[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49048-49060]
From the Federal Register Online via the Government Publishing Office [www.gpo.gov]
[FR Doc No: 2018-21143]


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Notices
                                                Federal Register
________________________________________________________________________

This section of the FEDERAL REGISTER contains documents other than rules
or proposed rules that are applicable to the public. Notices of hearings
and investigations, committee meetings, agency decisions and rulings,
delegations of authority, filing of petitions and applications and agency
statements of organization and functions are examples of documents
appearing in this section.

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Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 /
Notices

[[Page 49048]]



DEPARTMENT OF AGRICULTURE

Food Safety and Inspection Service

[Docket No. FSIS-2018-0014]


Petition To Permit Waivers of Maximum Line Speeds for Young
Chicken Establishments Operating Under the New Poultry Inspection
System; Criteria for Consideration of Waiver Requests for Young Chicken
Establishments To Operate at Line Speeds of Up to 175 Birds per Minute

AGENCY: Food Safety and Inspection Service, USDA.

ACTION: Response to comments and information on waiver criteria.

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SUMMARY: The Food Safety and Inspection Service (FSIS) is responding to
public comments on a petition submitted by the National Chicken Council
(NCC) on September 1, 2017, and is also providing information on the
criteria applicable to line speed waivers for young chicken
establishments. The NCC submitted a petition to FSIS requesting that
the Agency establish a waiver program to permit young chicken slaughter
establishments to operate without line speed limits if they participate
in the New Poultry Inspection System (NPIS) and the FSIS Salmonella
Initiative Program (SIP) and develop a system for monitoring and
responding to loss of process control. FSIS issued a response denying
the petition on January 29, 2018. The response explained that instead
of establishing a separate line speed waiver program under the
conditions requested in the petition, FSIS would make available
criteria that it will use under its existing waiver procedures to
consider individual waiver requests from young chicken establishments
to operate at line speeds of up to 175 bpm.
    FSIS published these criteria in the February 23, 2018, Constituent
Update. This notice provides additional information on the criteria
that FSIS will use to evaluate new line speed waiver request
submissions. Additionally, FSIS is announcing that the 20 young chicken
establishments already operating under line speed waivers must meet the
new criteria to remain eligible for the waiver. FSIS will issue these
establishments new waiver letters that reflect the eligibility criteria
described in this document. Failure by establishments already operating
under line speed waivers to meet the new criteria within 120 days of
receipt of these letters may result in the revocation of the waivers.

FOR FURTHER INFORMATION CONTACT: Roberta Wagner, Assistant
Administrator, Office of Policy and Program Development, FSIS, USDA;
Telephone: (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Background

    On August 24, 2014, FSIS published a final rule that, among other
things, established the NPIS as an additional inspection system for
young chicken and all turkey slaughter establishments (79 FR 49566).
The NPIS did not replace FSIS's other poultry slaughter inspection
systems, and young chicken and turkey slaughter establishments that do
not choose to operate under the NPIS may continue to operate under
their current inspection system.\1\ Under the inspection systems other
than the NPIS, FSIS online inspectors positioned along the slaughter
line 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 and reprocessing. The maximum line speeds
authorized under these inspection systems reflect the time it takes for
an inspector to effectively perform the online carcass inspection
procedures required for the system. The fastest line speed authorized
for a non-NPIS young chicken inspection system is 140 birds per minute
(bpm) with four online inspectors, i.e., 35 bpm per inspector, under
the Streamlined Inspection System (SIS) for young chickens.
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    \1\ Poultry slaughter inspections systems other than the NPIS
include the Streamlined Inspection System (SIS), New Line Speed
Inspection System (NELS), the New Turkey Inspection System (NTIS),
and Traditional Inspection.
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    Under the NPIS, establishment employees sort carcasses and remove
unacceptable carcasses and parts before the birds are presented to an
online inspector located at the end of the line before the chiller.
Because the online inspector under the NPIS is presented with carcasses
that have been sorted, washed, and trimmed by establishment employees,
and are thus much more likely to pass inspection, the inspector is able
to conduct a more efficient and effective online inspection of each
bird processed.
    The NPIS was informed by the Agency's experience under the Hazard
Analysis and Critical Control Point (HACCP)-Based Inspection Models
Project (HIMP) pilot study. FSIS's experience under the HIMP pilot
showed that online inspectors in HIMP young chicken establishments were
able to conduct an effective online inspection of each carcass when
operating at a line speed of up to 175 bpm and that HIMP establishments
were able to maintain process control at the line speeds authorized
under HIMP. Based on FSIS's experience under HIMP, the Agency initially
proposed 175 bpm as the maximum line speed for NPIS young chicken
establishments (77 FR 4408). However, after considering the public
comments submitted on the proposed rule, FSIS concluded that it was
important to assess young chicken establishments' ability to maintain
process control as they implement changes to operate under the NPIS (79
FR 49591). Therefore, the final rule that established the NPIS provided
for a maximum line speed of 140 bpm for young chicken establishments,
instead of 175 bpm as was proposed, with an exception for the 20 young
chicken establishments that participated in the HIMP pilot study.
    In the preamble to the final rule, FSIS explained that it decided
to grant waivers to the 20 young chicken HIMP establishments to permit
them to continue to operate at lines speeds of up to 175 bpm after they
convert to NPIS because data from the HIMP pilot demonstrated that
these establishments were capable of consistently producing safe,
wholesome and unadulterated product and meeting pathogen reduction and
other performance standards when operating under line speeds authorized
under HIMP (79 FR 49591). The preamble to the final rule

[[Page 49049]]

also explained that if an NPIS establishment operating under a line
speed waiver goes out of business or decides to give up its waiver,
FSIS will select another establishment to take its place (79 FR 49583).
Thus, when it published the final rule, FSIS planned to continue to
provide waivers for up to 20 young chicken establishments to operate at
up to 175 bpm under the NPIS.
    In the preamble to the final rule, FSIS also explained that
``[a]fter 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' [other consumer protection]
performance, and other relevant factors'' (79 FR 49591). The preamble
also stated that ``once the NPIS is fully implemented at most
establishments, data from these establishments can be used to compare
against data from the [former HIMP] young chicken establishments
operating under the [line speed] waivers'' (79 FR 49591). Thus, when
FSIS published the final rule establishing NPIS, it made clear that the
Agency would continue to consider line speeds at which establishments
are capable of consistently producing safe, wholesome, and
unadulterated product and are meeting pathogen reduction and other
performance standards.

National Chicken Council Petition and FSIS Response

    Petition. On September 1, 2017, NCC petitioned \2\ FSIS to
implement a waiver system to exempt young chicken slaughter
establishments from the regulation that prescribes 140 bpm as the
maximum line speed under the NPIS (9 CFR 381.69(a)). As conditions for
the waiver, the petition requested that establishments be required to
opt into the NPIS, participate in SIP,\3\ and develop a system for
monitoring and responding to loss of process control. According to the
petition, the 140 bpm maximum line speed for the NPIS has deterred many
young chicken establishments from opting into the NPIS. The petition
stated that FSIS has the authority to implement such a wavier program
under 9 CFR 381.3(b), which provides that ``[t]he Administrator may, in
specific cases, waive for limited periods . . . any provision of the
regulations . . . to permit experimentation so that new procedures,
equipment, and processing techniques may be tested to facilitate
definite improvements: Provided, [t]hat such waivers . . . are not in
conflict with the purposes or provisions of the [Poultry Products
Inspection Act (PPIA)].''
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    \2\ NCC petition available at: https://www.fsis.usda.gov/wps/wcm/connect/7734f5cf-05d9-4f89-a7eb-6d85037ad2a7/17-05-Petition-National-Chicken-Council-09012017.pdf?MOD=AJPERES.
    \3\ Under SIP, FSIS grants establishments a waiver of the
regulation under the condition that the establishment collects and
analyzes samples for microbial organisms and shares the results with
FSIS.
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    The petition asserted that the requested waiver program will
encourage more establishments to opt into the NPIS and will promote and
enhance Agency and industry efficiency without compromising food
safety, worker safety, or animal welfare. The petition referenced
information from the 2011 HIMP pilot study,\4\ a 2001 published study,
a report from the Department of Labor (DOL) Bureau of Labor Statistics
(BLS), and an unpublished industry survey conducted by NCC in 2017 to
support the requested action. The petition also stated that the current
line speed regulation imposes costs on the industry, creates
competitive disparities among U.S. poultry establishments, and places
U.S. poultry establishments at a competitive disadvantage with
international competitors. The petition said that allowing
establishments to operate without line speed limits is consistent with
Executive Order (E.O.) 13771 on ``Reducing Regulation and Controlling
Regulatory Costs.''
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    \4\ The 2011 HIMP Report is available at: https://www.fsis.usda.gov/wps/wcm/connect/fcd9ca3e-3f08-421f-84a7-936bc410627c/Evaluation_HACCP_HIMP.pdf?MOD=AJPERES.
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    Consistent with its regulations on petitions, FSIS posted the NCC
petition on the FSIS website and received comments from interested
persons on the petition (9 CFR 392.6 and 392.7). FSIS also announced
the availability of the petition in the October 13, 2017, Constituent
Update \5\ and explained that, based on communications with
stakeholders, the Agency anticipated that it would receive a
significant number of additional comments on the petition. Therefore,
to facilitate submission and public posting of comments on the
petition, FSIS announced that interested persons could submit comments
online through the Federal eRulemaking Portal at: https://www.regulations.gov. Comments were accepted online until December 13,
2017, and FSIS considered all timely comments on the petition as part
of its review of the petition (9 CFR 392.7).
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    \5\ The October 13, 2017 Constituent Update is available at:
https://www.fsis.usda.gov/wps/wcm/connect/a54d5331-372e-4df3-ac4d-8c2953969039/ConstiUpdate101317.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=a54d5331-372e-4df3-ac4d-8c2953969039.
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    FSIS Response to Petition. On January 29, 2018, FSIS sent a
response to the NCC denying the petition.\6\ In its response, FSIS
explained that it had decided to deny the petition because the Agency
already has detailed procedures for the submission of new technology
notifications and protocols and requests for waivers from regulatory
requirements. The response noted that these procedures include a
process for submitting requests for the use of alternative procedures,
such as faster line speeds, that would require regulatory waivers under
the SIP. The response further stated that because FSIS has already
implemented procedures for establishments to request regulatory
waivers, the Agency determined that it was not necessary to establish a
separate system to provide line speed waivers to young chicken
establishments operating under the NPIS.
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    \6\ FSIS's January 29, 2018, response to the petition is
available at: https://www.fsis.usda.gov/wps/wcm/connect/235092cf-e3c0-4285-9560-e60cf6956df8/17-05-FSIS-Response-Letter-01292018.pdf?MOD=AJPERES.
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    In addition to denying the request to establish a line speed waiver
program, the January 2018 response also stated that FSIS was denying
NCC's request to permit waivers that would allow NPIS young chicken
establishments to operate without a maximum line speed. As noted in the
response, the preamble to the final rule that established the NPIS
stated that, based on its experience under the HIMP pilot, FSIS found
that inspectors are able to conduct an effective online inspection of
each carcass at line speeds of up to 175 bpm (79 FR 49592). The
response noted that the petition did not include data to demonstrate
that online inspectors can conduct an effective carcass-by-carcass
inspection at line speeds faster than those authorized under HIMP.
    In addition to denying the petition, the response noted that FSIS
now has over a year of documented process control history for many
young chicken establishments operating under the NPIS. The response
explained that based on this history, FSIS has decided to consider
requests for waivers from young chicken establishments in addition to
the current 20 HIMP establishments, to operate at line speeds of up to
175 bpm. The response also explained that in the near future, FSIS

[[Page 49050]]

intends to make available criteria that it will use to consider these
waiver requests.

Criteria for FSIS To Consider Line Speed Waivers

    On February 23, 2018, in the Constituent Update, FSIS announced the
criteria that the Agency will use to consider requests from NPIS young
chicken slaughter establishments to operate at line speeds of up to 175
bpm and outlined the submission requirements.\7\ As provided in that
document, to be eligible for a line speed waiver, a young chicken
establishment:
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    \7\ The February 23, 2018, Constituent Update is available at:
https://www.fsis.usda.gov/wps/wcm/connect/ee977696-7f87-4b87-8717-15a824ce0a81/ConstiUpdate022318.pdf?MOD=AJPERES&CONVERT_TO=url&CACHEID=ee977696-7f87-4b87-8717-15a824ce0a81.
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     Must have been operating under the NPIS for at least one
year, during which time it has been in compliance with all NPIS
requirements;
     Must be in Salmonella performance standard category 1 or 2
for young chicken carcasses;
     Must have a demonstrated history of regulatory compliance.
More specifically, the establishment has not received a public health
alert \8\ for the last 120 days; has not had an enforcement action as a
result of a Food Safety Assessment (FSA) conducted in the last 120
days; and has not been the subject of a public health related
enforcement action in the last 120 days; and
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    \8\ This refers to a public health alert issued through the
Public Health Information System for non-compliance with public
health regulations (see FSIS Notice 15-08, Public Health Regulations
and Alerts for Use in Determining Inspection Program Personnel
Actions and Public Health Risk Evaluation Scheduling in Meat and
Poultry Establishments (March 20, 2018)).
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     Must be able to demonstrate that the new equipment,
technologies, or procedures that allow the establishment to operate at
faster line speeds will maintain or improve food safety.
    In addition to outlining the criteria that FSIS will consider to
determine whether to grant a line speed waiver, the February 23, 2018
Constituent Update also describes the documentation that establishments
will need to include with their waiver request submissions. As stated
in the Constituent Update, the waiver request submission will need to
include documentation that:
     Provides details about the establishment's HACCP system,
including how the establishment addresses the inhibition and reduction
of Salmonella;
     Demonstrates that the establishment has effective process
control by submitting one year of microbial data, methodology for
evaluating that microbial data (e.g., indicator organism data in a
process control chart identifying upper and lower control limits),
correlation of that microbial data to the establishment's sanitary
dressing process control data, correlation of that microbial data to
FSIS's Salmonella data, and interventions to address seasonality;
     Describes how existing or new equipment, technologies, or
procedures will allow for the operation at a faster line speed (e.g.,
descriptions or names of the equipment, line configuration, and
verification activities that will be used);
     Provides support on how the increased line speed will not
negatively impact FSIS employee safety nor interfere with inspection
procedures (e.g., information about safety protocols or line
configuration);
     Supports how the modifications to its food safety system
to operate at the faster line speed will maintain or improve food
safety (e.g., a statement that explains how the new equipment will
provide the same as or cleaner evisceration processes, or how an
improved line configuration will continue to prevent cross
contamination); and
     Indicates the type of records that will be maintained in
the new process, including the collection of information that will
assist FSIS in performing appropriate rule-making analysis (e.g.,
laboratory results, weekly or monthly summary production reports, or
evaluations from inspection program personnel).
    Because FSIS intends to use the data collected from young chicken
establishments to evaluate their ability to maintain process control at
higher line speeds, the Constituent Update explained that the Agency
will limit the additional line speed waivers to establishments that
have the ability and intend to operate at line speeds higher than 140
bpm.
    In addition, after reviewing comments submitted in response to the
NCC petition, FSIS is adding compliance with good commercial practices
(GCPs) to the criteria that the Agency will use to consider line speed
waiver requests submitted by NPIS young chicken slaughter
establishments. The regulations require that poultry be slaughtered in
accordance with GCPs, in a manner that will result in thorough bleeding
of the poultry carcass and will ensure that breathing has stopped
before scalding (9 CFR 381.65(b)). In a Federal Register notice
published on September 28, 2005, FSIS explained 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).
    If an establishment is not following GCPs, and birds are dying
other than by slaughter, FSIS inspection program personnel (IPP) will
document a non-compliance record (NR) citing 9 CFR 381.65(b). If birds
are being mistreated, but can still be fully bled and are not breathing
when they enter the scalder, IPP are instructed to discuss the
mistreatment with the establishment and document the discussion and any
planned action by the establishment in a Memorandum of Interview (MOI).
IPP will forward a copy of the MOI to the FSIS District Veterinary
Medical Specialist (DVMS) for review (FSIS Directive 6100.3, Ante-
Mortem and Post-Mortem Poultry Inspection, April 11, 2011).
    As discussed below, some comments raised issues related to line
speeds for NPIS young chicken establishments and compliance with GCPs.
Under all poultry inspection systems, including the NPIS,
establishments are required to slaughter poultry in accordance with
GCPs. Therefore, in addition to the criteria described above, the
Agency will consider compliance with GCPs as part of an establishment's
demonstrated history of regulatory compliance. Thus, consistent with
the above regulatory compliance criteria, to be eligible for a line
speed waiver, establishments must also have not had an NR for violation
of GCPs (9 CFR 381.65(b)) in the past 120 days.
    Finally, FSIS also will be requiring establishments with line speed
waivers to conduct daily Aerobic Plate Count (APC) testing, instead of
weekly testing for indicator organisms, and to make the results
available to FSIS. This testing will provide additional data for
consideration by FSIS when it determines whether rulemaking for young
chicken slaughter line speeds is supported.

Conditions for Operating Under a Waiver and FSIS Verification

    Establishments that are eligible for a line speed waiver and that
have assembled the documentation that needs to be included in their
waiver request described above should submit their line speed waiver
requests to the FSIS Office of Policy and Program Development (OPPD)
Risk Innovations and Management Staff (RIMS). After FSIS receives a
line speed waiver request, the Agency will follow the

[[Page 49051]]

procedures in FSIS Directive 5020.2, The New Technology Review Process
(October 24, 2017), to verify that the establishment meets the criteria
to be eligible for the waiver and to evaluate the establishment's
waiver request submission.
    As noted in the Constituent Update, if an establishment is granted
a waiver, RIMS will provide the establishment with a waiver letter that
specifies the required conditions for operating under the waiver. To
ensure consistency in data collection and analysis, when FSIS issues
the waiver letter, the Agency will also include a template for the
establishment to use to record and report to FSIS the data that the
establishment will be required to collect as a condition for its
waiver. This template will provide for the reporting of data on the
daily Aerobic Plate Count (APC) testing described above. FSIS will
require that all young chicken establishments with line speed waivers
use the template to submit their data to facilitate data aggregation
and analysis.
    As also noted in the Constituent Update, one of the conditions for
operating under a line speed waiver will be that establishments notify
the FSIS inspector-in-charge (IIC) when they are operating at line
speeds higher than 140 bpm and when they reduce their line speeds to
140 bpm or below to allow FSIS to evaluate the establishment's ability
to maintain process control at a given line speed. Young chicken
establishments that are granted a line speed waiver will routinely need
to operate at least one line at speeds above 140 bpm on average, but
not higher than 175 bpm. Establishments with multiple lines may operate
more than one line above 140 bpm and up to 175 bpm, but if they do,
they will need to collect separate data for each individual line. While
FSIS recognizes that establishments may need to occasionally reduce
line speed during the course of operations, the average speed for each
line used to collect data under the waiver will need to be higher than
140 bpm. Establishments consistently unable to maintain process control
at line speeds higher than 140 bpm or consistently operating at line
speeds lower than 140 bpm will be subject to waiver revocation.
    Consistent with the waivers granted to the 20 HIMP young chicken
establishments to operate at up to 175 bpm, any additional NPIS
establishments that are granted a line speed waiver will need to
participate in the SIP as a condition of their waivers. Under the SIP,
FSIS grants establishments a waiver of a regulation with the condition
that the establishment collects and analyzes samples for microbial
organisms including both Salmonella and indicator organisms, and shares
the results with FSIS. As discussed above, FSIS will require
establishments with line speed waivers to conduct daily APC testing,
instead of weekly testing for indicator organisms, as a condition of
their waivers. Establishments operating under a line speed waiver will
need to identify the line speed they were operating under when they
collected the microbial data required under the SIP and include the
line speed when they submit their SIP data to FSIS. FSIS intends to use
a six-month moving window approach to determine the establishment's
average line speed based on the line speeds recorded as part of the SIP
data.
    In addition to participating in the SIP, young chicken
establishments that have been granted a line speed waiver will need to
continue to meet the criteria outlined in the February 23, 2018,
Constituent Update described above to remain eligible for a waiver. The
Agency will follow the procedures in FSIS Directive 5020.1,
Verification Activities for the Use of New Technology in Meat and
Poultry Establishments, and Egg Products Plants (October 6, 2016), to
verify that establishments that have been granted waivers remain
eligible for their waivers and are following the process control
procedures agreed to as a condition for the waivers.
    Under Directive 5020.1, FSIS IPP verify, among other things, that
the establishment is effectively implementing its process control
procedures as documented in its waiver letter and collecting SIP
microbial data to monitor its ability to maintain process control. IPP
will review the results of the establishment's microbial sampling
program and verify that the establishment takes appropriate corrective
actions in response to its testing results, including slowing the line
when needed to maintain process control.
    Additionally, FSIS will review the results of the Agency's
Salmonella sampling to verify that the establishment continues to meet
the performance standards for Category 1 or 2 for young chicken
carcasses when operating at faster line speeds. FSIS will also evaluate
process control by reviewing the results of the Agency's 10-bird
offline verification checks to verify that the establishment is meeting
the zero tolerance standard for fecal contamination and septicemia/
toxemia, and that it is not producing product with persistent,
unattended non-food safety trim and processing defects when operating
at higher line speeds.
    Directive 5020.1 provides that FSIS may revoke a waiver of
regulatory requirements when an establishment fails to meet or follow
its alternative procedures associated with the waiver. Thus, if FSIS
finds that an establishment that has been granted a line speed waiver
is unable to meet the conditions of its waiver agreement, the Agency
will consider whether to allow the establishment to implement
corrective actions and resume operating under the waiver or whether the
waiver needs to be revoked. If the waiver is revoked, the establishment
will be required to comply with the 140 bpm maximum line speed for the
NPIS (9 CFR 381.69(a)).
    FSIS currently posts a table of all establishments that have been
granted regulatory waivers under the SIP on the FSIS website at:
https://www.fsis.usda.gov/wps/wcm/connect/188bf583-45c9-4837-9205-37e0eb1ba243/Waiver_Table.pdf?MOD=AJPERES. The 20 former HIMP young
chicken establishments now operating under the NPIS that have been
granted line speed waivers are included in the table. These
establishments are the only NPIS young chicken establishments that have
been granted line speed waivers under the SIP. FSIS intends to update
this table if the Agency grants additional SIP waivers or revokes
existing waivers.

Former HIMP Young Chicken Establishments' Line Speed Waivers

    As noted above, when FSIS implemented the NPIS, the Agency granted
waivers to allow the 20 young chicken establishments that participated
in the HIMP pilot to operate at line speeds up to 175 bpm after they
converted to the NPIS because data from the HIMP pilot showed that
these establishments were able to maintain process control when
operating at the line speeds authorized by HIMP (79 FR 49591). A
preliminary review of the SIP data that these establishments have
submitted to FSIS as a condition of their waivers shows that most of
them have operated at line speeds higher than 140 bpm since they
converted to the NPIS, and over half report that they have operated
between 170 and 175 bpm. Thus, the data collected under these waivers
has allowed FSIS to continue to evaluate the ability of the former HIMP
young chicken establishments to maintain process control when operating
at higher line speeds after they convert to the NPIS.
    As discussed above, FSIS now has over a year of documented process
control history for many young chicken

[[Page 49052]]

establishments operating under the NPIS.\9\ Therefore, the Agency
intends to consider additional waiver requests to allow NPIS young
chicken establishments that meet the criteria described above to
operate at line speeds of up to 175 bpm. FSIS intends to use the data
collected from young chicken establishments that are granted these
additional waivers, along with data collected from the 20 former young
chicken HIMP establishments that have been granted waivers, to assess
the ability of NPIS establishments to maintain process control at
higher line speeds and to inform future rulemaking, if supported.
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    \9\ As of August 21, 2018, 67 young chicken establishments were
operating under the NPIS, including the 20 former HIMP
establishments.
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    So that the data collected from all NPIS establishments with line
speed waivers will be comparable, the 20 former HIMP young chicken
establishments granted line speed waivers and establishments applying
for new line speed waivers will have to meet the new, additional line
speed waiver criteria. FSIS intends to issue new waiver letters
containing the eligibility criteria described above to the 20 former
HIMP establishments and grant them 120 days from receipt to meet the
criteria. If an establishment is unable to meet any of the criteria
within 120 days of receipt, FSIS may revoke its line speed waiver.

Comments

    As noted above, FSIS made the NCC petition available to the public
on the FSIS website and the Federal eRulemaking Portal at https://www.regulations.gov. FSIS received over 100,000 comments and signatures
on the NCC petition, most of them identical comments or form letters
submitted as part of organized write-in campaigns. FSIS received
comments from poultry slaughter establishments and their employees,
companies that own poultry slaughter establishments, trade associations
representing the poultry industry, consumer advocacy organizations,
animal welfare advocacy organizations, worker advocacy organizations,
civil rights advocacy organizations, environmental advocacy
organizations, labor unions, members of Congress, poultry establishment
employees, and individuals. The comments also included a petition from
an animal welfare advocacy organization with over 53,000 signatures and
a petition from a consumer advocacy organization with over 17,000
signatures. FSIS also received approximately 7,900 identical postcards
from individuals employed by poultry slaughter establishments urging
the Agency to deny the petition. In addition, several employees from
various poultry slaughter companies submitted comments on company
letterhead in support of the petition.
    Comments from poultry slaughter establishments and their employees,
companies that own poultry slaughter establishments, trade associations
representing the poultry industry, and a few individuals supported
granting the petition. Comments from consumer advocacy organizations,
animal welfare advocacy organizations, worker advocacy organizations,
civil rights advocacy organizations, labor unions, members of Congress,
poultry establishment employees, and several individuals urged FSIS to
deny the petition. All of the comments submitted in response to
organized write-in campaigns urged FSIS to deny the petition.
    A summary of the general issues raised by the comments received in
response to the NCC petition and FSIS's responses are presented below.
Several of the issues have been addressed by FSIS's denial of the NCC
petition.

Support for Petition

    Comment: Poultry slaughter establishments, companies that own
poultry slaughter establishments, and trade associations representing
the poultry industry said that granting the NCC petition would enhance
FSIS inspection procedures and increase industry efficiency while
ensuring safeguards are in place to promote worker safety and bird
welfare. The comments stated that line speeds should be based on an
establishment's ability to maintain process control rather than
regulatory line speed limits. The comments noted that the NPIS was
intended to improve food safety outcomes and generate cost efficiencies
for both establishments and FSIS. According to the comments, without
the incentive of higher line speeds, the 140 bpm line speed cap
established in the final NPIS rule has discouraged many establishments
from opting into the NPIS and has caused the industry and FSIS to
forego potential cost savings associated with making better use of
resources. The comments asserted that allowing establishments to
increase line speeds will enhance food safety by encouraging more
establishments to participate in the NPIS and SIP.
    Response: As stated in FSIS's response to the NCC petition, the
Agency has determined that it is not necessary to establish a separate
system to provide line speed waivers to young chicken establishments
operating under the NPIS because FSIS has already issued regulations
and implemented procedures for establishments to request regulatory
waivers. Establishments that meet the criteria to be eligible for a
line speed waiver may use the existing procedures to submit a waiver
request.
    FSIS established 140 bpm as the maximum line speed for the NPIS,
with an exception for the 20 former HIMP young chicken establishments,
because FSIS concluded that it is important to assess each young
chicken establishment's ability to maintain process control as they
implement changes to operate under the NPIS (79 FR 49591). In the final
rule that established the NPIS, FSIS made clear that it would continue
to evaluate the line speeds at which establishments are capable of
consistently producing safe, wholesome, and unadulterated product, as
well as meeting Salmonella and other performance standards.
    Although FSIS has denied NCC's request to establish a waiver
program that would provide for unlimited line speeds, the Agency will
consider granting individual waivers to allow young chicken
establishments that meet the criteria described above to operate at
line speeds of up to 175 bpm. The data collected from establishments
that are granted these waivers will allow FSIS to evaluate the ability
of NPIS establishments that did not participate in the HIMP pilot to
maintain process control at line speeds of up to 175 bpm. The waivers
do not provide for unlimited line speeds, as requested in the NCC
petition, because the Agency's experience under the HIMP pilot showed
that online inspectors are able to conduct an effective online
inspection of each bird processed at line speeds of up to 175 bpm.

Waiver Regulations

    Comment: Comments from consumer advocacy organizations, animal
welfare advocacy organizations, worker safety advocacy organizations,
civil rights advocacy organizations, labor unions, and members of
Congress stated that FSIS must deny the NCC petition because the
requested action does not meet any of the criteria to qualify for a
waiver under 9 CFR 381.3(b). The waiver regulations in 9 CFR 381.3(b)
provide that ``[t]he Administrator may, in specific cases, waive any
provision of the poultry inspection regulations in order to permit
appropriate and necessary action in the event of a public health
emergency or to permit experimentation so that new procedures,
equipment, and processing techniques may be tested to facilitate

[[Page 49053]]

definite improvements: Provided, That such waivers . . . are not in
conflict with the purposes or provisions of the Act.''
    The comments stated that the petition does not identify a public
health emergency, does not provide for experimentation, does not
identify a new technology, would not be for a limited period of time,
and does not describe any definite improvements as required under the
regulation. Specific issues raised in the comments received follow:
     Public health emergency. The comments stated that the
requested waiver system does not meet the first basis for granting a
waiver under 9 CFR 381.3(b) because providing for faster line speeds is
not ``an appropriate or necessary action in the event of a public
health emergency.''
     ``Specific classes of cases'' and ``limited periods''. The
comments noted that 9 CFR 381.3(b) only authorizes FSIS to grant
waivers in ``specific classes of cases'' for ``limited periods.'' The
comments said that the NCC petition does not identify any specific
classes of cases because the line speed waiver requested in the
petition would apply to any slaughter establishment that participates
in the NPIS or the SIP. The comments also asserted that the petition
does not provide for time limits for the requested waiver system. The
comments stated that granting the petition would establish an
indefinite waiver program in violation of the regulation.
     ``Experimentation with new technology''. The comments
stated that the petition asks that FSIS allow establishments
participating in the NPIS to operate without any line speed limitations
without identifying any new procedures, equipment, or processing
techniques. A worker rights advocacy organization and a labor union
commented that in FSIS's 2003 notice regarding procedures for
notification of new technology, the Agency acknowledged that line
speeds are not a new technology when it explained that ``a new
technology that changed the line speeds for poultry would require a
waiver to the regulations for a limited time to test the new
technology'' (68 FR 6874). According to the comments, a change in line
speed may be the result of a new technology, but is not a new
technology itself.
     ``Definite improvements''. The comments stated that the
NCC petition does not include any information to show how a waiver of
the maximum line speed authorized under the NPIS would ``facilitate
definite improvements'' consistent with the purposes or provisions of
the PPIA. Several comments stated that rather than describe how the
requested waiver system would facilitate definite improvements in food
safety, the petition asserts that allowing faster line speeds would not
be worse for public health or worker safety than the current line
speeds. Several comments stated that the economic considerations
identified in the petition, such as cost savings, profitability, and
competitiveness are not valid criteria for granting a waiver because
they do not qualify as ``definite improvements'' under 9 CFR 381.3(b).
    FSIS Response: For the reasons specified below, FSIS believes that
line speed waivers are consistent with its regulations under 9 CFR
381.3(b) and has developed criteria that the Agency intends to use to
consider these waiver requests and has specified the documentation that
establishments will need to include in their waiver request
submissions.
    ``Specified classes of cases'' and ``limited periods.''
    Any individual waivers that FSIS may grant using the aforementioned
criteria will comply with the regulatory requirements for waivers in 9
CFR 381.3(b) because the waivers will apply to specific classes of
cases, i.e., young chicken establishments that meet the criteria
described above. Further, the waivers are time limited in that if the
data generated under the waivers support regulatory changes, i.e., the
establishments are able to consistently maintain process control at the
higher line speeds, the waivers will be in effect only until the
rulemaking process is complete. If the data generated do not support
regulatory changes, the waivers will be terminated.
    ``Experimentation with new technology.''
    FSIS broadly defines ``new technology as new, or new applications
of, equipment, substances, methods, processes, or procedures affecting
the slaughter of livestock and poultry or processing of meat, poultry,
or egg products. (68 FR 6873, February 11, 2003). At a minimum,
increasing line speeds is a new application of existing technology in
facilities that have never operated at these higher speeds in the past.
Further, it is expected that some facilities that request waivers would
have to install new equipment or reconfigure existing equipment in
order to accommodate higher line speeds. In the same Federal Register
notice cited above, FSIS noted that technology changes that could
adversely affect product safety, interfere with FSIS inspection
procedures, or jeopardize the safety of inspection program personnel,
including changes in line speeds, would require regulatory waivers (68
FR 6874). Therefore, FSIS believes that the line speed waivers
contemplated in this document are consistent with past Agency policy
and the regulations at 9 CFR 381.3(b).
    ``Definite improvements.''
    FSIS interprets ``definite improvement'' to mean any improvement of
equipment, substances, methods, processes, or procedures affecting the
slaughter of livestock and poultry or processing of meat, poultry or
egg products, (83 FR 4782, February 1, 2018). FSIS believes that if an
establishment were able to increase efficiency in poultry production by
operating at higher line speeds, while consistently maintaining process
control, with no diminution in the food safety profile of the finished
product, it would constitute a ``definite improvement'' within the
meaning of 9 CFR 381.3(b). As previously noted, an establishment's
waiver submission request will need to explain how food safety system
modifications undertaken to operate at faster line speeds will maintain
or improve food safety.
    Comment: In addition to the criteria for granting waivers described
above, the comments also noted that under the regulation, FSIS may only
grant waivers that are not in conflict with the purposes or provisions
of the PPIA (9 CFR 381.3(b)).
    Comments from consumer advocacy organizations, animal welfare
organizations, members of Congress, and worker advocacy organizations
stated that the requested waiver system, if implemented, would be
inconsistent with the fundamental purpose of the PPIA because
eliminating maximum line speeds has the potential to increase the risk
that adulterated product will enter commerce. A consumer advocacy
organization stated that the potential for human error increases with
an increase in line speed, and workers forced to perform the same
repetitive activities at a faster pace will become increasingly
fatigued, making them more likely to make mistakes that result in
product contamination or failure to notice and address safety risks.
Consumer advocacy organizations, worker advocacy organizations, and an
environmental advocacy organization commented that higher line speeds
may also affect the accuracy of the equipment on the evisceration and
cause carcasses to become contaminated with fecal material.
    Several comments stated that faster line speeds give company
sorters less time to identify carcasses affected with food safety
defects, such as septicemia/

[[Page 49054]]

toxemia and visible fecal contamination. An animal welfare advocacy
organization commented that NCC's requested action would increase the
risk that poultry meat would become adulterated from inhumane handling
of chickens because faster line speeds are correlated with loss of
process control that results in birds being intentionally mistreated by
workers, improperly hung in shackles, insufficiently cut and bled, and
scalded alive.
    FSIS Response: Because FSIS has denied the NCC petition, the Agency
will not be establishing a waiver program that the comments state will
conflict with the purposes or provisions of the PPIA. Instead, as noted
throughout this document, the Agency will use its existing waiver
procedures to consider granting line speed waivers to individual
establishments that meet the criteria described above to operate at
line speeds of up to 175 bpm. Under these criteria, establishments will
only be eligible for a waiver if, among other things, they have been
operating under the NPIS for at least one year with a demonstrated
ability to maintain process control and demonstrated history of
regulatory compliance. After an establishment has been granted a
waiver, it will need to submit microbial data and other records, such
as statistical process control charts, to FSIS to demonstrate that it
is able to maintain process control when operating at faster line
speeds. FSIS will monitor the establishment's ability to maintain
process control by evaluating the results of the Agency's Salmonella
verification sampling, performing carcass verification checks,
performing sanitation verification activities, and reviewing the
records that the establishment maintains to demonstrate process
control, including the establishment's microbiological testing data.
Finally, in regard to the handling of live chickens, as discussed
above, compliance with GCP regulations will be a condition of operating
under a line speed waiver for both waiver applicants and establishments
already operating under waivers.
    Comment: Several comments asserted that, in addition to the
potential for increased contamination, the petition's requested waiver
system would conflict with the purposes or provisions of the PPIA
because high line speeds would make it difficult for FSIS inspectors to
conduct an effective online carcass-by-carcass inspection. Comments
from consumer and animal welfare advocacy organizations noted that the
PPIA requires FSIS inspectors to inspect ``the carcass of each bird
processed'' (21 U.S.C. 455(b)) and that ``inspection'' means that the
inspector gives a ``critical determination whether [a carcass or part
of a carcass] is adulterated or unadulterated'' (AFGE v. Glickman, 215
F 2nd 7 (D.C. Cir., 2000)). According to the comments, NCC's request to
allow poultry slaughter establishments to operate at line speeds
greater than 175 bpm would make it extremely difficult, if not
impossible, for FSIS to inspect the carcass of each bird processed. A
consumer advocacy organization stated that faster line speeds will also
reduce the percentage of carcasses assessed through offline inspections
because the number of assigned offline carcass verification checks does
not vary with line speed, meaning a smaller percentage of birds will be
inspected offline for fecal contamination as line speeds increase.
    FSIS Response: Because FSIS has denied the NCC petition, young
chicken NPIS establishments will not be granted waivers to operate
without line speed limits. FSIS's experience under the HIMP pilot
showed that online inspectors in HIMP young chicken establishments were
able to conduct an effective online inspection of each carcass when
operating at a line speed of up to 175 bpm. As discussed above, FSIS
intends to grant individual waivers to allow certain young chicken NPIS
establishments to operate at line speeds up to 175 bpm. To ensure that
online inspectors are able to conduct an effective online inspection of
each bird processed, FSIS inspectors-in-charge (IICs) in all NPIS
establishments, including those operating under waivers, are authorized
to direct establishments to operate at a reduced line speed when in the
IIC's judgment a carcass-by-carcass inspection cannot be 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 (9 CFR 381.69(d)).
    With respect to the comment that faster line speeds will reduce the
percentage of carcasses assessed through offline inspections, as stated
in the preamble to the rule that established the NPIS, under the NPIS,
the offline carcass verification checks will be more risk-based than
under the HIMP pilot to reflect the performance of the establishment
(79 FR 49587). As under the HIMP pilot, FSIS continues to conduct eight
10-bird verification checks per line per shift under the NPIS. However,
as noted in the final NPIS rule, FSIS monitors and analyzes the ongoing
results of its offline carcass verification activities to assess the
effectiveness of the establishment's sorting and other process control
procedures (79 FR 49587). FSIS conducts additional verification
activities in all NPIS establishments, including those operating under
waivers, as needed to respond to the Agency's verification findings
(FSIS Directive 6500.1, New Poultry Inspection System: Post-Mortem
Inspection and Verification of Ready-to-Cook Requirement, February 1,
2017).
    Comment: A worker rights advocacy organization stated that even if
the requirements of the waiver regulations are met, the NCC is not
authorized to submit a waiver request under CFR 381.3(b). The
organization stated that FSIS's Procedures for Notification of New
Technology (68 FR 6873) allow official establishments and companies
that manufacture and sell technology to official establishments to
submit new technology notifications to the Agency. The comment noted
that the NCC is not an official establishment or a company that
manufactures or sells new technologies.
    FSIS Response: Nothing in the regulations at 9 CFR 381.3(b) limits
the submission of waiver requests to the regulated industry or
companies that manufacture or sell new technologies. FSIS has denied
the NCC petition, but will continue to consider waiver requests from
official establishments, companies that manufacture or sell new
technologies, and other interested parties.

NPIS Line Speed Regulation

    Comment: Comments from consumer advocacy organizations, animal
welfare advocacy organizations, worker rights advocacy organizations,
civil rights advocacy organizations, and members of Congress asserted
that the NCC petition is an attempt to bypass the maximum line speed
for the NPIS prescribed in the regulations without going through the
rulemaking process in violation of the Administrative Procedure Act
(APA) (5 U.S.C. 553). These comments stated that the 140 bpm maximum
line speed is a legislative rule established through notice-and-comment
rulemaking and, therefore, can only be modified through notice-and-
comment rulemaking. A consumer advocacy organization stated that the
SIP waiver process is intended to facilitate experimentation, not
implement industry-wide changes.
    FSIS Response: Because FSIS has denied the NCC petition, the Agency
will not be establishing a line speed waiver system for all young
chicken establishments and will not allow all young chicken NPIS
establishments to operate at line speeds faster than the

[[Page 49055]]

maximum 140 bpm prescribed by the regulation (9 CFR 381.69(a)). The
Agency will consider individual line speed waiver request submissions
through its existing procedures using the criteria described above. It
should be noted that the existing waiver regulations were promulgated
by notice-and-comment rulemaking pursuant to the APA. FSIS's decision
to grant individual regulatory waivers under 9 CFR 381.3(b) will not
apply to all young chicken slaughter establishments nor establish a new
maximum line speed under NPIS and, therefore, would not be subject to
the APA's notice-and-comment rulemaking provisions.
    Comment: Comments from consumer advocacy organizations, animal
welfare advocacy organizations, worker rights advocacy organizations,
civil rights advocacy organizations, and members of Congress stated
that granting waivers from the line speed limits established for the
NPIS would be an arbitrary reversal of Agency position. The comments
asserted that FSIS considered and rejected requests to allow for faster
line speeds under the NPIS when the Agency finalized the rule that
established the NPIS in 2014 (79 FR 49566). The comments noted that the
2014 final rule was the result of a comprehensive, two-and-a-half year
rulemaking process during which FSIS received and considered more than
250,000 public comments. A worker safety advocacy organization noted
that the question of the maximum allowable line speed was the single
most commented-upon aspect of the NPIS rulemaking. Several comments
also noted that in the fall of 2013, a network of worker safety groups
petitioned the Occupational Safety and Health Administration (OSHA) and
USDA to regulate and reduce assembly line speeds in meat and poultry
processing establishments. The comments stated that OSHA ultimately
denied the petition due to ``a lack of resources,'' but in the 2014
NPIS final rule, FSIS chose not to increase the current maximum line
speed limits for poultry slaughter establishments.
    Comments from consumer advocacy organizations, animal welfare
advocacy organizations, worker rights advocacy organizations, civil
rights advocacy organizations, and members of Congress stated that in
FSIS's 2014 NPIS rulemaking, the Agency acknowledged that line speeds
should not increase without further research ``to assess
establishments' ability to maintain process control as they implement
changes to operate under the NPIS'' (79 FR 49615). The comments noted
that FSIS intended to conduct this assessment ``[a]fter 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'' (79 FR 49615). The
comments noted that at the time the NCC petition was submitted,
approximately 60 establishments had converted to the NPIS while in the
final rule that established the NPIS, FSIS had estimated that 219
establishment would convert. Therefore, the comments asserted, the NPIS
has not yet been fully implemented on a wide scale. According to the
comments, FSIS has not accrued the necessary experience to evaluate the
NPIS establishments' ability to maintain process control at any given
line speed.
    A consumer advocacy organization noted that FSIS granted SIP
waivers to allow the 20 former young chicken HIMP establishments to
continue to operate at line speeds of up to 175 bpm after they
converted to the NPIS because these establishments have demonstrated
that they are able to maintain process control under the line speeds
authorized by HIMP. The comment said that in granting these SIP
waivers, FSIS stated that it would compare the data from the former
HIMP young chicken establishments to data from other non-HIMP NPIS
establishments as a means of evaluating the new program (79 FR 49591).
The comment stated that FSIS has not made any efforts to conduct such
an assessment that is available to the public.
    FSIS Response: As noted above, FSIS has denied the NCC petition and
thus, will not be implementing the line speed waiver program requested
in the petition. FSIS's decision to consider individual waiver requests
to allow certain young chicken NPIS establishments to operate at line
speeds of up to 175 bpm does not affect the regulation that prescribes
140 bpm as the maximum line speed for NPIS young chickens
establishments (9 CFR 381.69(a)) and is consistent with the Agency's
position on line speeds as stated in the final rule that established
the NPIS.
    Also as discussed above, when FSIS published the final rule that
established the NPIS, the Agency made it clear that it would continue
to evaluate the line speeds at which establishments are capable of
consistently producing safe, wholesome, and unadulterated product, as
well as meeting pathogen reduction and other performance standards (79
FR 49591). The data collected from establishments that are granted new
line speed waivers will allow FSIS to evaluate the ability of NPIS
establishments that did not participate in the HIMP pilot to maintain
process control at line speeds up to 175 bpm. FSIS intends to use these
data, along with the data from establishments currently operating under
line speed waivers, to inform future rulemaking, if warranted, with
respect to line speeds under the NPIS.
    Comment: An animal welfare advocacy organization commented that the
PPIA requires a hearing be held for ``oral presentation of views'' for
interested parties when the Agency engages in rulemaking related to its
subject matter (21 U.S.C. 463(c)). The organization stated that FSIS
has not held such a public hearing, and the public comment period that
FSIS provided on regulations.gov is not a lawful substitute for the
hearing requirement.
    FSIS Response: FSIS's regulations on petitions provide for
interested persons to submit comments on a petition (9 CFR 392.7). The
public comment period that FSIS provided on regulations.gov is
consistent with this regulatory provision. Under 21 U.S.C. 463(c), FSIS
is required to provide interested persons an opportunity for the oral
presentation of views after the Agency has initiated informal
rulemaking. FSIS has not initiated informal rulemaking in response to
the petition. In addition, 21 U.S.C. 463(c) does not require that FSIS
hold public hearings to receive oral presentation of views as part of
the rulemaking process.

NPIS Line Speed Data

    Comment: As discussed earlier in this document, the NCC petition
cited data in support of its position, including information from the
2011 HIMP pilot study, a 2001 published study on the HIMP pilot, and a
2017 unpublished survey of NCC member companies operating under the
NPIS with and without line speed waivers. Comments from poultry
slaughter establishments and trade associations representing the
poultry industry stated that the available data demonstrate that young
chicken NPIS establishments are able to operate at line speeds above
140 bpm without compromising food safety. The comments stated that
FSIS's experience with the HIMP pilot upon which the NPIS is based
demonstrates that establishments can safely operate at higher line
speeds. The comments referenced data from the 2011 HIMP Report that
shows that establishments operating under the line speeds authorized by
HIMP perform as well as or better than comparable non-HIMP
establishments. A trade association representing the poultry industry
referenced the 2001 study cited in the

[[Page 49056]]

petition and claimed that this study reinforces the conclusions in the
HIMP Report. The comments also referenced a preliminary analysis of
data from NPIS and non-NPIS establishments that FSIS presented to
stakeholders in October 2017. The comments asserted that this analysis
further confirms that establishments permitted to operate at line
speeds greater than 140 bpm had comparable Salmonella and Campylobacter
percent positives for both whole chicken carcasses and chicken parts,
and that both were below the FSIS performance standards for these
pathogens. The comments also stated that an NCC analysis of FSIS
performance standards sampling data, NR rates, and other key food
safety performance indicators submitted in support of the petition
shows that NPIS establishments, including former HIMP establishments
operating with higher line speeds, are performing at least as well as
non-NPIS establishments.
    Consumer advocacy organizations, animal welfare advocacy
organizations, and worker advocacy organizations asserted that the
petition does not include any data to demonstrate that the NPIS
establishments would be able to maintain process control at faster line
speeds. The comments stated that although the petition discusses the
results of an unpublished industry survey, the discussion does not
provide sufficient detail for FSIS to consider the data. The comments
noted that the petition does not include any information on how
establishments were chosen for the survey, the methodology used to
conduct the survey, or how the results are statistically sound or
valid. Comments from a consumer advocacy organization and an animal
welfare advocacy organization noted that the petition did not present
the Campylobacter and Salmonella data, even in summary form. The
comments stated that the petition only lists the survey participants'
total Salmonella and Campylobacter percent positives and that the
petition states that the NPIS participants' percent positives were ``as
good as if not better than their non-NPIS counterparts.''
    The comments also noted that the NCC survey results were not peer
reviewed. A consumer advocacy organization stated that the survey also
did not include a pre-specified analysis plan, which could allow for
selective reporting, and that the survey relied upon data collected in
the winter months, a time period when Salmonella positives are
typically lower. Another consumer advocacy organization stated that the
NCC seeks to draw conclusions on line speeds beyond the range of actual
line speeds studied in its survey.
    Two consumer advocacy organizations noted that the petition also
referenced data from the 2011 HIMP Report to support the requested
action. The comments asserted that data in the 2011 HIMP Report does
not establish that food safety will be maintained should line speed
caps be lifted. The comments noted that the 2011 HIMP Report stated
that the average line speed under HIMP was 131 bpm, well below the
maximum line speed of 175 bpm authorized under HIMP. The comments also
asserted that line speed information from former HIMP establishments
does not provide insight into operation at unlimited line speeds. The
organizations also commented that the petition does not address the
concern that other young chicken establishments might behave
differently than the 20 former HIMP establishments. One comment stated
that the 2011 HIMP Report findings of no statistical difference in
fecal NRs and Salmonella positives based on line speed show that FSIS
did not find that increased line speeds were statistically related to
these indicia of contamination. The comment stated that this is not a
``definite improvement.''
    FSIS Response: Although FSIS considered the supporting data in the
petition and the comments on these data when evaluating the NCC
petition, the supporting data were not the primary basis for denying
the petition. FSIS denied the NCC petition because the Agency has
already implemented procedures for establishments to request regulatory
waivers and therefore, FSIS determined that it is not necessary to
establish a separate waiver system to provide line speed waivers to
young chicken establishments operating under the NPIS. FSIS reviews
submissions for the use of procedures or processes that require
regulatory waivers on a case-by-case basis to determine whether the
waiver request submission includes a method to document the performance
of the new technology, so the resulting data can be monitored and
analyzed.
    As noted above, FSIS has established criteria that the Agency
intends to use under its existing waiver process to consider waiver
requests by young chicken establishments to operate at line speeds of
up to 175 bpm. FSIS will consider individual waiver requests on a case-
by-case basis and will base its decision on whether to grant a waiver
on the information included in an establishment's waiver request
submission, not on the data submitted in support of the petition.

Worker Safety

    Comment: Comments from poultry slaughter establishments, trade
associations representing the poultry industry, and individuals stated
that permitting NPIS young chicken establishments to run at line speeds
faster than 140 bpm would not be expected to have a significant impact
on worker safety because the waivers would only apply to a specific
highly automated part of the processing line with little direct
employee interaction with the equipment or the birds. The comments
stated that the ``further processing lines'' where workers debone and
cut up chicken parts are separate from the evisceration line and do not
run at the same speed as the evisceration line. The comments stated
that even under the current NPIS system, these further processing lines
run at slower speeds appropriate for the type of work being done and
this would not change if FSIS were to grant the petition.
    Poultry establishments and trade associations representing the
poultry industry commented that the available data show that increased
line speeds do not present greater risks for worker safety. The
comments asserted that worker safety in poultry establishments has
improved in the past two decades, with worker illness and injury rates
reported by the Bureau of Labor Statistics (BLS) decreasing by more
than 80 percent since 1994. The comments stated that the incidence of
non-fatal occupational injuries and illnesses in the poultry sector,
which includes slaughter and processing, remains at an all-time low.
The comments further stated that the total recordable poultry
processing illness and injury rate for 2016 was 4.2 cases per 100 full-
time workers per year, down from 4.3 in 2005. The comments also stated
that the poultry industry's rate of 4.2 was below the rate of 6.9 for
similar agricultural industries in terms of injuries per 100 full-time
workers and lower than the rate of 4.7 for the entire food
manufacturing sector. In addition to these statistics, the comments
noted that the NCC's industry survey of establishments that have
recently opted into the NPIS and those that had been former HIMP
establishments revealed that all plants surveyed, on average, were
operating well below the industry's total DART (days away, restricted,
or transferred) rates. According to the comments, this provides
evidence that the increased line speeds have not resulted in an
increase in worker injuries.

[[Page 49057]]

    Comments from worker and civil rights advocacy organizations,
poultry establishment employees, consumer advocacy organizations, labor
unions, members of Congress, an environmental advocacy organization,
and private citizens asserted that establishing a line speed waiver
system as requested in the NCC petition would increase risks to worker
health and safety in establishments that operate under such waivers and
would expose workers to hazards that have not been studied. The
comments referenced studies, reports, and other data on work-related
injuries in the meat and poultry processing industry. The most commonly
referenced information sources included:
     Studies published by the National Institute for
Occupational Safety and Health (NIOSH) that found high rates of carpal
tunnel syndrome among workers in the poultry industry. One study found
that 34 percent of workers in poultry processing establishments had
carpal tunnel syndrome, and 76 percent had evidence of nerve damage in
their hands and wrists. Another study found that 42 percent of workers
at a poultry processing establishment had carpal tunnel syndrome.
     2016 BLS data showing that employer reported injury rates
for poultry workers were 60 percent above the national average for all
private industry, and illness rates were more than five times as high.
     Reports published by the Government Accountability Office
(GAO) in 2005, 2016, and 2017 that concluded, among other things, that
injury rates in the meat and poultry slaughter industries continue to
be higher than the rates for others in the manufacturing industry, that
meat and poultry workers may under-report illnesses and injuries
because they fear losing their jobs, and that employers may underreport
worker injuries because of concerns about potential costs.
     Various reports from worker advocacy organizations on
worker safety in meat and poultry processing establishments. These
reports include surveys of poultry workers that have suffered illnesses
and injury from the fast-paced repetitive tasks associated with the
current line speeds.
     OSHA citations of poultry processing establishments for
failure to record injuries and illnesses requiring more than first aid.
    The comments stated that the available studies, reports, and data
contradict NCC's assertion that worker illness and injury are at an
all-time low, and, according to the comments, the statistics that NCC
relied on are based on a potentially biased self-reporting system.
Several comments noted that in the preamble to the final rule that
established the NPIS, FSIS recognized that the systemic underreporting
of the poultry industry work-related injuries and illness ``could make
it difficult to accurately assess the extent to which poultry workers
suffer from work related injuries and musculoskeletal diseases and
disorders.'' Comments from a civil rights organization, members of
Congress, and a labor union expressed concern that increased line
speeds will disproportionately hurt women and people of color. The
labor union commented that nearly 40 percent of those who work in
animal slaughtering and processing are women and 67 percent are people
of color.
    FSIS Response: While FSIS agrees that working conditions in poultry
slaughter establishments is an important issue, the Agency has neither
the authority nor the expertise to regulate issues related to
establishment worker safety. FSIS has been delegated the authority to
exercise the functions of the Secretary of Agriculture under the
Federal Meat Inspection Act (FMIA) (21 U.S.C. 601 et seq.), the PPIA
(21 U.S.C. 451 et seq.), and the Egg Products Inspection Act (EPIA) (21
U.S.C 1301 et seq.) (the Acts). Under the Acts, FSIS protects the
public by verifying that meat, poultry, and egg products are safe,
wholesome, not adulterated, and properly marked, labeled, and packaged.
The Acts authorize FSIS to administer and enforce laws and regulations
solely to protect the health and welfare of consumers.
    The DOL's OSHA was created by the Occupational Safety and Health
Act of 1970 (29 U.S.C. 651 et seq.) to assure safe and healthful
working conditions for men and women by setting and enforcing standards
and by providing training, outreach, education, and assistance. As was
noted in the preamble to the final rule that established the NPIS, OSHA
is the Federal agency with statutory and regulatory authority to
promote workplace safety and health (79 FR 49600). FSIS's authority
with respect to working conditions in poultry slaughter establishments
extends only to FSIS inspection personnel. While FSIS is prepared to
address worker safety within the bounds of its authority, as noted
above, FSIS has neither the legal authority nor the expertise to
regulate or enforce workplace standards for establishment employees.
    During the development of the final rule that established the NPIS,
FSIS collaborated with OSHA and NIOSH, to address issues related to
worker safety raised by the public comments. OSHA and NIOSH are the
government agencies with the expertise and authority to address worker
safety issues in private industry workplaces. As a result of this
collaboration, the final NPIS regulations include provisions to remind
establishments of their existing legal obligations to comply with the
worker safety laws administered by OSHA (9 CFR 381.69(d)). The final
regulations also provide for establishments operating under the NPIS to
submit on an annual basis an 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
of establishment workers (9 CFR 381.45). Because OSHA is the Federal
agency with statutory and regulatory authority to promote workplace
safety and health, FSIS forwards the annual attestation to OSHA for use
in its own enforcement program. All establishments operating under the
NPIS are subject to the attestation regulation, including the NPIS
establishments operating under regulatory waivers. However, FSIS
employees are not responsible for determining the merit of the content
of the attestation or for enforcement of non-compliance with the
attestation provision.

Animal Welfare

    Comment: Comments from animal welfare advocacy organizations and
individuals concerned about animal welfare asserted that granting the
petition and allowing NPIS establishments to operate at faster line
speeds would have adverse effects on the humane handling of poultry.
The comments expressed concern about worker frustration over faster
line speeds and the potential for workers to take these frustrations
out on the birds; the potential for increased injuries that may occur
from shackling birds at faster line speeds; the potential for worker
injuries from birds vigorously flapping their wings while in shackles;
and the potential for ineffective stunning and throat cutting of birds
at faster line speeds. The comments noted that for over 12 years, FSIS
has recognized that ``poultry products are more likely to be
adulterated if, among other circumstances, they are produced by birds
who have not been treated humanely, because such birds are more likely
to be bruised or to die other than by slaughter'' (79 FR 49590). The
comments referenced FSIS NRs for cadavers, birds entering the scalder
alive or not fully bled out, and birds

[[Page 49058]]

exhibiting severe bruising primarily caused by dislocated legs and
broken wings. According to the comments, faster line speeds will
exacerbate these conditions. Two animal welfare advocacy organizations
asserted that setting policy for poultry slaughter that promotes better
animal handling practices would further compliance with the PPIA and
ensure more effective and efficient inspections.
    FSIS Response: Because the Humane Methods of Slaughter Act (HMSA)
(7 U.S.C. 1901-1907) does not apply to poultry, FSIS does not have
direct authority to regulate the humane handling of live poultry in
connection with slaughter. As noted above, under all poultry inspection
systems, including the NPIS, establishments are required to slaughter
poultry in accordance with GCPs, 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)). As noted in the comments, in
September 2005, FSIS 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). Under both the PPIA and its
implementing regulations, poultry carcasses showing evidence of having
died from causes other than by slaughter are considered adulterated and
as such must be condemned (21 U.S.C. 453(g)(5) and 9 CFR 381.90).
Establishments operating under the NPIS have always been, and will
continue to be, subject to these requirements regardless of their line
speed, including establishments that have been granted waivers to
operate at line speeds of up to 175 bpm. As outlined in FSIS Directive
6300.1, Ante-mortem and Post-mortem Poultry Inspection, FSIS verifies
GCPs as part of a daily, per-shift inspection task performed by the
public health veterinarian (PHV). Any non-compliances are documented
under 9 CFR 381.65(b) and reviewed weekly as one of many measures of
process control. However, in response to these comments, as discussed
above, FSIS has decided to add compliance with the GCP regulation to
the criteria that the Agency will consider when evaluating an
establishment's line speed waiver request submission. Also, as
discussed above, FSIS will now consider compliance with the GCP
regulations as a condition for existing line speed waivers.
    Comment: Two animal welfare advocacy organizations commented that
if FSIS grants NCC's petition, it should require multi-stage controlled
atmosphere killing (CAK) as a condition of increasing line speeds.
According to the comments, faster line speeds will likely result in
more frequent loss of process control, and FSIS is unlikely to be able
to provide a rational explanation on how removing line speed limits
will result in similar or better process control than is currently
achieved with the line speed limit for the NPIS. The comments asserted
that multi-stage CAK systems would help maintain process control
because birds stunned while in transport cages do not need to be
removed from their cages, dumped onto conveyor belts, and shackled
upside down while still conscious. The organizations stated that this
would facilitate proper handling.
    FSIS Response: FSIS does not prescribe specific methods that
establishments must use to stun or kill poultry in connection with
slaughter. Establishments are required to maintain process control and
comply with requirements for GCPs regardless of the methods they use to
stun or kill the birds. Establishments may use CAK stunning if they
choose to do so.

National Environmental Policy Act

    Comment: Comments from animal welfare advocacy organizations and an
environmental advocacy organization stated that if FSIS grants the NCC
petition, the Agency must prepare an Environmental Impact Statement
(EIS) as required under the National Environmental Policy Act (NEPA)(42
U.S.C. 4321 et seq.) because the requested action to allow poultry
slaughterhouses to increase line speeds would result in significant
environmental impacts. The comments stated that faster line speeds
would mean more birds slaughtered per shift. According to the comments,
more birds slaughtered would mean more waste, more water use, and more
fossil fuels required to transport the birds from farm to
slaughterhouse. The comments asserted that these are all significant
environmental impacts, with both individual and cumulative effects at
the local, state, and national levels. The comments also stated that if
FSIS grants NCC's petition, FSIS cannot claim the categorical exclusion
from the preparation of an Environmental Assessment (EA) or an EIS
under 7 CFR part 1b of the USDA regulations.
    FSIS Response: Because FSIS has denied the NCC petition, it will
not be implementing the waiver system that these commenters believe
could result in significant environmental impacts and thus is not
required to analyze potential environmental impacts resulting from the
waiver system proposed by NCC as suggested by the comments.
    With respect to the Agency's decision to consider granting waivers
to additional NPIS establishments to operate at line speeds of up to
175 bpm, that decision is categorically excluded from NEPA
requirements. Federal agencies may identify classes of actions that
normally do not require the preparation of either an EA or EIS because
such actions do not have a significant effect on the human environment,
either individually or cumulatively (40 CFR 1507.3(b)(2)). Such classes
of actions are ``categorically excluded'' from NEPA requirements (40
CFR 1508.4). Under 7 CFR 1b.4, all FSIS actions, including inspection
functions, are categorically excluded from preparation of an EA or EIS
unless the Agency head determines that a particular action may have a
significant environmental effect. Accordingly, FSIS is not required to
prepare an EA or EIS unless it anticipates that granting additional
line speed waivers may have a significant environmental effect.
    The Agency does not anticipate that its decision to consider
granting waivers to additional NPIS establishments to operate at line
speeds of up to 175 bpm will have individual or cumulative effects on
the environment. Expected sales of poultry products to consumers will
determine the total number of birds that a poultry establishment
slaughters, not the maximum line speed under which it operates. The
Agency has no authority to determine a poultry establishment's
production levels. An establishment may decide to increase production
hours to slaughter more birds in response to market demand, regardless
of its maximum line speed. Granting an establishment a waiver to
operate at up to 175 bpm will allow that establishment to slaughter
birds more efficiently, but will not affect consumer demand for the
establishment's poultry products. In some instances, an establishment
that is granted a waiver may be able to reduce its hours of operation
while maintaining production at a rate necessary to meet market demand
for its poultry products. Thus, granting waivers to allow additional
NPIS establishments to operate at up to 175 bpm is not expected to
affect the number of birds slaughtered or result in more waste, more
water use, or require more fossil fuels to transport the birds from
farm to slaughterhouse, as suggested by the comments. In addition,

[[Page 49059]]

all poultry slaughter establishments, regardless of line speed, are
required to meet all local, State, and Federal environmental
requirements.

Economic Issues and Regulatory Reform

    Comment: Comments from poultry slaughter establishments and an
individual stated that granting the NCC petition would be consistent
with Executive Order (E.O.) 13771, which requires that for each new
regulation issued, at least two existing regulations must be eliminated
to offset the cost of the new regulations. The comments noted that a
line speed waiver program would be a deregulatory action under E.O.
13771 because it would expand production options and provide for cost
savings to industry.
    Comments from consumer advocacy organizations and animal welfare
advocacy organizations noted that the petition states that the
requested waiver system would be consistent with the Administration's
emphasis on reducing regulatory burdens on the industry and assuring
competitiveness with other countries. Comments from consumer advocacy
and animal welfare advocacy organizations stated that enhanced
competitiveness and reduced regulatory burden are not justifications
for FSIS to take an action that is inconsistent with its regulatory
authority and that, according to the comments, could potentially
compromise food safety. Animal welfare advocacy organizations stated
that the petition exaggerates the regulatory burden of the maximum
authorized line speed under the NPIS. According to the organizations,
the petition does not identify any clear cost savings or decreases in
FSIS administrative burden and does not include any explanation of how
the administration of the requested action would be cost-effective or
even financially neutral to FSIS.
    FSIS Response: The purpose of the waiver process is to allow
establishments to experiment with new equipment, technologies, or
procedures to facilitate definite improvements, not to initiate
regulatory changes across the industry, as some of the comments seem to
suggest. FSIS evaluates the data generated by establishments operating
under regulatory waivers to inform future rulemaking, if warranted.
FSIS would consider the costs, benefits, and other economic impacts
associated with implementing a new technology, including new
technologies that would permit faster line speeds, if, based on the
data collected under regulatory waivers, the Agency decided to initiate
rulemaking to provide for the use of the new technology in the
regulations.
    Comment: Comments from poultry establishments, trade associations
representing the poultry industry, and an individual asserted that
allowing the 20 former young chicken HIMP establishments to operate
under line speed waivers after they convert to the NPIS gives these
establishments a competitive advantage over the other NPIS
establishments. The comments stated that all facilities operating under
the same inspection system should be regulated under identical
criteria, and that the granting of waivers should be done equitably as
well. According to the comments, limiting line speed waivers to the 20
former young chicken HIMP establishments has no justification and puts
the Agency in the position of apparently granting financial favors to
select poultry processing operations.
    Several worker advocacy organizations stated that, in the final
rule establishing the NPIS, after FSIS considered the extensive
comments from affected stakeholders on all sides, and in light of
evidence that young chicken establishments authorized to operate up to
175 bpm under the HIMP pilot were in fact operating at an average speed
of 131 bpm, FSIS determined that a maximum line speed of 140 bpm would
meet the economic needs of poultry slaughter establishments.
    A consumer advocacy organization stated that lifting line speed
caps across NPIS establishments will lead to new competitive pressures
that could undermine food safety in ways not predictable from currently
available data. According to the organization, it is conceivable that
lifting line speed caps across the industry would create competitive
pressure to push line speeds even higher than observed previously,
potentially compromising food safety.
    FSIS Response: FSIS disagrees that the line speed waivers granted
to the former HIMP establishments to operate at line speeds up to 175
bpm after they converted to the NPIS created a new competitive
advantage over other NPIS establishments subject to the 140 bpm maximum
line speeds prescribed in the final NPIS regulations. The 20 former
HIIMP young chicken establishments had been authorized to operate at
line speeds up to 175 bpm for over 20 years during the time they were
participating in the HIMP pilot. Under the final NPIS rule, these
establishments were permitted to run at the line speeds that were
authorized before FSIS established the NPIS.
    Although FSIS has denied NCC's request to establish a waiver
program to allow young chicken NPIS establishments to operate without
line speed limits, the Agency will consider granting individual waivers
to allow young chicken establishments that meet the criteria described
above to operate at line speeds of up to 175 bpm. Under these criteria,
line speed waivers will no longer be limited to the 20 former HIMP
establishments, and thus, will be equitably distributed to eligible
establishments. Because FSIS is not removing the maximum line speed for
all NPIS establishments, FSIS has no reason to believe that granting
additional individual waivers will create competitive pressure for
establishments to increase line speeds. Establishments will not submit
line speed waiver requests if their current line speeds meet their
business needs.
    Comment: Comments from poultry establishments, trade associations
representing the poultry industry, and individuals commented that the
current system places the U.S. chicken industry at a disadvantage
compared to global competitors in South America, Asia, Canada, and
Europe that are allowed to operate at line speeds in excess of 200 bpm
using the same equipment as processors in the United States. An
individual commented that animal welfare is important, and countries in
Europe have shown that poultry can be slaughtered humanely under faster
line speeds.
    Comments from worker advocacy organizations asserted that the
evidence points to clear problems with the faster line speeds permitted
in foreign countries. According to the comments, certain foreign
countries are not permitted to export poultry products to the United
States because their poultry inspection systems have not been found
equivalent to the U.S. system. The comments also stated that the
poultry processed in certain foreign establishments have high levels of
pathogens that continue to be of concern to European food safety
officials. However, the comments did not indicate what the maximum line
speeds permitted in these countries were and did not explain how
maximum line speeds affected the countries' pathogen levels.
    Response: As noted above, the purpose of the waiver process is to
allow establishments to experiment with new equipment, technologies, or
procedures, not to initiate regulatory changes across the industry.
Regulatory waivers are not the appropriate vehicle to address the
poultry industry's global competition issues. Additionally, countries
that currently export poultry to the United States require that

[[Page 49060]]

establishments that process poultry for export comply with maximum line
speeds regulations similar to those in the United States.

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.
    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).

Additional Public Notification

    FSIS will announce this notice online through the FSIS web page
located at http://www.fsis.usda.gov/federal-register. FSIS will also
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 constituents and stakeholders. The Update is
communicated via Listserv, a free electronic mail subscription service
for industry, trade groups, consumer interest groups, health
professionals, and other individuals who have asked to be included. The
Update is also available on the FSIS web page. In addition, FSIS offers
an electronic mail subscription service which provides automatic and
customized access to selected food safety news and information. This
service is available at http://www.fsis.usda.gov/subscribe. 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.

Paul Kiecker,
Acting Administrator.
[FR Doc. 2018-21143 Filed 9-27-18; 8:45 am]
 BILLING CODE 3410-DM-P