Modernization of Poultry Slaughter Inspection, 24873-24878 [2012-10111]
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24873
Proposed Rules
Federal Register
Vol. 77, No. 81
Thursday, April 26, 2012
This section of the FEDERAL REGISTER
contains notices to the public of the proposed
issuance of rules and regulations. The
purpose of these notices is to give interested
persons an opportunity to participate in the
rule making prior to the adoption of the final
rules.
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
Food Safety and Inspection
Service, USDA.
ACTION: Proposed rule; extension of
comment period.
AGENCY:
The Food Safety and
Inspection Service (FSIS) is extending
the comment period for the proposed
rulemaking ‘‘Modernization of Poultry
Slaughter Inspection’’ and responding to
questions and addressing issues that
have been raised concerning the
proposed rule. The comment period was
scheduled to close on April 26, 2012.
During the comment period, a coalition
of consumer advocacy organizations and
two trade associations representing the
poultry industry asked that FSIS clarify
certain aspects of the proposed rule to
help inform their comments. This
document summarizes the issues raised
by these groups and FSIS’s response.
FSIS is also soliciting additional
comments on how it should implement
the final rule resulting from the
proposal and requesting available data
on any worker safety issues associated
with increased line speeds.
FSIS received a request to hold a
public technical meeting on the
proposed rule. FSIS does not believe
that such a meeting would be useful.
The Agency will, however, assess public
understanding of the proposed rule in
connection with its review and
evaluation of the comments submitted
and will respond as appropriate.
DATES: The proposed rule published
January 27, 2012 (77 FR 4408) is
extended. Comments are due May 29,
2012.
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SUMMARY:
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Comments may be
submitted by either of the following
methods:
• Federal eRulemaking Portal: This
Web site provides the ability to type
short comments directly into the
comment field on this Web page or
attach a file for lengthier comments. Go
to https://www.regulations.gov. Follow
the online instructions at that site for
submitting comments.
• Mail, including floppy disks or CD–
ROMs, and hand- or courier-delivered
items: Send to Docket Clerk, U.S.
Department of Agriculture (USDA),
FSIS, Docket Clerk, Patriots Plaza 3, 355
E. Street SW., 8–163A, Mailstop 3782,
Washington, DC 20250–3700.
Instructions: All items submitted by
mail or electronic mail must include the
Agency name and docket number FSIS–
2011–0012. Comments received in
response to this docket will be made
available for public inspection and
posted without change, including any
personal information, to https://
www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Dr.
Daniel Engeljohn, Assistant
Administrator, Office of Policy and
Program Development, FSIS, U.S.
Department of Agriculture, 1400
Independence Avenue SW.,
Washington, DC 20250–3700, (202) 720–
2709.
SUPPLEMENTARY INFORMATION:
ADDRESSES:
Background
On January 27, 2012, FSIS published
a proposed rule, ‘‘Modernization of
Poultry Slaughter Inspection’’ (77 FR
4408). In that document, the Agency
proposed a new inspection system for
young chicken and turkey slaughter
establishments that would replace all of
the existing inspection systems except
for traditional inspection. Key elements
of the proposed new inspection system
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) reducing
the number of on-line carcass inspectors
to one; (3) permitting faster line speeds
than are permitted under the existing
inspection systems; and (4) replacing
the existing Finished Product Standards
(FPS) with a requirement that
establishments that operate under the
new inspection system maintain records
to document that the products resulting
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from their slaughter operations meet the
definition of ready-to-cook poultry. In
addition to the proposed new inspection
system, FSIS also proposed changes that
would require, among other things, that
all establishments that slaughter poultry
other than ratites develop, implement,
and maintain written procedures to
prevent contamination of carcasses and
parts by enteric pathogens and fecal
material, and that they incorporate these
procedures into their HACCP plan or
sanitation standard operating
procedures (SOP) or other prerequisite
programs.
During the comment period for the
proposal, FSIS officials met with
representatives from a coalition of
consumer advocacy organizations and
two trade associations representing the
poultry industry. The consumer
advocacy coalition and one of the trade
associations had requested that FSIS
clarify certain aspects of the proposed
rule to inform their comments on the
proposal. Because the issues addressed
in these meetings may be relevant to the
development of comments from other
stakeholders, a brief summary of these
issues and the Agency’s response are
described below. The other trade
association requested that FSIS provide
additional information on how the
Agency intends to implement the
proposed new poultry inspection
system. The groups submitted written
questions to the Agency to consider
before each meeting. The issues raised
on implementation are summarized in a
separate section of this document that
outlines and requests comments on how
the Agency plans to implement the final
rule.
Summary of Issues Raised and FSIS
Response
In addition to the questions outlined
below, certain members of consumer
advocacy organizations requested that
FSIS hold a public technical meeting on
the proposed rule. FSIS is clarifying
certain aspects of the proposed rule in
this Federal Register notice and will
assess public understanding of the
proposed rule in connection with its
review and evaluation of the comments
submitted. The Agency will provide any
needed clarification if a final rule is
adopted.
Following is a summary of the issues
raised and FSIS’s response.
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1. Issues Raised by the Consumer
Advocacy Coalition
Comment: Why does FSIS believe that
it is preferable for plant employees to
sort carcasses?
FSIS response: Under the existing
inspection systems, on-line inspectors
conduct activities that do not have a
direct impact on public health. If the
proposal is finalized, and the
establishment conducts sorting
activities, the only birds presented to
the carcass inspector (CI) would be
those that are likely to pass inspection.
Therefore, the CI will be able to focus
on food safety-related activities, such as
verifying that carcasses affected by
septicemia or toxemia or contaminated
with visible fecal material do not enter
the chiller. For these reasons, the
Agency is proposing to remove certain
on-line inspection activities that are not
directly related to public health.
Comment: Is there any guarantee that
FSIS inspectors would be performing
more food safety-related activities under
the proposed new inspection system?
FSIS response: Yes, generally
inspectors would be performing more
food safety-related activities. There are
three important aspects of the proposed
rule that would allow FSIS inspectors to
conduct more food safety-related
activities. First, because the on-line CI
would not be responsible for sorting
carcasses for quality-related defects, the
amount of time that the CI spends
focusing on food safety-related activities
would increase. Second, under the
proposed new inspection system, the
offline verification inspector (VI) would
primarily conduct food safety-related
activities, such as verifying compliance
with HACCP and sanitation SOP
requirements and collecting product
samples. Third, because FSIS considers
contamination by enteric pathogens and
fecal contamination to be hazards that
are reasonably likely to occur, FSIS is
proposing to require that all
establishments that slaughter poultry
have written programs to address
sanitary dressing procedures, and that,
at a minimum, these procedures include
microbiological testing at pre-chill and
post-chill to monitor process control. In
addition to conducting verification
checks on carcasses, FSIS off-line
inspectors would be reviewing the
establishment’s records and test results
to verify that the establishment
maintains process control.
Comment: What type of training
would FSIS require for establishment
employees assigned to sort carcasses?
FSIS response: The proposed rule
does not prescribe training for
establishment employees. However, as
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noted in the preamble to the proposed
rule, FSIS expects to convert the current
instructions that it provides to Agency
inspectors into guidance for industry to
use to train plant sorters (77 FR 4419).
Comment: What would establishment
employees be required to do as part of
their sorting activities?
FSIS response: Should the rule
become final, establishment sorters
would be required to identify carcasses
with septicemia/toxemia and other
condemnable conditions and to remove
them from the line before they reach the
CI. Establishment employees would also
need to conduct trimming and reprocessing before the birds reach the CI.
Comment: Will establishment
employees need to look inside the bird
as part of their sorting responsibilities?
FSIS response: Septicemic/toxemic
birds exhibit signs on the outside of the
carcass, so there is no need to look at
the viscera. The regulations that
prescribe conditions for condemnation
in 9 CFR 381.81–381.93 would still
apply. Establishment personnel would
need to conduct sorting activities to
address these condemnable conditions
before the birds reach the CI. The
conditions described in these
regulations can be readily identified by
examining the outside of the carcass.
Lesions on the viscera do not require
condemnation of the entire carcass
except for lesions associated with
visceral leukosis. The proposed rule
provides for a 300-bird inspection of
young chickens with the viscera (77
CFR 4421–4422). If the inspector finds
signs or symptoms associated with
visceral leukosis, then the entire flock
would be inspected for the disease. All
growers vaccinate birds for visceral
leukosis. Therefore, it is seen only on
rare occasions if the vaccine fails.
Comment: How does the proposed
rule address other consumer protection
(OCP) issues, such as digestive tract
contents found on products, that may
affect internal parts of the carcass?
FSIS response: There is a difference
between fecal material and ingesta as
digestive tract contents. We have no
evidence to show that ingesta carries the
same microbes as fecal contamination.
Under the proposal, FSIS would enforce
OCP processing defects that are
associated with digestive tract contents,
other than fecal contamination, in
enforcing the ready-to-cook (RTC)
poultry standard.
Comment: Where would the
establishment’s critical control point
(CCP) for visible fecal contamination be
located?
FSIS response: FSIS does not
prescribe where establishments must
locate CCPs. The CI would be located
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before the chiller. Visible fecal
contamination would need to be
removed before the carcass is presented
to the CI. The VI would be conducting
verification checks for fecal
contamination off-line. If the VI detects
fecal contamination offline, the plant
has exceeded the zero tolerance for
visible fecal contamination.
The present inspection system is
similar to the proposed system in that
there are inspectors located upstream,
and zero tolerance is enforced at a point
at final wash, before the carcass enters
the chiller. However, under the
proposed new system the CI is more
likely to observe visible fecal
contamination because the carcasses
would be free from animal diseases and
trim and processing defects.
Comment: Under the proposed rule,
can FSIS take regulatory action
throughout the entire dressing process?
FSIS Response: The proposed rule
would require that establishments
develop, implement, and maintain
procedures to address contamination by
enteric pathogens and fecal material
throughout the entire slaughter and
dressing process. Through inspection
activities, FSIS would ensure that the
establishment’s procedures are effective,
and the Agency would take appropriate
regulatory action when necessary.
Comment: Would there be an
approval process for the establishment’s
procedures to prevent contamination
with enteric pathogens and fecal
material?
FSIS response: There would be no
pre-approval of an establishment’s
procedures. However, establishments
would need to ensure that their
procedures for preventing
contamination are effective. To verify
that an establishment’s procedures are
effective, FSIS would consider: (1) The
microbiological data that the
establishment would be required to
collect pre-chill and post-chill to
demonstrate process control; (2)
presence of visible fecal contamination;
and (3) FSIS sampling results for
Salmonella and Campylobacter.
Comment: What was the basis for the
baseline sampling numbers presented in
the preamble to the proposed rule (74
FR 4442)?
FSIS response: The estimates for
sampling come from the economic
analysis and reflect what we estimate to
be the amount of sampling that plants
would conduct if the proposed rule is
adopted by the Agency. We are not
proposing to prescribe how often
establishments must test.
Establishments would need to
determine the frequency and type of
sampling that would be sufficient to
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demonstrate that they are maintaining
process control.
Comment: Why is FSIS not mandating
a frequency for testing?
FSIS response: As stated in the
preamble to the proposed rule, FSIS is
proposing to require that an
establishment’s sampling frequency be
adequate to monitor the effectiveness of
its process control for enteric pathogens
(77 FR 4428). The frequency with which
establishments would need to conduct
such testing would depend on a number
of factors, including their production
volume, the source of their flocks, their
slaughter and dressing process, and the
consistency of their microbial test
results over time. Because the testing
frequency would be an integral part of
an establishment’s HACCP system
verification procedures, establishments
would need to collect and maintain data
to demonstrate that their testing
frequency is adequate to verify the
effectiveness of their process control
procedures.
Comment: Why did the Agency
propose two points for microbiological
testing instead of three?
FSIS response: As noted in the
preamble to the proposed rule, FSIS had
considered requiring testing at three
points in the process, i.e., re-hang, prechill and post-chill (77 FR 4428). The
proposed rule provides for testing at
pre-chill and post-chill because the
Agency tentatively concluded that
verification testing conducted at these
two points would provide the evidence
establishments need to verify that their
process control measures are effective in
preventing carcasses from becoming
contaminated with pathogens. In the
preamble to the proposed rule, the
Agency explained that it considered
requiring a third verification test at the
re-hang position to monitor the
incoming load of pathogens but
tentatively decided that it was not
necessary to impose the additional costs
that would be associated with testing at
this point (77 FR 4428). FSIS also
considered requiring only one
verification test at any position along
the production line to provide
maximum flexibility but concluded this
approach may not be sufficient to
monitor the effectiveness of an
establishment’s procedures to prevent
contamination throughout the slaughter
and dressing operation. The Agency
requests comments on these
alternatives.
Comment: Can CI inspectors stop or
slow the line?
FSIS response: If the CI observes a
condemnable condition, either food
safety or generalized OCP condition
requiring condemnation of the entire
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carcass, the CI would be authorized to
stop the line to prevent such carcasses
from entering the chiller. The CI would
communicate the findings to the VI and
inspector-in-charge (IIC). The IIC would
consider available data to reset the line
speed. Line speed would be determined
by IIC’s assessment of the frequency of
carcass defects identified by the CI and
the VI and the plant’s control of its
processes.
Comment: Would offline inspectors
be available to visually inspect carcasses
under the proposed new system.
FSIS response: The off-line VI would
be checking carcasses to verify that they
do not contain food safety-related
contamination or defects.
Comment: How many HACCP
verification activities would occur
under the new system versus the old
system?
FSIS Response: HACCP and sanitation
verification activities would be a higher
fraction of inspection activities under
the proposed new inspection system as
the Agency reduces its focus on quality
and other OCP defects.
Comment: What is the relationship
between the ready-to-cook (RTC)
poultry standard in the proposed rule
and the existing Finished Product
Standards (FPS)?
FSIS response: Poultry products that
comply with the FPS meet the
definition of RTC poultry under the
existing regulations; i.e., they are
suitable for cooking without the need
for further processing. The FPS have
been in place for many years and were
used to inform the OCP standards in the
HIMP pilot. These OCP standards reflect
OCP performance in establishments
before HIMP. Establishments operating
under HIMP maintained OCP defect
levels that average about half the
corresponding OCP performance
standards. Therefore, FSIS has
determined that it is not necessary to
require that establishments operating
under the proposed new inspection
system meet prescriptive OCP
performance standards in order to
produce RTC poultry. Under the
proposed rule, establishments operating
under the proposed new inspection
system would have the flexibility to
implement the process controls that
they have determined would best allow
them to produce RTC poultry.
Comment: What happens to the
carcasses and parts that are rejected by
the plant?
FSIS response: All regulations that
apply to condemned carcasses/parts
would still apply under the new
inspection system, e.g., denaturing and
diverting away from human food. The
off-line VI would verify that the plant is
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properly disposing of inedible and
condemned carcasses and parts.
Comment: For OCP defects under
HIMP, there is a moving window in
which there is non-compliance if the
plant exceeds OCP standards. What
about under the proposed rule?
FSIS response: The Agency is moving
away from using the moving window to
meet OCP performance standards.
Under the proposed rule, establishments
would determine how they would
document that they are producing RTC
poultry. The Agency is not prescribing
where or how establishments would
address OCP defects.
Comment: If establishments under the
proposed new inspection system are
permitted to increase the line speed,
would the CI continue to detect
problems?
FSIS response: Analysis of HIMP data
shows that CIs are able to detect fecal
contamination and septicemia/toxemia
at line speeds of up to 175 birds per
minute (bpm) for young chickens.
Comment: Did the Agency consider
the effects of faster line speeds on
worker safety?
FSIS response: FSIS did consider
potential effects on safety. The Agency
is prepared to address worker safety
within the bounds of its regulatory
authority and will coordinate with the
Occupational Safety and Health
Administration (OSHA) as the
regulatory process moves forward. The
National Institute for Occupational
Safety and Health (NIOSH) study
described in the proposed rule is a start
to determine what the current baseline
performance indicators for worker safety
in plants are before an increase in line
speeds. We will use the NIOSH
assessment tool and consider ways that
we can supplement the NIOSH study.
We are interested in comments on the
effects of line speed and worker safety.
Comment: Why did the Agency
propose to reduce the length of the CI
inspection station so that there is no
room for a helper?
FSIS response: Helpers are necessary
under the existing inspection systems
because the inspectors are sorting, and
the birds have more defects. The
proposed rule does not preclude an
establishment from assigning a helper,
but because the birds presented to the
CI would have fewer defects, there is no
need for a helper. Therefore, under the
proposed rule, the requirement for the
helper stand at the inspection CI
inspection station would be removed.
Comment: The Salmonella results in
the HIMP report compare HIMP plants
with comparison plants. How many of
the HIMP plants, and how many of the
comparison plants, had received
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waivers for on-line reprocessing (OLR)
in each year since the HIMP pilot
began? Is it possible that OLR was
responsible for lower Salmonella
positive rates?
FSIS response: Before November
2011, FSIS did not track the date of
implementation of approved waivers for
OLR systems. In November 2011, all
establishments with existing waivers
were required to participate in the
Salmonella Initiative Project (SIP) or
forfeit their waivers. FSIS is able to
track the dates that OLR waivers were
implemented under SIP. Based on
information obtained under SIP, as of
March 2011, 15 of the 20 HIMP plants
had waivers for OLR (75%), and 61 of
the 64 comparison plants had waivers
for OLR (95.3%).
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2. Issues Raised by the Trade
Association
Comment: Can FSIS clarify how
visible fecal contamination would be
handled under the new poultry
inspection system?
FSIS response: An important aspect of
the proposed rule is the provision that
requires that all poultry establishments
develop procedures to prevent fecal
contamination and contamination by
enteric pathogens throughout the entire
process and not just cleaning up the
birds at the end of the process. These
written procedures would need to be
incorporated into the HACCP system.
Therefore, FSIS would not just be
checking at the end of the line to verify
that the establishment’s procedures for
preventing contamination are effective.
FSIS would be conducting verification
activities throughout the entire process
to assess whether the process is in
control, including proper
implementation and effective corrective
actions. Findings of fecal contamination
throughout the process would indicate a
lack of process control. The proposed
rule also requires that all poultry
slaughter establishments have
procedures to prevent carcasses with
visible fecal contamination from
entering the chiller, and that they
incorporate these procedures into their
HACCP system. FSIS would consider
these procedures to be ineffective if a
contaminated carcass entered the
chiller.
Comment: How were the line speeds
referenced in the proposed rule
determined? Do you have any additional
data on how maximum line speeds for
turkey plants were determined?
FSIS response: The line speeds were
based on our experience under HIMP.
We are interested in comments and data
on the proposed line speeds.
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Comment: What are the expectations
for validation under the proposed rule,
particularly for the proposed changes to
the time and temperature chilling
requirements?
FSIS response: The validation
requirement under the proposed rule
would be the same as what is required
under the existing regulations (9 CFR
417.4(a)). There would not be any
special validation requirement under
the new poultry slaughter rule.
Comment: Should establishments
continue to apply for SIP waivers if they
are interested in pursuing new
technologies in their slaughter
operations, or should they wait until
FSIS issues a final rule on the new
poultry inspection system?
FSIS response: Establishments should
continue to request waivers of
regulations that impact slaughter
operations, such as OLR and alternative
chilling procedures, if they are
interested in operating under such
waivers. Existing SIP waivers would
continue until FSIS implements the
final rule. If a waiver is not addressed
in any final rule resulting from this
proposal, then it would remain in effect
until another final rule is published.
Comment: What is pre-chill? When
would the pre-chill testing occur? Is
post-chill testing supposed to be
conducted after the final intervention?
FSIS response: Pre-chill occurs just
before the chilling operation, at the end
of the evisceration process. The prechill testing is intended to monitor the
effectiveness of all process controls up
to the point of the chilling operation.
Therefore, pre-chill testing should be
conducted before the chiller, at the end
of the evisceration process. Post-chill
testing would be at the same point in
the process as it is now for FSIS
Salmonella and Campylobacter
verification testing, that is, after all
interventions.
Comment: What would the
parameters for faster or slower line
speeds be?
FSIS response: The on-line inspector
would be authorized to stop the line to
prevent adulterated carcasses from
entering the chiller. The IIC would be
authorized to slow the line. This is the
same as in current HIMP and non-HIMP
establishments. The on-line CI and offline VI would communicate and inform
the IIC if they observe excessive food
safety or non-food safety- related
defects, and the IIC would assess the
need to reduce the line speed or take
other appropriate measures.
Comment: If the final rule becomes
effective, would plants be able to start
running at the faster line speeds right
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away or would there be a gradual
increase in line speeds?
FSIS response: To operate at faster
line speeds, plants would need to
comply with all of the requirements in
any final rule that results from this
rulemaking. The establishment’s
maximum line speed would depend on
the ability of the establishment to
maintain process control, and whether
conditions are affecting the ability of the
CI to properly inspect.
Implementation of the Proposed New
Inspection System
1. Proposed Implementation Approach
In the preamble to the proposed rule,
FSIS invited interested persons to
submit comments on how the Agency
should implement the new poultry
inspection system if it finalizes the
proposed rule. The Agency specifically
requested comment on whether it
should phase-in the implementation of
the final rule to provide additional time
for small and very small establishments
to adjust their operations to comply
with the new requirements (77 FR
4408). The Agency also requested
comments on how it can make the
phased implementation most effective.
In this document, FSIS is providing
additional information on how it
intends to implement the new poultry
inspection system to solicit more
focused comments on this issue.
The Agency has tentatively decided
that if it finalizes the proposed rule, it
would then 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 are interested in
operating under the proposed new
inspection system. Those
establishments that choose to operate
under the new inspection system would
then inform the Agency concerning
when they wish to begin implementing
the new inspection system in their
facilities. The Agency is considering
giving establishments six months to
decide whether they would operate
under the new inspection system and
up to 3 years to switch to the new
system. FSIS requests comments on this
proposed implementation approach and
the proposed time periods.
2. Issues Raised on Implementation
Comment: How would the district
offices direct their resources to
implement the final rule?
FSIS response: The FSIS
implementation plan would be
coordinated from headquarters through
the districts to ensure resource
availability and fair and equitable
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implementation across all interested
establishments.
Comment: Does the Agency anticipate
making additional resources available to
implement a final rule, even if only on
a temporary basis?
FSIS response: As discussed in the
preamble to the proposed rule, there
would be two consumer safety inspector
(CSI) positions for every slaughter
evisceration line assigned to
establishments that choose to adopt the
new poultry slaughter inspection
system, one CI and one VI (77 FR 4421–
4422). This represents a reduction in the
number of inspectors because under the
existing system, inspectors conduct
sorting activities. At this time, the
Agency does not anticipate that
additional resources would be needed to
implement the new poultry inspection
system but would make additional
resources available, such as guidance for
industry and training to FSIS inspectors,
as needed to ensure smooth
implementation of the final rule.
Comment: In the preamble to the
proposed rule, the Agency estimated
that 219 poultry slaughter
establishments would choose to operate
under the proposed new inspection
system. How does the Agency intend to
implement the proposed new system in
all 219 establishments in a smooth and
fair manner?
FSIS Response: The Agency is
interested in comments on the
implementation phase-in and would use
comments to inform implementation
planning, including strategies for
recruitment, staffing, training, and other
actions needed to ensure FSIS readiness
to implement the proposed rule in an
efficient and fair manner. The Agency
intends to begin implementing the
proposed NPIS when it finalizes the
rule. However, implementation would
not take place at all eligible plants at the
same time. It would be phased in over
time to ensure proper FSIS inspection
force readiness to successfully
implement the new system.
Comment: How does the Agency
intend to train inspectors in the new
inspection system and familiarize them
with the new requirements?
FSIS response: Inspectors assigned to
work in poultry slaughter
establishments converting to the
proposed new inspection system would
receive training on the new system
before the establishments they are
assigned to convert to the new system.
The Agency is considering various
approaches to ensure effectiveness and
uniformity in its workforce training.
Comment: Is the Agency planning to
provide any type of standardized
programs to assist in training the
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15:15 Apr 25, 2012
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establishment sorters in disease
recognition and disposition for
trimmable defects or is this
responsibility being left up to the
establishments?
FSIS response: As noted in the
preamble to the proposed rule, FSIS
plans to convert the current instructions
that it provides to Agency inspectors
into guidance for industry to use to train
plant sorters.
Comment: Does the Agency anticipate
developing a framework by which
establishments or inspectors can receive
quick and consistent clarification on
requirements or feedback on
inspectional decisions from
headquarters?
FSIS response: The Agency would
continue to provide technical support to
its workforce and industry through its
standard channels. For example, FSIS
would continue to encourage referring
questions to its Policy Development
Division through askFSIS at https://
askfsis.custhelp.com or by telephone at
1–800–233–3935. The Agency would
develop appropriate instructions to
inspectors as well as appropriate
compliance guides.
Worker Safety Issues
FSIS’s direct legal authority with
respect to regulating working conditions
extends only to inspection personnel.
The Department of Labor’s OSHA is the
lead Federal agency responsible for
establishment worker safety issues.
However, FSIS recognizes the
importance of establishment worker
safety and is interested in additional
information about the potential
intersection of increased line speeds
and worker safety.
As noted in the preamble to the
proposed rule, FSIS has asked NIOSH to
evaluate the effects of increased line
speed by collecting data from one to five
non-HIMP plants that requested waivers
from line speed restrictions under the
Salmonella Initiative Project (SIP) (77
FR 4422). NIOSH expressed its
willingness to evaluate the effects of
increased production volume on
employee health, with a focus on
musculoskeletal disorders and acute
traumatic injuries. NIOSH will prepare
a report based on its findings of short, intermediate-, and long-term effects
from the process modifications. We
expect that the NIOSH report will also
make recommendations to the Agency
as appropriate. FSIS, in collaboration
with OSHA, will consider the available
data on employee effects collected from
NIOSH activities when implementing
the final rule resulting from the
proposal.
PO 00000
Frm 00005
Fmt 4702
Sfmt 4702
24877
To facilitate further evaluation of this
issue, FSIS requests specific comments
on the effects of increased line speeds
and production volume on worker
safety. The Agency is particularly
interested in comments on the
availability of records or studies that
contain data that NIOSH may be able to
use to assist the Agency in analyzing the
effects of increased line speed on the
safety and health of employees
throughout the establishment, including
effects prior to and following the
evisceration line. The Agency is
interested in the availability of records
and studies that include documentation
on employees’ work, injuries, and
illnesses, as well as plant production,
both before and after establishments
made changes to their operations to
increase production volume. Such
records and studies include, but are not
limited to:
• Human resources and payroll data
for all employees on hours worked per
year, department, job title, hire date,
separation date, and position
responsibilities;
• OSHA logs, workers’ compensation
claims, first reports of injury or illness,
dispensary logs and records, and other
injury or illness narratives for all
employees; and
• Daily production hours;
• Results of ergonomic or industrial
engineering studies, such as time-andmotion analyses that document the
actual pace of work or physical stresses
on workers; and
• Any self-assessments of worker
safety conducted by establishments.
Comments on this issue should
describe the type of data available,
whether the data are available in an
electronic or paper format, where the
records are maintained, (e.g., at the
establishment or at corporate
headquarters), and any other
information that can be used to assess
the utility of the data. The comments
should provide information, including
contact information, on how FSIS or
NIOSH can gain access to the data or
studies.
In addition, FSIS will continue its
collaboration with NIOSH and OSHA,
developing guidance materials on
measures that establishments could
adopt and implement to promote and
better ensure worker safety. To facilitate
the development of such guidance, FSIS
requests comments on best practices
and other measures that establishments
can take to protect workers throughout
the plant, including possible protective
factors such as increasing the size of the
workforce, rotating assignments,
increased automation, or improved tools
and techniques.
E:\FR\FM\26APP1.SGM
26APP1
24878
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 / Proposed Rules
Additional Public Notification
FSIS will announce the availability of
this Federal Register notice on-line
through the FSIS Web page located at
https://www.fsis.usda.gov/regulations_&_
policies/Proposed_Rules/index.asp.
FSIS also will make copies of this
Federal Register publication available
through the FSIS Constituent Update,
which is used to provide information
regarding FSIS policies, procedures,
regulations, Federal Register notices,
FSIS public meetings, and other types of
information that could affect or would
be of interest to our constituents and
stakeholders. The Update is
communicated via Listserv, a free email
subscription service consisting of
industry, trade, and farm groups,
consumer interest groups, allied health
professionals, scientific professionals,
and other individuals who have
requested to be included. The Update
also is available on the FSIS Web page.
Through Listserv and the Web page,
FSIS is able to provide information to a
much broader, more diverse audience.
In addition, FSIS offers an email
subscription service which provides
automatic and customized access to
selected food safety news and
information. This service is available at
https://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.
Done in Washington, DC on April 23, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012–10111 Filed 4–25–12; 8:45 am]
BILLING CODE 3410–DM–P
DEPARTMENT OF JUSTICE
28 CFR Part 16
[CPCLO Order No. 008–2012]
Privacy Act of 1974; Implementation
Bureau of Prisons, Department
of Justice.
ACTION: Notice of proposed rulemaking.
AGENCY:
In the Federal Register, the
Bureau of Prisons (Bureau or BOP), a
component of the Department of Justice,
has published a notice of a revised
Privacy Act system of records, Inmate
Central Records System (JUSTICE/BOP–
005). In this notice of proposed
rulemaking, the Bureau proposes to
amend its Privacy Act regulations for
the Inmate Central Records System
emcdonald on DSK29S0YB1PROD with PROPOSALS
SUMMARY:
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15:15 Apr 25, 2012
Jkt 226001
(JUSTICE/BOP–005) by now exempting
this system from subsections (c)(3) and
(4); (d); (e)(1), (2), (3), (4)(G), (H), and (I),
(5), and (8); (f); and (g) of the Privacy
Act of 1974 pursuant to 5 U.S.C. 552a(j)
and (k) for the reasons set forth in the
following text. The exemptions are
necessary to avoid interference with the
law enforcement and functions and
responsibilities of the Bureau.
Public comment is invited.
DATES: Comments must be received by
May 29, 2012.
ADDRESSES: Address all comments to
the Privacy Analyst, Office of Privacy
and Civil Liberties, National Place
Building, Suite 1000, Washington, DC
20530, or by facsimile 202–307–0693.
To ensure proper handling, please
reference the CPCLO Order number in
your correspondence. You may review
an electronic version of the proposed
rule at https://www.regulations.gov. You
may also submit a comment via the
Internet by using the comment form for
this regulation at https://
www.regulations.gov. Please include the
CPCLO Order number in the subject
box.
Please note that the Department is
requesting that electronic comments be
submitted before midnight Eastern
Standard Time on the day the comment
period closes because https://
www.regulations.gov terminates the
public’s ability to submit comments at
that time. Commenters in time zones
other than Eastern Standard Time may
want to consider this so that their
electronic comments are received. All
comments sent via regular or express
mail will be considered timely if
postmarked on the day the comment
period closes.
Posting of Public Comments: Please
note that all comments received are
considered part of the public record and
made available for public inspection
online at https://www.regulations.gov
and in the Department’s public docket.
Such information includes personally
identifying information (such as name,
address, etc.,) voluntarily submitted by
the commenter.
If you want to submit personally
identifying information (such as your
name, address, etc.) as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
term ‘‘PERSONALLY IDENTIFYING
INFORMATION’’ in the first paragraph
of your comment. You must also place
all the personally identifying
information you do not want posted
online or made available in the public
docket in the first paragraph of your
PO 00000
Frm 00006
Fmt 4702
Sfmt 4702
comment and identify what information
you want redacted.
If you want to submit confidential
business information as part of your
comment, but do not want it to be
posted online or made available in the
public docket, you must include the
term ‘‘CONFIDENTIAL BUSINESS
INFORMATION’’ in the first paragraph
of your comment. You must also
prominently identify confidential
business information to be redacted
within the comment. If a comment has
so much confidential business
information that it cannot be effectively
redacted, all or part of that comment
may not be posted online or made
available in the public docket.
Personally identifying information
and confidential business information
identified and located as set forth above
will be redacted and the comment, in
redacted form, will be posted online and
placed in the Department’s public
docket file. Please note that the Freedom
of Information Act applies to all
comments received. If you wish to
inspect the agency’s public docket file
in person by appointment, please see
the FOR FURTHER INFORMATION CONTACT
paragraph.
FOR FURTHER INFORMATION CONTACT: C.
Darnell Stroble, Attorney-Advisor,
Federal Bureau of Prisons, 202–514–
9180.
SUPPLEMENTARY INFORMATION: In the
Notice section of today’s Federal
Register, the Bureau published a revised
Privacy Act system of records notice,
Inmate Central Records System
(JUSTICE/BOP–005). This system assists
the Attorney General and the Bureau of
Prisons in meeting statutory
responsibilities for the safekeeping, care
and custody of incarcerated persons. It
serves as the primary record system on
these individuals and includes
information critical to the continued
safety and security of federal prisons
and the public.
In this rulemaking, the Bureau
proposes to exempt this Privacy Act
system of records from certain
provisions of the Privacy Act pursuant
to 5 U.S.C. 552a(j) and (k). Although this
system of records was previously
exempt from certain provisions of the
Privacy Act pursuant to 5 U.S.C.
552a(j)(2), the Bureau is seeking
additional exemptions pursuant to 5
U.S.C. 552a(j)(2), adding exemptions
pursuant to 5 U.S.C. 552a(k), and
consolidating the exemptions together
in one location of the Code of Federal
Register. Therefore, the proposed rule
seeks to delete all references of the
Inmate Central Records System
(JUSTICE/BOP–005) from paragraphs (a)
E:\FR\FM\26APP1.SGM
26APP1
Agencies
[Federal Register Volume 77, Number 81 (Thursday, April 26, 2012)]
[Proposed Rules]
[Pages 24873-24878]
From the Federal Register Online via the Government Printing Office [www.gpo.gov]
[FR Doc No: 2012-10111]
========================================================================
Proposed Rules
Federal Register
________________________________________________________________________
This section of the FEDERAL REGISTER contains notices to the public of
the proposed issuance of rules and regulations. The purpose of these
notices is to give interested persons an opportunity to participate in
the rule making prior to the adoption of the final rules.
========================================================================
Federal Register / Vol. 77, No. 81 / Thursday, April 26, 2012 /
Proposed Rules
[[Page 24873]]
DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 381 and 500
[Docket No. FSIS-2011-0012]
RIN 0583-AD32
Modernization of Poultry Slaughter Inspection
AGENCY: Food Safety and Inspection Service, USDA.
ACTION: Proposed rule; extension of comment period.
-----------------------------------------------------------------------
SUMMARY: The Food Safety and Inspection Service (FSIS) is extending the
comment period for the proposed rulemaking ``Modernization of Poultry
Slaughter Inspection'' and responding to questions and addressing
issues that have been raised concerning the proposed rule. The comment
period was scheduled to close on April 26, 2012. During the comment
period, a coalition of consumer advocacy organizations and two trade
associations representing the poultry industry asked that FSIS clarify
certain aspects of the proposed rule to help inform their comments.
This document summarizes the issues raised by these groups and FSIS's
response. FSIS is also soliciting additional comments on how it should
implement the final rule resulting from the proposal and requesting
available data on any worker safety issues associated with increased
line speeds.
FSIS received a request to hold a public technical meeting on the
proposed rule. FSIS does not believe that such a meeting would be
useful. The Agency will, however, assess public understanding of the
proposed rule in connection with its review and evaluation of the
comments submitted and will respond as appropriate.
DATES: The proposed rule published January 27, 2012 (77 FR 4408) is
extended. Comments are due May 29, 2012.
ADDRESSES: Comments may be submitted by either of the following
methods:
Federal eRulemaking Portal: This Web site provides the
ability to type short comments directly into the comment field on this
Web page or attach a file for lengthier comments. Go to https://www.regulations.gov. Follow the online instructions at that site for
submitting comments.
Mail, including floppy disks or CD-ROMs, and hand- or
courier-delivered items: Send to Docket Clerk, U.S. Department of
Agriculture (USDA), FSIS, Docket Clerk, Patriots Plaza 3, 355 E. Street
SW., 8-163A, Mailstop 3782, Washington, DC 20250-3700. Instructions:
All items submitted by mail or electronic mail must include the Agency
name and docket number FSIS-2011-0012. Comments received in response to
this docket will be made available for public inspection and posted
without change, including any personal information, to https://www.regulations.gov.
FOR FURTHER INFORMATION CONTACT: Dr. Daniel Engeljohn, Assistant
Administrator, Office of Policy and Program Development, FSIS, U.S.
Department of Agriculture, 1400 Independence Avenue SW., Washington, DC
20250-3700, (202) 720-2709.
SUPPLEMENTARY INFORMATION:
Background
On January 27, 2012, FSIS published a proposed rule,
``Modernization of Poultry Slaughter Inspection'' (77 FR 4408). In that
document, the Agency proposed a new inspection system for young chicken
and turkey slaughter establishments that would replace all of the
existing inspection systems except for traditional inspection. Key
elements of the proposed new inspection system 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) reducing the number of on-line carcass inspectors to
one; (3) permitting faster line speeds than are permitted under the
existing inspection systems; and (4) replacing the existing Finished
Product Standards (FPS) with a requirement that establishments that
operate under the new inspection system maintain records to document
that the products resulting from their slaughter operations meet the
definition of ready-to-cook poultry. In addition to the proposed new
inspection system, FSIS also proposed changes that would require, among
other things, that all establishments that slaughter poultry other than
ratites develop, implement, and maintain written procedures to prevent
contamination of carcasses and parts by enteric pathogens and fecal
material, and that they incorporate these procedures into their HACCP
plan or sanitation standard operating procedures (SOP) or other
prerequisite programs.
During the comment period for the proposal, FSIS officials met with
representatives from a coalition of consumer advocacy organizations and
two trade associations representing the poultry industry. The consumer
advocacy coalition and one of the trade associations had requested that
FSIS clarify certain aspects of the proposed rule to inform their
comments on the proposal. Because the issues addressed in these
meetings may be relevant to the development of comments from other
stakeholders, a brief summary of these issues and the Agency's response
are described below. The other trade association requested that FSIS
provide additional information on how the Agency intends to implement
the proposed new poultry inspection system. The groups submitted
written questions to the Agency to consider before each meeting. The
issues raised on implementation are summarized in a separate section of
this document that outlines and requests comments on how the Agency
plans to implement the final rule.
Summary of Issues Raised and FSIS Response
In addition to the questions outlined below, certain members of
consumer advocacy organizations requested that FSIS hold a public
technical meeting on the proposed rule. FSIS is clarifying certain
aspects of the proposed rule in this Federal Register notice and will
assess public understanding of the proposed rule in connection with its
review and evaluation of the comments submitted. The Agency will
provide any needed clarification if a final rule is adopted.
Following is a summary of the issues raised and FSIS's response.
[[Page 24874]]
1. Issues Raised by the Consumer Advocacy Coalition
Comment: Why does FSIS believe that it is preferable for plant
employees to sort carcasses?
FSIS response: Under the existing inspection systems, on-line
inspectors conduct activities that do not have a direct impact on
public health. If the proposal is finalized, and the establishment
conducts sorting activities, the only birds presented to the carcass
inspector (CI) would be those that are likely to pass inspection.
Therefore, the CI will be able to focus on food safety-related
activities, such as verifying that carcasses affected by septicemia or
toxemia or contaminated with visible fecal material do not enter the
chiller. For these reasons, the Agency is proposing to remove certain
on-line inspection activities that are not directly related to public
health.
Comment: Is there any guarantee that FSIS inspectors would be
performing more food safety-related activities under the proposed new
inspection system?
FSIS response: Yes, generally inspectors would be performing more
food safety-related activities. There are three important aspects of
the proposed rule that would allow FSIS inspectors to conduct more food
safety-related activities. First, because the on-line CI would not be
responsible for sorting carcasses for quality-related defects, the
amount of time that the CI spends focusing on food safety-related
activities would increase. Second, under the proposed new inspection
system, the offline verification inspector (VI) would primarily conduct
food safety-related activities, such as verifying compliance with HACCP
and sanitation SOP requirements and collecting product samples. Third,
because FSIS considers contamination by enteric pathogens and fecal
contamination to be hazards that are reasonably likely to occur, FSIS
is proposing to require that all establishments that slaughter poultry
have written programs to address sanitary dressing procedures, and
that, at a minimum, these procedures include microbiological testing at
pre-chill and post-chill to monitor process control. In addition to
conducting verification checks on carcasses, FSIS off-line inspectors
would be reviewing the establishment's records and test results to
verify that the establishment maintains process control.
Comment: What type of training would FSIS require for establishment
employees assigned to sort carcasses?
FSIS response: The proposed rule does not prescribe training for
establishment employees. However, as noted in the preamble to the
proposed rule, FSIS expects to convert the current instructions that it
provides to Agency inspectors into guidance for industry to use to
train plant sorters (77 FR 4419).
Comment: What would establishment employees be required to do as
part of their sorting activities?
FSIS response: Should the rule become final, establishment sorters
would be required to identify carcasses with septicemia/toxemia and
other condemnable conditions and to remove them from the line before
they reach the CI. Establishment employees would also need to conduct
trimming and re-processing before the birds reach the CI.
Comment: Will establishment employees need to look inside the bird
as part of their sorting responsibilities?
FSIS response: Septicemic/toxemic birds exhibit signs on the
outside of the carcass, so there is no need to look at the viscera. The
regulations that prescribe conditions for condemnation in 9 CFR 381.81-
381.93 would still apply. Establishment personnel would need to conduct
sorting activities to address these condemnable conditions before the
birds reach the CI. The conditions described in these regulations can
be readily identified by examining the outside of the carcass.
Lesions on the viscera do not require condemnation of the entire
carcass except for lesions associated with visceral leukosis. The
proposed rule provides for a 300-bird inspection of young chickens with
the viscera (77 CFR 4421-4422). If the inspector finds signs or
symptoms associated with visceral leukosis, then the entire flock would
be inspected for the disease. All growers vaccinate birds for visceral
leukosis. Therefore, it is seen only on rare occasions if the vaccine
fails.
Comment: How does the proposed rule address other consumer
protection (OCP) issues, such as digestive tract contents found on
products, that may affect internal parts of the carcass?
FSIS response: There is a difference between fecal material and
ingesta as digestive tract contents. We have no evidence to show that
ingesta carries the same microbes as fecal contamination. Under the
proposal, FSIS would enforce OCP processing defects that are associated
with digestive tract contents, other than fecal contamination, in
enforcing the ready-to-cook (RTC) poultry standard.
Comment: Where would the establishment's critical control point
(CCP) for visible fecal contamination be located?
FSIS response: FSIS does not prescribe where establishments must
locate CCPs. The CI would be located before the chiller. Visible fecal
contamination would need to be removed before the carcass is presented
to the CI. The VI would be conducting verification checks for fecal
contamination off-line. If the VI detects fecal contamination offline,
the plant has exceeded the zero tolerance for visible fecal
contamination.
The present inspection system is similar to the proposed system in
that there are inspectors located upstream, and zero tolerance is
enforced at a point at final wash, before the carcass enters the
chiller. However, under the proposed new system the CI is more likely
to observe visible fecal contamination because the carcasses would be
free from animal diseases and trim and processing defects.
Comment: Under the proposed rule, can FSIS take regulatory action
throughout the entire dressing process?
FSIS Response: The proposed rule would require that establishments
develop, implement, and maintain procedures to address contamination by
enteric pathogens and fecal material throughout the entire slaughter
and dressing process. Through inspection activities, FSIS would ensure
that the establishment's procedures are effective, and the Agency would
take appropriate regulatory action when necessary.
Comment: Would there be an approval process for the establishment's
procedures to prevent contamination with enteric pathogens and fecal
material?
FSIS response: There would be no pre-approval of an establishment's
procedures. However, establishments would need to ensure that their
procedures for preventing contamination are effective. To verify that
an establishment's procedures are effective, FSIS would consider: (1)
The microbiological data that the establishment would be required to
collect pre-chill and post-chill to demonstrate process control; (2)
presence of visible fecal contamination; and (3) FSIS sampling results
for Salmonella and Campylobacter.
Comment: What was the basis for the baseline sampling numbers
presented in the preamble to the proposed rule (74 FR 4442)?
FSIS response: The estimates for sampling come from the economic
analysis and reflect what we estimate to be the amount of sampling that
plants would conduct if the proposed rule is adopted by the Agency. We
are not proposing to prescribe how often establishments must test.
Establishments would need to determine the frequency and type of
sampling that would be sufficient to
[[Page 24875]]
demonstrate that they are maintaining process control.
Comment: Why is FSIS not mandating a frequency for testing?
FSIS response: As stated in the preamble to the proposed rule, FSIS
is proposing to require that an establishment's sampling frequency be
adequate to monitor the effectiveness of its process control for
enteric pathogens (77 FR 4428). The frequency with which establishments
would need to conduct such testing would depend on a number of factors,
including their production volume, the source of their flocks, their
slaughter and dressing process, and the consistency of their microbial
test results over time. Because the testing frequency would be an
integral part of an establishment's HACCP system verification
procedures, establishments would need to collect and maintain data to
demonstrate that their testing frequency is adequate to verify the
effectiveness of their process control procedures.
Comment: Why did the Agency propose two points for microbiological
testing instead of three?
FSIS response: As noted in the preamble to the proposed rule, FSIS
had considered requiring testing at three points in the process, i.e.,
re-hang, pre-chill and post-chill (77 FR 4428). The proposed rule
provides for testing at pre-chill and post-chill because the Agency
tentatively concluded that verification testing conducted at these two
points would provide the evidence establishments need to verify that
their process control measures are effective in preventing carcasses
from becoming contaminated with pathogens. In the preamble to the
proposed rule, the Agency explained that it considered requiring a
third verification test at the re-hang position to monitor the incoming
load of pathogens but tentatively decided that it was not necessary to
impose the additional costs that would be associated with testing at
this point (77 FR 4428). FSIS also considered requiring only one
verification test at any position along the production line to provide
maximum flexibility but concluded this approach may not be sufficient
to monitor the effectiveness of an establishment's procedures to
prevent contamination throughout the slaughter and dressing operation.
The Agency requests comments on these alternatives.
Comment: Can CI inspectors stop or slow the line?
FSIS response: If the CI observes a condemnable condition, either
food safety or generalized OCP condition requiring condemnation of the
entire carcass, the CI would be authorized to stop the line to prevent
such carcasses from entering the chiller. The CI would communicate the
findings to the VI and inspector-in-charge (IIC). The IIC would
consider available data to reset the line speed. Line speed would be
determined by IIC's assessment of the frequency of carcass defects
identified by the CI and the VI and the plant's control of its
processes.
Comment: Would offline inspectors be available to visually inspect
carcasses under the proposed new system.
FSIS response: The off-line VI would be checking carcasses to
verify that they do not contain food safety-related contamination or
defects.
Comment: How many HACCP verification activities would occur under
the new system versus the old system?
FSIS Response: HACCP and sanitation verification activities would
be a higher fraction of inspection activities under the proposed new
inspection system as the Agency reduces its focus on quality and other
OCP defects.
Comment: What is the relationship between the ready-to-cook (RTC)
poultry standard in the proposed rule and the existing Finished Product
Standards (FPS)?
FSIS response: Poultry products that comply with the FPS meet the
definition of RTC poultry under the existing regulations; i.e., they
are suitable for cooking without the need for further processing. The
FPS have been in place for many years and were used to inform the OCP
standards in the HIMP pilot. These OCP standards reflect OCP
performance in establishments before HIMP. Establishments operating
under HIMP maintained OCP defect levels that average about half the
corresponding OCP performance standards. Therefore, FSIS has determined
that it is not necessary to require that establishments operating under
the proposed new inspection system meet prescriptive OCP performance
standards in order to produce RTC poultry. Under the proposed rule,
establishments operating under the proposed new inspection system would
have the flexibility to implement the process controls that they have
determined would best allow them to produce RTC poultry.
Comment: What happens to the carcasses and parts that are rejected
by the plant?
FSIS response: All regulations that apply to condemned carcasses/
parts would still apply under the new inspection system, e.g.,
denaturing and diverting away from human food. The off-line VI would
verify that the plant is properly disposing of inedible and condemned
carcasses and parts.
Comment: For OCP defects under HIMP, there is a moving window in
which there is non-compliance if the plant exceeds OCP standards. What
about under the proposed rule?
FSIS response: The Agency is moving away from using the moving
window to meet OCP performance standards. Under the proposed rule,
establishments would determine how they would document that they are
producing RTC poultry. The Agency is not prescribing where or how
establishments would address OCP defects.
Comment: If establishments under the proposed new inspection system
are permitted to increase the line speed, would the CI continue to
detect problems?
FSIS response: Analysis of HIMP data shows that CIs are able to
detect fecal contamination and septicemia/toxemia at line speeds of up
to 175 birds per minute (bpm) for young chickens.
Comment: Did the Agency consider the effects of faster line speeds
on worker safety?
FSIS response: FSIS did consider potential effects on safety. The
Agency is prepared to address worker safety within the bounds of its
regulatory authority and will coordinate with the Occupational Safety
and Health Administration (OSHA) as the regulatory process moves
forward. The National Institute for Occupational Safety and Health
(NIOSH) study described in the proposed rule is a start to determine
what the current baseline performance indicators for worker safety in
plants are before an increase in line speeds. We will use the NIOSH
assessment tool and consider ways that we can supplement the NIOSH
study. We are interested in comments on the effects of line speed and
worker safety.
Comment: Why did the Agency propose to reduce the length of the CI
inspection station so that there is no room for a helper?
FSIS response: Helpers are necessary under the existing inspection
systems because the inspectors are sorting, and the birds have more
defects. The proposed rule does not preclude an establishment from
assigning a helper, but because the birds presented to the CI would
have fewer defects, there is no need for a helper. Therefore, under the
proposed rule, the requirement for the helper stand at the inspection
CI inspection station would be removed.
Comment: The Salmonella results in the HIMP report compare HIMP
plants with comparison plants. How many of the HIMP plants, and how
many of the comparison plants, had received
[[Page 24876]]
waivers for on-line reprocessing (OLR) in each year since the HIMP
pilot began? Is it possible that OLR was responsible for lower
Salmonella positive rates?
FSIS response: Before November 2011, FSIS did not track the date of
implementation of approved waivers for OLR systems. In November 2011,
all establishments with existing waivers were required to participate
in the Salmonella Initiative Project (SIP) or forfeit their waivers.
FSIS is able to track the dates that OLR waivers were implemented under
SIP. Based on information obtained under SIP, as of March 2011, 15 of
the 20 HIMP plants had waivers for OLR (75%), and 61 of the 64
comparison plants had waivers for OLR (95.3%).
2. Issues Raised by the Trade Association
Comment: Can FSIS clarify how visible fecal contamination would be
handled under the new poultry inspection system?
FSIS response: An important aspect of the proposed rule is the
provision that requires that all poultry establishments develop
procedures to prevent fecal contamination and contamination by enteric
pathogens throughout the entire process and not just cleaning up the
birds at the end of the process. These written procedures would need to
be incorporated into the HACCP system. Therefore, FSIS would not just
be checking at the end of the line to verify that the establishment's
procedures for preventing contamination are effective. FSIS would be
conducting verification activities throughout the entire process to
assess whether the process is in control, including proper
implementation and effective corrective actions. Findings of fecal
contamination throughout the process would indicate a lack of process
control. The proposed rule also requires that all poultry slaughter
establishments have procedures to prevent carcasses with visible fecal
contamination from entering the chiller, and that they incorporate
these procedures into their HACCP system. FSIS would consider these
procedures to be ineffective if a contaminated carcass entered the
chiller.
Comment: How were the line speeds referenced in the proposed rule
determined? Do you have any additional data on how maximum line speeds
for turkey plants were determined?
FSIS response: The line speeds were based on our experience under
HIMP. We are interested in comments and data on the proposed line
speeds.
Comment: What are the expectations for validation under the
proposed rule, particularly for the proposed changes to the time and
temperature chilling requirements?
FSIS response: The validation requirement under the proposed rule
would be the same as what is required under the existing regulations (9
CFR 417.4(a)). There would not be any special validation requirement
under the new poultry slaughter rule.
Comment: Should establishments continue to apply for SIP waivers if
they are interested in pursuing new technologies in their slaughter
operations, or should they wait until FSIS issues a final rule on the
new poultry inspection system?
FSIS response: Establishments should continue to request waivers of
regulations that impact slaughter operations, such as OLR and
alternative chilling procedures, if they are interested in operating
under such waivers. Existing SIP waivers would continue until FSIS
implements the final rule. If a waiver is not addressed in any final
rule resulting from this proposal, then it would remain in effect until
another final rule is published.
Comment: What is pre-chill? When would the pre-chill testing occur?
Is post-chill testing supposed to be conducted after the final
intervention?
FSIS response: Pre-chill occurs just before the chilling operation,
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 chilling operation. Therefore, pre-chill testing should be
conducted before the chiller, at the end of the evisceration process.
Post-chill testing would be at the same point in the process as it is
now for FSIS Salmonella and Campylobacter verification testing, that
is, after all interventions.
Comment: What would the parameters for faster or slower line speeds
be?
FSIS response: The on-line inspector would be authorized to stop
the line to prevent adulterated carcasses from entering the chiller.
The IIC would be authorized to slow the line. This is the same as in
current HIMP and non-HIMP establishments. The on-line CI and off-line
VI would communicate and inform the IIC if they observe excessive food
safety or non-food safety- related defects, and the IIC would assess
the need to reduce the line speed or take other appropriate measures.
Comment: If the final rule becomes effective, would plants be able
to start running at the faster line speeds right away or would there be
a gradual increase in line speeds?
FSIS response: To operate at faster line speeds, plants would need
to comply with all of the requirements in any final rule that results
from this rulemaking. The establishment's maximum line speed would
depend on the ability of the establishment to maintain process control,
and whether conditions are affecting the ability of the CI to properly
inspect.
Implementation of the Proposed New Inspection System
1. Proposed Implementation Approach
In the preamble to the proposed rule, FSIS invited interested
persons to submit comments on how the Agency should implement the new
poultry inspection system if it finalizes the proposed rule. The Agency
specifically requested comment on whether it should phase-in the
implementation of the final rule to provide additional time for small
and very small establishments to adjust their operations to comply with
the new requirements (77 FR 4408). The Agency also requested comments
on how it can make the phased implementation most effective. In this
document, FSIS is providing additional information on how it intends to
implement the new poultry inspection system to solicit more focused
comments on this issue.
The Agency has tentatively decided that if it finalizes the
proposed rule, it would then 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 are interested in
operating under the proposed new inspection system. Those
establishments that choose to operate under the new inspection system
would then inform the Agency concerning when they wish to begin
implementing the new inspection system in their facilities. The Agency
is considering giving establishments six months to decide whether they
would operate under the new inspection system and up to 3 years to
switch to the new system. FSIS requests comments on this proposed
implementation approach and the proposed time periods.
2. Issues Raised on Implementation
Comment: How would the district offices direct their resources to
implement the final rule?
FSIS response: The FSIS implementation plan would be coordinated
from headquarters through the districts to ensure resource availability
and fair and equitable
[[Page 24877]]
implementation across all interested establishments.
Comment: Does the Agency anticipate making additional resources
available to implement a final rule, even if only on a temporary basis?
FSIS response: As discussed in the preamble to the proposed rule,
there would be two consumer safety inspector (CSI) positions for every
slaughter evisceration line assigned to establishments that choose to
adopt the new poultry slaughter inspection system, one CI and one VI
(77 FR 4421-4422). This represents a reduction in the number of
inspectors because under the existing system, inspectors conduct
sorting activities. At this time, the Agency does not anticipate that
additional resources would be needed to implement the new poultry
inspection system but would make additional resources available, such
as guidance for industry and training to FSIS inspectors, as needed to
ensure smooth implementation of the final rule.
Comment: In the preamble to the proposed rule, the Agency estimated
that 219 poultry slaughter establishments would choose to operate under
the proposed new inspection system. How does the Agency intend to
implement the proposed new system in all 219 establishments in a smooth
and fair manner?
FSIS Response: The Agency is interested in comments on the
implementation phase-in and would use comments to inform implementation
planning, including strategies for recruitment, staffing, training, and
other actions needed to ensure FSIS readiness to implement the proposed
rule in an efficient and fair manner. The Agency intends to begin
implementing the proposed NPIS when it finalizes the rule. However,
implementation would not take place at all eligible plants at the same
time. It would be phased in over time to ensure proper FSIS inspection
force readiness to successfully implement the new system.
Comment: How does the Agency intend to train inspectors in the new
inspection system and familiarize them with the new requirements?
FSIS response: Inspectors assigned to work in poultry slaughter
establishments converting to the proposed new inspection system would
receive training on the new system before the establishments they are
assigned to convert to the new system. The Agency is considering
various approaches to ensure effectiveness and uniformity in its
workforce training.
Comment: Is the Agency planning to provide any type of standardized
programs to assist in training the establishment sorters in disease
recognition and disposition for trimmable defects or is this
responsibility being left up to the establishments?
FSIS response: As noted in the preamble to the proposed rule, FSIS
plans to convert the current instructions that it provides to Agency
inspectors into guidance for industry to use to train plant sorters.
Comment: Does the Agency anticipate developing a framework by which
establishments or inspectors can receive quick and consistent
clarification on requirements or feedback on inspectional decisions
from headquarters?
FSIS response: The Agency would continue to provide technical
support to its workforce and industry through its standard channels.
For example, FSIS would continue to encourage referring questions to
its Policy Development Division through askFSIS at https://askfsis.custhelp.com or by telephone at 1-800-233-3935. The Agency
would develop appropriate instructions to inspectors as well as
appropriate compliance guides.
Worker Safety Issues
FSIS's direct legal authority with respect to regulating working
conditions extends only to inspection personnel. The Department of
Labor's OSHA is the lead Federal agency responsible for establishment
worker safety issues. However, FSIS recognizes the importance of
establishment worker safety and is interested in additional information
about the potential intersection of increased line speeds and worker
safety.
As noted in the preamble to the proposed rule, FSIS has asked NIOSH
to evaluate the effects of increased line speed by collecting data from
one to five non-HIMP plants that requested waivers from line speed
restrictions under the Salmonella Initiative Project (SIP) (77 FR
4422). NIOSH expressed its willingness to evaluate the effects of
increased production volume on employee health, with a focus on
musculoskeletal disorders and acute traumatic injuries. NIOSH will
prepare a report based on its findings of short-, intermediate-, and
long-term effects from the process modifications. We expect that the
NIOSH report will also make recommendations to the Agency as
appropriate. FSIS, in collaboration with OSHA, will consider the
available data on employee effects collected from NIOSH activities when
implementing the final rule resulting from the proposal.
To facilitate further evaluation of this issue, FSIS requests
specific comments on the effects of increased line speeds and
production volume on worker safety. The Agency is particularly
interested in comments on the availability of records or studies that
contain data that NIOSH may be able to use to assist the Agency in
analyzing the effects of increased line speed on the safety and health
of employees throughout the establishment, including effects prior to
and following the evisceration line. The Agency is interested in the
availability of records and studies that include documentation on
employees' work, injuries, and illnesses, as well as plant production,
both before and after establishments made changes to their operations
to increase production volume. Such records and studies include, but
are not limited to:
Human resources and payroll data for all employees on
hours worked per year, department, job title, hire date, separation
date, and position responsibilities;
OSHA logs, workers' compensation claims, first reports of
injury or illness, dispensary logs and records, and other injury or
illness narratives for all employees; and
Daily production hours;
Results of ergonomic or industrial engineering studies,
such as time-and-motion analyses that document the actual pace of work
or physical stresses on workers; and
Any self-assessments of worker safety conducted by
establishments.
Comments on this issue should describe the type of data available,
whether the data are available in an electronic or paper format, where
the records are maintained, (e.g., at the establishment or at corporate
headquarters), and any other information that can be used to assess the
utility of the data. The comments should provide information, including
contact information, on how FSIS or NIOSH can gain access to the data
or studies.
In addition, FSIS will continue its collaboration with NIOSH and
OSHA, developing guidance materials on measures that establishments
could adopt and implement to promote and better ensure worker safety.
To facilitate the development of such guidance, FSIS requests comments
on best practices and other measures that establishments can take to
protect workers throughout the plant, including possible protective
factors such as increasing the size of the workforce, rotating
assignments, increased automation, or improved tools and techniques.
[[Page 24878]]
Additional Public Notification
FSIS will announce the availability of this Federal Register notice
on-line through the FSIS Web page located at https://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.
FSIS also will make copies of this Federal Register publication
available through the FSIS Constituent Update, which is used to provide
information regarding FSIS policies, procedures, regulations, Federal
Register notices, FSIS public meetings, and other types of information
that could affect or would be of interest to our constituents and
stakeholders. The Update is communicated via Listserv, a free email
subscription service consisting of industry, trade, and farm groups,
consumer interest groups, allied health professionals, scientific
professionals, and other individuals who have requested to be included.
The Update also is available on the FSIS Web page. Through Listserv and
the Web page, FSIS is able to provide information to a much broader,
more diverse audience.
In addition, FSIS offers an email subscription service which
provides automatic and customized access to selected food safety news
and information. This service is available at https://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.
Done in Washington, DC on April 23, 2012.
Alfred V. Almanza,
Administrator.
[FR Doc. 2012-10111 Filed 4-25-12; 8:45 am]
BILLING CODE 3410-DM-P