# Modernization of Swine Slaughter Inspection

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URL: https://www.frixlaw.com/law-library/documents/fr%3A2018-01256

## Record

- **Collection:** Federal Register
- **Document type:** Proposed Rule
- **Published:** February 1, 2018
- **Citation:** 83 FR 4780

## Text

DEPARTMENT OF AGRICULTURE
Food Safety and Inspection Service
9 CFR Parts 301, 309, and 310
[Docket No. FSIS-2016-0017]
RIN 0583-AD62
Modernization of Swine Slaughter Inspection

AGENCY:

Food Safety and Inspection Service, USDA.

ACTION:

Proposed rule.

SUMMARY:

The Food Safety and Inspection Service (FSIS) is proposing to amend the Federal meat inspection regulations to establish a new inspection system for market hog slaughter establishments that has been demonstrated to provide public health protection at least equivalent to the existing inspection system. Market hog slaughter establishments that do not choose to operate under the new swine inspection system may continue to operate under their existing inspection system. The Agency is also proposing several changes to the regulations that would affect all establishments that slaughter any swine, regardless of the inspection system under which they operate or the age, size, or class of swine. These proposed changes would allow all swine slaughter establishments to develop sampling plans that are more tailored to their specific operations, and thus be more effective in monitoring their specific process control. These proposed changes also would ensure that before the start of slaughter operations, food-contact surfaces are sanitary and free of enteric pathogens.

DATES:

Comments must be received on or before April 2, 2018.

ADDRESSES:

FSIS invites interested persons to submit comments on this rule. Comments may be submitted by one of the following methods:

•
Federal eRulemaking Portal:
This website provides the ability to type short comments directly into the comment field on this web page or attach a file for lengthier comments. Go to
http://www.regulations.gov.
Follow the on-line instructions at that site for submitting comments.

•
Mail, including CD-ROMs, etc.:
Send to Docket Clerk, U.S. Department of Agriculture, Food Safety and Inspection Service, Patriots Plaza 3, 1400 Independence Avenue SW, Mailstop 3782, Room 8-163A, Washington, DC 20250-3700.

•
Hand- or courier-delivered submittals:
Deliver to Patriots Plaza 3, 355 E Street SW, Room 8-163A, Washington, DC 20250-3700.

Instructions:
All items submitted by mail or electronic mail must include the Agency name and docket number FSIS-2016-0017. Comments received in response to this docket will be made available for public inspection and posted without change, including any personal information, to
http://www.regulations.gov.

Docket:
For access to background documents or comments received, go to the FSIS Docket Room at Patriots Plaza 3, 355 E Street SW, Room 8-164, Washington, DC 20250-3700, between 8:00 a.m. and 4:30 p.m., Monday through Friday.

FOR FURTHER INFORMATION CONTACT:

Roberta Wagner, Assistant Administrator, Office of Policy and Program Development; Telephone: (202) 205-0495.

SUPPLEMENTARY INFORMATION:

Executive Summary

FSIS began experimenting with new approaches to slaughter inspection based on Hazard Analysis and Critical Control Point Systems (HACCP) principles shortly after publishing the Pathogen Reduction/HACCP rule in 1996. In 1997, the Agency developed the HACCP-Based Inspection Models Project (HIMP) study to determine whether applying new Government slaughter inspection procedures, along with new plant responsibilities, could promote innovation and provide at least the same food safety and consumer protection. FSIS initiated the HIMP study in 20 young chicken, five young turkey, and five market hog establishments on a waiver basis.

In 2014, the Agency amended the poultry products inspection regulations to establish a new optional inspection system for young chicken and all turkey slaughter establishments informed by the Agency's experiences under HIMP (79 FR 49566, August 21, 2014). The New Poultry Inspection System (NPIS) was designed 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. The risk model employed to assess the potential impact of the NPIS modeled scenarios involving an increase in targeted inspection activities (specifically unscheduled offline inspection activities). The results of this model, constructed on the assumption that the number of offline procedures performed in poultry establishments under the NPIS would increase proportionally to the number observed in HIMP establishments, suggested that implementing the NPIS would likely result in public health benefits, in the form of fewer poultry-associated foodborne
Salmonella
illnesses per year. Consistent with the underlying assumptions of the model, it is reasonable to conclude that inspection systems in which Agency resources are used to continue 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,
which in turn would likely lead to fewer human illnesses.

In addition to establishing the NPIS for young chickens and turkeys, FSIS also amended the poultry products inspection regulations that apply to all establishments that slaughter poultry other than ratites. The new requirements ensure that all poultry slaughter establishments implement appropriate measures in their HACCP plans, sanitation standard operating procedures (sanitation SOPs), or other prerequisite programs (hereafter referred to as their “HACCP systems”) to prevent contamination of carcasses and parts by enteric pathogens and visible fecal material throughout the entire slaughter operation, and ensure that both FSIS and establishments have the documentation they need to verify the effectiveness of these measures on an ongoing basis.

FSIS is now proposing to amend the Federal meat inspection regulations to establish a new optional inspection system for market hog slaughter establishments, the New Swine Slaughter Inspection System (NSIS), informed by the Agency's experiences under HIMP. FSIS is proposing this new inspection system to facilitate pathogen reduction in pork products; improve compliance with the HMSA; improve the effectiveness of market hog slaughter inspection; make better use of the Agency's resources; and remove unnecessary regulatory obstacles to innovation by revoking maximum line speeds and allowing establishments flexibility to reconfigure evisceration lines. If establishment personnel sorted and removed unfit animals before ante-mortem inspection and trimmed and identified defects on carcasses and parts before post-mortem inspection by FSIS inspectors, FSIS inspectors would be presented with healthier animals and carcasses that have fewer defects to inspect, which would allow inspectors to conduct a more efficient and effective inspection of each animal and each

carcass. Such a system would allow FSIS inspectors to conduct a more efficient inspection. As a result, FSIS could assign fewer inspectors to online inspection, freeing up Agency resources to conduct more offline inspection activities that FSIS has determined are more effective in ensuring food safety, such as verifying compliance with sanitation, HACCP, and humane handling requirements.

Key elements of the proposed NSIS include: (1) Requiring establishment personnel to sort and remove unfit animals before ante-mortem inspection by FSIS and to trim and identify defects on carcasses and parts before post-mortem inspection by FSIS; (2) requiring establishment personnel to identify animals or carcasses that they have sorted and removed for disposal before FSIS inspection with a unique tag, tattoo, or similar device and immediately denature all major portions of the carcass on-site, and maintain records to document the total number of animals and carcasses sorted and removed per day; (3) requiring establishment personnel to immediately notify FSIS inspectors if they suspect an animal or carcass with a reportable or foreign animal disease (
e.g.,
African swine fever, classical swine fever, or Nipah virus encephalitis) while conducting sorting activities; (4) shifting Agency resources to conduct more offline inspection activities that are more effective in ensuring food safety, which would allow for up to two offline verification inspectors per line per shift and would reduce the number of online inspectors to a maximum of three per line per shift; (5) requiring establishments to maintain records documenting that products resulting from their slaughter operations meet the new proposed definition of Ready-to-cook (RTC) pork product, which would be defined as any slaughtered pork product free from bile, hair, scurf, dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions, icterus, foreign material, and odor which is suitable for cooking without need of further processing; and (6) revoking maximum line speeds and authorizing establishments to determine their own line speeds based on their ability to maintain process control for preventing fecal contamination and meeting microbial performance measures during the slaughter operation. FSIS projects that the new system is unlikely to result in a higher prevalence of
Salmonella
on market hog carcasses and may even result in a lower prevalence of
Salmonella
on market hog carcasses, which in turn may lead to fewer human illnesses. In addition, the new system should improve animal welfare and compliance with the Humane Methods of Slaughter Act (HMSA) because more FSIS resources will be available to verify humane handling as an offline activity.

Under the proposed rule, market hog slaughter establishments that do not choose to operate under the NSIS may continue to operate under their existing inspection system (hereafter referred to as “traditional inspection”). As mentioned above, NSIS provides public health protection at least equivalent to traditional inspection. FSIS recognizes that some establishments may not be prepared to make the investment in facilities and labor needed to convert to NSIS. In addition, many small, very low volume establishments slaughter more than one type of livestock species and the facilities updates need to convert to the proposed NSIS may not accommodate the slaughter of livestock other than market hogs. Therefore, FSIS is proposing to give establishments the flexibility to operate under the system that is best suited to their operations.

FSIS is also proposing several changes that would affect all establishments that slaughter swine, regardless of the inspection system under which they operate. FSIS is proposing to require that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent the contamination of carcasses and parts by enteric pathogens, fecal material, ingesta, and milk throughout the entire slaughter and dressing operation. These procedures must include sampling and analysis for microbial organisms to monitor process control for enteric pathogens, as well as written procedures to prevent visible fecal material, ingesta, and milk contamination.

FSIS is proposing to prescribe a minimum frequency with which establishments would be required to collect two samples, one at pre-evisceration and one at post-chill (
i.e.,
the point in the slaughter process after the carcass has chilled in the cooler and after all slaughter interventions are completed), or, for very small and very low volume establishments, a single post-chill sample. FSIS considers the microbial load of hog carcasses at pre-evisceration to be a valuable source of data about how well an establishment is taking into account the sanitary condition of live hogs coming to slaughter and the processing steps (
i.e.,
washing, dehairing) they implement to reduce the external contamination of the carcass prior to evisceration. FSIS also considers the microbial characteristics of hog carcasses post-chill (after all processing steps have taken place) to be a valuable source of data about how well an establishment is minimizing contamination during chilling as well as the overall effectiveness of all process control interventions the establishment has chosen to apply throughout its production process. Because most establishments apply one or more interventions between the pre-evisceration and post-chill sampling points to help control microbiological hazards, FSIS would expect that a reduction in microbiological contamination between these two sampling points to be an indication of the effectiveness of those controls.

Under the proposed rule, establishments, except for very small and very low volume establishments, would be required to collect pre-evisceration and post chill samples at a frequency of once per 1,000 carcasses. Very small and very low volume establishments would be required to collect at least one sample during each week of operation each year. If, after consecutively collecting 13 weekly samples, very small and very low volume establishments can demonstrate that they are effectively maintaining process control, they can modify their sampling plans to collect samples less frequently. FSIS is proposing to allow very small and very low volume establishments to collect and analyze samples for microbial organisms at the post-chill point in the process only because these establishments typically are less automated and run at slower line speeds than larger establishments. The lower level of automation and the slower line speeds require less complicated measures for maintaining and monitoring process control on an ongoing basis. These proposed frequencies reflect the frequencies prescribed under the existing regulations for generic
Escherichia coli
(
E. coli
) testing. FSIS is proposing to remove the current requirement that swine establishments test carcasses for generic
E. coli
to monitor process control and to remove the codified
Salmonella
pathogen reduction performance standards for swine and replace them with the new testing requirements described above. The new testing requirements would allow establishments to develop sampling plans that are more tailored to the specific establishment, and thus more effective in monitoring their specific process control than the current generic
E. coli
criteria.

FSIS is proposing to allow establishments to substitute alternative sampling locations if they are able to

demonstrate that the alternative sampling locations are able to provide a definite improvement in monitoring process control than at pre-evisceration and post-chill. FSIS interprets “definite improvement” to mean
any
improvement of equipment, substances, methods, processes, or procedures affecting the slaughter of livestock and poultry or processing of meat, poultry, or egg products. FSIS is also proposing to allow establishments to substitute alternative sampling frequencies if they are able to demonstrate that the alternative is an integral part of the establishments' verification procedures for their HACCP plans and are able to provide a definite improvement in monitoring process control than at the prescribed frequency. FSIS is requesting comments on the proposed sampling requirements, particularly the incremental value (from both a process-improvement and public health standpoint) of pre-evisceration sampling over what is provided by post-chill sampling.

Finally, FSIS is proposing to require that all official swine slaughter establishments develop, implement, and maintain in their HACCP systems written procedures to prevent contamination of the pre-operational environment by enteric pathogens. The pre-operational environment comprises food contact surfaces, reuse water, and equipment, including knives, in edible food production departments before slaughter operations begin. These procedures would need to include sampling and analysis of food-contact surfaces in the pre-operational environment for microbial organisms to ensure that the surfaces are sanitary and free of enteric pathogens. The sampling frequency would need to be adequate to monitor the establishment's ability to maintain sanitary conditions in the pre-operational environment. Please see the draft compliance guide for additional information about implementation of this provision. FSIS is proposing this requirement as a direct result of a recent outbreak of foodborne illness associated with a hog slaughter establishment where food contact surfaces were found to be contaminated with the outbreak strain. FSIS is requesting comments on this proposed sampling requirement and the extent to which interventions in the pre-operational environment are needed to ensure food safety.

In Table 1 below, FSIS presents the estimated costs and benefits of the proposed rule. Later portions of the regulatory impact analysis section contain explanation of the assumptions, alternative adoption scenarios, and a discussion of the uncertainty surrounding the net benefits associated with how much of the industry would choose to adopt NSIS.

Table 1—Net Costs and (Benefits)
[M$]

Number of
establishments

One-time
Recurring

Costs To Industry

$3.88
$22.65

Voluntary *
** 40
0.84
22.17

Mandatory
612
3.03
0.48

Potential Health Benefits ***

(9.33)

Industrial Efficiency

(47.33)

Impacts to Agency's Budget

2.80
(8.73)

Totals:

One-Time Cost
$6.68

Recurring Cost
(42.75)

Annualized Costs, Assuming a 3% Discount Rate Over 10 Years
(31.77)

Annualized Costs, Assuming a 7% Discount Rate Over 10 Years
(30.40)

* Further explanation and details on the NSIS adoption rate are provided in section G. Expected Cost of the Proposed Rule, Table 6: NSIS Adoption Rate and section J. Net Benefits, Table 28: Quantified Cost and (Benefits) of Various Adoption Rates.
** Note, this includes 5 HIMP establishments, which are not expected to incur any costs or benefits associated with the NSIS.

*** Further explanation and details on the range of health benefits have been provided in section H. Expected Benefits Associated With Public Health, Table 20: Health Benefits from Averted Cases of
Salmonella.
The value of health benefits ranges from $0.19 million to $18.97 million, with a mean of $9.33 million.

Statutory Authority

FSIS inspects and regulates the production of meat and meat food products prepared for distribution in commerce under the authority of the Federal Meat Inspection Act (FMIA) (21 U.S.C. 601
et seq.
). The FMIA provides that the Secretary shall cause to be made by inspectors an examination and inspection of all amenable species before they enter into any establishment in which they are to be slaughtered and the meat and meat food products thereof are to be used in commerce (21 U.S.C. 603(a)). All amenable species found to show symptoms of disease are to be set apart and slaughtered separately; the carcasses of such animals are to be subject to a careful inspection (21 U.S.C. 603(a)). The FMIA requires that the livestock be slaughtered and handled in connection with slaughter in a manner that is consistent with the HMSA (21 U.S.C. 603(b)). Under the HMSA, the handling of livestock in connection with slaughter must be carried out only by humane methods (7 U.S.C. 1902).

The FMIA also requires inspectors to conduct a post-mortem examination and inspection, and any necessary reinspection, of carcasses and parts of amenable species prepared for human food (21 U.S.C. 604). The FMIA requires that all carcasses and parts found to be adulterated be condemned (21 U.S.C. 604). Under the FMIA, a meat or meat food product is adulterated, among other circumstances, if it bears or contains any poisonous or deleterious substance that may render it injurious to health; it is unhealthful, unwholesome, or otherwise unfit for human consumption; it was prepared, packaged, or held under insanitary conditions whereby it may have been rendered injurious to health; or if damage or inferiority has been concealed in any manner (21 U.S.C. 601(m)(1), (3), (4), and (8)). Finally, 21 U.S.C. 621 provides that the Secretary shall make such rules and regulations as are necessary for the efficient execution of the provisions of the FMIA. FSIS regulations and inspection programs are designed to verify that livestock are handled and slaughtered humanely, and that meat and meat food products are

unadulterated, wholesome, and properly marked, labeled, and packaged.

Table of Contents of Proposed Rule Discussion

I. Background

A. Traditional Market Hog Slaughter Inspection Under Existing Regulations

1. Description of the Inspection System Under Existing Regulations

2. Need for Modernization

B. Regulations for Microbiological Testing Under Traditional Inspection

1. Generic
E. Coli
Criteria for Measuring Process Control

2.
Salmonella
Pathogen Reduction/HACCP Performance Standards

C. Waivers of Regulatory Requirements

1. Waivers to Test New Technology

2.
Salmonella
Initiative Program Waivers

II. Consideration of Need for a New Swine Slaughter Inspection System

A. Early Development of the Inspection Models Program

B. Existing HACCP-Based Inspection Models Program

C. U.S. General Accountability Office (GAO) and the USDA's Office of the Inspector General (OIG) Reports on HIMP

D. Analysis of HIMP

1. FSIS Evaluation of HIMP

a. Overview of the HIMP Report

b. Verification by Offline Inspectors of the Establishment Executing Its HIMP Process Control Plan Under Which Establishment Employees Sort Acceptable and Unacceptable Carcasses and Parts

c. Verification of the Establishment Executing Its HACCP System Under 9 CFR Parts 416 and 417

d. Verification of the Outcomes of the Establishment Process Control Plan, Both Organoleptic and Microbiologic

e. Conclusion of HIMP Report

f. Verification of Humane Handling

E. Public Health Benefits Projected From Allocating More Inspection Resources to Food Safety-Related Inspection Activities

1. Market Hog Risk Assessment

2. Model

3. Conclusions of the Market Hog Risk Assessment

III. Proposed NSIS

A. Live Market Hog Sorting by Establishment Personnel

B. Post-Mortem Carcass Sorting by Establishment Employees and Online Carcass Inspection

C. Offline Verification Inspection

D. RTC Pork Product

E. Line Speeds Under NSIS

IV. Other Proposed Changes That Affect All Swine Slaughter Establishments

A. Procedures To Address Enteric Pathogens, Fecal Material, Ingesta, and Milk Contamination as Hazards Reasonably Likely to Occur

V. Implementation

VI. Executive Orders 12866 and 13563

A. Request for Comments Summary

B. Need for the Rule

C. Overview of the Market

D. Overview of the Proposed Rule's NSIS

E. Overview of the Proposed Rule's Mandatory Components

F. Overview of the Proposed Rule's Agency Impact

G. Expected Cost of the Proposed Rule

1. Costs Associated With the NSIS Components of the Rule

a. Costs of Additional Establishment Workers

b. Costs of Capital Improvements: Line Configuration and Inspection Stations

c. Costs of Developing Ante-Mortem Written Procedures

d. Ready-to-Cook Standards

2. Costs Associated With the Mandatory Components of the Rule

a. Costs of Developing, Composing, Training, Monitoring, Recording, and Verifying Written Sanitary Dressing Plans

b. Process Control Sampling and Analysis for Microbial Organisms

c. Environmental Sampling

H. Expected Benefits of the Proposed Rule

1. Expected Benefits Associated With Public Health

2. Other Benefits Associated With Modernizing Existing Regulations

I. Expected Budgetary Impacts

1. Agency Staffing

2. Agency Training

J. Net Benefits

K. Alternatives

VII. Regulatory Flexibility Act Assessment

VIII. E-Government Act

IX. Executive Order 12988, Civil Justice Reform

X. Executive Order 13175

XI. USDA Nondiscrimination Statement

XII. Environmental Impact

XIII. Paperwork Reduction Act

XIV. Additional Public Notification

XV. Proposed Regulatory Amendments

I. Background

A. Traditional Market Hog Slaughter Inspection Under Existing Regulations

1. Description of the Inspection System Under Existing Regulations

Under the existing regulations for traditional inspection, FSIS ante-mortem inspectors examine all market hogs for visible signs of condemnable diseases or conditions while they are at rest and in motion (see 9 CFR part 309). FSIS ante-mortem inspectors direct establishment personnel to set apart animals showing signs of condemnable diseases or conditions into separate “U.S. Suspect” pens for further examination by the FSIS Public Health Veterinarian (PHV). The FSIS PHV determines whether the animals shall be identified as “U.S. Condemned” and disposed of in accordance with 9 CFR 309.13 (9 CFR 309.2).

Most establishments under traditional inspection that slaughter only market hogs voluntarily segregate animals that show signs of diseases or conditions from healthy animals before the Agency performs ante-mortem inspection (see FSIS Directive 6100.1,
Ante-mortem Livestock Inspection
available at
http://www.fsis.usda.gov/wps/wcm/connect/2b2e7adc-961e-4b1d-b593-7dc5a0263504/6100.1.pdf?MOD=AJPERES
). Market hog establishment personnel segregate animals that appear to be normal and healthy from abnormal or unhealthy animals that appear to have condemnable diseases or conditions (
e.g.,
animals exhibiting signs of neurologic conditions, pyrexia, or severe lameness) into “subject” pens, where they are subject to additional FSIS inspection. FSIS requires these establishments to document their segregation procedures in their HACCP plans or prerequisite programs. FSIS inspectors examine all animals found by the establishment to be normal at rest, and five to ten percent of those animals in motion. If any animals exhibit signs of condemnable conditions, FSIS inspectors direct establishment employees to move the animals to the “U.S. Suspect” pens for final disposition by the FSIS PHV. The FSIS PHV examines all animals in the “subject” pens, and directs establishment employees to move animals to “U.S. Suspect” pens for final disposition. FSIS inspectors observe establishment employees performing segregation procedures at least once per month. Because establishment employees are responsible for identifying and removing market hogs that are not fit for slaughter before FSIS ante-mortem inspection, FSIS inspectors are presented with healthier animals that are more likely to pass inspection. Therefore, under the voluntary segregation procedures, FSIS inspectors are able to conduct a more efficient and effective ante-mortem inspection to determine whether each animal is fit for slaughter.

During post-mortem inspection at all market hog slaughter establishments, FSIS online inspectors inspect the head, viscera, and carcass of each animal for localized defects and direct establishment employees to remove the defects through trimming (9 CFR 310.1(b)(3)). FSIS online inspectors perform manual incisions, palpations, and other organoleptic inspections (
i.e.,
using sight, smell, and touch) to detect signs of disease or contamination. In large establishments, up to seven online inspectors are assigned per line per shift to cover inspection stations for the head, viscera, and carcass at fixed points along the slaughter and evisceration line. In small or very small establishments, one inspector may perform all of the post-mortem

inspection procedures on each animal. FSIS online inspectors identify and retain carcasses and parts with visible animal diseases and conditions. The FSIS PHV thoroughly examines retained carcasses and parts to determine whether they should be condemned; establishment personnel then dispose of condemned carcasses under FSIS supervision in accordance with 9 CFR part 314.

Under the existing regulations for traditional inspection, establishments conduct no post-mortem carcass sorting to identify which carcasses and parts appear eligible to bear the mark of inspection, which carcasses and parts contain removable defects correctable through trimming, and which carcasses and parts should be submitted to FSIS for condemnation because of generalized diseases or conditions. These sorting functions are conducted by establishment personnel under HIMP. Rather, the existing regulations for traditional inspection require establishments to assign competent assistants to take such actions as directed by FSIS online inspectors after the inspectors have conducted the initial sorting activities (see 9 CFR 307.2(g)). Therefore, under the existing regulations for traditional inspection, establishments rely on FSIS online inspectors to effectively control and direct their processing. Moreover, because FSIS online inspectors are responsible for identifying unacceptable carcasses and parts, it takes online inspectors more time to conduct a carcass-by-carcass inspection than would be necessary if establishments sorted carcasses and parts, trimmed dressing defects and contamination that do not impact the FSIS inspectors' ability to assess the fitness of the carcass or part, and identified pathology defects, before the carcasses and parts were inspected.

More FSIS resources also could be devoted to offline inspection activities if initial sorting and tagging functions were performed by establishment personnel. Under the existing regulations, only FSIS inspectors may direct the application and removal of “U.S. Condemned” tags from animals and carcasses condemned by FSIS inspectors on ante-mortem and post-mortem inspection (9 CFR 309.13 and 310.5). The tag must remain on the carcass until it goes into the tank, or the carcass is otherwise disposed of in accordance with 9 CFR part 314. Establishments are required to denature condemned carcasses and parts if they do not have tanking facilities and the carcasses and parts are to be rendered or otherwise disposed of off-site (see 9 CFR 314.3). FSIS inspectors enter the number on each “U.S. Condemned” tag into the Public Health Information System (PHIS). Under the existing regulations, most “U.S. Condemned” tags are applied during ante-mortem inspection to animals that arrive dead. Because FSIS inspectors are responsible for removing all of the “U.S. Condemned” tags and documenting each “U.S. Condemned” tag number into PHIS, it takes inspectors more time to complete ante-mortem and post-mortem inspections than it would if establishments sorted and removed these animals before FSIS inspection and maintained records that could be verified by FSIS, as appropriate, and reported their daily totals to FSIS inspectors.

In addition to the post-mortem inspection activities conducted by online inspectors, offline inspectors conduct additional food safety related activities such as verifying that establishments' processing meets their HACCP critical limits and verifying whether sanitation SOPs are effective.

2. Need for Modernization

Modernization of market hog slaughter inspection is necessary because traditional inspection was developed before FSIS issued its HACCP regulations, and before the Agency began targeting its resources to address public health risks associated with foodborne pathogens. Traditional inspection obscures the proper roles of industry and inspection personnel by assigning to FSIS inspectors responsibility for sorting acceptable animals from unacceptable animals, finding carcass defects, identifying production control problems for the establishment, and verifying corrective actions in addition to determining whether the carcasses meet regulatory requirements. Additionally, traditional inspection requires FSIS to allocate significant inspection personnel resources towards online inspection activities in large and high volume market hog establishments to detect quality defects and conditions that present minimal food safety risks, thus limiting the resources available for offline inspection activities such as verifying the effectiveness of HACCP plans and sanitation SOPs. FSIS has concluded, based on the Agency's analysis of the market hog HIMP pilot (discussed in more detail below), conducting more offline activities will be more effective in ensuring food safety and humane handling verification tasks.

Traditional inspection requires inspectors to conduct time-intensive ante-mortem and post-mortem sorting activities. This necessitates FSIS to allocate significant personnel resources to conduct activities that are more appropriately the responsibility of the establishment. As a result, traditional inspection limits line speeds, even if establishments can demonstrate that they are able to produce safe, unadulterated, wholesome products at more efficient rates. It also limits large and high volume market hog slaughter establishments' incentive to improve their processing methods and to develop more efficient slaughter and dressing technologies.

For example, under traditional inspection, the maximum line speed authorized for slaughter lines with one or two inspectors is partially based upon the distance walked (in feet) by the inspector between work stations to conduct the sorting activities mentioned above (see 9 CFR 310.1(b)(3)). For slaughter lines with three or more inspectors, line speeds may also depend on whether FSIS online inspectors observe the back of the carcasses by looking in a mirror or whether they must turn the carcass to observe the back of the carcass (see 9 CFR 310.1(b)(3)). The maximum line speed under the existing regulations for market hogs is 1,106 head per hour (hph) with seven online inspectors. Establishments determine their line speeds based on their equipment, size and condition of the animals, and their ability to maintain process control when operating at a given line speed.

Additionally, traditional inspection restricts establishments' ability to reconfigure and consolidate lines if they determine that they need more space to conduct other activities in their facilities. For example, establishments slaughtering 1,025 market hogs per hour must configure their evisceration lines to accommodate three online head inspectors, three online viscera inspectors, and one online carcass inspector. The regulations require that establishments provide an inspection station consisting of five feet of unobstructed line space for each head or carcass inspector and, for viscera table kills, eight feet for each viscera inspector on the inspector's side of the table (9 CFR 307.2 (m)(1)). As a result, the current regulations for traditional inspection prevent large and high volume market hog slaughter establishments from consolidating inspection stations or otherwise reconfiguring their evisceration lines in order to make room for more innovative, automated equipment such as head dropping equipment, bung equipment (which separates digestive and urinary organs from pelvic attachments),

eviscerating equipment, and back saws. Traditional inspection is generally sufficient for low volume establishments and for establishments that slaughter classes of swine other than market hogs because these establishments typically are less automated and run at slower line speeds than larger establishments.

Additionally, traditional inspection was developed when visually detectable animal diseases such as pneumonias, erysipelas, hog cholera, cystercercosis, parasites, and arthritis were more prevalent and considered to be more of a concern than they are today. The line speed limits prescribed under traditional inspection reflect the Agency's previous focus on the detection of visible defects and animal diseases and do not give establishments the flexibility to address these conditions before presenting the carcasses and parts to FSIS inspectors.

Traditional inspection focuses substantial FSIS resources on detecting visible trim and dressing defects that are not directly related to food safety, particularly in light of what is now known about the role microbial contamination plays in causing foodborne human illness. The traditional inspection model needs to be updated in light of the significant advances that have been made in the control or eradication of many animal diseases that were more prevalent and were considered to present a greater concern when the existing inspection systems were designed, particularly in generally healthy classes of animals such as market hogs.

Moreover, the analysis in FSIS's “Assessment of the Potential Change in Human Health Risk Associated with Modernizing Inspection of Market Hog Slaughter Establishments” (hereafter referred to as the market hog risk assessment) conducted by FSIS suggests a statistically significant correlation between increased scheduled and unscheduled offline inspection procedures and a reduction in the prevalence of
Salmonella
in market hog establishments. Projecting out illness reductions based on reduction in
Salmonella
prevalence in 35 plants results in wide uncertainty, but the model confidently estimates that the level of protection from
Salmonella
illnesses would be at least as good as the current system. Based on these results, the redeployment of Agency resources dedicated to online inspection under the traditional inspection system to unscheduled offline activities, such as increased HACCP and sanitation SOP verification, has the potential to contribute to improved food safety resulting from a lower prevalence of carcasses contaminated with
Salmonella,
which may in turn lead to fewer human illnesses. While prevalence of
Salmonella
measured in FSIS's market hog baseline study is low,
Salmonella
is a pathogen of public health concern for pork products, and the data available are adequate to estimate the potential changes in prevalence with changes in FSIS's swine inspection system.

B. Regulations for Microbiological Testing Under Traditional Inspection

1. Generic E. Coli Criteria for Measuring Process Control

The existing regulations require that official swine slaughter establishments conduct regular testing for generic
E. coli
at the end of the chilling process or after the final wash as a means to verify process control (9 CFR 310.25(a)(1)). These regulations prescribe requirements for collecting the samples, obtaining analytical results, and maintaining records of such results (9 CFR 310.25(a)(2), (3), and (4)). They also include criteria for evaluating an establishment's generic
E. coli
testing results (9 CFR 310.25(a)(5)). The regulations provide that generic
E. coli
testing results that do not meet the criteria described in the regulations indicate that the establishment may not be maintaining process controls sufficient to prevent fecal contamination (9 CFR 310.25(a)(6)). If an establishment is not meeting the
E. coli
test results criteria, the regulations state that FSIS will take further action as appropriate to ensure that all applicable provisions of the law are being met (9 CFR 310.25(a)(6)).

In 2014, FSIS rescinded the regulations that required that poultry establishments test carcasses for generic
E. coli
to monitor for process control (79 FR 49565, August 21, 2014). The final regulations replaced the generic
E. coli
regulations with new testing requirements that allow establishments to develop sampling plans that are more tailored to the specific establishment, and thus are more effective in monitoring their specific process control than the former generic
E. coli
criteria. The Agency concluded that the use of generic
E. coli
as an indicator for process control may not be as useful in certain poultry slaughter operations as originally thought. Therefore, FSIS made the change to allow poultry establishments to use other more relevant indicators of process control.

The Agency is aware that most swine slaughter establishments currently conduct additional sampling for micro-organisms other than generic
E. coli
(
e.g., Salmonella
spp. and aerobic plate count bacteria (APC)) because they have found these organisms to be more relevant indicators of their process control. Therefore, FSIS is proposing to remove the generic
E. coli
sampling requirements for swine slaughter establishments to give establishments more flexibility in monitoring their process control and to make the Federal meat inspection regulations more consistent with the Federal poultry products inspection regulations. FSIS is proposing that all swine slaughter establishments collect and analyze carcass samples for microbiological analysis at the pre-evisceration and post-chill points in the process. The discussion of the proposed testing requirements is set out later in this document.

2. Salmonella Pathogen Reduction/HACCP Performance Standards

In addition to generic
E. coli
criteria, the existing regulations contain
Salmonella
pathogen reduction performance standards for market hogs (9 CFR 310.25(b)). The codified performance standards are based on the prevalence of
Salmonella
found by two nationwide microbiological baseline surveys conducted from April 1995 to March 1996 and from June 1997 to May 1998. The regulations provide for FSIS to collect and analyze unannounced
Salmonella
samples sets in swine slaughter establishments to detect whether these establishments are meeting the pathogen reduction performance standards (9 CFR 310.25(b)(2)). The performance standards set a maximum number of
Salmonella
-positive samples allowable per sample set and are defined on a product class basis so that an establishment operating at the baseline level would have an 80 percent chance of meeting the standard. Establishments are required to take corrective actions when FSIS determines that they are not meeting the performance standards (9 CFR 310.25(b)(3)(i) and (ii)).

Under the regulations, an establishment's failure to take the corrective actions necessary to comply with the
Salmonella
performance standards, or an establishment's failure to meet the standards on the third consecutive series of FSIS-conducted tests for that product, constitutes a failure to maintain sanitary conditions and to maintain an adequate HACCP plan (9 CFR 310.25(b)(3)(iii)). The regulations provide that such failure will cause FSIS to suspend inspection services (9 CFR 310.25(b)(3)(iii)). However, the Agency's ability to

directly enforce the pathogen reduction performance standards has been limited since 2001, after a ruling by the U.S. Court of Appeals for the Fifth Circuit in
Supreme Beef Processors, Inc.
v.
USDA.
In that case, the court enjoined FSIS from suspending inspection services against a meat grinding operation for failure to meet the
Salmonella
performance standards. Since that time, FSIS has used
Salmonella
failures as a basis to conduct an in-depth evaluation of the establishment's HACCP systems, including its HACCP plan and sanitation SOPs.

From August 2010 to August 2011, FSIS conducted a third market hog baseline survey to estimate the national prevalence of
Salmonella
in market hogs (
The Nationwide Microbiological Baseline Data Collection Program: Market Hogs Survey August 2010-2011
available at
http://www.fsis.usda.gov/wps/wcm/connect/d5c7c1d6-09b5-4dcc-93ae-f3e67ff045bb/Baseline_Data_Market_Hogs_2010-2011.pdf?MOD=AJPERES
). The third market hog baseline survey included 253 establishments that produce approximately 99.9 percent of market hogs slaughtered in the United States. For the third baseline survey, FSIS collected samples in 152 random establishments from market hog carcasses at two points in the slaughter process: Pre-evisceration and post-chill. The
Salmonella
percent positive rate at pre-evisceration was 69.64 percent, but at post-chill it was reduced to 2.70 percent. The third baseline survey's percent positive rate at post-chill was significantly lower than the rates found in the two earlier surveys mentioned above, which reported
Salmonella
percent positive rates of 8.7 percent and 6.9 percent, respectively. Based on the data from the third baseline survey, FSIS estimated prevalence of
Salmonella
in market hogs was 1.66 percent with a 95 percent confidence interval between 0.82 percent and 2.51 percent. Because the estimated prevalence of
Salmonella
was low, and FSIS did not find enough pathogen positives to justify the resources needed (
e.g.,
time and supplies) to conduct carcass swabbing, the Agency determined that this type of sampling was not an effective use of resources for verifying process control. As a result, FSIS did not develop new
Salmonella
performance standards for market hogs. Rather, in September 2011, FSIS discontinued its
Salmonella
verification sampling program for market hogs to make better use of its resources.

Therefore, FSIS is proposing to eliminate the pathogen performance standards for market hogs in 9 CFR 310.25(b) because verifying the codified standards was not a good use of Agency resources and the standards have not been used since 2011. Instead, FSIS has decided to focus on its resources on sampling raw pork parts for pathogens of public health concern, as well as for indicator organisms.

FSIS is currently addressing
Salmonella
through the
Salmonella
Initiative Program (SIP) described below. In addition, FSIS has published a compliance guideline to help official establishments control and reduce the spread of
Salmonella
in hog slaughter facilities (79 FR 633, January 6, 2014). The guidance is available on the FSIS web page at:
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index.
The guidance provides information on best practices that may be applied at a hog slaughter facility to prevent, eliminate, or reduce levels of
Salmonella
on hogs at all stages of slaughter and dressing. Importantly, FSIS has identified microbial performance measures, as guidance, at the pre-evisceration and post chill points.

Moreover, FSIS is currently conducting exploratory sampling of raw pork products for pathogens of public health concern, as well as for indicator organisms (80 FR 12618). A summary of the Phase I positive sampling results collected from May 2015 to November 2015 are as follows: 16.7 percent
Salmonella,
1 percent
Campylobacter,
4.5 percent Methicillin-Resistant Staphylococ
cus aureus
(MRSA), 1 percent
Toxoplasma gondii,
1.5 percent
Yersinia enterocolitica,
0 percent
E. coli
O157:H7, and 5 percent non-O157 shiga toxin-producing
E. coli
(non-O157 STEC). FSIS has posted more detailed sampling results on its website at
https://www.fsis.usda.gov/wps/wcm/connect/68f5f6f2-9863-41a5-a5c4-25cc6470c09f/Sampling-Project-Results-Data.pdf?MOD=AJPERES.
The Agency may develop pathogen reduction performance standards for pork parts at a later date. In 2019, the Agency will use this data to determine whether standards or additional policies (
e.g.,
training, guidance to industry, or instructions to field personnel) are needed to address
Salmonella
in pork products.

C. Waivers of Regulatory Requirements

1. Waivers To Test New Technology

The regulations in 9 CFR 303.2(h) and 381.3(b) provide for the Administrator to waive for limited periods any provisions of the regulations to permit experimentation so that new procedures, equipment, or processing techniques may be tested to facilitate definite improvements. Under these regulations, FSIS may only grant waivers from the provisions in the regulations that are not in conflict with the purposes or provisions of the FMIA or PPIA (9 CFR 303.1(h) and 381.3(b)).

FSIS decides whether to grant requests for waivers based on proposals and documentation submitted by establishments to demonstrate that the use of a new technology is scientifically sound; that it will facilitate definite improvements; and that issuing the waiver will not conflict with the provisions of the FMIA or PPIA.
1

If FSIS determines that the information submitted by an establishment supports the requested waiver, the Agency will waive the appropriate provisions in the regulation for a limited period of time to allow the establishment to conduct an in-plant trial. The purpose of the in-plant trial is to gather data on the effects of the use of the new technology. FSIS reviews the data that is developed in the trial to determine whether they establish that the purpose of the waiver is being met.

1
For Agency New Technology waiver procedures, see
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/New-Technologies.

2. Salmonella Initiative Program Waivers

Under SIP, the Agency grants meat and poultry slaughter establishments waivers of regulatory requirements on condition that they will conduct regular microbial testing and share the resulting data with FSIS. The Agency described preliminary details of SIP in a January 28, 2008,
Federal Register
notice (73 FR 4767-4774) and announced its final terms and conditions in the July 13, 2011,
Federal Register
notice (76 FR 41186). SIP benefits public health in that it encourages slaughter establishments to conduct testing for microbial pathogens, which is a key feature of effective process control, and to respond to testing results by taking steps when necessary to regain process control. In addition, SIP enables FSIS to use establishment data to inform Agency policy aimed at enhancing public health protection.

SIP establishments test for
Salmonella, Campylobacter
(if applicable), and generic
E. coli
or other indicator organisms and share all sample results with FSIS. Establishments that had been operating under regulatory waivers before FSIS implemented the SIP were required to participate in SIP or forfeit their waivers. The list of establishments

participating in SIP is available on FSIS's website at
https://www.fsis.usda.gov/wps/wcm/connect/188bf583-45c9-4837-9205-37e0eb1ba243/Waiver_Table.pdf?MOD=AJPERES.
To date the regulations waived for swine slaughter establishments under SIP include: 9 CFR 310.1(b)(3)— line speed; 9 CFR 310.25(a)— generic
E. coli
testing
2

; 9 CFR 310.25(b)—
Salmonella
performance standards; 9 CFR 310.18(a)— contamination of organs; 9 CFR 310.11—cleaning and hair removal; and 9 CFR 310.14—handling of bruised parts. All swine slaughter establishments operating under SIP waivers will continue to operate under waivers and will continue to conduct testing under SIP if their waivers are not addressed in the final rule resulting from this proposal. If their waivers are addressed in the final rule resulting from this proposal, their waivers will end.

2
Some establishments continue to sample for generic
e. coli
to monitor their process control. The SIP waivers allow these establishments to use alternative sampling locations and frequencies.

II. Consideration of Need for a New Swine Slaughter Inspection System

A. Early Development of the Inspection Models Program

In 1996, FSIS published its Pathogen Reduction/HACCP (PR/HACCP) final rule as the first step of a comprehensive initiative to target the Agency's resources to address the public health risks associated with foodborne pathogens, which cannot be detected by organoleptic inspection (61 FR 38868, July 25, 1996). Under FSIS's PR/HACCP regulations, establishments are required to develop and implement a system of preventive controls to ensure that their products are safe. This approach gives establishments more flexibility to determine how they can best meet the Agency's regulatory requirements. FSIS verifies the adequacy and effectiveness of establishments' HACCP systems.

In 1997, in order to improve food safety and the effectiveness of inspection systems, reduce the risk of foodborne illness in the United States, remove unnecessary regulatory obstacles to innovation, and make better use of the Agency's resources, FSIS announced, in a
Federal Register
notice, that the Agency would be developing a new HIMP study (62 FR 31553, June 10, 1997). During the HIMP study, FSIS would design and test various new inspection models in a series of trials in volunteer meat and poultry slaughter establishments.

Under the initial HIMP inspection models approach, establishment personnel were responsible for sorting and removing animals unfit for slaughter and identifying and removing abnormal carcasses and parts, and FSIS inspection personnel performed inspection activities that focused on the areas of greatest risk in the hog slaughter inspection system in each establishment.

In 1998, the American Federation of Government Employees, several FSIS inspectors, and a public interest organization filed suit to enjoin FSIS from implementing the HIMP model. The plaintiffs alleged that HIMP violated the requirement in the FMIA that government inspectors conduct a post-mortem inspection of each carcass. Specifically, the FMIA provides that the Secretary shall cause to be made by inspectors a post-mortem inspection of the carcasses and parts thereof of all amenable species to be prepared at any slaughtering, meat-canning, salting, packing, rendering, or similar establishment (21 U.S.C. 604). The district court upheld HIMP, finding that the word “inspection”, as used in the statute, does not necessarily mandate a direct, physical examination of each carcass by an FSIS inspector, and that the model program was a rational policy judgment within the discretion afforded to the Secretary.

The plaintiffs appealed, and the Court of Appeals for the District of Columbia Circuit reversed the district court's decision. The Court of Appeals found that the FMIA requires Federal inspectors—rather than plant employees—to make the decision whether each carcass is adulterated within the meaning of the statute (
AFGE
v.
Glickman,
215 F.3d 7, 11 (D.C. Circ. 2000)). The case was remanded to the district court for further proceedings.

In response to the Court of Appeals' opinion, FSIS modified HIMP to position up to three
3

online inspectors at fixed locations along the slaughter lines: In the area where the carcass and head were separated; where the carcass and viscera were separated; and at the pre-wash carcass verification location. These inspectors were responsible for examining the head, viscera, and carcass of each hog. The modified models project also included FSIS offline inspectors who were responsible for conducting HACCP and sanitation system verification activities and for closely examining a sample of carcasses for food safety defects to ensure that the establishment's process was under control and that adulterated carcasses and parts were not getting past the establishment sorters. On remand, the district court found that HIMP, as modified, complied with both the applicable statutory provisions and the opinion issued by the Court of Appeals.

3
FSIS is able to assign fewer than three online inspectors if the physical configuration of the slaughter line allows one inspector to inspect both the head and viscera or the viscera and carcass. For example, in one establishment, the chain that carries the carcass is adjacent to the viscera pans, which enables one inspector to examine both the carcass and viscera.

The plaintiffs again appealed to the Court of Appeals for the D.C. Circuit. The plaintiffs argued that the modified inspection procedures were not in compliance with the Court of Appeals' prior opinion because FSIS had delegated some inspection duties to plant employees who were responsible for sorting defective carcasses and making preliminary decisions regarding adulteration. The Court of Appeals rejected this argument, finding that the FMIA does not prohibit plant employees from paring down the overall number of carcasses by sorting and removing carcasses before they reach the Federal inspector (
AFGE
v.
Veneman,
284 F.3d 125, 131 (D.C. Cir. 2002)). The Court held that the modified inspection model program satisfied the FMIA because it required Federal inspectors to personally examine all hog carcasses, heads, and viscera, as required by 21 U.S.C. 604.

The plaintiffs also argued that the line speeds allowed in the HIMP plants were too fast to allow Federal inspectors to make a critical appraisal of each carcass. The Court found that FSIS's decision to allow higher line speeds was reasonable in light of the fact that establishment employees are required to sort carcasses and parts and identify defects prior to Federal inspection, resulting in fewer adulterated carcasses and parts being presented for Federal inspection. The Court also noted that although the FMIA delineates what must be inspected and by whom, it does not define exactly what constitutes an inspection. The court concluded that HIMP, as modified, reflected a reasonable design of an inspection system by the agency charged with responsibility for administering the FMIA and that it would rely on the Agency's experience and informed judgment in evaluating the validity of the system under the law. Under these circumstances, the Court of Appeals upheld HIMP, as modified.

B. Existing HACCP-Based Inspection Models Program

The revised HIMP study was initiated in five market hog slaughter establishments on a waiver basis.

Similar to the voluntary segregation procedures described above in establishments that slaughter only

market hogs under traditional inspection, establishment personnel sort animals before they are presented to FSIS ante-mortem inspectors under HIMP. Establishment personnel sort animals that appear to be healthy into “Normal” pens and animals that appear to have condemnable diseases or conditions into “Subject” pens. Establishment personnel remove and dispose of dead and moribund animals and animals suspected of having central nervous system disorders (CNS) or pyrexia. Under HIMP, FSIS inspectors examine all animals found by the establishment to be normal at rest, and five to ten percent of those animals in motion. If any animals exhibit signs of condemnable conditions, FSIS inspectors direct establishment employees to move the animals to the “U.S. Suspect” pens for final disposition by the FSIS PHV. FSIS PHVs examine all animals in the establishment's “Subject” pens, and direct establishment employees to move animals to “U.S. Suspect” pens for final disposition by the FSIS PHV. The FSIS PHV determines if any animals must be identified as “U.S. Condemned” and disposed of in accordance with 9 CFR 309.13 (9 CFR 309.2). While establishment personnel sort and remove animals unfit for slaughter, only FSIS inspectors have the authority to condemn an animal. FSIS inspectors observe establishment employees performing sorting procedures at least twice per shift under HIMP compared to at least once per month under the voluntary segregation procedures permitted under traditional inspection of market hogs.

Under HIMP, post-mortem inspection is conducted by up to three online inspectors who visually inspect the head, viscera, and carcass of each hog at fixed locations on the evisceration line. Before FSIS online inspection, establishment personnel sort carcasses and parts and trim dressing defects and contamination (
e.g.,
hair, bruises, feces, ingesta, and milk). Establishment employees also mark with ink localized pathology defects intended for removal under FSIS supervision (
e.g.
localized nephritis and localized arthritis) and carcasses and parts intended for disposal under FSIS supervision (
e.g.,
carcasses and parts with malignant lymphoma). Online inspection is conducted much more efficiently and effectively under HIMP than under traditional inspection because establishment personnel have already sorted carcasses and parts, trimmed dressing defects and contamination, and identified pathology defects on the carcasses, thereby correcting most removable defects, before the FSIS online inspectors perform their carcass-by-carcass inspection.

Under HIMP, offline inspection consists of system verification activities through which FSIS continuously monitors and evaluates establishment process control. FSIS conducts more offline, food safety related verification inspection activities under HIMP than under traditional inspection. Some examples of food safety related verification inspection activities include: HACCP, sanitation SOP, and other prerequisite program verification procedures, including 24 carcass verification checks per shift specifically for generalized diseases and conditions and for contamination (compared to 11 carcass verification checks per shift under traditional inspection). FSIS also conducts more offline humane handling verification tasks under HIMP than under traditional inspection.

FSIS has concluded that the HIMP model has a number of benefits, such as focusing FSIS inspection personnel on the areas of greatest risk in the hog slaughter system and providing an incentive to establishments to improve and innovate, while ensuring effective online inspection.

C. U.S. General Accountability Office (GAO) and the USDA's Office of the Inspector General (OIG) Reports on HIMP

In 2013, the U.S. General Accountability Office (GAO) and the USDA's Office of the Inspector General (OIG) evaluated FSIS's HIMP pilot study and issued findings and recommendations.
4 5

GAO identified strengths in the pilot study, including that of giving plants responsibility and flexibility for ensuring food safety and quality and allowing FSIS inspectors to focus more on food safety activities. However, GAO also identified what it believed to be data gaps in the HIMP pilot study. GAO recommended that FSIS collect and analyze information to determine if the HIMP pilot study is meeting its purpose, and FSIS agreed with the recommendation.

4
GAO, 2013. More Disclosure and Data Needed to Clarify Impact of Changes to Poultry and Hog Inspections,
http://www.gao.gov/assets/660/657144.pdf.

5
OIG, 2013. Food Safety and Inspection Service—Inspection and Enforcement Activities at Swine Slaughter Plants,
https://www.usda.gov/oig/webdocs/24601-0001-41.pdf.

The OIG report also included recommendations related to HIMP procedures. According to the OIG, FSIS did not adequately oversee the HIMP program because the Agency did not evaluate whether the program resulted in a measurable improvement of the inspection process; allowed one HIMP plant to forgo the standard FSIS policy to manually inspect viscera; and did not have formal agreements with the HIMP plants. In response to OIG, FSIS agreed to complete an evaluation of HIMP market hog establishments.

D. Analysis of HIMP

1. FSIS Evaluation of HIMP

In 2014, in response to the GAO and OIG reports, FSIS conducted a comprehensive analysis of data collected from the operation of HIMP in market hog establishments and prepared a written report (the “Hog HIMP Report”) that presents a thorough evaluation of the models tested. Based on this evaluation, FSIS concluded that market hog slaughter establishments participating in HIMP were performing as well as comparable large non-HIMP market hog establishments and meeting FSIS requirements for operating under waivers through the HIMP project.

A summary of the Hog HIMP Report is provided below. The full Hog HIMP Report is available on the FSIS website at:
http://www.fsis.usda.gov/wps/wcm/connect/f7be3e74-552f-4239-ac4c-59a024fd0ec2/Evaluation-HIMP-Market-Hogs.pdf?MOD=AJPERES.
Before implementation of the HIMP project, an independent consulting firm, Research Triangle Institute (RTI) collected baseline organoleptic and microbiological data in the five market hog slaughter establishments that volunteered to participate in the HIMP program. These data reflect the performance of the establishments under traditional inspection and provided the basis to establish HIMP performance standards for food safety defects and non-food safety “Other Consumer Protection” (OCP) defects.

FSIS established three categories of food safety related performance standards under HIMP for these conditions: “FS-1” addresses infectious conditions (
e.g.,
septicemia, toxemia, pyemia, and cysticercosis); “FS-2” addresses contamination from fecal material, ingesta, and milk; and “FS-3” addresses certain conditions identified at ante-mortem (
e.g.
moribund, pyretic, and neurologic conditions). FSIS has a zero tolerance policy for food safety conditions identified as FS-1, FS-2, and FS-3 to protect consumers from conditions that may be harmful. Therefore, the HIMP performance standard for food safety defects was set at zero.

FSIS established the performance standard for non-food safety OCP

defects based on the performance level of the establishment representing the 75th percentile for each category of OCP defects (
i.e.,
slightly below the fourth of the five baseline results for each category). FSIS established three categories of OCP performance standards for various types of trim and dressing defects that primarily affect the quality of products: “OCP-1” addresses carcass pathology defects (
e.g.,
arthritis, emaciation, and erysipelas) and was set at 4.1 percent of carcasses, “OCP-2” addresses visceral pathology defects (
e.g.,
cystic kidneys, enteritis, and nephritis) and was set at 7.2 percent of carcasses, and “OCP-3” addresses miscellaneous defects such as bile, bruises, and skin lesions and was set at 20.5 percent of carcasses. The HIMP performance standards were finalized in November 2000 (see 65 FR 65828, November 2, 2000). To participate in the program, establishments operating under HIMP are required to maintain process control plans to meet the performance standards for food safety and non-food safety OCP defects. The HIMP performance standards are a measure for comparing the performance of establishments operating under the HIMP inspection system with performance when operating under the current non-HIMP, traditional inspection system.

a. Overview of the HIMP Report

The Hog HIMP Report describes FSIS's microbiological and inspection findings in the five market hog slaughter establishments participating in HIMP and compares them with 21 non-HIMP establishments of comparable production volume, line speed, and days of operation. The evaluation is based on establishment performance results for calendar years CY2006 through CY2010, and CY2012 through CY2013. Establishment performance results from CY2006 to CY2010 are based on data from the previously used Performance Based Inspection System (PBIS) database and results from CY2012 to CY2013 are based on data from the new Public Health Information System (PHIS) database. FSIS began transitioning establishments from PBIS to the PHIS in April 2011. The period April 2011 to December 2011 was a transitional period during which the inspection results for some establishments were recorded under PBIS, while others were recorded under PHIS. The data under the two systems are not completely compatible because inspection task codes and noncompliance records (NRs) were recorded differently in PHIS than in PBIS. For this reason, the transitional period CY2011 is not included in the Hog HIMP Report, and the analysis of CY2006 through CY2010 data is separate from the CY2012 through CY2013 data.

Across HIMP and non-HIMP establishments, analyses compared the number of offline inspection procedures, the rates of health-related regulatory non-compliances,
Salmonella
positive rates, and violative chemical residue rates. FSIS evaluated offline inspection procedures to determine whether comparable levels of inspection are being performed in HIMP establishments compared to non-HIMP establishments. The Hog HIMP Report found that establishments participating in HIMP performed as well as comparable large non-HIMP establishments and met the Agency's requirements for participating in the HIMP project.

b. Verification by Offline Inspectors of the Establishment Executing Its HIMP Process Control Plan Under Which Establishment Employees Sort Acceptable and Unacceptable Carcasses and Parts

The Hog HIMP Report found that the rate of ante- and post-mortem sorting by HIMP establishment personnel was comparable to the rate of ante- and post-mortem condemnation by FSIS inspectors at non-HIMP market hog establishments (3.0 per 1,000 hogs compared to 2.7 per 1,000 hogs, respectively). The Hog HIMP Report also found that FSIS inspectors in HIMP establishments performed more offline inspection activities than in non-HIMP establishments to verify that the establishments are executing their HIMP slaughter process control plans. In CY2010, FSIS inspectors performed an average of 2,061 offline verification inspections per HIMP market hog establishment compared to an average of 1,482 offline verification inspection procedures per non-HIMP establishment. Accordingly, FSIS inspectors performed 1.4 times more offline verification inspection procedures in HIMP market hog establishments than in non-HIMP market hog establishments. In CY2013, FSIS inspectors performed an average of 19,180 Public Health Regulation (PHR)
6

verification tasks per HIMP market hog establishment compared to an average of 14,099 PHR verification tasks per non-HIMP establishment. Thus, FSIS inspectors performed 1.4 times more of the offline inspection verifications of mandatory regulations in HIMP market hog establishments than in non-HIMP market hog establishments. The HIMP Report concluded that this increased level of offline inspection activities provides increased assurance that HIMP establishments are maintaining OCP and food safety defects at levels that are to or less than the levels in non-HIMP establishments.

6
PHRs consists of regulations and specific provisions of regulations that have higher rates of noncompliance three months before a pathogen positive or enforcement action. The inclusion of provisions of regulations in the PHR list allows FSIS to focus on specific health related provisions of regulations that may be most informative for prioritizing Food Safety Assessments (FSAs). FSAs are in-depth evaluations of an establishment's food safety system. FSAs can be routine or for cause.

c. Verification of the Establishment Executing Its HACCP System Under 9 CFR Parts 416 and 417

The sanitation SOP regulations in 9 CFR 416 and the HACCP regulations in 9 CFR 417 are among the regulations most strongly related to public health. The Hog HIMP Report found that in CY2010, FSIS inspectors performed 1.5 times more offline sanitation SOP and HACCP inspection verifications of public health-related regulations in HIMP than non-HIMP market hog comparison establishments. In CY2012 and CY2013, FSIS inspectors performed 1.1 times more offline sanitation SOP and HACCP inspection verifications of public health-related regulations in HIMP than non-HIMP market hog comparison establishments.

The regression analysis of historical data that was included in FSIS's “Risk Assessment for Guiding Public Health-Based Poultry Slaughter Inspection,” which was used to inform the final rule “Modernization of Poultry Slaughter Inspection” (79 FR 49565), showed a statistically significant correlation between unscheduled offline inspection procedures and reduction in the prevalence of
Salmonella
and
Campylobacter
positive samples. Based on these modeling results, FSIS thought it was reasonable to conclude that the redeployment of Agency resources to unscheduled offline activities was likely to contribute to improved food safety resulting from a lower prevalence of carcasses contaminated with Salmonella and Campylobacter, which in turn could lead to fewer human illnesses. Depending on how reallocation of inspection activities was implemented, it was likely that changes in off-line inspection could have resulted in a decrease in the numbers of positive microbial samples in FSIS-regulated young chicken and young turkey establishments. Specifically, the scenario that only increased unscheduled inspection procedures performed much better than the scenario that did not target specific

types of procedures, and the results suggest a reasonable degree of confidence that the discriminate scenario would do no harm. That poultry slaughter risk assessment is available on FSIS's website at
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/haccp/haccp-based-inspection-models-project/himp-study-plans-resources/poultry-slaughter-inspection.
The risk model and model results are also posted on-line as a technical support document for the risk assessment on the FSIS website. The market hog risk assessment uses a similar approach and model as the poultry slaughter risk assessment and estimates the reduction in illnesses likely to result from the reallocation of inspectors contemplated by this proposed rule. The market hog risk assessment is discussed in more detail below.

d. Verification of the Outcomes of the Establishment Process Control Plan, Both Organoleptic and Microbiologic

To assess the microbiological outcomes of HIMP establishments' process control plans, the Hog HIMP Report analyzed data from FSIS's
Salmonella
verification program. For the years CY2006-CY2009, the differences in
Salmonella
positive rates between HIMP market hog establishments and non-HIMP comparison establishments were not statistically significant for any of the years. The Hog HIMP Report also analyzed data from FSIS's
Salmonella
baseline study on market hog slaughter establishments, conducted from August 2010 to August 2011. The
Salmonella
positive rates in HIMP market hog establishments were not statistically significantly different from those in the subset of 21 non-HIMP comparison establishments. This is probably the result of the small sample size relative to the low
Salmonella
positive rate. However, in the August 2010 to August 2011 baseline study the
Salmonella
positive rates in HIMP market hog establishments were statistically significantly lower than those in all 147 non-HIMP market hog establishments (which included the subset of 21 non-HIMP comparison establishments, as well as all other non-HIMP market hog establishments) (0.65 percent versus 3.05 percent).

The Hog HIMP Report also analyzed data from FSIS's residue sampling program for chemical contaminants including approved and unapproved veterinary drugs, pesticides, and environmental compounds. FSIS conducts directed sampling scheduled by FSIS Headquarters and inspector-generated sampling when the FSIS PHV suspects that an animal may have a violative level of chemical residue. The Hog HIMP Report found no differences in the number of scheduled directed samples collected in the HIMP market hog establishments and those in the non-HIMP market hog comparison establishments. However, the Hog HIMP Report found that FSIS offline inspectors at the HIMP market hog establishments were able to collect 2.7 times more inspector-generated residue samples than inspectors at the non-HIMP market hog comparison establishments for CY2009-2010, and 1.7 times more for CY2012-2013 because the inspectors had more time to conduct offline activities. Data from FSIS's residue sampling program showed that from CY2006 to CY2010, the number of samples that tested positive for violative levels of chemical residues in HIMP market hog establishments were not statistically significantly different from those in the non-HIMP market hog comparison establishments (zero versus six (0.057 percent of samples)). However, from CY2012 to CY2013, the amount of samples that tested positive for violative levels of chemical residues in HIMP market hog establishments was statistically significantly lower than non-HIMP market hog comparison establishments (nine violative levels (0.15 percent of samples) versus 115 (0.76 percent of samples). The Hog HIMP Report explained that this difference could suggest that the HIMP market hog establishments are exercising active control of potential chemical hazards in their products, and that this approach may result from better control over contract grower relationships by the five HIMP market hog establishments.

e. Conclusion of HIMP Report

The Hog HIMP Report concluded that HIMP market hog establishments are receiving more offline food safety related inspection verification checks than the non-HIMP market hog comparison establishments, and that the HIMP inspection system, which provides for increased offline inspection activities that are directly related to food safety, results in greater compliance with sanitation and HACCP regulations (9 CFR parts 416 and 417); carcasses with equivalent or lower levels of
Salmonella
contamination; and carcasses with lower levels of violative chemical residues.

f. Verification of Humane Handling

FSIS inspectors verify that establishments comply with the HMSA by performing Humane Activities Tracking System (HATS) tasks that are divided into nine categories. The HATS tasks provide FSIS with data on the time that FSIS inspectors spend verifying whether (1) establishments adapt their facilities to inclement weather; (2) humanely handle livestock during truck unloading; (3) provide water and feed to livestock in holding pens; (4) humanely handle livestock during ante-mortem inspection; (5) humanely handle “U.S. Suspect” and disabled livestock; (6) move livestock without excessive prodding or the use of sharp objects after ante-mortem inspection; (7) prevent livestock from slipping and falling; (8) effectively administer stunning methods that produce unconsciousness in the animals; and (9) ensure that animals do not regain consciousness throughout the shackling, sticking, and bleeding process. FSIS inspectors enter the hours devoted to verifying humane handling activities for the HATS categories. The data is entered into PHIS in one-quarter hour increments (
e.g.,
.25, .5, .75, 1.0).

The Hog HIMP Report did not address compliance with the HMSA, but FSIS reviewed HATS task data in PHIS from January 2013 through September 2015 and compared the number of offline humane handling activities performed in five HIMP market hog establishments and the same 21 comparable large non-HIMP market hog establishments that FSIS used in the Hog HIMP Report. The Agency found that FSIS inspectors spent more time verifying that specific humane handling and slaughter requirements were met in HIMP market hog establishments than in non-HIMP market hog establishments. FSIS inspectors devoted approximately 5.33 hours per shift to verifying humane handling activities for the HATS categories in HIMP market hog establishments compared to approximately 4.29 hours per shift in the 21 non-HIMP market hog comparison establishments. FSIS also compared the rate of humane handling NRs issued in HIMP market hog establishments and non-HIMP market hog establishments. FSIS inspectors documented fewer humane handling NRs in HIMP market hog establishments than in non-HIMP market hog establishments. From January 2013 through September 2015, FSIS recorded 11 humane handling NRs in five HIMP market hog establishments and 117 NRs in the 21 non-HIMP market hog comparison establishments. It should be noted that none of the 11 NRs recorded in the HIMP establishments documented market hogs being forced to

move faster than normal walking speeds to keep up with faster evisceration line speeds. The data demonstrate that HIMP establishments have higher compliance with humane handling regulations than non-HIMP establishments, and that increased offline inspection may improve compliance with the HMSA.

E. Public Health Benefits Projected From Allocating More Inspection Resources to Food Safety-Related Inspection Activities

1. Market Hog Risk Assessment

FSIS completed a quantitative risk assessment to determine how performing a greater number of offline inspection procedures in market hog slaughter establishments might affect the number of human illnesses from
Salmonella.
These offline inspection procedures primarily involve activities that FSIS inspection personnel perform to verify the effectiveness of establishment sanitary operations and other food safety-related activities. The Hog HIMP Report, discussed above, found that FSIS inspectors performed more offline inspections to verify compliance with sanitation SOP and HACCP regulations in HIMP establishments than they do in non-HIMP establishments. The risk assessment is available for viewing by the public in the FSIS docket room and on the FSIS website at:
http://www.fsis.usda.gov/regulations_&_policies/Proposed_Rules/index.asp.

FSIS developed the market hog risk assessment to help the Agency inform its judgement about the potential impact of changes to FSIS's swine inspection system on risks to public health associated with pork products. To give the Agency the information it needed, the market hog risk assessment focused on three risk management questions:

(1) What predicted effects will various models for increasing the number of offline inspection tasks in non-HIMP establishments have on human salmonellosis rates?

(2) Where can inspectors be relocated to have the most impact toward reducing
Salmonella
prevalence and corresponding human illness?

(3) What is the magnitude of uncertainty about the predicted prevalence of pathogens and corresponding illness effects?

2. Model

FSIS developed a risk assessment model for exploring the potential relationships between current variations in inspection personnel assignments and prevalence of
Salmonella
on hog carcasses, and estimating the subsequent possible reductions in human illnesses attributable to that pathogen. FSIS paired inspection data with
Salmonella
prevalence data for the same establishments and timeframes. As explained above, FSIS based this risk assessment model on the model for the risk assessment that FSIS used to inform the final rule “Modernization of Poultry Slaughter Inspection” (79 FR 49565).

FSIS employed a stochastic simulation model using multi-variable logistic regressions to identify correlations between (1) the numbers of offline food-safety inspection procedures, both scheduled and unscheduled, along with the numbers of non-compliances and scheduled-but-not-completed procedures, and (2) contamination of hog carcasses with
Salmonella.
7

The correlations were used to predict the potential effect that devoting more resources to those offline procedures might have on human illness attributable to the consumption of pork products. Stochastic simulations were used to account for statistical uncertainty in the estimates relating inspection procedures in an establishment to detection of
Salmonella
in samples from hog carcasses. Illness estimates were based on data from the Centers for Disease Control and Prevention (CDC), and uncertainty distributions were used to account for the variability in annual
Salmonella
illnesses and statistical uncertainty about the relationship between the pathogen prevalence levels at the establishments and the corresponding annual number of illnesses that could be attributed to the pathogens.

7
Scheduled procedures are assigned to inspectors at an establishment by PBIS or PHIS. Unscheduled procedures are performed according to inspector needs at an establishment and may include verification checks for fecal, ingesta, and milk, or they may be a response to unforeseen hazards or unsanitary conditions arising from sanitation SOP failures, or the need to verify corrective actions taken under the establishment's HACCP plan.

3. Conclusions of the Market Hog Risk Assessment

The regression analysis of historical data included in the market hog risk assessment showed a statistically significant correlation between (1) increased scheduled and unscheduled offline procedures and decreased scheduled but not performed procedures and (2) reduction in the prevalence of
Salmonella
positive samples. Based on these results, the redeployment of Agency resources to scheduled and unscheduled offline activities, along with a reduction in scheduled but not performed procedures, is likely to contribute to food safety resulting from a lower prevalence of carcasses contaminated with
Salmonella,
which in turn we expect to lead to fewer human illnesses.

In answer to the first risk-management question, the market hog risk assessment results suggest that, depending on how reallocation of inspection activities is implemented, it is likely that changes in offline inspection would not result in an increase in the prevalence of
Salmonella
in hog carcasses, and could even result in a decrease in the prevalence of
Salmonella
in hog carcasses. Specifically, the scenario that simultaneously increases unscheduled and scheduled inspection procedures and decreases scheduled but not performed procedures performs better than scenarios that target the three specific types of procedures one at a time. Under the scenario where all types of procedures are targeted for increase, with resulting decrease in scheduled but not performed procedures and decrease in instances of observed and reported establishment non-compliance, the model estimates an average decrease of 2,533
Salmonella
-related illnesses per year attributable to pork products. FSIS assumes that 65,869 expected annual
Salmonella
illnesses are attributed to consumption of pork products. Thus, a reduction of 2,533 expected
Salmonella
illnesses annually, would reflect a 3.8 percent reduction in
Salmonella
illnesses attributable to pork products.

Responding to the second question, modeling and scenario analysis results suggest that increasing scheduled and unscheduled procedures and decreasing scheduled but not performed procedures would be most effective in reducing pathogen occurrence on carcasses because of consistency in the decision variable parameter's effect across all models. However, each category of offline procedures relates to an individual decrease in
Salmonella
contaminated carcasses which if any one of the three categories or a combination of categories of offline procedures were implemented still would result in decreased contamination, but less than if the scenario combining all three decision variables was adopted.

In answer to the third risk-management question, on the uncertainty of the results for pathogen prevalence and illness reductions, FSIS's modeling approach includes the inherent uncertainty about the relationship between the frequency of inspection activities and pathogen prevalence, about the actual change in future inspection activities that would

likely be observed, and about the representativeness of the rates of human
Salmonella
illnesses attributable to pork products.

III. Proposed NSIS

FSIS is proposing to create a new swine slaughter inspection system, the NSIS, informed by the Agency's experiences under HIMP and NPIS. All establishments that slaughter market hogs would be permitted to operate under the proposed NSIS. Establishments that slaughter classes of swine other than market hogs would be permitted to operate under NSIS under a waiver through the SIP. FSIS would consider the data collected in swine slaughter establishments operating under a SIP waiver to determine whether to expand NSIS to other classes of swine. Establishments that slaughter market hogs and other classes of swine, and that do not want to slaughter other classes of swine under NSIS under a waiver through the SIP, would be permitted to slaughter market hogs under NSIS and to slaughter the other classes of swine under traditional inspection. FSIS would staff such establishments to NSIS and would not add additional staff for traditional inspection; therefore, establishments would need to operate traditional inspection under slower line speeds than they are currently operating to accommodate for the reduced number of inspectors. FSIS seeks comment on the impact of staffing at establishments that slaughter market hogs and other classes of swine and how it will impact their decision to participate in NSIS.

A. Live Market Hog Sorting by Establishment Personnel

Under the proposed NSIS, establishment personnel would be required to sort market hogs and remove for disposal animals unfit for slaughter before they are presented to FSIS PHVs for inspection and final disposition. Establishment personnel would sort animals that appear to be healthy into “Normal” pens and animals that appear to have diseases or abnormal conditions into “Subject” pens. Establishment personnel may also sort and remove animals with localized conditions (
e.g.,
animals with arthritis or abscesses) or animals that do not meet establishment specifications (
e.g.,
hogs that are the wrong size or underweight) to be diverted to another official establishment for slaughter. Establishment personnel would remove and properly dispose of dead and moribund animals and animals suspected of having CNS conditions or pyrexia. Under the proposed NSIS, FSIS inspectors would inspect all animals found by the establishment to be normal at rest, and five to ten percent of those animals in motion. If any animals exhibit signs of condemnable conditions, FSIS inspectors would direct establishment employees to move the animals to the “U.S. Suspect” pens for final disposition by the FSIS PHV. The FSIS PHV would inspect all animals in the “Subject” and “U.S. Suspect” pens and render a final disposition decision. FSIS inspectors would observe establishment employees performing sorting procedures at least twice per shift. During this time, FSIS inspectors would verify that animals that are intended to be disposed of are humanely euthanized and that animals that are intended to be diverted to another official establishment are eligible for transport. FSIS inspectors also would conduct HACCP verification tasks in PHIS at least twice per shift to verify that establishments meet the regulatory requirements found in 9 CFR 417 for implementation, monitoring, recordkeeping, prerequisite programs (when applicable), and corrective actions. Under the proposed rule, if any market hogs become non-ambulatory disabled after ante-mortem inspection, establishments would be required to move them to the “Subject” pens for re-inspection by FSIS PHVs. All sorting would be a function of the establishment's HACCP plan or pre-requisite program. Because establishments operating under the proposed NSIS would be required to sort and remove market hogs that are unfit for slaughter before FSIS ante-mortem inspection, FSIS is proposing that establishments under the proposed NSIS address, as part of their HACCP system, procedures for sorting animals showing signs of diseases or abnormalities from healthy animals. These procedures must cover establishment sorting activities for dead and moribund swine and swine suspected of having CNS conditions or pyrexia.

FSIS also is proposing to require that establishments immediately notify FSIS inspectors in the rare circumstance that they suspect animals of having notifiable or foreign animal diseases during sorting activities. For example, establishments may suspect that market hogs have notifiable or foreign animal diseases if they observe animals with abnormal lesions or behavior, or an abnormal change in the amount of animals that arrive to the establishment dead. Notifiable diseases are those that are designated by the World Animal Health Organization (Office International des Epizooties or OIE). The list of notifiable diseases includes anthrax, cysticercosis, scabies, bovine tuberculosis, myiasis (screwworm), and vesicular diseases. Of these diseases, anthrax, cysticercosis, and bovine tuberculosis are transmissible to humans. The complete list is available on OIE's website at
http://www.oie.int/en/animal-health-in-the-world/oie-listed-diseases-2016/.
FSIS would report any animal disease issues to the USDA Animal and Plant Health Inspection Service (APHIS).

Under the proposed NSIS, FSIS would maintain its zero tolerance for market hogs exhibiting signs of moribundity, CNS conditions, and pyrexia. Market hogs exhibiting signs of these generalized diseases or conditions, if not sorted and removed by the establishment before ante-mortem inspection, would be condemned by FSIS PHVs, as under the existing regulations (9 CFR 309.3). FSIS PHVs would issue an NR for every animal exhibiting signs of moribundity, CNS conditions, or pyrexia found by the FSIS inspector after the establishment sorting step is completed.

Additionally, under the proposed NSIS, FSIS would maintain its zero tolerance for violative levels of chemical residues. Establishments would be required to address chemical hazards through their HACCP program including preventing animals with violative levels of chemical residues from being presented for slaughter. FSIS inspectors would continue to select animals at post-mortem and perform chemical residue sample collection and testing procedures in accordance with FSIS Directive 10,800.1, Residue Sampling, Testing and Other Verification Procedures under the National Residue Program for Meat and Poultry Products (available on FSIS's website at
http://www.fsis.usda.gov/wps/wcm/connect/147066f0-564c-4590-b36f-97ffc5ab9797/10800.1.pdf?MOD=AJPERES
).

Under the proposed NSIS, establishment personnel would be required to identify carcasses of market hogs sorted and removed by establishment employees before FSIS inspection and intended for disposal and destruction with a unique tag, tattoo, or similar device. Establishment personnel also would be required to immediately denature all carcasses and parts removed as unacceptable by plant sorters on-site, even if establishments have tanking facilities, to ensure that the carcasses and parts are properly disposed of and never enter commerce. Under the proposed NSIS, establishment personnel would be required to maintain records to

document the number of animals and carcasses and parts sorted and removed by establishment personnel per day. These records and procedures would be subject to daily review by FSIS inspectors. Under NSIS, FSIS inspectors would document in PHIS the total number of animals that the establishment employees have sorted and removed per day. Under the proposed rule, FSIS would still direct the application and removal of “U.S. Condemned” tags to animals condemned during ante-mortem inspection. FSIS would also continue to enter each and every “U.S. Condemned” tag into PHIS. However, FSIS inspectors should be able to complete these tasks faster because they would be presented animals that have been sorted by establishment employees and are thus more likely to pass ante-mortem inspection and not have condemnable conditions.

In addition to the total number of animals sorted and removed by establishment personnel per day before FSIS ante-mortem and post-mortem inspection, FSIS is requesting comments on whether or not the Agency should require establishments under NSIS to specify in their records the reason that the animals were removed from slaughter, including animals sorted and removed because they were dead on arrival or suspected of having CNS conditions, pneumonia, pyrexia, septicemia, erysipelas, or tuberculosis (
e.g.,
20 sorted and removed; 10 pneumonia, 10 dead on arrival) and how this information should be collected. Under traditional inspection, FSIS inspectors record similar condemnation information into PHIS for APHIS' swine slaughter condemnation monitoring system; however, this information is not being collected under HIMP. APHIS Veterinary Services (VS) uses this type of data to monitor changes in the rate or count of swine condemnations by swine type (market, roaster, sow, and boar) and by selected condemnation categories (
e.g.,
central nervous system disorders, dead on arrival, pneumonia, pyrexia, septicemia, erysipelas, and tuberculosis). APHIS conducts weekly monitoring to compare baseline (expected) condemnation counts by condemnation category to current weekly counts to identify noteworthy increases (signals) in condemnations in near-real time. APHIS produces a weekly report, and shares it with the National Pork Board to identify any noteworthy increases in condemnations which could indicate the emergence of disease and may warrant further investigation. FSIS and APHIS recognize that “presumptive diagnoses” by establishment personnel under the NSIS may not be as accurate as condemnation information entered by an FSIS PHV under traditional inspection. However, FSIS and APHIS believe that the self-reported information may still be useful and significant in monitoring disease conditions in the United States.

B. Post-Mortem Carcass Sorting by Establishment Employees and Online Carcass Inspection

Under the proposed NSIS, establishment personnel would be required to sort carcasses and parts and trim dressing defects and contamination (
e.g.,
hair, bruises, feces, ingesta, and milk) before the carcasses and parts are presented to an FSIS online inspector for post-mortem inspection. Establishment personnel also would be required to mark with ink, or otherwise identify, localized pathological defects intended for removal under FSIS supervision (
e.g.
localized nephritis and localized arthritis) and carcasses and parts intended for disposal under FSIS supervision (
e.g.,
carcasses and parts with malignant lymphoma). Under the proposed NSIS, the head, and viscera of each hog must be handled in a way as to identify them with the rest of the carcass and as being derived from the particular animal involved, until FSIS's post-mortem inspection of the carcass and parts thereof have been complete. FSIS would not complete an inspection of the carcass if the head or viscera were missing before the final rail, unless the head or viscera were properly disposed of under FSIS supervision. Consistent with traditional inspection, only FSIS inspectors would be authorized to condemn carcasses and parts.

Carcasses and parts contaminated with fecal material, ingesta, or milk or that exhibit signs of septicemia, toxemia, pyemia, or cysticercosis during post-mortem examination are likely to contain infectious agents, such as bacteria, virus, richettsia, fungus, protozoa, or helminth organisms, which can be transmitted to humans. For this reason, they present a food safety risk if they are permitted to enter the cooler. Therefore, FSIS is proposing that establishments under the new system address, as part of their HACCP systems, procedures for ensuring that carcasses and parts contaminated with fecal material, ingesta, or milk or affected by septicemia, toxemia, pyemia, or cysticercosis are trimmed or identified by the establishment before they are presented to the FSIS carcass inspector and disposed of under FSIS supervision. These procedures must cover establishment sorting activities for these conditions.

Under this proposal, FSIS would maintain its zero tolerance for carcasses and parts contaminated by fecal material, ingesta, or milk, or affected by septicemia, toxemia, pyemia, or cysticercosis. If FSIS online inspectors discover a carcass contaminated by fecal material, ingesta, or milk, they would stop the line for carcass reexamination and trimming by the establishment unless the establishment elected to provide a rail-out loop to rail contaminated carcasses offline for reexamination, trimming, and positioning back on the line for reinspection, consistent with the existing regulations (9 CFR 310.17 and 310.18) and FSIS Directive 6420.2,
Verification of Procedures for Controlling Fecal Material, Ingesta, and Milk in Slaughter Operations
(available on FSIS's website at
http://www.fsis.usda.gov/wps/wcm/connect/478aca76-37c5-4dc3-9925-1556402d8daf/PHIS_6420.2.pdf?MOD=AJPERES
). An NR would be issued by the FSIS offline inspector at or after the final rail for every carcass contaminated by fecal material, ingesta, or milk. FSIS online inspectors would also stop the line if they discover carcasses exhibiting septicemia, toxemia, pyemia, or cysticercosis, as under the existing regulations (9 CFR 311.16 and 311.17). The carcasses would be retained for FSIS PHV disposition. An NR would be issued by the PHV for every carcass affected by septicemia, toxemia, pyemia, or cysticercosis that reaches the online carcass inspection station. Moreover, because establishments would be required to address these food safety hazards in their HACCP systems, the Agency continuously would assess the effectiveness of an establishment's procedures for ensuring that carcasses are prevented from becoming contaminated with fecal material, ingesta, or milk, and that carcasses affected by septicemia, toxemia, pyemia, or cysticercosis do not reach the final FSIS inspection station.

FSIS is not proposing to prescribe specific sorter training or certification to give establishments operating under the NSIS the flexibility to select the training program that would best assist them to meet the requirements of this proposed rule. However, the Agency has developed a draft guidance document to assist establishments in training their sorters should this rule become final. The draft guidance is based on the training that FSIS provides to online inspection personnel that are responsible for identifying these non-food safety defects on carcasses and

parts under traditional inspection. FSIS has posted this draft compliance guide on its web page (
http://www.fsis.usda.gov/wps/portal/fsis/topics/regulatory-compliance/compliance-guides-index
) and is requesting comments on the guidance.

FSIS believes 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 proposed NSIS, if sorters do not make these decisions correctly, FSIS inspection personnel would take appropriate action such as stopping the line, issuing NRs, and directing the establishment to reduce the line speed. FSIS would thereby ensure that the establishment is able to maintain process control as evidenced by preventing fecal contamination and meeting microbial performance measures, that the establishment sorters are able to successfully perform their duties, and that the FSIS online inspectors are able to conduct a proper food safety inspection.

Establishments that operate under the proposed NSIS would have greater flexibility over their production process. For example, establishments operating under the proposed NSIS would have the flexibility to reconfigure lines if they decided to change the way that the head, viscera, and carcasses are presented to FSIS inspectors to improve ergonomics and process control and to maintain optimum line speed. FSIS would still inspect the head, viscera, and carcass of each animal. However, under the proposed NSIS, establishments may reconfigure their lines so that they present a ready-to-inspect head, viscera, and carcass for FSIS post-mortem inspection in one location or separately in two or three locations. FSIS would assign one to three inspectors to conduct online inspection activities, depending on need and line configuration. These inspectors would also rotate to conduct offline inspection activities. FSIS would assign one online inspector only if the Agency had the data and experience (including processes and procedures) to ensure that one inspector is able to conduct all online post-mortem inspection activities. Under the proposed NSIS, all establishments with fewer than three inspection stations would be required to provide a mirror at the carcass inspection station in accordance with 9 CFR 307.2 (m)(6) so that the inspector standing at the inspection station can readily view the back of the carcass for evidence that could impact food safety.

Under NSIS, as under HIMP, establishment sorters would be required to incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases (
e.g.,
Mycobacterium Avium) as part of their sorting activities before FSIS post-mortem inspection. FSIS is requesting comments on whether or not the Agency should allow establishments that operate under the proposed NSIS to use discretion when deciding, on a lot-by-lot basis, whether or not to incise mandibular lymph nodes and palpate the viscera to detect the presence of animal diseases (
e.g., M. Avium
) if they submit documentation to FSIS supporting that the presence of M. Avium is not likely to occur, such as records documenting their on-farm controls. In the last 10-15 years, industry led initiatives like the Pork Quality Assurance Plus certification program (
http://www.pork.org/pqa-plus-certification
) and the Common Industry Audit (
http://www.pork.org/common-industry-audit
) have improved biosecurity practices which not only reduce disease spread but also address risk factors for
M. Avium
such as exposure to birds.
8 9

Because on-farm practices have improved, the prevalence of
M. Avium
in U.S. swine is very low. After reviewing PHIS condemnation data from 21 large market hog establishments from 2012 through 2015, FSIS found that only 0.9 percent of all condemnations are due to
M. Avium.
The animal disease
M. Avium
does not present a food safety concern, and can be detected visually by inspectors.

8
United States Department of Agriculture, Animal and Plant Health Inspection Service. (2008). National Animal Health Monitoring System Swine 2006, Part IV: Changes in the U.S. Pork Industry, 1990-2006. Retrieved from
https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2006/Swine2006_dr_PartIV.pdf.

9
United States Department of Agriculture, Animal and Plant Health Inspection Service. (2015). National Animal Health Monitoring System Swine 2012, Part 1: Baseline Reference of Swine Health and Management in the United States, 2012. Retrieved from
https://www.aphis.usda.gov/animal_health/nahms/swine/downloads/swine2012/Swine2012_dr_PartI.pdf.

Moreover, Denmark and the Netherlands already conduct alternative post-mortem visual inspections and allow establishments to use discretion when determining, on a lot-by-lot basis, whether or not to incise lymph nodes and palpate the viscera. Under the FMIA and the regulations that implement it, meat and meat products imported into the United States must be produced under standards for safety, wholesomeness, and labeling accuracy that are equivalent to those of the United States (21 U.S.C. 620). FSIS has reviewed Denmark's and the Netherlands' market hog slaughter inspection systems and found them to be equivalent to the United States' market hog slaughter inspection system. FSIS determined that visual post-mortem inspection will still allow veterinary inspectors to palpate and incise lymph nodes and organs (as occurs in traditional inspection) at their discretion. Each herd of hogs that arrives at establishments to be slaughtered is accompanied by historical “Supply-Chain Information,” which consists of paperwork that documents the health status and history of each herd, complete traceback information, as well as details about the originating farm (
e.g.,
history of disease, use of medications, and on-farm practices that contribute to maintenance of the herd's health.) FSIS concluded that this documentation, as well as any ante-mortem inspection observances, will be sufficient to inform the veterinary inspector's decision whether or not to perform visual inspection or traditional inspection. Importantly, because lymphatic tissue may be contaminated with pathogens, not incising the lymphatic tissue may reduce contamination of food contact surfaces and other carcasses.

FSIS also is proposing to require establishment personnel to maintain records to document the number of carcasses and parts disposed of by establishment personnel per day as part of their sorting activities. The records would not need to include the number of carcasses condemned by FSIS. These records would be subject to review by FSIS inspectors. Under NSIS, FSIS inspectors would document in PHIS the total number of carcasses and parts sorted and disposed of by plant employees per day. FSIS inspectors would continue to enter dispositions for each and every carcass condemned by FSIS into PHIS.

C. Offline Verification Inspection

In addition to the online inspectors performing carcass inspection, FSIS is proposing that up to two inspectors be assigned for each evisceration line per shift to conduct offline verification activities in establishments operating under the proposed NSIS. Inspectors conducting offline inspection activities would rotate with the inspectors conducting online inspection activities. FSIS is also proposing to assign one PHV to make carcass and parts dispositions.

As in HIMP, offline inspectors under the new inspection system would conduct food safety related inspection activities and would continuously

monitor and evaluate establishment process control. Offline inspectors would conduct inspection activities including HACCP, sanitation SOP, and other prerequisite program verification procedures; verification checks for septicemia, toxemia, pyemia, cysticercosis, fecal material, ingesta, or milk contamination; checks to verify and ensure that sanitary dressing requirements are being met; and ante-mortem inspection. Under this proposed rule, offline inspectors would also conduct more humane handling verification tasks than are conducted under traditional inspection. The offline verification inspectors would work with the Inspector-In-Charge (IIC) to ensure that food safety related or non-food-safety related conditions do not impair the online carcass inspectors' ability to conduct the inspection of each head, viscera, and carcass or would notify the IIC whenever circumstances indicate a loss of process control. When circumstances indicate a loss of process control, the IIC will be authorized to require that the establishment slow the evisceration line speed.

D. RTC Pork Product

As discussed above, under HIMP, OCP standards are non-food safety standards concerned primarily with diseases of no public health significance and carcass processing defects. Data collected from market hog establishments operating under HIMP show that from CY 2012 through 2013, HIMP establishments maintained OCP defect levels that average about half the corresponding OCP performance standards derived from the performance of non-HIMP establishments. Thus, the data show that establishments operating under the HIMP system do exceptionally well in controlling OCP defects.

Accordingly, FSIS is not proposing OCP requirements as a condition for establishments to participate in the proposed NSIS. Under this proposal, establishments operating under NSIS would be allowed to implement the process controls that they have determined will best allow them to produce an RTC pork product that is wholesome and not adulterated. The new proposed definition of RTC pork product is any slaughtered pork product free from bile, hair, scurf, dirt, hooves, toe nails, claws, bruises, edema, scabs, skin lesions, icterus, foreign material, and odor which is suitable for cooking without need of further processing.

Under the proposed NSIS, establishments would have the flexibility to design and implement measures to address OCP defects that are best suited to their operations. They would also be responsible for determining the type of records that will best document that they are meeting the RTC pork product definition. The records would be subject to review and evaluation by FSIS inspectors.

For their record reviews, FSIS inspectors would verify that establishments operating under the proposed NSIS have written criteria for determining whether carcasses meet the RTC definition and that they are documenting that the pork products resulting from their slaughter operations meet these criteria before packaging or further processing that would conceal a defect. Records that would meet the proposed requirements include:

• The records system that the establishment uses to document that it is producing RTC pork. 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 record the results at a pre-evisceration 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-evisceration location and at least twice per shift per line for post-chill location.

• The definitions of the OCP non-conformances or processing and trim defects for which the establishment is monitoring. For example, the establishment may be monitoring carcasses for processing and trim non-conformances as specified 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 would use 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 trim and processing defect levels for the HIMP OCP performance standards, or it may determine the upper limits for non-conformances using a statistical process control program.

• The corrective actions that the establishment would take if the levels of defects and non-conformances exceed its evaluation criteria for RTC pork.

Under this proposed rule, pork carcasses that meet the OCP performance standards under HIMP would be considered “suitable for cooking without the need for further processing,” and as such, meet the RTC pork product definition. Therefore, establishments operating under the NSIS that adopt the OCP HIMP performance standards as their criteria for determining whether they are producing RTC pork product would 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 HIMP OCP standards would be required to have documentation to demonstrate how they will use these criteria to demonstrate that the products resulting from their slaughter operations meet the RTC pork product definition.

In addition to record reviews, FSIS inspectors would verify that establishments operating under the NSIS are producing RTC pork product 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 pork product. 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 would 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 pork that does not meet the RTC definition, the IIC would be authorized to take appropriate action to ensure that the establishment remedies the defects, including requiring that the establishment slow the evisceration line speed.

E. Line Speeds Under NSIS

Based on FSIS's experience under HIMP, the Agency is proposing to allow

establishments operating under NSIS to determine their own evisceration line speeds if Agency personnel verify that process control is maintained. The maximum line speed under the existing regulations for market hogs is 1,106 head per hour (hph) with seven online inspectors. Experience from the HIMP pilot shows that HIMP establishments operate with an estimated average line speed of 1,099 hph, and that the line speeds varied from 885 hph to 1,295 hph (under waiver). Thus, although they are authorized to do so, market hog HIMP establishments do not operate at line speeds that are significantly faster than the current maximum line speeds for market hogs. Establishments determine their line speeds based on their equipment, animal size and herd condition, 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 the establishments hire and train to perform sorting activities. If FSIS finalizes the proposed NSIS, establishments choosing to operate under the NSIS will likely determine their line speeds based on the same factors that establishments considered when setting line speeds under HIMP for the past 16 years.

Establishments operating under HIMP have demonstrated that they are capable of consistently producing safe, wholesome, and unadulterated pork products while operating at these line speeds. Moreover, they have consistently met pathogen reduction and other performance standards when operating at the line speeds they established under HIMP. The proposed new inspection system was informed by the Agency's experience under HIMP and, as discussed later in this document, also incorporates additional measures that will apply to all swine slaughter establishments. These measures, which include testing for microbial organisms at pre-evisceration and post-chill, are designed to ensure that establishments maintain process control.

FSIS recognizes that evaluation of the effects of line speed on food safety should include the effects of line speed on establishment employee safety. FSIS compared in-establishment injury rates between HIMP and traditional establishments from 2002 to 2010. The preliminary analysis shows that HIMP establishments had lower mean injury rates than non-HIMP establishments. The analysis uses injury rate data by occupational injury estimates that are derived from the BLS annual Survey of Occupational Injuries and Illnesses (SOII)
http://www.bls.gov/iif/data.htm
). The survey captures data from Occupational Safety and Health Administration (OSHA) logs of workplace injuries and illnesses maintained by employers. Fifty-six FSIS inspected market hog slaughter establishments voluntarily submitted injury rate data to OSHA (approximately nine percent of all market hog slaughter establishments). From these 56 establishments, 27 low volume establishments were excluded, leaving 29 plants (5 HIMP and 24 Traditional). The low volume plants were excluded to provide a better comparison group of traditional plants because all HIMP plants are high volume plants. The results showed HIMP plants had a lower mean number of injuries using three OSHA injury rate measures: Total Case Rate (TCR), Days Away Transferred Restricted (DART), and Days Away From Work (DAFW). However, FSIS realizes that factors other than line speed may affect injury rates (
e.g.,
automation and number of sorters per line).

FSIS is requesting comments on the effects of faster line speeds on worker safety. Specifically, FSIS is requesting comments on whether line speeds for the NSIS should be set at the current regulatory limit of 1,106 hph or some other number. The Agency is also interested in comments on the availability of records or studies that contain data that OSHA or the National Institute for Occupational Safety and Health (NIOSH) may be able to use in analyzing the effects of increased line speed on the safety and health of employees throughout the establishme

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Source: Frix Law Library, https://www.frixlaw.com/law-library/documents/fr%3A2018-01256. Public record. Not legal advice.