------------------------------------

FSIS considered requiring the mandatory use of dressing performance
standards and the NPIS in all federally inspected establishments that
slaughter young chickens and turkeys, but rejected that alternative in
order to provide small and very small HACCP size establishments with a
choice between using the NPIS, or using the modified Traditional
Inspection System. Given a choice, FSIS anticipates that large and
small HACCP size establishments that slaughter young chickens and
turkeys will find it in their economic interest to adopt the new
inspection system. In contrast, FSIS anticipates that HACCP very small
establishments that slaughter young chickens and turkeys will choose to
operate under the modified Traditional Inspection System. The very
small HACCP size young chicken and turkey establishments, in general,
do not have sufficient output volume over which to spread the initial
set-up costs of the NPIS or the training and maintenance costs
resulting from this system. There are 51 such establishments. In
addition, HACCP establishments that slaughter poultry other than young
chickens and turkeys will operate under the modified Traditional
Inspection System. There are 19 establishments that slaughter poultry
other than young chickens and turkeys, of which 14 are small HACCP size
establishments and three are very small HACCP size establishments.
Consequently, we identify 68 establishments that might not realize the
full benefits of the rule. Table 14 shows the number of poultry
slaughter facilities by HACCP size and type of poultry slaughtered
based on the above discussion.

Table 14--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 and Turkeys................................ 51 70 149 270 93
Other Poultry............................................ 3 14 2 19 7
----------------------------------------------------------------------------------------------
Total................................................ 54 84 151 289 100
--------------------------------------------------------------------------------------------------------------------------------------------------------

In Table 15, in contrast to Table 15, FSIS classified the 289
establishments into the appropriate SBA categories in order to show the
establishment distribution over SBA small and large companies by number
of companies and number of establishments.

Table 15--Distribution of Establishments Over SBA Defined Small and Not-Small Companies
----------------------------------------------------------------------------------------------------------------
Number of Number of Share of
Company size (SBA definition) companies establishments establishments
----------------------------------------------------------------------------------------------------------------
Small.................................................. 109 110 38%
Large.................................................. 49 179 61%
--------------------------------------------------------
Total.............................................. 158 289 100%
----------------------------------------------------------------------------------------------------------------

Approximately 38 percent, or 110, of all establishments belong to
SBA small companies. Some of the SBA companies are not very low volume
slaughter operations and FSIS expects many will choose to operate under
NPIS.

[[Page 49630]]

Consequently, to measure possible adverse impact on small business,
FSIS's analysis concentrates on the 68 establishments identified above.

Cost Impact--Very Small Establishments

FSIS projects the costs of the mandatory component of the rule to
be approximately $218, annualized over 10 years at a 7 percent discount
rate, per very small HACCP size establishment processing young
chickens, turkeys, or other types of poultry, for a total of about
$11,759 annualized annualized across the existing 54 very small
establishments (Table 7c). FSIS expects net annual recurring cost
savings after the sixth year, because the rule permits these
establishments to design more efficient process control plans, and
sample only at one location. The cost savings associated with
eliminating generic E. coli testing will more than offset the
additional costs associated with the new required microbial testing
requirement because the cost of analyzing for generic E. coli is more
than that of analyzing for other indicator organisms and FSIS does not
expect the number of samples per year to increase from the present.

Cost Impact--Small Establishments

For the 14 small HACCP size poultry slaughter establishments
covered in this rule that do not process young chickens and turkeys,
FSIS projects costs of the mandatory component of the rule to be
approximately $11,579, annualized 10 years at a 7 percent discount
rate, per establishment, for a total of about $162,100 annualized
across all 14 establishments. Net annual recurring costs are
approximately $10,319 per establishment after the sixth year, for a
total of $144,470 across all 14 small establishments.

Cost Impact--Total

Table 16 presents the combined cost impact for both very small
HACCP size establishments (Table 7c) and small HACCP size
establishments that do not slaughter young chickens and turkeys.

Table 16--Estimated Annual Cost (or Cost Savings) of the Rule for Very Small HACCP Size Establishments That Produce Young Chickens and Turkeys and Small
HACCP Size Establishments That Slaughter Poultry Other Than Young Chickens and Turkeys
--------------------------------------------------------------------------------------------------------------------------------------------------------
10 Year annualized
HACCP size Number of Year 1 Recurring -------------------------------------
establishments 7% 3%
--------------------------------------------------------------------------------------------------------------------------------------------------------
Very Small............................................... 54 $109,069 ($3,177) $11,759 $9,599
Small.................................................... 14 $276,960 $144,470 $162,100 $159,549
----------------------------------------------------------------------------------------------
Total................................................ 68 $386,029 $141,293 $173,859 $169,148
--------------------------------------------------------------------------------------------------------------------------------------------------------

VI. Executive Order 12988

This rule has been reviewed under Executive Order 12988, Civil
Justice Reform. When this final rule is adopted: (1) All State and
local laws and regulation that are inconsistent with this rule will be
preempted; (2) no retroactive effect will be given to this rule; and
(3) administrative proceedings will not be required before parties ay
file suit in court challenging this rule.

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 final 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 Non-Discrimination Statement

USDA Non-Discrimination Statement

No agency, officer, or employee of the USDA shall, on the grounds
of race, color, national origin, religion, sex, gender identity, sexual
orientation, disability, age, marital status, family/parental status,
income derived from a public assistance program, or political beliefs,
exclude from participation in, deny the benefits of, or subject to
discrimination any person in the United States under any program or
activity conducted by the USDA.

How To File a Complaint of Discrimination

To file a complaint of discrimination, complete the USDA Program
Discrimination Complaint Form, which may be accessed online at http://www.ocio.usda.gov/sites/default/files/docs/2012/Complain_combined_6_8_12.pdf, or write a letter signed by you or your authorized
representative. Send your completed complaint form or letter to USDA by
mail, fax, or email:
Mail
U.S. Department of Agriculture, Director, Office of Adjudication,
1400 Independence Avenue SW., Washington, DC 20250-9410.
Fax
(202) 690-7442.
Email
[email protected].

Persons with disabilities who require alternative means for
communication (Braille, large print, audiotape, etc.), should contact
USDA's TARGET Center at (202) 720-2600 (voice and TDD).

X. Paperwork Reduction Act

In accordance with section 3507(d) of the Paperwork Reduction Act
of 1995 (44 U.S.C. 3501 et seq.), the new information collection
requirements included in this final 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 final rule, each official poultry slaughter
establishment will need to maintain as part of its HACCP plan,
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

[[Page 49631]]

establishment operating under the New Poultry Inspection System (NPIS)
will also be required to maintain, as part of its HACCP system, written
procedures to prevent carcasses afflicted with septicemia and toxemia
from entering the chiller. The procedures addressing prevention of
contamination by enteric pathogens will need to include microbial
testing. In addition, each establishment operating under NPIS will need
to maintain records that document that the products resulting from its
slaughter operations meet the definition of ready-to-cook poultry. Each
establishment operating under the NPIS will also need to submit on an
annual basis an attestation to the management member of the local FSIS
circuit safety committee stating that it maintains a program to monitor
and document any work-related conditions of establishment workers.
The requirement that poultry slaughter establishments have written
procedures in their HACCP plans, 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). Therefore, this requirement of this
rule creates no new burden on establishments.
The requirement that poultry slaughter establishments monitor their
systems through microbial testing and recordkeeping creates a new
information collection burden. For each sample for which a microbial
test is conducted, there are two ``responses'' for the establishment:
one response for the actual collecting of the sample and sending it to
the laboratory for analysis, and the other for recording the sample
result. In its initial paperwork burden estimate, FSIS estimated that
large establishments would test and record microbial results at the two
prescribed locations (pre- and post-chill), 15 times a day; small
establishments, 7 times a day; and very small establishments, 3 times a
day. These estimates were based on the frequency with which
establishments operating under a Salmonella Initiative Program (SIP)
waiver conduct sampling. Under SIP, FSIS grants establishments a waiver
of regulations under the condition that the establishment collects and
analyzes samples for microbial organisms and shares the results with
FSIS.
In this final rule, FSIS has revised the regulations to prescribe a
minimum frequency with which all establishments that slaughter poultry
will need to conduct testing for microbial organism to monitor their
process control procedures. FSIS has also revised the testing
requirements to allow very small and very low volume establishments to
conduct sampling at the post-chill point in the process only. These
revisions are substantive changes that have resulted in a reduction in
burden. Therefore, FSIS has updated its paperwork burden estimates to
reflect these changes and has submitted the revised information and
recordkeeping requirement to OMB for review.
The average burden per response and the annual burden hours are
explained below and summarized in the charts which follow.
Estimated Annual Burden: Poultry Slaughter Inspection.
Recordkeeping:

Estimated Annual Recordkeeping Burden for Modernization of Poultry
Slaughter Inspection

Respondents: Official poultry establishments.
Estimated Number of Respondents: 289.
Estimated Average Annual Number of Responses (samples) per
Respondent: Large establishments 4,322.7; small establishments 1,318;
very small establishments 21.3.
Estimated Total Annual Responses: 764,594.
Estimated Total Annual Recordkeeping Burden: 31,858 hours.

----------------------------------------------------------------------------------------------------------------
Average
annual Total
Estimated number of Total Time per annual
Respondents number of responses annual response in burden
respondents per responses minutes hours
respondent
----------------------------------------------------------------------------------------------------------------
Large establishments......... Microbial 151 4,322.7 652,773 2.5 21,197
testing data
recordkeeping.
Small establishments......... Microbial 84 1,318 110,712 2.5 4,613
testing data
recordkeeping.
Very small establishments.... Microbial 54 21.3 1,134 2.5 48
testing data
recordkeeping.
----------------------------------------------------------------
Total Recordkeeping ................ 289 2,645.6 764,594 2.5 31,858
Burden.
----------------------------------------------------------------------------------------------------------------

Reporting

Estimated Annual Reporting Burden for Poultry Slaughter Inspection

Respondents for this Rule: Official poultry establishments.
Estimated Number of Respondents: 289.
Estimated Average Annual Number of Responses per Respondent: Large
establishments 4,322.7; small establishments 1,318; very small
etablishments 21.3.
Estimated Total Annual Responses: 764,594.
Estimated Total Annual Reporting Burden on Respondents: 159,339
hours.

----------------------------------------------------------------------------------------------------------------
Average
annual Total
Estimated number of Total Time per annual
Respondents number of responses annual respone in burden
respondents per responses minutes hours
respondent
----------------------------------------------------------------------------------------------------------------
Large establishments......... Microbial 151 4,322.7 652,773 12.5 135,986
testing.
Small establishments......... Microbial 84 1,318 110,712 12.5 23,065
testing.
Very small establishments.... Microbial 54 21.3 1,134 15 288
testing.
----------------------------------------------------------------

[[Page 49632]]

Total Reporting Burden... ................ 289 2,645.6 764,594 ........... 159,339
----------------------------------------------------------------------------------------------------------------

Summary of Burden--Poultry Slaughter Inspection
------------------------------------------------------------------------

------------------------------------------------------------------------
Total No. respondents................................... 289
Average Annual No. responses per respondent............. 5,291.3
Total annual responses.................................. 1,529,188
Average hours per response.............................. .125
Total annual burden hours............................... 191,197
------------------------------------------------------------------------

In this final rule, FSIS is adding a new regulation that creates a
new information collection burden, in that it requires that poultry
slaughter establishments operating under the NPIS submit on an annual
basis an attestation to the management member of the local FSIS circuit
safety committee stating that it maintains a program to monitor and
document any work-related conditions of establishment workers. This is
a new recordkeeping requirement that FSIS has submitted to OMB for
approval.
The average burden per response and the annual burden hours are
explained below and summarized in the charts which follow.
Estimated Annual Burden: Poultry Slaughter Inspection
Reporting:

Estimated Annual Reporting Burden for Submitting an Annual Attestation
on Work-Related to the FSIS Circuit Safety Committee

Respondents: Official poultry establishments that operate under the
NPIS.
Estimated Maximum Number of Potential Respondents: 219.
Estimated Average Annual Number of Responses per Respondent: Large
establishments 1; small establishments 1; very small establishments 0.
Estimated Maximum Total Potential Annual Responses: 219.
Estimated Total Annual Recordkeeping Burden: 7.27 hours.

----------------------------------------------------------------------------------------------------------------
Average
annual Total
Maximum potential Estimated number of Total Time per potential
respondents: establishments number of responses annual potential annual
operating under the NPIS potential per potential response in burden
respondents potential responses minutes hours
respondent
----------------------------------------------------------------------------------------------------------------
Large establishments......... Attestation on 149 1 149 2 4.97
Work-Related
Conditions.
Small establishments......... Attestation on 70 1 70 2 2.3
Work-Related
Conditions.
Very small establishments.... ................ 0 0 0 ........... 0
----------------------------------------------------------------
Total Reporting Burden... ................ 219 1 219 ........... 7.27
----------------------------------------------------------------------------------------------------------------

Copies of this information collection assessment can be obtained
from Gina Kouba, Paperwork Reduction Act Coordinator, Food Safety and
Inspection Service, USDA, 1400 Independence Ave. SW., Room 6065 South
Building, Washington, DC 20250-3700; (202) 720- 5627.
Comments are invited on: (a) Whether the proposed collection of
information is necessary for the proper performance of FSIS's
functions, including whether the information will have practical
utility; (b) the accuracy of FSIS's estimate of the burden of the
proposed collection of information, including the validity of the
methodology and assumptions used; (c) ways to enhance the quality,
utility, and clarity of the information to be collected; and (d) ways
to minimize the burden of the information collection on those who are
to respond, including through the use of appropriate automated,
electronic, mechanical, or other technological collection techniques or
other forms of information technology.
Comments on the proposed information collection may be sent to both
Gina Kouba, 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 final rule.

XI. 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 final rule, FSIS will announce it
online through the FSIS Web page located at http://www.fsis.usda.gov/regulations_&_policies/Final_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

[[Page 49633]]

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.

List of Subjects

9 CFR Part 381

Poultry inspection, Poultry products, Reporting and 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 amending 9 CFR
Chapter III as follows:

PART 381--POULTRY PRODUCTS INSPECTION REGULATIONS

0
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.

0
2. Amend Sec. 381.36 by adding a new paragraph (f) to read as follows:

Sec. 381.36 Facilities required.

* * * * *
(f) 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(b)(6)(ii), 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
(f)(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 designed so that it can be easily and rapidly adjusted
for a minimum of 14 inches vertically while standing on the platform.
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 have a safe
lift mechanism and 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 effect, 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 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 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 total
number of offline verification inspection 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 foot-candles 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 young chicken 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 foot-candles 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

[[Page 49634]]

must be sufficient to preclude contamination of carcasses by splashing.

0
3. A new subpart H is added to part 381 to read as follows:

Subpart H--Attestation on Work-Related Conditions

Sec.
381.45 Attestation requirements.
381.46 Severability.

Sec. 381.45 Attestation requirements.

Each establishment that participates in the New Poultry Inspection
System (NPIS) shall submit on an annual basis an attestation to the
management member of the local FSIS circuit safety committee stating
that it maintains a program to monitor and document any work-related
conditions of establishment workers, and that the program includes the
following elements:
(a) Policies to encourage early reporting of symptoms of injuries
and illnesses, and assurance that it has no policies or programs in
place that would discourage the reporting of injuries and illnesses.
(b) Notification to employees of the nature and early symptoms of
occupational illnesses and injuries, in a manner and language that
workers can understand, including by posting in a conspicuous place or
places where notices to employees are customarily posted, a copy of the
FSIS/OSHA poster encouraging reporting and describing reportable signs
and symptoms.
(c) Monitoring on a regular and routine basis of injury and illness
logs, as well as nurse or medical office logs, workers' compensation
data, and any other injury or illness information available.

Sec. 381.46 Severability.

Should a court of competent jurisdiction hold any provision of this
part 381, subpart H to be invalid, such action shall not affect any
other provision of this part 381.

0
4. Amend Sec. 381.65 as follows:
0
a. Redesignate paragraphs (e) and (f) as paragraphs (f) and (e)
respectively.
0
b. Revise newly redesignated paragraph (f).
0
c. Add new paragraphs (g) and (h).
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 chiller.
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 operation. Official poultry slaughter
establishments must develop, implement, and maintain written procedures
to prevent contamination of carcasses and parts by enteric pathogens
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 in accordance with the sampling location and
frequency requirements in paragraphs (g)(1) and (2) of this section to
monitor their ability to maintain process control.
(1) Sampling locations. Establishments, except for very small
establishments operating under Traditional Inspection or very low
volume establishments operating under Traditional Inspection must
collect and analyze samples for microbial organisms at the pre-chill
and post-chill points in the process. Very small establishments
operating under Traditional Inspection and very low volume
establishments operating under Traditional Inspection must collect and
analyze samples for microbial organisms at the post-chill point in the
process.
(i) Very small establishments are establishments with fewer than 10
employees or annual sales of less than $2.5 million.
(ii) Very low volume establishments annually slaughter no more than
440,000 chickens, 60,000 turkeys, 60,000 ducks, 60,000 geese, 60,000
guineas, or 60,000 squabs.
(2) Sampling frequency. (i) Establishments, except for very low
volume establishments as defined in paragraph (g)(1)(ii) of this
section, must, at a minimum, collect and analyze samples at a frequency
proportional to the establishment's volume of production at the
following rates:
(A) Chickens. Once per 22,000 carcasses, but a minimum of once
during each week of operation.
(B) Turkeys, ducks, geese, guineas, and squabs. Once per 3,000
carcasses, but at a minimum once each week of operation.
(ii) Very low volume establishments as defined in paragraph
(g)(1)(ii) of this section must collect and analyze samples at least
once during each week of operation starting June 1 of every year. If,
after consecutively collecting 13 weekly samples, a very low volume
establishment can demonstrate that it is effectively maintaining
process control, it may modify its sampling plan.
(iii) Establishments must sample at a frequency that is adequate to
monitor their ability to maintain process control for enteric
pathogens. Establishments must maintain accurate records of all test
results and retain these records as provided in paragraph (h) of this
section.
(h) Recordkeeping requirements. Official poultry slaughter
establishments 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 if the establishment implements appropriate
controls to ensure the integrity of the electronic data. Records
required by this section must be maintained for at least one year and
must be accessible to FSIS.

0
5. Amend Sec. 381.66 as follows:
0
a. Revise paragraph (b).
0
b. Remove paragraphs (c)(3) and (4).
0
c. Revise paragraph (e).
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

[[Page 49635]]

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 predominately with air. An antimicrobial
intervention may be applied with water at the beginning of the chilling
process, provided that its use does not result in any net pick-up of
water or moisture during the chilling process. The initial
antimicrobial intervention may result in some temperature reduction of
the product, provided that the majority of temperature removal is
accomplished exclusively by chilled air.
* * * * *

0
6. Add Sec. 381.69 to subpart I to read as follows:

Sec. 381.69 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
140 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 their 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.
(d) Establishments operating under the line speed limits authorized
in this section shall comply with all other applicable requirements of
the laws, including, but not limited to, 29 U.S.C. 654(a).

0
7. Amend Sec. 381.76 as follows:
0
a. Revise the section heading.
0
b. Revise paragraphs (a), (b)(1) introductory text, (b)(1)(iv), and
(b)(2).
0
c. Add paragraphs (b)(1)(v) and (b)(6).
The revisions read as follows:

Sec. 381.76 Post-mortem inspection under Traditional Inspection, the
Streamlined Inspection System (SIS), the New Line Speed (NELS)
Inspection System, the New Poultry Inspection System (NPIS), the New
Turkey Inspection System (NTI), 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)(1) There are six systems of post-mortem inspection: the New
Poultry Inspection System (NPIS), which may be used for young chickens
and turkeys; the Streamlined Inspection System (SIS) and the New Line
Speed Inspection System (NELS), both of which may be used only for
broilers and cornish game hens; the New Turkey Inspection (NTI) System,
which may be used only for turkeys; Traditional Inspection, which may
be used for all poultry, except for ratites; and Ratite Inspection.
* * * * *
(iv) The NPIS 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 paragraph (b)(6) of this section and the
Administrator approves the establishment's request. The Administrator
may permit establishments that slaughter classes of poultry other than
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).
(v) Traditional Inspection shall be used for turkeys when neither
the NTI System nor the NPIS is used. For other classes of poultry,
Traditional Inspection shall be used when SIS, NELS, and the NPIS are
not used.
(2) Official establishments that operate under Traditional
Inspection, SIS, NELS, NTI, or Ratite Inspection must meet the
following requirements:
(i) 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.
(ii) Each carcass to be eviscerated must be opened so as to expose
the organs and the body cavity for proper examination by the inspector.
(iii) If a carcass is frozen, it must be thoroughly thawed before
being opened for examination by an inspector.
* * * * *
(6) The following requirements are applicable to the NPIS:
(i) Facilities. The establishment must comply with the facilities
requirements in Sec. 381.36(f).
(ii) Carcass sorting and disposition. (A) The establishment must
conduct carcass with associated viscera sorting activities, dispose of
carcasses and parts exhibiting condemnable conditions, and conduct
appropriate trimming and reprocessing activities before carcasses are
presented to the online carcass inspector.
(B) 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 SOP, or other prerequisite program a process by
which parts, other than parts identified as ``major portions'' as
defined in Sec. 381.170(b)(22), are available for inspection offline
after reprocessing or salvage.
(C) The establishment must develop, implement, and maintain written
procedures to ensure that poultry carcasses contaminated with
septicemic and toxemic conditions do not enter the chiller. The
establishment must incorporate these procedures into its HACCP plan, or
sanitation SOP, or other prerequisite program. These procedures must
cover, at a minimum, establishment sorting activities required under
paragraph (b)(6)(ii) of this section.
(D) The establishment must maintain records to document that the
products resulting from its slaughter operation meet the definition of
ready-to-cook poultry in Sec. 381.1. These records are subject to
review and evaluation by FSIS personnel.
(iii) Presentation for online carcass inspection. To ensure the
online carcass inspector may properly inspect every carcass, the
establishment must present carcasses as follows:
(A) Each carcass, except carcasses and parts identified as ``major
portions'' under 9 CFR 381.179(b)(22), must be held by a single
shackle;
(B) Both hocks of each carcass must be held by the shackle;
(C) The back side of the carcass must be faced toward the
inspector;
(D) There must be minimal carcass swinging motion;
(E) The establishment must ensure that it can sufficiently identify
viscera and parts corresponding with each carcass inspected by the
online carcass

[[Page 49636]]

inspector so that if the carcass inspector condemns a carcass all
corresponding viscera and parts are also condemned.
(iv) Inspection for Avian Visceral Leukosis. (A) 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(f)(3).
(B) 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.

0
9. 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 reprocessed 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 (2) of this section.
(1) Online reprocessing. Poultry carcasses accidentally
contaminated with digestive tract contents may be cleaned by applying
an online reprocessing 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, or sanitation SOPs, 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 the Administrator.
Establishments must incorporate procedures for the use of any offline
reprocessing into their HACCP plans, or sanitation SOPs, or other
prerequisite programs.

0
10. Section 381.94 is amended by revising the section heading and
paragraph (a) and removing and reserving paragraph (b) to read as
follows:

Sec. 381.94 Contamination with microorganisms; process control
verification criteria and testing; pathogen reduction standards for
establishments that slaughter ratites.

(a) Criteria for verifying process control; E. coli testing. (1)
Each official establishment that slaughters ratites shall test for
Escherichia coli Biotype I (E. coli). Establishments that slaughter
ratites and livestock, shall test the type of ratites or livestock
slaughtered in the greatest number. The establishment shall:
(i) Collect samples in accordance with the sampling techniques,
methodology, and frequency requirements in paragraph (a)(2) of this
section;
(ii) Obtain analytic results in accordance with paragraph (a)(3) of
this section; and
(iii) Maintain records of such analytic results in accordance with
paragraph (a)(4) of this section.
(2) Sampling requirements. (i) Written procedures. Each
establishment that slaughters ratites shall prepare written specimen
collection procedures which shall identify employees designated to
collect samples, and shall address location(s) of sampling, how
sampling randomness is achieved, and handling of the sample to ensure
sample integrity. The written procedure shall be made available to FSIS
upon request.
(ii) Sample collection. The establishment must collect samples from
whole ratites at the end of the chilling process. Samples from ratites
may be collected by sponging the carcass on the back and thigh or
samples can be collected by rinsing the whole carcass in an amount of
buffer appropriate for that type of bird.
(iii) Sampling frequency. Establishments that slaughter ratites,
except very low volume ratite establishments as defined in paragraph
(a)(2)(v) of this section, must take samples at a frequency
proportional to the establishment's volume of production at the
following rate: 1 sample per 3,000 carcasses, but at a minimum one
sample each week of operation.
(iv) Sampling frequency alternatives. An establishment operating
under a validated HACCP plan in accordance with Sec. 417.2(b) of this
chapter may substitute an alternative frequency for the frequency of
sampling required under paragraph (a)(2)(iii) of this section if,
(A) The alternative is an integral part of the establishment's
verification procedures for its HACCP plan and,
(B) FSIS does not determine, and notify the establishment in
writing, that the alternative frequency is inadequate to verify the
effectiveness of the establishment's processing controls.
(v) Sampling in very low volume ratite establishments. (A) Very low
volume ratite establishments annually slaughter no more than 6,000
ratites. Very low volume ratite establishments that slaughter ratites
in the largest number must collect at least one sample during each week
of operation after June 1 of each year, and continue sampling at a
minimum of once each week the establishment operates until June of the
following year or until 13 samples have been collected, whichever comes
first.
(B) Upon the establishment's meeting the requirements of paragraph
(a)(2)(v)(A) of this section, weekly sampling and testing is optional,
unless changes are made in establishment facilities, equipment,
personnel or procedures that may affect the adequacy of existing
process control measures, as determined by the establishment or by
FSIS. FSIS determinations that changes have been made requiring
resumption of weekly testing shall be provided to the establishment in
writing.
(3) Analysis of samples. Laboratories may use any quantitative
method for analysis of E. coli that is approved as an AOAC Official
Method of the AOAC International (formerly the Association of Official
Analytical Chemists) or approved and published by a scientific body and
based on the results of a collaborative trial conducted in accordance
with an internationally recognized protocol on collaborative trials and
compared against the three tube Most Probable Number (MPN) method and
agreeing with the 95 percent upper and lower confidence limit of the
appropriate MPN index.
(4) Recording of test results. The establishment shall maintain
accurate records of all test results, in terms of colony forming units
(CFU)/ml of rinse fluid. Results shall be recorded onto a process
control chart or table showing at least the most recent 13 test
results. Records shall be retained at the establishment for a period of
12 months

[[Page 49637]]

and shall be made available to FSIS upon request.
(5) Establishments shall evaluate E. coli test results using
statistical process control techniques.
(6) Failure to meet criteria. Test results that do not meet the
criteria described in paragraph (a)(5) of this section are an
indication that the establishment may not be maintaining process
controls sufficient to prevent fecal contamination. FSIS shall take
further action as appropriate to ensure that all applicable provisions
of the law are being met.
(7) Failure to test and record. Inspection will be suspended in
accordance with rules of practice that will be adopted for such
proceeding, upon a finding by FSIS that one or more provisions of
paragraphs (a) (1) through (4) of this section have not been complied
with and written notice of same has been provided to the establishment.
* * * * *

0
11. 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).
* * * * *

PART 500--RULES OF PRACTICE

0
12. 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]

0
13. Section 500.6 is amended by removing and reserving paragraph (f).

Done at Washington, DC, on: July 31, 2014.
Alfred V. Almanza,
Administrator.
[FR Doc. 2014-18526 Filed 8-20-14; 8:45 am]
BILLING CODE 3410-DM-P