Vol. 79 Thursday, 

No. 162 August 21, 2014 

Part II 

Department of Agriculture 

Food Safety and Inspection Service 

9 CFR Parts 381 and 500 

Modernization of Poultry Slaughter Inspection; Final Rule 

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49566 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

1See ‘‘Evaluation of HACCP Inspection Models 

Project (HIMP), August 2011 (available on the FSIS 

Web site at: http://www.fsis.usda.gov/wps/wcm/

connect/fcd9ca3e-3f08-421f-84a7-936bc410627c/

Evaluation_HACCP_HIMP.pdf?MOD=AJPERES). 

DEPARTMENT OF AGRICULTURE 

Food Safety and Inspection Service 

9 CFR Parts 381 and 500 

[Docket No. FSIS–2011–0012] 

RIN 0583–AD32 

Modernization of Poultry Slaughter 

Inspection 

AGENCY: Food Safety and Inspection 

Service, USDA. 

ACTION: Final rule. 

SUMMARY: The Food Safety and 

Inspection Service (FSIS) is amending 

the poultry products inspection 

regulations to establish a new 

inspection system for young chicken 

and all turkey slaughter establishments. 

Young chicken and turkey slaughter 

establishments that do not choose to 

operate under the new poultry 

inspection system may continue to 

operate under their current inspection 

system. The Agency is also making 

several changes to the regulations that 

will affect all establishments that 

slaughter poultry other than ratites. This 

final rule is a result of the Agency’s 

2011 regulatory review efforts 

conducted under Executive Order 13563 

on Improving Regulation and Regulatory 

Review. 

DATES: 

Effective Date: October 20, 2014. 

Notification Date: All young chicken 

and turkey slaughter establishments will 

initially have until February 23, 2015, to 

notify their District Office in writing of 

their intent to operate under the New 

Poultry Inspection System (NPIS). 

Establishments that do not notify their 

District Office of their intent by 

February 23, 2015, will be deemed to 

have chosen the inspection system that 

they are currently operating under. 

Young chicken and turkey slaughter 

establishments that decide that they 

would like to convert to NPIS after the 

initial notification date may notify FSIS 

of their intent at any time after that date. 

The Agency will implement the NPIS in 

the additional establishments that 

intend to convert on a schedule 

consistent with Agency resources and 

readiness. The Agency intends to 

implement the NPIS in all young 

chicken and turkey establishments that 

choose to operate under the NPIS, 

regardless of when the establishment 

notifies FSIS of its intent to transition to 

the NPIS. However, the initial 

implementation wave will only include 

those establishments that submitted 

their notifications within the initial 

notification period. 

After October 20, 2014, FSIS will 

begin selecting from those 

establishments that have notified FSIS 

of their intent to switch to the NPIS. The 

Agency will use a computerized ranking 

system to determine the schedule of 

establishments for implementation of 

the NPIS. This ranking system will take 

into consideration several factors, such 

as FSIS staffing needs, past performance 

of the establishment, the location of the 

establishment with respect to other 

federally-inspected establishments, and 

establishment readiness to transition to 

the NPIS. FSIS will implement the NPIS 

in phases by clusters of establishments 

in close geographic proximity to one 

another. The initial implementation 

wave will only include those 

establishments that notified FSIS of 

their intent to switch to the NPIS during 

the initial six-month notification period. 

FSIS expects that in subsequent years 

many more establishments will choose 

to transition to the new system. The 

Agency’s implementation strategy for 

the NPIS is described in more detail in 

the preamble to this final rule. 

Applicability Dates: The regulations 

that prescribe procedures for controlling 

visible fecal contamination in 9 CFR 

381.65(f), the regulations that prescribe 

procedures for controlling 

contamination throughout the slaughter 

and dressing process in 9 CFR 381.65(g), 

and the regulations that prescribe 

recordkeeping requirements in 9 CFR 

381.65(h) will be applicable as follows: 

• In large establishments, defined as 

all establishments with 500 or more 

employees, on November 19, 2014; 

• In small establishments, defined as 

all establishments with 10 or more 

employees but fewer than 500, on 

December 19, 2014; 

• In very small establishments, 

defined as all establishments with fewer 

than 10 employees or annual sales of 

less than $2.5 million February 17, 

2015. 

FOR FURTHER INFORMATION CONTACT: 

Daniel Engeljohn, Assistant 

Administrator, Office of Policy and 

Program Development, FSIS, U.S. 

Department of Agriculture, 1400 

Independence Avenue SW., 

Washington, DC 20250–3700, (202) 205– 

0495. 

SUPPLEMENTARY INFORMATION: 

Executive Summary 

In January 2011, President Obama 

issued Executive Order (E.O.) 13563 on 

Improving Regulation and Regulatory 

Review. As part of this E.O., agencies 

were asked to review existing rules that 

may be outmoded, ineffective, 

insufficient, or excessively burdensome, 

and to modify, streamline, expand, or 

repeal them accordingly. As a result of 

FSIS’s regulatory review efforts 

conducted under E.O. 13563, on January 

27, 2012, the Agency published a 

proposed rule to modernize poultry 

slaughter inspection (‘‘Modernization of 

Poultry Slaughter Inspection,’’ 77 FR 

13512). This final rule adopts, with 

modifications, the provisions in the 

January 2012 proposal. FSIS is issuing 

this rule to facilitate pathogen reduction 

in poultry products, improve the 

effectiveness of poultry slaughter 

inspection, make better use of the 

Agency’s resources, and remove 

unnecessary regulatory obstacles to 

innovation. 

This final rule will establish a New 

Poultry Inspection System (NPIS) for 

young chicken and all turkey slaughter 

establishments. The NPIS will not 

replace, as was proposed, the current 

Streamlined Inspection System (SIS), 

the New Line Speed Inspection System 

(NELS), or the New Turkey Inspection 

System (NTIS). As such, young chicken 

and turkey slaughter establishments 

may choose to operate under the NPIS 

or may continue to operate under their 

current inspection system, i.e., SIS, 

NELS, NTIS, or Traditional Inspection, 

as modified by this final rule. 

Establishments that slaughter poultry 

other than young chickens or turkeys 

are not eligible to operate under the 

NPIS unless they obtain a waiver under 

the Salmonella Initiative Program. The 

Agency is not limiting the number of 

online inspectors in Traditional 

Inspection to two, as was proposed. 

FSIS will continue to staff all 

establishments that do not choose to 

operate under the NPIS with their 

current number of online inspectors. 

The NPIS is designed to facilitate 

pathogen reduction in poultry products 

by shifting Agency resources to allow 

FSIS inspectors to perform more offline 

inspection activities that are more 

effective in ensuring food safety, while 

providing for a more efficient and 

effective online carcass-by-carcass 

inspection. Data from the Agency’s 

Hazard Analysis and Critical Control 

Point Systems (HACCP)-Based 

Inspection Models Project (HIMP) pilot 

study,1 which was used to inform the 

NPIS, show that an inspection system 

that provides for increased offline 

inspection activities that are more 

directly related to food safety results in 

greater compliance with sanitation and 

HACCP regulations, carcasses with 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49567 

lower levels of visible fecal 

contamination, and carcasses with 

equivalent or lower levels of Salmonella 

contamination. 

Key elements of the NPIS include: (1) 

Requiring that establishment personnel 

sort carcasses and remove unacceptable 

carcasses and parts before the birds are 

presented to the FSIS carcass inspector; 

(2) shifting Agency resources to conduct 

more offline inspection activities that 

are more effective in ensuring food 

safety, which will allow for one offline 

verification inspector per line per shift 

and will reduce the number of online 

inspectors to one; (3) replacing the 

Finished Product Standards (FPS), 

which will apply to establishments that 

continue operating under SIS, NELS, 

and NTIS, with a requirement that 

establishments that operate under the 

NPIS maintain records to document that 

the products resulting from their 

slaughter operations meet the definition 

of ready-to-cook (RTC) poultry; and (4) 

authorizing young chicken slaughter 

establishments to operate at a maximum 

line speed of 140 birds per minute 

(bpm), provided that they maintain 

process control. 

Under all of the current inspection 

systems, online inspectors visually 

inspect every carcass, with its 

corresponding viscera, at fixed locations 

on the evisceration line immediately 

after separation of the viscera from the 

interior of the carcasses. The online 

inspectors are responsible for 

identifying unacceptable carcasses and 

parts, examining carcasses for visual 

defects, and directing establishment 

employees to take appropriate corrective 

actions if the defects can be corrected 

through trimming or reprocessing. The 

maximum line speeds authorized under 

the existing inspection systems reflect 

the time it takes for an inspector to 

effectively perform the online carcass 

inspection procedures required under 

these systems. 

Under the NPIS, there will be one 

online carcass inspector (CI) and one 

offline verification inspector (VI) 

assigned to each evisceration line. As 

under the HIMP inspection system, VIs 

and CIs under the NPIS will have 

different but complementary roles in 

ensuring that poultry products leaving 

the slaughter line are safe and 

wholesome. Under the NPIS, CIs will 

conduct a continuous online inspection 

of each carcass at a fixed location 

immediately before the chiller to 

determine whether each carcass is not 

adulterated. CIs under the NPIS will be 

able to conduct a more efficient and 

effective online carcass inspection than 

online inspectors do under the current 

inspection systems because the CIs are 

presented with carcasses that have been 

sorted, washed, and trimmed by 

establishment employees, and are thus 

much more likely to pass inspection. 

The VIs under the NPIS will conduct 

offline food safety-related inspection 

activities and will monitor and evaluate 

establishment process controls. The VIs 

will conduct carcass verification checks 

on carcass samples collected before the 

CI station to ensure that the 

establishment is effectively sorting 

carcasses and that it is producing 

products that comply with the Agency’s 

zero visible fecal tolerance and other 

performance standards. The VI and CI 

will work with the inspector-in-charge 

(IIC) to ensure that the carcasses 

presented to the CI are not affected with 

food safety defects or other conditions at 

levels that may impair the CI’s ability to 

effectively inspect each carcass. VIs will 

also perform offline activities in 

addition to carcass verification checks, 

such as verifying compliance with 

sanitation standard operating 

procedures (SOPs), sanitation 

performance standards (SPS), and 

HACCP regulatory requirements, and 

ensuring that the establishment is 

meeting all regulatory requirements and 

is effectively preventing contamination 

by enteric pathogens and fecal material 

throughout the entire slaughter and 

dressing process. 

The fastest maximum line speed 

authorized under the current inspection 

systems is 140 bpm under the SIS for 

young chickens. To determine line 

speeds for SIS, FSIS conducted field 

and work measurement studies of 

online inspectors to determine the time 

needed for an inspector to perform the 

SIS inspection procedure. The studies 

showed that online inspectors can 

perform the SIS inspection procedure at 

line speeds of up to 140 bpm if each 

inspector is presented with up to 35 

bpm. Thus, under SIS, establishments 

with automated evisceration equipment 

may operate at 140 bpm with four FSIS 

online inspectors assigned to the line. 

The maximum line speeds authorized 

under the other inspection systems are 

91 bpm with three online inspectors for 

NELS, and 51 bpm for light turkeys with 

two online inspectors and 45 bpm for 

heavy turkeys with two online 

inspectors for NTIS. As noted in the 

proposed rule, Traditional Inspection is 

typically employed at smaller lower 

production volume establishments that 

eviscerate carcasses by hand (77 FR 

4410). Thus, the maximum line speeds 

authorized under Traditional Inspection 

are slower than those under SIS, NELS, 

and NTIS. The maximum line speed for 

young chickens under Traditional 

Inspection is 64 bpm with four online 

inspectors. The maximum line speed for 

turkeys under Traditional Inspection is 

39 bpm with three online inspectors. 

As discussed in more detail later in 

this document, since 2007, HIMP young 

chicken establishments have been 

authorized to operate at line speeds of 

up to 175 bpm, depending on their 

ability to demonstrate consistent 

process control. Experience from the 

HIMP pilot shows that HIMP 

establishments operate with an average 

line speed of 131 bpm, and, although 

they are authorized to do so, most of the 

young chicken HIMP establishments do 

not operate line speeds at 175 bpm. 

Establishments determine their line 

speeds based on their equipment and 

facilities, bird size and flock conditions, 

and their ability to maintain process 

control when operating at a given line 

speed. In addition, line speeds under 

HIMP depend on the number of 

employees that the establishments hire 

and train to perform sorting activities. 

Although the maximum line speed 

under the NPIS is 140 bpm and not 175 

bpm as authorized under HIMP, FSIS 

believes that establishments choosing to 

operate under the NPIS will determine 

their line speeds based on the same 

factors that establishments considered 

when setting line speeds under HIMP 

for the past 15 years. 

Regardless of line speed, because 

HIMP and NPIS do not require that 

establishments configure their 

evisceration lines to accommodate more 

than one online carcass inspector, 

establishments operating under the 

NPIS will have greater control over their 

lines and greater flexibility over their 

production process. For example, as 

under HIMP, establishments operating 

under the NPIS will have the flexibility 

to reconfigure and consolidate lines if 

they determine that they need more 

space to conduct other activities in their 

facilities. In addition, because only one 

online inspector is required at the end 

of the line, establishments operating 

under the NPIS will not need to adjust 

their production based on the 

availability of FSIS inspection 

personnel to be stationed online. 

Establishment employees will staff the 

lines to perform the online sorting 

activities. Establishments that operate 

under NPIS will also have greater 

flexibility to increase production to 

respond to customer demands. 

As under HIMP, in addition to having 

more control over their production 

process, establishments operating under 

the NPIS will also have more 

opportunities for innovation and greater 

flexibility to develop and implement 

certain types of new technologies. 

Currently, if an establishment operating 

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49568 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

under the existing inspection systems 

wants to use new technologies for 

evisceration or for sorting, the 

establishment must work directly with 

the Agency to accommodate FSIS‘s 

online slaughter inspection 

methodologies. Doing so takes time and 

can become an obstacle to innovation. 

Under the NPIS, establishments will 

have direct control of the sorting 

process within their facilities and 

therefore will have the flexibility to 

implement and assess the technologies 

they think are beneficial to their 

operations. 

In addition to the NPIS for young 

chickens and turkeys, this final rule 

includes changes to the regulations that 

will apply to all establishments that 

slaughter poultry other than ratites. 

Under this final rule, all poultry 

slaughter establishments must develop, 

implement, and maintain written 

procedures to ensure that carcasses 

contaminated with visible fecal material 

do not enter the chiller, and they must 

incorporate these procedures into their 

HACCP plans, or sanitation SOPs, or 

other prerequisite programs (also 

referred to collectively as ‘‘the HACCP 

system’’ in this document). This final 

rule also requires that all poultry 

slaughter establishments develop, 

implement, and maintain written 

procedures to prevent contamination of 

carcasses and parts by enteric pathogens 

and fecal material throughout the entire 

slaughter and dressing operation, and 

that they incorporate their procedures 

into their HACCP systems. At a 

minimum, these procedures must 

include sampling and analysis for 

microbial organisms at the pre- and 

post-chill points in the process to 

monitor process control for enteric 

pathogens, with some exceptions for 

very small and very low volume 

establishments. Establishments will be 

required to maintain daily records 

sufficient to document the 

implementation and monitoring of these 

procedures. These new requirements 

will ensure that all poultry slaughter 

establishments implement appropriate 

measures to prevent contamination of 

carcasses by enteric pathogens and 

visible fecal material and that both FSIS 

and establishments have the 

documentation they need to verify the 

effectiveness of these measures on an 

ongoing basis. 

FSIS is also rescinding the regulation 

that requires that poultry establishments 

test carcasses for generic E. coli to 

monitor for process control. The generic 

E. coli regulations will be replaced by 

the new testing requirements described 

above. The new testing requirements 

will allow establishments to develop 

sampling plans that are more tailored, 

thus more effective in monitoring their 

specific process control than the current 

generic E. coli criteria. The Agency has 

concluded that the use of generic E. coli 

as an indicator for process control may 

not be as useful in broiler operations as 

originally thought. The Agency is taking 

this action to allow establishments to 

use other more relevant indicators of 

process control. The Agency established 

new performance standards for 

Salmonella and Campylobacter in 2011 

to more effectively manage these 

pathogens (76 FR 15282). Therefore, 

FSIS is removing the codified 

Salmonella pathogen reduction 

performance standards for poultry. 

Finally, FSIS is removing the 

prescriptive time and temperature 

parameters from the chilling 

requirements for RTC poultry and 

instead is requiring that poultry 

establishments incorporate procedures 

for chilling poultry into their HACCP 

systems. The Agency is also amending 

the regulations to permit poultry 

slaughter establishments to use (1) 

approved online reprocessing 

antimicrobial systems or (2) offline 

reprocessing antimicrobial agents 

including chlorinated water containing 

20 ppm to 50 ppm available chlorine or 

other antimicrobial substances that have 

been approved as safe and suitable for 

reprocessing poultry. Establishments 

will be required to address the use of 

online or offline reprocessing in their 

HACCP systems. 

TABLE 1—ESTIMATED NET SOCIAL BENEFITS FROM THE RULE (MILLIONS OF DOLLARS), ANNUALIZED OVER 10 YEARS

WITH A 7% DISCOUNT RATE, FOR VARYING PERCENT CHANGES THAT SWITCH TO NPIS 

[Percentage of Industry that Switches to NPIS] 

0% 10% 25% 50% 75% 90% 100% 

NPIS: 

Benefits: 

Public health benefits 

(10%, 90%) ............... 0.0 1.0 (0.3 to 1.7) 2.4 (0.8 to 4.3) 4.8 (1.6 to 8.7) 7.2 (2.4 to 13.0) 8.6 (2.9 to 15.7) 9.6 (3.3 to 17.4) 

FSIS net savings .......... 0.0 2.3 5.7 11.4 17.1 20.5 22.8 

Unquantified benefits ... Increased flexibility for establishments to design and implement production measures tailored to their operations, in some cases 

possibly including increased line speed up to 140 chickens or 55 turkeys per minute 

Costs: 

Costs to establishments 0.0 1.6 4.0 8.0 12.0 14.4 16.0 

Unquantified costs ....... Industry cost of responding to new NPIS inspections in a manner that may lead to public health benefits (e.g., discarding contaminated 

food or cooking it longer) 

Mandatory Component: 

Costs to establishments 9.1 9.1 9.1 9.1 9.1 9.1 9.1 

Unquantified benefits ... Potential additional public health benefits from documentation and testing 

Unquantified costs ....... Industry cost of responding to information generated by documentation and testing in a manner that may lead to public health benefits 

(e.g., discarding contaminated food or cooking it longer) 

Total benefits (10%, 

90%) ......................... 0.0 3.3 (2.6 to 4.0) 8.1 (6.5 to 10.0) 16.2 (13.0 to 20.1) 24.3 (19.5 to 30.1) 29.1 (23.4 to 36.2) 32.4 (26.0 to 40.2) 

Total costs .................... 9.1 10.7 13.1 17.1 21.1 23.5 25.1 

Net benefits (10%, 

90%) ......................... ¥9.1 ¥7.4 (¥8.1 to 

¥6.7) 

¥5 (¥6.6 to 

¥3.1) 

¥0.9 (¥4.1 to 

3.0) 

3.2 (¥1.6 to 9.0) 5.6 (¥0.1 to 12.7) 7.3 (0.9 to 15.1) 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49569 

FSIS presents the costs and cost 

savings that would be generated over a 

range of assumptions with respect to 

how much of the industry will choose 

to adopt NPIS within five years. These 

estimates are scaled from an illustrative 

calculation that assumes that all 219 

small and large non-Traditional 

establishments adopt NPIS, which, 

while used to calculate potential 

maximum effect, is not necessarily 

FSIS’s assumption of the most likely 

outcome. Later portions of the 

regulatory impact analysis section 

contain discussion of the uncertainty 

surrounding the net benefits associated 

with how much of the industry will 

choose to adopt NPIS. 

Table of Contents 

I. Background 

II. Summary of Modifications Made to the 

Proposed Rule 

III. Comments and Responses 

A. NACMPI and Public Process 

B. The HIMP Report 

1. Data and Methods Used in the HIMP 

Report 

2. HIMP as the Basis for the NPIS 

3. Carcass Inspection Under HIMP 

4. Public Health-Related Non-Compliances 

5. OCP Standards Under HIMP 

6. Salmonella Positive Rates in HIMP 

Establishments 

C. The Risk Assessment 

D. The New Poultry Inspection System 

(NPIS) 

1. General Comments on the NPIS 

2. Scope of the NPIS 

3. Carcass Sorting and Inspection Under 

the NPIS 

a. Carcass Sorting by Establishment 

Employees 

b. Online Carcass Inspection 

c. Inspection for Avian Visceral Leukosis 

d. Verification Inspection 

e. RTC Poultry Definition Under the NPIS 

4. Facilities Requirements and Staffing for 

NPIS 

a. Facilities Requirements 

b. Staffing 

5. Line Speeds Under the NPIS 

a. Line Speeds and Process Control 

b. Line Speeds and Online Carcass 

Inspection 

E. Implementation of the NPIS 

1. Background 

2. Implementation Strategy 

3. Comments on Proposed Implementation 

Plan 

F. Line Speeds and Worker Safety 

1. Collaboration With the National Institute 

for Occupational Safety and Health 

2. Collaboration With OSHA 

3. General Comments on Line Speed and 

Worker Safety 

4. Inspection Line Speed, Processing Line 

Speed, and Production Volume 

5. Factors Influencing Inspection Line 

Speed 

6. Inspection Line Speed and Inspector 

Safety Under the NPIS 

7. Industry Efforts To Address Worker 

Safety 

8. Reporting of Work-Related Injuries 

9. Attestation to FSIS on Work-Related 

Conditions 

G. Changes That Affect All Establishments 

That Slaughter Poultry Other Than 

Ratites 

1. Procedures and Recordkeeping 

Requirements for Preventing 

Contamination by Enteric Pathogens and 

Visible Fecal Contamination 

2. Sampling and Testing Requirements To 

Monitor Process Control 

a. Sampling Plan and Sampling Sites 

b. Very Small and Very Low Volume 

Establishment Sampling 

c. Sampling Frequency 

d. Indicator Organisms and Baseline 

3. Rescind Testing for Generic E. coli for 

Establishments That Slaughter Poultry 

Other Than Ratites 

4. Rescind Codified Salmonella 

Performance Standards 

H. Elimination of Time/Temperature 

Chilling Requirements 

I. Online Reprocessing 

J. Animal Welfare Considerations 

1. Welfare of Live Birds 

2. Line Speeds and Animal Welfare 

3. Animal Welfare and the Reduction in 

Number of Online Inspectors 

K. Environmental Impact 

L. Economic Impact 

1. General 

2. Environmental Justice 

3. Small Business Considerations 

4. Implementation Costs 

IV. Executive Order 12866 and 13563 

V. Final Regulatory Flexibility Act 

VI. Executive Order 12988 

VII. E-Government Act 

VIII. Executive Order 13175 

IX. USDA Non-Discrimination Statement 

X. Paperwork Reduction Act 

XI. Additional Public Notification 

XII. Final Regulatory Amendments 

I. Background 

On January 27, 2012, FSIS published 

the proposed rule, ‘‘Modernization of 

Poultry Slaughter Inspection,’’ to 

establish a new inspection system for 

young chickens and turkeys. Under the 

proposal, the new poultry inspection 

system (NPIS) would have replaced the 

current Streamlined Inspection System 

(SIS), the New Line Speed Inspection 

System (NELS), and the New Turkey 

Inspection System (NTIS). The NPIS 

that FSIS is adopting in this final rule 

is consistent with the inspection system 

that FSIS proposed in January 2012, 

with modifications, which are described 

below. However, in this final rule, FSIS 

is not eliminating SIS, NELS, or the 

NTIS, as was proposed. This final rule 

will leave all existing inspection 

systems in place to give establishments 

the flexibility to operate under the 

system that is best suited to their 

operations. 

In the proposed rule, FSIS also 

proposed changes to the regulations that 

would apply to all establishments that 

slaughter poultry other than ratites. 

FSIS is adopting these proposed 

changes, with some modifications, 

which are also described below. 

When FSIS issued the proposed rule, 

it initially gave the public until April 

26, 2012, to submit comments. The 

Agency later extended the comment 

period until May 29, 2012. The public 

meeting and the Agency’s decision to 

extend the comment period are 

discussed below. 

Comment Period and Public Meeting 

On March 21, 2012, FSIS held a 

public meeting with its National 

Advisory Committee on Meat and 

Poultry Inspection (NACMPI) via Web 

conference to discuss the January 2012 

proposed rule to modernize poultry 

slaughter inspection. FSIS held the 

meeting in response to a request from 

certain members of the committee. At 

the meeting, FSIS provided an overview 

of the proposed rule and then held an 

open discussion with the committee 

members. A transcript of the public 

meeting is available on the FSIS Web 

site at: http://www.fsis.usda.gov/wps/

portal/fsis/topics/regulations/advisorycommittees/nacmpi. 

When the Agency held the public 

meeting, the comment period for the 

proposed rule was scheduled to close on 

April 26, 2012. At the public meeting, 

some of the committee members 

representing consumer advocacy 

organizations requested that FSIS 

extend the comment period. A coalition 

of consumer advocacy organizations 

also submitted a written request for the 

Agency to extend the comment period. 

On April 26, 2012, FSIS announced that 

it was extending the comment period 

until May 29, 2012 (77 FR 24873). 

In the Federal Register document that 

announced the comment period 

extension, FSIS explained that during 

the comment period, the Agency had 

met with a coalition of consumer 

advocacy organizations and two trade 

associations representing the poultry 

industry to clarify certain aspects of the 

proposed rule to help inform their 

comments (77 FR 24873). Because the 

issues addressed in these meetings may 

have been relevant to the development 

of other stakeholders’ comments, the 

Federal Register document summarized 

the issues raised at the meetings and the 

Agency’s responses. In the Federal 

Register document, FSIS also requested 

additional comments on how it should 

implement the final rule resulting from 

the January 2012 proposal. The Agency 

also requested available data on 

potential worker safety issues associated 

with increased line speeds. In addition, 

the Agency explained that it had 

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49570 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

received a request to hold a public 

technical meeting on the proposed rule, 

but that the Agency did not believe that 

such a meeting would be useful. 

In developing this final rule, FSIS 

considered all comments submitted in 

response to the January 2012 proposed 

rule, as well as those provided at the 

NACMPI public meeting held in March 

2012. Based on its analysis of the issues 

and of the information provided by the 

comments, FSIS made certain changes 

to, and clarified certain aspects of, the 

proposed regulations. Those revisions 

are summarized below and are 

discussed in detail in the Agency’s 

responses to comments. 

II. Summary of Modifications Made to 

the Proposed Rule 

In this document, FSIS is finalizing, 

with some changes, the provisions in 

the January 27, 2012, proposed rule 

‘‘Modernization of Poultry Slaughter 

Inspection’’ (77 FR 4408). The Agency is 

modifying the proposal to: 

• Change the maximum line speed 

permitted under the NPIS to 140 bpm 

for young chickens, for entities that 

chose to operate under NPIS. The 

maximum line speed for turkeys will be 

55 bpm, as was proposed; 

• Leave all existing poultry 

inspection systems in place and allow 

young chicken and turkey slaughter 

establishments that do not choose to 

operate under the NPIS to continue to 

operate under their current inspection 

system; 

• Continue to staff all establishments 

that do not choose to operate under the 

NPIS with the number of online 

inspectors that they currently have; 

• Allow young chicken 

establishments that currently operate 

under HIMP through a Salmonella 

Initiative Program (SIP) waiver to 

continue to operate under a waiver to 

run at a maximum line speed of up to 

175 bpm; 

• Update the SIP waivers for young 

chicken establishments currently 

operating under HIMP to remove 

aspects of HIMP that are inconsistent 

with the NPIS; 

• Establish a phased approach to 

implement the NPIS in geographic 

clusters; 

• Establish separate applicability 

dates for large, small, and very small 

establishments to comply with the 

provisions in the rule that prescribe the 

new recordkeeping and microbiological 

sampling requirements that will apply 

to all establishments that slaughter 

poultry other than ratites. The 

applicability dates will provide 

additional time for small and very small 

establishments to comply with these 

provisions; 

• Revise the facilities requirements 

for the NPIS to require that the online 

carcass inspection platform be height 

adjustable; 

• Clarify that the records that 

establishments operating under the 

NPIS are required to maintain to 

document that the products resulting 

from their slaughter operations meet the 

definition of RTC poultry are subject to 

review and evaluation by FSIS 

personnel; 

• Revise the proposed regulation that 

prescribes maximum line speed rates 

under the NPIS to emphasize 

establishments’ existing legal obligation 

to comply with the Occupational Safety 

and Health Administration’s 

regulations; 

• Establish a new subpart in the 

regulations that requires each 

establishment that participates in the 

NPIS to submit on an annual basis an 

attestation to the management member 

of the local FSIS circuit safety 

committee stating that it maintains a 

program to monitor and document any 

work-related conditions of 

establishment workers. Current young 

chicken HIMP establishments that will 

be operating under the updated SIP 

waivers described above will be 

required to submit the annual 

attestation as a condition of their 

updated waivers; 

• Permit very small and very low 

volume establishments to conduct 

sampling for microbial pathogens only 

at the post-chill point in the slaughter 

and dressing process to monitor their 

process control procedures instead of 

requiring sampling at pre- and postchill, as was proposed; 

• Prescribe a minimum frequency 

with which all establishments that 

slaughter poultry other than ratites will 

need to conduct testing for microbial 

organisms to monitor the effectiveness 

of their process control procedures; and 

• Revise the definition for ‘‘air chill’’ 

to allow an antimicrobial intervention to 

be applied with water at the beginning 

of the chilling process if its use does not 

result in any net pick-up of water or 

moisture during the chilling process. 

The initial antimicrobial intervention 

may result in some temperature 

reduction of the product if the majority 

of temperature removal is accomplished 

exclusively by chilled air. 

In addition, because the proposed preand post-chill sampling requirements 

will not apply to ratite slaughter 

establishments, FSIS is retaining the 

generic E. coli testing regulations as they 

apply to ratites only, but is rescinding 

the provisions in these regulations that 

apply to all other poultry classes. 

Poultry establishments other than 

establishments that slaughter ratites will 

be required to comply with the new 

sampling requirements prescribed in 

this final rule. 

III. Comments and Responses 

FSIS received over 250,000 comment 

letters in response to the January 2012 

proposed rule. Most comments were 

submitted as part of organized write-in 

campaigns. The Agency also received a 

petition that included approximately 

150,000 signatures and form letters 

before the comment period closed. The 

Agency received two petitions in 

November 2012, after the comment 

period had closed. One of these 

petitions included approximately 

180,000 signatures and 13,000 

comments, and the other included over 

3,500 signatures. FSIS received an 

additional petition in September 2013 

with approximately 43,000 signatures. 

All of the petitions requested that the 

Agency withdraw the proposed rule. 

The issues raised in the petitions and 

comments submitted in November 2012 

and September 2013 are similar to the 

issues raised by the petition and 

comments submitted during the 

comment period. Therefore, the Agency 

will address the issues raised in all of 

the petitions and associated comments 

in this document. 

Most of the individual comments 

were submitted as part of various writein campaigns initiated by consumer 

advocacy organizations, labor unions, 

animal welfare organizations, and 

worker and human rights advocacy 

organizations. FSIS also received 

individual comments from private 

citizens, inspection personnel, and 

members of labor unions. 

In addition to the individual 

comments, form letters, and petitions, 

the Agency also received approximately 

120 separate comment letters from trade 

associations representing the poultry 

industry, companies that conduct 

poultry slaughter operations, consumer 

advocacy organizations, public health 

organizations, labor unions, animal 

welfare advocacy organizations, 

members of academia, a State 

Department of Agriculture, and worker/ 

immigrant/human rights advocacy 

organizations. Following is a summary 

of the comments and FSIS’s responses. 

A. NACMPI Meeting and Public Process 

Comments: Several consumer 

advocacy organizations expressed their 

concern that FSIS published the 

proposed rule in the Federal Register 

before it consulted with the NACMPI. 

According to the comments, the Agency 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49571 

is required to consult with members of 

the NACMPI before proposing changes 

to its meat and poultry inspection 

program, and that the Agency should 

have consulted with the NACMPI before 

publishing the proposed rule to 

modernize poultry slaughter inspection. 

Response: FSIS held the March 21, 

2012, NACMPI public meeting in 

response to a request from certain 

committee members representing 

consumer advocacy organizations that 

the Agency convene the committee to 

discuss the proposed rule. At the 

meeting, FSIS made clear that it was 

interested in the committee’s comments 

and suggestions, but that the Agency 

was not seeking consensus from the 

committee. 

FSIS disagrees that the Agency was 

required to consult with the NACMPI 

before proposing changes to its poultry 

inspection program. Under the Federal 

Meat Inspection Act (FMIA) and Poultry 

Products Inspection Act (PPIA), the 

Secretary is authorized to ‘‘appoint 

advisory committees consisting of such 

representatives of appropriate State 

agencies . . . to consult with him 

concerning State and Federal programs 

with respect to [meat and poultry] 

inspection and other matters within the 

scope of this chapter . . .’’ (21 U.S.C. 

661(a)(4) and 21 U.S.C. 454(a)(4)). The 

Secretary of Agriculture established the 

NACMPI to provide advice concerning 

State and Federal programs with respect 

to meat and poultry inspection, food 

safety, and other matters that fall within 

the scope of the FMIA and PPIA. Under 

the NACMPI Charter, FSIS consults 

with the committee in carrying out its 

specific responsibilities under 21 U.S.C. 

607(c), 624, 645, 661(a)(3), and 661(c) of 

the FMIA and 21 U.S.C. 454(a)(3), 

454(a)(4), 454(c), 457(b), and 460(e) of 

the PPIA. These sections address: Type 

styles and sizes of labeling; definitions 

and standards of identity or 

composition; standards of fill of 

container; consistency of Federal and 

Federal-State standards; storage and 

handling regulations; exemption of 

establishments subject to non-Federal 

jurisdiction; Federal provisions 

applicable to State or Territorial 

business transactions of a local nature 

and not subject to local authority; scope 

of cooperation; and State meat 

inspection requirements. Thus, the 

NACMPI charter does not require that 

FSIS consult with the NACMPI before 

proposing changes to its poultry 

inspection program, although the 

Agency conducted a public meeting 

after the proposed rule was issued to 

seek feedback on the proposal. 

Comment: Some consumer advocacy 

organizations noted that FSIS decided 

not to hold a technical public meeting 

as requested by a coalition of consumer 

advocacy organizations. 

Response: As stated in the Federal 

Register comment period extension 

document, FSIS decided not to hold a 

public technical meeting on the 

proposed rule because the Agency did 

not believe that such a meeting would 

be useful (77 FR 24873). In April 2012, 

in response to a request from a group of 

consumer advocacy organizations, FSIS 

extended the comment period for the 

proposed rule. In the Federal Register 

document that announced the comment 

period extension, FSIS summarized 

issues that were raised in separate 

meetings with consumer and industry 

stakeholders and clarified certain 

aspects of the proposed rule to help 

inform stakeholder comments. In that 

document, the Agency also provided 

additional information on worker safety 

issues and its tentative strategy to 

implement the NPIS, and it solicited 

comments and data on both issues. As 

such, FSIS provided the public with all 

of the information it might have during 

a technical meeting, but through the 

public comment process. Thus, the 

process for developing this final rule 

was open and transparent and provided 

several opportunities for stakeholder 

input. 

Comment: One public health 

association said that FSIS failed to 

comply with E.O. 12866 and E.O. 13563 

requirements with respect to public 

participation. The comment said E.O. 

13563 requires that agencies make all of 

the documents they rely on to justify 

rules available to the public, and FSIS 

did not do so. According to the 

comment, as of May 19, 2012, more than 

80 days after the proposal was 

published, there were only two 

documents in the public record posted 

by USDA at Regulations.gov, the 

January 27, 2012, and April 26, 2012, 

Federal Register document. The 

comment said that only 12 records are 

posted on the FSIS Web site. According 

to the comment, the public is unable to 

provide informed comments when the 

underlying records used to develop the 

proposed rule are not available for 

review. 

A labor union criticized the Agency 

for publishing a complex statistical 

analysis while providing little raw data 

in the supporting documents. The 

comment also questioned whether the 

comment period for the proposed rule 

provided sufficient time for 

stakeholders to adequately consider the 

supporting data. 

Response: The Agency plans to post 

supporting documentation for this final 

rule and future Agency rulemakings on 

Regulations.gov. Although FSIS 

acknowledges that the underlying 

records used to develop the proposed 

rule were not posted on 

Regulations.gov, the proposed rule and 

all related documents, including 

supporting materials, were posted on 

the FSIS Web site when the proposed 

rule published in the Federal Register. 

The supporting materials included the 

Evaluation of the HACCP-Based 

Inspection Models Project; the draft 

2011 FSIS Risk Assessment for Guiding 

Public Health-Based Poultry Slaughter 

Inspection; the Agency’s response to 

Peer Review Comments on its draft 2008 

Risk Assessment for Guiding Public 

Health Risk-Based Poultry Slaughter 

Inspection; and the On-Line and OffLine Reprocessing In-Plant Trial 

Analysis. The supporting data for the 

analyses in the Evaluation of the 

HACCP-Based Inspection Models 

Project are presented in tables in the 

report and in the appendices. The data 

and modeling methods used in the 2011 

FSIS Risk Assessment for Guiding 

Public Health-Based Poultry Slaughter 

Inspection are also fully described in 

the Appendix to that document. 

The proposed rule and the Federal 

Register document extending the 

comment period for the proposed rule 

were posted on both the FSIS Web site 

and Regulations.gov when those 

documents published in the Federal 

Register. The preamble to the proposed 

rule includes the FSIS Web site link to 

the related materials and supporting 

documents, and it explains that these 

documents are also available in the FSIS 

docket room. These materials have been 

available on the Agency’s Web site 

during the entire comment period and 

remain available at: http://www.fsis.

usda.gov/wps/portal/fsis/topics/

regulations/federal-register/proposedrules/proposed-rules-2012/!ut/p/a1/

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With respect to the comment that said 

that FSIS did not provide sufficient time 

for public comment, E.O. 12866, as 

supplemented by E.O. 13563, states that 

agencies are to ‘‘afford the public . . . 

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49572 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

2House Appropriations Committee report, p. 23 

(http://appropriations.house.gov/uploadedfiles/

hrpt-112-ap-fy13-agriculture.pdf). 

with a comment period that should 

generally consist of not less than 60 

days.’’ FSIS provided a 90-day comment 

period for the proposed rule and then 

extended it for an additional 30 days. 

The Agency believes that the public had 

ample time to consider the issues raised 

in the proposed rule and supporting 

documentation in order to develop their 

comments. 

Comment: A consumer advocacy 

organization criticized the Agency for 

including the anticipated cost savings 

from the proposal in the Agency’s 2013 

proposed budget to Congress before the 

public comment period for the proposal 

closed. 

Response: The Agency concluded that 

an open, transparent, and effective 

budgetary process requires that the 

Agency report on the rule and the 

associated estimated budget. In 

addition, the Appropriations Committee 

Report that accompanied the FY 2013 

appropriations bill directs the Agency to 

notify the Committee of the status of the 

rule not later than September 15, 2012.2

B. The HIMP Report 

In the proposed rule, FSIS explained 

that it was proposing to establish a new 

system of inspection for young chickens 

and turkeys based on its experience 

under the HACCP-based Inspection 

Models Project (HIMP) pilot study (77 

FR 4421). As discussed in the proposal, 

FSIS initiated the HIMP pilot study in 

20 young chicken and 5 turkey slaughter 

establishments on a waiver basis after 

the Agency implemented the 1996 

HACCP regulations. Similar to the NPIS, 

under HIMP, establishment personnel 

are responsible for sorting carcasses, 

disposing of carcasses affected with 

conditions that would require that they 

be condemned, and conducting any trim 

and reprocessing that they believe 

necessary to correct removable defects. 

In the HIMP inspection system, a 

single FSIS online carcass inspector (CI) 

visually inspects every carcass at a fixed 

point on the evisceration line 

immediately before the chiller. Under 

HIMP, an offline verification inspector 

(VI) is responsible for conducting 

system verification activities that the 

Agency has concluded will be more 

effective in ensuring food safety, such as 

conducting offline carcass verification 

checks for septicemia/toxemia and 

visible fecal contamination, collecting 

samples for pathogen testing, and 

verifying the effectiveness of an 

establishment’s HACCP system by, 

among other activities, reviewing the 

establishment’s HACCP plan and 

HACCP monitoring records, observing 

establishment employees performing 

tasks specified in the HACCP plan, 

reviewing and determining the 

adequacy of the corrective actions taken 

by the establishment when a deviation 

occurs, and conducting measurements 

of critical control points (CCPs). The 

Agency analyzed the data collected from 

the HIMP study and prepared a written 

report that presents an evaluation of the 

model tested (see the ‘‘HIMP Report,’’ 

available on the Agency’s Web site at: 

http://www.fsis.usda.gov/wps/wcm/

connect/fcd9ca3e-3f08-421f-84a7-

936bc410627c/Evaluation_HACCP_

HIMP.pdf?MOD=AJPERES). 

The HIMP Report assesses FSIS 

inspection findings across four 

interrelated inspection activities: 

1. Inspection of each carcass by the CI 

to determine whether the carcass is not 

adulterated and thus eligible to bear the 

mark of inspection. 

2. Verification by VIs of the 

establishment’s execution of its HIMP 

process control plan, under which 

establishment employees sort acceptable 

and unacceptable carcasses and parts. 

3. Verification of the establishment 

executing its sanitation SOPs and 

HACCP system. 

4. Verification of the outcomes of the 

establishment’s HIMP process control 

plan, both organoleptic and 

microbiological. 

Inspection of each carcass by the CI 

to determine whether the carcass is not 

adulterated. Based on an analysis of 

data collected from April 1, 2009, 

through March 31, 2011, the HIMP 

Report found that fewer than 0.0008 

percent of the carcasses presented to the 

CI were affected with septicemia/ 

toxemia, and fewer than 0.08 percent 

had visible fecal contamination. Despite 

these low rates, the CIs in HIMP 

establishments detected carcasses 

affected with septicemia/toxemia at a 

rate of 0.000004 percent or 4 per 100 

million carcasses slaughtered and 

carcasses with visible fecal 

contamination at a rate of 0.0009 

percent or 9 per 1 million carcasses 

slaughtered. 

Verification by VIs of the 

establishment’s execution of its HIMP 

process control plan. The HIMP Report 

compares the ratio of all offline 

inspection procedures conducted in 

HIMP and non-HIMP establishments in 

calendar year (CY) 2010. FSIS 

inspectors in HIMP establishments 

perform offline inspection procedures to 

verify that the establishments are 

properly executing their HIMP process 

control plans. This comparison shows 

that overall in CY 2010, FSIS offline 

inspection personnel performed 1.6 

times more offline inspection 

procedures in HIMP establishments 

than in non-HIMP establishments. 

Verification of the establishment 

executing its sanitation SOPs and 

HACCP system. The sanitation SOP and 

HACCP regulations are among the 

regulations most strongly related to 

public health. The HIMP Report’s 

comparison of the ratio of offline 

inspection procedures performed in 

HIMP and non-HIMP establishments in 

CY 2010 shows that FSIS offline 

inspectors in HIMP establishments 

performed about 3.0 times more 

sanitation SOP and HACCP inspection 

procedures than offline inspectors 

performed in non-HIMP establishments. 

It also shows that offline inspectors in 

HIMP establishments performed 3.4 

more HACCP procedures that include 

random verification of all HACCP 

requirements than inspectors in nonHIMP establishments. 

The HIMP Report also compares 

health-related non-compliances in 

HIMP and non-HIMP establishments 

from CY 2006 through CY 2010. These 

data show that health-related noncompliance record (NR) rates at HIMP 

establishments are not statistically 

different from or are statistically lower 

for all inspection procedures 

considered. The HIMP Report also 

found that the rate of health-related 

non-compliances for visible fecal 

contamination from CY 2006 through 

CY 2010 is about 1.6 times lower in 

HIMP establishments than in non-HIMP 

establishments. 

Verification of the outcomes of the 

establishment’s HIMP process control 

plan, both organoleptic and 

microbiological. To assess the outcomes 

of establishment’s process control plans 

in addressing visible food safety defects 

and defects related to the 

wholesomeness or quality of the 

product, referred to as ‘‘other consumer 

protection’’ (OCP) defects, FSIS 

developed performances standards for 

these defects based on the performance 

of non-HIMP establishments. The 

performance standards allow the 

Agency to compare the performance of 

establishments operating under HIMP 

and non-HIMP inspection systems in 

controlling visible food safety and OCP 

defects. 

A comparison of the findings of the 

offline VIs in HIMP establishments for 

the two-year period April 1, 2009, to 

March 31, 2011, with the HIMP food 

safety defect performance standards 

show that the rate of septicemia/toxemia 

in carcasses processed in HIMP 

establishments (8 per 1 million or 

0.0008 percent) is 125 times lower than 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49573 

3 GAO, 2001. Food Safety: Weaknesses in Meat 

and Poultry Inspection Pilot Should Be Addressed 

Before Implementation: http://www.gao.gov/

new.items/d0259.pdf. 

4The Hargis Report is available for viewing by the 

public in the FSIS docket room and on the FSIS 

Web site at: http://www.fsis.usda.gov/OPPDE/

nacmpi/Nov2002/Papers/NAFS97.pdf. 

the HIMP performance standard (0.1 

percent). The HIMP Report also found 

that the rate of visible fecal material on 

carcasses processed in HIMP 

establishments (fewer than 0.8 per 

thousand or 0.08 percent) is 19 times 

lower than the HIMP performance 

standards (1.5 percent). A comparison of 

the findings of the offline VIs in HIMP 

establishments for the two-year period 

January 1, 2009 through December 31, 

2010, with the HIMP OCP performance 

standards show that OCP defects 

identified on carcasses processed in 

HIMP establishments averaged about 

half the corresponding OCP HIMP 

performance standard. 

To assess the microbiological 

outcomes of HIMP establishments’ 

process control plans, the HIMP Report 

analyzed data from FSIS’s Salmonella 

verification testing program collected 

from CY 2006 through CY 2010. The 

HIMP Report compares the Salmonella 

percent positive rates in 20 HIMP 

broiler establishments, 64 non-HIMP 

comparison establishments, and all 176 

non-HIMP broiler establishments. The 

analysis shows that Salmonella positive 

rates in HIMP establishments average 

about 80 percent of those in non-HIMP 

establishments. 

In the preamble to the proposed rule, 

FSIS explained that the Agency had 

concluded, based on analysis of the twoyear data sets of food safety and OCP 

defects, that establishments operating 

under the HIMP inspection system 

performed better than establishments 

operating under non-HIMP inspection 

systems with respect to rates of food 

safety defects and OCP defects that may 

affect the wholesomeness or quality of 

the product (77 FR 4419). Data on 

health-related NRs collected from CY 

2006 through CY 2010 show that noncompliances for fecal contamination are 

lower in HIMP than in non-HIMP 

establishments and that HIMP 

establishments have a higher 

compliance with sanitation SOP and 

HACCP regulations. HIMP 

establishments also had equivalent or 

lower Salmonella positive rates than 

non-HIMP establishments. The Agency 

explained that it was proposing to 

establish a new poultry inspection 

system informed by HIMP that would 

replace the SIS, NELS, and NTIS 

inspection systems for young chickens 

and turkeys (77 FR 4421). 

FSIS received several comments on 

the HIMP Report and the Agency’s 

analysis of the data collected under the 

HIMP study. Comments from the 

poultry industry and trade associations 

representing the poultry industry 

generally agreed with the findings of the 

HIMP Report and supported the 

Agency’s decision to establish a new 

poultry inspection system. Comments 

from private citizens, consumer 

advocacy organizations, labor unions, 

and members of academia raised issues 

and concerns regarding the data 

collected under HIMP and the Agency’s 

conclusions based on the HIMP study 

results. 

1. Data and Methods Used in the HIMP 

Report 

Comment: Several comments from 

consumer advocacy organizations and 

private citizens questioned whether data 

collected under that HIMP study should 

be used to inform the NPIS. The 

comments said that the HIMP pilot has 

never been independently evaluated to 

determine whether the establishments 

operating under the HIMP inspection 

system are producing food that is as safe 

as product produced in establishments 

operating under non-HIMP inspection 

systems. 

Response: FSIS disagrees with the 

comment. In 2002, after the Government 

Accountability Office (GAO) issued its 

December 17, 2001, report on HIMP 3

(referred to as the ‘‘2001 GAO report’’), 

FSIS contracted with a technical review 

team selected by the National Alliance 

for Food Safety to review and evaluate 

the data collected from young chicken 

establishments operating under HIMP. 

The review team focused on the validity 

of the HIMP study design and 

methodology to determine whether FSIS 

could use the organoleptic and 

microbial data collected under HIMP to 

compare the performance of 

establishments operating under HIMP 

and non-HIMP inspection systems. 

Overall, the review team found that the 

HIMP study design and methodology 

were valid and provided a useful and 

legitimate comparison of the HIMP and 

non-HIMP inspection systems. The 

review team’s findings are described in 

the report: ‘‘Review of the HACCP-Based 

Inspection Models Project by the 

National Alliance for Food Safety 

Technical Team’’ 4 (also referred to as 

‘‘The Hargis Report’’). 

As stated in the report, ‘‘[t]he review 

team noted some issues related to 

optimal design and interpretation, but 

finds that overall the data collected 

were both meaningful and useful and 

that the study was designed and 

conducted under real-world conditions 

and limitations.’’ The review team also 

concluded that ‘‘the overall design and 

methodology . . . were perhaps the best 

available options to allow for 

comparison of organoleptic data 

between the traditional and HIMP 

systems.’’ 

Comment: One consumer advocacy 

organization noted that the HIMP Report 

said that the Agency’s evaluations of 

microbiological and inspection findings 

are based on data for calendar years 

(CY) 2006 through 2010, with certain 

exceptions where only more recent data 

are available. According to the 

comment, the HIMP Report does not 

explain why certain data are missing or 

why time periods for comparisons are 

not uniform. The comment noted that 

the Agency only analyzed data from CY 

2010 when comparing the ratio of 

offline inspection procedures performed 

in HIMP and non-HIMP establishments. 

Response: The time periods for the 

data that were analyzed for the HIMP 

Report vary because not all data were 

available as computerized data sets. 

Data on the number of carcasses affected 

with food safety and OCP defects were 

not available as computerized data sets. 

FSIS field personnel manually collected 

these data and recorded the results on 

paper forms. To reduce the burden on 

its field personnel, FSIS decided that an 

analysis of two years’ worth of these 

non-computerized data sets would be 

sufficient. The HIMP report data for the 

number of carcasses affected with food 

safety defects is from April 1, 2009, 

through March 31, 2011, and data for 

carcasses affected with OCP defects is 

from January 1, 2009, through December 

31, 2010. 

In the body of the HIMP Report, the 

Agency used computerized data 

collected from CY 2010 to compare the 

ratio of offline inspection procedures 

performed in HIMP and non-HIMP 

establishments. The Agency used data 

from 2010 for this analysis because it 

was the most recent data available. 

Tables C–2 and C–3 in the Appendix of 

the HIMP Report contain summary 

information on non-compliances with 

sanitation SOP and HACCP regulations 

and on the number of inspection 

procedures in HIMP and non-HIMP 

establishments from CY 2006 through 

2010. The data for these years are 

similar to the data from CY 2010. 

Comment: One comment noted that in 

the preamble to the proposed rule, the 

Agency compares findings (1) by VIs of 

OCP defects between January 1, 2009 

and December 31, 2010; (2) by VIs of 

food safety defects between April 1, 

2009 and March 31, 2011; and (3) by CIs 

of food safety defects between April 1, 

2009 and March 31, 2011. The comment 

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49574 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

said that while these time periods are 

not very different, it is possible that the 

slight shifts were made to conceal 

results that would be less supportive, or 

that would even contradict Agency 

claims. 

Response: The two-year period 

January 1, 2009 to December 31, 2010 

was used to evaluate OCP defects, while 

the two-year period April 1, 2009, to 

March 31, 2011 was used to evaluate 

compliance with the HIMP food safety 

standards. Both of these comparisons 

used the most recent data available at 

the time. This is the reason for the 

different time periods. 

2. HIMP as the Basis for the NPIS 

Comment: A trade association 

representing the poultry industry stated 

that the HIMP pilot program has been 

successfully carried out for the last 13 

years. The comment said that during 

that time, food safety records in 

establishments operating under the 

HIMP inspection system have been as 

good as those in non-HIMP 

establishments. The comment stated 

that the equivalent or lower pathogen 

rates in HIMP establishments compared 

to non-HIMP establishments, as 

documented in the HIMP Report, are 

evidence that the program has been 

successful. The comment noted that this 

success is especially significant given 

that the review team selected by the 

National Alliance for Food Safety 

determined that food safety performance 

standards provide a scientifically valid 

measure by which performance of HIMP 

establishments can be evaluated (Hargis 

et al. 2002). The comment stated that, 

based on the data, the trade association 

agreed with the Agency’s conclusion 

that the NPIS is a positive step toward 

enhancing food safety. 

On the other hand, several consumer 

advocacy organizations questioned 

whether it is appropriate for FSIS to use 

the HIMP study results to predict how 

establishments will perform when 

operating under the NPIS. The 

comments noted that the 2001 GAO 

report criticized FSIS for not randomly 

selecting establishments for the HIMP 

pilot study and questioned whether the 

data generated by the pilot could be 

used to predict how all of the young 

chicken establishments would perform 

if FSIS were to adopt the HIMP 

inspection system nationwide. 

Several comments stated that because 

participation in the HIMP study was 

voluntary and required that poultry 

establishments meet additional food 

safety and OCP performance standards, 

participating establishments could be 

viewed as high performers with respect 

to food safety. The comments asserted 

that for this reason, data from the HIMP 

pilot may not represent what FSIS is 

likely to see when the majority of young 

chicken and turkey slaughter 

establishments begin to operate under 

the NPIS. 

Response: The trade association 

comments support the agency proposal. 

With regard to concerns raised by the 

consumer advocacy organizations, FSIS 

addressed these issues in its comments 

on and response to the 2001 GAO 

Report. In that document, FSIS stated 

that although not randomly selected, 

there is evidence that volunteer 

establishments participating in the 

HIMP study are typical of the industry. 

The volunteer establishments represent 

diversity in geography, corporate 

structure, management styles, number of 

evisceration lines, product distribution 

patterns, inspection system in use prior 

to the pilot, and other variables. In 

addition, the Hargis Report, discussed 

above, noted that the establishments 

selected for the HIMP pilot represent the 

States supplying the majority of 

domestic chicken production and the 

size range of establishments included in 

the study are representative of almost 90 

percent of chickens slaughtered in 

federally-inspected facilities in the 

United States. The Hargis Report noted 

that establishment design, equipment, 

and procedures within poultry 

establishments are relatively uniform. 

The report concluded that ‘‘[i]t is very 

difficult to hypothesize a geographic or 

plant-selection bias in this study.’’ 

Comment: Two consumer advocacy 

organizations stated that the NPIS is not 

an exact replica of the HIMP pilot, 

which raises further concerns about 

whether results from the HIMP pilot 

accurately reflect how establishments 

will perform under the NPIS. 

Response: Although the NPIS is not 

an exact replica of HIMP, the NPIS was 

informed by the data collected under 

HIMP. These data demonstrate that an 

inspection system that combines the 

features described in this document, 

which include carcass sorting by 

establishment employees, a CI that 

conducts an inspection of each carcass 

before the chiller, and, most important, 

a VI that conducts more offline 

inspection activities that specifically 

focus on food safety, does not reduce 

the effectiveness and may, in fact, lead 

to better compliance with sanitation and 

HACCP regulations and in carcasses 

with lower levels of fecal contamination 

and equivalent or lower levels of 

Salmonella contamination. 

In addition, as discussed in detail 

below, in the 2014 risk assessment, 

analysis of historical data shows a 

statistically significant correlation 

between specifically targeted 

unscheduled offline inspection 

procedures and reductions in 

Salmonella positive samples in young 

chicken slaughter establishments and 

Campylobacter positive samples in 

young turkey slaughter establishments. 

Modeled scenarios involving an 

increase in targeted inspection activities 

(specifically unscheduled offline 

inspection activities, rather than a 

randomly selected set of activities) 

suggest that implementing the NPIS 

would likely result in public health 

benefits. Assuming that the number of 

offline inspection procedures performed 

in all poultry slaughter establishments 

increase proportionately to the number 

of such procedures currently performed 

in HIMP establishments, FSIS’s risk 

model predicts a likely public health 

benefit. Consistent with the underlying 

assumptions of the model, it is 

reasonable to conclude that inspection 

systems in which Agency resources 

continue the core online inspection 

activities while enhancing the frequency 

and focus of unscheduled offline 

activities directly related to food safety, 

such as HIMP and the NPIS, would 

likely result in a lower prevalence of 

carcasses contaminated with Salmonella 

and Campylobacter, which in turn 

would likely lead to fewer human 

illnesses. 

Comment: One consumer advocacy 

organization criticized the Agency’s 

evaluation of HIMP. The comment 

stated that the HIMP Report compares 

the current performance of HIMP 

establishments with performance levels 

observed from 1998–2000 when FSIS 

collected baseline data from 

establishments that later joined the 

HIMP pilot. 

The comment also stated that the 

Agency failed to explain how the 

performance level of the bottom four 

establishments that entered the HIMP 

pilot is representative of approximately 

200 other establishments more than a 

decade later. 

Response: The Hargis Report, 

described above, concluded that the 

design of the HIMP pilot ‘‘is generally 

appropriate for a field study of this 

nature, and the methodologies 

employed generally allow for 

interpretation and comparison of [HIMP 

versus non-HIMP inspection systems.]’’ 

The Hargis Report also concluded that 

comparison of HIMP food safety and 

OCP performance levels with 

performance standards does provide a 

scientifically valid measure by which 

changes in food safety and OCP 

performance under HIMP can be 

assessed. 

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With respect to the comment that 

suggests that the HIMP OCP 

performance standards represent the 

performance level of the bottom four 

establishments that entered the HIMP 

pilot, the HIMP OCP performance 

standards are set at the 75th percentile 

of what was achieved under the 

Research Triangle Institute (RTI) 

baseline study of 16 young chicken 

establishments under non-HIMP 

inspection systems before they entered 

the HIMP study. Thus, the performance 

standards were set so that 25 percent of 

the establishments that entered HIMP 

would have to improve upon their 

baseline results in order to meet the 

more stringent standards. 

3. Carcass Inspection Under HIMP 

In the preamble to the proposed rule, 

FSIS explained that the Agency 

concluded that establishments operating 

under the HIMP inspection system 

performed better than establishments 

operating under non-HIMP inspection 

systems with respect to rates of food 

safety and OCP defects (77 FR 4419). 

With respect to food safety-related 

defects, the Agency noted that data 

collected from the HIMP study show 

that the levels of carcasses affected with 

septicemic or toxemic conditions (also 

referred to as ‘‘septicemia/toxemia’’) or 

visible fecal contamination in HIMP 

establishments is very low (77 FR 4415). 

The HIMP Report concluded that 

notwithstanding these very low levels, 

the data demonstrate that CIs in HIMP 

establishments effectively identify 

carcasses affected with septicemia/

toxemia and visible fecal contamination. 

Several consumer advocacy 

organizations commented on this 

conclusion. 

Comment: Some consumer advocacy 

organizations stated that the CI 

detection rate for visible fecal 

contamination and septicemia/toxemia 

is based on the assumption that the rates 

at which VIs detect these food safetyrelated conditions represents the level at 

which these conditions occur in the 

establishment. The comments 

questioned this assumption. The 

comments noted that in HIMP 

establishments, the VI collects eight 10- 

bird verification samples per line per 

shift. The comment asserted that there 

is no evidence to indicate that this 

sample size is sufficient to represent the 

true level of food safety defects on 

carcasses throughout the shift. 

Response: FSIS disagrees that the CI 

detection rate is based on the 

assumption that the rate at which VIs 

detect carcasses affected with 

septicemia/toxemia or visible fecal 

contamination represents the level at 

which these conditions occur in the 

establishment. The CI detection rate is 

the rate at which CIs in HIMP 

establishments detected carcasses with 

these food safety-related conditions 

before the carcasses entered the chiller. 

It is not based on the VI detection rate. 

FSIS believes that its sampling for 

food safety defects under HIMP is 

sufficient to reflect the level of food 

safety defects on carcasses processed in 

HIMP establishments. Statistically, 

given the sample design, the precision 

of an estimate of an establishment’s 

level of food safety defects depends 

primarily on the total number of 

samples for an establishment collected 

over time. 

The food safety performance 

standards, which are based on 

thousands of samples collected by a 3rd 

party contractor and reflect the level of 

food safety defects on carcasses 

processed in establishments before they 

entered the HIMP pilot, vary by defect 

category. The performance standard for 

septicemia/toxemia is 0.1 percent, and 

the performance standard for visible 

fecal contamination is 1.5 percent. 

When deciding the number of samples 

that FSIS should take to reflect an 

establishment’s level of food safety 

defects over time, FSIS determined that 

collecting 80 birds per line per shift 

would provide an estimated defect rate 

that was close to the true defect rate. 

For example, if the true defect rate for 

visible fecal contamination was 0.1 

percent at an establishment that 

operated one line for two shifts, 300 

days per year, taking an 80 bird sample 

per line per shift would give a total of 

48,000 samples a year, per line. This 

number of samples, assuming a random 

distribution of defects throughout the 

year, would give FSIS an estimated 

defect rate between 0.72 and .128 

percent with about 95 percent 

probability. Thus, FSIS believes that the 

specified sample size is sufficient to 

make general comparisons of average 

defect rates among establishments or 

lines. 

Comment: One consumer advocacy 

organization stated that another reason 

that the VI detection rate may not 

represent the actual level of food safetyrelated defects in HIMP establishments 

is that statements it obtained from HIMP 

inspectors indicate that establishment 

employees take greater care to prevent 

and remove visible fecal contamination 

and to identify and remove septicemic/ 

toxemic carcasses when they know that 

the VI inspector is getting ready to take 

a sample. 

Response: The comments seem to 

suggest that establishment employees 

are able to manipulate the results of the 

VI’s verification checks. FSIS disagrees. 

As noted above, VIs in HIMP 

establishments collect scheduled 

verification samples that consist of eight 

10-bird samples per line per shift. VIs 

also collect targeted, unscheduled 10- 

bird samples in response to VI or CI 

findings of excessive food safety or OCP 

carcass defects. 

VIs in HIMP establishments collect 

scheduled and unscheduled verification 

samples for septicemia/toxemia and 

visible fecal contamination using the 

same offline verification methodology 

that offline inspectors in non-HIMP 

establishments use to collect samples 

for visible fecal contamination checks. 

In both HIMP and non-HIMP 

establishments, offline inspectors do not 

inform establishment employees when 

they collect verification samples and, 

equally important, take care to ensure 

that the samples represent the operating 

conditions in the establishment. Thus, 

there is no reason to believe that 

employees in HIMP establishments have 

any significant opportunity, and 

certainly no additional opportunity, to 

affect the results of the verification 

checks. 

Comment: Some consumer advocacy 

organizations said that the data in the 

HIMP Report do not support the 

Agency’s conclusion that CIs are able to 

identify carcasses affected with visible 

fecal contamination and septicemia/

toxemia. 

With respect to visible fecal 

contamination, one consumer advocacy 

organization stated that the data 

presented in the HIMP Report indicate 

that CIs did not detect 88 out of 89 birds 

with fecal contamination going down 

the line. The comment stated that the 

inspectors in the VI position who were 

able to examine both the inside and the 

outside of the bird detected visible fecal 

contamination on the carcass at 

approximately 90 times the rate that the 

CIs detected it. Another said that based 

on the data, it is reasonable to calculate 

that CIs failed to detect over a quarter 

of a million carcasses with fecal 

contamination in the 20 HIMP 

establishments within the two-year 

period of data collection. 

With respect to septicemia/toxemia, 

one comment said that data presented in 

the HIMP Report indicate that CIs detect 

approximately 1 of every 200 carcasses 

affected by septicemia/toxemia. The 

comment said that this means that the 

CI does not detect 199 of every 200 

carcasses affected with septicemia/

toxemia. 

Response: FSIS disagrees with the 

commenters’ conclusions. The 

commenters’ assessments are based on a 

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comparison of the results of the CI’s 

carcass inspection and the VI’s carcass 

verification checks and do not take into 

account the difference between the role 

of the CI and VI under HIMP. Under 

HIMP, the inspections performed by the 

VI and CI serve different purposes and 

are not done in the same way. Thus, the 

rate at which VIs identify food safety 

defects when conducting offline 

verification checks is not an appropriate 

basis for assessing whether the CI is 

conducting an effective inspection of 

each carcass leaving the slaughter line. 

Under the HIMP inspection system, 

the VI and CI have different but 

complementary roles in ensuring that 

poultry products leaving the slaughter 

line are safe and wholesome. CIs are 

responsible for conducting a continuous 

online inspection of each carcass to 

determine whether it is not adulterated. 

The VI’s role is very different. VIs 

collect carcass samples before the CI 

inspection station after the 

establishment has conducted sorting, 

trimming, and reprocessing activities to 

monitor and evaluate the 

establishment’s process controls. The 

samples collected by VIs may be either 

‘‘scheduled’’ or ‘‘unscheduled.’’ 

On the one hand, VIs collect eight 

randomly selected 10-bird samples per 

line per shift. These are referred to as 

the ‘‘scheduled’’ samples because the 

IIC schedules the collection of the eight 

sample sets before each shift. On the 

other hand, VIs also collect targeted, 

unscheduled 10-bird samples as 

directed by the IIC in response to VI or 

CI findings of excessive food safety or 

OCP carcass defects. These samples are 

in addition to the 80-bird scheduled 

samples. Because the VI’s unscheduled 

samples are collected when excessive 

carcass defects have been identified, the 

results typically show higher rates of 

carcass defects than the VI’s scheduled 

sampling results. 

The VI detection rates in the HIMP 

report reflect the combined results of 

the VI’s scheduled and unscheduled 

sampling and are thus are much higher 

than the rates that would have resulted 

had the VI only performed scheduled 

carcass sampling. Because CIs under 

HIMP perform an online inspection of 

each carcass, the CI detection rates are 

not subject to the same sampling bias 

introduced by the unscheduled 

sampling that VIs perform during high 

defect periods. Significantly, FSIS has 

not captured what percent of the defects 

found by VIs were found in scheduled 

as opposed to unscheduled sampling. 

Thus, the VI and CI detection rates are 

not comparable. Therefore, as stated 

above, the comparisons of the VI and CI 

detection rates cited by the comments 

do not provide a valid assessment of the 

CI’s ability to conduct an effective 

online carcass inspection. 

4. Public Health-Related NonCompliances 

In the proposed rule, the Agency 

noted that the HIMP Report shows that 

HIMP establishments have public 

health-related non-compliance 

record(NR) rates that are not statistically 

different from or that are statistically 

lower than the rates for non-HIMP 

establishments (77 FR 4416–4417). The 

Agency also noted that HIMP 

establishments had fewer NRs for 

visible fecal contamination than nonHIMP establishments. Several consumer 

advocacy organizations, FSIS 

inspectors, and a labor union 

commented on these conclusions. 

Comment: Comments from inspectors, 

labor unions, and consumer advocacy 

organizations stated that the location of 

the establishment’s critical control point 

(‘‘CCP’’) for food safety defects may 

prevent a CI from issuing an NR even if 

the CI detects such a defect. The 

comments noted that at the start of the 

HIMP pilot, the CCPs for visible fecal 

contamination and septicemia/toxemia 

were located before the FSIS carcass 

inspection station. The comments stated 

that before FSIS began collecting data to 

support the proposed rule, the Agency 

allowed the HIMP establishments to 

move their CCPs for fecal contamination 

and septicemia/toxemia to points after 

the CI. One comment said that the 

timing for allowing establishments to 

move CCPs to a point after the CI 

suggests that the primary purpose was 

to reduce the number of NRs issued to 

HIMP establishments for these 

conditions. Another comment said that 

the fact that CIs cannot issue an NR if 

they observe food safety defects before 

the CCP, affects the HIMP Report’s CI 

detection rate statistics. 

Response: FSIS disagrees with the 

suggestion that the location of the CCP 

with respect to the CI affects the 

comparison of NR rates between HIMP 

and non-HIMP establishments. The 

HIMP Report’s analysis of NRs for 

visible fecal contamination in HIMP and 

non-HIMP establishments is based on a 

comparison of visible fecal NRs detected 

through offline verification activities, 

not on the CI detection rate, as 

suggested by one of the comments. 

As noted above, the VI under HIMP 

collects carcass samples after 

establishment employees have sorted 

and trimmed the carcasses, but before 

the carcasses are presented to the CI. If 

the VI detects visible fecal 

contamination offline, the VI issues an 

NR because the establishment violated 

the Agency’s zero tolerance for visible 

fecal contamination. If a CI observes a 

carcass with visible fecal contamination 

the CI stops the line to prevent the 

carcass from entering the chiller. The 

location of the establishment’s CCP for 

food safety defects does not affect the 

CI’s or VI’s duties under HIMP. Thus, 

because the NR rate for visible fecal 

contamination under HIMP is based on 

the VI detection rate, the location of the 

CCP with respect to the CI inspection 

station does not affect the HIMP 

Report’s analysis of visible fecal NRs. 

With respect to the comment that 

suggested that the location of the CCP 

affects the CI detection rate statistics, 

the CI detection rate reflects the rate at 

which CIs stop the line to prevent 

carcasses with food safety defects from 

entering the chiller. Thus, contrary to 

the commenter’s suggestion, the 

location of the CCP after the CI 

inspection station does not affect the CI 

detection rate. 

Comment: One comment stated that 

the Agency provided no information to 

demonstrate that documentation 

policies and opportunities for 

documenting public health-related NRs 

were the same in HIMP and non-HIMP 

establishments. The comment stated 

that the 2001 GAO report on HIMP 

noted that after the switch to HIMP, a 

substantial number of establishments 

saw increased fecal NR rates. The 

comment said that the GAO report cited 

increased line speeds under HIMP as a 

potential factor for the increased rate of 

fecal NRs. The comment said that these 

findings suggest that the transition to 

HIMP may result in increased rates of 

fecal contamination. 

Response: As noted in the Agency’s 

comments on the 2001 GAO report, 

under HIMP, the Agency performs 

verification checks on approximately 80 

carcasses per line per shift as opposed 

to verification on approximately 20 

carcasses per line for fecal 

contamination under non-HIMP broiler 

inspection. In addition, VIs under HIMP 

perform more offline inspection 

activities that FSIS has concluded are 

more effective in ensuring food safety 

than inspectors perform in non-HIMP 

establishments. Thus, FSIS inspectors in 

HIMP establishments have more 

opportunities for detecting noncompliances with regulatory 

requirements that are directly related to 

public health than inspectors do in nonHIMP establishments. The procedures 

for documenting public-health related 

NRs are the same for both HIMP and 

non-HIMP establishments. 

Although the GAO report cited 

increased line speeds in HIMP 

establishments as a potential factor for 

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the increased rate of fecal NRs, the 

Agency is not aware of any data to 

support this hypothesis. The increased 

rates of fecal NRs that occurred at the 

beginning of the HIMP pilot could just 

as easily be the result of increased 

monitoring under the HIMP inspection 

system rather than an increase in fecal 

contamination. Further, the final rule 

includes a maximum line speed of 140 

bpm under the NPIS rather than the 175 

bpm allowed in the HIMP pilot. 

Comment: A consumer advocacy 

organization stated that it had recently 

acquired records of NRs written for 

visible fecal contamination within the 

last year from two HIMP establishments 

and two non-HIMP establishments. The 

comment stated that to the best of the 

commenter’s knowledge, all of the 

establishments are large establishments 

with two production lines and two 

production shifts. The comment said 

that the non-HIMP establishments had 

19 and 23 NRs for visible fecal 

contamination, respectively, and the 

HIMP establishments had 93 and 173 

visible fecal NRs, respectively. The 

comment stated that these comparisons 

add to the concerns that the lower NR 

rates for HIMP establishments described 

in the HIMP Report may not be good 

indicators of the actual level of food 

safety defects on carcasses. 

Response: Because the consumer 

advocacy organization did not indicate 

where it obtained the data or which 

establishments the data are from, FSIS 

is unable to respond to the comment in 

detail. 

The HIMP Report’s comparison of 

visible fecal NRs issued from offline 

verification checks in HIMP and nonHIMP establishments compares ‘rates,’ 

which adjust for the number of samples 

taken. The report shows that fecal NR 

rates at HIMP establishments are 

statistically lower than those in both the 

control set of 64 non-HIMP 

establishments and the 176 all nonHIMP comparison set. In addition, the 

rate of visible fecal material 

contamination on carcasses in HIMP 

establishments is about half that in nonHIMP establishments. Thus, when the 

sample is viewed as a whole and rates 

are the unit of comparison, the data 

show that HIMP establishments have 

both slightly lower visible fecal NR rates 

and slightly lower rates of visible fecal 

contamination than non-HIMP 

establishments. 

The comparison included in the 

comment is based on NR rates from two 

HIMP establishment and two non-HIMP 

establishments and does not necessarily 

reflect the average NR rates for all HIMP 

establishments. 

Comment: Another consumer 

advocacy organization stated that it had 

received records for the first shift of 

production for 11 young chicken and 3 

young turkey HIMP establishments from 

FSIS through a Freedom of Information 

(FOIA) request. The organization 

analyzed documents that covered the 

period of January 2011 through August 

2011. According to the comment, the 

overwhelming number of NRs filed for 

the 14 establishments was for visible 

fecal contamination found on the 

carcasses. The comment stated that out 

of 229 NRs filed from March to August 

2011, 208 (90 percent) were for visible 

fecal contamination. Other comments 

referenced this finding. 

Response: The analysis conducted by 

the consumer advocacy organization is 

not inconsistent with the conclusions in 

the HIMP Report. While it is true that 

a large percentage of public healthrelated NRs in poultry slaughter 

establishments are for visible fecal 

contamination, the occurrence of fecal 

contamination on carcasses in HIMP 

establishments is fewer than 8 per ten 

thousand carcasses, which is about 19 

times lower than the HIMP performance 

standards. In addition, the rate of visible 

fecal material contamination on 

carcasses in HIMP establishments 

averages about half that in non-HIMP 

establishments (Table 3–7 in HIMP 

Report). 

5. OCP Standards Under HIMP 

In the preamble to the proposed rule, 

FSIS noted that data from the HIMP 

Report show that OCP defects identified 

on carcasses processed in HIMP 

establishments averaged about half the 

corresponding OCP HIMP performance 

standards (77 FR 4418). Based on the 

HIMP data, the Agency concluded that 

establishments operating under the 

HIMP inspection system performed 

better than establishments operating 

under non-HIMP inspection systems 

with respect to OCP defects. Several 

consumer advocacy organizations and 

some private citizens commented on 

this conclusion. 

Comment: Some consumer advocacy 

organizations asserted that the OCP 

standards under HIMP were not 

stringent. The comments said that even 

with these less than rigorous OCP defect 

levels, HIMP establishments were still 

just meeting the standards. 

Response: While there is likely to be 

some variation in performance among 

establishments, for the two year period 

from CY 2009 through 2010, FSIS 

verification data show that OCP defect 

levels in HIMP establishments averaged 

about half the corresponding OCP 

performance standards. 

In addition, the HIMP OCP 

performance standards are set at the 

75th percentile of what was achieved 

under the RTI’s baseline study of the 

performance of 16 establishments before 

they entered the HIMP study. Thus, 25 

percent of the establishments that 

entered HIMP have had to improve 

upon their baseline results to meet the 

more stringent standards. 

Comment: One comment noted that 

the HIMP study’s statistics on 

compliance with OCP performance 

standards are based on a sampling of up 

to 80 carcasses per slaughter line per 

shift of production. The comment 

asserted that when each slaughter line is 

processing upwards of 100,000 chickens 

per eight hour shift, this sample size is 

likely to be too small to accurately 

reflect the level of OCP defects on RTC 

carcasses produced by the 

establishment. 

Response: FSIS disagrees with the 

comment. FSIS believes that its 

sampling for OCP defects under HIMP is 

sufficient to reflect an establishment’s 

level of OCP defects. Statistically, given 

the sample design, the precision of an 

estimate of an establishment’s level of 

OCP defects depends primarily on the 

total number of samples for an 

establishment collected over time. 

The OCP performance standards, 

which are based on a tightening of the 

FPS for removable animal diseases and 

trim and dressing defects for 

establishments before they entered the 

HIMP pilot, vary by OCP defect 

category. For example the performance 

standard for OCP–1, Condition-Animal 

Diseases, is 1.7 percent, and the 

performance standard for OCP–3, 

Digestive Content (Ingesta), is 18.6 

percent. When deciding the number of 

samples that FSIS should take to reflect 

an establishment’s level of OCP defects 

over time, FSIS determined that 

collecting at most 80 birds per line per 

shift would provide an estimated defect 

rate that was close to the true defect 

rate. For example, if the true defect rate 

for OCP–1 defects was 1 percent at an 

establishment that operated one line for 

two shifts, 300 days per year, taking an 

80 bird sample per line per shift would 

give a total of 48,000 samples a year, per 

line. Eighty samples are not always 

collected; but in general, close to this 

number were collected daily. It is 

reasonable to assume that the total 

number of samples would not be less 

than 90 percent, or 43,200 samples. This 

number of samples, assuming a random 

distribution of defects throughout the 

year, would give FSIS an estimated 

defect rate between 0.905–1.095 percent 

with about 95 percent probability. Thus, 

FSIS believes that the specified sample 

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size is sufficient to make general 

comparisons of average defect rates 

among establishments or lines. 

6. Salmonella Positive Rates in HIMP 

Establishments 

The HIMP Report compares 

Salmonella positive rates for HIMP 

young chicken slaughter establishments 

with a control set of 64 non-HIMP 

establishments and all 176 non-HIMP 

broiler establishments (77 FR 4418– 

4419). The data show that Salmonella 

positive rates are equivalent or lower in 

HIMP establishments than they are in 

non-HIMP establishments. The Agency 

concluded that the increase in offline 

inspection activities provided for under 

HIMP resulted in the initial lower levels 

of Salmonella contamination in HIMP 

establishments. Several consumer 

advocacy organizations and private 

citizens commented on the HIMP 

Report’s analysis of Salmonella positive 

rates in HIMP and non-HIMP 

establishments and on the Agency’s 

conclusions with respect to this 

analysis. 

Comment: A consumer advocacy 

organization stated that the HIMP 

Report’s analysis of the Salmonella 

positive rates for HIMP establishments 

may not reflect the rates for all 

establishments operating under HIMP. 

The comment noted that data from the 

Agency’s Salmonella testing program 

show that the Agency collected data on 

Salmonella positive rates from only 14 

HIMP establishments in 2006, 17 HIMP 

establishments in 2007, and 15 HIMP 

establishments in 2008. The comment 

noted that the Agency collected 

Salmonella data from only 10 of the 20 

HIMP broiler establishments in 2010. 

The comment also said that the Agency 

provided no comparison on Salmonella 

results in the turkey establishments. 

One member of academia said that the 

Agency’s microbial sampling and 

analysis under the HIMP pilot were not 

performed with adequate frequency or 

power to detect sporadic low-level 

contamination of carcasses. 

Response: FSIS uses the same 

methodology to schedule and conduct 

verification sampling for Salmonella in 

both HIMP and non-HIMP 

establishments. Under the FSIS riskbased methodology for scheduling 

Salmonella verification sample sets, not 

all establishments are sampled every 

year. FSIS schedules up to 75 new 

sample sets each month. The 

establishments and products selected 

for sample sets are chosen according to 

a risk-based algorithm that involves 

sorting the list of eligible establishments 

and their respective products by certain 

criteria and selecting the top 75 from 

this list. Depending on the frequency of 

production, product type, and 

availability of resources, the time to 

complete a sample set ranges from less 

than two months to over a year. In 

establishments that produce more than 

one product subject to Salmonella 

verification testing, only one product is 

tested at a time. However, since the 

same method is used in both HIMP and 

non-HIMP establishments, Salmonella 

positive levels represent a valid means 

of comparing the performance of HIMP 

and non-HIMP establishments. 

With respect to the comment that said 

that the Agency’s microbial sampling 

and analysis under the HIMP pilot were 

not performed with adequate frequency 

or power to detect sporadic low-level 

contamination of carcasses, the 

sampling and analysis for Salmonella 

under the HIMP pilot was used to 

compare performance of both HIMP and 

non-HIMP establishments, not to detect 

sporadic, low-levels of contamination in 

HIMP establishments. 

Comment: One consumer advocacy 

organization said that the Agency’s 

conclusion that HIMP establishments 

have lower Salmonella positive rates 

than non-HIMP establishments is 

misleading because the HIMP Report 

compared Salmonella positive rates for 

HIMP establishments with all 

establishments operating under nonHIMP inspection systems. According to 

the comment, the Agency should have 

compared rates for HIMP establishments 

with the rates for comparably sized nonHIMP establishments. 

Response: The HIMP Report 

compared Salmonella positive rates in 

HIMP establishments with both 

comparable non-HIMP establishments 

and all young chicken slaughter 

establishments. The first comparison set 

of establishments was a subset of 64 

non-HIMP establishments selected to be 

comparable to HIMP establishments 

with respect to total slaughter volume, 

line speeds, and geographic 

distribution. The second comparison set 

was all 176 non-HIMP establishments 

that slaughtered young chicken in all 5 

years considered in the study. The 

analysis shows that with respect to 

Salmonella positive rates, the HIMP 

establishments performed better than or 

as well as both the comparison set of 64 

non-HIMP establishments and the set of 

all 176 non-HIMP establishments from 

CY 2006 through 2010. 

Comment: A consumer advocacy 

organization asserted that the 

Salmonella positive rates in HIMP 

establishments do not support the 

Agency’s claim that HIMP 

establishments have consistently 

performed better under HIMP than they 

did under non-HIMP inspection 

systems. The comment stated that the 

Agency’s own Salmonella data from 

1998–2007 demonstrate that 14 of the 20 

HIMP establishments had lower 

Salmonella positive rates under the 

non-HIMP inspection systems than they 

did under the HIMP, and that the 

average Salmonella positive rate for all 

20 of the HIMP establishments was 

better when the establishments were 

operating under non-HIMP inspection 

systems. The organization conducted its 

own analysis of the Agency’s 

Salmonella data from January 1, 2006 

through September 20, 2007 and said 

that its analysis shows that the HIMP 

establishments had an average 

Salmonella positive rate of 8.9 percent, 

while the non-HIMP establishments had 

an average rate of 6.5 percent. 

Response: In CY 2006 through 2008, 

the Salmonella positive rate in HIMP 

establishments was statistically 

significantly lower than in the 64 nonHIMP comparison set, and there was no 

statistically significant difference in CY 

2009 and CY 2010. A comparison of 

HIMP establishments with all non-HIMP 

broiler establishments shows that the 

Salmonella positive rate in HIMP 

establishments was statistically 

significantly lower in CY 2006 through 

2009 and not statistically significantly 

different in CY 2010. This analysis 

demonstrates that with respect to 

Salmonella positives rates, HIMP 

establishments are performing at least as 

well as current non-HIMP 

establishments. 

With respect to Salmonella data from 

January 1, 2006, through September 20, 

2007, referenced by the comment, FSIS 

has analyzed the most recent data from 

that time period and found Salmonella 

positive rates of 7.55 percent and 9.61 

percent for HIMP and non-HIMP 

establishments, respectively. 

Comment: A consumer advocacy 

organization stated that in CY 2009 and 

CY 2010, HIMP establishments had 

higher Salmonella positive rates than 

the 64 non-HIMP comparison 

establishments. The comment noted that 

the HIMP Report shows that the rates for 

the HIMP establishment were 4.9 

percent and 4.7 percent in CY 2009 and 

CY 2010, respectively, and the rates for 

the non-HIMP establishments for these 

years were 4.3 percent and 4.0 percent, 

respectively. The comment suggested 

that before moving forward with the 

NPIS, FSIS should first try to 

understand why this happened. 

Response: FSIS disagrees with the 

comment’s suggestion that HIMP 

establishments had higher Salmonella 

rates than non-HIMP establishment in 

CY 2009 and CY 2010. The differences 

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in Salmonella positive rates in CY 2009 

and CY 2010 noted by the comment are 

not statistically significant. On the other 

hand, in CY 2006 through 2008, the 

Salmonella positive rate in HIMP 

establishments was statistically 

significantly lower than in the 64 nonHIMP comparison set. 

Comment: Some consumer advocacy 

organizations stated that reductions in 

Salmonella positive rates may be the 

result of factors other than increased 

offline inspection procedures performed 

under the HIMP inspection system. The 

comments noted that from CY 2006 

through 2008, Salmonella positive 

carcass rates in HIMP establishments 

were statistically significantly lower 

than in the non-HIMP comparison 

establishments, but that in CY 2009 and 

CY 2010, there was no statistically 

significant difference. The comments 

also noted that both HIMP and nonHIMP establishments lowered their 

Salmonella positive rates considerably 

between CY 2006 and CY 2010. 

The comments asserted that because 

the Agency did not report any changes 

to the HIMP or non-HIMP inspection 

systems during that time, it is 

reasonable to assume that factors other 

than increased offline inspection 

activities in HIMP establishments may 

have caused such a significant decrease 

in Salmonella positive rates. One 

comment noted that in 2008 FSIS began 

publishing the names of establishments 

in Categories 2 and 3 under the 

Agency’s new Salmonella performance 

standards. The comment stated that the 

data for CY 2009 and CY 2010 may 

indicate that the industry as a whole 

reduced its Salmonella positive rates as 

a result of this initiative. Another 

comment stated that the decline in 

Salmonella positive rates may have 

been caused by an increase in the use 

of online reprocessing technology 

throughout the industry. 

Response: In the preamble to the 

proposed rule, the Agency explained 

that results in CY 2010 most likely 

reflect the effects of the Salmonella 

initiatives that FSIS began 

implementing in 2006 to reverse the 

multi-year trend of persistently higher 

percent positive rates for Salmonella 

detected through the Agency’s HACCP 

verification testing each year (77 FR 

4419). As a result of these initiatives, 

the industry reduced the incidence of 

positive Salmonella results, particularly 

those establishments with the highest 

Salmonella positive rates. Nonetheless, 

before these initiatives were fully 

implemented, the HIMP report shows 

that HIMP establishments performed 

better than non-HIMP establishments 

with respect to Salmonella positive 

rates. The reduction in Salmonella 

positive rates in both HIMP and nonHIMP establishments reflects the 

effectiveness of FSIS’s initiatives to 

reduce Salmonella industry-wide. 

Comment: One member of academia 

said that the Agency needs to conduct 

more frequent sampling for a broader 

range of pathogens to assess the impact 

of the HIMP inspection system. 

Response: Salmonella is a key 

pathogen of concern in poultry 

products. FSIS conducts Salmonella 

verification sampling in both HIMP and 

non-HIMP establishments. Thus, 

Salmonella positive rates are a valid 

means of comparing the performance of 

both HIMP and non-HIMP 

establishments. 

C. The Risk Assessment 

The preamble to the proposed rule 

explained that in June 2011, FSIS 

completed a quantitative risk 

assessment to model how performing a 

greater number of sanitation, sampling, 

and other offline inspection procedures 

in young chicken and turkey slaughter 

establishments might affect the number 

of human illnesses from Salmonella and 

Campylobacter (77 FR 4420). FSIS 

updated the 2011 Risk Assessment in 

response to public comments received 

on the January 2012 proposed rule; that 

version of the risk assessment was 

subsequently posted to the FSIS Web 

site in August 2012 (referred to as the 

August 2012 version). In addition, the 

2011 risk assessment was subjected to 

independent external peer review; the 

risk assessment was further updated in 

response to the peer review comments. 

It has also benefited from editing 

consistent with the Office and 

Management memorandum, Final 

Guidance on Implementing the Plain 

Writing Act of 2010 (M–11–15), striving 

to make the risk assessment report 

language ‘‘clear, concise, wellorganized. The most recent version of 

the risk assessment, which reflects the 

revisions made in response to public 

and peer review comments, is referred 

to as the July 2014 version. Both the 

August 2012 version and the July 2014 

versions have been posted to the FSIS 

Risk Assessment Web page at: http://

www.fsis.usda.gov/wps/portal/fsis/

topics/science/risk-assessments. 

The HIMP Report explained that FSIS 

inspectors performed more offline 

inspections to verify compliance with 

sanitation SOP and HACCP regulations 

in HIMP establishment than they do in 

non-HIMP establishments. The 

regression analysis of historical data 

that was included in the risk assessment 

showed a statistically significant 

correlation between unscheduled offline 

inspection procedures and reduction in 

the prevalence of Salmonella and 

Campylobacter positive samples. Based 

on these results, FSIS thinks it is 

reasonable to conclude that the 

redeployment of Agency resources to 

unscheduled offline activities is likely 

to contribute to improved food safety 

resulting from a lower prevalence of 

carcasses contaminated with Salmonella 

and Campylobacter, which in turn we 

expect to lead to fewer human illnesses. 

Comment: Several comments 

requested that the Agency clarify the 

status of the 2011 risk assessment’s peer 

review. The comments noted that the 

Agency had prepared a risk assessment 

in 2005 that was peer reviewed. The 

comments said as a result of the peer 

review, the Agency prepared a revised 

risk assessment in 2008 but, according 

to the comments, the docket for the 

proposed rule contains neither the 2008 

risk assessment nor a peer review of that 

risk assessment. 

Response: The FSIS ‘‘Risk Assessment 

for Guiding Public Health-Based Poultry 

Slaughter Inspection’’ has been 

available to the public on the FSIS Risk 

Assessment Web site since 2008 at: 

http://www.fsis.usda.gov/wps/wcm/

connect/07c57a64-932f-4ebb-977b2b10e45a1830/Poultry_Slaughter_Risk_

Assess_Jan2008.pdf?MOD=AJPERES. 

The analysis was originally peer 

reviewed in 2006 by an independent 

group of mathematical modeling 

specialists. The risk assessment was 

modified and improved based on the 

initial peer review. Because the model 

and analysis has continued to evolve, 

the 2011 version of both the model and 

analysis have undergone a peer review. 

The 2011 risk assessment has been 

updated based on the peer review 

comments. The 2011 risk assessment, 

the peer review comments, FSIS’s 

response to those comments, and the 

current version of the risk assessment 

are available on the FSIS Web site at: 

http://www.fsis.usda.gov/wps/wcm/

connect/8f374626-ee06-49d3-9d41- 

6eb65ad32cbb/Poultry_Slaughter_Risk_

Assess_Aug2012.pdf?MOD=AJPERES. 

Comment: A consumer advocacy 

organization said that the risk 

assessment provides little raw data, 

little explanation of how it was 

analyzed, and is largely silent on the 

assumptions upon which it was based. 

A comment from a labor union was also 

critical of the FSIS risk assessment. 

Response: FSIS generally disagrees 

with the comments. The risk assessment 

uses all relevant data taken from FSIS’s 

inspection database paired with 

Salmonella and Campylobacter 

regulatory and baseline sampling data 

for young chickens and turkeys. Overall, 

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substantial amounts of empirical data 

were used in this risk assessment. It 

uses the Young Chicken Baseline and 

PR/HACCP Salmonella verification data 

from July 2007–September 2010 and the 

Young Chicken Baseline Campylobacter 

data from July 2008–September 2009. It 

also uses the Young Turkey Baseline 

and PR/HACCP Salmonella verification 

data from July 2007–September 2010 

and the Young Turkey Baseline 

Campylobacter data from August 2008– 

July 2009. There are about 40,900 raw 

data samples collected on 94 inspection 

procedures taken from the computerized 

Performance-Based Inspection System 

(PBIS). 

Although FSIS thinks that the 2011 

version of the risk assessment is fully 

documented, the July 2014 version has 

benefited from the addition of language 

that more clearly describes how the 

model works and articulates more it 

clearly the underlying assumptions. As 

noted above, this version also was 

updated in response to peer review 

comments. As discussed above, the 

2011 version of the risk assessment, the 

peer review comments on that version, 

FSIS’s response to the peer review 

comments, and the updated 2014 

version of the risk assessment are posted 

on the FSIS Web site. 

Comment: A commenter said that one 

of the major assumptions in the risk 

assessment is that if performing more 

unscheduled offline inspection 

procedures ‘‘either reduces (or does not 

change) the occurrence of foodborne 

pathogens such as Salmonella and 

Campylobacter on finished poultry 

products, then a net public health 

benefit may result.’’ The comment 

questioned how there could be a ‘‘net 

public health benefit’’ if there is no 

change to the incidence of pathogens on 

poultry carcasses. The comment said 

that FSIS should not predicate a 

significant restructuring of the poultry 

slaughter inspection program based on a 

finding that there will be no change to 

the incidence of contamination of 

poultry products. According to the 

comment, any substantial change to 

meat or poultry inspection should result 

in significant improvements to public 

health. 

Response: The Agency agrees that the 

statement in the risk assessment may 

not fully articulate how a net public 

health benefit may result if performing 

more unscheduled offline inspection 

procedures reduces (or does not change) 

the occurrence of foodborne pathogens. 

To clarify, the risk assessment estimates 

that if more unscheduled offline 

inspection procedures reduces the 

occurrence of a specific foodborne 

pathogen, such as Salmonella, but does 

not change the occurrence of a different 

pathogen, such as Campylobacter, there 

will be an overall reduction in 

pathogens on finished poultry products. 

This aggregate reduction of pathogens 

and the subsequent reduction in human 

illnesses is what was hypothesized to 

result in a net public health benefit. 

The risk assessment characterizes a 

negative correlation between the 

frequency of unscheduled offline 

inspection activities and the prevalence 

of both Salmonella and Campylobacter 

positive samples. Based on these 

modeling results, FSIS thinks it is 

reasonable to conclude that 

redeployment of Agency resources from 

online inspection activities to targeted 

unscheduled offline activities is likely 

to produce an improvement in the food 

safety system resulting from a lower 

prevalence of carcasses contaminated 

with Salmonella and Campylobacter, 

which could in turn result in a net 

reduction in the number of human 

illnesses. 

Comment: Several comments noted 

that the Agency conceded that 

‘‘substantial uncertainty about 

forecasted changes in illness rates’’ 

results from uncertainty about the 

change in future inspection activities 

and the rates of human illnesses 

attributable to poultry. 

Response: The risk assessment 

analyzed data on specific types of 

inspection activities and the prevalence 

of Salmonella and Campylobacter in 

young chicken and turkey slaughter 

establishments. The results suggest that, 

because inspection personnel assigned 

to the NPIS will conduct more of the 

type of inspection activities that were 

correlated with lower Salmonella and 

Campylobacter prevalence, the NPIS 

will likely result in fewer human 

illnesses than would be expected if not 

implemented. In addition to the 

expected values, the analysis provides 

the statistical uncertainty of the 

estimated number of averted illnesses 

by reporting the upper and lower 80 

percent confidence bounds around the 

estimates to acknowledge that 

uncertainty always will exist in such 

models. 

Comment: Several consumer 

advocacy organizations noted that the 

2011 version of the risk assessment 

predicts that additional unscheduled 

offline procedures could lead to as 

many as 986 fewer Campylobacterrelated illnesses per year. The comment 

noted that the risk assessment states that 

‘‘this analysis suggests ambiguous 

effects of the proposed rule with respect 

to Campylobacter occurrence on 

chicken carcasses’’ and thus does not 

show a clear public health benefit. 

Some comments noted that the 

Agency recently established a 

performance standard for 

Campylobacter. The comment said that 

the Agency does not have enough 

experience with the Campylobacter 

performance standards to assess 

industry efforts to reduce 

Campylobacter in poultry to make any 

reasonable predicted public health 

benefits. The comments said that if the 

Agency’s proposed changes to poultry 

slaughter inspection are truly intended 

to improve public health, the Agency 

needs a much better understanding of 

Campylobacter rates in poultry 

establishments and of how the Agency’s 

proposal will impact those rates. 

One comment added that the risk 

assessment suggests that ‘‘the positive 

Salmonella implications of HIMP’’ 

could be applied to Campylobacter, but 

the Agency provides no justification for 

this statement. The comment said that 

several studies point to the difficulty of 

making correlations between controlling 

for Salmonella and controlling for 

Campylobacter. 

The comments asserted that FSIS 

should postpone implementation of the 

proposed rule until it has collected 

additional data on Campylobacter and is 

better able to estimate the impacts of the 

proposed rule on reducing this 

pathogen. 

Response: The Risk Assessment 

presented the results of two scenarios— 

one that was based on only increasing 

unscheduled offline procedures 

(referred to as the ‘‘discriminate 

scenario’’) and one that did not specify 

the particular activities to be increased 

(referred to as the ‘‘indiscriminate 

scenario’’). The former (discriminate 

scenario), which was based on the type 

inspection procedures performed more 

often in the HIMP establishments, 

suggested larger improvements to public 

health than the indiscriminate model. 

FSIS peer-reviewed risk assessment 

(July 2014), results suggest that the 

discriminate scenario of increased offline inspection could decrease the 

number of positive Salmonella and 

Campylobacter samples in young 

chicken and young turkey 

establishments with high probability. 

This is the scenario upon which this 

rule is based. 

As noted by the comments, the 

Agency recently established 

performance standards for 

Campylobacter for young chicken and 

turkey slaughter establishments. 

Because the Agency has not been 

collecting and analyzing samples for 

Campylobacter as long as it has been 

collecting and analyzing samples for 

Salmonella, there are fewer 

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5http://www.fsis.usda.gov/wps/portal/fsis/topics/

regulations/federal-register/federal-register-notices/

notices-2011; Salmonella and Campylobacter 

Notice and comparisons of HACCP and baseline 

report. 

6See FSIS Notice 66–12, which reissued the 

policy in former FSIS Notice 42–11 at: http://

www.fsis.usda.gov/OPPDE/rdad/FSISNotices/66- 

12.pdf. 

Campylobacter sampling results 

available for analysis. Thus, although 

the trends for the Salmonella and 

Campylobacter results are the same, the 

Campylobacter results are less robust 

because of the smaller sample size. The 

updated risk assessment estimates that 

there would be a reduction of 3,980 

Salmonella illnesses attributable to 

young chicken and turkey 

establishments combined. This in itself 

would be a positive public health 

outcome. Because an increase in 

unscheduled offline inspection 

activities is expected to result in fewer 

Salmonella illnesses, FSIS believes that 

there is no reason to delay 

implementation of the rule until the 

Agency collects and analyzes more 

samples for Campylobacter. 

Additionally, Agency responses to 

Campylobacter sample set failures will 

continue to follow procedures for 

Salmonella set failures, i.e. immediate 

follow-up testing for both organisms 

and, in most instances, Food Safety 

Assessments, regardless of whether an 

establishment adopts the NPIS or not. 

Comment: A consumer advocacy 

organization said that the risk 

assessment relies heavily on the data 

collected through the HIMP pilot and 

the microbiological verification testing 

programs. The comment asserted that, 

because these programs are not 

representative of all poultry 

establishments, data collected through 

these programs cannot be generalized to 

the entire poultry industry. The 

comment said that the microbiological 

verification testing programs were not 

designed to estimate the incidence of 

foodborne pathogens in meat and 

poultry products, nor were they 

designed to evaluate trends over time. 

The comment said that despite these 

limitations, the risk assessment has used 

these data to evaluate the public health 

impact of reassigning online inspectors 

to offline activities and has concluded 

that there is a public health benefit to 

doing so. The comment suggested that 

FSIS conduct a pilot study in a 

representative sample of poultry 

establishments to ensure that there is a 

public health benefit before 

implementing the proposed rule in all 

poultry establishments. 

Response: The assertion that the risk 

assessment relies on data that are not 

representative of all poultry 

establishments is not accurate. The risk 

assessment uses a volume-weighted 

model to account for the fact that the 

microbiological sampling is not 

proportional to volume. The risk 

assessment relies on Salmonella data 

collected from 189 young chicken and 

25 turkey slaughter establishments and 

on Campylobacter data collected from 

181 young chicken and 65 young turkey 

slaughter establishments from July 2007 

to September 2010. There are 20 young 

chicken establishments and 5 turkey 

establishments operating under the 

HIMP inspection system. 

The risk assessment does not use the 

results of microbiological verification 

testing programs to estimate the 

prevalence of foodborne pathogens in 

poultry products or to evaluate trends 

over time, as suggested by the comment. 

The risk assessment uses FSIS 

microbiological verification testing 

results to analyze correlations between 

observed positive samples and offline 

inspection activities in young chicken 

and turkey slaughter establishments. 

These correlations are then used as one 

input to the model that characterizes 

changes in attributable human illness. 

The risk assessment showed that the 

greatest effect on Salmonella and 

Campylobacter prevalence and related 

illness would occur when inspection 

activities are concentrated on increased 

unscheduled offline procedures. Thus, 

FSIS disagrees with the comment’s 

suggestion that the Agency should not 

implement the proposed rule until it 

conducts a pilot study in a 

representative sample of poultry 

establishments to ensure that there is a 

public health benefit. The Agency has 

ample evidence to support its 

conclusions that there is a solid basis to 

allow for the NPIS. 

Comment: Comments from a 

consumer advocacy group and a labor 

union said that the risk assessment is 

based on the assumption that the 

Agency’s Salmonella verification data 

accurately reflect the performance of the 

establishments. The comments 

questioned whether the Agency’s 

Salmonella verification results reflect 

the typical operating conditions in 

establishments. According to the 

comments, establishments know when 

FSIS is about to collect Salmonella 

verification samples because the test kit 

is mailed to the establishment right 

before the inspectors are to collect the 

samples. According to the comments, on 

days when inspectors collect samples 

for Salmonella testing, it is not unusual 

for the establishments to increase the 

concentration of available chlorine in 

the chiller. The comments asserted that 

the results of the risk assessment are not 

reliable because the predictions are not 

based on typical operating conditions in 

establishments. As a result, the 

comments said that FSIS’s claims that 

the proposed rule may reduce the 

number of Salmonella and 

Campylobacter related illnesses are 

highly speculative and unlikely to be 

realized. 

Response: FSIS disagrees with the 

comments. The available data from 

FSIS’s microbiological baseline studies 

and the Agency’s Salmonella 

verification results indicate that FSIS’s 

Salmonella verification sampling results 

do reflect typical operating conditions 

in the establishment. 

The Agency compared its most recent 

baseline data for Salmonella prevalence 

in young chicken and turkey slaughter 

establishments collected under its 

National Microbiological Data 

Collection Programs completed in 2008 

and 2009, respectively, with the results 

of the Salmonella samples that it 

collected and analyzed under its 

HACCP Salmonella verification program 

for similar time periods. The estimated 

Salmonella prevalence associated with 

the two sets of data, when volume 

weighted and adjusted for other 

establishment characteristics, were not 

significantly different. FSIS has 

documented this conclusion in a series 

of Agency reports 5 and written material 

associated with the Federal Register 

notice, ‘‘New Performance Standards for 

Salmonella and Campylobacter in 

Young Chickens and Turkey Slaughter 

Establishments, Response to Comments 

and Announcement of Implementation 

Schedule,’’ which announced the new 

Salmonella and Campylobacter 

performance standards (76 FR 15282). 

In addition, under both HIMP and 

non-HIMP inspection systems, the 

protocol is for inspectors to randomly 

collect scheduled Salmonella 

verification samples and do not inform 

establishments when they collect the 

samples. FSIS uses the best available 

data and has taken steps to enhance data 

quality going forward. For example, 

FSIS authorizes its inspectors to request 

that the Agency schedule additional 

Salmonella verification sampling if they 

have evidence to demonstrate that an 

establishment altered its food safety 

system to coincide with the FSIS 

Salmonella verification sample set.6

Since FSIS implemented this policy, 

there have been 10 requests, from which 

3 were found to be process changes 

during Salmonella sampling that 

justified an additional verification set. 

As of July 21, 2014, there have been no 

requests since December 2013. Thus, 

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7See Appendix Tables 6–9 in the July 2014 Risk 

Assessment. 

FSIS has no basis to think that 

establishments are regularly making 

changes to their processes that would 

substantially affect the Agency’s 

Salmonella verification results or, in 

turn, affect the conclusions of the risk 

assessment or the HIMP report. 

Comment: A consumer advocacy 

organization said that the risk 

assessment’s assumptions regarding 

unscheduled inspection procedures 

were based on procedures assigned 

under the PBIS. The comment said that 

now that FSIS has implemented the 

Public Health Inspection System (PHIS), 

the number of pre-operational sanitation 

procedures that inspectors conduct on a 

monthly basis was reduced to 

accommodate other inspection 

procedures under PHIS. According to 

the comment, the risk assessment is 

flawed in that it is not based on the 

inspection tasks that FSIS inspectors 

will actually be performing under PHIS. 

Response: The risk assessment is 

based on the data that were available at 

the time that FSIS conducted the 

analysis. At that time, the available data 

on offline inspection procedures 

reflected the number of such procedures 

scheduled under PBIS. The analysis of 

historical data that is presented in the 

risk assessment showed a relationship 

between lower Salmonella in young 

chicken and Campylobacter in turkey 

prevalence and the type of inspection 

activities that will be conducted more 

frequently under the NPIS. FSIS 

inspectors will continue to conduct both 

unscheduled and scheduled offline 

inspection activities under PHIS. Thus, 

the Agency thinks that the risk 

assessment’s results are valid under 

PHIS. 

Comment: Two consumer advocacy 

organizations said that while the risk 

assessment details the uncertainty about 

the change in human illness rates when 

offline inspection activities are 

intensified, there is no comparable 

examination of the human illness 

changes from reducing online Federal 

inspection activities. One of the 

comments asserted that the risk 

assessment also did not fully consider 

the other changes to the inspection 

system that the Agency was proposing. 

This comment specifically noted that 

the risk assessment did not consider the 

increase in line speeds that had been 

proposed under the NPIS. Both 

comments asserted that the Agency 

should withdraw the rule until an 

analysis of all of the modifications and 

variables provides certainty that the 

inspection changes will not increase the 

risk to human health. 

Response: FSIS disagrees with the 

suggestion that the Agency withdraw 

the rule until it conducts an additional 

analysis. The modifications noted by the 

comments were addressed in the HIMP 

pilot study. FSIS thinks that the 

performance of establishments under 

HIMP, as documented in the HIMP 

report, represents what would be 

achieved under the NPIS. These results 

support moving forward with this final 

rule. 

As under HIMP, under the NPIS, 

establishment employees will be 

responsible for conducting online 

sorting activities that are currently 

conducted by FSIS online inspectors. 

Based on the results of the HIMP pilot, 

FSIS thinks that establishment 

employees can perform these activities 

as effectively as FSIS inspectors do. To 

ensure that they do, FSIS inspectors in 

establishments operating under the 

NPIS will verify that establishment 

employees are effectively sorting 

carcasses on an ongoing basis. As they 

do under HIMP, VIs under the NPIS will 

collect samples and conduct verification 

checks and CIs will perform a visual 

inspection of each carcass at the end of 

the line before the chiller. If inspection 

personnel find food safety-related 

defects or the presence of persistent, 

unattended trim and dressing defects or 

removable animal diseases on carcasses 

and parts, FSIS will require that the 

establishment take appropriate action to 

ensure that establishment employees are 

effectively sorting carcasses and that the 

establishment is operating under 

conditions needed to produce safe, 

wholesome, and unadulterated product. 

Therefore, the Agency believes that 

establishment employees operating 

under FSIS inspection can effectively 

perform the sorting activities that they 

will be responsible for under the NPIS. 

FSIS also disagrees with the comment 

that suggested that the Agency conduct 

an additional risk assessment to 

estimate the effects of line speeds on 

food safety and public health. The focus 

of the risk assessment is to determine 

how performing a greater number of 

sanitation, sampling, and other offline 

activities in young chicken and turkey 

slaughter establishments might affect 

the number of human illnesses from 

Salmonella and Campylobacter. 

Although the regression analysis used in 

the risk assessment did include a 

categorical variable representing line 

speed as a structural (fixed effect) 

variable in the regression model that 

predicts prevalence, the results do not 

reflect measures that establishments 

typically implement in response to a 

given line speed in order to maintain 

process control.7 The Agency believes 

that the performance of establishments 

under HIMP, as documented in the 

HIMP report, represent what would be 

achieved under the NPIS at similar line 

speeds. 

Comment: One comment said that the 

risk assessment concludes that more 

unscheduled offline procedures are the 

key to lowering Salmonella levels. The 

comment noted that the risk assessment 

did not consider whether this would be 

the case if inspectors also did not 

perform all of the scheduled food safety 

verifications, which were the only 

inspection tasks that inspectors 

performed more in HIMP establishments 

than in non-HIMP establishments. 

According to the comment, this is 

important because there are no 

scheduled offline food safety checks in 

the NPIS. The comment questioned the 

Agency’s ‘‘assum[ption] that offline 

inspection activities after the voluntary 

implementation of the new inspection 

system will parallel offline inspection 

activities in current HIMP 

establishments.’’ 

Response: Inspection procedures that 

will be performed in establishments 

operating under the NPIS will be 

determined by protocols currently 

required under PHIS. Under PHIS, 

inspectors perform both routine 

(scheduled) procedures and directed 

(unscheduled) procedures. Thus, 

inspectors assigned to establishments 

operating under the NPIS will perform 

both scheduled and unscheduled offline 

procedures, just as they currently do in 

both HIMP and non-HIMP 

establishments. These offline 

procedures include, verifying 

compliance with HACCP and Sanitation 

SOP requirements, performing carcass 

verification checks for septicemia/

toxemia and visible fecal contamination, 

verifying sanitary dressing 

requirements, and collecting samples. 

The offline inspection activities 

conducted under the NPIS are intended 

to be the same rather than parallel the 

procedures of the existing inspection 

systems, yielding the same or better 

public health outcomes. 

D. The New Poultry Inspection System 

(NPIS) 

In the preamble to the proposed rule, 

the Agency explained that, based on its 

experience under HIMP, it was 

proposing to establish the NPIS for 

young chickens and turkeys (77 FR 

4421). The proposed rule would have 

eliminated SIS, NELS, NTIS, and the 

HIMP pilot and would have required 

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that all young chicken and turkey 

slaughter establishments operate either 

under the NPIS or the Traditional 

Inspection System, as modified in the 

proposed rule. The proposed rule would 

also have limited the number of online 

inspectors under Traditional Inspection 

to two for each evisceration line, with 

an exception for existing establishments 

that slaughter poultry other than young 

chickens and turkeys that are currently 

operating with more than two online 

inspectors. 

As discussed below, after considering 

the comments, FSIS has decided to 

modify the proposed rule to leave in 

place all of the existing poultry 

inspection systems. FSIS has also 

decided to allow the 20 young chicken 

establishments that have been granted 

SIP waivers to operate under HIMP to 

continue to operate under a SIP waiver 

to run at line speeds of up to 175 bpm. 

However, FSIS will update these SIP 

waivers to remove aspects of HIMP that 

are inconsistent with the NPIS, such as 

the OCP performance standards. If an 

establishment operating under a SIP 

waiver described above goes out of 

business or decides to give up its 

waiver, FSIS will select another 

establishment to take its place. Thus, as 

under the current HIMP protocol, FSIS 

will continue to provide SIP waivers for 

up to 20 young chicken establishments 

to operate at 175 bpm. Under this final 

rule, the maximum line speed under the 

NPIS for turkeys will be 55 bpm, as was 

proposed. Thus, there is no need for the 

five HIMP turkey establishments to 

continue to operate under an updated 

SIP waiver because they will be able to 

achieve the same results by operating 

under the NPIS. FSIS has also decided 

that it will not limit the number of 

online inspectors under Traditional 

Inspection to two. Under this final rule, 

FSIS will continue to staff all 

establishments that do not choose to 

operate under the NPIS with the number 

of online inspectors currently assigned 

to the establishment. 

The preamble also explained that 

FSIS would allow establishments that 

slaughter classes of poultry other than 

young chickens and turkeys to operate 

under the NPIS under a waiver through 

the Salmonella Initiative Program (SIP). 

Under the SIP, meat and poultry 

slaughter establishments receive 

waivers of regulatory requirements on 

condition that they will conduct regular 

microbial testing and share the resulting 

data with FSIS. 

1. General Comments on the NPIS 

Comment: Comments from producers 

of poultry products and trade 

associations representing the poultry 

industry expressed general support for 

the NPIS. Comments from some FSIS 

inspection personnel and some private 

citizens also expressed support for the 

NPIS. Some comments noted that the 

existing inspection systems were 

designed before FSIS implemented 

HACCP and were developed to identify 

visual defects that affect the quality of 

the product. The comments agreed that 

Agency resources are better spent 

performing activities that are more 

effective in ensuring food safety rather 

than performing functions that 

establishments can effectively 

accomplish under FSIS inspection by 

both VIs and CIs. Another comment said 

that the NPIS will give establishments 

the flexibility to investigate and develop 

new and more efficient technologies. 

The comment agreed with the Agency’s 

conclusion that the new inspection 

system will improve the effectiveness of 

poultry slaughter inspection and overall 

food safety, remove unnecessary 

regulatory obstacles to innovation, and 

make better use of the Agency’s 

resources. Another comment said that 

the NPIS is the next logical step in 

protecting public health through 

modern, science-based food safety 

technology. 

One comment that supported the 

NPIS proposal stated that it should be 

considered as part of a comprehensive 

food safety program that includes the 

recently implemented PHIS and 

performance standards for Salmonella 

and Campylobacter in broilers and 

turkeys. The comment said that the 

proposal should not be considered 

separate and apart from other regulatory 

food safety programs. 

Response: The Agency agrees with the 

thrust of these comments and concurs. 

Certainly the NPIS is part of the 

initiatives that contribute to the 

Agency’s comprehensive food safety 

program. As noted by one comment, 

among these initiatives are the 

Salmonella and Campylobacter 

performance standards, the SIP, PHIS, 

as well as the NPIS. 

Comment: Comments from consumer 

advocacy organizations, labor unions, 

FSIS inspectors, public health 

organizations, animal welfare advocacy 

organizations, members of academia, 

human and worker rights advocacy 

organizations, and some private citizens 

objected to the NPIS for various reasons. 

Many of these comments objected to the 

NPIS because the commenters view the 

NPIS as a system that ‘‘privatizes’’ 

inspection by replacing USDA online 

inspectors in part with establishment 

employees. The petitions submitted in 

response to the proposed rule express 

these same views. 

Response: The NPIS will not privatize 

poultry inspection; this system makes 

Federal inspection of poultry more 

effective and carcass inspection by FSIS 

inspectors more efficient. 

Under the existing poultry slaughter 

inspection systems, FSIS inspectors 

check each carcass for defects and 

disease and direct establishment 

employees to take corrective actions. 

Under the NPIS, a well-trained FSIS CI 

will conduct a carcass-by-carcass 

inspection after establishment 

employees have sorted, trimmed, and 

conducted any necessary reprocessing. 

Thus, under the NPIS the CI will be able 

to conduct a more effective and efficient 

carcass-by-carcass inspection because 

carcasses will only be presented for 

inspection by the CI if they have been 

sorted by the establishment and are 

likely to pass inspection. 

As discussed earlier in this document, 

the VIs under the NPIS will conduct 

offline food safety-related inspection 

activities and will monitor and evaluate 

establishment process controls. The VIs 

will conduct carcass verification checks 

on carcass samples collected before the 

CI station to ensure that the 

establishment is effectively sorting 

carcasses and that it is producing 

products that comply with the Agency’s 

zero visible fecal tolerance and other 

performance standards. VIs will also 

perform offline activities in addition to 

carcass verification checks, such as 

verifying compliance with sanitation 

SOPs, SPS, and HACCP regulatory 

requirements, and ensuring that the 

establishment is meeting all regulatory 

requirements and is effectively 

preventing contamination by enteric 

pathogens and fecal material throughout 

the entire slaughter and dressing 

process. 

2. Scope of the NPIS 

Comment: One comment said that it 

interprets the proposed rule to limit 

establishments that slaughter mature 

fowl to operate under the NPIS only if 

they participate in the SIP. The 

comment noted that the only other 

alternative for establishments that 

slaughter mature fowl would be to 

operate under Traditional Inspection. 

The comment stated that FSIS should 

expand the scope of the NPIS to include 

classes of poultry other than young 

chickens and turkeys without additional 

qualifications. According to the 

comment, requiring that establishments 

that slaughter poultry classes other than 

young chickens and turkeys operate 

under a SIP waiver places them at a 

competitive disadvantage because they 

must incur costs associated with the 

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additional testing and data collection 

required under the SIP. 

Response: The NPIS was informed by 

the Agency’s experience under the 

HIMP pilot, which, for poultry, was 

limited to young chicken and turkey 

slaughter establishments. Thus, the 

Agency would need additional data to 

support an expansion of the NPIS to 

classes of poultry other than young 

chickens and turkeys. As noted by the 

comment, FSIS would permit 

establishments that slaughter classes of 

poultry other than young chickens and 

turkeys to operate under the NPIS under 

a waiver through the SIP. At a later 

time, the Agency would consider the 

data collected in such poultry slaughter 

establishments operating under a SIP 

waiver to determine whether to expand 

the NPIS to other classes of poultry. 

Comment: Comments from two labor 

unions and a worker rights advocacy 

organization stated that although the 

proposed rule allows young chicken and 

turkey slaughter establishments to 

choose whether they will operate under 

the NPIS or under Traditional 

Inspection, there is no real choice 

because the Agency proposed to limit 

the number of online inspectors in 

establishments operating under 

Traditional Inspection to two. The 

comments noted that because most of 

the establishments that slaughter young 

chickens and turkeys are large 

automated operations, it is unlikely that 

these establishments will choose the 

traditional method of inspection with 

slower line speed and two inspectors 

per line. A comment from an individual 

questioned why establishments cannot 

choose to continue to operate under 

their current inspection systems. The 

comment stated that FSIS did not 

require that establishments operate 

under SIS, NELS, or NTIS when the 

Agency established those inspection 

systems. The comment said that 

allowing establishments to choose to 

keep their current inspection system 

gives them a true choice and maintains 

competition in the marketplace. 

A comment from a member of 

academia said that the proposed rule 

gives establishments that slaughter 

young chickens and turkeys the 

flexibility to decide whether the benefits 

of switching to the NPIS exceed their 

estimated costs to operate under such a 

system. The comment said that many 

very small establishments are likely to 

choose to remain under Traditional 

Inspection because, unlike larger 

establishments, the benefits of operating 

under the NPIS may not exceed their 

costs. 

Response: After careful consideration 

of these comments, FSIS has decided to 

revise the proposed rule to allow 

establishments that do not choose to 

operate under the NPIS to continue to 

operate under their current inspection 

system, i.e., SIS, NELS, NTIS, or 

Traditional Inspection. FSIS has also 

decided to allow the 20 young chicken 

establishments that have been granted 

SIP waivers to operate under HIMP to 

continue to operate under a SIP waiver 

to run at line speeds of up to 175 bpm. 

However, FSIS will update these SIP 

waivers to remove aspects of HIMP that 

are inconsistent with the NPIS, such as 

the OCP performance standards. If an 

establishment operating under a SIP 

waiver described above goes out of 

business or decides to give up its 

waiver, FSIS will select another 

establishment to take its place. Thus, as 

under the current HIMP protocol, FSIS 

will continue to provide SIP waivers for 

up to 20 young chicken establishments 

to operate at 175 bpm. Under this final 

rule, the maximum line speed under the 

NPIS for turkeys will be 55 bpm, as was 

proposed. Thus, there is no need for the 

five HIMP turkey establishments to 

continue to operate under an updated 

SIP waiver. 

This final rule will give 

establishments the flexibility to operate 

under the system that is best suited to 

their operations. FSIS has also 

determined that allowing 

establishments to continue to operate 

under their current inspection system 

instead of converting to the modified 

Traditional Inspection with two online 

inspectors will create less disruption to 

the industry when FSIS begins to 

implement the NPIS. As noted by the 

comments, large establishments will 

likely choose to operate under the NPIS, 

while very small establishments are 

likely to choose to operate under the 

modified Traditional Inspection System. 

Some establishments may be interested 

in operating under the NPIS but are not 

prepared to make the capital 

investments needed to convert right 

away. Under this final rule, these 

establishments will have the option to 

switch to the NPIS at a later date 

without having to convert to a modified 

Traditional Inspection first. 

3. Carcass Sorting and Inspection Under 

the NPIS 

a. Carcass Sorting by Establishment 

Employees 

Comment: Several comments from 

consumer advocacy organizations, FSIS 

inspectors, labor unions, and private 

citizens objected to the NPIS’s 

requirement that establishment 

employees properly sort carcasses 

before they are presented to the CI for 

inspection because the comments 

believe that establishment employees 

will miss many food safety and OCP 

defects. Many of the comments 

referenced the analysis conducted by 

the consumer advocacy organization 

that obtained FSIS inspection records 

from 14 establishments participating in 

the HIMP pilot presented in an earlier 

comment. According to the comments, 

the analysis shows that establishment 

employees missed food safety and 

wholesomeness defects at high rates. 

Another comment stated that it had 

secured affidavits from three USDA 

inspectors who have worked in HIMP 

establishments who report that because 

of excessive line speeds and lack of 

training, company employees routinely 

miss many food safety and 

wholesomeness defects. The comments 

stated that FSIS must more thoroughly 

evaluate the proposal to allow 

establishment employees to perform 

preliminary carcass sorting before it 

implements the NPIS. 

Response: The overall performance of 

HIMP establishments measured by the 

findings of offline inspections by VIs 

was as good as or better than non-HIMP 

establishments. Results from the VI 

inspections in HIMP establishments, 

which are conducted after establishment 

employees have completed the initial 

carcass sorting, show that the rates of 

carcasses with septicemia/toxemia and 

visible fecal contamination in HIMP 

establishments were very low, well 

below the levels set by the HIMP 

performance standards. These results 

were discussed in detail above. In 

addition, as discussed above, OCP 

defect rates identified on carcasses in 

HIMP establishments average about half 

the corresponding OCP HIMP 

performance standard. Thus, the data 

from the HIMP pilot show that 

establishment employees do effectively 

sort carcasses, dispose of carcasses that 

must be condemned, and conduct 

necessary trimming and re-processing 

activities before the carcasses are 

presented to the CI for online carcass 

inspection. 

Comment: Several comments from 

consumer advocacy organizations and 

private citizens noted that the NPIS 

does not require that establishment 

employees performing the sorting 

function receive training or prove 

proficiency in performing their duties. 

The comments noted that the 2001 GAO 

report on the HIMP pilot program 

criticized FSIS for not requiring that 

establishment employees complete 

training before assuming carcass sorting 

activities. The comments said that FSIS 

should accept the GAO 

recommendation for FSIS to develop a 

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training and certification program in 

conjunction with industry. 

Response: FSIS is not prescribing 

specific sorter training or certification. 

However, the Agency has developed 

guidance documents to assist 

establishments in training their sorters. 

This guidance is available on the FSIS 

Web site at: http://www.fsis.usda.gov/

wps/portal/fsis/topics/regulatorycompliance/compliance-guides-index. 

The guidance that the Agency has 

developed is based on the training that 

FSIS provides to online inspection 

personnel that are responsible for 

sorting carcasses under the existing 

inspection systems. 

FSIS agrees with the comment that 

training of sorters is important to ensure 

that they are able to properly perform 

their duties. Proper training is necessary 

if sorters are to make accurate decisions 

on how to address animal disease 

conditions and trim and dressing 

defects. Under the NPIS, if sorters do 

not make these decisions correctly, FSIS 

inspection personnel will take 

appropriate action such as stopping the 

production line, issuing NRs, and 

directing the establishment to reduce 

the line speed to ensure that the 

establishment is able to maintain 

process control, that establishment 

sorters are able to successfully perform 

their duties, and that FSIS CIs are able 

to conduct a proper inspection. 

Comment: A comment from an animal 

welfare advocacy organization said that 

by requiring establishment employees to 

sort out damaged carcasses before FSIS 

conducts online inspection, employees 

remove the evidence, i.e., the carcasses 

themselves, that birds may have died 

from causes other than slaughter. The 

comment asserted that this eliminates 

one means by which FSIS can verify 

that establishments are employing good 

commercial practices. 

Response: Inspectors in both HIMP 

and non-HIMP establishments verify 

that poultry is being slaughtered in 

accordance with good commercial 

practices. Compliance with these 

requirements ensures that poultry are 

handled humanely prior to FSIS online 

inspection. On a daily basis, FSIS 

offline inspectors observe operations in 

the receiving, hanging, stunning, 

bleeding, and pre-scalding areas in both 

HIMP and non-HIMP establishments. 

Compliance and enforcement actions 

are taken as warranted and necessary. 

b. Online Carcass Inspection 

Comment: Several consumer 

advocacy organizations expressed 

concern that online inspectors will only 

look at the back of the bird under the 

NPIS. The petitions submitted in 

response to proposed rule also raised 

this issue. The comments stated that it 

is necessary to inspect the front and 

inside of the carcass in order to detect 

food safety defects. According the 

comments, under the NPIS, most 

inspectors will only look at the back of 

the bird as it quickly moves down the 

line and are therefore less likely to 

identify food safety defects in each 

carcass. 

Response: FSIS disagrees with the 

comments. The CI carcass presentation 

under the NPIS allows the CIs to focus 

their inspection on the same 

condemnable diseases and conditions 

that online inspectors focus on under 

the current inspection systems. 

Therefore, the Agency believes that the 

CI carcass presentation under the NPIS 

will allow the CI to conduct an effective 

online inspection to detect food safety 

defects. 

Under all four existing inspection 

systems, i.e., SIS, NELS, NTIS, and 

Traditional Inspection, FSIS online 

inspectors focus their inspection on 

identifying and condemning carcasses 

with septicemic and toxemic animal 

diseases and other condemnable 

conditions that cannot be corrected 

through trimming or reprocessing. 

Unlike septemia/toxemia, visible fecal 

material on the surfaces of a carcass is 

a food safety defect that can be corrected 

through reprocessing. Therefore, all 

poultry slaughter establishments have 

an online or offline reprocessing system 

for carcasses accidentally contaminated 

with fecal material. 

Under the current inspection systems, 

FSIS online inspectors do not issue NRs 

or condemn carcasses if they observe 

visible fecal contamination on the 

interior or exterior carcass surfaces. The 

Agency ensures that the establishment 

reprocesses the carcasses after online 

inspection to remove any fecal 

contamination before the carcasses enter 

the chiller. Unlike the NPIS, after such 

reprocessing, none of the current 

inspection systems provide for an 

additional online carcass inspection 

before the reprocessed birds enter the 

chiller. 

FSIS online CIs under the NPIS will 

continue to focus on identifying and 

condemning carcasses with septicemic 

and toxemic animal diseases and other 

condemnable conditions that cannot be 

corrected through trimming or 

reprocessing. In addition, while the 

Agency will continue to ensure that the 

establishments operating under the 

NPIS reprocess carcasses to remove any 

visible fecal contamination before the 

carcasses enter the chiller, the FSIS 

online CI will also inspect all of the 

carcasses after they have been sorted, 

washed, trimmed, and reprocessed, 

before the carcasses enter the chiller. If 

there is evidence of fecal material on a 

carcass, or that the carcass is affected 

with septicemia or toxemia, the CI will 

stop the line to prevent the affected 

carcass from entering the chiller. In 

addition, the CI will issue an NR 

because the establishment’s procedures 

for preventing visible fecal 

contamination and for addressing 

carcasses with septicemia/toxemia were 

not effective. 

Poultry diseases and conditions, 

except for avian visceral leukosis, are 

readily identified by observing the 

carcass alone; pathogens require testing. 

Inspection of the outside of the carcass 

for signs of septicemia/toxemia is 

sufficient to determine whether the 

carcass and corresponding viscera must 

be condemned. Carcasses affected with 

systemic septicemic or toxemic 

conditions are darker in color due to 

dehydration or hemorrhaging and may 

be smaller or have less body fat due to 

inappetence or increased metabolic rate. 

Accordingly, inspection of the exterior 

of the carcass in accordance with the 

presentation required under the NPIS is 

sufficient for CIs to effectively identify 

and condemn carcasses affected with 

septicemia/toxemia, along with their 

corresponding viscera. As discussed 

elsewhere in this document, an FSIS 

offline inspector will determine the 

leukosis status of each flock 

slaughtered. Viscera in leukosis positive 

flocks will be inspected by FSIS 

inspectors. 

Thus, online inspection under the 

NPIS is at least as good, if not better, 

than online inspection under the 

current inspection systems. CIs under 

the NPIS will focus their inspection not 

only on detecting septicemic and 

toxemic animal diseases, but on 

detecting visible fecal contamination as 

well. In addition, as discussed 

throughout this document, the VI under 

the NPIS will conduct carcass 

verification checks on carcass samples 

collected before the CI station to ensure 

that the establishment is effectively 

sorting carcasses and that it is 

producing products that comply with 

the Agency’s zero visible fecal tolerance 

and other performance standards. The 

VI and CI will work with the IIC to 

ensure that food safety defects or other 

conditions do not impair the CI’s ability 

to effectively inspect each carcass. 

Comment: Several labor unions and 

consumer advocacy organizations 

expressed concern that the NPIS does 

not require that an inspector examine 

the viscera of each bird or be able to 

identify each bird’s viscera for 

inspection. These comments asserted 

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that an examination of the viscera is 

important in determining whether or 

not a bird is diseased, contaminated, or 

otherwise adulterated. 

Response: All poultry diseases and 

conditions, except for avian visceral 

leukosis, are readily identified by 

observing the carcass alone. If the CI 

identifies a carcass with a condemnable 

condition, the viscera associated with 

that carcass must also be condemned. 

When a carcass is condemned, 

establishments that have maintained the 

identity of the corresponding viscera 

must dispose of that viscera as inedible 

or, where the identity has not been 

maintained, must dispose of all viscera 

harvested within the time period related 

to the condemned carcass. In either 

case, the CI’s visual examination of each 

carcass also determines the disposition 

of the corresponding viscera. The CI’s 

online carcass inspection serves as an 

inspection of the viscera. 

Additionally, FSIS inspectors conduct 

verification checks on all harvested 

giblets and necks and will apply the 

RTC standards under the NPIS. These 

inspection activities ensure that 

carcasses and parts, including viscera, 

have been inspected and are determined 

by FSIS inspectors to be not adulterated. 

Inspection procedures for avian visceral 

leukosis are discussed below. 

Comment: A few labor unions 

expressed concern that under the 

Traditional Inspection System retained 

by the proposed changes to part 381, 

there is no guarantee that an inspector 

will be able to inspect a carcass along 

with its viscera. The unions stated that 

under the current inspection 

regulations, the carcass and its viscera 

are inspected together, as the viscera is 

required to be ‘‘uniformly trailing or 

leading.’’ One union was of the view 

that while proposed 9 CFR 381.76(c) 

requires that the identity of each bird’s 

viscera be ‘‘maintained in a manner 

satisfactory to the inspector until such 

inspection is made,’’ this seems to 

depart from the current requirements in 

9 CFR 381.76 because the ‘‘new’’ 

Traditional Inspection System does not 

ensure that the viscera and the 

corresponding carcasses can be 

inspected by a government inspector. 

Response: As discussed above, under 

this final rule, the regulations that 

prescribe requirements for the existing 

inspection systems will remain in place, 

with some modifications. Thus, the 

regulations for all inspection systems 

except the NPIS and HIMP will 

continue to require that carcasses and 

viscera be inspected together. 

c. Inspection for Avian Visceral 

Leukosis 

As discussed in the preamble to the 

proposed rule, avian visceral leukosis is 

a rare manifestation of the viral disease 

leukosis that is not transmissible to 

humans (77 FR 4421–2). Avian visceral 

leukosis can only be detected by 

observing the viscera. Avian leukosis 

does not present a human health 

concern, but it may render poultry 

unwholesome or otherwise unfit for 

human food. 

As explained in the preamble to the 

proposed rule, it is common commercial 

practice to vaccinate each chicken flock 

for viral leukosis. On rare occasions, the 

vaccine is not effective. If it is not, 

visceral leukosis is present on a flock 

basis. Thus, under the NPIS, an offline 

inspector will observe the viscera of the 

first 300 birds slaughtered from each 

young chicken flock to determine 

whether the disease is present in the 

flock. FSIS has followed this practice in 

young chicken HIMP establishments, 

and it has been effective. In the HIMP 

report, FSIS explained that ‘‘[i]t is 

FSIS’s experience that when a flock has 

avian visceral leukosis, 10 to 15 percent 

of the birds in the flock have detectable 

leukosis lesions. For a flock in which 

10% of the birds have detectable avian 

leukosis, a 300 bird sample provides a 

greater than 95% probability of 

detecting 22 or greater more birds with 

visible leukosis lesions’’ (HIMP Report, 

p. 26). From these calculations, the 

Agency concluded that a 300-bird 

sample is adequate to detect avian 

leukosis in a flock. 

FSIS received several comments on 

the proposed avian visceral leukosis 

inspection procedures. 

Comment: A trade association and a 

poultry producer argued that FSIS 

should eliminate the proposed avian 

visceral leukosis check. According to 

the trade association, the check serves 

no meaningful public health purpose, is 

not scientifically sound, and is an 

outdated inspection approach. The trade 

association stated that when avian 

leukosis inspection procedures were 

originally designed, scientists did not 

know that the condition is caused by 

Marek’s Disease and the Avian Leukosis 

Complex. According to the trade 

association, modern treatment and flock 

handling practices have effectively 

eliminated these diseases in commercial 

poultry operations. The comment stated 

that comprehensive literature reviews of 

these conditions, including a statement 

by the National Institutes of Health, 

have concluded that neither disease 

presents an apparent risk to public 

health. Additionally, the trade 

association stated that as early as 1984, 

Agency data has shown that avian 

visceral leukosis was present in only 

.017 percent of young chickens 

slaughtered, and that number is lower 

today. 

Response: As noted by the comment, 

avian visceral leukosis is not 

transmissible to humans and does not 

present a human health concern. 

However, it may render poultry 

unwholesome or otherwise unfit for 

human food. Thus, carcasses affected 

with the condition need to be 

condemned. Because avian visceral 

leukosis, if present, will be present 

throughout an entire flock, inspecting 

the first 300 birds of each flock is an 

appropriate and effective procedure for 

identifying the disease. 

Under the NPIS, an establishment 

must ensure that it can identify viscera 

and parts corresponding with each 

carcass. This final rule also requires that 

establishments operating under the 

NPIS provide a location along the 

production line at which an inspector 

can inspect for avian leukosis ‘‘the first 

300 carcasses of each flock together with 

associated viscera either uniformly 

trailing or leading, or otherwise 

identified with the corresponding 

carcass.’’ 

Comment: One labor union stated that 

FSIS is going to require that 

establishments notify the IIC when they 

intend to slaughter a new flock so that 

FSIS may inspect the viscera, but 

‘‘flock’’ is not defined anywhere in the 

regulations. The union stated that FSIS’s 

clarification of flock, ‘‘In general, a flock 

constitutes birds raised under similar 

circumstances on the same premises’’ in 

the preamble to the proposed rule is 

imprecise and the clarification is not 

included in the PPIA or Federal 

regulations. The union asserted that this 

lack of a definition of ‘‘flock’’ makes the 

process for detecting avian leukosis 

problematic. 

Response: Establishments are able to 

identify which birds belong to the same 

flock because birds from the same flock, 

i.e., birds that have been raised under 

similar circumstances on the same 

premises, arrive at slaughter together. 

Establishments operating under the 

NPIS will identify when a new flock 

arrives and are required to notify the IIC 

when they intend to slaughter a new 

flock. 

d. Verification Inspection 

Comment: A consumer advocacy 

organization and a trade association 

requested that FSIS clarify the role of 

the VI under the NPIS. The consumer 

advocacy organization requested that 

FSIS explain how the NPIS will enable 

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inspectors to conduct more food safety 

checks; whether more VIs will be 

assigned to each slaughter line; whether 

VIs will have to cover more than one 

slaughter line in an establishment; and 

whether VIs will have more than one 

establishment to cover on a given shift, 

similar to processing assignments. 

Response: There will be one CI and 

one VI assigned to each evisceration line 

per shift in establishments that chose to 

operate under the NPIS. As stated 

throughout this document, because the 

establishment’s employees will be 

responsible for sorting carcasses, 

disposing of carcasses that must be 

condemned, and conducting any 

trimming or reprocessing activities 

before carcasses are presented to the 

online CI, the CI will be better able to 

focus on detecting carcasses with visible 

defects that impact food safety, such as 

visible fecal contamination and 

septicemia/toxemia. 

In addition to online inspection 

performed by CIs, VIs under the NPIS 

will conduct offline food safety-related 

inspection activities and will monitor 

and evaluate establishment process 

controls. The VIs will conduct carcass 

verification checks on carcass samples 

collected before the CI station to ensure 

that the establishment is effectively 

sorting carcasses and that it is 

producing products that comply with 

the Agency’s zero visible fecal tolerance 

and other performance standards. As in 

HIMP, VIs under the NPIS will also 

conduct an array of other inspection 

activities that are important to ensure 

food safety, such as performing antemortem inspection; collecting samples 

for pathogen testing; verifying the 

effectiveness of the establishment’s 

HACCP system; and verifying that the 

establishment is meeting sanitary 

dressing requirements. As noted 

throughout this document, the VI and CI 

will work with the IIC to ensure that 

food safety defects or other conditions 

do not impair the CI’s ability to 

effectively inspect each carcass. 

Comment: A consumer advocacy 

organization argued that the NPIS 

decreases the protections that are part of 

the HIMP pilot program. The comment 

stated that under HIMP, VIs collect and 

examine 10-bird samples for food safety 

defects every hour, and examine at least 

two of the 10-bird samples for 

wholesomeness defects. Because of the 

decreased role of online FSIS 

inspectors, the consumer advocacy 

organization stated that these 10 bird 

samples are the only hands-on 

verification of poultry carcasses under 

HIMP. This comment expressed concern 

that the NPIS does not provide for 

scheduled verification checks, i.e., food 

safety or wholesomeness checks, and 

the Agency has been unwilling to 

commit to any specific number of 

scheduled checks. 

Response: FSIS agrees with the 

consumer advocacy organization’s 

assertion that the verification checks 

that VIs conduct for food safety defects 

under HIMP are necessary to ensure that 

establishment employees are effectively 

sorting carcasses and disposing of 

carcasses that must be condemned 

before the carcasses are presented to the 

CI. Effective carcass sorting by 

establishment employees is essential for 

the CI to conduct an efficient and 

effective online carcass-by-carcass 

inspection. Therefore, under the NPIS, 

VIs will continue to conduct carcass 

verification checks for food safety 

defects at a point in the slaughter 

process before the CI’s online fixed 

position. VIs will also verify that 

establishments are effectively 

addressing OCP defects through review 

of establishment records documenting 

that the establishment is producing RTC 

poultry and through observation of 

carcasses when conducting verification 

checks. 

Because HIMP was a pilot study, the 

activities for offline VIs needed to be 

more controlled and prescriptive to 

ensure that the data collected from each 

establishment participating in the study 

were consistent. Under the NPIS, the 

carcass verification checks will be more 

risk-based to reflect the performance of 

the establishment. Thus, for some 

establishments, VIs may conduct more 

carcasses verification checks under the 

NPIS than they do under HIMP. 

Under the NPIS, the Agency will 

follow the same procedure used under 

HIMP to schedule VI carcass checks for 

food safety defects to ensure that VIs 

collect an appropriate number of 

verification samples to assess each 

establishment’s performance under the 

NPIS. The Agency will monitor and 

analyze the ongoing results of its 

verification activities to assess the 

effectiveness of the establishment’s 

carcass sorting and other process control 

procedures. The Agency will modify 

carcass verification checks and other 

verification activities as needed to 

respond to findings through the same 

data-driven process that FSIS uses for 

all in-plant verification. 

The inspection results recorded in 

PHIS provide FSIS with the information 

it needs to ensure that verification 

activities are targeted at identified 

public health risks. Under PHIS, FSIS is 

able to modify verification activities to 

respond to specific situations in 

individual establishments, to findings in 

a particular type of establishment, or 

across the entire regulated industry. Inplant inspection personnel use PHIS to 

initiate additional verification tasks if 

their inspection findings raise concerns 

about an establishment’s compliance 

with regulatory requirements. FSIS 

managers use PHIS to initiate additional 

verification and sampling tasks in 

individual establishments in response to 

certain criteria, such as not meeting the 

Salmonella performance standard. They 

are also able to adjust the frequencies 

and priorities of verification tasks on a 

national level to quickly shift 

inspectors’ focus to verify requirements 

where findings indicate problems may 

be occurring. 

Comment: One trade association 

requested that the Agency clarify where 

in the process a finding of fecal 

contamination would result in a 

regulatory noncompliance. 

Response: Similar to HIMP, under the 

NPIS, the VI will issue an NR for visible 

fecal contamination if the VI detects 

such contamination when performing 

carcass verification checks. 

In addition, this final rule requires 

that all poultry slaughter establishments 

develop, implement, and maintain 

written procedures to ensure that 

carcasses with visible fecal 

contamination do not enter the chiller 

and to incorporate these procedures into 

their HACCP systems. It also requires 

that all poultry slaughter establishments 

develop, implement, and maintain 

written procedures to prevent fecal 

contamination and contamination by 

enteric pathogens throughout the entire 

slaughter and dressing process and to 

incorporate these procedures into their 

HACCP systems. These requirements are 

intended to ensure that establishments 

are taking the necessary steps to prevent 

contamination throughout the process 

and not just cleaning up the birds at the 

end of the process. 

Accordingly, if the CI in an 

establishment operating under the NPIS 

observes a carcass with visible fecal 

contamination, in addition to stopping 

the line to prevent the carcass from 

entering the chiller, the CI will also 

issue an NR because the establishment’s 

procedures for preventing visible fecal 

contamination were not effective. 

Because establishments are required to 

prevent visible fecal contamination 

throughout the entire process, the CI 

will issue the NR regardless of where 

the establishment’s CCP for visible fecal 

contamination is located. 

In addition, under this final rule, FSIS 

inspectors under all poultry inspection 

systems will not just be inspecting at the 

end of the line to verify that the 

establishment’s procedures for 

preventing visible fecal contamination 

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8See FSIS Directive 7000.1, ‘‘Verification of NonFood Safety Consumer Protection Regulatory 

Requirements,’’ December 11, 2006 (http://

www.fsis.usda.gov/wps/wcm/connect/aa15d83fcd09-4553-a705-2e3a0eb94e5d/

7000.1.pdf?MOD=AJPERES). 

are effective. Inspection personnel will 

be conducting verification activities 

throughout the entire process to ensure 

that the establishment’s procedures for 

preventing contamination by enteric 

pathogens and visible fecal material are 

effective. 

e. RTC Poultry Definition Under the 

NPIS 

As noted in the preamble to the 

proposed rule, removing the SIS, NELS, 

and NTIS would have included 

removing the FPS prescribed under 

these inspection systems (77 FR 4422). 

As discussed above, FSIS has modified 

the proposed rule to leave all existing 

inspection systems in place. Therefore, 

under this final rule, establishments that 

continue to operate under SIS, NELS, 

and NTIS will continue to be subject to 

the FPS. 

However, as was proposed, under the 

NPIS, the FPS will be replaced with a 

requirement that establishments 

document that the products resulting 

from their slaughter operations meet the 

definition of ready-to-cook (RTC) 

poultry. As explained in the preamble to 

the proposed rule, establishments 

operating under the NPIS would (like 

HIMP establishments) have the 

flexibility to design and implement 

measures to address OCP defects that 

are suited to their operations (77 FR 

4423). FSIS received several comments 

from trade associations, consumer 

advocacy organizations, and industry 

members on the RTC poultry standard. 

Comments from members of the poultry 

industry and a trade association 

expressed support for the RTC poultry 

standard and agreed that establishments 

should have the flexibility to design and 

implement measures to address OCP 

defects that will be most effective in 

their operations. Other comments raised 

various issues that are discussed below. 

Comment: Comments from consumer 

advocacy organizations suggested that 

the RTC standard is not stringent 

enough and that the lack of enforceable 

OCP goals will make it difficult for FSIS 

to enforce the RTC standard. The 

comments said that in contrast to the 

HIMP inspection system, the Agency is 

not committing to any specific level of 

scheduled VI verifications for OCP 

defects under the NPIS. One comment 

said that the Agency should have a 

robust sampling scheme to deal with 

OCP defects. Another comment 

maintained that without specific 

standards for ensuring that OCP defects 

are promptly identified and addressed, 

it will be difficult to compare 

establishments across the industry and 

trace the causes of systematic defects. 

Response: FSIS disagrees with the 

comments that said that the RTC 

standards are not stringent. The Agency 

believes that it can effectively address 

OCP defects by requiring that 

establishments operating under the 

NPIS maintain records to document that 

the products resulting from their 

slaughter operations meet the RTC 

definition. However, to address 

concerns expressed by the consumer 

advocacy organizations, the Agency is 

making clear in this final rule that these 

records are subject to review and 

evaluation by FSIS inspectors. 

As noted above, the HIMP Report 

found that for the two-year period from 

CY 2009 through 2010, HIMP 

establishments maintained OCP defect 

levels that average about half the OCP 

performance standards derived from the 

performance of non-HIMP 

establishments. Because the data show 

that establishments operating under the 

HIMP inspection system performed well 

in controlling OCP defects, FSIS 

tentatively concluded that it was not 

necessary to adopt prescriptive OCP 

requirements under the NPIS (77 FR 

4423). Instead the Agency proposed to 

require that establishments operating 

under the NPIS document that the 

products resulting from their slaughter 

operations meet the definition of RTC 

poultry. Although the NPIS will give 

establishments the flexibility to design 

and implement effective measures for 

addressing OCP defects, establishments 

will still be responsible for ensuring that 

the poultry products resulting from their 

slaughter operations meet the RTC 

definition. 

As was proposed, under this final 

rule, FSIS will verify that an 

establishment operating under the NPIS 

is producing RTC poultry by reviewing 

the establishment’s records and 

observing carcasses as part of their 

inspection activities. This approach is 

consistent with the Agency’s view that 

the verification activities performed by 

FSIS inspectors should be 

predominantly focused on activities that 

are more important in ensuring food 

safety, but that it is also necessary to 

verify compliance with requirements 

that provide non-food safety protections 

to consumers.8

For their record reviews, FSIS 

inspectors will verify that 

establishments operating under the 

NPIS have written criteria for 

determining whether carcasses meet the 

RTC definition and that they are 

documenting that the poultry products 

resulting from their slaughter operations 

meet these criteria before packaging or 

further processing that will conceal the 

defect. FSIS expects that the 

establishment will maintain records 

that, at a minimum, include the 

following information: 

• The records system that the 

establishment uses to document that it 

is producing RTC poultry. For example, 

an establishment may use statistical 

process control charts, HACCP records, 

or other documentation. 

• The points in the operation where 

the establishment monitors carcasses to 

determine whether they meet the RTC 

definition and records the results of its 

monitoring activities. For example, an 

establishment may conduct monitoring 

and recording the results at a pre-chill 

and a post-chill station. 

• The frequency with which the 

establishment conducts monitoring 

activities. The records should specify 

how often the establishment monitors 

carcasses per line per shift. For 

example, an establishment may conduct 

and document its monitoring activities 

at least every two hours per line per 

shift at the pre-chill location and at least 

twice per shift per line for post-chill 

location. 

• The definitions of the OCP nonconformances or processing and trim 

defects that for which the establishment 

is monitoring. For example, the 

establishment may be monitoring 

carcasses for processing and trim nonconformances as specified in the current 

FPS regulations, for trim and processing 

OCP defects specified under the HIMP 

OCP performance standards, or defects 

as defined in a published study or a 

study that the establishment conducted 

itself. If the establishment references a 

study, it should give a brief description 

of the study and have the supporting 

information on file. 

• The criteria that the establishment 

uses to determine that the products 

resulting from its slaughter operation 

meet the RTC definition. For example, 

an establishment may follow the 

subgroup limits for non-conformances 

and defects in the current FPS 

regulations, the trim and processing 

defect levels for the HIMP OCP 

performance standards, or it may 

determine the upper limits for nonconformances using a statistical process 

control program. 

• The corrective actions that the 

establishment will take if the levels of 

defects and non-conformances exceed 

its evaluation criteria for RTC poultry. 

As noted in the preamble to the 

proposed rule, poultry carcasses that 

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9See 9 CFR 381.76(a) under the current 

regulation and this final rule. 

meet the FPS under SIS and NELS, or 

that meet the OCP performance 

standards under HIMP, are ‘‘suitable for 

cooking without the need for further 

processing,’’ and as such, meet the RTC 

poultry definition. Therefore, 

establishments operating under the 

NPIS that adopt the FPS or the OCP 

HIMP performance standards as their 

criteria for determining whether they 

are producing RTC poultry will meet the 

regulatory requirements if: (1) They can 

document that the products resulting 

from their slaughter operations 

consistently meet these standards and 

(2) FSIS inspectors do not observe 

persistent, unattended defects on the 

products resulting from the 

establishment’s slaughter operations. 

Establishments that adopt criteria other 

than the FPS or the HIMP OCP 

standards must have documentation to 

demonstrate how they will use these 

criteria to demonstrate that the products 

resulting from their slaughter operations 

meet the RTC poultry definition. 

In addition to record reviews, FSIS 

inspectors will verify that 

establishments operating under the 

NPIS are producing RTC poultry by 

visually observing carcasses as part of 

their inspection activities. The presence 

of persistent, unattended trim and 

dressing defects on carcasses at the end 

of the process would indicate that the 

establishment is not producing RTC 

poultry. It may also indicate a general 

lack of control in an establishment’s 

overall slaughter and dressing process. 

Thus, if inspectors observe persistent, 

unattended defects, FSIS will require 

that the establishment take appropriate 

actions to ensure that its process is 

under control and that it is operating 

under conditions necessary to produce 

safe, wholesome, and unadulterated 

RTC products. If inspection personnel 

through their record review or direct 

observation of carcasses find evidence 

that an establishment is producing 

poultry that does not meets the RTC 

definition, the IIC will be authorized to 

take appropriate action to ensure that 

the establishment remedies the defects, 

including requiring that the 

establishment slow the line speed. 

Comment: Some consumer advocacy 

organizations said that if FSIS does not 

establish specific OCP standards for the 

NPIS, consumers will have no 

assurances that poultry establishments 

operating under the NPIS are producing 

poultry in a uniform manner and 

adequately removing carcasses defects. 

One comment noted that there is an 

increasing market for chicken parts and 

processed chicken, which enables 

companies to profit from unwholesome 

product because consumers have no 

way to determine that the product has 

defects. As an example, the comment 

noted that consumers cannot recognize 

unwholesome tissue in breaded, 

battered, or marinated products. 

Response: Under the NPIS, 

establishments will be required to 

document that the products resulting 

from their slaughter operations meet the 

RTC poultry definition. Thus, because 

the RTC standard applies to carcasses 

and parts at the end of the slaughter 

process, establishments will be required 

to ensure and document that all 

carcasses and parts meet the RTC 

definition before the establishment 

conducts any additional processing to 

produce battered, marinated, or other 

processed products. 

Comment: Some consumer advocacy 

organizations noted that the 2001 GAO 

report on HIMP recommended that FSIS 

require establishments to implement 

statistical process controls (SPC), and 

that FSIS should monitor the efficacy of 

these systems. The comments noted that 

while FSIS encourages establishments 

to implement SPC, the proposed rule 

does not require it. 

Response: FSIS agrees that SPC 

systems are effective tools for 

establishments to use to manage and 

control their production. Some HIMP 

establishments currently use SPC 

systems to monitor their compliance 

with the HIMP OCP performance 

standards. The Agency believes that 

most establishments operating under the 

NPIS will choose to use SPC systems to 

allow them to document that their 

poultry products meet the RTC 

definition. However, instead of 

mandating the use of SPC, the Agency 

has decided to allow establishments 

operating under the NPIS to implement 

the process controls that they have 

determined will best produce RTC 

poultry that is wholesome and not 

adulterated. The Agency believes that it 

will be more effective and more 

consistent with HACCP requirements to 

provide each establishment operating 

under the NPIS the flexibility to 

determine how best to meet the RTC 

requirement within the context of its 

production environment while holding 

the establishment to the Salmonella and 

Campylobacter performance standards. 

Comment: Comments from poultry 

producers and trade associations 

recommended that the Agency allow 

establishments to apply the RTC 

standard at any appropriate location at 

or before the point of packaging or 

clarify that the Agency intended this 

flexibility if that is the case. One 

comment from a trade association said 

that because an establishment may 

apply processes targeting RTC criteria 

and other quality issues at various 

locations after the chiller, it is not 

appropriate for the CI to inspect for RTC 

criteria before the chiller. The comment 

noted that the RTC standard addresses 

quality not food safety issues, so there 

is no food safety concern associated 

with birds that may not yet meet the 

RTC standard entering the chiller. The 

comment said that a bird with bruising, 

for example, will not ‘‘contaminate’’ 

other birds in the chiller. The comment 

said that the CI should not be distracted 

from inspecting for food safety issues 

with the additional task of checking for 

RTC criteria. 

Response: This final rule maintains 

the current requirements that all poultry 

slaughter establishments prepare all 

eviscerated carcasses as RTC poultry.9

This final rule also requires that 

establishments operating under the 

NPIS maintain records to document that 

the products resulting from their 

slaughter operations meet the definition 

of RTC poultry. Thus, like the FPS, the 

RTC definition applies to the products 

at the end of the slaughter process. 

However, if the CI or the VI observe the 

presence of persistent unattended 

defects before the chiller when 

performing online inspection or 

conducting offline verification checks, 

FSIS will address the effectiveness of an 

establishment’s sorting process and its 

ability to maintain process control. The 

Agency will require that the 

establishment operating under the NPIS 

take appropriate actions to ensure that 

it is producing safe, wholesome 

products that meet the definition of RTC 

poultry. 

Comment: One consumer advocacy 

organization agreed that requiring that 

establishments operating under the 

NPIS maintain documentation to 

demonstrate that they are meeting the 

RTC standard is beneficial but stated 

that it did not have enough information 

on the difference between the FPS and 

the RTC standard to make a specific 

comment. Another comment requested 

that FSIS retain the existing FPS as a 

safe-harbor for establishments that 

choose to continue assessing 

compliance with the RTC standard prior 

to chilling. 

Response: RTC poultry is any 

slaughtered poultry free from protruding 

pinfeathers and vestigial feathers (hair 

or down) from which the head, feed 

crop, oil gland, trachea, esophagus, 

entrails, and lungs have been removed, 

and from which the mature 

reproductive organs and kidneys may 

have been removed, and with or without 

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giblets, and which is suitable for 

cooking without need for further 

processing (9 CFR 381.1). All poultry 

slaughter establishments are required to 

prepare all eviscerated carcasses as RTC 

poultry (9 CFR 381.76(a)). Carcasses 

affected with removable animal diseases 

or that contain numerous trim and 

dressing defects are not ‘‘suitable for 

cooking without the need for further 

processing,’’ and do not meet the RTC 

poultry definition. 

As discussed above, establishments 

operating under the NPIS will have the 

flexibility to design and implement 

measures to address OCP defects that 

are best suited to their operations, and 

certainly establishments may adopt 

procedures to address OCP defects 

based on the existing FPS in order to 

meet the RTC poultry standard. 

4. Facilities Requirements and Staffing 

for the NPIS 

a. Facilities Requirements 

Comment: One industry member 

suggested that establishments operating 

under that NPIS be permitted to place 

the carcass inspection station at any 

location before the chiller. The 

comment stated that establishments 

have many reasons for placing carcass 

inspection stations at locations other 

than immediately before the chiller. The 

industry member believed that a 

facility-specific approach would be 

more successful in ensuring food safety. 

An industry member expressed 

concern that because of space or linelayout constraints, establishments may 

not be able to place a carcass inspection 

station meeting FSIS requirements 

immediately before the chiller. 

According to this industry member, 

some equipment cannot be moved, or if 

it can be moved, it will result in higher 

costs and will be less effective 

elsewhere on the line. 

Response: The CI inspection station 

needs to be located at the end of the 

processing line immediately before the 

chiller to allow the CI to ensure that 

carcasses affected with food safety 

defects do not enter the chiller and to 

ensure that the establishment’s 

procedures for preventing visible fecal 

contamination are effective. Thus, FSIS 

disagrees and concludes that a 

prescribed location for the CI station 

best ensures effective inspection and 

food safety. 

Comment: Two comments from 

inspectors recommended that FSIS 

modify the proposed rule to require that 

the online CI’s platform be heightadjustable. The comments stated that, 

while handling of every carcass is not 

required under the NPIS, online 

inspectors will still be required to 

visually inspect each carcass and that 

the ideal platform height for one 

inspector may not be ideal for another 

significantly taller or shorter inspector. 

One comment believed that an 

adjustable platform will benefit 

inspectors that wear corrective lenses. 

Response: FSIS has considered the 

comments and agrees that the CI 

inspection platform should be heightadjustable to ensure that CIs are able to 

conduct an effective visual inspection of 

each carcass. The Agency is amending 

the proposed facilities requirements to 

require that the CI inspection platform 

under the NPIS be height-adjustable. 

Most establishments that choose to 

operate under the NPIS will likely move 

their present adjustable inspector 

platform to the new CI location when 

they convert to the NPIS. Other 

establishments may consolidate lines 

and therefore will have extra adjustable 

inspector platforms when they convert 

to the NPIS. 

Comment: One trade association 

stated, to be consistent with HACCP, 

FSIS should remove the requirement in 

proposed 9 CFR 381.36(c)(4) for a 

‘‘trough or other similar drainage 

facility’’ extending beneath the 

conveyor at all places where processing 

occurs. According to the trade 

association, drainage issues are covered 

by the general requirement for 

establishments’ to maintain sanitary 

conditions. 

Response: FSIS believes that requiring 

that establishments provide a trough or 

other drainage and collection facility 

beneath the conveyor at all places is 

necessary to maintain sanitary 

conditions in the establishment. The 

existing regulations that prescribe 

facilities requirements for the SIS, NELS 

and NTIS provide for a trough or other 

drainage facility under the conveyor. 

b. Staffing 

Comment: A consumer advocacy 

organization expressed concern that 

there will be fewer FSIS inspectors in 

establishments operating under the 

NPIS than there are in establishments 

operating under the HIMP pilot because, 

according to the comment, FSIS has 

refused to commit to maintaining 

similar, specific levels of food safety 

activities under the NPIS. The comment 

asserted that the Agency has already 

allowed staffing levels to decrease in 

some HIMP establishments. 

Another consumer advocacy 

organization stated that the proposed 

rule should include language regarding 

the number of full-time VIs and CIs 

needed in establishments operating 

under the NPIS. The comment said that 

FSIS should use production volume, 

along with other risk factors to 

determine the number of inspectors 

needed at each facility, and that the 

number of inspectors assigned to a 

facility be reviewed routinely based on 

the establishment’s performance. 

Response: The staffing for each 

evisceration line under the NPIS will 

remain the same as the staffing for each 

line under HIMP. As in HIMP, each 

establishment operating under the NPIS 

will have one VI and one CI per line per 

shift, as well as an IIC. While the 

verification activities of the VI under the 

NPIS may not necessarily be identical to 

those under HIMP, a VI will continue to 

be assigned to each line so there will be 

no net reduction in the level of 

verification inspection. FSIS District 

Managers and staff conduct periodic 

reviews of in-plant staffing requirements 

to ensure appropriate coverage of 

frontline inspection activities. This is 

already a standard practice and will not 

change under the NPIS. 

5. Line Speeds Under the NPIS 

Based on FSIS’s experience under 

HIMP, the Agency proposed that the 

maximum line speeds for young chicken 

establishments operating under the 

NPIS be 175 bpm and that maximum 

line speeds for turkey slaughter 

establishments be 55 bpm (77 FR 4423). 

However, the Agency’s experience from 

the HIMP pilot has shown that HIMP 

establishments operate with an average 

line speed of 131 bpm, and that, 

although they are authorized to do so, 

most of the young chicken HIMP 

establishments do not operate line 

speeds at 175 bpm. As noted above, the 

maximum line speed permitted under 

the current poultry inspection systems 

is 140 bpm under the SIS for young 

chickens, and there are many young 

chicken establishments that do not 

operate at the maximum line speeds 

authorized under the current inspection 

systems. Establishments determine their 

line speeds based on their equipment 

and facilities, bird size and flock 

conditions, and their ability to maintain 

process control when operating at a 

given line speed. 

Regardless of line speed, HIMP and 

NPIS do not require that establishments 

configure their evisceration lines to 

accommodate more than one online 

carcass inspector. Establishments 

operating under the NPIS will have 

greater control over their lines and 

greater flexibility over their production 

process. For example, consistent with 

HIMP, establishments operating under 

the NPIS will have the flexibility to 

reconfigure and consolidate lines if they 

determine that they need more space to 

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conduct other activities in their 

facilities. In addition, because only one 

online inspector is required at the end 

of the line, establishments operating 

under the NPIS will not need to adjust 

their production based on the 

availability of FSIS inspection 

personnel to be stationed online. 

Establishment employees will staff the 

lines to perform the online sorting 

activities. These establishments will 

also have greater flexibility to vary their 

line speeds within the limits established 

by this rule or increase production to 

respond to customer demands. 

In addition to having more control 

over their production process, 

establishments operating under the 

NPIS will also have more opportunities 

for innovation and greater flexibility to 

develop and implement new 

technologies. Currently, if an 

establishment operating under the 

existing inspection systems wants to use 

new technologies for evisceration or for 

sorting, the establishment must work 

directly with the Agency to 

accommodate FSIS’s online slaughter 

inspection methodologies. Doing so 

takes time and can become an obstacle 

to innovation. Under the NPIS, 

establishments will have direct control 

of the sorting process within their 

facilities and therefore will have the 

flexibility to implement and assess the 

technologies they think are beneficial to 

their operations and food safety. 

As will be mentioned in the section 

on ‘‘Implementation of the NPIS,’’ some 

comments from consumer advocacy 

organizations suggested that instead of 

allowing establishments to adopt all of 

the changes in the proposed NPIS at 

once, FSIS should implement the NPIS 

in phases to ensure that establishments 

maintain process control as each change 

is adopted. However, because 

establishments operating under the 

NPIS will have greater flexibility to 

adopt new technologies, it would be 

difficult to develop an implementation 

strategy to assess each change that 

establishments make to convert to the 

NPIS that could be applied consistently 

across the industry. 

After considering the comments, FSIS 

agrees that it is important to assess 

establishments’ ability to maintain 

process control as they implement 

changes to operate under the NPIS. Data 

from the HIMP pilot demonstrate that 

establishments operating under HIMP 

are able to maintain process control at 

line speeds of up to 175 bpm. However, 

as noted above, although they are 

authorized to do so, most HIMP 

establishments do not operate at 175 

bpm. The average line speed under 

HIMP is 131 bpm. It is also the case that 

non-HIMP establishments have been 

operating successfully at line speeds of 

140 bpm or less. 

Therefore, under this final rule, the 

maximum line speed for young chickens 

will be 140 bpm for establishments 

operating under the NPIS instead of 175 

bpm, as was proposed. Limiting the 

maximum line speed for young chickens 

under the NPIS to 140 bpm also 

addresses the concern raised in some of 

the industry comments that 

establishments permitted to implement 

the NPIS first during a staggered 

implementation will be able to increase 

their line speeds while other 

establishments will be economically 

harmed as they wait for their 

implementation date. 

After the NPIS has been fully 

implemented on a wide scale, and the 

Agency has gained at least a year of 

experience under the new system, FSIS 

intends to assess the impact of changes 

adopted by establishments operating 

under the NPIS by evaluating the results 

of the Agency’s Salmonella and 

Campylobacter verification sampling, 

reviewing documentation on 

establishments’ OCP performance, and 

other relevant factors. FSIS will 

consider these results in assessing 

whether establishments operating under 

the NPIS have implemented measures 

that are effective in maintaining process 

control. 

The maximum line speed for turkey 

establishments will remain at 55 bpm, 

as was proposed, because this is similar 

to the current maximum line speed of 

51 bpm authorized under the NTIS. The 

comments on line speeds under the 

NPIS were also directed at the proposed 

175 bpm line speeds for young 

chickens. 

FSIS has decided to allow the 20 

young chicken establishments that have 

been granted a SIP waiver to operate 

under HIMP to continue to operate line 

speeds at a maximum of 175 bpm. As 

discussed above, FSIS will update these 

SIP waivers to remove aspects of HIMP 

that are inconsistent with the NPIS, 

such as the OCP performance standards. 

Data from the HIMP pilot demonstrate 

that HIMP establishments operating at 

the line speeds authorized under HIMP 

were capable of consistently producing 

safe, wholesome, and unadulterated 

product, and that they consistently met 

pathogen reduction and other 

performance standards. Additionally, 

once the NPIS is fully implemented at 

most establishments, data from these 

establishments can be used to compare 

against data from the young chicken 

establishments operating under the 

updated SIP waivers. 

The comments on the NPIS maximum 

line speeds that would have been 

permitted under the proposed rule 

raised a number of issues. The issue that 

FSIS received the most comments on 

was the potential effects that increased 

line speeds may have on the health and 

safety of workers in poultry slaughter 

establishments. Because the issues 

raised by these comments do not 

involve the technical aspects of the 

NPIS, FSIS will address them in a 

separate section of this document. 

a. Line Speed and Process Control 

Comment: Comments from members 

of the poultry industry and trade 

associations representing members of 

the poultry industry supported faster 

line speeds under the NPIS. One 

comment stated that the industry has 

made technological advancements and 

has produced scientific data to 

demonstrate that establishments can 

operate at faster line speeds and still 

maintain food safety. According to the 

comment, since HIMP’s inception, 

establishments operating under HIMP 

have demonstrated that safe product 

could be produced at faster line speeds, 

as evidenced by pathogen testing data 

for these establishments. 

Some trade associations went further 

and suggested that the Agency remove 

the maximum line speed limits and 

allow establishments to determine their 

line speeds based on their ability to 

maintain process control while ensuring 

inspection of each carcass. The 

comments said that this would provide 

options for future changes as both 

Agency and industry technology evolve 

and food safety challenges change. 

According to one comment, limits on 

maximum line speeds could limit an 

establishment’s future investment 

decisions and affect hiring practices. 

Response: As discussed above, under 

this final rule the maximum line speed 

for young chickens will be 140 bpm 

instead of 175 bpm, as was proposed. 

FSIS has determined that maintaining a 

maximum line speed of 140 bpm under 

the NPIS will allow the Agency to assess 

the impact of the various changes and 

new technologies adopted by 

establishments operating under the 

NPIS. As noted above, establishments 

operating under the HIMP pilot may 

continue to operate under the line 

speeds authorized under HIMP. 

b. Line Speeds and Online Carcass 

Inspection 

Comment: Several labor unions, 

consumer advocacy organizations, and 

members of academia stated the 

maximum allowable line speeds that 

had been proposed under the NPIS 

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49592 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

10See FSIS Notice 64–13, ‘‘Inspection 

Responsibilities and Authorities for Reducing 

Slaughter or Evisceration Line Speed’’ at: http://

www.fsis.usda.gov/wps/wcm/connect/8612aba6- 

8f99-47c0-b024-1e33b3627a84/64- 

13.pdf?MOD=AJPERES&CONVERT_

TO=url&CACHEID=8612aba6-8f99-47c0-b024- 

1e33b3627a84. 

would be too fast to allow the CI to 

conduct an adequate online inspection. 

The petitions submitted in response to 

the proposed rule also raised this issue. 

Comments from a labor union, 

members of academia, and a private 

citizen stated that while the most 

significant food safety concern is 

microbiological contamination that is 

not visible to the naked eye, the visual 

inspection of birds for signs of disease, 

remaining feathers, and fecal matter 

remains critical to ensure that product 

is safe and wholesome. The comments 

stated that the faster line speeds that 

would have been permitted under the 

proposed NPIS would make it difficult 

for the CI to perform this task. 

Response: FSIS disagrees with the 

comments. Although the maximum line 

speeds allowed under the NPIS will be 

140 bpm for young chickens, the 

Agency’s experience under HIMP shows 

that CIs in HIMP establishments are able 

to conduct an effective online 

inspection of each carcass when 

operating under the line speeds 

authorized under HIMP, i.e., up to 175 

bpm for young chickens and 55 bpm for 

turkeys. 

Since 2007, HIMP young chicken 

establishments have been authorized to 

operate at line speeds of up to 175 bpm 

depending on their ability to 

demonstrate consistent process control. 

Experience during the HIMP pilot has 

shown that HIMP establishments 

operate with an average line speed of 

131 bpm, and, although they are 

authorized to do so, most of the young 

chicken HIMP establishments do not 

operate line speeds at 175 bpm. As 

stated throughout this document, 

establishments determine their line 

speeds based on their equipment and 

facilities, bird size and flock conditions, 

and their ability to maintain process 

control when operating at a given line 

speed. In addition, similar to HIMP, line 

speeds under the NPIS will depend on 

the number of employees that the 

establishments hire and train to perform 

sorting activities. Although the 

maximum line speed for young chickens 

under the NPIS will be 140 bpm instead 

of 175, as was proposed, FSIS believes 

that establishments choosing to operate 

under the NPIS will determine their line 

speeds based on the same factors that 

establishments considered when setting 

line speeds under HIMP for the past 15 

years. 

Furthermore, as noted throughout this 

document, under the NPIS, the VI and 

the CI will work with the IIC to ensure 

that the food safety defects or other 

conditions do not impair the CI’s ability 

to conduct an inspection of each 

carcass. The VI and CI will notify the IIC 

whenever circumstances indicate a loss 

of process control, e.g., if the VI 

observes the presence of persistent 

unattended defects or has evidence to 

indicate that the establishment is having 

difficulty maintaining sanitary 

conditions, or if the CI finds multiple 

carcasses with defects. The IIC will take 

appropriate remedial actions and will be 

authorized to and may require that the 

establishment slow the line speed. 

Under all of the poultry inspection 

systems, the IIC is authorized to direct 

establishments to operate at a reduced 

line speed when in his or her judgment 

the online inspector cannot perform an 

adequate carcass-by-carcass inspection 

because of the health conditions of a 

particular flock, or because of factors 

that may indicate a loss of process 

control.10

Comment: A comment from members 

of academia said that between routine 

cleanings of equipment, pathogens 

introduced by infected and colonized 

birds can spread throughout a 

processing facility, contaminating 

surfaces, equipment and workers’ 

personal protective equipment. The 

comment noted that studies have shown 

that Salmonella species, along with 

other human pathogens, may survive 

the various process controls and 

decontamination methods used in U.S. 

processing facilities. The comment 

stated that because of the faster line 

speeds that FSIS had proposed for the 

NPIS, more carcasses would be 

processed in each facility per shift. 

According to the comment, this may 

increase the likelihood that human 

pathogens will be introduced into the 

processing environment and that a 

greater number of carcasses will become 

cross-contaminated following the 

introduction of an infected and 

colonized bird. The comment did not 

submit studies or other evidence to 

support this view. 

Response: As explained above, the 

maximum line speed for the NPIS 

established in this final rule will be 140 

bpm, which is also the maximum line 

speeds permitted under the current SIS 

inspection system. Thus, the comment 

that faster line speeds under the NPIS 

may contribute to the introduction and 

spread of pathogens in the processing 

environment is no longer applicable to 

this final rule. 

Regardless of line speed, as discussed 

in more detail under the section of this 

document on ‘‘Changes that Affect All 

Establishments that Slaughter Poultry 

Other than Ratites,’’ in addition to 

proposing the NPIS for young chickens 

and turkeys, FSIS also proposed to 

require that all poultry slaughter 

establishments develop, implement, and 

maintain, as part of their HACCP 

systems, written procedures to prevent 

contamination of carcasses and parts by 

enteric pathogens and fecal material 

throughout the entire slaughter and 

dressing process. At a minimum, these 

procedures must include sampling and 

analysis for microbial organisms preand post-chill to monitor process 

control for enteric pathogens. FSIS also 

proposed to require that establishments 

maintain daily records sufficient to 

document the implementation and 

monitoring of their process control 

procedures. 

The records that will be required 

under this rule, including the records of 

the establishment’s testing results, will 

provide establishments and FSIS with 

ongoing information on the 

effectiveness of the establishment’s 

process controls. These records will also 

enable establishments to identify 

situations associated with an increase in 

microbial levels so that they can take 

the necessary corrective actions to 

prevent further potential contamination. 

Additionally, the new testing 

requirements will ensure that 

establishments are able to provide 

comprehensive, objective evidence to 

demonstrate that they are effectively 

preventing carcasses from becoming 

contaminated with pathogens before 

and after they enter the chiller. 

E. Implementation of the NPIS 

1. Background 

In the Federal Register document that 

extended the comment period for the 

proposed rule, the Agency provided 

additional information on proposed 

implementation of the NPIS to solicit 

more focused comments on the issue (77 

FR 24876). In that document, FSIS 

explained that it proposed to provide a 

time period in which all young chicken 

and turkey slaughter establishments 

would have an opportunity to contact 

the Agency to indicate whether they 

were interested in operating under the 

NPIS. The Agency explained that those 

establishments that choose to operate 

under the NPIS would inform the 

Agency when they would wish to begin 

implementing the NPIS in their 

establishment. When it issued the 

document, FSIS had tentatively decided 

that establishments would have six 

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months to decide whether they would 

operate under the NPIS and up to three 

years to switch to the new system. 

FSIS received comments on its 

proposed implementation plan from 

members of the poultry slaughter 

industry, trade associations representing 

the industry, and consumer advocacy 

organizations. The Agency considered 

these comments in developing the 

implementation strategy discussed 

below. 

2. Implementation Strategy 

Under FSIS’s final implementation 

strategy for the NPIS, all young chicken 

and turkey slaughter establishments will 

initially have six months from the date 

of publication of this final rule to notify 

their District Office in writing if they 

intend to operate under the NPIS. If an 

establishment does not give its District 

Office written notification of its intent 

before the end of the initial 6-month 

period, the establishment will be 

deemed to have selected to continue to 

operate under its current inspection 

system for purposes of the initial 

implementation. FSIS encourages 

establishments to notify their District 

Office as soon as possible after 

publication of this final rule of whether 

they intend transition to the NPIS 

during the initial implementation 

period and, if so, when they will be 

ready to transition to the NPIS. 

Implementation will not take place at all 

eligible establishments at the same time. 

It will be phased in over time to ensure 

proper FSIS inspection force readiness 

to successfully implement the NPIS. 

As soon as this final rule publishes in 

the Federal Register, and 

establishments have started to notify 

FSIS of their intent regarding the NPIS, 

FSIS will begin selecting establishments 

to switch to the NPIS. FSIS is using a 

computerized ranking system to 

determine the schedule of 

establishments for NPIS 

implementation. This ranking system is 

based on a number of factors, such as 

FSIS staffing needs, past performance of 

the establishment, and the location of 

the establishment in relation to other 

FSIS-regulated establishments. Scores 

for each establishment will be tabulated, 

and the establishments will be ordered 

from highest score to lowest. The 

highest scoring establishments will be 

placed first in the transition schedule. 

Many establishments will likely receive 

the same score so a random number will 

be added to their scores to separate 

these establishments and order them. A 

description of the ranking algorithm and 

the rational for the ranking process is 

available on the FSIS Web page at: 

http://www.fsis.usda.gov/wps/portal/

fsis/home. 

Once the ordered list of 

establishments is created, it will be 

divided into blocks based on the 

expected number of establishments that 

can be transitioned each month 

(expected to be approximately 12). A 

computer program then examines the 

list by looking at the corporate 

ownership (Dunn and Bradstreet 

corporate parent) of each establishment. 

If a disproportionate number of one 

corporation’s establishments appears in 

the transition schedule for any month, 

another random number will be added 

to the establishments’ scores to separate 

them. 

Because switching to the NPIS is 

voluntary, the implementation schedule 

will also need to be adjusted based on 

establishment readiness. Establishments 

that want to transition to the NPIS must 

notify FSIS and provide a date at which 

they can be ready to transition. Some 

establishments that are placed near the 

beginning of the transition schedule 

based on the computerized ranking 

system may need to be moved to a later 

month in the schedule because they are 

not ready. In addition, FSIS is aware 

that several large parent corporations 

are establishing roving teams to prepare 

their establishments for the transition. 

The work of these teams may also cause 

some establishments not to be ready to 

transition at the earliest opportunity and 

require rescheduling them into later 

months. 

FSIS will be implementing the NPIS 

by clusters of establishments in close 

geographic proximity to one another. 

Once the NPIS is fully implemented at 

all of the establishments in a cluster, 

FSIS will then begin implementing the 

NPIS in the next selected cluster. Young 

chicken and turkey slaughter 

establishments that decide that they 

would like to convert to NPIS after the 

initial notification date may notify FSIS 

of their intent at any time after that date. 

The Agency will implement the NPIS in 

the additional establishments that 

intend to convert to the NPIS on a 

schedule consistent with Agency 

resources and readiness. The Agency 

intends to implement the NPIS in all 

young chicken and turkey establishment 

that choose to operate under the NPIS, 

regardless of when the establishment 

notifies FSIS of its intent to transition to 

the NPIS. However, the initial 

implementation wave will only include 

those establishments that submitted 

their notification within the initial 

notification period. 

3. Comments on Proposed 

Implementation Plan 

Comment: A few trade associations 

and a poultry producer stated that the 

implementation process needs to be 

structured in a way that is fair and 

ensures that FSIS is not allowing one 

company a competitive advantage over 

another. One poultry producer was 

concerned that the establishments 

permitted to implement the NPIS first 

will be able to increase their line 

speeds, efficiency, and slaughter 

capacity, while other establishments 

will be economically harmed as they 

wait for their implementation date. 

Industry members and trade 

associations did not agree on what they 

believed to be the best implementation 

strategy. 

Response: The system that FSIS will 

be using to determine the schedule of 

establishments for implementation of 

the NPIS does take into consideration 

corporate ownership of the 

establishments. 

As discussed above, FSIS is using a 

computerized ranking scoring system 

based on various factors, such as FSIS 

staffing needs, establishment 

performance, and establishment 

location, to generate an ordered list of 

establishments for NPIS 

implementation. After the Agency 

establishes the initial establishment list, 

the list will be divided into blocks based 

on the expected number of 

establishments that can be transitioned 

each month. A computer program then 

examines the list by looking at the 

corporate ownership of each 

establishment. If a disproportionate 

number of one corporation’s 

establishments appear in the transition 

schedule for any month, another 

random number will be added to the 

establishments’ scores to separate them. 

FSIS believes that this process will 

provide for a fair and objective NPIS 

implementation schedule. 

With respect to the comment that 

expressed concern that the 

establishments permitted to implement 

the NPIS first will be able to increase 

their line speeds while other 

establishments wait for their 

implementation date, as discussed 

above, the maximum line speed for 

young chickens under the NPIS will be 

140 bpm. Thus, although establishments 

that convert to the NPIS will have 

greater control over their line and 

production process, the maximum line 

speeds for all young chicken 

establishments will be 140 bpm 

regardless of when they convert to the 

NPIS. 

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49594 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

Comment: A State Department of 

Agriculture and a trade association 

supported the idea of staggered 

implementation. One trade association 

stated that establishments should be 

given a greater amount of time to 

determine whether they want to convert 

to a new inspection system or operate 

under Traditional Inspection, as was 

proposed. Another trade association 

expressed concern that a turkey 

establishment may not know by the end 

of the 6-month period, as proposed by 

FSIS, if it will want to convert to the 

NPIS because of the long grow-out cycle 

for turkeys compared to chickens (18–22 

weeks for toms, broilers can be as short 

as 5 weeks). This trade association also 

stated that there needs to be a process 

for those establishments that want to 

adopt the NPIS at a date beyond the 

proposed 3-year implementation period. 

Response: FSIS agrees that staggered 

implementation is the best approach. 

The 6-month time period also works 

well for Agency planning and staffing 

needs. The Agency has concluded that 

an initial 6-month notification period is 

a reasonable amount of time. Therefore, 

all young chicken and turkey slaughter 

establishments will have 6 months to 

determine whether they want to convert 

to the NPIS during the initial transition 

period or continue to operate under 

their current inspection system. 

Additionally, there will be a process for 

those establishments that want to adopt 

the NPIS at a date beyond the initial 

implementation period. Those 

establishments may notify FSIS of their 

intent to operate under the NPIS at any 

time after the initial 6-month 

notification period. FSIS will 

implement the NPIS in the additional 

establishments as Agency resources and 

readiness allow. 

Comment: A consumer advocacy 

organization recommended that FSIS 

implement one new provision in the 

rule at a time and assess the potential 

food safety impact of each change before 

implementing the next provision. The 

comment said that the Agency must 

ensure that microbial contamination 

rates on carcasses continue to improve 

as incremental changes are 

implemented. For example, before 

implementing other changes for the 

NPIS, this consumer advocacy 

organization suggested that FSIS 

implement the proposed new 

mandatory testing provisions that would 

apply to all poultry slaughter 

establishments. According to the 

comment, all poultry establishments 

should be required to operate under the 

new testing program for at least 90 days 

to generate a baseline that FSIS could 

use to assess the effects that the 

additional proposed measures may have 

on contamination rates. This comment 

stated that after establishments have 

generated the necessary baseline data, 

FSIS could implement additional 

program changes while assessing the 

effects on microbial contamination rates 

against the existing baseline data to 

ensure that individual changes do not 

negatively impact process controls. The 

comment said that if establishments 

demonstrate that they are maintaining 

process control as each change is 

implemented, FSIS could consider 

additional individual changes. 

Response: As discussed above, 

because establishments operating under 

the NPIS will have more control over 

their lines and greater flexibility to 

implement new technologies, it is 

difficult to predict how establishments 

will implement the NPIS when this rule 

becomes effective. Thus, it would be 

difficult to develop an NPIS 

implementation strategy to assess 

individual changes adopted by each 

establishment that could be applied 

consistently across the industry. 

However, as discussed earlier in this 

document, after considering the 

comments, FSIS agrees that it is 

important to assess establishments’ 

ability to maintain process control as 

they implement changes to operate 

under the NPIS. Therefore, to allow the 

Agency to assess the impact of the 

various changes implemented by 

establishments to operate under the 

NPIS, the maximum line speed under 

the NPIS will be 140 bpm for young 

chickens. This is the maximum line 

speed permitted under the existing 

poultry inspection systems under SIS. 

After the NPIS has been fully 

implemented on a wide scale, and the 

Agency has gained at least a year of 

experience under the new system, FSIS 

intends to assess the impact of changes 

adopted by establishments operating 

under the NPIS by evaluating the results 

of the Agency’s Salmonella and 

Campylobacter verification sampling, 

reviewing documentation on 

establishments’ OCP performance, and 

considering other relevant factors. FSIS 

will consider this information in 

assessing whether establishments 

operating under the NPIS have 

implemented measures that are effective 

in maintaining process control. 

Furthermore, under this final rule, 

large establishments, small 

establishments, and very small 

establishments will be required to 

implement the new microbiological 

sampling requirements 90 days, 120 

days, and 180 days, respectively, after 

the publication of this final rule. 

Therefore, depending on when each 

establishment converts to NPIS, they 

will likely have already implemented 

the new sampling requirements when 

they transition to NPIS. When 

establishments transition to the NPIS, 

they will be expected to maintain 

records, including records of their test 

results, to demonstrate that they are 

maintaining process control. Therefore, 

FSIS has concluded that it is not 

necessary to require that establishments 

generate a baseline for at least 90 days 

before implementing the NPIS. 

Comment: A State Department of 

Agriculture stated that the smallest 

volume establishments should have the 

longest time to comply because they 

will find it difficult to implement 

certain sections of the proposed rule 

because of limitations in personnel, 

budget, time, and expertise in 

microbiology. As an example, the 

comment said that very small 

establishments may need additional 

time to implement their revised 

sampling programs. 

Response: FSIS agrees that small 

businesses should have more time to 

implement the new sampling 

requirements. Small establishments will 

have 120 days and very small 

establishments will have 180 days to 

implement the regulations that prescribe 

procedures for controlling visible fecal 

contamination in 9 CFR 381.65(f), the 

regulations that prescribe procedures for 

controlling contamination throughout 

the slaughter and dressing process in 9 

CFR 381.65(g), and the recordkeeping 

requirements in 9 CFR 381.65(h). 

Comment: A poultry producer and a 

trade association stated that FSIS should 

consider allowing industry the option of 

staggering implementation by line and 

shift as coordinated between 

establishment management and the 

District Office. This poultry producer 

argued that this will allow the industry 

to conduct on-the-job training with staff 

and help the Agency reallocate 

inspection resources over a period of 

time instead of having to reassign an 

entire establishment of inspection 

program personnel all at once. 

Response: FSIS has decided not to 

give establishments the option to stagger 

implementation by line and shift. It 

would be too difficult for FSIS to 

perform its inspection activities at 

establishments that are operating 

different lines or shifts under the NPIS 

and one of the other inspection systems 

at the same time. For Agency planning 

and resource purposes, if an 

establishment wants to convert to the 

NPIS, all of the establishment’s lines 

and shifts will be required to switch to 

the NPIS during the transition. 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49595 

Comment: A few trade associations 

stated that implementation plans should 

be establishment specific. One trade 

association stated that these 

establishment specific plans should be 

based on the systems, methods of 

processing, and supply considerations 

of that establishment. Another trade 

association argued that establishments 

should be allowed to develop 

individualized implementation plans in 

coordination with their District Offices 

to facilitate Agency planning and 

resource allocation. 

One trade association stated that there 

should be a significant transition period 

where establishments may continue to 

operate under their current inspection 

system while developing their 

implementation plans and making them 

available to the Agency. Under the trade 

association’s plan, the Agency would 

have a set period of time to comment on 

the plans, after which establishments 

would begin making the necessary 

financial, facility, and personnel 

changes to implement the NPIS. The 

trade association also recommended 

that the Agency publish a list of preapproved implementation strategies in 

an FSIS notice and encourage 

establishments to use strategies from the 

list to develop their individualized 

implementation plans. 

Response: FSIS expects that 

establishments will work closely with 

their District Offices to implement the 

NPIS. As stated above, all young 

chicken and turkey slaughter 

establishments will have 6 months from 

the date of publication of this final rule 

to notify their District Office in writing 

whether they intend to operate under 

the NPIS during the initial transition 

period. FSIS will attempt to 

accommodate establishments’ requests 

to transition to the NPIS at the times 

stated in their notification to the District 

Office. However, FSIS will be 

implementing the NPIS by clusters of 

establishments in close geographic 

proximity to one another. The system 

that FSIS will be using to determine the 

schedule of establishments for 

implementation of the NPIS is described 

above. Once an establishment is 

selected to convert to the NPIS, the 

District Office will work with the 

establishment to successfully transition 

its operations. 

FSIS does not plan to publish a list of 

pre-approved implementation strategies. 

However, if an establishment wants to 

make changes to its operation to prepare 

for conversion to the NPIS, FSIS will try 

and accommodate those changes as long 

as they do not affect FSIS inspection 

activities or procedures. For example, if 

an establishment operating under the 

current system wants to have employees 

practice sorting by removing carcasses 

with septicemic or toxemic conditions 

from the line before inspection and 

include these condemned birds in the 

official Lot Tally totals, the FSIS District 

Office will work with the establishment 

to try to accommodate such a request. 

FSIS will consider these requests on a 

case-by-case basis. FSIS has concluded 

that allowing this type of flexibility will 

help establishments successfully 

transition to the NPIS. 

Comment: A consumer advocacy 

organization stated that before FSIS 

allows an establishment to transition to 

the NPIS, the Agency should require 

that the establishment demonstrate that 

it is financially capable of meeting the 

new requirements and assuming its new 

role under the new inspection system. 

The comment stated that the theory 

behind the consideration is that a firm 

under financial duress might cut corners 

in its processes that could compromise 

food safety. 

Response: Before an establishment is 

allowed to transition to the NPIS, the 

establishment will need to develop a 

plan to meet the new requirements. 

FSIS will not be imposing any financial 

requirements on establishments before 

they are allowed to transition to the 

NPIS. Once an establishment transitions 

to NPIS, it will have to demonstrate that 

it is maintaining process control. 

In addition, as discussed above, rather 

than eliminate SIS, NELS, and NTIS, as 

was proposed, this final rule will leave 

in place all existing inspection systems. 

Thus, establishments that do not have 

the resources to convert to the NPIS 

during the first implementation phase 

will have the flexibility to operate under 

the inspection system that is best suited 

to their operations. These 

establishments will also have the option 

to convert to the NPIS at a later date 

without having to convert to a modified 

Traditional Inspection first. 

Comment: Several industry members 

and trade associations stated that the 

proposed rule lacks detail regarding 

implementation and that 

implementation plans need to be clearly 

communicated to industry through 

listening sessions or roundtables like 

HACCP or PHIS implementation to help 

successful transition to the NPIS. One 

poultry producer believed that FSIS 

may benefit from hosting a public 

meeting to receive feedback on how best 

to implement the NPIS. One trade 

association stated that the Agency needs 

to work closely with stakeholders on 

implementation. One trade association 

also stated that communication with 

inspection program personnel needs to 

happen well before implementation and 

that communication materials need to 

be shared with industry in an open and 

transparent manner. 

Response: This final rule provides 

more detail regarding implementation if 

an establishment chooses the NPIS. 

FSIS intends to communicate its plans 

to industry, inspection program 

personnel, other stakeholders, and the 

public through additional means as 

necessary. Before implementation, FSIS 

will communicate with its inspection 

program personnel about the NPIS and 

provide them with materials regarding 

the NPIS. FSIS issues instructions to 

inspection program personnel through 

FSIS Notices and Directives, which are 

published on the FSIS Web site and are 

accessible to the public. 

Comment: Several industry members 

and trade associations stated that FSIS 

needs to provide clear and consistent 

guidance to FSIS personnel and 

industry. One poultry producer argued 

that FSIS should provide industry with 

the training tools utilized for inspection 

program personnel under the existing 

slaughter systems to facilitate the 

transition to the NPIS. Additionally, one 

trade association stated that a 

compliance guide (e.g., describing 

training related to quality defects and 

disease conditions) that is at least 

equivalent to FSIS’s expectations of its 

inspection program personnel should be 

created. A State Department of 

Agriculture and a trade association 

stated that FSIS needs to provide scaleappropriate guidance and training 

materials (e.g., guidance on developing 

anti-contamination procedures and 

sampling programs) to small and very 

small establishments to assist in 

compliance with the rule. 

Response: As stated previously, FSIS 

has converted the current instructions 

that it provides Agency inspectors into 

guidance for industry to use to train 

establishment sorters. This guidance is 

available on the FSIS Web site at: http://

www.fsis.usda.gov/wps/portal/fsis/

topics/regulatory-compliance/

compliance-guides-index. 

FSIS intends to provide guidance to 

industry on the new sections of this 

final rule, including the new sampling 

plans. Guidance and training materials 

will be scale-appropriate and will focus 

on guidance that is appropriate for small 

and very small establishments. 

Comment: Several trade associations 

advocated that the Agency should create 

an experienced group of experts to 

coordinate implementation of the NPIS, 

address key issues that arise during 

implementation, and focus on facility 

and inspector concerns. According to 

one of the trade associations, this 

approach would minimize cost and 

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11http://www.fsis.usda.gov/wps/portal/

informational/aboutfsis/strategic-planning/

strategic+planning/. 

12 ‘‘Small Plant News, Vol. 4, No. 2. Available on 

the Internet at: http://www.fsis.usda.gov/wps/wcm/ 

disruption to the industry and 

inspection, provide mutually beneficial 

training opportunities, and ensure a 

consistent approach to implementing 

the NPIS across the nation. Several trade 

associations stated that the group of 

experts should function as an 

operational hotline (similar to the 

Agency’s Small Plant Hotline) to 

quickly address questions from 

establishments and inspectors about the 

NPIS and how it is supposed to work in 

specific situations. 

Response: The Agency will continue 

to provide technical support to its 

workforce and industry through its 

standard channels. For example, FSIS 

will continue to encourage referring 

questions to its Policy Development 

Staff through askFSIS at http://

askfsis.custhelp.com or by telephone at 

1–800–233–3935. Members of the Policy 

Development Staff were involved in the 

development of this final rule and will 

have the expertise to address issues that 

arise during implementation of this final 

rule. FSIS believes that its existing 

Agency resources are sufficient to 

address issues that arise with respect to 

this final rule. Additionally, the Agency 

will be providing appropriate 

instructions, guidance, and training to 

its inspectors on the NPIS. The Agency 

will also provide guidance to industry 

that will help establishments with 

regard to this final rule. 

F. Line Speeds and Worker Safety 

1. Collaboration With the National 

Institute for Occupational Safety and 

Health 

The National Institute for 

Occupational Safety and Health 

(NIOSH) is part of the Centers for 

Disease Control and Prevention (CDC) in 

the Department of Health and Human 

Services. NIOSH’s mission is to generate 

new scientific knowledge and provide 

practical solutions vital to reducing 

risks of illness, injury, and death in the 

field of occupational safety and health, 

and transfer that knowledge into 

practice. In the proposed rule, FSIS 

acknowledged the potential for an 

increase in inspection line speed to 

affect establishment employee safety (77 

FR 4423–4425). The Agency explained 

that to obtain preliminary data on the 

matter, it had asked NIOSH to evaluate 

the effects of increased inspection line 

speeds on establishment worker safety 

by evaluating the inspection lines and 

workers from establishments that had 

been granted waivers from line speed 

restrictions under the SIP. As noted in 

both the proposed rule and the Federal 

Register document to extend the 

comment period, NIOSH initiated such 

an evaluation in one non-HIMP 

establishment that is operating under a 

waiver from line speed restrictions 

under SIP (77 FR 4423 and 77 FR 2487). 

The current NIOSH evaluation 

assessed this establishment prior to any 

changes allowed under the SIP line 

speed waiver, and also after changes 

were implemented. NIOSH completed 

its evaluation and made its final report 

available to the public in March 2014 

(Evaluation of Musculoskeletal 

Disorders and Traumatic Injuries 

Among Employees at a Poultry 

Processing Plant; Report No. 2012– 

0125–3204, March 2014. Available on 

the Internet at: http://www.cdc.gov/

niosh/hhe/reports/pdfs/2012-0125- 

3204.pdf). The report describes NIOSH’s 

findings and recommendations from an 

evaluation conducted before and after 

the establishment combined two 

evisceration lines into one and 

increased the evisceration line speed. 

The NIOSH evaluation provides 

valuable information to FSIS, the 

Department of Labor’s Occupational 

Safety and Health Administration 

(OSHA), and other stakeholders. 

FSIS considers the NIOSH evaluation 

to be an important first step in 

measuring any impact of evisceration 

(or inspection) line speeds on workers 

in poultry slaughter and processing 

establishments. Without the NIOSH 

evaluation and access that FSIS was 

able to ensure, such information likely 

would not be developed. As stated 

previously, FSIS will consider the 

available data on employee effects 

collected from NIOSH activities when 

implementing the final rule. FSIS has 

committed to working with NIOSH and 

OSHA on disseminating the guidance 

resulting from the current NIOSH study, 

and ensuring greater awareness by FSIS 

and the industry about worker safety 

and health. 

2. Collaboration With OSHA 

OSHA is an agency of the United 

States Department of Labor, and was 

created to assure safe and healthful 

working conditions for working men 

and women by setting and enforcing 

standards and by providing training, 

outreach, education, and assistance. 

OSHA is helping FSIS address the 

health and safety of FSIS inspectors 

when they are performing their duties in 

federally-regulated establishments. FSIS 

has an Occupational Safety and Health 

Division, comprised of professional 

Occupational Safety and Health 

Specialists, a Certified Professional 

Ergonomist, Certified Industrial 

Hygienists, and Certified Safety 

Professionals dedicated to ensuring a 

safe and healthful work environment for 

FSIS employees. FSIS is in the process 

of establishing a Safety and Health 

Committee made up of program 

representatives as well as members of 

the National Joint Council of Food 

Inspection Locals to ensure continual 

improvement of FSIS’s safety and health 

programs. FSIS has recently placed an 

increased emphasis on occupational 

safety and health for its employees, and 

has identified a reduction of the injuries 

and illnesses for FSIS employees as a 

key measure in the FSIS Strategic Plan 

for FY 2011–2016.11 FSIS Directive 

4791.12, ‘‘Reporting and Correcting 

Occupational Hazards,’’ and FSIS 

Directive 4791.13, ‘‘Workplace 

Inspections, and Injury, Illness and 

Motor Vehicle Incident Reporting,’’ 

provide FSIS inspection personnel with 

procedures for reporting and correcting 

workplace safety and health hazards 

that affect FSIS employees. FSIS 

AgLearn Course 8500, ‘‘Recognizing and 

Reporting Occupational Safety and 

Health Hazards,’’ is available to 

improve FSIS employees’ ability to 

recognize and report workplace safety 

and health hazards in accordance with 

the FSIS worker safety directives. 

FSIS also recognizes the importance 

of establishment worker safety and will 

work with OSHA to heighten FSIS 

employees’ awareness of serious 

occupational safety hazards in FSISregulated establishments. FSIS has 

begun working with OSHA to 

continually update and improve the 

training of FSIS inspectors in 

recognition of serious workplace 

hazards and will provide a referral 

system to report such hazards to OSHA. 

The Agency will issue an FSIS Notice, 

‘‘Procedures for Notifying the 

Occupational Safety and Health 

Administration (OSHA).’’ The notice 

establishes a procedure for FSIS 

inspection personnel to notify OSHA 

directly of serious workplace hazards 

that may affect non-federal 

establishment personnel in meat and 

poultry products establishments and in 

egg product plants. The notice provides 

inspection personnel with OSHA’s 

confidential 1–800 number to refer an 

occupational safety or health concern 

for a plant employee directly to OSHA. 

FSIS has also taken action to 

encourage establishments to comply 

with OSHA requirements. In May 2011, 

the Agency published an article on 

‘‘Reporting Work Related Injuries’’ in its 

‘‘Small Plant News’’ publication.12 The 

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connect/d277c886-f942-447b-baec-3247b405ae8a/

Small_Plant_News_Vol4_No2.pdf?MOD=AJPERES. 

13 ‘‘Small Plant News, Vol. 6, No. 3. Available on 

the Internet at: http://www.fsis.usda.gov/wps/wcm/ 

connect/1b75a216-fa3c-43fb-a5eb-7cc27ed942fa/

Small_Plant_News_Vol6_No3.pdf?MOD=AJPERES. 

14OSHA [2013]. Prevention of Musculoskeletal 

Injuries in Poultry Processing. U.S. Department of 

Labor, Occupational Safety and Health 

Administration, OSHA 3213–09N; available at: 

https://www.osha.gov/Publications/OSHA3213.pdf. 

OSHA [2012]. Injury and Illness Prevention 

Programs—White Paper. U.S. Department of Labor, 

Occupational Safety and Health Administration; 

available at: http://www.osha.gov/dsg/

InjuryIllnessPreventionProgramsWhitePaper.html. 

article discussed the importance of 

OSHA’s requirements for recording and 

reporting work-related injuries, illnesses 

and fatalities, and provided guidance to 

small establishments on how to comply 

with these requirements. The article 

encouraged small establishments to 

contact OSHA with any questions on 

OSHA’s requirements and included 

contact information for OSHA’s regional 

recordkeeping coordinators. 

The Agency published another worker 

safety article in the December 2012 

‘‘Small Plant News’’ titled ‘‘Know 

OSHA’s Safety and Health 

Standards.’’ 13 The article provides an 

overview of the OSHA regulations that 

affect federally-inspected meat and 

poultry establishments and processed 

egg products plants. It also provides an 

excerpt of the standards described in 

OSHA’s Small Business Handbook and 

provides a link that allows interested 

parties to access the document on the 

Internet. 

As part of FSIS’s ongoing 

collaboration with OSHA, FSIS had 

numerous discussions with OSHA 

during the development of this final 

rule on how best to address potential 

issues related to line speeds and worker 

safety. As discussed above, to allow 

FSIS to assess the impacts of changes 

implemented by establishments that 

convert to the NPIS, the maximum line 

speeds under the NPIS established in 

this final rule will be 140 bpm for young 

chickens instead of 175 bpm, as was 

proposed. The highest maximum line 

speed under the current inspection 

systems is 140 bpm under SIS. Thus, 

under this final rule, any increase in 

line speed that establishments 

implement under the NPIS will not 

exceed the maximum line speeds 

authorized under the existing inspection 

systems. 

OSHA has provided FSIS with a set 

of recommended actions that poultry 

establishments can take to address the 

health and safety of establishment 

employees. These recommendations are 

as follows: 

• Develop and implement policies to 

encourage prompt reporting of injuries 

and illnesses; 

• Evaluate existing programs to 

ensure that they do not discourage 

employees from reporting injuries and 

illnesses; 

• Implement a training program for 

employees on job hazards, early 

symptoms of illnesses and injuries, and 

how to prevent them. Ensure that 

training is offered in a manner and 

language that workers can understand; 

• Conduct routine surveillance of 

injury and illness logs as well as the 

workplace to identify potential job 

hazards; 

• Establish an employee complaint or 

suggestion procedure designed to allow 

employees to raise job hazard issues 

without fear of reprisal; 

• Request employee feedback on 

workplace modifications; and 

• When job hazards are identified, 

implement mitigating measures. 

FSIS and OSHA agree that 

surveillance for injuries and illnesses is 

particularly important to identify 

whether workers are experiencing 

adverse health or safety effects when 

performing their duties and to trigger 

appropriate intervention if they are. 

Although FSIS does not have the 

authority to require that establishments 

adopt these recommendations, the 

Agency believes that prudent 

establishments will consider them 

carefully. FSIS recommends that 

establishments develop plans to 

implement OSHA’s recommendations. 

FSIS expects establishments to adopt 

the OSHA recommendations discussed 

in this preamble and any other 

reasonable measures to minimize the 

risk of adverse health and safety effects 

to establishment employees. 

Establishments are reminded that 

Federal and State OSHA retain authority 

over assuring worker safety, and that 

OSHA will be paying close attention to 

poultry slaughter establishments, 

including those that elect to operate 

under the NPIS. FSIS recommends that 

establishments review OSHA’s 

recordkeeping regulations at 29 CFR 

1904, OSHA’s General Industry 

Standards at 29 CFR 1910, and OSHA’s 

Prevention of Musculoskeletal Injuries 

in Poultry Processing (https://

www.osha.gov/Publications/

OSHA3213.pdf). 

In addition to the recommended 

actions to enhance surveillance for 

work-related injuries and illnesses, 

OSHA also recommended that 

establishments implement an employee 

injury and illness prevention program. 

FSIS and OSHA agree that injury and 

illness prevention programs may 

substantially reduce the number and 

severity of workplace injuries and 

alleviate the associated financial 

burdens on U.S. workplaces. Most 

successful injury and illness prevention 

programs are based on a common set of 

key elements, including management 

leadership, worker participation, hazard 

identification and assessment, hazard 

prevention and control, education and 

training, and program evaluation and 

improvement.14 The Agency expects 

that a prudent establishment would 

have such a program in place. FSIS 

recommends that establishments that do 

not have existing employee illness and 

injury prevention programs adopt 

OSHA’s recommendation and take the 

necessary actions to begin to implement 

such a program. 

All poultry establishments are 

required to comply with applicable laws 

administered by other agencies, 

including the occupational safety 

statutes administered by OSHA. To 

stress the importance of establishment 

worker safety, FSIS has modified the 

proposed regulation that prescribes 

maximum line speed rates under the 

NPIS to emphasize establishments’ 

existing legal obligation to comply with 

OSHA statutes. Thus, 9 CFR 381.69 now 

includes a new paragraph (d) that states 

that establishments operating under the 

line speed limits authorized in this 

section shall comply with all other 

applicable requirements of the law, 

including, but not limited to, 29 U.S.C. 

654(a). Although this new paragraph is 

included in the regulation that 

prescribes line speeds for 

establishments operating under the 

NPIS, establishments operating under 

any inspection system also must 

continue to comply with all other 

applicable requirements of the law. 

FSIS supports collaboration among 

industry, academia, and governmental 

bodies such as OSHA, NIOSH, and FSIS 

to identify causal relationships between 

workplace factors and musculoskeletal 

disorders (MSDs), and develop 

mitigation strategies that are technically 

and economically feasible. The NIOSH 

evaluation is a strong starting point for 

this effort, but additional work may be 

needed. 

3. General Comments on Line Speed 

and Worker Safety 

In the Federal Register document to 

extend the comment period on the 

proposed rule, FSIS requested 

comments on the effects of increased 

line speeds and production volume on 

worker safety (77 FR 24877). FSIS 

received many comments on this issue 

from worker and human rights advocacy 

organizations, poultry establishment 

employees, consumer advocacy 

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organizations, labor unions, public 

health associations, members of 

academia, companies that own poultry 

slaughter establishments, trade 

associations that represent the poultry 

industry, and private citizens. The vast 

majority of comments that the Agency 

received in response to the proposed 

rule were on this issue. 

Many of the comments stated that 

FSIS should consult with NIOSH and 

OSHA on the final rule. Additionally, 

many of the comments submitted by 

workers and human rights advocacy 

organizations, immigrant advocacy 

organizations, consumer advocacy 

organizations, labor unions, public 

health associations, and members of 

academia said that FSIS should 

withdraw the proposed rule because of 

risks that the proposed increased 

maximum line speeds could potentially 

pose to the health and safety of 

thousands of poultry slaughter and 

processing workers. These comments 

said that if FSIS does not withdraw the 

rule, the Agency should at least 

withhold implementation until NIOSH 

completes a comprehensive study of the 

effect of production line speed on the 

health and safety of workers, and OSHA 

considers any implications for potential 

rulemaking. 

Most of these comments referred to 

governmental reports, or research 

studies published in the occupational 

and public health literature. The most 

commonly cited sources included: 

• The 2005 GAO report, which linked 

production line speed to occupational 

injury and illness rates in the slaughter 

industry and called for independent 

research to better understand this 

relationship; 

• 2010 Bureau of Labor Statistics 

(BLS) data showing that injury rates 

were higher among poultry processing 

workers than the overall private 

industry average, and that more lost 

time, job transfers and restricted duty 

were incurred in the poultry industry 

than the overall private industry 

average; 

• A study by the Wake Forest School 

of Medicine Center for Worker Health, 

which reported a 59% prevalence of 

carpal tunnel syndrome (CTS) 

symptoms among Latino workers at 

selected poultry plants in North 

Carolina operating under the existing 

inspection systems; and 

• A 2007 study by researchers from 

the Duke University Medical Center’s 

Division of Occupational and 

Environmental Medicine, which found 

that among low-income AfricanAmerican women in rural North 

Carolina the prevalence of 

musculoskeletal symptoms of the upper 

extremities and neck was 2.4 times 

higher in those working at poultry 

plants compared to workers in other 

local industries. 

Most commenters were concerned 

that an increase in production line 

speed would lead to increased rates of 

musculoskeletal disorders, other 

traumatic injuries, and potentially 

adverse health effects of psychological 

and emotional stress among industry 

workers, particularly in processing jobs 

involving highly repetitive knife use. 

These will be discussed below. 

4. Inspection Line Speed, Processing 

Line Speed, and Production Volume 

The 2005 GAO report recognized that 

the speed of the production line may be 

‘‘an important factor influencing 

(worker) safety and health.’’ FSIS 

acknowledges NIOSH’s finding of a 

strong relationship between risk factors, 

such as prolonged or repetitive hand 

activity, gripping force and exposure to 

cold, and MSDs including carpal tunnel 

syndrome (CTS) in the processing 

environment. Increasing line speed in 

processing, without changing other 

factors, could result in an increase of 

work pace for establishment employees, 

and increasing work pace among 

establishment employees, without 

taking appropriate mitigation actions, 

could increase risk of injuries and 

illnesses among establishment 

employees. 

FSIS believes a key distinction should 

be made between processing line speed, 

inspection line speed, and daily 

production volume. The regulations 

require that establishments operate 

processing lines in a manner that 

maintains sanitary conditions and that 

will result in the production of poultry 

and poultry products that are not 

adulterated (9 CFR 381.65(a)). As the 

GAO report and many comments have 

pointed out, the poultry regulations 

limit the speed of poultry inspection 

lines to enable FSIS inspectors to 

effectively inspect each carcass 

presented to them. The current poultry 

regulations and this final rule do not 

prevent industry from running a 

processing line faster or slower than the 

inspection line. Slaughter 

establishments have always had the 

ability, at their discretion, to balance 

operating hours, staffing levels, and 

production line speed in processing 

departments to match the output of the 

inspection line. For example, an 

establishment could choose to operate 

its processing department at twice the 

speed of the inspection line, for half of 

the operating hours. Likewise, it could 

increase staffing in a processing 

department and slow the line speed 

proportionally to handle the volume of 

birds coming from the inspection line. 

These are operational and economic 

decisions made by each establishment, 

rather than a matter of FSIS regulations. 

Slaughter establishments must make 

operational and economic decisions 

balancing staffing levels, production 

line speeds, and operating hours to 

accommodate daily production volume. 

While inspection line speed does 

influence daily production volume, 

establishments determine their own 

maximum production volume through 

the number of inspection lines they 

choose to operate. 

We also note the difference between 

line speed and work pace. While work 

pace in processing departments is 

influenced by inspection line speed, 

factors such as staffing levels, plant 

layout, and product flow are more 

important predictors of work pace, as 

described in the following examples. 

FSIS does not directly regulate these 

factors. 

For example, if a single inspection 

line feeds a single processing line (e.g., 

manual deboning), the work pace of 

processing workers will depend on the 

number of workers assigned to that line. 

If the birds from a single processing line 

are exiting the chiller at a maximum of 

140 bpm, and if ten workers are 

assigned to that processing line, each 

worker will have an average work pace 

of 14 bpm. Adding an eleventh worker 

would reduce the work pace to an 

average of 12.7 bpm per worker. 

Additional staffing would reduce the 

workload proportionally. 

If, under this same scenario, the 

establishment changes its layout to add 

a second identical processing line 

staffed with 10 additional workers, the 

work pace for each worker would 

decrease from 14 bpm to 7 bpm. These 

are just some examples of how factors 

other than line speed are more likely to 

affect work pace. 

Industry employees’ actual exposure 

to MSD risk factors, such as repetitive 

or prolonged hand activity, will be 

affected by the number of birds 

presented to each worker during a shift 

and the amount of time each bird is in 

position to be worked on. In the 

simplest model of an equal number of 

inspection and processing lines, it may 

be that inspection line speed will 

influence the maximum processing line 

speed. The Agency does not believe, 

however, that this model adequately 

represents the industry as a whole, 

where a single inspection line may feed 

multiple processing lines or different 

end products. Although the inspection 

line speed is a potential factor, 

economic factors (e.g., consumer 

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demand and staffing/equipment 

capacity) will ultimately determine the 

number of birds presented to each 

worker for processing during a shift. 

These economic factors are addressed 

by industry and not regulated by FSIS. 

5. Factors Influencing Inspection Line 

Speed 

Many comments seem to assume that 

the faster line speeds for poultry 

inspection included in the proposed 

rule (but not included in the final rule) 

that would necessarily have been 

authorized under the NPIS would result 

in a very large increase in the volume 

of poultry products being processed by 

workers. However, as discussed earlier, 

line speed is not directly equivalent to 

production work pace; inspection line 

speed does not directly impact plant 

employees in further stages of an 

establishment (e.g., on the processing 

line). 

The proposed faster line speeds for 

inspection—not included in this final 

rule—would have allowed 

establishments to slaughter the birds 

more efficiently but would not 

necessarily have led to a substantial 

increase in processed output; consumer 

demand for poultry products determine 

the number of birds slaughtered rather 

than line speeds. 

FSIS thinks that establishments 

choosing to operate under the NPIS will 

determine their line speeds based on the 

same factors that establishments 

considered when setting line speeds 

under HIMP. 

6. Inspection Line Speed and Inspector 

Safety Under the NPIS 

Comment: A labor union expressed 

concern about the potential effects to 

the online CI if the proposed faster 

maximum line speed that would have 

been authorized under the NPIS. The 

comment said that the purpose of the 

NIOSH study described in the proposed 

rule is to assess the effects of line speeds 

on establishment personnel. The 

comment stated that the faster line 

speeds that would have been permitted 

under the NPIS would also likely affect 

inspection personnel. 

The comment noted that the NIOSH 

will study ‘‘a maximum of five nonHIMP establishments that applied 

through the SIP to receive waivers of 

existing regulations restricting line 

speeds.’’ The comment expressed 

concern that the NIOSH study is only 

intended to gather additional data of the 

effects of line speeds on the worker 

safety without saying how increased 

line speeds have the potential to cause 

unintended or foreseeable safety issues. 

The comment questioned how this plan 

to gather additional data will relate to 

ensuring FSIS online CIs are adequately 

protected, or how actual safety issues 

will be remedied. The comment said 

that before FSIS decides to implement 

the NPIS, it should make a serious, 

scientific inquiry into the potential 

dangers related to the online inspector’s 

new position. 

Response: Under the NPIS, 

establishment employees rather than 

online inspectors will be responsible for 

conducting sorting activities. Therefore, 

the online inspection procedures under 

the NPIS do not require that the CI 

touch or handle each carcass. Thus, 

because CIs will have infrequent contact 

with the carcasses, their inspection 

activities will involve less frequent head 

and hand motions than are conducted 

under the existing non-HIMP inspection 

systems. In addition, as discussed 

above, FSIS has revised the proposed 

facilities requirements for the online 

carcass inspection platform to require 

that the platform be height-adjustable to 

accommodate the individual CI. Based 

on recent studies published in the 

occupational health literature, FSIS 

believes the reduction in hand activity 

under the new inspection system will 

lead to a reduction in the risk of 

musculoskeletal disorders for inspection 

personnel. 

7. Industry Efforts To Address Worker 

Safety 

Comment: Some comments from trade 

associations agreed that worker safety 

must be considered when establishing 

line speeds, and stated that 

establishments do take worker safety 

into account. However, the comments 

maintained that worker safety should be 

addressed separately from food safety. 

The comments said the poultry industry 

has a strong record of working with 

OSHA to help in OSHA’s efforts to 

protect the safety and health of 

employees, most recently with a formal 

OSHA Alliance from 2007–2009. The 

comments expressed support for 

working with the government and 

industry to maintain a strong safety 

record. 

Response: FSIS will support effective 

industry efforts to protect the health and 

safety of employees. FSIS also supports 

industry collaboration with OSHA and 

NIOSH, and encourages the industry to 

work with OSHA to further protect the 

health and safety of employees. FSIS is 

willing to work with industry when it 

is appropriate and useful to do so to 

move collaborative efforts forward with 

OSHA. 

Comment: Two trade associations 

representing the poultry industry stated 

that after 13 years of the HIMP pilot 

program, the data indicate that the rate 

of worker injuries in HIMP 

establishments has been on average at or 

below industry average rates. One 

comment said that, in many instances, 

turkey HIMP establishments have 

reported worker injury rates well below 

the already low industry average. 

One comment stated that a recent 

survey of broiler establishments 

participating in the Agency’s HIMP pilot 

shows that, for both Total Recordable 

Injury Rates and Days Away, Restricted, 

or Transferred (DART) Rates, HIMP 

establishments are as safe for workers as 

establishments that operate under nonHIMP inspection systems. According to 

the comment, there is no statistical 

difference between establishments 

involved in the HIMP pilot project and 

establishments that operate under nonHIMP inspection systems with respect 

to Total Recordable Injury Rates and 

DART Rates. 

Response: The information provided 

in the comment suggests that worker 

injury rates in HIMP establishments 

may be at or below the worker injury 

rates in non-HIMP establishments. 

However, because the comment did not 

discuss the details on how the survey 

was conducted, the Agency is unable to 

assess the findings. As noted above, 

FSIS encourages the trade association 

and its members to work with OSHA on 

worker safety issues. It may be useful for 

the trade association to submit its 

survey and findings to OSHA, since 

OSHA has the expertise in evaluating 

this type of information regarding 

worker health and safety. 

8. Reporting of Work-Related Injuries 

Comment: Several comments said that 

although the data show that workers in 

the poultry slaughter and processing 

industry suffer adverse health and safety 

effects under the existing line speeds, 

studies indicate, and statements by 

poultry workers confirm, that the 

official injury statistics fail to accurately 

represent the extent to which worker 

injuries and musculoskeletal diseases 

and disorders affect workers in the 

poultry slaughter and processing 

industry. 

The comments said that workers in 

the poultry industry are regularly 

discouraged by their employers from 

reporting work-related health conditions 

or seeking relief under the workers’ 

compensation system. The comments 

also stated that workers do not report 

injuries for a variety of reasons, 

including concern about work hours, job 

security, and residency status in the 

United States. The comments added that 

injuries sustained by workers who are 

dismissed or resign during their initial 

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three month probationary period are 

also not reported. The comments noted 

that OSHA has recognized that there are 

problems related to the under reporting 

of work-related injuries and established 

a Special Emphasis Program on 

underreporting in 2009. According to 

the comments, OSHA identified poultry 

processing as a targeted industry under 

this program. 

Response: OSHA is the appropriate 

agency to address issues associated with 

the reporting of worker injuries. As 

discussed above, OSHA has provided 

several recommendations that poultry 

slaughter establishments can implement 

to improve surveillance for worker 

injuries. FSIS strongly encourages 

establishments to adopt these 

recommendations. 

FSIS recognizes that systematic 

underreporting of work-related injuries 

and illnesses could make it difficult to 

accurately assess the extent to which 

poultry workers suffer from workrelated injuries and musculoskeletal 

diseases and disorders. 

9. Attestation to FSIS on Work-Related 

Conditions 

As discussed above, in both the 

proposed rule and the Federal Register 

document extending the comment 

period, FSIS acknowledged the 

potential for increased inspection line 

speed to affect the safety of 

establishment workers (77 FR 4423– 

4424 and 77 FR 2487). FSIS also 

‘‘recognize[d] that the evaluation of the 

effects of line speed on food safety 

should include the effects of line speed 

on establishment employee safety’’ (77 

FR at 4423). And as noted above, 

commenters raised concerns about the 

effects that increased line speeds might 

have on the health and safety of workers 

in poultry slaughter establishments. 

Most of these comments expressed 

concern that workers subject to faster 

line speeds could suffer increased 

numbers of occupational injuries and 

illnesses, particularly musculoskeletal 

disorders (MSDs) such as carpal tunnel 

syndrome, and that potential negative 

effects on workers could also have an 

adverse effect on poultry safety. The 

comments specifically noted that MSDs 

could affect workers to the extent that 

they could not do their jobs properly, 

and also addressed the possibility of 

bacterial contamination between 

workers and poultry, exposure to other 

pathogens, and risk of laceration. 

Moreover, comments also expressed 

concern that poultry processors’ injury 

and illness logs may not reflect the full 

extent of work-related conditions 

experienced by poultry workers. A 

number of commenters requested that 

FSIS either withdraw the proposal 

because of the increased risk of injury 

to workers, or at least delay 

implementation of a final rule until 

NIOSH, a part of the Centers for Disease 

Control and Prevention in the 

Department of Health and Human 

Services, completed a comprehensive 

study of the effect of line speed on 

worker safety and health. 

As discussed above, in the proposed 

rule FSIS explained that it asked NIOSH 

to evaluate the effects of increased 

inspection line speeds on establishment 

worker safety by collecting data from 

establishments that had been granted 

waivers from line speed restrictions 

under the SIP (77 FR 4423–4425). 

NIOSH initiated such a study in one 

non-HIMP establishment that is 

operating under a waiver from line 

speed restrictions under SIP (77 FR 

4423 and 77 FR 2487). NIOSH has 

completed its evaluation and made its 

final report available to the public in 

March 2014 (Evaluation of 

Musculoskeletal Disorders and 

Traumatic Injuries Among Employees at 

a Poultry Processing Plant; Report No. 

2012–0125–3204, March 2014; available 

on the Internet at: http://www.cdc.gov/

niosh/hhe/reports/pdfs/2012-0125- 

3204.pdf). The results from this study 

lend support to the concerns noted in 

the comments that poultry processors’ 

injury and illness logs often do not 

reflect the full extent of work-related 

conditions experienced by poultry 

workers. 

To address these concerns, FSIS is 

establishing a new subpart H 

‘‘Attestation on Work-Related 

Conditions.’’ Subpart H includes an 

annual attestation requirement (9 CFR 

381.45) and a severability clause (9 CFR 

381.46). The attestation provision 

requires that each establishment that 

operates under the NPIS provide an 

annual attestation to the management 

member of the local FSIS circuit safety 

committee stating that the establishment 

maintains a program to monitor and 

document any work-related conditions 

that arise among establishment workers. 

The elements of this program include: 

(1) Policies to encourage early 

reporting of symptoms of work-related 

injuries and illnesses, and assurance 

that the establishment has no policies or 

programs intended to discourage the 

reporting of injuries and illnesses. 

(2) Notification to employees of the 

nature and early symptoms of 

occupational illnesses and injuries, in a 

manner and language that workers can 

understand, including by posting in a 

conspicuous place or places where 

notices to employees are customarily 

posted, a copy of the FSIS/OSHA poster 

encouraging reporting and describing 

reportable signs and symptoms. 

(3) Monitoring on a regular and 

routine basis of injury and illness logs, 

as well as nurse or medical office logs, 

workers’ compensation data, and any 

other injury or illness information 

available. 

As discussed earlier in this document 

FSIS has decided to allow the 20 young 

chicken establishments that have been 

granted SIP waivers to operate under the 

HIMP inspection system to continue to 

operate under a SIP waiver to run at line 

speeds of up to 175 bpm. FSIS will also 

update these SIP waivers to remove 

aspects of HIMP that are inconsistent 

with the NPIS, such as the OCP 

performance standards. To ensure that 

the updated SIP waivers are consistent 

with the NPIS, the Agency will also 

require that establishments operating 

under the updated waivers submit the 

annual attestation discussed above as a 

condition of their waivers. 

The severability clause states that 

should a court of competent jurisdiction 

hold any provision of part 381 to be 

invalid, such action shall not affect any 

other provision of part 381 (9 CFR 

381.46). 

As OSHA is the Federal agency with 

statutory and regulatory authority to 

promote workplace safety and health, 

FSIS will forward the annual 

attestations to OSHA for further review. 

OSHA, in turn, may use the information 

in the attestations in its own 

enforcement program. FSIS employees 

will not be responsible for determining 

the merit of the content of each 

establishment’s monitoring program or 

enforcement of noncompliance with this 

section. FSIS will work with OSHA to 

develop the poster that establishments 

must display providing information on 

the signs and symptoms of occupational 

injuries and illnesses experienced by 

poultry workers, and about workers’ 

rights to report these conditions without 

fear of retaliation. 

Consistent with the mandate of E.O. 

12866, OSHA has advised FSIS that the 

development and implementation of 

such a monitoring program will enable 

establishments both to protect their 

workers and to identify illnesses and 

injuries. Prompt intervention will also 

reduce the costs associated with worker 

injury by enabling establishments to 

adjust their processes or implement 

other appropriate measures before 

additional employees are affected. 

G. Changes That Affect All 

Establishments That Slaughter Poultry 

Other Than Ratites 

In addition to proposing to establish 

the NPIS, FSIS also proposed changes to 

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the regulations that would apply to all 

establishments that slaughter poultry 

other than ratites. The Agency proposed 

that all poultry slaughter establishments 

develop, implement, and maintain 

written procedures to ensure that 

carcasses contaminated with visible 

fecal material do not enter the chiller 

and that they incorporate these 

procedures into their HACCP plans, or 

sanitation SOPs, or other prerequisite 

programs (77 FR 4426). The Agency also 

proposed to require that all poultry 

slaughter establishments develop, 

implement, and maintain, as part of 

their HACCP systems, written 

procedures to prevent contamination of 

carcasses and parts by enteric 

pathogens, e.g., Salmonella and 

Campylobacter, and fecal material 

throughout the entire slaughter and 

dressing process, and that they maintain 

daily records sufficient to document the 

implementation and monitoring of those 

procedures (77 FR 4427). The Agency 

proposed that at a minimum, these 

procedures must include sampling and 

analysis for microbial organisms at the 

pre- and post-chill points in the process 

to monitor process control for enteric 

pathogens. 

The proposed new requirements are 

designed to ensure that establishments 

incorporate process control measures to 

prevent contamination into their 

HACCP systems, and that they develop 

and maintain documentation to verify 

the effectiveness of their procedures on 

an ongoing basis. In the preamble to the 

proposed rule, the Agency explained 

that it would verify that establishments’ 

procedures are effective by reviewing 

the establishment’s monitoring records, 

including the establishment’s 

microbiological testing results, 

observing the establishment 

implementing its procedures, and 

inspecting carcasses and parts for 

visible fecal contamination when 

performing both online carcass 

inspection and offline verification 

inspection (77 FR 4427). 

Under the proposed rule, each 

establishment would be responsible for 

developing and implementing a 

microbiological sampling plan, which 

would be required to include carcass 

sampling at pre-chill and post-chill (77 

FR 4428). The Agency also proposed to 

rescind the regulations that require that 

poultry establishments test for generic 

E. coli and to remove the codified 

Salmonella pathogen reduction 

standard for poultry. The proposed new 

microbiological sampling requirements 

would replace the generic E. coli testing 

regulations and would allow 

establishments to develop sampling 

plans that are more tailored, and thus 

more effective for monitoring their 

process control. FSIS would consider 

both the establishment’s testing results, 

as well as the results of the Agency’s 

testing Salmonella and Campylobacter 

performance standards, to assess how 

well the establishment is maintaining 

process control. 

FSIS received several comments on 

these proposed new requirements. 

1. Procedures and Recordkeeping 

Requirements for Preventing 

Contamination by Enteric Pathogens 

and Visible Fecal Contamination 

Comment: A consumer advocacy 

organization and an individual 

expressed support for the proposed new 

requirement that all establishments that 

slaughter poultry develop, implement, 

and maintain, as part of their HACCP 

systems, written procedures to prevent 

carcass contamination throughout the 

entire slaughter and dressing process. 

The consumer advocacy organization 

also supported the proposal to require 

that all poultry slaughter establishments 

develop, implement, and maintain 

written procedures to ensure that 

carcasses contaminated with visible 

fecal material do not enter the chiller, 

and incorporate these procedures into 

their HACCP systems. According to the 

comments, the proposed new 

requirements address a weakness of the 

current poultry inspection system, 

which is that verification checks 

performed at the end of the slaughter 

and chilling process encourage the 

industry to focus its activities on postprocess interventions to reduce 

contamination rather than prevention 

throughout the slaughter process. 

The comments also expressed support 

for the proposed requirement that 

establishments maintain daily records 

sufficient to document the 

implementation and monitoring of their 

procedures for preventing 

contamination by enteric pathogens and 

fecal material. The comments noted that 

many establishments may have in place 

process control measures that attempt to 

address contamination by enteric 

pathogens and fecal material, but 

nothing currently requires that the 

establishments develop and maintain 

documentation to verify on an ongoing 

basis that these procedures are effective. 

The comments said that without this 

documentation, establishments can 

quickly lose process control or rely on 

procedures that contribute to an ongoing 

risk of contamination. The comments 

stated that the documentation proposed 

by the Agency will allow both the 

establishment and the Agency to 

identify points of weak process control, 

and can provide a roadmap for 

corrective action. 

Response: FSIS agrees that requiring 

establishments to keep daily written 

records to document the 

implementation and monitoring of their 

process control procedures is a positive 

step forward for public health. This 

ongoing documentation will allow both 

the establishment and FSIS to identify 

specific points in the production 

process where a lack of process control 

may have resulted in product 

contamination or insanitary conditions. 

This will allow the establishment to 

take the necessary corrective action to 

prevent further product contamination. 

Comment: One trade association 

stated that it is unclear what additional 

steps will be required in regard to 

sanitary dressing. According to this 

trade association, all of its members 

already have significant sanitary 

procedures in place. 

Response: As noted above, in the 

preamble to the proposed rule, FSIS 

acknowledged that many establishments 

have in place process control measures 

to address the prevention of 

contamination by enteric pathogens and 

fecal material, but that they are not 

maintaining documentation to verify the 

effectiveness of these procedures on an 

ongoing basis (77 FR 4427). Under this 

final rule, establishments will be 

required to incorporate these procedures 

into their HACCP systems, and to 

maintain ongoing documentation to 

demonstrate that the procedures are 

effective. As noted above, this ongoing 

documentation will allow both the 

establishment and FSIS to identify 

specific points in the production 

process where a lack of process control 

may have resulted in product 

contamination or insanitary conditions. 

2. Sampling and Testing Requirements 

To Monitor Process Control 

a. Sampling Plan and Sampling Sites 

Comment: Several consumer 

advocacy organizations and a member of 

academia disagreed with the Agency’s 

proposal to allow each establishment to 

develop its own sampling plan. These 

comments argued that the sampling 

program needs to be standardized. 

According to one comment, in other 

countries, such as New Zealand, the 

government sets the testing frequencies 

and indicator pathogens for the 

industry. 

One consumer advocacy organization 

argued that requiring all establishments 

to conduct testing for the same 

organisms, at the same frequency, and at 

the same locations along the production 

line will provide the Agency and 

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stakeholders with valuable data on the 

impacts of incremental changes in 

production on contamination levels 

both within a specific establishment and 

industry-wide. According to this 

comment, under the proposed rule, data 

analysis will be difficult for anyone 

(e.g., the Agency, inspectors, and 

establishment management) trying to 

study the data because of the variations 

in sampling at each establishment. 

Another consumer advocacy 

organization stated that a uniform 

sampling program can help identify 

additional steps that should be taken to 

address hazards, modernize the system, 

and ensure facilities are operating at 

line speeds that do not cause poultry 

contamination to rise. 

Response: The purpose of the 

proposed new sampling requirement is 

to ensure that establishments monitor 

and evaluate the effectiveness of their 

procedures to prevent contamination of 

carcasses by enteric pathogens and 

visible fecal material on an ongoing 

basis. It is not intended to generate data 

to compare establishment performance 

across the industry. The data that FSIS 

collects from its Salmonella and 

Campylobacter sampling programs 

serves that purpose. Because 

establishments have differences in their 

operations, FSIS believes that each 

establishment should have the 

flexibility to develop a sampling plan 

that will accurately monitor the 

effectiveness of its process control 

procedures while holding the 

establishment accountable through the 

Salmonella and Campylobacter 

performance standards. As discussed 

below, the Agency is prescribing a 

minimum frequency with which all 

poultry establishments will need to 

collect samples. 

FSIS will scrutinize an 

establishment’s monitoring records, 

including its microbial testing results, to 

verify the effectiveness of the 

establishment’s process control 

procedures. The Agency will continue 

to assess and compare establishment 

performance across the industry through 

the Agency’s sampling program for 

Salmonella and Campylobacter. Under 

this program, the samples are collected 

by FSIS inspectors and analyzed by 

FSIS laboratories, ensuring that the 

sampling and testing program is 

consistent, and that the Agency is able 

to compare establishment performance 

and industry trends over time. 

Comment: Several trade associations 

and an industry member stated that, 

instead of requiring sampling at preand post-chill, FSIS should allow 

establishments the flexibility to select 

the number and sampling sites for their 

individual operations to demonstrate 

process control. These comments argued 

that each establishment is different and 

that sampling programs must be 

scientifically based and statistically 

valid and are most effective when they 

are establishment specific. According to 

these comments, sampling in one 

location could demonstrate process 

control in one establishment because of 

certain interventions, but sampling in 

two locations may be more appropriate 

to demonstrate process control in 

another establishment. One trade 

association believed that providing 

flexibility in sampling is consistent with 

HACCP principles, encourages industry 

innovations in operations and 

processing, and enables processors to 

develop new methods for demonstrating 

process control through sampling. 

Response: As stated in the preamble 

to the proposed rule, FSIS believes that 

microbiological test results that 

represent levels of microbiological 

contamination at key steps in the 

slaughter process are necessary for 

establishments to provide 

comprehensive, objective evidence to 

demonstrate that they are effectively 

maintaining process control to prevent 

carcasses from becoming contaminated 

before and after they enter the chiller 

(77 FR 4427). Process control in the 

context of poultry slaughter consists of 

the programs and procedures an 

establishment implements to ensure its 

processes are operating as intended in 

preventing contamination (including 

contamination with microbial pathogens 

and fecal material) of poultry carcasses 

and parts throughout the slaughter and 

dressing process and to ensure that the 

resulting products meet applicable 

regulatory standards or definitions. 

Establishments must demonstrate that 

their process is in control by 

implementing verification procedures, 

collecting data, and developing and 

maintaining accurate records to 

demonstrate that their processes and 

procedures are performing as intended 

and as required. 

An effective process control system 

entails an establishment responding 

effectively to re-establish control when 

its ongoing verification activities show 

that its processes or procedures are not 

producing the expected results. 

Effective process control procedures 

should lead to lower rates of pathogen 

contamination because establishments 

will discover deficiencies in processing 

sooner and more reliably than would be 

the case without effective process 

control procedures. 

FSIS considers the microbial 

characteristics of poultry carcasses at 

pre-chill to be a valuable source of data 

about how well an establishment is 

minimizing contamination with fecal 

material and enteric pathogens on live 

birds coming to slaughter and on 

carcasses throughout the evisceration 

and dressing process. FSIS considers the 

microbial characteristics of poultry 

carcasses post-chill to be a valuable 

source of data about how well an 

establishment is minimizing 

contamination during chilling and the 

overall effectiveness of any 

antimicrobial interventions the 

establishment has chosen to apply 

throughout its process. Because most 

establishments apply one or more 

antimicrobial interventions between the 

pre- and post-chill sampling points to 

help control microbiological hazards, 

FSIS would expect that a reduction in 

microbiological contamination between 

these two points to be an indication of 

the effectiveness of those controls. 

Therefore, FSIS is finalizing the 

proposed requirements that 

establishments collect samples for 

microbial analysis at the pre- and postchill locations to monitor for process 

control, with an exception for very 

small and very low volume 

establishments operating under the 

Traditional Inspection System. This 

exception is described below. 

Comment: One trade association 

noted that if the Agency requires 

sampling pre- and post-chill, the 

Agency needs to clarify that 

establishments have the flexibility to 

select the sampling locations where 

testing would occur before and after 

chilling. This comment also argued that 

the Agency should not require a third 

sampling location at re-hang because it 

would be overly prescriptive, 

burdensome, and would not further 

food safety. 

Response: Under this final rule, 

establishments will need to collect prechill samples before the chiller at the 

end of the evisceration process. The prechill testing is intended to monitor the 

effectiveness of all process controls up 

to the point of the chiller. An 

establishment will need to collect postchill testing after it has completed all 

interventions, which is the same point 

in the process that FSIS collects samples 

for Salmonella and Campylobacter 

verification testing. 

As stated in the preamble to the 

proposed rule, FSIS had considered 

requiring a third verification test at the 

re-hang position to monitor the 

incoming load of pathogens but the 

Agency concluded that it was not 

necessary to impose the additional costs 

that would be associated with testing at 

this point (77 FR 4428). 

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Comment: A consumer advocacy 

organization argued that allowing each 

establishment to use different tests with 

different indicator organisms and 

standards for verifying that their process 

controls are effective will create 

problems for inspectors. According to 

the comment, FSIS inspectors will have 

to determine on a case-by-case basis 

whether each test chosen is validated 

for that purpose and whether the 

standard used by the establishment is 

adequate. This comment stated that 

determining whether a HACCP plan is 

effective would be more complex for 

inspectors, whereas the current generic 

E. coli testing program that FSIS 

proposed to rescind provides an 

objective test and standard which are 

familiar to FSIS and industry. 

Response: As stated in the preamble 

to the proposed rule, because an 

establishment’s microbiological 

sampling plan will be part of its HACCP 

system, each establishment will be 

required to provide scientific or 

technical documentation to support the 

judgments made in designing its 

sampling plan (77 FR 4428). FSIS 

inspection personnel will verify the 

effectiveness of the establishment’s 

sampling plan by reviewing the 

supporting documentation and verifying 

that the establishment is implementing 

its sampling plan as designed. These 

procedures are consistent with the 

methodology that inspectors use to 

verify the effectiveness of other 

measures incorporated into an 

establishment’s HACCP system. In 

addition, FSIS intends to provide 

training to its inspectors and guidance 

to industry on all of the new 

requirements under this final rule, 

including the new sampling plans. The 

Agency’s inspection personnel will be 

prepared to carry out their 

responsibilities to ensure the 

effectiveness of establishments HACCP 

systems, including the new sampling 

requirements, when this final rule 

becomes effective. 

b. Very Small and Very Low Volume 

Establishment Sampling 

Comment: A State Department of 

Agriculture said that there should be 

two sampling locations for all 

establishments, but that the sampling 

frequency should be scale-dependent, 

e.g., the frequency should be decreased 

for very small establishments. The 

comment noted that it is just as 

important in a very small establishment 

as a large one to maintain and document 

process control, but very small 

establishments will have proportionally 

more difficulty than large 

establishments in absorbing the costs for 

a second sampling location. 

One industry member stated that 

sampling at small and very small 

establishments should be the same as at 

all other establishments. This industry 

member believed that the specific 

processes and programs in place, not the 

size of the establishment or the volume 

of production, should determine how 

process control is demonstrated. 

Response: In the preamble to the 

proposed rule, FSIS noted that small 

and very small low volume 

establishments that choose to operate 

under the revised Traditional Inspection 

System may not need to conduct testing 

for microbial organisms at two points in 

the slaughter process to adequately 

monitor process control (77 FR 4428). 

These establishments typically are less 

automated and run at slower line speeds 

than larger establishments operating 

under SIS, NELS, and NTIS. The lower 

level of automation and the slower line 

speeds require less complicated 

measures for maintaining and 

monitoring process control on an 

ongoing basis. Therefore, after 

considering this issue, FSIS has decided 

to revise the proposed rule to allow very 

small and very low volume 

establishments that operate under the 

modified Traditional Inspection System 

to collect and analyze samples for 

microbial organisms at the post-chill 

point in the process only. As stated in 

the preamble to the proposed rule, very 

low volume establishments would 

include those classified as very low 

volume establishments under the 

existing generic E. coli testing 

regulations (77 FR 4428). To make this 

clear, the Agency is establishing a 

codified definition for very low volume 

establishments that is based on the 

existing very low volume 

establishments definition under 9 CFR 

381.94(2)(v), i.e., establishments that 

annually slaughter no more than 

440,000 chickens, 60,000 turkeys, 

60,000 ducks, 60,000 geese, 60,000 

guineas, or 60,000 squabs. 

Under this rule, if FSIS has evidence 

to indicate that a very small or very low 

volume establishment conducting 

sampling at a single point in the process 

is not maintaining process control, such 

as not meeting FSIS’s pathogen 

performance standards, the 

establishment will need to conduct 

additional testing or implement 

additional measures to ensure that its 

process remains in control. 

c. Sampling Frequency 

Comment: Several consumer 

advocacy organizations requested that 

FSIS explain how it developed the 

estimates on how frequently 

establishments will conduct testing to 

monitor their process control 

procedures. The comments noted that 

FSIS estimated that large establishments 

will perform the prescribed tests 15 

times a day, small establishments 7 

times a day, and very small 

establishments 3 times a day. One of the 

consumer advocacy organizations asked 

that the Agency explain the justification 

for the presumed sample size. The 

comment stated that by providing 

clarification on the source of these 

estimates, stakeholders can better 

ascertain whether they represent a 

reasonable estimate of testing frequency. 

Response: The estimates on how 

frequently establishments will conduct 

sampling under the proposed rule are 

from the proposed rule’s Paperwork 

Reduction Act paperwork burden 

estimates. These estimates were based 

on the frequency with which 

establishments operating under a SIP 

waiver conduct sampling. Under SIP, 

FSIS grants establishments a waiver of 

regulations under the condition that the 

establishment collects and analyzes 

samples for microbial organisms and 

shares the results with FSIS. As 

discussed below, FSIS is revising the 

proposed rule to prescribe a minimum 

frequency with which all establishments 

that slaughter poultry will need to 

conduct testing for microbial organism 

to monitor their process control 

procedures. Thus, FSIS has updated its 

paperwork burden estimates to reflect 

these changes. 

Comment: Several consumer 

advocacy organizations and a member of 

academia asserted that FSIS needs to 

prescribe the frequency with which 

establishments must conduct sampling. 

One consumer advocacy organization 

stated that establishments need to 

collect samples at a specified frequency 

to evaluate whether any changes 

implemented by the establishment as a 

result of the proposed rule have positive 

or negative effects on rates of 

contamination. A consumer advocacy 

organization argued that FSIS needs to 

require a specific testing frequency per 

line and per shift to ensure that 

establishments achieve sufficient testing 

for pathogens. Another consumer 

advocacy organization suggested that 

FSIS require testing frequency per 

production day based on production 

volume. One comment expressed 

concern that poultry establishments 

have little incentive to incur costs to test 

beyond a very minimum frequency that 

may not be sufficient to monitor process 

control. 

One trade association stated that FSIS 

should not remove the generic E. coli 

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testing regulation because it includes 9 

CFR 381.94(a)(2)(v), which establishes 

definitions for very low volume 

establishments and provides sampling 

frequencies for very low volume 

establishments. This trade association 

asserted that specific testing frequencies 

for very low volume establishments 

should remain in the regulations. 

Several trade associations stated that 

FSIS should not prescribe how often 

establishments must collect samples for 

testing. These trade associations 

supported the flexibility in sampling 

frequency because they believed 

sampling should be specific to an 

individual establishment’s programs 

and processes. 

Response: After considering the 

comments from the consumer advocacy 

organizations, FSIS believes that there is 

merit to requiring a minimum frequency 

of testing to ensure that establishments 

will be able to detect changes in 

processing or inconsistencies that may 

occur. FSIS expects that for their 

sampling plans, most establishments 

will adopt sampling frequencies that are 

similar to what is required under the 

existing generic E. coli testing 

regulations because sampling less 

frequently may affect the 

establishment’s ability to detect 

problems with their process controls in 

a timely manner. However, as indicated 

by some of the comments, there is some 

concern that some establishments may 

attempt to reduce sampling to a very 

low frequency. While a very low testing 

frequency may be sufficient if the 

establishment is able to consistently 

maintain process control, it could also 

decrease the establishment’s ability to 

detect changes or inconsistencies in 

processing that may occur. 

Therefore, to address concerns about 

minimal sampling frequencies 

expressed by the consumer advocacy 

organizations, FSIS is revising the 

proposed sampling requirements to 

prescribe a minimum frequency with 

which establishments will be required 

to collect a pair of samples, one at prechill and one at post-chill, or, for very 

small and very low volume 

establishments that operate under 

Traditional Inspection, a single postchill sample. Under this final rule, 

establishments will be required to 

collect samples at a frequency of once 

per 22,000 processed carcasses for 

chickens and once per 3,000 processed 

carcasses for turkeys, ducks, geese, 

guineas, and squabs. These frequencies 

reflect the frequencies prescribed under 

the existing regulations for generic E. 

coli testing. 

Under the existing generic E. coli 

testing regulations, very low volume 

establishments that slaughter turkeys, 

ducks, geese, guineas, squabs, or ratites 

in the largest number must collect at 

least one sample during each week of 

operation each year but may stop 

sampling after 13 samples have been 

collected (9 CFR 381.94(a)(2)(v)). This 

final rule includes a similar provision 

that will apply to very low volume 

establishments to minimize the 

additional sampling costs to these 

establishments, many of which are also 

small or very small establishments. 

Thus, under this rule, if, after 

consecutively collecting 13 weekly 

samples, a very low volume 

establishment demonstrates that it is 

effectively maintaining process control, 

FSIS will allow it to modify its sampling 

plan. For example, after collecting 13 

weekly samples, a very low volume 

establishment could collect samples less 

frequently, such as once a month, and 

use visual observation and 

documentation at control points to 

monitor process control. FSIS will 

provide guidance to very low volume 

establishments in developing alternative 

sampling plans and establish criteria, 

e.g., lower limit (m) and upper limit (M) 

values for test results, that will allow 

them to effectively monitor process 

control. 

Because ratites were not subject to the 

proposed rule, establishments that 

slaughter ratites will continue to follow 

the generic E. coli testing regulations in 

9 CFR 381.94(a). These regulations have 

been revised to remove all other poultry 

classes. 

As noted in the preamble to the 

proposed rule, the frequency with 

which establishments will need to 

conduct testing to monitor for process 

control will depend on a number of 

factors, including their production 

volume, the source of their flocks, their 

slaughter and dressing processes, and 

the consistency of their microbial test 

results (77 FR 4428). Therefore, the 

prescribed minimum sampling 

frequencies may not necessarily be 

appropriate for every establishment to 

monitor process control. Some 

establishment may need to sample more 

frequently to effectively monitor process 

control. Because the testing frequency 

will be an integral part of an 

establishment’s HACCP system 

verification procedures, establishments 

will need to collect and maintain data 

to demonstrate that their testing 

frequency is adequate to verify the 

effectiveness of their process control 

procedures. 

Comment: Several trade associations 

stated that the source of flocks should 

not be a factor in determining the 

frequency of establishment testing. 

According to some of the comments, 

interventions at establishments ensure 

that only unadulterated product leaves 

the establishment, no matter where 

poultry is raised. One trade association 

added that the best methods of 

controlling Salmonella occur in the 

establishments, not on the farm. This 

trade association stated that the 

decontamination process during 

slaughter has allowed the industry to 

reduce its carcass swab incidence of 

Salmonella to less than 1.75 percent. 

Additionally, this comment noted that 

during a September 23, 2011, meeting, 

USDA’s NACMPI rejected efforts to tie 

flock source to process control because 

adequate science doesn’t currently exist 

to support such a relationship. 

Additionally, one trade association 

believed that production volume and 

slaughter and dressing processes should 

not be factors in determining sampling 

frequencies. This comment argued that 

the manner with which establishments 

demonstrate process control does not 

vary with the operations being 

conducted. Several trade associations 

stated that sampling frequency depends 

on an establishment’s total food safety 

system, not variables like volume or 

flock source that are already accounted 

for. 

Response: The proposed rule did not 

prescribe specific factors that 

establishments would need to consider 

when developing their microbiological 

sampling plans. However, because 

establishments are required to 

incorporate their sampling plans into 

their HACCP systems, they will be 

required to provide scientific or 

technical documentation to support the 

judgments made in designing their 

sampling plans. In the preamble to the 

proposed rule, the Agency stated that 

the frequency with which 

establishments will need to collect 

samples for analysis will depend on a 

number of factors, including, among 

other factors, their production volume, 

and source of their flocks. As noted 

above, even though the Agency is 

establishing a minimum testing 

frequency for establishments to monitor 

process control, establishments will be 

required to consider any factors that are 

relevant to their production process to 

determine the sampling frequency that 

will be effective for their operation to 

meet regulatory requirements. 

FSIS is not requiring that 

establishments address specific factors, 

such as flock source, to determine 

sampling frequency. However, because 

establishments are required to 

incorporate their sampling programs 

into their HACCP systems, they will 

need to provide scientific support for 

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15Laboratory cost for analyzing for Salmonella 

and Campylobacter could exceed $300 per sample 

though we expect costs would vary, and could be 

less, depending upon number of tests and 

laboratory availability. The costs of analyzing these 

pathogens we expect to be more than 10-fold greater 

than the costs for analyzing for indicator organisms. 16Altekruse, S.F., Berrang, M.E., Marks, H., Patel, 

B., Shaw, W.K., Sani, P., Bennett, P.A., and Baily, 

J.S., 2009, Enumeration of Escherichia coli Cells on 

Chicken Carcasses as a Potential Measure of 

Microbial Process Control in a Random Selection of 

Slaughter Establishments in the United States, 

Applied and Environmental Microbiology, 75(9): 

3522–3527. 

17Berrang, M.E., Bailey, J.S., Altekruse, S.F., and 

Shaw, W.K., 2008, J. Appl. Poultry Res 17: 354–360. 

18Habib, I., De Zutter, L, Van Huffel, X., Geeraerd, 

A.H., and Uyttendaele, M., 2012, Potential of 

Escherichia coli as a Surrogate Indicator for 

Postchill Broilers with High Campylobacter Counts, 

Food Control 25: 96–100. 

the decisions made in determining the 

sampling frequency. 

d. Indicator Organisms and Baseline 

Comment: Several consumer 

advocacy organizations argued that 

instead of allowing establishments to 

choose which organism to test for, FSIS 

should require that establishments test 

for Salmonella and Campylobacter. The 

comments said that these are the two 

pathogens of greatest public health 

concern in the products affected by the 

proposed rule and together account for 

nearly half of all poultry-related 

outbreaks in the United States. One 

comment added that establishments 

could still test for additional pathogens 

or indicator organisms as warranted. 

One member of academia suggested that 

rapid testing be used for Salmonella at 

pre- and post-chill testing locations, 

rather than an indicator organism such 

as generic E. coli, because Salmonella is 

the leading cause of bacterial foodborne 

disease. 

Response: As discussed above, the 

purpose of the proposed new testing 

requirements is to ensure that 

establishments are effectively 

monitoring process control on an 

ongoing basis. FSIS has determined that 

this can be achieved by sampling preand post-chill for enteric pathogens, 

such as Salmonella and Campylobacter, 

or for an appropriate indicator 

organism. The comments did not 

include any data to cause FSIS to 

question this conclusion. 

As discussed above, to effectively 

monitor their process control 

procedures, establishments will need to 

conduct testing at a frequency that is 

sufficient to detect a loss of process 

control soon after it occurs so that they 

can take the necessary corrective actions 

to prevent further product 

contamination. Because the percentage 

of carcasses that are expected to show 

positive test results for Salmonella and 

Campylobacter is small when compared 

with the percentage of carcasses that are 

expected to show positive results for 

indicator organisms, establishments 

would need to analyze a large number 

of samples for Salmonella or 

Campylobacter to detect a loss of 

control, much larger than when using an 

appropriate indicator organism, 

everything else being equal. The cost to 

analyze samples for Salmonella and 

Campylobacter is much greater than that 

to analyze for indicator organisms.15

Thus, the costs to effectively monitor a 

process using Salmonella and 

Campylobacter measurements would 

likely be considerably more expensive 

than the costs to monitor the process 

using measurements of levels of 

indicator organisms. FSIS has 

concluded that such costs would not be 

justifiable when measurements of 

indicator organisms are as effective for 

monitoring process control as 

measurements of pathogens.16 17 18

Comment: Several consumer 

advocacy organizations and a member of 

academia recommended that FSIS 

require that establishments conduct 

testing for a specific period of time that 

can be statistically justified to provide 

baseline testing data before the Agency 

moves forward with any changes to its 

poultry slaughter inspection program. 

One of the comments added that the 

baseline testing data will allow FSIS 

and the establishment to determine how 

changes to the poultry slaughter system 

impact pathogen rates at the 

establishment. Another comment stated 

that FSIS should require the continuous 

generation of baseline data for a period 

of at least 90 days prior to implementing 

other substantive changes to the poultry 

inspection system. 

Response: FSIS is requiring that 

establishments collect and analyze 

samples for microbial organisms to 

monitor the effectiveness of their 

process control procedures. As noted 

above, establishments will be 

responsible for determining which 

microbiological organisms will best help 

them to monitor the effectiveness of 

their process controls. The 

establishment’s baseline for its sampling 

plan will depend on the organism that 

it selects. Establishments that choose to 

collect and analyze samples for 

indicator microbial organisms rather 

than pathogens, such as Salmonella and 

Campylobacter, will be responsible for 

developing their own baseline for these 

organisms because the Agency is not 

establishing performance standards for 

indicator organisms. Of course, some 

establishments may already have data 

that they can use to develop a baseline. 

For those that do not, the length of time 

an establishment will need to develop a 

baseline will depend on several factors, 

including the volume of birds it 

slaughters, the number of lines, and the 

number of sources from which the 

establishment receives birds. 

Establishments must have developed 

their sampling plans before the effective 

dates established in this final rule. The 

sampling plan must be made part of the 

establishment’s HACCP system, and as 

such, the establishment is required to 

provide scientific or technical 

documentation to support the 

effectiveness of its sampling plan, 

which may include the development of 

an appropriate baseline to allow them to 

detect changes or inconsistencies in 

microbial levels that may occur during 

the slaughter and evisceration process. 

3. Rescind Testing for Generic E. coli for 

Establishments That Slaughter Poultry 

Other Than Ratites 

In the proposed rule, FSIS explained 

that it was proposing to rescind the 

generic E. coli testing requirements in 9 

CFR 381.94 and replace them with a 

new testing requirement that allow 

establishments to sample for other, 

potentially more useful indicator 

organisms. The new testing 

requirements were discussed above. 

FSIS received some comments on this 

aspect of the proposed rule (77 FR 

4428). 

Comment: Comments from a 

consumer advocacy organization and a 

member of academia said FSIS should 

not rescind the existing regulations that 

prescribe testing for generic E. coli. A 

consumer advocacy organization said 

that rescinding this regulation will 

remove performance standards as a 

regulatory matter, expose consumers to 

greater risks from contaminated poultry, 

and reduce options for enforcement. 

One member of academia also stated 

that given that USDA studies have 

shown that E. coli can serve as a 

reservoir or source of transferable 

genetic determinants for antimicrobial 

resistance in foodborne pathogens, 

testing for generic E. coli should not be 

rescinded. 

A consumer advocacy organization 

presented various arguments that, 

according to the organization, show that 

FSIS did not adequately support its 

decision to rescind the generic E. coli 

sampling requirements. First the 

comment asserted that FSIS 

inappropriately relied on a 2004 report 

of the National Advisory Committee on 

Microbiological Criteria for Foods 

(NACMCF) as a basis for rescinding the 

rule. Second, the comment argued that 

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49606 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

the studies that FSIS referenced that 

indicate that the presence of generic E. 

coli on young chicken carcasses may be 

a result of infectious process or air 

saculitis, and do not provide a basis for 

rescinding the generic E. coli testing 

regulations. According to the comment, 

regardless of whether the source of 

contamination is fecal or an infected 

carcass, testing and performance 

standards are still relevant because 

detecting generic E. coli would be 

evidence of problems in the 

establishment’s process controls. 

Response: As discussed in the 

preamble to the proposed rule, the 

Agency’s experience with the generic E. 

coli testing regulations has led the 

Agency to conclude that such testing 

may not be the most effective way for 

establishments to monitor the 

effectiveness of their process control 

procedures. 

The existing generic E. coli 

performance criteria represent the 

distribution of measured generic E. coli 

results observed in FSIS’s 1994 baseline 

survey of young chicken slaughter 

establishments. Since FSIS 

implemented the generic E. coli testing 

requirements, establishments have made 

changes to their processes that have led 

to further reductions in the detectable 

levels of generic E. coli on carcasses 

post-chill. The most recent young 

chicken baseline conducted from 2007– 

2008 shows that the levels of detectable 

generic E. coli on post-chill carcasses 

are well below the performance criteria 

in the existing regulations and that over 

60 percent of the sample measurements 

had non-detectable levels of generic E. 

coli. 

Data from FSIS’s 2007–2008 Young 

Chicken Baseline survey show that there 

were 12 establishments from which 10 

or more samples were analyzed during 

the survey and none with detectable 

levels of generic E. coli. FSIS analyzed 

22 samples each in 2 of these 

establishments. All 44 samples had 

detectable Aerobic Plate Count (APC) 

measurements even though none had 

detectable generic E. coli measurements. 

Thus, for these establishments, it might 

be more efficient to use APC counts 

instead of generic E. coli counts to 

monitor for process control because a 

higher percentage of samples would be 

expected to have measurable APC levels 

even when generic E. coli levels are not 

detected. 

In addition, FSIS used the most recent 

baseline survey of young chicken 

establishments to perform correlation 

analyses of pathogen presence and 

measured levels of indicator organisms 

on carcasses. The results indicate that 

measured APC levels at re-hang were 

more highly correlated with Salmonella 

presence at re-hang than were measured 

E. coli levels. Such results suggest that 

APC measurements might provide a 

better measure of process control. 

Although the Agency has determined 

that the existing post-chill testing for 

generic E. coli may not be the most 

effective means for monitoring process 

control, establishments may sample for 

generic E. coli or any other indicator 

organism pre- and post-chill, or for very 

small and very low volume 

establishments operating under 

Traditional Inspection, post-chill only, 

if the establishment provides scientific 

or technical documentation to 

demonstrate that the use of a specific 

indicator organism is appropriate for 

monitoring the establishment’s process 

control procedures. 

4. Rescind Codified Salmonella 

Performance Standards 

In the preamble to the proposed rule, 

FSIS explained that because it can 

effectively address pathogen reduction 

in poultry establishments through its 

new Salmonella and Campylobacter 

performance standards and the SIP, the 

Agency was proposing to rescind the 

codified Salmonella pathogen reduction 

performance standards in 9 CFR 

381.94(b). The Agency also explained 

that, since 2001, after a ruling by the 

U.S. Court of Appeals for the Fifth 

Circuit in Supreme Beef Processors, Inc. 

v. USDA, the Agency’s ability to directly 

enforce the codified Salmonella 

pathogen reduction performance 

standards has been limited. FSIS 

received several comments from 

consumer advocacy organizations on its 

decision to rescind the codified 

standards. 

Comment: A consumer advocacy 

organization said that in developing the 

proposed rule, FSIS should have 

considered the alternative of retaining 

both the generic E. coli testing 

requirements and the codified 

Salmonella performance standards as a 

way to ensure that an establishment’s 

processes are under control and its 

products meet a minimum level of 

sanitation. The comment said that FSIS 

should retain its ability to monitor endproducts for fecal and microbial 

contamination through mandated 

testing and performance standards. The 

comment asserted that in rescinding the 

E. coli and Salmonella testing 

provisions and their associated 

performance standards, FSIS is 

removing a useful verification check. 

Response: FSIS disagrees with the 

comments. The Agency does not believe 

that it needs to retain the existing 

codified generic E. coli performance 

criteria and the existing codified 

Salmonella performance standards to 

verify that establishments’ processes are 

in control and that the products meet a 

minimum level of sanitation. The 

reasons the Agency is rescinding the 

generic E. coli testing requirements were 

discussed above. The new testing 

requirements will give establishments 

the flexibility to sample for other 

potentially more useful indicator 

organisms to monitor for process 

control. 

As noted above, the Agency is 

rescinding the codified Salmonella 

performance standards because it can 

effectively address pathogen reduction 

in poultry establishments through its 

new Salmonella and Campylobacter 

performance standards and the SIP. 

FSIS will continue to collect verification 

samples and analyze them for 

Salmonella and Campylobacter and 

compare the results to the Agency’s 

most recent performance standards for 

these pathogens. The Agency will also 

continue to post the names of 

establishments that fail to meet the new 

performance standards on the Agency’s 

Web site and will continue to use an 

establishment’s failures to meet the 

standard as a basis for conducting an indepth evaluation of the establishment’s 

food safety system. 

Comment: Some comments disagreed 

with the Agency’s proposal to rescind 

the codified Salmonella performance 

standards. The comments said that 

under the existing regulations, an 

establishment’s consistent failure to 

comply with the Salmonella 

performance standards or take the 

corrective actions necessary to comply 

with the standards constitutes a failure 

to maintain sanitary conditions and to 

maintain an adequate HACCP plan. The 

comments said that the codified 

Salmonella performance standard is 

important because it informs poultry 

establishments of their responsibilities 

to control their processes and the 

consequences of repeated failures to do 

so. 

The comments stated that rather than 

removing the codified performance 

standards, the Agency should instead 

focus on updating them. The comments 

noted that the Agency has developed 

new performance standards for 

Salmonella and Campylobacter in 

young chicken and turkey slaughter 

establishments. The comments 

suggested that the Agency replace the 

existing codified Salmonella 

performance standards with the new 

Salmonella and Campylobacter 

performance standards. 

Response: One difficulty with 

establishing codified pathogen 

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reduction performance standards, as 

suggested by the comments, is that, 

although these standards may represent 

an appropriate level of pathogen 

reduction at the time they were 

established, over time, as establishments 

make adjustments to their processes to 

meet these standards, the standards may 

no longer be an effective means for 

accomplishing pathogen reduction. The 

Agency’s codified Salmonella 

performance standards demonstrate the 

need for flexibility to update 

performance standards based on 

changes in baseline levels for the 

pathogens of concern. 

As discussed in the preamble to the 

proposed rule, since 2001, after the 

ruling in Supreme Beef Processors, Inc. 

v. USDA, the Agency’s ability to directly 

enforce the codified Salmonella 

pathogen reduction performance 

standards has been limited (77 FR 

4412). Therefore, after the Supreme Beef 

ruling, the Agency began using 

Salmonella failures as a basis to conduct 

an in-depth evaluation of an 

establishment’s food safety system. In 

2006, after an intensive review of the 

results of several years of Salmonella 

testing that showed a trend of increasing 

prevalence of Salmonella in young 

chickens, FSIS initiated policies to 

reduce Salmonella. One of those 

initiatives was to create three 

establishment performance categories 

for Salmonella based on the codified 

performance standards. The new 

performance Category 1 represented the 

best performing establishments and was 

defined as not more than half the 

regulatory standard. Category 2 was set 

at more than half, but, did not exceeding 

the regulatory standard. Category 3 

establishments exceeded the standard, 

and represented the worse performing 

establishments. FSIS began publishing 

the names of young chicken 

establishments in Category 2 and 3 in 

March 2008, and has continued to 

publish the names of establishments in 

Category 3 on or about the 15th of each 

month. 

After it established the new 

Salmonella performance categories, 

FSIS completed new young chicken and 

turkey baselines in 2008 and 2009 

respectively. In May 2010, the Agency 

announced that it had developed 

tightened performance standards for 

Salmonella and a new performance 

standard for Campylobacter for chilled 

carcasses in young chicken and turkey 

slaughter establishments based on the 

new baseline results. In March 2011, the 

Agency announced that it would 

implement the new standards starting in 

July 2011 and that when two sets per 

establishment are completed, the 

Agency will post the names of young 

chicken and turkey establishments that 

fail the new Salmonella standards, i.e., 

Category 3, on the Agency’s Web site. 

The new, more stringent standards are 

used in place of the codified Salmonella 

performance standards. 

H. Elimination of Time/Temperature 

Chilling Requirements 

In the January 2012 proposed rule, 

FSIS proposed to replace the regulations 

that prescribe the specific time and 

temperature parameters needed to chill 

RTC poultry with a requirement that 

poultry slaughter establishments 

develop written procedures, and 

implement and maintain these 

procedures to control the levels and 

prevent the multiplication of spoilage 

organisms and pathogenic bacteria in 

the product after evisceration (77 FR 

4430). Establishments would be 

required to incorporate these procedures 

into their HACCP plans, or sanitation 

SOPs, or other prerequisite programs. 

The Agency also proposed to define ‘‘air 

chilling’’ as the method of chilling raw 

poultry carcasses and parts exclusively 

with air. In the preamble to the 

proposal, the Agency explained that 

under the proposed definition, an 

antimicrobial intervention that is 

applied with water may be used for a 

short duration if its use does not result 

in any pick-up of water or moisture, and 

if it does not assist the chilling process 

by lowering the product temperature. 

FSIS received comments on the 

proposed revision to its poultry chilling 

requirements as well as on the proposed 

definition of air chilling. 

Comment: One comment supported 

the Agency’s decision to permit 

establishments to develop and validate 

their own chilling processes while still 

retaining the current chilling processes 

as a validated safe harbor. The comment 

said that this approach was consistent 

with the Agency’s policies favoring a 

scientifically based approach to food 

safety. The comment suggested that 

FSIS provide guidance on how 

establishments should validate new 

chilling processes to facilitate 

compliance and encourage innovative 

chilling processes. The comment also 

said that the Agency should also 

reiterate the safe harbor provisions in 

the final rule. 

Response: As discussed in the 

proposed rule, establishments will be 

required to incorporate their procedures 

for chilling into their HACCP systems. 

Thus, establishments will need to 

validate their chilling procedures as 

prescribed in the HACCP validation 

regulations (9 CFR 417.4(a)). Under 

these regulations, establishments are 

required to: (1) Document the scientific 

or technical support for the judgments 

made in their chilling process and (2) 

repeatedly test the adequacy of their 

chilling process controls to demonstrate 

that their chilling process will perform 

as expected. As stated in the preamble 

to the proposed rule, FSIS will consider 

the existing time and temperature 

chilling regulations as safe harbors and 

will incorporate these requirements into 

compliance guidance on meeting the 

new chilling requirements. 

Comment: Two labor unions 

commented that it is unsound for the 

Agency to eliminate time and 

temperature chilling requirements and 

replace them with a performance-based 

approach that permits establishments to 

develop their own validated chilling 

procedures. One of the labor unions said 

that because the proposed rule will 

allow poultry slaughter establishments 

to select any chilling technique they 

please, small and medium 

establishments may eviscerate 175 bpm 

now and worry about adequate chilling 

later. According to the comment, the 

proposal to eliminate the time and 

temperature requirements is an attempt 

by the Agency to accommodate those 

small and medium-sized slaughter 

establishments that cannot safely 

increase production to 175 bpm under 

the NPIS but that have no choice but to 

adopt the new system. 

Response: The comments that suggest 

that the prescribed new chilling 

requirements will allow poultry 

slaughter establishments to increase line 

speeds before they have developed 

effective chilling procedures is 

incorrect. Under this final rule, 

establishments are required to develop, 

implement, and maintain validated 

chilling procedures that will effectively 

control the levels and prevent the 

multiplication of spoilage organisms 

and pathogenic bacteria before they may 

operate at any given line speed. In 

addition, the maximum line speed 

under the NPIS is 140 bpm and not 175 

bpm, as was proposed. 

FSIS also disagrees with the comment 

that the decision to amend the poultry 

chilling requirements is not a sound 

proposal. To the contrary, and as noted 

in the preamble to the proposal, FSIS 

has granted SIP waivers from the time 

and temperature regulations to six 

poultry slaughter establishments. The 

data collected from these establishments 

demonstrate that alternative chilling 

procedures can be as effective as the 

prescribed time and temperature 

requirements in controlling the levels 

and preventing the multiplication of 

spoilage organisms and pathogenic 

bacteria in the product after 

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evisceration. Under this rule, 

establishments will be required to 

incorporate procedures for chilling into 

their validated HACCP systems. These 

written procedures will include the 

conditions of use affecting carcass 

chilling and microbial multiplication 

identified by the establishment. 

Comment: A trade association 

recommended that FSIS clarify the 

definition of air chilled poultry to 

accommodate reasonable applications of 

antimicrobials using small amounts of 

water. The comment said that these 

applications are not designed to affect 

cooling or moisture pick-up, but that a 

strict technical reading of the proposed 

rule might be interpreted to prohibit 

their use. The comment suggested that 

the Agency revise the air chilling 

definition to permit antimicrobial 

applications applied with water if the 

water is used for a short duration and 

does not materially contribute to the 

chilling process or result in a material 

amount of water pick-up. According to 

the comment, this change would align 

the proposal with industry practice 

currently permitted by the Agency. 

A company that has created a 

combination air chilling system that 

begins with antimicrobial dips of birds 

at the end of the slaughter process 

requested that the Agency revise the 

proposed definitions of air chilling to 

make clear that poultry chilled using 

this process qualify as ‘‘air chilled.’’ 

The comment explained that under its 

chilling system, poultry carcasses are 

subject to an antimicrobial dip that lasts 

for 20–90 seconds at the end of the 

slaughter process and then are air 

chilled without any water or sprays. 

According to the company, the 

combination system results in no 

moisture pick-up when the entire 

process is viewed from start to finish, 

but there is an unavoidable reduction of 

product temperature because of the 

antimicrobial dip tanks prior to the start 

of air chilling. The company requested 

that FSIS permit the use of an ‘‘air 

chilled’’ claim for a process that begins 

with antimicrobial dips of limited 

duration immediately prior to air 

chilling, regardless of a reduction in 

product temperature because of the 

antimicrobial treatment, provided there 

is no pick-up of moisture for the entire 

process. 

According to the company, 

antimicrobials are generally more 

effective if applied when the carcasses 

are warm, i.e., directly after evisceration 

and before chilling, and its combination 

system has been shown to reduce 

Salmonella and Campylobacter. The 

company argued that allowing products 

chilled with this combination system to 

bear an ‘‘air chilled’’ label will provide 

marketing benefits and encourage 

establishments to adopt this food safety 

innovation. 

The company also stated that its 

combination system has been 

recognized as an air chill system by the 

European Union. According to the 

comment, if FSIS were to adopt the 

proposed ‘‘air chilled’’ definition, 

poultry chilled using the combination 

system would be allowed to be labeled 

as ‘‘air chilled’’ in the European Union 

but not in the United States because the 

system reduces the product 

temperature. The company stated the 

FSIS should allow establishments to 

choose when chilling begins, so that 

establishments could treat the 

antimicrobial dip tanks in a 

combination system as an intervention 

in the slaughter process, so that the 

chilling would begin after the 

intervention. 

Alternatively, the company requested 

that FSIS revise proposed 9 CFR 

381.66(e) to read ‘‘Air chilling. Air 

chilling is the method of chilling raw 

poultry carcasses and parts exclusively 

with air. No water, including mists or 

sprays, may be used to help chill the 

product. However, an antimicrobial 

intervention with water may be used 

provided its use does not result in any 

pick-up of water or moisture and the 

majority of the chilling time consists of 

chilling exclusively with air.’’ 

Response: After carefully considering 

these comments, FSIS believes they 

have merit. Therefore, FSIS is revising 

the proposed definition of air chilling to 

read as follows: 

‘‘Air chilling is the method of chilling 

raw poultry carcasses and parts 

predominantly with air. An 

antimicrobial intervention may be 

applied with water at the beginning of 

the chilling process if its use does not 

result in any net pick-up of water or 

moisture during the chilling process. 

The initial antimicrobial intervention 

may result in some temperature 

reduction of the product only if the 

majority of temperature removal is 

accomplished exclusively by chilled 

air.’’ 

FSIS believes the revised definition 

will allow change and innovation by 

industry, while still meeting the 

essential criteria for approval of the 

‘‘air-chilled’’ labeling claim, i.e., that the 

majority of chilling is accomplished 

with air and the process does not result 

in any pick-up of water or moisture. By 

allowing an antimicrobial intervention 

to reduce to a non-material extent the 

product temperature, FSIS will provide 

more opportunities for industry to apply 

antimicrobial interventions without 

delaying the start of the chilling process. 

This may well provide industry with 

more options to develop and apply 

innovative antimicrobial interventions 

to improve the microbiological 

characteristics of poultry products by 

reducing the numbers of foodborne 

pathogens and spoilage organisms. By 

applying antimicrobial interventions at 

a temperature that results in partial 

chilling of the poultry products, 

industry may be able to make those 

interventions more effective, while also 

decreasing the overall time to chill the 

product. 

FSIS has determined that this change 

in the definition of ‘‘air chilling’’ will 

not result in mislabeling or the 

misleading of consumers because it 

preserves the two essential 

characteristics that FSIS considers when 

reviewing ‘‘air chilled’’ labeling claims: 

(1) That the product does not gain 

moisture from the chilling process and 

(2) that the majority of the temperature 

reduction is done by chilled air. 

I. Online Reprocessing 

In the January 2012 proposed rule, 

FSIS proposed to permit poultry 

slaughter establishments to use 

approved online reprocessing 

antimicrobial systems and offline 

reprocessing antimicrobial agents 

including chlorinated water containing 

20 ppm to 50 ppm available chlorine or 

other antimicrobial agents that have 

been approved as safe and suitable for 

reprocessing poultry (77 FR 4432). The 

Agency proposed to require that 

establishments address the use of online 

or offline reprocessing in their HACCP 

plans, or sanitation SOPs, or other 

prerequisite programs. FSIS received a 

few comments on these proposed new 

requirements. 

Comment: Two trade associations 

expressed support for amending the 

regulations to permit the use of safe and 

suitable substances for both online and 

offline reprocessing, thereby eliminating 

the need for individualized waivers for 

the use of these technologies. 

One trade association recommended 

that the Agency eliminate the 

distinction between online and offline 

reprocessing and instead require that 

establishments justify the appropriate 

use of safe and suitable antimicrobials 

in their HACCP plans. According to the 

comment, establishments already must 

validate their processes, including the 

antimicrobials used in reprocessing. The 

comment asserted that a formalistic 

FSIS distinction serves no meaningful 

purpose and may confuse issues and 

deter innovation. The comment said 

that limiting uses of certain 

antimicrobials to online or offline 

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reprocessing overlooks the fact that all 

poultry must meet the same standards. 

The comment said that relying on 

individual establishment validations 

would reflect a more scientifically 

sound approach. The comment said if 

FSIS has concerns about the 

appropriateness of particular 

antimicrobials for certain applications, 

the Agency can limit the conditions of 

use for the antimicrobial when listing 

the antimicrobial as safe and suitable for 

use in poultry products. 

Response: FSIS is maintaining the 

distinction between online and offline 

reprocessing in this final rule because 

there are differences between the two 

processes that require separate 

regulatory requirements. 

Establishments that use offline 

reprocessing remove the carcasses 

accidentally contaminated with 

digestive tract contents from the main 

slaughter line and reprocess them at a 

designated offline station in any manner 

that will remove the contamination, 

such as vacuuming, washing, and 

trimming, singly or in combination. 

Establishments that reprocess carcasses 

online are permitted to leave the 

contaminated carcasses on the main 

slaughter line. The carcasses then 

proceed to an online reprocessing 

station where the contamination is 

removed by an approved antimicrobial 

agent that is applied to all carcasses on 

the line. The provisions in this final rule 

that permit poultry slaughter 

establishment to use approved online 

reprocessing antimicrobial systems and 

offline reprocessing antimicrobial agents 

do not affect the separate procedures 

used for offline or online reprocessing. 

Thus, this final rule maintains the 

distinction between the two processes. 

Comment: A member of academia 

commented that issues related to online 

reprocessing are complex and suggested 

that instead of addressing online 

reprocessing provisions in this 

rulemaking, FSIS should provide for 

online reprocessing in a separate 

rulemaking. According to the comment, 

two problems arise from online 

reprocessing. The comment said that 

first, carcasses will be allowed to remain 

on the line despite visible fecal 

contamination, and second, that the use 

of online reprocessing antimicrobial 

agents requires that all carcasses be 

treated with unspecified antimicrobial 

agents whether contaminated or not. 

The comment asserted that the data on 

online reprocessing that FSIS described 

in the preamble to the proposed rule do 

not provide sufficient information to 

determine whether the process can meet 

sanitary standards. The comment said 

that, before FSIS finalizes the rule, it 

needs to ensure that establishments 

conduct more pilot testing under the 

supervision of disinterested parties. 

Response: FSIS disagrees with the 

commenter. With respect to the 

comment that all carcasses will be 

treated with ‘‘unspecified antimicrobial 

agents,’’ as noted in the preamble to the 

proposed rule, before a new substance 

can be used as an online reprocessing 

agent, the Food and Drug 

Administration (FDA) will determine 

the safety of the substance for use in 

online reprocessing and FSIS will 

determine its suitability (77 FR 4433). 

Establishments opting to use online 

reprocessing will be permitted to use 

online reprocessing systems and 

antimicrobial agents that have been 

approved by FSIS under the specific 

conditions of use for which they have 

been approved. FSIS will list all 

antimicrobial agents that have been 

approved for use in online reprocessing, 

together with the specific parameters of 

use under which the antimicrobial 

agents have been approved, in FSIS 

Directive 7120.1: ‘‘Safe and Suitable 

Ingredients Used in the Production of 

Meat, Poultry, and Egg Products.’’ 

FSIS also disagrees with the comment 

that the data on online reprocessing do 

not provide sufficient information to 

determine whether the process can meet 

sanitary standards. As discussed in the 

preamble to the proposed rule, when 

FSIS published the proposed rule, 144 

poultry slaughter establishments were 

operating under waivers that allowed 

them to use online systems to reprocess 

carcasses accidentally contaminated 

with digestive tract contents (77 FR 

4432). The data generated from the inplant trials conducted under these 

waivers show that various online 

antimicrobial treatments have differing 

but equally effective results with respect 

to pathogen reduction. Thus, FSIS 

disagrees that it needs to ensure that 

establishments conduct more pilot 

testing on online reprocessing before the 

Agency finalizes the proposed rule. 

There are extensive data available to 

show that the use online reprocessing 

systems is an effective method for 

removing digestive tract contents from 

accidentally contaminated carcasses and 

that the process meets sanitary 

standards. 

J. Animal Welfare Considerations 

FSIS received thousands of comments 

from private citizens and comment 

letters from animal welfare advocacy 

organizations that expressed concerns 

about the potential impact that the NPIS 

may have on the welfare of the live 

birds at slaughter. These comments 

raised several issues related to the 

handling of live birds under the NPIS. 

1. Welfare of Live Birds 

Comment: Several animal welfare 

organizations stated that FSIS did not 

adequately consider the impact that the 

NPIS will have on animal welfare. The 

comments expressed concern that the 

NPIS would negatively impact the 

welfare of birds. Numerous individuals 

and several animal welfare 

organizations expressed their view that 

the NPIS is inconsistent with FSIS’s 

policy that ‘‘considers humane methods 

of handling animals and humane 

slaughter operations a high priority,’’ 

and it would undermine the Agency’s 

food safety and humane slaughter 

policies. 

Response: FSIS regulations require 

that establishments slaughter poultry in 

accordance with good commercial 

practices in a manner that results in 

thorough bleeding of the poultry 

carcasses and that ensures that 

breathing has stopped before scalding so 

that the birds do not drown (9 CFR 

381.65(b)). In September 2005, the 

Agency published a Federal Register 

notice to explain that poultry products 

are more likely to be adulterated if, 

among other circumstances, they are 

produced from birds that have not been 

treated humanely because such birds are 

more likely to be bruised or to die other 

than by slaughter (70 FR 56624). The 

PPIA (21 U.S.C. 453(g)(5)), as well as the 

regulations (9 CFR 381.90), provide that 

carcasses of poultry showing evidence 

of having died from causes other than 

slaughter are considered adulterated 

and condemned. The Agency did not 

propose changes to these regulations 

and this final rule maintains these 

requirements without change. 

Establishments operating under the 

NPIS will absolutely be required to 

comply with these requirements. FSIS 

does not have a basis to believe the 

NPIS will negatively impact bird 

welfare and does not expect the new 

system to do so. Nonetheless, FSIS does 

consider humane handling and good 

commercial practices to be a high 

priority and will continue to be diligent 

in enforcing these requirements. 

2. Line Speed and Animal Welfare 

Comment: Approximately 1,000 

individuals and several animal welfare 

organizations said that the proposed 

increase in maximum slaughter line 

speeds under the proposed rule would 

adversely impact humane handling of 

poultry. Many examples were suggested 

by individuals and animal welfare 

organizations of ways in which these 

adverse impacts could potentially occur. 

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49610 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

These encompass concerns about 

potential workers frustrations over faster 

line speed and taking these frustrations 

out on the birds, potential increased 

injuries that may occur from shackling 

birds at faster line speeds, potential 

injuries from birds vigorously flapping 

their wings while in shackles, and the 

potential for ineffective stunning and 

throat cutting at faster line speeds. 

Response: As discussed above, under 

this final rule, the maximum line speed 

permitted under the NPIS will be 140 

bpm for young chickens rather than 175 

bpm, as was proposed. Thus, the 

maximum line speed for the NPIS will 

be no faster than the maximum line 

speed permitted under the existing 

inspection systems under SIS. 

As the Agency explained in the 

previous response, under the NPIS, 

establishments are now and will 

continue to be required to slaughter 

poultry in accordance with good 

commercial practices, in a manner that 

results in thorough bleeding of the 

poultry carcasses and ensures that 

breathing has stopped before scalding (9 

CFR 381.65(b)). FSIS also considers 

poultry carcasses showing evidence of 

having died from causes other than 

slaughter to be adulterated and as such 

must be condemned (21 U.S.C. 453(g)(5) 

and 9 CFR 381.90). For example, poultry 

that are still breathing on entering the 

scalder die from drowning not from 

slaughter and are, therefore, considered 

adulterated and unfit for human food. 

Establishments operating under the 

NPIS will be subject to these 

requirements regardless of an 

establishment’s specific line speed. If an 

establishment fails to meet these 

requirements, it will have to adjust its 

operations to ensure that is does meet 

these requirements. For example, some 

establishments may reduce line speeds, 

others may station additional employees 

in the receiving-to-pre-scald areas to 

ensure compliance. 

Further, FSIS believes that employing 

humane methods of handling and 

slaughtering that are consistent with 

good commercial practices increases the 

likelihood of producing unadulterated 

product. In addition, if an establishment 

chooses the NPIS, FSIS inspection 

resources will be allocated to more 

offline food safety-related inspection 

activities, including verification tasks to 

systematically observe the conditions in 

the receiving to pre-scald area. When 

verifying good commercial practices in 

this area, offline inspection personnel 

observe whether establishment 

employees are mistreating birds or 

handling them in a way that will cause 

death, injury, prevent thorough 

bleeding, or result in excessive bruising. 

Offline inspection personnel also verify 

that the birds are stunned before being 

bled and determine whether there is 

other evidence that birds died other 

than by slaughter. If offline inspection 

personnel observe that the 

establishment is not following good 

commercial practices, they will take 

appropriate enforcement action and 

require corrective and remedial 

measures. 

3. Animal Welfare and the Reduction in 

Number of Online FSIS Inspectors 

Comment: Many individuals, several 

animal welfare organizations, and a 

consumer advocacy organization 

commented that a reduction in the 

number of online FSIS inspectors will 

harm animal welfare because FSIS 

inspectors will have less of an 

opportunity to observe and address 

inhumane handling. The comments 

expressed concern that current duties 

regarding handling and treatment of 

birds will not be adequately performed 

under the NPIS because there will be 

fewer FSIS inspectors. One consumer 

advocacy organization asserted that 

industry may also have less incentive to 

prevent injury to animals because of the 

Agency’s new approach to OCP defects. 

Response: Under this final rule, the 

NPIS will become one of the poultry 

inspection systems. FSIS disagrees that 

decreasing the number of online FSIS 

inspectors under the NPIS will harm 

animal welfare or impair its ability to 

carry out its human handling work 

effectively. As with HIMP, VIs under the 

NPIS will conduct food safety related 

inspection activities, including 

verification tasks to systematically 

observe the conditions in the receiving 

to pre-scald area, and will continuously 

monitor and evaluate establishment 

process control. For example, FSIS 

offline VIs will be verifying that 

establishments are following good 

commercial practices and will be 

checking for mistreatment or improper 

handling of birds. If inspection 

personnel observe that the 

establishment is not following good 

commercial practices, they will take 

appropriate enforcement action. If an 

establishment’s line speed is seen as a 

cause of failure to follow good 

commercial practices, or if food safety 

related or non-food safety related 

conditions impair the online CI’s ability 

to conduct the inspection of each 

carcass, the IIC will take appropriate 

remedial action and will be authorized 

to require that the establishment slow 

the line speed. 

K. Environmental Impact 

In the preamble to the proposed rule, 

FSIS explained that each USDA agency 

is required to comply with 7 CFR part 

1b of the USDA regulations, which 

supplement the National Environmental 

Policy Act (NEPA) regulations (77 FR 

4451). Under 7 CFR part 1b, actions of 

certain USDA agencies and agency units 

are categorically excluded from the 

preparation of an Environmental 

Assessment (EA) or Environmental 

Impact Statement (EIS) unless the 

agency head determines that an action 

may have a significant environmental 

effect. FSIS is among the agencies 

categorically excluded from the 

preparation of an EA or EIS. In the 

preamble to the proposed rule, FSIS 

explained that the Agency determined 

that the proposed rule was subject to the 

categorical exclusion from the 

preparation of an EA or EIS because the 

proposed rule will not have individual 

or cumulative effects on the human 

environment. FSIS received a few 

comments on the categorical exclusion. 

Comment: Comments from an animal 

welfare advocacy organization and a 

consumer advocacy organization 

asserted that FSIS did not adequately 

analyze the environmental impacts of 

the proposed rule and therefore, did not 

meet the burden to show that the 

proposed rule is appropriately subject to 

the NEPA categorical exclusion. 

According to the comments, the 

proposed increase in line speeds that 

would have been permitted under the 

NPIS would allow establishments to 

slaughter more birds, thereby increasing 

demand on water supplies, truck traffic 

and carbon emissions from the 

transportation for each facility, and 

consumption of electricity to run each 

facility. The comments also asserted 

that an increase in birds slaughtered 

will result in an increase in condemned 

and inedible carcasses and parts that 

will need to be disposed of. 

Response: As discussed above, under 

this final rule the maximum line speed 

permitted under the NPIS will be 140 

bpm for young chickens rather than 175 

bpm, as was proposed. Thus, the 

maximum line speed for the NPIS will 

be no faster than the maximum line 

speed permitted under the existing 

inspection systems under SIS. While the 

NPIS may give establishments the 

flexibility to slaughter and process birds 

more efficiently, consumer demand for 

poultry products will determine the 

number of birds slaughtered rather than 

line speeds. Thus, this final rule will 

not have a significant individual or 

cumulative effect on the human 

environment. 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49611 

Comment: Some comments said that 

the provision in the proposed rule that 

permits establishments to use online 

and offline antimicrobial systems to 

reprocess contaminated carcasses will 

increase the discharge of antimicrobial 

chemicals into the water supply. The 

comments stated that one such 

substance, trisodium phosphate (TSP), 

can cause high levels of phosphorus in 

water and cause algae blooms. The 

comment noted that in the proposed 

rule, FSIS stated that only 5 to 7 of the 

144 facilities with online reprocessing 

systems use TSP, and that the water is 

recycled and does not enter public 

water supplies. The comment said that 

the proposed rule did not account for 

whether there will be a foreseeable 

increase in facilities using online 

reprocessing systems that use TSP as a 

result of the proposed rule and what 

they will do with their TSP-laden water. 

A comment from a member of 

academia agreed with FSIS’s conclusion 

that the proposed rule was 

appropriately subject to a categorical 

exclusion from the preparation of an EA 

or EIS. The comment noted that 

although TSP may affect the aquatic 

environment, establishments that use 

this substance for online reprocessing 

are required to meet all local, State, and 

Federal environmental requirements. 

The comment said that water from 

slaughter facilities is treated 

appropriately and should continue to be 

treated appropriate within waste water 

treatment facilities. 

Response: FSIS considered the 

potential environmental effects of the 

provision in this rule that will permit 

poultry slaughter establishments to use 

approved online reprocessing 

antimicrobial systems. As noted by the 

comment, TSP is used in a few online 

reprocessing antimicrobial systems. 

However, regardless of the substances 

that an establishment uses in its online 

reprocessing system, it is required to 

meet all local, State, and Federal 

environmental requirements. The waste 

water from all poultry establishments is 

handled routinely by existing water 

treatment systems or recycled as byproduct without entering the 

establishment’s water system, municipal 

water system, or ground water. 

L. Economic Impact 

1. General 

Comment: One consumer advocacy 

organization stated that under the NPIS, 

FSIS would have authorized 

establishments operating under the 

NPIS to increase their maximum line 

speeds to allow establishments to 

operate more efficiently. The comment 

stated that this would allow large 

corporations that own multiple 

establishments to close some and still 

produce the same volume of product. 

The comment said that establishment 

closures will result in worker layoffs 

and community disruption, especially 

in locations where the establishment is 

the largest employer. 

Response: As discussed above, under 

this final rule the maximum line speed 

permitted under the NPIS will be 140 

bpm for young chickens rather than 175 

bpm, as was proposed. Thus, the 

maximum line speed for the NPIS will 

be no faster than the maximum line 

speed permitted under the existing 

inspection systems under SIS. 

Regardless of line speed, 

establishments may choose to 

implement the NPIS by adjusting shifts, 

reducing overtime, increasing output, 

reducing the number of lines, or 

consolidating establishments. 

Comment: One trade association 

stated that the NPIS will create new 

jobs. According to the comment, even in 

the current economy, members of the 

trade association that participate in the 

HIMP pilot have hired additional inplant personnel. The comment said that 

slaughter and processing establishments 

are only able to increase line speeds as 

staff levels permit, otherwise quality 

control could be adversely affected. The 

comment said that some establishments 

that have joined the HIMP pilot have 

expanded their facilities, hired new 

workers, and purchased additional 

equipment and technology, further 

fueling rural economies. 

Response: While it is difficult to 

predict, FSIS agrees that establishments 

adopting the NPIS will likely initially 

expand their labor resources by 

employing about 0.8 staff-years of 

online sorters and carcass-inspection 

helpers that substitute for every 1.0 

staff-year of FSIS online inspection 

program personnel (refer to number 1 

under Summary of Estimated Costs and 

Cost Savings of the Rule). 

Comment: A consumer advocacy 

organization questioned the incentive 

structures that would be in place with 

the NPIS. The comment questioned 

whether the NPIS would result in 

pathogen reduction and would lead to a 

reduction in health benefits. The 

comment questioned how the NPIS 

would limit the number of recalls. 

Response: It is within the 

establishment’s economic interest to 

take whatever actions are necessary to 

produce products that are safe, 

wholesome, and free from excessive 

trim and dressing defects. FSIS is 

responsible for ensuring that the 

establishment’s process control 

procedures for preventing 

contamination by enteric pathogens and 

fecal material and for controlling OCP 

defects are effective. The NPIS gives 

establishments the flexibility to more 

efficiently utilize their resources to 

design systems that ensure their process 

control. As a result, the NPIS is 

expected to improve food safety and the 

effectiveness of inspection systems. 

FSIS estimates that this rule could 

reduce the number of human illnesses 

attributed to young chicken and turkey 

products by an average of about 3,980 

Salmonella illnesses and about 840 

Campylobacter illnesses. 

The records that all establishments 

that slaughter poultry other than ratites 

would be required to keep under this 

rule, including the records of the 

establishment’s testing results, will 

provide establishments and FSIS with 

ongoing information on the 

effectiveness of the establishment’s 

process controls. This will allow FSIS 

and establishments to identify situations 

associated with an increase in microbial 

levels so that they can take the 

necessary corrective actions to prevent 

further potential contamination. The 

documentation that would result from 

this rule could also limit the scope of a 

product recall if the establishment 

maintains records sufficient to allow it 

to identify the point when a lack of 

process control could have resulted in 

product contamination. 

2. Environmental Justice 

Comment: Several comments from 

human and worker rights advocacy 

organizations and a public health 

professional trade association said that 

the Preliminary Regulatory Impact 

Analysis (PRIA) for the proposed rule 

failed to consider costs to workers’ 

health and safety. The comments noted 

that FSIS estimated that the benefits of 

the proposed rule would amount to at 

least $258.9 million, but that the Agency 

did not present any data or estimates of 

the cost of injury, illness and disability 

of the proposed increased in maximum 

line speed that would have been 

permitted on the affected poultry plant 

workers. One comment stated that PRIA 

must also consider costs associated with 

increased worker’s compensation, 

increased social service costs for State 

and local government, and reduced tax 

and Social Security payments. 

Response: Under this final rule the 

maximum line speed permitted under 

the NPIS will be 140 bpm for young 

chickens rather than 175 bpm, as was 

proposed. Thus, the maximum line 

speed for the NPIS will be no faster than 

the maximum line speed permitted 

under the existing inspection systems 

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49612 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

19See Martinez, Steve et al., Local Food Systems: 

Concepts, Impacts, and Issues, ERR 97, U.S. 

Department of Agriculture, Economic Research 

Service, May 2010 for a discussion of consumers’ 

willingness to pay a price premium (p. 29) for such 

characteristics as traceability (p. 26, p. 70) offered 

by local producers. 

under SIS. The FRIA for this final rule 

has been updated to reflect this change 

from the proposal. 

The effect of line speed on 

establishment employee safety is an 

important issue. As discussed above, the 

2005 GAO Report, which linked 

production line speed to occupational 

injury and illness rates in the slaughter 

industry, called for independent 

research to better understand this 

relationship. As discussed earlier in this 

document, to obtain at least preliminary 

data on the matter, FSIS has asked 

NIOSH to evaluate the effects of 

increased line speeds on worker safety 

by collecting data from establishments 

that had been granted waivers from line 

speed restrictions under the SIP. NIOSH 

has completed such a study in one nonHIMP establishment. FSIS considers the 

NIOSH study to be an important first 

step in better assessing the impact of 

line speeds on the health and safety of 

workers in poultry slaughter and 

processing establishments. 

3. Small Business Considerations 

Comment: Some consumer advocacy 

organizations stated that the NPIS will 

lead to further consolidation in the 

poultry industry and that large 

producers will benefit at the expense of 

smaller processors. The comments said 

that the proposed increase in line 

speeds that would have been authorized 

under the proposed rule would cause 

small processors that typically do not 

run at line speeds of up to 175 birds to 

go out of business because the market 

will be flooded with poultry products 

from the larger processors. One trade 

association and a member of academia 

believed that the proposed rule 

adequately addressed considerations for 

small and very small establishments. 

According to the comments, the option 

to remain under Traditional Inspection 

will benefit establishments that do not 

have the resources to absorb the costs 

associated with facility and personnel 

changes. One comment stated that 

because establishments will have an 

opportunity to opt-in or opt-out of the 

NPIS, smaller businesses that have 

‘‘niche’’ markets will not be adversely 

affected. The comments said that 

poultry sold in smaller markets has the 

appeal of being locally harvested and 

slaughtered under less commercial 

conditions. According to the comment, 

smaller establishments that have 

‘‘niche’’ markets for their poultry 

product may see an increase in 

consumer purchase as a result of larger 

slaughter facilities choosing the new 

system. 

Response: Under this final rule, 

establishments that do not choose to 

operate under the NPIS may continue to 

operate under their current inspection 

system, i.e., SIS, NELS, NTIS, or 

Traditional Inspection. FSIS expects 

little to no impact on small producers. 

Very small establishments that operate 

under Traditional Inspection generally 

slaughter birds that are sold in local, 

niche markets, where consumers have 

shown a willingness to pay more for a 

food product that is of local origin.19 An 

ability to charge a higher price based on 

product differentiation enables the very 

small establishments to continue to 

compete in the market. The same 

pricing power based on product 

differentiation holds for establishments 

that slaughter birds other than young 

chickens and turkeys. Moreover, FSIS 

has revised the rule to reduce the 

sampling requirements for very low 

volume and very small establishments, 

which further reduces their cost to 

operate under the Traditional Inspection 

System, as modified by this final rule. 

4. Implementation Costs 

Comment: One trade association 

stated that the proposed rule did not 

address the significant costs of 

implementation, such as developing 

training materials and training 

employees, developing new 

recordkeeping based on the new system, 

and retraining or hiring new personnel 

to manage those recordkeeping systems. 

This trade association also noted that 

implementation of the NPIS will require 

significant capital investments. This 

trade association argued that the 

potential costs of implementation are 

exacerbated because it is unclear how 

the Agency plans to implement the 

NPIS and establishments cannot yet 

begin to make financial plans. 

Response: FSIS carefully considered 

the costs associated with the final rule 

and included establishment costs 

associated with implementing the NPIS 

and complying with the mandatory 

recordkeeping and testing requirements 

of the rule in its FRIA. Annualized costs 

associated with the hiring of additional 

labor of sorters, both one-time and 

ongoing training as well as capital 

expenditures for the NPIS total $16.0 

million (Table 7a). Annualized costs 

and cost savings associated with both 

additional microbial testing, the 

elimination of E. coli testing, 

recordkeeping and updating HACCP 

plans total $9.1 million (Table 7b). 

Comment: One trade association 

questioned the Agency’s estimated 

industry savings in the PRIA. This trade 

association believed that some of the 

assumptions that the estimate are based 

on are unrealistic, such as, how many 

establishments will choose to or are 

capable of operating at higher line 

speeds. Additionally, this trade 

association stated that FSIS failed to 

take into account overall consumer 

demand when estimating industry-wide 

output. However, this trade association 

asserted that the benefits to food safety 

and the overall efficiencies to be gained 

are worth the cost and investment. 

Response: Under this final rule the 

maximum line speed permitted under 

the NPIS will be 140 bpm for young 

chickens rather than 175 bpm, as was 

proposed. Thus, the maximum line 

speed for the NPIS will be no faster than 

the maximum line speed permitted 

under the existing inspection systems 

under SIS. The FRIA for this final rule 

has been updated to reflect this change 

from the proposal. In the proposed rule, 

FSIS took into account overall consumer 

demand by using demand elasticity to 

predict the increase in young chicken 

and turkey products produced as a 

result of an increase in line speed. 

However, because the maximum line 

speed under the NPIS will now be no 

faster than the maximum line speed 

authorized under the existing inspection 

systems, the impact of consumer 

demand on consumer and producer 

benefits has been removed. 

IV. Executive Orders 12866 and 13563 

Executive Orders 12866 and 13563 

direct agencies to assess costs and 

benefits of available regulatory 

alternatives and, if regulation is 

necessary, to select regulatory 

approaches that maximize net benefits 

(including potential economic, 

environmental, public health and safety 

effects, distributive impacts, and 

equity). Executive Order 13563 

emphasizes the importance of 

quantifying both costs and benefits, of 

reducing costs, of harmonizing rules, 

and of promoting flexibility. This final 

rule has been designated a ‘‘significant’’ 

regulatory action, under section 3(f) of 

Executive Order 12866. Accordingly, 

the rule has been reviewed by the Office 

of Management and Budget, under 

Executive Order 12866. 

Introduction 

FSIS updated the PRIA to take into 

account recently published data and to 

reflect changes in the final rule in 

response to public comments. The 

changes to the costs and benefits 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49613 

sections incorporate the following 

factors: 

• Maximum line speeds permitted 

under the NPIS will be 140 bpm for 

young chickens. 

• Very small HACCP size 

establishments are required to only test 

at one location instead of two and the 

sampling frequency for very low volume 

establishments remains unchanged from 

the existing regulation. 

• Additional Labor Cost Due to 

Attestation of Work-Related Conditions 

is added to total cost. 

• Changes to the rule’s 

implementation plan, which are 

reflected in the Expected FSIS 

budgetary effects, establishment costs, 

and public health benefits. 

• Changes to the costs of illness 

estimate, including changes to the 

average cost per illness and to the 

averted number of illnesses estimated in 

FSIS’s risk assessment as a result of the 

latest peer review. 

• Establishments are also now 

required to have a height-adjustable CI 

stand (the proposed rule did not have 

the height-adjustable requirement). FSIS 

has not included the price difference 

between height-adjustable and non 

height-adjustable inspection stands in 

the Final Regulatory Impact Analysis 

(FRIA) since the difference in cost is 

expected to be minimal. 

Need for the Rule 

The current systems of poultry 

inspection are rooted in principles of 

command and control regulation, where 

broad, rigid standards are applied across 

finished products and establishments. 

As food processing and food safety 

technology becomes more diverse, FSIS 

has worked to reform its regulations 

with a focus on HACCP-based process 

control, enabling establishments to have 

more flexibility in tailoring their food 

safety plans to their products and 

processes. The new system of poultry 

slaughter will help to further this effort. 

Based on our experience with the HIMP 

program, FSIS expects the new 

inspection system to improve food 

safety and the effectiveness of 

inspection systems, remove unnecessary 

regulatory obstacles to innovation, and 

make better use of the Agency’s 

resources. 

Furthermore, FSIS has determined 

that contamination of poultry carcasses 

and parts by fecal material and enteric 

pathogens (e.g., Salmonella spp. and 

Campylobacter spp.) are hazards 

reasonably likely to occur in poultry 

slaughter establishments unless 

addressed in a sanitation SOP or other 

prerequisite program. 

Summary of the Rule’s Provisions 

A. Elements of the new system for the 

slaughter of young chickens and 

turkeys: 

(1) Requirements by establishment 

personnel to conduct carcass sorting 

activities before FSIS inspection 

program personnel (IPP) conduct online 

carcass inspection so that only carcasses 

that the establishment deems likely to 

pass inspection are presented to the 

FSIS carcass IPP. FSIS expects this 

action to impact 194 establishments (70 

small establishments plus 149 large 

establishments minus 25 HIMP 

establishments); 

(2) A limit of one FSIS online carcass 

inspector per evisceration line. FSIS 

expects this action to impact 194 

establishments; 

(3) Removal of the existing Finished 

Product Standards (FPS) and 

subsequent replacement with a 

requirement to maintain records that 

document that the finished products 

meet the definition of ready-to-cook 

poultry. Establishments will have the 

flexibility to design and implement 

measures for producing ready-to-cook 

poultry that are best suited to their 

operations. In addition to inspecting for 

food safety defects, the FSIS online 

carcass inspector will also conduct a 

carcass inspection for defects that are 

less important to food safety. The 

presence of persistent, unattended 

defects would indicate that the plant is 

not producing ready-to-cook poultry. 

FSIS expects this action to may impact 

up to 219 establishments; 

(4) Requirement that facilities in the 

establishment include: 

(a) An online carcass inspection 

station for each evisceration line; (b) one 

or more offline carcass inspection 

stations for each evisceration line; (c) an 

online area for the online inspection of 

carcasses for avian leukosis; and (d) an 

underline trough for each evisceration 

line in order to prevent the 

contamination of online carcasses by 

removed poultry waste or inedible 

products of the evisceration process. 

FSIS expects that this action would 

affect, at a maximum, about 219 

establishments that may choose to adopt 

this new inspection system out of 270 

official federally inspected 

establishments that slaughter young 

chickens and turkeys (refer to Table 4 

for further explanation of the number of 

establishments affected). This 219 total 

includes HIMP establishments, though 

they will have already installed this 

equipment, meaning that 194 

establishments are affected; and 

(5) a requirement that each 

establishment that participates in the 

New Poultry Inspection System (NPIS) 

shall submit on an annual basis an 

attestation to the management member 

of the local FSIS circuit safety 

committee stating that it maintains a 

program to monitor and document any 

work-related conditions of 

establishment workers, and that the 

program includes the elements listed in 

the preamble. 

B. Elements that would affect all 289 

poultry, non-ratite slaughter 

establishments: 

(1) Development, implementation, 

and maintenance of written procedures 

to prevent contamination of carcasses 

and parts by fecal material and enteric 

pathogens (e.g., Salmonella and 

Campylobacter) as part of an 

establishment’s HACCP plans, 

sanitation SOPs, or other prerequisite 

programs. FSIS is requiring that, at a 

minimum, these written procedures 

include sampling and analysis for 

microbial organisms at the pre-chill and 

post-chill points in the process to verify 

process control (except for very small 

HACCP size establishments and very 

low volume establishments, which are 

required to sample only at post-chill); 

(2) Development, implementation, 

and maintenance of written procedures 

to ensure that carcasses and parts with 

visible fecal contamination do not enter 

the chiller as part of an establishment’s 

HACCP plans, sanitation SOPs, or other 

prerequisite programs; 

(3) Removal of the current 

requirement to test for generic E. coli 

and the codified Salmonella pathogen 

reduction performance standards for 

poultry; 

(4) Removal of the chilling 

requirements for ready-to-cook (RTC) 

poultry, which now provide specific 

time and temperature parameters; and 

(5) Requirements regarding the use of 

approved online reprocessing 

antimicrobial systems or offline 

reprocessing approved antimicrobial 

agents, if these procedures for 

reprocessing are incorporated into their 

HACCP plans, sanitation SOPs, or other 

prerequisite programs. 

Baseline 

Table 2 compares the components or 

requirements of the actions of the final 

rule to the current regulatory regime for 

all federally inspected establishments 

that slaughtered all poultry other than 

ratites. From the FSIS Animal 

Disposition Reporting System (ADRS), 

we identified 289 establishments in 

2010 slaughtering poultry (excluding 

ratites). Actions include requirements 

for young chicken and turkey 

establishments and requirements for all 

poultry slaughter establishments 

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49614 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

excluding ratites. Table 2 includes 

information for SIS and NELS 

inspection systems and SIS Automated 

Evisceration Equipment Systems, 

referred to as MAESTRO, which is an 

acronym for ‘‘Meyn’s Automatic 

Evisceration System Total Removal of 

Organs’’, and Nu-Tech Nuova. These 

automated poultry evisceration systems 

were introduced in the late 1990s. For 

young chicken establishments, up to 

four FSIS inspectors are stationed on the 

same side of a processing line that runs 

at a maximum of 140 birds per minute 

(bpm) or 35 bpm per inspector—the 

same per-inspector line speed as under 

SIS. The evisceration equipment used in 

SIS or NELS must be supported by 

establishment employees who manually 

complete carcass and viscera 

presentation. In contrast, the automated 

evisceration systems do not require that 

support. 

TABLE 2—COMPARISON OF KEY COMPONENTS OF THE BASELINE REGULATORY ENVIRONMENT AND THE RULE

Key features or provisions of the rule 

Very small and small HACCP size 

establishments traditional 

Small and large non-traditional 

Baseline Rule 

Current 

inspection 

systems 

HIMP NPIS 

Number of Establishments .................. 70 ......................... .............................. 194 ....................... 25. 

Carcass Sorting Activities ................... FSIS ..................... FSIS ..................... FSIS ..................... Establishment ...... Establishment. 

Online Inspector per Line ................... 1–4 ....................... 1–4 ....................... 2–4 ....................... 1 ........................... 1. 

Online Inspector Limit ......................... No ........................ No ........................ No ........................ Yes ....................... Yes. 

Addition of Online Establishment 

Workers because of Relocation of 

Online IPP.

No ........................ No ........................ No ........................ Yes ....................... Yes. 

Line Speed Maximum Birds per 

minute for Young Chickens.

25–46 ................... 25–46 ................... 70–140 ................. 175 ....................... 140. 

Line Speed Maximum Birds per 

minute for Mature Chickens.

≤66 ....................... ≤66 ....................... N/A1 ..................... N/A ....................... SIP Waiver determined. 

Line Speed Maximum Birds per 

minute for Turkeys.

16–25 ................... 16–25 ................... 21–51 ................... 55 ......................... 55. 

Line Speed Maximum Birds per 

minute for Other Poultry.

≤66 ....................... ≤66 ....................... N/A ....................... N/A ....................... SIP Waiver determined. 

Records to document that products 

meet the definition of RTC poultry.

No ........................ No ........................ No ........................ No ........................ Yes. 

New Facilities Requirements .............. No ........................ No ........................ No ........................ Yes ....................... Yes. 

New carcass inspection station for 

each evisceration line.

No ........................ No ........................ No ........................ Yes ....................... Yes. 

New carcass inspection area online 

for avian leukosis for each evisceration line.

No ........................ No ........................ No ........................ No ........................ Yes. 

Underline Trough for each evisceration line.No ........................ No ........................ No ........................ Yes ....................... Yes. 

HACCP System—written to prevent 

Sep/Tox carcasses from entering 

chiller.

No ........................ No ........................ No ........................ No ........................ Yes. 

HACCP System—written to prevent 

contamination by enteric pathogens 

and fecal material & testing.

No ........................ Yes ....................... No ........................ No ........................ Yes. 

HACCP System—written to prevent 

carcasses contaminated with fecal 

material from entering the chill tank.

No ........................ Yes ....................... No ........................ No ........................ Yes. 

Replace Requirement to Test for Generic E. coli and Salmonella performance standards with 2-point 

testing.2

No ........................ Yes ....................... No ........................ No ........................ Yes. 

End Waivers for: Chilling Requirements for RTC Time and Temp 

Eliminated.

No ........................ Yes ....................... No ........................ No ........................ Yes. 

End Waivers for: Use Online Reprocessing (OLR) Antimicrobial Systems 

or Offline Antimicrobial Agents.

No ........................ Yes ....................... No ........................ No ........................ Yes. 

1 N/A—does not apply. 

2 Very small HACCP size establishments and very low volume establishments are required to test in one location. 

Under the final rule, any of the young 

chicken and turkey establishments 

(assumed to be limited to the 219 large 

and small non-Traditional 

establishments) that adopt the new 

inspection system (some while 

operating under updated SIP waivers), 

will have one online inspector per line. 

Currently, there are two to four online 

inspectors per line under the current 

non-traditional systems (SIS, NELS, and 

NTIS); however, there is one online 

inspector per line under HIMP. Even 

though FSIS, in the analysis that 

follows, only quantifies costs, rather 

than benefits, of switching to NPIS, FSIS 

predicts that some small and large nontraditional establishments alike will 

choose to adopt the NPIS because it will 

give them greater control over their 

production process and more flexibility 

to design, develop, and implement new 

technologies. Comments received from 

industry indicate that the benefits to 

food safety and the overall efficiencies 

to be gained by the NPIS would be 

worth the cost and investment to 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49615 

industry. These comments were 

submitted in response to the proposed 

rule that would have allowed a 

maximum line speed of 175 bpm under 

NPIS. Thus, the change in policy 

between the proposed and final rule 

may change the appropriate 

interpretation of some of these 

comments. However, one industry trade 

association commented that the 

proposed rule’s Preliminary Regulatory 

Impact Analysis contained unrealistic 

assumptions of how many 

establishments would have chosen to, or 

would have been capable of, operating 

at the faster line speeds that would have 

been permitted under the proposed 

NPIS. Nevertheless, regardless of line 

speed, this trade association believed 

that the benefits to food safety and the 

overall efficiencies to be gained by the 

NPIS would be worth the cost and 

investment to industry as noted 

throughout this document. 

Establishments will have the flexibility 

to design and implement measures for 

producing ready-to-cook poultry 

tailored to their operations. The NPIS 

would also give establishments the 

ability to investigate and develop new 

and more efficient technologies. 

The Agency’s experience under HIMP 

demonstrates that young chicken 

establishments have incentives to 

participate and remain in the HIMP 

pilot for reasons other than the ability 

to operate faster line speeds. Experience 

from the HIMP pilot shows that HIMP 

establishments operate with an average 

line speed of 131 bpm, and that 

although they are authorized to do so, 

most of the young chicken HIMP 

establishments do not operate line 

speeds at 175 bpm. Thus, the faster line 

speeds authorized under HIMP do not 

appear to be the primary incentive for 

establishments to participate in the pilot 

because the average line speed of 

establishments operating under the 

HIMP inspection is slower than the 140 

bpm maximum line speed authorized 

under the existing inspection systems. 

The Agency’s experience under HIMP 

also shows that once establishments are 

selected to participate in the HIMP 

pilot, they choose to remain under the 

HIMP inspection system. In 2002, after 

FSIS had selected 20 young chicken 

establishments to participate in the 

HIMP pilot, the Agency informed the 

industry that it would limit the pilot to 

20 establishments. At that time, over 40 

establishments were placed on a waiting 

list to participate in the HIMP pilot. 

Since then, two establishments left the 

pilot because they closed. These 

establishments were replaced by 

establishments on the waiting list, and 

more than 40 establishments remain on 

the list. Thus, the Agency’s experience 

under HIMP shows that young chicken 

establishments continue to be interested 

in participating in the HIMP pilot, and 

those that are selected for the pilot 

choose to remain under the HIMP 

inspection system even though many 

are not operating at the maximum line 

speeds authorized under HIMP. 

Table 3 shows the baseline 

characterization of the U.S. poultry 

market for birds other than ratites in 

2010. Domestic federally inspected 

establishments slaughtered and dressed 

about 8.8 billion birds other than ratites 

in 2010, including about 8.4 billion 

young chickens; about 140 million other 

chickens (e.g., fowl and capon); about 

252 million turkeys; and about 27 

million other poultry (e.g., ducks, geese, 

quail, pheasants, and squab). 

Establishments slaughtered about 8.64 

billion young chickens and turkeys. 

TABLE 3—BASELINE CHARACTERIZATION OF THE U.S. POULTRY MARKET

Young 

chickens Other chickens Turkey Other poultry 

Market price ($/bird) 1 ...................................................................................... $3.38 $1.34 $22.74 $9.02 

Market quantity 2 (thousand birds/year): 

Domestic production ................................................................................. 8,386,671.6 139,499.2 251,787. 8 26,781.1 

Exports ...................................................................................................... 1,314,710.8 14,675.8 18,428.9 903.4 

Imports ...................................................................................................... 9,314.1 0 229.8 243.2 

1 Market price is calculated by multiplying the wholesale price per pound by the average dressed weight. 

2 Market quantities in thousands of birds (dressed carcasses), or animal (dressed carcass) equivalence, other than ratites. Source: Muth, M.K., 

Beach, R.H., Viator, C.L., Karns, S.A., & Taylor, J.L. (2006). Poultry Slaughter and Processing Sector Facility-Level Model. Prepared for U.S. Department of Agriculture, Food Safety and Inspection Service. Research Triangle Park, NC: RTI International. 

A summary of the types of young 

chicken and turkey operations and the 

sizes of these official establishments is 

in Table 4 (FSIS ADRS 2010). Table 4 

summarizes the 270 federally inspected 

establishments that slaughtered young 

chickens (231 establishments) and 

turkeys (39 establishments) along with 

the 19 that slaughtered other chicken 

(such as fowl and capon) (6 

establishments) and only other poultry 

(such as squabs, pheasants, quail, ducks 

or geese) (13 establishments) in 2010. 

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49616 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

20 Included in this number are the very small 

establishments that annually slaughter a relatively 

small number of young chickens and turkeys by 

methods that do not use a high-speed line. 

FSIS ADRS 2010 records indicated 

that there were 663 line-shifts in 270 

establishments that slaughter young 

chickens and turkeys, as shown in Table 

5.20 In these establishments, one shift is 

defined as about 8 hours per day and 

two shifts as about 16 hours per day. 

Approximately 55 percent of the 270 

establishments operated two slaughter 

shifts per day in 2010. For this analysis, 

the 663 line-shifts of production results 

from multiplying the number of lines by 

the number of shifts. Table 5 shows the 

details of the FSIS ADRS 2010 

information on the 270 young chicken 

and turkey establishments, classified by 

current inspection system. FSIS 

maintains this type of information 

because staffing patterns in current 

inspection systems are determined 

based on the number and type of 

slaughter lines. These 663 lines operate 

daily in the 270 young chicken and 

turkey establishments with one or two 

8-hour-shift(s), on about 5 or 6 days of 

the week. 

Table 5 also summarizes the 

maximum potential transition over five 

years, assuming available resources and 

institutional readiness, of the young 

chicken and turkey industry to the new 

inspection system. This table shows the 

distribution of the 270 establishments 

that slaughtered young chickens and 

turkeys in 2010. 

Of the 187 young chicken 

establishments (not under the 

Traditional Inspection System) with 542 

lines, there were 117 establishments 

under SIS inspection, 50 under NELS 

inspection, and 20 under the HIMP 

inspection. Of the 32 turkey 

establishments (not under the 

Traditional Inspection System) with 56 

lines, there were 27 establishments 

under NTIS inspection, and 5 under the 

HIMP inspection. Altogether, this 

suggests a maximum of 219 of the 270 

young chicken and turkey 

establishments, or 81 percent, which 

have about 598 lines, have the 

opportunity to convert to NPIS. 


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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49617 

Table 6 shows that of the 187 young 

chicken establishments (not under the 

Traditional Inspection System) with 542 

lines, 127 were HACCP large 

establishments and 60 were HACCP 

small establishments. Of the 32 turkey 

establishments (not under the 

Traditional Inspection System) with 56 

lines, 22 were HACCP large 

establishments and 10 were HACCP 

small establishments. 


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49618 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

21Based on FSIS’s Animal Disposition Reporting 

System (ADRS) of 2010, 289 establishments 

slaughtered all classes of poultry, other than ratites, 

under all poultry inspection systems in 2010. Of the 

289 establishments, about 270 establishments 

slaughtered young chicken and young turkey in 

2010. 

Estimated Number of Establishments 

Predicted To Opt for the Modified 

Traditional Inspection System 

FSIS estimates that about 70 federally 

inspected establishments will switch 

from their current Traditional 

Inspection System to the modified 

Traditional Inspection System for the 

slaughter of poultry, other than ratites. 

The 70 establishments consist of 51 very 

small HACCP size establishments, or 

about 19 percent of the 270 official 

federally inspected establishments that 

slaughter young chickens and turkeys, 

and 19 establishments that slaughter 

poultry but not young chicken or turkey 

(or ratites). The very small HACCP size 

young chicken and turkey 

establishments, in general, do not have 

sufficient output volume over which to 

spread the initial set-up costs of any of 

the more automated systems or the 

training and maintenance costs resulting 

from this system. 

These 70 establishments represent 

about 24 percent of the 289 official 

federally inspected establishments that 

slaughtered one or more classes of 

poultry other than ratites,21 under all 

poultry inspection systems in 2010. 

Based on FSIS’s ADRS records, these 70 

establishments slaughtered about 1 

percent of all poultry (other than ratites) 

of the domestic poultry industry in 

2010. Furthermore, the approximately 

219 official federally inspected 

establishments slaughtered about 99.9 

percent of the young chickens and 

turkeys of the domestic poultry industry 

in 2010. 


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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49619 

22Most of the cost estimates in this section are 

also based on the data collected from these 12 

establishments. 

23According to the 2011 Bureau of Labor 

Statistics employment cost index, hourly wages for 

slaughtering and meatpacking workers is $11.63. 

Estimates of benefits as a percent of total wages 

range from 20 to 39 percent according to the 

American Meat Institute. Since the poultry industry 

is at the low end of the wage scale, we are 

estimating benefits to be 20 percent of total wages. 

24This is a simplifying assumption. 

25BLS reported that the overall private industry 

turnover rate was approximately 41 percent in 

2011. FSIS is rounding to 40 percent. U.S. 

Department of Labor. Bureau of Labor Statistics. 

(2011). Job Openings and Labor Turnover Survey. 

Washington, DC: U.S. Department of Labor. 

Summary of Estimated Costs and Cost 

Savings of the Rule 

In the following sub-sections, FSIS 

presents the costs and cost savings that 

would be generated over a range of 

assumptions with respect to how much 

of the industry will choose to adopt 

NPIS within five years. These estimates 

are scaled from an illustrative 

calculation that assumes that all 219 

small and large non-Traditional 

establishments adopt NPIS, which, 

while used to calculate potential 

maximum effect, is not necessarily 

FSIS’s assumption of the most likely 

outcome. Later portions of the 

regulatory impact analysis contain 

discussion of the uncertainty 

surrounding the net benefits associated 

with how much of the industry will 

choose to adopt NPIS. 

Items 1–7 are Costs and Cost Savings 

Associated With the New Poultry 

Inspection System 

1. Addition of Online Establishment 

Workers Because of the Relocation of 

Online Inspection Program Personnel 

and Online Sorters—Annual Cost 

Associated With the New Poultry 

Inspection System 

FSIS estimates that young chicken 

and turkey establishments that 

transition to NPIS will initially expand 

their labor resources by employing 

about an average of 0.8 staff-years of 

online sorters and carcass-inspection 

helpers that substitute for every 1.0 

staff-year of FSIS online inspection 

program personnel. For example, in one 

shift, an establishment that had ten FSIS 

online inspection program personnel 

would add eight online sorters and 

carcass-inspection helpers in response 

to the rule. This substitution rate is 

based on information provided by 12 

young chicken establishments in 2001 

who participated in the HIMP pilot 

program.22 If all of the 219 

establishments eventually slaughtered 

young chickens and turkeys under the 

NPIS, this would translate to between 

663 and 770 FSIS online inspection 

program personnel shifted from online 

inspection to verification inspection 

activities and online inspection of 

carcasses (carcass inspection, after the 

final wash and before the chiller). 

However, as noted above, there is not a 

way to predict how many of the 

establishments will transition to NPIS, 

or over what time frame FSIS would 

have the resources to accommodate 

requests after the initial 6 month period. 

As such, table 8b suggests that the range 

of personnel under assumptions that 

span 0 and 100 percent range from 0 to 

770 online inspectors. FSIS estimates 

that the 770 shifted FSIS online 

inspection program personnel is the 

upper bound if indeed all the 219 

establishments estimated earlier opt to 

transition to NPIS during the first five 

years. 

Using the expected substitution rate 

of 0.8 (8 for 10), under the 100 percent 

adoption assumption for analytic 

purposes, the estimated 219 

establishments would initially need 

about 616 (770 × 0.8) additional trained 

personnel to do the online sorting of 

young chickens and turkeys, and 

helping carcass inspection program 

personnel for all shifts. This implies 

that the range of reassignments by FSIS 

would be between 0 and about 770 

inspection program personnel to other 

inspection activities within the 

establishments (e.g. carcass inspection, 

verification inspection, and relief 

coverage). The upper bound of this 

range, or 770 inspection program 

personnel, however, may be an overestimate, because of attrition. The 

Bureau of Labor Statistics (BLS) 

indicated that the expected standard 

rate for establishment labor is about 

$13.96 per hour,23 and including 

benefits and related costs, the wage cost 

is taken for this analysis to be about 

$27,900 per staff-year (for about 2,000 

hours 24 per staff-year). Therefore, the 

average cost if 219 establishments were 

to adopt NPIS within five years, would 

be for the initial additional 616 staffyears of online sorter labor is about 

$17.2 million annually (616 × $27,900). 

2. Training Online Sorters, Under the 

New Inspection System—One-time Cost 

Associated With the New Poultry 

Inspection System 

Initial training costs are expected, 

based on information provided by 

establishments participating in the 

HIMP pilot program, to be about $200 to 

$600 per employee (sorter), or an 

average cost of about $400 per 

employee. Additional training costs 

accrue for the extra establishment 

employees (sorters) needed to cover for 

task rotation patterns and scheduled 

and unscheduled leave of trained 

establishment employees. FSIS projects, 

based on information provided by 

establishments participating in the 

HIMP pilot program, that rotation 

schedules would be about three times 

per shift. FSIS did not report costs in 

the official HIMP Report. FSIS, 

however, obtained information on 

establishment costs and practices from 

site visits to the HIMP project 

establishments and non-HIMP 

establishments that slaughter poultry. 

The HIMP establishments (20 young 

chickens and 5 turkeys, as shown in 

Table 5) reported a range of costs for 

their implementation of the FSIS’s 

requirements of the HIMP inspection 

system. Based on this information, FSIS 

made assumptions on costs and 

practices of the poultry establishments 

that would be affected by this rule. 

FSIS assumes that the, using the 

maximum potential upper bound of 

establishments, 219 establishments will 

need about 3.5 to 4 times the 

replacement staff-years, or about 2,310 

(3.75 × 616) establishment employees 

who are trained to perform online 

sorting and CI helper activities. 

Therefore, initially, an average of about 

2,310 establishment employees would 

need to be trained at a one-time average 

cost of about $400 each, or a total for 

estimated 219 establishments, of about 

$0.92 million (2,310 × $400). 

3. Training, Annually—for Replacement 

Sorters Due to Labor Turnover—Annual 

Cost Associated With the New Poultry 

Inspection System 

Annual training costs are estimated 

based on information provided by 

establishments participating in the 

HIMP pilot program, in order to account 

for the expected labor turnover rates in 

young chicken and turkey 

establishments and the need to train and 

educate replacement establishment 

personnel for sorting young chickens 

and turkeys. 

FSIS projects that, if the annual 

turnover rate of trained establishment 

sorters is, on average, 40 percent, 

establishments will need to train about 

924 (0.4 × 2,310) new establishment 

sorters annually.25 FSIS projects that the 

initial training costs are expected to be 

about $200 to $600, or an average of 

about $400 per employee (sorter). Using 

the $400 per employee values, 

additional training costs will average 

about $0.37 million (924 × $400), 

annually. 

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49620 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

26Please refer to the ‘‘Baseline’’ section for further 

explanation on the projected adoption rate of NPIS. 27The USDA, GIPSA 2012 Packers and 

Stockyards Annual Report states that the four 

largest broiler slaughterers posted a 52 percent 

market share in 2011. The share of the four largest 

turkey slaughterers was 55 percent in 2011. The 

U.S. Census Bureau 2007 Economic Census of the 

United States reports that the 50 largest Poultry 

Processing Companies (2007 NAICS 311615) post a 

91.5% share of the total value of shipments. For the 

purposes of this analysis, FSIS assumed that large 

establishments accounted for 90% of the 

production volume and small establishments 

accounted for the remaining 9.9%. According to our 

analysis, very small establishments account for the 

remaining 0.1%. 

4. Continuing Education & Training, 

Annually—for Existing Sorter Labor— 

Annual Cost Associated With the New 

Poultry Inspection System 

After the initial training, the 

establishments will have additional 

costs to provide ongoing annual 

education and training (formalized). 

This education and training is for the 

knowledgeable establishment staff 

(sorters) of an average of about 2,310 

persons who need to maintain a 

sufficiently high correlation of 

agreement with FSIS on regulatory 

compliance for dressing performance 

standards. The annual training cost, 

based on information provided by 

establishments participating in the 

HIMP pilot program, was about $150 to 

$200 per sorter, or an average of $175 

per sorter. Using this average value, the 

total average cost would be about $0.40 

million (2,310 × $175), annually. 

5. Additions to Facilities: Carcass 

Inspection Stations, Avian Leukosis 

Inspection Area, and Underline Troughs 

One Time Costs Associated With the 

New Poultry Inspection System 

Under the rule, all of the poultry 

establishments participating in the NPIS 

will need to add capital investments to 

install a carcass inspection heightadjustable station. 

Establishments operating under SIS, 

NELS, and NTIS are currently required 

to have an underline trough but they 

will need an additional new trough at 

the end of the evisceration line. The 25 

establishments (20 young chicken and 5 

turkey) that operate under HIMP (Table 

5) will not need new trough 

installations under the new rule. FSIS 

assumes installations will require a 

stainless steel underline trough (or 

equivalent) that will cost about $8,000 

to $12,000, or an average of about 

$10,000, for most establishments, based 

on information provided by commercial 

construction guidelines of costs for 

purchasing (or constructing) and 

installing such systems. FSIS estimates 

that as many as 194 establishments 

(Table 5, based on a projection that up 

to 219 establishments may adopt the 

NPIS, minus the 25 HIMP 

establishments) will need inspection 

stations that will cost about $5,000 to 

$6,000, or an average of about $5,500, 

for most establishments, based on 

information provided by establishments 

participating in the HIMP pilot program. 

For the carcass inspection station, this 

cost is for the construction of a stainless 

steel height-adjustable stand that has 

stairs and a surrounding guardrail. This 

carcass inspection stand must have a 

floor area large enough to allow 

sufficient space to accommodate the 

carcass inspection program person and 

an establishment employee, that is, a 

helper for removal of defective or 

rejected birds from the line. This 

inspection station would contain 

plumbing for hot and cold water, and a 

stainless steel hand-washing basin. 

Furthermore, electrical service must 

be installed for powering bright lights 

(200 foot-candles of illumination at the 

level of the bird) required for 

inspection, and control switches must 

be installed to allow the starting and 

stopping of the eviscerating line. The 

verification inspection station typically 

is already in place in most young 

chicken and turkey, and other poultry 

slaughter establishments. Therefore, in 

most cases, there would be no 

additional cost for a verification 

inspection station near the end of the 

eviscerating line. The verification 

inspection station is typically a stainless 

steel table illuminated with bright lights 

(200 foot-candles). 

These capital investments for the 

carcass inspection stations are necessary 

for each of the about 541 eviscerating 

lines now installed in the 194 nonHIMP establishments (Table 5) that may 

implement the NPIS. Therefore, the 

calculated cost for adding carcass and 

verification inspection stations for the 

194 establishments is about $8.39 

million (541 × $15,500). 

6. Carcass Dressing for Meeting the 

Definition of Ready-to-Cook (RTC) 

Poultry and the Removal of the Finished 

Product Standards (FPS) Associated 

With the New Poultry Inspection 

System 

FSIS is removing the existing 

Finished Product Standards (FPS) and 

replacing them with a requirement that 

establishments maintain documentation 

to demonstrate that the products 

resulting from their slaughter operations 

meet the definition of ready-to-cook 

poultry. Establishments will have the 

flexibility to design and implement 

measures for producing ready-to-cook 

poultry that are best suited to their 

operations and may have minimal 

savings. These savings are not included 

in the benefits estimate. 

FSIS online carcass inspectors will 

inspect each carcass for defects that are 

important for food safety, such as 

septicemia and toxemia, as well as for 

defects that are less important to food 

safety but that may render carcasses or 

parts unwholesome or adulterated, such 

as persistent, unattended removable 

animal diseases and trim and dressing 

defects. 

7. Additional Annual Labor Cost Due to 

Attestation of Work-Related Conditions 

Each establishment operating under 

the NPIS will need to submit on an 

annual basis an attestation to the 

management member of the local FSIS 

circuit safety committee stating that it 

maintains a program to monitor and 

document any work-related conditions 

of establishment workers. The cost of 

this attestation is estimated to take 2 

minutes at a wage rate of $13.96 per 

hour for a total of $102 annually. 

Total Costs and Cost Savings Associated 

With the New Poultry Inspection 

System 

FSIS assumes that the projected 

adoption of NPIS will take place over a 

five year time period.26 FSIS expects 

that HACCP size large establishments 

will be the first to convert to the new 

inspection system because they have 

greater resources available to them to 

make the necessary changes. For the 

purposes of estimating costs, FSIS 

assumed that 68% of all establishments 

that convert to NPIS will have 

implemented NPIS by the third year, 

with approximately 1/3 of these 

establishments converting each of the 

first three years. For the small 

establishments that implement NPIS, 

FSIS assumed that half would convert 

in year four, and half would convert in 

year five. If all large and small 

establishments adopt NPIS, this pattern 

would result in the complete conversion 

of establishments to the new inspection 

system within the five year period used 

for this analysis. FSIS is uncertain about 

how many and how fast establishments 

might opt into NPIS, as such, FSIS 

presents the data in table 8b to reflect 

that uncertainty. 

As such, the costs to industry 

associated with making the necessary 

changes to implement NPIS will 

fluctuate over the initial five years. FSIS 

used establishment information 

including HACCP size, line-shift data 

(see Table 5), and approximate volume 

contributions 27 to estimate how onetime industry costs will be spread across 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49621 

28FSIS assumes first-year costs are incurred at the 

end of the year. 29FSIS assumes that establishments would not 

necessarily use generic E coli because the cost per 

analysis of this organism is greater than that for 

other indicator organisms. While costs per sample 

can vary greatly depending on many factors, we 

assumed an average cost of $15 per sample, plus a 

modest laboratory labor cost ($3.75) for handling 

paper. Therefore, the cost per sampling event 

collecting two samples, excluding sending cost, is 

$30 + $3.75 + $29.03(25/60) = $45.85. The cost per 

sampling event collecting one sample is $15 + $1.87 

+ $29.03(15/60) = $24.13. 

30For example, for large HACCP size 

establishments, the cost per sampling event is: [(0.9) 

($45.85) + (0.1) (45.85 + 15)] = $47.35, because we 

assumed that 90 percent of the samples would not 

need to be sent by mail. 

31FSIS assumes these establishments would 

remain under Traditional Inspection. 

32For the original HACCP rule, FSIS required 13 

samples provided that statistical criteria that FSIS 

used were satisfied. The expected number of 

samples for this to occur is about 16. 

the first five years. FSIS also used this 

information to approximate the 

recurring costs to industry over time. 

These estimated costs are summarized 

in Table 7a. Annualized costs were 

calculated using a discount rate of 7 

percent over a ten-year period.28

TABLE 7a—ESTIMATED YEAR-BY-YEAR COST OF THE RULE IF ALL LARGE AND SMALL NON-TRADITIONAL ESTABLISHMENTS

SELECT THE NEW POULTRY INSPECTION SYSTEM

[Millions of dollars] 

Year 1 Year 2 Year 3 Year 4 Year 5 Recurring 

Annual sorting labor ......................................................... 5.01 10.03 15.04 16.12 17.20 17.20 

Knowledge costs (human capital): 

Initial one-time training of sorting workers ............... 0.27 0.27 0.27 0.06 0.06 ....................

Training annual sorting labor-turnover rate of 40% .................... 0.11 0.22 0.32 0.35 0.37 

Continuing annual education and training ................ .................... 0.12 0.24 0.35 0.38 0.40 

One-time capital expenditure ........................................... 2.44 2.44 2.44 0.53 0.53 ....................

Paperwork cost due to attestation of work-related conditions .............................................................................. **   **  ** ** 

Total costs to establishments from NPIS .......... 7.73 12.97 18.21 17.38 18.51 17.97 

Annualized (7%, 10 year) total cost to establishments from NPIS ...................................... 16.00 

Annualized (3%, 10 year) total cost to establishments from NPIS ...................................... 16.27 

** less than $1000, which rounds to zero. 

Items 8–12 Are Costs and Cost Savings 

Associated With the Mandatory 

Component of the Rule 

8. Sampling and Analysis for Microbial 

Organisms Pre-Chill and Post-Chill To 

Monitor Process Control for Enteric 

Pathogens—One-Time and Annual Cost 

Associated With the Mandatory 

Component 

FSIS is requiring microbial testing to 

demonstrate process control regarding 

the prevention of contamination of 

carcasses and parts by enteric pathogens 

and fecal contamination throughout the 

entire slaughter and dressing operation. 

FSIS is requiring establishments to 

incorporate these procedures into their 

HACCP plans, or sanitation SOPs, or 

other prerequisite programs, and to 

maintain records sufficient to document 

the implementation and monitoring of 

these procedures. 

The regulation requires most 

establishments for each poultry type to 

sample at two locations: pre-chill and 

post-chill. The exceptions are for very 

small HACCP size establishments that 

choose to operate under the modified 

Traditional Inspection System, which 

FSIS will permit to conduct sampling 

only at post-chill. For two samples per 

sampling event, FSIS assumes that it 

would take about 25 minutes for a QC 

technician to collect these samples; for 

one sample, FSIS assumes it would take 

15 minutes to collect the sample. FSIS 

assumes costs of $3.75 for material and 

time needed to provide sampling record 

identification at the laboratory for two 

samples, and one-half that amount of 

time for one sample. For two locations, 

the cost per sampling event is $45.85; 

for one location, the cost per sampling 

event is $24.13.29 FSIS assumes a cost 

of sending material and samples 

between the establishment and 

laboratory of about $15 per sampling 

event, if the laboratory is not on-site. 

Most large establishments have 

laboratories on premises; FSIS assumes 

that 90 percent of large HACCP size 

establishments have laboratories on the 

premises, and thus would not incur a 

cost for sending samples to the 

laboratory. FSIS assumes that 25 percent 

of small and very small HACCP size 

establishments have laboratories onsite. 

Accounting for our assumed percentages 

of samples that would need to be sent 

to laboratories, FSIS assumes a cost of 

$47.35 per sampling event for large 

HACCP size establishments, $57.10 per 

sampling event for small HACCP size 

establishments, and $35.38 per 

sampling event for very small HACCP 

size establishments (at one location).30

For record keeping (discussed in a later 

section), FSIS assumes 5 minutes for a 

sampling event for 2 locations, and 2.5 

minutes for 1 location, at the same 

$29.03 per hour wage. 

To establish a baseline, for other than 

very low volume establishments, FSIS 

assumes that large HACCP size 

establishments would collect 150 pairs 

of samples, on average; small HACCP 

size establishments, 75 pairs; and very 

small HACCP size establishments, 30 

samples. For very low volume 

establishments,31 FSIS assumes that 

sampling would be minimal, and that 

for these establishments there would be 

no baseline. The number of samples that 

establishments would collect for each 

poultry type is proportional to the 

number of slaughtered birds for the 

different poultry types. 

To estimate the recurring annual cost 

for sampling, FSIS assumes sampling at 

a rate of 1 sampling event per 22,000 

carcasses for sampling chicken, and 1 

per 3,000 carcasses for sampling other 

species. For very low volume 

establishments, FSIS assumes at least 

one sample per week to a maximum of 

16 samples per year, because some low 

volume establishments might need to 

take more than 13 samples to 

demonstrate process control.32 Based on 

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49622 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

33FSIS did not exclude HIMP establishments 

from this calculation, though FSIS believes that the 

cost for these establishments on average will be 

less. To the extent that this is true, the above 

estimate is high, given everything else being true. 

34The cost of analyzing generic E. coli is greater 

than that of analyzing for Aerobic Plate Count 

(APC) because the former involves extra steps for 

identifying E. coli cells. Based on its experience 

with contracting, FSIS estimates that the analytical 

cost per sample for E. coli is about $5 more. 

35U.S. Department of Agriculture. Food Safety 

and Inspection Service. (2011). Progress Report on 

Salmonella and Campylobacter Testing of Raw Meat 

and Poultry Products, 1998–2011. Washington, DC: 

U.S. Department of Agriculture. Retrieved from 

http://www.fsis.usda.gov/PDF/Progress_Report_

Salmonella_Testing_1998-2011.pdf#page=14. 

In the years 2009–2011, FSIS sent a yearly 

average of about 125 sample sets to establishments 

that slaughter young chicken and about 26 to 

establishments that slaughter turkey. Thus, per 

year, roughly 50 percent of the establishments 

received sample sets. Over 95 percent of the sets 

show results that are in compliance with the 

performance standard. 

these assumptions, we calculated an 

expected number of sampling events 

that establishments would take, and 

multiplied these numbers by the 

appropriate costs per sampling event 

(weighted sum with weights equal to the 

appropriate cost for the sampling event). 

We provide cost estimates in Table 7b. 

FSIS expects industry to incur a 

savings by reducing present costs 

associated with sampling for satisfying 

the present Finished Product Standards 

(FPS), and that additional cost to 

industry due to our Other Consumer 

Protection (OCP) requirements, if any, 

would be minimal. Thus, FSIS did not 

include costs associated with the 

replacement of the present FPS 

requirements with the and new OCP 

requirements. 

9. Additional Annual Recordkeeping, 

Monitoring, and Record Storage 

Associated With the Mandatory 

Component 

Establishments are required to 

maintain written documentation of 

sample results for verifying their 

process controls. FSIS assumes that the 

time spent for a QC technician salaried 

at $29.03 per hour for recording results 

(including review) for each sample is 

2.5 minutes. If two samples are 

collected (pre-chill and post-chill), FSIS 

assumes 5 minutes are needed. For the 

present required generic E. coli testing, 

FSIS assumes 2.5 minutes per sample. 

10. (a.) Modification of the HACCP 

Plans and Process Control Plans—Onetime Cost Associated With the 

Mandatory Component of the Rule 

Establishments will need to modify 

their HACCP plans, sanitation SOPs, or 

other pre-requisite programs to address 

septicemic and toxemic carcasses and 

food safety hazards that are reasonably 

likely to occur. Establishments will also 

be required to maintain records to 

document that their product meets the 

definition for ready-to-cook poultry. 

Under the rule, establishments will have 

the flexibility to design and implement 

measures to address OCP defects that 

are best suited to their operations. They 

will also be responsible for determining 

the type of records that will best 

document that they are meeting the 

ready-to-cook poultry definition. FSIS 

based its estimates on information 

provided by establishments 

participating in the HIMP pilot program 

regarding initial costs for modifications 

to their HACCP plans. FSIS estimates 

that, on average, the initial costs will be 

about $5,000 for small HACCP size 

establishments and about $9,000 for 

large HACCP size establishments. For 

the very small HACCP size 

establishments, FSIS projected a cost of 

about $2,000, on average. Therefore, we 

estimate the one-time cost to be equal to 

about $1.89 million ((84 × $5,000) + 

(151 × $9,000) + (54 × $2,000)) for the 

289 establishments.33 Moreover, once 

establishments design and implement 

these modifications, they will 

incorporate them in their present 

HACCP plans, and thus we assume no 

additional recurring cost associated 

with these modifications. FSIS does not 

expect these costs to vary by the type or 

species of bird that the establishments 

slaughter. 

10. (b.) Written Procedures To Ensure 

That Carcasses and Parts With Visible 

Fecal Contamination Do Not Enter the 

Chiller, After Evisceration Operations— 

One-time Cost Associated With the 

Mandatory Component of the Rule 

FSIS is requiring that all federally 

inspected establishments that 

slaughtered poultry (other than ratites) 

develop, implement, and maintain, as 

part of their HACCP plans, sanitation 

SOPs, or other prerequisite programs, 

written procedures to ensure that 

carcasses and parts with visible fecal 

contamination do not enter the chiller 

after evisceration operations. The onetime cost to develop the plan is 

included in the costs of changing the 

HACCP system as discussed above in 

item 10.a. 

10. (c.) Written Procedures To Ensure 

That Young Chicken and Turkey 

Carcasses Contaminated With 

Septicemic and Toxemic Conditions Do 

Not Enter the Chiller, for the New 

Poultry Inspection System Associated 

With the Mandatory Component of the 

Rule 

FSIS is requiring that the 219 

federally inspected establishments that 

may decide to slaughter young chickens 

and turkeys under the NPIS develop, 

implement, and maintain written 

procedures to ensure that poultry 

carcasses contaminated with septicemic 

and toxemic conditions do not enter the 

chiller. Establishments must incorporate 

these procedures into their HACCP 

plans, sanitation SOPs, or other 

prerequisite programs. The cost for 

developing these written procedures is 

accounted for in the costs given in 

section 10.a. 

11. Elimination of Generic E. coli and 

Salmonella Standards—Annual Cost 

Savings Associated With the Mandatory 

Component of the Rule 

FSIS is removing the current 

requirement that poultry establishments 

that slaughter more poultry than other 

species test for generic E. coli. 

Additionally, the agency is removing 

the codified Salmonella pathogen 

reduction performance standards for 

poultry because our existing Salmonella 

and Campylobacter performance 

standards are better able to contribute to 

food safety. We used the same 

assumptions for the cost of sampling as 

described above in section 9, with the 

exception of assuming the analytical 

cost for generic E. coli is $20 instead of 

$15.34

FSIS assumes the cost savings 

associated with eliminating the 

Salmonella performance standards are 

minimal, because typically 

establishments are sampled, on average, 

roughly once every two years; more than 

95 percent of the sample sets’ results 

satisfy FSIS’s criteria; 35 and 

establishment-recording costs for FSIS 

sampling are minimal. Therefore, FSIS 

did not account for savings due to 

eliminating this requirement. 

12. Elimination of Carcass Cooling 

Standards—Possible Cost Savings 

Associated With the Mandatory 

Component of the Rule 

FSIS projects that the elimination of 

carcass cooling standards will remove 

some of the ‘‘bottleneck’’ restrictions of 

the chilling system. FSIS projects that 

the birds may take less time to cool to 

meet this new requirement of no 

microbial growth. FSIS projects that the 

establishments will be able to increase 

the output from the chiller in order to 

accommodate increased line speed. 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49623 

36These costs annualized to about $25.3 million 

over 10 years using a 3 percent discount rate. 

37 In the final rule, FSIS is permitting very small 

HACCP size establishments to sample at one 

location, post-chill. Moreover, FSIS is permitting 

very low volume establishments to sample at a 

frequency similar to what is required presently. 

FSIS expects cost per sample to decrease because 

FSIS is no longer requiring establishments to 

sample for generic E. coli, but is permitting 

establishments to sample for other indicator 

organisms that are less expensive to analyze and 

expected to be more predictive of food safety 

concerns. 

Total Costs and Cost Savings Associated 

With the Mandatory Component of the 

Rule 

Table 7b shows the implementation 

costs of complying with the mandatory 

actions of the rule, over time, for the 289 

affected poultry establishments. For the 

70 establishments expected to transition 

to the modified Traditional Inspection 

System, FSIS assumed that half would 

convert in year four, and the remaining 

half would convert in year five, 

mirroring the implementation of the 

small young chicken and turkey plants 

converting to NPIS. Again, annualized 

costs are calculated using a discount 

rate of 7 percent over a ten year 

planning period. 

TABLE 7b—ESTIMATED ANNUAL COST (COST SAVINGS) OF THE RULE TO ALL ESTABLISHMENTS FOR ELEMENTS

ASSOCIATED WITH THE MANDATORY COMPONENT OF THE RULE

[Millions of dollars] 

Year 1 Recurring 

Additional PC microbial testing:* 

One-time baseline ................................................................................................................................ 1.34 

Annual recurring testing ....................................................................................................................... 23.59 23.59 

Annual recordkeeping, monitoring, and record storage .............................................................................. 1.17 1.17 

Eliminated generic E. coli testing recordkeeping ........................................................................................ (0.59) (0.59) 

One-time HACCP system and Process Control (PC) plan development ................................................... 1.89 

Reduced annual microbial testing—generic E. coli ..................................................................................... (15.51) (15.51) 

Total costs to establishments from mandatory component ........................................................................ 11.90 8.67 

Annualized (10 year, 7% discount) total mandatory costs .......................................................................... 9.10 

Annualized (10 year, 3% discount) total mandatory costs .......................................................................... 9.04 

For the poultry industry, as shown in 

Table 7a, the annualized costs incurred 

if all establishments convert to NPIS are 

about $16.0 million over 10 years at a 

7 percent discount rate. To comply with 

the mandatory component, the rule will 

cost establishments about $9.1 million 

over 10 years at a 7 percent discount 

rate. Net total costs to industry 

annualize to $25.1 million ($16.0 + 

$9.1).36

FSIS expects the 51 very small 

HACCP size establishments that 

slaughter young chicken and turkey and 

the three very small establishments that 

slaughter other poultry to adopt the 

modified Traditional Inspection System 

instead of NPIS. These establishments 

will only incur mandatory costs 

associated with items discussed above 

and listed in Table 7b. FSIS assumes a 

smaller analytical cost per sample for 

these establishments, and in some cases 

for establishments with large production 

volume, fewer numbers of samples.37

Table 7c lists estimated mandatory 

costs for the 54 very small HACCP size 

establishments. Estimated annualized 

costs to very small establishments are 

approximately $11,760, which is about 

$218 per establishment. This represents 

an average annual cost per bird of 

approximately 0.098 cents, or 0.025 

cents per pound, based on the 

assumption that very small 

establishments slaughter about 12 

million birds annually, at an average 

weight of about 4 pounds per bird. 

TABLE 7c—ESTIMATED ANNUAL COST (COST SAVINGS) OF THE RULE TO VERY SMALL HACCP SIZE ESTABLISHMENTS

(54) FOR ELEMENTS ASSOCIATED WITH THE MANDATORY COMPONENT OF THE NEW RULE

[Thousands of dollars] 

Year 1 Recurring 

Additional PC microbial testing—plate counts, collection, packaging, shipping 

One-time baseline (including recordkeeping) ....................................................................................... 4.25 

Annual recurring testing ....................................................................................................................... 22.47 22.47 

Annual recordkeeping, monitoring, and record storage .............................................................................. 0.77 0.77 

Eliminated generic E. coli testing recordkeeping ........................................................................................ (0.77) (0.77) 

One-time HACCP system plans and Process Control (PC) plan development (item 11.a) ....................... 108.00 

Reduced annual microbial testing—generic E. coli plate counts ................................................................ (25.64) (25.64) 

Total costs to establishments from mandatory component ........................................................................ 109.07 (3.18) 

Annualized total costs (7% for 10 years) .................................................................................................... 11.76 

Annualized total costs (3% for 10 years) .................................................................................................... 9.60 

Expected FSIS Budgetary Effects 

Table 8 shows the potential FSIS 

budgetary net savings from the rule for 

the slaughter of all poultry other than 

ratites and including the NPIS for the 

slaughter of young chickens and 

turkeys. 

FSIS used the following scenario 

assumptions to project the potential 

FSIS budgetary effects of the rule: 

• Of the 219 establishments that may 

adopt the NPIS, an estimated 175 

establishments (150 young chicken 

establishments and 25 turkey 

establishments) may be affected by FSIS 

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49624 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

38Some inspection personnel will be promoted 

from GS–7 to GS–8 due to assuming higher graded 

duties. These new Carcass/Verification Inspector 

positions will perform routine and directed 

inspection verification tasks to evaluate the 

establishment’s regulatory compliance and process 

control. The inspector collects samples for pathogen 

testing, performs certain sample analysis, and 

conducts post-mortem and ante-mortem inspection. 

The inspector also performs verifications of good 

commercial practices, zero tolerance for fecal and 

septicemia/toxemia, establishment microbiological 

testing for preventing contamination throughout 

operations, food safety systems, and sanitary 

dressing requirements. 

personnel changes. The estimated 175 

establishments do not include the 25 

young chicken and turkey 

establishments currently operating 

under the HIMP program. FSIS also 

excluded approximately 19 other 

poultry establishments currently 

operating under the SIP waivers, even 

though FSIS expects them to choose to 

participate in the NPIS because FSIS 

expects the impact on these 19 

establishments to be relatively small. 

Establishments that change operations 

but continue to produce will continue to 

have FSIS inspectors. 

• 1,498 food inspector grade increases 

(from GS–7 to GS–8) (1,284 inspectors 

in young chicken establishments and 

214 inspectors in turkey establishments) 

• 241 relief inspector grade increases 

(GS–7 to GS–8) 38

• FSIS is uncertain of the size of any 

reduction of food inspector positions 

through managing vacancy or refill 

rates. Some personnel are also expected 

to voluntarily retire. The range of 

potential reductions is 0 to 630 (see 

table 8b). For purpose of this analysis, 

FSIS includes the maximum potential 

change to calculate the maximum 

potential effect. Approximately 190 of 

the 630 inspector positions will be 

relocated to existing vacancies within 

the agency. 

• FSIS is uncertain of the size of any 

reduction of approximately 140 

Supervisory Consumer Safety Inspector 

(SCSI) positions. The range of potential 

reductions is 0 to 140 (see table 8b). For 

purpose of this analysis, FSIS includes 

the maximum potential change to 

calculate the maximum potential effect. 

Of those 140 SCSI personnel, 

approximately 112 will be relocated to 

existing vacancies within the agency 

with the remaining number expected to 

retire. 

• Training costs to include training of 

promoted personnel and training for all 

personnel on the NPIS implementation 

processes. 

TABLE 8—ESTIMATED POTENTIAL ANNUAL COST (COST SAVINGS) OF THE RULE TO FSIS: ELEMENTS ASSOCIATED WITH

THE NEW POULTRY INSPECTION SYSTEM

[Millions of dollars] 

Category Year 1 Year 2 Year 3 Year 4 Year 5 Recurring 

Cost from Grade Increases (Salary & Benefits) .......................... $1 .2 $3 .5 $5 .8 $7 .0 $7 .4 $7 .6 

Savings From Positions Eliminated ............................................. ($5 .2) ($16 .9) ($28 .6) ($36 .1) ($38 .1) ($39 .0) 

Training Costs .............................................................................. $2 .0 $2 .0 $2 .0 $0 .3 $0 .3 $0 .0 

Relocation Costs .......................................................................... $1 .4 $1 .4 $1 .4 $0 .2 $0 .2 $0 .0 

Total Cost (Savings) .................................................................... ($0 .6) ($10 .0) ($19 .4) ($28 .5) ($30 .1) ($31 .4) 

Source: FSIS, Office of the Chief Financial Officer. 

TABLE 8b—ESTIMATED POTENTIAL BUDGETARY EFFECTS TO FSIS BY ADOPTION RATE: ELEMENTS ASSOCIATED WITH THE

NEW POULTRY INSPECTION SYSTEM

Category 

Adoption Rate 

0% 10% 25% 50% 75% 90% 100% 

Food Inspector Grade Increases ..................................................................... ............ 150 375 749 1,124 1,348 1,498 

Relief Inspector Grade Increases .................................................................... ............ 24 60 121 181 217 241 

Reduction in Food Inspector Positions ............................................................ ............ 63 158 315 473 567 630 

Reduction in Supervisory Consumer Safety Inspectors .................................. ............ 14 35 70 105 126 140 

FSIS expects a potential net cost 

savings of $0.6 million in the first year 

of implementation. FSIS expects 

potential net cost savings to total $10.0 

million the second year of 

implementation. Cost savings from 

position elimination (potentially 

totaling $16.9 million) scale with the 

number of establishments that opt into 

NPIS and will therefore more than offset 

the increase in one-time costs the 

agency will incur the second year. 

Potential annual cost savings are 

expected to total $31.4 million after the 

fifth year. The Agency’s potential 

annual costs for FSIS food and relief 

inspectors upgrades from GS–7 to GS– 

8 will increase to $7.6 million after the 

fifth year of adoption. These additional 

costs will be more than offset by the 

Agency’s annual cost savings from 

position elimination, potentially 

totaling $39.0 million. 

Expected Benefits Associated With the 

New Poultry Inspection System—Public 

Health Benefits From Reallocating FSIS 

Inspection Activities 

FSIS hypothesizes that switching 

existing FSIS IPP activities towards 

more offline verification activities (such 

as sanitation performance standards, 

sampling, other inspection 

requirements, and fecal inspections) 

will reduce pathogen levels in poultry 

slaughter establishments. This is 

supported by the regression analysis of 

historical data presented in the FSIS 

Risk Assessment (July 2014), which 

found a significant correlation between 

more offline inspection activities and 

lower levels of Salmonella and 

Campylobacter in certain poultry 

products. It is possible that these 

reductions may lead to a corresponding 

reduction in illnesses. 

In Table 5 of FSIS’ Risk Assessment 

(July 2014), FSIS presents estimates that 

industry-wide adoption of NPIS would 

reduce the number of human illness 

attributed to young chicken and turkey 

products by an average of about 3,980 

(with a range of 1,510 to 6,960) 

Salmonella illnesses and about 840 

(with a range of 100 to 1,860) 

Campylobacter illnesses. Annual 

Salmonella cost savings from an averted 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49625 

39The FSIS estimate for the average cost of 

Salmonella illnesses ($2,423 per case—2010 

dollars) was developed using the USDA, ERS 

Foodborne Illness Costs Calculator: Salmonella 

(June-2011). FSIS updated the ERS calculator to 

include Scallan case distribution for Salmonella. 

Scallan, E., Hoekstra, R., Angulo, F., et.al. (2011). 

Foodborne Illness Acquired in the United States— 

Major Pathogens. Emerging Infectious Diseases, 17 

(1), 7–15. 

40The FSIS estimate for the average cost of 

Campylobacter illnesses ($2,067 per case—2010 

dollars) is based on Hoffman (2012). Annual Cost 

of Illness and QALY-Adjusted Life Year Losses in 

the United States Due to Fourteen Foodborne 

Pathogens. Journal of Food Protection, 75(7), 1292– 

1302. The ERS Cost calculator does not include an 

estimate for Campylobacter illnesses. 

41See footnote 27. 

case is estimated to be $2,423 39 and the 

annual Campylobacter cost savings from 

an averted case is estimated to be 

$2,067.40 Thus, FSIS estimates that the 

potential monetized value of the human 

illness reductions is an annual average 

of about $11.38 million (with a range of 

$3.87 million to $20.71 million). These 

estimates may underestimate the 

average cost of illness because they 

include medical costs and loss-ofproductivity costs. They do not include 

pain and suffering costs or, in the case 

of Salmonella, the cost of accelerated 

mortality. 

TABLE 9—TOTAL POTENTIAL REDUCTIONS IN HUMAN ILLNESSES OR ILLNESSES AVERTED AND PROJECTED COST SAVINGS

DUE TO BETTER INSPECTION PROCEDURE PERFORMANCE IN YOUNG CHICKEN AND TURKEY SLAUGHTER ESTABLISHMENTS

What happens if young chicken and turkey establishments have the anticipated increase in unscheduled 

offline inspection procedures?12345

Range 

Expected Value 10th Percentile 90th Percentile 

Annual Salmonella Cost Savings 6

and Averted Illnesses: 

$9.64 million .................................

(3,980 illnesses averted) ..............

$3.66 million .................................

(1,510 illnesses averted) ..............

$16.86 million. 

(6,960 illnesses averted). 

Annual Campylobacter Cost Savings 7 and Averted Illnesses: 

$1.74 million .................................

(840 illnesses averted) .................

$0.21 million .................................

(100 illnesses averted) .................

$3.84 million. 

(1,860 illnesses averted). 

Annual Total Cost Savings ......... $11.38 million ............................... $3.87 million ................................. $20.71 million. 

1The number of establishments in each size category throughout the economic analysis is different from the number used in the risk assessment. The risk assessment uses the most recent data for the correlation between baseline and inspection data (2008) and participating establishments, while the economic analysis uses 2010 size categories to reflect the most up-to-date size distribution. 2The reported expected reductions in illnesses represent the unscheduled inspection procedures scenario from the risk assessment. FSIS selected this scenario to represent expected reduction in illnesses because it involved an increase in targeted off-line inspection activities and not a 

random increase in all off-line inspection activities, as represented in the indiscriminate scenario. 3Totals may not add up due to rounding. 

4These estimates represent a lower bound for an average cost of illness because they only include medical costs, loss-of-productivity costs 

(Salmonella and Campylobacter), and the value of reduced mortality (Campylobacter only). They do not include pain and suffering costs. 5FSIS explored—using a modified database—the effect of the very small plants on the output of the risk assessment. Specifically, it used additional regression modeling post-analysis to look at what impact the removal of very small establishments would have on the risk assessment 

results (see the risk assessment for further details). That post-analysis showed no discernible difference from inclusion of very small establishments in the changes in attributable human illnesses due to the poultry slaughter rule. 6The FSIS estimate for the average cost of Salmonella illnesses ($2,423 per case—2010 dollars) was developed using the USDA, ERS 

Foodborne Illness Costs Calculator: Salmonella (June-2011). FSIS updated the ERS calculator to include Scallan case distribution for Salmonella. Scallan, E., Hoekstra, R., Angulo, F., et.al. (2011). Foodborne Illness Acquired in the United States—Major Pathogens. Emerging Infectious Diseases, 17 (1), 7–15. 7The FSIS estimate for the average cost of Campylobacter illnesses ($2,067 per case—2009 dollars, the latest cost per illness data available) 

is based on Hoffman (2012). Annual Cost of Illness and QALY-Adjusted Life Year Losses in the United States Due to Fourteen Foodborne 

Pathogens. Journal of Food Protection, 75(7), 1292–1302. The ERS Cost calculator does not include an estimate for Campylobacter illnesses. 

Potential annual benefits as shown in 

Table 9 would not be realized fully 

unless and until all establishments 

convert to NPIS. Since the adoption of 

NPIS may occur over a five year period, 

FSIS estimated the incremental public 

health benefits that would be achieved 

under this scenario as establishments 

make the transition to the new system. 

FSIS used approximate volume 

distributions 41 along with the assumed 

implementation timeline to calculate 

these estimates, displayed in Table 10. 

TABLE 10—ESTIMATED INCREMENTAL PUBLIC HEALTH BENEFITS IF ALL LARGE AND SMALL NON-TRADITIONAL

ESTABLISHMENTS ADOPT NPIS WITHIN 5 YEARS

Year 1 Year 2 Year 3 Year 4 Recurring 

Salmonella Cost Savings ........................................... 2 .89 5 .78 8 .68 9 .16 9 .64 

Campylobacter Cost Savings and Incremental Longevity Value ............................................................ 0 .52 1 .04 1 .57 1 .65 1 .74 

Total Cost Savings and Incremental Longevity Value 3 .41 6 .83 10 .24 10 .81 11 .38 

10th Percentile ........................................................... 1 .16 2 .32 3 .48 3 .68 3 .87 

90th Percentile ........................................................... 6 .21 12 .42 18 .63 19 .67 20 .70 

Expected value 10th Percentile 90th Percentile 

Annualized total cost savings and Incremental Longevity Value (7% for 10 

years) ............................................................................................................... 9.56 3.25 17.39 

Annualized total cost savings and Incremental Longevity Value (3% for 10 

years) ............................................................................................................... 9.79 3.33 17.81 

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49626 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

Unquantifiable Benefits and Costs 

Associated With NPIS and the 

Mandatory Portion of the Rule—Public 

Health Benefits Resulting From 

Preventing Contamination of Carcasses 

and Parts by Enteric Pathogens and 

Fecal Material Throughout the Entire 

Slaughter and Dressing Operation 

In addition to the benefits listed in the 

previous section, FSIS expects benefits 

associated with an increase in line 

speed for turkey establishments. Turkey 

establishments will have the option of 

increasing their line speed from a 

maximum of 51 to 55 birds per minute. 

Establishments will determine their line 

speeds based on their equipment and 

facilities, bird size and flock conditions, 

and their ability to maintain process 

control when operating at a given line 

speed. 

FSIS also expects public health 

benefits from the mandatory component 

of the rule, which will apply to all 

poultry slaughter establishments. FSIS 

is requiring that all poultry slaughter 

establishments develop, implement, and 

maintain, as part of their HACCP plans, 

sanitation SOPs, or other prerequisite 

programs, written procedures to prevent 

contamination of carcasses and parts by 

enteric pathogens and fecal 

contamination throughout the entire 

slaughter and dressing operation. FSIS 

is requiring that, at a minimum, these 

procedures must include sampling and 

analysis for microbial organisms at the 

pre-chill and post-chill points in the 

process to monitor process control for 

enteric pathogens. The exceptions are 

for very small HACCP size 

establishments and very low volume 

establishments that choose to operate 

under the modified Traditional 

Inspection System for which FSIS will 

permit sampling at post-chill only if 

they show that testing at one location is 

sufficient. Effective sanitary dressing 

and process control procedures are 

crucial to an establishment’s ability to 

produce a clean, safe, and wholesome 

product. The existing regulations 

require that establishments prevent 

poultry carcasses contaminated with 

visible fecal contamination from 

entering the chiller (9 CFR 381.65(a)). 

To enhance compliance with this 

requirement, FSIS is requiring that 

establishments develop, implement, and 

maintain written procedures that ensure 

that poultry carcasses contaminated 

with visible fecal material do not enter 

the chiller. 

While preventing poultry carcasses 

contaminated with visible fecal material 

from entering the chiller is an important 

safeguard for reducing the prevalence of 

pathogens on poultry carcasses, this 

result generally cannot be effectively 

accomplished unless establishments 

implement appropriate measures to 

prevent contamination from occurring 

throughout the slaughter and dressing 

operation and implement process 

controls for them. 

Although many establishments do 

have process control measures in place 

to prevent contamination of carcasses by 

enteric pathogens and fecal material 

throughout the slaughter and dressing 

process, they are not required to 

maintain written procedures that 

describe their measures and process 

controls or to maintain records to verify 

the effectiveness of their process 

controls in preventing contaminated 

carcasses from entering the chiller. 

Written plans that describe an 

establishment’s procedures and 

controls, including monitoring and 

evaluation criteria, will greatly aid 

establishments in consistently ensuring 

compliance with preventing fecal 

material on carcasses from entering the 

chiller. The written plans and record 

keeping requirement of this rule will 

also aid FSIS’s inspectors in evaluations 

of an establishment’s procedures that 

are designed to ensure compliance with 

the regulations. 

In addition, under the existing 

regulations, official poultry slaughter 

establishments are required to comply 

with requirements for testing for generic 

E. coli at the end of the chilling process 

as a means of verifying process control. 

As discussed earlier in this document, 

FSIS’s experience with using post-chill 

testing for generic E. coli to monitor 

process control for fecal contamination 

and sanitary dressing has led the 

Agency to conclude that such testing 

might not be the most effective way to 

prevent contamination from occurring 

throughout the slaughter and dressing 

operation. Therefore, FSIS is removing 

the generic E. coli testing requirements 

and replacing them with a more 

microbiological-focused testing scheme 

that provides for testing at the pre-chill 

and post-chill locations. Such a testing 

scheme has the benefit of allowing 

poultry slaughter establishments to have 

the flexibility they need to determine 

which microbiological organisms and 

measurement procedures will best help 

them to monitor the effectiveness of 

their process control procedures. This 

will lead to more tailored, and thus 

more effective process monitoring and 

quicker response to out of control 

processing, thereby reducing 

contamination of pathogens on 

carcasses. 

The information and procedural 

enhancements described above may be 

followed by the disposal of 

contaminated product, cooking the 

product longer, or other cost-generating 

actions by the establishment. Thus, any 

unquantified public health benefits of 

the rule may be accompanied by 

unquantified industry costs. 

In summary, FSIS is requiring that 

establishments incorporate their 

procedures for preventing 

contamination of carcasses with enteric 

pathogens and fecal material into their 

HACCP systems, and that they maintain 

records sufficient to document the 

implementation and monitoring of their 

procedures. These records will improve 

the establishment’s overall HACCP 

system by providing additional 

documentation that the establishment 

and FSIS can use to verify the 

effectiveness of the establishment’s 

process control procedures. The records 

that would be required under this rule, 

including the records of the 

establishment’s testing results, will 

provide an establishment with ongoing 

information on the effectiveness of its 

process controls, and allow it to identify 

situations associated with an increase in 

microbial levels so that it can take the 

necessary corrective actions to prevent 

further potential contamination. The 

documentation could result in the lower 

probability of recall, resulting in 

enhanced product reputation when a 

product is not subject to recall, which 

would benefit the implementing 

establishment. The rule’s 

documentation requirements could also 

lower the costs of identifying 

contaminated product of a recall as well 

as limit the scope of a product recall 

should a recall occur, since the 

establishment records would allow it to 

identify the point when a lack of 

process control could have resulted in 

product contamination. 

Summary of Net Benefits 

Considering the benefits and costs 

discussed, if we were to assume for 

purposes of analysis that all small and 

large non-Traditional establishments 

were to switch to NPIS, FSIS expects 

average benefits to the public health and 

FSIS of about $32.4 million (annualized, 

10-years at 7 percent). In this case, 

annualized (10-years, at 7 percent) 

industry costs are an estimated $25.1 

million. Annual net benefits, therefore, 

would be an estimated $7.3 million. 

Table 11 provides the summary of 

estimated annualized net benefits for 

various possible percentages of the 

industry that switch to NPIS. As noted 

above, NPIS may provide an incentive 

for establishments to switch from their 

current inspection systems to NPIS; 

however, it is possible that the costs 

associated with NPIS adoption will be 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49627 

greater than the potential benefits for 

some establishments. Given the lack of 

data with which to make cost-benefit 

comparisons across the industry, Table 

11 presents a wide range of possibilities 

for the percentage of large and small 

non-Traditional establishments that will 

choose to adopt NPIS. 

TABLE 11—ESTIMATED NET SOCIAL BENEFITS FROM THE RULE (MILLIONS OF DOLLARS), ANNUALIZED OVER 10 YEARS

WITH A 7% DISCOUNT RATE, FOR VARYING PERCENT CHANGES THAT SWITCH TO NPIS 

Percentage of Industry that Switches to NPIS1

0% 10% 25% 50% 75% 90% 100% 

NPIS: 2

Benefits: 

Public health benefits 

(10%, 90%) ..................... 0.0 1.0 (0.3 to 1.7) 2.4 (0.8 to 4.3) 4.8 (1.6 to 8.7) 7.2 (2.4 to 13.0) 8.6 (2.9 to 15.7) 9.6 (3.3 to 17.4) 

FSIS net savings ....................... 0.0 2.3 5.7 11.4 17.1 20.5 22.8 

Unquantified benefits 3 ....... Increased flexibility for establishments to design and implement production measures tailored to their operations, in some cases 

possibly including increased line speed up to 140 chickens or 55 turkeys per minute 

Costs: 

Costs to establishments ..... 0.0 1.6 4.0 8.0 12.0 14.4 16.0 

Unquantified costs 3 ........... Industry costs of responding to new NPIS inspections in a manner that may lead to public health benefits (e.g., discarding 

contaminated food or cooking it longer) 

Mandatory Component: 

Costs to establishments ..... 9.1 9.1 9.1 9.1 9.1 9.1 9.1 

Unquantified benefits ......... Potential additional public health benefits from documentation and testing 

Unquantified costs ............. Industry costs of responding to information generated by documentation and testing in a manner that may lead to public health 

benefits (e.g., discarding contaminated food or cooking it longer) 

Total benefits (10%, 90%) 0.0 3.3 (2.6 to 4.0) 8.1 (6.5 to 10.0) 16.2 (13.0 to 

20.1) 

24.3 (19.5 to 

30.1) 

29.1 (23.4 to 

36.2) 

32.4 (26.0 to 

40.2) 

Total costs .......................... 9.1 10.7 13.1 17.1 21.1 23.5 25.1 

Net benefits (10%, 90%) .... ¥9.1 ¥7.4 (¥8.1 to 

¥6.7) 

¥5 (¥6.6 to 

¥3.1) 

¥0.9 (¥4.1 to 

3.0) 

3.2 (¥1.6 to 9.0) 5.6 (¥0.1 to 

12.7) 

7.3 (0.9 to 15.1) 

1For costs and FSIS net savings, the relevant industry measure is the percentage of large and small establishments that switch to NPIS, whereas for public health 

benefits, the relevant industry measure is percentage of product volume that is slaughtered in establishments that switch to NPIS. 2 The switch to NPIS includes two sets of policy changes: (1) the removal of some online FSIS inspectors, which generates labor cost savings for NPIS, costs to industry of training and attestation, and the unquantified benefit to establishments of increased flexibility, and (2) the increase in offline inspection activities by FSIS, 

which generates the estimated public health improvements, the associated unquantified costs, the quantified costs to industry of installing new inspection stations, 

and the quantified costs to FSIS of grade increases, training and relocation. 3 As with quantified costs and benefits, unquantified NPIS-related cost and benefit estimates would be scaled proportionately to reflect the percentage of the industry that switches to NPIS. 

4 Annualized Over 10 Years with a 3% discount rate at 100% adoption rate, total benefits (10%, 90%) equal $33.6 million (27.1 to 41.6), total costs equal $25.3 

million. Net benefits equal $8.3 million (1.8 to 16.3). 

Analysis of Considered Alternatives 

TABLE 13—COMPARISONS OF THE CONSIDERED ALTERNATIVES TO THE FINAL POULTRY SLAUGHTER RULE

Considered alternatives Benefits Costs 1 Net benefits 

A. Taking No Action ....................... No change in the existing inspection systems for poultry. FSIS 

does not need significantly 

more resources.

Establishments would maintain 

existing practices.

Zero Net Benefits. 

B. The Rule .................................... Public health benefits from reduced illnesses and FSIS savings add to total benefits of 

$26.0 million to $40.2 million 

annually. Additional 

unquantified public health benefits from NPIS and mandatory 

components of the rule.

Annualized costs equal $25.1 million. See Tables 7a and 7b 

above for explanation of these 

costs.

Selected Alternative with 

annualized net benefits equal 

$7.3 million. 

C. The Final Rule Without Offline 

Inspection Activity.

Additional FSIS cost savings associated with a reduction in offline inspector positions.Annualized costs equal to Alternative B.Net benefits will be lower than Alternative B due to loss of public 

health benefits. 

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49628 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

42Please see the FDA’s preliminary regulatory 

impact analysis of the Preventive Controls rule for 

a similar discussion of recordkeeping benefits. 

TABLE 13—COMPARISONS OF THE CONSIDERED ALTERNATIVES TO THE FINAL POULTRY SLAUGHTER RULE—Continued 

Considered alternatives Benefits Costs 1 Net benefits 

D. Requiring Only the New Poultry 

Inspection System.

Public health benefits from reduced illnesses and FSIS savings add to total benefits of 

$26.1 million to $40.2 million 

annually No additional 

unquantified benefits, as detailed in section titled 

‘‘Unquantifiable Benefits Associated with the Mandatory Portion 

of the Rule.’’.

Annualized costs greater than 

$20.5 million. All establishments 

not included in Alternative B will 

accrue additional costs.

The net benefits will be lower than 

Alternative B due to the increased burden on very small 

establishments. 

A. Taking No Action 

FSIS considered maintaining the 

current inspection system and finished 

product standards requirements for the 

289 establishments that slaughtered 

young chickens and turkeys, and other 

poultry in 2010. FSIS rejected this 

alternative because the NPIS will allow 

poultry establishments slaughtering 

young chickens, turkeys and other 

poultry to benefit and to enhance their 

food safety efforts through increased 

flexibility and opportunity for 

innovation. FSIS would not be able to 

focus its inspection activities on 

verification of process controls for 

product safety and OCPs or on 

additional offline activities (such as 

unscheduled sanitary procedures, for 

example). Therefore this alternative 

would not result in any public health 

benefits. This action will have zero net 

benefits. 

B. The Rule 

FSIS’s preferred alternative is the 

final rule as discussed above. The final 

rule has an elective NPIS for young 

chickens and turkeys; a modified 

Traditional Inspection System for all 

poultry other than ratites; requirements 

that establishments develop, implement, 

and maintain written procedures to 

prevent contamination of carcasses with 

enteric pathogens and fecal material 

contamination, and that these 

procedures include, at a minimum, two 

locations for sampling for microbial 

organisms to monitor process control for 

enteric pathogens (except HACCP very 

small and very low volume 

establishments); and other actions (see 

Table 2). 

The rule gives the individual 

establishment the choice between the 

NPIS (with or without the HIMP SIP 

waiver), the modified Traditional 

Inspection System, and their current 

inspection system (SIS, NELS, or NTIS). 

An establishment will choose the NPIS 

if the benefits, primarily from the 

expected increased flexibility of 

operations, exceed the costs of 

implementation. While this would 

probably be true for the HACCP large 

and HACCP small establishments that 

slaughter young chickens and turkeys, it 

may not be true for the HACCP very 

small establishments. FSIS selected this 

alternative to minimize the impact on 

very small establishments and to allow 

them the flexibility to choose the 

modified Traditional Inspection System 

or their current inspection system if 

they stand to lose from the NPIS. 

Public health benefits (as discussed in 

section titled ‘‘Expected Benefits 

Associated with the NPIS—Public 

Health Benefits from Reallocating FSIS 

Inspection Activities’’) of the rule 

include a reduction in illnesses 

attributed to young chicken and turkey. 

The monetized annualized value of this 

reduction is $3.3 million to $17.4 

million. FSIS annualized savings under 

the rule are expected to equal $22.8 

million. 

Costs of the rule include $16.0 million 

annualized for the conversion of 

establishments to NPIS, and $9.1 

million annualized (10 years, 7 percent) 

for the mandatory component of the rule 

(see Tables 7a and 7b). This corresponds 

to total costs of about $25.1 million 

annualized. Net benefits of the rule are 

estimated at $7.3 million. 

C. The Rule Without Offline Inspection 

Activities 

Removing the offline inspectors 

would eliminate the health benefits of 

the rule which is the main purpose of 

the rule. While removing offline 

inspectors might affect the savings for 

FSIS, the Agency could not estimate any 

additional savings at this time because 

the offline inspectors were part of an 

integrated inspections plan so the 

offline inspectors could not be pulled 

out of the plan or the estimate. More 

importantly, any changes to FSIS 

savings would be insignificant 

compared to the loss of public health 

benefits. 

D. Requiring the New Poultry Inspection 

System 

FSIS considered requiring that all 

establishments convert to the NPIS. The 

benefits from this alternative include, as 

under the rule, the budgetary savings to 

FSIS from reallocation of personnel and 

public health benefits of $9.6 million 

annually from reduced illnesses. 

As shown in Table 7a, costs to firms 

that adopt the new rule are about $16.0 

million annualized over 10 years at 7 

percent. 

Under this alternative, all firms, 

including the very small firms that FSIS 

expects will not adopt the rule, must 

adopt some measures, as listed in Table 

7b. These costs are from plan 

development, recordkeeping and 

testing. The benefits 42 of these activities 

include the conduct of business in a 

manner more accountable to the public; 

the support and documentation of 

production safety decision-making; and 

the facilitation of oversight and 

transparency activities like audits and 

inspections. The recordkeeping 

requirements are designed to help 

operators of facilities and the Agency to 

identify potential sources of 

contamination as well as contain and 

mitigate the adverse health effects of 

contaminated food. Many of these 

benefits are unquantifiable: the lower 

probability of recall, the lower costs of 

identifying contaminated product if a 

recall occurs, and enhanced product 

reputation when a product is not subject 

to recall, all benefit the implementing 

firms. Table 7c lists the mandatory costs 

that FSIS expects for the 54 very small 

establishments that FSIS projects will 

not adopt the new inspection system. 

This alternative would result in 

higher costs for the industry, 

specifically for very small 

establishments that would have 

difficulty absorbing such costs. The 

annual benefits would be the same as 

alternative B, the rule. FSIS rejected this 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49629 

43The Small Business Administration defines a 

small business in poultry processing as an entity 

that is independently owned and operated, is 

organized for profit, is not dominant, and has 500 

or fewer employees. 44HAACP production size classes: large 

establishments, with 500 or more employees; small 

establishments, with 10–499 employees; and very 

small establishments, with fewer than 10 employees 

or annual sales of less than $2.5 million. 

alternative because it would result in 

lower net benefits. 

V. Final Regulatory Flexibility Act 

In accordance with the Regulatory 

Flexibility Act, FSIS reviewed the rule 

for its effects on small businesses. In 

response to public comments received 

on the impact on small business, FSIS 

relaxed the proposed requirement for 

small businesses to sample and test at 

pre-chill and post-chill to allow very 

small HACCP size establishments to 

sample and test only at post-chill. In 

addition, FSIS is maintaining its present 

sampling frequency requirement for 

very low volume establishments. This 

change reduces the costs imposed on 

small establishments. The FSIS 

Administrator certifies that, for the 

purposes of the Regulatory Flexibility 

Act (5 U.S.C. 601–602), this rule will 

not have a significant economic impact 

on a substantial number of small entities 

in the United States. 

In this final regulatory flexibility 

analysis, FSIS first analyzes the impact 

on the Agency-assigned HACCP small 

and very small size categories. Then, 

FSIS highlights the minimal impact of 

the regulation on very small and small 

companies. 

FSIS will modernize and streamline 

poultry slaughter inspection because of 

its 2011 regulatory review. The Agency 

is taking this action to improve food 

safety and the effectiveness of poultry 

slaughter inspection systems, remove 

unnecessary regulatory obstacles to 

innovation, and make better use of the 

Agency’s resources. 

In this final regulatory flexibility 

analysis, FSIS uses a definition of small 

entities that is similar, but not identical, 

to that used by the Small Business 

Administration 43 and is more 

appropriate with respect to estimating 

possible adverse economic effects. The 

Small Business Administration defines 

a small business in terms of ownership, 

while the HACCP production size 

definition 44 applies to individual 

establishments and not companies that 

might own more than one 

establishment. FSIS considers 

establishments to be the economic 

entity of interest in this rule and thus 

uses the HACCP size definition to 

characterize establishments that this 

rule might affect adversely. 

FSIS considered requiring the 

mandatory use of dressing performance 

standards and the NPIS in all federally 

inspected establishments that slaughter 

young chickens and turkeys, but 

rejected that alternative in order to 

provide small and very small HACCP 

size establishments with a choice 

between using the NPIS, or using the 

modified Traditional Inspection System. 

Given a choice, FSIS anticipates that 

large and small HACCP size 

establishments that slaughter young 

chickens and turkeys will find it in their 

economic interest to adopt the new 

inspection system. In contrast, FSIS 

anticipates that HACCP very small 

establishments that slaughter young 

chickens and turkeys will choose to 

operate under the modified Traditional 

Inspection System. The very small 

HACCP size young chicken and turkey 

establishments, in general, do not have 

sufficient output volume over which to 

spread the initial set-up costs of the 

NPIS or the training and maintenance 

costs resulting from this system. There 

are 51 such establishments. In addition, 

HACCP establishments that slaughter 

poultry other than young chickens and 

turkeys will operate under the modified 

Traditional Inspection System. There 

are 19 establishments that slaughter 

poultry other than young chickens and 

turkeys, of which 14 are small HACCP 

size establishments and three are very 

small HACCP size establishments. 

Consequently, we identify 68 

establishments that might not realize the 

full benefits of the rule. Table 14 shows 

the number of poultry slaughter 

facilities by HACCP size and type of 

poultry slaughtered based on the above 

discussion. 

TABLE 14—SUMMARY OF HACCP ESTABLISHMENT SIZE OF THE 289 OFFICIAL ESTABLISHMENTS THAT SLAUGHTERED ALL

POULTRY UNDER FEDERAL INSPECTION IN 2010 (FSIS ADRS, 2010) 

Type of Operation Very small Small Large Total Percent of all 

establishments 

Young Chicken and Turkeys ................. 51 70 149 270 93 

Other Poultry .......................................... 3 14 2 19 7 

Total ................................................ 54 84 151 289 100 

In Table 15, in contrast to Table 15, 

FSIS classified the 289 establishments 

into the appropriate SBA categories in 

order to show the establishment 

distribution over SBA small and large 

companies by number of companies and 

number of establishments. 

TABLE 15—DISTRIBUTION OF ESTABLISHMENTS OVER SBA DEFINED SMALL AND NOT-SMALL COMPANIES

Company size (SBA definition) Number of 

companies 

Number of 

establishments 

Share of 

establishments 

Small .......................................................................................................................... 109 110 38% 

Large .......................................................................................................................... 49 179 61% 

Total .................................................................................................................... 158 289 100% 

Approximately 38 percent, or 110, of 

all establishments belong to SBA small 

companies. Some of the SBA companies 

are not very low volume slaughter 

operations and FSIS expects many will 

choose to operate under NPIS. 

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49630 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

Consequently, to measure possible 

adverse impact on small business, 

FSIS’s analysis concentrates on the 68 

establishments identified above. 

Cost Impact—Very Small 

Establishments 

FSIS projects the costs of the 

mandatory component of the rule to be 

approximately $218, annualized over 10 

years at a 7 percent discount rate, per 

very small HACCP size establishment 

processing young chickens, turkeys, or 

other types of poultry, for a total of 

about $11,759 annualized annualized 

across the existing 54 very small 

establishments (Table 7c). FSIS expects 

net annual recurring cost savings after 

the sixth year, because the rule permits 

these establishments to design more 

efficient process control plans, and 

sample only at one location. The cost 

savings associated with eliminating 

generic E. coli testing will more than 

offset the additional costs associated 

with the new required microbial testing 

requirement because the cost of 

analyzing for generic E. coli is more 

than that of analyzing for other indicator 

organisms and FSIS does not expect the 

number of samples per year to increase 

from the present. 

Cost Impact—Small Establishments 

For the 14 small HACCP size poultry 

slaughter establishments covered in this 

rule that do not process young chickens 

and turkeys, FSIS projects costs of the 

mandatory component of the rule to be 

approximately $11,579, annualized 10 

years at a 7 percent discount rate, per 

establishment, for a total of about 

$162,100 annualized across all 14 

establishments. Net annual recurring 

costs are approximately $10,319 per 

establishment after the sixth year, for a 

total of $144,470 across all 14 small 

establishments. 

Cost Impact—Total 

Table 16 presents the combined cost 

impact for both very small HACCP size 

establishments (Table 7c) and small 

HACCP size establishments that do not 

slaughter young chickens and turkeys. 

TABLE 16—ESTIMATED ANNUAL COST (OR COST SAVINGS) OF THE RULE FOR VERY SMALL HACCP SIZE ESTABLISHMENTS THAT PRODUCE YOUNG CHICKENS AND TURKEYS AND SMALL HACCP SIZE ESTABLISHMENTS THAT SLAUGHTER POULTRY OTHER THAN YOUNG CHICKENS AND TURKEYS

HACCP size Number of 

establishments Year 1 Recurring 

10 Year annualized 

7% 3% 

Very Small .............................................. 54 $109,069 ($3,177) $11,759 $9,599 

Small ...................................................... 14 $276,960 $144,470 $162,100 $159,549 

Total ................................................ 68 $386,029 $141,293 $173,859 $169,148 

VI. Executive Order 12988 

This rule has been reviewed under 

Executive Order 12988, Civil Justice 

Reform. When this final rule is adopted: 

(1) All State and local laws and 

regulation that are inconsistent with this 

rule will be preempted; (2) no 

retroactive effect will be given to this 

rule; and (3) administrative proceedings 

will not be required before parties ay 

file suit in court challenging this rule. 

VII. E-Government Act 

FSIS and USDA are committed to 

achieving the purposes of the EGovernment Act (44 U.S.C. 3601, et 

seq.) by, among other things, promoting 

the use of the Internet and other 

information technologies and providing 

increased opportunities for citizen 

access to government information and 

services, and for other purposes. 

VIII. Executive Order 13175 

This final rule has been reviewed in 

accordance with the requirements of 

Executive Order 13175, Consultation 

and Coordination with Indian Tribal 

Governments. The review reveals that 

this regulation will not have substantial 

and direct effects on Tribal governments 

and will not have significant Tribal 

implications. 

IX. USDA Non-Discrimination 

Statement 

USDA Non-Discrimination Statement 

No agency, officer, or employee of the 

USDA shall, on the grounds of race, 

color, national origin, religion, sex, 

gender identity, sexual orientation, 

disability, age, marital status, family/

parental status, income derived from a 

public assistance program, or political 

beliefs, exclude from participation in, 

deny the benefits of, or subject to 

discrimination any person in the United 

States under any program or activity 

conducted by the USDA. 

How To File a Complaint of 

Discrimination 

To file a complaint of discrimination, 

complete the USDA Program 

Discrimination Complaint Form, which 

may be accessed online at http://

www.ocio.usda.gov/sites/default/files/

docs/2012/Complain_combined_6_8_

12.pdf, or write a letter signed by you 

or your authorized representative. Send 

your completed complaint form or letter 

to USDA by mail, fax, or email: 

Mail 

U.S. Department of Agriculture, 

Director, Office of Adjudication, 1400 

Independence Avenue SW., 

Washington, DC 20250–9410. 

Fax 

(202) 690–7442. 

Email 

program.intake@usda.gov. 

Persons with disabilities who require 

alternative means for communication 

(Braille, large print, audiotape, etc.), 

should contact USDA’s TARGET Center 

at (202) 720–2600 (voice and TDD). 

X. Paperwork Reduction Act 

In accordance with section 3507(d) of 

the Paperwork Reduction Act of 1995 

(44 U.S.C. 3501 et seq.), the new 

information collection requirements 

included in this final rule have been 

submitted for approval to the Office of 

Management and Budget (OMB). 

Title: Poultry Slaughter Inspection. 

Type of Collection: New. 

Abstract: Under this final rule, each 

official poultry slaughter establishment 

will need to maintain as part of its 

HACCP plan, sanitation SOP, or other 

prerequisite program, written 

procedures addressing (1) the 

prevention throughout the entire 

slaughter and dressing operation, of 

contamination of carcasses and parts by 

enteric pathogens (e.g., Salmonella and 

Campylobacter) and by fecal material, 

and (2) the prevention of carcasses and 

parts contaminated by visible fecal 

material from entering the chiller. Each 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49631 

establishment operating under the New 

Poultry Inspection System (NPIS) will 

also be required to maintain, as part of 

its HACCP system, written procedures 

to prevent carcasses afflicted with 

septicemia and toxemia from entering 

the chiller. The procedures addressing 

prevention of contamination by enteric 

pathogens will need to include 

microbial testing. In addition, each 

establishment operating under NPIS 

will need to maintain records that 

document that the products resulting 

from its slaughter operations meet the 

definition of ready-to-cook poultry. 

Each establishment operating under the 

NPIS will also need to submit on an 

annual basis an attestation to the 

management member of the local FSIS 

circuit safety committee stating that it 

maintains a program to monitor and 

document any work-related conditions 

of establishment workers. 

The requirement that poultry 

slaughter establishments have written 

procedures in their HACCP plans, 

sanitation SOPs, or prerequisite 

programs is already covered under an 

approved information collection, 

Pathogen Reduction/Hazard Analysis 

and Critical Control Point Systems 

(OMB control number 0583–0103). 

Therefore, this requirement of this rule 

creates no new burden on 

establishments. 

The requirement that poultry 

slaughter establishments monitor their 

systems through microbial testing and 

recordkeeping creates a new 

information collection burden. For each 

sample for which a microbial test is 

conducted, there are two ‘‘responses’’ 

for the establishment: one response for 

the actual collecting of the sample and 

sending it to the laboratory for analysis, 

and the other for recording the sample 

result. In its initial paperwork burden 

estimate, FSIS estimated that large 

establishments would test and record 

microbial results at the two prescribed 

locations (pre- and post-chill), 15 times 

a day; small establishments, 7 times a 

day; and very small establishments, 3 

times a day. These estimates were based 

on the frequency with which 

establishments operating under a 

Salmonella Initiative Program (SIP) 

waiver conduct sampling. Under SIP, 

FSIS grants establishments a waiver of 

regulations under the condition that the 

establishment collects and analyzes 

samples for microbial organisms and 

shares the results with FSIS. 

In this final rule, FSIS has revised the 

regulations to prescribe a minimum 

frequency with which all establishments 

that slaughter poultry will need to 

conduct testing for microbial organism 

to monitor their process control 

procedures. FSIS has also revised the 

testing requirements to allow very small 

and very low volume establishments to 

conduct sampling at the post-chill point 

in the process only. These revisions are 

substantive changes that have resulted 

in a reduction in burden. Therefore, 

FSIS has updated its paperwork burden 

estimates to reflect these changes and 

has submitted the revised information 

and recordkeeping requirement to OMB 

for review. 

The average burden per response and 

the annual burden hours are explained 

below and summarized in the charts 

which follow. 

Estimated Annual Burden: Poultry 

Slaughter Inspection. 

Recordkeeping: 

Estimated Annual Recordkeeping 

Burden for Modernization of Poultry 

Slaughter Inspection 

Respondents: Official poultry 

establishments. 

Estimated Number of Respondents: 

289. 

Estimated Average Annual Number of 

Responses (samples) per Respondent: 

Large establishments 4,322.7; small 

establishments 1,318; very small 

establishments 21.3. 

Estimated Total Annual Responses: 

764,594. 

Estimated Total Annual 

Recordkeeping Burden: 31,858 hours. 

Respondents 

Estimated 

number of 

respondents 

Average 

annual 

number of 

responses 

per 

respondent 

Total annual 

responses 

Time per 

response in 

minutes 

Total annual 

burden 

hours 

Large establishments ................... Microbial testing data recordkeeping.151 4,322.7 652,773 2.5 21,197 

Small establishments .................... Microbial testing data recordkeeping.84 1,318 110,712 2.5 4,613 

Very small establishments ............ Microbial testing data recordkeeping.54 21.3 1,134 2.5 48 

Total Recordkeeping Burden ....................................................... 289 2,645.6 764,594 2.5 31,858 

Reporting 

Estimated Annual Reporting Burden for 

Poultry Slaughter Inspection 

Respondents for this Rule: Official 

poultry establishments. 

Estimated Number of Respondents: 

289. 

Estimated Average Annual Number of 

Responses per Respondent: Large 

establishments 4,322.7; small 

establishments 1,318; very small 

etablishments 21.3. 

Estimated Total Annual Responses: 

764,594. 

Estimated Total Annual Reporting 

Burden on Respondents: 159,339 hours. 

Respondents 

Estimated 

number of 

respondents 

Average 

annual 

number of 

responses 

per 

respondent 

Total annual 

responses 

Time per 

respone in 

minutes 

Total annual 

burden 

hours 

Large establishments ................... Microbial testing ............................ 151 4,322.7 652,773 12.5 135,986 

Small establishments .................... Microbial testing ............................ 84 1,318 110,712 12.5 23,065 

Very small establishments ............ Microbial testing ............................ 54 21.3 1,134 15 288 

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49632 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

Respondents 

Estimated 

number of 

respondents 

Average 

annual 

number of 

responses 

per 

respondent 

Total annual 

responses 

Time per 

respone in 

minutes 

Total annual 

burden 

hours 

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

SUMMARY OF BURDEN—POULTRY

SLAUGHTER INSPECTION

Total No. respondents .......... 289 

Average Annual No. responses per respondent ... 5,291.3 

Total annual responses ........ 1,529,188 

Average hours per response .125 

Total annual burden hours ... 191,197 

In this final rule, FSIS is adding a new 

regulation that creates a new 

information collection burden, in that it 

requires that poultry slaughter 

establishments operating under the 

NPIS submit on an annual basis an 

attestation to the management member 

of the local FSIS circuit safety 

committee stating that it maintains a 

program to monitor and document any 

work-related conditions of 

establishment workers. This is a new 

recordkeeping requirement that FSIS 

has submitted to OMB for approval. 

The average burden per response and 

the annual burden hours are explained 

below and summarized in the charts 

which follow. 

Estimated Annual Burden: Poultry 

Slaughter Inspection 

Reporting: 

Estimated Annual Reporting Burden for 

Submitting an Annual Attestation on 

Work-Related to the FSIS Circuit Safety 

Committee 

Respondents: Official poultry 

establishments that operate under the 

NPIS. 

Estimated Maximum Number of 

Potential Respondents: 219. 

Estimated Average Annual Number of 

Responses per Respondent: Large 

establishments 1; small establishments 

1; very small establishments 0. 

Estimated Maximum Total Potential 

Annual Responses: 219. 

Estimated Total Annual 

Recordkeeping Burden: 7.27 hours. 

Maximum potential respondents: 

establishments operating under 

the NPIS 

Estimated 

number of 

potential 

respondents 

Average 

annual 

number of 

responses 

per 

potential 

respondent 

Total annual 

potential 

responses 

Time per 

potential 

response in 

minutes 

Total 

potential 

annual 

burden 

hours 

Large establishments ................... Attestation on Work-Related Conditions.149 1 149 2 4.97 

Small establishments .................... Attestation on Work-Related Conditions.70 1 70 2 2.3 

Very small establishments ............ ....................................................... 0 0 0 .................... 0 

Total Reporting Burden ......... ....................................................... 219 1 219 .................... 7.27 

Copies of this information collection 

assessment can be obtained from Gina 

Kouba, Paperwork Reduction Act 

Coordinator, Food Safety and Inspection 

Service, USDA, 1400 Independence 

Ave. SW., Room 6065 South Building, 

Washington, DC 20250–3700; (202) 720– 

5627. 

Comments are invited on: (a) Whether 

the proposed collection of information 

is necessary for the proper performance 

of FSIS’s functions, including whether 

the information will have practical 

utility; (b) the accuracy of FSIS’s 

estimate of the burden of the proposed 

collection of information, including the 

validity of the methodology and 

assumptions used; (c) ways to enhance 

the quality, utility, and clarity of the 

information to be collected; and (d) 

ways to minimize the burden of the 

information collection on those who are 

to respond, including through the use of 

appropriate automated, electronic, 

mechanical, or other technological 

collection techniques or other forms of 

information technology. 

Comments on the proposed 

information collection may be sent to 

both Gina Kouba, Paperwork Reduction 

Act Coordinator, at the address 

provided above, and the Desk Officer for 

Agriculture, Office of Information and 

Regulatory Affairs, Office of 

Management and Budget, Washington, 

DC 20253. To be most effective, 

comments should be sent to OMB 

within 60 days of the publication date 

of this final rule. 

XI. Additional Public Notification 

Public awareness of all segments of 

rulemaking and policy development is 

important. Consequently, in an effort to 

ensure that the public and in particular 

minorities, women, and persons with 

disabilities, are aware of this final rule, 

FSIS will announce it online through 

the FSIS Web page located at http://

www.fsis.usda.gov/regulations_&_

policies/Final_Rules/index.asp. 

FSIS also will make copies of this 

Federal Register publication available 

through the FSIS Constituent Update, 

which is used to provide information 

regarding FSIS policies, procedures, 

regulations, Federal Register notices, 

FSIS public meetings, and other types of 

information that could affect or would 

be of interest to our constituents and 

stakeholders. The Update is 

communicated via Listserv, a free email 

subscription service consisting of 

industry, trade, and farm groups, 

consumer interest groups, allied health 

professionals, scientific professionals, 

and other individuals who have 

requested to be included. The Update 

also is available on the FSIS Web page. 

Through Listserv and the Web page, 

FSIS is able to provide information to a 

much broader, more diverse audience. 

In addition, FSIS offers an email 

subscription service which provides 

automatic and customized access to 

selected food safety news and 

information. This service is available at 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49633 

http://www.fsis.usda.gov/news_&_

events/email_subscription/. Options 

range from recalls to export information 

to regulations, directives and notices. 

Customers can add or delete 

subscriptions themselves, and have the 

option to password protect their 

accounts. 

List of Subjects 

9 CFR Part 381 

Poultry inspection, Poultry products, 

Reporting and recordkeeping 

requirements. 

9 CFR Part 500 

Administrative practice and 

procedure, Meat inspection, Poultry and 

poultry products. 

For the reasons stated in the 

preamble, FSIS is amending 9 CFR 

Chapter III as follows: 

PART 381—POULTRY PRODUCTS 

INSPECTION REGULATIONS 

■ 1. The authority citation for part 381 

continues to read as follows: 

Authority: 7 U.S.C. 138f, 450; 21 U.S.C. 

451–470; 7 CFR 2.7, 2.18, 2.53. 

■ 2. Amend § 381.36 by adding a new 

paragraph (f) to read as follows: 

§ 381.36 Facilities required. 

* * * * * 

(f) Facilities for post-mortem 

inspection under the New Poultry 

Inspection System. The following 

facilities requirements apply to 

establishments operating under the New 

Poultry Inspection System and are in 

addition to the requirements for 

obtaining a grant of inspection. 

(1) The following provisions apply to 

the online carcass inspection station: 

(i) On each production line, at a point 

before the chiller and after the 

establishment has completed all sorting, 

trimming, and reprocessing activities 

necessary to comply with 

§ 381.76(b)(6)(ii), at least 4 feet of floor 

space along the conveyor line must be 

provided for one online carcass 

inspection station. 

(ii) The conveyor line must be level 

for the entire length of the online 

carcass inspection station. The vertical 

distance from the bottom of the shackles 

to the top of the platform (paragraph 

(f)(1)(iii) of this section) must not be less 

than 60 inches. 

(iii) Each online carcass inspection 

station must have a platform that is slipresistant and can be safely accessed by 

the inspector. The platform must be 

designed so that it can be easily and 

rapidly adjusted for a minimum of 14 

inches vertically while standing on the 

platform. The platform must be a 

minimum length of 4 feet and have a 

minimum width of 2 feet. The platform 

must be designed with a 42-inch high 

rail on the back side and with 1⁄2-inch 

foot bumpers on both sides and front to 

allow safe working conditions. The 

platform must have a safe lift 

mechanism and be large enough for the 

inspector to sit on a stool and to change 

stations during breaks or station 

rotation. 

(iv) Conveyor line stop/start switches 

must be located within easy reach of the 

online carcass inspector. 

(v) A minimum of 200 foot-candles of 

shadow-free lighting with a minimum 

color rendering index value of 85 must 

be provided where the birds are 

inspected to facilitate online carcass 

inspection. 

(vi) Hand rinsing facilities must be 

provided for use by and within easy 

reach of the online carcass inspector. 

The hand rinsing facilities must have a 

continuous flow of water or be capable 

of being immediately activated and 

deactivated in a hands-free manner, 

must minimize any splash effect, and 

must otherwise operate in a sanitary 

manner that prevents contamination of 

carcasses and inspector clothing. The 

hand rinsing facilities must provide 

water at a temperature between 65 and 

120 degrees Fahrenheit. 

(vii) A separate clipboard holder for 

holding recording sheets must be 

provided for and within easy reach of 

the online carcass inspector. 

(viii) Receptacles for condemned 

carcasses and parts that comply with the 

performance standards in § 416.3(c) of 

this chapter must be provided at each 

online carcass inspection station. 

(ix) Hangback racks designed to hold 

at least 10 carcasses must be provided 

and positioned within easy reach of the 

online carcass inspector. 

(x) A buzzer shall be located within 

easy reach of the online carcass 

inspector to be used by the carcass 

inspector to alert the inspector-incharge, offline inspectors, or 

establishment management of 

conditions that require their attention. 

(2) The following provisions apply to 

pre-chill and post-chill offline 

verification inspection stations: 

(i) One or more offline verification 

inspection stations must be located at 

the end of the line or lines prior to the 

chiller. One or more offline verification 

inspection stations must also be located 

after the chiller or chillers. The Agency 

will determine the total number of 

offline verification inspection stations 

needed in establishments having more 

than one processing line or more than 

one chiller. 

(ii) Floor space for all offline 

verification inspection stations must 

consist of a minimum of 3 feet along 

each conveyor line and after each 

chiller, as applicable, to allow carcasses 

to be removed for evaluation by the 

verification inspector. The space must 

be level and protected from all traffic 

and overhead obstructions. 

(iii) At the pre-chill location, the 

vertical distance from the bottom of the 

shackles to the floor must not be less 

than 48 inches. 

(iv) At each offline verification 

inspection station, a table designed to be 

readily cleanable and drainable must be 

provided for offline verification 

inspectors to conduct offline 

verification activities. At turkey 

slaughter establishments, the table must 

be at least 3 feet wide, 2 feet deep, and 

3 feet high. At all other poultry 

slaughter establishments, the table must 

be at least 2 feet wide, 2 feet deep, and 

3 feet high 

(v) A minimum of 200 foot-candles of 

shadow-free lighting with a minimum 

color rendering index of 85 on the table 

surface must be provided. 

(vi) The establishment must provide a 

separate clipboard holder for holding 

recording sheets; or alternatively, the 

establishment may provide electronic 

means for the offline verification 

inspector to record inspection results. 

(vii) Hangback racks designed to hold 

at least 10 carcasses must be provided 

and positioned within easy reach of the 

offline verification inspector. 

(viii) Hand washing facilities must be 

provided within easy access of all 

offline verification inspection stations. 

(3) Each young chicken establishment 

operating under the New Poultry 

Inspection System must provide a 

location at a point along the production 

line after the carcasses are eviscerated at 

which an inspector may safely and 

properly inspect for leukosis the first 

300 carcasses of each flock together with 

associated viscera either uniformly 

trailing or leading, or otherwise 

identified with the corresponding 

carcass. The leukosis inspection area 

must provide a minimum of 200 footcandles of shadow-free lighting on the 

surface where the viscera are inspected. 

(4) A trough or other similar drainage 

facility must extend beneath the 

conveyor at all places where processing 

operations are conducted from the point 

where the carcass is opened to the point 

where trimming has been performed. 

The trough must be of sufficient width 

to preclude trimmings, drippage, and 

debris from accumulating on the floor or 

platforms. The clearance between 

suspended carcasses and the trough 

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49634 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

must be sufficient to preclude 

contamination of carcasses by splashing. 

■ 3. A new subpart H is added to part 

381 to read as follows: 

Subpart H—Attestation on WorkRelated Conditions 

Sec. 

381.45 Attestation requirements. 

381.46 Severability. 

§ 381.45 Attestation requirements. 

Each establishment that participates 

in the New Poultry Inspection System 

(NPIS) shall submit on an annual basis 

an attestation to the management 

member of the local FSIS circuit safety 

committee stating that it maintains a 

program to monitor and document any 

work-related conditions of 

establishment workers, and that the 

program includes the following 

elements: 

(a) Policies to encourage early 

reporting of symptoms of injuries and 

illnesses, and assurance that it has no 

policies or programs in place that would 

discourage the reporting of injuries and 

illnesses. 

(b) Notification to employees of the 

nature and early symptoms of 

occupational illnesses and injuries, in a 

manner and language that workers can 

understand, including by posting in a 

conspicuous place or places where 

notices to employees are customarily 

posted, a copy of the FSIS/OSHA poster 

encouraging reporting and describing 

reportable signs and symptoms. 

(c) Monitoring on a regular and 

routine basis of injury and illness logs, 

as well as nurse or medical office logs, 

workers’ compensation data, and any 

other injury or illness information 

available. 

§ 381.46 Severability. 

Should a court of competent 

jurisdiction hold any provision of this 

part 381, subpart H to be invalid, such 

action shall not affect any other 

provision of this part 381. 

■ 4. Amend § 381.65 as follows: 

■ a. Redesignate paragraphs (e) and (f) 

as paragraphs (f) and (e) respectively. 

■ b. Revise newly redesignated 

paragraph (f). 

■ c. Add new paragraphs (g) and (h). 

The revisions and additions read as 

follows: 

§ 381.65 Operations and procedures, 

generally. 

* * * * * 

(f) Procedures for controlling visible 

fecal contamination. Official poultry 

slaughter establishments must develop, 

implement, and maintain written 

procedures to ensure that poultry 

carcasses contaminated with visible 

fecal material do not enter the chiller. 

Establishments must incorporate these 

procedures into their HACCP plans, or 

sanitation SOPs, or other prerequisite 

programs. 

(g) Procedures for controlling 

contamination throughout the slaughter 

and dressing operation. Official poultry 

slaughter establishments must develop, 

implement, and maintain written 

procedures to prevent contamination of 

carcasses and parts by enteric pathogens 

and fecal contamination throughout the 

entire slaughter and dressing operation. 

Establishments must incorporate these 

procedures into their HACCP plans, or 

sanitation SOPs, or other prerequisite 

programs. At a minimum, these 

procedures must include sampling and 

analysis for microbial organisms in 

accordance with the sampling location 

and frequency requirements in 

paragraphs (g)(1) and (2) of this section 

to monitor their ability to maintain 

process control. 

(1) Sampling locations. 

Establishments, except for very small 

establishments operating under 

Traditional Inspection or very low 

volume establishments operating under 

Traditional Inspection must collect and 

analyze samples for microbial organisms 

at the pre-chill and post-chill points in 

the process. Very small establishments 

operating under Traditional Inspection 

and very low volume establishments 

operating under Traditional Inspection 

must collect and analyze samples for 

microbial organisms at the post-chill 

point in the process. 

(i) Very small establishments are 

establishments with fewer than 10 

employees or annual sales of less than 

$2.5 million. 

(ii) Very low volume establishments 

annually slaughter no more than 

440,000 chickens, 60,000 turkeys, 

60,000 ducks, 60,000 geese, 60,000 

guineas, or 60,000 squabs. 

(2) Sampling frequency. (i) 

Establishments, except for very low 

volume establishments as defined in 

paragraph (g)(1)(ii) of this section, must, 

at a minimum, collect and analyze 

samples at a frequency proportional to 

the establishment’s volume of 

production at the following rates: 

(A) Chickens. Once per 22,000 

carcasses, but a minimum of once 

during each week of operation. 

(B) Turkeys, ducks, geese, guineas, 

and squabs. Once per 3,000 carcasses, 

but at a minimum once each week of 

operation. 

(ii) Very low volume establishments 

as defined in paragraph (g)(1)(ii) of this 

section must collect and analyze 

samples at least once during each week 

of operation starting June 1 of every 

year. If, after consecutively collecting 13 

weekly samples, a very low volume 

establishment can demonstrate that it is 

effectively maintaining process control, 

it may modify its sampling plan. 

(iii) Establishments must sample at a 

frequency that is adequate to monitor 

their ability to maintain process control 

for enteric pathogens. Establishments 

must maintain accurate records of all 

test results and retain these records as 

provided in paragraph (h) of this 

section. 

(h) Recordkeeping requirements. 

Official poultry slaughter 

establishments must maintain daily 

records sufficient to document the 

implementation and monitoring of the 

procedures required under paragraph (g) 

of this section. Records required by this 

section may be maintained on 

computers if the establishment 

implements appropriate controls to 

ensure the integrity of the electronic 

data. Records required by this section 

must be maintained for at least one year 

and must be accessible to FSIS. 

■ 5. Amend § 381.66 as follows: 

■ a. Revise paragraph (b). 

■ b. Remove paragraphs (c)(3) and (4). 

■ c. Revise paragraph (e). 

The revisions read as follows: 

§ 381.66 Temperatures and chilling and 

freezing procedures. 

* * * * * 

(b) Chilling performance standards, 

except for ratites. (1)(i) Each official 

poultry slaughter establishment must 

ensure that all poultry carcasses, parts, 

and giblets are chilled immediately after 

slaughter operations so that there is no 

outgrowth of pathogens, unless such 

poultry is to be frozen or cooked 

immediately at the official 

establishment. 

(ii) Previously chilled poultry 

carcasses and major portions must be 

kept chilled so that there is no 

outgrowth of the pathogens, unless such 

poultry is to be packed and frozen 

immediately at the official 

establishment. 

(2) After product has been chilled, the 

establishment must prevent the 

outgrowth of pathogens on the product 

as long as the product remains at the 

establishment. 

(3) The establishment must develop, 

implement, and maintain written 

procedures for chilling that address, at 

a minimum, the potential for pathogen 

outgrowth, the conditions affecting 

carcass chilling, and when its chilling 

process is completed. The establishment 

must incorporate these procedures into 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49635 

its HACCP plan, or sanitation SOP, or 

other prerequisite program. 

* * * * * 

(e) Air chilling. Air chilling is the 

method of chilling raw poultry carcasses 

and parts predominately with air. An 

antimicrobial intervention may be 

applied with water at the beginning of 

the chilling process, provided that its 

use does not result in any net pick-up 

of water or moisture during the chilling 

process. The initial antimicrobial 

intervention may result in some 

temperature reduction of the product, 

provided that the majority of 

temperature removal is accomplished 

exclusively by chilled air. 

* * * * * 

■ 6. Add § 381.69 to subpart I to read as 

follows: 

§ 381.69 Maximum line speed rates under 

the New Poultry Inspection System. 

(a) The maximum line speed for 

young chicken slaughter establishments 

that operate under the New Poultry 

Inspection System is 140 birds per 

minute. 

(b) The maximum line speed for 

turkey slaughter establishments that 

operate under the New Poultry 

Inspection System is 55 birds per 

minute. 

(c) Notwithstanding paragraphs (a) 

and (b) of this section, establishments 

that operate under the New Poultry 

Inspection System must reduce their 

line speed as directed by inspectors-incharge. Inspectors-in-charge are 

authorized to direct establishments to 

operate at a reduced line speed when in 

their judgment a carcass-by-carcass 

inspection cannot be adequately 

performed within the time available due 

to the manner in which the birds are 

presented to the online carcass 

inspector, the health conditions of a 

particular flock, or factors that may 

indicate a loss of process control. 

(d) Establishments operating under 

the line speed limits authorized in this 

section shall comply with all other 

applicable requirements of the laws, 

including, but not limited to, 29 U.S.C. 

654(a). 

■ 7. Amend § 381.76 as follows: 

■ a. Revise the section heading. 

■ b. Revise paragraphs (a), (b)(1) 

introductory text, (b)(1)(iv), and (b)(2). 

■ c. Add paragraphs (b)(1)(v) and (b)(6). 

The revisions read as follows: 

§ 381.76 Post-mortem inspection under 

Traditional Inspection, the Streamlined 

Inspection System (SIS), the New Line 

Speed (NELS) Inspection System, the New 

Poultry Inspection System (NPIS), the New 

Turkey Inspection System (NTI), and Ratite 

Inspection. 

(a) A post-mortem inspection shall be 

made on a bird-by-bird basis on all 

poultry eviscerated in every official 

establishment. Each carcass, or all parts 

comprising such carcass, must be 

examined by an inspector, except for 

parts that are not needed for inspection 

purposes and are not intended for 

human food and are condemned. Each 

carcass eviscerated shall be prepared as 

ready-to-cook poultry. 

(b)(1) There are six systems of postmortem inspection: the New Poultry 

Inspection System (NPIS), which may 

be used for young chickens and turkeys; 

the Streamlined Inspection System (SIS) 

and the New Line Speed Inspection 

System (NELS), both of which may be 

used only for broilers and cornish game 

hens; the New Turkey Inspection (NTI) 

System, which may be used only for 

turkeys; Traditional Inspection, which 

may be used for all poultry, except for 

ratites; and Ratite Inspection. 

* * * * * 

(iv) The NPIS may be used for young 

chickens and turkeys if the official 

establishment requests to use it and 

meets or agrees to meet the 

requirements of paragraph (b)(6) of this 

section and the Administrator approves 

the establishment’s request. The 

Administrator may permit 

establishments that slaughter classes of 

poultry other than young chickens and 

turkeys to operate under the New 

Poultry Inspection System under a 

waiver from the provisions of the 

regulations as provided in § 381.3(b). 

(v) Traditional Inspection shall be 

used for turkeys when neither the NTI 

System nor the NPIS is used. For other 

classes of poultry, Traditional 

Inspection shall be used when SIS, 

NELS, and the NPIS are not used. 

(2) Official establishments that 

operate under Traditional Inspection, 

SIS, NELS, NTI, or Ratite Inspection 

must meet the following requirements: 

(i) No viscera or any part thereof may 

be removed from any poultry processed 

in any official establishment, except at 

the time of post-mortem inspection, 

unless its identity with the rest of the 

carcass is maintained in a manner 

satisfactory to the inspector until such 

inspection is made. 

(ii) Each carcass to be eviscerated 

must be opened so as to expose the 

organs and the body cavity for proper 

examination by the inspector. 

(iii) If a carcass is frozen, it must be 

thoroughly thawed before being opened 

for examination by an inspector. 

* * * * * 

(6) The following requirements are 

applicable to the NPIS: 

(i) Facilities. The establishment must 

comply with the facilities requirements 

in § 381.36(f). 

(ii) Carcass sorting and disposition. 

(A) The establishment must conduct 

carcass with associated viscera sorting 

activities, dispose of carcasses and parts 

exhibiting condemnable conditions, and 

conduct appropriate trimming and 

reprocessing activities before carcasses 

are presented to the online carcass 

inspector. 

(B) Any carcasses removed from the 

line for reprocessing activities or salvage 

must be returned to the line before the 

online carcass inspection station. The 

establishment must include in its 

written HACCP plan, or sanitation SOP, 

or other prerequisite program a process 

by which parts, other than parts 

identified as ‘‘major portions’’ as 

defined in § 381.170(b)(22), are available 

for inspection offline after reprocessing 

or salvage. 

(C) The establishment must develop, 

implement, and maintain written 

procedures to ensure that poultry 

carcasses contaminated with septicemic 

and toxemic conditions do not enter the 

chiller. The establishment must 

incorporate these procedures into its 

HACCP plan, or sanitation SOP, or other 

prerequisite program. These procedures 

must cover, at a minimum, 

establishment sorting activities required 

under paragraph (b)(6)(ii) of this section. 

(D) The establishment must maintain 

records to document that the products 

resulting from its slaughter operation 

meet the definition of ready-to-cook 

poultry in § 381.1. These records are 

subject to review and evaluation by 

FSIS personnel. 

(iii) Presentation for online carcass 

inspection. To ensure the online carcass 

inspector may properly inspect every 

carcass, the establishment must present 

carcasses as follows: 

(A) Each carcass, except carcasses and 

parts identified as ‘‘major portions’’ 

under 9 CFR 381.179(b)(22), must be 

held by a single shackle; 

(B) Both hocks of each carcass must 

be held by the shackle; 

(C) The back side of the carcass must 

be faced toward the inspector; 

(D) There must be minimal carcass 

swinging motion; 

(E) The establishment must ensure 

that it can sufficiently identify viscera 

and parts corresponding with each 

carcass inspected by the online carcass 

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49636 Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 

inspector so that if the carcass inspector 

condemns a carcass all corresponding 

viscera and parts are also condemned. 

(iv) Inspection for Avian Visceral 

Leukosis. (A) Establishments that 

slaughter young chickens must notify 

the inspector-in-charge prior to the 

slaughter of each new flock to allow the 

inspection of viscera as provided in 

§ 381.36(f)(3). 

(B) If there is evidence that a flock 

may be affected by avian visceral 

leukosis, the inspector-in-charge is 

authorized to adjust inspection 

procedures as needed to ensure 

adequate inspection of each carcass and 

viscera for that condition. The 

inspector-in-charge is also authorized to 

require the establishment to adjust its 

processing operations as needed to 

accommodate the adjusted inspection 

procedures. 

■ 9. Section 381.91 is amended by 

revising paragraph (b) to read as follows: 

§ 381.91 Contamination. 

* * * * * 

(b) Any carcass of poultry 

accidentally contaminated during 

slaughter with digestive tract contents 

need not be condemned if promptly 

reprocessed under the supervision of an 

inspector and thereafter found not to be 

adulterated. Contaminated surfaces that 

are cut must be removed only by 

trimming. Contaminated inner surfaces 

that are not cut may be cleaned by 

trimming alone or may be re-processed 

as provided in subparagraph (b)(1) or (2) 

of this section. 

(1) Online reprocessing. Poultry 

carcasses accidentally contaminated 

with digestive tract contents may be 

cleaned by applying an online 

reprocessing antimicrobial intervention 

to all carcasses after evisceration and 

before the carcasses enter the chiller if 

the parameters for use of the 

antimicrobial intervention system have 

been approved by the Administrator. 

Establishments must incorporate 

procedures for the use of any online 

reprocessing antimicrobial intervention 

system into their HACCP plans, or 

sanitation SOPs, or other prerequisite 

programs. 

(2) Offline reprocessing. 

Contaminated inner surfaces that are not 

cut may be cleaned at an approved 

reprocessing station away from the main 

processing line by any method that will 

remove the contamination, such as 

vacuuming, washing, and trimming, 

singly or in combination. All visible 

specks of contamination must be 

removed, and if the inner surfaces are 

reprocessed other than solely by 

trimming, all surfaces of the carcass 

must be treated with chlorinated water 

containing 20 ppm to 50 ppm available 

chlorine or another approved 

antimicrobial substance in accordance 

with the parameters approved by the 

Administrator. Establishments must 

incorporate procedures for the use of 

any offline reprocessing into their 

HACCP plans, or sanitation SOPs, or 

other prerequisite programs. 

■ 10. Section 381.94 is amended by 

revising the section heading and 

paragraph (a) and removing and 

reserving paragraph (b) to read as 

follows: 

§ 381.94 Contamination with 

microorganisms; process control 

verification criteria and testing; pathogen 

reduction standards for establishments that 

slaughter ratites. 

(a) Criteria for verifying process 

control; E. coli testing. (1) Each official 

establishment that slaughters ratites 

shall test for Escherichia coli Biotype I 

(E. coli). Establishments that slaughter 

ratites and livestock, shall test the type 

of ratites or livestock slaughtered in the 

greatest number. The establishment 

shall: 

(i) Collect samples in accordance with 

the sampling techniques, methodology, 

and frequency requirements in 

paragraph (a)(2) of this section; 

(ii) Obtain analytic results in 

accordance with paragraph (a)(3) of this 

section; and 

(iii) Maintain records of such analytic 

results in accordance with paragraph 

(a)(4) of this section. 

(2) Sampling requirements. (i) Written 

procedures. Each establishment that 

slaughters ratites shall prepare written 

specimen collection procedures which 

shall identify employees designated to 

collect samples, and shall address 

location(s) of sampling, how sampling 

randomness is achieved, and handling 

of the sample to ensure sample integrity. 

The written procedure shall be made 

available to FSIS upon request. 

(ii) Sample collection. The 

establishment must collect samples 

from whole ratites at the end of the 

chilling process. Samples from ratites 

may be collected by sponging the 

carcass on the back and thigh or 

samples can be collected by rinsing the 

whole carcass in an amount of buffer 

appropriate for that type of bird. 

(iii) Sampling frequency. 

Establishments that slaughter ratites, 

except very low volume ratite 

establishments as defined in paragraph 

(a)(2)(v) of this section, must take 

samples at a frequency proportional to 

the establishment’s volume of 

production at the following rate: 1 

sample per 3,000 carcasses, but at a 

minimum one sample each week of 

operation. 

(iv) Sampling frequency alternatives. 

An establishment operating under a 

validated HACCP plan in accordance 

with § 417.2(b) of this chapter may 

substitute an alternative frequency for 

the frequency of sampling required 

under paragraph (a)(2)(iii) of this section 

if, 

(A) The alternative is an integral part 

of the establishment’s verification 

procedures for its HACCP plan and, 

(B) FSIS does not determine, and 

notify the establishment in writing, that 

the alternative frequency is inadequate 

to verify the effectiveness of the 

establishment’s processing controls. 

(v) Sampling in very low volume ratite 

establishments. (A) Very low volume 

ratite establishments annually slaughter 

no more than 6,000 ratites. Very low 

volume ratite establishments that 

slaughter ratites in the largest number 

must collect at least one sample during 

each week of operation after June 1 of 

each year, and continue sampling at a 

minimum of once each week the 

establishment operates until June of the 

following year or until 13 samples have 

been collected, whichever comes first. 

(B) Upon the establishment’s meeting 

the requirements of paragraph 

(a)(2)(v)(A) of this section, weekly 

sampling and testing is optional, unless 

changes are made in establishment 

facilities, equipment, personnel or 

procedures that may affect the adequacy 

of existing process control measures, as 

determined by the establishment or by 

FSIS. FSIS determinations that changes 

have been made requiring resumption of 

weekly testing shall be provided to the 

establishment in writing. 

(3) Analysis of samples. Laboratories 

may use any quantitative method for 

analysis of E. coli that is approved as an 

AOAC Official Method of the AOAC 

International (formerly the Association 

of Official Analytical Chemists) or 

approved and published by a scientific 

body and based on the results of a 

collaborative trial conducted in 

accordance with an internationally 

recognized protocol on collaborative 

trials and compared against the three 

tube Most Probable Number (MPN) 

method and agreeing with the 95 

percent upper and lower confidence 

limit of the appropriate MPN index. 

(4) Recording of test results. The 

establishment shall maintain accurate 

records of all test results, in terms of 

colony forming units (CFU)/ml of rinse 

fluid. Results shall be recorded onto a 

process control chart or table showing at 

least the most recent 13 test results. 

Records shall be retained at the 

establishment for a period of 12 months 

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Federal Register / Vol. 79, No. 162 / Thursday, August 21, 2014 / Rules and Regulations 49637 

and shall be made available to FSIS 

upon request. 

(5) Establishments shall evaluate E. 

coli test results using statistical process 

control techniques. 

(6) Failure to meet criteria. Test 

results that do not meet the criteria 

described in paragraph (a)(5) of this 

section are an indication that the 

establishment may not be maintaining 

process controls sufficient to prevent 

fecal contamination. FSIS shall take 

further action as appropriate to ensure 

that all applicable provisions of the law 

are being met. 

(7) Failure to test and record. 

Inspection will be suspended in 

accordance with rules of practice that 

will be adopted for such proceeding, 

upon a finding by FSIS that one or more 

provisions of paragraphs (a) (1) through 

(4) of this section have not been 

complied with and written notice of 

same has been provided to the 

establishment. 

* * * * * 

■ 11. Section 381.129 is amended by 

adding a new paragraph (b)(6)(v) to read 

as follows: 

§ 381.129 False or misleading labeling or 

containers. 

* * * * * 

(b) * * * 

(6) * * * 

(v) Ready-to-cook chicken may bear 

the claim ‘‘air chilled’’ or ‘‘air chilling’’ 

on its label only if the product was 

chilled under a process that meets the 

definition of air chilling in § 381.66(e). 

* * * * * 

PART 500—RULES OF PRACTICE 

■ 12. The authority citation for part 500 

continues to read as follows: 

Authority: 21 U.S.C. 451–470, 601–695; 7 

U.S.C. 450, 1901–1906; 7 CFR 2.18, 2.53. 

§ 500.6 [Amended] 

■ 13. Section 500.6 is amended by 

removing and reserving paragraph (f). 

Done at Washington, DC, on: July 31, 2014. 

Alfred V. Almanza, 

Administrator. 

[FR Doc. 2014–18526 Filed 8–20–14; 8:45 am] 

BILLING CODE 3410–DM–P 

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