83_FR_49237 83 FR 49048 - 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

83 FR 49048 - 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

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service

Federal Register Volume 83, Issue 189 (September 28, 2018)

Page Range49048-49060
FR Document2018-21143

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.

Federal Register, Volume 83 Issue 189 (Friday, September 28, 2018)
[Federal Register Volume 83, Number 189 (Friday, September 28, 2018)]
[Notices]
[Pages 49048-49060]
From the Federal Register Online  [www.thefederalregister.org]
[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, 
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statements of organization and functions are examples of documents 
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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



                                              49048

                                              Notices                                                                                                        Federal Register
                                                                                                                                                             Vol. 83, No. 189

                                                                                                                                                             Friday, September 28, 2018



                                              This section of the FEDERAL REGISTER                    will use to evaluate new line speed                       Under the NPIS, establishment
                                              contains documents other than rules or                  waiver request submissions.                            employees sort carcasses and remove
                                              proposed rules that are applicable to the               Additionally, FSIS is announcing that                  unacceptable carcasses and parts before
                                              public. Notices of hearings and investigations,         the 20 young chicken establishments                    the birds are presented to an online
                                              committee meetings, agency decisions and                already operating under line speed                     inspector located at the end of the line
                                              rulings, delegations of authority, filing of
                                              petitions and applications and agency
                                                                                                      waivers must meet the new criteria to                  before the chiller. Because the online
                                              statements of organization and functions are            remain eligible for the waiver. FSIS will              inspector under the NPIS is presented
                                              examples of documents appearing in this                 issue these establishments new waiver                  with carcasses that have been sorted,
                                              section.                                                letters that reflect the eligibility criteria          washed, and trimmed by establishment
                                                                                                      described in this document. Failure by                 employees, and are thus much more
                                                                                                      establishments already operating under                 likely to pass inspection, the inspector
                                              DEPARTMENT OF AGRICULTURE                               line speed waivers to meet the new                     is able to conduct a more efficient and
                                                                                                      criteria within 120 days of receipt of                 effective online inspection of each bird
                                              Food Safety and Inspection Service                      these letters may result in the revocation             processed.
                                              [Docket No. FSIS–2018–0014]                             of the waivers.                                           The NPIS was informed by the
                                                                                                      FOR FURTHER INFORMATION CONTACT:                       Agency’s experience under the Hazard
                                              Petition To Permit Waivers of                           Roberta Wagner, Assistant                              Analysis and Critical Control Point
                                              Maximum Line Speeds for Young                           Administrator, Office of Policy and                    (HACCP)-Based Inspection Models
                                              Chicken Establishments Operating                        Program Development, FSIS, USDA;                       Project (HIMP) pilot study. FSIS’s
                                              Under the New Poultry Inspection                        Telephone: (202) 205–0495.                             experience under the HIMP pilot
                                              System; Criteria for Consideration of                                                                          showed that online inspectors in HIMP
                                              Waiver Requests for Young Chicken                       SUPPLEMENTARY INFORMATION:                             young chicken establishments were able
                                              Establishments To Operate at Line                       Background                                             to conduct an effective online
                                              Speeds of Up to 175 Birds per Minute                                                                           inspection of each carcass when
                                                                                                         On August 24, 2014, FSIS published                  operating at a line speed of up to 175
                                              AGENCY:  Food Safety and Inspection                     a final rule that, among other things,
                                              Service, USDA.                                                                                                 bpm and that HIMP establishments were
                                                                                                      established the NPIS as an additional                  able to maintain process control at the
                                              ACTION: Response to comments and                        inspection system for young chicken                    line speeds authorized under HIMP.
                                              information on waiver criteria.                         and all turkey slaughter establishments                Based on FSIS’s experience under
                                                                                                      (79 FR 49566). The NPIS did not replace                HIMP, the Agency initially proposed
                                              SUMMARY:   The Food Safety and
                                                                                                      FSIS’s other poultry slaughter                         175 bpm as the maximum line speed for
                                              Inspection Service (FSIS) is responding
                                                                                                      inspection systems, and young chicken                  NPIS young chicken establishments (77
                                              to public comments on a petition
                                                                                                      and turkey slaughter establishments that               FR 4408). However, after considering
                                              submitted by the National Chicken
                                              Council (NCC) on September 1, 2017,                     do not choose to operate under the NPIS                the public comments submitted on the
                                              and is also providing information on the                may continue to operate under their                    proposed rule, FSIS concluded that it
                                              criteria applicable to line speed waivers               current inspection system.1 Under the                  was important to assess young chicken
                                              for young chicken establishments. The                   inspection systems other than the NPIS,                establishments’ ability to maintain
                                              NCC submitted a petition to FSIS                        FSIS online inspectors positioned along                process control as they implement
                                              requesting that the Agency establish a                  the slaughter line are responsible for                 changes to operate under the NPIS (79
                                              waiver program to permit young                          identifying unacceptable carcasses and                 FR 49591). Therefore, the final rule that
                                              chicken slaughter establishments to                     parts, examining carcasses for visual                  established the NPIS provided for a
                                              operate without line speed limits if they               defects, and directing establishment                   maximum line speed of 140 bpm for
                                              participate in the New Poultry                          employees to take appropriate corrective               young chicken establishments, instead
                                              Inspection System (NPIS) and the FSIS                   actions if the defects can be corrected                of 175 bpm as was proposed, with an
                                              Salmonella Initiative Program (SIP) and                 through trimming and reprocessing. The                 exception for the 20 young chicken
                                              develop a system for monitoring and                     maximum line speeds authorized under                   establishments that participated in the
                                              responding to loss of process control.                  these inspection systems reflect the time              HIMP pilot study.
                                              FSIS issued a response denying the                      it takes for an inspector to effectively                  In the preamble to the final rule, FSIS
                                              petition on January 29, 2018. The                       perform the online carcass inspection                  explained that it decided to grant
                                              response explained that instead of                      procedures required for the system. The                waivers to the 20 young chicken HIMP
                                              establishing a separate line speed                      fastest line speed authorized for a non-               establishments to permit them to
                                              waiver program under the conditions                     NPIS young chicken inspection system                   continue to operate at lines speeds of up
                                              requested in the petition, FSIS would                   is 140 birds per minute (bpm) with four                to 175 bpm after they convert to NPIS
                                              make available criteria that it will use                online inspectors, i.e., 35 bpm per                    because data from the HIMP pilot
                                              under its existing waiver procedures to                 inspector, under the Streamlined                       demonstrated that these establishments
amozie on DSK3GDR082PROD with NOTICES1




                                              consider individual waiver requests                     Inspection System (SIS) for young                      were capable of consistently producing
                                              from young chicken establishments to                    chickens.                                              safe, wholesome and unadulterated
                                              operate at line speeds of up to 175 bpm.                                                                       product and meeting pathogen
                                                                                                        1 Poultry slaughter inspections systems other than
                                                 FSIS published these criteria in the                                                                        reduction and other performance
                                                                                                      the NPIS include the Streamlined Inspection
                                              February 23, 2018, Constituent Update.                  System (SIS), New Line Speed Inspection System
                                                                                                                                                             standards when operating under line
                                              This notice provides additional                         (NELS), the New Turkey Inspection System (NTIS),       speeds authorized under HIMP (79 FR
                                              information on the criteria that FSIS                   and Traditional Inspection.                            49591). The preamble to the final rule


                                         VerDate Sep<11>2014   19:22 Sep 27, 2018   Jkt 244001   PO 00000   Frm 00001   Fmt 4703   Sfmt 4703   E:\FR\FM\28SEN1.SGM   28SEN1


                                                                          Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices                                                    49049

                                              also explained that if an NPIS                          establishments from opting into the                   could submit comments online through
                                              establishment operating under a line                    NPIS. The petition stated that FSIS has               the Federal eRulemaking Portal at:
                                              speed waiver goes out of business or                    the authority to implement such a                     https://www.regulations.gov. Comments
                                              decides to give up its waiver, FSIS will                wavier program under 9 CFR 381.3(b),                  were accepted online until December
                                              select another establishment to take its                which provides that ‘‘[t]he                           13, 2017, and FSIS considered all timely
                                              place (79 FR 49583). Thus, when it                      Administrator may, in specific cases,                 comments on the petition as part of its
                                              published the final rule, FSIS planned                  waive for limited periods . . . any                   review of the petition (9 CFR 392.7).
                                              to continue to provide waivers for up to                provision of the regulations . . . to                    FSIS Response to Petition. On January
                                              20 young chicken establishments to                      permit experimentation so that new                    29, 2018, FSIS sent a response to the
                                              operate at up to 175 bpm under the                      procedures, equipment, and processing                 NCC denying the petition.6 In its
                                              NPIS.                                                   techniques may be tested to facilitate                response, FSIS explained that it had
                                                 In the preamble to the final rule, FSIS              definite improvements: Provided, [t]hat               decided to deny the petition because the
                                              also explained that ‘‘[a]fter the NPIS has              such waivers . . . are not in conflict                Agency already has detailed procedures
                                              been fully implemented on a wide scale,                 with the purposes or provisions of the                for the submission of new technology
                                              and the Agency has gained at least a                    [Poultry Products Inspection Act                      notifications and protocols and requests
                                              year of experience under the new                        (PPIA)].’’                                            for waivers from regulatory
                                              system, FSIS intends to assess the                         The petition asserted that the                     requirements. The response noted that
                                              impact of changes adopted by                            requested waiver program will                         these procedures include a process for
                                              establishments operating under the                      encourage more establishments to opt                  submitting requests for the use of
                                              NPIS by evaluating the results of the                   into the NPIS and will promote and                    alternative procedures, such as faster
                                              Agency’s Salmonella and                                 enhance Agency and industry efficiency                line speeds, that would require
                                              Campylobacter verification sampling,                    without compromising food safety,                     regulatory waivers under the SIP. The
                                              reviewing documentation on                              worker safety, or animal welfare. The                 response further stated that because
                                              establishments’ [other consumer                         petition referenced information from the              FSIS has already implemented
                                              protection] performance, and other                      2011 HIMP pilot study,4 a 2001                        procedures for establishments to request
                                              relevant factors’’ (79 FR 49591). The                   published study, a report from the                    regulatory waivers, the Agency
                                              preamble also stated that ‘‘once the                    Department of Labor (DOL) Bureau of                   determined that it was not necessary to
                                              NPIS is fully implemented at most                       Labor Statistics (BLS), and an                        establish a separate system to provide
                                              establishments, data from these                         unpublished industry survey conducted                 line speed waivers to young chicken
                                              establishments can be used to compare                   by NCC in 2017 to support the requested               establishments operating under the
                                              against data from the [former HIMP]                     action. The petition also stated that the             NPIS.
                                              young chicken establishments operating                  current line speed regulation imposes                    In addition to denying the request to
                                              under the [line speed] waivers’’ (79 FR                                                                       establish a line speed waiver program,
                                                                                                      costs on the industry, creates
                                              49591). Thus, when FSIS published the                                                                         the January 2018 response also stated
                                                                                                      competitive disparities among U.S.
                                              final rule establishing NPIS, it made                                                                         that FSIS was denying NCC’s request to
                                                                                                      poultry establishments, and places U.S.
                                              clear that the Agency would continue to                                                                       permit waivers that would allow NPIS
                                                                                                      poultry establishments at a competitive
                                              consider line speeds at which                                                                                 young chicken establishments to operate
                                                                                                      disadvantage with international
                                              establishments are capable of                                                                                 without a maximum line speed. As
                                                                                                      competitors. The petition said that
                                              consistently producing safe, wholesome,                                                                       noted in the response, the preamble to
                                                                                                      allowing establishments to operate
                                              and unadulterated product and are                                                                             the final rule that established the NPIS
                                                                                                      without line speed limits is consistent
                                              meeting pathogen reduction and other                                                                          stated that, based on its experience
                                                                                                      with Executive Order (E.O.) 13771 on
                                              performance standards.                                                                                        under the HIMP pilot, FSIS found that
                                                                                                      ‘‘Reducing Regulation and Controlling                 inspectors are able to conduct an
                                              National Chicken Council Petition and                   Regulatory Costs.’’                                   effective online inspection of each
                                              FSIS Response                                              Consistent with its regulations on                 carcass at line speeds of up to 175 bpm
                                                Petition. On September 1, 2017, NCC                   petitions, FSIS posted the NCC petition               (79 FR 49592). The response noted that
                                              petitioned 2 FSIS to implement a waiver                 on the FSIS website and received                      the petition did not include data to
                                              system to exempt young chicken                          comments from interested persons on                   demonstrate that online inspectors can
                                              slaughter establishments from the                       the petition (9 CFR 392.6 and 392.7).                 conduct an effective carcass-by-carcass
                                              regulation that prescribes 140 bpm as                   FSIS also announced the availability of               inspection at line speeds faster than
                                              the maximum line speed under the                        the petition in the October 13, 2017,                 those authorized under HIMP.
                                              NPIS (9 CFR 381.69(a)). As conditions                   Constituent Update 5 and explained                       In addition to denying the petition,
                                              for the waiver, the petition requested                  that, based on communications with                    the response noted that FSIS now has
                                              that establishments be required to opt                  stakeholders, the Agency anticipated                  over a year of documented process
                                              into the NPIS, participate in SIP,3 and                 that it would receive a significant                   control history for many young chicken
                                              develop a system for monitoring and                     number of additional comments on the                  establishments operating under the
                                              responding to loss of process control.                  petition. Therefore, to facilitate                    NPIS. The response explained that
                                              According to the petition, the 140 bpm                  submission and public posting of                      based on this history, FSIS has decided
                                              maximum line speed for the NPIS has                     comments on the petition, FSIS                        to consider requests for waivers from
                                              deterred many young chicken                             announced that interested persons                     young chicken establishments in
                                                                                                                                                            addition to the current 20 HIMP
                                                                                                        4 The 2011 HIMP Report is available at: https://
                                                2 NCC petition available at: https://
                                                                                                                                                            establishments, to operate at line speeds
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                                              www.fsis.usda.gov/wps/wcm/connect/7734f5cf-             www.fsis.usda.gov/wps/wcm/connect/fcd9ca3e-
                                                                                                      3f08-421f-84a7-936bc410627c/Evaluation_HACCP_         of up to 175 bpm. The response also
                                              05d9-4f89-a7eb-6d85037ad2a7/17-05-Petition-
                                              National-Chicken-Council-09012017.pdf?                  HIMP.pdf?MOD=AJPERES.                                 explained that in the near future, FSIS
                                              MOD=AJPERES.                                              5 The October 13, 2017 Constituent Update is
                                                3 Under SIP, FSIS grants establishments a waiver      available at: https://www.fsis.usda.gov/wps/wcm/         6 FSIS’s January 29, 2018, response to the petition

                                              of the regulation under the condition that the          connect/a54d5331-372e-4df3-ac4d-8c2953969039/         is available at: https://www.fsis.usda.gov/wps/wcm/
                                              establishment collects and analyzes samples for         ConstiUpdate101317.pdf?MOD=AJPERES&                   connect/235092cf-e3c0-4285-9560-e60cf6956df8/
                                              microbial organisms and shares the results with         CONVERT_TO=url&CACHEID=a54d5331-372e-                 17-05-FSIS-Response-Letter-01292018.pdf?MOD=AJ
                                              FSIS.                                                   4df3-ac4d-8c2953969039.                               PERES.



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                                              49050                       Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices

                                              intends to make available criteria that it              submitting one year of microbial data,                products are more likely to be
                                              will use to consider these waiver                       methodology for evaluating that                       adulterated if, among other
                                              requests.                                               microbial data (e.g., indicator organism              circumstances, they are produced from
                                                                                                      data in a process control chart                       birds that have not been treated
                                              Criteria for FSIS To Consider Line
                                                                                                      identifying upper and lower control                   humanely because such birds are more
                                              Speed Waivers
                                                                                                      limits), correlation of that microbial data           likely to be bruised or to die other than
                                                On February 23, 2018, in the                          to the establishment’s sanitary dressing              by slaughter (70 FR 56624).
                                              Constituent Update, FSIS announced                      process control data, correlation of that                If an establishment is not following
                                              the criteria that the Agency will use to                microbial data to FSIS’s Salmonella                   GCPs, and birds are dying other than by
                                              consider requests from NPIS young                       data, and interventions to address                    slaughter, FSIS inspection program
                                              chicken slaughter establishments to                     seasonality;                                          personnel (IPP) will document a non-
                                              operate at line speeds of up to 175 bpm                    • Describes how existing or new                    compliance record (NR) citing 9 CFR
                                              and outlined the submission                             equipment, technologies, or procedures                381.65(b). If birds are being mistreated,
                                              requirements.7 As provided in that                      will allow for the operation at a faster              but can still be fully bled and are not
                                              document, to be eligible for a line speed               line speed (e.g., descriptions or names               breathing when they enter the scalder,
                                              waiver, a young chicken establishment:                  of the equipment, line configuration,                 IPP are instructed to discuss the
                                                • Must have been operating under the                  and verification activities that will be              mistreatment with the establishment
                                              NPIS for at least one year, during which                used);                                                and document the discussion and any
                                              time it has been in compliance with all                    • Provides support on how the                      planned action by the establishment in
                                              NPIS requirements;                                      increased line speed will not negatively              a Memorandum of Interview (MOI). IPP
                                                • Must be in Salmonella performance                   impact FSIS employee safety nor                       will forward a copy of the MOI to the
                                              standard category 1 or 2 for young                      interfere with inspection procedures                  FSIS District Veterinary Medical
                                              chicken carcasses;                                      (e.g., information about safety protocols             Specialist (DVMS) for review (FSIS
                                                • Must have a demonstrated history                    or line configuration);                               Directive 6100.3, Ante-Mortem and
                                              of regulatory compliance. More                             • Supports how the modifications to                Post-Mortem Poultry Inspection, April
                                              specifically, the establishment has not                 its food safety system to operate at the              11, 2011).
                                              received a public health alert 8 for the                faster line speed will maintain or                       As discussed below, some comments
                                              last 120 days; has not had an                           improve food safety (e.g., a statement                raised issues related to line speeds for
                                              enforcement action as a result of a Food                that explains how the new equipment                   NPIS young chicken establishments and
                                              Safety Assessment (FSA) conducted in                    will provide the same as or cleaner                   compliance with GCPs. Under all
                                              the last 120 days; and has not been the                 evisceration processes, or how an                     poultry inspection systems, including
                                              subject of a public health related                      improved line configuration will                      the NPIS, establishments are required to
                                              enforcement action in the last 120 days;                continue to prevent cross                             slaughter poultry in accordance with
                                              and                                                     contamination); and                                   GCPs. Therefore, in addition to the
                                                • Must be able to demonstrate that                       • Indicates the type of records that               criteria described above, the Agency
                                              the new equipment, technologies, or                     will be maintained in the new process,                will consider compliance with GCPs as
                                              procedures that allow the establishment                 including the collection of information               part of an establishment’s demonstrated
                                              to operate at faster line speeds will                   that will assist FSIS in performing                   history of regulatory compliance. Thus,
                                              maintain or improve food safety.                        appropriate rule-making analysis (e.g.,               consistent with the above regulatory
                                                In addition to outlining the criteria                 laboratory results, weekly or monthly                 compliance criteria, to be eligible for a
                                              that FSIS will consider to determine                    summary production reports, or                        line speed waiver, establishments must
                                              whether to grant a line speed waiver,                   evaluations from inspection program                   also have not had an NR for violation of
                                              the February 23, 2018 Constituent                       personnel).                                           GCPs (9 CFR 381.65(b)) in the past 120
                                              Update also describes the                                  Because FSIS intends to use the data               days.
                                              documentation that establishments will                  collected from young chicken                             Finally, FSIS also will be requiring
                                              need to include with their waiver                       establishments to evaluate their ability              establishments with line speed waivers
                                              request submissions. As stated in the                   to maintain process control at higher                 to conduct daily Aerobic Plate Count
                                              Constituent Update, the waiver request                  line speeds, the Constituent Update                   (APC) testing, instead of weekly testing
                                              submission will need to include                         explained that the Agency will limit the              for indicator organisms, and to make the
                                              documentation that:                                     additional line speed waivers to                      results available to FSIS. This testing
                                                • Provides details about the                          establishments that have the ability and              will provide additional data for
                                              establishment’s HACCP system,                           intend to operate at line speeds higher               consideration by FSIS when it
                                              including how the establishment                         than 140 bpm.                                         determines whether rulemaking for
                                              addresses the inhibition and reduction                     In addition, after reviewing comments              young chicken slaughter line speeds is
                                              of Salmonella;                                          submitted in response to the NCC
                                                • Demonstrates that the establishment                                                                       supported.
                                                                                                      petition, FSIS is adding compliance
                                              has effective process control by                        with good commercial practices (GCPs)                 Conditions for Operating Under a
                                                                                                      to the criteria that the Agency will use              Waiver and FSIS Verification
                                                7 The February 23, 2018, Constituent Update is

                                              available at: https://www.fsis.usda.gov/wps/wcm/        to consider line speed waiver requests                   Establishments that are eligible for a
                                              connect/ee977696-7f87-4b87-8717-15a824ce0a81/           submitted by NPIS young chicken                       line speed waiver and that have
                                              ConstiUpdate022318.pdf?MOD=AJPERES&                     slaughter establishments. The                         assembled the documentation that
                                              CONVERT_TO=url&CACHEID=ee977696-7f87-                   regulations require that poultry be                   needs to be included in their waiver
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                                              4b87-8717-15a824ce0a81.
                                                8 This refers to a public health alert issued         slaughtered in accordance with GCPs, in               request described above should submit
                                              through the Public Health Information System for        a manner that will result in thorough                 their line speed waiver requests to the
                                              non-compliance with public health regulations (see      bleeding of the poultry carcass and will              FSIS Office of Policy and Program
                                              FSIS Notice 15–08, Public Health Regulations and        ensure that breathing has stopped before              Development (OPPD) Risk Innovations
                                              Alerts for Use in Determining Inspection Program
                                              Personnel Actions and Public Health Risk
                                                                                                      scalding (9 CFR 381.65(b)). In a Federal              and Management Staff (RIMS). After
                                              Evaluation Scheduling in Meat and Poultry               Register notice published on September                FSIS receives a line speed waiver
                                              Establishments (March 20, 2018)).                       28, 2005, FSIS explained that poultry                 request, the Agency will follow the


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                                                                          Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices                                          49051

                                              procedures in FSIS Directive 5020.2,                    establishment collects and analyzes                   safety trim and processing defects when
                                              The New Technology Review Process                       samples for microbial organisms                       operating at higher line speeds.
                                              (October 24, 2017), to verify that the                  including both Salmonella and                            Directive 5020.1 provides that FSIS
                                              establishment meets the criteria to be                  indicator organisms, and shares the                   may revoke a waiver of regulatory
                                              eligible for the waiver and to evaluate                 results with FSIS. As discussed above,                requirements when an establishment
                                              the establishment’s waiver request                      FSIS will require establishments with                 fails to meet or follow its alternative
                                              submission.                                             line speed waivers to conduct daily APC               procedures associated with the waiver.
                                                 As noted in the Constituent Update, if               testing, instead of weekly testing for                Thus, if FSIS finds that an
                                              an establishment is granted a waiver,                   indicator organisms, as a condition of                establishment that has been granted a
                                              RIMS will provide the establishment                     their waivers. Establishments operating               line speed waiver is unable to meet the
                                              with a waiver letter that specifies the                 under a line speed waiver will need to                conditions of its waiver agreement, the
                                              required conditions for operating under                 identify the line speed they were                     Agency will consider whether to allow
                                              the waiver. To ensure consistency in                    operating under when they collected the               the establishment to implement
                                              data collection and analysis, when FSIS                 microbial data required under the SIP                 corrective actions and resume operating
                                              issues the waiver letter, the Agency will               and include the line speed when they                  under the waiver or whether the waiver
                                              also include a template for the                         submit their SIP data to FSIS. FSIS                   needs to be revoked. If the waiver is
                                              establishment to use to record and                      intends to use a six-month moving                     revoked, the establishment will be
                                              report to FSIS the data that the                        window approach to determine the                      required to comply with the 140 bpm
                                              establishment will be required to collect               establishment’s average line speed                    maximum line speed for the NPIS (9
                                              as a condition for its waiver. This                     based on the line speeds recorded as                  CFR 381.69(a)).
                                              template will provide for the reporting                 part of the SIP data.                                    FSIS currently posts a table of all
                                              of data on the daily Aerobic Plate Count                   In addition to participating in the SIP,           establishments that have been granted
                                              (APC) testing described above. FSIS will                young chicken establishments that have                regulatory waivers under the SIP on the
                                              require that all young chicken                          been granted a line speed waiver will                 FSIS website at: https://
                                              establishments with line speed waivers                                                                        www.fsis.usda.gov/wps/wcm/connect/
                                                                                                      need to continue to meet the criteria
                                              use the template to submit their data to                                                                      188bf583-45c9-4837-9205-
                                                                                                      outlined in the February 23, 2018,
                                              facilitate data aggregation and analysis.                                                                     37e0eb1ba243/Waiver_Table.pdf?MOD
                                                                                                      Constituent Update described above to
                                                 As also noted in the Constituent                                                                           =AJPERES. The 20 former HIMP young
                                                                                                      remain eligible for a waiver. The Agency
                                              Update, one of the conditions for                                                                             chicken establishments now operating
                                                                                                      will follow the procedures in FSIS
                                              operating under a line speed waiver will                                                                      under the NPIS that have been granted
                                                                                                      Directive 5020.1, Verification Activities
                                              be that establishments notify the FSIS                                                                        line speed waivers are included in the
                                                                                                      for the Use of New Technology in Meat
                                              inspector-in-charge (IIC) when they are                                                                       table. These establishments are the only
                                                                                                      and Poultry Establishments, and Egg
                                              operating at line speeds higher than 140                                                                      NPIS young chicken establishments that
                                                                                                      Products Plants (October 6, 2016), to
                                              bpm and when they reduce their line                                                                           have been granted line speed waivers
                                                                                                      verify that establishments that have                  under the SIP. FSIS intends to update
                                              speeds to 140 bpm or below to allow
                                              FSIS to evaluate the establishment’s                    been granted waivers remain eligible for              this table if the Agency grants additional
                                              ability to maintain process control at a                their waivers and are following the                   SIP waivers or revokes existing waivers.
                                              given line speed. Young chicken                         process control procedures agreed to as
                                                                                                      a condition for the waivers.                          Former HIMP Young Chicken
                                              establishments that are granted a line
                                                                                                         Under Directive 5020.1, FSIS IPP                   Establishments’ Line Speed Waivers
                                              speed waiver will routinely need to
                                              operate at least one line at speeds above               verify, among other things, that the                     As noted above, when FSIS
                                              140 bpm on average, but not higher than                 establishment is effectively                          implemented the NPIS, the Agency
                                              175 bpm. Establishments with multiple                   implementing its process control                      granted waivers to allow the 20 young
                                              lines may operate more than one line                    procedures as documented in its waiver                chicken establishments that participated
                                              above 140 bpm and up to 175 bpm, but                    letter and collecting SIP microbial data              in the HIMP pilot to operate at line
                                              if they do, they will need to collect                   to monitor its ability to maintain                    speeds up to 175 bpm after they
                                              separate data for each individual line.                 process control. IPP will review the                  converted to the NPIS because data from
                                              While FSIS recognizes that                              results of the establishment’s microbial              the HIMP pilot showed that these
                                              establishments may need to                              sampling program and verify that the                  establishments were able to maintain
                                              occasionally reduce line speed during                   establishment takes appropriate                       process control when operating at the
                                              the course of operations, the average                   corrective actions in response to its                 line speeds authorized by HIMP (79 FR
                                              speed for each line used to collect data                testing results, including slowing the                49591). A preliminary review of the SIP
                                              under the waiver will need to be higher                 line when needed to maintain process                  data that these establishments have
                                              than 140 bpm. Establishments                            control.                                              submitted to FSIS as a condition of their
                                              consistently unable to maintain process                    Additionally, FSIS will review the                 waivers shows that most of them have
                                              control at line speeds higher than 140                  results of the Agency’s Salmonella                    operated at line speeds higher than 140
                                              bpm or consistently operating at line                   sampling to verify that the                           bpm since they converted to the NPIS,
                                              speeds lower than 140 bpm will be                       establishment continues to meet the                   and over half report that they have
                                              subject to waiver revocation.                           performance standards for Category 1 or               operated between 170 and 175 bpm.
                                                 Consistent with the waivers granted to               2 for young chicken carcasses when                    Thus, the data collected under these
                                              the 20 HIMP young chicken                               operating at faster line speeds. FSIS will            waivers has allowed FSIS to continue to
                                              establishments to operate at up to 175                  also evaluate process control by                      evaluate the ability of the former HIMP
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                                              bpm, any additional NPIS                                reviewing the results of the Agency’s 10-             young chicken establishments to
                                              establishments that are granted a line                  bird offline verification checks to verify            maintain process control when
                                              speed waiver will need to participate in                that the establishment is meeting the                 operating at higher line speeds after
                                              the SIP as a condition of their waivers.                zero tolerance standard for fecal                     they convert to the NPIS.
                                              Under the SIP, FSIS grants                              contamination and septicemia/toxemia,                    As discussed above, FSIS now has
                                              establishments a waiver of a regulation                 and that it is not producing product                  over a year of documented process
                                              with the condition that the                             with persistent, unattended non-food                  control history for many young chicken


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                                              49052                       Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices

                                              establishments operating under the                      from individuals employed by poultry                  chicken establishments operating under
                                              NPIS.9 Therefore, the Agency intends to                 slaughter establishments urging the                   the NPIS because FSIS has already
                                              consider additional waiver requests to                  Agency to deny the petition. In                       issued regulations and implemented
                                              allow NPIS young chicken                                addition, several employees from                      procedures for establishments to request
                                              establishments that meet the criteria                   various poultry slaughter companies                   regulatory waivers. Establishments that
                                              described above to operate at line                      submitted comments on company                         meet the criteria to be eligible for a line
                                              speeds of up to 175 bpm. FSIS intends                   letterhead in support of the petition.                speed waiver may use the existing
                                              to use the data collected from young                       Comments from poultry slaughter                    procedures to submit a waiver request.
                                              chicken establishments that are granted                 establishments and their employees,                      FSIS established 140 bpm as the
                                              these additional waivers, along with                    companies that own poultry slaughter                  maximum line speed for the NPIS, with
                                              data collected from the 20 former young                 establishments, trade associations                    an exception for the 20 former HIMP
                                              chicken HIMP establishments that have                   representing the poultry industry, and a              young chicken establishments, because
                                              been granted waivers, to assess the                     few individuals supported granting the                FSIS concluded that it is important to
                                              ability of NPIS establishments to                       petition. Comments from consumer                      assess each young chicken
                                              maintain process control at higher line                 advocacy organizations, animal welfare                establishment’s ability to maintain
                                              speeds and to inform future rulemaking,                 advocacy organizations, worker                        process control as they implement
                                              if supported.                                           advocacy organizations, civil rights                  changes to operate under the NPIS (79
                                                 So that the data collected from all                  advocacy organizations, labor unions,                 FR 49591). In the final rule that
                                              NPIS establishments with line speed                     members of Congress, poultry                          established the NPIS, FSIS made clear
                                              waivers will be comparable, the 20                      establishment employees, and several                  that it would continue to evaluate the
                                              former HIMP young chicken                               individuals urged FSIS to deny the                    line speeds at which establishments are
                                              establishments granted line speed                       petition. All of the comments submitted               capable of consistently producing safe,
                                              waivers and establishments applying for                 in response to organized write-in                     wholesome, and unadulterated product,
                                              new line speed waivers will have to                     campaigns urged FSIS to deny the                      as well as meeting Salmonella and other
                                              meet the new, additional line speed                     petition.                                             performance standards.
                                              waiver criteria. FSIS intends to issue                     A summary of the general issues                       Although FSIS has denied NCC’s
                                              new waiver letters containing the                       raised by the comments received in                    request to establish a waiver program
                                              eligibility criteria described above to the             response to the NCC petition and FSIS’s               that would provide for unlimited line
                                              20 former HIMP establishments and                       responses are presented below. Several                speeds, the Agency will consider
                                              grant them 120 days from receipt to                     of the issues have been addressed by                  granting individual waivers to allow
                                              meet the criteria. If an establishment is               FSIS’s denial of the NCC petition.                    young chicken establishments that meet
                                              unable to meet any of the criteria within                                                                     the criteria described above to operate at
                                                                                                      Support for Petition
                                              120 days of receipt, FSIS may revoke its                                                                      line speeds of up to 175 bpm. The data
                                                                                                         Comment: Poultry slaughter                         collected from establishments that are
                                              line speed waiver.
                                                                                                      establishments, companies that own                    granted these waivers will allow FSIS to
                                              Comments                                                poultry slaughter establishments, and                 evaluate the ability of NPIS
                                                 As noted above, FSIS made the NCC                    trade associations representing the                   establishments that did not participate
                                              petition available to the public on the                 poultry industry said that granting the               in the HIMP pilot to maintain process
                                              FSIS website and the Federal                            NCC petition would enhance FSIS                       control at line speeds of up to 175 bpm.
                                              eRulemaking Portal at https://                          inspection procedures and increase                    The waivers do not provide for
                                              www.regulations.gov. FSIS received                      industry efficiency while ensuring                    unlimited line speeds, as requested in
                                              over 100,000 comments and signatures                    safeguards are in place to promote                    the NCC petition, because the Agency’s
                                              on the NCC petition, most of them                       worker safety and bird welfare. The                   experience under the HIMP pilot
                                              identical comments or form letters                      comments stated that line speeds should               showed that online inspectors are able
                                              submitted as part of organized write-in                 be based on an establishment’s ability to             to conduct an effective online
                                              campaigns. FSIS received comments                       maintain process control rather than                  inspection of each bird processed at line
                                              from poultry slaughter establishments                   regulatory line speed limits. The                     speeds of up to 175 bpm.
                                              and their employees, companies that                     comments noted that the NPIS was
                                                                                                      intended to improve food safety                       Waiver Regulations
                                              own poultry slaughter establishments,
                                                                                                      outcomes and generate cost efficiencies                 Comment: Comments from consumer
                                              trade associations representing the
                                                                                                      for both establishments and FSIS.                     advocacy organizations, animal welfare
                                              poultry industry, consumer advocacy
                                                                                                      According to the comments, without the                advocacy organizations, worker safety
                                              organizations, animal welfare advocacy
                                                                                                      incentive of higher line speeds, the 140              advocacy organizations, civil rights
                                              organizations, worker advocacy
                                                                                                      bpm line speed cap established in the                 advocacy organizations, labor unions,
                                              organizations, civil rights advocacy
                                                                                                      final NPIS rule has discouraged many                  and members of Congress stated that
                                              organizations, environmental advocacy
                                                                                                      establishments from opting into the                   FSIS must deny the NCC petition
                                              organizations, labor unions, members of
                                                                                                      NPIS and has caused the industry and                  because the requested action does not
                                              Congress, poultry establishment
                                                                                                      FSIS to forego potential cost savings                 meet any of the criteria to qualify for a
                                              employees, and individuals. The
                                                                                                      associated with making better use of                  waiver under 9 CFR 381.3(b). The
                                              comments also included a petition from
                                                                                                      resources. The comments asserted that                 waiver regulations in 9 CFR 381.3(b)
                                              an animal welfare advocacy
                                                                                                      allowing establishments to increase line              provide that ‘‘[t]he Administrator may,
                                              organization with over 53,000 signatures
                                                                                                      speeds will enhance food safety by                    in specific cases, waive any provision of
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                                              and a petition from a consumer
                                                                                                      encouraging more establishments to                    the poultry inspection regulations in
                                              advocacy organization with over 17,000
                                                                                                      participate in the NPIS and SIP.                      order to permit appropriate and
                                              signatures. FSIS also received
                                                                                                         Response: As stated in FSIS’s                      necessary action in the event of a public
                                              approximately 7,900 identical postcards
                                                                                                      response to the NCC petition, the                     health emergency or to permit
                                                9 As of August 21, 2018, 67 young chicken             Agency has determined that it is not                  experimentation so that new
                                              establishments were operating under the NPIS,           necessary to establish a separate system              procedures, equipment, and processing
                                              including the 20 former HIMP establishments.            to provide line speed waivers to young                techniques may be tested to facilitate


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                                                                          Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices                                          49053

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


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                                              49054                       Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices

                                              toxemia and visible fecal contamination.                means that the inspector gives a                      effectiveness of the establishment’s
                                              An animal welfare advocacy                              ‘‘critical determination whether [a                   sorting and other process control
                                              organization commented that NCC’s                       carcass or part of a carcass] is                      procedures (79 FR 49587). FSIS
                                              requested action would increase the risk                adulterated or unadulterated’’ (AFGE v.               conducts additional verification
                                              that poultry meat would become                          Glickman, 215 F 2nd 7 (D.C. Cir., 2000)).             activities in all NPIS establishments,
                                              adulterated from inhumane handling of                   According to the comments, NCC’s                      including those operating under
                                              chickens because faster line speeds are                 request to allow poultry slaughter                    waivers, as needed to respond to the
                                              correlated with loss of process control                 establishments to operate at line speeds              Agency’s verification findings (FSIS
                                              that results in birds being intentionally               greater than 175 bpm would make it                    Directive 6500.1, New Poultry
                                              mistreated by workers, improperly hung                  extremely difficult, if not impossible, for           Inspection System: Post-Mortem
                                              in shackles, insufficiently cut and bled,               FSIS to inspect the carcass of each bird              Inspection and Verification of Ready-to-
                                              and scalded alive.                                      processed. A consumer advocacy                        Cook Requirement, February 1, 2017).
                                                 FSIS Response: Because FSIS has                      organization stated that faster line                     Comment: A worker rights advocacy
                                              denied the NCC petition, the Agency                     speeds will also reduce the percentage                organization stated that even if the
                                              will not be establishing a waiver                       of carcasses assessed through offline                 requirements of the waiver regulations
                                              program that the comments state will                    inspections because the number of                     are met, the NCC is not authorized to
                                              conflict with the purposes or provisions                assigned offline carcass verification                 submit a waiver request under CFR
                                              of the PPIA. Instead, as noted                          checks does not vary with line speed,                 381.3(b). The organization stated that
                                              throughout this document, the Agency                    meaning a smaller percentage of birds                 FSIS’s Procedures for Notification of
                                              will use its existing waiver procedures                 will be inspected offline for fecal                   New Technology (68 FR 6873) allow
                                              to consider granting line speed waivers                 contamination as line speeds increase.                official establishments and companies
                                              to individual establishments that meet                     FSIS Response: Because FSIS has                    that manufacture and sell technology to
                                              the criteria described above to operate at              denied the NCC petition, young chicken                official establishments to submit new
                                              line speeds of up to 175 bpm. Under                     NPIS establishments will not be granted               technology notifications to the Agency.
                                              these criteria, establishments will only                waivers to operate without line speed                 The comment noted that the NCC is not
                                              be eligible for a waiver if, among other                limits. FSIS’s experience under the                   an official establishment or a company
                                              things, they have been operating under                  HIMP pilot showed that online                         that manufactures or sells new
                                              the NPIS for at least one year with a                   inspectors in HIMP young chicken                      technologies.
                                              demonstrated ability to maintain                        establishments were able to conduct an                   FSIS Response: Nothing in the
                                              process control and demonstrated                        effective online inspection of each                   regulations at 9 CFR 381.3(b) limits the
                                              history of regulatory compliance. After                 carcass when operating at a line speed                submission of waiver requests to the
                                              an establishment has been granted a                     of up to 175 bpm. As discussed above,                 regulated industry or companies that
                                              waiver, it will need to submit microbial                FSIS intends to grant individual waivers              manufacture or sell new technologies.
                                              data and other records, such as                         to allow certain young chicken NPIS                   FSIS has denied the NCC petition, but
                                              statistical process control charts, to FSIS             establishments to operate at line speeds              will continue to consider waiver
                                              to demonstrate that it is able to maintain              up to 175 bpm. To ensure that online                  requests from official establishments,
                                              process control when operating at faster                inspectors are able to conduct an                     companies that manufacture or sell new
                                              line speeds. FSIS will monitor the                      effective online inspection of each bird              technologies, and other interested
                                              establishment’s ability to maintain                     processed, FSIS inspectors-in-charge                  parties.
                                              process control by evaluating the results               (IICs) in all NPIS establishments,                    NPIS Line Speed Regulation
                                              of the Agency’s Salmonella verification                 including those operating under
                                              sampling, performing carcass                            waivers, are authorized to direct                        Comment: Comments from consumer
                                              verification checks, performing                         establishments to operate at a reduced                advocacy organizations, animal welfare
                                              sanitation verification activities, and                 line speed when in the IIC’s judgment                 advocacy organizations, worker rights
                                              reviewing the records that the                          a carcass-by-carcass inspection cannot                advocacy organizations, civil rights
                                              establishment maintains to demonstrate                  be performed within the time available,               advocacy organizations, and members of
                                              process control, including the                          due to the manner in which the birds                  Congress asserted that the NCC petition
                                              establishment’s microbiological testing                 are presented to the online carcass                   is an attempt to bypass the maximum
                                              data. Finally, in regard to the handling                inspector, the health conditions of a                 line speed for the NPIS prescribed in the
                                              of live chickens, as discussed above,                   particular flock, or factors that may                 regulations without going through the
                                              compliance with GCP regulations will                    indicate a loss of process control (9 CFR             rulemaking process in violation of the
                                              be a condition of operating under a line                381.69(d)).                                           Administrative Procedure Act (APA) (5
                                              speed waiver for both waiver applicants                    With respect to the comment that                   U.S.C. 553). These comments stated that
                                              and establishments already operating                    faster line speeds will reduce the                    the 140 bpm maximum line speed is a
                                              under waivers.                                          percentage of carcasses assessed through              legislative rule established through
                                                 Comment: Several comments asserted                   offline inspections, as stated in the                 notice-and-comment rulemaking and,
                                              that, in addition to the potential for                  preamble to the rule that established the             therefore, can only be modified through
                                              increased contamination, the petition’s                 NPIS, under the NPIS, the offline                     notice-and-comment rulemaking. A
                                              requested waiver system would conflict                  carcass verification checks will be more              consumer advocacy organization stated
                                              with the purposes or provisions of the                  risk-based than under the HIMP pilot to               that the SIP waiver process is intended
                                              PPIA because high line speeds would                     reflect the performance of the                        to facilitate experimentation, not
                                              make it difficult for FSIS inspectors to                establishment (79 FR 49587). As under                 implement industry-wide changes.
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                                              conduct an effective online carcass-by-                 the HIMP pilot, FSIS continues to                        FSIS Response: Because FSIS has
                                              carcass inspection. Comments from                       conduct eight 10-bird verification                    denied the NCC petition, the Agency
                                              consumer and animal welfare advocacy                    checks per line per shift under the NPIS.             will not be establishing a line speed
                                              organizations noted that the PPIA                       However, as noted in the final NPIS                   waiver system for all young chicken
                                              requires FSIS inspectors to inspect ‘‘the               rule, FSIS monitors and analyzes the                  establishments and will not allow all
                                              carcass of each bird processed’’ (21                    ongoing results of its offline carcass                young chicken NPIS establishments to
                                              U.S.C. 455(b)) and that ‘‘inspection’’                  verification activities to assess the                 operate at line speeds faster than the


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                                                                          Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices                                         49055

                                              maximum 140 bpm prescribed by the                       assessment ‘‘[a]fter the NPIS has been                in the HIMP pilot to maintain process
                                              regulation (9 CFR 381.69(a)). The                       fully implemented on a wide scale and                 control at line speeds up to 175 bpm.
                                              Agency will consider individual line                    the Agency has gained at least a year of              FSIS intends to use these data, along
                                              speed waiver request submissions                        experience under the new system’’ (79                 with the data from establishments
                                              through its existing procedures using                   FR 49615). The comments noted that at                 currently operating under line speed
                                              the criteria described above. It should be              the time the NCC petition was                         waivers, to inform future rulemaking, if
                                              noted that the existing waiver                          submitted, approximately 60                           warranted, with respect to line speeds
                                              regulations were promulgated by notice-                 establishments had converted to the                   under the NPIS.
                                              and-comment rulemaking pursuant to                      NPIS while in the final rule that                        Comment: An animal welfare
                                              the APA. FSIS’s decision to grant                       established the NPIS, FSIS had                        advocacy organization commented that
                                              individual regulatory waivers under 9                   estimated that 219 establishment would                the PPIA requires a hearing be held for
                                              CFR 381.3(b) will not apply to all young                convert. Therefore, the comments                      ‘‘oral presentation of views’’ for
                                              chicken slaughter establishments nor                    asserted, the NPIS has not yet been fully             interested parties when the Agency
                                              establish a new maximum line speed                      implemented on a wide scale.                          engages in rulemaking related to its
                                              under NPIS and, therefore, would not be                 According to the comments, FSIS has                   subject matter (21 U.S.C. 463(c)). The
                                              subject to the APA’s notice-and-                        not accrued the necessary experience to               organization stated that FSIS has not
                                              comment rulemaking provisions.                          evaluate the NPIS establishments’                     held such a public hearing, and the
                                                 Comment: Comments from consumer                      ability to maintain process control at                public comment period that FSIS
                                              advocacy organizations, animal welfare                  any given line speed.                                 provided on regulations.gov is not a
                                              advocacy organizations, worker rights                      A consumer advocacy organization                   lawful substitute for the hearing
                                              advocacy organizations, civil rights                    noted that FSIS granted SIP waivers to                requirement.
                                              advocacy organizations, and members of                  allow the 20 former young chicken                        FSIS Response: FSIS’s regulations on
                                              Congress stated that granting waivers                   HIMP establishments to continue to                    petitions provide for interested persons
                                              from the line speed limits established                  operate at line speeds of up to 175 bpm               to submit comments on a petition (9
                                              for the NPIS would be an arbitrary                      after they converted to the NPIS because              CFR 392.7). The public comment period
                                              reversal of Agency position. The                        these establishments have demonstrated                that FSIS provided on regulations.gov is
                                              comments asserted that FSIS considered                  that they are able to maintain process                consistent with this regulatory
                                              and rejected requests to allow for faster               control under the line speeds authorized              provision. Under 21 U.S.C. 463(c), FSIS
                                              line speeds under the NPIS when the                     by HIMP. The comment said that in                     is required to provide interested persons
                                              Agency finalized the rule that                          granting these SIP waivers, FSIS stated               an opportunity for the oral presentation
                                              established the NPIS in 2014 (79 FR                     that it would compare the data from the               of views after the Agency has initiated
                                              49566). The comments noted that the                     former HIMP young chicken                             informal rulemaking. FSIS has not
                                              2014 final rule was the result of a                     establishments to data from other non-                initiated informal rulemaking in
                                              comprehensive, two-and-a-half year                      HIMP NPIS establishments as a means                   response to the petition. In addition, 21
                                              rulemaking process during which FSIS                    of evaluating the new program (79 FR                  U.S.C. 463(c) does not require that FSIS
                                              received and considered more than                       49591). The comment stated that FSIS                  hold public hearings to receive oral
                                              250,000 public comments. A worker                       has not made any efforts to conduct                   presentation of views as part of the
                                              safety advocacy organization noted that                 such an assessment that is available to               rulemaking process.
                                              the question of the maximum allowable                   the public.                                           NPIS Line Speed Data
                                              line speed was the single most                             FSIS Response: As noted above, FSIS
                                              commented-upon aspect of the NPIS                       has denied the NCC petition and thus,                    Comment: As discussed earlier in this
                                              rulemaking. Several comments also                       will not be implementing the line speed               document, the NCC petition cited data
                                              noted that in the fall of 2013, a network               waiver program requested in the                       in support of its position, including
                                              of worker safety groups petitioned the                  petition. FSIS’s decision to consider                 information from the 2011 HIMP pilot
                                              Occupational Safety and Health                          individual waiver requests to allow                   study, a 2001 published study on the
                                              Administration (OSHA) and USDA to                       certain young chicken NPIS                            HIMP pilot, and a 2017 unpublished
                                              regulate and reduce assembly line                       establishments to operate at line speeds              survey of NCC member companies
                                              speeds in meat and poultry processing                   of up to 175 bpm does not affect the                  operating under the NPIS with and
                                              establishments. The comments stated                     regulation that prescribes 140 bpm as                 without line speed waivers. Comments
                                              that OSHA ultimately denied the                         the maximum line speed for NPIS young                 from poultry slaughter establishments
                                              petition due to ‘‘a lack of resources,’’ but            chickens establishments (9 CFR                        and trade associations representing the
                                              in the 2014 NPIS final rule, FSIS chose                 381.69(a)) and is consistent with the                 poultry industry stated that the
                                              not to increase the current maximum                     Agency’s position on line speeds as                   available data demonstrate that young
                                              line speed limits for poultry slaughter                 stated in the final rule that established             chicken NPIS establishments are able to
                                              establishments.                                         the NPIS.                                             operate at line speeds above 140 bpm
                                                 Comments from consumer advocacy                         Also as discussed above, when FSIS                 without compromising food safety. The
                                              organizations, animal welfare advocacy                  published the final rule that established             comments stated that FSIS’s experience
                                              organizations, worker rights advocacy                   the NPIS, the Agency made it clear that               with the HIMP pilot upon which the
                                              organizations, civil rights advocacy                    it would continue to evaluate the line                NPIS is based demonstrates that
                                              organizations, and members of Congress                  speeds at which establishments are                    establishments can safely operate at
                                              stated that in FSIS’s 2014 NPIS                         capable of consistently producing safe,               higher line speeds. The comments
                                              rulemaking, the Agency acknowledged                     wholesome, and unadulterated product,                 referenced data from the 2011 HIMP
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                                              that line speeds should not increase                    as well as meeting pathogen reduction                 Report that shows that establishments
                                              without further research ‘‘to assess                    and other performance standards (79 FR                operating under the line speeds
                                              establishments’ ability to maintain                     49591). The data collected from                       authorized by HIMP perform as well as
                                              process control as they implement                       establishments that are granted new line              or better than comparable non-HIMP
                                              changes to operate under the NPIS’’ (79                 speed waivers will allow FSIS to                      establishments. A trade association
                                              FR 49615). The comments noted that                      evaluate the ability of NPIS                          representing the poultry industry
                                              FSIS intended to conduct this                           establishments that did not participate               referenced the 2001 study cited in the


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                                              49056                       Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices

                                              petition and claimed that this study                    on line speeds beyond the range of                    Worker Safety
                                              reinforces the conclusions in the HIMP                  actual line speeds studied in its survey.
                                              Report. The comments also referenced a                     Two consumer advocacy                                 Comment: Comments from poultry
                                              preliminary analysis of data from NPIS                  organizations noted that the petition                 slaughter establishments, trade
                                              and non-NPIS establishments that FSIS                   also referenced data from the 2011                    associations representing the poultry
                                              presented to stakeholders in October                    HIMP Report to support the requested                  industry, and individuals stated that
                                              2017. The comments asserted that this                   action. The comments asserted that data               permitting NPIS young chicken
                                              analysis further confirms that                          in the 2011 HIMP Report does not                      establishments to run at line speeds
                                              establishments permitted to operate at                  establish that food safety will be                    faster than 140 bpm would not be
                                              line speeds greater than 140 bpm had                    maintained should line speed caps be                  expected to have a significant impact on
                                              comparable Salmonella and                               lifted. The comments noted that the                   worker safety because the waivers
                                              Campylobacter percent positives for                     2011 HIMP Report stated that the                      would only apply to a specific highly
                                              both whole chicken carcasses and                        average line speed under HIMP was 131                 automated part of the processing line
                                              chicken parts, and that both were below                 bpm, well below the maximum line                      with little direct employee interaction
                                              the FSIS performance standards for                      speed of 175 bpm authorized under                     with the equipment or the birds. The
                                              these pathogens. The comments also                      HIMP. The comments also asserted that                 comments stated that the ‘‘further
                                              stated that an NCC analysis of FSIS                     line speed information from former                    processing lines’’ where workers debone
                                              performance standards sampling data,                    HIMP establishments does not provide                  and cut up chicken parts are separate
                                              NR rates, and other key food safety                     insight into operation at unlimited line              from the evisceration line and do not
                                              performance indicators submitted in                     speeds. The organizations also                        run at the same speed as the
                                              support of the petition shows that NPIS                 commented that the petition does not                  evisceration line. The comments stated
                                              establishments, including former HIMP                   address the concern that other young                  that even under the current NPIS
                                              establishments operating with higher                    chicken establishments might behave                   system, these further processing lines
                                              line speeds, are performing at least as                 differently than the 20 former HIMP                   run at slower speeds appropriate for the
                                              well as non-NPIS establishments.                        establishments. One comment stated                    type of work being done and this would
                                                 Consumer advocacy organizations,                     that the 2011 HIMP Report findings of                 not change if FSIS were to grant the
                                              animal welfare advocacy organizations,                  no statistical difference in fecal NRs and            petition.
                                              and worker advocacy organizations                       Salmonella positives based on line                       Poultry establishments and trade
                                              asserted that the petition does not                     speed show that FSIS did not find that                associations representing the poultry
                                              include any data to demonstrate that the                increased line speeds were statistically              industry commented that the available
                                              NPIS establishments would be able to                    related to these indicia of                           data show that increased line speeds do
                                              maintain process control at faster line                 contamination. The comment stated that                not present greater risks for worker
                                              speeds. The comments stated that                        this is not a ‘‘definite improvement.’’               safety. The comments asserted that
                                              although the petition discusses the                        FSIS Response: Although FSIS                       worker safety in poultry establishments
                                              results of an unpublished industry                      considered the supporting data in the                 has improved in the past two decades,
                                              survey, the discussion does not provide                 petition and the comments on these data               with worker illness and injury rates
                                              sufficient detail for FSIS to consider the              when evaluating the NCC petition, the                 reported by the Bureau of Labor
                                              data. The comments noted that the                       supporting data were not the primary                  Statistics (BLS) decreasing by more than
                                              petition does not include any                           basis for denying the petition. FSIS                  80 percent since 1994. The comments
                                              information on how establishments                       denied the NCC petition because the                   stated that the incidence of non-fatal
                                              were chosen for the survey, the                         Agency has already implemented                        occupational injuries and illnesses in
                                              methodology used to conduct the                         procedures for establishments to request              the poultry sector, which includes
                                              survey, or how the results are                          regulatory waivers and therefore, FSIS                slaughter and processing, remains at an
                                              statistically sound or valid. Comments                  determined that it is not necessary to                all-time low. The comments further
                                              from a consumer advocacy organization                   establish a separate waiver system to                 stated that the total recordable poultry
                                              and an animal welfare advocacy                          provide line speed waivers to young                   processing illness and injury rate for
                                              organization noted that the petition did                chicken establishments operating under                2016 was 4.2 cases per 100 full-time
                                              not present the Campylobacter and                       the NPIS. FSIS reviews submissions for                workers per year, down from 4.3 in
                                              Salmonella data, even in summary form.                  the use of procedures or processes that               2005. The comments also stated that the
                                              The comments stated that the petition                   require regulatory waivers on a case-by-              poultry industry’s rate of 4.2 was below
                                              only lists the survey participants’ total               case basis to determine whether the                   the rate of 6.9 for similar agricultural
                                              Salmonella and Campylobacter percent                    waiver request submission includes a                  industries in terms of injuries per 100
                                              positives and that the petition states that             method to document the performance of                 full-time workers and lower than the
                                              the NPIS participants’ percent positives                the new technology, so the resulting                  rate of 4.7 for the entire food
                                              were ‘‘as good as if not better than their              data can be monitored and analyzed.                   manufacturing sector. In addition to
                                              non-NPIS counterparts.’’                                   As noted above, FSIS has established               these statistics, the comments noted that
                                                 The comments also noted that the                     criteria that the Agency intends to use               the NCC’s industry survey of
                                              NCC survey results were not peer                        under its existing waiver process to                  establishments that have recently opted
                                              reviewed. A consumer advocacy                           consider waiver requests by young                     into the NPIS and those that had been
                                              organization stated that the survey also                chicken establishments to operate at                  former HIMP establishments revealed
                                              did not include a pre-specified analysis                line speeds of up to 175 bpm. FSIS will               that all plants surveyed, on average,
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                                              plan, which could allow for selective                   consider individual waiver requests on                were operating well below the
                                              reporting, and that the survey relied                   a case-by-case basis and will base its                industry’s total DART (days away,
                                              upon data collected in the winter                       decision on whether to grant a waiver                 restricted, or transferred) rates.
                                              months, a time period when Salmonella                   on the information included in an                     According to the comments, this
                                              positives are typically lower. Another                  establishment’s waiver request                        provides evidence that the increased
                                              consumer advocacy organization stated                   submission, not on the data submitted                 line speeds have not resulted in an
                                              that the NCC seeks to draw conclusions                  in support of the petition.                           increase in worker injuries.


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                                                                          Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices                                          49057

                                                 Comments from worker and civil                       statistics that NCC relied on are based               address issues related to worker safety
                                              rights advocacy organizations, poultry                  on a potentially biased self-reporting                raised by the public comments. OSHA
                                              establishment employees, consumer                       system. Several comments noted that in                and NIOSH are the government agencies
                                              advocacy organizations, labor unions,                   the preamble to the final rule that                   with the expertise and authority to
                                              members of Congress, an environmental                   established the NPIS, FSIS recognized                 address worker safety issues in private
                                              advocacy organization, and private                      that the systemic underreporting of the               industry workplaces. As a result of this
                                              citizens asserted that establishing a line              poultry industry work-related injuries                collaboration, the final NPIS regulations
                                              speed waiver system as requested in the                 and illness ‘‘could make it difficult to              include provisions to remind
                                              NCC petition would increase risks to                    accurately assess the extent to which                 establishments of their existing legal
                                              worker health and safety in                             poultry workers suffer from work                      obligations to comply with the worker
                                              establishments that operate under such                  related injuries and musculoskeletal                  safety laws administered by OSHA (9
                                              waivers and would expose workers to                     diseases and disorders.’’ Comments                    CFR 381.69(d)). The final regulations
                                              hazards that have not been studied. The                 from a civil rights organization,                     also provide for establishments
                                              comments referenced studies, reports,                   members of Congress, and a labor union                operating under the NPIS to submit on
                                              and other data on work-related injuries                 expressed concern that increased line                 an annual basis an attestation to the
                                              in the meat and poultry processing                      speeds will disproportionately hurt                   management member of the local FSIS
                                              industry. The most commonly                             women and people of color. The labor                  circuit safety committee stating that the
                                              referenced information sources                          union commented that nearly 40                        establishment maintains a program to
                                              included:                                               percent of those who work in animal                   monitor and document any work-related
                                                 • Studies published by the National                  slaughtering and processing are women                 conditions of establishment workers (9
                                              Institute for Occupational Safety and                   and 67 percent are people of color.                   CFR 381.45). Because OSHA is the
                                              Health (NIOSH) that found high rates of                    FSIS Response: While FSIS agrees                   Federal agency with statutory and
                                              carpal tunnel syndrome among workers                    that working conditions in poultry                    regulatory authority to promote
                                              in the poultry industry. One study                      slaughter establishments is an important              workplace safety and health, FSIS
                                              found that 34 percent of workers in                     issue, the Agency has neither the                     forwards the annual attestation to OSHA
                                              poultry processing establishments had                   authority nor the expertise to regulate               for use in its own enforcement program.
                                              carpal tunnel syndrome, and 76 percent                  issues related to establishment worker                All establishments operating under the
                                              had evidence of nerve damage in their                   safety. FSIS has been delegated the                   NPIS are subject to the attestation
                                              hands and wrists. Another study found                   authority to exercise the functions of the            regulation, including the NPIS
                                              that 42 percent of workers at a poultry                 Secretary of Agriculture under the                    establishments operating under
                                              processing establishment had carpal                     Federal Meat Inspection Act (FMIA) (21                regulatory waivers. However, FSIS
                                              tunnel syndrome.                                        U.S.C. 601 et seq.), the PPIA (21 U.S.C.              employees are not responsible for
                                                 • 2016 BLS data showing that                         451 et seq.), and the Egg Products                    determining the merit of the content of
                                              employer reported injury rates for                      Inspection Act (EPIA) (21 U.S.C 1301 et               the attestation or for enforcement of
                                              poultry workers were 60 percent above                   seq.) (the Acts). Under the Acts, FSIS                non-compliance with the attestation
                                              the national average for all private                    protects the public by verifying that                 provision.
                                              industry, and illness rates were more                   meat, poultry, and egg products are safe,
                                              than five times as high.                                wholesome, not adulterated, and                       Animal Welfare
                                                 • Reports published by the                           properly marked, labeled, and packaged.                  Comment: Comments from animal
                                              Government Accountability Office                        The Acts authorize FSIS to administer                 welfare advocacy organizations and
                                              (GAO) in 2005, 2016, and 2017 that                      and enforce laws and regulations solely               individuals concerned about animal
                                              concluded, among other things, that                     to protect the health and welfare of                  welfare asserted that granting the
                                              injury rates in the meat and poultry                    consumers.                                            petition and allowing NPIS
                                              slaughter industries continue to be                        The DOL’s OSHA was created by the                  establishments to operate at faster line
                                              higher than the rates for others in the                 Occupational Safety and Health Act of                 speeds would have adverse effects on
                                              manufacturing industry, that meat and                   1970 (29 U.S.C. 651 et seq.) to assure                the humane handling of poultry. The
                                              poultry workers may under-report                        safe and healthful working conditions                 comments expressed concern about
                                              illnesses and injuries because they fear                for men and women by setting and                      worker frustration over faster line
                                              losing their jobs, and that employers                   enforcing standards and by providing                  speeds and the potential for workers to
                                              may underreport worker injuries                         training, outreach, education, and                    take these frustrations out on the birds;
                                              because of concerns about potential                     assistance. As was noted in the                       the potential for increased injuries that
                                              costs.                                                  preamble to the final rule that                       may occur from shackling birds at faster
                                                 • Various reports from worker                        established the NPIS, OSHA is the                     line speeds; the potential for worker
                                              advocacy organizations on worker safety                 Federal agency with statutory and                     injuries from birds vigorously flapping
                                              in meat and poultry processing                          regulatory authority to promote                       their wings while in shackles; and the
                                              establishments. These reports include                   workplace safety and health (79 FR                    potential for ineffective stunning and
                                              surveys of poultry workers that have                    49600). FSIS’s authority with respect to              throat cutting of birds at faster line
                                              suffered illnesses and injury from the                  working conditions in poultry slaughter               speeds. The comments noted that for
                                              fast-paced repetitive tasks associated                  establishments extends only to FSIS                   over 12 years, FSIS has recognized that
                                              with the current line speeds.                           inspection personnel. While FSIS is                   ‘‘poultry products are more likely to be
                                                 • OSHA citations of poultry                          prepared to address worker safety                     adulterated if, among other
                                              processing establishments for failure to                within the bounds of its authority, as                circumstances, they are produced by
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                                              record injuries and illnesses requiring                 noted above, FSIS has neither the legal               birds who have not been treated
                                              more than first aid.                                    authority nor the expertise to regulate or            humanely, because such birds are more
                                                 The comments stated that the                         enforce workplace standards for                       likely to be bruised or to die other than
                                              available studies, reports, and data                    establishment employees.                              by slaughter’’ (79 FR 49590). The
                                              contradict NCC’s assertion that worker                     During the development of the final                comments referenced FSIS NRs for
                                              illness and injury are at an all-time low,              rule that established the NPIS, FSIS                  cadavers, birds entering the scalder
                                              and, according to the comments, the                     collaborated with OSHA and NIOSH, to                  alive or not fully bled out, and birds


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                                              49058                       Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices

                                              exhibiting severe bruising primarily                       Comment: Two animal welfare                        in significant environmental impacts
                                              caused by dislocated legs and broken                    advocacy organizations commented that                 and thus is not required to analyze
                                              wings. According to the comments,                       if FSIS grants NCC’s petition, it should              potential environmental impacts
                                              faster line speeds will exacerbate these                require multi-stage controlled                        resulting from the waiver system
                                              conditions. Two animal welfare                          atmosphere killing (CAK) as a condition               proposed by NCC as suggested by the
                                              advocacy organizations asserted that                    of increasing line speeds. According to               comments.
                                              setting policy for poultry slaughter that               the comments, faster line speeds will                    With respect to the Agency’s decision
                                              promotes better animal handling                         likely result in more frequent loss of                to consider granting waivers to
                                              practices would further compliance                      process control, and FSIS is unlikely to              additional NPIS establishments to
                                              with the PPIA and ensure more effective                 be able to provide a rational explanation             operate at line speeds of up to 175 bpm,
                                              and efficient inspections.                              on how removing line speed limits will                that decision is categorically excluded
                                                 FSIS Response: Because the Humane                    result in similar or better process                   from NEPA requirements. Federal
                                              Methods of Slaughter Act (HMSA) (7                      control than is currently achieved with               agencies may identify classes of actions
                                              U.S.C. 1901–1907) does not apply to                     the line speed limit for the NPIS. The                that normally do not require the
                                              poultry, FSIS does not have direct                      comments asserted that multi-stage CAK                preparation of either an EA or EIS
                                              authority to regulate the humane                        systems would help maintain process                   because such actions do not have a
                                              handling of live poultry in connection                  control because birds stunned while in                significant effect on the human
                                              with slaughter. As noted above, under                   transport cages do not need to be                     environment, either individually or
                                                                                                      removed from their cages, dumped onto                 cumulatively (40 CFR 1507.3(b)(2)).
                                              all poultry inspection systems,
                                                                                                      conveyor belts, and shackled upside                   Such classes of actions are
                                              including the NPIS, establishments are
                                                                                                      down while still conscious. The                       ‘‘categorically excluded’’ from NEPA
                                              required to slaughter poultry in
                                                                                                      organizations stated that this would                  requirements (40 CFR 1508.4). Under 7
                                              accordance with GCPs, in a manner that
                                                                                                      facilitate proper handling.                           CFR 1b.4, all FSIS actions, including
                                              results in thorough bleeding of the
                                                                                                         FSIS Response: FSIS does not                       inspection functions, are categorically
                                              poultry carcasses and ensures that
                                                                                                      prescribe specific methods that                       excluded from preparation of an EA or
                                              breathing has stopped before scalding (9
                                                                                                      establishments must use to stun or kill               EIS unless the Agency head determines
                                              CFR 381.65(b)). As noted in the
                                                                                                      poultry in connection with slaughter.                 that a particular action may have a
                                              comments, in September 2005, FSIS
                                                                                                      Establishments are required to maintain               significant environmental effect.
                                              published a Federal Register notice to                  process control and comply with                       Accordingly, FSIS is not required to
                                              explain that poultry products are more                  requirements for GCPs regardless of the               prepare an EA or EIS unless it
                                              likely to be adulterated if, among other                methods they use to stun or kill the                  anticipates that granting additional line
                                              circumstances, they are produced from                   birds. Establishments may use CAK                     speed waivers may have a significant
                                              birds that have not been treated                        stunning if they choose to do so.                     environmental effect.
                                              humanely because such birds are more                                                                             The Agency does not anticipate that
                                              likely to be bruised or to die other than               National Environmental Policy Act                     its decision to consider granting waivers
                                              by slaughter (70 FR 56624). Under both                    Comment: Comments from animal                       to additional NPIS establishments to
                                              the PPIA and its implementing                           welfare advocacy organizations and an                 operate at line speeds of up to 175 bpm
                                              regulations, poultry carcasses showing                  environmental advocacy organization                   will have individual or cumulative
                                              evidence of having died from causes                     stated that if FSIS grants the NCC                    effects on the environment. Expected
                                              other than by slaughter are considered                  petition, the Agency must prepare an                  sales of poultry products to consumers
                                              adulterated and as such must be                         Environmental Impact Statement (EIS)                  will determine the total number of birds
                                              condemned (21 U.S.C. 453(g)(5) and 9                    as required under the National                        that a poultry establishment slaughters,
                                              CFR 381.90). Establishments operating                   Environmental Policy Act (NEPA)(42                    not the maximum line speed under
                                              under the NPIS have always been, and                    U.S.C. 4321 et seq.) because the                      which it operates. The Agency has no
                                              will continue to be, subject to these                   requested action to allow poultry                     authority to determine a poultry
                                              requirements regardless of their line                   slaughterhouses to increase line speeds               establishment’s production levels. An
                                              speed, including establishments that                    would result in significant                           establishment may decide to increase
                                              have been granted waivers to operate at                 environmental impacts. The comments                   production hours to slaughter more
                                              line speeds of up to 175 bpm. As                        stated that faster line speeds would                  birds in response to market demand,
                                              outlined in FSIS Directive 6300.1, Ante-                mean more birds slaughtered per shift.                regardless of its maximum line speed.
                                              mortem and Post-mortem Poultry                          According to the comments, more birds                 Granting an establishment a waiver to
                                              Inspection, FSIS verifies GCPs as part of               slaughtered would mean more waste,                    operate at up to 175 bpm will allow that
                                              a daily, per-shift inspection task                      more water use, and more fossil fuels                 establishment to slaughter birds more
                                              performed by the public health                          required to transport the birds from farm             efficiently, but will not affect consumer
                                              veterinarian (PHV). Any non-                            to slaughterhouse. The comments                       demand for the establishment’s poultry
                                              compliances are documented under 9                      asserted that these are all significant               products. In some instances, an
                                              CFR 381.65(b) and reviewed weekly as                    environmental impacts, with both                      establishment that is granted a waiver
                                              one of many measures of process                         individual and cumulative effects at the              may be able to reduce its hours of
                                              control. However, in response to these                  local, state, and national levels. The                operation while maintaining production
                                              comments, as discussed above, FSIS has                  comments also stated that if FSIS grants              at a rate necessary to meet market
                                              decided to add compliance with the                      NCC’s petition, FSIS cannot claim the                 demand for its poultry products. Thus,
                                              GCP regulation to the criteria that the                 categorical exclusion from the                        granting waivers to allow additional
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                                              Agency will consider when evaluating                    preparation of an Environmental                       NPIS establishments to operate at up to
                                              an establishment’s line speed waiver                    Assessment (EA) or an EIS under 7 CFR                 175 bpm is not expected to affect the
                                              request submission. Also, as discussed                  part 1b of the USDA regulations.                      number of birds slaughtered or result in
                                              above, FSIS will now consider                             FSIS Response: Because FSIS has                     more waste, more water use, or require
                                              compliance with the GCP regulations as                  denied the NCC petition, it will not be               more fossil fuels to transport the birds
                                              a condition for existing line speed                     implementing the waiver system that                   from farm to slaughterhouse, as
                                              waivers.                                                these commenters believe could result                 suggested by the comments. In addition,


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                                                                          Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices                                          49059

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


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                                              49060                       Federal Register / Vol. 83, No. 189 / Friday, September 28, 2018 / Notices

                                              establishments that process poultry for                 and notices. Customers can add or                     reports, is available at http://
                                              export comply with maximum line                         delete subscriptions themselves, and                  sterlinghighway.net/. For information
                                              speeds regulations similar to those in                  have the option to password protect                   related specifically to the Forest Plan
                                              the United States.                                      their accounts.                                       amendment, please contact David Fitz-
                                                                                                                                                            Enz, Forest Planner, Chugach National
                                              USDA Non-Discrimination Statement                       Paul Kiecker,
                                                                                                                                                            Forest at 907–743–9595 or dfitzenz@
                                                 No agency, officer, or employee of the               Acting Administrator.                                 fs.fed.us.
                                              USDA shall, on the grounds of race,                     [FR Doc. 2018–21143 Filed 9–27–18; 8:45 am]              Individuals who use
                                              color, national origin, religion, sex,                  BILLING CODE 3410–DM–P                                telecommunication devices for the deaf
                                              gender identity, sexual orientation,                                                                          (TDD) may call the Federal Information
                                              disability, age, marital status, family/                                                                      Relay Service (FIRS) at 1–800–877–8339
                                              parental status, income derived from a                  DEPARTMENT OF AGRICULTURE                             between 8 a.m. and 8 p.m., Eastern
                                              public assistance program, or political                                                                       Time, Monday through Friday.
                                              beliefs, exclude from participation in,                 Forest Service
                                                                                                                                                            SUPPLEMENTARY INFORMATION:
                                              deny the benefits of, or subject to                     Chugach National Forest; Alaska;
                                              discrimination any person in the United                                                                       Background
                                                                                                      Notice of a Proposed Amendment to
                                              States under any program or activity                                                                             This notice is specific to the Forest
                                                                                                      the Chugach National Forest Land and
                                              conducted by the USDA.                                                                                        Service. The FHWA was the lead
                                                                                                      Resource Management Plan, Applying
                                                 To file a complaint of discrimination,                                                                     Federal agency for the Sterling Highway
                                                                                                      Only to the Sterling Highway Milepost
                                              complete the USDA Program                                                                                     Mile 45–60 Project EIS and Record of
                                                                                                      45–60 Project
                                              Discrimination Complaint Form, which                                                                          Decision, which was signed on May 31,
                                              may be accessed online at http://                       AGENCY:  Forest Service, USDA.                        2018. The decision, implementing the
                                              www.ocio.usda.gov/sites/default/files/                  ACTION: Notice; project-specific                      ‘‘Juneau Creek Alternative,’’ requires 3.3
                                              docs/2012/Complain_combined_6_8_                        amendment to the Chugach National                     miles of new road construction across
                                              12.pdf, or write a letter signed by you                 Forest 2002 Land and Resource                         lands managed by the Chugach National
                                              or your authorized representative.                      Management Plan.                                      Forest in the Kenai Peninsula Borough,
                                                 Send your completed complaint form                                                                         Alaska. The Forest Service must
                                              or letter to USDA by mail, fax, or email:               SUMMARY:    On May 31, 2018, the U.S.                 determine whether to consent to the
                                                 Mail: U.S. Department of Agriculture,                Department of Transportation, Federal                 transfer of a highway easement for these
                                              Director, Office of Adjudication, 1400                  Highway Administration (FHWA)                         lands under 23 U.S.C. 317. This consent
                                              Independence Avenue SW, Washington,                     signed a Record of Decision for the                   is conditioned on the Forest Service
                                              DC 20250–9410.                                          Sterling Highway MP 45–60 Project,                    completing a project-specific plan
                                                 Fax: (202) 690–7442.                                 which involves highway construction                   amendment because the new route is
                                                 Email: program.intake@usda.gov.                      and reconstruction near Cooper                        inconsistent with a Forest Plan standard
                                                 Persons with disabilities who require                Landing, Kenai Peninsula Borough,                     prohibiting new road construction
                                              alternative means for communication                     Alaska. The U.S. Department of                        within a certain type of brown bear
                                              (Braille, large print, audiotape, etc.)                 Agriculture, Forest Service participated              habitat. This notice pertains only to this
                                              should contact USDA’s TARGET Center                     as a cooperating agency with FHWA and                 project-specific plan amendment.
                                              at (202) 720–2600 (voice and TDD).                      Alaska Department of Transportation                      The policy for project consistency
                                              Additional Public Notification                          and Public Facilities in the preparation              with prior plans amended using the
                                                                                                      of the draft and final Environmental                  2012 Planning Rule is set out at FSH
                                                 FSIS will announce this notice online                                                                      1909.12, Chapter 20, Section 21.33. For
                                                                                                      Impact Statements (EIS). To support the
                                              through the FSIS web page located at                                                                          a plan developed or revised under a
                                                                                                      FHWA decision, the Forest Service
                                              http://www.fsis.usda.gov/federal-                                                                             prior planning regulation (1982
                                                                                                      proposes a project-specific Land and
                                              register. FSIS will also make copies of                                                                       Planning Rule) that is amended
                                                                                                      Resource Management Plan (Forest
                                              this Federal Register publication                                                                             pursuant to the 2012 Planning Rule, the
                                                                                                      Plan) amendment to make the selected
                                              available through the FSIS Constituent                                                                        consistency requirement is that the 2012
                                                                                                      route consistent with the Chugach
                                              Update, which is used to provide                                                                              Planning Rule consistency provisions at
                                                                                                      Forest Plan.
                                              information regarding FSIS policies,                                                                          36 CFR 219.15(d) apply only to plan
                                              procedures, regulations, Federal                        DATES: Publication of this notice marks
                                                                                                                                                            component(s) added or modified in
                                              Register notices, FSIS public meetings,                 the initiation of a public comment
                                                                                                                                                            conformance with, and as defined by,
                                              and other types of information that                     period for the proposed action.
                                                                                                                                                            the 2012 Planning Rule. With respect to
                                              could affect or would be of interest to                 Comments concerning the scope of the
                                                                                                                                                            other plan provisions, the Forest
                                              constituents and stakeholders. The                      analysis must be received by November
                                                                                                                                                            Service’s prior interpretation of
                                              Update is communicated via Listserv, a                  13, 2018. The agency expects to release               consistency applies, that projects need
                                              free electronic mail subscription service               a draft Record of Decision for the                    only be consistent with plan standards
                                              for industry, trade groups, consumer                    proposed amendment in late 2018.                      and guidelines. (See 2012 Final Rule 77
                                              interest groups, health professionals,                  ADDRESSES: Send written comments to                   FR 21162, 21241 (April 9, 2012); 1991
                                              and other individuals who have asked                    Chugach National Forest Supervisor’s                  Advanced Notice of Proposed
                                              to be included. The Update is also                      Office, Attn: Sterling Highway Plan                   Rulemaking 56 FR 6508, 6519–6520
                                              available on the FSIS web page. In                      Amendment, 161 East 1st Avenue, Door                  (Feb 15, 1991) and the 1995 Proposed
                                              addition, FSIS offers an electronic mail                8, Anchorage, AK 99501. Comments                      Rule, at 60 FR 18886, 18902, 18909
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                                              subscription service which provides                     may also be sent via email to comments-               (April 13, 1995).)
                                              automatic and customized access to                      alaska-chugach@fs.fed.us, or via                         As analyzed and disclosed in the
                                              selected food safety news and                           facsimile to 907–743–9476.                            Sterling final EIS, this project is also
                                              information. This service is available at               FOR FURTHER INFORMATION CONTACT:                      inconsistent with one guideline related
                                              http://www.fsis.usda.gov/subscribe.                     Detailed information about the Sterling               to brown bear habitat. This
                                              Options range from recalls to export                    Highway Project, including the FHWA’s                 inconsistency does not require a plan
                                              information to regulations, directives,                 Record of Decision, FEIS, and related                 amendment (Forest Plan, p. 3–22), but is


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Document Created: 2018-09-28 01:22:41
Document Modified: 2018-09-28 01:22:41
CategoryRegulatory Information
CollectionFederal Register
sudoc ClassAE 2.7:
GS 4.107:
AE 2.106:
PublisherOffice of the Federal Register, National Archives and Records Administration
SectionNotices
ActionResponse to comments and information on waiver criteria.
ContactRoberta Wagner, Assistant Administrator, Office of Policy and Program Development, FSIS, USDA; Telephone: (202) 205-0495.
FR Citation83 FR 49048 

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